New Commission proposal on specialised food products Vasilis Gatzios (Veterinarian MSc) Greek Food Safety Authority (EFET

Directive 2009/39/EC on Foodstuffs Intended for Particular Nutritional Uses (ammending Dir 89/398)

1.Infant formulae 2.Follow up milk and other follow up foods and baby foods 3.Low/reduced energy foods for weight control 4.Dietary foods for special medical purposes 5.Low-sodium foods (including dietary salts) 6.Gluten-free foods 7.Foods intended especially for sportsmen 8.Foods for persons suffering from carbohydrate-metabolism disorders (diabetes)

Rules on labelling, presentation and advertising Addition of Vitamins and Minerals to foodstuffs Nutrition and Health Claims Legisaltion on food supplements Legislation on fortified foods Legisaltion on novel foods

Background (1) The designation under which a dietetic food is sold is accompanied by a suitability statement for the particular nutritional use and the specific group of the population to whom the food is intended (e.g.: gluten-free food for celiac people, processed cereal-based food for young children, infant formulae for infants from birth, food for sports people etc).

Background (2) After more than 30 years of application, and given the evolution of food products and the evolution of EU food legislation, a review of the dietetic food legislation became necessary. Specialised "normal" foods have increasingly been targeting sub-groups of the general population (e.g. protein bar supporting muscle building for sportspeople, food supplements for pregnant women, fortified food in calcium and vitamin D suitable for older adults, slimming products etc).

Background (3) Consequently, the difference between "dietetic foods" for specific groups of the population and "specialised foods" for the general population or sub-groups is no longer clear for citizens, stakeholders and enforcement authorities. Therefore, it became clear that the existence of a specific EU framework for "dietetic foods" existing in parallel with other, more recent, pieces of legislation was no longer justified.

What would the proposal change? Regulation instead of Directive Strengthen provisions on foods for vulnerable population groups that need particular protection e.g. infants and children up to 3 years old and people with specific medical conditions e.g. cancer patients or people with metabolism disorders. Keep current compositional and labelling rules for infant and follow-on formulae, processed cereal- based foods and other baby foods and foods for special medical purposes.

What would the proposal change? Replace the current 3 lists with a single EU list of substances that can be added to these foods including minerals and vitamins Reduce the administrative burden, brings clarity and consistency within the EU and flexibility in the innovative food market. Repeal Directive 2009/39/EC and abolishes the concept of dietetic foods

dietetic foods The concept of dietetic foods does not correspond with the reality of the food market: Non clear differentiation between dietetic and specialized foods No clear differentiation between foods for specific people and normal consumer A big number of food products on the market today, without necessarily being "dietetic foods," target certain groups of the population with specific nutritional needs e.g. a food supplement concentrated in caffeine to enhance performance or fortified cereals in vitamins B for growing children

Sport foods, energy drinks, foods for elderly, slimming products today Legislation shopping If diatetic – national notification system If use of healthclaims – centralised authorisation system applies So, different application, confusion for consumers and competent authorities, distortion of competition, misleading practices

The proposal (1): Abolishes the concept of dietetic foods Because its application differs significantly between Member States and creates distortions in the internal market. similar foods could be marketed in some member States as dietetic foods while in others as food for normal consumption addressed to the population in general or certain sub-groups, such as pregnant women, active individuals, older adults etc.

The proposal (2): Dietetic foods will be solely covered by other already existing legislation, such as, for instance, the one on nutrition and health claims and/or the regulation on the addition of vitamins, minerals and other substances to foods.

The proposal (3): strengthens and clarifies provisions for foods intended for vulnerable groups of the population who need particular protection – namely infants and children up to three years old, and people with specific medical conditions, such as cancer patients or individuals with metabolism disorders

The proposal (4): maintaining the existing compositional and labelling rules applicable to infant and follow-on formulae, processed cereal-based foods and other baby foods and foods for special medical purposes. establishes a single EU list of substances, instead of the existing three, that can be added to these foods. The substances covered in the list include, among others, minerals and vitamins.

Other benefits The new framework will result in less administrative burden, more clarity and consistency within the EU and consequently allow for more flexibility for the evolving, innovative food market. No products will have to be withdrawn from the market as a result of the new rules. Those covered by the dietetic food legislation can remain on the market but will be legislated fully by the other pieces of existing food legislation. In order to facilitate the adaptation of products and reduce costs for operators, mainly in terms of re-labelling, a two-year transitional period is foreseen.

Example: foods for diabetes? Directive 89/398 applies today No specific directive. Different treatment among Member States Commission report1 concludes that there is no scientific basis on which to develop specific compositional requirements for this group of foods.1 People with diabetes should be able to meet their dietary needs by choosing appropriate foods intended for the general population (Nutrtional labelling, nutritional and health claims)

Having no general rules on dietetic foods and clearer rules for foods for specific groups of the population will provide clarity and legal certainty.

Other benefits The proposal will be now submitted to the European Parliament and the Council. If these Institutions reach an agreement on the proposal the new regulation should be in force by the end of 2012.

HVALA!!