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Cruelty Free Europe

Cruelty Free Europe is a network of animal protection groups working to end animal testing across Europe through policy and advocacy.

Lobbying Activity

Cruelty Free Europe urges ECHA to prioritize non-animal testing

2 Dec 2025
Topic — Proposal to update the governance and financial sustainability of the European Chemicals Agency.
Message — The group demands ECHA establish an Expert Committee on non-animal approaches and provide mandatory staff training. They also propose formalizing NGO collaboration and requiring public justifications for any new animal tests.123
Why — This would institutionalize the transition away from animal testing within the agency’s core strategic planning.4
Impact — Laboratories using traditional methods may face lower demand and stricter procedural requirements for animal tests.5
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Meeting with Rasmus Nordqvist (Member of the European Parliament)

5 Nov 2025 · Animal welfare

Cruelty Free Europe Urges Animal Testing Ban in Circular Economy

15 Oct 2025
Topic — The Circular Economy Act promotes sustainable production and the use of recycled materials.
Message — The group demands that the Act prohibits new tests on live animals. They want new safety data generated exclusively through non-animal approaches. Better data sharing is requested to prevent duplicative and unnecessary testing.123
Why — This would lower costs by preventing burdensome testing and removing regulatory obstacles.45
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Response to Evaluation of the Good Laboratory Practice (GLP) Directives

27 Jun 2025

Cruelty Free Europe thanks for the Commission for the opportunity to provide comments on the EU GLP Directives, an invaluable tool for ensuring the quality and reliability of data used for regulatory decision-making. We fully support Directives 2004/9/EC and 2004/10/EC as a means to contribute towards the protection of human health and the environment, as well as the avoidance of quality issues which could lead to the repeat of tests on animals, and to help avoid duplicate testing on animals between jurisdictions. We identify five key areas where the evaluation of the GLP Directives should focus. 1 - GLP helps prevent duplicate animal testing. 2 - The GLP Principles and Directives should support non-animal approaches. 3 - EU legislation must be able to encompass evolving standards for all types of data generation, as appropriate. 4 - GLP is not one size fits all for data generated by in vivo, in vitro and in silico means. 5 - GLP standards must be ensured within the EU and globally. In summary, GLP is an essential tool to ensure high quality data is used for regulatory decision-making across the EU and beyond. The importance and execution of GLP, and related inspections, holds particular weight when it comes to animal tests as it can help prevent repeated and duplicate tests through the MAD system. We also recognise the benefits of assuring high quality in vitro and in silico data but urge that this should be considered under a tailored set of data type-specific principles, such as GIVIMP, rather than attempting to make them fit the established mould used for animal tests.
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Cruelty Free Europe urges priority for non-animal biotech innovation

5 Jun 2025
Topic — The EU is consulting on a new act to accelerate biotechnology market transition.
Message — The organization calls for prioritizing non-animal science as a core biotech sector. It requests a clear pathway for regulatory acceptance and improved funding for alternative testing methods.1234
Why — This would accelerate the replacement of animal testing with cheaper, human-relevant alternatives.5
Impact — Traditional laboratories and researchers using animal models face being phased out by modern technologies.6
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Cruelty Free Europe urges AI strategy to replace animal testing

5 Jun 2025
Topic — The initiative creates a policy framework for AI adoption within European scientific research.
Message — CFE urges the Commission to prioritize AI applications that replace animal testing. They recommend funding human-relevant models over those that merely reduce animal usage.12
Why — This approach would validate and accelerate the organization's primary goal of ending animal testing.34
Impact — Patients are harmed by medical breakthroughs delayed by high failure rates in animal testing.56
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Meeting with Majdouline Sbai (Member of the European Parliament, Rapporteur) and Association Internationale de la Savonnerie, de la Détergence et des Produits d'Entretien

20 May 2025 · Révision du règlement Détergents

Response to Chemicals regulation - update of EU rules for test methods

28 Apr 2025

Cruelty Free Europe (CFE) thanks the European Commission for the opportunity to provide feedback on the update of EU rules for test methods via Regulation 440/200 (TMR, Test Methods Regulation). The annual update of the Test Methods Regulation (TMR) is of vital importance to ensure the broadest application of available non-animal testing methods appropriate for the purpose of fulfilling REACH standard information requirements. CFE thanks the Commission for its regular updating of the TMR and we hope this is a practice that will endure. We welcome the addition of three new non-animal test guidelines to the TMR in this latest update. To further support the transition away from testing on animals, through as rapid as possible uptake of newer non-animal approaches, we encourage the Commission to seek opportunities whereby any new non-animal method could be added to the TMR (even where an OECD test guideline is not yet available, or even planned) once there is sufficient confidence that the method is robust and appropriate to meet EU chemicals regulatory requirements. In addition to adding new non-animal methods to the TMR, progress in the transition away from animal testing would be supported by continued efforts to remove redundant animal tests from the regulation. We wish to highlight that the Guinea Pig Maximisation and Buehler tests for skin sensitisation (OECD TG 406) may be ready for deletion from the TMR, now that several non-animal test guidelines (OECD TGs 442C, D and E) and a Defined Approach (OECD TG 497) are available. Similarly, in vivo tests for skin corrosion and irritation and serious eye damage and irritation testing may soon be ready for deletion. We are pleased to see the proposed addition of three non-animal test guidelines (OECD TGs 252, 253 and 321) to the TMR. We support the addition of the HYBIT as soon as possible to align the with the most recent proposals from the Commission to amend the REACH regulations Annexes as well as the EU roadmap to phase-out animal testing in chemical safety assessment. We also strongly support the addition of the REACTIV and the Short-term JH activity screening assay as non-animal methods for the assessment of endocrine disruption, in light of the Commissions most recent proposal. We support the inclusion of revised guidelines OECD TG 442D, 467 and 496, which introduce additional test methods to expand the applicability domain of test guidelines available for assessing serious eye damage and irritation and skin sensitisation. We also support the inclusion of the revised guideline for OECD TG 403 which now states it should only be performed as a last resort following the assessment of all existing information. This revision reflects the aim of the EU chemicals roadmap to phase-out animal testing.
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Cruelty Free Europe urges non-animal methods for life sciences

