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					Technical Assistance in the field of Chemicals                TeACH




                   Institutional and Legal
                   Framework for Chemicals
                   Management
                   agement
                   Report on the establishment of an Institutional Framework for
                   Chemicals Management in Turkey



                   Final




                   Client:
                   Ministry of Environment & Forestry

                   Prof. Mustafa Öztürk
                   Ankara


                   Teach Consortium




Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals           TeACH
Resume




Project title         :   TeACH Institutional Framework report

Project number            197928

Document number       :
Revision                  1
                      :
Date                      January 12, 2007
                      :




Author(s)                 Ferd Schelleman/Sema Alpan Atamer/Gülün Egeli
                      :
e-mail address

Checked by:               Gulun Egeli
                      :
Approved by:              Ferd Schelleman
                      :




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Institutional Framework for Chemicals Management
Technical Assistance in the field of Chemicals                                              TeACH

Table of Contents



1        Introduction ............................................................................................ 6

2        Existing Legal Framework ..................................................................... 7

3        Institutional review .............................................................................. 14
3.1      Ministry of Environment and Forestry (MoEF) ................................... 14
3.2      Ministry of Health (MoH) .................................................................... 21
3.2.1    Refik Saydam Hygiene Center............................................................. 23
3.3      Ministry of Labour and Social Security (MLSS) ................................. 24
3.3.1    Occupational Health and Safety Center (ISGUM)............................... 27
3.4      Ministry of Agriculture and Rural Affairs (MARA)............................ 27
3.4.1    Agricultural Pest Control Central Research Institute (ZMMAE) ........ 29
3.5      Energy Market Regulatory Authority (EMRA) ................................... 29
3.6      Ministry of Industry and Trade ............................................................ 31
3.7      Tobacco, Tobacco Products and Alcoholic Beverages Market
         Regulatory Authority (TAPDK) .......................................................... 32
3.8      Other pertinent stakeholders ................................................................ 32
3.8.1    State Planning Organisation ................................................................. 32
3.8.2    Undersecreteriat for Foreign Trade ...................................................... 33
3.8.3    Undersecretariat for Customs............................................................... 36

4        Institutional and Legal Analysis with Respect to EU Requirements .. 38
4.1      Industrial substances and preparations ................................................. 38
4.1.1    Institutional analysis ............................................................................ 38
4.1.2    Legal Analysis ..................................................................................... 41
4.2      Asbestos ............................................................................................... 42
4.2.1    Institutional analysis ............................................................................ 42
4.2.2    Legal analysis....................................................................................... 45
4.3      Ozone Depleting Substances................................................................ 46
4.3.1    Institutional analysis ............................................................................ 46
4.3.2    Legal analysis....................................................................................... 48
4.4      Biocidals .............................................................................................. 48
4.4.1    Institutional analysis ............................................................................ 48
4.4.2    Legal analysis....................................................................................... 51
4.5      Cosmetics ............................................................................................. 52
4.5.1    Institutional analysis ............................................................................ 52
4.5.2    Legal analysis....................................................................................... 54
4.6      Plant Protection Products ..................................................................... 54
4.6.1    Institutional analysis ............................................................................ 54
4.6.2    Legal analysis....................................................................................... 56
4.7      Petroleum Products .............................................................................. 57
4.7.1    Institutional analysis ............................................................................ 57
4.7.2    Legal analysis....................................................................................... 59
4.8      Methyl alcohol and Ethyl Alcohol ....................................................... 60
4.8.1    Institutional analysis ............................................................................ 60
4.8.2    Legal analysis....................................................................................... 63


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4.9      Chemicals which can be used for manufacturing chemical weapons .. 64
4.9.1    Institutional analysis ............................................................................ 64
4.9.2    Legal analysis....................................................................................... 66

5        Requirements and Conditions for the Institutional Framework ........... 68
5.1      Requirements for all options ................................................................ 68
5.2      Boundary conditions ............................................................................ 69

6        Institutional Framework Options ......................................................... 70
6.1      Option 1: The MoEF-option ................................................................ 74
6.2      Option 2: The TCA-option................................................................... 77
6.3      Option 3: The NEA-option: ................................................................. 78
6.4      Option 4: The TCBPA-option .............................................................. 80
6.5      Main problems and advantages of the different options ...................... 81

7        Legal gap analysis with respect to EU directives................................. 86

8        Conclusions and Recommendations .................................................. 186




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Appendices:




Appendix I:   Legal gap analysis with Respect to EU Directives

Appendix II: Chemicals Governed by Different Institutes and by Different
             Legislation




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1        Introduction




This report will detail how the EU requirements in the field on chemicals man-
agement can be implemented through an effective institutional framework in Tur-
key. The legal framework will be developed in parallel with the institutional set-
ting as the legal system must represent and support the different institutions. This
relates to all administrative institutions involved:
    1. Ministry of Environment and Forestry;
    2. Ministry of Health;
    3. Ministry of Labour and Social Security;
    4. Ministry of Agriculture and Rural Affairs;
    5. Under-secretariat for Foreign Trade;
    6. Under-secretariat for Customs
    7. Other government institutions as mentioned in Chapter 3 on Institutional
         review.

A provisional implementation needs assessment has been prepared as part of the
project ―Analysis of Environmental Legislation for Turkey‖, demonstrating that
considerable efforts have to be undertaken to strengthen the regulatory cycle in
relation to the chemicals sector (policy development, legislation drafting, licens-
ing, monitoring and enforcement) and to set the institutional framework for im-
plementation. In addition, considerable capacity building will be required to all
relevant authorities and institutions that will have a future role in the implementa-
tion of the aforementioned EU Directives on chemicals.

The first legislation regarding the management of industrial chemicals was put
into effect in 1993. However, since 1993 no systematic market control of the im-
plementation of the regulations takes place by the MoEF regarding the industrial
chemicals, because of insufficient number of qualified experienced staff and lack
of certified appropriate laboratories and gaps in the legislation concerning moni-
toring and inspection.

The institutional setting proposed will therefore address the full regulatory cycle
and take into account the way Turkish government institutions normally operate.
The boundary conditions that have to be met are presented in Chapter 2.

Chapter 4 then presents three options for the governmental organization of
chemicals management in accordance with the EU requirements for first discus-
sions.




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2 Existing Legal Framework




The legal framework for dangerous substances and preparations consists mainly
of the Environmental Protection Law no. 2872 of 9 August 1983, as amended and
completed, the Dangerous Chemicals Regulation of 11 July 1993 (Official Ga-
zette No.21634/1993), with subsequent amendments, and the Communiqué on the
Procedure for the Preparation of the Safety Data Sheet (Official Gazette no.
24692, 2002).

In April 2006 a new amendment was brought to Environment Law no. 2872 of 9
August 1983 by Law no. 5491 of 26 April 2006. Art. 2 of Law no. 5491 contains
a definition of ‗dangerous chemicals‘ (any chemical substance and product which
has physical, chemical and/or biological adverse effects and thus lead to the im-
pairment of ecological balance and the natural structure of human beings and
other living beings). Art. 13, which deals both with dangerous chemicals and
hazardous waste, establishes the basis for subsequent regulation of dangerous
chemicals, including classification, packaging, labelling or risk assessment, upon
consultation with other relevant stakeholders. It is also mentioned that the enter-
prises or institutions which placed dangerous chemicals on the market in violation
of the regulation are responsible for the collection and disposal of materials con-
taining dangerous chemicals.

As regarding the inspection, MoEF shall be authorized to inspect and, where nec-
essary, MoEF may assign this power to special provincial administrations, mu-
nicipalities with environmental inspection units, etc. (Art. 9). Law 5491 also pre-
scribes administrative fines for non-observance of the dangerous chemicals re-
gime (Art. 14), which shall be applied by MoEF or the institutions and authorities
to which the inspection power is assigned by MoEF (Art. 16). Judicial penalties
are foreseen (Art. 18) for providing incorrect and misleading information (pun-
ished by sentence to prison). In conclusion, the Environmental (framework) Law
does not contain contradictory provisions with the EU Chemicals Directives and
allows secondary legislation to be adopted for further regulation.

The existing Dangerous Chemicals Regulation, amended in 2001, (Official
Gazette no. 24379/2001) consists of 9 main parts as follows:
       Aim, Scope, Legal Basis and Definitions;
       Import Control of Chemical Substances: obligation to observe the Regu-
        lation for those dealing with dangerous chemicals; prohibition to aban-
        don dangerous chemicals as a pile to the environment; obligation of the
        manufacturer and importer to notify upon request of the Ministry harmful
        chemical substances and products or to submit additional information,
        etc;
       Responsibilities of Distributors and Enterprise Managers;



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        Rules for Labelling;
        Packaging, Storage and Transport;
        Duties of the Authority – (MoEF): evaluation of notifications, inspection
         of manufacturers, importers & distributors, control of actual import and
         inspection of the market;
        Limitations (asbestos, PCB, PCT).

Other Provisions, among which Articles 44-45 refer to the Chemicals Safety
Commission to be established by the Ministry of Environment and Forestry with
the main purpose to ensure the implementation of the Regulation, but also to deal
with updating required provisions by providing national and international infor-
mation exchange and to inform opinion for satisfaction of deficiencies; in case of
necessity to perform as an adviser; to deal with the to do with required studies
concerning the accidents caused by chemical substances.

Annexes - Dangerous Substances List (Annex I), Information Form for the notifi-
cation by Manufacturers or Importer (Annex II), Danger Symbol and Signs for
the Dangerous Substances and Preparations (Annex III), Packaging Classes (An-
nex IV), Carcinogenic Substances List (Annex V), Risk Phrases and Safety
Phrases for Labelling of the Dangerous Substances and Preparations (Annex VI),
Classification related with Storage (Annex VII).

On the overall, the declared scope of the Regulation covers provisions, proce-
dures and principles related to: determination, classification, labelling and pack-
aging of dangerous chemicals; production, storage, transportation activities of
dangerous chemicals; usage and placing on the market of dangerous chemicals
and dangerous goods; importing and exporting of chemicals; dealing with dan-
gerous chemicals and dangerous goods; market surveillance and inspection of
chemicals and dangerous goods; and finally preparation and distribution of Safety
Data Sheets.

The Dangerous Chemicals regulation transposes some definitions (Art. 4), Safety
Data Sheet (Art. 12 and 22), symbols and indication of danger (Annex IV, nature
of special risk attaching to dangerous substances (Annex VII), safety advice con-
cerning dangerous chemical substances (Annex VII).

The Dangerous Chemicals Regulations transposes partially the objectives and
scope (Art.), packaging (Art. 23-27), labelling (Art. 16-18 and 20), implementa-
tion of labelling requirements (Art. 16-18 and 20), exemption from labelling re-
quirements (Art. 16-18 and 20), and list of dangerous substances (Annex I).

The gaps in the Dangerous Chemicals Regulation compared to the Key Chemicals
Directives (Dangerous Substances Directive 67/548/EEC and Dangerous Chemi-
cals Directive 99/45/EC) have been identified to be as follows: (a) definitions
(new and existing substances, notification, EINECS, ELINCS); (b) some provi-
sions on information exchange, risk assessment, classification, notification, con-
fidentiality of data, assessment properties of substances, list of existing and new
substances); (c) some annexes of Directive 67/548/EEC (Annex V, VI, VII, IX)
all annexes of Directive 99/45/EC; (d) the dangerous chemicals list arranged ac-
cording to Annex I of Directive 67/548/EEC.




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Concerning the risk assessment (RA) for notified new substances, there is no
Turkish Legislation transposing the requirements of the Commission‘s Daughter
Directive 93/67/EEC laying down the principles for assessment of risks to man
and the environment of substances notified in accordance with Council Directive
67/548/EEC.

There are four Implementing Regulations issued by the Ministry of Labour and
Social Security require the employer to carry out a health risk assessment – ac-
cording to in the workplaces where the workers are exposed to asbestos, chemi-
cal agents , carcinogen & mutagen substances, and explosive atmospheres, re-
spectively:
       Implementing Regulation on Health and Safety In Asbestos Related
        Works – the RA will take into consideration the type and physical prop-
        erties of asbestos and the exposure level of workers;
       Implementing Regulation on the Protection of the Health and Safety
        Measures from the Risks Related to Chemical Agents at Work – the
        RA will consider: hazards and harms of the chemical agent to the health
        and safety; SDS provided by the supplier, manufacturer or importer;
        level, type, and duration of exposure; chemical agents amount, frequency
        of use, and conditions of use; occupational exposure limit values and bio-
        logical limit values mentioned in the annexes of the Implementing Regu-
        lation; the effect of preventive measures taken or to be taken; where
        available, previously made health surveillance results.
       Implementing Regulation for the Protection of Workers from the
        Risks Related to Exposure to Carcinogen and Mutagen Substances at
        Work – the RA will be based on working conditions, type and level of
        exposure of the workers to carcinogen and mutagen substances; and
       Implementing Regulation for the Protection Against Risks Of Explo-
        sive Atmospheres – the RA will take into consideration: the possibility
        of an explosive atmosphere forming and its permanency; the presence of
        sources of ignition including static electricity and the likelihood to be-
        coming active and effective, the installations, substances used, processes
        and their possible interaction in the workplace, as well as the scale of the
        effect of a potential explosion.

It is mentioned in the Regulations presented above that the risk assessment will
be carried out in compliance with MLSS‘s Implementing Regulation for Occupa-
tional Health and Safety. However, there is no procedure designed for the evalua-
tion of risks to human health.

The MLSS‘s Occupational Health and Safety Implementing Regulation -
published in the Official Gazette no. 25311 of 9 December 2003 - introduces the
measures to improve the occupational safety and health at the workplace, and the
general principles concerning prevention of occupational risks, protection of
health & safety, elimination of risk and accident factors, information and training
of the workers and their representatives on occupational health and safety, consul-
tation of the workers, working conditions of people that need special protection
due to their age, gender and special situations.

In Article 4, risk assessment is defined as the body of studies carried out with the
purpose of determining the hazards present in the workplace or those coming
from outside, the adverse effects these hazards may have on the workers, work-


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place or the work environment and the measures to be taken against these haz-
ards. Also in the same article prevention is defined as comprising all the steps or
measures taken or planned at all stages of work in the undertaking to prevent or
reduce occupational risks. Women, children, elderly, disabled and other sensitive
risk groups must be protected against the dangers that specifically affect them.

Obligations of employers related to the compliance with health and safety provi-
sions are described in Article 6 of this Implementing Regulation. It is stated that
the employer shall take the measures necessary for the safety and health protec-
tion of workers, including prevention of occupational risks and provision of in-
formation and training as well as provision of the necessary organization and
means. The employer shall take necessary measures for avoiding risks, evaluating
the risks, which cannot be avoided, combating the risks at the source. The em-
ployer, taking into account the nature of the activities at the workplace, shall
evaluate the risks to the safety and health of the workers, from the point of view
of the choice of work equipment, the chemical substances or preparations used,
and the fitting-out of workplaces. Subsequent to this evaluation, the preventive
measures and the working and production methods implemented by the employer
must assure an improvement in the level of protection ensured for workers with
regard to health and safety.

Various other obligations of the employer are prescribed in this Implementing
Regulation. In Sub-sections (1) and (2) of Section (a) of Article 9 it is stated that
the employer along with the obligations above shall also carry out the following
provisions:
       The employer shall carry out an assessment of risks to the health and
        safety of workers, including those groups of workers that may be affected
        particularly from those risks, at the workplace;
       Based on the results of the risk assessment, the employer will decide on
        the protective measures to be taken and the protective equipment to be
        used.

The Dangerous Chemicals Regulation (which is a by-law), as amended, trans-
poses Article 27 of the Directive 67/548/EEC dealing with the Safety Data Sheets
(SDS) and some provisions of SDS Directive 91/155/EEC defining and laying
down the detailed arrangements for the system of specific information relating to
dangerous preparations. The Communiqué on the Procedure for the Preparation of
the Safety Data Sheet, 2002 (MoEF) was published to achieve full transposition
of Safety Data Sheet Directive 91/155/EEC. The Ministry of Health makes refer-
ence to the legislation published by the Ministry of Environment and Forestry.

The existing legal framework in Turkey for the two key and two daughter direc-
tives was outlined above and it was pointed out that there is still much to be done
for reaching full transposition. The two extremes of the existing status are the full
transposition of the SDS Directive 91/155/EEC and the inexistence of any legisla-
tion on carrying out risk assessment – either by the Ministry of Environment and
Forestry or other ministries, which will need to amend their legislation in order to
regulate the obligation to carry out RA. In between there is the full range of EC
requirements which will make object of the work carried out under the TeACH
project. The result of this work will be materialised in the establishment of legal
framework dedicated to the four main EU Chemicals Directives. Other legisla-
tions will be in ―stand-by‖, depending on the details established in the future


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chemicals legal framework. Such examples are the Prior Informed Consent pro-
cedure deriving from the Rotterdam Convention - on export and import of dan-
gerous chemicals) or the restrictions to marketing and use of dangerous chemicals
(Directive 76/769/EEC).

The Regulation on Environmental Inspection entered into force by being pub-
lished in the Official Gazette in January 5, 2001. The purpose of this Regulation
is to regulate the procedures and principles for environmental inspections for
environmental protection; from establishments of facilities, operation and until
final disposal of waste produced in any stage of production.

The scope of the Regulation consists of the implementation issues related to envi-
ronmental inspection, qualities of environmental inspectors, and legal responsi-
bilities of persons performing concerned activities, as well duties and authorities
of inspecting bodies.

The competent authority to carry out environmental inspection is the MoEF
through its Directorate General for Protection and Inspection of Environmental
Pollution. The units authorised with inspection in the MoEF are as follows:
       Chairmanship of Inspection Board;
       Directorate General for Protection and Inspection of Environmental Pol-
         lution;
       Directorate General for Environmental Impact Assessment and Planning;
       Provincial Directorates of Environment and Chairmanship of Special
         Environmental Protection Organisation present in special environmental
         protection provinces according to the Article 25 of the Decree Law con-
         cerning the Establishment of the Special Environmental Protection Or-
         ganization No. 383.

For determining the enterprises to be inspected, the annual inspection program is
prepared. In cases of accident, denunciations or complaints or when inspection
out of the program deemed necessary by the MoEF, assignments are carried out
separately from the annual inspection program.

Evaluation of compliance with the points requiring measurements in the envi-
ronmental report is performed according to the results of measurement to be made
by the private and public institutions and enterprises accredited.

Ceasing of activities of the organisations and enterprises failing to perform the
legal liabilities stated in Article 10 of the Environmental Law is subjected to the
provisions of Article 28 of the Environmental Impact Assessment Regulation
published in the Official Journal dated 23.06.1997, No. 23028.

The staff of the MoEF in charge with the inspection prepares the inspection report
in one month following the date of the completion of the inspection.

Other relevant legislation: The Law Relating to the Preparation and Imple-
mentation of the Technical Legislation on Products no. 4703/2001 (published
in the Official Gazette 24459/2001).

This law is a framework law, which transposes the EU General Product Safety
Directive, aims to lay down the principles and the procedures for the placing on


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the market of the products, the obligations of the producers and the distributors;
conformity assessment bodies; notified bodies; market surveillance and inspec-
tion; prohibition of the placing on the market of the products, withdrawal and
destruction of the marketed products and the notifications relating to these ar-
rangements.

According to the article 4 of the law, the competent authorities shall prepare tech-
nical regulations on the products. Also according to Article 10 of the law, market
surveillance and inspection shall be carried out in accordance with the procedures
and principles laid down in the relevant technical regulations and/or this law and
the regulations relating to the implementation of this law. The competent authori-
ties shall determine the required administrative arrangements.

Based on art.14 of the above mentioned law, the Regulation Relating to the
Market Surveillance and Inspection of the Products no. 2001/3529 (published
in the Official Gazette 24643/2002) was issued.

The objective of this Regulation is to lay down the principles and the procedures
for the surveillance and inspection of the conformity of a product with the rele-
vant technical regulation and with the requirements related to safety at the stage
of placing on the market. This Regulation contains the provisions relating to:
       The preparation of the technical regulations;
       The principles concerning the conformity of the products with technical
        regulations and product safety;
       The obligations of the producers and the distributors at the stage of plac-
        ing the product on the market;
       The principles and the procedures for market surveillance and inspection;
       The tasks and the obligations of the public authorities;
       The establishment of the Market Surveillance Coordination Board; the
        tasks and working principles and procedures of the Board.

Law on Consumer Protection no. 4077 with its further amendments: the main
objective of this law is to take measures aimed at protecting the health, safety and
economic interests of consumers in line with the public good, building consumer
awareness, indemnifying losses incurred by consumers and protecting them
against environmental hazards; to promote consumer initiatives aimed at protect-
ing consumer interests and to encourage volunteer organizations aimed at devis-
ing consumer-related policies.

Article 18 mentions the Hazardous and Dangerous Goods and Services, which
requires information and warning measures to be provided, if the goods or ser-
vices offered for the consumer's use endanger or harm a person's physical or men-
tal health or the environment. The information and warning on this issue shall be
added or written, in an easily visible and legible manner, on the goods or in the
user's guide included, for the safe usage of such goods.

Also the provision emphasizes the Ministry of Industry and Trade‘s obligation as
the Ministry is authorized to determine, together with pertinent ministries and
other institutions, which of the goods and services shall contain explanatory in-
formation and warnings, and the form and place of such information and warn-
ings, and announce the same.



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Goods or services offered to the consumer have to comply with the mandatory
technical regulations, including the standards put into mandatory application by
the pertinent ministries after being published in the Official Gazette.
The pertinent ministries shall implement or cause to be implemented inspections
in accordance with such principles. The principles and guidelines relating to the
inspection of goods and services shall be separately established and announced by
each pertinent ministry.

A "Consumer Council" has been set up according to the provisions of this law
under the coordination of the Ministry to search the measures necessary to deal
with consumer problems, needs and interests, convey the views as to the meas-
ures to be taken to solve the problems in line with universal consumer rights, as
well as the views as to the measures to be taken concerning the application of this
Law, to pertinent authorities so that prompt action can be taken. Ministry of Envi-
ronment and Forestry is one of the participants of this Council. A legal gap analy-
sis has been carried out as well with reference to the four directives, which are in
the scope of TeACH Project (see Appendix I). Only Risk Assessment Directive is
left out, since there is not any such legislation to compare with in Turkey and
there is a gap in this sense.




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3 Institutional review




The existing structure of the main government institutions as well as relevant
institutions, which have roles in the management of chemicals are reviewed in
this section. Only the Ministry of Environment and Forestry are responsible for
industrial chemicals. However, some other ministries are responsible for label-
ling, packaging, market surveillance and inspection of other chemicals, for the
same directives prevail. This section depicts the general institutional framework
for the management of chemicals by in large.


3.1       Ministry of Environment and Forestry (MoEF)

The Ministry of Environment was established in 1991. The act on the establish-
ment of the Ministry of the Environment and Forestry adopted in May 2003 (Act
no. 4856) has merged the two existing ministries, namely Ministry of Environ-
ment and the Ministry of Forest. The new act defines the roles and responsibilities
of the Ministry of the Environment and Forestry on the basis of the original acts
on their establishment and reduces the overlaps in the respective responsibilities
and implementation.

The MoEF has the responsibility for coordinating the Environment Chapter of
EU legislation. The general mandates of the MoEF defined in the Organic
Law No. 4856 that can be relevant to the management of chemicals are:
      Setting the environmental standards which are applicable in Turkey;
      Inspecting disposal of pollutants, which can be persistent in air, water
       and soil;
      Issuing guidelines for emergency cases and risk management;
      Establishing laboratories for analysis, control and measurements;
      Ensuring collaboration and cooperation among the institutions and issu-
       ing regulations for setting the principles of cooperation between the line
       ministries;
      Monitoring and inspecting all kinds of activities, which have adverse
       impacts on environment.

In the 2004 Regular Report on Turkey‘s progress towards accession, it has been
noted that “The establishment of an integrated Ministry of the Environment and
Forestry is a positive step in relation to administrative capacity. However, it ap-
pears that this integration has not yet been effective in enhancing implementation.
There are overlaps in competencies between different ministries and institutions,
and therefore further efforts are needed. Special attention should be given to the
administrative set up at different levels of the country under the newly proposed
local administrative reform law. The overall planning, implementation and en-


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forcement of environmental legislation are a major concern. Significant efforts
towards effective implementation of environmental legislation, especially re-
cruitment and training of specialized staff and the purchase of equipment, are
needed”1.

The MoEF has 81 Provincial Directorates, one in each Province. The problem is
the fact that not all Provinces have a functional MoEF office due to lack of the
skilled and experienced staff2.

The organogram of the Ministry of Environment and Forestry is shown in Figure
1. Regarding the management of chemicals, the General Directorate of Environ-
mental Management has the main role.

According to the Organic Law No. 4856, management of chemicals is under the
responsibility of the General Directorate of Environmental Management. All
kinds of measurement, monitoring, analysis, inspections and control regarding
environmental pollution, and inspection of activities which cause environmental
pollution by chemicals, setting limitations and criteria for importing and export-
ing of chemicals, identifying proper economic tools for management of chemi-
cals, are also in the scope of the responsibility of the General Directorate of Envi-
ronmental Management. Moreover setting targets, defining policies, establishing
systems for management of chemicals, preparing emergency plans for chemical
plants, regulating licenses concerning transport of chemicals, detecting sites pol-
luted by chemicals, taking necessary actions to clean up and initiate counter
measures to minimize the impact on the environment and human health are
among the responsibilities of this General Directorate. The organisational chart
of the General Directorate is given in Figure 2.

The MoEF has the main responsibility for the co-ordination of chemicals man-
agement and co-ordination of implementation of international conventions such
as Prior Informed Consent Procedure (PIC) and Persistent Organic Pollutants
(POPs) related with chemicals. The MoEF co-ordinates the activities and makes
harmonization studies under its responsibility in this field through its Chemicals
Management Department, which is one of the units of the General Directorate of
Environmental Management within the structure of MoEF. There are 17 staffs
working in the Chemicals Management Department at present.




1 2004 Regular Report on Turkey’s progress towards accession, EC, 2004
2 Integrated Environmental Approximation Strategy for Turkey, Carl Bro, 2003




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  Counselor                                                                               Inspection
 Of the Ministry                                                                            Board
                                                     MINISTER


  Advisory of                                 UNDERSECRETARY                             Directorate of
  Media and                                                                              Private Office
Public Relations



                                     DEPUTY UNDERSECRETARIES




   Main Services                    Consultation                Auxiliary             Related Institu-
                                     Services                   Services                   tions




                                                                                        General Directorate
     General Directorate           Research Planning and          Department                Of Forest
      Of Environmental              Coordination Board                Of
        Management                                                 Personnel




                                                                 Department of         General Directorate
    General Directorate of                Legal                 Managerial and         of State Meteoro-
    Environmental Impact                 Advisory               Financial Affairs        logical Affairs
         Assessment




                                                                  Information          Authority for Special
     General Directorate                                          Department            Protected Areas
      of Forest Village
          Relations




     General Directorate                                          Secretariat
     of Nature Protection         Permanent Boards                    Of
      and Natural Parks                                            Security




       Department of                   Higher                       Local
      Foreign Relations             Environmental               Environmental
           and EU                       Board                      Boards




         Department of             Environment and                 Central
         Education and                 Forestry                    Hunting
          Publication                   Council                  Commission



                     Figure 1: Organogram of Ministry of Environment and Forestry




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                     Institutional and Legal Framework for Chemicals Management
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There are 3 divisions under the Chemicals Management Department (see Figure 2).
There are 4 staffs working in the Division of Dangerous Chemicals Management.
They are in charge of issuing Control Certificate (for the chemicals in Annex I of
the Communiqué) and Chemical Substances Importation Certificate (for the chemi-
cals in Annex II of the Communiqué) based on the Communiqué of Standardization
for Foreign Trade No. 2006/6. The permits are company specific, not substance
specific. There are about 50 applications annually from importing companies. The
substances or preparations, which are prohibited, to be placed on the market are
listed in Annex III of the Communiqué. The chemicals, which are under control
regarding the environmental protection are listed in Annex I/A and Annex I/B. For
these chemicals, MoEF requires the companies to submit a copy of the label of the
substance/preparation as well as its SDS Form; and issues an ―importer recording
document‖. At the end of each year, the import companies return the ―importer
recording document‖ back to the MoEF about the identity of chemicals and their
imported amounts together with the country of origin, company, accompanied with
actual import documents, including labels, SDS Forms, etc.

MoEF issues Chemical Substances Importation Certificate for importing the sub-
stances listed in Annex II. Division of Dangerous Chemicals Management keeps
records of the imported chemicals and other relevant information about them.

Turkey has signed the Rotterdam Convention on the Prior Informed Consent Pro-
cedure for Certain Hazardous Chemicals and Pesticides in International Trade but
not has ratified it yet. Therefore, there is not any national legislation regarding
PIC procedure. However, when there is an application from the EU Member
States, the MoEF acts as the Competent Authority; and processes applications by
getting opinions and consent of the relevant ministries.

The Division of Dangerous Chemicals Management has also responsibilities in
controlling manufacturing and importing of asbestos; cooperating with the industrial
stakeholders on ―responsible care‖ issues; contributing in the process and represent-
ing the MoEF in the meetings of Market Surveillance and Inspection Commission
coordinated by the Undersecreteriat for Foreign Trade; issuing the list of chemicals,
which are restricted or prohibited.

Beside the above tasks, the Division of Dangerous Chemicals Management coordi-
nates the work to be done related to UN, World Trade Organization, EU (specifi-
cally on EC/304/2003 regarding Import and Export Procedures), EU Customs Union
and OECD processes and procedures on management of chemicals as well as tech-
nical barriers to trade; follows up the Rotterdam Convention and Stockholm Con-
vention processes; participates in international meetings; represents Turkey in inter-
national fora.

There are 5 staffs working in the Division of Inventory and Risk Assessment. Since
there is a gap regarding the mandate to be assigned to the Division of Inventory and
Risk Assessment regarding data collection and establishing and inventory could not
be achieved by the Division until recently. The Division of Inventory and Risk As-
sessment has responsibilities in risk assessment of existing chemicals. The Division
is in the process of establishing the necessary system in order to implement the EU
Regulation EC/793/93 on Risk Assessment of Existing Chemical Substances. The
Division of Inventory and Risk Assessment works on national Plan of Implementa-
tion Regarding the POPs Convention establishing the PCB and dioxins inventory in



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Turkey; follows up the international process to this end. The Division is also respon-
sible for developing the inventory carried out under the TeACH Project.




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                                            General Director



                                                 Deputy
                                            General Director (3)




Department           Department              Department         Department        Department      Department of
    of                   of                      of              of Water             of             Marine
Monitoring               Air                   Waste                 &             Chemicals        & Coastal
    &                Management              Management             Soil          Management      Management
Inspection                                                      Management




                          Division of            Division of        Division of     Division of      Division of
  Division of         Industrial Sourced         Household            Water                         Marmara and
                         Air Pollution                                              Dangerous
 Environmental                                     Waste            Resources                          Straits
  Inspection                Control                                                 Chemicals
                                                                                   Management



    Division of       Division of Heating        Division of        Division        Division of      Division of
  Env. Standards        and Motorized            Hazardous                                           Mediterra-
 Quality Assurance     Vehicle Sourced                                 of            Inventory
                                                   Waste              Soil                             nean
  and Education          Air Pollution                                               and Risk
                                                                                                   & Aegean
                                                                                    Assessment     Sea



   Division of            Division of           Division of         Division of     Division of       Division
   Laboratory               Noise               Medical and         Treatment
                         and Vibration                                             Chemical and          of
                                               Special Waste       Technologies                      Black Sea
                           Control                                                   Industrial
                                                                                    Accidents



                          Division of            Division of
                        Transboundary            Packaging
                         Air Pollution             Waste
                          Monitoring




                         Division of             Division of
                        Natural Fuel          Waste Inventory
                        and Material
                                               and Planning
                      Depending Control




                     Figure 2: Organisational Chart of the General Directorate of Environmental
                     Management




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The Division of Industrial and Chemical Accidents is working on issuing the
relevant legislation, including the technical guidelines, regarding the implementa-
tion of SEVESO II Directive. The Division has already established the database
for pre-notification system to implement the SEVESO II Directive. In this regard,
The Division of Industrial and Chemical Accidents collaborate with the Ministry
of Labour and Social Security.

Beside the above tasks, the Division of Industrial and Chemical Accidents coordi-
nates the work to be done related to UNOCHA, World Maritime Organization
processes and procedures, other requirements regarding the implementation of
SEVESO I Directive and APELL; participates in international meetings; represents
Turkey in relevant international fora. The Division coordinates the preparation of
local emergency action plans, acts as focal point for notification of industrial and
chemical accidents to be reported by the provincial governorships in compliance
with the OECD format. There have been 6-7 accidents reported since 1999.

In addition to all these specific tasks, all three divisions are responsible, wherever
is appropriate, for commenting on the draft national and international legislation;
commenting on EIA Reports; contributing in relevant on-going projects within or
outside the Ministry; participating in training programmes carried out in relevant
fields in the EU accession process.

The Department of Monitoring and Inspection under the same General Director-
ate carries out the inspection activities. There are 7 chief inspectors in this De-
partment, who are in charge of planning the inspections and training the inspec-
tors, who work in the provincial directorates. There are about 170 inspectors, who
are trained in different subjects for inspection. However, there are no specifically
trained inspectors in the field of chemicals. Because of that, in line with the an-
nual inspection program, the Department of Monitoring and Inspection invites an
expert from the Chemicals Management Department whenever is appropriate.
There are about 25 programmed inspections per year; some of them being in rela-
tion to chemical industries. The inspections are carried out according to the Envi-
ronmental Inspection By-law issued on 5 January 2002. The objectives of By-law
cover only the environmental inspection of the process lifecycle in the installa-
tions, but not the market surveillance and inspection of chemicals placed on the
market.

According to the Organic Law of the MoEF, the Ministry is entitled to establish
enterprises operating with revolving funds in relation to the mandates of the Min-
istry. The tasks and duties of these enterprises, their revenues, operation and in-
spection of them are regulated in b a By-law. The By-law on Enterprises with
Revolving Funds (dated 15 April 2004) include the following provisions, which
may be the legal basis for the charging some fees for the activities carried out for
the management of chemicals:
        Without prejudice to the restrictions in the existing legislation, carrying
         out measurements, analysis and tests in the laboratories affiliated to the
         Ministry and in relation to that issuing some reports and some documents
         by charging a fee;
        Delivering application, permit, control and alike forms and documents,
         which are identified in the by-laws and in their annexes, by charging a
         fee;



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Institutional and Legal Framework for Chemicals Management
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         Delivering course, conference, seminar, study, inventory, research, pro-
          ject preparation, project implementation, project development, operation
          and maintenance, protection, guidance, consultancy, management, opera-
          tion, etc. services.


3.2       Ministry of Health (MoH)

The MoH is the main government body responsible for health sector policy mak-
ing, implementation of national health strategies through programs and direct
provision of health services. MoH is the major provider of primary and secondary
health care, maternal health services, children‘s and family planning services. It is
essentially the only provider of preventive health services through an extensive
network of health facilities (health centers and health posts) providing primary,
secondary, and specialized in-patient and out-patient services.

The organisation and duties of the Ministry of Health (MoH) are described in the
Decree Law No.181 dated 13.12.1983. The Ministry‘s most related duties for the
management of chemicals is defined as ―Control and inspection of medi-
cines/drugs and psychotropic substances at all phases of production and consump-
tion, setting the principals of opening and operating of production and distribution
places for pharmaceuticals and medicinal substances and preparations as well as
inspecting these places‖.

Ministry of Health is responsible for implementation of Directive 98/8/EC Plac-
ing Biocidal Products on the Market. There are 23 groups of biocidals. Out of
this, the Ministry of Health manages seven groups of them.

General Directorate of Primary Health Care is responsible for the management of
five groups of biocidal products, which are used in the living environment of the
human beings such as houses, work places, schools, parks, picnic areas etc. and
its mandate to this end is described as ―Inspecting toxic and narcotic substances,
medicinal and vital preparations, all kinds of serums and vaccines used for human
health as well as the places they are produced and/or marketed‖. The Division of
Pesticides and Vector Control under the Department (see Figure 3) of Environ-
ment and Public Health undertakes implementation functions together with the
related laboratories and provincial directorates.

There is 8 staff working in this division. However, there are about 6,000 person-
nel in charge of environmental health care; out of which 1800 are environmental
health technicians working in the 81 provincial directorates of the MoH.




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                                 Head of Environment
                                          and
                                  Public Health Dept.




      Division of          Division of           Division of           Division of
    Environmental        Pesticides and            Market            Drinking and
       Impact            Vector Control         Surveillance          Utility Water
     Assessment                                and Inspection               and
    and Monitoring                              and Cleaning        Thermal Springs
                                                  Products




Figure 3: Organisational chart of the ministry of Health, Department of Envi-
ronment and Public Health.

The General Directorate of the Drug and Pharmacy is responsible for the disinfec-
tants used for personal care and that are in direct contact with the human body.
This General Directorate is also responsible for the management and control of
cosmetics and implementation of the Cosmetics Directive 76/768/EEC.

The General Directorate of Curative Services is responsible for the group of bio-
cidals used for disinfecting the medical tools and equipment.

At the provincial level, provincial health directorates (for 81 provinces) are re-
sponsible for administering health services provided by the MOH. The provincial
health directorates are accountable to provincial governors for administrative
matters and to the MoH for technical matters. Directors of MoH hospitals report
to the Director General of Curative Services, while Directors of Health Centers
report to the Director General of Primary Health Care3.

The Ministry of Health established revolving funds for operating costs of the
hospitals affiliated to the Ministry. While revolving funds are collected and kept
in the facilities, MoH hospital managers are bound by guidelines from the MoH
Directorate of Curative Services. Thus, as per the guidelines, a maximum of 50%
of the funds can be used for topping up salaries, if the hospital has no other out-
standing bills. The payment of salary supplements is expected to be based on
performance. In the same context, MoH passed the legislation effective 1.11.2001
to introduce revolving funds for enhancing the operating budgets of primary care
facilities and 45 provinces received permission from the Ministry of Finance
(MoF) to establish revolving funds for selected primary care. These revolving


3
 Turkey Health Report The Ministry of Health of Turkey-Refik Saydam Hygiene Center
School of Public Health, February 2004, Ankara.


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funds may give room for topping up some margin to the salaries of the technical
staff.

The services pertaining to protect public health and conducting laboratory-based
services are among the duties of MoH and are carried out by Refik Saydam Hy-
giene Center, which is an affiliate institution of the Ministry of Health. The Cen-
ter also acts as the ―Reference Center‖ of the provincial public health laboratories
offering services all over the country.

3.2.1     Refik Saydam Hygiene Center

Refik Saydam Hygiene Center is based in Ankara and has 7 regional laboratories
throughout Turkey.

Refik Saydam Hygiene Center has the following mandates, which are relevant to
the management of chemicals:

Controlling all kinds of medicines and cosmetics, which are manufactured within
the country or imported to the country, carrying out research and laboratory ser-
vices, analysing pesticides and conducting efficacy tests;
        Carrying out research and delivering laboratory services pertaining to the
         environmental pollution;
        Carrying out research and control services for toxic substances and prepa-
         rations;
        Delivering reference laboratory services.

There are 14 specialized technical units including Environmental Health Direc-
torate, Toxicological Research Directorate, Pharmaceuticals and Cosmetics
Research Directorate.

Toxicological Research Directorate is responsible for carrying out research on
impacts of chemical substances and preparations on human health; as well as
delivering help desk services for medical doctors and other medical personnel,
and for individuals to a certain extent.

Toxicological Research Directorate has the following laboratories/sections:
       Entomology laboratory;
       Pesticide formulation laboratory;
       Pesticide residue laboratory;
       Analytical toxicology laboratory;
       National Toxicology Center.

Environmental Health Directorate within the Refik Saydam Hygiene Center has 9
laboratories specialized in air pollution, water quality, wastewater control, soil
pollution control, environmental microbiology, noise control, cleaning products,
occupational hygiene, disinfectant substances/preparations.

Pharmaceuticals and Cosmetics Research Directorate has specialised laboratories
as well. The tests regarding the manufacturing and importing of cosmetics as well
as market surveillance are carried out under the Cosmetics Preparations Control
Laboratories.



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3.3        Ministry of Labour and Social Security (MLSS)

The Ministry of Labour and Social Security has a joint responsibility with the
MoEF for adopting and implementing legislation aimed at controlling of some
certain chemicals both at the workplaces and at import4. MLSS is responsible for
implementing Directive 83/477/EEC on the protection of workers from the risks
related to exposure to asbestos at work and Directive 90/394/EC on the protection
of workers from the risks related to exposure to carcinogens or mutagens at work
and Directive 1998/24/EC(5) on the protection of the health and safety of workers
from the risk related to chemical agents at work and Directive 1999/92/EC on
minimum requirements for improving the safety and health protection of workers
potentially at risk from explosive atmospheres. Risk assessment and training and
informing of workers are duties of employer‘s which is mentioned in Implement-
ing Regulation on the Protection of the Health and Safety Measures from the
Risks Related to Chemical Agents at Work which is published in Official
Gazzette numbered 25328 and dated 26/12/2003 and Implementing Regulation
for the Protection of Workers from the Risks Related to Exposure to Carcinogen
and Mutagen Substances at Work which is published in Official Gazzette num-
bered 25328 and dated 26/12/2003. Also, by-law on principles and procedures of
workers health and safety training states that employers are responsible from
training of workers and details about training are given in this by-law. Inspection
related with the responsibilities of the employers are made by labour inspectors of
Head of the Board of Labour Inspectors. Implementing Regulation on the Protec-
tion of the Health and Safety Measures from the Risks Related to Chemical
Agents at Work contains chemical names of substances and CAS number which
has occupational exposure limit value..

According to the Work Code No. 4857, the enterprises, which employ more than
3 persons, have to apply to the regional directorates of the MoLSS for registra-
tion. In the application form they have to include the information about the
chemicals they use in their processes.

There is an inspection commission directly affiliated to the Minister. For inspec-
tion of legislations Article 92 of Labour Law and Article 17 of Labour Inspection
Regulations are employed. Currently there are about 600 inspectors working all
over Turkey for monitoring and inspecting the workplaces. Half of them are re-
sponsible from inspection with regard to occupational health and safety and other
half is responsible for inspection of other matters related with work and work-
place for example working hours, other workers‘ rights within work place. The
inspection results are kept confidential. Employers are responsible to carry out
―risk assessment‖ for occupational health and safety with respect to the SDS
Forms and prepare a risk management plan. However, the ―risk assessment‖ term
here does not have the same concept of ―risk assessment‖ used for chemicals in
1993/67/EEC. Employers are also responsible for training the employees for risk
reduction measures. There are sanctions stated in the legislation for non-
compliance with the SDS related articles.

According to the Undersecretariat for Foreign Trade- Import Communiqué (No.
2006/13) for the Importation of Some Products Which Affect Occupational

4 www.calisma.gov.tr




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Institutional and Legal Framework for Chemicals Management
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Health and Safety, during registration of customs declaration a document pre-
pared by Ministry of Labour and Social Security should be present.

The General Directorate of Occupational Health and Safety (see organisational
chart of the Ministry) is responsible for all kinds of monitoring, inspection, policy
development, and planning issues regarding occupational health and safety.

The Occupational Health and Safety Centre, which is affiliated to the Ministry,
has laboratory and inspection facilities as well as qualified staff. There is a EU-
funded     project   for    up-grading      the    capacity    of     the    Center.




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                                              Minister of
                                              Labor and
                                            Social Security


                                            Undersecretary




                                                                          Legal                 Secretary of
                                        Deputy
                                                                         Advisor                  Defense
                                     Undersecretary




  General                      GD of                       GD of                   Department                    Department
 Directorate               Foreign Affair               Occupational                   of                             of
 of Labour                  and Abroad                   Health and                    EU                        Research and
                             Workers                       Safety                  Coordination                    Planning




                             Head of                      ISGUM
                            Inspection
                            Committee                                                      Department
      Advisors                                                                              of Social
                                                                                            Security
                                                                                            Authority
                           Head of Works
                             Inspection
                            Commission

      Cabinet of the
        Minister                                                  Social                    GM of Social               GM of
                                                                                            Insurance of              Turkish
                                                                Insurances                 Tradesmen and
                             Manager for                                                                               Works
                               Media                            Institution                 Independent
                                                                                            Businessmen
                                                                                                                     Institution
                              and PR




 Regional              Abroad            Training and   Department of         Department          Department            Workers
                                                        Administrative          of IT             of Personnel         Solidarity
Directorates           Attachés           Research      and Financial
                                            Center                                                   Works            Fund - Ereğli
                                                          Matters



  Figure 4: Organisational chart of the ministry of Labour and Social Security.




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3.3.1     Occupational Health and Safety Center (ISGUM)

The mandate of the ISGUM is carrying out studies and researches for developing
norms and standards regarding occupational health and safety, updating these
norms and standards in parallel to the technological developments, identifying
the vocational education needs and suggesting for the curricula of these education
as well as issuing publications. In order to accomplish these mandates, ISGUM
conducts surveys and researches, works on adjusting the work environment and
production processes with respect to the skills of the human beings, and delivers
on-the-job training and consultancy services.

There are 3 main technical sections in the Center:
       Labor‘s Health Section;
       Occupational Hygiene Section;
       Occupational Safety Section.

ISGUM has one central laboratory in Ankara and 5 regional laboratories in Istan-
bul, Izmir, Adana, Kocaeli and Zonguldak. Based on the Article 15 (a, e) of Work
Inspection Regulation inspectors check production and manufacturing processes,
harmful and dangerous (according to limits) raw materials and products and if
necessary he/she wants measurements for verification. The measurements are
carried out in the laboratories of General Directorate of Occupational Health and
Safety; however when the laboratories are not functional (for example during
upgrading activities) TÜBITAK MAM and FĠġEK Institute Laboratories are
used.

The Project for ―Upgrading Occupational Health and Safety in Turkey‖ funded
by EU was completed in January 2006. Improvement of laboratories constituted
one of the main activities of the Project. In this frame, Kocaeli and Ankara have
been chosen as pilot regions for laboratory support in the occupational health and
safety.


3.4       Ministry of Agriculture and Rural Affairs (MARA)

The most relevant but not very specific duties of the Ministry (according to the
Government Decree no. 441 in Force of Law) regarding the management of
chemicals are as follows:
      To make research, surveys, plans, programs and projects, or have them
       made, on the production, consumption and input as well as the protection
       and improvement of soil, water, plants and animals in accordance with
       the requirements of development and growing demands;
      To ensure the improvement of livestock and aquatic products.

The ministry performs its related duties through its peripheral organisation. The
peripheral organisation of the ministry consists of research institutes, provincial
and district directorates, agricultural farms and supervision units.

The General Directorate of Protection and Control within the Ministry of Agri-
culture and Rural Affairs is in charge of control and management of placing on
the market of plant protection products as well as 2 groups of biocidal products.


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                         The areas for which the General Directorate of Protection and Control is respon-
                         sible are protecting the resources of plants, animals and fisheries as well as the
                         related products, ensuring their integrity and contributing to delivery of agricul-
                         tural inputs such as feedstuffs, veterinary drugs and pesticides, animal vaccines
                         and seeds to the producers in a healthy manner. The General Directorate performs
                         all these activities and responsibilities through the Provincial and Sub-provincial
                         Directorates, Food Control Laboratories, Research Institutes, and Veterinary and
                         Agricultural Quarantine Directorates whichever is appropriate. There are also
                         Provincial Control Laboratory Directorates in 39 provinces. They serve for water
                         quality control as well as fertilizer use advises.



                                             General Director



                                                  Deputy
                                             General Director (5)




Department         Department        Department          Dept. of    Department       Department      Department   Department
    of             of Feedstuff         of           Environment          of              of               of           Of
Coordination          Control          Public             and       Medicaments a       Aqua-          Livestock    Livestock
 Services                              Health          Disasters     & Equipment       products         Health     Quarantine



                                                                      Division of
                                                                        Plant
                                                                      Protection
                                                                      Products
      Department of                         Department of
                                                                                            Department of
    Feedstuff, Foods-                      Plant Protection
                                                                                             Agricultural
    tuff and Registra-                        Services                                      Quarantine and
      tion Services                                                  Department
                                                                          of                Seed Services
                                                                      Veterinary
                                                                     Medicaments



                                                                       Depart. of
                                                                      Pesticide and
                                                                       Equipment
                                                                        Control




                         Figure 5: Organisational chart of the Ministry of Agriculture and Rural Affairs,
                         General Directorate of Protection and Control.




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                         Institutional and Legal Framework for Chemicals Management
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3.4.1     Agricultural Pest Control Central Research Institute (ZMMAE)

Agricultural Pest Control Central Research Institute based in Ankara is responsi-
ble for research, delivering laboratory services, issuing publications and conduct-
ing training programs on agricultural pest control. Among others, the Institute has
the following duties:
        Carrying out studies on pesticide residues in agricultural products, water
         and soil;
        Carrying out research on impacts of pesticides on environment and hu-
         man health;
        Carrying out physiological and toxicological research in insects, fungi
         and bacteria;
        Carrying out eco-toxicological research;
        Carrying out physical and chemical analysis of pesticides, which are
         subject to registration, and compliance checks of the samples of these
         preparations collected from the market;
        Analysing the dangerous impurities in the formulations and advising on
         ingredients, which are not dangerous for human health;
        Participating in the Pesticide Registration Committee.

There are 12 sections in the institute. Two of them are related to pesticides:
       Physiology and Toxicology Section;
       Pesticide Section.

There are 3 laboratories under this section:
       Physical Analysis Laboratory;
       Chemical Analysis Laboratory;
       Residue Analysis Laboratory.

There are about 138 persons working in the Institute, 57 of them are technical
staff.

Beside the Central Research Institute, there are 3 plant protection research insti-
tutes in Adana, Diyarbakır and Bornova (Izmir).


3.5       Energy Market Regulatory Authority (EMRA)

The Electricity Market Regulatory Authority had been established as per Law no.
4628 and it was later renamed as Energy Market Regulatory Authority as per the
provisions of Natural Gas Market Law no. 4646. With the enactment of the Pe-
troleum Market Law no. 5015 and Liquefied Petroleum Gas (LPG) Market Law
no. 5307, the Authority has been commissioned to regulate and supervise the
petroleum and LPG markets. The objective of the aforementioned Laws is to
establish a financially viable, stable and transparent energy market, which will
function as per the provisions of private law and within a competitive environ-
ment to ensure the independent regulation and supervision of the market in order
to provide sufficient electricity, natural gas, petroleum and LPG of good quality
to consumers, at low cost, in a reliable and environment friendly manner.




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The organizational chart of EMRA is in Figure 6.




Figure 6: Organisational chart of the energy Market Regulatory Authority.

The Petroleum Market Regulating Law of 5015 regulates the guidance, surveil-
lance and supervision activities for the petroleum products placed on the market.
The petroleum products are described in the Law No. 5015 as ―any hydrocarbon
of product or by-product produced from crude oil and/or crude oil products via
physical and chemical processes or refining and other methods‖. The petroleum
products include all types of gasoline, naphtha (except for raw material and sol-
vent naphtha) gas oil, jet fuel, diesel oil and fuel oil types, asphalt, products that
can be blended with liquid fuel, such as methyl tarsier butyl ether (MTBE), etha-
nol (except for those produced artificially from domestic agricultural products
and bio-diesel).

