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european consensus-platform for alternatives

ecopa

The primary aim of ecopa is to promote “the three Rs” (Replacement, Reduction, Refinement) in the use of animals in research, testing, education and training in Europe.

Lobbying Activity

Response to Evaluation of the Cosmetic Products Regulation

15 Mar 2025

This submission addresses key considerations for the evaluation of the Cosmetic Products Regulation (CPR), focusing on its effectiveness, relevance, coherence, and EU added value. The revision presents a crucial opportunity to align the regulation with scientific advancements, public expectations, and ethical principles while ensuring consumer and environmental protection. Key Considerations: 1. Political Context Aligning with Public Expectations The CPR revision must reflect the demands of the European Citizens Initiative "Save Cruelty-Free Cosmetics Commit to a Europe Without Animal Testing," which gathered over 1.2 million signatures in 2023. This initiative highlights public concern over continued animal testing for cosmetic ingredients. The revision should ensure full alignment with the existing ban on in vivo testing under CPR and phase out animal testing through the regulatory acceptance of New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA). 2. Environmental Impact Strengthening the Scope of CPR The CPR currently focuses solely on human health but should be expanded to address the environmental impact of cosmetic products. Many cosmetics, particularly sunscreens, contribute significantly to environmental pollution. Additionally, the ban on animal testing should be extended to environmental risk assessments, prohibiting in vivo testing on fish. 3. PIF Repository Improving Regulatory Oversight Currently, the Product Information File (PIF) is only accessible at the location of the Responsible Person, limiting oversight by competent authorities, especially across different Member States. A centralized, EU-wide platform should be established to store and standardize PIFs, ensuring fair market competition and enhancing regulatory enforcement. This would also address inconsistencies in PIF quality, which currently pose risks to consumer safety. 4. Effectiveness Strengthening Enforcement Measures The number of PIFs inspected across Member States is unclear, raising concerns about enforcement. The lack of a harmonized system creates disparities between companies, disadvantaging those that fully comply with CPR requirements. 5. Relevance Expanding CPR to Address Environmental Risks The regulation should be updated to consider environmental risks associated with cosmetic products, alongside human health. Expanding the ban on animal testing to cover environmental safety would ensure consistency with the EUs commitment to ethical and scientific progress. 6. Coherence Resolving the Conflict Between CPR and REACH There is a clear regulatory contradiction between CPR and REACH, which mandates new animal tests on cosmetic ingredients to assess worker exposure risks during manufacturing. The situation is expected to worsen with the implementation of new Classification, Labelling, and Packaging (CLP) hazard classes for endocrine disruptors. To ensure consistency, regulatory provisions should be updated to accept NAMs and NGRA for both worker risk assessment and the classification of cosmetic ingredients under CLP regulations. 7. EU Added Value Only an EU-wide regulation can ensure the effective protection of human health and the environment while maintaining the free circulation of cosmetic products within the internal market. A harmonized CPR will prevent regulatory fragmentation, enhance consumer safety, and create a fair competitive landscape for all companies operating within the EU. Conclusion The CPR revision provides a unique opportunity to enhance regulatory effectiveness, promote ethical testing methods, and strengthen environmental protection. By addressing inconsistencies with REACH, establishing a centralized PIF repository, and adopting modern scientific approaches, the EU can ensure a fair and forward-thinking regulatory framework. Disclaimer The views expressed in this submission do not necessarily represent a unanimous consensus among all members of the association.
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Response to Introducing new hazard classes–CLP revision

