Countdown to 2027 - maximising use of NAMs in food safety assessment: closing the gap for regulatory assessments in Europe.

IF 3 4区 医学 Q1 MEDICINE, LEGAL
Adam Wood, Franck Atienzar, Danilo Basili, Myriam Coulet, Rebeca Fernandez, Melina Galano, Maricel Marin-Kuan, Gina Montoya, Przemyslaw Piechota, Ans Punt, Elena Reale, Si Wang, Paul Hepburn
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Abstract

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.

2027年倒计时-在食品安全评估中最大限度地使用NAMs:缩小欧洲监管评估的差距。
欧盟(EU)对受监管食品的安全评估主要依赖于实验动物研究。目前,欧盟委员会正在制定路线图,逐步淘汰所有相关立法(包括食品)中用于化学安全评估的动物试验,而欧洲食品安全局(EFSA)的目标是,到2027年,新的科学发展,即新方法/非动物方法(NAMs)将被整合到评估中,从而实现“动物试验最小化”。然而,考虑到最近对一些受监管产品进行新的动物研究的要求,需要取得重大进展,以进一步减少并最终取代食品安全环境中的动物试验。为了推进这一点,我们审查了几个适用于食品安全评估的NAMs,并反思了它们在欧盟食品安全法规和部门指导中的存在。多年来,将NAMs纳入食品安全评估的建议一直受到监管影响的质疑。因此,我们提出了几项可以对欧盟食品监管体系和当前逐步淘汰动物试验的战略进行的修订,如果采用这些修订,可能会导致食品安全环境中动物试验程度的切实差异。认识到其中一些NAMs可能需要进行研究以加强监管吸收,我们提出了潜在的后续项目,以补充欧洲食品安全局公布的近期研究与创新(R&I)需求,食品安全利益相关者可以协调或参与。
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来源期刊
CiteScore
6.70
自引率
8.80%
发文量
147
审稿时长
58 days
期刊介绍: Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)
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