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European Coalition to End Animal Experiments

ECEAE

The European Coalition to End Animal Experiments (ECEAE) is an umbrella organisation of currently 17 animal protection, anti-vivisection and scientific organisations across Europe.

Lobbying Activity

Response to Proposal for a basic regulation of the European Chemicals Agency

25 Nov 2025

This Regulation represents an important opportunity to ensure ECHAs additional tasks are fully aligned with the objectives of the Chemicals Strategy for Sustainability (CSS), Directive 2010/63/EU on the use of animals for research and testing and key commitments under the Commissions Roadmap towards phasing out animal testing in chemical safety assessments. We are pleased to see ECHAs role in the promotion of non-animal approaches and the reduction of animal testing recognised in the draft Regulation. This provides legal clarity to ECHAs role in upholding these key principles in the existing REACH Regulation. However, to ensure that ECHA delivers on this mandate, we propose that its tasks in this area are expanded upon so that it is appropriately funded and there is accountability. A reinforced ECHA mandate on non-animal approaches would advance human health and environmental protection by promoting more predictive, human-relevant science, reducing costs for SMEs through the elimination of redundant animal testing, and enhancing transparency and oversight. This is increasingly important as ECHAs role with respect to commissioning and evaluating testing requirements is set to expand. Specific expertise is vital to ensure the evaluation of chemicals keeps pace with the development of new methodologies. We propose the addition of tasks related to the promotion of the development, regulatory acceptance, and use of non-animal approaches such as; Requirement to cooperate with other EU bodies, such as EURL ECVAM, International bodies such as the OECD and civil society, on the promotion of the validation, harmonisation, and uptake of non-animal approaches across sectors. Provision of a safe space for dialogue on testing strategies prior to testing proposal submission to ensure that animal testing is used only as a last resort. This would bring ECHA in line with the EMA and EFSA who provide several paths for discussion with industry including, but not limited to provision of scientific advice, the Innovation Task Force and safe harbour options. Requirement to publish a justification document whenever new tests on animals are commissioned by ECHA to demonstrate the rationale for why the animal test is needed and why non-animal approaches are not applicable. This will help reduce avoidable animal use, ensure compliance with legal mandates to only test on animals as a last resort, and improve the predictability of regulatory decision-making. Provision of training for staff and committee members on non-animal approaches. Inclusion of ECHAs activity on the promotion and regulatory uptake of non-animal approaches into strategic planning documents and reports, incorporating performance indicators. To support ECHA in these tasks we propose the establishment of a dedicated expert committee on non-animal approaches to advise on their development, promotion, and regulatory uptake. This would bring ECHA in line with similar bodies at the EMA and EFSA. There should also be consideration for adding expertise in non-animal approaches to all ECHA Committees (not just the SCCS) and the Management Board.
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Response to European Innovation Act

