Safety of the proposed extension of use of synthetic β‐carotene [E 160a(ii)] in foods for special medical purposes in young children
2016; Wiley; Volume: 14; Issue: 3 Linguagem: Inglês
10.2903/j.efsa.2016.4434
ISSN1831-4732
Tópico(s)Dye analysis and toxicity
ResumoEFSA JournalVolume 14, Issue 3 4434 OpinionOpen Access Safety of the proposed extension of use of synthetic β-carotene [E 160a(ii)] in foods for special medical purposes in young children EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author First published: 18 March 2016 https://doi.org/10.2903/j.efsa.2016.4434 Panel members: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Correspondence: [email protected] Acknowledgement: The Panel wishes to thank the members of the Working Group on Applications for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo and Camilla Smeraldi for the support provided to this scientific output. Adoption date: 9 March 2016 Published date: 18 March 2016 Correction date: 13 April 2016 Question number: EFSA-Q-2015-00136 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of the extension of use of the food colour synthetic β-carotene [E 160a(ii)] when added to dietary food for special medical purposes (FSMP) intended for young children aged 1–3 years. Currently, the use of colours in foodstuffs is prohibited in any food for infants and young children, including FSMPs. According to the applicant, the use of food colours is required to ensure appealing and palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The exposure scenarios, based on the use level proposed by the applicant, indicated that the total daily protein requirement (up to 3 g protein/kg bw) could be covered by the products containing synthetic β-carotene [E 160a(ii)] at the level of 5 mg/L in the final diluted product as consumed, without exceeding the amount of β-carotene likely to be ingested from the regular diet as estimated for the same age group (i.e. 0.5–2.9 mg/day). Also, exposure in other scenarios based on different assumptions was always within the range of the typical dietary intake of β-carotene. The ANS Panel concluded that the proposed extension of use of synthetic β-carotene [E 160a(ii)] at the proposed level of 5 mg/L in the final diluted FSMP in young children aged 1–3 years would not be of safety concern. References GFSA, Codex STAN 192–1995 (Codex General Standard for Food Additives), online. Available at: http://www.fao.org/gsfaonline/index.html EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessment carried out by EFSA. Part 2: general principles. EFSA Journal 2009; 7(5): 1051, 22 pp. doi:10.2903/j.efsa.2006.395 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2012a. Scientific Opinion on the re-evaluation of Mixed Carotenes (E 160a (i)) and beta-Carotene (E 160a (ii)) as a food additive. EFSA Journal 2012; 10(3): 2593. 67 pp. doi:10.2903/j.efsa.2012.2593 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2012b. Guidance for submission for food additive evaluations. EFSA Journal 2012; 10(7): 2760. 60 pp. doi:10.2903/j.efsa.2012.2760 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012. Scientific Opinion on Dietary Reference Values for protein. EFSA Journal 2012; 10(2): 2557, 66 pp. doi:10.2903/j.efsa.2012.2557 FSANZ (Food Standards Australia and New Zealand), online. Available online: http://www.foodstandards.gov.au/code/Pages/default.aspx JECFA (Joint FAO/WHO Expert Committee on Food Additives), 1989. Evaluation of certain food additives. Fifty-first Report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Technical Report Series No 891, 35– 37. JECFA (Joint FAO/WHO Expert Committee on Food Additives), 1991. Toxicological evaluation of certain food additives and contaminants. 37th meeting, World Health Organization, Food Additive Series, No 28. WHO, Geneva. SCF (Scientific Committee on Food), 1989. Reports of the Scientific Committee for Food on Sweeteners. 21st series. Opinion expressed 11 December 1987 and 10 November 1988, and adopted 10 November 1988. SCF (Scientific Committee on Food), 1989. SCF (Scientific Committee on Food), 1997. Opinion on Colours in Foods for Special Medical Purposes for Young Children (expressed on 13 December 1996). UK Department of Health, 1991. Dietary Reference Values for Food Energy and Nutrients for the United Kingdom no. 41. London, HMSO. Volume14, Issue3March 20164434 This article also appears in:Foods for infants and young children ReferencesRelatedInformation
Referência(s)