Get ready to comment substance evaluation draft decisions

11-Apr-2014 - Finland

In 2013, Member States have been evaluating 47 registered substances under the substance evaluation process and they have also prepared a draft decision in case further information is needed in order to assess the safety of the substance. The deadline for submitting a draft decision to ECHA was on 20 March 2014. ECHA has now received draft decisions on 37 substances, and the registrants should get ready to give their consolidated comments on the draft decisions addressed to them. ECHA plans to send out the draft decisions to the relevant registrants in week 18, 28 April – 2 May 2014. As foreseen by REACH, registrants of these substances will have 30 days to consider and submit their joint or individual comments. A notification letter will contain the deadline by when the comments must be submitted. This deadline will include an extra seven-day period as addressed in the latest update of point 9(d) of the Terms and Conditions of REACH-IT.

The registrants receiving a draft decision on substance evaluation will be those with active registrations on a substance on the date when the draft for the decision is first sent. However, two categories of registrants will be excluded, i.e. registrants who exclusively use the substance as an on-site isolated intermediate and under strictly controlled conditions, and those who have ceased or will still cease manufacture/import of the substance in accordance with Article 50(3) of REACH before the decision is adopted by ECHA.

For one substance, 1,4-benzenediamine, N,N'-mixed phenyl and tolyl derivs. (EC 273-227-8) examined by Germany, which was exceptionally added to the CoRAP on 1 July 2013, the Member State's deadline for submitting a draft decision to ECHA is 1 July 2014 and this draft decision is not yet available to ECHA. Registrants of that substance will be informed directly by ECHA.

For nine substances there are no draft decisions. In such cases the evaluating Member State has been asked to submit a conclusion document according to Article 48 of REACH normally within four months from the end of the evaluation period. When available and cleared for confidential information the documents will be published.

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