PETA International Science Consortium Ltd.
PISC
PETA International Science Consortium Ltd.
ID: 83485908659-40
Lobbying Activity
Meeting with Sebastian Kruis (Member of the European Parliament)
25 Sept 2024 · Testing on animals
Meeting with Sebastian Everding (Member of the European Parliament) and European Industrial Hemp Association
11 Sept 2024 · Introductory meeting
Response to Clarification of requirements for the Registration, Evaluation, Authorisation and Restriction of Chemicals
16 Nov 2020
16 November 2020
Draft regulation: chemicals - clarification of requirements for registering, evaluating, authorising and restricting chemicals
Comments from Cruelty Free Europe, Humane Society International/Europe, and PETA International Science Consortium Ltd.
Introduction
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 [1]. 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 [2]. 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.
[1] NCad. Transition to non-animal research: On opportunities for the phasing out of animal procedures and the stimulation of innovation without laboratory animals. https:// www.ncadierproevenbeleid.nl/ documenten/rapport/2016/12/15/ ncad-opinion-transition-to-nonanimal-research. Published December 2016. Accessed 15 November 2018.
[2] News Releases from Headquarters.Chemical Safety and Pollution Prevention (OCSPP).Administrator Wheeler Signs Memo to Reduce Animal Testing, Awards $4.25 Million to Advance Research on Alternative Methods to Animal Testing. US Environmental Protection Agency. https://www.epa.gov/newsreleases/ administrator-wheeler-signs-memoreduce-animal-testing-awards-425- million-advance. Published 9 October 2019. Accessed 24 January 2020.
Read full response30 Sept 2020
The PETA International Science Consortium Ltd. welcomes the progress the Commission has made regarding the implementation of Regulation (EU) 2019/1381 (commonly known as the Transparency Regulation) and in particular the draft regulations which establish rules on the procedure for the renewal of the approval of active substances within the meaning of Regulation (EC) No 1107/2009. We highlight below a number of measures which are of utmost importance in order to reduce animal testing while ensuring the most effective protection of human health and the environment.
Article 3, paragraph 1: We support the inclusion of a public consultation period on intended studies for future applications of renewal, and we suggest the addition of a specific timeframe for commenting prior to the conduct of the study (for example, an adequate period would be 60 days, which has been selected as the timeframe for the final post-assessment commenting period).
Article 4, paragraph 1: We welcome the opportunity for applicants to request pre-submission advice from the European Food Safety Authority (EFSA). Through consultations with EFSA, applicants will be able to ensure that any proposed tests conducted for renewals will avoid the use of animals wherever possible, and duplication of tests on vertebrate animals, in accordance with Article 7 (d), Article 33 (c) and Article 62 of Regulation 1107/2009.
Article 6, paragraph 2 (e), (f), (l) and (m): We welcome the inclusion of these articles as they will allow for greater transparency concerning how tests on animals are used within risk assessments.
Article 6, paragraph 2 (h): We support the requirement for applicants to justify their use of vertebrate animals in tests, as this brings the Implementing Regulation in line with Article 7 (d) and 33 (c) of Regulation 1107/2009.
Article 6, paragraph 3: The publication of data from previous studies will allow for independent scientific scrutiny, and we suggest the addition of a clarification regarding the efforts applicants are expected to take in order to obtain access to these studies. For instance, applicants should be required to disclose the cost of obtaining access to full study data should that be perceived as a block to submission of the information. Lack of access to full study data should not be treated as sufficient justification for tests on animals to be repeated.
Article 10: We support public access to the information in the application for renewal, and suggest clarifying whether raw study data will be included within this information.
Read full responseResponse to Chemicals strategy for sustainability
20 Jun 2020
Please see the attached file with comments from the PETA International Science Consortium Ltd.
Read full responseResponse to Amendments of the Annexes to REACH for registration of nanomaterials
5 Nov 2017
The draft Regulation is fundamentally flawed and should be withdrawn. Firstly, it was inappropriately based on a draft impact assessment report that was only made available to targeted stakeholders. Secondly, the draft impact assessment report upon which the proposed amendments were based does not contain an adequate and transparent assessment of the potential animal-welfare impacts. Thirdly, the proposed amendments call for more tests on animals, appear to reduce opportunities to waive animal tests, and jeopardise the REACH objective of promoting alternative methods for assessing the hazard potential of substances.
These changes have far-reaching consequences that will dramatically increase the number of animals used in regulatory testing, and their proposal completely disregards the ongoing discussions concerning the applicability of current Test Guidelines, and animal test methods in general, to nanomaterial hazard assessment [1-4]. Furthermore, the changes proposed do not take into consideration the conclusions from the European Chemicals Agency Board of Appeal in A-014-2015 [4] and A-015-2015 [5], which stated that nanomaterials are not inherently dangerous and should not be treated as such.
With regard to the draft impact assessment, the lack of transparency regarding the calculation of the animal numbers estimated for each regulatory option is particularly concerning. By not publishing a finalised impact assessment that thoroughly evaluates the potential magnitude of animal testing, the Commission fails to adhere to the general principles of openness and accountability, does not allow for a transparent consultation process, and does not facilitate informed responses by stakeholders. Changes should only be made to the REACH Annexes after a thorough impact assessment has been conducted – one that demonstrates a thorough analysis of the number of animals who will be used. Furthermore, a wide range of stakeholders should be actively solicited and involved throughout the process in order to ensure a balanced outcome.
Attached separately is feedback from the PETA International Science Consortium Ltd. on the draft Annex amendments, with specific suggestions on the manner in which the amendments must be changed to minimise animal use, as well as our detailed response to the draft impact assessment.
References
1. Rasmussen K, González M, Kearns P, Sintes JR, Rossi F, Sayre P. Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines. Regul Toxicol Pharm. 2016;74: 147-160.
2. Rauscher H, Rasmussen K, Sokull‐Klüttgen B. Regulatory Aspects of Nanomaterials in the EU. Chemie Ingenieur Technik. 2017;89(3):224-231.
3. Hansen SF, Hjorth R, Skjolding LM, Bowman DM, Maynard A, Baun A. A critical analysis of the environmental dossiers from the OECD sponsorship programme for the testing of manufactured nanomaterials. Environ Sci: Nano. 2017;4(2), 282-291.
4. Knight A. Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare. Rev Recent Clin Trials. 2008;3(2),89–96.
5. European Chemicals Agency Board of Appeal. Decision of the Board of Appeal of the European Chemicals Agency on A-014-2015. https://echa.europa.eu/documents/10162/84c38038-4636-ec10-e9a0-6b961cac34b8. Published June 2017. Accessed November 2017.
6. European Chemicals Agency Board of Appeal. Decision of the Board of Appeal of the European Chemicals Agency on A-015-2015. https://echa.europa.eu/documents/10162/02fb4c79-dcfd-ecc7-a474-b28781c202b0. Published June 2017. Accessed November 2017.
Read full response