Alternative approaches to animal testing

In Europe, the REACH regulation sets out information requirements aiming to protect people and the environment from unintended effects of chemicals. And like most regions in the world, Europe has relied on both animal testing and non-animal testing methods to perform chemical safety assessments.

More than a decade ago, the European Commission committed to ultimately replace animal testing in the Directive 2010/63/EU on the protection of animals used for scientific purposes. Yet still today, acceptance of existing non-animal testing methods remains low in Europe. The Chemicals Strategy for Sustainability (CSS) published in 2020, also remains unclear how this commitment will be achieved. According to animal protection organisation, Cruelty Free Europe, new information requirements foreseen the Chemicals Strategy could lead to at least 4 million more animals being used in the EU.

With the aim of safeguarding animal welfare and reducing reliance on animal testing, Cefic members fully support the development and use of fit-for-purpose alternative testing methods, which can be used in Integrated Approaches to Testing and Assessment (IATAs), to more reliably, accurately and predictably set safe levels of chemicals. Accelerated development, validation and use of new testing methods will further reduce reliance on animal testing for chemical safety assessment. Cefic members acknowledge that further scientific and technical innovation will be necessary to achieve the ultimate replacement of animal testing.

The uptake and implementation of New Assessment Methodologies (NAMs) and IATAs can only be possible if Europe increases regulatory acceptance of these methodologies and sets more funding at Member State level and EU level, like Horizon 2020, for the development and validation of these methodologies.

Cefic members see the upcoming REACH Revision as the key opportunity to modernise data generation under REACH to reflect scientific advances and to ensure both existing data as well as reliable NAMs are further developed, promoted and accepted by the European Commission, EU Member States and the European Chemicals Agency (ECHA) at an increased rate.

What actions have been taken by industry so far?

The chemical industry has been investing in, and using, where possible and applicable, alternative methods and approaches like computational toxicology models, grouping and categorising similar substances, read-across to validated data of similar substances, and validated in vitro and in chemico assays to demonstrate the safety of a substance in REACH dossiers.

Cefic continues to fund and facilitate many projects in this area through its Long-Range Research Initiative (LRI) and has invested €4.5 million in alternative testing research since 2018. Cefic participated in a joint project with the Organisation for Economic Cooperation and Development (OECD) to develop the QSAR-Toolbox  – a free software that allows its users to fill gaps in (eco)toxicity data needed for assessing chemical safety. Read more about LRI outcomes.

Cefic is also a member of the EPAA, the European Partnership for Alternative Approaches to Animal Testing. The partnership consists of the European Commission, 37 companies, and 8 European industry federations. The EPAA partners commit to pooling knowledge and resources to accelerate the development, validation and acceptance of alternative approaches to further promote the replacement, reduction and refinement of animal use in regulatory product testing.

Supporting documents