17 Oct 2022

Regarding the “Draft delegated regulation - Ares(2022)6485391”, the whereas section should contain the following sentence: “The guidance on the application of the endocrine disruptor criteria should consider the applicability of New Approach Methodologies (NAMs), including in this term in silico, in chemico and advanced in vitro test methods that can efficiently and more rapidly identify endocrine disruptor properties of chemicals” This can either be a new issue or added as a new one. Regarding the “Annex - Ares(2022)6485391”, ecopa is proposing the following updates: Page 3, Table 3.11.1, Hazard categories for endocrine disruptors for human health, the new sentences for criteria should be: “The classification in Category 1 shall be largely based on evidence from human or animal data or data derived from New Approach Methodologies, or from two of them” “The classification in Category 2 shall be largely based on evidence from human or animal data or data derived from New Approach Methodologies, or from two of them” Page 8, Table 4.2.1, Hazard categories for endocrine disruptors for the environment, the new sentences for criteria should be: “The classification in Category 1 shall be based on evidence from animal data or data derived from New Approach Methodologies, or from both of them.” And in the following page: “The classification in Category 2 shall be based on evidence from animal data or data derived from New Approach Methodologies, or from both of them.”
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Response to Proposal for a basic regulation of the European Chemicals Agency

7 Oct 2022

The functioning of the European Chemical Agency is defined in Title II of REACH assigning the duty of “managing and in some cases carrying out the technical, scientific and administrative aspects of this Regulation and to ensure consistency at Community level in relation to these aspects” (Art. 75). Article 1 of REACH states that the aim of the regulation is “to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances”. The promotion of alternative methods should be a key aspect of the functioning of the agency. In fact, according to article 117(3) staes that “Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the Commission a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation.” From these articles the involvement of ECHA in the promotion of alternative methods is clear, as reiterated by the ombudsman decision in response to Case 1606/2013/AN The call for evidence about the “Proposal for a basic regulation of the European Chemicals Agency” should be very clear about that. Regarding the political context, “promoting alternative methods” is listed among the aims of the political context. This is not a marginal role. It goes beyond the ethics of the animal tests and the correct word for New Approach Methodologies (NAMs) should be used to indicate a modern and effective way to challenge the issue of chemical strategy for sustainability. This initiative includes how the Agency works with other agencies and the EURL-ECVAM from the JRC should be included among them
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Response to Improving access to and availability, sharing and re-use of chemical data for the purpose of chemical safety assessments

20 Jul 2022

This initiative is remarkable. Just one comment about:"create a data-generation mechanism for EU and national authorities and oblige industry and (external) testing laboratories to notify these authorities of any studies they commission, based on existing notification rules in the food sector.". This obligation has a negative impact on basic research about NAMs (New Approach Methodologies). Explanation: The scientific community is engaged in developing new strategies that aim to replace the use of animals in toxicology through a different approach, focused on the study of the impact of substances on human organism. For example, refer to the EU projects of the ASPIS cluster (https://aspis-cluster.eu/). This possibility is promising, but requires extensive investigation before adoption. From this point of view, testing known chemicals is fundamental. The provision of notifying the authorities about a new study is already in place in the food sector. What we're facing is that companies in the food area are reluctant in collaborating because they are obliged to declare a new study even if based on a protocol which is still under development and therefore with limits in the interpretation of the results. If this obligation is extended to all chemicals, there will be a strong restrain in research. Proposal: The proposal is to exempt from notification all studies that are performed with the aim of developing or validating new non-animal methods and keep it for all in vivo studies and validated in vitro methods.
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Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

31 Mar 2022

This initiative is positive as having a more efficient harmonization among the EU agencies, with optimization of resources and expertise is important. Just a couple of issues: 1. It is not clear why the fitness check of all chemicals legislation should exclude REACH which is THE chemical legislation by definition 2. More importantly, the definition of what the initiative aims to achieve and how, should contain the roadmap to eliminate the use of animals in toxicological tests. This is gained by acknowledging the limitations of the standard in vivo tests while promoting the applicability and use of the New Approach Methodologies (NAMs). All regulators should think of what Darwin wrote to the Oxford zoologist Ray Lankester in 1871: “You ask about my opinion on vivisection. I quite agree that it is justifiable for real investigations on physiology; but not for mere damnable and detestable curiosity. It is a subject which makes me sick with horror, so I will not say another word about it, else I shall not sleep to-night.” The same principle should inspire legislators when thinking about a new piece of legislation about chemicals risk assessment.
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Response to EU Chemicals Strategy for sustainability - Revision of the Cosmetic Products Regulation

