Andreassen Monica, Aquilina Gabriele, Bastos Maria Lourdes, Boon Polly, Castle Laurence, Fallico Biagio, FitzGerald Reginald, Frutos Fernandez Maria Jose, Grasl-Kraupp Bettina, Gundert-Remy Ursula, Gürtler Rainer, Kurek Marcin Andrzej, Louro Henriqueta, Morales Patricia, Passamonti Sabina, Oomen Agnes, Corsini Emanuela, Wright Matthew, Furst Peter, Gaffet Eric, Loeschner Katrin, Mast Jan, Undas Anna, Mech Agnieszka, Rincon Ana Maria, Ruggeri Laura, Smeraldi Camilla
EFSA J. 2025 Apr 23;23(4):e9316. doi: 10.2903/j.efsa.2025.9316. eCollection 2025 Apr.
Silver (E 174) is a food colour that was re-evaluated by the EFSA ANS Panel (2016). The ANS Panel concluded that the information available then, was insufficient to assess the safety of silver as food additive. The major issues included limited characterisation of silver E 174 (e.g. quantity of nanoparticles) and release of ionic silver. Following a European Commission call for further data to fill the data gap, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of silver (E 174). One interested business operator (IBO) submitted limited data on particle size distribution and morphology, two genotoxicity studies and one subchronic study. The Panel concluded that the technical data submitted on physicochemical characterisation of all types of silver used as food additive E 174 were not adequate. As a result, the Panel was unable to propose changes to the EU specifications of E174 on particle size and morphology. As the additional information requested was not provided, the assessment was based solely on the submitted data. Nonetheless, given the data provided and silver insolubility in water, the Panel concluded that E174 requires risk assessment at the nanoscale following the EFSA Guidance on Risk assessment of nanomaterials to be applied in the food and feed chain, to complement the conventional risk assessment. The Panel considered that the genotoxicity data and sub-chronic toxicity data were inadequate. Consequently, the Panel could not conclude on the safety of the food additive silver E 174.
银（E 174）是一种食用色素，欧洲食品安全局（EFSA）的食品添加剂和营养源添加剂专家委员会（ANS Panel）于2016年对其进行了重新评估。ANS专家委员会得出结论，当时可获得的信息不足以评估银作为食品添加剂的安全性。主要问题包括对银E 174的特性描述有限（例如纳米颗粒的数量）以及离子银的释放。应欧盟委员会要求提供更多数据以填补数据空白，食品添加剂和香料专家委员会（FAF）被要求评估银（E 174）的安全性。一位利益相关企业经营者（IBO）提交了关于粒径分布和形态的有限数据、两项遗传毒性研究和一项亚慢性研究。专家委员会得出结论，提交的关于用作食品添加剂E 174的所有类型银的物理化学特性的技术数据并不充分。因此，专家委员会无法提议更改欧盟对E174在粒径和形态方面的规范。由于未提供所要求的额外信息，评估仅基于提交的数据。尽管如此，鉴于所提供的数据以及银在水中的不溶性，专家委员会得出结论，按照欧洲食品安全局关于应用于食品和饲料链的纳米材料风险评估指南，E174需要在纳米尺度上进行风险评估，以补充传统的风险评估。专家委员会认为遗传毒性数据和亚慢性毒性数据不充分。因此，专家委员会无法就食品添加剂银E 174的安全性得出结论。
