Jan Vernon Risk & Policy Analysts Ltd Jan@rpalon.demon.co.uk

REACH Implementation Projects Guidance Workshop Guidance for the downstream user: Reach Implementation Project 3.5 Jan Vernon Risk & Policy Analysts Ltd Jan@rpalon.demon.co.uk

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

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”

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

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

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)

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

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)

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

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?

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?

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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.

Jan Vernon Risk & Policy Analysts Ltd Jan@rpalon.demon.co.uk