REACH USA 2008 SOCMA CEC How to Implement a REACH-Proof System in a Company! ..

1. REACH USA 2008SOCMA CECHow to Implement a REACH-Proof System in a Company!.. Evonik Degussa GmbH Shaun Clancy Friday 16 May 2008

2. About Evonik Degussa GmbH As an industrial group with three business sectors. Evonik is a new name announced on September 12, 2007 Evonik Industries Energy Real Estate Chemicals 2006 sales: €10,1 billion Employees: about 32000 2006 sales: €2,6 billion Employees: about 4600 2006 sales: €0,4 billion Employees: About 500 RAPRA Boston Volker Soballa 2008

3. Elements of REACH: Scope (2) STRUCTURE • Elements of REACH (scope, R&D, articles) • Time frame • Roles under REACH • Evonik Degussa´s REACH Project • Implementing REACH • Where do we stand today? • Useful helpdesks RAPRA Boston Volker Soballa 2008

4. What means REACH? REGISTRATION EVALUATION AUTHORISATIONand RESTRICTION of CHEMICALS RAPRA Boston Volker Soballa 2008

5. Elements of REACH: Scope (1) Scope: • REACH is valid for all substances, being manufactured or imported in amounts exceeding 1 ton/year BUT: • Completely exempt from REACH: • Radioactive substances • Non-isolated intermediates • Substances under customs control • Waste (according to 75/442/EC) • Subject to transportation regulation • Defence RAPRA Boston Volker Soballa 2008

6. Elements of REACH: Scope (2) Scope: • Exempt only from registration, evaluation and information duties: • Annex IV: e.g.: water, starch, vitamin A, glucose…. • Annex V: e.g.: by-products, hydrates, natural substances…… • Polymers (from registration and evaluation, not from authorisation!) • Re-imported, already registered substances • Substances already regulated (e.g. Medical products, foodstuff, Biocides, feedstuff….) under revision RAPRA Boston Volker Soballa 2008

7. Elements of REACH: R&D Special exemptions for R&D-substances Substances of product- and process oriented R&D are exemptedfor a period of 5 years. The Agency may extend the five-year exemption by a further maximum of five years (5+5). The manufacturer/importer shall notify the Agency of some basic information (manufacturer, substance identity, C&L, amount, customer) RAPRA Boston Volker Soballa 2008

8. Elements of REACH: Articles Articles Substances in articles have to be registered only if: - The substance in the article exceeds 1 metric ton/year per manufacturer and - The substance is intended to be released under normal or foreseeable conditions No intended release intended release mobile pen tyre cartridge RAPRA Boston Volker Soballa 2008

9. REACH-Time frame (pre-registration, registration) 1 June 2007 + 12 months: Start ofpre-registration/registration period Pre-registration required for utilizing the transition periods for phase-in substances End of pre-registration period + 18 months: Start of transition periods for registration of pre-registered substances (Art. 21) + 3,5 years: Registration:  CMR 1+2;  R 50/53 > 100 mt/a;  Substances > 1,000 mt/a Registration: Substances 100-1,000 mt/a + 6 years: + 11 years: Registration: Substances 1-100 mt/a RAPRA Boston Volker Soballa 2008

10. Time frame of REACH (all parts) 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 ChemG Registration acc. REACH (incl. evaluation + authorisation) Registration of non-phase-in-substances 0,5 years Pre-registration of phase-in-substances missing pre-registration means registration as Non-Phase-in-substance Registration of phase-in-substances • substances >1000 t/a • substances R50/R53 and >100 t/a • CMR, categories 1 and 2, >1 t/a 3,5 years 6 years • substances >100 – 1000 t/a 11 years • substances 1 – 100 t/a 5 years (+ 5 years prolongation possible) Registration of R&D-substances Subsequent requirements Dossier evaluation by the Agency Authorisation Inventory of Classification & labelling of Substances placed on the market Transition period 01.06.07 – REACH effective 01.06.08 – opening of Europ. Chemicals Agency 30.11.08 - end of pre-registration 31.05.09 - presentation of Candidate list (every 2 years) RAPRA Boston Volker Soballa 2008

