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How can non-animal methods (NAMs) be maximised under existing EU regulations? That was the challenging question for attendees and speakers at the European Partnership for Alternative Approaches to Animal Testing (EPAA) Annual Conference on 13 November.
The EPAA is a joint European Commission-industry partnership focused on phasing out animal testing by developing and promoting NAMs – variously understood as non-animal methods or new approach methodologies to testing and is of central concern to animal welfare activists.
Instrumental in fostering collaboration between sectors and facilitating dialogue between industry and the Commission, the EPAA’s work includes projects on systemic toxicity, carcinogenicity and environmental safety assessment.
Kristin Schreiber, Director for Chemicals, Health, Retail and Agrifood at DG GROW in the European Commission, opened the conference by highlighting the various projects developed by EPAA working groups in 2024, including those on systemic toxicity and carcinogenicity.
Animal-free assessments
Schreiber emphasised that shifting to animal-free assessments is not only ethical but can also bring economic and industrial benefits as well.
“Maximising the uptake of new animal-free methods is not only an ethical imperative due to animal welfare considerations, but such methods can also improve our understanding of how chemicals act and lead to adverse effects, and it’s hence also a chance for improving the protection of our citizens and the environment even further than today,” said Schreiber.
She added: “I think that should not be forgotten either, shifting to animal-free assessments can bring clear benefits to our economy by reducing reliance on traditional animal testing. Companies can streamline their processes and cut down on expensive and often time-consuming testing procedures.”
Tilly Metz, MEP, also welcomed the EPAA’s role in fostering collaboration between regulators, scientists, industry, NGOs, and stakeholders to promote animal welfare and innovation.
However, she noted the challenges given the high numbers of animals used in experiments despite the time elapsed since the directive.
Aligning research investments and science policy
Statistics from the European Commission show 9.3 million experiments were conducted on animals across the EU and Norway in 2022, with an additional 9.6 million animals bred and killed, bringing the total that year to 18.9 million animals used for scientific purposes in the EU.
Metz recalled the 2021 resolution calling for an action plan to accelerate non-animal testing and stressed the importance of aligning EU research investments and scientific policies with the three R’s (Replacement, Reduction, Refinement).
“Finally, we now have a Commissioner with the animal welfare competence in the title. Whether this new change will help us to bring forward our agenda, especially with this Commissioner, remains to be seen so, but you can count on me to do my utmost to keep reminding [them] that animals used in science are sentient beings too and need better protection as well, and also that there are more efficient alternatives than testing on animals,” she said.
The European Citizens Initiative “Save Cruelty-Free Cosmetics” gathered more than 1.2 million signatures, and Metz said she hoped for a positive response from the European Commission to protect animal welfare and close loopholes – Particularly with the inclusion of REACH in the Commission’s upcoming work program to address cruel practices in chemical testing. She also looked forward to the Commission’s work on “One Substance, One Assessment” to enhance the phase-out of animal testing in chemicals.
Food safety assessments
The third keynote speaker of the morning, Dirk Jacobs, Director General of FoodDrinkEurope, discussed the integration of NAMs in food safety risk assessments, emphasising their importance for ethical, sustainable, and competitive food safety.
Jacobs highlighted the sector’s commitment to phasing out unnecessary animal testing and the need for regulatory frameworks that support NAMs, such as in vitro tests and computational models. He noted progress in sectoral guidance by the European Food Safety Authority (EFSA) but stressed the limited uptake of NAMs.
Calling for increased collaboration between industry, regulators and academia, Jacobs said this would help build trust and invest in scientific validation of NAMs, aiming to make them the standard for chemical safety assessments in the food and drink sector.
He reminded attendees that the European food and drink sector represents nearly 300,000 companies, and as a whole, the industry is committed to consumer safety, sustainability and innovation. He also highlighted the potential impact of artificial intelligence on providing better methodologies for food safety.
The demand for cruelty-free products is increasing, Jacobs added.
“And the good thing about NAMs,” he said, “is that these methodologies provide human-relevant data without the need for animal testing, aligning not only with society’s ethical expectations but also, importantly, with the demand for cruelty-free products, and that’s what consumers want.”
“So as public and consumer awareness around animal welfare increases, our industry has responded by offering more ethically certified products, including vegan foods, which by definition do not involve vegan animal testing. NAMs helps us meet these ethical and societal expectations while maintaining the highest food safety standards.”
Jacobs commended the European Food Safety Authority (EFSA) for taking initial steps to integrate NAMs into food safety assessments but encouraged them “and other regulatory bodies to provide more specific guidance on integrating NAMs into food safety assessments, and particularly when it comes to sector-specific standards tailored to unique needs of sectors such as the food and drink industry.”
EFSA’s sectoral guidance on novel foods is an example of NAMs gaining credibility as an effective tool for safety evaluations, he added.
As part of the Annual Conference, the 3Rs Science Prize 2024 was also awarded to an early careers scientist whose research significantly advances the principles of the 3Rs – replacement, reduction, refinement of animal testing – aiming to acknowledge and stimulate meaningful contributions from both industry and academia. Dr. Jakub Tomek received the award for his work on a computational model for drug safety assessment.
The afternoon sessions covered the possibilities for maximising the uptake of new approach methodologies under existing EU regulations in the chemicals and pharmaceutical sectors. Both these industries are identified as key to increasing NAMs uptake, with opportunities to increase competitiveness by using innovative new approaches.
Giulia Del Brenna, EPAA European Commission Co-Chair, closed the day by praising the innovative work accomplished by EPAA over the past year and mentioning the upcoming 20th meeting.
Del Brenna stressed the need to constantly advance the replacement, reduction, and refinement of animal testing. Chemical legislation already mandates animal testing as a last resort, but the European Commission is working on a roadmap to phase out animal testing for chemical safety assessments.
She remarked on the importance of cooperation and partnership from stakeholders to work on this shift. “We need you. We need this period of cooperation and partnership. We need your enthusiasm and your work towards these objectives.”
[Edited By Brian Maguire | Euractiv’s Advocacy Lab ]
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