Today the Commission adopted some 100 new and updated test methods for the regulatory safety testing of chemicals under REACH, the Regulation for the registration, evaluation, authorisation and restriction of chemicals. Under these new rules, internationally approved methods (e.g. OECD- test guidelines) for the new test methods are referred to directly in the Regulation. Lengthy procedures previously used for reproducing and translating test guidelines into all EU official languages are no longer needed and hence any approved new test methods will be included in REACH much faster.
The majority of the newly approved toxicity test methods are New Approach Methods (NAMs) which do not involve animals. With this faster procedure, the Commission is responding to calls to speed up regulatory uptake of non-animal alternatives. It is one of the Commission’s actions to make NAMs more useful, and it will help to achieve the EU policy objective of ultimately phasing out the use of animals for regulatory testing.
REACH requires industry to manufacture, import and use chemicals safely. In order to achieve this objective, sufficient information on hazardous chemicals must be available. In some cases, the need to gather this information still requires the use of laboratory animals. Some hazardous properties of chemicals, such as endocrine disruption, cannot be sufficiently determined using currently available non-animal testing methods. Relying solely on such methods can underestimate the potentially hazardous properties of chemicals that could be harmful to humans and the environment.
The European Commission strives to reduce and ultimately replace the use of animals for testing. REACH therefore requires companies to share data and so avoid unnecessary animal testing. Those wishing to perform tests must indicate these to the European Chemicals Agency and must then obtain approval before carrying them out. Under REACH, animal testing must be avoided in favour of alternative methods and registrants can only carry out tests involving the use of animals as a last resort.
Through the EU Research and Innovation Framework Programmes over the past two decades more than 1 billion EUR have been dedicated to supporting over 300 projects to develop a variety of human-relevant non-animal methods and strategies. Some of these tools are now being used also for regulatory purposes. Further development of alternatives to animal testing is being pursued in the Horizon Europe Framework Programme for research and innovation that runs from 2021 to 2027. In 2022, more than 200 million EUR were allocated to this area.
- Regulation - new and updated test methods
- European Chemicals Agency: alternatives to animal testing under REACH: Alternatives to animal testing under REACH - ECHA (europa.eu)
- European Chemicals Agency workshop: All Events - ECHA (europa.eu)
- How to avoid unnecessary testing on animals - ECHA (europa.eu)
- Data di pubblicazione
- 3 marzo 2023
- Direzione generale dell’Ambiente