11 Sept 2025

The replacement of animal testing through innovation is a potential beneficiary of the European Innovation Act and is therefore an important sector to consider when drafting the measures to support innovation within the Act. The desire to end animal testing by the use of replacement methods is firmly rooted within EU Directive 2010/63/EU on the protection of animals used for scientific purposes. Furthermore, the Chemicals Strategy for Sustainability (CSS) states that safety testing and chemical risk assessment need to innovate in order to reduce dependency on animal testing but also to improve the quality, efficiency and speed of chemical hazard and risk assessments. The CSS commits the Commission to Foster multidisciplinary research and digital innovations for advanced tools, methods and models, and data analysis capacities to also move away from animal testing. With these two policies in mind, the Commission is working on a roadmap towards animal-free chemical safety assessment, which will be published in Q1 2026 and will include recommendations for policy, funding and infrastructure to support the development of non-animal methods (NAMs). Innovation will be central to implementation of the EUs commitment to end animal testing. It is therefore vital that there are joined-up policy measures in place to support innovation in biosciences and technology toward this aim and we strongly urge the Commission to consider the roadmap when drafting the European Innovation Act. NAMs represent the very cutting edge of innovative computer and biologically-based technologies such as AI, organ-on-a -chip, 3D tissue models and transcriptomics. The drive towards NAMs is not only ethical, they offer the opportunity to accelerate drug discovery and development, reducing time to market as well as improving drug safety and efficacy (for example, organoids; Smirnova and Hartung, 2024 doi: 10.1002/adhm.202302745 and microphysiological systems; Ewart et al. 2022 doi:10.1038/s43856-022-00209-1). Whilst their development is on the increase, particularly in Europe (see Taylor et al. DOI: 10.3389/frlct.2024.1426895), there are known problems with access to funding to validate these methods and achieve regulatory acceptance (Taylor 2019 E-Book ISBN: 9789004356184). These two areas of intervention mentioned in the Call for Evidence are therefore particularly pertinent when it comes to supporting innovation in animal-free science: Supporting access of innovative companies to EU and national funds. There is fragmented member state investment in NAMs, poor reporting and low levels of funding overall (Taylor, 2024 doi.org/10.14573/altex.2410111 ). There is also a need for sustained investment in NAMs at a central level. Academia, start-ups and SMEs need to know that there is funding available for the development, validation and implementation of NAMs so that they can support the biomedical industry with innovative methods to replace animal testing. Supporting innovative companies in developing and testing their innovations. Improving pharmaceutical guidance to expedite the safe assessment of innovative drugs using innovative animal-free methods will be key to speeding up patient access to drugs. The use of regulatory sandboxes and access to free, rapid advice will give companies the confidence to design innovative, safe drug testing protocols without the use of animals.
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Response to Biotech Act

11 Jun 2025

Any attempts to improve the EU biotechnology industry will also need to consider developments in the replacement of animal testing. Non-animal methods (NAMs) will be crucial to a successful biotech industry for several reasons. They can represent the very cutting edge of computer and biologically-based technologies such as AI, organ-on-a -chip, 3D tissue models and transcriptomics. They offer the opportunity to accelerate drug discovery and development, reducing time to market as well as improving drug safety and efficacy (for example microphysiological systems; Ewart et al. 2022 doi.org/10.1038/s43856-022-00209-1 ). Support for NAMs is therefore highly pertinent to support a strong biotechnology industry. Not least because new biological drug modalities, which include antibody, cell, and gene therapies, are generally highly specific for human genetic and protein sequences, necessitating the need for ever more human-relevant technologies for safety prediction (Chien et al. 2023 doi.org/10.1016/j.yrtph.2022.105329, Hartung, 2024 doi.org/10.3389/fddsv.2024.1355044). The desire to work towards a Europe where animal testing is no longer conducted is firmly rooted within EU Directive 2010/63/EU on the protection of animals used for scientific purposes. And Article 13 of the TFEU asks that the sentience of animals be regarded in the formulation of EU research policies. Furthermore, the Chemicals Strategy for Sustainability (CSS, https://environment.ec.europa.eu/strategy/chemicals-strategy_en#policy-areas ) commits the Commission to Foster multidisciplinary research and digital innovations for advanced tools, methods and models, and data analysis capacities to also move away from animal testing. Finally, the Commission has recently proposed the adoption of a Roadmap towards an animal-free chemical safety assessment (https://single-market-economy.ec.europa.eu/publications/communication-commission-european-citizens-initiative-eci-save-cruelty-free-cosmetics-commit-europe_en). The roadmap will be adopted in Q1 2026 and will include recommendations for policy, funding and infrastructure. It is highly relevant to the biotech sector, specifically food and pharmaceuticals, and we urge those involved in the drafting of the Biotech Act to take this and all these other commitments into account. Strategic support for NAMs that do not use live animals is relevant to all five areas of concern in the Call for Evidence: Speed and streamlining Improving the pharmaceutical legislation to expedite the safe assessment of biotechnology drugs without the use of animals will be key to speeding up patient access to drugs. However it will also reduce costs to industry not only by avoiding costly animal tests but by reducing the number of clinical trial failures caused by misleading animal tests. The use of regulatory sandboxes and provision of rapid advice will give companies the confidence to design safe drug testing protocols without the use of animals. This needs to be supported by flexible legislation so that regulators can adapt to developments in the use of NAMs. Financing There is fragmented member state investment in NAMs, poor reporting and low levels of funding overall (Taylor, 2024 doi.org/10.14573/altex.2410111 ). There is also a need for sustained investment in NAMs at a central level that supports the aims of the Directive, the CSS and the Roadmap. Scale and 4. Skills If the EU is to maximise its potential to be a world leader in the development of biotechnology products developed using modern NAMs-based technologies it needs to provide better incentives and networks for academics, start-ups and SMEs. There is also a need to up-skill regulators, researchers and students on the use of NAMs (see https://data.europa.eu/doi/10.2873/34576) 5. Use of data and AI Artificial intelligence and other computer-based techniques are also significant NAM-based technologies (Taylor and Rego Alvarez 2020 doi.org/10.1016/j.comtox.2019.100112 ).
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Response to EU Life sciences strategy

