The specialised nutrition industry is one of the most strictly regulated sectors in the European Union, with legislation covering hygiene, additives, labelling, and advertising, among other areas.
Given the contribution of these products to public health in Europe, specific legislation covering their composition, production, labelling and marketing has been harmonised at EU level since 1989, thereby guaranteeing a safe and effective use of these products by the consumers who rely on them. These strict levels of regulatory control support our industry aim of ensuring consumer trust.
Directive 2009/39/EC of the European Parliament and Council of 6 May 2009 on Foodstuffs intended for Particular nutritional uses (PARNUTs) provides the current legal framework for these foods.
However, this Framework Directive was reviewed in 2013. The new Regulation on Foods for Specific Groups (No 609/2013) was published in the Official Journal of the EU in July 2013, and will become applicable in the Member States as from 21 July 2016.
The new Regulation reconfirmed the specific nature of specialised nutrition products and continues to provide an umbrella legislative framework for various category-specific products. At the same time, it refined the scope of the former PARNUTs Regulation and will provide a new and modernised legislative landscape for specialised nutrition.
It did however also create a number of legislative uncertainties for some product categories, which the European Commission will need to resolve prior to the repeal of the PARNUTs framework in 2016. Further details on these categories can be found below.
Category specific legislation part of the new regulatory framework on foods for special groups
Detailed vertical Directives have been established for certain food categories:
· Foods for Infants and young children:
Infant foods are used by healthy babies aged 0-6 months, and follow-on formula is used by babies aged 6-12 months. Both infant and follow-on formulae are covered by one piece of legislation- Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae. This Directive ensures that infant food products are subject to some of the strictest rules in the world. These products have been retained within the scope of the new FSG Regulation, and this Directive will be repealed when it becomes applicable.
Processed cereal-based foods and baby foods for infants and young childrenare covered by Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children. These products have also been explicitly included within the scope of the new FSG Regulation, and this Directive will therefore be repealed when it becomes applicable in July 2016. The definition of these products will be included within the scope of the new Regulation.
Milk-based drinks for young children, products used by children aged 12-36 months, are considered within the scope of the current framework PARNUTs Directive. However, the new FSG Regulation notes that further information is needed on the role of these products. They have therefore been removed from the scope of the FSG Regulation, and further legislative action for these products will be taken after the Commission, supported by the European Food Safety Authority, will present a report on the nutritional role these products play for this group of consumers.
· Foods for special medical purposes:
Foods for special medical foods are a vital element of patient care, and refer to foods which are given to patients while under medical supervision. Only a healthcare provider is best placed to determine which foods will be best for a patient.
These products refer not only to those foods which are given to adults while under medical care, but also to foods for premature infants, who require very specific nutrients and who often times cannot breastfeed.
Dietary foods for special medical purposes are covered by Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes. These products have also been included within the scope of the new FSG Regulation. Their definition will be included within the scope of the new Regulation.
· Foods intended for weight control:
This category of food products are intended for overweight or obese consumers, who require specific diets to ensure weight control. This category includes a range of products such as low calorie diet products (LCD), very low calorie diet products (VLCD), meal replacements, and en-cas products.
They are currently governed by Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy restricted diets for weight reduction. Once the new FSG Regulation becomes applicable only LCD and VLCD products will remain within the scope of the new rules.
The Commission will be updating the definitions of these products with independent scientific support from the European Food Safety Authority.
Meal replacements and en-cas products will fall under general food rules. The Commission must ensure appropriate amendments to general food law to take into account the specificities and ensure a soft landing for them into the general food rules.
· Gluten free products:
These products are intended for people with coeliac disease, who represent a specific consumer group suffering from a permanent intolerance to gluten. Around one percent of Europeans (5 million citizens) are diagnosed Coeliacs and it is estimated that a further 5 million are undiagnosed.
A simple diet of foods without gluten is not sufficient for these consumers, who require foods which are specifically formulated to include critical nutrients that they would otherwise not receive. These products are currently governed by Regulation 41/2009/EC of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.
With the review of the PARNUTs legislation, a new legal solution has been established: The provisions of Regulation 41/2009 will be moved into the new Food information to Consumers Regulation 1169/2011.
The Commission must ensure that specific conditions of use are included in the new rules prior to the repeal of the current framework, so that coeliac patients will have the information they require on product labels in order to determine which products are specifically formulated to meet their needs.
· Foods intended for intense muscular expenditure
These products are intended for sportsmen who require foods which are specifically formulated to support intense muscular expenditure.
Although the Commission originally intended to draft specific legislation to govern the specific characteristics of these products, this never came to fruition, and they have remained within the scope of the current PARNUTS framework without specific vertical legislation.
However, in the review process, it was determined that additional information about these products is needed in order to determine the appropriate future legal framework.
Therefore, the Commission will, before the repeal of the existing framework and with the scientific support of the European Food Safety Authority, publish a report on these products, at which point further decisions can be taken on the best way to relate these products.
Other relevant legislation:
· Addition of nutrients to PARNUTS
A number of nutritional substances such as vitamins, minerals, amino acids and other substances may be added to foods for specific groups, in order to ensure that the specific nutritional requirements of the persons for whom these 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 the Framework Directive 2009/39/EC.
These nutritional substances are regulated by 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.
Following the repeal of the PARNUTs legislation this Regulation will also be repealed, and a new Union list of substances contained in the Annex of the new FSG Regulation will form the new legal basis for substances which can be added to these products.
· Foodstuffs for general consumption
Specialised nutrition products 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 a Directive 90/496/EC, and the addition of vitamins and minerals to foodstuffs 1925/2006/EC.
The claims used on these products are regulated by the nutrition and health claims regulation 1924/2006/EC.
Specialised nutrition products shall also comply with the requirements of Additives Regulation 1333/2008.
About 5% of turnover is invested in research:
the food industry average is 0,53%
The annual turnover of the specialised nutrition industry across the European Union (including exports) is around €24bn
The specialised nutrition industry is a world leader:
each year, exports total around €8bn