Importers, who do not carry any license from EMRA are required to get import
permit from EMRA in accordance with the Communiqué for Standardizing Im-
ports No. 2006/12. There are about 200 manufacturing companies, which apply
for import procedures each year. On the other hand, for importing bulk products,
there are about 15-20 importers, which apply for import permit. For packed prod-
ucts import permit applications are from 300-350 companies each year.

Licensing and importing procedures are carried by the Petroleum Market De-
partment. There are 50 personnel working in the Department. Licenses are issued
by the Energy Market Regulatory Board, comprising of 8 appointed members.

Inspection procedures are set by the Department of Audit and Supervision. There
are about 20 persons working in this Department. However, the trained personnel
of gendarmerie, police, coast guard and the Ministry of Industry and Trade, ac-



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cording to the protocol signed between EMRA and these institutions, carry out
inspections.


3.6       Ministry of Industry and Trade

According to the Organic Law of Ministry of Industry and Trade (No. 3143 dated
18 January 1985), the Ministry has the following duties among others, which can
be relevant to the placing on the market of chemicals:
       Preparing the standards of industrial goods, providing or identifying the
        norms, carrying out quality controls, or making it carried out;
       Establishing the central and other quality control laboratories or cooper-
        ating with the other institutions in this line for improving industry;
       Carrying out standardization activities for export goods and other goods
        that are not under the responsibilities of other ministries;
       Carrying out studies, research and regulation activities for developing a
        fair competition environment;
       Taking the legal and administrative measures for introducing and protect-
        ing universally accepted consumer rights and carrying out studies, re-
        search and regulation activities for developing consumer rights.

The General Directorate for Protection of Consumers and Fair Competition is the
main body, which is responsible for market surveillance and inspection of some
chemicals with regard to Law no. 4703. The General Directorate has the follow-
ing duties among others stated in the Organic Law of the Ministry, which can be
relevant to the placing on the market of chemicals:
       Taking the necessary measures for protecting the interests of the con-
        sumers in terms of their health, safety and economy as well as compen-
        sating their losses, issuing regulations to this end;
       Cooperating with the relevant ministries and institutions for identifying
        the measures to protect the consumers from environmental hazards be-
        cause of consumer goods;
       Carrying out quality control inspections developing quality control sys-
        tems, commenting and recommending the standards drafted by other or-
        ganizations and institutions for improving the quality of goods that are
        placed on the market;
       Taking measures for informing and training the consumers, encouraging
        the initiatives for consumers‘ self-protection, ensuring representation of
        consumers through voluntary organizations in policy making for con-
        sumer protection.

Communiqué of Import No. (2006/17) on importation of substances listed in the
annexes to the Convention on the Control of Chemical Weapons lay down the
principles and the procedures for regulation of importation. According to Com-
muniqué, importation of some chemicals is prohibited and some of them are re-
stricted to from some countries. Undersecretariat for Foreign Trade is authorized
to issue the import permits. A copy of the permit is sent to the Ministry of Indus-
try and Trade as well as to the Undersecretariat for Customs and to the Ministry
of National Defence. The responsibility of the Ministry of Industry and Trade is
not clearly defined anywhere in the legislation, regarding this group of chemicals.




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It is not clear as well which institution is responsible for market surveillance and
inspection of this group of chemicals.

Ministry of Industry and Trade is also responsible for market surveillance and
inspection of the petroleum products, based on the protocol signed by EMRA and
the Ministry.


3.7       Tobacco, Tobacco Products and Alcoholic Beverages
          Market Regulatory Authority (TAPDK)

Tobacco, Tobacco Products and Alcoholic Beverages Market Regulatory Author-
ity was established in 2002 in order to ensure the regulation of the tobacco, alco-
hol and alcoholic beverages market. All kind of regulation, implementation and
inspection as well as enforcement regarding the manufacturing, importing and
distribution of methyl alcohol and ethyl alcohol are under the responsibility of
TAPDK.

Communiqué on the Market Supply of Ethyl Alcohol regulates the ethyl alcohol
to be put on the market, either for producing alcoholic beverages or for other
industrial uses. The purpose of the communiqué is to set the procedures and prin-
ciples governing safe and purposeful storage, denaturation, distribution and plac-
ing ethyl alcohol produced or imported on the market.


3.8       Other pertinent stakeholders

The government institutions described below have some indirect roles in the
management of chemicals, like macro economic planning, public investment
programming, export, import regulations and controls.

3.8.1     State Planning Organisation

The Under-secretariat for the State Planning Organisation (DPT) affiliated to the
Prime Ministry‘s Office is a consultative body for the Government and drafts
national development plans and annual investment programmes (general gov-
ernment investment budget), to be endorsed by the parliament. DPT has recently
issued the 9th Development Plan (2007-2013).

The DPT also prepares sectoral plans including environment and chemicals
manufacturing sectors with due emphasis on macro-economic policy issues. The
policies set are instructive for the public institutions, and guiding for the private
companies.

General Directorate of Social Planning and Coordination is responsible for, in-
cluding others, overall environmental policies while General Directorate of Eco-
nomic Planning and Coordination is responsible for drafting the policies regard-
ing all manufacturing sectors including chemicals.




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3.8.2     Undersecreteriat for Foreign Trade

Undersecrateriat for Foreign Trade was an integral part of the Treasury for 11
years and the title of the institution was the Under-secretariat for Treasury and
Foreign Trade until 1994. The mandates of the Under-secretariat for Foreign
Trade are:
      Assisting in developing foreign policies;
      Regulating exports, incentives for exports, imports, contracting services
       in abroad, bi-lateral and multi-lateral trade and economic relations;
      Implementing all these, monitoring and improving implementations.

The Undersecretariat has also the responsibility for coordinating the ―Free
Movement of Goods‖ Chapter of the EU legislation during the EU accession
negotiations.

The Undersecretariat is responsible for transposing the EU General Product
Safety Directive (2001/95/EC amending 92/59/EC). Accordingly, The Law
Relating to the Preparation and Implementation of the Technical Legislation on
the Products (Law No. 4703), which transposes the EU General Product
Safety Directive, was prepared by the Undersecretariat. The Law No. 4703
defines the “competent authority” as any public body which is legally au-
thorized for preparing and implementing the legislation relating to the
products, and for implementing the provisions of this Law for the products
under its responsibility (Art.3 (k)), i.e. 13 competent authorities including the
Ministry of Environment and Forestry, Ministry of Agriculture and Rural Affairs,
and Ministry of Health exist.

The objective of the Law is to lay down the principles and the procedures for the
placing on the market of the products, conformity assessment, market surveil-
lance and inspection and the notifications relating to these arrangements. The
Law covers the conditions of placing on the market of the products; the obliga-
tions of the producers and the distributors; conformity assessment bodies; noti-
fied bodies; market surveillance and inspection; prohibition of the placing on the
market of the products, withdrawal and destruction of the marketed products and
the notifications relating to these arrangements. Law No 4703 ensures that the
new products to be placed on the market shall be in conformity with the relevant
technical regulations (Art.5; parag.1), and that producers shall place only safe
products on the market (Art.5; parag.3). There is a Market Surveillance
Board established in compliance with the By-law on Market Surveillance and
Inspection dated 11 January 2002. The council comprises of 13 members includ-
ing the –Under-secretariat for Foreign Trade, Ministry of Environment and For-
estry, Ministry of Health, Ministry of Agriculture and Rural Affairs, Ministry of
Labour and Social Security, Ministry of Industry and Trade.

The organizational chart of the Under-secretariat for Foreign Trade is in Figure 7.




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                                          Undersecretary




                                              Deputy
                                         Undersecretaries (3)




 General         General         General         General         General        Gen. Dir.     Gen. Dir. of
Directorate    Directorate    Directorate of   Directorate      Directorate   Standardiza-     Economic
of Exports      of Imports    Agreements       of EU Affairs      of Free        tion in       Research
                                                               Trade Zones      Foreign       and Evalua-
                                                                                 Trade            tion


              Figure 7: Organisational chart of the Undersecretariat of Foreign Trade.

              The Under-secretariat of Foreign Trade prepared the "Ministerial Decree on the
              Regime of Technical Regulations and Standardization for Foreign Trade" No.
              2005/9454 and its supplementary legislation with the aim of providing transpar-
              ency in the implementations, assembling all the dispersed regulations regarding
              standardization policies in Turkey and establishing a legal base for the harmoni-
              zation of Turkish legislation with the Community‘s. The Regime mainly consists
              of the Ministerial Decree, a Regulation and some Communiqués. The General
              Directorate of Standardisation in Foreign Trade amends the Regulation and the
              Communiqués every year. The following communiqués include standardization
              of the control of importing of chemicals, which are under the responsibility of
              Ministry of Environment and Forestry, Ministry of Health and Ministry of Agri-
              culture and Foreign Affairs.

                       Communiqué of Standardization for Foreign Trade No. (2007/6) is re-
                        lated to importation of ozone depleting substances and chemicals, which
                        are listed under the Annexes of this Communiqué. These are subject to
                        the control of Ministry of Environment and Forestry.
                       Communiqué of Standardization for Foreign Trade No. (2007/12) is re-
                        lated to importation cosmetic products. The importers are subject to sub-
                        mitting notifications to Ministry of Health according to Cosmetic Law
                        and Regulations of Cosmetics;


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         In addition, Communiqué of Standardization for Foreign Trade No.
          (2007/13) is related to importation of detergent products. The importers
          should submit notifications to Ministry of Health for these products.
         Communiqué of Standardization for Foreign Trade No. (2007/20) is re-
          lated to importation of certain goods such as narcotics, psychotropic sub-
          stances, cleaning agents, chemicals, pharmaceutical products, medicines,
          detergents, etc. These substances are subject to the control of Ministry of
          Health.
         Communiqué of Standardization for Foreign Trade No. (2007/21) is re-
          lated to importation of certain goods such as foodstuffs, agricultural and
          animal products and veterinary products. These are subject to the control
          of Ministry of Agriculture and Rural Affairs;

The importation of some products including some chemicals are regulated by the
General Directorate of Imports with the following communiqués, which are up-
dated every year. These Communiqués appended to the Import Regulation ar-
range imports with regard to the public order, public moral and public security,
the preservation of the human, animal and plant health, the protection of the envi-
ronment, consumer rights and the international agreements (such as Chemical
Weapons Convention and Montreal Protocol):

         Communiqué on Imports No. 2007/11 on some explosives;
         Communiqué on Imports No. 2007/12 on solvents and some petroleum
          products;
         Communiqué on Imports No. 2007/13 on some products, which effect
          occupational health and safety;
         Communiqué on Imports No. 2007/14 on ozone depleting substances;
         Communiqué on Imports No. 2007/15 on some dyestuff;
         Communiqué on Imports No. 2007/16 on fertilizers;
         Communiqué on Imports No. 2007/17 on chemical substances, which are
          listed in the annex of the Chemical Weapons Convention.

The General Directorate of Exports, regulates the exportation of the goods in-
cluding some chemicals. The relevant communiqués are listed below:
       According to the Communiqué of Export No. (96/31), goods whose ex-
        portation is prohibited by laws, decrees and international agreements and
        dependent on prior authorization of certain establishments are listed in
        the annexes of this Communiqué. This list also contains certain chemi-
        cals;
       According to the Communiqué of Export No. (2003/12), Concerning the
        Control of the Export of Dual-use and Sensitive Goods, the export of
        dual-use and sensitive goods capable of utilization for both civilian and
        military purposes, and which are subject to control in accordance with
        the international arrangements and regimes which our country is a party
        to and which have been introduced in order to control the export of mate-
        rials and technologies that can be used in the development of mass de-
        struction weapons is regulated. This Communiqué also includes certain
        chemicals;
       According to the Communiqué of Export No. (2004/13), procedures and
        principles for the export of ozone depleting substances are regulated.




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         According to the Communiqué of Export No. (2002/12), procedures and
          principles for the export of substances listed in the annexes to the Con-
          vention on the Control of Chemical Weapons are regulated.

The duties of the General Directorate of Economic Research and Evaluation in-
clude establishing, managing and operating a Foreign Trade Information Center
in order to ensure that information is readily accessible by the users.

3.8.3     Undersecretariat for Customs

The Undersecretariat for Customs is affiliated to the Prime Ministry. According
to its organic law, the principles for the establishment and functions of the Cus-
toms Undersecretariat is to organize and coordinate the customs and customs
enforcement services and to combat smuggling.

The duties of the Customs Undersecretariat are as follows:
       To contribute to the preparation of customs policy;
       To assist to apply the provisions of the Customs Law and other related
        legislation and international agreements;
       To assist to determine the customs tariff rates and to collect and to con-
        trol the customs taxes and other revenues and funds;
       To control and inspect goods and vehicles and to take necessary precau-
        tions to carry out the procedures effectively and swiftly;
       To compile the statistical data concerning the customs;
       To assist to protect the goods and vehicles subject to customs control.
        and to control whether they comply with the certain norms and standards,
       To prevent, inspect and investigate the smuggling in the customs gates
        and ―laissez-passer‖1 gates on territorial borders and customs seaports
        and airports and free trade zones and various warehouses and inland cus-
        toms territories;
       To prevent and prosecute and investigate the smuggling, if necessary, in
        collaboration with the other related organizations in other locations;
       To pursue studies on the Under-secretariat services and to make deci-
        sions and to coordinate national and international activities;
       To execute duties assigned to the Under-secretariat with various laws;
       To train professionals to fulfill their tasks duly and to organize the rele-
        vant studies;
       To pursue and evaluate and investigate and control whether the above-
        mentioned functions are fulfilled properly.

The customs authorities at the borders can control only 15% of the goods that are
imported.

The organogram of the Under-secretariat for Customs is in Figure 8.




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Figure 8: Organisational chart of the Undersecretariat of Customs.

Imported goods are subject to the customs tax and VAT; funds are collected on
some goods such as agricultural products.

Turkey is in a Customs Union with the EC since 1996, the application of which
has been extended to the ten new members by a Decree dated 2 October 2004.
Subsequently, products circulate freely with all EU members. Indeed, latest for-
eign trade figures confirm that Turkey has trade relations with all EU members
within the framework of the Turkey-EC Customs Union. Turkish Customs legis-
lation was adapted to EU legislation so as to enable two or more countries to
annul the customs taxes mutually and impose them on third countries due to the
establishment of the Customs Union.




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4 Institutional and Legal Analysis
  with Respect to EU Requirements




In this section, the present constituencies of the relevant institutions and their
relevant legislation are analysed taking the EU requirements into consideration.
The analysis is based on the type of chemical without limiting with the scope of 4
directives listed in the ToR of this project. The aim of the analysis is to have an
insight of the existing distribution of roles, capacities and procedures of the gov-
ernment institutions in Turkey. Please see the legal gap analysis as well presented
in Appendix I with regard to the directives, which are in the scope of the TeACH
Project.


4.1       Industrial substances and preparations

Responsible authority: Ministry of Environment and Forestry
                       General Directorate of Environmental Management
                       Chemicals Management Department

4.1.1     Institutional analysis

Design procedures for licensing/registering
There are procedures for registration of chemicals and preparations for manufac-
turers and importers set by the Dangerous Chemicals By-law; however, the An-
nex I of the By-law, which is supposed to cover the list of dangerous substances
and preparations, is not applicable; and there were no enforcement mechanisms
set for non-compliance, the By-law could not be implemented.

Design procedures for compliance programmes
There are not such programmes set in the by-law.

Design procedures for notification
Procedures for notification of manufacturing and importing of certain chemicals
and preparations are specified in Dangerous Chemicals By-law. However, since
there isn‘t any reference to EINECS and ELINCS chemicals, they are not in
compliance with the EU requirements.

Design procedures for inspection and verification
Inspection procedures are specified in the Environmental Inspection By-law
dated 5 January 2002. However, it covers only the environmental inspections of
the processes there isn‘t any specific article for market surveillance and inspec-
tion of dangerous chemicals and preparations. The Department of Monitoring and
Inspection, which is responsible for all kinds of environmental inspection pre-
pares an annual inspection programme, and informs and invites the Chemicals



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Management Department about it whenever appropriate. There are 25 pro-
grammed inspections each year, some of them concerning chemicals manufactur-
ers.

Design procedures for safety requirements
        Classification
The classification procedures for dangerous chemicals and substances are de-
scribed in Art. 4 of the Dangerous Chemicals By-law dated 6 November 2001.
However, these procedures cannot be implemented because of the above-
mentioned reasons.
        Packaging
The packaging requirements are described in section 5 of the Dangerous Chemi-
cals By-law. These requirements are in compliance with the EU requirements,
except some fastening requirements for children‘s safety.
        Labelling
The labelling requirements are given in section 4 of the Dangerous Chemicals
By-law. These requirements are in compliance with the EU requirements, except
a specific warning for toxic and flammable substances and preparations; and limi-
tations for label size according to the size of the package.
        SDS
MSDS Forms are required according to the Art. 22 of the Dangerous Chemicals
By-law both from manufacturers and importers. The MSDS Forms are specified
in the Communiqué on the Procedures and Principles for Issuance of SDSs. The
manufacturers, distributors and importers are responsible for submitting the
MSDSs to the professional users in written or in electronic formats free of
charge.

Implementing By-law on the Protection of the Health and Safety Measures from
the Risks Related to Chemical Agents at Work and Implementing By-law for the
Protection of Workers from the Risks Related to Exposure to Carcinogen and
Mutagen Substances at Work issued by the Ministry of Labour and Social Secu-
rity requires manufacturers/distributors to make MSDS Forms available at the
workplaces.

Evaluate data supplied by manufacturers and importers
The applications for import are evaluated by the staff of the Ministry. However,
this evaluation is in the sense of compliance check.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.
However, the existing information regarding the human health impacts is re-
quired to be included in the application dossier for notification and permit.

Implementing By-law on the Protection of the Health and Safety Measures from
the Risks Related to Chemical Agents at Work and Implementing By-law for the
Protection of Workers from the Risks Related to Exposure to Carcinogen and
Mutagen Substances at Work issued by the Ministry of Labour and Social Secu-
rity require health risk assessment in the workplaces, which are exposed to such
chemicals.




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Evaluate risks to environment
There is not any procedure designed for evaluation of risks to environment.
However, the existing information regarding the ecological impacts is required to
be included in the application dossier for notification and permit.

Develop a strategy to limit risks and ensure emergency plans are in place
There are some R and S phrases specified for labelling in order to limit the risks.
However, there is no provision in the Dangerous Chemicals By-law to ensure
emergency plans are in place. Therefore, there is no strategy to limit risks and
ensure emergency plans are in place.

Implementing By-law on the Protection of the Health and Safety Measures from
the Risks Related to Chemical Agents at Work and Implementing By-law for the
Protection of Workers from the Risks Related to Exposure to Carcinogen and
Mutagen Substances at Work issued by the Ministry of Labour and Social Secu-
rity require identifying general measures and a work plan for occupational health
and safety.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, MoEF is responsible
for designing the procedures for placing of dangerous industrial chemicals and
preparations on the market. There are some restrictions regarding the marketing
and use of some chemicals according to the Dangerous Chemicals By-law. The
Ministry controls dangerous substances and preparations through notification and
permitting system.

Control the import of certain chemicals
MoEF requires importers to get permit for importing certain chemicals. Commu-
niqué of Standardization for Foreign Trade No. (2006/6) lays down procedures
and principles of permitting chemicals, which are subject to getting Chemical
Substances Importation Certificate.

For Annex II chemicals, which are industrial chemical substances and/or prepara-
tions subject to the Chemical Substances Import Certificate, the following proce-
dures are applied:

Importers who want to import chemicals listed in Annex II of the Communiqué
should receive Chemical Substance Import Certificate from MoEF (Article 7).
Importers should apply to the MoEF Department of Chemicals Management (Ar-
ticle 8). Following the end of the validity of certificate within one year, original
copy of the Certificate together with other actual import documents including the
label and MSDS Form should be returned to the Ministry. The MoEF is informed
about importation (name of the supplier, importer, amount of substances im-
ported) during given back of Certificate. Label and MSDS is checked for the
conformity of the importation after it actually occurred.

There are about 50 companies, which apply for getting import permit from the
MoEF each year. Under-secretariat for Foreign Trade is responsible for taking
necessary measures during process and making necessary arrangements.



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The MoEF acts as the Competent Authority for PIC Procedure, although Turkey
is not a party to the Rotterdam Convention yet. Whenever there is an application
from the EU Member States for PIC procedure, MoEF informs the relevant min-
istries to get their consent.

Control the export of certain chemicals.
The scope of the Dangerous Chemicals By-law covers exports as well. However
there is no specific mechanism set for control.

Ensure compliance with rules on confidentiality of information
Confidentiality of the information is secured somewhat in Annex III of the Dan-
gerous Chemicals By-law. However, it needs to be revised in compliance with
the Directive 67/548/EEC.

Publicise requirements to relevant manufacturers
By-law on Dangerous Chemicals is publicized in the web site of the Ministry of
Environment and Forestry.

Publicise requirements to relevant importers
Requirements to relevant importers of chemical substances and preparations are
available in the web site of the Undersecreteriat for Foreign Trade.

Publicise requirements to relevant exporters
There is not such requirements set in Turkey.

Ensure health and safety information is available to workers
Implementing By-law on the Protection of the Health and Safety Measures from
the Risks Related to Chemical Agents at Work and Implementing By-law for the
Protection of Workers from the Risks Related to Exposure to Carcinogen and
Mutagen Substances at Work issued by the Ministry of Labour and Social Secu-
rity ensure health and safety information is available to workers. Workplaces are
inspected by the MLSS, including MSDS Forms and risk reduction plans.

Report to the Commission
There is not such a responsibility in the existing legislation, since it is not appli-
cable for Turkey yet.

4.1.2     Legal Analysis

Licensing/registration

Inspection and Monitoring
        Authorisation of establishments such as laboratories
Laboratories are authorized according to the suggestion of the reference labora-
tory of the Ministry of Environment and Forestry and by the Decision of the Min-
ister. The MoEF works on a new Regulation for that. The laboratories are sup-
posed to comply with the requirements of Good Laboratory Practices By-law.
        The collection and evaluation of written or computerised information
         such as notifications from manufacturers/importers
All the data and information submitted by the importers and manufacturers are
kept in written forms in the Ministry of Environment and Forestry. The Ministry



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staff evaluates the submitted data according to the provisions of the Dangerous
Chemicals By-law.

The record of notifications made in the other countries and that are informed by
the EU countries are also kept in the Ministry.

A survey is being carried out for inventory and establishing a database under the
TeACH Project.
        Inspection and monitoring of activities to check that the correct proce-
         dures are being carried out
Inspections are carried out according to the Environmental Inspection By-law.
There are 170 inspectors all over Turkey. However, they are not specifically
trained in the field of chemicals. Therefore, one staff from the Chemicals Man-
agement Department joins in the inspection team, whenever there is inspection of
manufacturers/importers of chemicals/preparations according to the annual pro-
gramme. Among others, MSDS Forms are checked as well; however, they are not
checked for content but rather if they are in place.

Ministry of Labour and Social Security inspects the workplaces for their compli-
ance with the Implementing By-law on the Protection of the Health and Safety
Measures from the Risks Related to Chemical Agents at Work and Implementing
By-law for the Protection of Workers from the Risks Related to Exposure to Car-
cinogen and Mutagen Substances at Work as well as the Implementing Regula-
tion for the Protection Against Risks of Explosive Atmospheres.
        Enforcement action
Ministry of Environment and Forestry is entitled to issue administrative penalties
in compliance with the Amending Law of the Environment Law (No. 5491 dated
26 April 2006).


4.2       Asbestos

Responsible authority: Ministry of Environment and Forestry
                       General Directorate of Environmental Management
                       Chemicals Management Department

4.2.1     Institutional analysis

Design procedures for licensing/registering
There is no licensing requirement for manufacturing asbestos. However, prohibi-
tions and restrictions regarding manufacturing and use of asbestos with respect to
its types are defined in Section 7 of the Dangerous Chemicals By-law.

Communiqué of Standardization for Foreign Trade No. (2006/6) lays down pro-
cedures and principles for white asbestos, which is subject to receiving Chemical
Substances Importation Certificate from the MoEF together with other chemicals
listed in Annex II of the Communiqué.

Blue asbestos on the other hand is subject to import permission by the Ministry of
Labour and Social Security according to Import Communiqué 2006/13.




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Design procedures for compliance programmes

Design procedures for notification

Design procedures for inspection and verification
Inspection procedures are specified in the Environmental Inspection By-law
dated 5 January 2002. However, they are not specific for asbestos and the inspec-
tors are not specifically trained for inspecting asbestos related requirements.

Design procedures for safety requirements
       Classification
The classification procedures for dangerous chemicals and substances are de-
scribed in Art. 4 of the Dangerous Chemicals By-law dated 6 November 2001.
However, these procedures cannot be implemented because of the above men-
tioned reasons.
       Packaging
The packaging and storage requirements for asbestos are specified in section 7 of
the Dangerous Chemicals By-law.
       Labelling
The labelling requirements are described in section 4 of the Dangerous Chemicals
By-law. Specific requirements for labelling of asbestos are defined in Section 7.
       SDS
MSDS Forms are required according to the Art. 22 of the Dangerous Chemicals
By-law both from manufacturers and importers. The MSDS Forms are specified
in the Communiqué on the Procedures and Principles for Issuance of SDSs. The
manufacturers, importers and distributors are responsible for submitting the
MSDSs to the professional users in written or in electronic formats free of
charge.

Implementing By-law on Health and Safety in Asbestos Related Works issued by
the Ministry of Labour and Social Security requires manufacturers/distributors to
make MSDS Forms available at the workplaces.

Evaluate data supplied by manufacturers and importers
The applications for import are evaluated by the staff of the Ministry of Envi-
ronment and Forestry and by the staff of the Ministry of Labour and Social Secu-
rity whichever is applicable according to the type of asbestos. However, these
evaluations are in the sense of compliance check.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.

Implementing By-law on Health and Safety in Asbestos Related Works issued by
the Ministry of Labour and Social Security requires health risk assessment in the
workplaces, which are exposed to asbestos.

Evaluate risks to environment
There is not any procedure designed for evaluation of risks to environment.
However, the existing information regarding the ecological impacts is required to
be included in the application dossier for notification and import permit.




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Develop a strategy to limit risks and ensure emergency plans are in place
There are some R and S phrases specified for labelling in order to limit the risks.
However, there is no provision in the Dangerous Chemicals By-law to ensure
emergency plans are in place.

Implementing By-law on Health and Safety in Asbestos Related Works issued by
the Ministry of Labour and Social Security requires identifying general measures
and a work plan for occupational health and safety.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, MoEF is responsible
for designing the procedures for placing of asbestos on the market. There are
some restrictions and prohibitions regarding the marketing and use of some types
of asbestos according to the Dangerous Chemicals By-law. However, inspection
and enforcement mechanisms are not sufficient for effective control.

Control the import of certain chemicals
MoEF requires importers to get permit for importing certain chemicals. Commu-
niqué of Standardization for Foreign Trade No. (2006/6) lays down procedures
and principles of permitting chemicals, which are subject to getting Chemical
Substances Importation Certificate.

For Annex II chemicals, which are industrial chemical substances and/or prepara-
tions subject to the Chemical Substances Import Certificate, the following proce-
dures are applied:

Importers who want to import chemicals listed in Annex II of the Communiqué,
which includes white asbestos, should receive Chemical Substance Import Cer-
tificate from MoEF (Article 7). Importers should apply to the MoEF Department
of Chemicals Management (Article 8). Following the end of the validity of cer-
tificate within one year, original copy of the Certificate together with other actual
import documents including the label and MSDS Form should be returned to the
Ministry. The MoEF is informed about importation (name of the supplier, im-
porter, amount of substances imported) during given back of Certificate. Label
and MSDS is checked for the conformity of the importation after it actually oc-
curred.

Import of asbestos except white asbestos is forbidden according to Article 37 of
Dangerous Chemicals By-law since 1996. Asbestos samples which will be im-
ported are checked by Laboratories of General Directorate of Occupational
Health and Safety to learn if they are white asbestos or not and import of asbestos
except white asbestos is not allowed.

Under-secretariat for Foreign Trade is responsible for taking necessary meas-
ures during process and making necessary arrangements.

Control the export of certain chemicals.
The scope of the Dangerous Chemicals By-law covers exports as well. However
there is no specific mechanism set for control.

Ensure compliance with rules on confidentiality of information


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Confidentiality of the information is secured somewhat in Annex III of the Dan-
gerous Chemicals By-law. However, it needs to be revised in compliance with
the Directive 67/548/EEC.

Publicise requirements to relevant manufacturers
By-law on Dangerous Chemicals is publicized in the web site of the Ministry of
Environment and Forestry.

Publicise requirements to relevant importers
Requirements to relevant importers of chemical substances and preparations are
available in the web site of the Undersecreteriat for Foreign Trade.

Publicise requirements to relevant exporters

Ensure health and safety information is available to workers
Implementing By-law on Health and Safety in Asbestos Related Works issued by
the Ministry of Labour and Social Security ensures health and safety information
is available to workers. Workplaces are inspected by the MLSS, including MSDS
Forms and risk reduction plans.

Report to the Commission
There is not such a responsibility in the existing legislation, since it is not appli-
cable for Turkey yet.

4.2.2     Legal analysis

Licensing/registration

Inspection and Monitoring
        Authorisation of establishments such as laboratories
Laboratories are authorized according to the suggestion of the reference labora-
tory of the Ministry and by the Decision of the Minister. The MoEF works on a
new Regulation for that. The laboratories are supposed to comply with the re-
quirements of Good Laboratory Practices By-law.
        The collection and evaluation of written or computerised information
         such as notifications from manufacturers/importers
All the data and information submitted by the importers and manufacturers are
kept in written forms in the Ministry. The Ministry staff evaluates the submitted
data according to the provisions of the Dangerous Chemicals By-law.

The record of notifications made in the other countries and that are informed by
the EU countries are also kept in the Ministry.

A survey is being carried out for inventory and establishing a database under the
TeACH Project.
       Inspection and monitoring of activities to check that the correct proce-
        dures are being carried out
Inspections are carried out according to the Environmental Inspection By-law
under the coordination of Monitoring and Inspection Department. There are about
170 inspectors all over Turkey, however, they are not specifically trained for
inspection of asbestos.



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Ministry of Labour and social Security inspects the workplaces for their compli-
ance with the Implementing By-law on Health and Safety in Asbestos Related
Works.
       Enforcement action
Ministry of Environment and Forestry is entitled to issue administrative penalties
in compliance with the Amending Law of the Environment Law (No. 5491 dated
26 April 2006).

Ministry of Labour and Social Security is also entitled to issue fines to the enter-
prises, which do not comply with the Implementing By-law on Health and Safety
in Asbestos Related Works.


4.3       Ozone Depleting Substances

Responsible authority: Ministry of Environment and Forestry
                       General Directorate of Environmental Management
                       Air Quality Management Department

4.3.1     Institutional analysis

Design procedures for licensing/registering
The By-law on Ozone Depleting Substances was first issued in 1999 and it was
repealed very recently. The new By-law on Phasing out of Ozone Depleting Sub-
stances was put into effect on 23 May 2006. Manufacturing of ozone depleting
substances as well as establishing new plants which uses ozone-depleting sub-
stances is prohibited by the By-law. The By-law on Phasing out of Ozone Deplet-
ing Substances regulates manufacturing, importing, use and prohibition of ozone
depleting substances. It also defines a ―phasing out calendar‖ starting from 2006.

Communiqué of Standardization for Foreign Trade No. (2007/6) lays down pro-
cedures and principles for issuing control certificate by the Ministry of Environ-
ment and Forestry for ozone depleting substances listed in Annex I of the Com-
muniqué.

Communiqué No. 2007/14 on ozone depleting substances, on the other hand,
defines the prohibitions and restrictions brought to the importation of the ozone
depleting substances as well as lists the substances, which are subject to permis-
sion by the MoEF. The annual amounts of importation of substances are identi-
fied in the Communiqué. Currently, the annual amounts are phased out ac-
cording to an action plan and reduced to zero.

Under-secretariat for Foreign Trade is responsible for taking necessary meas-
ures during process and making necessary arrangements.

Design procedures for compliance programmes
Phasing out calendar is defined in the By-law on Phasing out of Ozone Depleting
Substances.

Design procedures for notification




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Procedures for notification of imported substances by the distributors including
the information on quantities sold, purchasers, end uses, etc. are specified in the
By-law on Phasing out of Ozone Depleting Substances.



Design procedures for inspection and verification
Inspection procedures are specified in the Environmental Inspection By-law
dated 5 January 2002.

Design procedures for safety requirements
        Classification
List of substances, which are prohibited or restricted are listed in the By-law on
Phasing out of Ozone Depleting Substances.
        Packaging
The packaging requirements for the substances destined for laboratory use are
given in Annex I of the By-law on Phasing out of Ozone Depleting Substances.
        Labelling
Labelling requirements are mentioned regarding the substances destined for labo-
ratory use only in the By-law on Phasing out of Ozone Depleting Substances; but
requirements are not specified in detail.
        SDS
Not applicable

Evaluate data supplied by manufacturers and importers
The applications for import are evaluated by the staff of the Ministry.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.

Evaluate risks to environment
The risks to environment are very well known. So there is not any procedure
designed for evaluation of risks to environment.

Develop a strategy to limit risks and ensure emergency plans are in place

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, MoEF is responsible
for designing the procedures for placing of ozone depleting substances on the
market. There are some prohibitions and restrictions/limitations regarding the
marketing and use of ozone depleting substances according to the By-law on
Phasing out of Ozone Depleting Substances. The Ministry controls import per-
mitting system of these substances.

Control the import of certain chemicals
The quotas on ozone depleting substances are phased out and import of
these substances is prohibited. However, for essential use in laboratories
maintenance, repair and servicing needs of the equipment, pre-
transportation / shipping and emergency use, MoEF and MARA give the
permissions.



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Control the export of certain chemicals.
Not applicable



Ensure compliance with rules on confidentiality of information
Confidentiality of the information is secured by Article 7 of the By-law on Phas-
ing out of Ozone Depleting Substances.

Publicise requirements to relevant manufacturers

Publicise requirements to relevant importers

Publicise requirements to relevant exporters

Ensure health and safety information is available to workers
It is not under the responsibility of the MoEF.

Report to the Commission
There is not such a responsibility in the existing legislation.

4.3.2     Legal analysis

Licensing/registration

Inspection and Monitoring
       Authorisation of establishments such as laboratories
Customs laboratories if possible, otherwise laboratories of public institutions or
universities are authorized to perform the compliance checks.
       The collection and evaluation of written or computerised information
        such as notifications from manufacturers/importers
All the data and information submitted by the importers are kept in written forms
in the Ministry. The Ministry staff evaluates the submitted data according to the
provisions of the By-law on Phasing out of Ozone Depleting Substances.

There is also on-going project of TeACH for establishing the database.
       Inspection and monitoring of activities to check that the correct proce-
        dures are being carried out
Inspections are carried out according to the Environmental Inspection By-law.
       Enforcement action
The sanctions are defined in Article 21 of the By-law on Phasing out of Ozone
Depleting Substances. Ministry of Environment and Forestry is entitled to issue
administrative penalties in compliance with the Amending Law of the Environ-
ment Law (No. 5491 dated 26 April 2006).


4.4       Biocidals

4.4.1     Institutional analysis

Responsible authority: General Directorate of Primary Health Care



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                              General Directorate of Curative Services
                              General Directorate of Drug and Pharmacy

Design procedures for licensing/registering
In the existing system, the General Directorate of Primary Health Care is respon-
sible for 5 groups of biocidals , the General Directorate of Curative Services is
responsible for one group and the General Directorate of Drug and Pharmacy is
responsible for another group of biocidal products. Registration and licensing are
required for manufacturing and/or importing of 5 groups of biocidal and disinfec-
tants based on a circular referring to the General Hygiene Law and Regulation on
Specifications for Foodstuff and Articles and Supplies Involving Public Health.
The registrants are required to fill in the ―Application Form for Import and
Manufacturing of Insecticides, Rodenticides, Mollulicides‖. Active ingredients,
results of the scientific tests (for effectiveness?) are required to be submitted with
the application dossier.

Design procedures for compliance programmes
There is an on-going twinning project on Biocidals. One of the outputs of the
project is the transposition of the Directive 98/8/EC. There is no designed com-
pliance program yet. The first draft of the By-law on Biocidals was be issued by
the end of September 2006.

Design procedures for notification
Since manufacturing and importing of a newly developed substance, i.e. a sub-
stance, which is intended to be placed on the market for the first time in the world
are not allowed, there is no notification procedure designed for them.

Design procedures for inspection and verification
MoH is entitled to perform the inspections through its provincial directorates and
public health laboratories.

There are 3 universities, which are authorised to carry out the effectiveness tests
for biocidals: Ankara University, Akdeniz University (Antalya) and Ege Univer-
sity (Izmir). However, these university laboratories are neither in compliance
with the GLP requirements nor accredited5.

There are no inspection programs and procedures. Inspections are based on the
claims raised by the consumers and/or competitors.

Design procedures for safety requirements
       Classification
Classification procedures are described in the Circular on Import and Manufac-
turing of Insecticides, Rodenticides, Mollulicides. The classification is based on
the WHO system.
       Packaging
       Labelling
The procedures for labelling are described in the Circular mentioned above.
While submitting the application form for licensing, applicant should also submit
the proposal for the label. This proposal is subject to approval by the MoH, based


5
    There are some on-going efforts for accreditation of the R. S. Hygiene Institute.


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on the results of the analysis carried by the R.S. Central Hygiene Institute (Toxi-
cology Research Laboratories) and the labelling system of WHO.
       SDS
The MSDSs are also under the responsibility of the companies, which are the
professional users of the biocidals. They have to request the MSDSs from the
manufacturers/importers/distributors; and comply with the instructions in the
MSDSs.

Evaluate data supplied by manufacturers and importers
The scientific committee comprising of 3 toxicologists/biologists from the uni-
versities, 1 representative from the Pest Control Research Laboratories, 1 repre-
sentative from Institute for Combating Malaria and 2 representatives from the
Refik Saydam Hygiene Institute evaluates the application dossier. After evalua-
tion of the dossier, the samples are analysed in the Refik Saydam Hygiene Insti-
tute, Toxicology Laboratories for verification.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.
However, the existing information regarding the human health risks is required to
be included in the dossier.

Evaluate risks to environment
There is not any procedure designed for evaluation of risks to environment.
However, the existing information regarding the environmental risks is required
to be included in the dossier.

Develop a strategy to limit risks and ensure emergency plans are in place
The Regulation on the Guidelines and Techniques of Using Biocidals Against
Vectors in the Field of Public Health sets the rules for permitting the legal entities
and real persons, for using biocidals and specifies measures to limit the health
risks of biocidals.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, the MoH is responsible
for designing the procedures for placing of biocidals on the market. However,
Ministry‘s identified responsibilities cover only 7 groups of biocidals. Consider-
ing that 2 groups are under the responsibility of MARA, the competent authority
for 14 groups of biocidals still remains undefined.

Control the import of certain chemicals
The MoH issues import permits through a similar procedure for licensing. The
MoH requires submission of the documents including the approval of the Compe-
tent Authority for marketing and use of that biocidal in the country of origin be-
fore issuing any import permit.

Control the export of certain chemicals.
No defined responsibility

Ensure compliance with rules on confidentiality of information
There isn‘t any provision regarding rules on confidentiality of information in the
existing legislation.


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Publicise requirements to relevant manufacturers
There is a web page of the Ministry. All new legislation is publicised in the web
site.



Publicise requirements to relevant importers
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Publicise requirements to relevant exporters
Responsibility of the Ministry is not clear

Ensure health and safety information is available to workers
The By-law on the Guidelines and Techniques of Using Biocidals Against Vec-
tors in the Field of Public Health identifies some measures to ensure health and
safety of the workers. However, the responsibilities for the availability of the
health and safety information are not clear.

Report to the Commission
There is not such a responsibility in the existing legislation.

4.4.2     Legal analysis

Licensing/registration
Manufacturing and Import of the biocidals is subject to licensing in compliance
with the Organic Law of the Ministry of Health (No. 181) General Hygiene Law
(No. 1593 dated 1930) and Regulation on Specifications for Foodstuff and Arti-
cles and Supplies Involving Public Health (dated 1952 amended 1982).

Inspection and Monitoring
       Authorisation of establishments such as laboratories
Laboratories are authorised in compliance with the By-law on Good Laboratory
Practices and Authorisation of Testing Laboratories dated 25.06.2002.
       The collection and evaluation of written or computerised information
        such as notifications from manufacturers/importers
A survey is carried out to develop the inventory of biocidals in Turkey, within the
scope of the on-going Twinning Project on Biocidals. Information in the licens-
ing dossiers are kept in written forms.
       Inspection and monitoring of activities to check that the correct proce-
        dures are being carried out
Inspections are based on General Hygiene Law. There is no provisions regarding
monitoring.
       Enforcement action
Enforcement action is carried out in compliance with the General Hygiene Law
(No. 1593 dated 1930) and Turkish Penal Code. Penalties are removing the prod-
ucts from the market and seizing of production.

Data Collection and Reporting
     To gather and analyse data, as well as to inform the Commission



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There is not such a responsibility of the Ministry in the existing legislation.




4.5       Cosmetics

4.5.1     Institutional analysis

Responsible authority: Ministry of Health General Directorate of Pharmacy and
Pharmaceuticals

Design procedures for licensing/registering
All producers, which include ―the manufacturer of the product and any other
person or legal person presenting himself as the manufacturer by affixing to the
product his name, trade mark or other distinctive mark, or the person or legal
person who reconditions the product; the manufacturer's representative and/or
importer, when the manufacturer is not established in Turkey; besides other pro-
fessionals in the supply chain, insofar as their activities may affect the safety
properties of a product‖ cosmetic products to the Ministry of Health, General
Directorate of Pharmacy and Pharmaceuticals, Cosmetics Unit in compliance
with the .

Design procedures for compliance programmes
Based on the Cosmetics Law 5324, Cosmetics By-law was issued on 23 May
2005 for transposition of the Directive 76/768/EEC and reflecting the Council
Decision 96/335/EC. The Ministry is entitled to give 36-month transition period
for the cosmetics already on the market to comply with this regulation.

Design procedures for notification
Procedures for notification are clearly defined in the Cosmetics By-law dated 23
May 2005 issued by the MoH.

Design procedures for inspection and verification
MoH is entitled to perform the inspections through its provincial directorates.
The samples are analysed in the R. S. Central Hygiene Institute, Medicine and
Cosmetics Research Laboratories. There are some on-going efforts for accredita-
tion of the R. S. Hygiene Institute.

Inspections are based on the claims raised by the consumer and/or competitors.
There is not any guideline for the procedures of inspections yet. There has been
an inspection program recently regarding the eau-de-cologne on the market. Min-
istry is planning to prepare some programs for inspections regarding the safety of
the products on the market.

Design procedures for safety requirements
      Classification
Not applicable
      Packaging
Not applicable


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      Labelling
The procedures for labelling are described in Article 10 of the Cosmetics By-law.
      SDS
Not applicable.

Evaluate data supplied by manufacturers and importers
Not applicable.

Evaluate risks to human health
Not applicable.


Evaluate risks to environment
Not applicable.

Develop a strategy to limit risks and ensure emergency plans are in place
Producers are required to notify the Toxicology Consultancy Centre by sending
the form in Annex 10 of the By-law before placing the cosmetic products on the
market. Thus, in case of any adverse impact on the consumers, all the information
is available in the Centre.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, the MoH is responsible
for controlling the placing of cosmetics on the market. The Cosmetics By-law
regulates it.

Annex II of the By-law will be revised according to the new By-law on Danger-
ous Chemicals, after the transposition of 67/548/EEC. The deadline declared to
the EU is June 2007.

Control the import of certain chemicals
The MoH requires similar notification from the importers of cosmetic products.

Control the export of certain chemicals.
No defined responsibility

Ensure compliance with rules on confidentiality of information
Article 12 of the By-law ensures confidentiality.

Publicise requirements to relevant manufacturers
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Publicise requirements to relevant importers
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Publicise requirements to relevant exporters
Responsibility of the Ministry is not clear

Ensure health and safety information is available to workers


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It is not under the responsibility of the MoH.

Report to the Commission
There is not such a responsibility in the existing legislation.

4.5.2     Legal analysis

Licensing/registration
Manufacturing and Import of the cosmetics is subject to registration in compli-
ance with the Cosmetics Law (No. 5324) and Cosmetics By-law dated 23 May
2005.

Inspection and Monitoring
        Authorisation of establishments such as laboratories
        The collection and evaluation of written or computerised information
         such as notifications from manufacturers/importers
All registrations are kept in a database in the General Directorate of Medicines
and Pharmacology, Cosmetics Unit.
        Inspection and monitoring of activities to check that the correct proce-
         dures are being carried out
Inspections are based on General Hygiene Law. There is no provisions regarding
monitoring.
        Enforcement action
Enforcement is in compliance with the Cosmetics Law. Not being in conformity
with the procedures deserves 10 thousand YTL penalty, incompliance with the
notified specifications deserves 50 thousand YTL.

Data Collection and Reporting
       To gather and analyse data, as well as to inform the Commission
There is not such a responsibility of the Ministry in the existing legislation.


4.6       Plant Protection Products

4.6.1     Institutional analysis

Responsible authority: Ministry of Agriculture and Rural Affairs-
                       General Directorate of Protection and Control

Design procedures for licensing/registering
Registration is required for manufacturing and/or importing of pesticides (as
preparations), referring to the By-law on Registration of Pesticides and Similar
Products dated 17.02.1999. Formulations, toxicological test results, eco-
toxicological test results are required to be submitted with the application dossier.
Applications are admitted on one application for one preparation basis.

Design procedures for compliance programmes
The Ministry works on transposing 99/414/EC and 79/117/EEC to Turkish legis-
lation.

Design procedures for notification


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Since manufacturing and importing of newly developed substances, i.e. a sub-
stance, which is intended to be introduced into market for the first time in the
world are not allowed, there is no notification procedure designed for them.
However, the preparations, which are new for the Turkish market, are subject to
registration. Preparations, which are originating from EU Countries, G7 Coun-
tries or the country of origin of the preparation is within the top three producers
in the world are eligible for registration.

Design procedures for inspection and verification
MARA is entitled to perform the inspections through its provincial directorates
and sub-provincial directorates. Procedures for inspection and verification are
clearly specified in the By-law on the Control of Pesticides dated 22 June 1995.

Verification is carried out through physical and chemical analysis of the samples
in the Pest Control Central Research Institute laboratories.

Design procedures for safety requirements
        Classification
The pesticides are classified according to their toxicity specifications in compli-
ance with the Directive on Toxicological Classification of Pesticides.
        Packaging
There is not any specific provision regarding packaging of pesticides in the exist-
ing legislation. However, the By-law on the Wholesale and Retail Marketing and
Storage of Pesticides specifies how the packages should be handled. Transposi-
tion of Directive 67/548/EEC is expected to lead to the packaging provisions in
the legislation.
        Labelling
The procedures for labelling are described in the By-law on Labelling of Pesti-
cides. While submitting the application form for registration, applicant should
also submit the proposal for the label. This proposal is subject to approval by
MARA. However, the By-law on Labelling is not in compliance with
67/548/EEC. It is in compliance with WHO system.
        SDS
The MSDSs are not required in the existing system, except for pheromones.

Evaluate data supplied by manufacturers and importers
The application dossier is evaluated by the Pesticide Registration Committee,
comprising of 25-30 members from universities, Pesticide Research Institutes of
the Ministry. After evaluation of the dossier, the samples are analysed in the
laboratories of Pesticides Research Institutes in Ankara and in Istanbul for verifi-
cation.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.
However, the existing information regarding the toxicity is required to be in-
cluded in the dossier.

Evaluate risks to environment
There is not any procedure designed for evaluation of risks to environment.
However, the existing information regarding the eco-toxicity is required to be
included in the dossier.



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Develop a strategy to limit risks and ensure emergency plans are in place
There isn‘t any strategy developed for limiting the risks, except marketing and
storage measures in the By-law.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, MARA is responsible
for designing the procedures for placing of pesticides on the market. MARA al-
ready banned some plant protection products by issuing the Communiqué on
Banning the Marketing and Use of Some Plant Protection Products with some
Specific Active Ingredients (No. 2003/43). They control pesticides through regis-
tration of manufacturers and importers as well as authorisation of distributors in
compliance with the By-law on the Wholesale and Retail Marketing and Storage
of Pesticides.

Control the import of certain chemicals
MARA requires registration for importers as well. Control of imported pesticides
are subject to Communiqué on Standardisation in Import No. 2006/5.

Control the export of certain chemicals.
Export of pesticides are subject to the provisions in Section 3 of the Regulation
on Agricultural Pesticides and Equipment.

Ensure compliance with rules on confidentiality of information
Confidentiality of the information is secured by Article 3 of the Regulation on
Agricultural Pesticides and Equipment.

Publicise requirements to relevant manufacturers
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Publicise requirements to relevant importers
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Publicise requirements to relevant exporters
There is a web page of the Ministry. All new legislation is publicised in the web
site.

Ensure health and safety information is available to workers
It is not under the responsibility of the MARA.

Report to the Commission
There is not such a responsibility in the existing legislation.

4.6.2     Legal analysis

Licensing/registration
With Respect to the By-law on Registration of Pesticides and Similar Products
dated 17 February 1999.

Inspection and Monitoring


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        Authorisation of establishments such as laboratories
Art. 5 of the Regulation on Agricultural Pesticides and Equipment give responsi-
bility of authorization of laboratories for verification.
        The collection and evaluation of written or computerised information
         such as notifications from manufacturers/importers
All the data and information are kept in written forms in the Ministry. There are
electronic forms of the information since 2002.
        Inspection and monitoring of activities to check that the correct proce-
         dures are being carried out
Pesticide distributors and manufacturers are inspected by the staff of the Ministry
in the Provincial and Sub-Provincial Directorates in compliance with the proce-
dures set in the By-law on the Control of Pesticides.
        Enforcement action
Increasing sanctions expanding from warning, notification, fines to the termina-
tion of operation in compliance with the Law on Agricultural Quarantine and
Control dated 15 May 1957 and Turkish Penal Code. Penalties set in the Law on
Agricultural Quarantine and Control are obsolete.

Data Collection and Reporting
       To gather and analyse data, as well as to inform the Commission
There is not such a responsibility of the Ministry in the existing legislation.


4.7       Petroleum Products

4.7.1     Institutional analysis

Responsible authority: Energy Market Regulatory Authority
                       Department of Petroleum Products

Design procedures for licensing/registering
According to the Petroleum Market licensing By-law, licensing is required for all
the activities of placing on market the petroleum or petroleum products after
processing. These activities include refining, manufacturing, processing, import-
ing, distributing, handling, transportation, storage, retail sales etc. Licenses are
issued for real persons or legal entities for each product and for each installation.
The general purpose of licensing is based on regulating the market for fair com-
petition. The licensing procedures cover gasoline types, naphtha (except naphtha
used as raw material and solvent), kerosene, jet fuel, diesel types, fuel types and
bio-diesel.