14 Apr 2025

The European Coalition to End Animal Experiments (ECEAE) warmly welcomes the EU Life Sciences Strategy and requests that the final draft includes the promotion of alternatives to animal testing as one of the areas to benefit from it. The desire to work towards a Europe where animal testing is no longer conducted is firmly rooted within EU Directive 2010/63/EU, the Chemicals Strategy for Sustainability and the Commissions response to the Citizens Initiative on animal testing with its planned Roadmap for 2026. Given this, we are disappointed not to see non-animal methods/new approach methodologies (NAMs) already as one of the areas of focus in the Life Sciences Strategy. NAMs are crucial to the life sciences for many reasons. They can represent the very cutting edge of computer and biologically-based technologies such as AI, organ-on-a -chip, 3D tissue models and transcriptomics. NAM-based advances are likely to have much wider applicability than just replacement of animals. Strategic support for NAMs is a key research area of the Life Sciences and the four areas of concern in the Call for Evidence are highly relevant aspects to address. We ask that NAMs are included in the final strategy document.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

Currently, in the Medical Devices Regulation (MDR) there is an absence of consistency with the aims expressed within Directive 2010/63 EU on the use of animals for scientific purposes; namely that the use of animals should be phased out by replacement as soon as possible and that the welfare of the animals that are used should be maximized. Directive 2010/63/EU is not even referenced in the MDR. There is also an inconsistency in the MDR with positive language found in other pieces of legislation that may require animal testing such as REACH, which expressly states - in Article 1- that one of the aims is the promotion of alternatives to animal testing and that -in Article 25- animal testing should be a last resort. No such language appears in the MDR. These two important sentiments, reflecting the aims of Directive 2010/63/EU, should be inserted. However, to ensure that there is meaning to these statements, they should be supported with clear actions and responsibilities, I.e. that Member States should ensure animal testing is a last resort, that manufacturers should seek to use all available and suitable non-animal methods in their preclinical safety evaluation and document their justification for using, as a last resort, tests in live animals, etc. There are currently problems with a lack of transparency on the preclinical safety requirements for medical devices which makes it difficult to assess if all possible non-animal approaches are available to manufacturers. This is exacerbated by an apparent dependence on ISO standards, which are governed by a broader membership than the EU, and are currently falling behind EU standards. For example, the ISO standards for local tolerance testing currently specifies animal tests, typically in rabbits, and is inconsistent with in vitro developments in other sectors. There should be a better mechanism built into the MDR to enable manufacturers to use more modern and more ethical pre-clinical methods. We would appreciate the Commission looking at ways in which the MDR can be revised to reflect the aims of DIrective 2010/63 along with the Commissions roadmap towards ending toxicity testing in animals which is due to report in Q1 2026 and is very likely to have recommendations that are directly applicable to medical devices.
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Response to Evaluation of the Cosmetic Products Regulation

