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					Polish Chemical Industry AC
                        E
vs. REACH




                                                                         H
                                                                    R
                       26 November 2004
                                Meeting
                on REACH organized
  by the American Chamber of Commerce in Poland
             Hotel Marriott, Warszawa

   Wojciech Lubiewa-Wieleżyński
   Polish Chamber of Chemical Industry

   Andrzej Krześlak
   Environmental Management Centre in the Chemical Industry
   Industrial Chemistry Research Institute
   Polish Chamber of Chemical Industry

   Marcela Palczewska-Tulińska
   Group for Physicochemical Properties of the Technological Processes
   Industrial Chemistry Research Institute                               1
  Up-to-date activities - role of
     the ChemLeg Project
White Paper on future chemicals’ policy published
  on 27 February 2001;
ChemLeg Project launched in May 2001;
Scope of the Project:
• Classification, packaging and labelling,
• Preparation of MSDSs,
• Notification of new substances,
• Risk assessment,
• Restrictions in marketing and use;
Translation of the White Paper and its distribution
  to the Polish chemical companies.                    2
          Role of the
   ChemFed/ChemLeg-2 Project
ChemFed/ChemLeg-2 Project launched in May 2003 –
  termination planned for 30 April 2005;
5 major clusters:
• Chemicals’ legislation – REACH:
Establishment of the ChemFed/ChemLeg-2 Task Force
  in CEFIC
• Human health and environmental protection – IPPC;
• Chemicals’ transport – SQUAS;
• Social policy and employment – cooperation with
  ECEG;
• Economical benchmarking;
Project Coordinator:                               3
Sustainable development




                          4
          Basic problems
      concerning registration
Approximately 25 000 existing substances at
  the tonnage band 1 – 100 tons annually will
  require registration within 11 years after entry
  into force;
Assumption: companies will register as late as
  possible → ussually just before 2017;
Consequences:
• Unpredictable rating of market and profitability
  of substances;
• Purchasers of chemicals will know very late in
  case of substances’ majority, whether they will
  be still available on the market after 2017. ?
       2006                              2017    5
                                          Basic problems
                                      concerning registration
                       30.000 substances to be registered within 11 years;
                       Simplification: no multiple registrations.


                              Parallel registrations in all                                                       Consecutive registration in
                              tonnage bands                                                                       tonnage bands
Daily no. of registrations




                                                                                Daily no. of registrations
                             20                                                                              25



                             15                                                                              20



                                                                                                             15
                             10

                                                                                                             10
                              5

                                                                                                              5
                              0
                                  1   2   3   4   5   6   7   8   9   10   11
                                                                                                              0
                                                                                                                  1   2     3   4   5    6   7   8   9   10   11



