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How Downstream Users REACH?
Impacts and challenges of REACH
for EU Cutlery, Flatware, Holloware, and Cookware Industries
FEC General Assembly
20 November 2007
Françoise Duplat
Orgalime secretariat
The European Engineering Industries Association
• 35 Member Associations
• 23 European Countries
• 130 000 Companies
FI • €1779 Bn output 2006 (EU-27
estimates for the whole
engineering industry)
• 10.6 Mio employment
NO
SE
LV
DK
LT
IE UK
PL
NL DE
BE
CZ AT
FR
CH
SL HR
PT ES IT BG
LU
The European Engineering Industries Association
Brief outline
Introduction
REACH priorities for DU
Communication in the supply chain
Substances in articles
Authorisation procedures
Conclusion
The European Engineering Industries Association
Why « REACH »?
REACH: « Registration Evaluation Authorisation of Chemicals »
Before REACH – various legislation relating to chemicals :
Directive 67/548/EEC, Directive 1999/45/EC, Regulation (ECC) n° 793/93,
Directive 76/769/EEC etc
BUT lack of harmonisation between so-called «new» and
« existing» substances
Therefore elaboration of « REACH Regulation »
Publication of the COM Proposal on REACH: 29 Oct. 2003
Negociation European Parliament and Council: end of 2003-Dec. 2006
European Regulation n° 1907/2006 adopted 18 Dec. 2006
Publication in EU Official Journal : 30 Dec. 2006
Creation of European Chemicals Agency (ECHA)
The European Engineering Industries Association
REACH Regulation n°1907/2006
Entered into force on 1st June 2007
Directly applicable and full harmonisation except enforcement
Strengthened industry responsibility to provide and communicate
safety information on substances and to properly manage the risk
realted to their use.
Scope: All substances, on their own, in preparations, in articles
Exemption to scope: radioactive, non-isolated intermediates, waste, transport, transit or
reexportation, interest of defence
Further exemptions to some parts of REACH, e.g. for R&D, acc. to use, nature of substance etc
All EU actors of supply chain concerned: from e.g. EU
manufacturer/importer (M/I) of substances to downstream users
(DU)/article producer or article importer
REACH obligations according to role in supply chain
The European Engineering Industries Association
What focus for Orgalime?
Downstream users of
Substance Formulator of substances/
manufacturer/ preparations preparations
importer (“1st level downstream users”) (“2d level downstream users”)
e.g. chemical industry e.g. paint manufacturer Orgalime Industries
FEC industries
Orgalime practical guide for downstream users, article Article producers/
producers and article importers to understanding Regulation Article importers
N°1907/2006 on REACH (May 2007) Orgalime Industries
FEC industries
Available free of charge at www.publications.orgalime.org
Structure:
Introduction (definitions, acronyms etc.)
Overview important dates and deadlines
Orgalime quick screens
More detailed guidelines on selected issues
One page summary on timelines and obligations
The European Engineering Industries Association
REACH priorities
?
Check Orgalime
quick screens
for Orgalime industries 1,2,3,4
In the context of registration of substance:
Title V (mainly)
Communication in the supply chain
Registration of substances intentionally released
from articles under certain conditions
Article 7
Notification of substances of very high concern
present in articles under certain conditions
Article 7
Communication requirements on substances of very
high concern present in articles under certain
Article 33
conditions
Use of authorised substances/application for
authorisation for substances included in Annex XIV
Title VII
REACH
The European Engineering Industries Association
First and foremost…
?
Check
Orgalime
Guidelines 1,2,3,4
What is my role in the Downstream user means….
supply chain? “any natural or legal person established within the Community,
other than the manufacturer or the importer, who uses a substance,
either on its own or in a preparation, in the course of his industrial or
professional activities (…)
Downstream user?
Establish inventories
Importer? Article producer
with key information
(« only representative» means….
nominated in the EU?) according to role “means any natural or legal person who
makes or assembles an article within the
Community”
Article
producer/importer? Takes time and
ressources -
early preparation
Check REACH
A company may play
is key
scope/exemptions
several roles!
The European Engineering Industries Association
Registration procedure
in a nutshell
Registration of substances on their own or in preparations, intentionally
released from articles ≥ 1 t/y per M/I
For “non phase-in substances” ≥ 1 t/y: as of 1/06/2008, before
manufacturing/importing/putting on the market
For “phase-in” substances ≥ 1 t/y: transitional regime
≥1000 t/y, CMR ≥1 t/y, aqu.tox. ≥100 t/y : 30 /11/2010
100 - 1000 t/y: 31/05/2013
1- 100 t/y : 31/05/2018
To benefit from transitional regime: PRE-REGISTRATION required!