21 Mar 2025

The CPR has not delivered on its objective to end the testing of cosmetics products and ingredients on animals for two reasons: 1. Despite repeated pleas from animal protection organisations since the inception of REACH in 2001 to ensure that there is coherence between the CPR and REACH with respect to animal testing requirements, the Commission have failed to address this issue. Companies have been left in limbo and consumers misled over the EUs apparent trailblazing cosmetics animal testing ban. The situation has become more and more unclear and unsatisfactory as REACH has been implemented, i.e. from 2013 onwards and the ECHA have requested animal testing of cosmetic ingredients, culminating in a Court of Appeal case (Symrise, 2023). The position of the Commission and ECHA has been unsatisfactory - animal testing for worker safety even of an ingredient used 100% in cosmetic products is mandatory, if REACH-compliant waiving options are not possible. This is not what EU citizens asked for, nor what they expected to see when the cosmetics testing bans were first implemented in 2003 and completed in 2013. The strength of feeling can be seen in the recent Citizens Initiative on cosmetic testing in animals (2023). It is imperative that this evaluation concludes with recommendations to address both the lack of clarity in the implementation of the cosmetics testing bans and to reverse the position taken by the Commission and ECHA that runs contrary to the objectives of the CPR and EU citizens. 2. The mechanism by which the animal testing bans on products and ingredients can be externally checked is not clear and too weak. It is not clear if companies are declaring any animal testing conducted for other purposes, such as REACH, on the Product Information File (PIF) given the Commissions position that the animal testing bans in the CPR is only testing for the purposes of this regulation. The enforcement mechanism of the testing bans is through the PIF, which is the responsibility of Member States and, perhaps because of the Commissions position, we have not seen any evidence that they are checking the PIFs in this regard. With regard to whether the CPR remains fit for purpose: 1. We agree that the CPR needs to be extended to cover the risks to the environment of cosmetics products. However, it is important that the animal testing bans extend to any additional information requirements and that environmental safety of products is assessed through existing data on ingredients, such as that generated via REACH, and/or non-animal approaches. 2. The Scientific Committee on Consumer Safety (SCCS) performs an important function within the CPR and should be retained. It has additional benefits in its independence and its positive approach to risk assessment and the use of non-animal approaches.
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Response to Commission Roadmap to phase out animal testing

14 Oct 2024

We applaud the Commission on its proposal to develop a roadmap that will outline milestones and specific actions to be implemented in the short to longer term to further reduce animal testing and ultimately transition to an animal-free regulatory system under relevant pieces of chemical legislation. This was requested by the Citizens' Initiative and the EP Resolution of September 2021, reflecting citizens concerns about the use of animals in chemicals safety testing. As the Commission notes, ultimately transitioning away from the use of animals has the potential to lower costs for industry and authorities and to accelerate chemical safety assessments. Whilst avoiding harmful use of animals, the implementation of non-animal methods will also only occur if they are just as- if not more- effective at screening out harmful substances, for the betterment of human and environmental health. We support nothing less. We want to stress that the roadmap needs to analyse and describe the steps that need to be taken as concretely as possible, i.e. avoiding generalisations. The commitment was to map the status quo and the gaps with non-animal assessment and to identify what needs to change to close those gaps. We hope that the Commission can continue to work with stakeholders to be as specific as possible, avoiding over complicating and broadening the issue unnecessarily. The roadmap should identify necessary changes that need to be made to the legislation, regulatory frameworks and guidance documents and, importantly, responsibility must be given to the appropriate agencies to follow them through. We disagree wholeheartedly that the Roadmap should be extended to methods that use fewer animals or cause less suffering (the 3Rs). The Citizens Initiative and the EP Resolution were both very clear that this should focus on non-animal methods because citizens want to see an end to animal testing. We support the need for an expert committee to provide advice on the development of non-animal approaches. However, the implementation of the roadmap following its development also needs the oversight of an expert committee. The conclusion of our multistakeholder roundtable on the roadmap was that a supervisory steering committee, with some level of independence from the European Commission, was needed to guide the process of change. An interagency approach is needed at this point as well. We encourage the Commission to continue to include stakeholders as much as possible so that this process is transparent and benefits from the varied expertise that they provide. We hope that further working groups will also include stakeholders and that they will be involved in the responsibility for the follow up, for example in the steering committee. Finally, and importantly, this roadmap addresses the use of animals in chemical safety assessment (only), which was Objective 2 in the Commissions Response to the Citizens Initiative. It does not address Objective 3 of the Commisions response to the Citizen's Initiative which stated that; The Commission is proposing a set of action points to accelerate the reduction of animal testing in research, education and training, including activities that will increase cooperation with Member States. Nor does it address that part of the EP resolution, requesting the Commission to develop an EU-wide action plan to accelerate the transition to innovation without the use of animals in research, regulatory testing and education. Both of these objectives are broader than the use of animals in chemical testing. To this end we would like the Commission to be clear about its intention to deliver on Objective 3, noting that it is also similar to a roadmap. We refer the Commission to the Recommendations from a multi-stakeholder Roundtable to shape the discussion on the EU Roadmap towards phasing out animal testing for chemical safety assessments that can be found here: https://zenodo.org/
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Response to Communication on the European Research Area Implementation

