Clarifying the health claim assessment procedure of EFSA will benefit functional food innovation

Journal of Functional Foods

Volumn 47, Issue , 2018, Pages 386-396

  Lenssen, Karin G M ^a   Bast, Aalt ^a   de Boer, Alie ^a  

^a MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

European food law; Food innovation; Functional foods; Nutrition; Nutrition and health claims; Scientific substantiation

Indexed keywords

EID: 85048172361     PISSN: 17564646     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jff.2018.05.047     Document Type: Article

References (62)

1. Archibugi, D., Evangelista, R., Simonetti, R., Concentration, firm size and innovation: Evidence from innovation costs. Technovation 15:3 (1995), 153–163.
2. Avermaete, T., Viaene, J., Morgan, E., Determinants of innovation in small food firms. European Journal of Innovation Management 6:1 (2003), 8–17.
3. Baker, R.G., Hayden, M.S., Ghosh, S., NF-κB, inflammation, and metabolic disease. Cell Metabolism 13:1 (2011), 11–22.
4. Bast, A., Briggs, W., Calabrese, E., Scientism, legalism and precaution-contending with regulating nutrition and health claims in Europe. European Food & Feed Law Review 6 (2013), 401–409.
5. Bigliardi, B., Galati, F., Innovation trends in the food industry: The case of functional foods. Trends in Food Science & Technology 31:2 (2013), 118–129.
6. Binns, N., Howlett, J., Functional foods in Europe: International developments in science and health claims. European Journal of Nutrition 1 (2007), 3–13.
7. Brandenburger, S., Birringer, M., European health claims for small and medium-sized companies–Utopian dream or future reality?. Functional Foods in Health and Disease 5:2 (2015), 44–56.
8. Bremmers, H.J., van der Meulen, B.M.J., Purnhagen, K., Multi-stakeholder responses to the European Union health claims requirements. Journal on Chain and Network Science 13:2 (2013), 161–172.
9. Bröring, S., Khedkar, S., Ciliberti, S., Reviewing the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What do we know about its challenges and potential impact on innovation?. International Journal of Food Sciences and Nutrition 68 (2017), 1–9.
10. Carocho, M., Ferreira, I.C.F.R., A review on antioxidants, prooxidants and related controversy: Natural and synthetic compounds, screening and analysis methodologies and future perspectives. Food and Chemical Toxicology 51 (2013), 15–25.
11. Costa, A., Jongen, W., New insights into consumer-led food product development. Trends in Food Science & Technology 17:8 (2006), 457–465.
12. de Bock, M., Thorstensen, E.B., Derraik, J.G.B., Henderson, H.V., Hofman, P.L., Cutfield, W.S., Human absorption and metabolism of oleuropein and hydroxytyrosol ingested as olive (Olea europaea L.) leaf extract. Molecular Nutrition & Food Research 57:11 (2013), 2079–2085.
13. de Boer, A., Bast, A., Stakeholders’ perception of the nutrition and health claim regulation. International Journal of Food Sciences and Nutrition 66:3 (2015), 321–328.
14. de Boer, A., Urlings, M., Bast, A., Active ingredients leading in health claims on functional foods. Journal of Functional Foods 20 (2016), 587–593.
15. de Boer, A., Vos, E., Bast, A., Implementation of the nutrition and health claim regulation–The case of antioxidants. Regulatory Toxicology and Pharmacology 68:3 (2014), 475–487.
16. EFSA. (2011). Consolidated list of Article 13 health claims - List of references received by EFSA - Part 2 IDs 1001-2000, 1–856. Retrieved from: https://www.efsa.europa.eu/en/topics/topic/article13.
17. EFSA. (2017a). General function health claims under Article 13 | European Food Safety Authority. Retrieved October 11, 2017, from https://www.efsa.europa.eu/en/topics/topic/article13.
18. EFSA. (2017b). Register of Questions. Retrieved from http://registerofquestions.efsa.europa.eu/roqFrontend/login?0. Last accessed: October 11, 2017.
19. EFSA NDA Panel. (2007). Scientific Opinion - Scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim. EFSA Journal 530, 1–44.
20. EFSA NDA Panel. (2009a). Scientific opinion on the substantiation of health claims related to Justicia adhatoda L. and protection of DNA, proteins and lipids from oxidative damage (ID 2508) and function of the upper respiratory tract (ID 3970) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 7(9), 1294.
21. EFSA NDA Panel. (2009b). Scientific Opinion on the substantiation of health claims related to kaki fruit and maintenance of vision (ID 1261) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 7(9), 1275.
22. EFSA NDA Panel. (2010a). Scientific Opinion on the substantiation of health claims related to Camellia sinensis (L.) Kuntze (tea), including catechins in green tea and tannins in black tea, and protection of DNA, proteins and lipids from oxidative damage (ID 1103, 1276, 1311, 1708, 2664), reduction of acid production in dental plaque (ID 1105, 1111), maintenance of bone (ID 1109), decreasing potentially pathogenic intestinal microorganisms (ID 1116), maintenance of vision (ID 1280), maintenance of normal blood pressure (ID 1546) and maintenance of normal blood cholesterol concentrations (ID 1113, 1114) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(2), 1463.
