News | 26.02.2020

Nutraceutics, functional foods and food supplements

Marketing & Communication

Nutraceutics, even if it has not been defined by the law, may be identified as a new scientific discipline having as object the identification of the benefits contained in food products and of the relevant effects on health. In this respect it has to be considered as nutraceutic any food that, containing determined substances, may have beneficial effects on a specific function of the organism acknowledged scientifically (definition from “Feeding the planet, feeding it healthy. Nutritional balance of a healthy diet” contained in “Quaderni della Salute”, No 25, October 2015 – Italian Ministry of Health).

The above-mentioned definition correctly underlines the characteristics of this discipline summarized in the name itself “nutraceutic” deriving from the words “nutrition” and “pharmaceutic”. These terms recall the words “nutrition” and “pharmaceutical product” which have been duly disciplined by EU and national law. It seems appropriate to assert that nutraceutic borders the Food and Pharma markets and that the strict detailed discipline concerning the production, communication and sale of food products shall apply. The ample definition of food also includes (but it is not limited to) nutraceutic products; food, in fact, is defined as follows under article 2 of Regulation (EC) No 178/2002 – “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”.

Nutraceutics also present similarities to the so called “functional foods”. Even if, functional foods have been considered and disciplined starting from the 1980s in Japan, under the definition of FOSHU (Foods for Specified Health Use) and, afterwards, in Europe from the beginning of the 1990s, the law has not specifically disciplined their production and commercialization. As well as for nutraceutic their use aims to achieve a benefit for one or more body functions; this result may be obtained thanks to the ingredients naturally contained in such product or due to specific growing or production techniques which improve its beneficial effects and its contents. However, while functional foods are likely to be consumed as regular food, nutraceutics are more similar to pharmaceutical products.

Food supplements have to be considered separately since they differ from nutraceutics. Nutraceutics are more similar to pharmaceutical products, not only in respect of their apparel but mainly because their scope is to prevent potential diseases, while food supplements are characterised by the concentration of a specific substance or other nutritional element in order to supply such substance in case of lack of the same for nutritional or physiological purposes. Food supplements have been disciplined by Directive 2002/46/EC and by Italian Legislative Decree 21 May 2004 No 169, and also by Commission Regulation (EC) no. 1170/2009 of 30 November 2009 (amending Directive 2002/46/EC), as well as by Italian Decree of the Health Ministry 10 August 2018 concerning the use of plant and vegetable derived substances in dietary supplements.
In particular:

  • under article 2, letter a), of Directive 2002/46/EC, “food supplements means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”;
  • under article 9, par. 1, of Legislative Decree No 169/2004, the production and packaging of food supplements has to be carried out in premises authorised by the Health Ministry;
  • under article 6, par. 2 of Directive 2002/46/EC “the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties”, par. 3 lists the mandatory contents of the labels;
  • article 10 of Legislative Decree No 169/2004 provides that the commercialization of food supplements is subject to the prior notification of a model label to the Health Ministry which verifies its compliance and registers the product giving it a code, which may be shown on the label. The Ministry, in case it deems it necessary in order to carry out a complete evaluation, may ask for further documentation in respect of effects and safety of the product and/or ask for changes in the information contained in the label.

Save for some specific rules concerning food supplements, food law apply to all such products. In particular with reference to food information:

  • article 7, par. 3, Regulation (EU) No 1169/2011 concerning the supply of information to consumers regarding food products provides that: “food information shall not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties”;
  • article 3, lett. a), Regulation (EC) No 1924/2006 concerning nutritional and health information given on food products (either on the label or in any other form), evidences, among others, that such information must not be false, ambiguous or misleading or raise doubts on the nutritional safety and/or adequacy of other food;
  • article 6, par. 1, Regulation (EC) No 1924/2006 requires that nutritional and health information have to be based on scientific generally accepted evidence;
  • article 8, par. 1, Regulation (EC) No 1924/2006 concerns nutritional claims (as defined under article 2, par. 2.4 of the same Regulation) specifying that only the indications listed in the relevant annex may be used under the conditions stated in the Regulation;
  • article 10 and following of Regulation (EC) No 1924/2006 concerns health claims (as defined underarticle 2, par. 2.5 of the same Regulation), the relevant discipline is stricter and requires that the such indications have been previously authorised; specifically only the indications contained in the relevant list approved by the European Commission may be used, or in case of new and different indications, a request has to be filed with the Health Ministry, that after the first review, sends the application to the European Food Safety Authority for its technical-scientific evaluation. The application shall be filed to the European Commission, that heard the Standing Committee on the Food Chain and Animal Health, provided that nothing to the contrary is filed by the European Parliament or by the Council, takes the final decision.

LCA has a long experience in dealing in functional food and nutraceutic markets and offers qualified advice to its clients – as producers, suppliers and market leaders multinational companies – in respect of any issue connected to such sector. Specifically, the law firm advices in respect of the negotiation and execution of all relevant agreements and in regulatory compliance procedures.


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