Safety assessment of the substance N,N‐bis(2‐hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids, for use in food contact materials
Competing interests: Roland Franz declared that Fraunhofer institute at which he was employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA's Policy on Independence** and the Decision of the Executive Director on Competing Interest Management,*** a waiver was granted to Roland Franz regarding his participation to the EFSA's Working Group on Food Contact Materials (FCM WG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of Roland Franz is authorised as member in the FCM WG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.
Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information has been provided under confidentiality and it is redacted awaiting the decision of the Commission: manufacturing process; composition of main constituents; results of migration tests; detailed results of in vitro mammalian chromosomal aberration test and 90‐day oral toxicity study.
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.