European Commission Enterprise and Industry Directorate-General European Commission workshop on RIP 3 Development of REACH Guidance for Industry Brussels, 25 September 2006 Brief outline of timelines and obligations of industry under REACH Otto Linher DG ENTR / G1 - REACH Will we reach REACH? ð REACH is a considerable challenge ð It covers a very wide range of issues and substances ð How can guidance help companies? ð Companies will look for simple guidance ð Companies will ask us to cover their specific issues in sufficient detail 26/09/2006 2. How can we reach REACH? ð Simple guidance needs to be available ðfor those with limited experience and capacities (normally also those with limited obligations under REACH) ðto give an overview for more experienced users ð In addition, detailed guidance need to be provided ðfor those who have more substantial obligations ðfor those who need specific information 26/09/2006 3. HOW can you reach REACH? Key steps: § Start today with analysing your portfolio of chemicals! § Check the scope of obligations § Identify your role and tasks under REACH § By when do tasks have to be fulfilled? 26/09/2006 4. Scope of obligations ð REACH applies to the manufacturing, import, placing on the market and use of substances § However, there are exemptions for certain: § Substances § Uses of substances § Reduced obligations for research, product and process related research and development (PPORD) and intermediates 26/09/2006 5. Downstream users: Obligations ð Downstream users are users of chemical substances that are neither produced nor imported by the company ð Be careful not to overlook that you also may be an importer! u Key question: Do you receive Safety Data Sheets? ð If no: only very limited obligations under REACH ð If yes: apply the risk management measures identified in the SDS 26/09/2006 6. Downstream users: Rights u DUs have the right: v To make their uses known to manufacturers/importers To carry out their own CSA (e.g. for confidentiality reasons) To contribute to SIEFs v v 26/09/2006 7. Manufacturers/Importers: Registration § Registration for all substances >1 t § Chemical Safety Report (CSR) for all substances >10 t ð In the absence of available information, tests may have to be conducted ð Data sharing (in particular for vertebrate tests) ð Substance Information Exchange Fora (SIEFs) 26/09/2006 8. Manufacturers/Importers : Registration § Timetable: v Non phase-in substances (neither in EINECS nor already registered): before a substance can be marketed Phase in substances: benefit from transition periods if preregistered w v Pre-registration: 12 to 18 months after entry into force (except where newly produced/imported) s s Identify substance, manufacturer, tonnage band/deadline Agency will publish list w Registration: Transition period depending on the tonnage band 26/09/2006 9. (Pre)Registration Timeline REACH (not to scale) Request Data SIEF December 2008 > 1t/a April 2018 Pre-registration PreApril 2008 – October 2008 EIF April 2007 EIO Agency April 2008 List + SIEF November 2008 >1000 t/a Prepare testing strategies, CSA CMR >1 t/a aqu.tox.>100 t/a aqu.tox.>100 100 - 1000 t/a April 2013 April 2010 Reg ‘new’ subst. C&L notification (independent of tonnage) 26/09/2006 10. Substances in articles § Registration required if: § Substance is intended to be released, and § Substance is present in quantities >1 t § Notification required if: § Substance is on candidate list for authorisation § Substance is present in quantities >1 t § Substance is present in concentration >0.1% by weight (except where there is no exposure; at the earliest 42 months after entry into after force, or 6 months of identification of substance on candidate list) list) 26/09/2006 11. Evaluation § Dossier evaluation: checking completeness and compliance of registration dossiers § Substance evaluation: checking whether further information is needed on a substance 26/09/2006 12. Authorisation/Restriction § Authorisation: for substances of very high concern § Identification of SVHC § “Sunset date” by which manufacturing and use is only allowed if it is covered by an authorisation § Restriction: only minor changes compared to existing system § Also manufacturing covered § Wider range of possible measures 26/09/2006 13. Will we reach REACH? § Most downstream users and SMEs will have limited obligations ð Simple guidance will be available ð More information will come from manufacturers/importers § However, manufacturers/importers will have more significant obligations, depending on: § Hazards and risks of substances § Production volume ð Careful check needed to identify tasks and obligations ð Guidance will assist and can be used to look up details 26/09/2006 14. European Commission Enterprise and Industry Directorate-General ðThank you! 26/09/2006 15.