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PETA Science Consortium International e.V.

PSCI

PSCI was established in Germany (Registration Number VR 724927) as a result of the UK’s withdrawal from the EU, in order to carry forward in the EU the work of the UK-based PETA International Science Consortium Ltd.

Lobbying Activity

Meeting with Paul Speight (Head of Unit Environment) and Cosmetics Europe and The European Federation for Cosmetic Ingredients AISBL

22 Jan 2026 · The CE – EFfCI Joint Position on Animal Testing Under EU REACH

Response to European strategy on research and technology infrastructures

21 May 2025

PETA Science Consortium International e.V. welcomes the opportunity to contribute to the consultation for the European Commissions initiative 'European Strategy on Research and Technology Infrastructures. In the attached document, we would like to specifically address the questions posed in the call for evidence.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

PETA Science Consortium International e.V. (the Science Consortium) welcomes the opportunity to comment on Regulation (EU) 2017/745 on medical devices (MDR) as part of the targeted evaluation launched by the European Commission. The Science Consortium promotes robust non-animal regulatory testing methods that protect human health and the environment. In the attached document, we comment on the need for clearer guidance on borderline medical device cases and propose a procedure for non-legally binding advice. Secondly, the Science Consortium highlights that medical devices are also included in the European Commissions roadmap towards phasing out tests on animals for chemical safety assessments. In this context, we recommend providing free pre-submission meetings with regulators to discuss non-animal testing methods, centrally managed by the European Medicines Agency (EMA).
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Meeting with Anja Hazekamp (Member of the European Parliament)

24 Sept 2024 · PETA breakfast event ban on animal testing

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

8 Apr 2024

PETA Science Consortium International e.V. is grateful for the opportunity to comment on the Commissions call for evidence for an evaluation of the European Food Safety Authority (evaluation of performance 2017 2024). We address the survey prompts in the attached response, with a focus on two main points: 1) the transition to non-animal testing and 2) increased stakeholder engagement (accurate representation of multi-disciplinary experts). Please see the attached document for details.
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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

4 Apr 2024

PETA Science Consortium International e.V. welcomes the opportunity to contribute to the consultation 'Chemical safety better access to chemicals data for safety assessments', which includes the aim of establishing a common data platform for chemicals to ensure data findability, accessibility, interoperability, and reusability of data. We support the Commissions initiative to make data more available and accessible, as improved access to data is crucial for streamlining and accelerating decision-making. The current risk assessment framework indeed faces challenges in effectively managing risks posed by existing and new chemicals. For example, tests on animals may delay the decision-making process as they are slow to conduct, are poorly reproducibility, and are often of limited relevance to human situations, making them an inadequate tool for risk assessment. Therefore, we recommend that this initiative adheres to the goal of the Chemical Strategy for Sustainability (CSS) to reduce dependency on animal testing and the proposal for an EU roadmap for phasing out animal testing in chemical safety. Although supportive of an initiative to establish a common data platform on chemicals, we have identified aspects of the proposal that may diverge from the goal to reduce and replace tests on animals. In the attached document, we suggest improvements to help ensure that all efforts are uniformly directed towards this shared objective.
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Response to Revision of the variation framework for medicines

27 Feb 2024

PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the initiative Pharmaceuticals changes to marketing authorisations. Please find our response attached.
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Response to Data requirements for safeners and synergists; work programme for the gradual review of safeners and synergists.

20 Dec 2023

The PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the initiative Plant protection products-data requirements and gradual review of safeners and synergists. Please find our response attached.
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Response to Evaluation and revision of the general pharmaceutical legislation

3 Nov 2023

PETA Science Consortium International e.V. response to the European Commissions call for views on the revision of the EU general pharmaceuticals legislation
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Meeting with Caroline Roose (Member of the European Parliament) and Eurogroup for Animals and Humane World for Animals Europe

