Outcome of a public consultation on the draft guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

Abstract

EFSA Supporting PublicationsVolume 13, Issue 1 985E Technical reportOpen Access Outcome of a public consultation on the draft guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 18 January 2016 https://doi.org/10.2903/sp.efsa.2016.EN-985 Published date: 18 January 2016 Question number: EFSA-Q-2015-00017 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 Share a linkShare onFacebookTwitterLinkedInRedditWechat References Albers R, Bourdet-Sicard R, Braun D, Calder PC, Herz U, Lambert C, Lenoir-Wijnkoop I, Meheust A, Ouwehand A, Phothirath P, Sako T, Salminen S, Siemensma A, van Loveren H and Sack U, 2013. Monitoring immune modulation by nutrition in the general population: identifying and substantiating effects on human health. Br J Nutr, 110 Suppl 2, S1– 30. Calder PC, Ahluwalia N, Albers R, Bosco N, Bourdet-Sicard R, Haller D, Holgate ST, Jonsson LS, Latulippe ME, Marcos A, Moreines J, M'Rini C, Muller M, Pawelec G, van Neerven RJ, Watzl B and Zhao J, 2013. A consideration of biomarkers to be used for evaluation of inflammation in human nutritional studies. Br J Nutr, 109 Suppl 1, S1– 34. EFSA (European Food Safety Authority), 2016. Outcome of a public consultation of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the draft general scientific guidance for stakeholders on health claim applications. EFSA Supporting Publication 2016: EN-986. 98 pp. Available at http://www.efsa.europa.eu/en/supporting/pub/986e EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009a. Scientific Opinion on the substantiation of health claims related to vitamin D and maintenance of bone and teeth (ID 150, 151, 158), absorption and utilisation of calcium and phosphorus and maintenance of normal blood calcium concentrations (ID 152, 157), cell division (ID 153), and thyroid function (ID 156) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1227, 19 pp. doi:10.2903/j.efsa.2009.1227 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1227 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009b. Scientific Opinion on the substantiation of health claims related to vitamin C and protection of DNA, proteins and lipids from oxidative damage (ID 129, 138, 143, 148), antioxidant function of lutein (ID 146), maintenance of vision (ID 141, 142), collagen formation (ID 130, 131, 136, 137, 149), function of the nervous system (ID 133), function of the immune system (ID 134), function of the immune system during and after extreme physical exercise (ID 144), non-haem iron absorption (ID 132, 147), energyyielding metabolism (ID 135), and relief in case of irritation in the upper respiratory tract (ID 1714, 1715) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1226, 28 pp. doi:10.2903/j.efsa.2009.1226 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1226 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009c. Scientific Opinion on the substantiation of health claims related to lactase enzyme and breaking down lactose (ID 1697, 1818) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1236, 13 pp. doi:10.2903/j.efsa.2009.1236 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1236 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009d. Scientific Opinion on the substantiation of health claims related to glutamine and immune health (ID 733) and integrity of the intestinal lining and normal intestinal permeability (ID 1602) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1235, 14 pp. doi:10.2903/j.efsa.2009.1235 Available at http://www.efsa.europa.eu/ en/efsajournal/pub/1235 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010a. Scientific Opinion on the substantiation of health claims related to "wheat dextrin" and maintenance of normal blood pressure (ID 844, 1682), maintenance of normal (fasting) blood concentrations of triglycerides (ID 844, 1682), maintenance of normal blood cholesterol concentrations (ID 844, 1682), reduction of post-prandial glycaemic responses (ID 845, 3096), increase in magnesium and/or calcium retention (ID 846, 3097), short chain fatty acid (SCFA) production in the bowel (ID 1681), decreasing potentially pathogenic gastro-intestinal microorganisms (ID 843, 1681), and maintenance of normal bowel function (ID 843, 1680) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(10):1761, 23 pp. doi:10.2903/j.efsa.2010.1761 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1761 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010b. Scientific Opinion on the substantiation of health claims related to wheat bran fibre and increase in faecal bulk (ID 3066), reduction in intestinal transit time (ID 828, 839, 3067, 4699) and contribution to the maintenance or achievement of a normal body weight (ID 829) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(10):1817, 18 pp. doi:10.2903/j.efsa.2010.1817 Available at http://www.efsa.europa.eu/it/efsajournal/pub/1817 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010c. Scientific Opinion on the substantiation of health claims related to live yoghurt cultures and improved lactose digestion (ID 1143, 2976) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(10):1763, 18 pp. doi:10.2903/j.efsa.2010.1763. Available at http://www.efsa.europa.eu/en/efsajournal/pub/1763 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010d. Scientific Opinion on the substantiation of health claims related to lactulose and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 806) and reduction in intestinal transit time (ID 807) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(10):1806, 15 pp. doi:10.2903/j.efsa.2010.1806 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1806 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011a. Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011; 9(4):1984, 12 pp. doi:10.2903/j.efsa.2011.1984 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1984 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011b. Scientific Opinion on the substantiation of health claims related to rye fibre and changes in bowel function (ID 825), reduction of post-prandial glycaemic responses (ID 826) and maintenance of normal blood LDL-cholesterol concentrations (ID 827) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(6):2258, 18 pp. doi:10.2903/j.efsa.2011.2258 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2258 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011c. Scientific Opinion on the substantiation of health claims related to oat and barley grain fibre and increase in faecal bulk (ID 819, 822) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(6):2249, 13 pp. doi:10.2903/j.efsa.2011.2249 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2249 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011d. Scientific Opinion on the substantiation of claims on meat or fish and the improvement of non-haem iron absorption (ID 1223) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(4):2040, 14 pp. doi:10.2903/j.efsa.2011.2040 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2040 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011e. Scientific Opinion on the substantiation of health claims related to fats and "function of the cell membrane" (ID 622, 2900, 2911) and normal absorption of fat-soluble vitamins (ID 670, 2902) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(6):2220, 15 pp. doi:10.2903/j.efsa.2011.2220 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2220 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011f. Scientific Opinion on the substantiation of a health claim related to beta-palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(7):2289, 16 pp. doi:10.2903/j.efsa.2011.2289 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2289 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011g. Scientific Opinion on the substantiation of health claims related to activated charcoal and reduction of excessive intestinal gas accumulation (ID 1938) and reduction of bloating (ID 1938) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(4):2049, 15 pp. doi:10.2903/j.efsa.2011.2049 Available at http://www.efsa.europa.eu/it/efsajournal/pub/2049 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011h. Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus GR-1 (ATCC 55826) in combination with Lactobacillus reuteri RC-14 (ATCC 55845) and defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts (ID 945) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(6):2232, 15 pp. doi:10.2903/j.efsa.2011.2232 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2232 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012. Scientific Opinion on the substantiation of health claims related to dried plums of „prune" cultivars (Prunus domestica L.) and maintenance of normal bowel function (ID 1164, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. 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EFSA Journal 2014; 12(7):3756, 13 pp. doi:10.2903/j.efsa.2014.3756 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3756 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015a. Outcome of a public consultation on the discussion paper for the revision of the guidance on the scientific requirements for health claims related to gut and immune function. EFSA Supporting Publication 2015: EN-758. 117 pp. Available at http://www.efsa.europa.eu/en/supporting/pub/758e EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015b. Scientific opinion on lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2015; 13(10):4252, 12 pp. doi:10.2903/j.efsa.2015.4252 Available at http://www.efsa.europa.eu/en/efsajournal/pub/4252 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015c. 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