23. EFSA NDA Panel. (2010b). Scientific Opinion on the substantiation of health claims related to cocoa flavanols and protection of lipids from oxidative damage (ID 652, 1372, 1506, 3143), and maintenance of normal blood pressure (ID 1507) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(10), 1792.
24. EFSA NDA Panel. (2010c). Scientific Opinion on the substantiation of health claims related to honey and “respiratory health through presence of antioxidant phytochemicals” (ID 1161), “the unique composition and ratio of effective substances adds energy to the human body” (ID 3188), and “it stimulates the whole metabolism and the immune system” (ID 3189) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(2), 1484.
25. EFSA NDA Panel. (2010d) Scientific Opinion on the substantiation of health claims related to rutin and improvement of endothelium-dependent vasodilation (ID 1649, 1783) and protection of DNA, proteins and lipids from oxidative damage (ID 1748) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(10), 1751.
26. EFSA NDA Panel. (2010e). Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and protection of cells from premature ageing (ID 1668, 1917, 2515, 2527, 2530, 2575, 2580, 2591, 2620, 3178, 3179, 3180, 3181, 4329, 4415), antioxidant activity, antioxidant content and antioxidant properties (ID 857, 1306, 2515, 2527, 2530, 2575, 2580, 2591, 2629, 2728, 4327, 4365, 4380, 4390, 4394, 4455, 4464, 4507, 4694, 4705), protection of DNA, proteins and lipids from oxidative damage (ID 1196, 1211, 1216, 1306, 1312, 1440, 1441, 1666, 1668, 1692, 1900, 1914, 1948, 2023, 2158, 2517, 2522, 2527, 2575, 2591, 2620, 2637, 2639, 2663, 2860, 3079, 3276, 3564, 3818, 4324, 4329, 4351, 4397, 4416, 4424, 4507, 4527, 4528, 4542, 4611, 4629, 4659) and bioavailability of anthocyanins in black currants (ID 4220) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(10), 1752.
27. EFSA NDA Panel. (2010f). Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and protection of cells from premature aging, antioxidant activity, antioxidant content and antioxidant properties, and protection of DNA, proteins and lipids from oxidative damage pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(2), 1489.
28. EFSA NDA Panel. (2010g). Scientific Opinion on the substantiation of health claims related to various food(s)/food constituents(s) and “immune function/immune system” (ID 433, 605, 645, 791, 1384, 1451, 1624, 1743, 1776, 1838, 1851, 1854, 1891, 1895, 3074, 3191, 3211, 3218, 3336, 3341, 3450, 3514, 3658, 3756, 3802, 3805, 3841, 3935, 3979), “contribution to body defences against external agents” (ID 2344, 3208, 3213, 3270, 3278, 3285, 3294, 3309, 3387, 3424, 3428, 3536, 3537, 3539, 3575, 3577, 3579, 3582, 3603, 3618, 3755, 3776, 3777, 3778, 3801, 3804, 3840, 4367, 4472), reduction of inflammation (ID 1327, 1391) and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 2362, 2730, 4064) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 8(10), 1799.
29. EFSA NDA Panel. (2011a). Scientific Opinion - General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal 9(4), 2135.
30. EFSA NDA Panel. (2011b). Scientific Opinion - Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA Journal 9(12), 2474.
31. EFSA NDA Panel. (2011c). Scientific Opinion - Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1). EFSA Journal 9(5), 2170.
32. EFSA NDA Panel. (2011d). 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), “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) seeds and seed extracts (ID 2029, 2365) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 9(6), 2243.
33. EFSA NDA Panel. (2012). Scientific Opinion - Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions. EFSA Journal 10(7), 2816.
34. EFSA NDA Panel. (2017). Scientific Opinion - Scientific and technical guidance for the preparation and presentation of a health claim application (revision 2). EFSA Journal 15(1), 4680.
35. Ercisli, S., Akbulut, M., Ozdemir, O., Sengul, M., Orhan, E., Phenolic and antioxidant diversity among persimmon (Diospyrus kaki L.) genotypes in Turkey. International Journal of Food Sciences and Nutrition 59:6 (2008), 477–482.
36. European Parliament and Council of the European Union. (2002). Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Union 31, 1–44.
37. European Parliament and the Council of the European Union. (2004). Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and vetrinary use and establishing a European Medicines Agency. Official Journal of the European Union 136, 1–70.