26 Sept 2024

Inclusion of all relevant stakeholders is key to the success of ERA Actions. The current ERA Forum stakeholders do not represent the breadth of stakeholders necessary to achieve its aims. For example, the Forums stakeholder group does not include relevant NGOs or patient or citizens groups. NGOs offer a unique set of expertise and are highly motivated to work alongside other scientists and EU experts to support the development and implementation of the ERA policy agenda. They often have cross-border knowledge and excellent overview of the research landscape and all its relevant issues. They typically represent the opinion of important patient or citizen groups. As we look forward to seeing the proposed new ERA Action Non-animal approaches in biomedical research and testing of pharmaceuticals, it is important that all relevant stakeholders are involved in this. Achieving the goal to ultimately transition away from the use of animals in science requires the active involvement of a substantial number of stakeholders operating at Member State level and beyond. These actors include international, national and regional regulatory agencies, ministries, industry, academia, funding bodies, publishers, ethics committees and other organisations such as NGOs. It will also require active coordination of projects and policies concerning the acceptance of non-animal methods and a harmonised approach to the sharing of best practices.
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Response to 8th Environment Action Programme – Mid-term Review

26 Jan 2024

The 8th EAP Article 3 notes the need to move away from animal testing and REACH Article 1 sets the objective of promoting alternative methods for the hazard assessment of chemicals. Stepping up and coordinating efforts to promote the development and validation of alternatives to animal testing, as noted in the 8th EAP Article 3, is an essential element of achieving the the goal of zero pollution. The Commission has established the need to create a Roadmap towards phasing out the use of animals for chemical safety assessments allowing for the generation of more reliable, less time-consuming human-relevant data, and increase knowledge on the vast amount of substances that are currently on the market without proper assessment. Far more should be done in the immediate term to move away from animal testing - which is also an objective of the Chemicals Strategy for Sustainability - and support the Commission's overarching policy objectives. Notably, there is a lack of funding allocated for the validation of non-animal test methods that have potential to improve protection of human health in areas such as endocrine disruption and neurotoxicology. We very much hope and expect the Commission to step up efforts to move away from animal testing, and respond more meaningfully to the overarching goals set out in the EAP which depend on promoting the transition to non-animal test methods.
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Meeting with Anja Hazekamp (Member of the European Parliament, Shadow rapporteur) and European Federation of Essential Oils

