2. 2echa.europa.eu/reach-2018 Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about the REACH 2018, i.e. last registration deadline of phase-in substances. The intention is that you can select relevant slides and modify them as necessary to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission. This presentation gives a brief overview of the registration in the context of REACH and gives an overview of ECHA’s REACH 2018 Roadmap. It is the opening of a series of presentations relating to REACH 2018, which are on the ECHA website. We welcome your comments and suggestions at reach- 2018@echa.europa.eu. Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Release: May 2016

3. Outline Background REACH registration by 2018 ECHA‘s REACH 2018 Roadmap Six phases to successful registration REACH 2018 Communication 3echa.europa.eu/reach-2018

4. Background

5. 5echa.europa.eu/reach-2018 REACH registration Knowledge on hazards and uses of substances is a pre-requisite for responsible action REACH puts the burden of proof to individual companies – they have to demonstrate that their substances can be used safely Companies collect information, analyse it and document their conclusions in a registration dossier Information from registrations is used by authorities and published by ECHA on its website Registration of chemicals already in the European market in a stepwise manner: 2010, 2013 and 2018

6. 6echa.europa.eu/reach-2018 Information flow from registration

7. 7echa.europa.eu/reach-2018 Public information on chemicals comes from registrations Infocard Brief Profile Registration dossiers CoRAP List Authorisation List Restriction List Harmonised C&Ls Approved Active Substances PIC Annex I Source Data

8. REACH registration by 2018

9. 9echa.europa.eu/reach-2018 REACH 2018 Third and last registration deadline for phase-in substances Concerns: Companies that manufacture/import substances between 1 to 100 tonnes/year and have pre-registered them What is new? – Higher % of SMEs – Many SMEs might consider becoming lead registrants for the first time – Many small SIEFs/registrants alone in their SIEF – Less information  need to generate new data – Different levels of sector organisations – New economical and political contexts

10. 10echa.europa.eu/reach-2018 REACH 2018 - 2 Experience proves: REACH registration is manageable! – Thousands of companies have already done it since 2008 – More than 5 600 registrations for the last deadline received, 16% from SME companies ECHA, European Commission, national authorities and industry organisations are joining their forces to support companies!

11. ECHA’s REACH 2018 Roadmap

12. 12echa.europa.eu/reach-2018 Roadmap document Published on 14 January 2015 – Consultation with stakeholders June–September 2014 – Comments received from 26 organisations Documents ECHA’s activities planned for 2014-2018 – Actions to support inexperienced and SME registrants – Main focus in improving the readability and accessibility of support material – Milestones revised on an annual basis; annual progress report published Must be complemented by Member State and industry actions for successful management of the 2018 registration deadline

13. Roadmap structure: Seven phases 13echa.europa.eu/reach-2018 Know your portfolio Find co-registrants Share data Assess hazards and risks Prepare your dossier Submit your registration Keep your dossier up-to-date

14. 14echa.europa.eu/reach-2018 Know your portfolio Identify if you need to register (role in the supply chain) and if yes, which substances in your portfolio need to be registered Identify and name your substances  accurate identification essential for data sharing and joint registration Familiarise yourself with the information requirements Plan your work and inform your downstream users

15. 15echa.europa.eu/reach-2018 Find your co-registrants Check your pre-registration Identify the lead registrant, or Find your co-registrants Discuss the sameness of your substance to share data and submit jointly

16. 16echa.europa.eu/reach-2018 Share data Organise your SIEF cooperation, or get active in the existing SIEF of your substance Share data to meet your information requirements – Avoid unnecessary testing on animals – Reduce costs of registration Negotiate costs in a fair, transparent and non- discriminatory manner Share the costs of common data

17. 17echa.europa.eu/reach-2018 Assess hazards and risks Information required depends on tonnage and uses 1-10 tonnes: Possible reduced data requirements for less hazardous substances > 10 tonnes: chemical safety report needed Pay attention to data quality: relevance, adequacy and reliability Animal testing is the last resort - consider alternatives first Some long-term studies require a testing proposal

18. 18echa.europa.eu/reach-2018 Prepare your dossier Prepare your technical dossier in IUCLID – Identity of the registrant – Identity of the substance – Information on the substance’s intrinsic properties – Information on use and exposure Companies preparing a member dossier without any opt-outs can do it on-line in REACH-IT Chemical safety report needs to be included if manufacture/import is at or above 10 tonnes/year – Use of ECHA tool Chesar recommended ECHA provides IUCLID free-of-charge

19. 19echa.europa.eu/reach-2018 Submit your registration Check and update the information that is relevant for registration in REACH-IT Carefully assess your SME status Set up or join the joint submission in REACH-IT Submit your registration dossier: first the lead registrant, then all co-registrants Follow up on the communication in REACH-IT

20. 20echa.europa.eu/reach-2018 Keep you registration up-to-date Registration dossier is a living document! Duty to update the registration dossier if – Regulatory decision – New information on substance (properties, uses) Be proactive – Consult ECHA’s Evaluation Progress Reports for most common anomalies in registration dossiers – Follow regulatory developments for your substance on the ECHA website

21. REACH 2018 Communication

22. 22echa.europa.eu/reach-2018 REACH 2018 website: http://echa.europa.eu/reach-2018 Simple language Available in 23 languages Structured around the registration workflow ECHA support material for each step organised in three layers of complexity – Getting started – Essential reading – Going deeper Advance notice on upcoming issues

23. 23echa.europa.eu/reach-2018

24. 24 Support material in three categories echa.europa.eu/reach-2018 1.Getting started: An overview of what the phase is about 2.Essential reading: More about the content to help you decide e.g. if you need to outsource the work 3.Going deeper: How to carry out the tasks

25. 25echa.europa.eu/reach-2018 REACH 2018 Communicators’ Network Set up to: -Plan and coordinate awareness raising activities -Help to produce and distribute material in all EU languages -Collect feedback from target audiences -Measure impact of coordinated activities ECHA, European Commission, Member States, industry organisations, Enterprise Europe Network local organisations Active since early 2015

26. 26echa.europa.eu/reach-2018 Joint activities around phase launches

27. 27echa.europa.eu/reach-2018 Awareness raising through various audiences