Guidance for submission for food additive evaluations
Guidance for submission for food additive evaluations
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DOI：
10.2903/j.efsa.2012.2760
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发表时间：
2012-07-01
期刊：
影响因子：
3.3
通讯作者：
Wright, Matthew
中科院分区：
文献类型：
--
作者：
Aguilar, Fernando;Crebelli, Riccardo;Wright, Matthew
本指导文件涉及新食品添加剂的授权申请或已授权食品添加剂的修改申请，将数据要求及其背景的描述以及所应用的风险评估范式的描述合并在一个文件中。该文件分为四个主要部分：化学和规格、现有授权和评估、拟议用途和暴露评估以及毒理学研究。对食品添加剂暴露的评估是基于已知或预期的人类暴露于来自食品和任何其他潜在膳食来源的拟议添加剂或添加剂的毒理学相关成分的信息。对于毒理学研究，本指南描述了一种分层方法，平衡数据要求与风险，通过采用符合 3-R（替换、细化、减少）的动物测试策略来考虑动物福利。这种毒理学研究的分层方法由 3 层组成，描述了测试要求、关键问题和触发因素。根据这种分层方法，适用于所有化合物的最小数据集已在第 1 层下开发，而第 1 层测试中被吸收和/或表现出（基因）毒性的化合物将需要进行第 2 层测试，生成更广泛的数据。第 3 层应根据具体情况进行，考虑所有可用数据，以阐明需要进一步调查第 2 层测试结果的具体终点。本指导文件取代了食品科学委员会 2001 年发布的先前指导文件。 (C) 欧洲食品安全局，2012 年
This guidance document refers to the applications for authorisation of a new food additive or to a modification of an already authorised food additive, combining in a single document the description of the data requirements and their context, and also a description of the risk assessment paradigm applied. The document is arranged in four main sections: chemistry and specifications, existing authorisations and evaluations, proposed uses and exposure assessment, and toxicological studies. Assessment of the exposure to food additives is based on information on known or anticipated human exposure to the proposed additive or toxicologically relevant components of the additive from food, and any other potential dietary sources. For the toxicological studies, this guidance describes a tiered approach which balances data requirements against the risk, taking into consideration animal welfare by adopting animal testing strategies in line with the 3-Rs (replacement, refinement, reduction). This tiered approach for toxicological studies consists of 3 tiers, for which the testing requirements, key issues and triggers are described. According to this tiered approach, a minimal dataset applicable to all compounds has been developed under Tier 1, while Tier 2 testing, generating more extensive data, will be required for compounds which are absorbed and/or demonstrate (geno) toxicity in Tier 1 tests. Tier 3 should be performed on a case-by-case basis taking into consideration all the available data, to elucidate specific endpoints needing further investigation of findings in Tier 2 tests. This guidance document replaces the previous guidance document by the Scientific Committee for Food published in 2001. (C) European Food Safety Authority, 2012