Opinion on the re-evaluation of ascorbyl palmitate (E 304i) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups.
Ascorbyl palmitate
E 304(i)
food additive
infants
Journal
EFSA journal. European Food Safety Authority
ISSN: 1831-4732
Titre abrégé: EFSA J
Pays: United States
ID NLM: 101642076
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
entrez:
3
9
2020
pubmed:
3
9
2020
medline:
3
9
2020
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 32874329
doi: 10.2903/j.efsa.2020.6153
pii: EFS26153
pmc: PMC7448004
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e06153Informations de copyright
© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Références
Nephrol Dial Transplant. 2014 Jan;29(1):128-36
pubmed: 23229929
FAO Nutr Meet Rep Ser. 1974;(53A):1-520
pubmed: 4459150
EFSA J. 2017 Jan 26;15(1):e04662
pubmed: 32625258
EFSA J. 2017 May 05;15(5):e04785
pubmed: 32625490
World Health Organ Tech Rep Ser. 2000;896:1-128
pubmed: 11286008
Clin Pediatr (Phila). 2013 Oct;52(10):910-7
pubmed: 23820000
Toxicology. 2015 Apr 1;330:55-61
pubmed: 25724353
Clin Pediatr (Phila). 2014 Dec;53(14):1375-82
pubmed: 25009115
J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830
pubmed: 29216020
Clin Nutr. 2014 Aug;33(4):588-95
pubmed: 24411489
EFSA J. 2017 May 31;15(5):e04849
pubmed: 32625502
Science. 1951 Jun 1;113(2944):628-31
pubmed: 14845692
Ann Nutr Metab. 2016;69 Suppl 2:28-40
pubmed: 28103608
Proc Soc Exp Biol Med. 1946 Feb;61:195-8
pubmed: 21017617
Int J Vitam Nutr Res Suppl. 1982;23:221-38
pubmed: 6811482
Pediatr Res. 1997 Jan;41(1):1-10
pubmed: 8979282
Breast. 2003 Apr;12(2):128-35
pubmed: 14659342
Clin Pediatr (Phila). 2014 Jun;53(6):585-92
pubmed: 24662422
Ergonomics. 2007 Jun;50(6):920-60
pubmed: 17457750
EFSA J. 2020 Aug 13;18(8):e05874
pubmed: 32817762
Nutr Metab (Lond). 2011 Jun 08;8(1):33
pubmed: 21651771
Adv Pharm Bull. 2018 Jun;8(2):341-346
pubmed: 30023336