REACH Implementation Projects Guidance Workshop Guidance for the downstream user: Reach Implementation Project 3.5

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REACH Implementation Projects Guidance Workshop
Guidance for the downstream user Reach
Implementation Project 3.5

• Jan Vernon
• Risk Policy Analysts Ltd
• Jan_at_rpalon.demon.co.uk

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Objectives of RIP 3.5

• Enable the user of a substance or preparation to
  identify easily what is required of them under
  REACH
• Give the necessary guidance on meeting those
  requirements
• Supply-chain driven, usable by different actors

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Status of the guidance (1) Disclaimer

• This document aims at helping companies to
  fulfil their obligations under the REACH
  Regulation. Its content does not constitute
  professional or legal advice. Only the text of
  the Regulation is authentic and the Commission
  accepts no responsibility or liability whatsoever
  with regard to the information in this
  publication

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Status of the guidance (2)

• The guidance distinguishes as clearly as possible
  between obligations under REACH (with references
  to specific articles) and voluntary activities
  which may help to meet those obligations
• Legal interpretations of obligations have been
  sought from Commission lawyers where necessary
• Voluntary guidance is based on the advice of the
  SEG and input from case studies with a wide range
  of downstream users

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Target Group

• REACH defines DUs as
• any natural or legal person established
  within the Community, other than a 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.
• Distributors are not DUs under REACH, but have
  obligations which are addressed in the guidance

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RIP 3.5-1 Preliminary Study

• Evaluation of current experience (what are the
  barriers to communication)
• Characterisation of DUs (who are they and how do
  they differ)
• Analysis of DU obligations under REACH (what is
  required)
• Development and pilot-testing of a general
  structure for the guidance (TGD)
• Report available at http//ecb.jrc.it/REACH
  (select document, public access, RIP Final
  Reports, RIP 3.5-1)

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RIP 3.5-2 Main Project

• Further development of procedures, methods,
  formats and tools
• Targeting of guidance needs
• Case-studies in different sectors/supply chains
  to provide examples for the text (closely
  co-ordinated with RIP 3.2)
• Final version of Technical Guidance Document
• Final report will be submitted in October 2007
  publication will follow approval by the
  Commission Working Group

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Challenges in Preparing Guidance

• Making a complex process simple to follow
• Different requirements of different users
  (formulators vs users, SMEs and professional
  users, distributors)
• Interactions with other RIPs (especially 3.2,
  regarding exposure scenarios)
• Overcoming communication barriers
  (confidentiality, linguistic especially REACH
  vocabulary, dissemination)

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General Approach of the Guidance

• Introductory sections give the background (how to
  use the guidance, roles and obligations of DUs,
  preparing for REACH)
• The main sections provide further detail to help
  downstream users to meet their specific
  obligations
• Charts workflows - outline the overall
  processes (compliance with REACH, communication
  upstream and downstream)
• Text explanations provide additional guidance,
  indicate sources of further information
• ABBREVIATIONS AVOIDED AS FAR AS POSSIBLE

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Questions answered by the guidance (1) general

• What is REACH and what does it mean for me?
• Am I a DU and what are my obligations?
• How should I prepare for REACH?
• What should I do when I receive information from
  my suppliers?
• What if the information includes an exposure
  scenario?
• What if the exposure scenario does not cover my
  use?

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Questions answered by the guidance (2) specific

• How do I prepare a downstream user CSA?
• How do I inform my supplier of my use?
• What information will my supplier need and how
  can I get it?
• What if I disagree with information in the SDS or
  ES
• What is authorisation and what does it mean for
  me?
• What are restrictions?
• I am a formulator what do I need to do?
• I am a distributor what are my duties?

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Who is a downstream user

• Downstream users include formulators, end-users,
  craftsmen, professional service providers,
  re-fillers, importers where there is an only
  representative, re-importers
• Distributors are not downstream users but have a
  specific duty to communicate information up and
  down the supply chain

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Key obligations of downstream users

• Identify and apply appropriate measures to
  adequately control the risks identified in
  information supplied to you
• Check compliance with the exposure scenario, if
  received
• Check compliance with any authorisation
  conditions or restrictions
• Inform suppliers of any new information on
  hazards of the substances you use or that might
  call into question risk management measures
• Forward relevant information to your customers
  (SDS, ES, other information) or include their use
  in your chemical safety report

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Preparing for REACH

• The guidance stresses the benefits of preparing
  for REACH, especially early communication with
  suppliers and customers
• Voluntary actions are suggested to help DU
• Understand the substances they use
• Gather information that suppliers might need
• Decide who to contact, when and how

