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Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority
Food Research International ( IF 8.1 ) Pub Date : 2020-07-07 , DOI: 10.1016/j.foodres.2020.109515
Ermolaos Ververis , Reinhard Ackerl , Domenico Azzollini , Paolo Angelo Colombo , Agnès de Sesmaisons , Céline Dumas , Antonio Fernandez-Dumont , Lucien Ferreira da Costa , Andrea Germini , Tilemachos Goumperis , Eirini Kouloura , Leonard Matijevic , Gabriela Precup , Ruth Roldan-Torres , Annamaria Rossi , Roman Svejstil , Emanuela Turla , Wolfgang Gelbmann

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document.

The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003–2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues.

In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product’s toxicological profile. Recurring issues related to specific novel food categories were noted.

The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made.



中文翻译:

欧盟的新型食品:欧洲食品安全局的科学要求和风险评估程序的挑战

自2003年以来,欧洲食品安全局(EFSA)参与了新食品的风险评估。2018年实施的现行新食品法规使EFSA成为负责此类安全评估的欧盟唯一实体。风险评估是根据申请人根据相应的EFSA指导文件中所述的科学要求提交的数据进行的。

本工作旨在详细阐述在对新型食品进行风险评估期间提出的科学问题的基本原理,重点是复杂的混合物和完整食品。欧洲食品安全局在2003–2019年期间收到的新颖食品已根据性质和复杂性进行筛选和分类。对EFSA在所有风险评估期间提出的有关补充或补充信息的请求进行了分析,以识别重复出现的问题。

简而言之,显示出其应用主要涉及源自植物,微生物,真菌,藻类和动物的新型食品。大量的要求与生产过程,新颖食品的成分表征以及产品的毒理学特征评估有关。注意到与特定新颖食品类别有关的反复出现的问题。

新奇食品的异质性和复杂性凸显了挑战,要根据每种产品的特性定制评估方法的各个方面。重要的是,欧洲食品安全局(EFSA)对新型食品应用的科学要求是相互关联的,只有申请人在准备相应的应用档案时采用严格而跨领域的方法,才能得出科学合理的档案。这是首次对欧洲食品安全局在新食品风险评估中获得的经验进行深入分析,并分析了欧洲食品安全局对申请人提出的最频繁的科学要求的原因。

更新日期:2020-07-13
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