Ursula Schumacher

1. Chemicals Inventory Management as a Tool to Check Compliance with Restricted Substances Regulations Ursula Schumacher

2. Contents • Chemicals Safety Regulations • Legal Approaches • Chemicals Registration: REACH • Effect on Industries • Chemical Safety Assessment • Substances of Very High Concern SVHC (new„Blacklist“) • Communication up and down the supply chain • The Need to Manage the Chemicals Inventory • Basic Features of a Chemicals Inventory System • Intertek‘s „ChemSafe“ Solution AAFA Seminar Sept. 21, 2006in Dongguan, China

3. Chemicals Safety Regulations AAFA Seminar Sept. 21, 2006in Dongguan, China

4. Legal Approaches „Use Specific“ Restrictions • For a certain use the exposure is calculated • The derived no effect dose rate is compared with the exposure dose rate:Exposure < DNEL = no Risk • If consumers (or environment) are not exposed, then there is no risk, even though the toxic effect of the chemical may be quite high • Toxic chemicals may be allowed for certain uses „General“ Restrictions • Toxic chemicals are generally restricted or prohibited to sell and use • State authorities enforce this even though the use may be safe and there is no risk for the consumer AAFA Seminar Sept. 21, 2006in Dongguan, China

5. REACHChemicals Registration • All substances must be assessed with regard to their toxicological properties regarding human health and the environment • In Europe only chemicals with registration numbers will be available • Many more substances than now will have restrictions, but only for certain uses AAFA Seminar Sept. 21, 2006in Dongguan, China

6. Effect on industries • About 30,000 marketed substances will need to be registered • About 1500 substances will require an Authorisation • More than 5 million articles will require an extended Safety Data Sheet SDS AAFA Seminar Sept. 21, 2006in Dongguan, China

7. Chemical Safety Assessment CSA AAFA Seminar Sept. 21, 2006in Dongguan, China

8. According to REACH importer of consumer products have to do the following: • Check whether Registration is required §6.1 a) If substances are intended to be released b) If the imported amount > 1 t per yearc) If the substance was not registered already • Check whether Substances of Very High Concern (Annex XIV) are in the consumer products §6.2 a) To more than 0.1%b) Whether the imported amount > 1t per year=> § 30 information is required • Check whether Notification is required a) Product contains SVHC and conditions §6.2 are met and Sb) substance is not registered for this use yetc) Exposure cannot be excluded( AAFA Seminar Sept. 21, 2006in Dongguan, China

9. Substances of Very High Concern (a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC; (b) substances meeting the criteria for classification as mutagenic category1 or 2 in accordance with Directive 67/548/EEC; (c) substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC; (d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XII of the REACH Regulation; (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XII of the REACH Regulation; (f) substances, such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) and (e), and for which there is scientific evidence of probable serious effects to humans or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 56 to the REACH Regulation. AAFA Seminar Sept. 21, 2006in Dongguan, China

10. The obligation of the importer • REACH expressively forces Importer to explore the supply chain • Only if no information can be obtained about the history of the product or individual components chemical and/or toxicological testing should be performed • If testing is performed, the test method must have a detection limit of 0.05% AAFA Seminar Sept. 21, 2006in Dongguan, China

11. Risk Communication • Safety Data Sheets SDS are regarded to be the best established document to communicate risks. Must contain additionally:a) Registration Numberb) Emission Scenario DescriptionHowever!! For consumer products no eSDS is required, only for substances and preparations. If two ore more substances react with each other to form a new substance, it is called an article and doesn’t require an eSDS • §30(4) information is a document that must be supplied to industial and professional users of a consumer product, if contains SVHC >0.1%. This information must contain as a minimum the name of the substance and sufficient information to allow safe use of the the product. AAFA Seminar Sept. 21, 2006in Dongguan, China

12. Additional information • eSDS and §30(4) information can only state that a product contains SVHC. Both documents cannot be used to exclude the presence of SVHC. • RIP 3.8 Technical Guidance Document TGD gives a description of how to request standardized information from suppliers, if no eSDS or §30(4) is obtained from a product or component. The suppliers must officially state, that no SVHC are contained in the supplied components or products. If however contains SVHC, then eSDS (preparations) or §30(4) information must be prodvided • Only if manufacturers and presuppliers have a management system in which the chemical ingredients are listed with their relative amounts it is possible to track back the concentration from the final product. • Importer must force their suppliers to collect either a) no SVHC declaration or eSDS (preparations) or §30(4) information from the suppliers of every component in an article. If they don‘t have, they must test. AAFA Seminar Sept. 21, 2006in Dongguan, China

13. The Need to Manage the Chemicals Inventory Manufacturing • Worker‘s health • Sustainable environment • Minimize waste Retail • Liable, if risk for consumer‘s • Quality assurance • minimize customer complaints AAFA Seminar Sept. 21, 2006in Dongguan, China

14. Basic Features of a Chemicals Inventory System • Raw Materials Inventory • Products Inventory (Bill of Materials) • Warehouse Management • Safety Data Sheet Management • Operating Instructions (Safe Handle) • Transport Labels and Tremcards • Supplier Management • Waste Management AAFA Seminar Sept. 21, 2006in Dongguan, China

15. Level 0 Chair Leg Assembly Back Assembly 1 Seat Cross Bar(2) Side Rails (2) Cross bar Back Supports (3) Legs (4) 2 Product Structure Tree or Bill of Materials BOM AAFA Seminar Sept. 21, 2006in Dongguan, China

16. Consumer Products consist of many parts, each having a complex chemical composition AAFA Seminar Sept. 21, 2006in Dongguan, China

17. Example AAFA Seminar Sept. 21, 2006in Dongguan, China

18. Example AAFA Seminar Sept. 21, 2006in Dongguan, China

19. Example AAFA Seminar Sept. 21, 2006in Dongguan, China

20. Example AAFA Seminar Sept. 21, 2006in Dongguan, China

21. Intertek’s solution: ChemSafe™ OSHA Process EPA Risk Mgmt Safety Mgmt (PSM) Plan (RMP)EPA Environmental Management System REACH compliance (ISO 14001) Voluntary Protection Program (VPP) Chemical Manufacturers Association (CMA) A unique Chemicals Inventory Management System that helps manufacturers and buyers to comply with mandatory and voluntary requirements Responsible Care AAFA Seminar Sept. 21, 2006in Dongguan, China