EU - Amendment on the Duties Placed on Registrants to Update Their Registrations under REACH
Business description
Article 22(1) of Regulation (EC) No 1907/2006 (EU REACH Regulation) places a responsibility on registrants (whether individual registrants
or the lead registrant and other members of a joint submission) to update their registrations without undue delay
with relevant new information and submit them to the European Chemicals Agency (‘the Agency’).
The responsibility to update their registrations requires registrants to monitor and track
all relevant information in order to ensure their registrations remain up-to-date at all times. In the case of joint
submissions, the responsibility to update the registration is, for information that was jointly submitted, the
responsibility of all the registrants in accordance with Article 11 of EU REACH Regulation and is covered
by the data-sharing and cost-sharing provisions laid down in Commission Implementing Regulation (EU) 2016/9.
The latest general report published by the Commission in accordance with Article 117(4) of EU REACH Regulation indicated a need to improve compliance with the obligation placed on registrants in Article 22(1) of
that Regulation. Compliance with that obligation is important to ensure that registration dossiers reflect the current
situation at all times, so that the Agency and Member States can evaluate dossiers and substances in an efficient
manner and advice on safe use is based on up-to-date and reliable data. Therefore, this Implementing Regulation amends the current registration requirements by specifying deadlines, in most cases as 3 months and in more complex cases for up to 12 months, for the following obligations / circumstances:
- Changes in a registrant's status or in his identity
- Changes in the composition of the substance
- Changes in tonnage band
- New identified uses and new uses advised against
- New knowledge of the risks to human health and environment
- Changes in the classification and labeling of the registered substance
- Updates or amendments of the chemical safety report or the guidance on safe use
- Testing proposals prior to conducting a test listed in Annex IX or X
- Changes in the access granted to information in the registration
- Updates involving further testing
- Other combined updates
- Updates of joint submissions
- Updates following an amendment to the Annexes to EU REACH Regulation in accordance with Article 131 of that Regulation
Effective date: 60 days after the publication in the EU Official Journal, i.e. December 11, 2020
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