Comparison of requirements for using health claims on foods in the European Union, the USA, Canada, and Australia/New Zealand.

Publisher: Institute of Food Technologists Country of Publication: United States NLM ID: 101305205 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1541-4337 (Electronic) Linking ISSN: 15414337 NLM ISO Abbreviation: Compr Rev Food Sci Food Saf Subsets: MEDLINE

Original Publication: Chicago, Ill. : Institute of Food Technologists

Food Labeling*; Australia/epidemiology ; Canada ; European Union ; New Zealand/epidemiology

Nutrition is recognized as one of the leading factors influencing the growing incidence of noncommunicable diseases. Despite society experiencing a global rise in obesity, specific populations remain at risk of nutrient deficiencies. The food industry can use health claims to inform consumers about the health benefits of foods through labeling and the broader promotion of specific food products. As health claims are carefully regulated in many countries, their use is limited due to considerable investments required to fulfill the regulatory requirement. Although health claims represent a driving force for innovation in the food industry, the risk of misleading of consumers need to be avoided. The health claim scientific substantiation process must be efficient and transparent in order to meet the needs of companies in the global market, but should be based on strong scientific evidence and plausible mechanisms of actions, to ensure highest level of consumer protection. The objective of this review is to compare the possibilities for using health claims on foods in the European Union, the USA, Canada, and Australia and New Zealand. In particular, we focused on differences in the classification of claims, on the scientific substantiation processes and requirements for health claims use on foods in the selected regions. Reduction of disease risk (RDR) claims are associated with relatively similar procedures and conditions for use, whereas several notable differences were identified for other types of claims. In all cases, RDR claims must be approved prior their introduction to the market, and only a few such claims have been authorized. Much greater differences were observed concerning other types of claims.
(© 2021 The Authors. Comprehensive Reviews in Food Science and Food Safety published by Wiley Periodicals LLC on behalf of Institute of Food Technologists.)

Aggett, P., Hathcock, J., Jukes, D., Richardson, D., Calder, P., Bischoff-Ferrari, H., …. Prock, P. (2012). Nutrition issues in Codex: Health claims, nutrient reference values and WTO agreements: A conference report. European Journal of Nutrition, 51(1), 1-7. https://doi.org/10.1007/s00394-012-0306-8.
Aggett, P. J. (2009). The process for the assessment of scientific support for claims on food. European Journal of Nutrition, 48, S23-S26. https://doi.org/10.1007/s00394-009-0072-4.
Aggett, P. J., Antoine, J. M., Asp, N. G., Bellisle, F., Contor, L., Cummings, J. H., …. Verhagen, H. (2005). PASSCLAIM - Consensus on criteria. European Journal of Nutrition, 44, 5-30.
Al-Ani, H. H., Devi, A., Eyles, H., Swinburn, B., & Vandevijvere, S. (2016). Nutrition and health claims on healthy and less-healthy packaged food products in New Zealand. British Journal of Nutrition, 116(6), 1087-1094. https://doi.org/10.1017/s0007114516002981.
Baldwin, N., & Poon, T. (2014). General comparison of health claims with regards to food and supplement legislation frameworks in Europe, the United States, and Canada. International News on Fats, Oils and Related Materials, 25(6), 394-396. Retrieved from http://www.scopus.com/inward/record.url?eid=2-s2.0-84903214921&partnerID=40&md5=b81a44e1a69233463bf80651ea7bb1c1.
Benkhedda, K., Boudrault, C., Sinclair, S. E., Marles, R. J., Xiao, C. W., & Underhill, L. (2014). Health Canada's proposal to accept a health claim about soy products and cholesterol lowering. International Food Risk Analysis Journal, 4(22), 1-12. https://doi.org/10.5772/59675.
Brecher, S. J., Bender, M. M., Wilkening, V. L., McCabe, N. M., & Anderson, E. M. (2000). Status of nutrition labeling, health claims, and nutrient content claims for processed foods: 1997 Food Label and Package Survey. Journal of the American Dietetic Association, 100(9), 1057-1062. https://doi.org/10.1016/s0002-8223(00)00308-4.
Bröring, S., Khedkar, S., & Ciliberti, S. (2017). 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(1), 1-9. https://doi.org/10.1080/09637486.2016.1212816.
CA. (1985). Food and Drugs Act. Retrieved from http://www.wipo.int/edocs/lexdocs/laws/en/ca/ca015en.pdf.
CA. (2008). Natural Health Products Regulations. SOR/2003-196. Retrieved from http://laws-lois.justice.gc.ca/PDF/SOR-2003-196.pdf.
