REACH Update: New Facts from ECHA and Other Parties

Posted: August 11, 2008

This column will update earlier issues with information that has been published by the European Chemicals Agency (ECHA) or  other parties involved in the REACH procedures. Now that one-third of the pre-registration phase has lapsed, the bulk of legal papers or guidance documents are now available. However, publication and reviewing of existing issues is still ongoing. Uncertainties exist and a general recommendation is to pre-register a substance in order to avoid a potential need of direct registration before any manufacturing or importing can continue. This advice considers the fact that pre-registration does not result in any registration obligations and is free of charge.

In the July edition of C&T Today, "REACH Update: REACH-IT Status and ECHA Activities with Specific Relevance for Cosmetic Ingredients" reported technical problems for REACH-IT. Temporary submission procedures existed for bulk pre-registrations, PPORD notifications, inquiries and registrations. Bulk pre-registration, however, was made available on July 22, 2008. A maximum of 500 substances that have to be listed in EINECS can be submitted in one file. Both IUCLID 5 and XML bulk pre-registration procedures are possible. The software tools can be found on the IUCLID 5 webpage.

In the May C&T Today, "Two Weeks to the Start of Pre-registration," it was stated that several important documents were still not available, including Annexes IV and V, which are of major importance for the personal care industry. A draft version of these annexes is now accessible on the ECHA Web site. The REACH Committee voted in June 2008 and the adoption of the proposal is forecast to go into effect in September or October 2008.

Open questions for natural polymers were addressed in the March 2008 issue of C&T Today in "REACH Update: Specifics for Natural Ingredients." The updated Guidance on Monomers and Polymers, issue May 2008, explains that a naturally occurring polymer is exempt from registration under Title II when fulfilling the definition of naturals given in Article 3 of the REACH regulation. According to the guidance document, there is no requirement to identify the monomers or any other substances constituting as building blocks of the polymer because of their natural source.

The REACH Update topic for the January issue of C&T Today was "SIEFs and Consortia."  Since that time, activities for consortia formation have surfaced, often initiated through industry trade organizations. Many of these groups, however, have restricted access. An open consortium of interest for the personal care sector is being formed by the European Silicones Centre (CES). To obtain information on further existing consortia, industry trade organizations in Europe should be addressed directly.