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

Abstract

EFSA Supporting PublicationsVolume 13, Issue 1 986E Technical reportOpen Access 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 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-986Citations: 2 Published date: 18 January 2016 Question number: EFSA-Q-2015-00402 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 References EFSA (European Food Safety Authority), 2008. Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from Unilever PLC/NV on Plant Sterols and lower/reduced blood cholesterol, reduced the risk of (coronary) heart disease. The EFSA Journal 2008, 781, 1– 12. Available at http://www.efsa.europa.eu/en/efsajournal/pub/781 EFSA (European Food Safety Authority), 2009. Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on the scientific substantiation of a health claim related to water-soluble tomato concentrate (WSTC I and II) and platelet aggregation. The EFSA Journal 2009, 1101, 1– 15. Available at http://www.efsa.europa.eu/it/efsajournal/pub/1101 EFSA (European Food Safety Authority), 2015a. Tools for critically appraising different study designs, systematic review and literature searches. EFSA Supporting Publication 2015: EN-836. 65 pp. Available at http://www.efsa.europa.eu/en/supporting/pub/836e EFSA (European Food Safety Authority), 2015b. EFSA's Catalogue of support initiatives during the lifecycle of applications for regulated products. EFSA Supporting Publication 2015: EN-777. 26 pp. Available at http://www.efsa.europa.eu/en/supporting/pub/777e EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009a. Scientific Opinion on the substantiation of health claims related to beta-glucans and maintenance of normal blood cholesterol concentrations (ID 754, 755, 757, 801, 1465, 2934) and maintenance or achievement of a normal body weight (ID 820, 823) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9):1254, 18 pp. doi:10.2903/j.efsa.2009.1254 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1254 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009b. Briefing document for Member States and European Commission on the evaluation of Article 13.1 health claims on request of EFSA. EFSA Journal 2009; 7(11):1386, 10 pp. doi:10.2903/j.efsa.2009.1386 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1386 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010a. Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(12):1885, 15 pp. doi:10.2903/j.efsa.2010.1885 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1885 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010b. Scientific Opinion on the substantiation of a health claim related to soy protein and reduction of blood cholesterol concentrations pursuant to Article 14 of the Regulation (EC) No 1924/2006. EFSA Journal 2010; 8(7):1688, 14 pp. doi:10.2903/j.efsa.2010.1688 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1688 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011a. General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal 2011; 9(4):2135, 24 pp. doi:10.2903/j.efsa.2011.2135 Available at http://www.efsa.europa.eu/en/ efsajournal/pub/2135 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011b. Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1). EfSa Journal 2011; 9(5):2170, 36 pp. doi:10.2903/j.efsa.2011.2170 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2170 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011c. Scientific Opinion on the substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations (ID 1648, 1700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(7):2304, 16 pp. doi:10.2903/j.efsa.2011.2304 Available at http://www.efsa.europa.eu/it/efsajournal/pub/2304 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012a. Scientific Opinion on the substantiation of a health claim related to isolated soy protein and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2012; 10(2):2555, 17 pp. doi:10.2903/j.efsa.2012.2555 Available at http://www.efsa.europa.eu/it/efsajournal/pub/2555 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012b. Scientific Opinion on the substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2012; 10(7):2809, 21 pp. doi:10.2903/j.efsa.2012.2809 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2809 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products. EFSA Journal 2014; 12(1):3553, 37 pp. doi:10.2903/j.efsa.2014.3553 Available at http://www.efsa.europa.eu/it/efsajournal/pub/3553 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. 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), 2016. General scientific guidance for stakeholders on health claim applications. EFSA Journal 2016; 14(1): 4367, 38 pp. doi:10.2903/j.efsa.2016.4367 Russo M, Martinelli M, Sciorio E, Botta C, Miele E, Vallone G, Staiano A, 2013. Stool consistency, but not frequency, correlates with total gastrointestinal transit time in children. J Pediatr, 162, 1188– 1192. Saad RJ, Rao SS, Koch KL, Kuo B, Parkman HP, McCallum RW, Sitrin MD, Wilding GE, Semler JR, Chey WD, 2010. Do stool form and frequency correlate with whole-gut and colonic transit? Results from a multicenter study in constipated individuals and healthy controls. Am J Gastroenterol, 105, 403– 411. Standing Committee on the Food Chain and Animal Health, 2007. Guidance on the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods - Conclusions of the Standing Committee on the Food Chain and Animal Health, 14 December 2007. Available at http://ec.europa.eu/food/safety/docs/labelling_nutrition_claim_reg-2006-124_guidance_en.pdf Citing Literature Volume13, Issue1January 2016986E ReferencesRelatedInformation