Implementing Regulation (EU/2020/1435) on the duties placed on registrants to update their registrations along with proposed deadlines under the EU REACH Regulation
Article 22(1) of Regulation (EC) No 1907/2006 (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 (ECHA).
Information counts as ‘new’ if the registrant has become aware of it or may reasonably be expected to have become aware of it since the last update or, in the absence of any updates, since initial registration, whether or not the information actually existed before then.
The latest general report published by the Commission in accordance with Article 117(4) of REACH Regulation indicated a need to improve compliance with the obligation placed on registrants in Article 22(1) of REACH 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, in order to facilitate compliance with and enforcement of Article 22(1) of REACH Regulation and improve efficiency in giving effect to the provisions of that Regulation, it is appropriate to specify deadlines by which that obligation is to be complied with.
On 12 October 2020, the European Commission has published an implementing regulation in the Official Journal of the European Union which clarifies the meaning of ‘without undue delay’ related to registration updates under REACH regulation.
The table below provides a brief over on triggers and timings when registrants are expected to update their REACH registration dossiers:
| Type of update | Details of update | Deadline (no later than) |
| Administrative nature | Changes in a registrant’s status or in his identity | 3 months from the date when that change takes effect |
| Changes in the composition of the substance | 3 months from the date when manufacture or import begins with that change in substance composition | |
| Cessation of manufacture or import | 3 months from the date when manufacture or import ceased | |
| Changes in tonnage band | Change that results in a higher tonnage band | |
| New data is generated for an update derived from the application of Annex VII or Annex VIII to REACH Regulation | 3 months from the date when all the final test reports needed for the update have been received | |
| Other cases | 3 months from the date when the higher tonnage band is reached | |
| New identified uses and new uses advised against | New identified uses | 3 months from the date when the registrant receives all the information needed to carry out the risk assessment for this new use |
| New use advised against | 3 months from the date when the information on the risks associated with that use is available to the registrant | |
| Changes in the classification and labelling of the registered substance | Due to the addition, modification or deletion of a harmonised classification in Annex VI to CLP Regulation | Date as of which that change is to apply |
| Due to an adaptation in the classification of a substance as a result of a new evaluation in accordance with Article 15 of CLP Regulation | 6 months from the date when the decision to change the classification and labelling of the substance has been taken | |
| New knowledge of the risks to human health and/or the environment | New knowledge of the risks to human health and/or the environment | 6 months from the date when the registrant becomes aware or may reasonably be expected to have become aware of the new knowledge in question |
| Updates or amendments of the chemical safety report or the guidance on safe use | Any update or amendment of the chemical safety report or Section 5 of Annex VI | 12 months from the date when the need to update or amend the chemical safety report or the guidance on safe use referred to in Section 5 of Annex VI to REACH Regulation was identified |
| Testing proposals prior to conducting a test listed in Annex IX or X of REACH regulation | The registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed | 6 months from the date when the registrant identifies the need to perform one or more of the tests listed in Annex IX or X to REACH Regulation |
| A testing proposal developed as part of a testing strategy addressing a group of substances | 12 months from the date when the registrant or registrants identify the need to perform one or more of the tests listed in Annex IX or X to REACH Regulation | |
| Changes in the access granted to information in the registration | Any change in the access granted to information in the registration | 3 months from the date when the change occurred |
| Other combined updates | If any updates discussed above also triggers the need to update or amend the chemical safety report or the guidance on safe use | 12 months from the date when the final test reports needed for the update have been received |
| An update of a registration that is the result of a circumstance falling within more than one of the above discussed points | Longest deadline specified in this Regulation, counting from the date when the first need to update the registration was identified | |
| Updates of joint submissions | Where an update is dependent on the lead registrant making a prior update to the registration | |
| an update or amendment of the chemical safety report or the guidance on safe use | 9 months from the date when the ECHA informs the lead registrant and the other members of the joint submission that the registration dossier as updated by the lead registrant is complete | |
| an update or amendment apart from the chemical safety report or the guidance on safe use | 3 months from the date when the ECHA informs the lead registrant and the other members of the joint submission that the registration dossier as updated by the lead registrant is complete | |
| If any updates discussed above also triggers the need to update or amend the chemical safety report or the guidance on safe use | 9 months from the date when the ECHA informs the lead registrant and the other members of the joint submission that the registration dossier as updated by the lead registrant is complete | |
| Updates not dependent on the lead registrant making a prior update to the registration | ||
| Updates not dependent on the lead registrant making a prior update to the registration | Deadline specified in this table for non-joint submission updates apply | |
| Updates following an amendment to the Annexes to REACH Regulation in accordance with Article 131 of REACH Regulation | An amendment to one or more Annexes to REACH Regulation in accordance with Article 131 of REACH Regulation that results in a change to the information required to be submitted to the ECHA in accordance with Article 10 or Article 12 of REACH Regulation | The date from which that amendment is to apply, at the latest, unless otherwise provided in that amendment |
| An amendment to one or more Annexes to REACH Regulation in accordance with Article 131 of REACH Regulation engages an obligation to update a registration dossier pursuant to Article 22(1) of REACH Regulation subject to a deadline specified in this implementing Regulation | The date from which that amendment is to apply, at the latest, unless otherwise provided in that amendment | |
The deadlines only concern REACH Regulation Article 22(1) and so they apply to updates that are done by the registrants once they become aware of relevant new information related to the data included in their registrations. It does not affect or change those deadlines that ECHA communicates in its opinions and decisions to registrants, for example, when requesting further information after evaluating a testing proposal or a compliance check.
This Implementing Regulation specifying the duties placed on registrants to update their registrations under REACH Regulation shall enter into force on the 60th day following that of its publication in the Official Journal of the European Union.
