REACH Update: Responsibilities for Manufacturers of Cosmetic Ingredients

Posted: December 5, 2007

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REACH Implementation Projects (RIP) are developing in close collaboration with all stakeholders. They are guidance documents essential to understanding the tasks under REACH and they provide IT support tools for all obligations to the agency, the industry and the authorities. The RIPs include seven main areas and a number of sub subjects including:
– RIP 1: Process descriptions
– RIP 2: Development of IT systems (IUCLID & REACH-IT)
– RIP 3: Guidance Documents for industry
– RIP 4: Guidance Documents for authorities
– RIP 5/6: Setting up the (pre-)Agency Overall Guidance package, http://ecb.jrc.it/reach/rip/

FAQs:
Do I have to preregister my substances?
Only phase-in substances can be preregistered. Preregistration allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached. These deadlines do not apply to not preregistered phase-in substances.

We are a manufacturer of  preparations and located outside the EU, but we have a subsidiary within the EU. Can this subsidiary fulfill the obligations under REACH?
If the subsidiary is a separate legal entities to the parent company, (a natural or legal person as defined under applicable national law), then it may fulfill the obligations under REACH.

Will it be possible to test C&T ingredients on animals for REACH purposes?
According to the existing legislation, REACH and the Cosmetics Directive, an ingredient for cosmetics cannot be tested on animals after March 2009. REACH requires the use of alternative methods, for example, in vitro methods, qualitative and quantitative structure-activity relationship models or information from structurally related substances such as grouping or read-across. The Cosmetic Directive requires a replacement through validated alternative test methods. The responsibility for validation of alternative tests lies with the European Centre for the Validation of Alternative Methods. Alternative tests, validated as of now, can be found at http://ecvam.jrc.it/index.htm. Readers are reminded, that the text of the REACH Regulation (Regulation(EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.

Annelie Struessmann, PhD
CONUSBAT
Aachen, Germany