11. Roles under REACH (1) Registrant: Means the manufacturer or the importer of a substance or the Manufacturer or importer of an article submitting a registration for a substance. Manufacturer: Means any natural or legal person established within the Community who manufactures a substance within the EU. Importer: Means any natural or legal person established within the EU who is responsible for import of substances into the EU. Downstream user: Means any natural or legal person established within the EU, other than the 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. - Distributor: Distributor is not a downstream user. - Consumer: Consumer is not a downstream user. - Re-importer: Re-importer is a downstream user. . RAPRA Boston Volker Soballa 2008

12. Roles under REACH (2) Import: Means the physical introduction into the customs territory of the EU. Who is an importer? This definition is still under discussion! Some explanation: • Importer is the entity that pays the import duties (to be discussed). Please note that the person responsible for the physical introduction into the EU customs territory is not necessarily the person responsible for the customs clearance. • The responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but this might not be conclusive on its own. • Possibility of using an Only Representative (OR). This option provided for in Art 8 will be very relevant for multinational companies with major production sites outside the EU. RAPRA Boston Volker Soballa 2008

13. Evonik Degussa´s REACH – Project Objectives Preparation, organization, tools, cost, clearinghouse, technical questions Steering Committee • Board/Head of ESHQ Tasks and responsibilities • Sponsoring Project team • Overall project coordination • Central monitoring (pre-registration data, Group-wide processing status) • Communication: current status of implementation (nat./internat. associations) • Management of REACH Implementation Working Group • Support for subgroups • Definition and controlling of milestones • Inclusion of Regions, Procurement, and Marketing • Degussa Corporate ESHQ REACH Implementation Working Group Authorized officers of the business units (primarily product safety), IT, LI, PR … 5 Subgroups (SG) • Coordination and decision-making body for all REACH-relevant questions • Determination of joint approaches • Interpretation of the REACH Regulation (clearing) • Harmonization of decentralized activities (to avoid duplication of work) SG4: Consortia SG1: Pre-registration SG2: Evaluation SG3: Communication SG5: IT Tools • Development of approaches and proposals • SG1: Substance identification, checklists, data requirements • SG2: Standard dossiers, CSR, exposure scenarios, categories • SG3: Questionnaires, training, procurement, raw materials, authorization letters • SG4: Establishment of consortia (agreements), preparation of SIEF • SG5: System environment, IUCLID. REACH-IT, SuRe, data recording, volume Business Units RAPRA Boston Volker Soballa 2008

14. Evonik Degussa´s REACH - Project REACH Subgroups (assigned Nov. 2006) RAPRA Boston Volker Soballa 2008

15. Implementing REACH (1) 1st Action: Inventory (done) • Compile an inventory of all substances and preparations that the company handles (CAS, EINECS) • Product • Intermediate (“On site”): simple registration (name, company, C&L, available data, no tests) • Intermediate (“transported”): simple registration, under strictly controlled conditions, beginning with quantities of 1,000 metric tons/year: Annex VII necessary • Polymers (Register monomers!, clarify whether PBT, vPvB) • Break preparations down into their individual substances • Raw materials as manufacturer, importer, user (break down according to purchased within the EU, outside the EU) • Assign the names/addresses of customers/suppliers to all substances (important for communication in the supply chain) • Assign substances to the tonnage bands (observe deadlines; “distribute” quantities, if needed) • Assign applications (own use, customer) RAPRA Boston Volker Soballa 2008

16. Implementing REACH (2) Pre-registration Registration 2st Action: Develop IT (in progress) Degussa Database Evaluations (e.g., Excel, Access, Web) • Substance • Registration Decisions • - Substance name, LE • Decision data (generally, not in IUCLID 5) • cost planning Pre-registration substances - Substance name, LE - Little data Registration Substances - Substance name, LE - Registration data • Management Data • - Substance checklists • Endpoint status • Endpoint costs Add on IUCLID5 Add on Add on IUCLID5 Front End Front End (Access, Web) RAPRA Boston Volker Soballa 2008

17. Implementing REACH (3) 3th Action: Information in the Supply Chain • 1. Step: Questionnaires (supplier), e.g. Cefic-portal “REACH-LINK”), own IT-Portal • 2. Step: Questionnaires (customer), e.g. Cefic-portal “REACH-LINK”), own IT-Portal • Additional limit values, requirements etc.: • DNEL (Derived No Effect Level) • PNEC (predicted no effect concentration) (http://chimie.ineris.fr/en/index.php/) • PEC (predicted effect concentation) (PEC/PNEC <1) • Exposure scenarios (RIP 3.2-2) • Use and exposure categories (UEC) • Wastewater, water treatment plant • Extended safety data sheets (eSDS) • For the present, change the order of Chapters 2 and 3, and provide e-mail address. Later, the data listed above. • Necessary to modify all SDS since June 1? No: RAPRA Boston Volker Soballa 2008

