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REACH: Implementing regulation for dossier updates published

On 12.10.2020, Commission Implementing Regulation (EU) 2020/1435 of October 9, 2020, on the duties placed on registrants to update their registrations under Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was published in the Official Journal of the EU. The regulation already enters into force on 11.12.2020.

To ensure that registration dossiers are always up to date, the new Implementing Regulation sets deadlines for registrants to carry out so-called dossier updates. Specifically, the following deadlines must be observed:

  • Changes to the status or identity of a registrant must be made within three months after the change takes effect. Changes in the composition of the substance must also be made within three months after the start of manufacture or import of the substance in the changed composition.
  • A deadline of three months shall also apply to tonnage range changes if a higher tonnage range is reached. In the case of updates due to the application of Annex VII or Annex VIII of REACH, the period shall start on the day on which all final test reports required for the update have been received, whereby negotiations with a test laboratory must also be commenced within three months of the tonnage threshold being reached. The commencement of such negotiations, to be demonstrated by the registrant in case of dispute, should therefore be carefully documented. In all other cases, the update must be made within three months of reaching the next tonnage threshold. The same applies in case of discontinuation of production or import. Correctly, however, the deadline does not apply if the change is due to the registrant resuming manufacture or import in accordance with Article 50(2) REACH. In this case, the deadline for the update is in any case the responsibility of the registrant, as he may only resume the manufacture or import after the relevant change.
  • For newly identified uses or new uses advised against, changes shall be made within three months. The date on which the registrant receives the required information shall be the relevant date.
  • In the case of new information on risks to human health and/or the environment, the update of the registration shall be submitted within six months. It should be noted that the period starts to run not only when the registrant has actually become aware of the new knowledge, but already when the registrant can reasonably be expected to have become aware of it.
  • Changes in the classification and labelling of the registered substance shall be submitted in case of inclusion, amendment or deletion of a harmonised classification in Annex VI to Regulation (EC) No 1272/2008 (CLP) no later than the date on which the change takes effect. In the case of other re-evaluation of the classification, the deadline shall be six months from the date of the decision to change the classification and labelling of the substance.
  • A period of twelve months shall apply for any updates or amendments to the chemical safety report or the guidance on safe use.
  • Any supplementary testing proposals shall be submitted within six months of the date on which the need is identified in accordance with Annex IX or Annex X. A period of twelve months shall apply to testing proposals as part of a testing strategy for a substance group.
  • Changes concerning the accessibility of information in the registration dossier shall be submitted within three months of the change.
  • By way of derogation from the other provision, updates relating to further testing shall be subject to a period of three months if supplementary data needs to be generated. In this case, the period shall be determined from the date of receipt of the final test reports required for the update, again subject to negotiations with a testing laboratory within three months after the need for additional data has been identified. The determination of the necessity is otherwise based on the deadlines for the relevant case groups as defined in the implementing regulation.

Furthermore, special rules apply to combined updates and updates of joint submissions as well as updates following a change in data requirements according to the annexes of the REACH Regulation.

  • For combined updates of the chemical safety report and other items, a common deadline of twelve months shall apply. The co-registrants of a joint registration shall be granted nine months for updates of the chemical safety report and three months if only other triggers exist. For combined updates of the co-registrants, which include the chemical safety report, the common period shall be nine months.
  • In case of amendments to the Annexes of REACH, registrations shall be updated until the date of application of the amendment, unless a different transition period has been specified in an implementing regulation amending the REACH Annexes.

The newly introduced deadlines will increase the pressure on affected registrants to update their registrations. In addition, the deadline provisions of the new implementing regulation in many respects require additional proof of decision-making processes that were not previously subject to specific documentation requirements. This is already the case because affected companies must, in their own interest, provide evidence of the respective start of the deadline in order to prove that an update was made in time.

In addition, it should be noted that the new implementing regulation will also have an impact on the design of procedures in the case of dossier evaluations and any subsequent data requests. Due to the time limits set, any dossier updates and the absence of corresponding updates will in future be more reliably incorporated into the decision-making process. In addition, affected registrants may be required to demonstrate the timeframe for any dossier updates where the deadlines under the Implementing Regulation conflict with decision-making processes in the context of dossier evaluations. It remains to be seen whether and to what extent ECHA will take this into account in the future.

Link to the document: Implementing Regulation (EU) 2020/1435

Do you have any questions about this news, or would you like to discuss the news with the author? Please contact: Martin Ahlhaus

12. October 2020 Martin Ahlhaus