United States: Commission Consults On Deadlines For REACH Dossier Updates Under Article 22

The Commission has put forward a proposal (Draft Implementing Regulation), establishing legal deadlines for the obligations to update REACH registration dossiers (3 months for updates of "a more administrative nature" and 6 or 12 months for "more complex updates"), for consultation. Feedback can be submitted to the Commission until January 15, 2020 (midnight CET).

As a reminder, the REACH Regulation provides that a registrant is "responsible on his own initiative to for updating his registration without undue delay" in a number of cases, enumerated in Article 22(1) (a)-(i), without establishing specific timelines.

Given that the REACH Regulation requires updates to be made "without undue delay," it must be assessed whether the Commission actually has the competence to impose specific deadlines, which would amount to interpreting the terms of the REACH Regulation. The Court of Justice of the EU has exclusive competence to interpret EU legislation.

Further, the Draft Implementing Regulation establishes that its deadlines "operate as upper limits" which, if exceeded, would "automatically" lead to the conclusion that an undue delay to update the registration dossier had occurred. Such an automatic conclusion seems to shift the burden of proof and could directly trigger potential national enforcement actions. This is especially worrisome since considerable (legal) uncertainty as to the application and potential interpretation of the starting points of the different deadlines can be envisaged. This is, for instance, the case for deadlines running from "the date when all the final test reports needed for the update have been received,"  or "the date when the registrant (...) may reasonably be expected to have become aware of the new knowledge in question." The Draft Implementing Regulation also appears to define/expand the concept of what is to be considered "new" information.

Next steps

Dossier updates (and the lack thereof) have been the focus of the second REACH Review, which required the Commission to make appropriate proposals to encourage updates of registration dossiers.¹ Previous drafts of proposed legal deadlines had been discussed and commented upon. In particular, concerns on the workability of the deadlines were raised.

After the public consultation, the REACH Committee has to adopt an opinion (by qualified majority vote) on the Draft Implementing Regulation. If that opinion is positive, the Commission is obliged to adopt the Draft Implementing Regulation. If adopted in its current form, the measure would enter into force within 60 days from its publication in the Official Journal.

Footnote

1. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions Conclusions and Actions, COM/2018/0116 final, Section 3.1.: "Action 1: Encourage updating of registration dossiers- The Commission in collaboration with ECHA, Member States and industry will identify why registrants are not updating their dossiers and make proposals for improvements by first quarter 2019, as appropriate."

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