CA. (2009). Food and Drug Regulations. Consolidated Regulations of Canada, c. 870. Retrieved from http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._870.pdf.
CA. (2016). Food and Drugs Act. Revised Statutes of Canada, c. F-27. Retrieved from http://laws.justice.gc.ca/PDF/F-27.pdf.
CAC. (2013). Guidelines for use of nutrition and health claims [CAC/GL 23-1997, rev. 2013). Retrieved from http://www.codexalimentarius.org/download/standards/351/CXG_023e.pdf.
Cappuccio, F. P., & Pravst, I. (2011). Health claims on foods: Promoting healthy food choices or high salt intake? British Journal of Nutrition, 106, 1770-1771. https://doi.org/10.1017/S0007114511002856.
CFIA. (2020a). Food labelling for industry: Function claims. Retrieved from https://www.inspection.gc.ca/food-label-requirements/labelling/industry/health-claims-on-food-labels/eng/1392834838383/1392834887794?chap=8#s13c8.
CFIA. (2020b). Food Labelling for Industry: General health claims. Retrieved from http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=11.
CFIA. (2020c). Food labelling for industry: Health claims. Retrieved from http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794.
CFIA. (2020d). Food labelling for industry: Nutrient function claims Retrieved from http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=8.
CFIA. (2020e). Food labelling for industry: Probiotic claims. Retrieved from http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=9.
CFIA. (2020f). Overview of the proposed regulatory changes for the food labelling modernization initiative. Retrieved from https://www.inspection.gc.ca/consultations-and-engagement/proposed-regulatory-changes/eng/1560907775533/1560907775762.
Colby, S. E., Johnson, L., Scheett, A., & Hoverson, B. (2010). Nutrition marketing on food labels. Journal of nutrition education and behavior, 42(2), 92-98. https://doi.org/10.1016/j.jneb.2008.11.002.
DC Circuit. (1999). Pearson vs. Shalala, 164 F.3d 650. Retrieved from https://casetext.com/case/pearson-v-shalala.
de Boer, A., & Bast, A. (2015a). International legislation on nutrition and health claims. Food Policy, 55, 61-70. https://doi.org/10.1016/j.foodpol.2015.06.002.
de Boer, A., & Bast, A. (2015b). Stakeholders' perception of the nutrition and health claim regulation. International Journal of Food Sciences and Nutrition, 66(3), 321-328. https://doi.org/10.3109/09637486.2014.986071.
de Boer, A., Urlings, M. J. E., & Bast, A. (2016). Active ingredients leading in health claims on functional foods. Journal of Functional Foods, 20, 587-593. https://doi.org/10.1016/j.jff.2015.11.025.
Devi, A., Eyles, H., Rayner, M., Ni Mhurchu, C., Swinburn, B., Lonsdale-Cooper, E., & Vandevijvere, S. (2014). Nutritional quality, labelling and promotion of breakfast cereals on the New Zealand market. Appetite, 81, 253-260. https://doi.org/10.1016/j.appet.2014.06.019.
EC. (2006). Regulation (EC) No 1924/2006 of the European Parliament and of the council on nutrition and health claims made on foods. Retrieved from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1924-20141213.
EC. (2007). Guidance on the implementation of Regulation No 1924/2006 on nutrition and health claims made on foods: Conclusions of the Standing committee on the food chain and animal health. Retrieved from https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition_claim_reg-2006-124_guidance_en.pdf.
EC. (2008). Commission Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2008R0353:20091221:EN:PDF.
EC. (2013a). Commission implementing decision 2013/63/EU adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006. Retrieved from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013D0063&from=EN.
EC. (2013b). Commission Regulation (EU) No 907/2013 setting the rules for applications concerning the use of generic descriptors (denominations). Retrieved from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013R0907&from=EN.
EC. (2015a). Commission decision of 19.5.2020 establishing the REFIT Platform Retrieved from https://ec.europa.eu/info/sites/info/files/commission-decision-establishing-refit-platform_may2015_en_1.pdf.
EC. (2015b). Regulation (EU) 2015/2283 of the European Parliament and the Council of 25 November 2015 on novel foods. Retrieved from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R2283.
EC. (2017). REFIT - Evaluation of the regulation on nutrition and health claims. Retrieved from https://ec.europa.eu/food/safety/labelling_nutrition/claims/refit_en .
EC. (2020a). EU Register of nutrition and health claims made on foods. Retrieved from http://ec.europa.eu/nuhclaims/ .
EC. (2020b). European Commission Executive summary of the evaluation of the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods. Retrieved from https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-claims_swd_2020-96_sum_en.pdf.
