2. Legal provisions to avoid unnecessary testing
UK REACH states that testing on vertebrate animals for the purposes of the regulation ‘shall be undertaken only as a last resort’ (Article 25(1)).
The UK REACH regulation provides various means to support these aims. The main provisions are data sharing, testing proposals and adaptation of the information requirements.
Furthermore, the information requirements are tiered according to the registered tonnage.
Data sharing and joint submission
A key principle of UK REACH is that of 'one substance, one registration'. One of the main objectives of this principle is to avoid duplication of tests.
Before they submit a registration dossier, potential new registrants of a substance must inquire of HSE if a registration has already been submitted for that substance. This ‘Article 26' inquiry step enables the potential new registrant to liaise with existing and other potential registrants of the same substance and to arrange the sharing of data. Registrants of the same substance must share information on tests that relate to vertebrate animals.
Adaptation of the standard information requirements
Information on the intrinsic properties of substances can be generated by means other than tests, provided that the conditions set out in Annex 11 are met (Article 13(1)). Article 13(1) of UK REACH also states that, whenever possible, information shall be generated by means other than vertebrate animal tests, through the use of alternative methods.
Annex 11 of UK REACH provides general rules for the adaptation of the standard information requirements. These outline a variety of alternative approaches to the methods set out in column 1 of Annexes 7 to 10.
These approaches are briefly described under General rules for adaptation given in UK REACH Annex 11.
Column 2 in each of Annexes 7 to 10 provides specific rules for adaptation of the tests specified in column 1. These rules outline the circumstances in which a particular information requirement might be omitted, replaced by other information, provided at a later stage or modified.
Some examples are given in Table 1 on the further considerations for meeting the standard information requirements page.
Testing proposals and third-party consultations
Under Article 40 of UK REACH, registrants who wish to generate information to meet the requirements of Annex 9 (registrations for substances ≥ 100 tonnes per year) or Annex 10 (registrations for substances ≥ 1000 tonnes per year) of UK REACH must first submit a testing proposal to HSE. The information requirements included in Annexes 9 and 10 are those that inform on the most complex end-points and that potentially require the most animals.
As part of a testing proposal submission, registrants must outline the steps they have taken to consider adaptations and alternatives. If a test on vertebrates is proposed, they must explain why an adaptation or alternative approach was not suitable to meet the information requirement.
One of the objectives of the testing proposal process is to ensure that third parties have the opportunity to provide scientifically valid, existing data that could address the information requirement covered by the testing proposal. To this end, HSE holds a third-party consultation for each testing proposal in which a study on vertebrate animals is proposed.
Only when HSE has issued a decision to request the proposed test, a modification of the proposed test, or a different test, may the registrant proceed with a test. HSE can also reject the testing proposal.