In this feature, Caroline Raine outlines the requirements that were introduced in October 2020 by the European Commission on the deadlines for updating REACH registration dossiers, otherwise known as the REACH Implementing Regulation.
On 9 October 2020, the Commission Implementing Regulation (EU) 2020/1435 was published concerning 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, Authorisation and Restriction of Chemicals (REACH).
The implementing regulation now gives clarity on what is meant by the term ‘without undue delay’ in relation to the updating of REACH dossiers. Updates may be required when tonnages change, or when more chemical data is available, or perhaps when company information needs to be updated. In most cases updates will be required within three months and, in more complex cases, up to twelve months.
The implementing regulation entered into force in December 2020 (60 days from publication).
In Article 22 (1) of the REACH regulation, Regulation (EC) No 1907/2006 there is a responsibility placed or 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).
ECHA defines 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.
ECHA requires registrants to monitor and track all relevant information in order to ensure their registrations remain up to date at all times. For joint registrations the responsibility to update is, for information that was jointly submitted.
The European Commission indicated in a recent general report that there is a need to improve compliance with the obligation placed on registrants in Article 22(1) of that Regulation. The Commission insists that this obligation to update 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.
Hence the specification of deadlines to submit this information.
The Commission indicated that where possible deadlines should be as short as possible and so it was decided that a deadline of three months should be specified for updates of a more administrative nature and if updates include the generation of data to fulfil the requirements of Annex VII or VIII to Regulation (EC) No 1907/2006 following receipt of the study report.
Deadlines of six, nine or twelve months should be specified for more complex updates, such as those requiring the generation of data based on a testing proposal or changes to the chemical safety report or the guidance on safe use. In cases where a member of a joint submission cannot make a particular update until the lead registrant has first updated the registration, that member should be given nine months for the update of a chemical safety report and three months for any other update from the date when the Agency confirmed that the registration as updated by the lead registrant is complete. In cases where an update is required as a consequence of an amendment to the Annexes to Regulation (EC) No 1907/2006, the deadline should be its date of applicability except where another deadline is provided in such an amendment.
The Regulation is also very clear that the deadlines specified should operate as upper limits. In other words, registrants should be required to provide updates as swiftly as possible and in any event by no later than the relevant specified deadline.
13 types of updates given specific deadlines
There are 13 articles in the regulation, one for each of the 13 types of updates given specific deadlines. The following table identifies the article number associated with each type of update and the timescales within which the update must be done.
Type of update
Changes in a registrant’s status or in his identity
Within 3 months from the date when that change takes effect.
Changes in the composition of the substance
Within 3 months from the date when manufacture or import begins with that change in substance composition.
Changes in tonnage band
Moving to a higher tonnage band, within 3 months from when all the final test reports needed for the update have been received or from the date when manufacture or import ceased.
New identified uses and new uses advised against
Within 3 months from when the new information was received.
New knowledge of the risks to human health and/or the environment
Within 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.
Changes in the classification and labelling of the registered substance
Where this is as a result of an addition, modification or deletion of a harmonised classification in Annex VI of CLP the registration shall be updated by the date specified in the relevant legal text.
Where this is as a result of new data the registration shall be updated within 6 months.
Updates or amendments of the chemical safety report or the guidance on safe use
Within 12 months from the date when the need to update or amend the chemical safety report or the guidance on safe use was identified.
Testing proposals prior to conducting a test listed in Annex IX or X
Within 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 that Regulation.
Where it is a case of a testing proposal developed as part of a testing strategy addressing a group of substances. The update shall be within 12 months from the date when the registrant or registrants identify the need to perform one or more of the tests.
Changes in the access granted to information in the registration
Within 3 months from the date when the change occurred.
Updates involving further testing
Within 3 months from the date when the final test reports needed for the update have been received.
Other combined updates
Within 12 months from the date when the final test reports needed for the update have been received.
Updates of joint submissions
Within 3 months, for updates to falling within points (a)to(f), or (i) of Article 22(1) of the REACH Regulation (Regulation (EC) No 1907/2006).
Within 9 months where an update to the chemical safety report or guidance on safe use is required.
The date applies from when the registration dossier is updated by the lead registrant.
Updates following an amendment to the Annexes to Regulation (EC) No 1907/2006 in accordance with Article 131 of that Regulation
The registration shall be updated by the date from which that amendment is to apply.
It is important that as REACH registrants you ensure that your dossier is updated in accordance with the deadlines.
A deadline of three months applies for administrative updates, such as a change in a registrant’s status or identity.
A deadline of six, nine or twelve months applies for more complex updates, for example when the classification and labelling of a substance without a harmonised classification changes, or there are changes in the chemical safety report or guidance on safe use.
When there are multiple reasons for updating a registration, only one submission is required and the longest deadline applies.
A deadline of three months applies to inform that the manufacture or import of a substance has ceased.
These deadlines also apply for changes to substances previously notified under the Dangerous Substances Directive (NONS), which are considered registered under REACH.