EC. (2020c). Health claims for which protection of proprietary data is granted. Retrieved from http://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=getListOfPropClaims.
EFSA. (2015). Tools for critically appraising different study designs, systematic review and literature searches. EFSA Supporting Publications, 12(7), 836E. https://doi.org/10.2903/sp.efsa.2015.EN-836.
EFSA. (2020a). EFSA applications helpdesk: Health claims application procedure. Retrieved from http://www.efsa.europa.eu/sites/default/files/applications/apdeskapplworkflownutrihealthclaims.pdf.
EFSA. (2020b). EFSA register of questions database. Retrieved from http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=ALL.
EFSA NDA Panel. (2008). The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the regulation (EC) No 1924/2006. The EFSA Journal, 644, 1-44. https://doi.org/10.2903/j.efsa.2008.644.
EFSA NDA Panel. (2012a). Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal, 10(3), 2604. https://doi.org/10.2903/j.efsa.2012.2604.
EFSA NDA Panel. (2012b). Guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. EFSA Journal, 10(5), 2702. https://doi.org/10.2903/j.efsa.2012.2702.
EFSA NDA Panel. (2012c). Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions. EFSA Journal, 10(7), 2816. https://doi.org/10.2903/j.efsa.2012.2816.
EFSA NDA Panel. (2015a). Biotin and contribution to normal energy-yielding metabolism: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 13(7), 4181. https://doi.org/10.2903/j.efsa.2015.4181.
EFSA NDA Panel. (2015b). Niacin and contribution to normal energy-yielding metabolism: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 13(7), 4180. https://doi.org/10.2903/j.efsa.2015.4180.
EFSA NDA Panel. (2015c). Vitamin C and contribution to the normal function of the immune system: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 13(11), 4298. https://doi.org/10.2903/j.efsa.2015.4298.
EFSA NDA Panel. (2015d). Vitamin D and contribution to the normal function of the immune system: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 13(7), 4182. https://doi.org/10.2903/j.efsa.2015.4182.
EFSA NDA Panel. (2016a). Calcium and contribution to the normal development of bones: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 14(10), 4587. https://doi.org/10.2903/j.efsa.2016.4587.
EFSA NDA Panel. (2016b). General scientific guidance for stakeholders on health claim applications EFSA Journal, 14(1), 4367. https://doi.org/10.2903/j.efsa.2016.4367.
EFSA NDA Panel. (2016c). Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. EFSA Journal, 14(1), 4369. https://doi.org/10.2903/j.efsa.2016.4369.
EFSA NDA Panel. (2016d). Iron and contribution to the normal function of the immune system: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 14(7), 4548. https://doi.org/10.2903/j.efsa.2016.4548.
EFSA NDA Panel. (2016e). Vitamin E and protection of DNA, proteins and lipids from oxidative damage: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 14(10), 4588. https://doi.org/10.2903/j.efsa.2016.4588.
EFSA NDA Panel. (2017a). Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2). EFSA Journal, 15(1), e04680. https://doi.org/10.2903/j.efsa.2017.4680.
EFSA NDA Panel. (2017b). Vitamin C and protection of DNA, proteins and lipids from oxidative damage: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 15(1), 4685. https://doi.org/10.2903/j.efsa.2017.4685.
EFSA NDA Panel. (2018a). Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA Journal, 16(1), e05136. https://doi.org/10.2903/j.efsa.2018.5136.
EFSA NDA Panel. (2018b). Guidance on the scientific requirements for health claims related to muscle function and physical performance. EFSA Journal, 16(10), e05434. https://doi.org/10.2903/j.efsa.2018.5434.
EU. (2012). Commission Regulation (EU) No 432/2012 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. Retrieved from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0432-20170822&qid=1598860651032.
FAO. (2006). Understanding the Codex Alimentarius. Rome: WHO/FAO.
FAO. (2020). Codex Alimentarius: About codex. Retrieved from http://www.fao.org/fao-who-codexalimentarius/about-codex/en/.
FSANZ. (2012). FSANZ review report P293: Nutrition, health and related claims. Retrieved from https://www.foodstandards.gov.au/code/proposals/pages/proposalp293nutritionhealthandrelatedclaims/p293reviewreport.aspx.
FSANZ. (2013a). Australia New Zealand Food Standards Code: Standard 1.1A.2: Transitional Standard - Health Claims. Food Standards Gazette, F2013C00095. Retrieved from http://www.comlaw.gov.au/Details/F2013C00095.
FSANZ. (2013b). Australia New Zealand Food Standards Code: Standard 1.2.7: Nutrition, Health and Related Claims Food Standards Gazette, F2014C01191. Retrieved from http://www.comlaw.gov.au/Details/F2014C01191.
