Codex recommendations on the scientific basis of health claims

Aggett PJ (2007) Criteria for substantiating claims. Novartis Found Symp 282:46–53 discussion 53–58

Aggett PJ, Antoine JM, Asp NG, Bellisle F, Contor L, Cummings JH, Howlett J, Muller DJ, Persin C, Pijls LT, Rechkemmer G, Tuijtelaars S, Verhagen H (2005) Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM): consensus on criteria. Eur J Nutr 44(Suppl 1):5–30

Arvanitoyannis IS, Van Houwelingen-Koukaliaroglou M (2005) Functional foods: a survey of health claims, pros and cons, and current legislation. Crit Rev Food Sci Nutr 45:385–404

Asp N-G (2002) Health claims within the Swedish Code. Generic claims and product-specific physiological claims in relation to current European and international developments. Scand J Nutr 46:131–136

Asp N-G, Bryngelsson S (2008) Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr 138:1210S–1215S

Bellisle F, Diplock ST, Hornstra G, Koletzko B, Roberfroid M, Salminen S, Saris WHM (1998) Functional food science in Europe. Br J Nutr 80(Suppl 1):1–193

CAC (2006a) Proposed draft recommendations on the scientific basis of health claims at step 3. CX/NFSDU 06/28/7 June 2006

CAC (2006b) Proposed draft recommendations on the scientific basis of health claims at step 3. CX/NFSDU 06/28/7-Add.1 October 2006

CAC (2006c) Report of the 28th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses. Chiang Mai, Thailand, 30 October–3 November 2006, ALINORM 07/30/26, para. 131–134

CAC (2007a) Food Labelling, 5th edn. Guidelines for use of nutrition and health claims (CAC/GL 23-1997 Rev. 1-2004). World Health Organization/Food and Agriculture Organization of the United Nations, Rome, p 33

CAC (2007b) Proposed draft recommendations on the scientific basis of health claims at Step 3. CX/NFSDU 07/29/6, September 2007

CAC (2007c) Proposed draft recommendations on the scientific basis of health claims at Step 4. CX/NFSDU 07/29/6-Add.1, September 2007

CAC (2007d) Report of the 29th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses. Bad Neuenahr-Ahrweiler, Germany, 12–16 November 2007, ALINORM 08/31/26, para. 79–97

Diplock AT, Aggett PJ, Ashwell M, Bornet F, Fern EB, Roberfroid MB (1999) Scientific concepts of functional foods in Europe: consensus document. Br J Nutr 81:1–27

EFSA (2007) Scientific opinion of the Panel on dietetic products, nutrition and allergies on a request from the Commission related to scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim. EFSA J 530:1–44

FAO, WHO (2006) A model for establishing upper levels of intake for nutrients and related substances. Report of a Joint FAO/WHO technical workshop on nutrient risk assessment, Geneva, Switzerland, 2–6 May 2005. Published 30 June 2006

FDA/CFSAN/OSN (1999) Guidance for industry. Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. December 22, 1999. http://vm.cfsan.fda.gov/~dms/ssaguide.html

FDA/CFSAN (2003a) Guidance: Interim procedures for qualified health claims in the labelling of conventional human food and human dietary supplements. July 10, 2003. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053832.htm

FDA/CFSAN (2003b) Guidance for industry and FDA. Interim evidence-based ranking system for Scientific Data. July 10, 2003. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053855.htm

FDA/CFSAN (2005) Questions and answers qualified health claims in food labeling—report on effects of strength of science disclaimers on the communication impacts of health claims. September 28, 2005. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm109470.htm

Hurt E (2002) International guidelines and experiences on health claims in Europe. Asia Pac J Clin Nutr 11:S90–S93

Jones PJH, Asp N-G, Silva P (2008) Evidence for health claims on foods: how much is enough? Introduction and general remarks. J Nutr 138:1189S–1191S

Katan MB, De Roos NM (2004) Promises and problems of functional foods. Crit Rev Food Sci Nutr 44:369–377

Kim JY, Kim DB, Lee HJ (2006) Regulations on health/functional foods in Korea. Toxicology 221:112–118

Kwak NS, Jukes D (2001) Issues in the substantiation process of health claims. Crit Rev Food Sci Nutr 41:465–479

Ohama H, Ikeda H, Moriyama H (2006) Health foods and foods with health claims in Japan. Toxicology 221:95–111

Randell AW, Whitehead AJ (1997) Codex Alimentarius: food quality and safety standards for international trade. Rev Sci Tech 16:313–321

Richardson DP, Affertsholt T, Asp N-G, Bruce A, Grossklaus R, Howlett J, Pannemans D, Ross R, Verhagen H, Viechtbauer V (2003) PASSCLAIM—synthesis and review of existing processes. Eur J Nutr 42(Suppl. 1):I/96–I/111

Richardson DP (2005) The scientific substantiation of health claims with particular reference to the grading of evidence and consumer understanding. Food Sci Technol Bull Funct Foods 2:1–10

Rowlands JC, Hoadley JE (2006) FDA perspectives on health claims for food labels. Toxicology 221:35–43

Sanders ME, Tompkins T, Heimbach JT, Kolida S (2005) Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U, and U.S. Eur J Nutr 44:303–310

Schneeman B (2007) FDA’s review of scientific evidence for health claims. J Nutr 137:493–494

Tapsell LC (2008) Evidence for health claims: a perspective from Australia-New Zealand region. J Nutr 138:1206S–1209S

The Netherlands Ministry of Health (2004) Netherlands proposal for a systematic approach for a generic list of health claims. VWA (Dutch Food Authority) Nutrition Centre

Tontisiri K, Lepretre C (2001) Codex as the basis for national standards and international harmonization. Biomed Environ Sci 14:137–144

Turner RE, Degnan FH, Archer DL (2005) Label claims for foods and supplements: a review of the regulations. Nutr Clin Pract 20:21–32

Verhagen H, Coolen S, Duchateau G, Hamer M, Kyle J, Rechner A (2004) Assessment of the efficacy of functional food ingredients—introducing the concept “kinetics of biomarkers”. Mutat Res 551:65–78

WCRF (1997) Food, nutrition and the prevention of cancer: a global perspective. World Cancer Research Fund (American Institute for Cancer Research), Washington, DC

WHO (2004) Diet, nutrition and the prevention of chronic diseases: report of a joint FAO/WHO Expert Consultation. WHO Technical Report Series 916, Geneva, pp 53–54

Yang Y (2008) Scientific substantiation of functional food health claims in China. J Nutr 138:1199S–1205S