EFSA Updates Safety Assessment of FCM No 19 and No 20 in Food-Contact Materials

The European Food Safety Authority (EFSA) published an updated safety assessment 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) used in plastic food contact materials. EFSA reviewed their compliance with Regulation (EC) No 1935/2004 following a request from the European Commission.

The EFSA Food Contact Materials (FCM) Panel concluded that certain uses of FCM No 19 may result in migration exceeding the specific migration limit (SML(T)) of 1.2 mg/kg food. However, its use is not a safety concern if specific conditions are met, including a maximum concentration of 0.1% w/w as polymer production aid and as processing aid in polyolefin materials up to 1 mm thick, excluding infant food applications. For FCM No 20, EFSA found that no supporting information was provided to confirm its compliance, and no uses were claimed.