ECHA refers a draft decision for one testing proposal to the Commission for the first time
Media enquiries: ECHA Press
The MSC could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal. For the first time, the procedure foreseen in Article 51(7) of the REACH Regulation will therefore be used, requiring the referral of the case to the Commission for decision making involving the Commission REACH Committee.
Helsinki, 26 September 2011 - ECHA's Member State Committee (MSC) held its 19th meeting from 20-23 September 2011. The MSC's agenda had four draft decisions on testing proposal examinations and five draft decisions on compliance checks, with which to find unanimous agreement on their content. The MSC agreed unanimously on the draft decisions for all five compliance checks and on two draft decisions for the testing proposal examinations. A draft decision on one testing proposal was refined at the meeting but agreement seeking will take place by written procedure, following the meeting.
The draft decision, which will be sent to the Commission for decision making, concerns a testing proposal examination where the registrant has proposed to perform a two-generation reproductive toxicity test in accordance with the EU test method B.35. This information would be necessary to fill the data gap regarding reproductive toxicity for the substance that is produced in quantities of over 1000 tonnes per annum.
Some MSC members preferred to ask the registrant to use the recently adopted OECD test guideline 443, the extended one-generation reproductive toxicity study (EOGRTS). Others wanted to maintain the present requirement of performing a two-generation study.
The OECD adopted the new test guideline 443 in June 2011. Discussion is ongoing, lead by the European Commission, with regard to how to use this test guideline for regulatory purposes, and in particular what role it will play under the REACH information requirements concerning reproductive toxicity.