The implications of REACH

FRAME recognises the need for greater protection to humans, wildlife and the environment, but considers the REACH proposals to be ill conceived and unlikely to achieve their stated purpose.  FRAME believes efforts should be made to minimise the number of animals required and that more effort should be applied to the development and validation of non-animal alternatives with respect to extra tests required by REACH.

REACH (Registration, Evaluation and Authorisation of Chemicals) is a new EU legislation on chemicals safety which introduced new registration and testing rules for all substances produced (or imported) at volumes greater than 1 tonne per year.

It has been estimated that there are 30,000 substances which will have to undergo testing as a result, even though all are currently on the open market and being used throughout the world.

Additional testing required by REACH will use a large number of animals. Initial reports suggested up to 4 million animals may be required but this does not include any offspring from reproductive studies, when these are included, the figures rise to around 40 million animals.

Additional information

FRAME believes that there are many ways in which the number of animals required by REACH can be minimised including:

• the use of exposure levels of a substance. If a substance is unlikely to be exposed to humans, it is therefore unlikely to cause any adverse effects and so does not need extensive safety testing.
• the development of guidelines and incentives to promote data sharing by industry. This is needed because there may already be a lot of the required information for a substance, but because of the confidential nature of research, companies are unwilling to share this data in case it gives their competitors an unfair advantage.
• the use of validated non-animal tests as soon as they become available. The development of alternative non-animal tests is a slow process but as soon as one is validated and endorsed by a body of professionals within the EU, it should be made available for use and the corresponding animal test stopped.

All substances which have to be registered under the REACH legislation will have to fulfil a set of safety testing requirements determined by the amount produced. The higher the production volume of the substance, the more tests are required. These include animal tests for short-term and long-term toxicity, effects on reproduction, mutagenicity and carcinogenicity, along with various other tests on fish and other species in the environment.