2016, Number 3
Good for your health? An analysis of the requirements for scientific substantiation in European health claims regulation
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ABSTRACTObjective. To identify the various types of evidence, as well as their relative importance in European health claims regulation, in order to analyze the consequences for consumer protection of the requirements for scientific substantiation in this regulation. Materials and methods. Qualitative analysis of various documents relevant to the regulatory process, particularly as to the implications of the standards of proof for the functional food market, as well as consumer behavior. Results. European regulation defines a hierarchy of evidence that turns randomized controlled trials into a necessary and sufficient condition for health claim authorizations. Conclusions. Consumer protection can be interpreted in different manners. High standards of proof protect consumers from false information about the health outcomes of functional foods, while lower standards lead to more, albeit less accurate information about such outcomes being available to consumers.
Aggett P. Dose-response relationships in multifunctional food design: assembling the evidence. Int J Food Sci Nutr 2012;63(supl.1):37-42. http:// doi.org/bdwr
Yamada K, Sato-Mito N, Nagata J, Umegaki K. Health Claim Evidence Requirements in Japan. J Nutr 2008;138:1192S-1198S.
Lalor F, Wall P. Health claims regulations. Comparison between USA, Japan and European Union. Brit Food J 2011; 113: 298-313. http://doi.org/ czbnf9
European Parliament and Council. Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ Official Journal of the European Union 2006; L.404:9-25.
Aggett P, Antoine J, Asp N, Bellisle F, Contor L, Cummings, J, et al. Passclaim: consensus on criteria, Eur J Nutr 2005;44(supl.1):I/1-I/30.
Levidow L, Carr S. Europeanising advisory expertise: The role of ‘independent, objective and transparent’ scientific advice in agri-biotech regulation. Environ Plann C 2007;26:880-895. http://doi.org/bsvw7g
Boobis A, Chiodini A, Hoekstra J, Lagiou P, Przyrembel H, Schlatter J, et al. Critical appraisal of the assessment of benefits and risks for foods - BRAFO Consensus Working Group. Food Chem Toxicol 2013; 55: 659-675. http://doi.org/bdws
Tijhuis MJ, de Jong N, Pohjola M, Gunnlaugsdóttir H, Hendriksen M, Hoekstra J, et al. State of the art in benefit-risk analysis: Food and nutrition. Food Chem Toxicol 2012; 50: 5-25. http://doi.org/drsk9d
Flynn A. Scientific substantiation of health claims in the EU. Proc Nutr Soc 2012; 71:120-126. http://doi.org/b2d3s6
Vero V, Gasbarrini A. The EFSA health claims ‘learning experience’. Int J Food Sci Nutr 2012;63(suppl1):14-16. http://doi.org/dsvxzj
European Commission. Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementation 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. OJ 2008; L.109:11-16.
Hill A. The Environment and Disease: Association or Causation? Proc R Soc Med 1965;58:295-300.
EFSA. Scientific and Technical Guidance for the Preparation and Presentation of an Application for Authorisation of a Health Claim (Revision 1). EFSA J 2011; 9(15):2170:1-36.
Verhagen H, Vos E, Francl S, Heinonen M, van Loveren H. Status of nutrition and health claims in Europe. Arch Biochem Biophys 2010;501:6-
http://doi.org/ckt24z 15. EFSA. Technical Report: Briefing document for Member States and European Commission on the evaluation of Article 13.1 health claims. EFSA J 2009;7:1386:1-10.
de Boer A, Vos E, Bast A. Implementation of the nutrition and health claim regulation – The case of antioxidants. Regul Toxicol Pharmacol 2014;68:475-487.
Richardson D. Preparing dossiers: strength of the evidence and problems of proof. Proc Nutr Soc 2012;71:127-140. http://doi.org/b4vgtf
Gilsenan M. Nutrition & health claims in the European Union: a regulatory overview. Trends Food Sci Tech 2011; 22: 536-542. http://doi. org/fkk2hz
Verkerk R. Implementing an EU health claim converting scientific language to consumer language. Agro Food Ind Hi Tech 2013;24:32-35.
Heaney R. Nutrients, Endpoints, and the Problem of Proof. J Nutr 2008;138:1591-1595.
Blumberg J, Heaney R, Huncharek M, Scholl T, Stampfer M, Vieth R, et al. Evidence-based criteria in the nutritional context. Nutr Rev 2010;68:478-484. http://doi.org/c8274x
Bast A, Briggs W, Calabrese E, Fenech M, Hanecamp J, Heaney R, et al. Scientism, Legalism and Precaution – Contending with Regulation Nutrition and Health Claims in Europe. EFFL 2013;6:401-409.
Todt O, Luján JL. The role of epistemic policies in regulatory science: scientific substantiation of health claims in the European Union. J Risk Res 2016;19. http://doi.org/bdwv