The European Food Safety Authority (EFSA) has announced that it is extending a public call for 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). The agency originally set a deadline for information submission of April 20, 2020 (FPF reported), however Chemical Watch reports that it has extended the deadline until December 31, 2020 at the request of stakeholders still carrying out studies on the substances.

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 provided evidence that FCM No. 20 “may cause previously unknown adverse effects to health in an OECD 414 developmental toxicity study,” prompting the call for additional information.


EFSA (October 2020). “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.” (pdf)

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Chemical Watch (October 22, 2020). “Efsa extends call for data on two plastic FCM additives.”