The European Commission has published a draft of an implementing regulation which clarifies the meaning of ‘without undue delay’ related to registration updates under REACH. The draft includes deadlines for different scenarios which may trigger the need for registrants to update their dossiers.
Since registration dossiers are the main source of information for authorities when prioritising substances for regulatory action and considering appropriate risk management measures for harmful substances, it is important that registration data is kept up-to-date at all times.
The deadlines only concern REACH 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.
The implementing regulation does not change the basic rule that companies need to update their registrations as soon as possible after noticing that information included in their dossier has changed. The given deadlines are meant to help in situations where an immediate reaction from registrants would be unrealistic.
If the update is of a more administrative nature, such as changing the name, address or status of the company, or the registrant ceases manufacturing the registered substance, they have three months to update their registrations and submit them to ECHA. Other situations where the three-month deadline applies are, for example, if new uses are identified, or if there is new information related to how the substance should not be used.
Additional deadlines are set at six, nine and 12 months depending on the complexity of the update. For example, if companies need to update their registrations with a testing proposal, they will have six months to do so. But if they are developing the testing proposal for a group of substances, as part of a testing strategy, a 12-month deadline will apply. If the new information leads to changes in a chemical safety report or affects the guidance on safe use, the deadline for an update is 12 months.
There is no deadline for updating information related to a change to a lower tonnage band since this may be temporary and the change would not have negative consequences for human health and the environment. This update should, however, still be done ‘without undue delay’ as it may influence the priority of the substance for regulatory action.
If registrants have several reasons for updating their registrations, they can include all changes in one submission and apply the longest deadline.
Updates for jointly submitted registration data
Since the principle of ‘one substance, one registration’ is at the core of REACH, all registrants are responsible for keeping the data they have submitted together up-to-date. All joint submission members are required to monitor and track the information that could be relevant to their registration and trigger the need for an update.
There are cases, where the lead registrant needs to update their dossier first, before members can fulfil their duties. In these situations, the deadline for member registrants starts to run only after ECHA has confirmed that the Agency has received a complete update from the lead. In general, members have three months to act after the lead has successfully submitted an update. However, if the update concerns the chemical safety report, they have nine months.
Earlier this year, ECHA modified REACH-IT to improve the transparency of joint submissions, for example by including messages to all registrants when there are changes to the tonnage band of the joint submission.
Tracking and recording changes
If registrants do not update their registrations within the given deadlines, they have failed to update the necessary information ‘without undue delay’. This is where enforcement authorities may step in.
Registrants need to track and monitor all relevant information to ensure that their registrations are updated by the respective deadlines. Member State enforcement authorities can ask for these data during inspections and as the deadlines are included in the legal text, they can more easily check if the update was done in time.
The implementing regulation is expected to be published in the Official Journal of the European Union later this autumn and will enter into force 60 days after that.
To help registrants, ECHA is updating its guidance on registration. The guidance will be available on ECHA’s website during the first half of 2021.