General scientific guidance for stakeholders on health claim applications

EFSA Journal

Volumn 14, Issue 1, 2016, Pages

  Bresson, Jean Louis ^a   Burlingame, Barbara ^a   Dean, Tara ^a   Fairweather Tait, Susan ^a   Heinonen, Marina ^a   Hirsch Ernst, Karen Ildico ^a   Mangelsdorf, Inge ^a   McArdle, Harry ^a   Naska, Androniki ^a   Neuhäuser Berthold, Monika ^a   Nowicka, Grazyna ^a   Pentieva, Kristina ^a   Sanz, Yolanda ^a   Siani, Alfonso ^a   Sjödin, Anders ^a   Stern, Martin ^a   Tomé, Daniel ^a   Turck, Dominique ^a   Van Loveren, Hendrik ^a   Vinceti, Marco ^a   Willatts, Peter ^a   more..

^a NONE

Author keywords

applications; general principles; guidance; health claims; scientific aspects

Indexed keywords

EID: 85092678271     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2016.4367     Document Type: Article

References (29)

1. Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E and Stein RE, 2002. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res, 11, 193–205.
2. Chun J and Rainey FA, 2014. Integrating genomics into the taxonomy and systematics of the Bacteria and Archaea. Int J Syst Evol Microbiol, 64, 316–324.
3. 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
4. EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the evaluation of molecular typing methods for major food-borne microbiological hazards and their use for attribution modelling, outbreak investigation and scanning surveillance: Part 1 (evaluation of methods and applications). EFSA Journal 2013;11(12): 3502, 84 pp. doi:10.2903/j.efsa.2013.3502 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3502
5. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009a. 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
6. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009b. Scientific opinion on the substantiation of health claims related to non-characterised microorganisms pursuant to Article 13 of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009;7(9): 1247, 64 pp. doi:10.2903/j.efsa.2009.1247 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1247
7. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010a. Scientific Opinion on the substantiation of health claims related to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA) and maintenance of normal cardiac function (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325), maintenance of normal blood glucose concentrations (ID 566), maintenance of normal blood pressure (ID 506, 516, 703, 1317, 1324), maintenance of normal blood HDL-cholesterol concentrations (ID 506), maintenance of normal (fasting) blood concentrations of triglycerides (ID 506, 527, 538, 1317, 1324, 1325), maintenance of normal blood LDL-cholesterol concentrations (ID 527, 538, 1317, 1325, 4689), protection of the skin from photo-oxidative (UV-induced) damage (ID 530), improved absorption of EPA and DHA (ID 522, 523), contribution to the normal function of the immune system by decreasing the levels of eicosanoids, arachidonic acid-derived mediators and pro-inflammatory cytokines (ID 520, 2914), and “immunomodulating agent” (4690) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(10): 1796, 32 pp. doi:10.2903/j.efsa.2010.1796 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1796
8. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010b. Scientific Opinion on the modification of the authorisation of a health claim related to water-soluble tomato concentrate and helps to maintain a healthy blood flow and benefits circulation pursuant to Article 13(5) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of the Regulation (EC) No 1924/2006. EFSA Journal 2010;8(7): 1689, 9 pp. doi:10.2903/j.efsa.2010.1689 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1689
9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010c. Scientific Opinion on the substantiation of health claims related to non-characterised bacteria and yeasts pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(2): 1470, 44 pp. doi:10.2903/j.efsa.2010.1470 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1470
10. 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
11. 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
12. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011c. Scientific Opinion on the substantiation of health claims related to: dairy products (ID 1140, 1141, 1191), raw or processed food products of animal origin, plus bread and panification products (ID 1193, 1194), herbal yeast plasmolysate (ID 1815, 1816), apple polyphenols (ID 2713), rye flour (ID 1266), tomato juice (ID 1202), whey protein and alphalactalbumin (ID 424, 430, 432, 725, 1433) and “brocco shoots”, “broccoli sprout powder” and “Brassica oleracea var. italica (broccoli)” (ID 1362, 1481, 2844, 2845), honey (ID 1159, 1160, 1318, 4678, 4679), and Cucurbita pepo L. (pumpkin) seed and seed extracts (ID 2029, 2365) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6): 2243, 33 pp. doi:10.2903/j.efsa.2011.2243 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2243
13. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011d. Scientific Opinion on the substantiation of health claims related to arabinoxylan produced from wheat endosperm and reduction of post-prandial glycaemic responses (ID 830) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6): 2205, 15 pp. doi:10.2903/j.efsa.2011.2205 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2205
14. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011e. Scientific Opinion on the substantiation of health claims related to caffeine and increase in physical performance during short-term high-intensity exercise (ID 737, 1486, 1489), increase in endurance performance (ID 737, 1486), increase in endurance capacity (ID 1488) and reduction in the rated perceived exertion/effort during exercise (ID 1488, 1490) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4): 2053, 24 pp. doi:10.2903/j.efsa.2011.2053 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2053
15. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012a. Scientific Opinion on the substantiation of a health claim related to OXY 280 and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2012;10(12): 2999, 8 pp. doi:10.2903/j.efsa.2012.2999 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2999
16. 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
17. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(7): 3327, 16 pp. doi:10.2903/j.efsa.2013.3327 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3327
18. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014a. Guidance on Statistical Reporting. EFSA Journal 2014;12(12): 3908, 18 pp. doi:10.2903/j.efsa.2014.3908 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3908
19. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014b. Scientific Opinion on the substantiation of a health claim related to non-digestible carbohydrates and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(1): 3513, 13 pp. doi:10.2903/j.efsa.2014.3513 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3513
20. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014c. Scientific Opinion on the substantiation of a health claim related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(7): 3754, 14 pp. doi:10.2903/j.efsa.2014.3754 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3754
21. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014d. Scientific Opinion on the modification of the authorisation of a health claim related to cocoa flavanols and maintenance of a normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(5): 3654, 13 pp. doi:10.2903/j.efsa.2014.3654 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3654
22. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014e. Scientific Opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL-cholesterol; high blood LDL-cholesterol is a risk factor in the development of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006, following a request in accordance with Article 19 of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(2): 3577, 14 pp. doi:10.2903/j.efsa.2014.3577 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3577
23. 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
24. EFSA Scientific Committee, 2009. Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA. EFSA Journal 2009; 7(9): 1249, 19 pp. doi:10.2093/j.efsa.2009.1249 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1249
25. FDA (Food and Drug Administration Center for Drug Evaluation and Research (CDER)), 2009. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available online: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf
26. Goris J, Konstantinidis KT, Klappenbach JA, Coenye T, Vandamme P and Tiedje JM, 2007. DNA-DNA hybridization values and their relationship to whole-genome sequence similarities. Int J Syst Evol Microbiol, 57, 81–91.
27. Kim M, Oh HS, Park SC and Chun J, 2014. Towards a taxonomic coherence between average nucleotide identity and 16S rRNA gene sequence similarity for species demarcation of prokaryotes. Int J Syst Evol Microbiol, 64, 346–351.
28. 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
29. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM and de Vet HC, 2007. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol, 60, 34–42.