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Rules & Revelations: REACH—The Cosmetic Impact
By: Carl Geffken
Posted: June 5, 2007, from the June 2007 issue of GCI Magazine.
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Additionally, the required CSR must include formal hazard assessments, exposure assessments and risk characterizations for both human health and environmental impact. Details will be provided in the REACH implementation guidelines. CSR preparation must be coordinated via the assigned SIEF, with funding arranged and assessed proportionally from participating companies or parties. These contributions are compulsory in order to do business in the EU.
Based upon the average annual tonnage for each individual substance used, there are scheduled dates for the required registration and submission of technical dossiers and chemical safety reports. If the substance has been pre-registered, the closing date is November 30, 2010, for Category I or II CMRs (carcinogens, mutagens or reproductive toxicants). These materials are banned from cosmetic use but could, perhaps, be required as a starting ingredient for a given raw material generation process or synthesis. Other substances used at more than 1,000 tons per year also fall under this deadline. May 31, 2013, is the deadline for substances used at an average of 100–999 tons per year, and May 31, 2018, for substances used at one to 99 tons per year.
The intent of REACH is to identify substances that pose a high safety risk for humans or potentially detrimental environmental impact—certainly a continuing objective for the cosmetic industry as well. Substitution plans would be required for chemicals that fall into certain classes such as:
- CMRs, Category I or II
- Persistent and Bioaccumulative and Toxic (PBT)
- Very Persistent and Very Bioaccumulative and Toxic (vPvBT)
- Substances of equivalent concern
Refinement and interpretation of these potential classifications will be made by the European Chemical Agency at a future date.
The best way to prepare your company is with a comprehensive chemical inventory of substances used for products or materials being exported to Europe that addresses the specific identity, CAS and EINECS numbers, and quantity information for each. Next, contact suppliers and identify their plans for pre-registration, so they can coordinate with others in their supply base and determine their ability and willingness to comply with REACH requirements. If they are unable to provide a commitment, you may be obliged to seek other alternatives to support future European business.
REACH is complex, and there are numerous questions yet to be answered. The review and interpretation of existing legislation, as well as input from various contributors to the REACH negotiations over the last six years, is helpful—but not always definitive. Information about the forms for pre-registration and registration, and potential cost assessments will follow once the ECHA has been staffed and trained. Additional details and clarifications are also expected after a European Commission workshop to be held in Bonn, Germany, this month.