29 Mar 2023 · classification and packaging

Response to Introducing new hazard classes–CLP revision

14 Oct 2022

The need to use non-animal methods to the maximum possible extent and to transition away from testing on animals is clear. The End Animal Testing European Citizens Initiative (www.endanimaltesting.eu), which recently closed with 1,413,383 signatures, calls on the Commission to transform EU Chemicals regulation and ensure that human health and the environment are protected by managing chemicals without the addition of new animal testing requirements, and to modernise science in the EU. To ease the transition away from a dependency on animal testing while improving the quality, efficiency and speed of chemical hazard and risk assessments, barriers to the expanded use of non-animal tests and approaches need to be eliminated. The CLP regulation impacts on animals For many thousands of chemical substances, it is the REACH regulation that defines the information industry must supply so that potential hazards associated with those substances may be identified. Many of the requirements set by REACH mean that new tests on animals are conducted. The CLP regulation describes how the available information is to be used to describe and communicate the hazards associated with particular chemicals. Today, the CLP regulation only explains how to use information on chemicals that has been obtained by testing on animals, a legacy of a long reliance on testing on animals to generate information of chemical substances. We ask the Commission to future-proof the CLP regulation Endocrine disruptors The European Commission proposes to add new a hazard class for endocrine disruptors to the CLP regulation. Combined with proposals to add new requirements to REACH for the supply of information on endocrine disruption, the impact on animals looks set to be extremely high. It is vital that the descriptions of how information is to be used to classify a substance as an endocrine disruptor within the CLP regulation are sufficiently flexible so that the maximum possible use of non-animal testing information can always be used. Without flexibility built into the CLP regulation, needless barriers will be created against the use of non-animal testing information about the endocrine disrupting properties of chemicals now and in future. The CLP regulation should not block use of the best possible non-animal tools available to rapidly provide human-relevant information on the many thousands of chemicals manufactured and sold in the EU. Bioaccumulation The CLP must also use flexible language to describe how information can be used to describe the bioaccumulation behaviour of a substance – it is clear that there is much potential to use of non-animal information here. The CLP regulation should always be fit-for-purpose The draft amending regulation describes how “The scientific criteria against which available evidence for classification in those hazard classes are to be assessed should reflect the current state of the science” (emphasis added). However, we know that science constantly evolves through the development of new non-animal methods as well as advances in understanding how information from non-animal tests can be used to inform the best chemical safety decisions, including for those non-animal test methods that we have in-hand today. Infrequent updates of the CLP regulation are not enough. We ask the Commission to use this opportunity to install mechanisms within the CLP regulation that will keep it up to date with the state-of-the-art of non-animal testing and regulatory decision making. Animal testing does not provide perfect information A true understanding of the benefits offered by non-animal methods will only be realised through the fair evaluation of the performance of animal tests – as the regulatory community gets to grips with managing the uncertainties offered by all test methods, the CLP regulation must not block the fullest use of non-animal test methods.
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Response to Fitness Check of the EU legislation on animal welfare

7 Jul 2020

The European Coalition to End Animal Experiments (ECEAE) welcomes the Fitness Check on animal welfare. There is a noticeable change of attitude within the European Society regarding how we treat animals. Within an increasing part of the society, animals are no longer regarded as mere food, products or tools, but as what they are: sentient beings with the right to live according to their needs. The EU legislation must adapt to this social change. Unfortunately, animals in science are not included in the Roadmap on Animal Welfare. The European Directive EU/63/2010 on the Protection of Animals Used for Scientific Purposes acknowledges animals as sentient beings with an intrinsic value (recital 12), and gives as its goal the “full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so” (recital 10). However, the Directive is merely regulating animal experiments. What is missing and desperately needed is a concrete strategy to phase-out animal experiments within the European Union. Animal experiments are not only rejected for ethical concerns, but they are also the subject of criticism from within the scientific community itself. An awareness is growing that new methodologies are required to gain insight into important questions of human health and disease. Animal experimentation has not provided the hoped-for and much needed answers to these vital questions. This is because of significant differences of animals and humans regarding anatomy, organ functions and metabolism. A substance can elicit completely divergent responses in animals and humans. In addition, research based on animal experiments is methodologically wrong. Human diseases are artificially induced in animals in so-called ‘animal models’. These ‘animal models’ do not reflect the complex pathogenesis in a human patient. Important life style factors such as diet, physical activity, environmental influences as well as psychological and social factors are not taken into account in this type of research. Animal experiments are therefore not suitable for investigating and curing human diseases. Transferring results from animals to humans is misleading and bears an incalculable risk. The result is that 95% of all drugs that have been tested on animals and deemed safe and effective fail when tested on humans. On the other hand, human-based, animal-free research has accelerated all over the world. Highly innovative research methods have been successfully developed over the past decade such as 3-dimensional cell cultures and mini-organs of human origin as well as multiorgan-chips simulating a human body on a biochip, and also high-end computer models predicting the toxicity of chemicals. Unlike animal experiments, these models provide human-relevant data, that are highly reliable, reproducible and much more time- and cost-effective. In order to pave the way to a fully animal-free research, testing and education a comprehensive phase-out strategy within the EU is needed which must include concrete targets and dates in addition to shifting funds from animal research towards animal-free science.
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