The European Commission responded on 25 July to the European Citizens’ Initiative (ECI) ‘Save Cruelty-free Cosmetics – Commit to a Europe without Animal Testing’. The response provides a comprehensive overview of the EU’s legislative and policy framework relevant to the use of animals for testing purposes. It also proposes additional actions to further reduce animal testing.
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What are the objectives of the European Citizens’ Initiative ‘Save Cruelty-Free Cosmetics Commit to a Europe without Animal Testing’ about?
The ECI ‘Save Cruelty-Free Cosmetics Commit to a Europe without Animal Testing’ has three objectives:
- Protect and strengthen the cosmetics animal testing ban initiate legislative change to achieve consumer, worker, and environmental protection for all cosmetics ingredients without testing on animals for any purpose at any time.
- Transform EU chemicals regulation ensure human health and the environment are protected by managing chemicals without the addition of new animal testing requirements.
- Modernise science in the EU – commit to a legislative proposal plotting a roadmap to phase-out all animal testing in the EU before the end of the current legislative term.
How does the existing legislative framework address animal testing and need for alternative testing methods?
The EU Cosmetics Regulation, in place since 2013, is already the most advanced legislation as regards phasing out animal testing, since it bans the placing on the market of cosmetic products that have been tested on animals to meet the requirements of the regulation.
In addition, EU chemicals legislation (REACH), which defines rules for the assessment of chemicals used in specific sectors or products, stipulates animal testing is to be used as a last resort when registering specific chemicals. Vertebrate animal tests should be replaced whenever possible using alternative methods. Alternative methods to adapt the standard testing regime are provided in the Annexes to the Regulation. In addition, the European Chemicals Agency (ECHA) provides comprehensive guidance on this matter. Furthermore, the REACH Regulation contains dedicated rules on data sharing to avoid unnecessary tests.
The Directive on the protection of animals used for scientific purposes sets strict rules and conditions on how animal testing can be carried out where still necessary with the goal of fully phasing out all animal use in research and for regulatory purposes in the EU.
Other pieces of legislation also specifically address animal testing by taking into account the “Three Rs principle”, which stipulates the need to replace studies relying on animals with other methods; reduce the number of animals needed in scientific test methods; and refine methods to minimise pain, suffering and distress of animals used for such purposes a legal requirement in the EU since 2013.
What does it mean that animal testing is used as a last resort under the REACH Regulation?
The REACH Regulation requires registrants to use non-animal testing methods whenever possible. It also requires them to submit testing proposals for certain tests involving animal testing. Stakeholders have the possibility to provide input on such testing proposals and can inform on alternative methods, if available. Guidance on applying this is provided in the ECHA report “The use of alternatives to testing on animals for the REACH Regulation” published in June 2023.
What has the Commission done in recent years to support research and innovation in non-animal testing and development of alternative measures?
Over the past two decades, the EU has provided more than 1 billion dedicated to support more than 300 projects to develop alternatives to animal testing. The budget to this area has constantly progressed over the years from around 11 million per year for the Framework Programme FP5 (1998-2002) to more than 75 million per year on average to Horizon 2020 (2014-2020). In addition, industrial sectors have complemented this effort by providing at least an additional 150 million to develop alternatives to animal testing.
The Commission continues to provide funding for the development of alternative methods in the Horizon Europe Framework Programme for research and innovation that runs from 2021 to 2027. The 2024 Horizon Europe work programme contains several topics for the development of alternatives to animal testing in biomedical research or their improved regulatory uptake.
What is the Commission proposing now in response to the ECI request to strengthen the ban on animal testing in cosmetics?
The Commission underlines that the Cosmetics Regulation already bans the marketing of products tested on animals. However, the REACH Regulation requires in some cases to perform animal testing for cosmetic ingredients for the assessment of risks to workers and the environment, unless non-animal methods are available for this purpose. The interpretation of the interface between the two regulations is currently being scrutinised by the General Court in two ongoing court cases. The outcome of these Court cases will be analysed by the Commission and will be the basis for any potential legislative changes in the future.
What the Commission plans to do to ensure that animal testing is not required in the framework of EU chemicals legislation?
The Commission will prepare a roadmap defining milestones and concrete actions to reduce animal testing, aiming for a transition towards an animal-free testing system for chemicals legislation (e.g. REACH, Biocidal Product Regulation, Plant Protection Products Regulation and human and veterinary medicines). This roadmap will involve collaboration with agencies, Member States, NGOs, industry, and research stakeholders. The Commission will evaluate the effectiveness of existing legislative and non-legislative tools supporting the phasing out of animal testing.
What will the Commission do to phase out animal testing in research, education and training?
