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REACH

REACH. What is it and what does it mean to me?. Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy. Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden

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REACH

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  1. REACH What is it and what does it mean to me?

  2. Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom European Union

  3. EU map

  4. What is REACH? • Really Excessive Aggravating Chemical Headaches • Ridiculously Exorbitant Analysis of Chemical History • Redundant and Extremely Annoying Compounded Hardship • Requirements that are Entirely Appalling for Chemists Harassed Actually…..

  5. REACH • Registration • Evaluation • Authorisation and Restriction of • CHemicals

  6. What it does • Creates a requirement for registration of most chemicals • Chemicals manufactured or imported • Chemicals inFinished Products manufactured or imported

  7. REACH • Creates a new Agency for the regulation of Chemicals • European Chemicals Agency

  8. Important Terms • European Chemicals Agency • EINECS • ELINCS • Substances • Articles • Preparations • Manufactured • Imported • Downstream Users

  9. REACH • Requires Safety Profile for each chemical registration • Depends on chemical • Level specific • Tox testing • Eco-tox • Chemical specific addressing specific uses

  10. REACH requirements • Each user/manufacturer must register separately, even though the chemical is already registered • Testing, especially Animal testing, must be minimized • “Appropriate” buy-in to previous testing submitted

  11. When • Under discussion for years • Adopted December 18, 2006 • Published December 30, 2006

  12. What does this mean to me? • Old “Chemical Legislation” pertains only to chemicals themselves sold in Europe • REACH pertains to all uses of chemicals- not just stand-alone Chemicals • The most important concept is the “downstream user” • “Downstream Users” include finished product marketers which use chemicals in their products

  13. Registration Requirements • Registration is required for • Substances manufactured • Substances imported • Substances manufactured and used in products • Substances imported and used in products

  14. Registration exemptions • Natural substances that are not chemically modified and are not classified as dangerous • Miscellaneous “limited groups” of substances • Substances already registered and well-known as Dangerous Substances • Safety Data must be available

  15. Disclosure of Information • June 2007 EU manufacturers of products required to report new information on hazardous properties to suppliers • EU manufacturers must notify to the National Authorities or the ECA upon request

  16. REACH Downstream Users • 800+ pages of initial regulations • Establishes European Chemicals Agency • Definitions • Exceptions • Rules • Enforcement • Vagueness

  17. Supply Chain and Life Cycle • Philosophic Approach • Chemical Vendors share information with Downstream Users via SDS (MSDS) • Downstream Users advise Chemical vendors of experience with material, both in process and finished product

  18. Registration Dossier Technical Dossier with data on • Toxic (human health) • Ecotoxic Characteristics • Chemical Safety Report, assessing • Hazards • Exposure • Risks of use • Chemical Life cycle in supply chain

  19. Registration • 10 tons or more per chemical, per manufacturer/importer • Projected 30,000 substances will be registered • Approximately 140,000 technical dossiers submitted

  20. Cosmetic Product Importers • By December 2010 importers of Cosmetic products are required to report to the ECA the chemical classification of allsubstances in their products • Quantities of 1 metric ton (2204 pounds) or greater must be notified • Calculations are per importer, per manufacturer

  21. Many questions remain • What is the effect on product packaging? • How will existing data be communicated? • How will the usage be tracked? • Will my records be legally accessible? • Can this really be done? • What were they thinking?

  22. Chemists and Chemicals • Now is the time to become educated about raw materials • Plan ahead with new formulations • Monitor constant, rapid changes in the law

  23. Dates to Remember • June 2007 First Phase report to suppliers • June 2008 Producers of Preparations in EU must ensure registration of substances • June 2008-December 2008: Producers of Preparations must ensure registration of Phase in substances • December 2010-June 2018 Further registrations of Dangerous Substances, encouraging the development of alternatives

  24. Thank you Janet Winter Blaschke International Cosmetics & Regulatory Specialists, L.L.C. 947 Manhattan Beach Blvd., Suite A Manhattan Beach, CA 90266 USA 310-545-3223

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