“No data - no market”
DU to communicate uses to allow manufacturer/importer (i.e.
supplier) to complete registration dossier
The European Engineering Industries Association
·
Communication in
?
Check
Orgalime
the supply chain (1) guideline 5
ESSENTIAL to ensure that substances used will
be pre-registered/registered by supplier
Pre-registration : between 1/06/2008 and 1/12/2008 (Art. 28)
DU not considered as potential registrant
List of pre-registered substances on the ECHA website by 1/1/2009
Notification to Agency of interest for a non pre-registered substances
DU may be part to Substance Information Exchange Forum (SIEF)
« No data - No market »
Possible consequences on continuity of supply
Time is running!
The European Engineering Industries Association
Communication in
?
Check
Orgalime
the supply chain (2) guideline 5
Supplier (M/I) to compile registration dossier
Technical dossier: starting at 1 t/y
Chemical safety report (CSR): starting at 10 t/y
CSR to include exposure scenario (ES) if substance is dangerous,
PBT or vPvB
ES to cover manufacture of sub. and DU identified uses
DU «identified use» covered ? DU has the right to make his use
known to supplier (« brief description of use »)
DU to provide sufficient information to allow supplier to prepare
exposure scenario/use and exposure category (ES/UEC) for his use
ES annexed to safety data sheet (SDS)
The European Engineering Industries Association
Communication in
?
Check
Orgalime
the supply chain (3) guideline 5
Possible uses advised against, but only for reasons of
protection of human health or the environment
If no SDS but risks management measures (RMMs):
Article 32
DU to identify, apply and where suitable recommend
RMMs ( listed in SDS or Article 32)
12 Months to comply with Art. 37 after receiving
registration number in SDS
Further DU communication duties
Important to BE PRO-ACTIVE and inquire early enough
on supplier’s policy towards substance/preparation used
The European Engineering Industries Association
DU own chemical
?
Check
Orgalime
safety report guideline 6
Specific cases : DU to perform own chemical safety
report (CSR) and report to ECHA (Art. 37.4, 38 and
Annex XII) for:
Use outside conditions described ES/UEC of supplier
Use advised against (protection of health and the environment)
DU to identify, apply and where suitable recommend
RMMs of his own CSR
Information to be kept available and up to date
Exemptions foreseen!
Requires specific chemical knowledge
Time consuming and expensive
Make sure supplier’s ES covers DU uses
The European Engineering Industries Association
Substances in articles
What is an « article »?
? Check
Orgalime
Guidelines 7,8,9
“an object which during production is given a
special shape, surface or design which
determines its function to a greater degree
than does its chemical composition” (Art. 3.3)
E.g.: electrical and electronic equipment, a screw,
a bolt, a motor, cutlery, cookware, etc.
The European Engineering Industries Association
Registration of substances
intentionally released from articles
? Check
Orgalime
guideline 7
Article producer,article importer/«only representative» to
REGISTER any substance in articles if
Intentional release under normal or reasonably foreseeable
conditions of use AND
Total amount of substance present in articles over 1 tonne per
producer/ importer per year (Art. 7.1)
Same timeline to register as for any other substances (2010-
2013-2018) - Registration fees
NO registration of substance in article if substance has
already been registered for that use (Art. 7.6)
The European Engineering Industries Association
?
Check
Notification of substances Orgalime
guideline 8
present in articles
Article producer,article importer/«only representative»
to NOTIFY substances in articles if the substance
Has been identified as of very high concern (Art.57) i.e. CMR 1 & 2, PBT/ vPvB
and any other substance of equivalent concern AND
Is present in articles in quantities over 1 t/y AND
Has been included in the candidate list (Art.59) AND
Is present in the article above a concentration of 0.1% w/w (Art. 7.2)
FROM 1/06/2011, 6 months after inclusion in candidate list
Notification of substance in article NOT required
If substance has already been registered for that use (Art. 7.6)
If exposure to human health and the environment, including disposal, can be
excluded (appropriate instructions to recipient) (Art. 7.3)
The European Engineering Industries Association
Further points to consider….
