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.
The December 2007 "REACH Update: Responsibilities for Manufacturers of Cosmetic Ingredients" addressed prohibiting animal tests on ingredients for personal care products by March 2009. In addition to the SIEF procedures, in July 2008, ECHA established a consultation page on its Web site as requested in Article 40 of the REACH regulation. All proposals in registration dossiers on further tests involving vertebrate animals will be published on the ECHA Web site before the testing is carried out. Third parties have 45 days to submit scientifically valid information and studies related to the testing proposal. Questions can be directed to ECHA's helpdesk.
• Bulk pre-registrations are possible since July 22
• A draft issue of the Annexes IV & V is now available
• Natural polymers and their monomers are exempt from registration
• For obtaining information on existing consortia, European industry trade organizations have to be contacted directly
• In July 2008 the ECHA introduced third-party consultation for registration dossiers’ test proposals involving vertebrate animals
Further questions? Go to C&T magazine online's REACH Round Table
Links & further useful information:
New Guidance Documents
Templates for a Chemical Safety Report (CSR) (July 30, 2008)
Guidance on info requirements & Chemical Safety Assessment (part F) update (July 30, 2008) http://reach.jrc.it/docs/guidance_document/information_requirements_part_f_en.pdf?vers=30_07_08
Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.