1. HORIZONTAL and VERTICAL LEGISLATION ON PARNUTS ON PARNUTS Vasilis Gkantzios Veterinarian MSc GREEK FOOD AUTHORITY Belgrade 24 Nov 2011

2. Main topics of presentation… Definitions – common language General Rules and Production Standards Sections of specific legislation

3. Definition PARNUTS Foodstuffs, clearly distinguishable from normal foodstuffs owing to their special composition or manufacturing process suitable for their claimed nutritional purposes marketed as suitable for particular nutritional purposes

4. 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)

5. General legislation

6. Regulation (EC) No. 178/2002 Article 3 General objectives Food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers' interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment.

7. Medical claims on all foods Foods with medical claims are considered medicines, food law does not apply The labelling and methods used must not attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties These prohibitions also apply to: a) the presentation of foodstuffs (shape, appearance or packaging), the way in which they are arranged and the setting in which they are displayed b) advertising

8. Rules on labelling, presentation and advertising Foodstuffs intended for particular nutritional uses which have not been regulated by a specific directive shall comply with the of foodstuffs for general consumption: Labelling Directive 2000/13/EC, Nutrition Labelling Directive 90/496/EC Addition of Vitamins and Minerals to foodstuffs 1925/2006/EC.

9. Compulsory labelling TOP 10 1. Name under which product is sold* 2. List of ingredients 3. Name or Business name and address of manufacturer or packager, or of seller in the EU 4. Net quantity* 5. Date of minimum durability* 6. Actual alcoholic strength of beverages >1.2% alcohol by volume* *Must appear in the same field of vision

10. Compulsory Labelling TOP 10 7. Special storage instructions/conditions of use 8. Origin – if absence misleads the consumer 9. Instructions for use where necessary 10. Quantity of certain ingredients (QUID)

11. Dir 2000/13 on labelling The labelling and methods used must not mislead the purchaser:  (i) as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production;  (ii) by attributing to the foodstuff effects or properties which it does not possess;  (iii) by suggesting that the foodstuff possesses special characteristics

12. Dir 2000/13 No medicinal claims on food contain medicinal products in significant quantities  however food and medicine may contain same ingredients like glucose, guar gum be claimed to prevent, treat or cure diseases  referrals to the relief of symptoms is not allowed either

13. Horizontal provisions

14. Directive 2009/39/EC on Foodstuffs Intended for Particular Nutritional Uses Approximation of National laws through: Common definitions Defined product composition Standards on products nature Common notification procedures Labelling rules

15. User groups of PARNUTS Products should meet requirements of: 1. Persons whose digestive processes or metabolism are disturbed 2. Persons in a special physiological condition especially benefiting from controlled consumption of certain substances in foodstuffs 3. Infants or young children in good health only i and ii may be called ‘dietetic’ or ‘dietary’ products

16. In the labelling of foodstuffs for normal consumption is prohibited: the use of the adjectives ‘dietetic’ or ‘dietary’ either alone or in conjunction with other words, to designate those foodstuffs other markings or any presentation likely to give the impression that it a product for particular nutritional use

17. Specific requirements for Parnuts essential requirements as to the nature or composition of the products provisions regarding the quality of raw materials list of specific additives provision on labelling, presentation and advertising

18. Labelling requirements Only pre-packaged products Nutritional characteristics must accompany the designation of products Detailed nutritional composition Particular elements or special manufacture process must be labeled Specific labelling requirements for products under specific directives

19. Notification Detailed provisions in specific legislation For products that do not belong to Annex I  Notification of model of label when marketed for first time (even if marketed in another MS)  Qualitative or quantitative information  Scientific substantiation of nutritional characteristics

20. Rules to come… list of substances to be added to Parnuts and the purity criteria applicable to them conditions of use provisions for foodstuffs for normal consumption that are suitable for a particular nutritional use special provisions for foods for persons with diabetes use of terms concerning the reduction or absence of sodium or salt content or the absence of gluten

21. Category specific legislation

22. Annex I of Directive 2009/39/EC 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

23. These so-called vertical directives cover the following categories of foods (1): Infant Formulae and Follow-on Formulae covered by Commission Directive 2006/141/EC Processed Cereal-based foods and baby foods for infants and young children is covered by Commission Directive 2006/125/EC Foods intended for weight reduction is covered by Commission Directive 96/8/EC Dietary Foods for Special Medical Purposes is covered by Commission Directive 1999/21/EC.

24. These so-called vertical directives cover the following categories of foods (2): foods intended to meet the expenditure of intense muscular effort, especially for sportsmen Foods for persons suffering from carbohydrate metabolism disorders (diabetes).

25. Infant formula and follow-on formula ‘infant formulae’ means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding ‘follow-on formulae’ means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants

26. Gluten – free category of foods The ‘gluten-free’ and ‘very low gluten’ foods category are covered by the stand alone Regulation 41/2009/EC 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.

27. Foods for persons suffering from diabetes Commission has not yet given any specific directive for foods for persons suffering from diabetes There is only Report from the Commission to the European Parliament and the Council from the year 2008

28. Conclusions in the report There are no scientific grounds for specific compositional criteria for foods for particu- lar nutritional uses in people with diabetes People with diabetes should be able to meet their diatary needs from normal foods

29. Foods for sportsmen Commission has not yet given any specific directive for foods for sportsmen There is only Report of the Scientific Committee for food from the year 2001 on composition and specifications In this report four food categories for sportsmen have been identified

30. Carbohydrate rich energy products Carbohydrate intake is essential in all types of exercise lasting longer than one hour High glyacemic index carbohydrates foods are recommended and they should provide 10 g per kg during 24-h recovery The refuelling should begin immediatelly after the exercise

31. Carbohydrate-electrolyte drinks During prolonged exercise drinks containing carbohydrate and electrolytes improve the performance The only electrolyte added to drinks that is known to give benefit is sodium (460-1150 mg/l) The optimum carbohydrate concentration in the drink is 80-350 kcal/1000 ml

32. Protein rich products Atheletes continue to believe, that extra protein intake is essential for maximal performance.There is not much evidence to support this. The protein requirement for strength athletes, who have trained for years, is not higher than 1,0 – 1,2 g/per kgbw per day

33. Supplemented foods There is no scientific evidence, that additional supplementation of minerals and vitamins is needed Only for caffeine and creatine there is scientific data to show they have some effect. Caffeine levels of 3-8 mg/kgbw and creatine levels of 2-3 g per day improve short-term performance

34. 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

35. Products which have similarities with PARNUTS  Functional or fortified foods  Food supplements  Novel foods  Medical devices  Medicinal products incl. herbal medicines

36. THANK YOU!!