Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Husøy Trine, Manco Melania, Mennes Wim, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Dusemund Birgit, Mortensen Alicja, Turck Dominique, Barmaz Stefania, Tard Alexandra, Vianello Giorgia, Gundert-Remy Ursula
EFSA J. 2020 Nov 10;18(11):e06266. doi: 10.2903/j.efsa.2020.6266. eCollection 2020 Nov.
Lecithins (E 322) were re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As follow-up to that assessment, 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 13.1.5.1 and as carry over in line with Annex III to Regulation (EC) No 1333/2008. In addition, the FAF Panel was 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 Panel considered 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 Panel in 2017 concerned potential neurodevelopmental effects. For the reason that choline is a precursor of the neurotransmitter acetylcholine, the Panel considered 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 Panel concluded that the intake of lecithins (E 322) 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).
2017年，前欧洲食品安全局食品添加剂和添加到食品中的营养源专家委员会（ANS）对卵磷脂（E 322）进行了重新评估。作为该评估的后续行动，食品添加剂和调味剂专家委员会（FAF）被要求评估卵磷脂（E 322）作为食品添加剂在16周龄以下婴儿食品（属于食品类别13.1.1和13.1.5.1）中的安全性，以及根据欧盟第1333/2008号法规附件III作为带入物的安全性。此外，FAF专家委员会被要求解决食品添加剂（E 322）重新评估期间发现的问题。该过程包括发布数据征集通知，以便感兴趣的商业经营者提供所需信息以完成风险评估。基于对数据征集通知的回复中提交的信息，FAF专家委员会认为修订欧盟规范是可行的，特别是对于有毒元素砷、铅、汞，并引入镉的新规范和微生物标准。ANS专家委员会在2017年确定的安全问题涉及潜在的神经发育影响。由于胆碱是神经递质乙酰胆碱的前体，专家委员会认为通过比较人乳和配方奶中胆碱的浓度来解决卵磷脂（E 322）作为16周龄以下婴儿使用的婴儿配方食品中的食品添加剂的安全性是合适的。专家委员会得出结论，在属于食品类别13.1.1的婴儿配方食品或属于食品类别13.1.5.1的特殊医学用途食品中，作为食品添加剂的卵磷脂（E 322）的摄入量在卵磷脂（E 322）的最大允许水平（MPL）以下不会引发安全问题。
