BUAV welcomes DEFRA statement on animal testing under REACH

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Thursday, 28, Jan 2010 12:00

The BUAV welcomes a statement by DEFRA (Department of Environment, Food and Rural Affairs) Minster Dan Norris regarding REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and animal testing in response to a Parliamentary Question tabled by Mr Hancock MP. The BUAV has been raising the issue of the dire animal testing implications of REACH with DEFRA for some time.

The Minister clearly states in an answer today that animal testing under REACH should be a last resort and that companies must not conduct pre-emptive testing before testing proposals are agreed by the European Chemicals Agency (ECHA):

“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.”

In addition, DEFRA has produced an easy to read guidance note about animal testing under REACH in which they encourage chemical companies to use alternative methods such as computer programs (QSARs and read across) and in vitro, cell based assays. See www.defra.gov.uk/environment/quality/chemicals/reach/index.htm

Current estimates for the extent of animal testing under the REACH legislation are 8-54 million animals over the next 10 years, a truly staggering figure. The BUAV hopes this statement will help chemical companies feel more confident about the acceptability of alternative methods as well as reiterating to them their obligation to avoid animal testing.

The BUAV’s Scientific Co-ordinator Dr Katy Taylor says;

“We are pleased to see DEFRA reaffirm the key principles within the REACH legislation; that animal tests must be considered a last resort and that all efforts should be made to use alternative methods. It is important that the UK takes a firm stance on the avoidance of animal testing and we encourage DEFRA to maximise all opportunities to do so; in the interests of sound science, cost to the industry and, of course, animal welfare.”

For further information, please contact Dr Katy Taylor at +44 207 700 4888 or pressenquiries@buav.org. Visit our website at www.buav.org

NOTES:

Chemicals: Animal Experiments

Mr. Hancock: To ask the Secretary of State for Environment, Food and Rural Affairs if he will bring forward proposals to require the chemical industry to minimise the number of animals used in testing covered by the provisions of the EU Regulation on the registration, evaluation and authorisation of chemicals. [312689]

Dan Norris: 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:

www.defra.gov.uk/environment/quality/chemicals/reach/index.htm

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.