Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.
Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.
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DOI：
10.2903/j.efsa.2021.6769
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Schoonjans R
中科院分区：
文献类型：
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作者：
EFSA Scientific Committee;More S;Bampidis V;Benford D;Bragard C;Halldorsson T;Hernández-Jerez A;Bennekou SH;Koutsoumanis K;Lambré C;Machera K;Naegeli H;Nielsen S;Schlatter J;Schrenk D;Silano Deceased V;Turck D;Younes M;Castenmiller J;Chaudhry Q;Cubadda F;Franz R;Gott D;Mast J;Mortensen A;Oomen AG;Weigel S;Barthelemy E;Rincon A;Tarazona J;Schoonjans R
根据欧盟委员会的授权，欧洲食品安全局制定了技术要求指南（颗粒- TR指南），定义了评估一小部分小颗粒存在的标准，并规定了在受监管的食品和饲料产品领域（例如新型食品、食品/饲料添加剂、食品接触材料和农药）应用的信息要求。这些要求适用于传统材料中需要在纳米尺度上进行特定评估的颗粒，这些颗粒不符合新食品法规（EU） 2015/2283中对工程纳米材料的定义。该指南概述了分为三个部分的评估标准，以确定是否应该用纳米特异性考虑来补充传统的风险评估。第一组将溶解度和溶解速率作为关键的物理化学性质，以评估消费者是否会接触到颗粒。第二组建立了评估常规材料是否含有一小部分或由小颗粒组成的信息要求，以及其特征。第三组描述了为现有安全性研究提供的信息，以证明小颗粒的比例，包括纳米级颗粒，已经得到了适当的评估。此外，为了指导对现有安全性研究的评估，提出了在尽量减少进行新的动物研究的需要的同时缩小数据差距的建议。该《颗粒- TR指南》补充了《用于食品和饲料链、人类和动物健康的纳米材料风险评估指南》，该指南由欧洲食品安全局科学委员会更新，并与本指南共同发布。建议申请人在进行新的研究之前查阅这两份指导文件。本出版物链接到以下欧洲食品安全局期刊文章：http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6768/full本出版物链接到以下欧洲食品安全局支持出版物文章：http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6804/full
Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle‐TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle‐TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co‐published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6768/full This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6804/full