EU Chemicals Agency Seeks Improved REACH Dossiers from Manufacturers

March 8, 2010 - The European Chemicals Agency (ECHA) told chemical manufacturers who are submitting dossiers required under the registration, evaluation and authorization of chemicals (REACH) regulations that they should improve the descriptions of chemicals' identities, provide detailed summaries of research results used in reaching a conclusion on toxicity or other chemical properties, and justify any proposed waivers for animal testing. The notice to chemical manufacturers came from a March 1 publication entitled Evaluation Under REACH: Progress Report 2009.

ECHA based the report primarily off of 35 of the 406 dossiers received by the agency in 2009 on which it initiated preliminary evaluations. Preliminary evaluations typically look at whether dossiers comply with REACH requirements regarding proposed animal testing. REACH requires animal testing only as a last resort, but will not allow animal testing to be waived if it would result in a potentially unsafe use of the chemicals. ECHA determined that five of 16 non-phase-in substances (chemicals entering the European market for the first time under REACH) evaluated had waived reproductive and repeated dose toxicity testing with inadequate justification.

ECHA will begin a more detailed evaluation of dossiers' contents beginning in 2011 with the first expected report expected in 2012. Evaluation Under REACH: Progress Report 2009 is available at http://echa.europa.eu/doc/progress_report_2009.pdf.