Design procedures for compliance programmes
There is no procedure for compliance of petroleum products in line with the re-
quirements of 67/548 and 99/45, as well as MSDS Directive.

Design procedures for notification
There is no notification procedure in line with the EU requirements. However, all
the refiners, manufacturers, importers, distributors, transporters, processors, re-
tailers are required to get license from EMRA.

Design procedures for inspection and verification



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The personnel of gendarmerie, police, coast guard and Ministry of Industry and
Trade according to the protocols between EMRA and these institutions carry out
inspections. Inspections are usually carried out upon claims and suspects for
quality compliance. The substances and preparations under suspect are sent to
laboratories for testing. METU PAL laboratory, TUBITAK MAM Laboratories
and Vitsan (Dilovası) Laboratories are authorize to carry out the tests.

Design procedures for safety requirements
       Classification
There is not such legislation. Classification is made according to the Customs
Tariff Statistical Position Number (GTIP)
       Packaging
There is not any specific legislation issued by EMRA regarding packaging of
petroleum products in the existing legislation. However, there is a general Turk-
ish standard (TS 4331) for Packaging and Labelling.
       Labelling
There is not any specific provision regarding labelling of petroleum products in
the existing legislation. Only lube-oil is subject to labelling according to the By-
law on Labelling of Lube Oil issued by the Ministry of Industry and Trade.
       SDS
The MSDSs are not required in the existing system.

Evaluate data supplied by manufacturers and importers
The application dossier is evaluated by the staff of Petroleum Market Department
in EMRA.

Evaluate risks to human health
There is not any procedure designed for evaluation of risks to human health.

Evaluate risks to environment
There is not any procedure designed for evaluation of risks to environment.

Develop a strategy to limit risks and ensure emergency plans are in place
There isn‘t any strategy developed for limiting the risks.

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, EMRA is responsible
for designing the procedures for placing of petroleum products on the market.
They control petroleum products through licensing and permitting for import.
The priority is given at present to the final products or semi-products, which are
directly supplied to consumers.

Control the import of certain chemicals
EMRA requires permitting for importers, who do not carry any license; in other
words the persons or legal entities, who will import the petroleum products (bulk
or packed) for their own use in industrial process. Controls of imported petro-
leum products are subject to Communiqué on Imports No. 2007/12.

Control the export of certain chemicals.




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Ensure compliance with rules on confidentiality of information
Confidentiality of the information is secured by Article 54 of the Petroleum Mar-
ket Licensing By-law as well as Article 6 of Petroleum Market Information Sys-
tem By-law.

Publicise requirements to relevant manufacturers
There is a web page EMRA. All new legislation is publicized in the web site.

Publicise requirements to relevant importers
There is a web page of EMRA. All new legislation is publicized in the web site.

Publicise requirements to relevant exporters
There is a web page of EMRA. All new legislation is publicized in the web site

Ensure health and safety information is available to workers
It is not under the responsibility of the EMRA.

Report to the Commission
Not applicable

4.7.2     Legal analysis

Licensing/registration
With Respect to the Petroleum Market Licensing By-law dated 17 June 2004.

Inspection and Monitoring
        Authorisation of establishments such as laboratories
The quality of substances and preparations are verified in Middle East Technical
University Petroleum Research Laboratory (METU PAL), TUBITAK MAM
(Gebze) Laboratories and Vitsan (Dilovası) Laboratories, which are accredited
for 20 tests in total out of 35 required tests. None of these laboratories has the
capacity to carry out even 20 tests.
        The collection and evaluation of written or computerised information
         such as notifications from manufacturers/importers
All the refiners, manufacturers, importers, distributors, transporters, processors,
retailers, etc. are required to send the data required by the Petroleum Market In-
formation System By-law. All the data and information required by the kept in
databases.
        Inspection and monitoring of activities to check that the correct proce-
         dures are being carried out
Inspection and monitoring activities are for product quality checks.
        Enforcement action
Administrative and other sanctions, which cover fines, cancellation of licenses,
sending off-spec products to refineries, or country of origin are applied as en-
forcement action, as a result of quality checks of petroleum products.

Data Collection and Reporting
       To gather and analyze data, as well as to inform the Commission
The data are gathered according to the Petroleum Market Information System By-
law.




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4.8       Methyl alcohol and Ethyl Alcohol

4.8.1     Institutional analysis

Responsible authority: Tobacco, Tobacco Products and Alcoholic
                       Beverages Market Regulatory Authority (TAPDK)

Design procedures for licensing/registering
The ones who want to produce and sell tobacco products must receive produc-
tion, sale and/or conformity certificates according to Law dated 9/01/2002 and
no. 47336 and those who wish to sell any kind of beverages with spirit including
spirits, beer wine must acquire a license from the Monopoly Administration ac-
cording to Law dated 8/6/1942 and no. 42507. In the application of production
license technical specifications related to the product need to be submitted to the
Authority. Applications are evaluated by the Tobacco, Tobacco Products and
Alcoholic Beverages Market Regulatory Authority and concluded by Tobacco,
Tobacco Products and Alcoholic Beverages Market Regulatory Board (TTPAB).

Design procedures for compliance programmes

Design procedures for notification
Manufacturing of alcohol and alcoholic beverages are subject to permit by the
Tobacco Products and Alcoholic Beverages Market Regulatory Authority.

Each firm submits notification to the Authority for manufacturing of methanol
and ethanol; and submits its three-month activity report regularly. The firm re-
ports registered the raw materials, semi-products, manufactured goods, by-
products and refuses showing the mass equilibrium concerning the production
process of the enterprise in the form of operation report. A fiscal report in which
is registered the tax assessment presenting the commercial activity of the enter-
prise according to By-law on Principles and Procedures Governing Domestic and
Foreign Trade of Alcohol and Alcoholic Beverages is also reported.

Producer or importer firms are obliged to submit their sale report demonstrating
their monthly trade activities in the electronic form required by the Authority and
to send it to the Authority of the 20th day of the month following the reporting
month according to By-law on Principles and Procedures Governing Domestic
and Foreign Trade of Alcohol and Alcoholic Beverages Article 15.

Design procedures for inspection and verification
At all stages of the production process, inspection is carried out in conformity
with the determined inspection program or in case of doubt or complaint.

The Tobacco, Tobacco Products and Alcoholic Beverages Regulatory Au-
thority is authorized to do any kind of market surveillance and supervision or to
have these done with regard to products and services according to By-law on

6
  Law on the Amendments to the Law No 4046, Decree in Force of Law No 233 and the
Restructuring of the Directorate General for Tobacco, Tobacco Products, Salt and Alco-
hol Facilities
7
  Law on Monopoly of Spirits Beverages with Spirit



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Principles and Procedures Governing Domestic and Foreign Trade of Alcohol
and Alcoholic Beverages. Final decision in market surveillance and supervision
lies with the Authority. Production By-law8 covers the inspection procedures and
principles regarding the production of alcohol and alcoholic beverages.

Design procedures for safety requirements
       Classification
       Packaging
Communiqué on the Market Supply of Ethyl Alcohol states regulations on pack-
aging.
       Labelling
Communiqué on the Marketing of Ethyl Alcohol states regulations about label-
ling and packaging. On alcohol pack, product information should be indicated
fully, accurately and understandably in line with the By-law on Dangerous
Chemicals published in the Official Gazette dated 11/7/1993 and no. 21634; lan-
guage of the label should be Turkish; all writings should be resistant to alcohol
and water, in a readable colour and the label should be stuck to the pack safely.

On the label, there should also be the danger sign given in Annex-4 of the Com-
muniqué on the Marketing of Ethyl Alcohol and clear indication of safety instruc-
tions. The Tobacco, Tobacco Products and Alcoholic Beverages Market Regula-
tory Board should approve alcoholic beverages labels.

Evaluate data supplied by manufacturers and importers
The applications completed are evaluated by the Authority within 3 months the
latest and concluded by the Board, taking into consideration the requirements of
the public health, and other requirements. The firm notifies for test production.
After the evaluation of the results of the test production, Board issues the manu-
facturing permit.

Evaluate risk to human health
Information may be required with the application.

Evaluate risks to environment

Develop a strategy to limit risks and ensure emergency plans are in place

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, TTPAB is responsible
for designing the procedures for placing of methanol and ethanol on the market.
However, the responsibilities of the TTPAB and TAPDK are not clear when
methanol and ethanol are placed on the market for industrial use, other than
manufacturing of alcoholic beverages.

Placing of methanol and ethanol is controlled through permission and licensing
of the manufacturers and certificate of conformity for importers as well as au-
thorization of distributors.

8
 By-law on the Technical Conditions that the Alcohol and Alcoholic Beverage Facilities
Must Bear and on the Procedures and Principles Concerning Their Foundation, Operation
and Control


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Control the import of certain chemicals
Firms are obliged to receive certificate of conformity with imports on firm and
product brand basis from the Authority for import of alcohol, alcoholic beverage
and methanol to be supplied to the market and included in the Annex 1 men-
tioned in paragraph (b) of the article 6 of By-law on Principles and Procedures
Governing Domestic and Foreign Trade of Alcohol and Alcoholic Beverages.
Customs administration requires certificate of conformity issued by the Author-
ity, for import of these products.

For import of food alcohol, industry type of ethyl alcohol, alcoholic mixtures and
methanol to be imported, firms are obliged to receive a certificate of conformity
with imports on firm and product basis from the Authority to give it to the rele-
vant customs administration in compliance with the By-law on Principles and
Procedures Governing Domestic and Foreign Trade of Alcohol and Alcoholic
Beverages.

Control the export of certain chemicals
Export of the products covered with the By-law on Principles and Procedures
Governing Domestic and Foreign Trade of Alcohol and Alcoholic Beverages is
subject to provisions of the Export Regime Resolution, Export By-law and rele-
vant Communiqués. Those who wish to export raw ethyl alcohol or methyl alco-
hol are obliged to acquire a permit from the Monopoly Administration.

Ensure compliance with rules on confidentiality of information
Information and documentation provided to the Authority by firms and other
relevant agencies during the procedures of certificate of conformity and authori-
zation and during surveillance and supervision are kept confidential in exclusive
of those ensuring the sector transparency and improving awareness of consump-
tion and so long as they don‘t pose an urgent threat for public safety according to
By-law on Principles and Procedures Governing Domestic and Foreign Trade of
Alcohol and Alcoholic Beverages.

Publicise requirements to relevant importers
There is a web page of the Authority. All new legislation is publicised in the web
site of the Authority. According to the By-law on Principles and Procedures
Governing Domestic and Foreign Trade of Alcohol and Alcoholic Beverages, it
is under the responsibility of the authorised firms to follow up all the information
publicised in the web site of the Authority and make necessary changes in their
operations in compliance with the changes in the legislation and procedures and
notify the Authority.

Publicise requirement to relevant manufacturers
Same as above.

Publicise requirement to relevant exporters
Same as above.

Ensure health and safety information is available to workers
No provision in the existing legislation.

Report to the Commission


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There is not such a responsibility in the existing legislation.

4.8.2     Legal analysis

Licensing/registration
For manufacturing and import of tobacco and alcohol products the firms should
apply for licensing according to Law on Restructuring of the Directorate General
for Tobacco, Tobacco Products, Salt and Alcohol Facilities (dated 9/1/2002 and
no. 4733) and Law on Monopoly of Spirits Beverages with Spirit (dated 8/6/1942
and no. 4250), By-law on Principles and Procedures Governing Domestic and
Foreign Trade of Alcohol and Alcoholic Beverages Production By-law.

Authorisation of establishments such as laboratories
Article 3 of Law dated 9/1/2002 and no. 4733 states that the Tobacco, Tobacco
Products and Alcoholic Beverages Market Regulatory Board, decision body of
the Tobacco, Tobacco Products and Alcoholic Beverages Market Regulatory
Authority determines the conditions regarding the establishment and management
of accredited laboratories linked to the Authority.

The collection and evaluation of written or computerised information such
as notifications from manufacturers
All applications are collected and evaluated by Authority. All information are
kept in a database. However, the Authority does not track the amount of metha-
nol and ethanol placed on the market for industrial use other than manufacturing
of alcoholic beverages.

The collection and evaluation of written or computerized information such
as notifications from importer/exporter
All applications are collected and evaluated by Authority. All information are
kept in a database.

Inspection and monitoring of activities to check that the correct procedures
are being carried out
By-law on Principles and Procedures Governing Domestic and Foreign Trade of
Alcohol and Alcoholic Beverages and Production By-law covers procedures and
principles of inspection and monitoring of alcohol and alcoholic beverages.
However, these procedures do not cover the inspection of the methanol and etha-
nol placed on the market for industrial use other than alcoholic beverages. There
is a gap in market surveillance and inspection in this sense.

Enforcement action
Enforcement is applied in compliance with the Law dated 9/01/2002 and no.
4733. The ones producing tobacco, tobacco products and alcoholic beverages at
factories, facilities or workshops, without a permit to establish and operate such
places; the ones who manufacture such products at their workplace or residence
shall be sentenced to one to three years of imprisonment and obliged to pay a fine
which is ten times more than the market value of the tobacco, tobacco products
and alcoholic beverages seized but not less than two hundred twenty five million
TL (225 YTL).

Regarding those who keep or supply to the market unsafe products are notified to
administrative authorities pursuant to the Turkish Penal Code and those who


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cause loss of tax by misstating the sale figures in monthly commercial activities
sales report are notified to administrative authorities pursuant to the Law dated
8/6/1942 and no. 4250.

To gather and analyse data, as well as to inform the Commission
Not applicable.




4.9       Chemicals which can be used for manufacturing chemi-
          cal weapons

Responsible authorities: Ministry of Industry and Trade (MIT) and
                         Under-secretariat for Foreign Trade (UFT)

4.9.1     Institutional analysis

Design procedures for licensing/registering
Communiqué of Import No. (2006/17) on importation of substances listed in the
annexes to the Convention on the Control of Chemical Weapons lay down the
principles and the procedures for regulation of importation.

Importation of the substances listed in Annex I is prohibited. In case of research,
pharmaceutical and protective purpose importation of the substances listed in
Annex I from the countries, which are party to the Convention, are subject to
permission of UFT.

Importation of chemical substances, which are listed in Annex II from countries
present in Annex-A, and importation of substances listed in Annex III are subject
to permission of UFT.

For each importation process applications should be done to UFT with the appli-
cation document given in Annex-B of Communiqué and other necessary docu-
ments required.

For importation of substances listed in Annex I and II Capacity Report which is
prepared by Chamber of Industry and approved by Turkish Union of Chambers
and Stock Exchanges is required.

For the registration of Custom Declaration about importation of substances listed
in Annex I, II and III a copy of Permission Certificate is required. An approved
copy of this certificate by customs declaration should be added to Custom Decla-
ration. Permission Certificate is valid for one batch of importation.

Copy of Permission Certificate is send to Under-secretariat for Customs, import-
ers, Ministry of Industry and Trade, Ministry of National Defence by UFT.

Following the importation within 15 days (without looking whether importation
occurred partly or completely) original copy of Permission Certificate and origi-



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nal copy of Custom Declaration, which is approved by related customs admini-
stration or public notary should be sent to UFT.

In case of any action which is contrary to the provision of Article 4, request of
Permission Certificate will be evaluated after all responsibilities are performed.

Design procedures for compliance programmes
There is no such programme


Design procedures for notification
There is no notification procedure other than the import procedure described
above.

Design procedures for inspection and verification
There are only conformity checks for import permits at the customs. There is no
other inspection and verification procedure.

Design procedures for safety requirements
      Classification
      Packaging
      Labelling
      SDS

Evaluate data supplied by manufacturers and importers
Import data are kept by the Undersecretariat for Foreign Trade and Undersecrete-
riat for Customs. However, these data are according to the customs coding and
data are not shared with other institutions.

Ministry of Industry and Trade keeps record of a copy of the import permit.

Evaluate risks to human health
Not applicable.

Evaluate risks to environment
Not applicable.

Develop a strategy to limit risks and ensure emergency plans are in place

Control the placing of dangerous substances/preparations on the market
In compliance with the framework law (No. 4703) related to Preparation and
Implementation of the Technical Legislation on Products, the Ministry of Indus-
try and Trade and Undersecreteriat for Foreign Trade are supposed to be respon-
sible for market surveillance and inspection; however there is no specific legisla-
tion and administrative arrangement for that.

Control the import of certain chemicals
See design procedures for licensing.

Control the export of certain chemicals.
No defined responsibility



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Ensure compliance with rules on confidentiality of information

Publicise requirements to relevant manufacturers

Publicise requirements to relevant importers

Publicise requirements to relevant exporters

Ensure health and safety information is available to workers

Report to the Commission
Not applicable

4.9.2     Legal analysis

Licensing/registration
See licensing procedures

Inspection and Monitoring
       Authorisation of establishments such as laboratories
There isn‘t any laboratory for this purpose.
       The collection and evaluation of written or computerized information
        such as notifications from manufacturers/importers
       Inspection and monitoring of activities to check that the correct proce-
        dures are being carried out
There is no institutional structure for market surveillance and inspection other
than importation for this group of chemicals; and it is not clear which institution
should take the responsibility for that.
       Enforcement action

Data Collection and Reporting
      To gather and analyse data, as well as to inform the Commission
Not applicable

Although the responsibilities of the institutions seem to be defined very clearly
according to the information above, there are some overlaps regarding the chemi-
cals which are subject to import permit. The table in Appendix I summarizes the
constituencies of the institutions on chemicals basis.

Table 1 summarizes the information given in this section.




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Table 1: Responsibilities of institutions with respect to categories of chemicals

     Categories of Pesticides      Biocidals         Cosmetics     Ethanol      Petroleum   Substances in Asbestos   Ozone de- Industrial
        chemicals                                                  and          products    the Annex of             pleting sub- substances
                                                                   methanol     and VOCs    the Chemical             stances      and prepara-
Tasks                                                                                       Weapons                               tions
                                                                                            Convention
Licensing/           MARA          MoH+              MoH           TTPAB        EMRA        MIT           MoEF       MoEF        MoEF
registration/                      MARA
notification   for
manufacturing
Import permit/       MARA          MoH+              MoH           TTPAB        MLSS+       UFT           MoEF+      MoEF+       MoEF
Control document                   MARA                                         EMRA                      MLSS+UFT   UFT
End use (con-        MARA+         MoH+              MoH+          MLSS         MLSS        MLSS          MLSS       MLSS        MLSS
sumer and labour     MLSS          MARA              MLSS
health)
Market Surveil-      MARA          MoH+              MoH           TTPAB        EMRA                      MoEF       MoEF        MoEF
lance and Inspec-                  MARA
tion
Enforcement          MARA+         MoH+Courts+M      MoH           TTPAB                                  MoEF       MoEF        MoEF
                     Courts        ARA
Customs control      UC+MARA       UC+MoH            UC+MoH        UC+          UC+MLSS+    UC+UFT        UC+ UFT    UC+ MoEF+   UC+ MoEF
                                                                   TTPAB        EMRA                                 UFT




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5 Requirements and Conditions for
  the Institutional Framework




The development of an effective institutional framework must be based on a
number of assumptions, requirements and conditions coming from the EU as well
as from the Turkish governmental organization and culture.

The main requirements and conditions to be taken into account are summarized
below.


5.1       Requirements for all options

The main requirements resulting from EU legislation and the Turkish systems are:
      Harmonise the national legislation in line with existing international
       commitments and especially the acquis communautaire;
      Designate a competent authority for the management of chemicals as it is
       required directly by the EU;
      Enact a legal basis for the management of chemicals preferably by means
       of a framework law implementing all EU requirements, and taking spe-
       cific Turkish circumstances into account;
      Introduce the relevant regulations mentioned in the framework law as by-
       laws, specifying the technical elements in more detail;
      The following topics, in other words, the ‗compliance functions‘ will be
       mentioned and further elaborated in the law: (1) assignment of responsi-
       bilities, (2) developing standards, (3) communicating standards (code of
       working relations), (4) inspection, monitoring and enforcement, (5) con-
       fidentiality, (6) keeping up with the technical progress and (7) personnel-
       related measures;
      Establish a uniform system of classification and labelling of chemicals in
       full compliance with the EU system, which is subject to changes with the
       technical progress made;
      Build institutional capacity including human resources at all levels of
       chemicals management and especially related to monitoring, control, in-
       spection and enforcement;
      Develop the supporting information infrastructure including inventories,
       monitoring, reporting and laboratories;
      Enforce the legislation and rationalize and harmonize sanctions e.g. in-
       clude specific measures in the legal framework;
      Introduce economic tools to support implementation.




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  5.2        Boundary conditions
   As already indicated, the institutional strengthening required will have to address
   the full Regulatory Cycle. The findings during the inception phase as presented in
   the Inception Report have been summarized in the figure below:


                                                 EU requirements
                       Policy planning           not transposed;


No Monitoring sys-       Objectives                                      Notification proce-
tem;                                     Legislation                     dures;
Lack of staff                                                            Lack of trained staff
Training
                       Assessment &                         Permitting
                         feedback


                        Enforcement                     Compliance
                                                          control
ISGUM                                    Compliance                      No inspection and
Guidelines required                      promotion                       enforcement;
                                                                         No monitoring

                                  No Information dissemi-
                                  nation
                                  Training required




   Figure 9: Regulatory Cycle.

            The Ministry of Environment and Forestry will be the competent author-
             ity in the field of chemicals management in Turkey. The competent au-
             thority must be at ministerial level. In view of the leading position of the
             MoEF in transposition of the EU Chemicals Directives in Turkey, it
             seems logical that MoEF will also be the competent authority;
            Strengthening of the executive and implementation capacity of the gov-
             ernment in the field of chemicals management. Currently, knowledge and
             experience related to notification procedures, risk assessments, chemicals
             monitoring and priority setting etc. is limited;
            Strong and well-developed, i.e. efficient and effective co-operation and
             co-ordination between the three mostly involved Ministries: Environment
             & Forestry, Health, and Labour and Social Security including their re-
             gional/provincial offices requires strengthening. In addition co-operation
             with Customs, Foreign Trade and Agriculture and Rural Affairs is re-
             quired;
            Inspection and enforcement of the regulatory requirements needs to be
             enhanced and structured.




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6 Institutional Framework Options




As already formulated in the ToR for this project, the Ministry of Environment
and Forestry (MoEF) has the main implementing responsibilities at national level
related to chemicals management and has full responsibility for the harmonisation
of the following key EU Directives on chemicals:
        Council Directive 1967/548/EEC relating to the Classification, packaging
         and labelling of Dangerous Substances;
        Directive 1999/45/EEC relating to the classification, packaging and label-
         ling of dangerous preparations;
        Directive 93/67/EEC on the risk assessment of the notified substances;
        Directive 1991/155/EEC on the establishment of the specific information
         system.

The MoEF co-ordinates the activities and makes harmonisation studies under its
responsibility in this field through its Chemicals Management Department, which
is one of the departments under the General Directorate of Environmental Man-
agement.

The institutional framework will provide the capacity and structure to allow for
effective implementation and enforcement of the regulatory requirements.

The Project Team has prepared four options for chemicals management in Turkey
based on the following assumptions:
      MoEF will be the Turkish Competent Authority;
      MoEF committed itself for establishing the National Environment Agency
       (NEA) and drafting the Organic Law of it;
      The National Environment Agency (NEA)9 will be established to under-
       take monitoring, inspection and enforcement functions of the Ministry of
       Environment and Forestry.

9
  Regardless of the chemicals management institutional framework, National Environ-
mental Agency has already been intended to be established and initiated by the staff of the
Ministry. NEA will undertake the monitoring, inspection and enforcement functions of
the Ministry of Environment and Forestry. A new special law is essential for the estab-
lishment of NEA. The special law for NEA would be an organic law which designates
NEA as the competent authority and sets the duties and responsibilities of NEA moreover,
it must reflect the close cooperation and working principles of NEA with the other rele-
vant ministries. Besides, the new law would involve incorporating the activities of the
concerned parties with NEA. NEA would be an institute of MoEF as Specially Protected
Areas Institution or Turkish State Meteorological Service. On the other hand, the Organic
Law of MoEF would be amended to subsume NEA. However, NEA will be established
with the personnel and equipment of MoEF and will not be able to deal with the require-
ments of EU law so, the financial resources of NEA should be defined in law.


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         The Turkish Chemicals Bureau/Agency/Department, which will be re-
          sponsible for carrying out technical tasks regarding the management of
          chemicals, will thus be subordinated to the MoEF;
         MoH will establish a similar Biocidal Products Bureau/Agency
          /Department;
         Effective working relations between different institutions will be estab-
          lished through a Committee for policy development in chemicals man-
          agement and international relations;
         The Chemicals Advisory Committee (CAC) will be established to work
          with the MoEF as advisory body;
         Close working relations with the other institutions will be developed for
          risk assessment, risk management and import/export of the chemical sub-
          stances and preparations;
         Risk assessment units/expertise will be developed in the specialized insti-
          tutions of the relevant ministries;
         Monitoring and inspection activities will be carried out by the re-
          gional/provincial/ sub-provincial directorates of the pertinent institutions.

In all 4 options developed by the Project Team the pertinent institutional bodies
will carry out the following tasks similarly.

Chemicals Advisory Committee (CAC)
Main tasks of the Chemicals Advisory Committee (CAC) will be to:
      Exchange information between the different Ministries;
      Follow the activities of the Technical Unit and provide guidance e.g. ap-
       prove the yearly programme of the Technical Unit as well as evaluate its
       performance;
      Set priorities in the activities of the Technical Unit;
      Develop recommendations to improve the functioning of the Technical
       Unit and improve the co-ordination and co-operation with other institu-
       tions;
      Harmonize the policies and the position of Turkey in the field of chemi-
       cals in the relations with the European Union and the other Member
       States;
 Bakanlıklar, ilgili kurum ve kuruluĢlar arasında bilgi alıĢ veriĢini sağlar.
   Yönetmeliğin uygulanmasını izler, değerlendirir ve önerilerde bulunur.
   Yönetmeliğin uygulamasının iĢlerliğini artırmak ve diğer kurumlarla koordi-
    nasyon ve iĢbirliğini artırmak için tavsiyeler geliĢtirir.
           ç) Bu Yönetmelik kapsamında, ulusal ölçekte ve uluslararası iliĢkilerde
    Türkiye‘nin politikaları ve stratejisi hakkında görüĢ bildirir.

The Chemicals Advisory Committee (CAC) will be chaired by the competent
authority i.e. the MoEF. The CAC will be composed of representatives from the
following Government institutions:
1.      MoEF who will chair the committee and have one additional representa-
        tive in the committee from the Chemicals Management Department;
2.      The TU of MoEF, acting as the secretariat of the CAC;
3.      Ministry of Health;


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4.        Ministry of Labour and Social Security;
5.        Ministry of Agriculture and Rural Affairs
6.        Under-secretariat for Foreign Trade;
7.        Under-secretariat for Customs;
8.        Ministry of Industry and Trade;
9.        Energy Market Regulatory Authority;
10.       Turkish Chemical Manufacturers Association;
11.       Scientific experts (for example from the Toxicology Association);
12.       Other participants (ad-hoc members) to be decided/discussed.

The CAC will meet regularly at the premises of the MoEF. The MoEF will pre-
pare comments and a final position on all conclusions and recommendations is-
sued by the CAC.

MoH
The Ministry of Health will have the following tasks regarding chemicals man-
agement:
      Provide the environmental and human health risk assessment of chemical
      substances and preparations which are in their responsibility;
      Draft risk limiting strategies of chemical substances and preparations,
      based on the risk assessment results of the existing chemical substances
      listed in the List of Priority Chemical Substances, and provide informa-
      tion to the Ministry of Environment and Forestry on it;
      Inform the Ministry of Environment and Forestry in the case that a
      chemical substance or preparation is classified and labelled by the com-
      pany as dangerous, about the need to obtain further additional tests on
      which results can arise a necessity:
            To incorporate the chemical substance to the List of Priority
              Chemical Substances; or
            To restrict use or to prohibit placing on the market of this chemical
              substance;
      Provides its opinion on the import of certain dangerous chemical sub-
      stances and certain dangerous chemical preparations;
      Registers biocidals;
      Ensure classification, labelling & packaging of biocidal products are in
      accordance with the legislation issued by the MoEF;
      Undertakes inspection and enforcement related to biocidal products;
      Ensures that public is informed about health risks and risk reduction
      measures regarding dangerous chemical substances and preparations.

MoLSS
The Ministry of Labour and Social Security will have the following tasks:
     Provide the risk assessment of chemical substances and preparations from
      the view of their effects in view of occupational health and safety;
     Draft risks limiting strategies for workplaces and labour health;
     Inform the Ministry of Environment and Forestry in the case that a
      chemical substance or preparation is classified and labelled by the com-
      pany as dangerous, about the need to obtain further additional tests on
      which results can arise a necessity:
             To incorporate the chemical substance to the List of Priority
              Chemical Substances; or


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                To restrict use or to prohibit placing on the market of this chemical
                substance;
         Provide its opinion on import of certain substances and preparations in the
          context of the PIC procedure;
         Undertake inspection and enforcement in workplaces;
         Ensure health and safety information is available to workers.

MARA
The Ministry of Agriculture and Rural Affairs will have similar tasks as the Min-
istry of Health but restricted to pesticides as mentioned in the EU Directives. The
MARA will exchange information on its experiences with these substances with
the MoEF and MoH.

The Ministry of Agriculture and Rural Affairs will have the following tasks:
     Responsible for Pesticides under separate EU Directive and legislation;
     Publicise requirements to relevant manufacturers, importers, exporters, etc
     Register pesticides;
     Ensure the farmers and other professional users are informed about envi-
      ronmental and health risks and risk reduction measures;
     Ensure classification & labelling of plant protection products are in accor-
      dance with the provisions of the legislation issued by the MoEF;
     Undertake inspection and enforcement related to Pesticides.

The following four options are elaborated:
1.      MoEF-option: The Turkish Chemicals Agency (TCA) is an integral part
        of the MoEF as a technical unit;
2.      TCA-option: A separate TCA is established under the MoEF;
3.      NEA-option: The TCA is established as part of the National Environment
        Agency, now being established by the MoEF;
4.      TCBPA-option: The TCA will also be responsible for handling Biocidal
        Products (similar to the structure in Slovakia), still under the MoEF, thus
        becoming the TCBPA.

The above options will be explained further in the next sections.




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                   6.1        Option 1: The MoEF-option

                   Figure 10: Organisational scheme for the MoEF option




                                MoEF                  MLSS                 MoH                      MARA

                            Chemicals
                           Management
                           Department                       Chemicals Advisory Committee
                          Div. of Planning and
                           Regulating
                          Div. of Notification
                           and Risk Assessment
                                                                    Biocidals
                          Div. of Inventory &
                           Information                                Bu-
                          Div. of industrial                  reau/Agency/Dept.
                           accidents and risk
                           management



                                                        Risk Assessment
                                                      Technical Committee

National Environment Agency                       ISGUM       R.S. Hygiene Inst.                 ZMMAE




Regional Environment                  Provincial/Regional Offices of MoEF, MoH, MLSS, MARA
      Agencies



                   In this option the Chemicals Management Department of the Ministry of Envi-
                   ronment and Forestry will be expanded to cover a so called ―technical unit‖ with
                   addition of some technical divisions to extend the tasks of the Department. These
                   divisions will deal with notifications, monitoring and reporting, risk assessment
                   (if required) and information dissemination, including helpdesk function for min-
                   isterial, regional and provincial staff, including staff of other Ministries in addi-
                   tion to their existing functions. This will involve an important increase of staff of
                   this Department.




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Figure 11: Organisation of Technical Unit

                          Department of
                       Chemicals Management




     Division of              Div. of In-          Div. of In-            Div. of
     Notification             ventory &            dustrial Ac-        Planning and
      and Risk               Information           cidents and          Regulation
     Assessment                                    Risk Man-
                                                    agement

               TECHNICAL UNIT


The duties and responsibilities of the Division of Planning and Regulating under
the Department of Chemicals Management of MoEF regarding the management
of chemicals will include but not limited to the following:
a)     Provide and co-ordinate all activities in the field of chemicals manage-
       ment in co-operation with the Ministry of Health, the Ministry of Labour
       and Social Security and the Ministry of Agriculture and Rural Affairs in
       the field of free movement of chemical substances and preparations;
b)     Elaborate strategies and policies in the field of chemical substances and
       preparations;
c)     After receiving opinions of the Ministry of Health, the Ministry of La-
       bour and Social Security and the Ministry of Agriculture and Rural Af-
       fairs issue a preliminary consent to import the certain dangerous chemical
       substances and preparations subject to the PIC procedure;
d)     Evaluate data supplied by importers and exporters on chemical sub-
       stances in order to issue the preliminary consent under the PIC procedure;
e)     Verify the possibility to export the certain dangerous chemical substances
       and preparations restricted due to their effects on environment and human
       health;
f)     Design, in collaboration with the Technical Unit, procedures for compli-
       ance programmes, notification, inspection and verification, safety re-
       quirements;
g)     Based on the proposal of the Technical Unit and in cooperation with the
       Ministry of Health and the Ministry of Labour and Social Security decide
       on restricting or prohibiting the placing on the market of certain danger-
       ous chemical substances and preparations, and on incorporating a chemi-
       cal substance in the List of Priority Chemical Substances;
h)     Keep the records of importers and exporters of certain dangerous chemi-
       cal substances and preparations and collaborate with the Technical Unit
       in this respect;
i)     Create permanent communication channels with the chemical industry
       sector to allow effective exchange of information to take place and for the
       preparation of proposals for classification of existing substances;
j)     Publish in the Official Journal the Lists of Chemical Substances and
       Chemical Preparations, review and amend them;


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k)        Publicise requirements to relevant manufacturers, importers, exporters,
          etc.;
l)        Conduct, in cooperation with the Department of Monitoring and Inspec-
          tion personnel, monitoring and inspection for compliance checking;
m)        Conduct in cooperation with the Department of Monitoring and Inspec-
          tion personnel effective custom and internal controls, monitoring and in-
          spection activities to avoid illegal import and marketing of non-notified
          chemicals from third countries, as well as non-compliance with the legal
          rules on the restriction or prohibition of chemical substances and prepara-
          tions;
n)        Ensure that manufacturers of controlled substances reduce and cease pro-
          duction in line with the monitoring and inspection activities presented
          above in indents l) and m);
o)        Introduce appropriate legal and administrative sanctions to deal with non-
          compliance by manufacturers, importers and dealers;
p)        Act as body of appeal for decisions made by the National Chemicals Bu-
          reau/Agency/Department;
q)        Issue the risk reducing strategies elaborated by the Technical Unit;
r)        Ensure that emergency plans are in place;
s)        Ensure compliance with rules on confidentiality of information;
t)        Prepare, in collaboration with the Technical Unit, regular reports to the
          EU Commission on transposition and implementation of the EU Direc-
          tives in the field of chemicals management in Turkey;
u)        Be in charge of the exchange of information with the European Commis-
          sion and the other Member States of the European Union and attends the
          sessions of the European Commission Committees as well as other rele-
          vant international fora;
v)        Convene and chair the meetings of the Chemicals Advisory Committee.
w)        Ensure that professional users are informed about environmental and
          health risks and risk reduction measures;
x)        Contribute in the projects, which are carried out regarding management
          of chemicals.;
y)        Co-ordinate together with line ministries the training and further training
          of the staff certified to control and supervise chemical substances and
          training the competent bodies.
z)        Co-ordinate and provide information in the field of the dangerous chemi-
          cal substances and preparations.

The primary tasks of the Technical Unit will include, but not limited to the
following:
a)      Manage and assess the flow of information linked to the placing on the
        market of a new and existing chemical substances;
b)      Request and receive information on the properties, including chemical
        composition, of the chemical substances and preparations;
c)      Collaborate with the Division of Planning and Regulation in designing
        procedures for compliance programmes, notification, inspection and veri-
        fication, safety requirements;
d)      Evaluate the dossiers submitted together with the notification of new
        substances and report the findings obtained to the CAC and to the Minis-
        try of Health;
e)      Assess the risk of dangerous substances based on the information pro-
        vided by manufacturers and importers from the view of their impacts on


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          the environment and collaborate with the Ministry of Health in the
          evaluation of risks to human health and the Ministry of Labour and Social
          Security in the evaluation of the risks to occupational health and safety;
f)        Draft, in cooperation with the Ministry of Health and Ministry of Labour
          and Social Security, the risk assessment report through consolidating the
          risk assessment for the environment, human health, and occupational
          health and safety;
g)        Draft risk reducing strategies of such chemical substances basing on the
          risk assessment results of existing chemical substances listed in the List
          of Priority Chemical Substances;
h)        In case that a chemical substance is classified and labelled by the manu-
          facturer or importer as dangerous, decide, in cooperation with the Minis-
          try of Health and of the Ministry of Labour and Social Security, about the
          need to obtain further additional tests. Based on that, submit a proposal to
          the Division of Planning and Regulating on the necessity:
                To incorporate the chemical substance to the List of Priority
                 Chemical Substances; or
                To restrict use or to prohibit placing on the market of this chemical
                 substance.
i)        Set up a data collection system for chemical substances and preparations,
          and publishes statistical information;
j)        Keep and update the inventory of chemical substances in compliance
          with the relevant regulation and collaborate with the Division of Planning
          and Regulating in order to establish the records of importers and export-
          ers of certain dangerous chemical substances and preparations;
k)        Permit labelling of the chemical substances and preparations in excep-
          tional cases;
l)        Develop, manage and update the necessary databases to be consulted by
          manufacturers and importers to avoid unnecessary duplication of testing
          especially for what involves animal testing;
m)        Cooperate with the Division of Planning and Regulating in order to pre-
          pare regular reports to the European Commission on transposition and
          implementation of the EU Directives in the field of chemicals manage-
          ment in Turkey;
n)        Maintain the Secretariat of the Chemicals Advisory Committee;
o)        Collaborate with the inspectors in checking the SDS Forms;
p)        Train the staff certified to control and supervise chemical substances and
          the competent bodies;
q)        Supply specific and detailed data and information to all Government
          agencies and bodies with duties in the field of dangerous chemical sub-
          stances and preparations;
r)        Perform helpdesk function for ministerial, regional and provincial staff,
          including staff of other ministries.


6.2       Option 2: The TCA-option

The Turkish Chemicals Agency (TCA) option is in fact very similar to the option
described above. The main difference now is that the TCA is not directly part of
the MoEF but is a separate organisation, subordinated directly to the MoEF (simi-
lar to Authority for Protection of Special Areas).



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                  Figure 11: Organisational scheme of the TCA-option


                              MoEF                   MLSS                  MoH                      MARA

                             Chemicals
                            Management
                            Department                      Chemicals Advisory Committee



                                                                    Biocidals
                              Turkish
                             Chemicals
                              Agency                                 Bu-
                                                              reau/Agency/Dept.



                                                      Technical Committee




National Environment Agency                  ISGUM            R.S. Hygiene Inst.                ZMMAE



Regional Environment               Provincial/Regional Offices of MoEF, MoH, MLSS, MARA
      Agencies



                  The tasks and responsibilities of the organizations and institutions in the TCA-
                  option are identical to the tasks and responsibilities in the MoEF-option. The rela-
                  tionship between MoEF and the TCA will be slightly different. Chemicals Man-
                  agement Department within the MoEF will undertake only the planning and regu-
                  lating functions including international relations. TCA will carry out other techni-
                  cal functions, similar to the ―technical unit‖ as in the first case.


                  6.3       Option 3: The NEA-option:

                  The NEA option has been prepared to show the possibility of integration of the
                  executive agencies of the MoEF. MoEF intends to establish an important execu-
                  tive organisation responsible for implementing a wide range of environmental
                  legislation in Turkey, including the IPPC, Seveso, Water and Waste legislations.




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              This provides a clear opportunity to integrate the Turkish Chemicals Agency in
              this NEA to improve and strengthen the co-ordination and co-operation at the
              implementation and executive level.

              Figure 12: Organisational scheme for the NEA option.

                     MoEF                     MLSS                     MoH                   MARA
                   Chem. Man.
                     Dept.

                                                     Chemicals Advisory Committee
                 National Envi-
                 ronment Agen-
                       cy                                    Biocidals

                 Chemicals De-                                 Bu-
                   partment                             reau/Agency/Dept.




                                      ISGUM            R.S. Hygiene Inst.                   ZMMAE



Regional Environment            Provincial/Regional Offices of MoEF, MoH, MLSS, MARA
      Agencies




              The tasks and responsibilities of the different government institutions presented in
              the above scheme are very similar to the tasks and responsibilities as described
              under the MoEF option.

              The Chemicals Management Department will be responsible for planning and
              setting standards, issuing legislation as well as international relations. The so
              called ―Technical Unit‖ under the Chemicals Management Department will be
              moved under the National Environment Agency. Therefore, there will be Chemi-
              cals Department established in NEA to carry out other technical functions similar
              to the technical unit suggested in the first case. The Department of Monitoring
              and Inspection moved to NEA will collaborate with the Chemicals Department
              for inspection and enforcement functions. The relationship between MoEF and
              Chemicals Department of NEA will also depend on how the relationship between
              NEA and MoEF will be developed. It is clear that now the management of NEA
              will also have an important role in managing the Chemicals Department.




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              6.4       Option 4: The TCBPA-option

              The TCBPA-option can be considered as an extension e.g. further integration of
              the implementation organisations presented in the TCA-option. TCBA stands for
              Turkish Chemicals and Biocidal Products Agency.

              This already clearly shows the main intention of this option: establish a joint
              Agency responsible for implementing the governmental tasks following from the
              Chemicals legislation of MoEF and from the Biocidal products legislation im-
              plemented by MoH. This corresponds with the approach followed in Slovakia.


              Figure 13: Organisational scheme of the TCBPA-option

                        MoEF                 MLSS                MoH                     MARA




                                                   Chemicals Advisory Committee



        National Envi-                     Turkish Chemicals and
        ronment Agen-                        Biocidal Products
              cy                             Agency (TCBPA)




                                                      R.S. Hygiene Inst.                ZMMAE



Regional Environment           Provincial/Regional Offices of MoEF, MoH, MLSS, MARA
      Agencies




              The tasks and responsibilities of the institutions indicated in the above scheme
              will be the same as the tasks and responsibilities described under the MoEF-
              option.

              However, now MoH will be the appeal body for decisions taken by the TCBPA
              directly related to human health.

              TCBPA will be responsible for notification procedures for the industrial chemi-
              cals as well as registration procedures for biocidals. Both environmental and


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health risk assessments will be carried out by the TCBPA. The inventory database
managed by the TCBPA will cover not only the industrial chemicals but also the
biocidal products in collaboration with the Ministry of Labour and Social Secu-
rity for occupational health risk assessment.

Important issue for this option will be to elaborate the co-operation between MoH
and MoEF.


6.5       Main problems and advantages of the different options
In carrying out a preliminary SWOT (strengths, weaknesses, threats and opportu-
nities) analysis of the four institutional options identified above, the project team
have used a number of criteria in order to guide selection of the most suitable
option for Turkey. The criteria are summarised below.

Fit with the chemicals management objectives
     EU Requirements
     Turkish institutional structure

Flexibility to accommodate future change
     Flexibility to cope with the changes in EU legislation
     Adaptation to REACH system

Implementation Issues:
    Institutional acceptability
    Cooperation/coordination/collaboration with other institutions
    Time requirements
    Institutional capacity (people, financial, technical)

Practicality
     Number of new institutional bodies established
     Number of personnel needed/affected
     Personnel regime

These criteria have been applied to all four options and the outcomes are summa-
rised below:




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      Table 2: Option 1

Strengths                                        Weaknesses
Fit with Objectives                      Fit with Objectives
 Able to cover all the objectives        Institutional capacity needs to develop
                                             to achieve all the objectives
Accommodation of Future Change           Accommodation of Future Change
 Possible to adjust the structures in a  It is not among the preferred options at
   straightforward manner                    EU level

Implementation Issues                     Implementation Issues
                                           Somewhat continuation of the existing
 Relatively easy to implement via existing
   legal/institutional structure             institutional structure may lead to sus-
 Almost no additional time requirement      taining the same problems/issues
   other than the establishment of NEA     May lead overlaps in the functions
 Requires only some additional staff and    within the same administration
   training                                Technical and technological capacity of
                                             the Department needs to develop
                                           Background of the existing staff may not
                                             be suitable to undertake new functions
                                           Demotivation may develop among the
                                             existing staff due to restructuring
                                          Practicality
Practicality                               Needs restructuring and assignment of
 Quite straightforward since legal basis    new tasks within the same department
   already exists                          Personnel policy may not allow for em-
                                             ployment of new highly qualified staff
                                             in addition to the existing ones
Opportunities                             Threats
Fit with Objectives                           Fit with Objectives
 Potential to develop a fully compliant sys-  Lack of financial resources or fluctua-
    tem                                           tions of start turnover may obstruct the
                                                  institutional development

Accommodation of Future Change                   Accommodation of Future Change
 Easy to adapt the institutional structure if    Might not be acceptable by EU
   Turkey does not become a member of EU
Implementation Issues                            Implementation Issues
 Better communication between the divi-          If other institutions decline to collabo-
   sions for accommodating the implementa-          rate/cooperate some tasks cannot be ac-
   tion of legal amendments in line with the        complished
   changes in EU legislation

Practicality                               Practicality
 EU may require a new personnel regime to  Ministry of Finance may not allow for
   be introduced for better implementation    introducing a different personnel regime
                                              within the same department




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Table 3: Option II
Strengths                                    Weaknesses
Fit with Objectives                          Fit with Objectives
 Able to cover all the objectives            Institutional capacity needs to develop to
                                                 achieve all the objectives
Accommodation of Future Change               Accommodation of Future Change
 Relatively flexible to accommodate to       Necessity to start from zero in developing this
   the new REACH system                          structure
Implementation Issues                        Implementation Issues
 New institution may bring new system        Will require establishment of a revolving fund
   with new motivation                        Requires time to establish the Agency in addi-
 Newly employed staff may be more               tion to the time required for the establishment
   motivated                                     of NEA
 May open new capacity building op-          Might be perceived by other institutions as too
   portunities                                   inexperienced to coordinate/collaborate/ coop-
                                                 erate
                                              Might be some overlaps with the duties of
                                                 NEA
                                             Practicality
                                              Requires issuing a new organic law for the
Practicality                                     establishment of the agency
 Strengthens the MoEF in general by          Requires amendments in the Organic Law of
    adding a new institution                     the MoEF
                                              Might be relatively costly to establish a new
                                                 agency in addition to NEA
                                              Requires employment of new administrative
                                                 support staff in addition to the ones in the
                                                 Chemicals Management Department and NEA
Opportunities                                Threats
Fit with Objectives                          Fit with Objectives
 Might be very well accepted by EU           Potential for duplication or conflicts with the
                                                 Chemicals Management Department if Turkey
                                                 does not become a member of EU
                                              May fall too low in ranking in the organisa-
                                                 tional structure of Turkish State to undertake
                                                 an effective role
Accommodation of Future Change               Accommodation of Future Change
 Easy to adapt to the REACH system           May become obsolete if Turkey does not be-
                                                 come a member of EU
Implementation Issues                        Implementation Issues
 Opportunity to review existing imple-       Low acceptability of a new agency in addition
   mentation structures and amend im-            to NEA in Turkish administrative system
   plementation mechanisms                    There might be some overlaps with the
                                                 Chemicals Management Department in policy
                                                 making and relations with EU
                                              Timing is even more improper for this option
Practicality                                     compared to NEA option.
 Creates new posts for employment           Practicality
 Opportunity to employ highly quali-         Risk of not getting approval from the Ministry
    fied staff with a new personnel regime       of Finance for a new personnel regime
 May lead to new capacity building
    opportunities




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       Table 4: Option III

Strengths                                         Weaknesses
Fit with Objectives                               Fit with Objectives
 Able to cover all the objectives                 Institutional capacity needs to develop to
 More clearly defined roles compared to Option       achieve all the objectives
    2 and 4.
 More integrated functions within one institu-
    tion compared to Options 1, 2 and 4.
Accommodation of Future Change
 Relatively more flexible to accommodate all     Accommodation of Future Change
    future changes                                 NEA is not yet established and the parlia-
                                                     mentary procedure is very time consuming
Implementation Issues                             Implementation Issues
 Newly establishing NEA can easily accommo-       Will require establishment of a revolving
    date Chemicals Department                        fund
 Newly establishing NEA may bring new sys-        Might be perceived by other institutions as
    tem with new motivation                          too inexperienced to coordinate/collaborate/
 Newly employed staff may be more motivated         cooperate
 Better coordination between the technical de-
    partments and inspection
Practicality                                      Practicality
 No additional Organic Law to be issued other     Requires issuing a new organic law for the
    than NEA‘s.                                       establishment of the NEA
                                                   Requires amendments in the Organic Law
                                                      of the MoEF
Opportunities                                     Threats
Fit with Objectives                               Fit with Objectives
 Risks to accommodate a new agency in Turk-       May fall too low in ranking in the organisa-
    ish institutional structure                       tional structure of Turkish State to under-
                                                      take an effective role
Accommodation of Future Change                    Accommodation of Future Change
 Easy to adapt to the REACH system                Delay in establishing NEA and subse-
 May easily get support from EU                      quently modifying its roles
Implementation Issues
 Opportunity to review existing implementation   Implementation Issues
   structures and amend implementation mecha-      The timing is not proper for political ac-
   nisms                                              ceptability due to coming elections
                                                   There might be some overlaps with the
                                                      Chemicals Management Department in pol-
                                                      icy making and relations with EU
Practicality                                      Practicality
 Opportunity to employ highly qualified staff     No additional risk of not getting approval
    with a new personnel policy and waging sys-       from the Ministry of Finance for a new per-
    tem within NEA                                    sonnel regime other than for NEA.
 May lead to new capacity building opportuni-
    ties




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       Table 5: Option IV
Strengths                                      Weaknesses
Fit with Objectives                            Fit with Objectives
 Able to cover all the objectives includ-      Difficult to fit into the Turkish administrative
    ing the objectives for the management          system, since one agency cannot be affiliated to
    of biocidals                                   two ministries
 Can easily carry out registration as well
    as both environmental and health risk
    assessment functions                       Accommodation of Future Change
Accommodation of Future Change                  Necessity to create a structure under the sub-
 May well accommodate REACH                      ordination of two ministries


Implementation Issues                          Implementation Issues
 New institution may bring new system          Will require establishment of a revolving fund
    with new motivation                         Requires time to establish the Agency in addition
 Newly employed staff may be more                 to the time required for the establishment of NEA
    motivated                                   Might be perceived by other institutions as too
 May open new capacity building oppor-            inexperienced to coordinate/collaborate/ cooperate
    tunities                                    Might be some overlaps with the duties of NEA
 Relatively less costly compared to Op-        Not clearly defined working relations to carry out
    tion 2, where there two separate agen-         inspection
    cies: one for chemicals and one for bio-    Accountable and reporting to which institution
    cidals                                         might be a problem area
Practicality                                   Practicality
 The new institution established can           Requires issuing a new organic law for the estab-
    contribute to avoidance of overlaps be-        lishment of the agency
    tween the regimes for biocides and          Requires amendments in the Organic Laws of the
    chemicals                                      MoEF and MoH
                                               Might be relatively costly to establish a new agency
Opportunities                                  Threats
Fit with Objectives                            Fit with Objectives
 Might be well accepted by EU                  Potential for duplication or conflicts with the
                                                   MoEF and MoH if Turkey does not become a
                                                   member of EU
                                                May fall too low in ranking in the organisational
                                                   structure of Turkish State to undertake an effective
                                                   role
Accommodation of Future Change                 Accommodation of Future Change
 Relatively more flexible to adapt to the      May become obsolete if Turkey does not become a
   REACH system                                    member of EU
Implementation Issues                          Implementation Issues
 Opportunity to review existing imple-         Low acceptability of a new agency in addition to
   mentation structures and amend imple-           NEA in Turkish administrative system
   mentation mechanisms                         There might be some overlaps in policy making
                                                   and EU relations functions of the MoEF and MoH.
                                                Timing is even more inproper for this option com-
Practicality                                       pared to NEA option.
 Opportunity to employ highly qualified       Practicality
    staff with a new personnel policy and       Risk of not getting approval from the Ministry of
    waging system                                  Finance for a new personnel regime
 May lead to new capacity building op-
    portunities




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7         Legal gap analysis with respect
          to EU directives




67/548/EEC
Article 1
Objectives
1.      The purpose of this Directive is to approximate the laws, regulations
         and administrative provisions of the Member States on:
        a)      the notification of substances;
        b)      the exchange of information on notified substances;
        c)      the assessment of the potential risk to man and the environ-
                ment of
        d)      notified substances;
        e)      the classification, packaging and labelling of substances dan-
                gerous
        f)      to man or the environment,

where such substances are placed on the market in the Member States.

