Progress of the EU chemicals policy, Reach, highlights the need for alternative tests
The recent approval of the European chemicals policy, Reach (registration, evaluation and authorisation of chemicals) by the European parliament makes the need to develop alternatives to animal tests more urgent.
The European parliament approved the new rules last month. Reach is now expected to come into force in late 2006 or early 2007 (see p10). When it does, the requirements to test at least 10000 chemicals will result in greater numbers of animals being used.
Currently 10.7 million animals are used annually in testing in Europe. Estimates of what the Reach requirements will add vary and the numbers will depend on the final wording of the legislation. Predictions range from 3.9 million to 25 million additional animals in total.
It is timely, therefore, that just before the Reach vote, the European Commission and six industry bodies from the pharmaceuticals, cosmetics, chemicals and biotechnology sectors, including Cefic (the European chemical industry council), signed a partnership agreement ’to promote alternative approaches to animal testing’ aiming at refining, reducing or replacing animal use. The plan is to ’identify barriers to progress and propose appropriate solutions to promote the development, validation and regulatory acceptance of alternative approaches’. An action plan will be drawn up next spring, to be followed by annual progress reports (see p10).
Legislation already aims to reduce the numbers of animals used by requiring that an animal experiment should not be performed when an alternative method exists, and by encouraging the development and validation of alternative methods (EU directive 86/609/EEC). Also, under Reach, the authorities will try to ensure there is no duplication of animal tests through companies sharing animal test data. So will this agreement between industry and the commission achieve anything more?
Cefic says it will because it is a partnership. It will bring existing work together and make it more effective, says Cefic.
Animal testing is currently required by law for all new drugs, unless there is an alternative. In most cases there is not. Replacement tests are desirable for many reasons - to end animal suffering and to improve upon existing animal tests that do not always reliably predict human outcomes. Innovative alternatives could also help Europe’s competitiveness, and they are generally more cost-effective.
But the science is complex. Some human health effects, such as skin corrosion and absorption, can be assessed with replacement methods but scientists do not yet know how to model other effects, such as sensitisation.
While the development phase can’t be rushed, there are ways to speed it up, through funding, encouragement and by bringing scientists together. Those who are working to create alternatives need to collaborate with those using animal tests.
There are many barriers to remove and incentives to provide and the focus must be on the science involved. The need to replace animal tests is urgent, particularly now that Reach is heading into law.
Karen Harries-Rees, editor