FSANZ. (2013c). Health claims standard timeline. Retrieved from http://www.foodstandards.gov.au/consumer/labelling/nutrition/pages/healthclaimsstandard5081.aspx.
FSANZ. (2015a). Australia New Zealand Food Standards Code: Schedule 6 - Required elements of a systematic review. Food Standards Gazette, F2015L00476. Retrieved from https://www.legislation.gov.au/Details/F2015L00476.
FSANZ. (2015b). Australia New Zealand Food Standards Code: Standard 1.2.7: Nutrition, health and related claims (in effect from 1 March 2016). Food Standards Gazette, F2015L00394. Retrieved from https://www.legislation.gov.au/Series/F2015L00394.
FSANZ. (2015c). FSANZ high level health claims committee. Retrieved from http://www.foodstandards.gov.au/science/expertise/Pages/High-Level-Health-Claims-Committee.aspx.
FSANZ. (2016). Review of health claims authorised in the European Union (EU) and existing high level health claims in Standard 1.2.7 Retrieved from http://www.foodstandards.gov.au/industry/labelling/Pages/healthclaimsapprovedintheEuropeanUnion.aspx.
FSANZ. (2017a). Australia New Zealand Food Standards Code: Schedule 4 - Nutrition, health and related claims. Food Standards Gazette, F2017C00317. Retrieved from https://www.legislation.gov.au/Details/F2017C00317.
FSANZ. (2017b). Australia New Zealand Food Standards Code: Schedule 5 - Nutrient profiling scoring method. Food Standards Gazette, F2017C00318. Retrieved from https://www.legislation.gov.au/Details/F2017C00318.
FSANZ. (2017c). Australia New Zealand Food Standards Code: Standard 1.2.7: Nutrition, Health and Related Claims (last revision). Food Standards Gazette, F2017C00310. Retrieved from https://www.legislation.gov.au/Details/F2017C00310.
FSANZ. (2017d). Australia New Zealand Food Standards Code: Standard 2.9.3 Formulated meal replacements and formulated supplementary foods. Food Standards Gazette, F2017C00314. Retrieved from https://www.legislation.gov.au/Details/F2017C00314.
FSANZ. (2017e). FSANZ outcomes from consideration of European Union-authorised health claims. Retrieved from https://www.foodstandards.gov.au/industry/labelling/Pages/Outcomes-from-consideration-of-European-Union-authorised-health-claims.aspx.
FSANZ. (2019). FSANZ application handbook. Retrieved from https://www.foodstandards.gov.au/code/changes/Documents/FSANZ%20Application%20Handbook%201%20July%202019.pdf.
FSANZ. (2020a). FSANZ food standards work plan. Retrieved from http://www.foodstandards.gov.au/code/changes/workplan/pages/default.aspx.
FSANZ. (2020b). FSANZ information on establishing food-health relationships for general level health claims. Retrieved from http://www.foodstandards.gov.au/publications/Documents/Information%20on%20establishing%20food%20health%20relationships.pdf.
FSANZ. (2020c). FSANZ notified food-health relationships. Retrieved from http://www.foodstandards.gov.au/industry/labelling/fhr/Pages/default.aspx.
FSANZ. (2020d). Notifying a self-substantiated food-health relationship. Retrieved from http://www.foodstandards.gov.au/industry/labelling/fhr/Pages/notifications.aspx.
Greene, H. L., Prior, T., & Frier, H. I. (2001). Foods, health claims, and the law: Comparisons of the United States and Europe. Obesity Research, 9(Suppl 4), 276S-283S. Retrieved from http://www.scopus.com/inward/record.url?eid=2-s2.0-0035514602&partnerID=40&md5=7b8ca91938197746852f3b50929188ce.
Grossklaus, R. (2009). Codex recommendations on the scientific basis of health claims. European Journal of Nutrition, 48(1), 15-22. https://doi.org/10.1007/s00394-009-0077-z.
Hasler, C. M. (2008). Health claims in the United States: An aid to the public or a source of confusion? Journal of Nutrition, 138(6), 1216S-1220S.
HC. (2009). Guidance document for preparing a submission for food health claims. Retrieved from http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/health-claims_guidance-orientation_allegations-sante-eng.pdf.
HC. (2010). Classification of products at the food-natural health product interface: Products in food formats - Version 2.0. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodnatur/food-nhp-aliments-psn-guide-eng.pdf.
