Lambré Claude, Crebelli Riccardo, da Silva Maria, Grob Konrad, Lampi Evgenia, Milana Maria Rosaria, Pronk Marja, Ščetar Mario, Theodoridis Georgios, Van Hoeck Els, Waegeneers Nadia, Bolognesi Claudia, Cariou Ronan, Castle Laurence, Di Consiglio Emma, Franz Roland, Wölfle Detlef, Al Harraq Zainab, Barthélémy Eric, Comandella Daniele, Vela Julia Fontán, Halamoda Blanka, Rivière Gilles
EFSA J. 2025 Feb 10;23(2):e9104. doi: 10.2903/j.efsa.2025.9104. eCollection 2025 Feb.
The European Commission asked EFSA to review whether the authorisation of N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine (FCM No 19) and N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO-coco, PFAEO-oleyl, PFAEO-HT, PFAEO-T and PFAO-C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.
欧盟委员会要求欧洲食品安全局（EFSA）审查N,N-双(2-羟乙基)烷基（C8 - C18）胺（食品接触材料编号19）和N,N-双(2-羟乙基)烷基（C8 - C18）胺盐酸盐（食品接触材料编号20）的授权是否仍符合第12(3)条规定的（EC）No 1935/2004号法规。食品接触材料小组得出结论，N,N-双(2-羟乙基)烷基（C8 - C18）胺（食品接触材料编号19）的某些用途不符合该法规，因为在某些使用条件下，迁移量可能超过目前食品中1.2毫克/千克的特定迁移限量（SML(T)）。根据所提供的数据，食品接触材料小组得出结论，如果满足以下条件，食品接触材料编号19的物质N,N-双(2-羟乙基)烷基（C8 - C18）胺对消费者不存在安全问题：(i) 该物质作为聚合物生产助剂和加工助剂，用于制造厚度达1毫米的聚烯烃材料和制品，用量最高为0.1% w/w，这些材料和制品旨在与除婴儿食品外的所有类型食品接触。婴儿食品的这一例外情况和最大厚度限制不适用于瓶盖；(ii) 迁移量不超过5毫克/千克食品；(iii) 烷基的来源要么是氢化植物油，要么是由具有高度线性结构的乙烯低聚物合成；(iv) 杂质不超过5% w/w。由于PFAEO-椰油基、PFAEO-油基、PFAEO-HT、PFAEO-T和PFAO-C18含有不饱和键，不属于食品接触材料编号19的物质范围。与这些物质相关的信息仅被视为对食品接触材料编号19的支持性信息。如果打算使用它们来制造食品接触材料，应按照欧洲食品安全局的指导文件提交适当的申请。未申报食品接触材料编号20的物质N,N-双(2-羟乙基)烷基（C8 - C18）胺盐酸盐的任何用途，也未提供信息来支持目前的授权符合（EC）No 1935/2004号法规。
