Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Chesson Andrew, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Castle Laurence, Di Consiglio Emma, Franz Roland, Hellwig Nicole, Merkel Stefan, Milana Maria Rosaria, Barthélémy Eric, Rivière Gilles
EFSA J. 2021 Aug 9;19(8):e06790. doi: 10.2903/j.efsa.2021.6790. eCollection 2021 Aug.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the additive silver nanoparticles intended to be used in plastics. All the silver particles are in the size range of 1-100 nm, with about 15 nm mean diameter and 99% by number of particles below 20 nm. The additive is intended to be used as a surface biocide at up to 0.025% w/w in non-polar plastics for contact with a wide variety of foods, times, temperatures and food contact surface/mass of food ratios. The particulate form is maintained when the additive is incorporated into plastics, albeit with some aggregation/agglomeration observed. The data and information on theoretical considerations, on specific migration and abrasion tests show that, under the intended and tested conditions of uses, the silver nanoparticles stay embedded in the polymer, do not migrate and resist release by abrasion, thus, do not give rise to exposure via food and to toxicological concern. There is migration of silver in soluble ionic form up to 6 μg/kg food from the surface of the additive particles. This is below the group restriction of 50 μg silver/kg food proposed by the AFC Panel in 2004 and would lead to a maximum exposure from FCM that would be below the acceptable daily intake (ADI) of 0.9 μg silver ions/kg body weight (bw) per day established by ECHA. Therefore, the Panel concluded that the substance does not raise safety concern for the consumer if used as an additive at up to 0.025% w/w in polymers, such as polyolefins, polyesters and styrenics, that do not swell in contact with aqueous foods and food simulants. The Panel noted, however, that exposure to silver from other sources of dietary exposure may exceed the ADI set by ECHA.
欧洲食品安全局食品接触材料、酶和加工助剂专家委员会（CEP）评估了拟用于塑料中的添加剂银纳米颗粒的安全性。所有银颗粒的尺寸范围为1 - 100纳米，平均直径约为15纳米，按数量计99%的颗粒直径低于20纳米。该添加剂拟用作表面杀菌剂，在非极性塑料中的使用量最高可达0.025%（重量/重量），用于与各种食品接触，包括不同时间、温度以及食品接触表面/食品质量比的情况。当添加剂掺入塑料中时，颗粒形态得以保持，不过会观察到一些聚集/团聚现象。关于理论考量、特定迁移和磨损测试的数据及信息表明，在预期和测试的使用条件下，银纳米颗粒会嵌入聚合物中，不会迁移且能抵抗磨损释放，因此，不会通过食品导致暴露以及引发毒理学担忧。添加剂颗粒表面有可溶离子形式的银迁移，迁移量最高可达6微克/千克食品。这低于食品添加剂和调味剂联合专家委员会（AFC Panel）2004年提议的50微克银/千克食品的组限量，并且由此导致的食品接触材料（FCM）的最大暴露量将低于欧洲化学品管理局（ECHA）确定的每日可接受摄入量（ADI），即0.9微克银离子/千克体重（bw）/天。因此，专家委员会得出结论，如果该物质在与水性食品和食品模拟物接触时不会溶胀的聚合物（如聚烯烃、聚酯和苯乙烯类聚合物）中用作添加剂，使用量最高可达0.025%（重量/重量），则不会对消费者造成安全担忧。然而，专家委员会指出，来自其他膳食暴露源的银暴露量可能会超过ECHA设定的ADI。
