Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Chesson Andrew, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mortensen Alicja, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Castle Laurence, Di Consiglio Emma, Franz Roland, Hellwig Nicole, Kolf-Clauw Martine, Milana Maria Rosaria, Pfaff Karla, Volk Katharina, Rivière Gilles
EFSA J. 2020 Mar 13;18(3):e06047. doi: 10.2903/j.efsa.2020.6047. eCollection 2020 Mar.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids (SABOFOG F1), FCM No 1081, which is intended to be used as an antistatic and anti-fog agent in all types of polymers at up to 2% w/w. It was requested for use in contact with dry food, acidic foods and alcoholic beverages (represented by simulants E, B and C, respectively) with storage up to 6 months at ambient temperature. The migration data provided did not enable the assessment of the safety of applications intended for contact with foods represented by simulants B and C. In the migrate into simulant E, the non-esterified N,N-bis(2-hydroxyethyl)stearylamine was the main constituent. Its mono- and di-esters migrated to a lower extent. According to the data provided, the Panel concluded that the substance does not raise concern for genotoxicity and accumulation in humans. Based on the results of 28-day oral toxicity study with SABOFOG F1 and on the 90-day oral toxicity study with the read-across substance bis(2-hydroxyethyl)oleylamine, the Panel considered the current SML(T) of 1.2 mg/kg food provided a margin sufficiently large to accommodate the uncertainties related to the read-across approach. Overall, the CEP Panel concluded that N,N-bis(2-hydroxyethyl)stearylamine, of which at least ■■■■■ is partially or fully esterified with saturated C16/C18 fatty acids is not of safety concern for the consumer when used at up to 2% (w/w) in all polymers intended for contact with foods represented by simulant E for up to 6 months at room temperature. Additionally, the migration of the sum of N,N-bis(2-hydroxyethyl)stearylamine and its mono- and di-ester, calculated as N,N-bis(2-hydroxyethyl)stearylamine, should not exceed 1.2 mg/kg, i.e. the SML(T) for FCM substances 19 and 20, in which also the migration of the mono- and di-ester of N,N-bis(2-hydroxyethyl)stearylamine should be included.
欧洲食品安全局食品接触材料、酶和加工助剂小组（CEP）评估了与饱和C16/C18脂肪酸部分酯化的N,N-双（2-羟乙基）硬脂胺（SABOFOG F1，FCM编号1081）的安全性。该物质拟用作抗静电和防雾剂，用于所有类型的聚合物中，最高使用量为2%（w/w）。其被要求用于与干食品、酸性食品和酒精饮料接触（分别由模拟物E、B和C代表），在室温下储存长达6个月。所提供的迁移数据无法评估用于与模拟物B和C代表的食品接触的应用的安全性。在迁移到模拟物E中的物质中，未酯化的N,N-双（2-羟乙基）硬脂胺是主要成分。其单酯和二酯的迁移程度较低。根据所提供的数据，小组得出结论，该物质不会引起对人类遗传毒性和蓄积的担忧。基于对SABOFOG F1进行的28天经口毒性研究结果以及对交叉参照物质双（2-羟乙基）油胺进行的90天经口毒性研究结果，小组认为当前1.2毫克/千克食品的特定迁移限量（SML(T)）提供了足够大的安全余量，以适应与交叉参照方法相关的不确定性。总体而言，CEP小组得出结论，当在所有拟与模拟物E代表的食品接触的聚合物中以最高2%（w/w）的用量使用时，至少■■■■■被饱和C16/C18脂肪酸部分或完全酯化的N,N-双（2-羟乙基）硬脂胺对消费者不存在安全问题。此外，以N,N-双（2-羟乙基）硬脂胺计算，N,N-双（2-羟乙基）硬脂胺及其单酯和二酯的迁移总量不应超过1.2毫克/千克，即FCM物质19和20的SML(T)，其中还应包括N,N-双（2-羟乙基）硬脂胺单酯和二酯的迁移量。
