Registrants should get ready to comment on 2015 substance evaluation draft decisions

Registrants should get ready to comment on 2015 substance evaluation draft decisions

ECHA/NA/16/12

ECHA will soon send requests for further information on 32 substances to registrants for comments. These substances were evaluated by the Member States in 2015.

Helsinki, 30 March 2016 – On the last week of April, ECHA plans to  send draft decisions on 32 substances to registrants. If you are a registrant of these substances, you will have 30 days to consider and submit your comments. ECHA recommends that one representative, the registrants' contact point, sends consolidated comments on the draft decision on behalf of all addressed registrants of a substance.

In 2015, the Member States evaluated 48 registered substances under the substance evaluation process. In 32 cases, further information is considered necessary to assess the safety of the substance and a draft decision was prepared to request for this data. These substances are listed in the document referred to below.

The registrants receiving a draft decision will be those with active, standard registrations for a substance on the date when the draft decision is first sent. Registrants who, after having received an ECHA draft decision, cease manufacture or import of the substance before the decision is adopted by ECHA will not receive the decision and their registrations will become invalid.

Registrants who have registered the substance exclusively as an on-site isolated intermediate or  as a transported isolated intermediate under strictly controlled conditions will normally not be addressed in the (draft) decision under substance evaluation. However, where there are specific grounds of concern for intermediate uses, registrants of transported isolated intermediates may be requested to provide further information under substance evaluation.

For 14 substances, the evaluating Member State is concluding the substance evaluation without the need to request further data. The evaluating Member State will submit a conclusion document which will be published on ECHA's website in due course.

In two cases, the evaluating Member State could not conclude the evaluation as information related to the standard information requirements was missing. A compliance check process will be used to request the missing data. In those cases, the substance evaluation process is suspended, and will resume once the necessary information is submitted.. The concerned registrants will have an opportunity to comment on the compliance check draft decisions once they are issued.

The 16 substances with conclusion or suspension outcomes are listed in the document referred to below.