Abstract
European legislation on foods and medicine has failed to keep pace with the developments in nutrition and medical science that now recognise many important contributions that diet and individual foods may make to the promotion and maintenance of health. EU food law prevents the communication of these benefits to consumers, whilst the law on products is established on a very broad basis that also encompasses foods making preventive, therapeutic or curative claims. This legislation, together with the lack of universal definitions in food law, results in divergence and legal uncertainty within and between Member States, and is in urgent need of revision. In this article, these aspects are investigated and illustrated by relevant case law. The legal boundaries of such concepts as food, medicinal prevention, risk reduction, etc., based on current EU legislation, national practices and case law, are explored. Finally, the concept of Disease Risk Reduction, as proposed by various international bodies, is discussed in the light of current legislation, together with a proposal that claims for foods based on this concept should be excluded from the medical scope of the term prevention. It is concluded that it is necessary to set clear-cut unambiguous definitions for products and foodstuffs and to clarify in the labelling directive that reduction of disease risk claims do not fall under the prohibition of preventive claims. The recently proposed changes to the definition of products, the proposed definition of foodstuffs in the general food law regulation, and the discussion paper on health claims on European level fundamentally fail to clarify these issues
Highlights
The recently proposed changes to the definitionof medicinalproducts,the proposed definitionof foodstuffsin the generalfood law regulation, and the discussion paper on health claims on European level fundamentally fail to clarify these issues. It is a general principle, worldwide, that in communicationwith consumers, no properties relating to the ability to prevent, treat or cure human diseases may be directly or indirectly attributed to individual foods
There is increasing evidence that a healthy diet and life-style can effectively diminish the risk of several chronic diseases
References to a limited number of specific "preventive" effects have already been legally accepted, for example relating to the link between several chronic "Western" diseases and the consumptionof fruit and vegetables and food components such as unsaturated fatty acids, dietary fibre and folic acid
Summary
It is a general principle, worldwide, that in communicationwith consumers, no properties relating to the ability to prevent, treat or cure human diseases may be directly or indirectly attributed to individual foods. This may derive from aspects such as the product's composition, pharmacologicalproperties,claimsand associatedcommercialand noncommercial communication, its presentation (including any similarity to medicinal products) and point of sale, any risks arising from prolonged consumption, the way it is used, and its familiarity to the consumer All these aspects will be taken into consideration by the Courts, there is currently no systematic mechanism on the basis of Directive 65/65 whereby a product generally regarded as a food, but bearing disease or health related claims, can be excluded from the legal scope of "medicinal products". This would require a modification of the labelling Directive 2000113, in order to establish, uniformly at the European level that the concept of "disease risk reduction" is valid for foods and inherently different from the concept of "prevention" in the absolute sense The latter is a medical concept and should continue to be regulated under medicinal product legislation. It was rather disappointing that in its White Paper [35], the European Commission declared that labelling and advertising of a food should not contain 'health claims.The European Commission is currently prepared only to consider specific provisionsto govern 'nutrition and function7claims, as reflected in the recent discussion paper on claims [36], on which all stakeholders have been invited to comment
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