REACH Implementing Regulation 2020/1435
Since its original entry into force, the REACH Regulation has mandated REACH Registrants to maintain their dossiers through updates to capture new information becoming available after initial registration.
When new information is being generated as a result of a regulatory Decision, ECHA specifies a deadline for submission of updates. However, although REACH (Article 22) set out numerous scenarios of new information which should prompt a registrant to make a voluntary update submission, no time frame was specified. An implementing Regulation (2020/1435) now clarifies the requirement to update dossiers ‘without undue delay’ (Article 22(1) of REACH), setting deadlines for the first time.
The regulation covers new information or changes which:
Relate to the registrants’ own circumstances (changes in a registrant’s status or identity, composition of the registrant’s substance, tonnage band supplied, new identified uses)
Affect the chemical safety assessment (new knowledge of the risks to human health and/or the environment, new test results, changes in the classification and labelling, changes to the chemical safety report or the guidance on safe use)
Otherwise affect the technical dossier (testing proposals, changes in data access)
The time frames vary for different circumstances but are between 3 months and 1 year. In case there are multiple pieces of new information or changes, the longest time period applies. If a lead registrant submits an update that affects the dossiers of member registrants within the joint submission, the member registrants too are due to submit an update in a timely manner.
To ensure updates are prepared in good time, registrants would be well advised to:
Review the methods they use to identify new information or changes in the areas that would trigger an update.
Understand the implications of new information, especially whether it will have an effect on classification and labelling or require an update to the CSR, and determine the effective deadline.
Communicate with co-registrants about changes that affect members of the Joint Submission, and the timings indicated for updating.
Keep records of new information and decisions taken with dates, in case of inspection.