18. Implementing REACH (4) Conclusion The Chair of Commission Working Group (CWG) concluded that there was consensus that the content, not the format, of the SDS is the priority for the enforcement and that the changes required by REACH; that is, the changed order of Chapters 2 and 3 and the addition of the e-mail address can be introduced when (substantial) changes/updates are made of the SDS. A substantial change could be classification according to GHS or the addition of exposure scenarios. The changes required by REACH should be introduced, however, before the first deadline for registration on December 1, 2010. RAPRA Boston Volker Soballa 2008

19. Implementing REACH (5) 4nd Action: Pre-registration • Pre-registration • All substances in quantities > 1 metric ton/year that will be manufactured/imported in the future (in 11 years), including intermediates • EINECS substances (substances currently manufactured and imported) • Substances that are manufactured in the EU, but have not been marketed in the 15 years prior to REACH (e.g. intermediates, export products, R&D) • No-longer polymers (NLP) • Monomers being part of polymers • Substances manufactured and imported earlier (this includes all substances that could possibly be “revived” again) -> better too many than too few! • Substances from preparations (information from suppliers, check quantities: 0.1% = 1 metric ton of 1,000 metric tons) • All legal entities (LE) within a company must pre-register! • Pre-register all strategic or critical raw materials! RAPRA Boston Volker Soballa 2008

20. Implementing REACH (6) 5th Action: Registration • Registration for phase-in substances is staggered. Phase 1: (Jun. 2008 – Dec. 2010) • Substances in quantities > 1,000 metric tons/year • CMR substances in quantities > 1 metric ton/year • Substances that are extremely toxic to aquatic organisms and are produced in quantities > 100 metric tons/year • Phase 2: (Jun. 2008 – Jun. 2013) • Substances in quantities > 100 metric tons/year Phase 3: (Jun. 2008 – Jun. 2018) • Substances in quantities > 1 metric ton/year RAPRA Boston Volker Soballa 2008

21. Where do we stand today (1) REACH completely changes the situation for manufacturer and importer • Same data requirement for existing and new substances • In principle, substances > 1 to/year do need: • pre-registration • registration (dossier) per Legal Entity • authorisation (in some cases) • Depending on tonnage band, distinct data (toxicological, eco-toxicological, physical-chemical) are required • Uses must be identified and registered per Legal Entity • Exposure scenarios must be prepared • Chemical Safety report must be prepared • Communication with suppliers and customers must be intensified • The SDS must be extended (eSDS), e.g. use and exposure categories/exposure scenarios, uses, RAPRA Boston Volker Soballa 2008

22. Where do we stand today (2) That means: You as manufacturers from outside the EU have the same duties as manufacturers from inside the EU. Therefore you need to: • Define your role under REACH • Check, whether you bring substances in amounts > 1to/year into the EU • Check, whether any exemption might be applicable • Seek a partner within the EU (e.g. Only Representative), who will fulfil all requirements of REACH, e.g. pre-registration, registration dossier, risk assessment, Chemical Safety Report (CSR), extended Safety Data Sheet, tracking of amounts brought to EU market etc. • Prepare a registration dossier and use the official IT-tool IUCLID 5 • Use the pre-registration phase properly (transition periods!) RAPRA Boston Volker Soballa 2008

23. Useful helpdesks • BAuA (Federal Institute for Occupational Safety and Health www.reach-helpdesk.de • Cefic (European Chemical Industry Council) www.reachcentrum.org • BDI (German Industry Association): www.reach.bdi.info/ • IUCLID 5 program (for preparation of registration dossier) http://ecbwbiu5.jrc.it/ • ECHA (European Chemicals Agency) http://echa.europa.eu/ RAPRA Boston Volker Soballa 2008

24. Contact: Volker J. Soballa Volker.soballa@evonik.com RAPRA Boston Volker Soballa 2008

25. Thank you very much for your attention! RAPRA Boston Volker Soballa 2008