Commission unveils details on plan for phasing out animal testing for chemicals safety

Animal testing rules and non-animal test method development in the EU

• Avoiding animal testing is one of the main objectives of the EU’s cornerstone Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH), which includes registration testing requirements for registrants assessing the intrinsic properties of their substances for safety. While at times animal testing may be unavoidable to ensure compliance with these requirements, the cross-sectoral legislation emphasizes that such tests should be conducted “ only as a last resort,” when all other possible non-animal testing avenues have been exhausted. Accordingly, REACH requires registrants to avoid the use of vertebrate animals for generation of toxicity data whenever possible, considering, instead, alternatives like read-across methods, (quantitative) structure-activity relationship ((Q)SAR) models or in vitro methods. Where REACH stipulates certain methods to be used for animal testing, it mandates that these methods continually be subject to review and further development “with a view to reducing testing on vertebrate animals and the number of animals involved.” The rules also require testing proposals to be submittedwhen animal tests are needed, and oblige stakeholder sharing of information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.
• A total ban on animal testing for cosmetics has been in place in the EU since 2013 under Regulation (EC) No 1223/2009 on cosmetic products (Cosmetics Regulation). Article 18 prohibits the marketing of cosmetic products that involved animal testing and extends to products using ingredients or combinations of ingredients that were subject to animal testing. Animal testing conducted within the EU on cosmetic products, ingredients and combinations of ingredients is also prohibited.
• The EU has provided significant funding for research in non-animal testing and alternative measures. According to the Commission’s July 2023 communication, over the past two decades, the EU executive has spent over 1 billion euros across more than 300 research projects investigating alternatives to animal testing. The EU Horizon and Horizon 2020 Initiatives provided generous funding to work on reducing animal use in chemicals assessment (e.g., the PARC partnership with a budget of 400 million euros).

European Citizens’ Initiative (ECI) “Save cruelty-free cosmetics”

• The Commission last year promised to set out a blueprint for systematically addressing animal testing after a European Citizens’ Initiative (ECI) advocating for the EU executive to “commit to a Europe without animal testing” obtained more than one million signatures within one year, a threshold triggering the Commission’s mandatory consideration of the initiative and a response, pursuant to Regulation (EU) 2019/788.
• The initiative called on the Commission to undertake three main actions, introducing provisions that underpin and expand the article 18 ban on animal testing under the Cosmetics Regulation; calling for concrete steps for the development of human-relevant alternatives to animal testing, including actual timelines, funding opportunities, and cross-sectoral support, for the EU chemicals management regulatory framework; and urging the Commission “to prioritise a transition to non-animal approaches as an integral part of all EU research, innovation, and education initiatives,” while, at the same time, appreciating that the EU law protecting animals used for scientific purposes (i.e., Directive 2010/63/EU) “does not in and of itself represent a roadmap towards full replacement.” [See AgencyIQ’s article here for more details on ECIs in general and this initiative in particular.]

The Commission’s response to the initiative

• On July 25, 2023, the EU executive published a communication and accompanying press release, stating its intention to “accelerate phasing out of animal testing in response to a European Citizens’ Initiative.” The Commission said it aimed to accomplish this with both legislative and non-legislative changes, envisioning actions undertaken as part of key pieces of chemical regulation such as REACH, the Biocidal Product Regulation (528/2012/EU), and the Plant Protection Products Regulation (1107/2009/EC).
• The Commission further stated that it would “immediately” begin work on a roadmap to further reduce animal testing and transition to an animal-free regulatory framework. The roadmap, it stated in the press release, would provide milestones and specific actions to further reduce animal testing, on the path to an eventual complete phase-out of animal testing. The “core of the roadmap will be to analyse and to describe necessary steps to replace animal testing in pieces of legislation that currently require animal testing for chemical safety assessment,” according to the Commission communication. The EU executive had originally expected to finalize the roadmap “in the first quarter of the term of the next Commission,” or the first quarter of 2025.

The Commission followed up with an update on the roadmap’s development

• The EU executive presented on its roadmap at the July 1-2 meeting of REACH and CLP regulatory experts (CARACAL), offering concrete details about its plans for developing the roadmap. Below, AgencyIQ summarizes the accompanying slides, highlighting the most important aspects of this presentation.

