对食品和非食品产品进行特别人类健康风险评估的新方法(NAMs)--研讨会记录。

IF 3 4区 医学 Q1 MEDICINE, LEGAL Regulatory Toxicology and Pharmacology Pub Date : 2024-03-28 DOI:10.1016/j.yrtph.2024.105615
Lianne de Wit , Hester Hendriks , Jacqueline van Engelen , Harm Heusinkveld , Anne Kienhuis , Emiel Rorije , Marjolijn Woutersen , Margriet van der Zee , Suzanne Jeurissen
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引用次数: 0

摘要

国际兽疫局召开了一次关于使用新方法(NAMs)对食品和非食品进行特别人类健康风险评估的研讨会。研讨会的中心议题是两个具有潜在健康问题的上市产品案例研究:植物药 Tabernanthe iboga,用于促进心理或精神洞察力或(非法)治疗毒瘾,并与心脏毒性有关;以及含有女性性激素的皮肤乳膏,用于围绝经期妇女在没有医疗监督的情况下减轻更年期症状。研讨会与会者认识到,虽然现有方法不足以得出基于健康的指导值,但从非杀伤人员地雷方法中获得的数据为这些产品的特别风险评估增加了宝贵的信息。与会者就如何在监管风险评估中进一步加强和实施非杀伤人员地雷方法提出了建议,具体说明了科学和技术方面以及利益相关者参与方面的问题。
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New Approach Methodologies (NAMs) for ad hoc human health risk assessment of food and non-food products - Proceedings of a workshop

RIVM convened a workshop on the use of New Approach Methodologies (NAMs) for the ad hoc human health risk assessment of food and non-food products. Central to the workshop were two case studies of marketed products with a potential health concern: the botanical Tabernanthe iboga which is used to facilitate mental or spiritual insight or to (illegally) treat drug addiction and is associated with cardiotoxicity, and dermal creams containing female sex hormones, intended for use by perimenopausal women to reduce menopause symptoms without medical supervision. The workshop participants recognized that data from NAM approaches added valuable information for the ad hoc risk assessment of these products, although the available approaches were inadequate to derive health-based guidance values. Recommendations were provided on how to further enhance and implement NAM approaches in regulatory risk assessment, specifying both scientific and technical aspects as well as stakeholder engagement aspects.

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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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