HC. (2011). Guidance document for preparing a submission for food health claims using an existing systematic review. Retrieved from http://www.hc-sc.gc.ca/fn-an/alt_formats/pdf/legislation/guide-ld/systemat-revi-sub-eng.pdf.
HC. (2020a). Food and nutrition: Health claims. Retrieved from http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/index-eng.php.
HC. (2020b). Health claim assessments: Substantiation of health claims (scientific evidence). Retrieved from http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/index-eng.php.
HC. (2020c). Natural and non-prescription health products. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php.
Hieke, S., Kuljanic, N., Pravst, I., Miklavec, K., Kaur, A., Brown, K. A., …. Rayner, M. (2016). Prevalence of nutrition and health-related claims on pre-packaged foods: A five-country study in Europe. Nutrients, 8(3), 1-16. https://doi.org/10.3390/nu8030137.
Hieke, S., Kuljanic, N., Wills, J. M., Pravst, I., Kaur, A., Raats, M. M., …. Grunert, K. G. (2015). The role of health-related claims and health-related symbols in consumer behaviour: Design and conceptual framework of the CLYMBOL project and initial results. Nutrition Bulletin, 40(1), 66-72. https://doi.org/10.1111/nbu.12128.
Hoffmann, D., & Schwartz, J. (2016). Stopping deceptive health claims: The need for a private right of action under federal law. American Journal of Law and Medicine, 42(1), 53-84. https://doi.org/10.1177/0098858816644715.
Hughes, C., Wellard, L., Lin, J., Suen, K. L., & Chapman, K. (2013). Regulating health claims on food labels using nutrient profiling: What will the proposed standard mean in the Australian supermarket? Public Health Nutrition, 16(12), 2154-2161. https://doi.org/10.1017/s136898001200540x.
ISFR. (2018). Getting your claims right - A guide to complying with the nutrition, health and related claims standard of the Australia New Zealand food standards code. Retrieved from http://foodregulation.gov.au/internet/fr/publishing.nsf/Content/31BDC68CEC4A1964CA25801B00166C1F/$File/Getting-Your-Claims-Right-2018.pdf.
Kaur, A., Scarborough, P., Hieke, S., Kusar, A., Pravst, I., Raats, M., & Rayner, M. (2016a). The nutritional quality of foods carrying health-related claims in Germany, The Netherlands, Spain, Slovenia and the United Kingdom. European Journal of Clinical Nutrition, 70(12), 1388-1395. https://doi.org/10.1038/ejcn.2016.114.
Kaur, A., Scarborough, P., Matthews, A., Payne, S., Mizdrak, A., & Rayner, M. (2016b). How many foods in the UK carry health and nutrition claims, and are they healthier than those that do not? Public Health Nutrition, 19(S6), 988-997. https://doi.org/10.1017/S1368980015002104.
Khedkar, S., Broring, S., & Ciliberti, S. (2017). 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), 10-17. https://doi.org/10.1080/09637486.2016.1212818.
Khedkar, S., Ciliberti, S., & Bröring, S. (2016). The EU health claims regulation: Implications for innovation in the EU food sector. British Food Journal, 118(11), 2647-2665. https://doi.org/10.1108/bfj-01-2016-0021.
Kušar, A., & Pravst, I. (2014). Quality and safety of botanical food products and their labelling. Agro Food Industry Hi-Tech, 25(2), 33-35.
L'Abbe, M. R., Dumais, L., Chao, E., & Junkins, B. (2008). Health claims on foods in Canada. Journal of Nutrition, 138(6), 1221S-1227S.
Lahteenmaki, L. (2013). Claiming health in food products. Food Quality and Preference, 27(2), 196-201. https://doi.org/10.1016/j.foodqual.2012.03.006.
Lalor, F., Kennedy, J., Flynn, M. A., & Wall, P. G. (2010). A study of nutrition and health claims-A snapshot of what's on the Irish market. Public Health Nutrition, 13(5), 704-711. https://doi.org/10.1017/s1368980009991613.
Lalor, F., & Wall, P. G. (2011). Health claims regulations: Comparison between USA, Japan and European Union. British Food Journal, 113(2), 298-313. https://doi.org/10.1108/00070701111105358.
Lapenna, S., Gemen, R., Wollgast, J., Worth, A., Maragkoudakis, P., & Caldeira, S. (2015). Assessing herbal products with health claims. Critical Reviews in Food Science and Nutrition, 55(13), 1918-1928. https://doi.org/10.1080/10408398.2012.726661.
Lenssen, K. G. M., Bast, A., & de Boer, A. (2018). Clarifying the health claim assessment procedure of EFSA will benefit functional food innovation. Journal of Functional Foods, 47, 386-396. https://doi.org/10.1016/j.jff.2018.05.047.
