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

2. RAPRA Boston Volker Soballa 2008Seite | 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 Chemicals Real EstateEnergy 2006 sales: €10,1 billion Employees: about 32000 2006 sales: €2,6 billion Employees: about 4600 2006 sales: €0,4 billion Employees: About 500

3. RAPRA Boston Volker Soballa 2008Seite | 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

4. RAPRA Boston Volker Soballa 2008Seite | 4 What means REACH? R EGISTRATION E VALUATION A UTHORISATION and RESTRICTION of CH EMICALS

5. RAPRA Boston Volker Soballa 2008Seite | 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

6. RAPRA Boston Volker Soballa 2008Seite | 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….)

7. RAPRA Boston Volker Soballa 2008Seite | 7 Elements of REACH: R&D Special exemptions for R&D-substances Substances of product- and process oriented R&D are exempted for 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)

8. RAPRA Boston Volker Soballa 2008Seite | 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 cartridge mobile tyre pen No intended releaseintended release

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

10. RAPRA Boston Volker Soballa 2008Seite | 10 200920102011201220132014201520162017200720082018 Registration acc. REACH (incl. evaluation + authorisation) Subsequent requirements 3,5 years 11 years 6 years 5 years (+ 5 years prolongation possible) ChemG Transition period Authorisation Pre-registration of phase-in-substances Registration of phase-in-substances Inventory of Classification & labelling of Substances placed on the market substances >1000 t/a substances R50/R53 and >100 t/a CMR, categories 1 and 2, >1 t/a substances >100 – 1000 t/a substances 1 – 100 t/a Registration of non-phase-in-substances 01.06.07 – REACH effective 01.06.08 – opening of Europ. Chemicals Agency Dossier evaluation by the Agency 30.11.08 - end of pre-registration 31.05.09 - presentation of Candidate list (every 2 years) Registration of R&D-substances Time frame of REACH (all parts) missing pre- registration means registration as Non- Phase-in-substance 0,5 years

11. RAPRA Boston Volker Soballa 2008Seite | 11 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.. Roles under REACH (1)

12. RAPRA Boston Volker Soballa 2008Seite | 12 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. Roles under REACH (2)

13. RAPRA Boston Volker Soballa 2008Seite | 13 Steering Committee Board/Head of ESHQ Evonik Degussa´s REACH – Project 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 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 Sponsoring Tasks and responsibilities Project team Degussa Corporate ESHQ REACH Implementation Working Group 5 Subgroups (SG) SG1: Pre-registration SG2: Evaluation SG3: Communication SG4: Consortia SG5: IT Tools 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) Authorized officers of the business units (primarily product safety), IT, LI, PR … Objectives Preparation, organization, tools, cost, clearinghouse, technical questions Business Units

14. RAPRA Boston Volker Soballa 2008Seite | 14 Evonik Degussa´s REACH - Project Degussa REACH Implementation Working Group (assigned Jan/2006) REACH Subgroups ( assigned Nov. 2006) Pre-registrationEvaluationCommunicationConsortiaIT tools Pre-registrationRisk assessmentProcurement (checklist) Data sharingInternal IT (SuRe, EH&S etc.) Checklist (for Product safety) Registration dossier Marketing, salesCosts of studies, values Degussa REACH- Base Substance identification Form of CSR (standard) Survey, questionnaires Competitors, contracts Volume thresholds (SVT) IT (Agency)CSR, ES, UEC..Training (intern. customers..) Contacts, letter of acc. REACH IT (Agency) Flyer/LetterAuthorizationStandardizationSIEF prep.IUCLID 5

15. RAPRA Boston Volker Soballa 2008Seite | 15 Implementing REACH (1) 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) 1 st Action: Inventory (done)

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

17. RAPRA Boston Volker Soballa 2008Seite | 17 Implementing REACH (3)  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/)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: 3th Action: Information in the Supply Chain

18. RAPRA Boston Volker Soballa 2008Seite | 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.

19. RAPRA Boston Volker Soballa 2008Seite | 19 Implementing REACH (5) 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! 4nd Action: Pre-registration

20. RAPRA Boston Volker Soballa 2008Seite | 20 Implementing REACH (6) 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 5th Action: Registration

21. RAPRA Boston Volker Soballa 2008Seite | 21 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, Where do we stand today (1)

22. RAPRA Boston Volker Soballa 2008Seite | 22  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!) 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:

23. RAPRA Boston Volker Soballa 2008Seite | 23  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/ Useful helpdesks

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

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