                                      Years after entry into force                                                        Years after entry into force        6
           Doubts – Example No. 1
             derived from SDS
    Adhesive X → annual production: 1.8 t → tonnage band 1 – 10 t:
    Components:
1.   Cyclohexane:          11 – 38 – 50/53 – 65 – 67             45%
2.   Acetone:              11 – 36 – 66 – 67                       4%
3.   Ethyl acetate:        11 – 36 – 66 – 67                     21%
    Classification of the adhesive: 11 – 36/38 – 50/53 – 65 – 67:
•    (F) Highly flammable;
•    (Xi) Irritating to eyes and skin;
•    (N) Very toxic to aquatic organisms; may cause long - term
          adverse effects in the aquatic environment;
•    (Xn) Harmful: may cause lung damage if swallowed;
          vapours may cause drowsiness and dizziness.
There is no CSR required for the preparation;
 none of the components will be registered → all
 components below 1 t;
Therefore, we strongly support prioritization of
 substances based on risk instead of tonnage band 7
      Doubts – Example No. 2
        derived from SDS
 Adhesive Y → annual production: 8 t → tonnage
  band 1 – 10 t:
 Components:
• Cyclohexane:       10%       →    0.8 t
• Acetone:           62%       →    5.0 t
• Butane-2-one       10%       →    0.8 t
Will be acetone only registered, additionally
  without CSR ?
If the components of differentiated adhesives
  are repeated – should they be registered only
  once or several times accordingly to the
  number of marketed final products with the
  deadline resulted from the tonnage band ???
                                                  8
      Doubts – Example No. 3
        derived from SDS
 Product ZZZ → annual production: 11 t →
  tonnage band 10 – 100 t:
 Components:
• Polyols:         80 - 90% →       exempted
                                    from
                                    registration
• Diethanoloamine: 1 - 5% → R22 – 38 – 41
                                    – 48/22
• Triethylenediamine:2 - 8% → ?
NONE OF THE ABOVE COMPONENTS WILL BE
  REGISTERED;
Product should be classified at least as irritant;
Triethylenediamine – no tests performed, no
  data available.                                  9
          Doubts – Example No. 4
            derived from SDS
 Automotive lacquer → annual production: 30 t → tonnage
     band 10 – 100 t:
    Components:
1.   Toluene:         36%        →      10.8 t
2.   Butane-2-one 27%            →       8.1 t
3.   Butyl acetate 10%           →       3.0 t
4.   Acetone:          7%        →       2.1 t
5.   Cyclohexanone 3%            →       0.9 t
    Registration for the components 1, 2, 3, 4;
    Substances 2, 3, 4 – standard information requirements
     according to Annex V – no CSR – deadline for registration
     11 years ?
    Toluene – additional standard information requirements
     according to Annex VI – CSR required – deadline for
     registration 11 years ?                                 10
 Doubts concerning evaluation
Substances marketed above 100 t
 annually;
Draft decision concerning evaluation
 prepared by competent authority of one
 Member State submitted then for
 approval to the competent authorities of
 the remaining 24 Member States, will
 unnecessarily prolong decision making
 process – this will enlarge inertia of the
 whole system;
CEFIC and selected delegations propose
 Agency as the Central Entity fully
 responsible also for the evaluation
 process.                                     11
Doubts concerning evaluation –
     duplication of work
                                              • Company A manufactures substance X in
                                                  the tonnage band > 1000 t annually in
                                                  Germany → evaluation performed by the
                                                  German Competent Authority;
                                              •   Company B manufactures the same
                                                  substance X in the tonnage band > 100 t
                                                  annually in France → evaluation performed
                                                  by the French Competent Authority;
                                              •   Company C imports the same substance X
                                                  in the tonnage band > 100 t annually on
                                                  the territory of Spain → evaluation
                                                  performed by the Spanish Competent
                                                  Authority;
                                                    Consequences:
                                                  • Duplication of the same work;
                                                  • Necessity of statements harmonization
                                                    in case of the substance X by
                                                    differentiated tonnage bands
                                                    (differentiated test requirements);
                                                  • Unjustified costs which may be avoided.
In case the companies A,B and C form a consortium – only one competent authority will be in charge
                                                                                                 12
 Activities in Poland

Impact assessment of REACH implementation
 in Poland – starting of the activities in
 September 2003 with support of Industrial
 Policy Department of the Polish Ministry of
 Economy, Labour and Social Policy;
Industrial Chemistry Research Institute,
 Warsaw, Poland – selected as the entity
 responsible for independent initial analysis;
Continuation of the work in 2004.

                                                 13
                Preliminary results
Surveyed companies employ more than 20 000
 people and operate with annual turnover above
 1.6 milliard € (ca. 7% of the whole sector in
 terms of employment);
Ca. 700 chemicals were analysed:
59 substances were identified as existing
 substances from the priority lists;
232 substances are listed in Annex I of
 Directive 67/548/EEC (29th ATP);
189 substances as „existing” listed on EINECS;
239 substances exempted from registration as
 polymers or as substances mentioned in Annex
 II or Annex III of the REACH regulation draft of
 29 October 2003.                              14
Analyses made in Poland in 2003

                         Priority lists
             8%

 34%                     Annex I of Dir.
                         67/548/EWG
                  32%
                         Existing,
                         EINECS

       26%               Exempted
                         from the scope
                   66%   of REACH
                                          15
         Results of analysis
      examples – small company