Lopéz-Galán, B., & De-Magistris, T. (2017). Prevalence of relevant nutritional claims related to prevention of obesity in Spanish market. Nutricion Hospitalaria, 34(1), 154-164. https://doi.org/10.20960/nh.991.
Lynam, A.-M., McKevitt, A., & Gibney, M. J. (2011). Irish consumers’ use and perception of nutrition and health claims. Public Health Nutrition, 14(12), 2213-2219. https://doi.org/10.1017/S1368980011000723.
Malla, S., Hobbs, J., & Kofi Sogah, E. (2013). Functional foods and natural health products regulations in Canada and around the world: Nutrition labels and health claims. Retrieved from http://www.ag-innovation.usask.ca/cairn_briefs/publications%20for%20download/Publication%2036%20Malla%20et%20al.pdf.
Martin, A. (2015). Assessment and management of health claims in Europe 9 years after the adoption of the regulation. Journal of Nutritional Science and Vitaminology, 61, S50-S52.
Martínez, S. V., & Siani, A. (2017). Health claims made on food in the EU: The edge between scientific knowledge and regulatory requirements. Trends in Food Science & Technology, 69(Part B), 315-323. https://doi.org/10.1016/j.tifs.2017.01.005.
Miklavec, K., Pravst, I., Grunert, K. G., Klopčič, M., & Pohar, J. (2015). The influence of health claims and nutritional composition on consumers’ yoghurt preferences. Food Quality and Preference, 43, 26-33. https://doi.org/10.1016/j.foodqual.2015.02.006.
MPI. (2016). New Zealand Food (Supplemented Food) Standard 2016. Retrieved from https://www.mpi.govt.nz/document-vault/11365.
Navas-Carretero, S., & Martinez, J. A. (2015). Cause-effect relationships in nutritional intervention studies for health claims substantiation: Guidance for trial design. International Journal of Food Sciences and Nutrition, 66, S53-S61. https://doi.org/10.3109/09637486.2015.1025720.
Ni Mhurchu, C., Brown, R., Jiang, Y., Eyles, H., Dunford, E., & Neal, B. (2016). Nutrient profile of 23 596 packaged supermarket foods and non-alcoholic beverages in Australia and New Zealand. Public Health Nutrition, 19(03), 401-408. https://doi.org/10.1017/S1368980015000968.
Nocella, G., & Kennedy, O. (2012). Food health claims: What consumers understand. Food Policy, 37(5), 571-580. https://doi.org/10.1016/j.foodpol.2012.06.001.
Petersen, K. S. (2019). The dilemma with the soy protein health claim. Journal of the American Heart Association, 8(13), e013202. https://doi.org/10.1161/JAHA.119.013202.
Petty, R. E., & Cacioppo, J. T. (1986). The elaboration likelihood model of persuasion. In L. Berkowitz (Ed.), Advances in Experimental Social Psychology (Vol. 19, pp, 123-205): Academic Press.
Pothoulaki, M., & Chryssochoidis, G. (2009). Health claims: Consumers' matters. Journal of Functional Foods, 1(2), 222-228. https://doi.org/10.1016/j.jff.2009.01.012.
Pravst, I. (2010). The evaluation of health claims in Europe: What have we learned? Agro Food Industry Hi-Tech, 21(4), 4-6.
Pravst, I. (2011). Risking public health by approving some health claims? - The case of phosphorus. Food Policy, 36, 725-727. https://doi.org/10.1016/j.foodpol.2011.05.005.
Pravst, I. (2012). Functional foods in Europe: A focus on health claims. In B. Valdez (Ed.), Scientific, health and social aspects of the food industry. Rijeka: InTech.
Pravst, I., & Kušar, A. (2015). Consumers’ exposure to nutrition and health claims on pre-packed foods: Use of sales weighting for assessing the food supply in Slovenia. Nutrients, 7(77), 9353-9368. https://doi.org/10.3390/nu7115474.
Pravst, I., Kušar, A., Žmitek, K., Miklavec, K., Lavriša, Ž., Lähteenmäki, L., …. Raats, M. M. (2018). Recommendations for successful substantiation of new health claims in the European Union. Trends in Food Science & Technology, 71, 259-263. https://doi.org/10.1016/j.tifs.2017.10.015.
Raats, M., Malcolm, R., Lähteenmäki, L., Pravst, I., Gage, H., Cleary, A., & Klopčič, M. (2015). Understanding the impact of European Regulation on the substantiation and use of claims on food and drinks: Design of the REDICLAIM project and initial results. Nutrition Bulletin, 40(4), 340-348. https://doi.org/10.1111/nbu.12179.
