Consequences of the EC framework of health claims made on food: are we protecting the consumer by means of human trials?

L. Escajedo San Epifanio

Consequences of the EC framework of health claims made on food: are we protecting the consumer by means of human trials?

In: Ethical futures: bioscience and food horizons

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L. Escajedo San Epifanio

L. Escajedo San Epifanio Constitutional Law, Inter-university Chair in Law and the Human Genome, University of the Basque Country, University of Deusto, Spain; leire.escajedo@ehu.es

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Type:: Chapter

Pages:: 46–51

DOI:: https://doi.org/10.3920/9789086866731_007

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With regards to initiatives adopted in other countries, the EU regulation on functional foods was delayed for well over a decade. A complex sharing of competences and the variety of cultural and legal conceptions that coexist around food are factors which help explain the potential source of conflict in the food sector. Another is the fact that this is a strategic sector for many countries. The EU appealed to a peculiar interpretation of its competence of minimum harmonisation. The White Paper on Food Safety (2000) reflected the objective of harmonising a high level of consumer safety and protection with the backing of a scientific authority of acknowledged prestige and independence (the EFSA). Within this regulatory framework, in 2006, a regulation on health claims made on foods was adopted. It is noteworthy that the Union draws a distinction and places these products outside the scope of drugs. However, in order to publicise a health claim on a food it is required a scientific substantiation that includes, among others, data from studies in humans ‘addressing the relationship between consumption of the food and the claimed effect is required for substantiation of a health claim’. This requirement, very high in terms of comparative law, looks for a high protection for the consumer but it has a sad counter effect. The regulation which protects the rights of humans who participate in clinical trials has been centred on medicines, and it is practically non-existent with reference to food studies on humans. Some Member State authorities and Research Ethic Committees are reacting to fill this gap in the law. This is the case, for example, of the Spanish Clinical Research Ethic Committees, within the Law on Biomedical Research (2007). Nevertheless, in the medium-term, it is necessary to provide a more adequate solution.

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Ethical futures: bioscience and food horizons

E-Book ISBN:: 9789086866731

Publisher:: Wageningen Academic

Print Publication Date:: 30 Oct 2009

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- Life Sciences

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Consequences of the EC framework of health claims made on food: are we protecting the consumer by means of human trials?

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Ethical futures: bioscience and food horizons

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