1. 1 by Jan Hermans Secretary General A.I.J.N. Update on EU Health Claims Regulation IX INTERNATIONAL SYMPOSIUM POLISH ASSOCIATION OF JUICE PRODUCERS Belchatow, 9-11 May, 2006

2. 2 Content 1. EU legislation related to health claims 2.Making the case for 100 % juices

3. 3 1. EU Legislation on Health Claims

4. 4 Proposed EP and Council Regulation on Nutrition and Health Claims made on Foods General Proposed EP and Council Regulation on Nutrition and Health Claims made on Foods General Aims Harmonisation of rules at European level in order to ensure free movement of foods and to protect consumers Harmonisation of rules at European level in order to ensure free movement of foods and to protect consumers Defining nutrition and health claims to be used by food producers in commercial communications to the final consumer Defining nutrition and health claims to be used by food producers in commercial communications to the final consumer Specifying the conditions for the use of nutrition and health claims ( & prohibits certain claims) Specifying the conditions for the use of nutrition and health claims ( & prohibits certain claims)

5. 5 Nutrition and Health Claims Reg. Timetable 2003, July 16 – Proposal adopted by the European Commission 2003, July 16 – Proposal adopted by the European Commission 2003, July 17 - Proposal transmitted to European Parliament 2003, July 17 - Proposal transmitted to European Parliament Leading Committee: Environment, Public Health and Consumer Protection 2005, May 25 - First vote in plenary session EP 2005, May 25 - First vote in plenary session EP 2005, May 26 - Commission position on EP amendments 1st reading 26.05.2005 2005, May 26 - Commission position on EP amendments 1st reading 26.05.2005 2005, December 8 - Council common position 2005, December 8 - Council common position

6. 6 Nutrition and Health Claims Reg. Timetable 2006, March 21 - Second vote in ENVI Committee 2006, March 21 - Second vote in ENVI Committee Trilogue meetings (Council-EC-EP meetings) through April and early May with the aim to agree on compromise amendments for the second reading in the EP Plenary (deadline 17/05) Trilogue meetings (Council-EC-EP meetings) through April and early May with the aim to agree on compromise amendments for the second reading in the EP Plenary (deadline 17/05) 2006, May 10 COREPER 2006, May 10 COREPER 2006, May 15-18 EP Plenary Session vote 2006, May 15-18 EP Plenary Session vote Council has 4 months to consider Parliament’s amendments. If Council does not accept all amendments, 2-month conciliation procedure Council has 4 months to consider Parliament’s amendments. If Council does not accept all amendments, 2-month conciliation procedure

7. 7 Nutrition and Health Claims Reg. Definitions Nutrition claim: any claim stating/implying that a food has particular beneficial nutritional properties due to Nutrition claim: any claim stating/implying that a food has particular beneficial nutritional properties due to - the energy it provides or not, either at reduced or increased rate “no added sugar”, “light” - the nutrients or other substances it contains or not, either in reduced or increased proportions “rich in vitamin c”, “source of potassium” Health claims: any claim stating/implying a relationship between a food or one of its constituents and health Health claims: any claim stating/implying a relationship between a food or one of its constituents and health “ Calcium strengthens bones and teeth”

8. 8 Nutrition and Health Claims Reg. Definitions Disease risk reduction claim: any health claim stating/implying that the consumption of a food or one of its constituents significantly reduces a risk factor in the development of a human disease Disease risk reduction claim: any health claim stating/implying that the consumption of a food or one of its constituents significantly reduces a risk factor in the development of a human disease “ Potassium maintains a healthy heart and can help to reduce the risk of strokes” “ Calcium intake can help reduce the risk of osteoporosis”  A trade mark, brand name or fancy name appearing in the labelling or advertising of a food which may be construed as a nutrition of health claim may be used provided that it is accompanied by a related nutrition of health claim complying with the Regulation

9. 9 Nutrition and Health Claims Reg. General Principles Nutrition and health claims shall not be false or misleading be false or misleading give rise to doubt about safety/nutritional adequacy of other foods give rise to doubt about safety/nutritional adequacy of other foods encourage excess consumption encourage excess consumption state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general

10. 10 Nutrition and Health Claims Reg. General Conditions of use The Commission is to set specific nutrient profiles and the conditions to be respected for the use of N & H claims on foods and categories of foods The Commission is to set specific nutrient profiles and the conditions to be respected for the use of N & H claims on foods and categories of foods The nutrient profiles established for food will take into account: The nutrient profiles established for food will take into account: - quantities of certain nutrients such as fat-sugar-salt - role and importance of the food in the population’s diet - overall nutritional composition of food and presence of nutrients scientifically recognised as health beneficial nutrients scientifically recognised as health beneficial Nutrient profiles to be based on scientific knowledge Nutrient profiles to be based on scientific knowledge Advice to come from Eur. Food Safety Authority Advice to come from Eur. Food Safety Authority