Dangerous Chemicals Regulation
Article 1
Objectives
Purpose of this regulation is to determine administrative and technical procedures
and principles for the control of the dangerous chemicals and the protection of
environment and man from their negative effects.

The objective of the regulation above should be revised according to the re-
quirements of directive. Especially the concepts of notification, health and
environmental risk assessment should be mentioned in the regulation, be-
cause these concepts are essential in order to place the dangerous chemicals
on the market in MS. In other words, Directive lays down rules on the classi-
fication, packaging and labelling of certain chemical substances, which are
placed on the market in the Community, including rules on the notification
of substances, the exchange of information on notified substances, and the
assessment of the potential risks of substances to humans and the environ-
ment.

67/548/EEC
Article 1
Scope
2.       This Directive shall not apply to the following preparations in the
         finished state, intended for the final user:




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          a)    medicinal products for human or veterinary use, as defined in
                Directive 65/65/EEC (10), as last amended by Directive
                87/21/EEC (11);
          b)    cosmetic products defined by Directive 76/768/EEC (12), as
                last amended by Directive 86/199/EEC (13);
          c)    mixtures of substances which, in the form of waste, are cov-
                ered by Directives 75/442/EEC (14) and 78/319/EEC (15);
          d)    foodstuffs;
          e)    animal feeding stuffs;
          f)    pesticides;
          g)    radioactive substances as defined by Directive 80/836/EEC
                (16);
          h)    other substances or preparations for which Community notifi-
                cation or approval procedures exist and for which require-
                ments are equivalent to those laid down in this Directive.

Not later than 12 months after notification of this Directive, the Commission,
in accordance with the procedure laid down in Article 29 (4) (a), shall establish
a list of substances and preparations referred to above. This list will be re-
examined periodically and as necessary revised in accordance with the said
procedure.

In addition, this Directive shall not apply to:
        the carriage of dangerous substances by rail, road, inland waterway,
         sea or air,
        substances in transit which are under customs supervision, provided
         they do not undergo any treatment or processing.

Dangerous Chemicals Regulation
Article 2
The following elements are covered by this Regulation:
a)      procedures and principles related to the determination, classification, la-
        belling and packaging of dangerous chemicals;
b)      principles related to production, storage, transportation activities of dan-
        gerous chemicals;
c)      principles related to usage and placing on the market of dangerous chemi-
        cals and dangerous materials;
d)      procedures and principles related to importing and exporting of chemi-
        cals;
e)      provisions related to dealing with dangerous chemicals and dangerous
        materials;
f)      provisions related to market surveillance and inspection of chemicals and
        dangerous materials;
g)      (Additional paragraph: 06/11/2001-24575 N. O.J./Artc. 1) procedures and
        principles related to preparation and distribution of Safety Data Sheets.

However, the following topics are not covered by this Regulation:
a)   Substances or preparations, which are reached as the final products to the
     users;
      1)       Medical preparations for the usage of human health and veteri-
               nary;
      2)       Cosmetics;


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          3)       Wastes and their mixtures, and chemical materials wastes;
          4)       Foodstuffs;
          5)       Animal feeds;
          6)       Pesticides;
          7)       Radioactive substances and radioactive substances contained
                   preparations and materials;
          8)       Explosives, war materials and explosion equipments to obtain ex-
                   plosive and pyrotechnic impact;
b)        Rules for (related to) classification, labelling and packaging rules related
          to transportation;

In our regulation the scope also mentions the included concepts. However,
the directive mentions only the excluded concepts. That means all dangerous
chemicals other than the ones excluded specifically should be considered
under this directive.

Definitions

67/548/EEC
Article 2
"substances" means chemical elements and their compounds in the natural state
or obtained by any production process, including any additive necessary to
preserve the stability of the products and any impurity deriving from the proc-
ess used, but excluding any solvent which may be separated without affecting
the stability of the substance or changing its composition,

Dangerous Chemicals Regulation
Article 4
" substance" means chemical elements and their compounds in the natural state or
obtained by any production process, excluding any solvent which may be sepa-
rated without affecting the stability of the substance or changing its composition,
and including any additive necessary to preserve the stability of the products and
any impurity deriving from the process used,

67/548/EEC
Article 2
"preparations" means mixtures or solutions composed of two or more sub-
stances,

Dangerous Chemicals Regulation
Article 4
"preparation" means mixture or solution composed of minimum two or more
substances,

67/548/EEC
Article 2
"polymer" means a substance consisting of molecules characterized by the
sequence of one or more types of monomer units and comprising a simple
weight majority of molecules containing at least three monomer units which
are covalently bound to at least one other monomer unit or other reactant and
consists of less than a simple weight majority of molecules of the same mo-
lecular weight. Such molecules must be distributed over a range of molecular


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weights wherein differences in the molecular weight are primarily attributable
to differences in the number of monomer units. In the context of this definition
a "monomer unit" means the reacted form of a monomer in a polymer,

Dangerous Chemicals Regulation
Article 4
"polymer" means a substance consisting of molecules characterized by the se-
quence of one or more types of monomer units and comprising a simple weight
majority of molecules containing at least three monomer units which are cova-
lently bound to at least one other monomer unit or other reactant and consists of
less than a simple weight majority of molecules of the same molecular weight.
(These molecules are distributed over a range of molecular weights wherein dif-
ferences in the molecular weight are primarily attributable to differences in the
number of monomer units. "Monomer unit" means the reacted form of a mono-
mer in a polymer),

67/548/EEC
Article 2
"placing on the market" means the making available to third parties. Importa-
tion into the Community customs territory shall be deemed to be placing on the
market for the purposes of this Directive,

Dangerous Chemicals Regulation
Article 4
"placing on the market" defines the first activity which the making available to
third parties. Importation into the Community customs territory shall be deemed
to be placing on the market for the purposes of this Directive,

67/548/EEC
Article 2
"scientific research and development" means scientific experimentation, analy-
sis or chemical research carried out under controlled conditions; it includes the
determination of intrinsic properties, performance and efficacy as well as sci-
entific investigation related to product development,

Dangerous Chemicals Regulation
Article 4
"scientific research and development" means scientific experimentation, analysis
or chemical research carried out under controlled conditions which includes the
determination of intrinsic properties, performance and efficacy as well as scien-
tific research related to product development,

67/548/EEC
Article 2
"process-orientated research and development" means the further development
of a substance in the course of which pilot plant or production trials are used to
test the fields of application of the substance,


Dangerous Chemicals Regulation
Article 4



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"process-orientated research and development" means the development of a sub-
stance in the course of which pilot plant or test production unit are used to test the
fields of application of the substance,

67/548/EEC
Article 2
"explosive substances and preparations" solid, liquid, pasty or gelatinous sub-
stances and preparations which may also react exothermically without atmos-
pheric oxygen thereby quickly evolving gases, and which, under defined test
conditions, detonate, quickly deflagrate or upon heating explode when partially
confined,

Dangerous Chemicals Regulation
Article 4
"explosive substance/preparation" solid, liquid, pasty or gelatinous substances
and preparations which may also react exothermically without atmospheric oxy-
gen thereby quickly evolving gases, and /or which, under defined test conditions,
detonate, quickly deflagrate or upon heating explode when partially confined,

67/548/EEC
Article 2
"oxidizing substances and preparations" substances and preparations which
give rise to a highly exothermic reaction in contact with other substances, par-
ticularly flammable substances,

Dangerous Chemicals Regulation
Article 4
"oxidising substance/preparation" means particularly flammable substances
and substances and preparations which give rise to highly exothermic reaction
when in contact with other substances,

67/548/EEC
Article 2
"extremely flammable substances and preparations" liquid substances and
preparations having an extremely low flash-point and a low boiling-point and
gaseous substances and preparations which are flammable in contact with air at
ambient temperature and pressure,

Dangerous Chemicals Regulation
Article 4
"extremely flammable substance/preparation" means liquid substances and prepa-
rations having an extremely low flash-point (lower than 0°C) and a low boiling-
point (lower than 35°C) and gaseous substances and preparations which are
flammable in contact with air at ambient temperature and pressure,

67/548/EEC
Article 2
"highly flammable substances and preparations"
       substances and preparations which may become hot and finally catch
        fire in contact with air at ambient temperature without any application
        of energy; or



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         solid substances and preparations which may readily catch fire after
          brief contact with a source of ignition and which continue to burn or to
          be consumed after removal of the source of ignition; or
         liquid substances and preparations having a very low flash-point; or
         substances and preparations which, in contact with water or damp air,
          evolve highly flammable gases in dangerous quantities.

Dangerous Chemicals Regulation
Article 4
"easily flammable substance/preparation": means,
a.       substances and preparations which may become hot and finally catch
         fire in contact with air at ambient temperature without any application
         of energy, or
b.       solid substances and preparations which may readily catch fire after
         brief contact with a source of ignition and which continue to burn after
         removal of the source of ignition, or
c.       liquid substances and preparations having a flash point below 21º C, or
d.       substances and preparations which, in contact with water or damp air,
         evolve highly flammable gases in dangerous quantities.

67/548/EEC
Article 2
"flammable substances and preparations" liquid substances and preparations
having a low flash-point,

Dangerous Chemicals Regulation
Article 4
"flammable substance/preparation" means liquid substances and preparations
having low flash point (21º C - 55º C)

67/548/EEC
Article 2
"very toxic substances and preparations" substances and preparations which in
very low quantities cause death or acute or chronic damage to health when
inhaled, swallowed or absorbed via the skin,

Dangerous Chemicals Regulation
Article 4
"very toxic substance/preparation" means substances/preparations which in very
low quantities cause lethal or acute or chronic damage to health when inhaled,
swallowed, absorbed via the skin,

67/548/EEC
Article 2
"toxic substances and preparations" substances and preparations which in low
quantities cause death or acute or chronic damage to health when inhaled,
swallowed or absorbed via the skin,


Dangerous Chemicals Regulation
Article 4



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"toxic substance/preparation‖ means substances/preparations which in low quan-
tities cause lethal or acute or chronic damage to health when inhaled, swallowed
or absorbed via the skin,

67/548/EEC
Article 2
"dangerous substances and preparations" substances and preparations which
may cause death or acute or chronic damage to health when inhaled, swallowed
or absorbed via the skin,

Dangerous Chemicals Regulation
Article 4
"dangerous substance/preparation" means substances/preparations which may
cause lethal or acute or chronic damage to health when inhaled, swallowed or
absorbed via the skin,

67/548/EEC
Article 2
"corrosive substances and preparations" substances and preparations which
may, on contact with living tissues, destroy them,

Dangerous Chemicals Regulation
Article 4
"corrosive substance/preparation" means substances and preparations which may
destroy living tissues on contact with them,

67/548/EEC
Article 2
"irritant substances and preparations" non-corrosive substances and prepara-
tions which, through immediate, prolonged or repeated contact with the skin or
mucous membrane, may cause inflammation,

Dangerous Chemicals Regulation
Article 4
"irritant substance/preparation "means non-corrosive substances and preparations
which, through immediate, prolonged or repeated contact with the skin or mucous
membrane, may cause local inflammation, swelling or oedema,

67/548/EEC
Article 2
"sensitising substances and preparations" substances and preparations which, if
they are inhaled or if they penetrate the skin, are capable of eliciting a reaction
of hypersensitization such that on further exposure to the substance or prepara-
tion, characteristic adverse effects are produced,

Dangerous Chemicals Regulation
Article 4
"allergic substance/preparation" means substances and preparations which, if they
are inhaled or if they penetrate the skin, are capable of initiating a reaction of
hypersensitization and such that on further exposure to the substance or prepara-
tion, characteristic adverse effects are produced,



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67/548/EEC
Article 2
"carcinogenic substances and preparations" substances or preparations which,
if they are inhaled or ingested or if they penetrate the skin, may induce cancer
or increase its incidence,

Dangerous Chemicals Regulation
Article 4
"carcinogenic substance/preparation" means substances or preparations which, if
they are inhaled, ingested, if they penetrate the skin, may cause cancer or increase
its incidence,

67/548/EEC
Article 2
"mutagenic substances and preparations": substances and preparations which,
if they are inhaled or ingested or if they penetrate the skin, may induce herita-
ble genetic defects or increase their incidence,

Dangerous Chemicals Regulation
Article 4
"mutagenic substance/preparation" means substances and preparations which, if
they are inhaled, ingested or if they penetrate the skin, may cause heritable ge-
netic defects or increase their incidence,

67/548/EEC
Article 2
"substances and preparations "which are toxic for reproduction: substances and
preparations which, if they are inhaled or ingested or if they penetrate the skin,
may produce, or increase the incidence of, non-heritable adverse effects in the
progeny and/or an impairment of male or female reproductive functions or
capacity,

Dangerous Chemicals Regulation
Article 4
"substance/preparation which is toxic for reproduction" means substances and
preparations which, if they are inhaled, ingested, if they penetrate the skin, may
produce, or increase the incidence of, an impairment of male or female reproduc-
tive functions and capacity and/or non-heritable negative effects in the progeny,

67/548/EEC
Article 2
"substances and preparations which are dangerous for the environment": sub-
stances and preparations which, were they to enter the environment, would
present or may present an immediate or delayed danger for one or more com-
ponents of the environment,




Dangerous Chemicals Regulation
Article 4



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"substance/preparation which is dangerous for the environment" means sub-
stances and preparations which enter the environment, present an immediate or
delayed danger for one or more aspects of the environment.

The definitions of the regulation more or less meet the requirements of the
directive. On the other hand, in line with the copy-out principle, the defini-
tions of the directive should be taken as is so some minor modifications will
be necessary in order to have the full transposition.

“EINECS” and “notification” definitions should be included in the regula-
tion.

The Directive distinguishes the difference between new and existing sub-
stances. Existing substances are those that were placed on the Community
market before 18 September 1981 and that are listed in the European Inven-
tory of Existing Commercial Chemical Substances (EINECS), and new sub-
stances are those that are not listed in EINECS.


67/548/EEC
Article 3
Testing and assessment of the properties of substances
    1) Tests on chemicals carried out within the framework of this Directive
        shall as a general principle be conducted according to the methods laid
        down in Annex V. The physico-chemical properties of substances shall
        be determined according to the methods specified in Annex V. A; their
        toxicity shall be determined according to the methods specified in Annex
        V. B and their ecotoxicity according to the methods specified in Annex
        V. C.

          However, for some of the substances on the EINECS it is possible that
          test data exist which have been generated by methods other than those
          laid down in Annex V. The adequacy of such data for the purposes of
          classification and labelling and the need to conduct new tests according
          to Annex V must be decided on a case-by-case basis taking into account
          among other factors the need to minimize testing on vertebrate animals.
          Laboratory tests shall be carried out in compliance with the principles of
          good laboratory practice provided for in Directive 87/18/EEC and with
          the provisions of Directive 86/609/EEC.

    2) The real or potential risk to man and the environment shall be assessed on
       the basis of the principles adopted, by 30 April 1993, in accordance with
       the procedure laid down in Article 29 (4) (b). These principles shall be
       regularly reviewed and, where appropriate, revised in accordance with the
       same procedure.

Dangerous Chemicals Regulation
No provision about testing and assessment of the properties of the substances

The test methods are mentioned in the Annex 5 of the directive. The Annex 5
should be included in our regulation as is and the relevant article should be
added to the regulation.


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67/548/EEC
Classification
Article 4.1.
Substances shall be classified on the basis of their intrinsic properties according
to the categories laid down in Article 2 (2). In the classification of substances,
impurities shall be taken into account as far as the concentration(s) of the latter
exceed the concentration limits specified in paragraph 4 of this Article and in
Article 3 of Directive 88/379/EEC.
Article 4.2.

The general principles of the classification and labelling of substances and
preparations shall be applied according to the criteria in Annex VI (24), save
where contrary requirements for dangerous preparations are specified in sepa-
rate Directives.

Dangerous Chemicals Regulation
No provision about classification.

The general principles of classification are mentioned in the Annex 6 of the
directive. The Annex 6 should be included in our regulation as is and the
relevant article should be added to the regulation.

67/548/EEC
Article 4.3.
Annex I (25) contains the list of substances classified in accordance with the prin-
ciples outlined in paragraphs 1 and 2, together with their harmonized classifica-
tion and labelling. The decision to place a substance in Annex I together with the
harmonized classification and labelling shall be taken in accordance with the pro-
cedure laid down in Article 29.

Article 4.4.
The dangerous substances listed in Annex I shall, where appropriate, be char-
acterized by concentration limits or any other parameter enabling an assess-
ment to be made of the health or environmental hazard of preparations contain-
ing the said dangerous substances or substances containing other dangerous
substances as impurities.

Dangerous Chemicals Regulation
Dangerous chemical substances and products mentioned in the Annex I.

The Annex 1 should be included in our regulation as is and the relevant arti-
cle should be added to the regulation. Annex I of the Directive lists those new
and existing substances whose classification and labelling have been officially
agreed at Community level.

67/548/EEC
Duties of the Member States
Article 5.1.
Without prejudice to Article 13, Member States shall take all the necessary
measures to ensure that substances cannot be placed on the market on their
own or in preparations unless they have been:


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         notified to the competent authority of one of the Member States in ac-
          cordance with this Directive,
         packaged and labelled in accordance with Articles 22 to 25 and with
          the criteria in Annex VI, and in accordance with the results of the tests
          provided for in Annexes VII and VIII, save in the case of preparations
          where provisions exist in other Directives.

In addition, Member States shall take all the necessary measures to ensure that
the provisions concerning safety data sheets as laid down in Article 27 are ob-
served.

Dangerous Chemicals Regulation
No provision.

The Directive requires Member States to ensure that producers and import-
ers who place new substances on the market for the first time notify the
competent authorities. This notification is progressive in that the data re-
quirements increase stepwise as the tonnage levels of the notified substance
cross specific thresholds. So, in our legislation we have to establish a proce-
dure for the notification of new substances by manufacturers, importers and
distributors. Also we have to establish a mechanism to ensure that all sub-
stances are packaged and labelled in accordance with the directive that the
substances should be packaged and labelled in accordance with the specified
criteria and procedures. Besides, establish a mechanism to ensure that
manufacturers, importers and distributors provide safety data sheets.

67/548/EEC
Obligation to carry out investigations
Article 6
Manufacturers, distributors and importers of dangerous substances which ap-
pear in the EINECS but which have not yet been introduced into Annex I shall
be obliged to carry out an investigation to make themselves aware of the rele-
vant and accessible data which exist concerning the properties of such sub-
stances. On the basis of this information, they shall package and provisionally
label these substances according to the rules laid down in Articles 22 to 25 and
the criteria in Annex VI.

Dangerous Chemicals Regulation
Article 10
Obligation for Testing of the Products
Manufacturer is obliged to use national and international standard methods for
measurements that are performed in order to prove specifications mentioned in
the notification related to concerned substances, temporarily, until publication of
the edict concerning the test methods of the dangerous substances.

The relevant article should be modified according to the directive. The An-
nex 5 should be taken as is into the new legislation. The manufacturers, im-
porters and distributors will carry out investigations into the properties of
dangerous substances that appear in the EINECS, but which have not yet
been introduced into Annex I of the Directive so the mechanism should be
established accordingly.



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67/548/EEC
Article 7.1.
Full notification
Without prejudice to Articles 1 (2), 8 (1), 13 and 16 (1), any notifier of a sub-
stance shall be required to submit to the competent authority referred to in Ar-
ticle 16 (1) of the Member State in which the substance is manufactured, or in
the case of a manufacturer located outside the Community, the Member State
within which the notifier is established, a notification including:
        a technical dossier supplying the information necessary for evaluating
         the foreseeable risks, whether immediate or delayed, which the sub-
         stance may entail for man and the environment, and containing all
         available relevant data for this purpose. As a minimum, the dossier
         shall contain the information and results of the studies referred to in
         Annex VII. A, together with a detailed and full description of the stud-
         ies conducted and of the methods used or a bibliographical reference to
         them,
        a declaration concerning the unfavourable effects of the substance in
         terms of the various foreseeable uses,
        the proposed classification and labelling of the substance in accordance
         with this Directive,
        in the case of dangerous substances only, a proposal for a safety data
         sheet as provided for in Article 27,
        in the case of a manufacturer located outside the Community, the noti-
         fier shall, in accordance with Article 2 (1) (d), second indent, include,
         if appropriate, a statement from the manufacturer to the effect that, for
         the purpose of submitting a notification for the substance in question,
         he is designated as the manufacturer's sole representative,
        if so desired, a statement by the notifier requesting, on reasoned
         grounds, that the notification be exempted from the provisions of Arti-
         cle 15 (2) for a maximum period which shall not in any case exceed
         one year following the date of notification.

Besides the information referred to above, the notifier may also provide the
authority with a preliminary assessment of the risks, which he has made in
accordance with the principles laid down in Article 3 (2).

Dangerous Chemicals Regulation
Article 8
Obligation for Notification of Manufacturer and Importer
In the borders of the country, after production and importation, relevant who deal
with the dangerous chemical substances and products in the scope of related
edicts and the Annex-1 are obliged to;
a.       prove their compliance with the rules related to labelling, packaging,
         storage and transportation in the frame of provisions of this Regulation
         and its Annexes,
b.       notify in the case of Ministry request.

Minimum information shall be present at notification file is stated in the Annex
III.

Manufacturer and importer are obliged to submit proof of notified information to
the Ministry in the case of necessity.


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Ministry makes changes concerning the substances scope the Annex I in line with
the opinion of Chemical Safety Commission which is constituted in the Article 44
of this Regulation.

Article 9
Obligation for Submission of Additional Information

In the case of Ministry request, applicants in the frame of the relevant edicts are
obliged to obtain additional information including:
a)      Present scientific expert reports,
b)      Relevant experiment methods and their sources,
c)      Representative sample of substance and product,
d)      Labels or drafts, and Safety Data Sheets,
e)      Proofs of the notified information.

Ministry could request additional experiments, tests and their results if submitted
documents were found insufficient.

In our regulation, the notification is not a must concept. On the other
hand, establishment of a notification system and to implement the system
accordingly is a must requirement of the directive. The notification should
be made in accordance with the specified criteria and procedures men-
tioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 7.2.
Without prejudice to Article 14, any notifier of a substance already notified
shall inform the competent authority:
        when the quantity of the substance placed on the market reaches 10
         tonnes per year per manufacturer or when the total quantity placed on
         the market reaches 50 tonnes per manufacturer; in this case, the com-
         petent authority may require some or all of the additional tests/studies
         laid down in Annex VIII, level 1, to be carried out within a time limit it
         will determine;
        when the quantity of the substance placed on the market reaches 100
         tonnes per year per manufacturer or when the total quantity placed on
         the market reaches 500 tonnes per manufacturer; in this case, the com-
         petent authority shall require the additional tests/studies laid down in
         Annex VIII, level 1, to be carried out within a time limit it will deter-
         mine, unless the notifier can give good reason why a given test/study is
         not appropriate or an alternative scientific test/study would be prefer-
         able;
        when then quantity of a substance placed on the market reaches 1 000
         tonnes per year per manufacturer or when the total quantity placed on
         the market reaches 5 000 tonnes per manufacturer; in this case, the
         competent authority shall draw up a programme of tests/studies ac-
         cording to Annex VIII, level 2, to be carried out by the notifier within a
         time limit which the competent authority will determine.

Dangerous Chemicals Regulation
No detail on quantity of the substance placed on the market.


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The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.


67/548/EEC
Article 7.3. When additional testing is carried out either in accordance with the
requirements of paragraph 2 or voluntarily, the notifier shall provide the com-
petent authority with the results of the studies carried out.

Dangerous Chemicals Regulation
No detail about additional testing.

The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 8
Reduced notification requirements for substances placed on the market in
quantities of less than one tonne per annum per manufacturer:
1. Without prejudice to Articles 1 (2), 13 (1) and 16 (1), any notifier intending
to place a substance on the Community market in quantities of less than one
tonne per annum per manufacturer shall be required to submit to the competent
authority referred to in Article 16 (1) of the Member State in which the sub-
stance is produced, or in the case of a manufacturer located outside the Com-
munity, the Member State within which the notifier is established, a notifica-
tion including:
        a technical dossier supplying the information necessary for evaluating
         the foreseeable risks, whether immediate or delayed, which the sub-
         stance may entail for man and the environment, and containing all
         available relevant data for this purpose. As a minimum, the dossier
         shall contain the information and results of the studies referred to in
         Annex VII. B, together with a full and detailed description of the stud-
         ies conducted and of the methods used or a bibliographical reference to
         them if the Member State in which the notification is made so requires,
        all the other information referred to in Article 7 (1).

2. When the quantities to be placed on the market are below 100 kg per year
per manufacturer the notifier may, without prejudice to Article 16 (1), restrict
the information in the technical dossier of the said notification above to that
provided for in Annex VII. C.

3. In the case of a notifier who has submitted a reduced notification dossier in
conformity with paragraph 2, he shall, before the quantity of the substance
placed on the market reaches 100 kg per year per manufacturer or before the
total quantity placed on the market reaches 500 kg per manufacturer, provide
the competent authority with the additional information necessary to complete
the technical dossier to the level of Annex VII. B.




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4. Similarly, when a notifier has submitted a reduced notification dossier in
conformity with paragraph 1 he shall, before the quantity of the substance
placed on the market reaches 1 tonne per year per manufacturer, or before the
total quantity placed on the market reaches 5 tonnes per manufacturer, submit a
full notification according to the requirements of Article 7.

5. The substances notified in conformity with paragraphs 1 and 2 must, in so
far as the notifier may reasonably be expected to be aware of their dangerous
properties, be packaged and provisionally labelled in accordance with the rules
laid down in Articles 22 to 25 and with the criteria imposed in Annex VI.
Where it is not yet possible to label them in accordance with the principles set
out in Article 23, the label should bear, in addition to the label deriving from
the tests already carried out, the warning "Caution - substance not yet fully
tested".

Dangerous Chemicals Regulations
No detail about reduced notification.

The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 9
Substances already notified (10-year rule)
A notifier need not supply the information required under Articles 7 and 8 for
the technical dossiers in Annexes VII. A, VII. B, VII. C and VII. D with the
exception of items 1 and 2 thereof, if the data were originally submitted at least
10 years previously.

Dangerous Chemicals Regulation
No detail about substances already notified.

The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 10
Placing of notified substances on the market
1. Substances notified under Article 7 may, in the absence of any indication to
the contrary from the competent authority, be placed on the market no sooner
than 60 days after receipt by the authority of a dossier in conformity with the
requirements of this Directive.

If the competent authority considers that the dossier is not in conformity with
the Directive and advises the notifier accordingly, as provided for in Article 16
(2), the substance may be placed on the market only 60 days after receipt by
the authority of the information necessary to bring the notification into con-
formity with the Directive.




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2. Substances notified under Article 8 (1) or (2) may, in the absence of any
indication to the contrary from the competent authority, be placed on the mar-
ket no sooner than 30 days after receipt by the authority of a dossier in confor-
mity with the requirements of this Directive.

If the competent authority considers that the dossier is not in conformity with
the Directive and advises the notifier accordingly, as provided for in Article 16
(3), the substance may be placed on the market only 30 days after receipt by
the authority of the information necessary to bring the notification into con-
formity with the Directive. However, if the notifier has received notice in ac-
cordance with Article 16 (3) that the dossier has been accepted, the substance
may be placed on the market no sooner than 15 days after receipt of the dossier
by the competent authority.

Dangerous Chemicals Regulation
No detail about placing of notified substances on the market.

The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 11
Substances manufactured outside the Community
Where, for substances manufactured outside the Community, more than one
notification exists for a substance manufactured by the same manufacturer, the
cumulative yearly tonnages placed on the Community market shall be deter-
mined by the Commission and the national authorities on the basis of the in-
formation submitted under Articles 7 (1), 8 (1) and 14. The obligation to carry
out supplementary testing in accordance with Article 7 (2) will fall collectively
on all notifiers.

Dangerous Chemicals Regulation
No detail about substances manufactured outside the Community.

The legislation should be modified according to the directive. The notifica-
tion should be made in accordance with the specified criteria and proce-
dures mentioned in articles 5, 7, 8, 9, 10 and 15.

67/548/EEC
Article 12
Polymers
For polymers, the specific provisions concerning the technical dossiers con-
tained in the notifications and referred to in Articles 7 (1) and 8 (1) shall be laid
down in Annex VII, in the form of Annex VII. D, in accordance with the pro-
cedure referred to in Article 29 (4) (b).

Dangerous Chemicals Regulation
No detail about notification of polymers.

The legislation should be modified according to the directive.



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67/548/EEC
Article 13
Exemptions
1. The following substances shall be exempt from the provisions of Articles 7,
8, 14 and 15:
       substances which appear on the EINECS inventory;
       additives and substances for exclusive use in animal feeding stuffs as
        covered by Directives 70/524/EEC and 82/471/EEC (28);
       substances used exclusively as additives in foodstuffs, as covered by
        Directive 89/107/EEC (29), and substances used exclusively as fla-
        vourings in foodstuffs and which are covered by Directive
        88/388/EEC;
       active ingredients used exclusively in the medicinal products referred
        to in Article 1 (2) (a). This does not include chemical intermediates;
       substances for exclusive use in other product sectors for which Com-
        munity notification or approval procedures exist and for which the re-
        quirements for data submission are equivalent to those laid down in
        this Directive. Not later than 12 months after notification of this Direc-
        tive, the Commission, in accordance with the procedure laid down in
        Article 29 (4) (a), shall establish a list of such Community legislation.
        This list will be re-examined periodically and, as necessary, revised in
        accordance with the said procedure.

2. The substances listed below shall be considered as having been notified
within the meaning of this Directive when the following conditions are ful-
filled:
       polymers, with the exception of those which contain in combined form
        2 % or more of any substance which is not on EINECS;
       substances placed on the market in quantities of less than 10 kg per
        year per manufacturer, provided the manufacturer/importer satisfies all
        the conditions imposed by the Member States in which the substance is
        placed on the market. These conditions shall not exceed the informa-
        tion provided for in Annex VII. C, points 1 and 2;
       substances placed on the market in limited quantities, and in any case
        not exceeding 100 kg per manufacturer per year, and intended solely
        for purposes of scientific research and development carried out under
        controlled conditions.

       Any manufacturer or importer making use of this exemption must
       maintain written records containing the identity of the substance, label-
       ling data, quantities and a list of customers; this information shall be
       made available upon request to the competent authorities of each
       Member State where the manufacture, importation or scientific research
       and development takes place;
       substances placed on the market for the purposes of process-orientated
        research and development with a limited number of registered custom-
        ers in quantities which are limited to the purpose of process-orientated
        research and development. These substances shall qualify for an ex-
        emption for a period of one year provided that the manufacturer or im-
        porter communicates their identity, labelling data, quantity, the justifi-
        cation for the quantity and a list of customers and the research and de-



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           velopment programme to the competent authorities of each Member
           State where the manufacture, importation or process-orientated re-
           search and development takes place and complies with any conditions
           imposed by these authorities or the Member States on such research
           and development. The conditions imposed by the Member States may
           include information not exceeding that provided for in Article 8. After
           one year, these substances will normally be subject to notification. The
           manufacturer or importer shall also give an assurance that the sub-
           stance or the preparation in which it is incorporated will be handled
           only by customers' staff in controlled conditions and will not be made
           available to the general public at any time either on its own or in a
           preparation. In addition, if the competent authority considers that there
           may exist an unacceptable risk for man and the environment, it may
           extend the restriction referred to above to include any products con-
           taining the new substances which were produced during the process-
           orientated research and development.

           The one-year exemption period referred to above may in exceptional
           circumstances be extended for a further year if the notifier can demon-
           strate, to the satisfaction of the competent authorities, that such an ex-
           tension is justified.

3. The substances referred to in paragraph 2 must, in so far as the manufacturer
may reasonably be expected to be aware of their dangerous properties, be
packaged and provisionally labelled by the manufacturer or his representative
in accordance with the rules laid down in Articles 22 to 25 and with the criteria
imposed in Annex VI.

If it is not possible to label the substances completely, and in accordance with
the principles set out in Article 23, because the results of tests provided for in
Annex VII. A are not all available, the label should bear, in addition to the
label deriving from tests already carried out, the warning "Caution - substance
not yet fully tested".

4. Where a substance as referred to in paragraph 2, labelled in accordance with
the principles set out in Article 23, is very toxic, toxic, carcinogenic, toxic for
reproduction or mutagenic, the manufacturer or importer of such a substance
must transmit to the competent authority any appropriate information as re-
gards Annex VII. A, Sections 2.3, 2.4 and 2.5. Moreover, acute toxicity data
shall be given where available.

Dangerous Chemicals Regulation
No detail about exemptions.

Article 13 sets the exemptions to the rules of notification. While establish-
ing the notification system the exemptions mentioned in the elaborated
article should be considered. In notification the specified criteria and pro-
cedures are subject to the exemptions listed in the article 13.

67/548/EEC
Article 14
Follow-up information


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1. Any notifier of a substance already notified in conformity with Articles 7 (1)
or 8 (1) shall be responsible on his own initiative for informing in writing the
competent authority to which the initial notification was submitted of:
       changes in the annual or total quantities placed on the Community
        market by him or, in the case of a substance manufactured outside the
        Community for which the notifier has been designated as sole repre-
        sentative, by him and/or others;
       new knowledge of the effects of the substance on man and/or the envi-
        ronment of which he may reasonably be expected to have become
        aware;
       new uses for which the substance is placed on the market of which he
        may reasonably be expected to have become aware;
       any change in the composition of the substances as given in Annex
        VII. A, B or C, section 1.3;
       any change in his status (manufacturer or importer).

2. Any importer of a substance produced by a manufacturer established outside
the Community who imports the substance within the framework of a notifica-
tion previously submitted by a sole representative in accordance with Article 2
(1) (d) shall be required to ensure that the sole representative is provided with
up-to-date information concerning the quantities of the substance introduced by
him on to the Community market.

Dangerous Chemicals Regulation
No information

In our legislation, there is no information about the procedure that should
be followed in case of changes occurred in the quantities of substance, new
knowledge of the effects of the substance and new uses for the substance
which is already notified. The system must ensure that notifiers of sub-
stances that have already been notified inform the competent au-
thority of changes in quantities placed on the market and of new
knowledge about the substance (Art. 14, subject to exemptions listed
in Article 13). The legislation should be modified according to the direc-
tive.

67/548/EEC
Article 15
Renotification of the same substance and avoidance of duplicating testing on
vertebrate animals.
1. In the case of a substance which has already been notified in accordance
with Articles 7 (1) or 8 (1), the competent authority may agree that the subse-
quent notifier of that substance may, for the purposes of sections 3, 4 and 5 of
Annex VII. A and B and sections 3 and 4 of Annex VIII. C, refer to the results
of the tests/studies forwarded by the first notifier, in so far as the subsequent
notifier can provide evidence that the substance renotified is the same as the
one previously notified, including the degree of purity and the nature of impu-
rities. The first notifier must give his agreement in writing to the reference to
the results of the tests/studies he has forwarded before such reference can be
made.




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2. Before carrying out testing on vertebrate animals for the purpose of submit-
ting a notification in conformity with Articles 7 (1) or 8 (1), and without preju-
dice to paragraph 1, prospective notifiers shall enquire of the competent au-
thorities of the Member State within which they intend subsequently to notify;
as to:
a)       whether or not the substance they intend to notify has already been
         notified; and
b)       the name and address of the first notifier.

This enquiry shall be supported by evidence that the prospective notifier has
intention to place the substance on the market and of the quantities he intends
to place on the market.
In the event that:
a)       the competent authority receiving the enquiry is satisfied that the pro-
         spective notifier intends to place the substance on the market in the
         quantities stated; and
b)       the substance has been notified previously; and
c)       the first notifier has not requested and been granted a temporary ex-
         emption from the provisions of this Article.

The competent authority shall provide the prospective notifier with the name
and address of the first notifier and shall inform the first notifier of the name
and address of the prospective notifier.

The first notifier and the prospective notifier shall take all reasonable steps to
reach an agreement on the sharing of information so as to avoid the duplication
of testing on vertebrate animals.

3. Notifiers of the same substance who have agreed to share information relat-
ing to Annex VII in accordance with paragraphs 1 and 2 shall also take all nec-
essary steps to reach an agreement on the sharing of information derived from
testing on vertebrate animals submitted in conformity with Article 7 (2).

4. If, despite the provisions of paragraphs 2 and 3, notifiers and prospective
notifiers of the same substance can still not reach an agreement on the sharing
of data, Member States may, for notifiers and prospective notifiers located
within their territory, introduce national measures obliging notifiers and pro-
spective notifiers to share the data with a view to avoiding duplicative testing
on vertebrate animals and determine both the procedure for utilizing informa-
tion, including regulations on the temporary exemption referred to in the final
indent of Article 7 (1) and the reasonable balance of the interests of the parties
concerned.



Dangerous Chemicals Regulation
No information about renotification of the same substance and avoidance of
duplicating testing on vertebrate animals

The avoidance of tests on vertebrate animals is an important concept in
EU so; the legislation should be modified according to the directive.



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67/548/EEC
Article 16
Rights and duties of the authorities
1. Member States shall appoint the competent authority or authorities responsi-
ble for receiving the information provided for in Articles 7 to 14 and examin-
ing its conformity with the requirements of this Directive.

Moreover, if it can be shown to be necessary for the evaluation of the risk
which may be caused by a substance, the competent authorities may ask for
further information, verification and/or confirmatory tests concerning the sub-
stances or their transformation products, of which they have been notified or
have received information under this Directive; this may also include request-
ing any of the information referred to in Annex VIII earlier than provided for in
Article 7 (2).

Additionally, the competent authorities may:
      carry out such sampling as is necessary for control purposes,
      require the notifier to supply such quantities of the notified substance
       as it deems necessary for the carrying out of verification tests,
      take appropriate measures relating to safe use of a substance pending
       the introduction of Community provisions.

In the case of substances notified in accordance with Articles 7 (1) and 8 (1)
and (2), the competent authority which received notification shall carry out an
assessment of the risks in accordance with the general principles laid down in
Article 3 (2). The assessment shall include recommendations on the most ap-
propriate method for testing the substance and, where appropriate, also include
recommendations on measures which will enable the risk for man and the envi-
ronment in connection with the marketing of the substance to be lessened. The
assessment shall be updated from time to time in the light of additional infor-
mation provided under this Article or Articles 7 (2), 8 (3) and 14 (1).

2. In the case of notifications submitted in conformity with Article 7, within a
period of 60 days following receipt of the notification, the authority shall in-
form the notifier in writing as to whether the notification has, or has not, been
accepted as being in conformity with this Directive.

If the dossier is accepted, the authority shall at the same time advise the notifier
of the official number which has been allocated to the notification. If the dos-
sier is not accepted, the authority shall inform the notifier as to what further
information he is required to provide in order to bring the dossier into confor-
mity with this Directive.

3. For notifications submitted in accordance with Article 8, the competent au-
thority shall, within a period of 30 days following receipt of the notification,
decide whether the notification is in conformity with this Directive and, where
the notification is adjudged not to be in conformity, inform the notifier as to
what further information he is required to provide in order to bring the dossier
into conformity with the Directive. Where the notification is in conformity with
the Directive, the authority shall, within the same period, advise the notifier of
the official number which has been allocated to his notification.



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4. For substances manufactured outside the Community for which more than
one notification has been submitted for the substance produced by one manu-
facturer, the competent authorities, together with the Commission, shall be
responsible for calculating the annual and cumulative tonnages placed upon the
Community market. If the tonnage thresholds detailed in Article 7 (2) are at-
tained, the competent authority responsible for receiving the notification(s)
shall contact each notifier informing them of the identity of the other notifiers
and drawing their attention to their collective responsibility as outlined in Arti-
cle 11.

5. The procedure laid down in Article 28 shall be followed confirming or
amending proposals for classification and labelling.

6. Without prejudice to Article 19 (1), Member States and the Commission
shall ensure that any information concerning commercial exploitation or manu-
facturing is kept secret.

Dangerous Chemicals Regulation
Duties of the Authority
Evaluation of the Notifications
Article 30
Ministry evaluates the notifications concerning the dangerous chemical sub-
stances and products mentioned in the Annex I and required in the case of ne-
cessity according to provisions of this Regulation.

The designation of competent authority/authorities should be included into
the regulation in order to receive and assess information from manufactur-
ers and importers on the substances to be placed on the market and ensure
that competent authorities carry out their duties in accordance with pre-
scribed principles under article 16. The relevant article should be modified
according to the directive. It should be emphasized that the competent au-
thority must provide information to manufacturers, importers and distribu-
tors to ensure they understand the requirements of the directive.

67/548/EEC
Article 17
Involvement of the Commission in the notification procedure
When a Member State has received the notification dossier referred to in Arti-
cles 7 (1) and 8 (1), or information on the supplementary testing carried out in
accordance with Articles 7 (2) and 8 (3), or follow-up information submitted in
conformity with Article 14, it shall as soon as possible send the Commission a
copy of the dossier or of the further information or a summary thereof.

In the case of the further information referred to in Article 16 (1), the compe-
tent authority shall notify the Commission of the tests chosen, the reasons for
their choice, the results and, if appropriate, an assessment of the results. In the
case of information received in conformity with Article 13 (2), the competent
authority shall forward to the Commission such elements as would be of com-
mon interest for the Commission and the other competent authorities.




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The assessment of the risks referred to in Article 16 (1) or a summary of that
assessment shall be forwarded to the Commission as soon as it becomes avail-
able.

Dangerous Chemicals Regulation
No information in the Regulation.

These provisions should be taken to the legislation however they will be
valid after EU accession.

67/548/EEC
Article 18
Duties of the Commission
1. On receipt of the dossiers and information referred to in Article 17, the
Commission shall forward copies to the Member States. In addition, the Com-
mission may also forward any other relevant information it has collected pur-
suant to this Directive, as it sees fit.

2. The competent authority of any Member State may consult directly the com-
petent authority which received the original notification, or the Commission,
on specific details of the data contained in the dossier required under this Di-
rective or the assessment of the risks provided for in Article 16 (1); it may also
suggest that further tests or information be requested or that the assessment of
the risks be modified. If the competent authority which received the original
notification fails to comply with the suggestions of other authorities regarding
further information, confirmation tests or amendments in the study pro-
grammes provided for in Annex VIII or the assessment of the risks, it shall
give its reasons to the other authorities concerned. Should it not be possible for
the authorities concerned to reach agreement and should any one authority feel,
on the basis of detailed reasons, that additional information, confirmation tests
or amendments in the study programmes or an assessment are nevertheless
really necessary to protect man and the environment, it may ask the Commis-
sion to take a decision in accordance with the procedure laid down in Article
29 (4) (b).

Dangerous Chemicals Regulation
No information.

These provisions should be taken to the legislation however they will be
valid after EU accession.

67/548/EEC
Article 19
Confidentiality of data
If he considers that there is a confidentiality problem, the notifier may indicate
the information provided for in Articles 7, 8 and 14 which he considers to be
commercially sensitive and disclosure of which might harm him industrially or
commercially, and which he therefore wishes to be kept secret from all persons
other than the competent authorities and the Commission.

Dangerous Chemicals Regulation
Annex III


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Ministry,
- in case of proof for confidentiality conditions of specification and composition
of substance, do not require some information mentioned in this list (Information
form for notification of harmful chemical substances and harmful chemical prod-
ucts) or change with other equivalence or more appropriate one.

The competent authority must respect the industrial and commercial secrecy
which was mentioned also in article 16 and establish the procedures and the
criteria in order to maintain the industrial and commercial secrecy.

67/548/EEC
Article 20
Exchange of the summary dossier
1. The data supplied in accordance with Articles 17 and 18 may be forwarded
to the Commission and the Member States in summary form.
In such cases and in the context of Article 18 (2), the competent authorities of a
Member State and the Commission shall have access to the notification dossier
and the additional information at all times.

2. For the purpose of the exchange of information referred to in Articles 17 and
18 (1), the Commission shall develop a common format. This format shall be
adopted by the procedure laid down in Article 29.

Dangerous Chemicals Regulation
No information about exchange of the summary dossier.

The legislation should be revised according to the directive.
67/548/EEC
Article 21
Lists of existing and new substances
1. The Commission shall keep a list of all substances notified under this Direc-
tive. This list shall be compiled in accordance with the provisions of Commis-
sion Decision 85/71/EEC (32).

2. The Commission shall allocate an EEC number to each substance contained
on the EINECS inventory and on the list referred to in paragraph 1.

Dangerous Chemicals Regulation
No information about list of existing and new substances.

The legislation should be revised according to the directive.

67/548/EEC
Article 22.1.
Packaging
Member States shall take all necessary measures to ensure that dangerous sub-
stances cannot be placed on the market unless their packaging satisfies the
following requirements:

Dangerous Chemicals Regulation
Article 23



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Those who deal with one or some of the matters such packaging, storage, trans-
port of the dangerous chemical substances and products are subjected to provi-
sions of this Regulation.

When these works are made by third person or enterprise, employer or enterprise
is responsible uninterruptedly with those who deal with.

Article 24
Dangerous substances and products shall be placed on the market in compliance
with the provisions of this Regulation in Article 27 and after packed that prevents
the overflow from package by leakage, spillage, spread and similar ways.
Above mentioned provision shall not apply for substances and products whose
placing on the market method subjected to particular legislation.

Those who deal with transport and storage of unpacked substances and prod-
ucts, except for substances and products whose placing on the market method
subjected to particular legislation, shall get distinctive permit from relevant
authority

The legislation should be revised according to the directive although in our
legislation the provisions are more detailed.

67/548/EEC
Article 22.1.a
Package shall be so designed and constructed that its contents cannot escape;
this requirement shall not apply where special safety devices are prescribed.

Dangerous Chemicals Regulation
Article 27.1.a.
Package shall be so constructed that its contents cannot escape.

The legislation should be revised according to the directive. The phrases
“designed” and “this requirement shall not apply where special safety
devices are prescribed.” should be added to our regulation.


67/548/EEC
Article 22.1.b
The materials constituting the packaging and fastenings must not be susceptible
to adverse attack by the contents, or liable to form dangerous compounds with
the contents.

Dangerous Chemicals Regulation
Article 27.1.b.
The materials constituting the packaging and fastenings must not be susceptible
to adverse attack by the contents, or liable to form dangerous compounds with
the contents.

The relevant article is compliant to the relevant article of the directive.

67/548/EEC
Article 22.1.c.


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Packaging and fastenings must be strong and solid throughout to ensure that
they will not loosen and will safely meet the normal stresses and strains of
handling.

Dangerous Chemicals Regulation
Article 27.d.
Containers must be designed throughout to ensure that they will be strong
while facing with the effect of air pressure variations.

No information related with fastening so the relevant article should be
revised according to the directive.


67/548/EEC
Article 22.1.d.
Containers fitted with replaceable fastening devices shall be so designed that
the packaging can be refastened repeatedly without the contents escaping;

Dangerous Chemicals Regulation
No information about fastening devices.

No information related with fastening so the relevant article should be
revised according to the directive.

67/548/EEC
Article 22.1.e.
Every container of whatever capacity, containing substances sold or made
available to the general public and labelled "very toxic", "toxic" or "corrosive",
as defined in this Directive, must have a child-resistant fastening and a tactile
warning of danger;

Dangerous Chemicals Regulation
No information about child-resistant fastening and a tactile warning of danger.
No information about child-resistant fastening and a tactile warning of
danger so the relevant article should be revised according to the directive.

67/548/EEC
Article 22.1.f.
Every container, of whatever capacity, containing substances sold or made
available to the general public and labelled "harmful", "extremely flammable"
or "highly flammable" as defined in this Directive must bear a tactile warning
of danger.


Dangerous Chemicals Regulation
No information about tactile warning of danger.

No information about tactile warning of danger so the relevant article
should be revised according to the directive.

67/548/EEC
Article 22.2.


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Member States may also prescribe that packaging shall be closed initially with
a seal in such a way that when the packaging is opened for the first time the
seal is irreparably damaged.

Dangerous Chemicals Regulation
No information about sealing.

No information about sealing so the relevant article should be revised ac-
cording to the directive.

67/548/EEC
Article 22.3.
The categories of substances for which the packaging must be equipped with
the devices mentioned in paragraph 1 (e) and (f) shall be modified in accor-
dance with the procedure provided for in Article 29.

Dangerous Chemicals Regulation
No information about devices.

No information about the devices so the relevant article should be revised
according to the directive.

4. The technical specifications relating to the devices referred to in paragraph 1
(e) and (f) shall be modified in accordance with the procedure provided for in
Article 29 (4) (a) and are to be found in points A and B of Annex IX to this
Directive.

Dangerous Chemicals Regulation
No provision related with devices referred to in paragraph 1 (e) and (f), child-
resistant fastening and a tactile warning of danger.

No information about the devices child-resistant fastening and a tactile
warning of danger so the relevant article should be revised according to
the directive.

67/548/EEC
Labelling
Article 23.1.
Member States shall take all necessary measures to ensure that dangerous sub-
stances cannot be placed on the market unless the labelling on their packaging
satisfies the following requirements.



Dangerous Chemicals Regulation
Article 16
All concerned parties with the dangerous chemical substances and products are
responsible for labelling of them according to their specifications. Manufacturers
are obliged to obey labelling rules stated in this section.

The relevant article is almost compliant to the relevant article of the direc-
tive. However, the wording should be revised according to the directive.


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67/548/EEC
Article 23.2.a.
Every package shall show clearly and indelibly the following: the name of the
substance under one of the designations given in Annex I. If the substance is
not yet listed in Annex I, the name must be given using an internationally rec-
ognized designation.

Dangerous Chemicals Regulation
Article 17.b.
Labels should contain commercial name and closed formula of the chemical sub-
stance.

Annex 1 should be inserted to our legislation as is and the article should be
revised according to the directive.

67/548/EEC
Article 23.2.b.
Every package shall show the name and full address including the telephone
number of the person established in the Community who is responsible for
placing the substance on the market whether it be the manufacturer, the im-
porter or the distributor.

