LEGISLATION

• Chemicals
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• Lab Animals (86/609)

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Chemicals

EU Regulation for the Registration, Evaluation and Authorisation of Chemicals - REACH

	As well as the poisoning effects of toxic chemicals, animals used for chemical testing suffer painful force-feeding and handling.

A compromise has been reached between the Parliament, Commission and Council on the final text of the REACH legislation.  This is almost certain to be voted through by the end of the year.  This document is based on the compromise agreed.

What is REACH?

The aim of the new EU Directive on the Registration, Evaluation and Authorisation of all CHemicals (REACH) is to ensure that all chemicals manufactured or imported into the European Union are safe for its citizens to use.  As the current legislation is a hotchpotch of different directives and legislations that has developed historically, this legislation is designed to bring the vast majority of chemical safety testing under one Directive.  Prior to 1981, chemicals did not have to be safety tested before being put on the market. REACH will require the systematic testing of all chemicals that were put on the market prior to 1981, as well as all new chemicals manufactured or imported in quantities greater than 1 tonne a year.

REACH spells out the tests that each product (and each substance that the product is composed of) that a company wishes to place on the market must undergo to ensure its safety.  A European Chemicals Agency will be established in Helsinki, Finland, to oversee these chemical safety tests.

A company wishing to obtain authorisation to use a chemical will have to submit their testing proposals to the Agency, which will in turn then publishes the proposal for 45 days.  If there are other companies needing to test the same substance, they can join together with the initial company to share testing and costs.

Once the testing proposals have been accepted by the Agency, the company or group of companies then performs the tests.  They assemble a dossier containing all the relevant information which they send to the Agency who will then check to ensure the substance is safe.  If the Agency deems the substance safe, the company or companies are then authorised to manufacture or import it into the European Union.

The number of chemicals believed to have been on the market prior to 1981 is estimated at around 100,000.  Of these, about 30,000 are thought to be imported or manufactured in excess of 1 tonne a year and will therefore have to undergo authorisation under REACH.

REACH and Animal Testing

The ECEAE fully supports the idea that we should ensure the safety of chemicals we use.  In support of this the ECEAE, in conjunction with the BUAV, published a report entitled ‘The Way Forward: A Non-Animal Testing Strategy for Chemicals’, which demonstrated how chemicals could be tested to ensure they are safe without having to use animals.

The European Union did not fully embrace our strategy and will force companies to use many old-fashioned animal methods instead.  This means REACH will require a massive number of animals to be used in painful experiments to test for the safety of chemicals.  Initially it was estimated that around 45 million animals would be used in these experiments.  However, due to our work, this has been reduced and the present estimate is around 8-12 million animals – still a staggering amount, but substantially less than it would have been.

One of the reasons for this large reduction is the now mandatory sharing of animal test data.  Often a number of companies are using the same or similar chemicals.  This results in the same substance being safety tested many times over, with each battery of tests potentially involving hundreds of animals.  Mandatory data sharing ensures that safety testing is only carried once where there is not existing data, and that testing is not duplicated.  There was initial reluctance among big business to share their own data but due to intense pressure it was decided that repeating animal tests would be unacceptable.  Data sharing is now a central feature of the legislation and there are penalties for companies that don’t comply.

A positive aspect of the whole REACH process is that the promotion of alternatives to animal testing has now been placed firmly on the political agenda.  When this process started over five years ago, few politicians took the idea seriously and there was no mention of animals or alternatives in the proposals.  However, due to intensive lobbying and the sheer numbers of animals involved, the development and use of alternatives has been placed centrally in the legislation.  Article 1 now states specifically that one of the aims of REACH is the ‘promotion of alternative methods for assessment of hazards of substances’.  It also states that the development of alternatives should be prioritised in future European Union research.

Another success we fought hard for was a 45-day window of public scrutiny for any tests that companies are planning to carry out for REACH. The experience gained through the HPV Challenge Programme in the USA, a scheme which posted proposed tests on the internet, showed that many proposed tests were  avoidable.   It was shown that the relevant data was available elsewhere, there was an alternative test available, or that by redesigning testing regimes they could significantly reduce or replace animal use.  Consequently, public scrutiny of testing proposal has the potential to significantly reduce the numbers of animals used in REACH.

Finally the 7th Amendment to the Cosmetics Directive which bans the use of animals in safety testing for most cosmetics ingredients or products from 2009 (and all from 2013) was preserved.

A Missed Opportunity

Sadly, other aspects of the final REACH legislation concerning animals demonstrate a real missed opportunity. There were earlier proposals, for example, to create a specific Committee for Alternatives within the Chemicals agency, apportion some of the fee towards the development of alternatives and create strong enforcement measures for not sharing data.  However, these were lost in the intense negotiations surrounding the final agreement.  It is a testament to the 5-year campaign we conducted that our main demands were not seriously compromised but accepted by all sides.

Looking to the future, there is still an urgent need for the European Union to adopt a non-animal testing strategy and to prioritise the development and validation of alternatives, allocating sufficient funds to allow this to happen.  Companies need to realise that they have an ethical duty to adopt a non-animal approach and that strict enforcement measures are in place to ensure they do so.

REACH has been a protracted and difficult struggle.  We have moved the debate on animal testing a long way forward, now we need to complete the rest of the journey.

Our Non-Animal Testing Strategy

If you would like have more information on our strategy concerning the development and use of non-animal toxicity testing methods, please read our two key reports, The Way Forward: A Non-Animal Testing Strategy for Chemicals ( part 1 and part 2) and Chemical Safety and Animal Testing: Regulatory Smokescreen?

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