Lianne de Wit , Hester Hendriks , Jacqueline van Engelen , Harm Heusinkveld , Anne Kienhuis , Emiel Rorije , Marjolijn Woutersen , Margriet van der Zee , Suzanne Jeurissen
{"title":"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。","authors":"Lianne de Wit , Hester Hendriks , Jacqueline van Engelen , Harm Heusinkveld , Anne Kienhuis , Emiel Rorije , Marjolijn Woutersen , Margriet van der Zee , Suzanne Jeurissen","doi":"10.1016/j.yrtph.2024.105615","DOIUrl":null,"url":null,"abstract":"<div><p>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 <em>Tabernanthe iboga</em> 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.</p></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"149 ","pages":"Article 105615"},"PeriodicalIF":3.0000,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0273230024000564/pdfft?md5=0ac95f66a6a6e14cf1beb757443c4ed5&pid=1-s2.0-S0273230024000564-main.pdf","citationCount":"0","resultStr":"{\"title\":\"New Approach Methodologies (NAMs) for ad hoc human health risk assessment of food and non-food products - Proceedings of a workshop\",\"authors\":\"Lianne de Wit , Hester Hendriks , Jacqueline van Engelen , Harm Heusinkveld , Anne Kienhuis , Emiel Rorije , Marjolijn Woutersen , Margriet van der Zee , Suzanne Jeurissen\",\"doi\":\"10.1016/j.yrtph.2024.105615\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>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 <em>Tabernanthe iboga</em> 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.</p></div>\",\"PeriodicalId\":20852,\"journal\":{\"name\":\"Regulatory Toxicology and Pharmacology\",\"volume\":\"149 \",\"pages\":\"Article 105615\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-03-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0273230024000564/pdfft?md5=0ac95f66a6a6e14cf1beb757443c4ed5&pid=1-s2.0-S0273230024000564-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regulatory Toxicology and Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0273230024000564\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, LEGAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0273230024000564","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
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.
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)