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, Smeraldi Camilla, Tard Alexandra, Vianello Giorgia, Rincon Ana Maria, Gundert-Remy Ursula
EFSA J. 2020 Jun 30;18(6):e06153. doi: 10.2903/j.efsa.2020.6153. eCollection 2020 Jun.
Ascorbyl palmitate (E 304(i)) was re-evaluated in 2015 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of ascorbyl palmitate (E 304(i)) for its uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. 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. On the basis of the data submitted by interested business operators and the considerations from the Panel, a revision of the existing EU specifications for ascorbyl palmitate (E 304 (i)) has been recommended. Based on in vitro data, the FAF Panel assumed that ascorbyl palmitate fully hydrolyses pre-systemically to ascorbic acid and palmitate. The Panel concluded that the intake of both metabolites, at the MPLs for ascorbyl palmitate 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 health concerns.
抗坏血酸棕榈酸酯（E 304(i)）于2015年由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）重新评估。作为此次评估的后续行动，要求食品添加剂和香料专家委员会（FAF）评估抗坏血酸棕榈酸酯（E 304(i)）作为食品添加剂在16周龄以下婴儿食品中的安全性，这些食品属于食品类别13.1.1（婴儿配方食品）和13.1.5.1（特殊医学用途婴儿膳食食品和婴儿特殊配方食品），并按照欧盟法规（EC）No 1333/2008附件III第5部分B节的规定进行带入。此外，要求FAF专家委员会解决在对该食品添加剂用于一般人群食品的重新评估过程中已经确定的问题。该过程包括发布数据征集通知，以使感兴趣的企业经营者能够提供所需信息以完成风险评估。根据感兴趣的企业经营者提交的数据以及专家委员会的考虑，建议修订欧盟现有的抗坏血酸棕榈酸酯（E 304 (i)）规范。基于体外数据，FAF专家委员会假定抗坏血酸棕榈酸酯在系统前完全水解为抗坏血酸和棕榈酸。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，按照抗坏血酸棕榈酸酯作为食品添加剂的最大使用量摄入这两种代谢物，不会引起健康问题。
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