16 Apr 2025
Topic — The EU strategy aims to boost competitiveness and innovation in the life sciences sector.
Message — Cruelty Free Europe demands that non-animal methodologies lead the new life sciences strategy. They want the EU to prioritise funding for modern technologies while phasing out animal testing. The group advocates for regulatory changes to speed up the adoption of non-animal tests.123
Why — Adopting these methods would fulfill the group's mission of ending animal testing in European labs.45
Impact — Traditional research facilities using animal models would face significant funding cuts and regulatory hurdles.67
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Response to Evaluation of the Cosmetic Products Regulation

21 Mar 2025

Revision of the CPR could simplify the implementation of EU legislation applicable to chemicals. The Call for Evidence asks whether the CPR is internally consistent and whether it aligns with other chemicals legislation. The answer, certainly in relation to alignment of animal testing provisions, is clearly that it does not. Revision is needed to bring alignment with other regulations including REACH, Detergents, Biocides, and Medical Devices, and also the Plant Protection Product Regulation. Such regulations each have their own separate requirements relating to the testing on animals of ingredients. Revision of the CPR can bring mutual compatibility between this Regulation and various other Regulations, improving coherence across overlapping EU legislation and reducing the burden on industry, regulators and the legal system. The EU cosmetics bans have been a beacon and a model for many similar bans across the world. It is of utmost importance, not least for the credibility of the EU, that they achieve what they set out to. We welcomed the introduction of the testing and marketing bans (the cosmetics bans) and the assurances given at the time that consumers can be sure that the cosmetic use of an ingredient in Europe cannot be the reason for any new animal testing. However, since then the way this Regulation has been implemented alongside other regulations applicable to chemicals has been extremely disappointing; substances used in cosmetics are still being tested on animals to meet European regulatory requirements. It has become clear that the CPR is not fit for purpose and needs to be amended to reflect the original policy intent. We welcome the fact that the Call for Evidence does not suggest any change to the EUs policy position adopted two decades ago. Indeed, that would be fly in the face of public opinion which across the EU remains strongly opposed to animal testing for cosmetics. This is consistently reflected in opinion polls and we note that the European Citizens Initiative Save Cruelty Free Cosmetics gained over 1.2 million verified signatures. Resolutions to ban cosmetics testing on animals globally (and to phase out all animal experiments in the EU) have received consistently overwhelming support from the European Parliament. The primary objective of the CPR remains to ensure human safety. CFE endorses that objective and maintain that were the cosmetics bans to be applied in the way originally intended, there is no safety risk. An important objective of the cosmetics bans is to further animal welfare and thereby reflect the ethical objection of EU citizens to causing animal suffering for this purpose. Members of the public, industry and regulators alike are entitled to understand what EU legislation aims to do and how it is applied in practice. The very fact that the cosmetics bans have led to so much litigation shows that these objectives have not been met with the CPR, and also with REACH. The need for amendments to restore the policy intent is clear; just three simple amendments to the CPR are required.
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Meeting with Stine Bosse (Member of the European Parliament)

14 Jan 2025 · Animal testing

Meeting with Catarina Martins (Member of the European Parliament)

21 Nov 2024 · animal welfare

Meeting with Lynn Boylan (Member of the European Parliament)

21 Nov 2024 · Animal testing in research

Meeting with Niels Fuglsang (Member of the European Parliament)

20 Nov 2024 · Meeting on animal welfare

Meeting with Majdouline Sbai (Member of the European Parliament, Rapporteur)