20 Apr 2023 · Animal Welfare Intergroup - Tests sur les animaux

Response to Introducing new hazard classes–CLP revision

18 Oct 2022

PETA Science Consortium International e.V. ('the Science Consortium') is grateful for the opportunity to comment on the draft Commission delegated regulation amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures ('CLP regulation'). Epidemiological and clinical evidence confirm the negative impacts of endocrine disrupting chemicals (EDC). Hence, the Science Consortium supports measures that seek to ensure the sustainability of the EU’s chemical regulatory system for the decades to come, providing the best possible protection for human health and the environment while simultaneously meeting the existing commitments and legal requirements to replace and reduce tests on animals. The EU has the opportunity to lead the way towards a paradigm shift in regulatory chemical ‘safety testing’, and to establish momentum for further development in this direction. To do so, the following points must be addressed in the amendment of CLP regulation: 1. Identification and classification of hazards must always be based on the best available science and therefore must not be based on unreliable animal testing. 2. Introduction of new hazard classes needs to be globally harmonized and aligned with the United Nation’s Global Harmonized System Classification and Labelling of Chemicals (UN GHS) Recommendations for amendments to the proposed text of the draft regulation Based on scientific justifications explained in detail in the attached document, we urge the Commission to consider the following changes to draft Annex I: 1) Sections 3.11.1.1. and 4.2.1.1., please consider the addition of the following definition, adapted from a statement of leading ED experts[1]: "g) ‘intact organism’ means that the effect would occur in vivo, either observable in an animal system, or based on epidemiological or clinical evidence from humans. However, it does not necessarily mean that the adverse effect has to be demonstrated in an intact test animal, but may be shown in adequately validated alternative test systems predictive of adverse effects in humans and/or wildlife." 2) Table 3.11.1.: "The classification in Category 1 shall be largely based on evidence from human or other human-relevant data, or from both human and other human-relevant data. Such data shall provide evidence that the substance meets all the following criteria: (a) endocrine activity; (b) an adverse effect which can conclusively be predicted or shown to occur in an intact organism or its offspring and future generations; (c) a biologically plausible link between the endocrine activity and the predicted adverse effect in humans.” 3) Sections 3.11.2.3.1(a) and 4.2.2.3.1.(a) “(a) studies performed with validated testing systems (in vivo, in vitro, in silico studies) predictive of adverse effects in humans or animals;" 4) Sections 3.11.3.2.1. and 4.2.3.2.1: "Classification of mixtures shall be based on the available test data for the individual components of the mixture using concentration limits for the components classified as endocrine disruptor for human health. Testing mixtures on animals should be prohibited if data on individual substances is available." 5) Table 4.2.1.: "The classification in Category 1 shall be largely based on evidence from data showing the substance meets all the following criteria: (a) endocrine activity; (b) an adverse effect which can conclusively be predicted or shown to occur in an intact organism or its offspring and future generations; (c) a biologically plausible link between the endocrine activity and the predicted adverse effect." [1] Solecki R, Kortenkamp A, Bergman Å, et al. Scientific principles for the identification of endocrine-disrupting chemicals: a consensus statement. Arch Toxicol. 2017;91(2):1001-1006. doi:10.1007/s00204-016-1866-9 Please find detailed explanations in the uploaded document.
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Response to Amendment of data requirements for applications for the authorisation of plant protection products

23 Nov 2021

The PETA Science Consortium International e.V. (the Science Consortium) welcomes the European Union’s ambition set out under the Farm to Fork Strategy to reduce the dependency on and use of chemical plant protection products, inter alia, by facilitating the placing on the market and use of biological active substances such as micro-organisms as plant protection products. Please find attached the Science Consortium’s comments on the draft regulations with a specific focus on the information requirements for microbial pest control products laid out in the Regulation (EU) 284/2013 and its Annexes.
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Response to Amendment of data requirements for applications for the approval of active substances

23 Nov 2021

The PETA Science Consortium International e.V. (the Science Consortium) welcomes the European Union’s ambition set out under the Farm to Fork Strategy to reduce the dependency on and use of chemical plant protection products, inter alia, by facilitating the placing on the market and use of biological active substances such as micro-organisms as plant protection products. Please find attached the Science Consortium’s comments on the information requirements for microbial pest control agents laid out in the Regulation (EU) 283/2013 and its Annexes.
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Response to EU Chemicals Strategy for sustainability - Revision of the Cosmetic Products Regulation

1 Nov 2021

PETA Science Consortium International e.V. is grateful for the opportunity to comment on the 'EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision)'. Please see the attached document for our response to the aforementioned consultation.
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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. 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

The PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the consultation ‘Revision of EU legislation on hazard classification, labelling and packaging of chemicals‘. Please find our response attached.
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Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

1 Jun 2021

The PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the consultation ‘Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment‘. Please find our response attached.
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Meeting with Thierry Breton (Commissioner) and European Environmental Bureau and

5 May 2021 · Implementation of the chemicals strategy for sustainability