Company with 65 employees, 40 employees      Annual sale:
working directly on the plant. Company has     5 810 230 €
one technological installation
Cost of the raw materials                      3 989 100 €
Sales value                                    5 810 230 €
Cost directly resulted from REACH              2 361 000 €
Cost of production increase resulted from          59.2 %
REACH
Share of cost resulted from REACH in sales         40.6 %
value
                                                         16
         Results of analysis
  examples – medium sized company
Company with ca. 350 employees, above 100                Annual sale:
employees working directly on the plants. Company       33 197 770 €
has 8 chemical plants
                                Plant 1
Raw materials outside EU                            Registration for 4
                                                           Tests for 2
Products                                            Registration for 3
Total cost                                                 626 000 €
Cost of production increase resulted from REACH              20.80 %
Share of cost resulted from REACH in sales value             15.60 %
                                Plant 2
Raw materials outside EU                            Registration for 3
Products                                            Registration for 8
Total cost                                                 187 000 €
Cost of production increase resulted from REACH               1.15 %
Share of cost resulted from REACH in sales value              0.96 %     17
     Results of analysis, examples –
     medium sized company (cont.)
Company with ca. 350 employees, above 100                Annual sale:
employees working directly on the plants. Company       33 197 770 €
has 8 chemical plants
                              Plant 3 big
Raw materials outside EU                            Registration for 1
Products                                            Registration for 2
Total cost                                                   51 000 €
Cost of production increase resulted from REACH               3.40 %
Share of cost resulted from REACH in sales value              2.20 %
                             Plant 4 small
Raw materials outside EU                            Registration for 1
Products                                            Registration for 2
Total cost                                                   51 000 €
Cost of production increase resulted from REACH            115.90 %
Share of cost resulted from REACH in sales value             10.40 %
                                                                         18
                Results of analysis
             examples – big company
Company with ca. 1500 employees, above 750            Annual sale:
employees working directly on the plants. Company   102 864 600 €
has 6 chemical plants
                                Plant 1
Total cost                                               45 400 €
Cost of production increase resulted from REACH           9.60 %
Share of cost resulted from REACH in sales value          8.40 %
                                Plant 2
Total cost                                              802 170 €
Cost of production increase resulted from REACH          11.30 %
Share of cost resulted from REACH in sales value          2.10 %
                                Plant 3
Total cost                                            1 274 350 €
Cost of production increase resulted from REACH          13.20 %
Share of cost resulted from REACH in sales value          6.70 %     19
    Preliminary results – cont.
 It was estimated that registration under the REACH system
  will cover ca. 5000 substances; ca. 1000 substances will be
  subject of testing and ca. 200 will fall under authorisation
  procedure;
 Total costs are estimated in the range of 340 – 600 million €
  (however taking into account other sources of information
  – for example DOW EUROPE S.A., VCI data or Procter &
  Gamble, these costs may be even 5 times higher);
 In big chemical companies ca. 5 – 10% of employees may
  lose work places resulting from shut-down of unprofitable
  plants;
 In case of small enterprises (in particular when production
  profile is not diversified) the companies as a whole may be
  shut-down;
 In some cases increase of production cost may amount
  from few dozens up to even several hundreds per cent. 20
Number of chemicals under
REACH requirements - estimation