16 Oct 2024 · Révision règlement Détergents

Response to Commission Roadmap to phase out animal testing

15 Oct 2024

We thank the European Commission for their commitment to develop this roadmap and for conducting this consultation. We support the full transition away from testing chemicals on animals. - European Citizens want to see an end to the use of testing on animals, with 1.2 million people showing their support for the European Citizens Initiative 'Save Cruelty Free Cosmetics - Commit to a Europe Without Animal Testing'. The need for action is clear; according to the latest EU statistics for 2022 around 418,000 tests on animals were conducted for chemicals, medicines and veterinary medicines, biocides and plant protection products in that year alone with around 34 % having a severity classification of moderate (26 %) or severe (8 %). - A roadmap is a vital tool which will help ensure specific goals are met, that progress is measured, and that the very latest and best methods are always used to ensure the safety of chemicals. This transition is necessary if the EU is to meet the sustainability and protection aims set out in the European Green Deal and Chemicals Strategy for Sustainability. - We do not advocate for reduced protection of human health and the environment. The transition away from testing on animals is an opportunity to modernise the science behind the regulation of chemicals; we want to see a future where people and the environment are afforded better, and more comprehensive, protection from chemicals through the use of more advanced, reliable and relevant non-animal approaches which support faster and efficient regulatory decision making. - The roadmap must allow for and facilitate the long-term evolution of the regulatory framework itself as the intended protection goals are better defined and as the science of non-animal methods advances. The deficiencies of animal tests, and their inadequacy as proxies for actual protection goals, needs to be accounted for. - The focus of the roadmap must remain clearly on the elimination of animal tests and the future role of non-animal tests should not be limited to use as screening tools, or as complementary to tests on animals. - Short-term activity, such as revisions to chemicals regulations should not work against the ultimate goal of the roadmap. Wherever possible, chemicals legislation should be future-proofed so as to be able to accommodate anticipated scientific developments in non-animal chemicals testing. - Mapping the coverage of the chemicals space by the currently accepted non-animal test methods, as well as tracking progress as new and expanded methods become available, is an important exercise. - In line with the One-Substance-One-Assessment aims, we call for the establishment of an inter-agency body to facilitate the implementation of the roadmap and the replacement of regulatory animal tests of chemicals across all relevant legislation. - Please see the uploaded document for a fuller response.
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Meeting with Tilly Metz (Member of the European Parliament)

11 Sept 2024 · Animal Welfare

Response to Evaluation of the European Food Safety Authority (EFSA) 2017-2024

8 Apr 2024

CFE welcomes the opportunity to input into this call for evidence. The upcoming public consultation, targeted Member State consultation and stakeholder consultation must enable the evaluation of EFSAs performance specifically on the overall progress made towards the objective of the complete replacement of testing on animals. This objective must be included in the scope of those consultations to properly inform policy decisions relating to EFSAs performance. Also, EFSAs progress towards objectives which contribute to the overarching goal of full replacement of tests on animals should be covered. We detail examples in the uploaded supporting document. Whilst many aspects of EFSAs ongoing work is commendable, the objective for a complete replacement of testing on animals must be explicitly addressed by the upcoming consultations. The reduction and refinement of methods is important, but all projects should ultimately be aligned with the European Commissions roadmap for phasing out animal testing in chemical safety assessments. The evaluation of EFSAs performance must explicitly address progress towards the complete replacement of testing on animals as a discrete goal.
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Meeting with Manuela Ripa (Member of the European Parliament, Rapporteur)

19 Sept 2023 · Detergents Regulation

Meeting with Thomas Waitz (Member of the European Parliament)

19 Sept 2023 · Animal Welfare

Meeting with João Albuquerque (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

25 Apr 2023 · CLP - Classification, labelling and packaging

Response to Triannual evaluation of the six Executive Agencies

27 Mar 2023

Thank you for the opportunity to provide feedback on the three-year evaluation of the EU executive agencies. Cruelty Free Europe is a Brussels based network of animal protection groups working to bring animal testing to an end across Europe. Our interest in the evaluation comes from the crucial roles of the European Research Council Executive Agency and Research Executive Agency in managing and administering Horizon Europe and previous framework programmes, through which research and development of chemicals testing approaches, including non-animal methods, are funded. To improve efficiency, we propose that the agencies routinely conduct robust and comprehensive post-project reviews to evaluate whether funding spent on such approaches has the intended impact, i.e. to advance the transition away from testing chemicals on animals. This is particularly important in relation to non-animal methods intended to generate data for regulatory decision making there is often a recognised disconnect between methods being developed and their regulatory application, some methods are never used in a regulatory context and some serve only to increase the total amount of animal testing performed. Reviews would enable future spending to be directed in the most efficient way, ensuring the highest possible level of impact.
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Meeting with Sirpa Pietikäinen (Member of the European Parliament)

1 Mar 2023 · Classification, Labelling, and Packaging (CLP) Regulation

Cruelty Free Europe urges EU to prioritize non-animal testing

18 Oct 2022
Topic — This consultation concerns updating EU chemical classification rules with new hazard classes.
Message — The group calls for future-proofing the CLP regulation by removing barriers to non-animal data. They request mechanisms to keep rules updated with the latest scientific advances. They also want the European Chemicals Agency to support industry in using non-animal information.123
Why — This shift would reduce reliance on animals while improving chemical assessment accuracy.45
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Cruelty Free Europe urges ECHA to prioritize non-animal testing

10 Oct 2022
Topic — Modernizing the governance and operational structure of the European Chemicals Agency.
Message — ECHA’s mandate should explicitly include promoting non-animal methods and transitioning from animal testing. They propose creating a dedicated expert body to maximize the use of alternative methods. They also advocate for mandatory training on non-animal data for regulatory decisions.12
Why — This would legally institutionalize animal welfare goals within the agency’s core operations.34
Impact — Industry players would face increased financial pressure to fund these transition activities.5
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Cruelty Free Europe Urges Data Sharing to Stop Animal Testing

