New Approach Methodologies (NAMs) for ad hoc human health risk assessment of food and non-food products - Proceedings of a workshop

Lianne de Wit, Hester Hendriks, Jacqueline van Engelen,Harm Heusinkveld,Anne Kienhuis, Emiel Rorije, Marjolijn Woutersen, Margriet van der Zee, Suzanne Jeurissen

Regulatory Toxicology and Pharmacology(2024)

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摘要
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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关键词
New approach methodologies (NAMs),Ad hoc risk assessment,Regulatory risk assessment,Borderline products,Tabernanthe iboga,Dermal creams containing female sex hormones
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