Legislative context
Framework legislation
The food industry is one of the most regulated sectors in the European Union. Legislation covers hygiene, additives, labelling, advertising etc. Because of its important contribution to public health, additional legislation covering the composition, production, labelling and marketing of dietetic foods has been introduced and harmonised in the EU since 1989.
This guarantees safe and effective use of these products by appropriate consumers in all EU countries. This level of regulatory control supports the industry aim of consumer trust.
The rules relating to foodstuffs intended for particular nutritional uses (for infants and young children, persons whose digestive processes or metabolism are disturbed or for persons with a specific physiological condition) have been harmonised at European level. Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on Foodstuffs Intended for Particular Nutritional Uses provide the legal framework for these foods.
Category specific legislation
In addition to the framework directive, which established the basic rules for the dietetic foods, for certain dietetic foods categories have been established detailed specific directives. These additional provisions mainly relate to the nature or the composition of these products and to the labeling requirements. These so-called vertical directives cover the following categories of foods:
- Infant Formulae and Follow-on Formulae covered by Commission Directive 2006/141/EC of 22 December 2006 on Infant Formulae and Follow-On Formulae;
- Processed Cereal-based foods and baby foods for infants and young children is covered by Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children;
- Foods intended for weight reduction is covered by Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction;
- Dietary Foods for Special Medical Purposes is covered by Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes.
Gluten – free category of foods
The ‘gluten-free’ and ‘very low gluten’ foods category are covered by the stand alone Regulation 41/2009/EC of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. This Regulation was drafted in order to help meet the needs of the people with coeliac disease who are a specific group of population suffering from a permanent intolerance to gluten.
Addition of nutrients to PARNUTs
A number of nutritional substances such as vitamins, minerals, amino acids and others may be added to foods for particular nutritional uses in order to ensure that the particular nutritional requirements of the persons for whom those foods are intended are fulfilled and/ or in order to satisfy the legal requirements laid down in specific directives adopted pursuant to Article 4(1) of Directive 2009/39/EC. These nutritional substances are regulated by the Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses.
Horizontal legislation
Foodstuffs intended for particular nutritional uses which have not been regulated by a specific directive shall comply with the rules on labelling, presentation and advertising of foodstuffs for general consumption, i.e. Labelling Directive 2000/13/EC, Nutrition Labelling Directive 90/496/EC and Addition of Vitamins and Minerals to foodstuffs 1925/2006/EC.
The claims on the PARNUTs are regulated by the Nutrition and Health Claims regulation 1924/2006/EC.
FACTS & FIGURES
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About 5% of turnover is invested in research:the food industry average is 1% |
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The annual turnover of the European dietetic foods sector (including exports) is around €24bn |
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The dietetic foods sector is a world leader:each year, exports total around €8bn |
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