16 Aug 2022
Topic — This initiative aims to improve chemical data access and transparency for safety assessments across the EU.
Message — The organization calls for increased data transparency and sharing to prevent redundant animal experiments. They insist that authorities must only commission animal testing as a final option after exhaustive data reviews. Furthermore, the Commission should prioritize the validation of non-animal testing methods within the regulatory framework.123
Why — Improved data accessibility would directly advance the organization's mission to eliminate animal testing across Europe.45
Impact — Companies would lose competitive advantage as the proposal removes intellectual property protections for chemical data.6
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Meeting with Anja Hazekamp (Member of the European Parliament)

21 Jun 2022 · ECI End Animal Testing flashmob

Response to A New European Innovation Agenda

10 May 2022

Cruelty Free Europe supports the need for innovation, particularly when it comes to the methods and approaches used for scientific research and testing. Two-thirds of EU citizens want an immediate end to animal testing (https://comresglobal.com/polls/cruelty-free-europe-animal-testing-in-the-eu/), yet there were 12.3 million tests on animals in 2018 in the EU and Norway, and, at the current pace of change, we estimate that animals will continue to suffer in EU laboratories for the best part of another century. Meanwhile, mounting evidence demonstrates a scientific need to move away from animal tests, which impede progress and waste resources by producing unreliable and irrelevant information. For example, failure of animal “models” to correctly predict human responses – 92% of drugs fail in human trials even though they passed pre-clinical tests, including animal tests (https://go.bio.org/rs/490-EHZ-999/images/ClinicalDevelopmentSuccessRates2011_2020.pdf) – contributes to the huge amount of time (up to 15 years) and money ($2.6 billion) it takes to bring a new drug to market, resulting in fewer safe and effective medicines for those who need them. Unlike animal tests, new approach methodologies (animal-free methods and approaches to research and testing, also known as “NAMs”) use human-relevant approaches like three-dimensional cell culture, genetic analysis and sophisticated computer simulation to understand biological processes or predict how a substance will interact with the cells and proteins in a human’s body. NAMs are already widely used in areas including respiratory disease and breast cancer research and are outperforming animal tests in their ability to identify substances that may cause allergic skin reactions or damage the liver. Supporting the development and uptake of emerging NAMs, and ensuring the fullest possible use of existing NAMs, is crucial to a thriving research and innovation ecosystem, which will aid post-COVID recovery and ensure that the EU remains a world leader in science, innovation and animal welfare. To this end, Cruelty Free Europe urges the Commission to embed the goal of transitioning away from animal tests and towards greater use of NAMs into its Innovation Agenda.
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Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

12 Apr 2022

Cruelty Free Europe supports closer alignment of EU agencies tasked with chemicals management, and the streamlining of substance assessments, in order to ensure a high level protection of human health and the environment. As part of these efforts, the avoidance of animal testing must be a common, shared goal across all agencies. The ‘One Substance, One Assessment’ (OSOA) approach should bring opportunities for reduction in animal testing and should not hamper the use of non-animal methods (NAMs) – rather, OSOA should work to promote NAMs use for new data generation. While the simplification of chemicals management and a reduction in administrative burden may bring certain benefits, complete harmonisation of approaches for all chemical substances will not always be appropriate. For instance, substances for which there is no, or very limited, human or environmental exposure should not require the same level of data (and testing) as those with extensive potential for exposure. It is also crucial to stress that cosmetics and cosmetic-only ingredients must not undergo testing using animals, honouring Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products – this needs to be factored into any plans for implementation of OSOA. Reduction in administrative burden should under no circumstance override the legal requirement to avoid and/or minimise testing using animals. We are concerned that adoption of OSOA and the proposed move of the Scientific Committee on Consumer Safety (SCCS) to the European Chemicals Agency (ECHA) could see cosmetics regulated in a more conservative, hazard-based way, in line with industrial chemicals, preventing companies from using advanced NAMs and next-generation risk assessment (NGRA). The SCCS itself has expressed concern over how the move would affect its independence and fit with the animal testing bans. We would be grateful for reassurance that the SCCS’s knowledgebase and open-mindedness towards NAMs and NGRA will not be jeopardised by any move to ECHA, and that a risk-based approach to cosmetics regulation will be maintained and promoted further, making full use of NAMs. Many of the changes described under the Chemicals Strategy for Sustainability (CSS) will significantly increase testing using animals. Although this ‘Call for evidence’ clearly states that the Commission will not undertake an impact assessment on changes relating to OSOA directly, we ask that the potential of the OSOA approach to mitigate the negative impacts on animals is carefully considered. This could be accomplished by, for example: • Ensuring that all existing data relevant to the assessment of any given substance, including on similar substances (e.g. to apply read-across and/or grouping), are discoverable, accessible, and that a mechanism is in place for those data to be shared between registrants and agencies (for instance, as in accordance with OECD/LEGAL/0203, available at: https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0203). • Ensuring that the generation of duplicate hazard data under different regulations is completely avoided. • Applying considerations of the potential for exposure – e.g. via sharing of exposure information and/or best practise for estimating and collecting real-world information on exposure and refinement of risk assessments without the need to generate new animal-based data. • By maximising the use of NAMs to generate new data and by sharing best-practice on the use of such data for regulatory decision making. While the CSS describes in broad terms the actions aimed at consolidating the technical and scientific work on chemicals using the OSOA approach, there is a lack of clarity as to the concrete plans for their implementation. In order to allow proper scrutiny, these will need to be presented in sufficient detail to all relevant stakeholders, and with sufficient time to respond and discuss the various options.
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Response to Amendment of Regulation 440/2008 (TMR) – 9th ATP / or possibly change to listing of references

