PowerPoint Presentation - FEC by wuxiangyu

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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

								
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