 Requirements


• Registration    30 000     5 000

• Evaluation       5 000     1 000

• Authorisation    1 600 ?    200
                                     21
   Activities planned in 2004
Extended analysis including bigger
 number of enterprises, especially small
 companies employing below 50 people; at
 least 50 – 100 such small companies
 should be analysed;
Including other branches using the
 chemical industry products (e.g., textile,
 automotive, leather industries, etc.);
An impact on innovation and
 competitiveness included;
The costs of Polish laboratories’
 adjustment to the GLP.
                                         22
    Tests vs. GLP requirements
• In Poland only two entities are certified in GLP system; a
  few fulfill requirements resulted from the Parliament Act
  on tests and certification of 3 April 1993;
• All issues connected with accreditation, authorisation
  and notification of goods as well as performing the tests
  by certified laboratories are regulated by the Parliament
  Act on system of compatibility assessment of 30 August
  2002 (Polish Official Journal No. 166, item 1360), which
  entered into force on 1 January 2003;
• There will be deficiency of authorized laboratories to
  carry out studies and tests in the framework of REACH
  system, laboratories, which would be accepted by the
  other EU Member States;
• Chemical companies in Poland wishing to place their
  products on the national and European markets will be
  forced to order the relevant tests to the certified
  laboratories operating abroad, bearing high costs…, or
  to abandon development.
                                                          23
       Independent estimations –
         Registration costs in thousand $
             for the new substances
                                USA               40
        Costs                  Japan              80
                                 EU              177
      Time                      USA               18
     (weeks)                     EU               52
      New                       USA              425
    products                   Japan             154
   (annually)                    EU              143
Source: Herbert Frankenstein, BASF Poland Ltd.         24
              Advocacy Process
• Meeting of the PIPC, Polish industry and Polish Ministry
  of Economy and Labour Experts with the
  Representatives of BASF AG held on 5 October 2004 at
  the BASF Polska Ltd. premises, Warsaw, POLAND;
• Chemistry & Art: 11-14 October 2004 at the EP,
  Brussels;
• Meeting with Polish MEPs organised by PIPC in
  cooperation with BASF Representatives, 19 October
  2004 at the EP, ASP Building, Brussels;
• Dutch Presidency Workshop on REACH Impact
  Assessment, 25-27 October 2004, The Netherlands;
• Permanent cooperation with Polish MEPs, Polish
  Government and the Parliament (both chambers: Sejm
  & Senate).                                        25
              Other international activities
 EU Council: REACH Ad-hoc Working Group on Chemicals:
• Analysis and discussion on the draft regulation following the particular
    chapters (Titles);
•   Discussion on the proposals of individual delegations – eventual approval;
   Memorandum of Understanding (MoU):
•   Published in February 2004, signed in March 2004;
•   Parties: DG Enterprise, DG Environment and Union des Industries de la
    Communauté Européenne / Union of Industrial and Employers’
    Confederations of Europe – UNICE, European Chemical Industry Council
    CEFIC;
   Additional Impact Assessment of REACH with the following scope:
•   Analysis of the potential impacts of REACH on business throughout the
    supply chain;
•   Analysis of the potential impacts of REACH on innovation;
•   Analysis of the potential impacts of REACH on New Member States:
-   Selected companies of specialty chemicals sector in Poland, Czech Republic
    and Slovenia;
-   Contractor for the first two bullets: KPMG, in case of third bullet: IPTS JRC,
    Seville, Spain;
   Title of the study: „Techno-economic case studies to illustrate the ability of
    chemical firms in selected NMS to cope with the implementation of REACH”26
                                                                            .
Questions and doubts concerning MoU
• One agreed contractor should be selected to
    perform whole study – why is distinction
    between „old fifteen” and „new ten” still
    maintained artificially?
•   Decision to analyse specialty chemicals sector –
    justified in case of Slovenia; Poland and Czech
    Republic are focused rather on commodity
    chemicals;
•   Scope of the questionnaires considerably
    exceeded beyond REACH subject matter;
•   Resources for the study → scope: 3 – 4
    companies to be analysed in each country (max.
    12 enterprises);
•   The goals to achieve from the worked out study
    presented by EC and chemical sector in Poland
    are at the crossroads and not complementary. 27
   Our views and expectations
• REACH too bureaucratic and unworkable
  in the form of draft of 29 October 2004;
• Prioritisation of substances – basic
  criterion → risk for the health and
  environment not only tonnage band;
• Flexibility of the company’s decision –
  registration performed individually or in
  consortia (excluding tests on animals);
• Centralized role of the Agency – should be
  also responsible for the evaluation
  procedure.                                28
Thank you for your attention
• Contact:
  Wojciech Lubiewa-Wieleżyński
  President of Board of the Polish Chamber of Chemical Industry
  tel. +48-22-828-75-06 to 07, fax: +48-22-829-73-39
  e-mail: lubiewa@pipc.org.pl
  Andrzej Krześlak
  Environmental Management Centre for the Chemical Industry
  Industrial Chemistry Research Institute
  tel. (0-22) 568-20-33, fax: (0-22) 568-23-90
  e-mail: Andrzej.Krzeslak@ichp.pl
  Polish Chamber of Chemical Industry
  e-mail: Andrzej.Krzeslak@pipc.org.pl
  Marcela Palczewska-Tulińska
  Group of the Physicochemical Properties for the Technological Processes
  Industrial Chemistry Research Institute
  tel. (0-22) 568-20-33, fax: (0-22) 568-23-90
  e-mail: Marcela.Palczewska-Tulinska@ichp.pl                               29