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Responding to information received

• Receipt of an SDS and/or other information is the
  key trigger for action
• Checking compliance with an SDS is even more
  important than now, because of the duty to apply
  relevant risk management measures
• For many companies and substances, this may be
  the main requirement of REACH
• If an exposure scenario is received, more
  detailed checking is needed

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Checking compliance with the exposure scenario

• There are three potential outcomes
• Your conditions of use and risk management
  measures correspond to the ES you comply
• Your conditions/measures give rise to higher
  exposure you do not comply
• Your condition/measures are different in type and
  scale, but require further checking (and maybe
  scaling of parameters) to establish compliance

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If you do not comply with the exposure scenario

• Various options are identified
• Request to your supplier that your use becomes
  identified
• Prepare your own DU chemical safety report
  (unless you use lt1t/y)
• Implement the conditions of use in the exposure
  scenario
• Find another supplier with an exposure scenario
  that covers your use
• Substitute the substance/preparation with one
  that covers your use

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Making a downstream user chemical safety report

• The detailed methodology is covered by the
  guidance on preparing a chemical safety report
  (RIP 3.2)
• Focus of the RIP 3.5 guidance is on
• Identifying the exact requirements
• Outlining the process
• Giving an overview of the method
• Explaining basic hazard assessment options
• The case studies indicated that few end users are
  likely to take this step themselves

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Requesting that a use becomes identified

• You have the right to make a use known, with the
  aim of making it an identified use in the
  registration
• But there are some constraints to this right
• If your immediate supplier is another DU, he may
  chose neither to forward your request to the
  registrant nor to include you in his DU CSA (Art
  37.3)
• In this case, or if a request is refused for
  non-safety reasons, the supplier must stop
  supplying
• So making a formal request has some risks for DU

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Communicating on use conditions (1) when to
communicate

• When preparing for REACH, to ensure suppliers are
  aware of your use and can include it in their
  registration
• When requesting that a use becomes identified
• Responding to supplier enquiries
• Many companies will already hold much of the
  information required, in occupational health or
  environmental management systems

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Communicating on use conditions (2) what to
communicate

• The RIP 3.2 standard short descriptor system
  provides a starting point drop-down menus for
  industry type, technical function, process
  category, article category
• Details of the conditions of use are needed to
  prepare an ES guidance is given on internal
  sources of the information required
• Suppliers may develop questionnaires for this
  there is no single format but examples are given
  in RIP 3.2
• Sector associations may develop standard
  descriptions

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Managing preparations (1) Obligations

• Provide SDS (as now, but also when containing
  PBTs, vPvBs above 0.1 w/w)
• Communicate information when no SDS required
  (when containing substances subject to
  authorisation, restrictions or when needed to
  enable risk management)
• Identify, apply and recommend suitable risk
  management measures (as now)
• Include relevant exposure scenarios you receive
  when delivering SDS for your preparation

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Managing preparations (2) main changes in SDS

• Minor changes in overall format
• New information required in several sections
• 1 registration numbers of substances
• 2 identified uses
• 3 PBT/vPvBs and registration numbers
• 7 reference to any sector-specific guidance
• 8 available DNEL/PNEC, list all RMM and
  summarise RMM for identified use
• 12 results of PBT/vPvB assessment
• 13 waste management measures
• 15 authorisation and restrictions
• 16 uses advised against

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Managing preparations (3) voluntary steps

• Merge exposure scenarios you receive to provide a
  consolidated exposure scenario to your customers.
  Guidance
• When customer is a formulator, forward separate
  exposure scenarios
• When customer is an end-user, consolidate
• Take account of substances for which you have not
  received an exposure scenario (e.g. during
  phase-in)

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Managing preparations (4) merging ES

• Key steps
• Select substances for consideration (exclude
  those below threshold, decide about those where
  you have no ES)
• Compare SDS/ES of selected substances (exposure
  routes, classification, PNEC/DNEL)
• If no overlap of exposure types, merge
• If there is overlap, use critical component
  analysis to identify the most appropriate use
  conditions/risk management measures

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RIP 3.5 conclusions and next steps

• For most downstream users, REACH will be quite
  simple and only certain sections of the guidance
  will be required
• Others will require more detail, particularly
  formulators
• The modular structure of the guidance, linked to
  the navigator is designed to address these
  differences
• Next steps finalisation of the guidance, with
  most work on preparations address any further
  changes in RIP 3.2 guidance submit to the
  Commission for finalisation.