Health food and health and nutritionally claims

Notwithstanding the differences in the specific regulations, some foodstuffs (i.e., natural mineral waters, foodstuffs for particular nutritional uses, food supplements, enriched or fortified foods and functional foods) have in common the production of a positive physiological effect, due to a set of characteristics naturally present in said products or which can be reproduced by the manufacturer. The properties of these products aim at satisfying a specific health need of the consumer. In order to define a specific category of foodstuffs as health foods based on their intrinsic properties, the shared purpose of said foodstuffs must be to produce a positive effect on human health. The health function (understood to be the ability of the foodstuff to produce positive effects on the human body under normal conditions due to its nutritional and/or physiological benefits) constitutes a true requirement for quality, no longer linked to a specific foodstuff, but rather identifying properties common to a category of foods, where said properties are declared through appropriate claims on labelling, addressed to the final consumer and capable to orientate the decision of purchase. A comprehensive category of health food is still not expressly defined as such within the EU legal framework, and can therefore be specified only through interpretation. Recognition of the category could help to solve some relevant issues on the production and marketing of foodstuffs beneficial to human health, assuring coherence with high standards in protecting human health and the efficient circulation of goods in a free market. European legislation has traditionally introduced specific directives to regulate product description, composition, manufacture, control, authorization and labeling/advertising for the various types of health foods, but whenever food products include substances whose use is not harmonized at European level recognition of their beneficial health effects can raise barriers to the free circulation in the European market. These barriers can take the form of authorizations required by Member States prior to the introduction in the market, in order to protect consumers’ health, and can also be due to different national classification of health foods, in some cases as foodstuffs, in others as medicinal products. Bringing the multiple legislation approved for single foodstuffs beneficial to health within one comprehensive systemic category would render these laws more meaningful and complementary in order to overcome the uncertainties, that undermine the border between medicinal products and foodstuffs. In addition, it would help to identify the mechanisms needed to overcome impasses in the circulation of goods within the European Union through indirect harmonization. Such harmonization favours new standardization processes, that can be pursued by the private sector (e.g. through non-compulsory nutritional and health information foreseen in Regulation No 1924/2006) or by the Commission itself and the Member States (e.g. by the procedure regulated in Article 8 of Regulation No 1925/2006). We may therefore assume that a commonly accepted definition of health food is that it produces positive effects on human health if used as intended, but it is not able to appreciably restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, nor does it have the function of treating or preventing disease. Health food can be marketed through the use of claims, established by national or Community legislation, or defined by food business operators and authorized by the Commission in compliance with the provisions set forth in Regulation No 1924/2006. In the absence of total harmonization of the legislation regulating health food claims at the Community level, a voluntary alignment of State Members legislation to the guarantees, required by Regulation No 1924/2006 for the use of nutrition and health claims for foodstuffs, would foster a reduction in trade barriers in the European internal market