31 Oct 2021

Revision of the cosmetic product regulation is welcome, with the aim to increase protection of human health and the environment. Attribution to ECHA of the SCCS tasks can lead to a more efficient management of the cosmetic product control. However, this should not fade the principle from which no new animal tests should be performed for safety assessment of both cosmetic products and ingredients. In this sense, The Product Information File of the cosmetic products should include the assessment of worker exposure during the manufacturing of the cosmetic product, by removing it from the REACH requirements as is now. In this way, the cosmetic ban for animal test will include the worker safety, in line with the principle of “one substance, one assessment”. The ban should be enlarged to embrace the environmental assessment. Note that the fact that many new animal tests are performed on cosmetic ingredients for REACH purposes is causing confusion and frustration among both consumers and cosmetic product manufacturer (Knight et al. ALTEX 38(4), 653-668. doi:10.14573/altex.2104221). The assessment through integrated in vitro systems is more efficient, bringing the opportunity to screen a high number of substances with more relevant evaluation of the impact on the human health and the environment. The possibility of testing several combinations of mixtures is also important, considering the difficulty of performing many tests in vivo. It is important to remind that in vivo tests also have a negative impact on the environmental. In fact, the facilities that use animals for toxicological tests are responsible for a large amount of environmental waste and energy consumption and this is against the goal pf reaching sustainable climate neutral and circular economy.
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Response to Clarification of requirements for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

19 Jul 2021

Thank you for the opportunity to comment on this draft regulation. This amendment represents a step back towards modernisation of REACH. In toxicology, the concept "the more, the better" is not applicable and more in vivo tests may bring more confusion to the assessment of the chemicals. New tests should be focused to the elucidation of the chemical properties. Article 1 of REACH states that "The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances". Step 4 of Annex VI says that "New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted." The proposed amendment to Annexes VII through X goes exactly in the opposite direction, by setting new in vivo tests as the standard procedure for the risk assessment of chemicals. Actually, the proposed amendments is more or less the regular procedure as described in the guidelines, in particular for what mutagenicity regards. However, having it written in the regulation makes the implementation of NAM (New Approach Methodologies) more difficult as soon as they’re available. I would like to remind that the scientific progress of NAMs is running fast and more methods will be available soon. If the text of the regulation explicitly asks for new in vivo tests, the application of the new methods will be difficult. Another aspect is the possibility to the Agency to directly propose new tests. It is not clear whether this will be by skipping the testing proposal phase. This is very important to give the possibility for someone owning that test to make it available before a new in vivo test is performed. It is also not clear whether the adaptation provided in Annex XI is still possible if the Agency directly requires the new test.
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Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

31 May 2021

CLP Regulation is first of all the implementation of the GHS. Therefore, it is very important for CLP to strictly follow the GHS. Adding new hazards category is helpful only if those are included in GHS, in order to avoid confusion during circulation of chemicals across countries. Additional information is included in the eSDSs as requested for REACH regulation. Regarding objective and policy options, we advise to consider the introduction of new hazard classes only when requested by the GHS and only if the same hazard is not already considered in other cases, such as the restriction of using endocrine disruptor components as either a PPP or biocide products or the insertion of a substance in the SVHC or Annex XVII lists. The CLP should contain improving rules for the acceptability of in vitro testing and New Approach Methodologies (NAMs) for hazard characterisation and category identification.
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Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

31 May 2021

ecopa is the European consensus-platform for alternatives. The primary aim of ecopa is to promote “the three Rs” (Replacement, Reduction and Refinement) in the use of animals in research, testing, education and training in Europe. ecopa strives for consensus between all four stakeholders in attempting to achieve its goals: - Government and regulatory authorities - Academia - Industry - Animal protection and welfare organisations Our comments are focused on the need to base safety assessment of chemicals with a modern holistic approach using integrated in vitro methods combined with in silico analysis, acknowledging that in vivo methods are not suitable to highlight possible adverse effects on humans. On the other hands, the high doses applied in animal tests causes toxicity to animals that is not useful to the definition of the risk for humans. Moreover, animal tests are too long and from a practical point of view they cannot be applied to all chemicals, lacking lab capacity. Downstream users should have the possibility to register, for example in case of intermediates not used under SCC or substances that are manufactured for non-REACH application (food additives, biocide or pesticide active substances, etc.).
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Response to Adapting data requirements in the Annexes to the BPR to the ED criteria

