Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups

Lecithins (E 322) were re-evaluated in 2017 by the former EFSA Panelon Food Additives and Nutrient sources added to Food (ANS). As follow-up to that assessment, the Panelon Food Additives and Flavourings (FAF) was requested to assess the safety of lecithins (E 322) for uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 and 13.1.5.1 and as carry over in line with Annex III to Regulation (EC) No 1333/2008. In addition, the FAF Panelwas requested to address the issues identified during the re-evaluation of the food additive (E 322). The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. Based on the information submitted in response to the call for data, the FAF Panelconsidered it feasible to amend the EU specifications, in particular for the toxic elements arsenic, lead, mercury and introduce new specifications for cadmium and microbiological criteria. The safety issue identified by the ANS Panelin 2017 concerned potential neurodevelopmental effects. For the reason that choline is a precursor of the neurotransmitter acetylcholine, the Panelconsidered it appropriate to address the safety of lecithins (E 322) as food additive in infant formula used in infants below the age of 16 weeks by comparing the concentration of choline in human milk with that in the formula. The Panelconcluded that the intake of lecithins (E322) as a food additive in infant formula belonging to FC 13.1.1 or in food for special medical purposes belonging to FC 13.1.5.1 does not raise safety concerns up to the maximum permitted level (MPL) of lecithins (E 322).