Key commitments

• The roadmap will likely be delivered in the form of a Commission communication. According to the presentation slides, it will represent “a navigation plan” or “schedule” that “is listing actions and milestones necessary to reach the goal of phasing out animal testing.” The roadmap will be “applicable to all relevant pieces of EU chemical legislation that might lead to animal testing for chemical safety assessments.”
• The core elements of the “navigation plan” will encompass (1) an “analysis” describing “the steps to replace (reduce/refine) animal testing”; (2) an outline of “the path to expand and accelerate the development, validation and implementation of non-animal methods”; and (3) a description of “the path for uptake across legislations.” In this context, the Commission emphasized that, “for many endpoints,” unknowns endure about which non-animal testing methods, or combinations of them, can replace animal methods, indicating a consensus that “we need to think of designing a new regulatory system based on non-animal testing.”
• Other elements of the roadmap will include a determination about the “need” or “feasibility of an advisory scientific committee on non-animal methods”; an outreach component, bolstering links to multilateral organizations, with the aim of “strengthening the acceptance of non-animal testing” in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS); considering avenues for expediting “the acceptance and validation of new non-animal methods, while taking into account the importance of mutual acceptance of data across different jurisdictions.”

Development of the roadmap

• Which parts of the Commission will develop the roadmap is laid out visually in the presentation on slide 10. The EU executive foresees assigning main responsibility for its drafting to an “Interservice Group” with representation from the directorates general (DGs) for the environment (ENV), internal market (GROW), research and innovation (RTD), health (SANTE), and the Commission Secretariat-General (SG), as well as from ECHA, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), and the Joint Research Centre (JRC). Individual tasks will be carried out by three separate working groups (WGs) for human health, environmental safety assessment, and change management. Several stakeholders outside the Commission, including EPAA, ASPIS, PARC, member state competent authorities, and NGOs will also be key sources of feedback, input, and ideas leading to the draft roadmap. Planned public consultations will also contribute to its development.

Status of roadmap development today

• So far, the Interservice Group has met six times, discussing terminology, structure, and overarching organization of the roadmap development. Likewise, the members have decided that 15 areas or pieces of legislation will comprise the regulatory scope included in roadmap development. The presentation, however, does not specify which areas. Finally, one of the group’s meetings was dedicated to the topic of how to accelerate non-animal method validation.
• The initial activities of the WGs were also summarized. Among other activities, the WGs on human health and environmental safety assessment initiated analyses on currently used animal methods and available non-animal methods; discussed “short-term solutions and methods requiring development”; and examined the level of protection provided under the EU’s current testing scheme versus that desired in the new framework.

Acceleration of validation

• The presentation underscores the steps that the Commission has taken thus far to ensure that the pace of validating non-animal testing methods is hastened. Actions taken toward this end include a December 2023 workshop session (Day 2, Session 4), for which, the slides note, a workshop report “will be published soon.” The Commission’s Interservice Group dedicated meeting, which took place in May of this year, discussed issues related to validation, including funding, mutual acceptance of data, and “learnings from the EMA qualification process to enhance the acceptance of new methods.”

Analysis and next steps

• The roadmap is expected to be finalized sometime in late 2025, or early 2026, according to the presentation. An “implementation phase that implements the planned actions” will follow its release.
• Several stakeholder events are in the pipeline in support of the roadmap’s development, including a call for evidence, which the presentation indicates will be announced shortly; a targeted consultation in the fourth quarter of 2024, with focus on validation acceleration; and a follow-up workshop organized by the Commission, planned for October 25.
• The presentation makes clear that the Commission’s exercise of creating a “navigation plan” toward the ultimate elimination of animal testing in favor of yet-to-be-developed non-animal methods is no simple task. Expected to take at least a year and a half to complete from today, just the roadmap is already behind schedule by almost a year, compared to the Commission’s original expectations laid out in the 2023 communication. This fact alone hints at how long the journey could potentially be to actually realize the Commission’s commitments made to phase out animal testing.

Featuring previous analysis by Kirsten Messmer and Rayan Bhargava

To contact the author of this piece, email Scott Stephens (sstephens@agencyiq.com).
To contact the editor of this piece, email Kari Oakes ( koake@agencyiq.com).

Key Documents and Dates

• Commission Roadmap towards phasing out animal testing for chemical safety assessment; CARACAL-52; July 1, 2024
• Factsheet summarizing Commission’s response to the European citizens’ initiative ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’; July 25, 2023
• Q&As: Commission’s response to Citizens’ Initiative “Save Cruelty-Free Cosmetics – Commit to a Europe without Animal Testing”
• European Citizens’ Initiative – “ Save Cruelty-Free Cosmetics – Commit to a Europe without Animal testing”; first registered June 30, 2021, initiative answered July 25, 2023