Dangerous Chemicals Regulation
Article 17.a. Labels should contain name and address of the Manufacturer.

The relevant article should be revised according to the directive.

67/548/EEC
Article 23.2.c.
Every package shall show danger symbols, when laid down, and indication of
the danger involved in the use of the substance. The design of the danger sym-
bols and the wording of the indications of danger shall comply with those laid
down in Annex II (34). The symbol shall be printed in black on an orange-
yellow background. The danger symbols and indications of danger to be used
for each substance shall be those indicated in Annex I. For dangerous sub-
stances not yet appearing in Annex I the danger symbols and indications of
danger shall be assigned according to the rules laid down in Annex VI.
When more than one danger symbol is assigned to a substance:
- the obligation to indicate the symbol T makes the symbols X and C optional,
unless Annex I provides otherwise,
- the obligation to indicate the symbol C makes the symbol X optional,
- the obligation to indicate the symbol E makes the symbol F and O optional;

Dangerous Chemicals Regulation
Article 20
Danger Symbols shall be printed in black on an orange-yellow background.
Article 17.e.

Relevant danger symbols mentioned individually for the substances in the Annex-
IV.



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Dangerous conditions for man and environmental health and safety precautions
are indicated by symbols in the labels. Symbols except stated in the Annex IV are
not allowed to use.

The relevant article should be revised according to the directive.

67/548/EEC
Article 23.2.d.
Every package shall show standard phrases (R-phrases) indicating the special
risks arising from the dangers involved in using the substance. The wording of
those R-phrases shall comply with that laid down in Annex III. The R-phrases
to be used for each substance shall be as indicated in Annex I. For dangerous
substances not yet appearing in Annex I the R-phrases to be used shall be as-
signed according to the rules laid down in Annex VI;

Dangerous Chemicals Regulation
Article 17.d.
Those remarkable expressions ―Extremely Explosive‖, ―Very Toxic‖, safety rec-
ommendations (chosen from relevant special risks (R) and safety precausions (S)
of dangerous substances according to Annex-VII), concise information concern-
ing measures to be taken, specifications of the dangerous substance stated in the
Annex II,

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

67/548/EEC
Article 23.2.e.
Every package shall show standard phrases relating to the safe use of the sub-
stance (S-phrases). The wording of these S-phrases shall comply with that laid
down in Annex IV. The S-phrases to be used for each substance shall be as
indicated in Annex I. For dangerous substances not yet appearing in Annex I,
the S-phrase to be used shall be assigned according to the rules laid down in
Annex VI;

Dangerous Chemicals Regulation
Article 17.d.
Those remarkable expressions ―Extremely Explosive‖, ―Very Toxic‖, safety
recommendations (chosen from relevant special risks (R) and safety precau-
tions (S) of dangerous substances according to Annex-VII), concise informa-
tion concerning measures to be taken, specifications of the dangerous sub-
stance stated in the Annex II,

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

67/548/EEC
Article 23.2.f.
Every package shall show the EEC number, when allocated. The EEC number
shall be obtained from the EINECS or from the list referred to in Article 21 (1).
In addition, as regards substances appearing in Annex I, the label shall also
include the words "EEC label".


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Dangerous Chemicals Regulation
No information about EEC number.

The relevant article should be revised according to the directive and the
concept of “EEC label” should be included in our legislation.

67/548/EEC
Article 23.3.
In the case of irritant, highly flammable, flammable and oxidizing substances,
an indication of R-phrases and S-phrases need not be given where the package
does not contain more than 125 ml. This shall also apply in the case of the
same volume of dangerous substances not retailed to the general public.

Dangerous Chemicals Regulation
Article 20
In the case of labels of combustible and highly flammable substances not exceed-
ing 0.25 liters, an indication of substance characteristic and measures to be taken
do not need be stated on the package.

The relevant article should be revised according to the directive and the
elaborated amount should be considered in our legislation.

67/548/EEC
Article 23.4.
Indications such as "non-toxic", "non-harmful" or any other similar indications
must not appear on the label or packaging of substances subject to this Direc-
tive.

Dangerous Chemicals Regulation
Article 18
Such expressions ―Non-toxic‖, ―Harmful for health‖, ―Harmful in the case of
usage according to the instruction‖ that cause carelessness are not allowed to use
in the labels.

The relevant article should be revised according to the directive.

67/548/EEC
Article 24
Implementation of labelling requirements
1. Where the particulars required by Article 23 appear on a label, that label
shall be firmly affixed to one or more surfaces of the packaging so that these
particulars can be read horizontally when the package is set down normally.
The dimensions of the label shall be as follows:

Capacity of the package-Dimensions (in millimetres)
      not exceeding 3 litres at least 52 × 74;
      greater than 3 litres but not exceeding 50 litres at least 74 × 105;
      greater than 50 litres but not exceeding 500 litres at least 105 × 148;
      greater than 500 litres at least 148 × 210.




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Each symbol shall cover at least one-tenth of the surface area of the label but
not be less than 1 cm². The entire surface of the label shall adhere to the pack-
age immediately containing the substance.

These dimensions are intended solely for provisions of the information re-
quired by this Directive and if necessary of any supplementary health or safety
indications.

Dangerous Chemicals Regulation
Article 20
Dimensions of the dangerous chemical substances or products labels are men-
tioned below according to volume of the packaging containers

a)         Appropriate size up to 0,25 liters;
b)         Between 0.26 and 3,0 liters, at least 52 mm. x 74 mm;
c)         Between 3.1 and 50 liters, at least 74 mm. x105 mm;
d)         Between 51 and 500 liters, at least 105 mm. x 148 mm;
e)         Greater than 500 liters, at least 148 mm. x 210 mm.

Danger Symbols shall be printed in black on an orange-yellow background. Each
symbol shall cover at least 1 cm² surface area and one-tenth of the surface area of
the label. Symbols without danger mentioned in the paragraph (e), Article 17 of
this Regulation may not be required to mention, If symbol used for certain danger
class include one of the other danger class as well.

Label, except for matters stated in this Regulation, has other obligatory symbols
required by the provisions of relevant Regulations for the area such as health and
safety as a complementary.

The relevant article should be revised according to the directive and the
elaborated amounts should be considered in our legislation.

67/548/EEC
Article 24.2.
A label is not required where the particulars are clearly shown on the package
itself, as specified in paragraph 1.

Article 24.3.
The colour and presentation of the label or, in the case of paragraph 2, of the
package shall be such that the danger symbol and its background stand out
clearly.


Article 24.4.
The information required on the label under Article 23 shall stand out clearly
from its background and shall be of such size and spacing as to be easily read.
Specific provisions regarding the presentation and dimensions of this informa-
tion shall be laid down in Annex VI in accordance with the procedure referred
to in Article 29 (4) (b).

Dangerous Chemicals Regulation
Article 20


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Label shall be affixed to one or more surfaces of the packaging so that these
particulars can be read when the package is set down normally. If it is not pos-
sible to affix to surface of the package due to type or dimensions of the pack-
age, labelling shall be made on the one of the plaque connected to package.
Necessary measures shall be taken in order to prevent removing of label be-
cause of external factors and inner substance, or leaving of plaque if used.

The relevant article should be revised according to the directive and the
elaborated criteria should be taken as is to our legislation.

67/548/EEC
Article 24.5.
Member States may make the placing on the market of dangerous substances in
their territories subject to the use of the official language or languages in re-
spect of the labelling thereof.

Dangerous Chemicals Regulation
Article 17
Labels are prepared in Turkish for dangerous chemicals and dangerous goods
placing on the market, they are prepared in one of the official languages of the
exported country for exporting dangerous chemicals and dangerous goods.

The relevant article should be revised according to the directive.

67/548/EEC
Article 24.6.
For the purpose of this Directive, labelling requirements shall be deemed to be
satisfied:
a)       in the case of an outer package containing one or more inner packages,
         if the outer package is labelled in accordance with international rules
         on the transport of dangerous substances and the inner package or
         packages are labelled in accordance with this Directive;
b)       in the case of a single package:
                 if such a package is labelled in accordance with international
                  rules on the transport of dangerous substances and with Article
                  23 (2) (a), (b), (d), (e) and (f); and
                 where appropriate, for particular types of packaging such as
                  mobile gas cylinders, in accordance with the specific require-
                  ments referred to in Annex VI.

Where dangerous substances do not leave the territory of a Member State, la-
belling may be permitted which complies with national rules instead of with
international rules on the transport of dangerous substances.

Dangerous Chemicals Regulation
Article 18
Labels of the packed substances and products should be sticked to the package.
If packages are covered by second package, labels should be sticked to these
packages as well. If transparent second package is used, in case of clear read-
ability of label, it is not obliged to put label to the second package.




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The directive requires the establishment of a mechanism to ensure that all
substances packaged and labelled according to the provisions of the direc-
tive.

67/548/EEC
Article 25
Exemptions from labelling and packaging requirements
1. Articles 22, 23 and 24 shall not apply to the provisions governing munitions
and explosives placed on the market with a view to producing a practical effect
by explosion or a pyrotechnic effect.
Nor shall the abovementioned Articles be applicable to the provisions relating
to butane, propane and liquefied petroleum gas until 30 April 1997.

2. In addition, Member States may:
a)       permit the labelling required by Article 23 to be applied in some other
         appropriate manner on packages which are either too small or other-
         wise unsuitable for labelling in accordance with Article 24 (1) and (2);
b)       by way of derogation from Articles 23 and 24, permit the packaging of
         dangerous substances which are not explosive, very toxic or toxic to be
         unlabelled or to be labelled in some other way if they contain such
         small quantities that there is no reason to fear any danger to persons
         handling such substances or to other persons;
c)       where packages are too small for the labelling provided for in Articles
         23 and 24 and there is no reason to fear any danger to persons handling
         such substances or to other persons, by way of derogation from the
         above provisions, permit the packaging of explosive, very toxic or
         toxic substances to be labelled in some other appropriate way.

This derogation does not permit use of symbols, indications of danger, risk (R)
phrases or safety (S) phrases different from those laid down in this Directive.
3. If a Member State makes use of the options provided for in paragraph 2, it
shall inform the Commission thereof forthwith.

Dangerous Chemicals Regulation
No provision about exemptions from labelling and packaging requirements.

No provision about exemptions from labelling and packaging require-
ments so the relevant article should be revised according to the directive
and the exemptions from labelling and packaging requirements which
were elaborated in articles 22, 23, 24 should be considered in our legisla-
tion.



67/548/EEC
Article 26
Advertisement
Any advertisement for a substance which belongs to one or more of the catego-
ries referred to in Article 2 (2) shall be prohibited if no mention is made therein
of the category or categories concerned.
Dangerous Chemicals Regulation
No provisions.


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No provision on prohibiting the advertisement of substances belonging to
categories of dangerous substances without reference to the category in our
legislation so the legislation should be revised according to the directive.

67/548/EEC
Article 27
Safety data sheet
1. To enable professional users in particular to take the necessary measures as
regards the protection of the environment and health and safety at the work-
place, at, or if appropriate, before the first delivery of a dangerous substance,
any manufacturer, importer or distributor shall communicate to the recipient a
safety data sheet. This sheet must contain the information necessary for protec-
tion of man and the environment.

It may be communicated on paper or electronically. Subsequently, the manu-
facturer, importer or distributor shall forward to the recipient of the safety data
sheet any new relevant information on the substance which has become known
to him.

2. General rules for the elaboration, distribution, contents and format of the
safety data sheet referred to in paragraph 1 will be established in accordance
with the procedure laid down in Article 29 (4) (a).

Dangerous Chemicals Regulation
Article 22
Following rules is obliged to obey during preparation of safety data sheet and its
distribution.

a) Safety Data Sheets are prepared by manufacturer of the dangerous substance
   and dangerous preparation and preparation which contain at least one danger-
   ous chemical according to the provisions of this Regulation.

b) In the case of request from professional users, although it is not classified as
    dangerous according to provisions of this Regulation, for preparations that
    contain at least one of the substances whose workplace exposure limits deter-
    mined or which have harmful characteristic to man and environment, and for
    at least one or more one by one of such substances;
(1)      contain 1% (weight) and not to be in gaseous phase,
(2)      contain 0.2% (volume) and to be in gaseous phase, Safety Data Sheet in-
         cluded detailed information, shall be prepared by producer of this prepa-
         ration and deliver to demander.

c) Safety Data Sheet;
(1)     shall be prepared by producer for every dangerous substance, dangerous
         preparation or preparation contained at least one dangerous substance
         separately,
(2)     shall be updated according to technical developments and scientific re-
         search,
(3)     shall be provided to customer in the first delivery of the dangerous
         chemical after production or If possible before delivery,



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(4)        in the second or following deliveries on request, as a written text free of
            charge or transmitted in electronic version.

Safety Data Sheet; shall be prepared in Turkish for chemicals placed on the mar-
ket, in one of the official language of the exported country for the exported
chemicals.

In case of update of the Safety Data Sheet in light of new information; updated
form, until 12 month before the update date, shall be transmitted to users and
those who store dangerous chemicals within a period of 3 months following up-
date date and changing date and number of change shall be mentioned in the
form.

After preparation of Safety Data Sheet obtained from producer for imported
chemicals according to provisions of the Regulation by the importer, shall be
provided to customer in the first delivery of the dangerous chemical after produc-
tion or If possible before delivery, in the second or following deliveries on re-
quest, as a written text in Turkish free of charge or transmitted in electronic ver-
sion.

In case of not to be obtaining of Safety Data Sheets of imported chemicals from
their producer by their importer, importer is obliged to prepare Safety Data Sheets
in line with the provisions of this Regulation.

Minimum information and procedures and principles to be complied with in the
preparation of the form shall be determined by the Ministry with edicts to be pub-
lished.

The directive requires the establishment of a mechanism in order to ensure
that manufacturers, importers and distributors comply with their obliga-
tions to supply safety data sheets to users of dangerous substances. The rele-
vant article should be revised according to the directive. However, it is sig-
nificant that the Communiqué on the safety data sheets almost compliant to
this article of the directive.

67/548/EEC
Article 30
Free movement clause
Member States may not prohibit, restrict or impede the placing on the market
of substances which comply with the requirements of this Directive, on
grounds relating to notification, classification, packaging or labelling within
the meaning of this Directive.



Dangerous Chemicals Regulation
No provision about free movement clause.

No provision on free movement of the substances in our legislation. It is not
possible to restrict the placing on the market of substances that comply with
the Directive, for reasons relating to notification, classification, packaging or
labelling, unless the restriction is temporary and is imposed in accordance


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with specified conditions. This article 30 should be considered with article 31
below and these provisions should be included in the legislation.

67/548/EEC
Article 31
Safeguard clause
a)      Where, in the light of new information, a Member States has justifiable
        reasons to consider that a substance, which has been accepted as satis-
        fying the requirements of the Directive, nevertheless constitutes a dan-
        ger for man or the environment, by reason of classification, packaging
        or labelling which is no longer appropriate, it may temporarily reclas-
        sify or, if necessary, prohibit the placing on the market of that sub-
        stance or subject it to special conditions in its territory. It shall imme-
        diately inform the Commission and the other Member States of such
        action and give reasons for its decision.
b)      The Commission shall take a decision in accordance with the proce-
        dure referred to in Article 29 (4) (a).
c)      If, subsequent to the decision taken in accordance with paragraph 2,
        the Commission considers that for cases falling under paragraph 1
        above, technical adaptations to the Annexes of this Directive are nec-
        essary, it shall take a decision on the matter in accordance with the
        procedure provided for in Article 29.

Dangerous Chemicals Regulation
No provision about safeguard clause.

No provision on safe guard in our legislation. It is not possible to restrict the
placing on the market of substances that comply with the Directive, for rea-
sons relating to notification, classification, packaging or labelling, unless the
restriction is temporary and is imposed in accordance with specified condi-
tions. This article 30 should be considered with article 31 below and these
provisions should be included in the legislation.

67/548/EEC
Article 32
Reports
1. Every three years, Member States shall forward to the Commission a report
on the implementation of this Directive in their respective territories. The first
report shall be submitted three years after the implementation of this Directive.

2. Every three years, the Commission shall prepare a composite report based on
the information referred to in paragraph 1, which shall be forwarded to the
Member States.'


Dangerous Chemicals Regulation
No provision about reports to the Commission.

These provisions should be taken to the legislation however they will be
valid after EU accession.

67/548/EEC


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Annex I List of dangerous substances classified in the order of the atomic number
of the element most characteristic of their properties

Dangerous Chemicals Regulation
Annex I is not same with the Annex I of Directive.

67/548/EEC
Annex II Symbols and indications of danger

Dangerous Chemicals Regulation
Annex IV same with the Directive.

67/548/EEC
Annex III Nature of special risk attaching to dangerous substances

Dangerous Chemicals Regulation
Annex VII same with the Directive.

67/548/EEC
Annex IV Safety advice concerning dangerous chemical substances

Dangerous Chemicals Regulation
Annex VII same with the Directive.

67/548/EEC
Annex V Test methods for the determination of physicochemical, toxicological
and ecotoxicological properties listed in Annex VII and VIII

Dangerous Chemicals Regulation
Not present should be taken as is.

67/548/EEC
Annex VI General classification and labelling requirements for dangerous sub-
stances and preparations

Dangerous Chemicals Regulation
Not present should be taken as is.

67/548/EEC
Annex VII A Information required for the technical dossier (―Base Set‖) referred
to in Art. 7.1

Dangerous Chemicals Regulation
Not present.

67/548/EEC
Annex VII B Information required for the technical dossier (―Base Set‖) referred
to in Art. 8.1 and 8.3

Dangerous Chemicals Regulation
Not present.



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67/548/EEC
Annex VII C Information required for the technical dossier (―Base Set‖) referred
to in Art. 8.2

Dangerous Chemicals Regulation
Not present.

67/548/EEC
Annex VII D Specific provisions concerning the technical dossier (―Base set‖)
contained in the notifications referred to in Art. 12.

Dangerous Chemicals Regulation
Not present.

67/548/EEC
Annex VIII Additional information and tests required under Art. 7.2

Dangerous Chemicals Regulation
Not present.

67/548/EEC
Annex IX Part A: Provisions relating to child-proof fastenings Part. B: Provisions
relating to tactile warning devices

Dangerous Chemicals Regulation
Not present.

99/45/EC
Article 1
Objectives
1. This Directive aims at the approximation of the laws, regulations and adminis-
trative provisions of the Member States relating to:
        the classification, packaging and labelling of dangerous preparations,
 and to
        the approximation of specific provisions for certain preparations

which may present hazards, whether or not they are classified as dangerous within
the meaning of this Directive, when such preparations are placed on the market of
the Member States.




Dangerous Chemicals Regulation
Article 1
Objectives
Purpose of this regulation is to determine administrative and technical procedures
and principles for the control of the dangerous chemicals and the protection of
environment and man from their negative effects.



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The objective of the regulation above should be revised according to the re-
quirements of directive. The Council Directive on Dangerous Preparations
specifies the hazard classification, packaging and labelling requirements for
chemical preparations (mixtures or solutions composed of two or more sub-
stances). When a dangerous substance is used as part of a preparation, the
producer is required to determine or calculate the content and apply the
correct classification and labelling.

99/45/EC
Article 1
Scope
2. This Directive shall apply to preparations which:
contain at least one dangerous substance within the meaning of Article 2,
and are considered dangerous within the meaning of Article 5, 6 or 7.

3. The specific provisions set out:
        in Article 9 and defined in Annex IV,
        in Article 10 and defined in Annex V, and
        in Article 14
shall also apply to preparations which are not considered dangerous within the
meaning of Articles 5, 6 or 7 but may nevertheless present a specific hazard.

4. Without prejudice to Directive 91/414/EEC, the articles on classification, pack-
aging, labelling and safety data sheets of this Directive shall apply to plant protec-
tion products.

5. This Directive shall not apply to the following preparations in the finished
state, intended for the final user:
a)        medicinal products for human or veterinary use, as defined in Directive
          65/65/EEC (1);
b)        cosmetic products as defined in Directive 76/768/EEC (2);
c)        mixtures of substances which, in the form of waste, are covered by Direc-
          tives 75/442/EEC (3) and 78/319/EEC (4);
d)        foodstuffs;
e)        animal feeding stuffs;
f)        preparations containing radioactive substances as defined by Directive
          80/836/Euratom (5);
g)        medical devices which are invasive or used in direct physical contact with
          the human body in so far as Community measures lay down provisions
          for the classification and labelling of dangerous
h)        substances and preparations which ensure the same level of information
          provision and protection as this Directive.

6. This Directive shall not apply to:
— the carriage of dangerous preparations by rail, road, inland waterway, sea or
air,
— preparations in transit which are under customs supervision,
provided they do not undergo any treatment or processing.

Dangerous Chemicals Regulation
Article 2
Scope


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a)         procedures and principles related to the determination, classification,
           labelling and packaging of dangerous chemicals,
b)         principles related to production, storage, transportation activities of dan-
           gerous chemicals,
c)         principles related to usage and placing on the market of dangerous
           chemicals and dangerous materials,
d)         procedures and principles related to importing and exporting of chemi-
           cals,
e)         provisions related to dealing with dangerous chemicals and dangerous
           materials,
f)         provisions related to market surveillance and inspection of chemicals and
           dangerous materials,
g)         (Additional paragraph: 06/11/2001-24575 N. O.J./Artc. 1) procedures and
           principles related to preparation and distribution of Safety Data Sheets,

are covered by this Regulation.

However,
c)   which are reached as the final products to the users,
9)   Medical preparations for the usage of human health and veterinary,
10)  Cosmetics,
11)  Wastes and their mixtures, and chemical materials wastes,
12)  Foodstuffs,
13)  Animal feeds,
14)  Pesticides,
15)  Radioactive substances and radioactive substances contained preparations
      and materials,
16)  Explosives, war materials and explosion equipments to obtain explosive
      and pyrotechnic impact
d)   Rules for (related to) classification, labelling and packaging rules related
      to transportation,

are not in the scope of this Regulation.

In our regulation and the Directive, the scope also specifies both the included
concepts and excluded concepts. The excluded concepts are consistent with
the Directive. However, the included concepts specified in our legislation
should be revised according to the Directive.

Definitions
99/45/EC
Article 2
"substances" means chemical elements and their compounds in the natural state
or obtained by any production process, including any additive necessary to
preserve the stability of the products and any impurity deriving from the proc-
ess used, but excluding any solvent which may be separated without affecting
the stability of the substance or changing its composition,

Dangerous Chemicals Regulation
Article 4
" substance" means chemical elements and their compounds in the natural state or
obtained by any production process, excluding any solvent which may be sepa-


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rated without affecting the stability of the substance or changing its composition,
and including any additive necessary to preserve the stability of the products and
any impurity deriving from the process used,

99/45/EC
Article 2
"preparations" means mixtures or solutions composed of two or more sub-
stances,

Dangerous Chemicals Regulation
Article 4
"preparation" means mixture or solution composed of minimum two or more
substances,

99/45/EC
Article 2
"polymer" means a substance consisting of molecules characterized by the
sequence of one or more types of monomer units and comprising a simple
weight majority of molecules containing at least three monomer units which
are covalently bound to at least one other monomer unit or other reactant and
consists of less than a simple weight majority of molecules of the same mo-
lecular weight. Such molecules must be distributed over a range of molecular
weights wherein differences in the molecular weight are primarily attributable
to differences in the number of monomer units. In the context of this definition
a "monomer unit" means the reacted form of a monomer in a polymer,

Dangerous Chemicals Regulation
Article 4
"polymer" means a substance consisting of molecules characterized by the se-
quence of one or more types of monomer units and comprising a simple weight
majority of molecules containing at least three monomer units which are cova-
lently bound to at least one other monomer unit or other reactant and consists of
less than a simple weight majority of molecules of the same molecular weight.
(These molecules are distributed over a range of molecular weights wherein dif-
ferences in the molecular weight are primarily attributable to differences in the
number of monomer units. "Monomer unit" means the reacted form of a mono-
mer in a polymer),

99/45/EC
Article 2
"placing on the market" means the making available to third parties. Importa-
tion into the Community customs territory shall be deemed to be placing on the
market for the purposes of this Directive,

Dangerous Chemicals Regulation
Article 4
"placing on the market" defines the first activity which the making available to
third parties. Importation into the Community customs territory shall be deemed
to be placing on the market for the purposes of this Directive,

99/45/EC
Article 2


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"scientific research and development" means scientific experimentation, analy-
sis or chemical research carried out under controlled conditions; it includes the
determination of intrinsic properties, performance and efficacy as well as sci-
entific investigation related to product development,

Dangerous Chemicals Regulation
Article 4
"scientific research and development" means scientific experimentation, analysis
or chemical research carried out under controlled conditions which includes the
determination of intrinsic properties, performance and efficacy as well as scien-
tific research related to product development,

99/45/EC
Article 2
"process-orientated research and development" means the further development
of a substance in the course of which pilot plant or production trials are used to
test the fields of application of the substance,

Dangerous Chemicals Regulation
Article 4
"process-orientated research and development" means the development of a sub-
stance in the course of which pilot plant or test production unit are used to test the
fields of application of the substance,

99/45/EC
Article 2
"explosive substances and preparations" solid, liquid, pasty or gelatinous sub-
stances and preparations which may also react exothermically without atmos-
pheric oxygen thereby quickly evolving gases, and which, under defined test
conditions, detonate, quickly deflagrate or upon heating explode when partially
confined,

Dangerous Chemicals Regulation
Article 4
"explosive substance/preparation" solid, liquid, pasty or gelatinous substances
and preparations which may also react exothermically without atmospheric oxy-
gen thereby quickly evolving gases, and /or which, under defined test conditions,
detonate, quickly deflagrate or upon heating explode when partially confined,

99/45/EC
Article 2
"oxidizing substances and preparations" substances and preparations which
give rise to a highly exothermic reaction in contact with other substances, par-
ticularly flammable substances,

Dangerous Chemicals Regulation
Article 4
"oxidising substance/preparation" means particularly flammable substances
and substances and preparations which give rise to highly exothermic reaction
when in contact with other substances,

99/45/EC


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Article 2
"extremely flammable substances and preparations" liquid substances and
preparations having an extremely low flash-point and a low boiling-point and
gaseous substances and preparations which are flammable in contact with air at
ambient temperature and pressure,

Dangerous Chemicals Regulation
Article 4
"extremely flammable substance/preparation" means liquid substances and prepa-
rations having an extremely low flash-point (lower than 0°C) and a low boiling-
point (lower than 35°C) and gaseous substances and preparations which are
flammable in contact with air at ambient temperature and pressure,

99/45/EC
Article 2
"highly flammable substances and preparations"
a.      substances and preparations which may become hot and finally catch
        fire in contact with air at ambient temperature without any application
        of energy, or
b.      solid substances and preparations which may readily catch fire after
        brief contact with a source of ignition and which continue to burn or to
        be consumed after removal of the source of ignition, or
c.      liquid substances and preparations having a very low flash-point, or
d.      substances and preparations which, in contact with water or damp air,
        evolve highly flammable gases in dangerous quantities,

Dangerous Chemicals Regulation
Article 4
"easily flammable substance/preparation": means,
a.       substances and preparations which may become hot and finally catch
         fire in contact with air at ambient temperature without any application
         of energy, or
b.       solid substances and preparations which may readily catch fire after
         brief contact with a source of ignition and which continue to burn after
         removal of the source of ignition, or
c.       liquid substances and preparations having a flash point below 21º C, or
d.       substances and preparations which, in contact with water or damp air,
         evolve highly flammable gases in dangerous quantities.

99/45/EC
Article 2
"flammable substances and preparations" liquid substances and preparations
having a low flash-point,

Dangerous Chemicals Regulation
Article 4
"flammable substance/preparation" means liquid substances and preparations
having low flash point (21º C - 55º C)

99/45/EC
Article 2



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"very toxic substances and preparations" substances and preparations which in
very low quantities cause death or acute or chronic damage to health when
inhaled, swallowed or absorbed via the skin,

Dangerous Chemicals Regulation
Article 4
"very toxic substance/preparation" means substances/preparations which in very
low quantities cause lethal or acute or chronic damage to health when inhaled,
swallowed, absorbed via the skin,

99/45/EC
Article 2
"toxic substances and preparations" substances and preparations which in low
quantities cause death or acute or chronic damage to health when inhaled,
swallowed or absorbed via the skin,

Dangerous Chemicals Regulation
Article 4
"toxic substance/preparation" means substances/preparations which in low quanti-
ties cause lethal or acute or chronic damage to health when inhaled, swallowed or
absorbed via the skin,

99/45/EC
Article 2
"dangerous substances and preparations" substances and preparations which
may cause death or acute or chronic damage to health when inhaled, swallowed
or absorbed via the skin,

Dangerous Chemicals Regulation
Article 4
"dangerous substance/preparation" means substances/preparations which may
cause lethal or acute or chronic damage to health when inhaled, swallowed or
absorbed via the skin,

99/45/EC
Article 2
"corrosive substances and preparations" substances and preparations which
may, on contact with living tissues, destroy them,

Dangerous Chemicals Regulation
Article 4
"corrosive substance/preparation" means substances and preparations which may
destroy living tissues on contact with them,


99/45/EC
Article 2
"irritant substances and preparations" non-corrosive substances and prepara-
tions which, through immediate, prolonged or repeated contact with the skin or
mucous membrane, may cause inflammation,

Dangerous Chemicals Regulation


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Article 4
"irritant substance/preparation "means non-corrosive substances and preparations
which, through immediate, prolonged or repeated contact with the skin or mucous
membrane, may cause local inflammation, swelling or edema,

99/45/EC
Article 2
"sensitizing substances and preparations" substances and preparations which, if
they are inhaled or if they penetrate the skin, are capable of eliciting a reaction
of hypersensitization such that on further exposure to the substance or prepara-
tion, characteristic adverse effects are produced,

Dangerous Chemicals Regulation
Article 4
"allergic substance/preparation" means substances and preparations which, if they
are inhaled or if they penetrate the skin, are capable of initiating a reaction of
hypersensitization and such that on further exposure to the substance or prepara-
tion, characteristic adverse effects are produced,

99/45/EC
Article 2
"carcinogenic substances and preparations" substances or preparations which,
if they are inhaled or ingested or if they penetrate the skin, may induce cancer
or increase its incidence,

Dangerous Chemicals Regulation
Article 4
"carcinogenic substance/preparation" means substances or preparations which, if
they are inhaled, ingested, if they penetrate the skin, may cause cancer or increase
its incidence,

99/45/EC
Article 2
"mutagenic substances and preparations": substances and preparations which,
if they are inhaled or ingested or if they penetrate the skin, may induce herita-
ble genetic defects or increase their incidence,

Dangerous Chemicals Regulation
Article 4
"mutagenic substance/preparation" means substances and preparations which, if
they are inhaled, ingested or if they penetrate the skin, may cause heritable ge-
netic defects or increase their incidence,



99/45/EC
Article 2
"substances and preparations "which are toxic for reproduction: substances and
preparations which, if they are inhaled or ingested or if they penetrate the skin,
may produce, or increase the incidence of, non-heritable adverse effects in the
progeny and/or an impairment of male or female reproductive functions or
capacity,


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Dangerous Chemicals Regulation
Article 4
"substance/preparation which is toxic for reproduction" means substances and
preparations which, if they are inhaled, ingested, if they penetrate the skin, may
produce, or increase the incidence of, an impairment of male or female reproduc-
tive functions and capacity and/or non-heritable negative effects in the progeny,

99/45/EC
Article 2
"substances and preparations which are dangerous for the environment": sub-
stances and preparations which, were they to enter the environment, would
present or may present an immediate or delayed danger for one or more com-
ponents of the environment,

Dangerous Chemicals Regulation
Article 4
"substance/preparation which is dangerous for the environment" means sub-
stances and preparations which enter the environment, present an immediate or
delayed danger for one or more aspects of the environment.

The definitions of the regulation more or less meet the requirements of the
directive. On the other hand, in line with the copy-out principle, the defini-
tions of the directive should be taken as is so some minor modifications will
be necessary in order to have the full transposition. See the GAP analysis of
67/548.

99/45/EC
Article 3
Determination of dangerous properties of preparations
1. The evaluation of the hazards of a preparation shall be based on the determina-
tion of:
        physico-chemical properties,
        properties affecting health,
        environmental properties.

These different properties shall be determined in accordance with the provisions
laid down in Articles 5, 6 and 7. Where laboratory tests are conducted, they shall
be carried out on the preparation as placed on the market.

2. Where the determination of dangerous properties is carried out in accordance
with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2
and in particular those which:
       are listed in Annex I to Directive 67/548/EEC,
       are listed in ELINCS in accordance with Article 21 of Directive
        67/548/EEC,
       are classified and labelled provisionally by the person responsible for the
        placing on the market in accordance with Article 6 of Directive
        67/548/EEC,
       are classified and labelled in accordance with Article 7 of Directive
        67/548/EEC and are not yet included in ELINCS,



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          are covered by Article 8 of Directive 67/548/EEC,
          are classified and labelled in accordance with Article 13 of Directive
           67/548/EEC,

shall be taken into consideration in accordance with the provisions laid down in
the method used.

3. For preparations covered by this Directive, dangerous substances as referred to
in paragraph 2 which are classified as dangerous on the basis of their health
and/or environmental effects, whether they are present as impurities or additives,
shall be taken into consideration when their concentrations are equal to, or greater
than, those defined in the following table unless lower values are given in Annex
I to Directive 67/548/EEC, or in Part B of Annex II to this Directive or in Part B
of Annex III thereto, unless otherwise specified in Annex V to this Directive.

Dangerous Chemicals Regulation
No information on determination of dangerous preperations.

The determination of dangerous preparations does not mentioned in the
Regulation should be revised according to the Directive.

99/45/EC
Article 4
General principles of classification and labelling
4.1. The classification of dangerous preparations according to the degree and
   specific nature of the hazards involved shall be based on the definitions of
   categories of danger laid down in Article 2.

4.2. The general principles of the classification and labelling of preparations shall
   be applied in accordance with the criteria laid down in Annex VI to Directive
   67/548/EEC, save where alternative criteria referred to in Article 5, 6, 7 or 10
   and the relevant Annexes of this Directive are applied.

Dangerous Chemicals Regulation
No provision about classification.

The general principles of classification are mentioned in the Annex 6 of the
directive. The Annex 6 should be included in our regulation as is and the
relevant article should be added to the regulation. When a dangerous sub-
stance is used as part of a preparation, the producer is required to determine
or calculate the content and apply the correct classification and labelling. See
the GAP analysis of 67/548.



99/45/EC
Article 5
Evaluation of the hazards deriving from physico-chemical properties
1. The hazards of a preparation deriving from its physico-chemical properties
shall be assessed by determining, by means of the methods specified in Part A of
Annex V to Directive 67/548/EEC, the physicochemical properties of the prepara-



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tion necessary for appropriate classification and labelling in accordance with the
criteria laid down in Annex VI to that Directive.

2. By way of derogation from paragraph 1:
the determination of the explosive, oxidising, extremely flammable, highly flam-
mable, or flammable properties is not necessary provided that:
       none of the constituents possesses such properties and that, on the basis
        of the information available to the manufacturer, the preparation is
        unlikely to present hazards of this kind,
       in the event of a change in the composition of a preparation of known
        composition, scientific evidence indicates that a reassessment of the haz-
        ards will not lead to a change in classification,
       preparations placed on the market in the form of aerosols satisfy the pro-
        visions of Article 9a of Directive 75/324/EEC (1).

3. For certain cases for which the methods laid down in Part A of Annex V to
Directive 67/548/EEC are not appropriate, alternative calculation methods are
laid down in Part B of Annex I to this Directive.

4. Certain exemptions from the application of the methods laid down in Part A of
Annex V to Directive 67/548/EEC are referred to in Part A of Annex I to this
Directive.

5. The hazards deriving from the physico-chemical properties of a preparation
covered by Directive 91/414/EEC shall be assessed by determining the physico-
chemical properties of the preparation necessary for appropriate classification in
accordance with the criteria set out in Annex VI to Directive 67/548/EEC. These
properties shall be determined by means of the methods laid down in Part A of
Annex V to Directive 67/548/EEC unless other internationally recognised meth-
ods are acceptable in accordance with the provisions of Annexes II and III to
Directive 91/414/EEC.

Dangerous Chemicals Regulation
No information in the regulation.

The Directive does not apply to certain preparations in finished states, in-
tended for the final user, or to the carriage of dangerous preparations or
those in transit under customs supervision. The relevant article should be
added to the regulation. The references should be made according to the
provisions of the Directive.




99/45/EC
Article 6
Evaluation of health hazards

1. The health hazards of a preparation shall be assessed by one or more of the
following procedures:


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a.         by a conventional method described in Annex II;
b.         by determining the toxicological properties of the preparation

necessary for appropriate classification in accordance with the criteria in Annex
VI to Directive 67/548/EEC. These properties shall be determined by means of
the methods laid down in Part B of Annex V to Directive 67/548/EEC, unless, in
the case of plant protection products, other internationally recognised methods are
acceptable in accordance with the provisions of Annexes II and III to Directive
91/414/EEC.

2. Without prejudice to the requirements of Directive 91/414/EEC, only where it
can be scientifically demonstrated by the person responsible for placing the
preparation on the market that the toxicological properties of the preparation can-
not correctly be determined by the method outlined in paragraph 1(a), or on the
basis of existing test results on animals, the methods outlined in paragraph 1(b)
may be used, provided they are justified or specifically authorised under Article
12 of Directive 86/609/EEC.

When a toxicological property is established by the methods outlined in para-
graph 1(b) to obtain new data, the test shall be conducted in compliance with the
principles of good laboratory practice provided for in Council Directive
87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and
administrative provisions relating to the application of the principles of good
laboratory practice and the verification of their applications for tests on chemical
substances (1) and the provisions of Directive 86/609/EEC, in particular Articles
7 and 12 thereof.

Subject to the provisions of paragraph 3, where a toxicological property has been
established on the basis of both the methods outlined in paragraphs 1(a) and (b),
the results from the methods outlined in paragraph 1(b) shall be used for classify-
ing the preparation, except in the case of carcinogenic, mutagenic or toxic effects
for reproduction for which only the method outlined in 1(a) shall be used.

Any of the toxicological properities of the preparation which are not assessed by
the method outlined in paragraph 1(b) shall be assessed in accordance with the
method outlined in paragraph 1(a).

3. Furthermore, where it can be demonstrated:
       by epidemiological studies, by scientifically valid case studies as speci-
        fied by Annex VI to Directive 67/548/EEC or by statistically backed ex-
        perience, such as the assessment of data from poison information units or
        concerning occupational diseases, that toxicological effects on man differ
        from those suggested by the application of the methods outlined in para-
        graph 1, then the preparation shall be classified according to its effects on
        man,
       that, owing to effects such as potentiation, a conventional assessment
        would underestimate the toxicological hazard, those effects shall be taken
        into account in classifying the preparation,
       that, owing to effects such as antagonism, a conventional assessment
        would overestimate the toxicological hazard, those effects shall be taken
        into account in classifying the preparation.



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4. For preparations of a known composition, with the exception of those covered
by Directive 91/414/EEC, classified in accordance with paragraph 1(b), a new
evaluation of health hazard by the methods outlined in either paragraph 1(a) or (b)
shall be performed whenever:
        changes of composition of the initial concentration, as a weight/weight or
         volume/volume percentage, of one or more of the dangerous constituents
         are introduced by the manufacturer, in
accordance with the following table:
        changes of composition involving the substitution or addition of one or
         more constituents, which may or may not be dangerous within the mean-
         ing of the definitions set out in Article 2, are introduced by the manufac-
         turer.

This new evaluation will apply unless there is valid scientific justification for
considering that a re-evaluation of the hazard will not result in a change of classi-
fication.

Dangerous Chemicals Regulation
No information in the regulation on health hazards.

It distinguishes the methods for determining the dangerous properties of
preparations and lists general principles of classification and labeling ac-
cording to the degree and specific nature of the hazards involved. It also lays
down procedures for evaluating health hazards. The relevant article should
be taken to our legislation in line with the provisions of Directive.

99/45/EC
Article 7
Evaluation of environmental hazards
1. The hazards of a preparation for the environment shall be assessed by one or
more of the following procedures:
a.      by a conventional method described in Annex III to this Directive;
b.      by determining the hazardous properties of the preparation for the envi-
        ronment necessary for appropriate classification in accordance with the
        criteria set out in Annex VI to Directive 67/548/EEC. hese properties
        shall be determined by means of the methods laid down in Part C of An-
        nex V to Directive 67/548/EEC unless, in the case of plant protection
        products, other internationally recognised methods are acceptable in ac-
        cordance with the provisions of Annexes II and III to Directive
        91/414/EEC. Without prejudice to the testing requirements set out in Di-
        rective 91/414/EEC, the conditions for application of the test methods are
        described in Part C of Annex III to this Directive.

2. Where an ecotoxicological property is established by one of the methods out-
lined in paragraph 1(b) to obtain new data, the test shall be conducted in compli-
ance with the principles of good laboratory practice provided for in Directive
87/18/EEC and with the provisions of Directive 86/609/EEC.
Where the environmental hazards have been assessed in compliance with both the
procedures mentioned above, the results of the methods referred to in paragraph
1(b) shall be used for classifying the preparation.




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3. For preparations of a known composition, with the exception of those covered
by Directive 91/414/EEC, classified in accordance with the method outlined in
paragraph 1(b), a new evaluation of environmental hazard either by the method
outlined in paragraph 1(a) or that outlined in paragraph 1(b) shall be performed
whenever:
       changes of composition of the initial concentration, as a weight/weight or
        volume/volume percentage, of one or more of the dangerous constituents
        are introduced by the manufacturer, in accordance with the following ta-
        ble:
       changes of composition involving the substitution or addition of one or
        more constituents, which may or may not be dangerous within the mean-
        ing of the definitions set out in Article 2, are introduced by the manufac-
        turer.

This new evaluation will apply unless there is valid scientific justification for
considering that are-evaluation of the hazard will not result in a change of classi-
fication.

Dangerous Chemical Regulation
No information in the regulation on environmental hazards.

It distinguishes the methods for determining the dangerous properties of
preparations and lists general principles of classification and labeling ac-
cording to the degree and specific nature of the hazards involved. It also lays
down procedures for evaluating environmental hazards. The relevant article
should be taken to our legislation in line with the provisions of Directive.

99/45/EC
Article 8
Obligations and duties of the Member States
1. Member States shall take all necessary measures to ensure that the preparations
covered by this Directive cannot be placed on the market unless they comply with
it.

2. In order to ensure compliance with this Directive, the authorities of the Mem-
ber States may request information on the composition of the preparation and any
other pertinent information from any person responsible for placing the prepara-
tion on the market.

3. Member States shall take all necessary measures to ensure that those responsi-
ble for placing the preparation on the market hold at the disposal of the authorities
of the Member States:
        the data used for the classification and labelling of the preparation,
        any pertinent information relating to packaging requirements in accor-
         dance with Article 9(1.3), including the test certificate issued in accor-
         dance with Part A of Annex IX to Directive 67/548/EEC,
        the data used for establishing the safety data sheet, in accordance with
         Article 14.

4. Member States and the Commission shall exchange information concerning the
name and full address of the national authority (authorities) responsible for com-



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municating and exchanging information relating to the practical application of
this Directive.

Dangerous Chemicals Regulation
No information in the regulation.

Member States must take measures to ensure proper packaging and label-
ling of dangerous preparations, and that persons responsible for placing the
preparation on the market provides a data sheet. Member States must desig-
nate a body responsible for receiving information relating to dangerous
preparations placed on the market. The relevant article should be taken to
our legislation in line with the provisions of Directive. In our legislation, a
body must be designated as the competent authority and the competent au-
thority must establish measures to ensure preparations are not placed on the
market unless they comply with this Directive. Also we should establish
measures to ensure persons placing preparations on the market retain the
data used for classification, labelling, establishing the safety data sheet, and
the information relating to packaging requirements in the new legislation.

99/45/EC
Article 9
Packaging
1. Member States shall take all necessary measures to ensure that:
1.1. preparations within the meaning of Article 1(2) and preparations covered by
Annex IV pursuant to Article 1(3) cannot be placed on the market unless their
packaging satisfies the following requirements:

Dangerous Chemicals Regulation
Article 23
Those who deal with one or some of the matters such packaging, storage, trans-
port of the dangerous chemical substances and products are subjected to provi-
sions of this Regulation.

Producer, importer and distributor is respobsible uninterruptedly concerning the
notification of customer.

When these works are made by third person or enterprise, employer or enterprise
is responsible uninterruptedly with those who deal with.

Article 24
Dangerous substances and products shall be placed on the market in compliance
with the provisions of this Regulation in Article 27 and after packed that prevents
the overflow from package by leakage, spillage, spread and similar ways.

Above mentioned provision shall not apply for substances and products whose
placing on the market method subjected to particular legislation.

Those who deal with transport and storage of unpacked substances and products,
except for substances and products whose placing on the market method sub-
jected to particular legislation, shall get distinctive permit from relevant authority.




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The legislation should be revised according to the directive although in our
legislation the provisions are more detailed.

99/45/EC
Article 1.1.
Package shall be so designed and constructed that its contents cannot escape; this
requirement shall not apply where special safety devices are prescribed.

Dangerous Chemicals Regulation
Article 27.1.a.
Package shall be so constructed that its contents cannot escape.

The legislation should be revised according to the directive. The phrases
“designed” and “this requirement shall not apply where special safety
devices are prescribed.” should be added to our regulation.

99/45/EC
Article 9.1.1.
The materials constituting the packaging and fastenings must not be susceptible
to adverse attack by the contents, or liable to form dangerous compounds with the
contents.

Dangerous Chemicals Regulation
Article 27.1.b.
The materials constituting the packaging and fastenings must not be susceptible
to adverse attack by the contents, or liable to form dangerous compounds with
the contents.

The relevant article is compliant to the relevant article of the directive.

99/45/EC
Article 9.1.1.
Packaging and fastenings must be strong and solid throughout to ensure that they
will not loosen and will safely meet the normal stresses and strains of handling,

Dangerous Chemicals Regulation
Article 27.d.
Containers must be designed throughout to ensure that they will be strong
while facing with the effect of air pressure variations.

No information related with fastening.

No information related with fastening so the relevant article should be
revised according to the directive.




99/45/EC
Article 9.1.1.
Containers fitted with replaceable fastening devices shall be so designed that the
packaging can be refastened repeatedly without the contents escaping;


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Dangerous Chemicals Regulation
No information about fastening devices.

No information related with fastening so the relevant article should be
revised according to the directive.

99/45/EC
Article 9.1.2.
Containers which contain preparations within the meaning of Article 1(2) and
preparations covered by Annex IV pursuant to Article 1(3) offered or sold to the
general public do not have:
       either a shape and/or graphic decoration likely to attract or arouse the
        active curiosity of children or to mislead consumers, or
       a presentation and/or a designation used for foodstuffs or animal feeding
        stuffs or medicinal or cosmetic products.

Dangerous Chemicals Regulation
Article 26.a.
Form and label of the package are not allowed to choose same or confusing simi-
lar ones with the food stuff packages in respect of general appearance and scope.

The relevant article should be revised according to the Directive. Annex 4
should be taken as is. We should establish a mechanism to ensure the pack-
aging of all preparations does not arouse the curiosity of children, mislead
consumers, and in no way resembles the packaging of human or animal food
products or medical and cosmetic products.

99/45/EC
Article 9.1.3.
Containers which contain certain preparations offered or sold to the general pub-
lic covered by Annex IV to this Directive:
       are fitted with child-resistant fastenings,
and/or
       carry a tactile warning of danger.

The devices must conform to the technical specifications given in Parts A and B
of Annex IX to Directive 67/548/EEC.

Dangerous Chemicals Regulation
No information about child-resistant fastening and tactile warning of danger.

No information about child-resistant fastening and a tactile warning of
danger so the relevant article should be revised according to the directive.




99/45/EC
Article 9.2.




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The packaging of preparations shall be deemed to satisfy the requirements of
paragraph 1.1, first, second and third indents, if it complies with the requirements
for carriage of dangerous goods by rail, road, inland waterway, sea or air.

Dangerous Chemicals Regulation
Article 23
Those who deal with one or some of the matters such packaging, storage, trans-
port of the dangerous chemical substances and products are subjected to provi-
sions of this Regulation.

Article 24
Dangerous substances and products shall be placed on the market in compliance
with the provisions of this Regulation in Article 27 and after packed that prevents
the overflow from package by leakage, spillage, spread and similar ways.

The relevant article should be revised according to the directive.

99/45/EC
Article 10
Labelling
1.1. Member States shall take all necessary measures to ensure that:
a.      preparations within the meaning of Article 1(2) cannot be placed on the
        market unless the labelling on their packaging satisfies all the require-
        ments of this Article and the specific provisions of Part A and B of An-
        nex V;
b.      preparations within the meaning of Article 1(3) as defined in Parts B and
        C of Annex V cannot be placed on the market unless the labelling on
        their packaging satisfies the requirements of paragraphs 2.1 and 2.2 and
        the specific provisions of Parts B and C of Annex V.

1.2. With respect to plant protection products subject to Directive 91/414/EEC,
the labelling requirements in accordance with this Directive shall be accompanied
by the following wording: ‗To avoid risks to man and the environment, comply
with the instructions for use.‘ This labelling shall be without prejudice to the in-
formation required in accordance with Article 16 of, and Annex V to, Directive
91/414/EEC.

Dangerous Chemicals Regulation
Article 16
All concerned parties with the dangerous chemical substances and products are
responsible for labeling of them according to their specifications. Manufacturers
are obliged to obey labeling rules stated in this section.

Article 16 states that dangerous chemical substances and products should be la-
beled with rules given in regulation which is not fully same with the rules of Di-
rective. Annex V of Directive should be included in a regulation and also there is
no detail related with labelling of plant protection products subject to Directive
91/414/EEC in regulation.

In the legislation, we should ensure that the label of all preparations placed
on the market satisfies the requirements of this Directive. The Annex 5



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should be taken as is into our legislation. Also, the relevant article should be
revised according to the Directive.

99/45/EC
Article 10.2.
The following information shall be clearly and indelibly marked on any package:
2.1. the trade name or designation of the preparation;

Dangerous Chemicals Regulation
Article 17.b.
Labels should contain commercial name and closed formula of the chemical sub-
stance.

Article 17.c.
Labels should contain commercial name and fields of use of the products and
danger symbols of the containing substances.

The relevant article should be revised according to the Directive.

99/45/EC
Article 10.2.2.
Label should contain the name, full address and telephone number of the person
established in the Community who is responsible for placing the preparation on
the market, whether it be the manufacturer, the importer or the distributor.

Dangerous Chemicals Regulation
Article 17.a.
Labels should contain name and address of the Manufacturer.

The relevant article should be revised according to the Directive.

