Wood Adam, Atienzar Franck, Basili Danilo, Coulet Myriam, Fernandez Rebeca, Galano Melina, Marin-Kuan Maricel, Montoya Gina, Piechota Przemyslaw, Punt Ans, Reale Elena, Wang Si, Hepburn Paul
Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK.
Coca-Cola Services SA/NV, Chaussée De Mons 1424, 1070, Anderlecht, Belgium.
Regul Toxicol Pharmacol. 2025 Nov;162:105863. doi: 10.1016/j.yrtph.2025.105863. Epub 2025 May 29.
Safety assessments of regulated food products in the European Union (EU) largely rely on experimental animal studies. Currently, the European Commission is developing a roadmap to phase out animal testing for chemical safety assessment across all relevant pieces of legislation, including foods, while the ambition of the European Food Safety Authority (EFSA) is that by 2027, new scientific developments, i.e., new approach/non-animal methods (NAMs), will be integrated into assessments leading to "the minimisation of animal testing". However, considering recent requests that have been made to conduct new animal studies for some regulated products, significant progress is required to minimise further and ultimately replace animal testing in the food safety environment. To advance this, we review several NAMs amenable for use in food safety assessment and reflect on their presence in EU food safety regulation and sectoral guidance. For many years, proposals to incorporate NAMs into food safety assessments have been made with questionable regulatory impact. Therefore, we present several amendments which could be made to the EU food regulatory system and current strategies towards phasing out animal testing which, if taken up, could lead to a tangible difference in the extent of animal testing within the food safety environment. Recognising that research may be required for some of these NAMs to enhance regulatory uptake, we propose potential follow-up projects that complement recent research & innovation (R&I) needs published by EFSA which food safety stakeholders could coordinate or participate in.
欧盟对受监管食品的安全性评估很大程度上依赖于实验动物研究。目前，欧盟委员会正在制定一项路线图，以逐步淘汰在包括食品在内的所有相关立法中进行化学安全性评估时的动物试验，而欧洲食品安全局（EFSA）的目标是，到2027年，新的科学进展，即新方法/非动物方法（NAMs），将被纳入评估，以实现“动物试验的最小化”。然而，考虑到最近有人要求对一些受监管产品进行新的动物研究，要在食品安全环境中进一步减少并最终取代动物试验，还需要取得重大进展。为推动这一目标，我们审查了几种适用于食品安全评估的非动物方法，并思考它们在欧盟食品安全法规和部门指南中的存在情况。多年来，将非动物方法纳入食品安全评估的提议所产生的监管影响存疑。因此，我们提出了几项可以对欧盟食品监管体系及当前逐步淘汰动物试验的策略进行的修订，如果采纳这些修订，可能会在食品安全环境中动物试验的程度上产生切实的改变。认识到可能需要对其中一些非动物方法进行研究以提高监管接受度，我们提出了一些潜在的后续项目，这些项目补充了欧洲食品安全局最近公布的研究与创新（R&I）需求，食品安全利益相关者可以进行协调或参与。
