Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

EFSA Journal

Volumn 14, Issue 1, 2016, Pages

[No Author Info available]

Author keywords

applications; gastrointestinal tract; guidance; health claims; immune system; microorganisms; pathogens

Indexed keywords

EID: 85092679734     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2016.4369     Document Type: Article

References (63)

1. EFSA (European Food Safety Authority), 2008. Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on the scientific substantiation of a health claim related to LGG® MAX and reduction of gastro-intestinal discomfort. The EFSA Journal 2008, 853, 1–15. Available at http://www.efsa.europa.eu/en/efsajournal/pub/853
2. EFSA (European Food Safety Authority), 2009a. Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on the scientific substantiation of a health claim related to BimunoTM and reduction of the bad bacteria that can cause travellers' diarrhoea. The EFSA Journal 2009, 1105, 1–9. Available at http://www.efsa.europa.eu/en/efsajournal/pub/1105
3. EFSA (European Food Safety Authority), 2009b. Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on the scientific substantiation of a health claim on Ocean Spray Cranberry Products® and reduced risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract. The EFSA Journal 2009, 943, 1–15. Available at http://www.efsa.europa.eu/en/efsajournal/pub/943
4. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009a. Scientific Opinion on the substantiation of health claims related to vitamin A and cell differentiation (ID 14), function of the immune system (ID 14), maintenance of skin and mucous membranes (ID 15, 17), maintenance of vision (ID 16), maintenance of bone (ID 13, 17), maintenance of teeth (ID 13, 17), maintenance of hair (ID 17), maintenance of nails (ID 17), metabolism of iron (ID 206), and protection of DNA, proteins and lipids from oxidative damage (ID 209) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9): 1221, 25 pp. doi:10.2903/j.efsa.2009.1221 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1221
5. 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
6. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009c. Scientific Opinion on the substantiation of health claims related to selenium and protection of DNA, proteins and lipids from oxidative damage (ID 277, 283, 286, 1289, 1290, 1291, 1293, 1751), function of the immune system (ID 278), thyroid function (ID 279, 282, 286, 1289, 1290, 1291, 1293), function of the heart and blood vessels (ID 280), prostate function (ID 284), cognitive function (ID 285) and spermatogenesis (ID 396) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9): 1220, 24 pp. doi:10.2903/j.efsa.2009.1220 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1220
7. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009d. Scientific opinion on the substantiation of health claims related to vitamin B12 and red blood cell formation (ID 92, 101), cell division (ID 93), energy-yielding metabolism (ID 99, 190) and function of the immune system (ID 107) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009; 7(9): 1223, 16 pp. doi:10.2903/j.efsa.2009.1223 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1223
8. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009e. Scientific Opinion on the substantiation of health claims related to vitamin B6 and protein and glycogen metabolism (ID 65, 70, 71), function of the nervous system (ID 66), red blood cell formation (ID 67, 72, 186), function of the immune system (ID 68), regulation of hormonal activity (ID 69) and mental performance (ID 185) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009;7(9): 1225, 20 pp. doi:10.2903/j.efsa.2009.1225 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1225
9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009f. Scientific Opinion on the substantiation of health claims related to zinc and function of the immune system (ID 291, 1757), DNA synthesis and cell division (ID 292, 1759), protection of DNA, proteins and lipids from oxidative damage (ID 294, 1758), maintenance of bone (ID 295, 1756), cognitive function (ID 296), fertility and reproduction (ID 297, 300), reproductive development (ID 298), muscle function (ID 299), metabolism of fatty acids (ID 302), maintenance of joints (ID 305), function of the heart and blood vessels (ID 306), prostate function (ID 307), thyroid function (ID 308), acid-base metabolism (ID 360), vitamin A metabolism (ID 361) and maintenance of vision (ID 361) pursuant to Article 13 of Regulation (EC) No 1924/2006 on request from European Commission. EFSA Journal 2009;7(9): 1229, 34 pp. doi:10.2903/j.efsa.2009.1229 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1229
10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009g. Scientific Opinion on the substantiation of health claims related to copper and protection of DNA, proteins and lipids from oxidative damage (ID 263, 1726), function of the immune system (ID 264), maintenance of connective tissues (ID 265, 271, 1722), energy yielding metabolism (ID 266), function of the nervous system (ID 267), maintenance of skin and hair pigment (ID 268, 1724), iron transport (ID 269, 270, 1727), cholesterol metabolism (ID 369), and glucose metabolism (ID 369) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009;7(9): 1211, 21 pp. doi:10.2903/j.efsa.2009.1211 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1211
11. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009h. Scientific Opinion on the substantiation of health claims related to folate and blood formation (ID 79), homocysteine metabolism (ID 80), energy-yielding metabolism (ID 90), function of the immune system (ID 91), fustion of blood vessels (ID 94, 175, 192), cell division (ID 193), and maternal tissue growth during pregnancy (ID 2882) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commision. EFSA Journal 2009;7(9): 1213, 22 pp. doi:10.2903/j.efsa.2009.1213 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1213
12. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009i. Scientific Opinion on the substantiation of health claims related to iron and formation of red blood cells and haemoglobin (ID 249, ID 1589), oxygen transport (ID 250, ID 254, ID 256), energy-yielding metabolism (ID 251, ID 1589), function of the immune system (ID 252, ID 259), cognitive function (ID 253) and cell division (ID 368) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009;7(9): 1215, 20 pp. doi:10.2903/j.efsa.2009.1215 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1215
13. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009j. 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
14. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009k. 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
15. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2009l. Scientific Opinion on the substantiation of a health claim related to Uroval® and urinary tract infection. EFSA Journal 2009; 7(12): 1421, 8 pp. doi:10.2903/j.efsa.2009.1421 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1421
16. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010a. Scientific Opinion on the substantiation of a health claim related to fermented milk containing Lactobacillus casei DN-114 001 plus yoghurt symbiosis (Actimel®), and reduction of Clostridium difficile toxins in the gut of patients receiving antibiotics and reduced risk of acute diarrhoea in patients receiving antibiotics pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(12): 1903, 17 pp. doi:10.2903/j.efsa.2010.1903 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1903
17. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010b. 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
18. 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
19. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010d. Scientific Opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(2): 1468, 17 pp. doi:10.2903/j.efsa.2010.1468 Available at http://www.efsa.europa.eu/en/efsajournal/pub/1468
20. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010e. Scientific Opinion on the substantiation of a health claim related to Lactobacillus casei strain Shirota and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(10): 1860, 15 pp. doi:10.2903/j.efsa.2010.1860 Available at http://www.efsa.europa.eu/it/efsajournal/pub/1860
21. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2010f. 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
22. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011a. Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of defence against pathogenic gastrointestinal microorganisms pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6): 2167, 19 pp. doi:10.2903/j.efsa.2011.2167 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2167
23. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011b. Scientific Opinion on the substantiation of health claims related to proanthocyanidins from cranberry (Vaccinium macrocarpon Aiton) fruit and defence against bacterial pathogens in the lower urinary tract (ID 1841, 2153, 2770, 3328), “powerful protectors of our gums” (ID 1365), and “heart health” (ID 2499) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6): 2215, 18 pp. doi:10.2903/j.efsa.2011.2215 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2215
24. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011c. 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
25. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011d. 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
26. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011e. 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
27. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011f. Scientific Opinion on the substantiation of health claims related to Bifidobacterium longum BB536 and improvement of bowel regularity (ID 3004), normal resistance to cedar pollen allergens (ID 3006), and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 3005) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4): 2041, 18 pp. doi:10.2903/j.efsa.2011.2041 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2041
28. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011g. Scientific Opinion on the substantiation of a health claim related to ProteQuine® and increasing suppressed concentrations of secretory IgA and reducing the risk of influenza and common cold pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4): 2128, 10 pp. doi:10.2903/j.efsa.2011.2128 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2128
29. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011h. Scientific Opinion on the substantiation of a health claim related to ProteQuine® and bovine lactoferrin and increasing suppressed concentrations of secretory IgA and reducing the risk of common cold with sore throat pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4): 2129, 10 pp. doi:10.2903/j.efsa.2011.2129 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2129
30. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011i. Scientific Opinion on the substantiation of a health claim related to Bimuno® GOS and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(12): 2472, 13 pp. doi:10.2903/j.efsa.2011.2472 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2472
31. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011j. 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
32. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011k. 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
33. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011l. 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
34. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011m. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA Journal 2011;9(12): 2474, 13 pp. doi:10.2903/j.efsa.2011.2474 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2474
35. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011n. 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
36. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011o. 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
37. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011p. 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
38. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012a. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal 2012;10(3): 2604, 11 pp. doi:10.2903/j.efsa.2012.2604 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2604
39. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012b. Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract defence against pathogens (ID 931, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2012;10(6): 2718, 15 pp. doi:10.2903/j.efsa.2012.2718 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2718
40. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012c. 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. EFSA Journal 2012;10(6): 2712, 17 pp. doi:10.2903/j.efsa.2012.2712 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2712
41. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012d. Scientific Opinion on the substantiation of a health claim related to Saccharomyces cerevisiae var. boulardii CNCM I-3799 and reducing gastro-intestinal discomfort pursusant to Article 13(5) of Regulation (EC) no 1924/2006. EFSA Journal 2012;10(7): 2801, 9 pp. doi:10.2903/j.efsa.2012.2801 Available at http://www.efsa.europa.eu/en/efsajournal/pub/2801
42. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013a. Scientific Opinion on the substantiation of a health claim related to Yestimun® and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(4): 3159, 12 pp. doi:10.2903/j.efsa.2013.3159 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3159
43. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013b. Scientific Opinion on the substantiation of a health claim related to proanthocyanidins in Urell® and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(7): 3326, 10 pp. doi:10.2903/j.efsa.2013.3326 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3326
44. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013c. Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(10): 3412, 12 pp. doi:10.2903/j.efsa.2013.3412 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3412
45. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013d. Scientific Opinion on the substantiation of a health claim related to a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and reducing intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(2): 3085, 9 pp. doi:10.2903/j.efsa.2013.3085 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3085
46. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014a. Scientific Opinion on the substantiation of a health claim related to Bimuno® GOS and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006. 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
47. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014b. Scientific Opinion on the substantiation of a health claim related to beta-galactosidase from Streptococcus thermophilus and reduction of gastrointestinal discomfort pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(10): 3841, 8 pp. doi:10.2903/j.efsa.2014.3841 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3841
48. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014c. Scientific Opinion on the substantiation of a health claim related to Pacran® and defence against bacterial pathogens in the lower urinary tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(5): 3656, 11 pp. doi:10.2903/j.efsa.2014.3656 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3656
49. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014d. Scientific Opinion on the substantiation of a health claim related to a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and reducing intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(5): 3658, 10 pp. doi:10.2903/j.efsa.2013.3658 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3658
50. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014e. Scientific Opinion on the substantiation of a health claim related to CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(5): 3657, 11 pp. doi:10.2903/j.efsa.2014.3657 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3657
51. 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
52. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015b. Scientific Opinion on the substantiation of a health claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2015;13(1): 3951, 12 pp. doi:10.2903/j.efsa.2015.3951 Available at http://www.efsa.europa.eu/en/efsajournal/pub/3951
53. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015c. Scientific Opinion on the substantiation of a health claim related to β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 2015;13(7): 4187, 13 pp. doi:10.2903/j.efsa.2015.4187 Available at http://www.efsa.europa.eu/en/efsajournal/pub/4187
54. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015d. 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
55. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015e. Scientific Opinion on the substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2015;13(5): 4094, 9 pp. doi:10.2903/j.efsa.2015.4094 Available at http://www.efsa.europa.eu/en/efsajournal/pub/4094
56. 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 Available at http://www.efsa.europa.eu/en/efsajournal/pub/4367
57. Harber MJ and Asscher AW, 1985. Virulence of urinary pathogens. Kidney Int, 28, 717–721.
58. Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF and Taminiau J, 2006. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology, 130, 1519–1526.
59. Irvine EJ, Whitehead WE, Chey WD, Matsueda K, Shaw M, Talley NJ and Veldhuyzen van Zanten SJ, 2006. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology, 130, 1538–1551.
60. Ronald A, 2003. The etiology of urinary tract infection: traditional and emerging pathogens. Dis Mon, 49, 71–82.
61. Shamir R, St James-Roberts I, Di Lorenzo C, Burns AJ, Thapar N, Indrio F, Riezzo G, Raimondi F, Di Mauro A, Francavilla R, Leuchter RH, Darque A, Huppi PS, Heine RG, Bellaiche M, Levy M, Jung C, Alvarez M and Hovish K, 2013. Infant crying, colic, and gastrointestinal discomfort in early childhood: a review of the evidence and most plausible mechanisms. J Pediatr Gastroenterol Nutr, 57 Suppl 1, S1–45.
62. 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
63. Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ and Zinsmeister AR, 1999. Design of treatment trials for functional gastrointestinal disorders. Gut, 45 Suppl 2, II69–77.