7 Apr 2022

Cruelty Free Europe thanks the Commission for the opportunity to provide feedback. We have long been concerned about the slow pace at which the Test Methods Regulation No. 440/2008 (TMR) is updated. Failure to include methods that replace, reduce and refine the use of animals as they become available leads to the unnecessary suffering of animals, as well as confusion for companies regarding the most appropriate test method/version to use. This has become more pressing over the last 20 years with the rapid creation and revision of test guidelines that replace, reduce and refine animal use. We fully support the aim of ensuring that the TMR provides correct, up-to-date and relevant test methods that are appropriate to generate information under Regulation (EC) No. 1907/2006, in particular where that can help to avoid new and/or inappropriate tests on animals being performed. We appreciate and welcome the proposed amendments to the TMR. We additionally offer a number of recommendations on this draft amending regulation and also on further steps that should be taken to ensure that the TMR is kept appropriately up to date in a timely manner. In particular, the current suggested wording for the amended TMR Annex (which is meant to indicate that selected test methods are either i) no longer recognised as appropriate, or ii) the DESCRIPTIONS of the test method protocols have been deleted because they are now out of date) is not at all clear - please consider our suggested text to avoid misunderstanding.
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Response to EU Chemicals Strategy for sustainability - Revision of the Cosmetic Products Regulation

29 Oct 2021

The revision of the CPR provides an opportunity to ensure that cosmetics and their ingredients are not tested on animals. Cruelty Free Europe is disappointed to see that the initiative does not aim to protect and strengthen the animal testing bans, for which there is overwhelming public and political support. The proposals to extend the generic approach to risk management to other hazard classes and the move towards “One Substance, One Assessment” instead run the risk of stimulating new animal tests for substances used in cosmetics and the IIA is worryingly silent on the impact of this. An opinion poll carried out for Cruelty Free Europe in 2020 found that 74% of adults in EU member states agreed that animal testing for cosmetic products and their ingredients is unacceptable in all circumstances. An ongoing European Citizens’ Initiative named “Save Cruelty Free Cosmetics” has already gained over 260,000 signatures within two months, 8.3 million people signed a petition in 2018 to ban cosmetics testing on animals globally, and resolutions to ban cosmetics testing on animals globally and phase out all animal experiments in the EU received overwhelming support from the European Parliament. It is imperative that the impact of the proposals on animal welfare – including the risk of a direct or indirect increase in animals used in testing – are covered in the impact assessment, as required by Article 13 of the Treaty. Objectives and policy options- Generic approach to risk management: We are concerned that extension of the generic risk management approach to new hazard classes could create additional, indirect reliance on animal testing, since classification under the CLP Regulation – which, as it stands, largely relies on animal test data – will likely be the basis for banning substances from cosmetics. To protect the animal testing bans and ensure that cosmetics can remain cruelty free, we urge the Commission to find a way of implementing the generic risk management approach for cosmetics that will not stimulate new animal testing, directly or indirectly. One Substance, One Assessment: We are concerned that adoption of the “One Substance, One Assessment” approach and the proposed move of the scientific committee on consumer safety’s (SCCS) to ECHA could see cosmetics regulated in a more conservative, hazard-based way in line with industrial chemicals, preventing companies from using advanced non-animal approaches like next-generation risk assessment (NGRA) to demonstrate the safety of cosmetics and their ingredients. The SCCS itself has expressed concern over how the move would affect its independence and fit with the animal testing bans. We would be grateful for reassurance from the Commission that the SCCS’s knowledge of and open-mindedness towards new approach methodologies and NGRA will not be jeopardised by its move to ECHA, and that a risk-based approach to cosmetics, making full use of NAMs, will be maintained. We ask that the Commission: • Provides clarity on how its proposals will affect the use of animals in testing, • Fully considers the welfare of animals used in testing in its impact assessment and legislative proposal, • Finds a way of implementing the generic risk management approach that does not rely on the generation of new animal test data, • Maintains the independence and open-mindedness of the SCCS, • Allows companies to demonstrate the safety of cosmetics and their ingredients using non-animal methods including NGRA and • Ensures that any changes to the CPR serve to protect and strengthen the cosmetics animal testing bans and support the promotion of non-animal methods.
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Response to Clarification of requirements for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

