Pfaff Karla, Wölfle Detlef, Luch Andreas
Bundesinstitut für Risikobewertung, Max-Dohrn-Str. 8-10, 10589, Berlin, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Jul;60(7):707-714. doi: 10.1007/s00103-017-2565-2.
Diverse materials intended for contact with food are important sources of food contamination. Harmonised European regulations including whitelists (so-called "positive lists") of substances along with migration limits and restrictions exist for plastics and regenerated cellulose films only. The European Food Safety Authority (EFSA) is responsible for the risk assessment of substances prior to their authorization and inclusion into the positive lists. In 2016 the EFSA issued an opinion on recent developments in the risk assessment of substances migrating into food for public consideration. Also migration related to non-intentionally added substances (NIASs), e. g. impurities, degradations products or oligomers, may be relevant for risk assessment. For substances migrating in quantities up to 50 ppb the requested data are restricted to genotoxicity testing based on a tiered approach for toxicological data requirements. In the case of higher migration levels (>50 ppb) experimental animal studies are also requested. Along with an evaluation of the available information, toxicological data on structurally similar substances may be used for the assessment if sufficiently justified with the aim to reduce animal studies as far as possible. For the risk assessment of NIASs it is possible to apply in silico methods in the absence of experimental toxicological data. Additionally, new technologies such as the use of nanomaterials, active and intelligent packaging and recycled plastics are challenging tasks in EFSA's risk assessment in accordance with the regulations by the European Commission.
各类与食品接触的材料是食品污染的重要来源。目前，统一的欧洲法规仅针对塑料和再生纤维素薄膜，包括物质白名单（所谓的“肯定列表”）以及迁移限量和限制规定。欧洲食品安全局（EFSA）负责在物质获得授权并被列入肯定列表之前进行风险评估。2016年，欧洲食品安全局发布了一份关于物质迁移到食品中的风险评估最新进展的意见供公众参考。此外，与非有意添加物质（NIASs）相关的迁移，例如杂质、降解产物或低聚物，可能与风险评估相关。对于迁移量高达50 ppb的物质，所需数据仅限于基于毒理学数据要求的分层方法进行的遗传毒性测试。对于较高迁移水平（>50 ppb）的情况，还需要进行实验动物研究。在对现有信息进行评估的同时，如果有充分理由，结构相似物质的毒理学数据可用于评估，以尽可能减少动物研究。对于非有意添加物质的风险评估，在没有实验毒理学数据的情况下可以应用计算机模拟方法。此外，诸如使用纳米材料、活性和智能包装以及再生塑料等新技术，是欧洲食品安全局根据欧盟委员会法规进行风险评估中的具有挑战性的任务。