Ritz, E., Hahn, K., Ketteler, M., Kuhlmann, M. K., & Mann, J. (2012). Phosphate additives in food - A health risk. Deutsches Ärzteblatt International, 109(4), 49-55.
Sacco, J. E., Sumanac, D., & Tarasuk, V. (2013). Front-of-package references to fiber on foods in Canadian supermarkets highlight the need for increased nutrition knowledge among consumers. Journal of nutrition education and behavior, 45(6), 518-524. https://doi.org/10.1016/j.jneb.2013.02.003.
Schermel, A., Emrich, T. E., Arcand, J., Wong, C. L., & L'Abbe, M. R. (2013). Nutrition marketing on processed food packages in Canada: 2010 Food Label Information Program. Applied Physiology, Nutrition, and Metabolism, 38(6), 666-672. https://doi.org/10.1139/apnm-2012-0386.
Shimizu, T. (2003). Health claims on functional foods: The Japanese regulations and an international comparison. Nutrition Research Reviews, 16(2), 241-252. https://doi.org/10.1079/NRR200363.
Shimizu, T. (2015). Health claims regulation and scientific substantiation of functional foods and the international comparison. In D. Ghosh, D. Bagchi, & T. Konishi (Eds.), Clinical aspects of functional foods and nutraceuticals (pp. 217-255). Boca Raton, FL: CRC Press.
Stancu, V., Grunert, K. G., & Lähteenmäki, L. (2017). Consumer inferences from different versions of a beta-glucans health claim. Food Quality and Preference, 60, 81-95. https://doi.org/10.1016/j.foodqual.2017.03.001.
Storcksdieck genannt Bonsmann, S., Fernandez Celemin, L., Larranaga, A., Egger, S., Wills, J. M., Hodgkins, C., & Raats, M. M. (2010). Penetration of nutrition information on food labels across the EU-27 plus Turkey. European Journal of Clinical Nutrition, 64(12), 1379-1385.
Tapsell, L. C. (2008). Evidence for health claims: A perspective from the Australia-New Zealand region. Journal of Nutrition, 138(6), 1206S-1209S.
TGA. (2013). An overview of the regulation of complementary medicines in Australia. Retrieved from https://www.tga.gov.au/overview-regulation-complementary-medicines-australia.
US. (1990). Nutrition labelling and education act of 1990. Public Law, 101-535, 104 stat. 2353. Retrieved from http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104-Pg2353.pdf.
US. (1994). Dietary Supplement Health and Education Act of 1994. Public Law, 103-417, 108 stat. 4325. Retrieved from http://www.gpo.gov/fdsys/pkg/STATUTE-108/pdf/STATUTE-108-Pg4325.pdf.
US. (1997). Food and drug administration modernization act of 1997 Public Law, 105-115.111 stat. 2296. Retrieved from http://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf.
US. (2010). United States Code, Title 21: Food and drugs; Chapter 9: Federal Food, Drug, and Cosmetic Act; Subchapter IV: Food; Sec. 343: Misbranded food. 21 USC 343. Retrieved from http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapIV-sec343.html.
US. (2014a). Code of Federal Regulations, Title 21: Food and drugs; Chapter I: Food and drug administration department of health and human services; Subchapter B: Food for human consumption; Part 101: Food labeling: Subpart A: General Provisions; Sec. 101.13 Nutrient content claims -general principles. 21 CFR 101.13. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.13.
US. (2014b). Code of Federal Regulations, Title 21: Food and drugs; Chapter I: Food and drug administration department of health and human services; Subchapter B: Food for human consumption; Part 101: Food labeling: Subpart A: General Provisions; Sec. 101.14: Health claims: General requirements. 21 CFR 101.14. Retrieved from https://www.ecfr.gov/cgi-bin/text-idx?SID=3b3dc0b3eaede490ddb9b436779cdcd4&mc=true&node=se21.2.101_114&rgn=div8.
US. (2014c). Code of Federal Regulations, Title 21: Food and drugs; Chapter I: Food and drug administration department of health and human services; Subchapter B: Food for human consumption; Part 101: Food labeling: Subpart E: Specific Requirements for Health Claims; Sec. 101.70: Petitions for health claims. 21 CFR 101.70. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.70.
US FDA. (2003a). Consumer health information for better nutrition initiative: Task force final report. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/consumer-health-information-better-nutrition-initiative-attachment-e-interim-procedures-qualified.
