Transcript Business Impact Assessment

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Risk & Policy Analysts
REACH Implementation Projects Guidance
Workshop
Guidance for the downstream user: Reach
Implementation Project 3.5
Jan Vernon
Risk & Policy Analysts Ltd
[email protected]
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, endusers, 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 <1t/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.
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