Wednesday, September 28, 2011

ECHA Goes to Commission on REACH Testing Proposal

How many Member State Competent Authorities does it take to make a decision on REACH testing proposals?  Apparently more than they have.  The Member State Committee (MSC) at the European Chemicals Agency (ECHA) "could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal."

Let's go to the Commission!  For the first time ECHA will employ Article 51(7) of the REACH Regulation and refer a case to the European Commission for decision making.

This non-decision by the MSC took place last week.  Not that they were stymied on all decisions.  They did agree on the draft decisions "for all five compliance checks" they were charged with reviewing.  And they did come to unanimous agreement on two of the four draft decisions on "testing proposal examinations." But two testing proposals were particularly tricky.  For one, the MSC refined the proposal during the meeting and expect to agree in writing shortly. 

The final testing proposal reached stalemate, hence the referral to the Commission.  The proposal:

"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."

No information on when (or if) the Commission will make its decision.

More on what the Member States Committee does can be found on their web page here.

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