Dossier evaluation
Dossier evaluation in UK REACH includes two activities: compliance checking of registration dossiers and the assessment of toxicity testing proposals submitted by registrants.
HSE as the Agency for UK REACH may examine a registration dossier at any time to verify if the information submitted by registrants is compliant with the legal requirements. This includes consideration of whether adaptations of standard information requirements in Annexes VII to X comply with the rules laid out in the respective annexes. The legal requirements (standard information requirements) are cumulative and depend on the tonnage band.
A registrant who intends to perform a new test listed in Annexes IX or X must submit a testing proposal to HSE. In line with UK REACH Article 40, HSE examines all testing proposals to ensure that proposals address information needs and avoid unnecessary testing, particularly when testing would involve the use of vertebrate animals.
The registrant may only proceed with testing when HSE has issued a formal decision to request the proposed test, a modification of the proposed test, or a different test.
Compliance checks
In 2021, our approach to compliance checking of registrations was affected by the transitional provisions for data submission that apply to grandfathered registrations and “downstream user import notifications”. Consequently, many UK registrations currently contain little data. It is anticipated that this will remain the situation for most registrations until the relevant submission deadlines approach in October 2023, October 2025 or October 20271. Therefore, we focused our compliance checking activity on the registration dossiers of ‘novel’ substances, i.e., those that were not registered under EU REACH prior to 1 January 2021. These were not subject to the transitional arrangements described above.
In 2021, 24 registrations of 'novel' substances were submitted under UK REACH. The majority of these were for substances in the one to ten tonnes per annum band. By close of 2021, compliance checks had been initiated on three dossiers. Compliance checks on the remainder of the dossiers will be progressed early in 2022.
Testing proposal evaluations
All valid testing proposals included in registration dossiers were examined to ensure that the generation of data on a given substance will be driven by appropriate information needs and that unnecessary animal testing will be avoided.
In 2021, we received five testing proposals, all of which were submitted as part of the grandfathering of registrations into UK REACH. Of these, three related to human health endpoints, one to an ecotoxicity endpoint, and one proposed testing for both human health and ecotoxicity endpoints. All were subjected to a public consultation relating specifically to the proposed vertebrate testing to establish if data already existed that could fulfil the information requirements. We received a single response to one consultation, and this was incorporated into the evaluation and testing proposal draft decision.
Draft decisions were produced for two testing proposals. The conclusion in both draft decisions supported the principles of the 3Rs (Reduction, Refinement and Replacement). Final decisions for these evaluations will be issued early in 2022, and the remainder of the testing proposals continue to be processed.
Footnotes
1.These dates are subject to any consultation which may be undertaken regarding the Reach Alternative Registration Approach (RARA) Deadline for UK REACH to be extended - GOV.UK (www.gov.uk). Back to reference of footnote 1