EFSA calls for information on FCM No. 19 and 20

On December 6, 2019, the European Food Safety Authority (EFSA) announced a call for technical and toxicological information on two substances used as additives in plastic food contact materials (FCMs): 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). Both substances are listed within Annex I of Regulation (EU) No 10/2011 and have a group specific migration limit (SML) of 1.2 mg/kg food, as well as other restrictions. EFSA informed that a business has recently provided evidence that FCM No. 20 “may cause previously unknown adverse effects to health in an OECD 414 developmental toxicity study.” Following this new information, EFSA has been requested to review and update its assessments for the substances. It is therefore asking for information from stakeholders to support this assessment, including information on manufacturing, properties, uses, migration, residual content, and potential toxicity, among other data. Interest in participating in the call for information should be declared to EFSA by January 20, 2020, and the deadline for submission of information is April 20, 2020.

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EFSA (December 6, 2019). “Call for technical and toxicological data on the substances 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) for their use in plastic materials and articles intended to come into contact with food, including in food for infants.”

Chemical Watch (December 17, 2019). “Efsa consults on safety of plastic FCM additives.”