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Registrants of certain intermediates to receive substance evaluation decisions


As of January 2018, ECHA will send substance evaluation draft decisions also to registrants of transported isolated intermediates.

Helsinki, 19 December 2017 - ECHA sends substance evaluation draft decisions for comments to all registrants with active registrations. As of January 2018, this includes active registrations with transported isolated intermediate status only, but not registrations of on-site isolated intermediates.

The change in practice follows a consultation of the Member States in November 2017. It gives all registrants an equal possibility to comment substance evaluation decisions. The registrants are advised to speak with one voice in the commenting phase. The registrants of transported isolated intermediates may in the comments seek to demonstrate that the concern identified in the draft decision is not relevant to their specific strictly controlled conditions of use, as further substantiated. The evaluating Member State will take the comments into account.

Any issues regarding data and cost sharing among the registrants need to be solved within the substance information exchange forums (SIEFs) or consortia. The substance evaluation decision is not setting rules on how to share data and costs among the registrants of the same substance. The data and cost sharing should happen in accordance with the data sharing obligation set out in REACH and in the Commission Implementing Regulation 2016/9.

REACH contains rules for the registration of intermediates (on-site isolated intermediates and transported isolated intermediates) and, under specific conditions, reduced information requirements may apply. On-site isolated intermediates under strictly controlled conditions are exempt from evaluation procedures, whereas transported isolated intermediates are not. Thus transported isolated intermediate registration may be subject to an evaluation decision.

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