16 Jul 2021

Thank you for the opportunity to comment on this draft regulation. We believe that the proposed changes to REACH Annexes VII to X are premature and should be subject at least to a full impact assessment, or maybe more appropriately, only proposed as part of the revision of REACH. The Commission is currently planning the revision and has committed to assess the impact of any measures proposed on animals used in tests. By contrast, these changes – which are wrongly described as “clarifications” – would, if adopted, considerably increase animal data requirements without the benefit of either an impact assessment or Parliamentary scrutiny. There is also reason to question whether the changes would actually result in any improvement in protection of human health or the environment. Throughout the process leading up to this consultation, the Commission has maintained that the proposed changes will not have an impact on animal testing. This is simply not the case. Several of the proposed changes alter the meaning of the original legal text and present a real possibility of increased testing on animals, for example: • Introducing an in vivo genotoxicity study as mandatory requirement at Annex VII in case of a positive result in any of the in vitro genotoxicity studies. • Introducing in vivo germ cell studies as standard information requirements at Annexes IX and X. • Introducing QSARs and in vitro data as specific triggers for extended one generation reproductive toxicity and/or prenatal developmental toxicity tests at Annex VIII. • Specifying oral route of administration for reproductive toxicity tests throughout the Annexes. • Adding language to suggest that a long-term fish test can be proposed or required in addition to a short-term test at Annex VIII. Some changes have been proposed to bring the legal text in line with ECHA’s practices that are already in place, but this is the wrong way around – ECHA’s practices must be dictated by the legal text. If there is a discrepancy, it is for the European Court of Justice to reconcile the legislators’ intention with the legal text, or for the Commission to propose changes based on an impact assessment where appropriate. Similarly, it is inappropriate to use these updates to cement in the legal text a number of controversial issues that have not yet been settled by the European Court of Justice, for example: • Whether a prenatal developmental toxicity test on a second species is required at Annex X. The intention of legislators is not clearly conveyed by the current REACH text, but the proposed text would cement a second species prenatal developmental toxicity test as a mandatory requirement. • Whether both long-term Daphnia and fish tests are required at Annex IX. Previously, the decision has been made based on the outcome of the chemical safety assessment, but proposed changes to the wording of Annex IX, section 9.1, column 2 would make long-term tests on both fish and Daphnia mandatory. In many cases, a high level of protection of human health and the environment will be achievable using strategies that do not involve new tests on animals, so the legal text must be flexible and pragmatic enough to accommodate use of such strategies. Since Directive 2010/63/EU requires implementation of the 3Rs and Articles 13(1) and 25(1) of REACH require that non-animal methods be used wherever possible and that animals be used only as a last resort, this is not just an ethical obligation but a legal one too. Disappointingly, our suggestions to use these updates as an opportunity to improve animal protection were ignored, and there is no indication that any of the proposed changes will lead to a reduction in animal testing. The Commission’s apparent lack of consideration for this issue calls into question its commitment to the 3Rs and the promotion of alternative methods for assessment of hazards of substances (Article 1(1) of REACH). Please see the attached document for further information.
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Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

1 Jun 2021

Cruelty Free Europe believes that the revision of the CLP Regulation in parallel with the Revision of REACH is an opportunity to bring animal testing to an end and move towards a modern EU regulatory system for chemicals based solely on non-animal methods. This would ensure better and more reliable information on chemicals for human health and the environment while ending cruel animal testing. These inputs are made in addition to Cruelty Free Europe’s submission to the consultation on the inception impact assessment for REACH which contain further points and supporting information. See link at the end of the submission. Cruelty Free Europe would raise the following points on the inception impact assessment on the revision of CLP: 1 ) Problem Definition The problem definition identifies ‘incomplete information about hazards to human health and the environment’ as a key problem that the revision of CLP aims to tackle. The problem definition should be updated to include the link between information requirements for CLP hazard classification and increases in animal testing as an important issue in this context. The REACH and non-REACH Fitness Checks of EU Chemicals legislation raises the lack of coherence between rules on data requirements as a key problem resulting in unnecessary testing. 2 ) Policy Options and Preliminary Assessment of Expected Impacts The preliminary assessment of impacts neglects to consider the impact on the number of animals used in testing as a result of changes to the CLP Regulation. Several of the policy options could result in new animal testing, such as introduction of new hazard classes, introduction of an obligation to provide certain hazard information on labels for products currently outside the scope of CLP, and clarification of the obligations to classify mixtures and some complex substances. As it is the case for the revision of REACH (see response to the EU parliamentary question E-001215/2021), the impact assessment on the revision of CLP must consider the impacts on animals of each of the policy options. Cruelty Free Europe would emphasize the need to look at the impacts of introducing new hazard classes and the interface with extension to more products. A ) ED hazard classes in CLP The supporting study as well as the impact assessment, should consider how many animal tests could be required for existing substances if a new Endocrine Disruptors (ED) hazard category is included under CLP. Testing on animals to generate ED-related data for CLP classification, for example under REACH, may have a huge impact on animals (see attachment). Considering that ED-mediated adverse effects may in many instances be captured by existing hazard categories, it is vitally important to understand if this huge increase in the burden on animals will result in any meaningful difference to the way risks from chemicals are managed. The impact on animals should be set against the number of substances expected to have more stringent risk management measures as a result of a specific ED hazard classification. Furthermore, Implementing ED hazard classes in CLP before any introduction in UN GHS will make global harmonisation considerably more difficult. The impact on animals of diverging from the UN GHS global standards should be addressed in the upcoming impact assessments. B ) Cosmetics The supporting study and impact assessment should consider all possible ramifications of amending the scope of the CLP regulation and the product types that are covered; in particular, the need to respect the cosmetics animal testing and marketing bans should be carefully considered.
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Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