38. European Parliament and Council of the European Union (2006). Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the European Union 49, 9–25.
39. European Commission (2012). Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. Official Journal of the European Union L. 136, 1–55.
40. European Commission (2018). Proposal for a regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods]. 2018/0088 (COD). Brussels.
41. Flammer, A.J., Hermann, F., Sudano, I., Spieker, L., Hermann, M., Cooper, K.A., Corti, R., Dark chocolate improves coronary vasomotion and reduces platelet reactivity. Circulation 116:21 (2007), 2376–2382.
42. Gheldof, N., Xiao-Hong, Wang, A., & Engeseth, N. J. (2003). Buckwheat Honey Increases Serum Antioxidant Capacity in Humans. Journal of Agricultural and Food Chemistry 51(5), 1500–1505.
43. Hajjar, D.P., Gotto, A.M.J., Biological relevance of inflammation and oxidative stress in the pathogenesis of arterial diseases. The American Journal of Pathology 182:5 (2013), 1474–1481.
44. Kerckhoffs, D.A.J.M., Hornstra, G., Mensink, R.P., Cholesterol-lowering effect of beta-glucan from oat bran in mildly hypercholesterolemic subjects may decrease when beta-glucan is incorporated into bread and cookies. The American Journal of Clinical Nutrition 78:2 (2003), 221–227.
45. Khedkar, S., Bröring, S., Ciliberti, S., Exploring the nutrition and health claims regulation (EC) No. 1924/2006: What is the impact on innovation in the EU food sector?. International Journal of Food Sciences and Nutrition 68:1 (2017), 10–17.
46. Khedkar, S., Ciliberti, S., Bröring, S., The EU health claims regulation: Implications for innovation in the EU food sector. British Food Journal 118:11 (2016), 2647–2665.
47. Lucey, A., Heneghan, C., Kiely, M.E., Guidance for the design and implementation of human dietary intervention studies for health claim submissions. Nutrition Bulletin 41:4 (2016), 378–394.
48. Mathur, S., Devaraj, S., Grundy, S.M., Jialal, I., Cocoa products decrease low density lipoprotein oxidative susceptibility but do not affect biomarkers of inflammation in humans. The Journal of Nutrition 132:12 (2002), 3663–3667.
49. McClements, D.J., Enhancing nutraceutical bioavailability through food matrix design. Current Opinion in Food Science 4 (2015), 1–6.
50. Menrad, K., Market and marketing of functional food in Europe. Journal of Food Engineering 56:2–3 (2003), 181–188.
51. Moors, E., Functional foods: Regulation and innovations in the EU. Innovation: The European Journal of Social Science 25:4 (2012), 424–440.
52. Murphy, K.J., Chronopoulos, A.K., Singh, I., Francis, M.A., Moriarty, H., Pike, M.J., Sinclair, A.J., Dietary flavanols and procyanidin oligomers from cocoa (Theobroma cacao) inhibit platelet function. The American Journal of Clinical Nutrition 77:6 (2003), 1466–1473.
53. Mursu, J., Voutilainen, S., Nurmi, T., Rissanen, T.H., Virtanen, J.K., Kaikkonen, J., Salonen, J.T., Dark chocolate consumption increases HDL cholesterol concentration and chocolate fatty acids may inhibit lipid peroxidation in healthy humans. Free Radical Biology and Medicine 37:9 (2004), 1351–1359.
54. Regnstrom, J., Koenig, F., Aronsson, B., Reimer, T., Svendsen, K., Tsigkos, S.,.. Vamvakas, S. (2010). Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. European Journal of Clinical Pharmacology 66(1), 39–48.
55. Richardson, D.P., Eggersdorfer, M., Opportunities for product innovation using authorised European Union health claims. International Journal of Food Science & Technology 50:1 (2015), 3–12.
56. Roberfroid, M., Concepts and strategy of functional food science: The European perspective. The American Journal of Clinical Nutrition 71:6 (2000), 1660s–1664s.
57. Siró I., Kápolna, E., Kápolna, B., Lugasi, A., Functional food. Product development, marketing and consumer acceptance—A review. Appetite 51 (2008), 456–467.
58. Smith, A., Terry, S., Detken, D., 10 Years of the European Food Safety Authority (EFSA) and the EU food safety system. European Food & Feed Law Review 3 (2012), 111–116.
59. Todt, O., Luján, J., The role of epistemic policies in regulatory science: Scientific substantiation of health claims in the European Union. Journal of Risk Research 20:4 (2017), 551–565.
60. Verhagen, H., van Loveren, H., Status of nutrition and health claims in Europe by mid 2015. Trends in Food Science & Technology 56 (2016), 39–45.
61. Wang, J.F., Schramm, D.D., Holt, R.R., Ensunsa, J.L., Fraga, C.G., Schmitz, H.H., Keen, C.L., A dose-response effect from chocolate consumption on plasma epicatechin and oxidative damage. The Journal of Nutrition 130:8S Suppl (2000), 2115S–2119S.
62. Wiswedel, I., Hirsch, D., Kropf, S., Gruening, M., Pfister, E., Schewe, T., Sies, H., Flavanol-rich cocoa drink lowers plasma F2-isoprostane concentrations in humans. Free Radical Biology and Medicine 37:3 (2004), 411–421.