1. Directive 2009/39/EC on PARNUTS Directive 96/8/EC on Foods for use in energy- restricted diets for weight reduction Martijn Martena, PhD Netherlands Food and Consumer Product Safety Authority Utrecht, the Netherlands Belgrade 19-20 March 2012

2. Workshop on PARNUTS - Belgrade, 19-20 March 2012 2 Topics  2009/39/EC: Foodstuffs intended for particular nutritional uses  96/8/EC: Food intended for use in energy-restricted diets for weight reduction

3. Workshop on PARNUTS - Belgrade, 19-20 March 2012 3 PARNUTS Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses Directive 2009/39/EC is a recast of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses because of many amendments

4. Workshop on PARNUTS - Belgrade, 19-20 March 2012 4 Definition PARNUTS Foodstuffs intended for particular nutritional uses (PARNUTS) are foodstuffs which, owing to their special composition or manufacturing process, are: clearly distinguishable from foodstuffs for normal consumption suitable for their claimed nutritional purposes marketed as suitable for particular nutritional purposes

5. Workshop on PARNUTS - Belgrade, 19-20 March 2012 5 User groups of PARNUTS PARNUTS should meet requirements of: iPersons whose digestive processes or metabolism are disturbed iiPersons in a special physiological condition who benefit especially from controlled consumption of certain substances in foodstuffs iiiInfants or young children in good health only i and ii may be called ‘dietetic’ or ‘dietary’ products normal foods cannot be presented as PARNUTS through the use of the words ‘dietetic’ or ‘dietary’ or in any other way

6. Workshop on PARNUTS - Belgrade, 19-20 March 2012 6 Groups of PARNUTS Existing Directives: 1.Infant formulae and follow-on formulae (Directive 2006/141/EC) 2.Processed cereal-based foods and baby foods for infants and young children (Directive 2006/125/EC) 3.Food intended for use in energy-restricted diets for weight reduction (Directive 96/8/EC) 4.Dietary foods for special medical purposes (Directive 1999/21/EC)

7. Workshop on PARNUTS - Belgrade, 19-20 March 2012 7 Groups of PARNUTS Directives not yet introduced: 1. Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen; 2. Foods for persons suffering from carbohydrate- metabolism disorders (diabetes) (article 3 and annex I)

8. Workshop on PARNUTS - Belgrade, 19-20 March 2012 8 Labelling PARNUTS (1) Conditions for claims concerning the absence of gluten or absence/ reduction of sodium are to be defined by the Commission (article 5) Regulation (EC) No 41/2009 of 20 January concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten applies since 1 January 2012

9. Workshop on PARNUTS - Belgrade, 19-20 March 2012 9 Labelling PARNUTS (2) In labelling, presentation or advertising of PARNUTS no properties for the prevention, treatment or cure of human disease may be used or suggested derogation for information to persons with qualifications in medicine, nutrition or pharmacy! (article 8)

10. Workshop on PARNUTS - Belgrade, 19-20 March 2012 10 Labelling PARNUTS (3) Labelling must include Indication of its particular nutritional characteristics very important: this indication is mandatory and is therefore not covered by Regulation No. 1924/2006 Products for which no specific Directive has been adopted: composition particulars or special manufacturing process that provides it with its particular nutritional characteristics energy in kJ and kcal, carbohydrates, fat, protein per 100g or ml if energy <50kJ words may be used:energy value less than 50 kJ (article 9)

11. Workshop on PARNUTS - Belgrade, 19-20 March 2012 11 Packaging Products only allowed on retail market in pre-packaged form Package shall completely cover products Member States may permit derogations, provided that product is accompanied by obligatory labelling conditions (article 10)

12. Workshop on PARNUTS - Belgrade, 19-20 March 2012 12 Notification For PARNUTS which do not fit one of existing categories: When placed on the market for the first time the competent authority in that Member State must be notified by sending the label At each subsequent placing on the market in other Member States the same information including the initial notification has to be sent to the competent authority The producer must present scientific data proving the suitability for the intended goal and the beneficial effects of the product (article 11)

13. Workshop on PARNUTS - Belgrade, 19-20 March 2012 13 Composition Addition of nutritional substances to PARNUTS is controlled by: positive lists included in the specific directives Directive Regulation (EC) No 953/2009 (applies since 1 January 2010) contains lists of permitted minerals, vitamins, amino acids, carnitine and taurine, nucleotides, choline and inositol The addition must meet the special requirements of the users and is based on scientific data (to be presented when desired)

14. Workshop on PARNUTS - Belgrade, 19-20 March 2012 14 Topics  2009/39/EC: Foodstuffs intended for particular nutritional uses  96/8/EC: Food intended for use in energy-restricted diets for weight reduction

15. Workshop on PARNUTS - Belgrade, 19-20 March 2012 15

16. Workshop on PARNUTS - Belgrade, 19-20 March 2012 16 Foods for use in energy-restricted diets for weight reduction (96/8/EC) Divided in: products presented as a replacement for the whole of the daily diet =>labelling: “total diet replacement for weight control” products presented as a replacement for one or more meals of the daily diet => labelling: “meal replacement for weight control”

17. Workshop on PARNUTS - Belgrade, 19-20 March 2012 17 meal replacement for weight control? Products are not covered by Directive 96/8/EC but by the food supplements directive 2002/ 46/EC Green Coffee 1000: instant coffee with botanicals “1000 years history with Asian wisdom for healthy weight loss”

18. Workshop on PARNUTS - Belgrade, 19-20 March 2012 18 Composition (annex 1)

19. Workshop on PARNUTS - Belgrade, 19-20 March 2012 19 Labelling(1) In addition to art 3 of labelling Directive 2000/13/EC (current labelling directive which replaced Directive 79/112/EEC): energy in kcal and kJ, protein, carbohydrates, fat, expressed per quantity for consumption minerals and vitamins as stipulated per quantity for consumption; for meal replacement also as % of RDA (Directive 90/496/EEC, nutrition labelling) Directives 2000/13/EC and 90/496/EEC will be replaced by Regulation No. 1169/2011, which will apply starting 13 December 2014

20. Workshop on PARNUTS - Belgrade, 19-20 March 2012 20 Labelling(2) instructions for appropriate preparation + statement of importance of following these instructions statement of laxative effect if polyols > 20 g/day statement of importance of maintaining adequate daily fluid intake

21. Workshop on PARNUTS - Belgrade, 19-20 March 2012 21 Labelling(3) Compulsory statements for total diet replacement products: that it provides adequate amounts of nutrients/ d that it should not be used for more than 3 weeks without medical advice for meal replacement products: use only as part of energy-restricted diet that includes other foodstuffs No references to rate or amount of weight loss Claims regarding reduction of hunger or increase of satiety are allowed by Regulation No. 1924/2006 on nutrition and health claims

22. Workshop on PARNUTS - Belgrade, 19-20 March 2012 22 Claims on foods intended for use in energy-restricted diets for weight reduction (96/8/EC) in relation to Regulation No. 1924/2006 For foods intended for use in energy-restricted diets for weight reduction, no specific provisions on the use of nutrition and health claims are laid down in Directive 96/8/EC. Thus, nutrition and health claims made on foods intended for use in energy-restricted diets for weight reduction are governed by Regulation No. 1924/2006 on nutrition and health claims.