1 Jun 2021

Cruelty Free Europe sees the revision of REACH as an opportunity to move towards a modern EU regulatory system for chemicals based on non-animal methods. This would end the suffering of millions of animals and address citizens’ concerns while providing better information on chemicals for human health and the environment. Cruelty Free Europe would raise the following points on the inception impact assessment: 1 ) Problem definition The Commission's initial problem definition overlooks the limited uptake of non-animal testing methods and lack of compliance with the requirement to use animal testing only as a last resort in REACH, despite the fact that we are now approaching the ‘worst case’ scenario estimated in the initial the impact assessment on REACH 12 years ago (see attachment). The problem definition should be updated to include these aspects and that animal tests very often are unreliable, highly variable and provide little hazard information of relevance to humans (see attachment). This would be in line with art. 13 TFEU, stipulating that full regard should be paid to animal welfare when formulating and implementing policies. It would also make the REACH revision consistent with Directive 2010/63/EU’s final goal of full replacement of procedures on live animals for scientific and educational purposes. Furthermore, EU citizens do not support animal tests (see attachment). 2 ) Objectives and policy options Non-animal data generation, effective data sharing, use of existing data and read-across within groups of similar substances are important ‘alternatives’ that should be maximally used. However, the upcoming changes to REACH look set to massively increase the number of animals used (see attachment). The legislative changes arising from the REACH Revision are an opportunity to improve the quality of the information on the hazards posed by chemicals by the use of non-animal methods. It is also an opportunity to move away from the current ‘checklist approach’ based on in vivo test guidelines (see conclusion of EURL ECVAM 2020 report). Non-animal methods are constantly evolving, and a policy option should be to introduce new mechanisms in REACH which promote their fullest integration to ensure that highest quality data is available to realise the objectives of the Chemicals Strategy for Sustainability. 3) Preliminary assessment of expected impacts The preliminary assessment of impacts does not include potential increases in animal testing as a result of the policy options outlined. This is despite the Environment Commissioner confirming in the reply to a parliamentary question (E-001215/2021) that the impact on animal testing will be considered in the REACH Revision. It is vital that the full impact assessments (IA) for all relevant actions include the impact on animal testing as both a societal and an economic impact. Importantly, this should include an assessment of the most effective scenarios to reduce and replace animal testing whilst satisfying the objectives of the REACH Revision. Estimates should be made for each proposed change to REACH, so it is clear which option will have the lowest impact on animals. For instance, the implications in terms of numbers of animals used in tests should be counted for each policy option -as a societal impact- as well as the cost of these tests- as an economic impact. The IA must include the likely impact on the use and promotion of non-animal methods in the future, not just estimate their likely use now. 4 ) Evidence base The studies planned for 2021-2022 to support the development of options for REACH changes and the forthcoming impact assessments must feature analysis of animal testing implications in the near and long-term, in particular for the studies relating to Endocrine Disruptors; Mixture Assessment Factor; increased hazard information requirements; use and exposure; DMELs for non-threshold substances; and extended use of generic risk approach.
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Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides), Panayiotis Pourgourides (Cabinet of Commissioner Stella Kyriakides)

9 Dec 2020 · Introductory exchange of views on animal testing replacements and the pharmaceutical strategy

Meeting with Camilla Bursi (Cabinet of Commissioner Virginijus Sinkevičius)

9 Dec 2020 · to discuss the recently published Chemicals Strategy for Sustainability and animals testing

Response to Clarification of requirements for the Registration, Evaluation, Authorisation and Restriction of Chemicals

16 Nov 2020

The requirement for member states to “ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure” involving animals (i.e. implementation of the 3Rs;Article 4(1); Directive 2010/63/EU); the requirement to use non-animal methods wherever possible, and to conduct tests on vertebrate animals only as a last resort (Article 13(1) and Article 25(1); REACH) are ethical and legal obligations within the EU. Any amendments to the REACH Regulation must not violate these obligations, and should in fact encourage movement towards the EU’s final goal of fully replacing tests on animals (Recital 10; Directive 2010/63/EU). However, many of the proposed amendments to Annexes VII – XI could further restrict the use of non-animal approaches under REACH, leading to the data requirements being considered even more as a tick-box exercise and could result in additional testing on vertebrate animals. Therefore, the proposed amendments raise significant concerns regarding the Commission’s commitment to the 3Rs and the application of non-animal methods for safety assessment. This is out of step with other regions which are making strong commitments to phasing out tests on animal for hazard and risk assessment. For example, the Netherlands National Committee for the Protection of Animals Used for Scientific Purposes has published an advice report on the country's transition to animal-free innovation in which it concluded, among other things, that toxicity tests on animals for chemicals, food ingredients, pesticides, veterinary medicines, and vaccines could be phased out by 2025. More recently, the US Environmental Protection Agency announced in 2019 that it would provide additional funding for the development of non-animal methods and reduce tests on mammals by 30 per cent by 2025, with a view to eliminating these tests completely by 2035. We strongly urge the Commission to make a similar commitment to the use of non-animal approaches for regulatory testing and would welcome the opportunity to work with ECHA and the Commission to implement such a strategy. In the attachment, we outline our primary concerns related to the proposed amendments to the proposed text for Annexes VII to XI.
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Response to Amending of the rules governing the renewal procedure for active substances in view of new “Transparency Regulation"

