Registrants: get ready to comment on the 2017 substance evaluation draft decisions
ECHA is preparing to send out the draft decisions on information requests for 16 substances to registrants for comments. Because of the REACH 2018 registration deadline, draft decisions on 15 substances will be sent later than usual. The registrants will have 30 days to submit their comments.
Helsinki, 10 April 2018 – ECHA will be sending out substance evaluation draft decisions to up to 200 registrants in early June, instead of April, to allow the registrants to focus on their REACH registrations with a 31 May 2018 deadline.
The draft decisions address substances that were evaluated by Member States in 2017 and on which the Member State concluded that further information is required to clarify the identified concerns. Registrants will have 30 days to consider and submit their comments.
ECHA recommends that one representative sends consolidated comments on behalf of all addressed registrants of a substance. ECHA’s new practical guide on how to act in substance evaluation provides registrants with further advice for commenting on the draft decisions.
Draft decisions will be sent for comments to all registrants of the substance, including those who have by that date submitted a registration that is not yet complete in the submission pipeline. Recipients will also include registrants of transported isolated intermediates. Registrants for on-site isolated intermediates will not receive draft decisions for commenting.
In one exceptional case (ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate), the registrants of the substance will receive a draft decision for commenting already in April. ECHA has informed the affected registrants in advance, providing the specific reasons for this timeline.
In 2017, the Member States evaluated 22 substances listed in the Community rolling action plan (CoRAP). In 16 cases, further information is expected to be needed to assess the safety of the substance and a draft decision was prepared to request this data. For six substances, the evaluating Member State concluded that no further data is needed. The conclusion documents with possible indications for further regulatory action will be published on ECHA’s website in due course.