26 Feb 2020

New in vivo experiments are allowed only if no alternative method is available. There are validated methods for the assessment in vitro of the endpoints skin (irritation and corrosion, skin sensitisation. REACH Regulation (regulation 1907/2006) already contains provision in this sense. Row 8.1, 8.2 and 8.3 for both Annex II and Annex III to Regulation 528/2012, in column 3 should contain the date of the REACH amendments that inserted the need to perform in vitro first, i.e. 31st May 2016 (Regulation 2016/863) for skin and eye irritation and 20th September 2016 (Regulation 2016/1688) for skin sensitisation respectively. In conclusion: rows 8.1, column 3 of both Annexes should state: “In vivo studies for skin corrosion or irritation that were carried out or initiated before 31st May 2016 shall be considered appropriate to address this information requirement." rows 8.2, column 3 of both Annexes should state: “In vivo studies for serious eye damage or eye irritation that were carried out or initiated before 31st May 2016 shall be considered appropriate to address this information requirement." rows 8.3, column 3 of both Annexes should state: “In vivo skin sensitisation studies that were carried out or initiated before 20th September 2016 shall be considered appropriate to address this information requirement." Last sentence in column 3 of Row 8.10 in Annex II, about reproductive toxicity is redundant and should be deleted. I am referring to: “Notwithstanding the provisions of this column of this subsection, studies on reproductive toxicity may need to be conducted to obtain information on endocrine disrupting properties as laid down in 8.13.3.1.”. This request is already contained in row 8.13.3 on endocrine disruption. The two conditions in column 3 of Row 8.10.3 in Annex II on Developmental Toxicity should be linked by “or” instead of “and”. This is very important. Adequate data to support a robust risk assessment are enough even though the substance is not classified. Row 8.13.2 in Annex II on Neurotoxicity should include the possibility to use either in vivo methods or any other relevant study (set) providing equivalent information. The first two sentences should be: “The preferred test species is the rat unless another test species or any other relevant study (set) providing equivalent information is justified to be more appropriate”; “For delayed neurotoxicity tests the preferred species will be the adult hen unless any other relevant study (set) providing equivalent information information is justified to be more appropriate” Column 3 of Row 8.7 of Annex III should consider conclusion as such, independently on whether it is for active or not active endocrine disruptor. The sentence should be: “a conclusion can be made on the biocidal product regarding endocrine disrupting properties”
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Response to Amendment of REACH Annex II (Safety Data Sheets)

8 Oct 2019

The original text, in section 11.1.7. states: 11.1.7. Delayed and immediate effects as well as chronic effects from short and long-term exposure Information shall be provided on whether delayed or immediate effects can be expected after short or long-term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicated whether toxicological data is based on human or animal data. Our comment regards the importance of including the option to accept experimental results obtained through NAMs (New Approach Methods), i.e. in vitro, in chemico and in silico combined in an advanced strategy. Even though maybe not yet possible, there is sound scientific evidence that this opportunity will be available soon. In order to be ready to immediately accept it as soon as they’re available, it is important to change the text to comprise the chance. For example: 11.1.7. Delayed and immediate effects as well as chronic effects from short and long-term exposure Information shall be provided on whether delayed or immediate effects can be expected after short or long-term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, information on the experimental data should be summarised, with details on either animal data and the species clearly identified or the in vitro tests and the cell types clearly identified. It shall be indicated whether toxicological data is based on human or animal data or in vitro tests. This change has no immediate effect, but it makes the regulation ready for the near future, when more and more NAMs will be used in risk assessment.
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