Background

A legal framework cannot ensure that a food will never pose a risk to any consumer. Risk management procedures are put in place to control potential risks occurring from food consumption. In the EU, this is translated into premarket authorisation decisions to allow novel food products on the market, laid down in the Novel Food Regulation (NFR).

Scope and approach

In the authorisation decision under the NFR, the scientific dossier dealing with the food product's safety is key. Various adjustments were made in updating the 1997 NFR to the new NFR (Regulation 2015/2283), but scientific dossier requirements seem comparable between both versions. This paper aims to optimise the crosstalk between the two corner stones of the NFR, science and regulation, and therefore reviews methodological requirements to establish food safety.

Key findings and conclusions

For novel foods, the scientific dossier must provide evidence that no adverse effects are elicited by consuming the product and consequently, kinetics, toxicology, nutritional information and allergenicity must be analysed. Methodological developments within these fields and specifically in toxicology will reduce required resources as well as the need for large numbers of experimental animals in conducting risk assessments. New methods should be embraced throughout the EU by promoting their (of course critical) use in safety assessments of foods.

中文翻译：

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要求安全食品–新食品法规下的安全测试（2015/2283）

背景

法律框架无法确保食品永远不会对任何消费者构成风险。制定了风险管理程序，以控制因食用食物而产生的潜在风险。在欧盟，这被转化为“新食品法规（NFR）”中规定的允许将新食品投放市场的售前授权决定。

范围和方法

在NFR的授权决定中，处理食品安全性的科学档案是关键。在将1997年NFR更新为新NFR（2015/2283号法规）时，进行了各种调整，但两个版本之间的科学档案要求似乎是可比的。本文旨在优化NFR，科学和法规的两个基石之间的串扰，因此回顾了建立食品安全的方法要求。

主要发现和结论

对于新颖食品，科学档案必须提供证据表明食用该产品不会引起不良影响，因此必须分析动力学，毒理学，营养信息和致敏性。这些领域特别是毒理学领域的方法学发展将减少进行风险评估所需的资源，以及对大量实验动物的需求。通过在食品安全评估中推广使用（当然很关键）的新方法，应在整个欧盟范围内采用。