The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation contains strong provisions to minimise the amount of animal testing by EU-based companies when compiling their substance registration dossiers. These require that animal tests be the last resort, with the use of non-animal test methods instead wherever possible, and prohibit the repetition and duplication of animal tests. REACH also requires that when preparing registration dossiers, data derived from animal tests must be shared between all members of a Substance Information Exchange Forum (SIEF) in order to achieve this. Where further tests are necessary to complete registrations for substances on the market in quantities of 10 tonnes or more per year, then proposals must be submitted to the European Chemicals Agency (ECHA) for approval before any such tests are undertaken, so pre-emptive testing would be illegal. Part of this approval process involves a 45-day public consultation on the test proposals, so that third parties have the opportunity to provide information on the substance that would render the proposed animal tests unnecessary.
In order to help companies address the issue of using animal tests when preparing registration dossiers, a short guidance note has been published on the DEFRA website:
which draws attention to these legal requirements, and suggests a number of possible non-animal alternative test methods including chemical grouping and read-across approaches, use of (Quantitative) Structural Activity Relationships (QSARs), and in vitro tests. Information can also be provided by way of a weight of evidence assessment, and certain tests specified in REACH may also be waived where it can be shown that exposure of humans or the environment to a substance is insignificant or absent.
It is important that companies remember that they should not be undertaking animal testing for REACH registration before their test proposals are approved by ECHA as being necessary. Companies should actively look for alternatives to animal testing wherever possible, and refer to the REACH Test Methods Regulation for what is available for use. Other internationally-valid non-animal test methods that do not appear in the Test Methods Regulation may also be used. However, where animal tests are the last resort, then companies should use the most refined method possible to reduce the numbers of animals involved.
ECHA has published detailed guidance on data-sharing and information requirements for the REACH registration process on its website, and the UK REACH Competent Authority (provided by the Health and Safety Executive) is also shortly to publish a guidance leaflet for industry on animal testing and use of alternatives on its website. This will explain the REACH testing obligations, help with identifying the most appropriate test method, with information on the various available non-animal test methods.