Minimisation of animal testing

1. Key messages to registrants

This guidance is for registrants under UK REACH who must provide information on the toxicological and ecotoxicological properties (including bioaccumulation) of their substances.

In this guidance, an ‘animal’ means any living, non-human vertebrate that is defined as a protected animal under the Animals (Scientific Procedures) Act 1986.

Many opportunities are available to UK REACH registrants to minimise animal testing.

The key messages for registrants are:

• tests on vertebrates must be conducted only as a last resort and the 3Rs, (reduction, refinement or replacement of animals in testing) implemented
• identify the standard information requirements for your tonnage. Consider if any of the specific adaptations in column 2 of Annexes 7 to 10 apply to your substance
• compile all the available existing toxicological, ecotoxicological and physico-chemical information on the substance. Data sharing within substance groups is facilitated through the Article 26 inquiry process. The sharing of information from tests on animals is mandatory
• consider if any of the Annex 11 ‘general rules for adaptation’ apply to your substance. These include existing data, (quantitative) structure-activity relationships (QSAR), grouping and read-across and in vitro methods that meet the conditions set out in Annex 11
• all available, relevant information on an endpoint from multiple evidence sources can be considered in a weight-of-evidence approach. This might enable the information requirement to be met even if the individual sources of information are not sufficient to do so by themselves
• identify if there is still a data gap in any of the standard information requirements. If more information needs to be generated, determine if the UK Test Methods Regulation or international test methods provide for an appropriate non-animal approach
• if no adaptations or non-animal alternatives are applicable or possible and information must be generated from a test on vertebrates, ensure that the test of least severity and that uses the fewest animals is employed
• if you need to generate new information to meet an information requirement listed in Annex 9 and/or Annex 10, you must submit a testing proposal to HSE. If you propose to conduct a test on vertebrate animals, you must explain the steps you have taken to consider alternative approaches and why they were not suitable to meet the information requirement

This information applies to the registration of new substances, those that were not registered under EU REACH before 1 January 2021.

Process to gather information for REACH registration, to minimise animal testing

1. Identify standard information requirements. Consider if any Column 2 adaptations apply (Annexes 7 to 10)
2. Consider the following:
   1. compile existing information
   2. apply read-across and chemical category approach if appropriate. Registrants must have legitimate access to or permission to refer to information on other substances
   3. using in vitro methods if applicable
   4. use quantitative structure–activity relationship models (QSAR) if appropriate
3. Assess information and apply weight of evidence
4. Identify if there’s still an information gap
5. Use alternative approaches to generate information if available and appropriate
6. Test on vertebrates must be done only as a last resort. The test of least severity and that uses the least number of animals shall be used
7. Submit testing proposal for Annexes 9 and 10 requirements. If this is for a test on vertebrates explain the steps you took to consider the use of alternatives approaches and why these were not suitable