This guidance document compiles best practices from different chemical sectors for REACH dossier updating. The aim is not to replicate the information on the reviewed version of the REACH Guidance of Registration1 but to provide feedback on how the chemical industry updates IUCLID dossiers based on the different scenarios provided in the Implementing Regulation (EU) 2020/1435.
Under the REACH Regulation (EC 1907/2006), manufacturers, importers, and only representatives of non-EU companies must submit a registration dossier to the European Chemical Agency (ECHA) for the substances they produce and import. Companies are obliged to update the REACH dossier with any relevant new information without undue delay.
In 2017 and 2018, when the phase-in period was coming to a close, Member States and ECHA focused on updates of already registered dossiers. A concern was raised as to whether the update frequency ensured timely updating of the dossiers. In addition, measures to provide clear and specific requirements and timelines to the registrants were discussed. As a result, it was suggested that ECHA provide clear criteria and explanations on:
Thus, on 12 October 2020, the European Commission published an Implementing Regulation (EU) 2020/1435 in the Official Journal of the European Union2 , which clarifies the meaning of “without undue delay” related to registration updates under the REACH Regulation.
The Implementing Regulation included deadlines for different scenarios, which trigger the need for the registrant to update their dossiers.
The Commission’s Implementing Regulation states that “a deadline of three months should be specified for updates of a more administrative nature and deadlines of six or twelve months for more complex updates, such as those requiring the generation of data or changes to the safety assessment.”
The deadlines identified in the Commission Implementing Regulation (EU) 2020/1435 are to be counted from the specific trigger event described by each article of the Implementing Regulation. These defined deadlines are not to be confused with those communicated by ECHA or the Commission in their opinions and decisions to registrants; in such cases, the registrant must update the dossier following the deadlines specified by ECHA/ the Commission in the decision.
The Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) Regulation entered into force in 2007. Since its inception, manufacturers and importers have registered more than 22,000 unique substances; over 200 substances have been added to the Candidate List, and many amendments to the lists of restrictions and substances subject to ...