1 Oct 2020

Cruelty Free Europe welcomes the draft Implementing Regulation which aims to establish rules on the procedure for the renewal of the approval of active substances whilst recognising the importance of the Transparency Regulation. We support the following elements in particular: (7) … public disclosure of all scientific data, studies and other information supporting an admissible application by the Authority, and a consultation of third parties on the submitted scientific data, studies and other information supporting an admissible application. 6. The applicant shall identify and list the new data it submits, including any new studies involving vertebrate animals in a separate list. It shall demonstrate that the new data is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009 and, where applicable, refer to advice received during the pre-submission phase in accordance with Articles 32a and 32c of Regulation (EC) No 178/2002. We welcome these steps to ensure public disclosure of information and the opportunity for third parties to provide input. We especially support the requirement to demonstrate that new data is necessary. We wish to contribute to the Commission’s efforts by providing suggested amendments to the draft text as follows: Current text: Article 10 Public access to the information in the application for renewal and consultation of third parties … whether other relevant scientific data or studies are available on the subject matter concerned by the application for renewal… Suggested amendment: Article 10 Public access to the information in the application for renewal and consultation of third parties …whether other relevant scientific data or studies are available relating to the subject matter concerned by the application for renewal… Rationale: Use of the words “relating to” as opposed to “on” would bring the opportunity for third parties to submit information relating to the quality of scientific data, and the methods used to generate that data, more generally. Such information may not directly relate to the subject matter concerned in the application for renewal but may still be relevant to the evaluation of the available data for that purpose. Current text: (h) for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals; Suggested amendment: (h) for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals and any factors which may have prevented studies involving vertebrate animals being avoided. Rationale: It is important to learn about what can lead to a potentially avoidable vertebrate study being conducted so that improvements can be made, thus ensuring that such studies are avoided wherever possible.
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Response to Review of the general product safety directive

1 Sept 2020

Revision of the GPSD is an excellent opportunity to demonstrate the EUs’ progressive stance on animal welfare, drawing on the experience of the intent of the animal testing bans in the Cosmetics Directive (7th amendment, in 2003). In the event that there is a revision of the GPSD, it would be appropriate to reflect both public opinion and common industry practice and indicate that animal testing of any ‘final product’ is not permitted.
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Response to Fitness Check of the EU legislation on animal welfare

20 Jul 2020

Although the replacement of experiments on animals in laboratories with modern, humane and human-relevant new approach methodologies (NAMS) has unfortunately not historically been captured in the European Union’s Animal Welfare Strategy, we would argue that this Fitness Check is an opportunity to think about the intersections between animal welfare and other policy areas, including research. More investment in NAMS and a strategic, pro-active plan for replacing animal testing would not only be good for animals but would also help deliver the Green Deal and a globally competitive and resilient Next Generation EU. We would also argue that animals used in research should indeed be included in the Animal Welfare Strategy. Whilst Directive 2010/63/EU purports to provide for the welfare of animals used in science, ongoing infringement procedures – as well as issues of inspections of testing facilities and other breaches of the law thrown under the spotlight by the recent Cruelty Free International and SOKO Tierschutz investigation at a site owned and run by the Laboratory of Pharmacology and Toxicology in Germany – show that it is evident that rather than being a tool for the future of science and research, it upholds the past. Article 2 of the Directive, rather than enabling Member States to improve animal welfare, prevents them from moving forward in pro-actively replacing animal tests.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

In order to achieve the goal of safe and affordable medicines and to support the European pharmaceutical industry to remain an innovator the Commission must put innovation in humane nonclinical safety and efficacy assessment at the heart of the strategy. The pharmaceutical sector will continue to struggle to respond to both long term health issues such as our ageing population and new pandemics like coronavirus unless it invests in better methodologies to predict the safety and efficacy of new pharmaceuticals. We support the Commission’s view that the coronavirus pandemic clearly demonstrates the need to modernise the way the EU ensures access to medicines for its population, including a need to future proof. This has to involve moving away from outdated animal models that have not been proven to be safe or effective. Investing in replacing animal testing will improve the quality as well as the humaneness of our science. Improving the flexibility of the regulatory regime will give companies the confidence to innovate and streamline testing so that they can respond quickly to emerging health needs.
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Response to Chemicals strategy for sustainability

19 Jun 2020

Cruelty Free Europe calls on the Commission to create a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment, minimising exposure to hazardous chemicals, whilst making every effort to ensure animal testing is only ever performed as a last resort, with a view to replacing animal testing with better and more reliable non-animal methods. In order to achieve that we need: • to be mindful that simplifying chemicals legislation must not come at the cost of ensuring the existing REACH obligation of animal testing as a last resort is maintained and must protect the animal testing bans in the Regulation on Cosmetic Products. It is important that these important principles, already accepted by the EU community, are repeated wherever relevant • to caution against excessive testing demands, instead focusing on protecting human and environmental health by assessing exposure and biomonitoring. The precautionary approach requires action, not the delay that is caused by reliance on lengthy, inconclusive animal tests • greater investment in non-animal approaches, which are faster, more relevant and more humane • to commit to a phase-out of animal testing as a means of determining human health hazards and its complete replacement with innovative, efficient techniques
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