ECHA to possibly require registration for
substances present in articles under certain
conditions (Art. 7.5)
Concentration calculation « 0.1% w/w » at the
level of the article
Consequences on smooth running of supply
chain and just in time delivery of articles
The European Engineering Industries Association
Communication requirements
on substances in articles ? Check
Orgalime
guideline 9
Supplier of an article to provide sufficient information
available to him, as a minimum name of substance, to
recipient of article to allow safe use if the substance
Is identified as of very high concern AND
Is included in the candidate list for inclusion in Annex XIV AND
Is present in the article in concentration above 0.1% w/w
Extended to consumers upon request (within 45 days
free of charge)
The European Engineering Industries Association
Authorisation
?
Check
Orgalime
procedure (1) guideline 10
Concerns substances of very high concern on their own/in
preparations/ incorporated in articles during process phase
« Progressive» procedure:
Sub. incorporated in the candidate list
Priority list from ECHA no later than 01/06/09
Further inclusion of sub. in Annex XIV
Application for authorisation (by M/I/DU - analysis of alternatives - fees!)
COM to decide on granting/reviewing authorisation
NO tonnage threshold
DU may use a substance listed in Annex XIV if authorisation granted
for that use up the supply chain
Notification to ECHA within 3 months of first supply!
Exemption certain uses and categories of uses
Further exemptions foreseen!
Two routes foreseen
The European Engineering Industries Association
Authorisation
?
Check
Orgalime
procedure (2) guideline 10
An authorisation for the use of a substance listed in Annex
XIV will be granted only if :
Risks adequately controlled, OR
Adequate control cannot be demonstrated but it is shown
that socio-economic benefits outweigh the risk to
human health or the environment arising from the use of
the substance and if there are no suitable alternative
substances or technologies.
The European Engineering Industries Association
Possible consequences
of authorisation procedures
Substance withdrawal from the market
Disruption in the supply chain
Technology changes
Costly and time consuming procedures
(analysis of alternatives and where such alternative
exists – substitution plan)
DU to make sure that the substance used
is authorised for his use up the supply chain
The European Engineering Industries Association
To know more….
Orgalime REACH guide 4.1. Orgalime REACH Quick Screen 1
Registration of substances/substances in preparations
used in industrial (including engineering) processes
No further
requirement
yes
Make substance inventory:
Do you use substances/preparations
in your industrial processes?
See guideline 3
yes
Are the substances/
substances in preparations
exempted from registration?
no No further
requirement
4.2. Orgalime REACH Quick Screen 2
REACH authorisation procedures
Supply of substance in the EU
Make substance inventory: do you use substances
?
See guideline 2 no No further
•Only representative •Only representative on their own/in preparations identified as substances of
will no longer be possible requirement
will act as importer will act as importer (« no data - no market »):very high concern (Svhc)? (Art. 57)
and has to register no
and has to apply for You may re-consider alternative
supplier outside the EU/notify the yes
the substance (Art. 6) Authorisation.
Does your non
•You are a •Youyou import make
Do are DU: substancesyes Does of your interest for that
Agencyyour non Do you import Svhc/
yes EU supplier yes
downstream user: sure your use
/preparations substance (Art. 28.4 and 28.5). preparations containing Svhc
EU supplier yes
have an only
check whether be outside the EU?
willfromincluded in See guideline 5
have an only from outside the EU?
representative the application for 4 representative
your use will be See guideline See guideline 4
covered.
in the EU? (Art.8) authorisation. in the EU? (Art.8) 4.3. Orgalime REACH Quick Screen 3
no no
See guideline 10
See guideline 5 no no no Registration of substances intentionally released from articles
Is the
an alternative substance or your use generally yes
Is there yes
Is there an exempted from authorisation? No further
yes Will the supplier pre-register/ no there an supplier in the EU
Is
requirement
alternative supplier (Art. 2, Art. 56.3 to 56.6)
who
register the substance/substances alternative supplierwill pre-register/
in the EU? in the EU? register? no
in preparations? (Art. 28)
no no Make uses
Is your use /category ofinventory of articles:
yes no
yes No further
yes Do you produce in
specifically exempted from the EU articles that No further
•You act as importer of •You act as importer of intentionally release
authorisation? (Art. 58.2) substances or do you requirement requirements
substance/preparation and may substance/preparation. import such articles from outside the EU?