With today’s Communication, the Commission is launching a series of actions to accelerate the reduction of animal testing including exploratory workshops and sustaining new training initiatives for early career scientists. The activities propose also to increase cooperation with Member States. It will also provide further funding to support research on alternative methods to animal testing.
What is the connection between the REACH Regulation and the current legislation on cosmetics when it comes to animal testing?
The Cosmetics Regulation already prohibits the placing on the market of cosmetic products that have been tested on animals. However, most ingredients used in cosmetic products are equally used in other consumer and industrial products, where animal testing might be required to assess hazards and risks to human health and environment. For instance, animal testing may be necessary to ensure compliance with the legal frameworks applicable to industrial products under the REACH Regulation. However, the REACH Regulation also stipulates that registrants must provide the required information, wherever possible, by using alternatives to animal testing (e.g., computer modelling, read-across, weight of evidence), with animal testing remaining the last resort.
In such cases, the Commission clarified that animal testing that has been motivated by compliance with non-cosmetics related legislative frameworks should not trigger the marketing ban of cosmetics. Such data can be relied on for the cosmetics safety assessment under the Cosmetics Regulation if they are relevant for that assessment.
What is the European Partnership on Alternative Approaches to Animal testing?
The Commission established a European Partnership on Alternative Approaches to Animal Testing (EPAA) in 2005 as a platform for collaboration and knowledge exchange among various stakeholders involved in (non-)animal testing for scientific purposes. EPAA brings together representatives from different Commission services, EU agencies, industry stakeholders, animal-welfare NGOs, academic experts, and other relevant parties. The partnership aims to promote the development, validation, acceptance, and implementation of alternative methods to animal testing in regulatory testing and decision-making processes.
One of EPAA’s key activities is the Project Platform, where partners and stakeholders collaborate on projects to advance the field of alternative testing methods and their integration into regulatory frameworks. EPAA also organizes an annual conference focused on activities related to alternative approaches to animal testing; as well as a Partners’ Forum to facilitate information exchange and the identification of synergies across different sectors involved in animal testing alternatives. In addition, the EPAA also awards a Refinement Prize to support students and young scientists who have made exceptional contributions in the field of alternative approaches.
What is the role of the EU Reference Laboratory for alternatives to animal testing?
The EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commission’s Joint Research Centre (JRC) and plays a crucial role in promoting and facilitating the use of non-animal methods in testing and research within the EU. Its main duties include engaging in research and development activities to improve non-animal methods for scientific purposes, often in collaboration with EU and international research initiatives. It is also responsible for the validation of alternative methods used for safety assessments of chemicals, to promote the acceptance and adoption of scientifically valid methods by regulatory authorities. In addition, the laboratory also plays a crucial role in helping to disseminate information and knowledge related to the Three Rs principles and alternative methods by providing guidance, organizing workshops and conferences, and fostering collaboration among stakeholders involved in non-animal approaches.
What is a European citizens’ initiative?
The European citizens’ initiative (ECI) was introduced in April 2012 as an agenda-setting tool in the hands of citizens. An ECI allows 1 million citizens from at least seven EU Member States to invite the European Commission to propose legal action in areas where the Commission has the power to do so.
Under the new ECI Regulation applicable since 1 January 2020, the Commission must react within 6 months of submission of a successful ECI that has managed to collect the required one million validated statements of support in at least seven Member States.
The Commission must decide whether it acts by proposing legislation, acts in some other way to achieve the goals of the ECI, or does not act at all, stating its reasons in each case. The Commission has to explain its reasoning in a Communication that is adopted by the College of Commissioners. If the Commission intends to act, the Communication must also set out the indicative timeline of its actions.
How many ECIs have been registered in total? What is their status?
Since 2012, the Commission has registered 102 European citizens’ initiatives, thus allowing them to collect citizens’ support. Of these 102:
- 10 have so far reached the threshold of one million signatures and were submitted to the Commission, with “Save cruelty free cosmetics” being the 9th one; 8 among them already received a Commission response, the latest being “Stop Finning Stop the Trade” on 5 July 2023. One more ECI will receive Commission’s reply in December 2023: “Fur Free Europe”.
- 2 initiatives have declared having reached the required support, but have not been submitted to the Commission for examination;
- 1 has finished collecting support but has not yet informed about its outcome;
- 8 are currently collecting statements of support and 4 have been registered but are yet to start their collection;
- 56 have reached the end of their collection period without reaching the threshold; 21 were withdrawn by the organisers during the collection period.
European citizens’ initiative “‘Save Cruelty-Free Cosmetics Commit to a Europe without Animal”
EU actions for the protection of animals used for scientific purposes
Source: European Commission
