Public consultation on the draft guidance on the use of read-across for chemical safety assessment in food and feed

European Food Safety Authority (EFSA)
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Abstract

The European Food Safety Authority (EFSA) has developed a guidance on the use of read-across for chemical safety assessment in food and feed. The guidance aims to enhance the scientific robustness and transparency of read-across approaches, aligning with the EU's commitment to the 3Rs principle (replacement, reduction and refinement of animal testing). The guidance provides a structured, step-by-step framework for implementing read-across as part of a weight-of-evidence approach. The draft version of the guidance was open for public consultation from 10 March to 21 April 2025, receiving input from eleven stakeholders across seven countries. Feedback addressed general read-across methodology, uncertainty management, and the integration of New Approach Methodologies (NAMs). In response, EFSA's Scientific Committee working group (WG) revised the document to enhance clarity and robustness. Key updates include improved explanations of food and feed risk assessment contexts, clearer figures, and expanded guidance on the use of NAMs. The guidance was revised to include clearer recommendations for characterising uncertainty using expert judgment and quantitative methods, where feasible. The revised version also reinforces the importance of standardised procedures to ensure consistency, transparency, and regulatory compliance, and provides clearer criteria for the integration of NAMs to support uncertainty reduction and strengthen the scientific basis of read-across.

关于在食品和饲料中使用解读法进行化学品安全评估的指南草案的公众咨询
欧洲食品安全局(EFSA)制定了一项关于在食品和饲料化学品安全评估中使用读取的指南。该指南旨在增强解读方法的科学稳健性和透明度,与欧盟对3r原则(替代、减少和改进动物试验)的承诺保持一致。该指南提供了一个结构化的、逐步实施的框架,作为证据权重方法的一部分。该指南草案于2025年3月10日至4月21日公开征求公众意见,听取了来自7个国家11个利益攸关方的意见。反馈涉及一般的跨读方法、不确定性管理和新方法方法(NAMs)的集成。作为回应,欧洲食品安全局科学委员会工作组(WG)修订了该文件,以提高清晰度和稳健性。主要的更新包括改进了对食品和饲料风险评估背景的解释,更清晰的数字,以及扩大了对nama使用的指导。对指南进行了修订,在可行的情况下,纳入了使用专家判断和定量方法描述不确定性特征的更明确建议。修订后的版本还强调了标准化程序对确保一致性、透明度和法规遵从性的重要性,并为NAMs的整合提供了更明确的标准,以支持减少不确定性并加强解读的科学基础。
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