99/45/EC
Article 10.2.3.
Labels should contain the chemical name of the substance or substances present
in the preparation in accordance with the following detailed rules:
2.3.1. for preparations classified T+, T, Xn in accordance with Article 6, only the
    substances T+, T, Xn present in concentrations equal to, or greater than, the
    lowest limit (limit Xn) for each of them laid down in Annex I to Directive
    67/548/EEC or, failing that, Part B of Annex II to this Directive have to be
    taken into consideration;

2.3.2. for preparations classified C in accordance with Article 6, only C sub-
        stances present in concentrations equal to, or greater than, the lowest limit
        (limit Xi) laid down in Annex I to Directive 67/548/EEC or, failing that,
        Part B of Annex II to this Directive have to be taken into consideration;

2.3.3. the name of the substances which have given rise to the classification of
        the preparation in one or more of the following danger categories:
        carcinogen category 1, 2 or 3,
        mutagen category 1, 2 or 3,
        toxic for reproduction category 1, 2 or 3,



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        very toxic, toxic or harmful due to non-lethal effects after a single expo-
         sure,
        toxic or harmful due to severe effects after repeated or prolonged expo-
         sure,
        sensitising;
shall be mentioned on the label.

The chemical name shall be one of the designations listed in Annex I to Directive
67/548/EEC or an internationally recognised chemical nomenclature if no corre-
sponding designation is yet listed in that Annex.

2.3.4. As a consequence of the above provisions the name of any substance which
        led to the classification of the preparation in the following danger catego-
        ries:
        explosive,
        oxidising,
        extremely flammable,
        highly flammable,
        flammable,
        irritant,
        dangerous for the environment,
need not be mentioned on the label unless the substance has to be mentioned pur-
suant to paragraphs 2.3.1, 2.3.2 or 2.3.3.

2.3.5. As a general rule, a maximum of four chemical names shall suffice to iden-
        tify the substances primarily responsible for the major health hazards
        which have given rise to the classification and the choice of the corre-
        sponding phrases referring to the risk involved. In some cases, more than
        four chemical names may be necessary.

Dangerous Chemicals Regulation
No detailed information in the regulation.

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

99/45/EC
Article 10.2.4.
The danger symbol(s) and indication(s) of danger.

The danger symbols, where specified in this Directive, and indications of the
dangers involved in the use of the preparation, shall be in accordance with the
wording of Annexes II and VI to Directive 67/548/EEC and shall be applied in
accordance with the evaluation of the hazards carried out in accordance with An-
nexes I, II and III to this Directive.

Where more than one danger symbol must be assigned to a preparation the obli-
gation to apply the symbol:
       T shall make the symbols C and X optional unless otherwise specified in
        Annex I to Directive 67/548/EEC,
       C shall make the symbol X optional,



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          E shall make the symbols F and O optional,
          Xn shall make the symbol Xi optional.

The symbol(s) shall be printed in black on an orange-yellow background.

Dangerous Chemicals Regulation
Article 20
Danger Symbols shall be printed in black on an orange-yellow background.

Article 17.e.
Relevant danger symbols mentioned individually for the substances in the Annex-
IV.

Dangerous conditions for man and environmental health and safety precautions
are indicated by symbols in the labels. Symbols except stated in the Annex IV are
not allowed to use.

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

99/45/EC
Article 10.2.5.
The risk phrases (R phrases)
The indications concerning special risks (R phrases) shall comply with the word-
ing in Annexes III and VI to Directive 67/548/EEC and shall be assigned in ac-
cordance with the results of the hazard evaluation carried out in accordance with
Annexes I, II, and III to this Directive.

As a general rule, a maximum of six R phrases shall suffice to describe the risks;
for this purpose, the combined phrases listed in Annex III to Directive
67/548/EEC shall be regarded as single phrases. However, if the preparation falls
within more than one danger category, those standard phrases shall cover all the
principal hazards associated with the preparation. In some cases more than six R
phrases may be necessary.

The standard phrases ‗extremely flammable‘ or ‗highly flammable‘ need not be
used where they describe an indication of danger used in accordance with 2.4.

Dangerous Chemicals Regulation
Article 17.d.
Labels should contain remarkable expressions ―Extremely Explosive‖, ―Very
Toxic‖, safety recommendations (chosen from relevant special risks (R) and
safety precautions (S) of dangerous substances according to Annex-VII), concise
information concerning measures to be taken, specifications of the dangerous
substance stated in the Annex II.

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

99/45/EC
Article 10.2.6.
The safety advice (S phrases)


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The indications giving safety advice (S phrases) shall comply with the wording in
Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in
accordance with the results of the hazard evaluation carried out in accordance
with Annexes I, II and III to this Directive.

As a general rule, a maximum of six S phrases shall suffice to formulate the most
appropriate safety advice; for this purpose the combined phrases listed in Annex
IV to Directive 67/548/EEC shall be regarded as single phrases. However, in
some cases more than six S phrases may be necessary. Where it is physically
impossible to include the advice on the label or package itself, the package shall
be accompanied by safety advice on the use of the preparation.

2.7. The nominal quantity (nominal mass or nominal volume) of the contents in
the case of preparations offered or sold to the general public.

3. For certain preparations classified as dangerous within the meaning of Article
7, by way of derogation from paragraphs 2.4, 2.5, and 2.6 of this Article, exemp-
tions to certain provisions on environmental labelling or specific provisions in
relation to environmental labelling may be determined in accordance with the
procedure referred to in Article 20, where it can be demonstrated that there would
be a reduction in the environmental impact. These exemptions or specific provi-
sions are defined and laid down in Part A or B of Annex V.

4. If the contents of the package do not exceed 125 ml:
         in the case of preparations that are classified as highly flammable, oxidis-
          ing, irritant, with the exception of those assigned R41, or dangerous for
          the environment and assigned the N symbol it shall not be necessary to
          indicate the R phrases or the S phrases,
         in the case of preparations that are classified as flammable or dangerous
          for the environment and not assigned the N symbol it shall be necessary
          to indicate the R phrases but it shall not be necessary to indicate the S
          phrases.

5. Without prejudice to Article 16(4) of Directive 91/414/EC, indications such as
‗non-toxic‘, ‗non-harmful‘, ‗non-polluting‘, ‗ecological‘ or any other statement
indicating that the preparation is not dangerous or likely to lead to underestima-
tion of the dangers of the preparation in question shall not appear on the packag-
ing or labelling of any preparation subject to this Directive.

Dangerous Chemicals Regulation
Article 17.d.
Labels should contain remarkable expressions ―Extremely Explosive‖, ―Very
Toxic‖, safety recommendations (chosen from relevant special risks (R) and
safety precautions (S) of dangerous substances according to Annex-VII), concise
information concerning measures to be taken, specifications of the dangerous
substance stated in the Annex II.

The relevant article should be revised according to the directive and the
elaborated annexes should be taken as is to our legislation.

99/45/EC
Article 11.1.


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Implementation of the labelling requirements
Where the particulars required by Article 10 appear on a label, that label shall be
firmly affixed to one or more surfaces of the packaging so that those particulars
can be read horizontally when the package is set down normally. The dimensions
of the label are laid down in Annex VI to Directive 67/548/EEC and the label is
intended solely for provision of the information required by this Directive and if
necessary of any supplementary health or safety information.

Dangerous Chemicals Regulation
Article 20
Label shall be affixed to one or more surfaces of the packaging so that these
particulars can be read when the package is set down normally. If it is not pos-
sible to affix to surface of the package due to type or dimensions of the pack-
age, labelling shall be made on the one of the plaque connected to package.
Necessary measures shall be taken in order to prevent removing of label be-
cause of external factors and inner substance, or leaving of plaque if used.

The relevant article should be revised according to the directive.

99/45/EC
Article 11.2.
A label shall not be required when the particulars are clearly shown on the pack-
age itself, as specified in paragraph 1.

Dangerous Chemicals Regulation
No information.

The relevant article should be taken to our legislation since there is no in-
formation for this situation.

99/45/EC
Article 11.3.
The colour and presentation of the label or, in the case of paragraph 2, of the
package shall be such that the danger symbol and its background stand out clearly
from it.

Dangerous Chemicals Regulation
No information.

The relevant article should be taken to our legislation since there is no in-
formation for this situation.

99/45/EC
Article 11.4.
The information required on the label under Article 10 shall stand out clearly
from its background and shall be of such size and spacing as to be easily read.
Specific provisions regarding the presentation and format of this information shall
be laid down in Annex VI to Directive 67/548/EEC.

Dangerous Chemicals Regulation
No information.



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The relevant article should be taken to our legislation since there is no in-
formation for this situation.

99/45/EC
Article 11.5.
Member States may make the placing on the market of preparations covered by
this Directive within their territories subject to use of their official language or
languages in respect of the labelling thereof.

Dangerous Chemicals Regulation
Article 17
Labels are prepared in Turkish for dangerous chemicals and dangerous goods
placing on the market, they are prepared in one of the official languages of the
exported country for exporting dangerous chemicals and dangerous goods.

The relevant article should be revised according to the directive.

99/45/EC
Article 11.6.
For the purposes of this Directive, labelling requirements shall be deemed to be
satisfied:
        in the case of an outer package containing one or more inner packages, if
         the outer package is labelled in accordance with international rules on the
         transport of dangerous goods and the inner package or packages are la-
         belled in accordance with this Directive;
        in the case of a single package:
          if such a package is labelled in accordance with international rules on
              the transport of dangerous goods and with Article 10 (2.1), (2.2),
              (2.3), (2.5) and (2.6); for preparations classified according to Article
              7, the provisions of Article 10(2.4) shall additionally apply with re-
              spect to the property in question when it has not been so identified on
              the label, or where appropriate, for particular types of packaging such
              as mobile gas cylinders, if the specific requirements referred to in
              Annex VI to Directive 67/548/EEC are complied with.

Dangerous Chemicals Regulation
Article 18
Labels of the packed substances and products should be sticked to the package. If
packages are covered by second package, labels should be sticked to these pack-
ages as well. If transparent second package is used, in case of clear readability of
label, it is not obliged to put label to the second package.

The relevant article should be taken to our legislation since there is no in-
formation for this situation.




99/45/EC
Article 11



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Where dangerous preparations do not leave the territory of a Member State, label-
ling may be permitted which complies with national rules instead of with interna-
tional rules on the transport of dangerous goods.

Dangerous Chemicals Regulation
No information.

The relevant article should be taken to our legislation however it will be
valid after EU accession.

99/45/EC
Article 12
Exemptions from the labelling and packaging requirements
1. Articles 9, 10 and 11 shall not apply to explosives placed on the market with a
view to obtaining an explosive or pyrotechnic effect.

2. For certain dangerous preparations within the meaning of Article 5, 6 or 7 de-
fined in Annex VII which, in the form in which they are placed on the market, do
not present any physico-chemical risk, or risk to health or to the environment,
Articles 9, 10 and 11 shall not apply.

3. Member States may also:
a.    permit the labelling required by Article 10 to be applied in some other
      appropriate manner on packages which are either too small or otherwise
      unsuitable for labelling in accordance with Article 11 (1) and (2);
b.    by way of derogation from Articles 10 and 11 permit the packaging of
      dangerous preparations which are classified as harmful, extremely flam-
      mable, highly flammable, flammable, irritant or oxidising to be unla-
      belled or to be labelled in some other way, if they contain such small
      quantities that there is no reason to fear any danger to persons handling
      such preparations or to other persons;
c.    by way of derogation from Articles 10 and 11, for preparations classified
      according to Article 7, permit the packaging of dangerous preparations to
      be unlabelled or labelled in some other way if they contain such small
      quantities that there is no reason to fear any dangers to the environment;
d.    by way of derogation from Articles 10 and 11 permit the packaging of
      dangerous preparations which are not mentioned in (b) or (c) above to be
      labelled in some other appropriate way, if the packages are too small for
      the labelling provided for in Articles 10 and 11 and there is no reason to
      fear any danger to persons handling such preparations or to other persons.
      Where this paragraph is applied, the use of symbols, indications of dan-
      ger, risk (R) phrases or safety (S) phrases different to those laid down in
      this Directive shall not be permitted.

4. If a Member State makes use of the options provided for in paragraph 3, it shall
forthwith inform the Commission and Member States thereof. Where it is appro-
priate, measures shall be decided upon in the framework of Annex V and in ac-
cordance with the provisions of article 20.


Dangerous Chemicals Regulation
No provision about exemptions from labeling and packaging requirements.


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No provision about exemptions from labeling and packaging requirements
so the relevant article should be revised according to the directive and the
exemptions from labeling and packaging requirements which were elabo-
rated in relevant articles should be considered in our legislation.

99/45/EC
Article 13
Distance selling
Any advertisement for a preparation within the meaning of this Directive which
enables a member of the general public to conclude a contract for purchase with-
out first having sight of the label for that preparation must make mention of the
type or types of hazard indicated on the label. This requirement is without preju-
dice to Directive 97/7/EC of the European Parliament and of the Council of 20
May 1997 on the protection of consumers in respect of distance contracts (1).

Chemicals Dangerous Regulation
No information related with distance selling

You are not obliged to mention the hazards of your preparation in an adver-
tisement if you can be certain that nobody will use the advertisement to
make a purchase in a private capacity. The relevant article should be taken
to our legislation since there is no information for this situation.

99/45/EC
Article 14
Safety data sheet
1. The safety data sheet information is principally intended for use by profes-
sional users and must enable them to take the necessary measures as regards the
protection of health, safety and the environment at the place of work.

2.1. Member States shall take all the necessary measures to ensure that:
a.     the person responsible for placing on the market a preparation within the
       meaning of Article 1(2) provides a safety data sheet;
b.     the person responsible for placing on the market a preparation provides
       on request of a professional user a safety data sheet providing proportion-
       ate information for preparations not classified as dangerous within the
       meaning of Articles 5, 6 and 7 but containing in an individual concentra-
       tion of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by
       volume for gaseous preparations at least:
              one substance posing health or environmental hazards, or
              one substance for which there are Community workplace expo-
               sure limits.

2.2. The safety data sheet and its supply must comply with the provisions of Di-
rective 91/155/EEC.

2.3. The necessary amendments required to adapt to technical progress Directive
91/155/EEC shall be adopted in accordance with the procedure laid down in Arti-
cle 20 of this Directive.




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In particular, the necessary amendments to take account of provisions in para-
graph 2.1(b) shall be adopted before the date specified in Article 22(1).

2.4. The safety data sheet may be supplied on paper or electronically, provided
that the addressee has the necessary means of receiving it.

Dangerous Chemicals Regulation
Article 22
Following rules is obliged to obey during preparation of safety data sheet and its
distribution.
a.       Safety Data Sheets are prepared by manufacturer of the dangerous sub-
         stance and dangerous preparation and preparation which contain at least
         one dangerous chemical according to the provisions of this Regulation.
b.       In the case of request from professional users, although it is not classified
         as dangerous according to provisions of this Regulation, for preparations
         that contain at least one of the substances whose workplace exposure lim-
         its determined or which have harmful characteristic to man and environ-
         ment, and for at least one or more one by one of such substances;

(3) contain 1% (weight) and not to be in gaseous phase,
(4) contain 0.2% (volume) and to be in gaseous phase, Safety Data Sheet in-
    cluded detailed information, shall be prepared by producer of this preparation
    and deliver to demander.

    d) Safety Data Sheet;

(5) shall be prepared by producer for every dangerous substance, dangerous
    preparation or preparation contained at least one dangerous substance sepa-
    rately,
(6) shall be updated according to technical developments and scientific research,
(7) shall be provided to customer in the first delivery of the dangerous chemical
    after production or If possible before delivery,
(8) in the second or following deliveries on request, as a written text free of
    charge or transmitted in electronic version.

Safety Data Sheet; shall be prepared in Turkish for chemicals placed on the mar-
ket, in one of the official language of the exported country for the exported
chemicals.

In case of update of the Safety Data Sheet in light of new information; updated
form, until 12 month before the update date, shall be transmitted to users and
those who store dangerous chemicals within a period of 3 months following up-
date date and changing date and number of change shall be mentioned in the
form.

After preparation of Safety Data Sheet obtained from producer for imported
chemicals according to provisions of the Regulation by the importer, shall be
provided to customer in the first delivery of the dangerous chemical after produc-
tion or if possible before delivery, in the second or following deliveries on re-
quest, as a written text in Turkish free of charge or transmitted in electronic ver-
sion.



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In case of not to be obtaining of Safety Data Sheets of imported chemicals from
their producer by their importer, importer is obliged to prepare Safety Data Sheets
in line with the provisions of this Regulation.

Minimum information and procedures and principles to be complied with in the
preparation of the form shall be determined by the Ministry with edicts to be pub-
lished.

Although the article seems compliant to the provisions of the Directive, it
should be revised according to the Directive. We should establish a mecha-
nism to ensure safety data sheets for all preparations packaging are pro-
duced.

99/45/EC
Article 15
Confidentiality of chemical names
Where the person responsible for placing the preparation on the market can dem-
onstrate that the disclosure on the label or safety data sheet of the chemical iden-
tity of a substance which is exclusively classified as:
      irritant with the exception of those assigned R41 or irritant in combina-
          tion with one or more of the other properties mentioned in point 2.3.4 of
          Article 10, or
      harmful or harmful in combination with one or more of the properties
          mentioned in point 2.3.4 of Article 10 presenting acute lethal effects
          alone will put at risk the confidential nature of his intellectual property,
          he may, in accordance with the provisions of Annex VI, be permitted to
          refer to that substance either by means of a name that identifies the most
          important functional chemical groups or by means of an alternative name.
          This procedure may not be applied where the substance concerned has
          been assigned a Community exposure limit.

Where the person responsible for placing a preparation on the market wishes to
take advantage of confidentiality provisions, he shall make a request to the com-
petent authority of the Member State in which the preparation is to be first placed
on the market.

This request must be made in accordance with the provisions of Annex VI and
must provide the information required in the form in Part A of that Annex. The
competent authority may nevertheless request further information from the person
responsible for placing the preparation on the market if such information appears
necessary in order to evaluate the validity of the request.

The authority of the Member State receiving a request for confidentiality shall
notify the applicant of its decision. The person responsible for placing the prepa-
ration on the market shall forward a copy of this decision to each of the Member
States where he wishes to market the product.

Confidential information brought to the attention of the authorities of a Member
State or of the Commission shall be treated in accordance with Article 19(4) of
Directive 67/548/EEC.

Dangerous Chemicals Regulation


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Annex III
Ministry,
    in case of proof for confidentiality conditions of specification and com-
        position of substance, do not require some information mentioned in this
        list (Information form for notification of harmful chemical substances and
        harmful chemical products) or change with other equivalence or more
        appropriate one.

Under EU legislation, there is an obligation to disclose the chemical
identities of hazardous chemicals on packaging labels and in safety
data sheets. This is to convey important information on the ingredients
that contribute to the hazard(s) of the substance or preparation. How-
ever, it has been acknowledged by the EC that such disclosure of con-
stituents of preparations may put at risk the confidential nature of a
manufacturer's intellectual property. To address this, the Directive
allows for confidentiality of some chemical names, i.e. an alternative
name may be used instead of the chemical name to preserve intellec-
tual property. Article 15 of the Directive states that confidentiality is
only applicable to substances classified as irritant (excluding severe
eye irritation) and/or acutely harmful, or these classifications in com-
bination with a physico-chemical or environmental hazard. Therefore,
a substance classified as Dangerous for the Environment only is not in
scope for confidentiality. This will not affect the label since these sub-
stances do not need to be mentioned on it. However, the chemical iden-
tity of such substance must be disclosed on the Safety Data Sheets.
The relevant article of the directive should be taken to our legislation.

99/45/EC
Article 16
Rights of Member States regarding safety of workers
This Directive shall not affect the right of Member States to specify, in compli-
ance with the Treaty, the requirements they deem necessary to ensure that work-
ers are protected when using the dangerous preparations in question, provided
that this does not mean that the classification, packaging, and labelling of danger-
ous preparations are modified in a way not provided for in this Directive.

Dangerous Chemicals Regulation
No information in the regulation.

99/45/EC
Article 17
Bodies responsible for receiving information relating to health
Member States shall appoint the body or bodies responsible for receiving infor-
mation, including chemical composition, relating to preparations placed on the
market and considered dangerous on the basis of their health effects or on the
basis of their physico-chemical effects.

Member States shall take the necessary steps to ensure that the appointed bodies
provide all the requisite guarantees for maintaining the confidentiality of the in-
formation received. Such information may only be used to meet any medical de-



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mand by formulating preventive and curative measures, in particular in case of
emergency.

Member States shall ensure that the information is not used for other purposes.
Member States shall ensure that the appointed bodies have at their disposal all the
information required from the manufacturers or persons responsible for marketing
to carry out the tasks for which they are responsible.

Dangerous Chemicals Regulation
No information in the regulation.

The relevant article should be taken to our legislation.

99/45/EC
Article 18
Free movement clause
Without prejudice to the provisions set out in other Community legislation,
Member States may not prohibit, restrict or impede the placing on the market of
preparations because of their classification, packaging, labelling or safety data
sheets if such preparations comply with the provisions laid down in this Direc-
tive.

Dangerous Chemicals Regulation
No information in the regulation.

The relevant article should be taken to our legislation.

99/45/EC
Article 19
Safeguard clause
1. Where a Member State has detailed evidence that a preparation, although satis-
fying the provisions of this Directive, constitutes a hazard for man or the envi-
ronment on grounds relating to the provisions of this Directive, it may provision-
ally prohibit the placing on the market of that preparation or subject it to special
conditions in its territory. It shall immediately inform the Commission and the
other Member States of such action and give reasons for its decision.

2. In the case referred to in paragraph 1, the Commission shall consult the Mem-
ber States as soon as possible.

3. The Commission shall take a decision in accordance with the procedure laid
down in Article 20.

Dangerous Chemicals Regulation
No information in the regulation.

The relevant article should be taken to our legislation.




99/45/EC


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Article 20
1. Amendments required to adapt the Annexes to this Directive to technical pro-
gress shall be adopted in accordance with the procedure laid down in Article
29(4)(a) of Directive 67/548/EEC.

2. The Commission shall be assisted by a committee.

3. Where reference is made to this Article, Articles 5 and 7 of Decision
1999/468/EC (1) shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at
three months.

4. The Committee shall adopt its rules of procedure.

99/45/EC
Article 21
Repeal of Directives
1. The Directives listed in Part A of Annex VIII are hereby repealed, without
prejudice to the obligation of the Member States concerning the deadlines for
transposition into national law and for application of the Directives indicated in
Part B of Annex VIII.

2. The Directives listed in Part A of Annex VIII shall apply to Austria, Finland
and Sweden subject to provisions laid down in Part C of that Annex and pursuant
to the Treaty.

3. References to the repealed Directives shall constitute references to this Direc-
tive and should be read in accordance with the correlation table set out in Annex
IX.

91/155/EC
Article 1.1. (a)
The person who is responsible for placing a chemical substance or preparation on
the market, whether the manufacturer, importer or distributor, shall supply the
recipient, who is a professional user of the substance or preparation, with a safety
data sheet containing the information set out in Article 3 and the Annex to this
Directive, if the substance or preparation is classified as dangerous according to
Directive 67/548/EEC or European Parliament and Council Directive
1999/45/EC.

Dangerous Chemicals Regulation
Article 12
Concerned parties (manufacturers, distributors and importers) with harmful
chemical substances and their products are obliged to provide producers of sub-
stances with important information and user instructions concerning the environ-
ment.
Article 22
a) Safety Data Sheets are prepared by manufacturer of the dangerous substance
and dangerous preparation and preparation which contain at least one dangerous
chemical according to the provisions of this Regulation.

SDS Communiqué


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Aim
Article 1
The aim of this Communiqué is to determine the principles and procedures car-
ried out during the arrangement of Safety Data Sheets, the information located in
the form and the manner of the form.

A safety data sheet must be provided to professional users of certain
chemical products. A safety data sheet must be provided by the manu-
facturer or importer or by anyone placing a chemical product on the
market for the first time.

In our legislation, indeed we have 3 provisions in connection with article
1.1.a. However, the article 1 of the SDS Communiqué should be modified
according to the provisions of Directive.

The new legislation will not tell exactly what the manufacturer or importer
should go into a safety data sheet but does:
      set a standard for the quality of information to be included; and
      give 16 headings under which the information has to be provided.

The quality standard puts the responsibility on manufacturer or importer to
ensure that the information provided is sufficient, i.e. enough to allow the
user to decide how to protect:
       people at work; and
       the environment.
This will usually include information on:
     the hazards of the chemical;
     handling and storage;
     its environmental effects; and
     exposure controls/personal protection.

The information included under these headings will help the professional
users to make sure that the product is used safely.

The compilation of safety data sheets which offers guidance to the sort of
information that should be provided under the 16 headings. However, it
should be the supplier‟s responsibility to ensure that the user has enough
information to decide how to protect people at work and the environment.

91/155/EC
Article 1.1. (b)
Any person who is responsible for placing a preparation on the market, whether
the manufacturer, importer or distributor, shall supply, on request of a profes-
sional user, a safety data sheet providing proportionate information as set out in
Article 3 and the Annex to this Directive, if the preparation is not classified as
dangerous according to Articles 5, 6 and 7 of Directive 1999/45/EC, but the
preparation contains in an individual concentration of ≥ 1 % by weight for non-
gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one
substance posing health or environmental hazards, or one substance for which
there are Community workplace exposure limits.




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Dangerous Chemicals Regulation
Article 22
b) In the case of request from professional users, although it is not classified as
dangerous according to provisions of this Regulation, for preparations that con-
tain at least one of the substances whose workplace exposure limits determined or
which have harmful characteristic to man and environment, and for at least one or
more one by one of such substances;
(5) contain 1% (weight) and not to be in gaseous phase,
(6) contain 0.2% (volume) and to be in gaseous phase, Safety Data Sheet in-
     cluded detailed information, shall be prepared by producer of this preparation
     and deliver to demander.

SDS Communiqué
Annex
2. COMPOSITION/INFORMATION ON INGREDIENTS
2.3. For a preparation not classified as dangerous according to the
principles and procedures indicated in „Regulation of Hazardous
Chemicals‟ published and entered into force in Official Journal dated
July 11th 1993 and numbered 21634, the following substances shall be
indicated, together with their concentration or concentration range, if
they are present in an individual concentration of 1 % by weight for
non-gaseous preparations and 0,2 % by volume for gaseous prepara-
tions:

       Substances presenting a health or environmental hazard within
       the meaning of „Regulation of Hazardous Chemicals‟ (1)
      substances for which there are workplace exposure limits and
       not already included under (i).

(i)=Substances presenting a health or environmental hazard within the
meaning of „Regulation of Hazardous Chemicals‟,

For preparations that are not classified as hazardous, a safety data
sheet must be provided to the professional user upon request. The
packaging of such preparations must contain information that a
safety data sheet is available.

Chemical products comprised by the provisions on safety data sheets:
          Substances and preparations that are hazardous to health or the en-
           vironment according to the classification and labelling of chemical
           products regulations
          Non-hazardous preparations but containing at least 1% (0.2% for
           gases) of a substance that is hazardous to health or the environment.
          Non-hazardous preparations but containing at least 1% (0.2% for
           gases) of a substance assigned a EC limit value for exposure at the
           workplace or a hygienic limit value.

The provisions of our legislation more or less meet the requirements of the
Directive. However, the relevant article of the SDS Communiqué should be
modified according to the provisions of Directive.



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91/155/EC
Article 1.2.
The information shall be provided free of charge at the latest when the substance
or preparation is first supplied and thereafter following any revision due to any
significant new information regarding safety and protection of health and the
environment.

Dangerous Chemicals Regulations
Article 22
c) Safety Data Sheet;
       shall be provided to customer in the first delivery of the dangerous
        chemical after production or if possible before delivery,
       in the second or following deliveries on request, as a written text free of
        charge or transmitted in electronic version.

SDS Communiqué
No information.

The safety data sheet itself is not an assessment. However, it will describe the
hazards, helping the professional users to assess the probability of those haz-
ards (ie the risk) arising in the workplace. So in accordance with the results
of the risk assessments the SDS should be changed if necessary.

The relevant article of the SDS Communiqué should be modified according
to the provisions of Directive.

91/155/EC
Article 1.2.
The new dated version, identified as 'Revision:... (date)' shall be provided free of
charge to all former recipients who received the substance or preparation within
the preceding 12 months.

Dangerous Chemicals Regulations
Article 22
In case of update of the Safety Data Sheet in light of new information; updated
form, until 12 month before the update date, shall be transmitted to users and
those who store dangerous chemicals within a period of 3 months following up-
date date and changing date and number of change shall be mentioned in the
form.

SDS Communiqué
No information.

In the case of products that are hazardous to health and the environment,
the safety data sheet must be provided to the user at the latest when the
product is supplied for the first time. Companies must sent updated sheets to
customers who have received the product in the last twelve months.

SDS should indicate when it was last revised. It should be revised every time
there is important new information on the chemical and should be checked



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at regular intervals to ensure that the latest environmental, toxicological and
legal information is provided.

The relevant article of the SDS Communiqué should be modified according
to the provisions of Directive.

91/155/EC
Article 1.3.
The safety data sheet need not be supplied where dangerous substances or prepa-
rations offered or sold to the general public are furnished with sufficient informa-
tion to enable users to take the necessary measures as regards the protection of
health and safety. However, a safety data sheet must be supplied at the request of
an industrial user.

Dangerous Chemicals Regulation
No information.

SDS Communiqué
No information.

Some groups of chemicals, such as medicines and cosmetics, are covered by
other legislation and have different rules for packaging and labelling. Retail-
ers do not have to supply safety data sheets to the general public. But if you
buy a dangerous chemical from a retailer for use at work, the retailer must
provide a safety data sheet if you ask for one. Retailers do not have to give
you the safety data sheet with the product, provided they make arrange-
ments to forward it promptly.

The relevant article of the SDS Communiqué should be modified according
to the provisions of Directive since there is no information about this subject.

91/155/EC
Article 2
Member States may make the placing of dangerous substances or preparations on
the market in their territory subject to the use of their official language or lan-
guages for the compilation of the safety data sheet referred to in Article 1.

Dangerous Chemicals Regulation
Article 22
Safety Data Sheet; shall be prepared in Turkish for chemicals placed on the mar-
ket, in one of the official language of the exported country for the exported
chemicals.

Producer and importer are obliged to prepare data sheet in Turkish for those sold
to other producer as a user that explain the effect of dangerous chemical sub-
stances or products on environmental and man health.

SDS Communiqué
No information.




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The provisions of our legislation more or less meet the requirements of the
Directive. However, the relevant article of the SDS Communiqué should be
modified according to the provisions of Directive.

91/155/EC
Article 3
The safety data sheet referred to in Article 1 shall contain the following obliga-
tory headings:
1.      identification of the substance/preparation and of the com-
        pany/undertaking;
2.      composition/information on ingredients;
3.      hazards identification;
4.      first-aid measures;
5.      fire-fighting measures;
6.      accidental release measures;
7.      handling and storage;
8.      exposure controls/personal protection;
9.      physical and chemical properties;
10.     stability and reactivity;
11.     toxicological information;
12.     ecological information;
13.     disposal considerations;
14.     transport information;
15.     regulatory information;
16.     other information.

Dangerous Chemicals Regulation
No information.

SDS Communiqué
Article 6
In the second part of Safety Data Sheets information given are numbered and
designated under 16 standard subheadings.
1.      Substance Identity and Company Contact Information
2.      Composition and Data on Components
3.      Hazards Identification
4.      First aid Measures
5.      Fire Fighting Measures
6.      Accidental Release Measures
7.      Handling and Storage
8.      Exposure Control and Personal Protection
9.      Physical and Chemical properties
10.     Stability and Reactivity
11.     Toxicological Information
12.     Ecological Information
13.     Disposal Considerations
14.     Transport Information
15.     Regulations
16.     Other Information

Fully in compliance with the Directive.



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91/155/EC
Article 3
It shall be incumbent on the person responsible for placing the substance or
preparation on the market to supply the information specified under these head-
ings. This information shall be compiled in accordance with the Explanatory
Notes in the Annex. The safety data sheet shall be dated.

Dangerous Chemicals Regulation
No information.

SDS Communiqué
Arrangement of Safety Data Sheets
Article 5.a.
Safety Data Sheets should be prepared by a competent person who should take
into account the management of hazardous chemicals compatibly trained even
taken update training on the subject. Bearing in mind the 22nd article of Regula-
tion of Hazardous Chemicals, real and legal entity liable for arranging Safety
Data Sheets should make these data sheets arranged to people having these quali-
fication.

Article 5.b.
Safety Data Sheets; should be prepared in accordance with the sample form speci-
fied in annex I in this communiqué and information laid down under heading
numbered 6 should be in clear and concise manner.

Article 5.c.
List the mandatory headings specified under 6 and subheadings in Annex II.

Information to be included in the Safety Data Sheets
Article 6 mentions information to be included in the SDS. Information is arranged
as 2 parts. In the first part, the name of the substance/preparation, legislation used
during the arrangement of the form, if the form is revised the date of the last revi-
sion and after how many it is, page and form number are revealed separately.

The provisions of our legislation more or less meet the requirements of the
Directive. However, the relevant article of the SDS Communiqué should be
modified according to the provisions of Directive. “The safety data sheet
shall be dated.” should be added to the relevant article of our legislation.

91/155/EC
Article 5.1.
Member States shall adopt and publish the provisions necessary to comply with
this Directive by 30 May 1991 at the latest and shall forthwith inform the Com-
mission thereof.

SDS Communiqué
Article 23 mentions about adaptation with European Union but Article 5.1.
of 91/155/EC is not applicable until accession.

The relevant article should be modified according to the Directive however,
it will be valid after EU accession.



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91/155/EC
Article 5.2.
These provisions shall take effect from 8 June 1991. However, existing informa-
tion systems of the safety data sheet type in use in some Member States may con-
tinue to be used until 30 June 1993.

SDS Communiqué
Article 23 is about entry of communiqué in force but Article 5.2. of
91/155/EC is not applicable until accession.

The relevant article should be modified according to the Directive however;
it will be valid after EU accession.

91/155/EC
Article 5.3.
When Member States adopt these provisions, these shall contain a reference to
this Directive or shall be accompanied by such reference at the time of their offi-
cial publication. The procedure for such reference shall be adopted by Member
States.

SDS Communiqué
Article 23
This communiqué is prepared for adaptation to 3rd article and annex of Council
Directive numbered 91/ 155/ EEC related to the definition and arrangement of
detailed specific information system in accordance with the hazardous substances
and preparations by taking into account the alterations directing towards carrying
out the European Union‘s 14th article of European Parliament and Council Direc-
tive related to the Hazardous Preparations numbered 1999/ 45/ EC and 27th arti-
cle of the Council Directive related to the Hazardous Substances numbered 67/
548/ EEC.

Fully in compliance with the Directive.

91/155/EC
Article 6
This Directive is addressed to the Member States.

SDS Communiqué
No information.

The relevant article should be modified according to the Directive however;
it will be valid after EU accession.

91/155/EC
‗ANNEX‘
GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
The purpose of this Annex is to ensure consistency and accuracy in the content of
each of the mandatory headings listed in Article 3, so that the resulting safety data
sheets will enable professional users to take the necessary measures relating to
protection of health and safety at the workplace, and protection of the environ-
ment.



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The information provided by safety data sheets should meet the requirements set
out in Council Directive 98/24/EC (1) on the protection of the health and safety of
workers from the risks related to chemical agents at work. In particular, the safety
data sheet should enable the employer to determine whether any hazardous
chemical agents are present in the workplace, and to assess any risk to the health
and safety of workers arising from their use. The information must be written in a
clear and concise manner. The safety data sheet should be prepared by a compe-
tent person who should take into account the specific needs of the user audience,
as far as it is known. Persons placing substances and preparations on the market
should ensure that competent persons have received appropriate training, includ-
ing refresher training.

For preparations not classified as dangerous, but for which a safety data sheet is
required according to Article 14(2.1)(b) of Directive 1999/45/EC, proportionate
information should be provided under each heading.

Additional information may be necessary in some cases in view of the wide range
of properties of the substances and preparations. If in other cases it emerges that
information on certain properties is of no significance or that it is technically im-
possible to provide, the reasons for this must be clearly stated under each heading.
Information must be provided for each hazardous property. If it is stated that a
particular hazard does not apply, clearly differentiate between cases where no
information is available to the classifier, and cases where negative test results are
available. Give the date of issue of the safety data sheet on the first page.

When a safety data sheet has been revised, the changes should be brought to the
attention of the recipient.

Note
Safety data sheets are also required for certain special substances and preparations
(e.g. metals in massive form, alloys, compressed gases etc.) listed in chapters 8
and 9 of Annex VI to Directive 67/548/EEC, for which there are labelling deroga-
tions.

SDS Communiqué
ANNEX II
GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
This guide ensures the consistency and accuracy in the content of each
of the mandatory headings that should be included in Safety Data
Sheets listed and it is prepared to inform the compliers of Safety Data
Sheets.
Additional information may be necessary in some cases in view of the
wide range of properties of the substances and preparations. The in-
formation provided by safety data sheets should meet the require-
ments set out in on the protection of the health and safety of workers
from the risks related to chemical agents at work. In particular, the
safety data sheet should enable the employer to determine whether
any hazardous chemical agents are present in the workplace, and to
assess any risk to the health and safety of workers arising from their
use.



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If in other cases it emerges that information on certain properties is of
no significance or that it is technically impossible to provide, the rea-
sons for this must be clearly stated under each heading. Information
must be provided for each hazardous property. If it is stated that a
particular hazard does not apply, clearly differentiate between cases
where no information is available to the classifier, and cases where
negative test results are available.

The provisions of our legislation more or less meet the requirements of the
Directive. However, the relevant article of the SDS Communiqué should be
modified according to the provisions of Directive.

91/155/EC
1.1. Identification of the substance or preparation
The term used for identification must be identical to that provided on the label as
set out in, Annex VI to Directive 67/548/EEC. Other means of identification
available may also be indicated.

SDS Communiqué
Annex II
1.1. Identification of the substance or preparation
The term used for identification must be identical to that provided on
the label as set out in „Regulation of Hazardous Chemicals‟ published
in Official Journal dated July 11th 1993 and numbered 21634.

The provisions of our legislation more or less meet the requirements of the
Directive. “Other means of identification available may also be indicated.”
Should be added to our legislation.

91/155/EC
1.2. Use of the substance/preparation
Indicate the intended or recommended uses of the substance or preparation as far
as they are known. Where there are many possible uses, only the most important
or common uses need be listed. This should include a brief description of what it
actually does, e.g. flame retardant, anti-oxidant, etc.

SDS Communiqué
1.2. Use of the substance/preparation
Indicate the intended or recommended uses of the substance or prepa-
ration as far as they are known. Where there are many possible uses,
only the most important or common uses need be listed. This should
include a brief description of what it actually does, e.g. flame retar-
dant, anti-oxidant, etc.

Fully in compliance with the Directive.




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91/155/EC
1.3. Company/undertaking identification
Identify the person responsible for placing the substance or preparation on the
market within the Community, whether it be the manufacturer, importer or dis-
tributor. Give the full address and telephone number of this person.

In addition, where this person is not located in the Member State where the sub-
stance or preparation is placed on the market, give a full address and telephone
number for the person responsible in that Member State, if possible.

SDS Communiqué
1.3. Company/undertaking identification
Identify the person responsible for placing the substance or prepara-
tion on the market within the Community, whether it is the manufac-
turer, importer or distributor. Give the full address and telephone
number of this person.

The second part should be added to our legislation for full compliance.

91/155/EC
1.4. Emergency telephone
In addition to the abovementioned information, supply the emergency telephone
number of the company and/or relevant official advisory body (this may be the
body responsible for receiving information relating to health, which is referred to
in Article 17 of Directive 1999/45/EC).

SDS Communiqué
1.4 Emergency telephone number
In addition to the abovementioned information, supply the emergency
telephone number of the company and/or relevant official advisory
body

Fully in compliance with the Directive.

91/155/EC
2. COMPOSITION/INFORMATION ON INGREDIENTS
The information given should enable the recipient to identify readily the hazards
of the components of the preparation. The hazards of the preparation itself should
be given under heading 3.

SDS Communiqué
2. COMPOSITION/INFORMATION ON INGREDIENTS
The information given should enable the recipient to identify readily
the hazards of the components of the preparation. The hazards of the
preparation itself should be given under 3.

Fully in compliance with the Directive.




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91/155/EC
2.1. It is not necessary to give the full composition (nature of the ingredients and
their concentration), although a general description of the components and their
concentrations can be helpful.

SDS Communiqué
2.1. It is not necessary to give the full composition (nature of the in-
gredients and their concentration), although a general description of
the components and their concentrations can be helpful.

Fully in compliance with the Directive.

91/155/EC
2.2. For a preparation classified as dangerous according to Directive 1999/45/EC,
the following substances shall be indicated, together with their concentration or
concentration range:
        substances presenting a health or environmental hazard within the mean-
         ing of Directive 67/548/EEC, if they are present in concentrations equal
         to or greater than those laid down in the table set out in Article 3(3) of
         Directive 1999/45/EC (unless lower limits are given in Annex I to Direc-
         tive 67/548/EEC or in Annexes II, III or V to Directive 1999/45/EC);
        and substances for which there are Community workplace exposure lim-
         its, which are not already included under (i).

SDS Communiqué
2.2. For a preparation classified as dangerous according to the princi-
ples and procedures indicated in „Regulation of Hazardous Chemicals‟
published and enter into force in Official Journal dated July 11 th 1993
and numbered 21634, the following substances shall be indicated, to-
gether with their concentration or concentration range:
(i)    Substances presenting a health or environmental hazard within
       the meaning of „Regulation of Hazardous Chemicals‟,
(ii)   and substances for which there are workplace exposure limits,
       which are not already included under (i).

EU references should be added to our legislation for full compliance.

91/155/EC
2.3. For a preparation not classified as dangerous according to Directive
1999/45/EC, the following substances shall be indicated, together with their con-
centration or concentration range, if they are present in an individual concentra-
tion of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for
gaseous preparations:
        substances presenting a health or environmental hazard within the mean-
         ing of Directive 67/548/EEC (1);
        and substances for which there are Community workplace exposure lim-
         its.




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SDS Communiqué
2.3. For a preparation not classified as dangerous according to the
principles and procedures indicated in „Regulation of Hazardous
Chemicals‟ published and entered into force in Official Journal dated
July 11th 1993 and numbered 21634, the following substances shall be
indicated, together with their concentration or concentration range, if
they are present in an individual concentration of 1 % by weight for
non-gaseous preparations and 0,2 % by volume for gaseous prepara-
tions:
 
       substances presenting a health or environmental hazard within
       the meaning of „Regulation of Hazardous Chemicals‟ (1)
and
      substances for which there are workplace exposure limits and
       not already included under (i).

EU references should be added to our legislation for full compliance.

91/155/EC
2.4. The classification (deriving either from Articles 4 and 6 or from Annex I to
Directive 67/548/EEC) of the above substances shall be given, including the
symbol letters and R phrases which are assigned in accordance with their phys-
icochemical, health and environmental hazards. The R phrases do not need to be
written out in full here: reference should be made to heading 16, where the full
text of each relevant R phrase shall be listed.

SDS Communiqué
2.4. The classification of the above substances shall be given, including
the symbol letters and R phrases, which are assigned in accordance
with their physicochemical, health and environmental hazards. The R
phrases do not need to be written out in full here: reference should be
made to 16, where the full text of each relevant R phrase shall be
listed.

EU references should be added to our legislation for full compliance.

91/155/EC
2.5. The name and the EINECS or ELINCS number of the above substances
should be given in accordance with Directive 67/548/EEC. The CAS number and
IUPAC name (if available) may also be helpful. For substances listed by a generic
name, according to Article 15 of Directive 1999/45/EC or the footnote to point
2.3 of this Annex, a precise chemical identifier is not necessary.

SDS Communiqué
2.5. The name and the EINECs or ELINICs number of the above sub-
stances should be given in accordance with „Regulation of Hazardous
Chemicals‟ published and enter into force in Official Journal dated
July 11th 1993 and numbered 21634. The CAS number and IUPAC
name (if available) may also be helpful.




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For substances listed by a generic name, according to Regulation or
the footnote to point (1) of this Guide, a precise chemical identifier is
not necessary.

EU references should be added to our legislation for full compliance.

91/155/EC
2.6. If, in accordance with the provisions of Article 15 of Directive 1999/45/EC
or the footnote to point 2.3 of this Annex, the identity of certain substances is to
be kept confidential, their chemical nature shall be described in order to ensure
safe handling. The name used must be the same as that which derives from the
above procedures.

SDS Communiqué
2.6. If, in accordance with the provisions of „Regulation of Hazardous
Chemicals‟ published and enter into force in Official Journal dated
July 11th 1993 and numbered 21634 or the footnote to point (1) of this
Guide, the identity of certain substances is to be kept confidential,
their chemical nature shall be described in order to ensure safe han-
dling. The name used must be the same as that which derives from the
above procedures.

Fully in compliance with the Directive.

91/155/EC
3. HAZARDS IDENTIFICATION
Give here the classification of the substance or preparation which arises from
application of the classification rules in Directives 67/548/EEC or 1999/45/EC.
Indicate clearly and briefly the hazards the substance or preparation presents to
man and the environment. Distinguish clearly between preparations which are
classified as dangerous and preparations which are not classified as dangerous
according to Directive 1999/45/EC. Describe the most important adverse phys-
icochemical, human health and environmental effects and symptoms relating to
the uses and possible misuses of the substance or preparation that can reasonably
be foreseen.

It may be necessary to mention other hazards, such as dustiness, suffocation,
freezing or environmental effects such as hazards to soil-dwelling organisms, etc.,
which do not result in classification but which may contribute to the overall haz-
ards of the material. The information shown on the label should be given under
heading 15.

(1) Where the person responsible for placing the preparation on the market can
demonstrate that the disclosure in the safety data sheet of the chemical identity of
a substance which is exclusively classified as:
       irritant with the exception of those assigned R41 or irritant in combina-
        tion with one or more of the properties mentioned in point 2.3.4 of Article
        10 of Directive 1999/45/EC,
       or harmful in combination with one or more of the properties mentioned
        in point 2.3.4 of Article 10 of Directive 1999/45/EC presenting acute le-
        thal effects alone, will put at risk the confidential nature of his intellectual


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           property, he may, in accordance with the provisions of Part B of Annex
           VI to Directive 1999/45/EC, refer to that substance either by means of a
           name that identifies the most important functional chemical groups, or by
           means of an alternative name. EN Official Journal of the L 212/28 Euro-
           pean Communities 7.8.2001

SDS Communiqué
3. HAZARDS IDENTIFICATION
Give here the classification of the substance or preparation, which
arises from application of the classification rules in Regulation of Haz-
ardous Chemicals‟ published and enter into force in Official Journal
dated July 11th 1993 and numbered 21634. Indicate clearly and
briefly the hazards the substance or preparation presents to man and
the environment.

If the related legislation is insufficient or absent classification should
be done in accordance with the one prescribed by European Union.
Distinguish clearly between preparations, which are classified as dan-
gerous, and preparations, which are not classified as dangerous ac-
cording to Directive of EU.

Describe the most important adverse physicochemical, human health
and environmental effects and symptoms relating to the uses and pos-
sible misuses of the substance or preparation that can reasonably be
foreseen.

It may be necessary to mention other hazards, such as dustiness, suf-
focation, freezing or environmental effects such as hazards to soil-
dwelling organisms, etc., which do not result in classification but
which may contribute to the overall hazards of the material.

The information shown on the label should be given under 15. The
information given under 15 should be consistent with the one on the
label. Rather than label information should consist of detailed infor-
mation.

The provisions of our legislation more or less meet the requirements of the
Directive. However, the relevant article of the SDS Communiqué should be
modified according to the provisions of Directive.

91/155/EC
4. FIRST AID MEASURES
Describe the first-aid measures.
Specify first whether immediate medical attention is required. The information on
first aid must be brief and easy to understand by the victim, bystanders and first-
aiders. The symptoms and effects should be briefly summarised. The instructions
should indicate what is to be done on the spot in the case of an accident and
whether delayed effects can be expected after exposure. Subdivide the informa-
tion according to the different routes of exposure, i.e. inhalation, skin and eye



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contact and ingestion, under different subheadings. Indicate whether professional
assistance by a doctor is needed or advisable. For some substances or preparations
it may be important to emphasise that special means to provide specific and im-
mediate treatment must be available at the workplace.

SDS Communiqué
4. FIRST AID MEASURES
Describe the first-aid measures and specify first whether immediate
medical attention is required under this heading numbered 4.

The information on first aid must be brief and easy to understand by
the victim, bystanders and first-aiders. The symptoms and effects
should be briefly summarized. The instructions should indicate what
is to be done on the spot in the case of an accident and whether de-
layed effects can be expected after exposure.

Subdivide the information according to the different routes of expo-
sure, i.e. inhalation, skin and eye contact and ingestion, under differ-
ent subs.

Indicate whether professional assistance by a doctor is needed or ad-
visable.

For some substances or preparations it may be important to empha-
size that special means to provide specific and immediate treatment
must be available at the workplace.

Fully in compliance with the Directive.

91/155/EC
5. FIRE-FIGHTING MEASURES
Refer to requirements for fighting a fire caused by the substance or preparation,
or arising in its vicinity by indicating:
        suitable extinguishing media,
        extinguishing media which must not be used for safety reasons,
        special exposure hazards arising from the substance or preparation itself,
         combustion products, resulting gases,
        special protective equipment for fire-fighters.

SDS Communiqué
5. FIRE-FIGHTING MEASURES
Refer to requirements for fighting a fire caused by the substance or
preparation, or arising in its vicinity by indicating:
a.     Suitable extinguishing media,
b.     Extinguishing media which must not be used for safety reasons,
c.     Special exposure hazards arising from the substance or prepa-
       ration itself, combustion products, resulting gases,
d.     Special protective equipment for fire fighters.



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Fully in compliance with the Directive.

91/155/EC
6. ACCIDENTAL RELEASE MEASURES
Depending on the substance or preparation involved, information may be needed
on:
        personal precautions such as:
removal of ignition sources, provision for sufficient ventilation/respiratory protec-
tion, control of dust, prevention of skin and eye contact,
        environmental precautions such as:
keeping away from drains, surface- and ground-water and soil, possible need to
alert the neighbourhood,
        methods for cleaning up such as:
use of absorbent material (e.g. sand, diatomaceous earth, acid binder, universal
binder, sawdust, etc.), reduction of gases/fumes with water, dilution.

Also consider the need for indications such as: ―never use, neutralise with …‖.

Note
If appropriate refer to headings 8 and 13.

SDS Communiqué
6. ACCIDENTAL RELEASE MEASURES
Depending on the substance or preparation involved, information may
be needed on:
      Personal precautions such as:
Removal of ignition sources, provision for sufficient ventila-
tion/respiratory protection, control of dust, prevention of skin and eye
contact,
      Environmental precautions such as:
Keeping away from drains, surface- and ground-water and soil, possi-
ble need to alert the neighborhood,
      Methods for cleaning up such as:
Use of absorbent material (e.g. sand, diatomaceous earth, acid binder,
universal binder, sawdust, etc.), reduction of gases/fumes with water,
dilution.

Also consider the need for indications such as: "never use, neutralize
with ...”

Note
If appropriate, refer to s 8 and 13.

Fully in compliance with the Directive.




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91/155/EC
7. HANDLING AND STORAGE
Note
Information in this section should relate to the protection of health, safety and the
environment. It should assist the employer in devising suitable working proce-
dures and organisational measures according to Article 5 of Directive 98/24/EC.