Will the supplier cover your use no no
have to pre-register/register Is for an
•You may have to applytherean alternative
in his registration file? (Art. 37) yes Monitor Agency website
the substance on its own/ supplier who
authorisation and cannot benefitwill cover
yes Is the substance no and priority list (Art. 58.3)
in preparation (Art. 6) from an authorisation granted to your use? included in the candidate list (liable
for possible inclusion of
yes
•If Svhc: check Orgalime yes an actor up the supply chain no
Make inventory of
for authorisation)? (Art. 57 and 59) substances substance in candidate list.
for that use. intentionally released from the article: No further
Quick Screen 2 yes
See guideline 10 Are they exempted from registration? requirements
•Identify, apply and where suitable recommend •Carry out your own chemical See
Is the substanceguidelines 2 and 3 no Follow closely comitology
risk management measures communicated to you safety report (Art. 37.4, Annex XII) listed in annex XIV? procedure prior to inclusion
Check exemptions! yes no of substance in Annex XIV.
in safety data sheet or in information communicated
to you in accordance with Article 32. •Report to the Agency (Art. 38). yes
Has in accordance
Do you use a substancethe substance in the article
•Identify, apply and where suitable No further
See guideline 5 yes Notify the Agency within
recommend risk management been already registered
with the conditions of authorisation requirements
•If substance of very high concern (Svhc): 3 months of first supply
measures (Art. 37.5). for up
granted to an actorthat use? (Art. 7.6)
check Orgalime Quick Screen 2 (Art. 66.1).
See guideline 6 your supply chain? (Art. 56.2)
no See guideline 10
•If Svhc: check Orgalime no
Quick Screen 2 no
Is the substance present yes
Has the sunset date been reached? in article You may no longer further No use the
in quantity over 1 tonne per substance unless the request
requirements
RECOMMENDATIONS: no producer/importer per year? (Art. 7.1)
for an authorisation
•Start your substance inventory NOW. Apply for an authorisation yes
Do you wish to keep your use has been made at least
•Start communicating with suppliers EARLY: to ensure continuous supply of aown use. be PRO-ACTIVE,
for your substance, confidential?
yes
18 months before the sunset
don’t wait until the supplier has registered the substance you are using See guideline 10 communicating!
in processes to start date and the decision
no no
•Make sure the substance you use will be pre-registered. In case the substance you use has not been pre- no Is the substance intended
no Is the substance of very
is still pending (Art. 56.1). high No further
registered, you have the possibility to notify the Agency of your interest in that substance. The Agency shall to be released under normal and concern (Svhc)? (Art. 57) requirements
Is there alternative supplier Willforeseeable conditions of use? (Art. 7.1)
your supplier apply
publish on its website the name of that substance and, on request, provide your contact details to a potential no
who will apply for authorisation for your use?
registrant (Article 28.5 REACH). Transition periods for registration will however not be allowed. yes
for authorisation
•Check also Orgalime Quick Screens 2, 3 and 4 for further possible obligations. use?for your 13 yes yes
Notify the Agency within 3 months Notification obligations under
yes certain conditions and
of first supply (Art. 66.1).
•You have to register the substance (Art. 7.1).
See guideline 10 duty to communicate information
•If phase-in substance, make sure the substance down the supply chain may occur.
RECOMMENDATIONS: is pre-registered before 1 Dec. 2008 then register Check Orgalime
according to transition periods (Art.
•Please be aware that authorisation may cause substance withdrawal from the market. 23). Quick Screen 4
•If non phase-in substance or not pre-registered
•Application for authorisation must include an analysis of alternatives (Article 62.4 REACH). Please consider
substance, register before
manufacturing/importing/putting on to market.
Article 62.4 REACH at an early stage, especially if the use of the substance is critical the your processes.
•Check also Orgalime Quick Screens 1, 3 and 4 for See guideline 7
further possible obligations.
•If Svhc, check Orgalime Quick Screen 2
14
RECOMMENDATIONS:
Article producers/importers should pay attention under which provision of the REACH Regulation the intentionally
released substance/substance in preparation should be registered:
•If the substance that requires registration is considered as a substance delivered in a container, the substance has to
be registered according to Article 6 REACH. Please note that the container itself may be considered as an article
Guide available free of charge at
according to Article 3.3 REACH.
•If the substance to be registered is considered as a substance in an article, the substance requires registration
according to Article 7.1 REACH.
•Check also Orgalime Quick Screens 1, 2 and 4 for further possible obligations. 15
www.publications.orgalime.org
The European Engineering Industries Association
Conclusion
REACH : complex legislation
New duties for inter alia downstream users,
article producers and article importers
Important to prepare NOW
Orgalime practical guide to understanding
REACH Regulation 1907/2006
http://publications.orgalime.org/
The European Engineering Industries Association
Thank you for your attention!
Orgalime
Diamant building 5th floor
80 Boulevard Reyers
1030 Brussels
Secretariat@orgalime.org
Tel.:0032.(0)2.706.82.35
Fax.:0032.(0)2.706.82.50
www.orgalime.org
The European Engineering Industries Association
