How Downstream Users REACH?

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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

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• 35 Member Associations
• 23 European Countries
• 130 000 Companies
• 1779 Bn output 2006 (EU-27 estimates for the
  whole engineering industry)
• 10.6 Mio employment

FI
NO
SE
LV
DK
LT
IE
UK
PL
NL
DE
FR
CH
SL
HR
ES
PT
BG
IT
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Brief outline

• Introduction
• REACH priorities for DU
• Communication in the supply chain
• Substances in articles
• Authorisation procedures
• Conclusion

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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)

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REACH Regulation n1907/2006

• 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 RD, 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

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What focus for Orgalime?
Substance manufacturer/ importer e.g. chemical
industry
Formulator of preparations (1st level downstream
users) e.g. paint manufacturer
Downstream users of substances/ preparations (2d
level downstream users) Orgalime Industries
FEC industries

• Orgalime practical guide for downstream users,
  article producers and article importers to
  understanding Regulation N1907/2006 on
  REACH (May 2007)
• Available free of charge at www.publications.orgal
  ime.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

Article producers/ Article importers Orgalime
Industries FEC industries
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REACH prioritiesfor Orgalime industries
Check Orgalime quick screens 1,2,3,4
In the context of registration of substance Communication in the supply chain Title V (mainly)
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 conditions Article 33
Use of authorised substances/application for authorisation for substances included in Annex XIV REACH Title VII
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First and foremost
Check Orgalime Guidelines 1,2,3,4
What is my role in the supply chain?
Downstream user means. 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 ()
Establish inventories with key
information according to role

• Downstream user?
• Importer?
• ( only representative
• nominated in the EU?)
• Article producer/importer?
• A company may play
• several roles!

Article producer means. means any natural or
legal person who makes or assembles an article
within the Community

• Takes time and
• ressources -
• early preparation
• is key

Check REACH scope/exemptions
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Registration procedurein 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
•    

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Communication in the supply chain (1)
Check Orgalime 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!

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Communication in the supply chain (2)
Check Orgalime 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)

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Communication in the supply chain (3)
Check Orgalime 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 suppliers policy towards
substance/preparation used
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DU own chemical safety report
Check Orgalime 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 suppliers ES
covers DU uses
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Substances in articles
Check Orgalime Guidelines 7,8,9

• What is an  article ?
• 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.
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Registration of substancesintentionally 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)

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Notification of substances present in articles
Check Orgalime guideline 8

• 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)

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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

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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)

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Authorisation procedure (1)
Check Orgalime 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

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Authorisation procedure (2)
Check Orgalime 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.

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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
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To know more. Orgalime REACH guide
Guide available free of charge at
www.publications.orgalime.org
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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/

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Thank you for your attention!

• Orgalime
• Diamant building 5th floor
• 80 Boulevard Reyers
• 1030 Brussels
• Secretariat_at_orgalime.org
• Tel.[phone]
• Fax.[phone]
• www.orgalime.org