SDS Communiqué
7. HANDLING AND STORAGE
Information in this section should relate to the protection of health,
safety and the environment. It should assist the employer in devising
suitable working procedures and organizational measures according
to Regulation.

Fully in compliance with the Directive. There is only one problem originated
from Turkish language. We have to find a word to be used instead of han-
dling.

91/155/EC
7.1. Handling
Specify precautions for safe handling including advice on technical measures
such as: containment, local and general ventilation, measures to prevent aerosol
and dust generation and fire, measures required to protect the environment (e.g.
use of filters or scrubbers on exhaust ventilation, use in a bunded area, measures
for collection and disposal of spillages, etc.) and any specific requirements or
rules relating to the substance or preparation (e.g. procedures or equipment which
are prohibited or recommended) and if possible give a brief description.

SDS Communiqué
7.1. Handling
Specify precautions for safe handling including advice on technical
measures such as: containment, local and general ventilation, meas-
ures to prevent aerosol and dust generation and fire, measures re-
quired to protect the environment (e.g. use of filters or scrubbers on
exhaust ventilation, use in a bounded area, measures for collection and
disposal of spillages, etc.) and any specific requirements or rules relat-
ing to the substance or preparation (e.g. procedures or equipment
which are prohibited or recommended) and if possible give a brief
description.

Fully in compliance with the Directive. There is only one problem originated
from Turkish language. We have to find a word to be used instead of han-
dling.

91/155/EC
7.2. Storage
Specify the conditions for safe storage such as: specific design for storage rooms
or vessels (including retention walls and ventilation), incompatible materials,
conditions of storage (temperature and humidity limit/range, light, inert gas, etc.)
special electrical equipment and prevention of static electricity.



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Give advice if relevant on quantity limits under storage conditions. In particular
indicate any special requirements such as the type of material used in the packag-
ing/containers of the substance or preparation.

SDS Communiqué
7.2. Storage
Specify the conditions for safe storage such as specific design for stor-
age rooms or vessels (including retention walls and ventilation), in-
compatible materials, conditions of storage temperature and humidity
limit/range, light, inert gas, etc.) Special electrical equipment and pre-
vention of static electricity.

Give advice if relevant on quantity limits under storage conditions. In
particular, indicate any special requirements such as the type of mate-
rial used in the packaging/containers of the substance or preparation.

Fully in compliance with the Directive.

91/155/EC
7.3. Specific use(s)
For end products designed for specific use(s), recommendations should refer to
the intended use(s) and be detailed and operational. If possible, reference should
be made to industry — or sector — specific approved guidance.

SDS Communiqué
7.3. Specific use(s)
For end products designed for specific use(s), recommendations
should refer to the intended use(s) and be detailed and operational. If
possible, reference should be made to industry - or sector - specific
approved guidance.

Fully in compliance with the Directive.

91/155/EC
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1. Exposure limit values
Specify currently applicable specific control parameters including occupational
exposure limit values and/or biological limit values. Values should be given for
the Member State where the substance or preparation is placed on the market.
Give information on currently recommended monitoring procedures.

For preparations, it is useful to provide values for those constituent substances
which are required to be listed in the safety data sheet according to heading 2.

SDS Communiqué
8.1. Exposure limit values
Specify currently applicable specific control parameters including oc-
cupational exposure limit values and/or biological limit values. Values
should be given for the Member State where the substance or prepara-



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tion is placed on the market. Give information on currently recom-
mended monitoring procedures.

For preparations, it is useful to provide values for those constituent
substances, which are required to be listed in the safety data sheet ac-
cording to 2.

Fully in compliance with the Directive.

91/155/EC
8.2. Exposure controls
For the purposes of this document exposure control means the full range of spe-
cific protection and prevention measures to be taken during use in order to mini-
mize worker and environmental exposure.

SDS Communiqué
No information.

Our legislation should be modified in line with the Directive.

91/155/EC
8.2.1. Occupational exposure controls
This information will be taken into account by the employer in carrying out an
assessment of risk to the health and safety of workers for the substance or prepa-
ration under Article 4 of Directive 98/24/EC, which requires the design of appro-
priate work processes and engineering controls, the use of adequate equipment
and materials, the application of collective protection measures at source, and
finally the use of individual protection measures, such as personal protection
equipment. Therefore provide suitable and adequate information on these meas-
ures to enable a proper risk assessment to be carried out under Article 4 of Direc-
tive 98/24/EC. This information should complement that already given under
heading 7.1.

Where personal protection is needed, specify in detail which equipment will pro-
vide adequate and suitable protection. Take into account Council Directive
89/686/EEC (1) and make reference to the appropriate CEN standards:

SDS Communiqué
8.2.1. Occupational exposure controls
This information will be taken into account by the employer in carry-
ing out an assessment of risk to the health and safety of workers for
the substance or preparation under related regulation, which requires
the design of appropriate work processes and engineering controls, the
use of adequate equipment and materials, the application of collective
protection measures at source, and finally the use of individual protec-
tion measures, such as personal protection equipment. Therefore pro-
vide suitable and adequate information on these measures to enable a
proper risk assessment to be carried out under related regulation.
This information should complement that already given under 7.1.



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Where personal protection is needed, specify in detail which equip-
ment will provide adequate and suitable protection. Take into account
European Union Council Directives and refer to the appropriate CEN
standards:

Fully in compliance with the Directive.

91/155/EC
8.2.1.1. Respiratory protection
For dangerous gases, vapours or dust, specify the type of protective equipment to
be used, such as self contained breathing apparatus, adequate masks and filters.

SDS Communiqué
8.2.1.1. Respiratory protection
For dangerous gases, vapors or dust, specify the type of protective
equipment to be used, such as self-contained breathing apparatus,
adequate masks and filters.

Fully in compliance with the Directive.

91/155/EC
8.2.1.2. Hand protection
Specify clearly the type of gloves to be worn when handling the substance or
preparation, including:
— the type of material,
— the breakthrough time of the glove material, with regard to the amount and
duration of dermal exposure.
If necessary indicate any additional hand protection measures.

SDS Communiqué
8.2.1.2. Hand protection
Specify clearly the type of gloves to be worn when handling the sub-
stance or preparation, including:
       The type of material,
       The breakthrough time of the glove material, with regard to
        the amount and duration of dermal exposure.

If necessary, indicate any additional hand protection measures.

Fully in compliance with the Directive.

91/155/EC
8.2.1.3. Eye protection
Specify the type of eye protection equipment required such as: safety glasses,
safety goggles, face shield.

SDS Communiqué
8.2.1.3. Eye protection
Specify the type of eye protection equipment required such as safety
glasses, safety goggles, and face shield.


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Fully in compliance with the Directive.

91/155/EC
8.2.1.4. Skin protection
If it is necessary to protect a part of the body other than the hands, specify the
type and quality of protection equipment required, such as: apron, boots and full
protective suit. If necessary, indicate any additional skin protection measures and
specific hygiene measures.

SDS Communiqué
8.2.1.4. Skin protection
If it is necessary to protect a part of the body other than the hands,
specify the type and quality of protection equipment required, such as
apron, boots and full protective suit. If necessary, indicate any addi-
tional skin protection measures and specific hygiene measures.

Fully in compliance with the Directive.

91/155/EC
8.2.2. Environmental exposure controls
Specify the information required by the employer to fulfil his commitments under
Community environmental protection legislation.

SDS Communiqué
8.2.2. Environmental exposure controls
Specify the information required by the employer to fulfill his com-
mitments under Community environmental protection legislation.

Fully in compliance with the Directive.

91/155/EC
9. PHYSICAL AND CHEMICAL PROPERTIES
To enable proper control measures to be taken, provide all relevant information
on the substance or preparation, particularly the information listed under heading
9.2.

SDS Communiqué
9. PHYSICAL AND CHEMICAL PROPERTIES
To enable proper control measures to be taken, provide all relevant
information on the substance or preparation, particularly the infor-
mation listed under 9.2.

Fully in compliance with the Directive.

91/155/EC
9.1. General information
Appearance
Indicate the physical state (solid, liquid, gas) and the colour of the substance or
preparation as supplied.



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Odor
If odor is perceptible, give a brief description of it.

SDS Communiqué
9.1. General information
9.1.1. Appearance
Indicate the physical state (solid, liquid, gas) and the color of the sub-
stance or preparation as placed on the market.
9.1.2. Odor
If odor is perceptible, give a brief description of it.

Fully in compliance with the Directive. However, “placed on the market”
should be replaced by “supplied”.

91/155/EC
9.2. Important health, safety and environmental information
pH
Indicate the pH of the substance or preparation as supplied or of an aqueous solu-
tion; in the latter case, indicate the concentration.
         Boiling point/boiling range
          Flash point
          Flammability (solid, gas)
          Explosive properties
          Oxidizing properties
          Vapor pressure
          Relative density
          Solubility
            Water solubility
            Fat solubility (solvent-oil to be specified)
          Partition Coefficient
          Viscosity
          Vapor density
          Evaporation rate:

SDS Communiqué
9.2. Important health, safety and environmental information
      pH; Indicate the pH of the substance or preparation as sup-
       plied or of an aqueous solution; in the latter case, indicate the
       concentration.
      Boiling point/ boiling range
      Flash point
      Flammability (solid, gas)
      Explosive properties
      Oxidizing properties
      Vapor pressure
      Relative density
      Solubility
        Water solubility

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            Fat solubility (solvent-oil to be specified)
          Partition Coefficient
          Viscosity
          Vapor density
          Evaporation rate/ratio

Fully in compliance with the Directive.

91/155/EC
9.3. Other information
Indicate other important safety parameters, such as, miscibility, conductivity,
melting point/melting range, gas group (useful for European Parliament and
Council Directive 94/9/EC) (1), auto-ignition temperature etc.
(1) OJ L 100, 19.4.1994, p. 1.
EN Official Journal of 7.8.2001 the European Communities L 212/31

Note 1
The above properties should be determined in accordance with the specifications
of Part A of Annex V to Directive 67/548/EEC or any other comparable method.

Note 2
For preparations, information should normally be given on the properties of the
preparation itself. However, if it is stated that a particular hazard does not apply,
clearly differentiate between cases where no information is available to the classi-
fier, and cases where negative test results are available. If it is considered neces-
sary to give information about the properties of individual components, please
indicate clearly what the data refers to.

SDS Communiqué
9.3. Other information
Indicate other important safety parameters, such as, miscibility, con-
ductivity, melting point/melting range, gas group), auto-ignition tem-
perature etc.

Note 1:
The above properties should be determined in accordance with the
specifications of „regulation of Hazardous Chemicals‟ published and
enter into force in Official Journal dated July 11th 1993 and numbered
21634 or any other comparable method.

Note 2:
For preparations, information should normally be given on the prop-
erties of the preparation itself. However, if it is stated that a particular
hazard does not apply, clearly differentiate between cases where no
information is available to the classifier, and cases where negative test
results are available. If it is considered necessary to give information
about the properties of individual components, please indicate clearly
what the data refers to.

EU references should be added to our legislation for full compliance.


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91/155/EC
10. STABILITY AND REACTIVITY
State the stability of the substance or preparation and the possibility of hazardous
reactions occurring under certain conditions of use and also if released into the
environment.

SDS Communiqué
10. STABILITY AND REACTIVITY
State the stability of the substance or preparation and the possibility
of hazardous reactions occurring under certain conditions of use and
if released into the environment.

Fully in compliance with the Directive.

91/155/EC
10.1. Conditions to avoid
List those conditions such as temperature, pressure, light, shock, etc., which may
cause a dangerous reaction and if possible give a brief description.

SDS Communiqué
10.1. Conditions to avoid
List those conditions such as temperature, pressure, light, shock, etc.,
which may cause a dangerous reaction and if possible give a brief de-
scription.

Fully in compliance with the Directive.

91/155/EC
10.2. Materials to avoid
List materials such as water, air, acids, bases, oxidising agents or any other spe-
cific substance which may cause a dangerous reaction and if possible give a brief
description.

SDS Communiqué
10.2. Materials to avoid
List materials such as water, air, acids, bases, oxidizing agents or any
other specific substance, which may cause a dangerous reaction and if
possible give a brief description.

Fully in compliance with the Directive.

91/155/EC
10.3. Hazardous decomposition products
List hazardous materials produced in dangerous amounts upon decomposition.
Note
Address specifically:
       the need for and the presence of stabilisers,
       the possibility of a hazardous exothermic reaction,
       safety significance, if any, of a change in physical appearance of the sub-
        stance or preparation,


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          hazardous decomposition products, if any, formed upon contact with wa-
           ter,
          possibility of degradation to unstable products.

SDS Communiqué
10.3. Hazardous decomposition products
List hazardous materials produced in dangerous amounts upon de-
composition.

Address the information below specifically:
     The need for and the presence of stabilizers,
     The possibility of a hazardous exothermic reaction,
     Safety significance, if any, of a change in physical appearance
      of the substance or preparation,
     Hazardous decomposition products, if any, formed upon con-
      tact with water,
     Possibility of degradation to unstable products.

Fully in compliance with the Directive.

91/155/EC
11. TOXICOLOGICAL INFORMATION
This section deals with the need for a concise but complete and comprehensible
description of the various toxicological (health) effects which can arise if the user
comes into contact with the substance or preparation.

Include dangerous-to-health effects from exposure to the substance or prepara-
tion, based on both experiences and conclusions from scientific experiments.
Include information on the different routes of exposure (inhalation, ingestion,
skin and eye contact), and describe the symptoms related to the physical, chemi-
cal and toxicological characteristics.

EN Official Journal of the L 212/32 European Communities 7.8.2001
Include known delayed and immediate effects and also chronic effects from short-
and long-term exposure: for example sensitisation, narcosis, carcinogenicity,
mutagenicity and reproductive toxicity (developmental toxicity and fertility).

Taking account of the information already provided under heading 2, composi-
tion/information on ingredients, it may be necessary to make reference to specific
health effects of certain components in preparations.

SDS Communiqué
11. TOXICOLOGICAL INFORMATION
This section under the mandatory heading numbered 11, deals with
the need for a concise but complete and comprehensible description of
the various toxicological (health) effects, which can arise if the user is
exposed to the substance or preparation.

Include dangerous-to-health effects from exposure to the substance or
preparation, based on both experiences and conclusions from scientific


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experiments. Include information on the different routes of exposure
(inhalation, ingestion, skin and eye contact), and describe the symp-
toms related to the physical, chemical and toxicological characteristics.

Include known delayed and immediate effects and chronic effects from
short- and long-term exposure: for example allergic effect (sensitiza-
tion), narcosis, carcinogenicity, mutagenicity and reproductive toxicity
(developmental toxicity and fertility).

Taking account of the information already provided under 2, composi-
tion/information on ingredients, it may be necessary to make reference to specific
health effects of certain components in preparations.

EU references should be added to our legislation for full compliance.

91/155/EC
12. ECOLOGICAL INFORMATION
Describe the possible effects, behaviour and environmental fate of the substance
or preparation in air, water and/or soil. Where available, give relevant test data
(e.g. LC50 fish ≤ 1 mg/l).

Describe the most important characteristics likely to have an effect on the envi-
ronment owing to the nature of the substance or preparation and likely methods of
use. Information of the same kind shall be supplied for dangerous products aris-
ing from the degradation of substances and preparations.

SDS Communiqué
12. ECOLOGICAL INFORMATION
Describe the possible effects, behaviour and environmental fate of the
substance or preparation in air, water and/or soil. Where available,
give relevant test data (e.g. LC50 fish ≤ 1 mg/L).

Describe the most important characteristics likely to have an effect on
the environment owing to the nature of the substance or preparation
and likely methods of use. Information of the same kind shall be sup-
plied for dangerous products arising from the degradation of sub-
stances and preparations. This may include the following:

Fully in compliance with the Directive.

91/155/EC
12.1. Ecotoxicity
This should include relevant available data on aquatic toxicity, both acute and
chronic for fish, daphnia, algae and other aquatic plant. In addition, toxicity data
on soil micro- and macro-organisms and other environmentally relevant organ-
isms, such as birds, bees and plants, should be included when available. Where
the substance or preparation has inhibitory effects on the activity of micro-
organisms, the possible impact on sewage treatment plants should be mentioned.




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SDS Communiqué
12.1. Ecotoxicity
This should include relevant available data on aquatic toxicity, both
acute and chronic for fish, daphnia, algae and other aquatic plant. In
addition, toxicity data on soil micro- and macro-organisms and other
environmentally relevant organisms, such as birds, bees and plants,
should be included when available. Where the substance or prepara-
tion has inhibitory effects on the activity of microorganisms, the possi-
ble impact on sewage treatment plants should be mentioned.

Fully in compliance with the Directive.

91/155/EC
12.2. Mobility
The potential of the substance or the appropriate constituents of a preparation (1),
if released to the environment, to transport to groundwater or far from the site of
release.

Relevant data might include:
      known or predicted distribution to environmental compartments,
      surface tension,
      absorption/desorption.

For other physicochemical properties see heading 9.

SDS Communiqué
12.2. Mobility
The potential of the substance or the appropriate constituents of a
preparation (2), if released to the environment, to transport to ground-
water or far from the site of release.

Relevant data might include:
     Known or predicted distribution to environmental compart-
      ments,
     Surface tension,
     Absorption/desorption.

For other physicochemical properties, see heading 9.

Fully in compliance with the Directive.

91/155/EC
12.3. Persistence and degradability
The potential of the substance or the appropriate constituents of a preparation (1)
to degrade in relevant environmental media, either through biodegradation or
other processes such as oxidation or hydrolysis. Degradation half lives should be
quoted where available. The potential of the substance or appropriate constituents
of a preparation (1) to degrade in sewage treatment plants should also be men-
tioned.



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SDS Communiqué
12.3. Persistence and degradability
The potential of the substance or the appropriate constituents of a
preparation(2) to degrade in relevant environmental media, either
through biodegradation or other processes such as oxidation or hy-
drolysis. Degradation half-lives should be quoted where available. The
potential of the substance or appropriate constituents of a preparation
(2)
    to degrade in sewage treatment plants should also be mentioned.

Fully in compliance with the Directive.

91/155/EC
12.4. Bioaccumulative potential
The potential of the substance or the appropriate constituents of a preparation (1)
to accumulate in biota and pass through the food chain, with reference to the Kow
and BCF, if available.

SDS Communiqué
12.4. Bioaccumulative potential
The potential of the substance or the appropriate constituents of a
preparation(8) to accumulate in biota and pass through the food
chain, with reference to the Kow and BCF (Bio Cumulative Factor), if
available.

Fully in compliance with the Directive.

91/155/EC
12.5. Otheradver se effects
If available, include information on any other adverse effects on the environment,
e.g. ozone depletion potential, photochemical ozone creation potential and/or
global warming potential.

SDS Communiqué
12.5. Other adverse effects
If available, include information on any other adverse effects on the
environment, e.g. ozone depletion potential, photochemical ozone crea-
tion potential and/or global warming potential.

Fully in compliance with the Directive.

91/155/EC
Remarks
Ensure that information relevant to the environment is provided under other head-
ings of the safety data sheet, especially advice for controlled release, accidental
release measures, transport and disposal considerations under headings 6, 7, 13,
14 and 15.

(1) This information cannot be given for the preparation because it is substance
specific. It should therefore be given, where available and appropriate, for each




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constituent substance in the preparation which is required to be listed in the safety
data sheet according to the rules under heading 2 of this Annex.
EN Official Journal of 7.8.2001 the European Communities L 212/33

SDS Communiqué
Remarks
Ensure that information relevant to the environment is provided under other s of
the safety data sheet, especially advice for controlled release, accidental release
measures, transport and disposal considerations under headings 6, 7, 13, 14 and
15.

91/155/EC
13. DISPOSAL CONSIDERATIONS
If the disposal of the substance or preparation (surplus or waste resulting from the
foreseeable use) presents a danger, a description of these residues and information
on their safe handling shall be given. Specify the appropriate methods of disposal
of both the substance or preparation and any contaminated packaging (incinera-
tion, recycling, landfilling, etc.)

Note
Refer to any relevant Community provisions relating to waste. In their absence, it
is useful to remind the user that national or regional provisions may be in force.

SDS Communiqué
13. DISPOSAL CONSIDERATIONS
If the disposal of the substance or preparation (surplus or waste re-
sulting from the foreseeable use) presents a danger, a description of
these residues and information on their safe handling shall be given.
Specify the appropriate methods of disposal of both the substance or
preparation and any contaminated packaging (incineration, recycling,
land filling, etc.)

Refer to any relevant Community provisions relating to waste. In their
absence, it is useful to remind the user that national or regional provi-
sions may be in force.

Fully in compliance with the Directive.

91/155/EC
14. TRANSPORT INFORMATION
Indicate any special precautions which a user needs to be aware of or needs to
comply with in connection with transport or conveyance either within or outside
his premises.

Where relevant, provide information on the transport classification for each of the
modal regulations: IMDG (sea), ADR (road, Council Directive 94/55/EC (1)),
RID (rail, Council Directive 96/49/EC (2)), ICAO/IATA (air).

This might include inter alia:
      UN number,
      class,


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          proper shipping name,
          packing group,
          marine pollutant,
          other applicable information.

SDS Communiqué
14. TRANSPORT INFORMATION

Indicate any special precautions, which a user needs to be aware of or
needs to comply with in connection with transport or conveyance ei-
ther within or outside his premises.

Where relevant, provide information on the transport classification
for each of the modal regulations:
a) Land Transport
   - For Railway, „RID‟ (Regulation related to International Trans-
      portation of Dangerous Burden on Railway)
   - For Road, „ADR‟ (European Agreement related to International
      Transportation of Dangerous Burden on Road)
b) Continental Water Ways „ADNR‟ (Circular related to International
Transportation of Dangerous Burden on River)
c) Shipping „IMDG Code‟ (Circular related to International Trans-
portation of Dangerous Burden on Sea)
d) Airway Transport „ICAO-TI (……………………….) and IATA-
DGR (…………………)

IMDG (sea), ADR (road, Council Directive 94/55/EC (9)), RID (rail,
Council Directive 96/49/EC (10)), ICAO/IATA (air). This might in-
clude inter alia:

          UN number,
          Class,
          Proper shipping name,
          Packing group,
          Marine pollutant,
          Other applicable information

Fully in compliance with the Directive.

91/155/EC
15. REGULATORY INFORMATION
Give the health, safety and environmental information shown on the label accord-
ing to Directives 67/548/EEC and 1999/45/EC.

If the substance or preparation covered by this safety data sheet is the subject of
specific provisions in relation to protection of man or the environment at Com-
munity level (e.g. restrictions on marketing and use set out in Council Directive
76/769/EEC (3)) these provisions should, as far as is possible, be stated.



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Also mention, where possible, the national laws which implement these provi-
sions and any other national measures that may be relevant.

SDS Communiqué
15. REGULATORY INFORMATION
Give the health, safety and environmental information shown on the
label according to principles and procedures laid down in Regulation
of Hazardous Chemicals published in Official Journal dated July 11 th
1993 and numbered 21634.

If the substance or preparation covered by this safety data sheet is the
subject of specific provisions in relation to protection of man or the
environment at Community level (e.g. restrictions on marketing and
use set out in Council Directive 76/769/EEC (11)) these provisions
should, as far as is possible, be stated.

Also, mention, where possible, the national laws, which implement
these provisions and any other national measures that may be rele-
vant.

Fully in compliance with the Directive.

91/155/EC
16. OTHER INFORMATION
Indicate any other information which the supplier assesses as being of importance
for the health and safety of the user and for the protection of the environment, for
example:
        list of relevant R phrases. Write out the full text of any R phrases referred
         to under headings 2 and 3 of the safety data sheet,
        training advice,
        recommended restrictions on use (i.e. non-statutory recommendations by
         supplier),
        further information (written references and/or technical contact point),
        sources of key data used to compile the data sheet,
        for a revised safety data sheet, indicate clearly the information which has
         been added, deleted or revised (unless this has been indicated else-
         where).‘

SDS Communiqué
16. OTHER INFORMATION
Indicate any other information, which the supplier assesses as being of
importance for the health and safety of the user and for the protection
of the environment, for example:

          List of relevant R phrases. Write out the full text of any R
           phrases referred to under s 2 and 3 of the safety data sheet,
          Training advice,
          Recommended restrictions on use (i.e. non-statutory recom-
           mendations by supplier),


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          Further information (written references and/or technical con-
           tact point),
          Sources of key data used to compile the data sheet,
          For a revised safety data sheet, indicate clearly the information,
           which has been added, deleted or revised (unless this has been
           indicated elsewhere).
(1)
   Where the person responsible for placing the preparation on the
market can demonstrate that the disclosure in the safety data sheet of
the chemical identity of a substance which is exclusively classified as:

      Irritant with the exception of those assigned R41 or irritant in
       combination with one or more of the properties.
      or harmful in combination with one or more of the properties

will put at risk the confidential nature of his intellectual property, he
may, in accordance with the provisions of Regulation of Hazardous
Chemicals, refer to that substance either by means of a name that
identifies the most important functional chemical groups, or by means
of an alternative name.
(2)
   This information cannot be given for the preparation because it is
substance specific. It should therefore be given, where available and
appropriate, for each constituent substance in the preparation, which
is required to be listed in the safety data sheet according to the rules
under heading 2 of this Annex

Fully in compliance with the Directive.




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8      Conclusions and Recommenda-
       tions




          When the above assessment based on the comparison between several
           options is considered the most feasible strategy would be to choose the
           first option, i.e. expanding the existing Department of Chemicals Man-
           agement and assigning new tasks to it for accomplishing EU require-
           ments; then going for option 3 whenever the NEA is established. In this
           case the technical will be moved under the NEA with its full capacity,
           leaving only one division behind, .i.e. the Division of Planning and Regu-
           lating.
          Although different institutions are responsible for market surveillance and
           inspection of different set of chemicals, there should be only one classifi-
           cation and labelling legislation for substances and preparations, which is
           in line with the relevant EU acquis; and relevant institutions should har-
           monize their own legislation with it. .
          In any case, the MoEF, MoH, and MLSS will collaborate and cooperate
           for generating an integrated risk assessment report for notified sub-
           stances. The working relations should be set by a mutually agreed legal
           document.




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Appendix I: Legal gap analysis with
            Respect to the Topics




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           LEGAL GAP ANALYSIS WITH RESPECT TO TOPICS
                     CODES OF LEGISLATION


MOEF 1       DANGEROUS CHEMICALS BY LAW (2001)
MOEF 2       COMMUNIQUE OF STANDARDIZATION FOR FOREIGN TRADE ON
             CHEMICALS WHICH ARE SUBJECT TO THE CONTROL FOR PROTECTION OF
             ENVIRONMENT     (2006/6)

MOEF 3       COMMUNIQUE ON IMPORTS OF OZONE DEPLETING SUBSTANCES (2006/14)

MOEF 4       ENVIRONMENTAL INSPECTION BY LAW (2002)

MOEF 5       BY LAW ON PHASING OUT OF THE OZONE DEPLETING SUSTANCES (2006)

MOEF 6       ENVIRONMENT LAW (2006)

UFT 1        COMMUNIQUE ON IMPORTS OF SUBSTANCES LISTED IN THE ANNEXES TO
             THE CONVENTION ON THE CONTROL OF CHEMICAL WEAPONS (2006/17)
UFT 2        THE LAW RELATING TO THE PREPARATION AND IMPLEMENTATION OF THE
             TECHNICAL LEGISLATION ON THE PRODUCTS 4703 (2001)
UFT 3        BY LAW RELATING TO THE MARKET SURVEILLANCE AND INSPECTION OF
             THE PRODUCTS (2001)
EMRA 1       COMMUNIQUE ON IMPORTS OF SOLVENTS AND CERTAIN PETROLEUM
             PRODUCTS (2006/12)
MARA 1       DIRECTIVE CONCERNING THE METHOD AND PRINCIPLES OF
             REGISTRATION OF PLANT PROTECTION PRODUCTS (1999)

MARA 2       COMMUNIQUE ON USE AND RESTRICTIONS ABOUT PLACING INTO MARKET
             ON PLANT PROTECTION PRODUCTS CONTAINING CERTAIN ACTIVE
             SUBSTANCES (2003)

MARA 3       INSTRUCTIONS FOR THE TOXICOLOGICAL CLASSIFICATION OF PESTICIDES
             (2001)

MARA 4       COMMUNIQUE OF STANDARDIZATION FOR FOREIGN TRADE THE IMPOR-
             TATION OF CERTAIN GOODS WHICH ARE SUBJECT TO THE CONTROL OF
             MINISTRY OF AGRICULTURE AND RURAL AFFAIRS          (2006/5)

MARA 5       BY LAW ON SPECIFIC LABORATORIES WHICH WILL MAKE QUALITY
             CONTROL ANALYSIS IN PLANT PROTECTION PRODUCTS (2002)

MARA 6       LABEL REGULATION FOR PESTICIDES (1983)

MARA 7       PROSPECTUS DIRECTIVE FOR PESTICIDES (2001)

MARA 8       BY LAW ON THE WHOLESALE AND RETAIL MARKETING AND STORAGE OF
             PESTICIDES (1996)

MARA 9       BY LAW ON CONTROL OF PESTICIDES (1995)

MARA 10      COMMUNIQUE ON IMPORT OF FERTILIZERS (2006/16)
MLSS 1       IMPLEMENTING REGULATION ON THE PROTECTION OF THE HEALTH AND
             SAFETY MEASURES FROM THE RISKS (2003)


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MLSS 2       IMPLEMENTING REGULATION FOR THE PROTECTION OF WORKERS FROM
             THE RISKS RELATED TO EXPOSURE TO CARCINOGEN AND MUTAGEN
             SUBSTANCES AT WORK (2003)

MLSS 3       THE IMPLEMENTING REGULATION FOR THE PROTECTION AGAINST RISKS
             OF EXPLOSIVE ATMOSPHERES (2003)


MLSS 4       COMMUNIQUE ON IMPORTS OF SOME PRODUCTS WHICH AFFECT WORK-
             ERS‘ HEALTH AND WORK SECURITY (2006/13)

MLSS 5       IMPLEMENTING REGULATION ON HEALTH AND SAFETY IN ASBESTOS RE-
             LATED WORKS (2003)

MLSS 6       LABOR LAW (2003)

GM 1         CUSTOMS LAW (1999)

GM 2         BY-LAW ON CUSTOMS (2002)

MOH 1        BY-LAW ON MEDICAL DEVICE (2002)

MOH 2        BY-LAW ABOUT CHEMICAL SUBSTANCES WHICH ARE SUBJECT TO CON-
             TROL (2005)

MOH 3        BY-LAW ON MEDICAL PREPARATION (1990)

MOH 4        BY-LAW ON MEDICAL PREPARATION (1935)

MOH 5        COMMUNIQUE OF STANDARDIZATION FOR FOREIGN TRADE ON PRODUCTS
             WHICH ARE SUBJECT TO THE CONTROL OF MINISTRY OF HEALTH (2006/4)

MOH 6        BY-LAW ON COSMETIC (2005)

MOH 7        BY-LAW ON THE GUIDELINES AND TECHNIQUES OF USING BIOCIDALS
             AGAINST VECTORS IN THE FIELD OF PUBLIC HEALTH (2005)

MOH 8        COMMUNIQUE ON DETERJANLARIN BĠLDĠRĠM ESASLARININ
             BELĠRLENMESĠNE DAĠR TEBLĠĞ (2005)

MOH 9        CIRCULAR ON IMPORT AND MANUFACTURING OF INSECTICIDES, RODEN-
             TICIDES, MOLLULICIDES (1983)

MOH 10       COMMUNIQUE ON IMPORTS OF CERTAIN DYERS (2006/15)

MOH 11       BY-LAW ON SPECIFICATIONS FOR FOODSTUFF AND ARTICLES AND SUP-
             PLIES INVOLVING PUBLIC HEALTH (DATED 1952 )

MOH 12       BY-LAW ON AMMENDMENTS TO BY-LAW ON SPECIFICATIONS FOR FOODS-
             TUFF AND ARTICLES AND SUPPLIES INVOLVING PUBLIC HEALTH (2004)

TTPAB 1      LAW ON MONOPOLY OF SPIRITS BEVERAGES WITH SPIRIT
             NO. 4250 (1942)



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TTPAB 2      LAW ON THE AMENDMENTS TO THE LAW NO 4046, DECREE IN FORCE OF
             LAW NO 233 AND THE RESTRUCTURING OF THE DIRECTORATE GENERAL
             FOR TOBACCO, TOBACCO PRODUCTS, SALT AND ALCOHOL FACILITIES

TTPAB 3      BY LAW ON PRINCIPLES AND PROCEDURES ABOUT TOBACCO
             PRODUCTION, MARKETING OF MANUFACTURERS TOBACCO, DOMESTIC
             AND FOREIGN MARKET, INSPECTION AND TOBACCO EXPERT (2002)
TTPAB 4      TOBACCO, TOBACCO PRODUCTS AND ALCOHOLIC BEVERAGES
             REGULATORY AUTHORITY DECISION ON FACILITIES USED FOR
             PROCESSING ETHYL ALCOHOL AND METHYL ALCOHOL CONTAINING
             PRODUCTS, BY-PRODUCTS AND PRODUCTION WASTE FOR ALCOHOL
             RECYCLING (2005)
TTPAB 5      BY-LAW ON THE TECHNICAL CONDITIONS THAT THE ALCOHOL AND AL-
             COHOLIC BEVERAGE FACILITIES MUST BEAR AND ON THE PROCEDURES
             AND PRINCIPLES CONCERNING THEIR FOUNDATION, OPERATION AND
             CONTROL (2002)
TTPAB 6      TOBACCO, TOBACCO PRODUCTS AND ALCOHOLIC BEVERAGES
             REGULATORY AUTHORITY DECISION ON FACILITIES USED FOR
             PROCESSING ETHYL ALCOHOL AND METHYL ALCOHOL IN PURITY FOR
             ANALYSIS PURPOSE (2005)
TTPAB 7      COMMUNIQUÉ ON THE MARKET SUPPLY OF ETHYL ALCOHOL (2004)


TTPAB 8      BY-LAW ON PROCEDURE AND BASIS GOVERNING DOMESTIC AND FOREIGN
             TRADE OF ALCOHOL AND ALCOHOLIC BEVERAGES (2003)

MIA 1        COMMUNIQUE ON IMPORTS OF SOME EXPLOSIVE SUBSTANCES, FIREGUNS,
             KNIVES AND SIMILAR ARTICLES (2006/11)




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                                                                                            LABELLING

67/548 EEC         ÇOB 1              SB 2             SB 6        SB 8         SB 9               SB 11            SB 12     TAPDK      TAPDK 7         TKB 3            TKB 6             TKB 7           TKB 9
                                                                                                                              6
Art. 23            Art. 17, 18 and    Art. 5 No        Should be   No           VIII               Addendum 3       Art. 2:   Describ    Art. 7 de-      Art. 8.1, 9.2,   Art. 3: defines   Art. 3:         Art. 4:
Labelling          19:                danger           checked     specific     Instructions       (1971)           for       es the     scribes sizes   10 , 12 and      ‖label‖.The       defines both    defines
 the name of                         symbols, R       against     requirem      for labelling:    specifies the    labelli   informat   of labelling    13 describes     by-law speci-     ―label for      ―label‖.
   the substance   In compliance      and/or S         Cosmetics   ent for      describes          information to   ng of     ion to     and imple-      the danger       fies details of   small           The
 the name,        except tel no.     phrases          Directive   labelling.   ―label‖ and        be given on      deterg    be         mentation of    symbols to       the labels;       packages‖       Labels
   address, tel
                   of the             defined/specif                            specifies the      the labels,      ents,     placed     labelling.      be used for      however,          and             are
   no. of the
   manufacturer,   manufacturer/      ied                                       information to     however does     refers    on the     Annex IV        labelling.       danger sym-       ―prospectus     subject
   the importer    importer/distrib                                             be given on        not specify      to the    labels,    defines         Art. 14          bols, R and S     ‖. Refers to    to
   or the          utor, as well as                                             the labels.        the color,       comm      however    danger          specifies the    phrases are       Labelling       control
   distributor     the EEC                                                      However,           size, place      uniqué    does not   symbols, R      color of         not in com-       By-law, and     accordin
 danger           number;                                                      does not           etc. of the      publis    give any   and s Phras-    labels           pliance. Since    Classificatio   g to Art.
   symbols         however                                                      specify size       label.           hed by    specific   es. Labels      according to     classification    n By-law.       6 the By-
   printed in
   black on an     wording is not                                               of the label                        the       ation.     are subject     the type of      is different,     Both ―label     law on
   orange-yellow   as clear as in                                               and danger                          MoH.                 to endorse-     preparation.     danger sym-       for small       Control
   background      the Directive                                                symbols                             Refers               ment by                          bols are dif-     packages‖       of Plant
   (Annex II).     (Danger                                                      other than                          the lab              TAPDK.                           ferent and        and             Protectio
 standard R-      symbols:                                                     toxicity;                                                Refers to                        there is no       ―prospectus     n
   phrases (An-    Annex IV;                                                    leaves color                                             Dangerous                        standard.         es‖ are         Products
   nex III)
                   R and S                                                      of the label                                             Substances                       MARA re-          subject to
 standard S-
                   phrases: Annex                                               to the notifier.                                         By-law.                          quires en-        endorsement
   phrases (An-
   nex IV)         VII,                                                         Instructions                                             Needs trans-                     dorsement of      by MARA.
 the EEC          Carcinogenic                                                 require                                                  position of                      labels. Art. 11   Needs
   number          substances:                                                  endorsement                                              67/548/EEC                       defines some      transpositio
   obtained from   Annex VI)                                                    of the label                                                                              risk phrases,     n of
   the EINECS      +an additional                                               by the MoH.                                                                               Art. 12 de-       67/548/EEC
125 ml.            provision on                                                 Transposition                                                                             fines some        and
Limitation for     banning of                                                   of                                                                                        safety phras-     99/45/EEC
irritant, highly   dangerous                                                    67/548/EEC                                                                                es. Needs
flammable,         substances to                                                is needed.                                                                                transposition
flammable and      water referring                                                                                                                                        of
oxidizing          Water Pollution                                                                                                                                        67/548/EEC
substances         Control By-law                                                                                                                                         and
                   04/09/1988                                                                                                                                             99/45/EEC.
                   (should be                                                                                                                                             Art. 14 de-

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                    amended as                                  scribes im-
                    31/12/2004).                                plementation
                    250 ml                                      of labelling.
                    limitation for
                    highly
                    flammable and
                    oxidizing
                    substances is
                    not in
                    compliance
                    with the
                    Directive.
Article 24          Art. 20: in full                            Art. 14 and 15
Implementation      compliance                                  describes the
of labelling        Art. 39:                                    size, format,
requirements        Labeling                                    position of the
Describes size,     requirements                                labels.
language,           for asbestos
position, spacing
of labels (Annex
VI)




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                                                                                  PACKAGING

67/548/EC                                                  ÇOB 1             TKB 6            TKB 7                     TKB 8              SB 2                  SB 6
Article 22                                                 Art. 24, 26, 27   Art. 3 defines   Art. 3 defines "small     needs              Art. 5 No danger      Art. 10 does not
                                                           and Annex V       "packaging"      packaging" and limits     transposition of   symbols, R and/or S   specify the
Packaging                                                  24 Obligation                      it with 100 g for solid   67/548/EEC and     phrases               packaging but only
                                                           for Packaging                      content and 250 ml        99/45/EEC          defined/specified     the information to be
1.Dangerous substances cannot be placed on the market
unless their packaging satisfies the following             26 General                         with liquid content.                                               placed on the
requirements:                                              Appearance of                                                                                         packages.
                                                           the Containers
(a) it shall be so designed and constructed that its       27 Packaging
contents cannot escape;                                    Conditions
(b) the materials constituting the packaging and
fastenings must not be susceptible to adverse attack by
the contents, or liable to form dangerous compounds
with the contents;
(c) packaging and fastenings must be strong and solid
throughout to ensure that they will not loosen and will
safely meet the normal stresses and strains of handling;
(d) containers fitted with replaceable fastening devices
shall be so designed that the packaging can be
refastened repeatedly without the contents escaping;
(e) every container of whatever capacity, containing
substances sold or made available to the general public
and labelled "very toxic", "toxic" or "corrosive", as
defined in this Directive, must have a child-resistant
fastening and a tactile warning of danger;
(f) every container, of whatever capacity, containing
substances sold or made available to the general public
and labelled "harmful", "extremely flammable" or
"highly flammable" as defined in this Directive must
bear a tactile warning of danger.
2. Member States may also prescribe that packaging
shall be closed initially with a seal in such a way that
when the packaging is opened for the first time the seal
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is irreparably damaged.
3. The categories of substances for which the packaging
must be equipped with the devices mentioned in
paragraph 1 (e) and (f) shall be modified in accordance
with the procedure provided for in Article 29.

4. The technical specifications relating to the devices
referred to in paragraph 1 (e) and (f) shall be modified in
accordance with the procedure provided for in Article 29
(4) (a) and are to be found in points A and B of Annex IX
to this Directive.




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                                                                                       NOTIFICATION

67/548/EEC          ÇOB 1                ÇOB 5               ÇOB 6              SB 6                      SB 8               SB 12          ÇSGB 2         ÇSGB 5         TAPDK 5
Article 7:          Art. 8 & Art. 9:      Art. 7: Liabili-   Art. 12 obliges    Art. 14: Requires noti-   Art. 4 requires    Art. 2:        Requires       Requires       Requires only
                    Liability of          ties of the im-    enterprises and    fication by the manu-     notification to    requires       availability   notification   quarterly noti-
Full notification   manufacturer         porters regard-     institutions to    facturer/importer, who    the Provincial                                                  fication of raw
                                                                                                                             notification   of informa-    of the
The manufac-        and importer            ing control      give required      places a cosmetic         Directorate of                                                  materials,
                                            documents,                                                                       of deter-      tion regard-   workplace
turer/ notifier     regarding sub-                           information        product on the market     the MoH or                                                      products, by-
                    mitting informa-       registration      whenever re-                                 directly to the    gents          ing the use    to the         products, waste
should submit:                                                                  (Annex IX).
                    tion and notifica-     and notifica-     quested by the                               MoH (Annex I)      which are      of carcino-    MLSS.          materials, etc.
- - a technical
                    tion:                       tion         MoEF. Art 13                                 once at the        placed for     genic and                     Art. 5: Estab-
  dossier with                                                                  Art. 15 require another
                                         The importers       requires having                              beginning. If      the first      mutagenic                     lishing an alco-
  information                                                                   form (Annex X) to be
  on risks to       Manufacturer         of ozone deplet-    dangerous                                    there is any                                                    hol and alco-
                                                                                submitted to the R. S.                       time in the    substances,
  man and envi-     and importer are     ing substances      chemicals                                    change in the                                                   holic beverages
                                                                                Hygiene Institute-                           market.        their
  ronment and       subject to submit    are required to     liability insur-                             information,                                                    facility is sub-
                                         receive customs                        Toxicology Consultation                                     amounts as
  at least infor-   information and                          ance before                                  then notifiers                                                  ject to getting a
                                         checking docu-                         Centre for emergency                                        well as
  mation re-        notification upon                        commencement                                 have to submit                                                  "Permit to
                                         ments from the                         cases.                                                      processes,
  quired in An-     request of the                           of any opera-                                Producer                                                        Establish a
  nex VII A ,       MoEF. Mini-          Undersecreteriat    tion; otherwise                              Amendment                         their risks                   Facility (Art.
  together with     mum informa-         for Foreign         enterprises                                  Form (Annex                       and safety                    17)" and "Pro-
  a detailed and    tion required to     Trade. The          cannot get                                   II).                              measures                      duction Permit
  full descrip-     be submitted in      importers are       permit.                                                                                                      (Art. 18)"
                                                                                                                                            taken in the
  tion of the       the technical        required to                                                                                                                      from TAPDK.
                                                                                                          Art. 5 requires                   workplaces
  studies con-      dossier is speci-    submit informa-                                                                                                                  Project renova-
  ducted and of                                                                                           notification of                   upon re-
                    fied in Annex        tion about their                                                                                                                 tion permission
  the methods                            imports of the                                                   the importers                     quest by the
                    III. (Annex III is                                                                                                                                    (Art. 19) and
  used                                   previous year to                                                 to the Provin-                    MLSS.
                    not in com-                                                                                                                                           Transfer permit
- a declaration                          the MoEF. They                                                   cial Directorate
  concerning        pliance with the                                                                                                                                      (Art. 20)
                    Annex VII of         have to register                                                 of the MoH in                                                   should be re-
  the unfavour-                          the name and
                    67/548/EC).                                                                           the province                                                    ceived from
  able effects of                        origin of the
  the substance                                                                                           where the                                                       TAPDK in case
                                         substance, name                                                                                                                  of changing the
- the proposed                                                                                            product enters
                                         and address of                                                                                                                   product/process
  classification                                                                                          customs or
                                         the user, and the                                                                                                                line or transfer-
  and labelling                                                                                           directly to the
                                         purpose of use.                                                                                                                  ring the plant
  of the sub-                                                                                             MoH referring
  stance                                                                                                                                                                  to any other
- a proposal for                                                                                          to the Commu-                                                   person/entity
                                                                                                          niqué on Stan-
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  a safety data                                                 dardization for
  sheet                                                         Foreign Trade.
- a statement
  from the
  manufacturer
  that he is des-
  ignated as the
  manufactur-
  er's sole rep-
  resentative
- a statement by
  the notifier
  requesting,
  that the notifi-
  cation be ex-
  empted from
  the provisions
  of Article 15
  (2)
The notifier may
also provide the
authority with a
preliminary
assessment of
the risks

Any notifier of a
substance al-
ready notified
shall inform the
competent au-
thority:

- when the
  quantity of the
  substance
  placed on the
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  market reach-
  es 10 tonnes
  per year per
  manufacturer
  or when the
  total quantity
  placed on the
  market reach-
  es 50 tonnes
  per manufac-
  turer, the
  competent au-
  thority may
  require addi-
  tional tests
  (Annex VIII
  Level 1);
- - when the
  quantity of the
  substance
  placed on the
  market reach-
  es 100 tonnes
  per year per
  manufacturer
  or when the
  total quantity
  placed on the
  market reach-
  es 500 tonnes
  per manufac-
  turer , the
  competent au-
  thority shall
  require (An-
  nex VIII Lev-
  el 1);
- when then
  quantity of a
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  substance
  placed on the
  market reach-
  es 1 000
  tonnes per
  year per man-
  ufacturer or
  when the total
  quantity
  placed on the
  market reach-
  es 5 000
  tonnes per
  manufacturer
  ((Annex VIII
  Level 2);

Article 8          Art. 9 Liabilities
Reduced            regarding sub-
notification       mission of addi-
requirements       tional informa-
for sub-           tion:
stances            Detailed and full
placed on the      description of
market in          the studies con-
quantities of      ducted and of the
less than one      methods used;
tonne per          the proposed
annum per          classification
manufacturer:      and labelling of
Any notifier       the substance; a
intending to       proposal for a
place a sub-       safety data sheet,
stance on the      proofs/references
Community          of the informa-
market in quan-    tion submitted
tities of less     are required if
than one tonne     the Ministry
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Technical Assistance in the field of Chemicals          TeACH

per annum per        deems necessary.
manufacturer         There is no dis-
shall be required    tinction for the
to submit            amount of sub-
- - a technical      tance put into the
   dossier with      market.
   information
   on risks to
   man and envi-
   ronment and
   at least infor-
   mation re-
   quired in An-
   nex VII B ,
   together with
   a detailed and
   full descrip-
   tion of the
   studies con-
   ducted and of
   the methods
   used
- all other
   infoırmation
   required in
   Art. 7
When the quan-
tities to be
placed on the
market are be-
low 100 kg per
year per manu-
facturer the
notifier may,
restrict the in-
formation to that
provided for in
Annex VII C.

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Technical Assistance in the field of Chemicals          TeACH

Before the quan-
tity of the sub-
stance placed
on the market
reaches 100 kg
per year per
manufacturer or
before the total
quantity placed
on the market
reaches 500 kg
per manufactur-
er, the notifier
will provide the
competent au-
thority with the
additional in-
formation to the
level of Annex
VII. B.
Before the quan-
tity of the sub-
stance placed on
the market
reaches 1 tonne
per year per
manufacturer, or
before the total
quantity placed
on the market
reaches 5 tonnes
per manufactur-
er, submit a full
notification
according to the
requirements of
Article 7.

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Technical Assistance in the field of Chemicals          TeACH

Article 9
Substances
already notified
(10-year rule):
A notifier need
not supply the
information
required under
Articles 7 and 8
for the technical
dossiers in An-
nexes VII. A,
VII. B, VII. C
and VII. D with
the exception of
items 1 and 2
thereof, if the
data were origi-
nally submitted
at least 10 years
previously.
Article 10 Plac-
ing of notified
substances on
the market:
Substances
notified under
Article 7 may,
be placed on the
market no soon-
er than 60 days
after receipt by
the authority of
a dossier.
Substances
notified under
Article 8 may,
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

be placed on the
market no soon-
er than 30 days
after receipt by
the authority of
a dossier.
If the notifier
has received that
the dossier has
been accepted,
the substance
may be placed
on the market
no sooner than
15 days after
receipt of the
dossier by the
competent au-
thority.
Article 11
   Substances
 manufactured
   outside the
  Community:
Where, for sub-
stances manu-
factured outside
the Community,
more than one
notification
exists for a
substance manu-
factured by the
same manufac-
turer, the cumu-
lative yearly
tonnages placed
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

on the Commu-
nity market shall
be determined
by the Commis-
sion and the
national authori-
ties on the basis
of the informa-
tion submitted.
The obligation
to carry out
supplementary
testing in accor-
dance with Ar-
ticle 7 (2) will
fall collectively
on all notifiers.




