EFSA Opinion on Re‐evaluation of Lecithins (E 322) as a Food Additive in Infant Foods and for all Age Groups

Posted By: Trace One

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On November 10, 2020, the European Food Safety Authority release the scientific 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”.

As a follow‐up to EFSA’s 2017 risk assessment on substances in infant foods, the Panel on 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 and as carry over in line with Annex III to Regulation (EC) No 1333/2008.

The scientific panel provided the below technical information based on the re-evaluation of Lecithins (E322) as follows:

  • It is feasible to amend the EU specifications, in particular for the toxic element’s arsenic, lead, mercury and introduce new specifications for cadmium and microbiological criteria for all age groups.
  • The safety issue identified by the ANS Panel in 2017 is related to potential neurodevelopmental effects.
  • Choline is a precursor of the neurotransmitter acetylcholine. Choline released from lecithins (E 322) is a minor contributor (around 8.7% as the mean) of the total content of choline of the formula and does not raise concern at the current use levels including the MPL for lecithin’s (E 322). Most of the choline in the formula is due to the choline added as a nutrient.
  • To address the safety of lecithin as a 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.

EFSA concluded Intake of lecithins as a food additive in infant formula belonging to Food category 13.1.1 or in food for special medical purposes belonging to does not raise safety concerns up to the maximum permitted level (MPL) of lecithins (E 322).


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