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 or Annex 11. The 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 2021-22, in 2023 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 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 2026, October 2028 or October 20301. Therefore, we continued to focus our compliance checking activity on dossiers relating to ‘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 2023, a total of 53 valid dossiers relating to ‘novel’ substances were received. Of these, by the end of 2023 compliance checks had been completed on 29 (55%), with 4 draft decisions being issued – see Table 1, below.
Table 1: Number of dossiers relating to novel substances for which HSE completed compliance checks, 2021-2023
| Tonnage band (per annum) | Dossiers received | Compliance checks completed | Draft decisions issued | % of dossiers received that were checked |
|---|---|---|---|---|
| More than 1,000 | 1 | 1 | 0 | 100% |
| 100 – 1,000 | 2 | 2 | 0 | 100% |
| 10 – 100 | 7 | 3 | 0 | 43% |
| 1 – 10 | 43 | 23 | 4 | 53% |
| Total | 53 | 29 | 4 | 55% |
An additional 8 dossiers originally selected for checking were found to be out of scope after an initial examination revealed the substance had been misidentified as novel (6 dossiers), the import/manufacture of the substance had ceased (1 dossier) or an invalid dossier had been provided (1 dossier).
Testing proposal evaluations
In 2023, HSE received one testing proposal relating to toxicological information. The registrant’s proposal supported the 3Rs. 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. HSE adopted a decision on this proposal and so supported the 3Rs (Reduction, Refinement and Replacement of animals in testing). One testing proposal relating to a human health endpoint received in 2022 is ongoing.
A further decision was adopted in 2023 for a testing proposal submitted in 2022. In this, HSE modified the in vivo test that was proposed by the registrant to request an in vitro test instead. For two other ongoing testing proposal evaluations, the Environment Agency recommended that ecotoxicological tests proposed by the registrants be modified to non-vertebrate methods. Therefore, the requests in the adopted decisions were modified accordingly. Details of decisions adopted in 2023 are presented in Table 2.
Table 2: Testing proposal decisions adopted in 2023
| Substance | Testing proposed | Testing requested |
|---|---|---|
(R)-1-((4-amino-2-bromo-5-fluorophenyl)amino)-3-(benzyloxy)propan-2-ol 4-methylbenzenesulfonate CAS: 1294504-64-5 EC: 810-796-9 |
Genetic toxicity in vivo (OECD TG 474 combined with OECD TG 489) | Genetic toxicity in vivo (OECD TG 474 combined with OECD TG 489) |
8-Oxa-3,5-dithia-4-stannatetradecanoic acid, 10-ethyl-4,4-dimethyl-7-oxo-, 2-ethylhexyl ester (in IUCLID named 2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate) CAS: 57583-35-4 EC: 260-829-0 |
Genetic toxicity in vivo (OECD TG 474 combined with OECD TG 489) | Modification supporting 3Rs Genetic toxicity in vitro (OECD TG 490) |
2,2-dimethyl-3-oxopropyl dodecanoate CAS: 102985-93-3 EC: 468-880-2 |
Long term toxicity to fish (OECD 210) |
Modification supporting 3Rs Tiered testing strategy involving non-vertebrate methods. A second testing proposal is required for the long term fish test should it be considered necessary after following the strategy |
1,6-hexanediyl-bis-carbamic acid-bis[2-[2-(1-ethylpentyl)-3-oxazolidinyl]-ethyl]-ester CAS: 140921-24-0 EC: 925-259-5 |
Repeated dose 90-day oral toxicity study in the rat (OECD 408) Long term toxicity to fish (OECD 210) Long term toxicity to aquatic invertebrates (OECD 211) |
Repeated dose 90-day oral toxicity study in the rat (OECD 408)
Tiered testing strategy involving non-vertebrate methods. A second testing proposal is required for the long term fish test should it be considered necessary after following the strategy |
Footnotes
1The transitional deadlines have been extended by 3 years in The REACH (Amendment) Regulations 2023 (Statutory Instruments 2023 No. 722).