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Technical Assistance in the field of Chemicals                          TeACH

                                                                                       LICENCE

67/548/EC                        TKB 1                TKB 2                  TKB 4                         TKB 6               TKB 8                  TKB 10
Article 7:                       Licensing requires   Prohibits some         The chemicals listed in the   defines "licence"    Wholesale and         Importing of the
                                 most of the data     chemicals to be used   Communiqé are subject to                          retail marketing and   substances listed in
Full notification The manu-
                                 and information in   as plant protection    getting "customs check doc-                       storage of pesti-      the Communique
facturer/ notifier should
                                 compliance with      products. It is sup-   ument" from MARA.                                 cides are subject to   are subject to get-
submit:
                                 the 67/548/EEC       posed to be in com-                                                      getting permit from    ting concent from
- - a technical dossier with
                                 and even more        pliance with the                                                         MARA.                  MARA.
  information on risks to
                                 than that regard-    76/769/EEC
  man and environment and
  at least information re-       less of the amount
  quired in Annex VII A ,        placed on the
  together with a detailed       market. Limits the
  and full description of the    origin of the ac-
  studies conducted and of       tive ingredient
  the methods used               with EU, G7
- a declaration concerning       countries and top
  the unfavourable effects       3 producers.
  of the substance
- the proposed classifica-
  tion and labelling of the
  substance
- a proposal for a safety
  data sheet
- a statement from the
  manufacturer that he is
  designated as the manu-
  facturer's sole representa-
  tive
- a statement by the notifier
  requesting, that the notifi-
  cation be exempted from
  the provisions of Article
  15 (2)
The notifier may also pro-
vide the authority with a
preliminary assessment of

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

the risks

Any notifier of a substance
already notified shall inform
the competent authority:

- when the quantity of the
  substance placed on the
  market reaches 10 tonnes
  per year per manufacturer
  or when the total quantity
  placed on the market
  reaches 50 tonnes per
  manufacturer, the compe-
  tent authority may require
  additional tests (Annex
  VIII Level 1);
- - when the quantity of the
  substance placed on the
  market reaches 100
  tonnes per year per manu-
  facturer or when the total
  quantity placed on the
  market reaches 500
  tonnes per manufacturer ,
  the competent authority
  shall require (Annex VIII
  Level 1);
- when then quantity of a
  substance placed on the
  market reaches 1 000
  tonnes per year per manu-
  facturer or when the total
  quantity placed on the
  market reaches 5 000
  tonnes per manufacturer
  ((Annex VIII Level 2);


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Article 8 Reduced notifi-
cation requirements for
substances placed on the
market in quantities of
less than one tonne per
annum per manufacturer:
Any notifier intending to
place a substance on the
Community market in quan-
tities of less than one tonne
per annum per manufacturer
shall be required to submit
- - a technical dossier with
   information on risks to
   man and environment and
   at least information re-
   quired in Annex VII B ,
   together with a detailed
   and full description of the
   studies conducted and of
   the methods used
- all other infoırmation
   required in Art. 7
When the quantities to be
placed on the market are
below 100 kg per year per
manufacturer the notifier
may, restrict the informa-
tion to that provided for in
Annex VII C.
Before the quantity of the
substance placed on the
market reaches 100 kg per
year per manufacturer or
before the total quantity
placed on the market reach-
es 500 kg per manufacturer,

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

the notifier will provide the
competent authority with
the additional information
to the level of Annex VII.
B.
Before the quantity of the
substance placed on the
market reaches 1 tonne per
year per manufacturer, or
before the total quantity
placed on the market reach-
es 5 tonnes per manufactur-
er, submit a full notification
according to the require-
ments of Article 7.
Article 9

Substances already notified
(10-year rule):
A notifier need not supply
the information required
under Articles 7 and 8 for
the technical dossiers in
Annexes VII. A, VII. B,
VII. C and VII. D with the
exception of items 1 and 2
thereof, if the data were
originally submitted at least
10 years previously.
Article 10 Placing of noti-
fied substances on the mar-
ket:
Substances notified under
Article 7 may, be placed on
the market no sooner than
60 days after receipt by the
authority of a dossier.
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

Substances notified under
Article 8 may, be placed on
the market no sooner than
30 days after receipt by the
authority of a dossier.
If the notifier has received
that the dossier has been
accepted, the substance may
be placed on the market no
sooner than 15 days after
receipt of the dossier by the
competent authority.
Article 11Substances manu-
factured outside the Com-
munity:

Where, for substances man-
ufactured outside the Com-
munity, more than one
notification exists for a
substance manufactured by
the same manufacturer, the
cumulative yearly tonnages
placed on the Community
market shall be determined
by the Commission and the
national authorities on the
basis of the information
submitted. The obligation to
carry out supplementary
testing in accordance with
Article 7 (2) will fall collec-
tively on all notifiers.




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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals                           TeACH

                                                                                      REGISTRATION

67/548/        TAPDK       TAPDK       TAP       SB2        SB 5      SB 7            SB 9             SB 11                ÇSGB 1                  ÇSGB 3        ÇSGB 4        EPDK 1
EEC            1           4           DK 8
Article        Art. 3:     Alcohol     For-      Import-    Re-       Commercial      Requires li-     Addendum Art. I      Art. 11 Bans: re-       Requires      Importing     The sub-
7:             Those       recovery    eign      ing,       quires    use of insec-   censing by the   (1971): Import-      quires getting permit   work permit   of sub-       stances
               who         installa-   and       export-    permis-   ticides, ro-    MoH regard-      ing, manufactur-     for the use of chemi-   by the        stances       listed in
Full noti-
               wish to     tions are   do-       ing,       sion of   denti-          less of the      ing of subtances     cals listed in Annex    MLSS.         (solvents,    the Com-
fication
               import      subject     mes-      carry-     MoH       cides,molluss   amount of the    and preparations     III.                                  asbestos      muniqué
The man-
               industri-   to get-     tic       ing out    for       icides and      substance/       to be used as                                              (other        with a
ufacturer/
               al raw      ting        trad-     cus-       import-   alike is sub-   preparation.     insecticides, ro-                                          than white    packed
notifier
               ethyl       permit      ing of    toms       ing       ject to per-    However, it is   denticides and                                             asbestos) )   weight of
should
               alcohol     from        alco-     proce-     psyco-    mission by      not in the       mollusicides are                                           are sub-      more than
submit:
               pro-        TAPDK.      hol       dures,     tropes.   the MoH.        power of         subject to permit                                          ject to       25 kg or
- -a
               duced                   and       intro-                               law/by-law.      by the MoH.                                                permis-       25 lt are
   technic-
   al dos-     from                    alco-     ducing                                                Applicants for                                             sion of       subject to
   sier        ethylene                holic     into the                                              permit should                                              MLSS.         permis-
   with in-    for use                 beve-     free                                                  give all the in-                                                         sion by
   forma-      in indus-               rages     trade                                                 formation on                                                             EMRA.
   tion on     tries                   are       zone of                                               characteristics
   risks to    other                   sub-      the                                                   and methods of
   man and     than                    ject to   psyco-                                                analysis to the
   envi-       food, are               is-       tropes                                                Ministry upon
   ronment     obliged                 suanc     and                                                   request. These are
   and at      to ac-                  e of      pre-                                                  not specified.
   least in-   quire a                 "Cer-     cursers                                               Addendum Art.2
   forma-      permit                  tifi-     are                                                   (1971) requires
   tion re-    from                    cate      subject                                               getting permit
   quired      Tekel                   of        to                                                    from the MoH for
   in An-      Directo-                Con-      permis-                                               the wholesale of
   nex VII     rate                    for-      sion by                                               insecticides, ro-
   A , to-     General                 mity      the                                                   denticides and
   gether      Art. 4:                 with      MoH.                                                  mollusicides; and
   with a      Produc-                 Im-                                                             getting permit
   detailed    ing me-                 ports"                                                          from the Gover-
   and full
               thyl                    and                                                             norates for retail
   descrip-
Page 209

Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

    tion of     alcohol       is-                               sales.
    the stu-    is sub-       suanc
    dies        ject to       e of
    con-        acquire a     "Dis-
    ducted      permit        tribu-
    and of      from the      tion
    the me-     Mono-         Au-
    thods       poly          thori-
    used        Admin-        sa-
-   a decla-
                istra-        tion"
    ration
                tion.Art.     by
    con-
                19:           TAP
    cerning
    the un-     Those         DK.
    favour-     who
    able ef-    wish to
    fects of    sell any
    the sub-    kind of
    stance      beverag-
-    the        es with
    pro-        spirit
    posed       includ-
    classifi-   ing spi-
    cation      rits, beer
    and la-     wine
    belling     must
    of the      acquire a
    sub-        license
    stance      from the
-   a pro-      Mono-
    posal       poly
    for a       Admin-
    safety      istration.
    data
    sheet
-   a state-
    ment
    from the
    manu-
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

   facturer
   that he
   is des-
   ignated
   as the
   manu-
   factur-
   er's sole
   repre-
   senta-
   tive
- a state-
   ment by
   the no-
   tifier
   request-
   ing, that
   the noti-
   fication
   be ex-
   empted
   from the
   provi-
   sions of
   Article
   15 (2)
The noti-
fier may
also pro-
vide the
authority
with a
prelimi-
nary as-
sessment
of the


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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

risks

Any noti-
fier of a
substance
already
notified
shall in-
form the
competent
authority:

- when
  the
  quantity
  of the
  sub-
  stance
  placed
  on the
  market
  reaches
  10
  tonnes
  per year
  per
  manu-
  facturer
  or when
  the total
  quantity
  placed
  on the
  market
  reaches
  50
  tonnes
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

  per
  manu-
  facturer,
  the
  compe-
  tent au-
  thority
  may re-
  quire
  addi-
  tional
  tests
  (Annex
  VIII
  Level
  1);
- - when
  the
  quantity
  of the
  sub-
  stance
  placed
  on the
  market
  reaches
  100
  tonnes
  per year
  per
  manu-
  facturer
  or when
  the total
  quantity
  placed
  on the
  market
  reaches
Page 213

Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

  500
  tonnes
  per
  manu-
  facturer
  , the
  compe-
  tent au-
  thority
  shall re-
  quire
  (Annex
  VIII
  Level
  1);
- when
  then
  quantity
  of a
  sub-
  stance
  placed
  on the
  market
  reaches
  1 000
  tonnes
  per year
  per
  manu-
  facturer
  or when
  the total
  quantity
  placed
  on the
  market
  reaches
  5 000
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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

   tonnes
   per
   manu-
   facturer
   ((Annex
   VIII
   Level
   2);

Article
8 Re-
duced
notifi-
cation
require-
ments
for
sub-
stances
placed
on the
market
in
quanti-
ties of
less
than
one
tonne
per
annum
per
manu-
factur-
er:

Any no-
tifier in-

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

tending to
place a
substance
on the
Commu-
nity mar-
ket in
quantities
of less
than one
tonne per
annum per
manufac-
turer shall
be re-
quired to
submit
- -a
  technic-
  al dos-
  sier
  with in-
  forma-
  tion on
  risks to
  man and
  envi-
  ronment
  and at
  least in-
  forma-
  tion re-
  quired
  in An-
  nex VII
  B , to-
  gether
  with a

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

   detailed
   and full
   descrip-
   tion of
   the stu-
   dies
   con-
   ducted
   and of
   the me-
   thods
   used
- all
   other
   infoırm
   ation
   required
   in Art. 7
When the
quantities
to be
placed on
the market
are below
100 kg per
year per
manufac-
turer the
notifier
may,
restrict the
informa-
tion to
that pro-
vided for
in Annex
VII C.
Before the

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

quantity
of the
substance
placed on
the market
reaches
100 kg per
year per
manufac-
turer or
before the
total quan-
tity placed
on the
market
reaches
500 kg per
manufac-
turer, the
notifier
will pro-
vide the
competent
authority
with the
additional
informa-
tion to the
level of
Annex
VII. B.
Before the
quantity
of the
substance
placed on
the market

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

reaches 1
tonne per
year per
manufac-
turer, or
before the
total quan-
tity placed
on the
market
reaches 5
tonnes per
manufac-
turer,
submit a
full notifi-
cation
according
to the
require-
ments of
Article 7.
Article 9

Sub-
stances
already
notified
(10-year
rule):
A notifier
need not
supply the
informa-
tion re-
quired
under

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

Articles 7
and 8 for
the tech-
nical dos-
siers in
Annexes
VII. A,
VII. B,
VII. C and
VII. D
with the
exception
of items 1
and 2
thereof, if
the data
were orig-
inally
submitted
at least 10
years
previous-
ly.
Article 10
Placing of
notified
substances
on the
market:
Sub-
stances
notified
under
Article 7
may, be
placed on
the market

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

no sooner
than 60
days after
receipt by
the au-
thority of
a dossier.
Sub-
stances
notified
under
Article 8
may, be
placed on
the market
no sooner
than 30
days after
receipt by
the au-
thority of
a dossier.
If the
notifier
has re-
ceived
that the
dossier
has been
accepted,
the sub-
stance
may be
placed on
the market
no sooner
than 15

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

days after
receipt of
the dossier
by the
competent
authority.
Article 11
Sub-
stances
manufac-
tured
outside
the Com-
munity:

Where,
for sub-
stances
manufac-
tured
outside
the Com-
munity,
more than
one notifi-
cation
exists for
a sub-
stance
manufac-
tured by
the same
manufac-
turer, the
cumula-
tive yearly

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Institutional and Legal Framework for Chemicals Management
Technical Assistance in the field of Chemicals          TeACH

tonnages
placed on
the Com-
munity
market
shall be
deter-
mined by
the Com-
mission
and the
national
authorities
on the
basis of
the infor-
mation
submitted.
The obli-
gation to
carry out
supple-
mentary
testing in
accor-
dance
with Ar-
ticle 7 (2)
will fall
collective-
ly on all
notifiers.




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                                                                                   SAFETY DATA SHEET

67/548/EEC                                                                                                              ÇOB 4                        ÇSGB 1
  Article 27 Safety data sheet                                                                                          Art. 4 defines SDS and       Art. 6 requires availability of safety
                                                                                                                        Art. 22 is in full com-      data sheet provided by the supplier,
  1. To enable professional users in particular to take the necessary measures as regards the protection of the         pliance with the Directive   manufacturer or importer
  environment and health and safety at the workplace, at, or if appropriate, before the first delivery of a dangerous
  substance, any manufacturer, importer or distributor shall communicate to the recipient a safety data sheet. This
  sheet must contain the information necessary for protection of man and the environment.
  It may be communicated on paper or electronically. Subsequently, the manufacturer, importer or distributor shall
  forward to the recipient of the safety data sheet any new relevant information on the substance which has become
  known to him.
  2. General rules for the elaboration, distribution, contents and format of the safety data sheet referred to in
  paragraph 1 will be established in accordance with the procedure laid down in Article 29 (4) (a).




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                                                                            CONFIDENTIALITY OF DATA

67/548/EC                                                           ÇOB 1                                ÇOB 5                        TKB 1                      SB 6
Article 19 Confidentiality of data:                                 Annex III secures the                Art. 7: Liabilities of the   Art. 10 Confidentiality:   Art. 15:
                                                                    confidentiality of the information   importers regarding          ensures the
1. If he considers that there is a confidentiality problem, the     submitted by the notifier by         control documents,           confidentiality of the     Secures confidentiality of
notifier may therefore wishes to be kept secret from all persons    omitting the confidential            registration and notifi-     information submitted to   data and information and
other than the competent authorities and the Commission. Full       information from the notification;   cation                       MARA                       to be used only for taking
justification must be given in such cases.                          therefore not in conformity with                                                             necessary action in case of
                                                                    67/548/EEC.                          Secures confidentiality                                 emergency.
With respect to the notifications and information submitted                                              of the submitted data
industrial and commercial secrecy shall not apply to:                                                    and information.

(a) the trade name of the substance;

(b) the name of the manufacturer and the notifier;

(c) physico-chemical data concerning the

(d) the possible ways of rendering the substance harmless;

(e) the summary results of the toxicological and ecotoxicologi-
cal tests;

(f) the degree of purity of the substance and the identity of
impurities and/or additives which are known to be dangerous;

(g) the recommended methods and precautions referred to in
Annex VII, and the emergency measures referred to in Annex
VII;

(h) the information contained in the safety data sheet;

(i) in the case of substances in Annex I, analytical methods that
make it possible to detect a dangerous substance when dis-
charged into the environment as well as to determine the direct
exposure of humans.

2. Information accepted as being confidential by the authority
receiving the notification dossier from the notifier shall be
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treated as being confidential by the other competent authorities
and the Commission.

3. For substances appearing in the list provided for in Article
21 (1) and which are not classified as dangerous within the
meaning of this Directive, the name may be included in the
form of its trade name in those cases where the competent
authority to which the notification has been submitted so re-
quests. Normally, such substances may be included in the list
in the form of their trade name for a maximum of three years.
However, if the competent authority to which the dossier was
submitted considers that the publication of the chemical name
in the IUPAC nomenclature itself could reveal information
concerning commercial exploitation or manufacture, the name
of the substance may be recorded under its trade name alone
for as long as that competent authority sees fit.

Dangerous substances may, at the request of the competent
authority receiving the notification, be entered on the list in the
form of their trade names alone until such time as they are
introduced into Annex I.

4. Confidential information brought to the attention either of
the Commission or of a Member State shall be kept secret.




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Institutional and Legal Framework for Chemicals Management
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                                                                              INSPECTION

   ÇOB 1        ÇOB 5       ÇOB 6            DTM 2            TKB 8          TKB 9          ÇSGB 6           SB 1        SB 7            GM 1          GM 2        TAPDK 5

Art. 31, 32,   GAP      Art. 12 Autho-     Art. 3 de-      Art. 20        Defines         Art. 91, 92,    Annex VI   Art. 26 gives    Art. 3 de-    Art. 3 de-    Art. 22
33, 34                  rises MoEF for     fines market    defines        rules and       93 authoris-               way and          fines "cus-   fines "cus-   defines both
                        inspection,        survillance     inspectors     procedures      es the in-                 defines in-      toms con-     toms con-     planned
                        informing and      and inspec-     authorised     for inspec-     spectors of                spection of      trol"         trol"         inspections
                        notification as    tion: Art. 10   by MARA        tion of prep-   the MLSS                   the                                          and inspec-
                        well as com-       authorises      for inspec-    arations,       for inspec-                workplaces,                                  tion upon
                        pliance checks.    the relevant    tion of        labels, pro-    tion and Art.              which are                                    claim.
                        If necessary       institutions    wholesale      duction,        95 authoris-               authorised
                        MoEF may           for market      distributors   market,         es other                   for applica-
                        transfer this      surveillance    and retail     plant, and      government                 tion of insec-
                        authorisation to   and inspec-     sub-           complains.      institutions               ticides, ro-
                        mayors, Under-     tion.           distributors                   for inspec-                denticid
                        secreteriat for                    authorised                     tion                       and mollusi-
                        Maritime,                          by the Min-                                               cides.
                        Command of                         istry.
                        Coast Guard,
                        and other perti-
                        nent institu-
                        tions.




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     Technical Assistance in the field of Chemicals                               TeACH

                                                                                              ENFORCEMENT

ÇOB 1           ÇOB 2                 ÇOB 6              DTM 2              ÇSGB 6         SB 6             SB 7            SB 8        GM 1      GM 2        TAPDK 1           TAPDK       TAPDK       TAPDK       TKB 1
                                                                                                                                                                                2           5           6
Art 47 refers   Art. 21 refers to     The dangerous      Art. 12 defines    Art. 105       Article 18       Art. 6 refers   Art. 29     Art.      Art. 721    Defines penal-    Art. 8      Art. 24     Art 33      Art 31
to Environ-     The Environment       chemicals and      fines to be        defines the    defines penal-   to the Regu-    refers to   231       and 722     ties from fines   defines     defines     defines     lists, in
ment Law.       Law and the Deci-     chemical prod-     executed in case   fines to be    ties from        lation and      Turkish     defines   refers to   to imprison-      sanctions   sanctions   sanctions   which
                sion on Technical     ucts, which are    of non-            executed in    banning of       Law on          Penal       fines.    Customs     ment.                                                 cases the
                Regulations and       not in com-        compliance.3       case of non-   some produts     Protection      Code                  Law.                                                              licences
                Standardisation       pliance with the   defines market     compliance.    to collection    of Consum-                                                                                              issued are
                scheme. In case of    legislation, are   survillance and                   and annihila-    ers (No.                                                                                                cancelled.
                non-compliance,       collected and      inspection: Art.                  tion of them.    4077)
                customs control       annihilated by     10 authorises                     Art. 19 refers
                documents are         the MoEF at        the relevant                      to Cosmetics
                cancelled and         expense of the     institutions for                  Law (5324),
                never issued again.   owner of these     market surveil-                   Law No. 4703
                                      substances and     lance and in-                     and Turkish
                                      preparations.      spection.                         Penal Code.




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                                                                            DATA COLLECTION

ÇOB 1                     ÇOB 5                  SB 1                       SB 2                        SB 7                      TAPDK 3                    TAPDK 5
Art. 8 requires submis-   Requires reporting     Art. 16 defines the data   Art. 6 Requires monthly     Art. 7 requires MoH       Art. 16: Wholesalers,      Art. 23 requires only
sion of data and infor-   about information on   collection and database    reporting of the state of   keep files of the         distributors, and subdi-   quarterly reporting of
mation regarding pro-     the previous year.     for medical devices.       consumption and stocks      workplaces, which         stributors, who received   raw materials, products,
duction and importing                                                       of the imported psyco-      received permit for       permit from TAPDK          by-products, waste
in the previous year                                                        tropes to the MoH.          applying insecticides,    are publicised regularly   materials, etc.
upon request by the                                                                                     rodenticides and mollu-   on the website.
MoEF.                                                                                                   sicised.




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Appendix II: Chemicals Governed by Different
            Institutes and by Different Legisla-
            tion

List of legislation codes used in the table below:

MoH 5          Communiqué of Standardization for Foreign Trade on products which are subject to the
               control of Ministry of Health (2006/4)

MoEF 2         Communiqué of Standardization for Foreign Trade on chemicals which are subject to the
               control for protection of environment (2006/6)

MoEF 3         Communiqué on imports of ozone depleting substances (2006/14)

MARA 4         Communiqué of Standardization for Foreign Trade on products which are subject to the
               control of Ministry of Agriculture and Rural Affairs (2006/5)

EMRA 1         Communiqué on imports of solvents and certain petroleum products (2006/12)

MLSS 4         Communiqué on imports of some products which affect workers‘ health and work secu-
               rity (2006/13)

UFT 1          Communiqué on imports of substances listed in the annexes to the Convention on the
               Control         of             Chemical              Weapons             (2006/17)




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CHEMICALS GOVERNED BY DIFFERENT INSTITUTES AND BY DIFFERENT LEGISLATION

MoH 5 Communique of Standardization for Foreign Trade on products which are subject to the control of Ministry of Health (2006/4)

MoEF 2 Communique of Standardization for Foreign Trade on chemicals which are subject to the control for protection of environment (2006/6)

MoEF 3 Communique on imports of ozone depleting substances (2006/14)

MARA 4 Communique of Standardization for Foreign Trade on products which are subject to the control of Ministry of Agriculture and Rural Affairs (2006/5)

EMRA 1 Communique on imports of solvents and certain petroleum products (2006/12)

MLSS 4 Communique on imports of some products which affect workers‘ health and work security (2006/13)

UFT 1 Communique on imports of substances listed in the annexes to the Convention on the Control of Chemical Weapons (2006/17)



1
    1: ONLY FOR FEEDSTUFF INDUSTRY
2
    2: ONLY USED IN FOOD INDUSTRY AND/OR CONTACT WITH FOOD
3
3: DRUG RAW MATERIALS AND EXCIPIENT MATERIALS PRESENT IN THE COMPOSITION OF VETERINARY PRODUCTS AND VETERINARY PROD-
UCTS
4
 : DRUG RAW MATERIALS AND INITIAL MATERIALS PRESENT IN THE COMPOSITION OF PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL
PRODUCTS




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G.T.İ.P.           Chemical Name                                                                     MoEF     MARA      MoH     MLSS     EMRA     UFT
2707.10            Benzol (benzen)                                                                                              MLSS 4   EMRA 1
2707.20            Toluol (toluen)                                                                                              MLSS 4   EMRA 1
2707.50.90.00.11   Solvent nafta (çözücü nafta)                                                               MARA 4            MLSS 4   EMRA 1
2710.11.21.00.00   White spirit                                                                                                 MLSS 4   EMRA 1
2710.19.85.00.11   Beyaz yağlar                                                                                         MoH 5            EMRA 1
2710.19.85.00.12   Sıvı parafin (pirinç yağı)                                                                           MoH              EMRA 1
2710.19.99.00.19   Diğerleri                                                                                  MARA 4                     EMRA 1
2901.10.00.90.11   Hekzan                                                                                               MoH 5   MLSS 4   EMRA 1
2901.10.00.90.12   Heptan                                                                                                       MLSS 4   EMRA 1
2902.20.00.00.00   Benzen (benzol)                                                                                              MLSS 4   EMRA 1
2902.30.00.00.00   Toluen (toluol)                                                                                      MoH 5   MLSS 4   EMRA 1
2902.41.00.00.00   o-Ksilen                                                                                   MARA 4            MLSS 4   EMRA 1
2902.42.00.00.00   m-Ksilen                                                                                   MARA 4            MLSS 4   EMRA 1
2902.43.00.00.00   p – Ksilen                                                                                 MARA 4            MLSS 4
2902.44            Ksilen izomerleri karıĢımları                                                                                MLSS 4   EMRA 1

2909.19.00.00.13   Metil tersiyer bütil eter (MTBE)                                                                     MoH 5            EMRA 1

2524.00            Amyant (aspest)                                                                   MoEF 2                     MLSS 4

39.01              Etilen polimerleri                                                                         MARA 42           MLSS 4

39.02              Propilen ve diğer olefinlerin polimerleri                                                  MARA 42           MLSS 4

39.03              Stiren polimerleri                                                                         MARA 42           MLSS 4

39.04              Vinil klorür veya diğer halojenlenmiĢ olefinlerin polimerleri                              MARA 42           MLSS 4

39.05              Vinil asetat veya diğer vinil esterlerinin polimerleri; diğer vinil polimerleri            MARA 42           MLSS 4

39.06              Akrilik polimerler                                                                         MARA 42           MLSS 4


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39.07              Poliasetaller, diğer polieterler ve epoksi reçineler; polikarbonatlar, alkit      MARA 42   MLSS 4
                   reçineler, polialilesterler ve diğer poliesterler

39.08              Poliamidler                                                                       MARA 42   MLSS 4

39.09              Amino reçineler, fenolik reçineler ve poliüretanlar                               MARA 42   MLSS 4

39.11              Petrol reçineleri, kumaron-inden reçineleri, politerpenler, polisülfürler, po-    MARA 42   MLSS 4
                   lisülfolar ve bu fasılın 3 numaralı notunda belirtilen diğer ürünler (tarifenin
                   baĢka yerinde belirtilmeyen veya yer almayan) (ilk Ģekillerde)




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G.T.İ.P.           Chemical Name                                      MoEF          MARA                 MoH                        MLSS     EMRA   UFT
39.12              Selüloz ve kimyasal türevleri (tarifenin baĢka                   MARA 42                                         MLSS 4
                   yerinde belirtilmeyen veya yer almayan)

39.13              Tabii polimerler (aljinik asit gibi) ve tadil                    MARA 42                                         MLSS 4
                   edilmiĢ tabii polimerler (sertleĢtirilmiĢ pro-
                   teinler, tabii kauçuğun kimyasal türevleri gibi)
                   (tarifenin baĢka yerinde belirtilmeyen veya
                   yer almayan)

2903.19.10.00.00   1,1,1,-Trikloretan (metilkloroform)                MoEF 2 ve 3                                                                   UFT 1

3808.10.90.00.11   Bromoklormetan ya da bromometan (Metil             MoEF 2        MARA 43              MoH 5 (Except medical                      UFT 1
                   bromür) içerenler                                                                     equipment disifectant),
                                                                                                         (Except ones used in
                                                                                                         agricultural protection)
3808.40.90.00.11   Bromoklormetan ya da bromometan (Metil             MoEF 2        MARA 41+3
                   bromür) içerenler

3808.90.10.00.11   Bromoklormetan ya da bromometan (Metil             MoEF 2                             MoH 5 (Except medical                      UFT 1
                   bromür) içerenler                                                                     equipment disifectant),
                                                                                                         (Except ones used in
                                                                                                         agricultural protection)
3808.90.90.00.11   Bromoklormetan ya da bromometan (Metil             MoEF 2        MARA 42+3                                                       UFT 1
                   bromür) içerenler

3307.49.00.00.00   Yalnız sprey Ģeklinde olanlar                      MoEF 2                             MoH 5 (only room
                                                                                                         sprays)
3910.00            Yalnız silikon aerosoller (sprey Ģeklinde olan-    MoEF 2        MARA 42
                   lar)

3204.13.00.00.00   Bazik boyalar ve esası bu boyalar olan                           MARA 43              MoH 54
                   müstahzarlar
2921.19.80.00.29   Diğerleri                                                        MARA 41 (Only com-                                              UFT 1
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                                                                     pounds having amine
                                                                     group)
2922.19.80.00.17   N,N-diisopropilaminoetan-2-ol ve bunun                                  MoH 54   UFT 1
                   protonlanmıĢ tuzları
2931.00.10.00.00   Dimetil metil fosfanat                                                  MoH 54   UFT 1
2931.00.30.00.00   Metilfosfonoil diklorür (metilfosfonik dik-                             MoH 54   UFT 1
                   lorür)




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G.T.İ.P.           Chemical Name                                                       MoEF     MARA                         MoH                  MLSS     EMR   UFT
                                                                                                                                                           A
2843.29.00.10.11   GümüĢ siyanürler (yalnız gümüĢ siyanür ve gümüĢ disiyanür)          MoEF 2                                MoH 54
2903.21.00.00.00   Vinil klorür (kloretilen)                                           MoEF 2                                MoH 54
2915.90.80.00.21   Metilbromasetat                                                     MoEF 2                                MoH 54
2915.90.80.00.22   Etilbromasetat                                                      MoEF 2                                MoH 54
2915.90.80.00.23   Propilbromasetat                                                    MoEF 2                                MoH 54
2915.90.80.00.24   Butilbromasetat                                                     MoEF 2                                MoH 54
2921.44.00.10.00   Difenilamin                                                         MoEF 2                                MoH 54
2921.45.00.00.11   1- Naftilamin (alfa -naftilamin)                                    MoEF 2                                MoH 54
2921.45.00.00.22   2- Naftilaminin tuzları                                             MoEF 2                                MoH 54
2931.00.95.10.00   Arsenikli Organik BileĢikler                                        MoEF 2   MARA 41
2931.00.95.20.00   Civalı organik bileĢikler                                           MoEF 2                                MoH 54
6812.90.20.90.00   Diğerleri (yalnız Krizotil (Beyaz Asbest))                          MoEF 2                                                     MLSS 4
3002.10.10.00.19   Diğerleri                                                                    MARA 4 (Only ones used for   MoH 5
                                                                                                animal health)               (Except ones used
                                                                                                                             in veterinary med-
                                                                                                                             icine)
3002.90.50.90.00   Diğer mikroorganizma kültürleri                                              MARA 4 1+2                   MoH 5
                                                                                                (Only ones used for animal   (Except ones used
                                                                                                health)                      in veterinary med-
                                                                                                                             icine)
3822.00.00.20.00   Laboratuvarlarda veya teĢhiste kullanılan reaktifler emdirilmiĢ              MARA 4 (Only ones used for   MoH 5
                   veya sıvanmıĢ kağıttan plakalar, levhalar,yapraklar, ince tabaka-            animal health)               (Only ones used in
                   lar ve Ģeritler (rulo veya tabaka halinde)                                                                medical laborato-
                                                                                                                             ry)
1702.11.00.10.00   Laktoz                                                                       MARA 41+3                    MoH 54
2519.90.10.00.11   Saf magnezyum oksit                                                          MARA 43                      MoH 54
2811.22.00.00.00   Silisyum dioksit                                                             MARA 41+3                    MoH 54
2816.10.00.00.00   Magnezyumun hidroksit ve peroksiti                                           MARA 41                      MoH 54
2841.70.00.90.11   Sodyum molibdat                                                              MARA 41                      MoH 54



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G.T.İ.P.           Chemical Name                   MoE   MARA                                            MoH                                    MLSS   EMR   UFT
                                                   F                                                                                                   A
2842.10.00.00.00   Kompleks veya çift sili-              MARA 41 (including alumina silicate regard-     MoH 54
                   katlar                                less of whether having a specific chemical
                                                         structure or not)
2842.90.10.00.11   Selen asitlerin tuzları, çift         MARA 41                                         MoH 54
                   tuzları ve kompleks tuzları
2906.13.90.00.00   Ġnositoller                           MARA 41                                         MoH 54
2909.50.90.90.00   Diğerleri                             MARA 41                                         MoH 54
2914.70.00.        Diğerleri                             MARA 41+3 (except keton miski (4,-tert –bütil   MoH 54
90.00                                                    –2‘,6‘-dimetil – 3‘,5‘ –dinitroasetofenon))
 2923.10.00.00.    Kolin ve tuzları                      MARA 41                                         MoH 54
              00
 2923.90.00.10.                         Betain           MARA 41                                         MoH 54
              12
 2923.90.00.10.    Betain hidroklorür                    MARA 41                                         MoH 54
              13
2933.59.95.00.39   Diğerleri                             MARA 41+3                                       MoH 54
3203.00.10.90.00   Diğerleri                             MARA 41 (Only colouring materials)              MoH 54
3204.19.00.00.19   Azoic Diazo Component                 MARA 41                                         MoH 54
                   11
3302.90.90.00.00   Diğerleri                             MARA 41                                         MoH 5
                                                                                                         (Only room sprays)
3507.90.90.00.19   Diğer enzimler                        MARA 41                                         MoH 54
                                                                                                         (Only ones used in medical laborato-
                                                                                                         ry)
3808.40.90.00.19   Diğerleri                             MARA 41+3                                       MoH 5
                                                                                                         (Except medical equipment disifec-
                                                                                                         tant), (Except ones used in agricul-
                                                                                                         tural protection)
3824.90.99.90.58   Diğerleri                             MARA 4 1+3                                      MoH 54
3913.90.00.90.00   Diğerleri                             MARA 41 (Only polymers)                         MoH 54
1108.12.00.10.00   Torba içinde olanlar (ilaç            MARA 43                                         MoH 54
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                   hammaddeleri)
1302.20.10.10.00   Pektik maddeler (pektin-   MARA 43             MoH 54
                   ler)
2707.50.90.00.19   Diğerleri                  MARA 42+3                    MLSS 4




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G.T.İ.P.           Chemical Name                                                  MoEF   MARA                             MoH                         MLSS     EMRA   UFT
2707.50.90.00.19   Diğerleri                                                             MARA 42+3                                                    MLSS 4
2831.10.00.00.12   Sodyum sülfoksilat                                                    MARA 43                          MoH 54
2833.25.00.20.00   Bakır II sülfat (göz taĢı)                                            MARA 43                          MoH 54
2833.29.50.00.11   Demir II sülfat                                                       MARA 43                          MoH 54
2833.40.00.30.00   Potasyum                                                              MARA 43                          MoH 54
2835.25.10.00.00   Ġçerdiği flor miktarı ağırlık itibariyle kuru anhidrit madde          MARA 43                          MoH 54
                   üzerinden % 0,005 'den az olanlar
2836.99.18.30.00   Bizmut karbonat (bazik bizmut karbonat)                               MARA 43                          MoH 54
2905.12.00.00.12   Ġzopropil alkol                                                       MARA 43                          MoH 5 (Only ones for
                                                                                                                          room sprays)
2905.32.00.00.00   Propilen glikol (1,2 -propandiol)                                     MARA 43                          MoH 5 (Only ones for
                                                                                                                          room sprays)
2905.43.00.00.00   Mannitol                                                              MARA 43                          MoH 54
2905.44.91.00.00   D -glusitol miktarı üzerinden hesaplandığında ağırlık                 MARA 43                          MoH 54
                   itibariyle % 2 veya daha az mannitol içerenler
2905.59.10.00.19   Diğerleri                                                             MARA 43 (Only ones belong to     MoH 54 (Only ones belong
                                                                                         saturated monohydric alcohols)   to unsaturated monohydric
                                                                                                                          alcohols)
2906.21.00.00.00   Benzil alkol                                                          MARA 43                          MoH 54
2906.29.00.10.11   Feniletil alkol ( 2-fenil etanol)                                     MARA 43                          MoH 54
2907.11.00.10.00   Fenol (hidroksibenzen,fenik asit)                                     MARA 43                          MoH 54
2908.10.00.10.12   p-Klor-m-krezol                                                       MARA 43                          MoH 54
2908.10.00.90.19   Diğerleri                                                             MARA 43                          MoH 54
2914.69.90.00.19   Diğerleri                                                             MARA 43                          MoH 54
2915.29.00.00.19   Asetik asitin diğer tuzları                                           MARA 43                          MoH 54
2915.31.00.00.00   Etil asetat                                                           MARA 43                          MoH 54




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G.T.İ.P.           Chemical Name                                        MoEF   MARA            MoH                                            MLSS   EMRA   UFT
2915.50.00.00.19   Propionik asitin diğer tuzları ve esterleri                 MARA 43         MoH 54
2915.60.90.90.19   Diğerleri                                                   MARA 43         MoH 54
2915.70.30.00.13   Magnezyum stearat                                           MARA 43         MoH 54
2915.90.80.00.29   Diğer bromoasetatlar                                        MARA 43         MoH 54
2916.31.00.90.12   Sodyum benzoat                                              MARA 43         MoH 54
2918.11.00.00.11   Laktik asit                                                 MARA 43         MoH 54
2918.11.00.00.12   Kalsiyum laktat                                             MARA 43         MoH 54
2918.12.00.00.00   Tartarik asit                                               MARA 43         MoH 54
2918.15.00.90.29   Sitrik asitin diğer esterleri                               MARA 43         MoH 54
2918.16.00.00.12   Kalsiyum glukonat                                           MARA 43         MoH 54
2918.16.00.00.19   Glukonik asitin diğer tuzları                               MARA 43         MoH 54
2918.21.00.00.11   Salisilik asit                                              MARA 43         MoH 54
2919.00.10.90.00   Diğerleri                                                   MARA 43         MoH 5 (Only ones used in insecticide, ro-
                                                                                               denticide, molluscicide and odor remover
                                                                                               industry) (Except ones used for agricultural
                                                                                               purpose)
2921.11.90.00.19   Metilamin, dimetilamin ve trimetilaminin diğer              MARA 43         MoH 54
                   tuzları
2921.45.00.00.29   Naftilaminlerin türevleri ve bu türevlerin tuzları          MARA 43         MoH 54
2922.11.00.00.11   Monoetanolamin (etanolamin)                                 MARA 43         MoH 54
2922.41.00.00.12   Lizin monohidroklorür                                       MARA 43         MoH 54
2922.49.95.00.32   Etilendiamintetraasetik asit (EDTA)                         MARA 43         MoH 54
2922.49.95.00.39   Diğerleri                                                   MARA 43         MoH 54
2924.21.90.00.19   Diğerleri                                                   MARA 43         MoH 54
2924.29.95.00.17   Lidokain hidroklorür                                        MARA 43         MoH 54
2924.29.95.00.29   Diğerleri                                                   MARA 4(1+2+3)   MoH 54
                                                                                               (Only N-acetyl antranilic acid)
2925.20.00.00.29   Diğerleri                                                   MARA 43         MoH 54
2926.90.95.00.19   Diğerleri                                                   MARA 43         MoH 54 (Only isoaminil citrate)
2930.90.70.90.43   Dimetil sülfoksit ve sülfonlar                              MARA 4(3+1)     MoH 54



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G.T.İ.P.           Chemical Name                 MoEF   MARA                           MoH                                       MLSS   EMRA   UFT
2930.90.70.90.68   Diğerleri                            MARA 43                        MoH 54
2932.29.85.90.19   Diğer laktonlar                      MARA 43                        MoH 5 (Only ones used for production of
                                                                                       insecticide, rodenticide, molluscicide)
2933.11.90.00.11   Fenazon (antiprin)                   MARA 43                        MoH 54
2933.11.90.00.19   Diğerleri                            MARA 43                        MoH 54
2933.49.90.00.29   Diğerleri                            MARA 41+3 (Only nitrogenized   MoH 54
                                                        heterocyclic compounds)
2933.79.00.00.19   Diğer laktamlar                      MARA 43                        MoH 54
2933.91.90.00.49   Diğerleri                            MARA 43                        MoH 5 (Only chlordiazepokside salts)
2934.99.20.00.00   Furazolidon (INN)                    MARA 43                        MoH 54
2934.99.90.90.18   Diğerleri                            MARA 43                        MoH 54 (Etodolac and etodolic methyl
                                                                                       ester)
2935.00.90.00.11   Sülfodiazin                          MARA 43                        MoH 54
2935.00.90.00.18   Sodyum sülfadimiden                  MARA 43                        MoH 54
2935.00.90.00.29   Diğerleri                            MARA 43                        MoH 54
2936.21.00.00.12   Vitamin A asetat                     MARA 43                        MoH 54
2936.21.00.00.13   Vitamin A propiyonat                 MARA 43                        MoH 54
2936.21.00.00.14   Vitamin A palmitat                   MARA 43                        MoH 54
2936.22.00.00.12   Tiyamin hidroklorür                  MARA 43                        MoH 54
2936.22.00.00.13   Tiyamin mononitrat                   MARA 43                        MoH 54
2936.23.00.00.11   Vitamin B 2 [riboflavin              MARA 43                        MoH 54
                   (INN), lakta flavin]

2936.24.00.00.13   Kalsiyum pantonat                    MARA 43                        MoH 54
2936.25.00.00.11   Vitamin B 6 [piridoksin              MARA 43                        MoH 54
                   (INN), adermin, piridoksol]
2936.26.00.00.11   Vitamin B 12 [siyonokoba-            MARA 43                        MoH 54
                   lamin (INN) ]
2936.26.00.00.12   Hidroksi kobalamin                   MARA 43                        MoH 54
2936.27.00.00.11   Vitamin C [L-veya DL-                MARA 43                        MoH 54
                   askorbik asit (INN) ]
2936.27.00.00.12   Sodyum askorbat                      MARA 43                        MoH 54
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G.T.İ.P.             Chemical Name                                              MoEF   MARA        SB       ÇSGB   EPDK   DTM
2936.27.00.00.19     Vitamin C'nin diğer türevleri                                     MARA 43     MoH 54
2936.28.00.00.12     Tokoferil asetat                                                  MARA 43     MoH 54
2936.29.10.00.11     Vitamin B 9 [folikasit (INN) veya fitoroilglutamik asit]          MARA 43     MoH 54
2936.29.30.00.11     Vitamin H (biyotin)                                               MARA 43     MoH 54
2936.29.90.00.13     Vitamin PP (nikotinamit (INN) )                                   MARA 43     MoH 54
2936.29.90.00.22     Vitamin D 3 (7-dehidrokollesterol)                                MARA 43     MoH 54
2937.19.00.00.12     Hipofiz arka lobu hormonları                                      MARA 43     MoH 54
2937.22.00.00.00     Kortikosteroidal hormonlarının halojenlenmiĢ türevleri            MARA 43     MoH 54
2938.90.90.90.18     Diğerleri                                                         MARA 43     MoH 54
2939.30.00.00.11     Kafein                                                            MARA 43     MoH 54
2939.99.00.90.12     Atropin                                                           MARA 43     MoH 54
2941.10.10.00.11     Amoksilin trihydrate                                              MARA 43     MoH 54
2941.10.10.00.13     Amoksilin sodium                                                  MARA 43     MoH 54
2941.10.90.00.19     Diğerleri                                                         MARA 43     MoH 54
2941.20.80.00.00     Diğerleri                                                         MARA 43     MoH 54
2941.30.00.00.14     Oxytetrasiklin                                                    MARA 43     MoH 54
2941.30.00.00.15     Oxytetrasiklin HCI                                                MARA 43     MoH 54
2941.30.00.00.17     Chlortetrasiklin HCI                                              MARA 43     MoH 54
2941.50.00.00.19     Diğerleri                                                         MARA 43     MoH 54
2941.90.00.00.13     Neomisin ve türevleri; bunların tuzları                           MARA 43     MoH 54
2941.90.00.00.15     Kanomisin ve türevleri; bunların tuzları                          MARA 43     MoH 54
2941.90.00.00.23     Gentamisin sülfat                                                 MARA 43     MoH 54
2941.90.00.00.29     Gentamisin'in diğer türevleri; bunların tuzları                   MARA 43     MoH 54
2941.90.00.00.32     Linkomisin HCI                                                    MARA 43     MoH 54
2941.90.00.00.59     Antibiyotikler                                                    MARA 43+1   MoH 54
3204.17.00.00.11     Pigmentler                                                        MARA 43     MoH 54
3402.13.00.00.00     Ġyonlu olmayanlar                                                 MARA 43     MoH 54
3404.20.00.00.00     Poli(oksietilen)(polietilen glikol)den elde edilenler             MARA 43     MoH 54




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Technical Assistance in the field of Chemicals                         TeACH

G.T.İ.P.           Chemical Name                                            MoEF   MARA                    MoH                                   MLSS   EMRA   UFT
3808.10.10.00.00   Esası pretroitler olanlar                                       MARA 43                 MoH 5 (Except medical equipment
                                                                                                           disifectant), (Except ones used in
                                                                                                           agricultural protection)
3808.10.30.00.00   Esası karbamatlar olanlar                                       MARA 43                 MoH 5 (Except medical equipment
                                                                                                           disifectant), (Except ones used in
                                                                                                           agricultural protection)
3808.10.90.00.19   Diğerleri                                                       MARA 43                 MoH 5 (Except medical equipment
                                                                                                           disifectant), (Except ones used in
                                                                                                           agricultural protection)
3808.40.10.00.00   Esası kuaterner amonyum tuzları olanlar                         MARA 43                 MoH 5 (Except medical equipment
                                                                                                           disifectant), (Except ones used in
                                                                                                           agricultural protection)
3907.20.11.00.00   Polietilen glikoller                                            MARA 43                 MoH 5 (Only ones used in production
                                                                                                           of pharmaceutical products)
1804.00.00.00.00   Kakao yağı (katı ve sıvı)                                       MARA 42                 MoH 54
1521.90.91.00.11   Balmumu                                                         MARA 42 (Except ones    MoH 54
                                                                                   used in drug and cos-
                                                                                   metic industry)
2823.00.00.00.00   Titan oksitleri (saf titan oksitleri)                           MARA 42                 MoH 54
29.02              Siklik hidrokarbonlar                                           MARA 42                 MoH 5
                   (2902.30.00.00.00 ―Toluen (toluol)‖ hariç)
29.05              Asiklik alkoller ve bunların halojenlenmiĢ,                     MARA 42                 MoH 5                                               UFT 1
                   sülfolanmıĢ, nitrolanmıĢ veya nitrozolanmıĢ türev-
                   leri (2905.51.00.00.00 ―Ethchlorvynol (INN)‖
                   hariç)
29.09              Eterler, eter -alkoller, eter -fenoller, eter -alkol –          MARA 42                 MoH 5                                               UFT 1
                   fenoller, alkol peroksitler, eter peroksitler, keton
                   peroksitler (kimyasal olarak belirli bir yapıda olsun
                   olmasın) ve bunların halojenlenmiĢ, sülfolanmıĢ,
                   nitrolanmıĢ veya nitrozolanmıĢ türevleri
                   (2909.11.00.00.00 ―Dietil eter (eter)‖ hariç)


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Technical Assistance in the field of Chemicals                          TeACH

G.T.İ.P.           Chemical Name                                                                       MoEF   MARA        MoH      MLSS   EMRA   UFT
29.14              Ketonlar ve kinonlar (baĢka oksijen fonksiyonlu grubu olsun olmasın) ve                    MARA 42     MoH 5
                   bunların halojenlenmiĢ, sülfolanmıĢ, nitrolanmıĢ veya nitrozolanmıĢ türe-
                   vIeri
                   (2914.11.00.00.00 ―Aseton (propanon)‖,
                   2914.12.00.00.00 ―Butanon (metil etil keton)‖,
                   2914.13.00.00.00 ―4 -Metil - 2 –pentanon (metil izobütil keton)‖,
                   2914.39.00.00.15 ―1-phenyl-2-propanone‖,
                   2914.39.00.00.16 ―3,4-methylendioxy-phenyl-2-propanone‖ hariç)
29.15              DoymuĢ asiklik monokarboksilik asitler ve bunların anhidritleri, halo-                     MARA 42     MoH 5
                   jenürleri, peroksitleri ve peroksiasitleri; bunların halojenlenmiĢ,
                   sülfolanmıĢ, nitrolanmıĢ veya nitrozolanmıĢ türevleri
                   (2915.24.00.00.00 ―Asetik anhidrit‖,
                   2915.39.90.90.14 ―Ethylidene di acetate‖,
                   2915.90.80.00.11 ―Asetil klorür‖ hariç)
29.16              DoymamıĢ asiklik monokarboksilik asitler, siklik monokarboksiklik asitler,                 MARA 42     MoH 5
                   bunların anhidritleri, halojenleri, peroksitleri ve peroksi asitleri; bunların
                   halojenlenmiĢ, sülfolanmıĢ, nitrolanmıĢ veya nitrozolanmıĢ türevleri
                   (2916.34.00.00.00 ―Fenilasetik asit ve tuzları‖ hariç)
29.18              BaĢka oksijen fonksiyonlu grubu olan karboksilik asitler ve bunların anhi-                 MARA 42     MoH 5                  UFT 1
                   dritleri, halojenürleri, peroksitleri ve peroksiasitleri; bunların halojenlenmiĢ,
                   sülfolanmıĢ, nitrolanmıĢ veya nitrozolanmıĢ türevleri
                   (2918.90.90.00.14 ―Misoprostol‖ hariç)
2922.50            Amino-alkol fenoller, amino-asit fenoller ve oksijen gruplu diğer amino                    MARA 42     MoH 5
                   bileĢikleri
                   (2922.50.00.90.14 ―Fluoxetin (INN),
                   2922.50.00.90.15 ―Tramadol hidroklorür‖ hariç)
2923.20.00.10.00   Lesitin                                                                                    MARA 42     MoH 54
2923.90.00.90.19   Diğerleri                                                                                  MARA 42     MoH 54
                                                                                                              (Only L-
                                                                                                              Carnitin)




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G.T.İ.P.           Chemical Name                                                   MoEF   MARA      MoH                                                  MLSS   EMRA   UFT
2924.19.00.00.17   Glutamin                                                               MARA 42   MoH 54

2924.29.95.00.23   Aspartam (Aspartil fenilalanin metil ester)                            MARA 42   MoH 54

29.25              Karboksiimid grublu bileĢikler (sakkarin ve tuzları dahil) ve          MARA 42   MoH 5
                   imin gruplu bileĢikler
                   (2925.12.00.00.00 ―Glutetimit (INN)‖ hariç)
29.32              Sadece oksijenli heterosiklik bileĢikler                               MARA 42   MoH 5
                   (2932.91.00.00.00 ―Ġzosafrol‖,
                   2932.93.00.00.00 ―Piperonal‖,
                   2932.94.00.00.00 “Safrol” hariç)
29.34              Nükleik asitler ve bunların tuzları, (kimyaca belirli yapıda           MARA 42   MoH 5
                   olsun olmasın); diğer heteroksiklik bileĢikler
                   (2934.91.00.00.11 ―Aminorex (INN)‖,
                   2934.91.00.00.12 ―Brotizolam (INN)‖,
                   2934.91.00.00.13 ―Clotiazepam (INN)‖,
                   2934.91.00.00.14 Cloxazolam (INN),
                   2934.91.00.00.16 Haloxazolam (INN)‖,
                   2934.91.00.00.17 ―Ketazolam (INN)‖
                   2934.91.00.00.18 ―Mesocarb (INN)‖,
                   2934.91.00.00.21 ―Oxazolam (INN),
                   2934.91.00.00.22 ―Pemoline (INN) hariç)
29.41              Antibiyotikler                                                         MARA 42   MoH 54

3002.90.50.10.19   Diğerleri                                                              MARA 42   MoH 5 (Only ones used for the purpose of in vitro
                                                                                                    medical diagnostic) (Except ones used for research
                                                                                                    purposes and veterinary medicine)
3002.90.90.00.19   Diğerleri                                                              MARA 42   MoH 5 (Only ones used in medical laboratory)
                                                                                                    (Except one used in veterinary medicine)
4009.11.00.00.00   Bağlantı elemanları olmayanlar                                         MARA 42   MoH 5 (Only ones used in drinking water and
                                                                                                    daily usage water)

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