US FDA. (2003b). Guidance for industry and FDA: Interim evidence-based ranking system for scientific data. Retrieved from https://www.federalregister.gov/documents/2003/07/11/03-17702/release-of-task-force-report-guidance-for-industry-and-fda-interim-evidence-based-ranking-system-for.
US FDA. (2009). Guidance for industry: Evidence-based review system for the scientific evaluation of health claims. Retrieved from https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm073332.htm.
US FDA. (2013). Guidance for industry: A food labeling guide. Retrieved from http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm.
US FDA. (2016a). Food labeling: Health claims; dietary saturated fat and cholesterol and risk of coronary heart disease. Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-29997.pdf.
US FDA. (2016b). Food labeling: Revision of the nutrition and supplement facts labels. Retrieved from https://www.federalregister.gov/documents/2016/05/27/2016-11867/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels.
US FDA. (2017). Food labeling: Health claims; Soy protein and coronary heart disease- Proposed rule. Federal Register, 82(209), 50324-50346.Retrieved from https://www.govinfo.gov/content/pkg/FR-2017-10-31/pdf/2017-23629.pdf.
US FDA. (2020a). FDA Modernization Act (FDAMA) claims. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/fda-modernization-act-fdama-claims.
US FDA. (2020b). Health claims meeting significant scientific agreement (SSA). Retrieved from https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard.
US FDA. (2020c). Qualified health claims. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims.
US FDA. (2020d). Structure and function Claims. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims.
van Trijp, H. C. M., & van der Lans, I. A. (2007). Consumer perceptions of nutrition and health claims. Appetite, 48(3), 305-324. https://doi.org/10.1016/j.appet.2006.09.011.
Van Wezemael, L., Caputo, V., Nayga, R. M., Chryssochoidis, G., & Verbeke, W. (2014). European consumer preferences for beef with nutrition and health claims: A multi-country investigation using discrete choice experiments. Food Policy, 44, 167-176. https://doi.org/10.1016/j.foodpol.2013.11.006.
Verhagen, H., & van Loveren, H. (2016). Status of nutrition and health claims in Europe by mid 2015. Trends in Food Science & Technology, 56, 39-45. https://doi.org/10.1016/j.tifs.2016.07.005.
Verhagen, H., Vos, E., Francl, S., Heinonen, M., & van Loveren, H. (2010). Status of nutrition and health claims in Europe. Archives of Biochemistry and Biophysics, 501(1), 6-15. https://doi.org/10.1016/j.abb.2010.04.012.
Vero, V., & Gasbarrini, A. (2012). The EFSA health claims ‘learning experience’. International Journal of Food Sciences and Nutrition, 63, 14-16. https://doi.org/10.3109/09637486.2011.633899.
Walker, K. Z., Woods, J. L., Rickard, C. A., & Wong, C. K. (2008). Product variety in Australian snacks and drinks: How can the consumer make a healthy choice? Public Health Nutrition, 11(10), 1046-1053. https://doi.org/10.1017/s1368980007001462.
Wellard-Cole, L., Li, R., Tse, C., Watson, W. L., & Hughes, C. (2020). Changes in nutrition content and health claims post-implementation of regulation in Australia. Public Health Nutrition, 23(12), 2221-2227. https://doi.org/10.1017/S1368980019004890.
Wellard-Cole, L., Watson, W. L., Hughes, C., & Chapman, K. (2019). How effective is food industry self-substantiation of food-health relationships underpinning health claims on food labels in Australia? Public Health Nutrition, 22(9), 1686-1695. https://doi.org/10.1017/S1368980018004081.
Williams, P., Yeatman, H., Ridges, L., Houston, A., Rafferty, J., Ridges, A., …. Spratt, B. (2006). Nutrition function, health and related claims on packaged Australian food products - prevalence and compliance with regulations. Asia Pacific Journal of Clinical Nutrition, 15(1), 10-20.
Williams, P., Yeatman, H., Zakrzewski, S., Aboozaid, B., Henshaw, S., Ingram, K., …. Ghani, F. (2003). Nutrition and related claims used on packaged Australian foods - implications for regulation. Asia Pacific Journal of Clinical Nutrition, 12(2), 138-150.
Wills, J. M., Storcksdieck genannt Bonsmann, S., Kolka, M., & Grunert, K. G. (2012). European consumers and health claims: Attitudes, understanding and purchasing behaviour. Proceedings of the Nutrition Society, 71(2), 229-236. https://doi.org/10.1017/s0029665112000043.

Keywords: food labeling; functional foods; health claims; regulation; substantiation

Date Created: 20210210 Date Completed: 20211025 Latest Revision: 20211025

20231215

10.1111/1541-4337.12716

33565710