Dossier evaluation
Dossier evaluation in UK REACH includes two activities: compliance checking of registration dossiers and the assessment of Annex 9 or Annex 10 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 7 to 10 comply with the rules laid out in the respective annexes and Annex 11. The legal requirements (standard information requirements) are cumulative and depend on the tonnage band.
A registrant who intends to generate information to meet any of the requirements set out in Annexes 9 or 10 must submit a testing proposal to HSE. In line with UK REACH Article 40, HSE examines all testing proposals to ensure that they address information needs and avoid unnecessary testing that 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. The tests proposed by a registrant can also be rejected entirely.
Compliance checks
As for 2021, in 2022 our approach to compliance checking of registrations remained 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 transitional1 deadlines. Therefore, we continued to focus 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 substances were not subject to the transitional arrangements described above. Between the end of the EU exit transition period (1 January 2021) and 31 December 2022, a total of 39 registrations for ‘novel’ substances were received. Of these, by the end of 2022, compliance checks had been completed on 13 (33%) of the supporting dossiers. No draft decisions were issued in relation to these checks; however, a number of quality observations were made and communicated to registrants. Quality observations are issued where the Agency identifies that dossiers would benefit from additional information or clarity without them being out of compliance with the information requirements. Compliance checks were underway on a further 23 dossiers (59%) and these will be completed during 2023.
In addition, preliminary checks were undertaken on dossiers submitted for new registrations of existing substances (NRES; i.e., for substances which had been registered under EU REACH prior to 1 January 2021) to ensure that any deferment of the information requirements was in accordance with the transitional arrangements. No cases of non-compliance were detected.
Testing proposal evaluations
In 2022, HSE received one testing proposal relating to a human health endpoint. The proposal was the subject of a public consultation to establish if data already existed that could fulfil the information requirement. HSE did not receive any responses to the consultation. This evaluation is ongoing, and we expect to produce a draft decision in 2023.
Draft decisions were produced for two testing proposals received in 2021, both of which included conclusions that supported the 3Rs (Reduction, Refinement and Replacement of animals in testing). Additionally, one decision was adopted in 2022 that also supported the 3Rs.
Footnotes
1. Transitional deadlines were the subject of a consultation by Defra with regard to an extension to allow more time to explore the Alternative Transitional Registration model. Summary of responses and government response (GOV.UK website).