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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引用次数: 0
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.
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)