Exploring EU's Animal Testing: From Bans to Regulatory Interfaces and Beyond

Animal testing plays an important role in assessing risks from chemicals to human health, and evaluating medicines. The knowledge gained from these areas has been significantly contributing to better health, improving the life quality, and increasing the life expectancy of human beings.

While animal testing serves such a crucial purpose, EU prioritizes the protection and welfare of animals, including those used for scientific purposes. The term "scientific purposes" refers to all uses of animals for basic, translational and applied research, regulatory testing and production, education and training, as well as the creation and maintenance of genetically altered animal lines. EU has set an ultimate goal of phasing out animal's use for scientific purposes, and is taking concrete actions to achieve this goal. 

Current Status of Animal Testing in the EU

EU legislation on animals used in science centers on the principle of the "Three Rs": Replacement, Reduction, and Refinement. This principle, which first appeared in 1959, is embedded in EU's legislative policies. 

In addition to regulatory restrictions, the European Commission has been actively supporting research and innovation in non-animal testing, and promoting alternative testing approaches. Over the past 20 years, the Commission has invested more than EUR 1 billion into over 300 research projects related to alternatives to animal testing¹.

With these efforts by the Commission, the number of animals used in science has been decreasing throughout the EU. In 2020, a total of 7.9 million animals were used for testing purposes in research, training and education, and for regulatory purposes in the EU (excluding the UK) and Norway. This figure represents a 7.5% and an 11.4% decrease compared to 2019 (8.5 million) and 2018 (8.8 million), respectively¹. 

The Animal Testing Ban on Cosmetics

The former Directive 76/768/EEC (the Cosmetics Directive) provides the regulatory framework of the phasing out of animal testing for cosmetic purposes. It implemented the ban on both testing and marketing of finished cosmetic products and cosmetic ingredients tested on animals, with the following timelines:

• September 11, 2004: The ban on the performance of animal testing for cosmetic products came into force (the "testing ban");

• March 11, 2009: A ban on the performance of animal testing for cosmetic ingredients came into force (the "testing ban"). Besides, the ban on the marketing of finished cosmetic products tested on animals came into force (the "marketing ban"), except for testing related to the most complex human effects, including repeated-dose toxicity, reproductive toxicity, and toxicokinetics;

• March 11, 2013: The full marketing ban on cosmetic products tested on animals came into force. 

The same provisions are included in the new Cosmetics Regulation, which replaced the Cosmetics Directive as from July 11, 2013. To comply with the Cosmetics Regulation, the marketing of cosmetic products is prohibited if the finished product, the final formulation, or any ingredients in the final formulation, have undergone animal testing.

In exceptional circumstances, where serious safety concerns arise regarding an existing cosmetic ingredient, a Member State may request the Commission to grant a derogation from the animal testing ban. The derogation may only be granted by the Commission with conditions where:

1. the ingredient is widely used and cannot be replaced by any other ingredient that can perform a similar function;

2. the specific human health problem is substantiated, and the need to conduct animal tests is justified by a detailed research protocol proposed for the evaluation.

Interface Between Cosmetics and Chemicals Regulations

Under REACH, EU's chemicals regulation, EU-based manufacturers and importers are required to register chemical substances manufactured and imported into the EU whose quantity exceeds 1 metric ton per year. This registration obligation entails providing information on the intrinsic properties of the substance, including the chemical safety assessment information. While gathering the necessary information for registration, testing on vertebrate animals may be involved.

Substances used in cosmetic products may require registration as per REACH. This has led to some uncertainties about whether animal testing can be conducted to comply with REACH, or whether it should be avoided to comply with the Cosmetics Regulation. In 2014, the European Chemicals Agency (ECHA) released a factsheet to clarify the interface between the Cosmetics Regulation and REACH. According to this factsheet, the relationship between the (testing/marketing) bans laid in the Cosmetics Regulation and the information requirements specified in REACH can be described as follows:

• Registrants of substances that are exclusively used in cosmetics should not perform animal testing to meet the information requirements of REACH for human health endpoints, with the exception of tests to assess the risks to workers exposed to the substance;

• Registrants of substances that are used also for non-cosmetic purposes (i.e., mixed-use substances), are permitted to perform animal testing, as the last resort, for all human health endpoints;

• Registrants are permitted to perform animal testing, as the last resort, for all environmental endpoints.

With this description, it is evident that the testing and marketing bans within the framework of the Cosmetics Regulation do not extend to testing necessary for environmental endpoints, worker exposure, and non-cosmetic uses of substances under REACH. 

Updates on the EU's Animal Testing Policy

EU citizens have the right to request the Commission to propose legislation for matters they believe necessitate legal action to uphold the EU treaties. To initiate this process, they must submit a European citizens' initiative (ECI) in accordance with Article 11(4) of the Treaty on European Union (TEU), which requires collecting at least one million signatures in total from nationals of a significant number of Member States.

"Save Cruelty-free Cosmetics—Commit to a Europe Without Animal Testing" is the ninth ECI that has reached the thresholds specified by TEU. This initiative echoes public concerns regarding the use of animals for scientific purposes. Its objective is to urge the Commission to strengthen the animal testing ban on cosmetics, transform EU chemicals regulation, and modernize the science in the EU through legislative changes.

In response, on August 18, 2023, the Commission published a Communication regarding this ECI in its official journal1. The Communication expresses the perspective that the phase-out of all animal testing is desirable. However, it acknowledges that this is a long-term goal that will be achieved gradually. In the short and medium term, animal testing remains important for assessing the risks posed by chemicals to human health and the environment. In fact, the ongoing revisions of several chemical legislations manifest the promotion of the use of non-animal approaches.

Moreover, the Commission has thoroughly examined the three objectives outlined in the ninth ECI, and proposes the following actions in the Communication:

1. Continuing to uphold and enforce the animal testing ban within the framework of the Cosmetics Regulation;

2. Assessing the necessity for legislative changes to further clarify the interface between the Cosmetics Regulation and REACH based on the ongoing judicial reviews;

3. Initiating the development of a roadmap aimed at replacing animal testing in chemical safety assessments. This roadmap will outline milestones and specific actions to reduce animal testing, involving all relevant stakeholders;

4. Implementing a series of actions to accelerate the reduction of animal testing in research, education and training, including organizing more exploratory workshops, and sustaining new training initiatives for early career scientists;

5. Continuing to support research on alternatives to animal testing through EU funding. 

Further Reading

• Analysis | EU Safety Gate Alerts 411 Batches of Non-compliant Cosmetics in 2023 H1, with 93.3% Containing Prohibited Ingredients

• News | EU Amends the Restricted Ingredients List Regarding the Labelling of Fragrance Allergens

• Pedia | EU Cosmetic Regulation