11. 11 Nutrition and Health Claims Reg. General conditions of use Use of N & H claims only allowed if Use of N & H claims only allowed if - the presence/absence/reduction of the nutrient or substance has a shown nutritional or physiological effect (scientifically established) - the nutrient or substance is present in the final product in a significant quantity - the food quantity to be consumed is reasonable - the nutrient must be bio-available for the body Claims must be understandable to the average consumer Claims must be understandable to the average consumer Claims shall refer to ready to eat/drink food Claims shall refer to ready to eat/drink food

12. 12 Nutrition and Health Claims Reg. Specific conditions of use – Nutrition Claim Nutrition claims only permitted if listed in the Annex to the Regulation Nutrition claims only permitted if listed in the Annex to the Regulation Comparative claims only between foods of the same category Comparative claims only between foods of the same category

13. 13 Nutrition and Health Claims Reg. Specific conditions of use – Health Claims Health claims only permitted if the labeling, or by its absence, the presentation and advertising, includes: Health claims only permitted if the labeling, or by its absence, the presentation and advertising, includes: - a statement related to benefit of balanced diet & healthy lifestyle - the quantity and pattern of consumption to obtain the beneficial effect - warning statements as to risks related to excess or when consumption should be avoided Reference to general, non-specific benefits for overall good health or health related well-being can only be made if accompanied by a specific health claim Reference to general, non-specific benefits for overall good health or health related well-being can only be made if accompanied by a specific health claim

14. 14 Nutrition and Health Claims Reg. Specific conditions of use – Health Claims Health claims Health claims - suggesting that health could be affected by not consuming the food - making reference to rate or amount of weight loss - making reference to recommendations of individual doctors or health professionals or other associations are not allowed

15. 15 Nutrition and Health Claims Reg. Specific conditions of use – Health Claims A Community list/Register of permitted health claims with conditions of use will be established by the Commission A Community list/Register of permitted health claims with conditions of use will be established by the Commission The initial list is to include scientifically justified claims provided by the Member States and viewed by the EFSA The initial list is to include scientifically justified claims provided by the Member States and viewed by the EFSA Health claims included in the list may be made without undergoing the authorisation procedure Health claims included in the list may be made without undergoing the authorisation procedure Additional claims will need to be adopted following the authorisation procedure Additional claims will need to be adopted following the authorisation procedure

16. 16 Nutrition and Health Claims Reg. Specific conditions of use – Disease risk reduction claims The authorisation procedure applies to all disease risk reduction claims The authorisation procedure applies to all disease risk reduction claims The labelling of disease risk reduction claims, or by absence of labelling, the presentation or advertising shall state that the disease to which the claim refers has multiple risk factors and that altering one of these factors may or may not have a beneficial effect The labelling of disease risk reduction claims, or by absence of labelling, the presentation or advertising shall state that the disease to which the claim refers has multiple risk factors and that altering one of these factors may or may not have a beneficial effect

17. 17 Nutrition and Health Claims Reg. Authorisation procedure Applications for authorisation will have to be submitted to national competent authorities Applications for authorisation will have to be submitted to national competent authorities Detailed guidance for applications will be drafted by EFSA Detailed guidance for applications will be drafted by EFSA Envisaged authorisation procedure will take at least 9 months Envisaged authorisation procedure will take at least 9 months Data protection clause of 7 years can restrict health claim use to original applicant Data protection clause of 7 years can restrict health claim use to original applicant

18. 18 Nutrition and Health Claims Reg. Status of proceedings Nutrition and Health Claims Reg. Status of proceedings after 2nd reading in EP ENVI Committee Main controversial issues Art.4 Foods must comply with specific nutrient profiles in order to bear nutrition or health claims Art.4 Foods must comply with specific nutrient profiles in order to bear nutrition or health claims - ENVI wants to allow claims if one element of the nutrient profile is exceeded provided reference is made to the profile is exceeded provided reference is made to the nutrient in question nutrient in question Art. 14-18 Requirements set in the authorisation procedure i.e. time frame/timing data protection Art. 14-18 Requirements set in the authorisation procedure i.e. time frame/timing data protection - ENVI wants a faster procedure & shorten data protection

19. 19 2. Making the case for 100% fruit juices in the Five-a-Day Programmes

20. 20 Background WHO and EU Commission support 5-a-Day programmes which promote consumption of fruits & vegetables as a way to reduce noncommunicable diseases. It is explicitly recognised that 1 serving of 100% fruit juice (6 ounces or <20 cl) counts as one portion of fruit & vegetables WHO and EU Commission support 5-a-Day programmes which promote consumption of fruits & vegetables as a way to reduce noncommunicable diseases. It is explicitly recognised that 1 serving of 100% fruit juice (6 ounces or <20 cl) counts as one portion of fruit & vegetables cfr. Eurodiet report / WHO

21. 21 Background Official recommendation is of strategic importance for the industry because it confirms & strengthens the positive image of juices Official recommendation is of strategic importance for the industry because it confirms & strengthens the positive image of juices The official recognition that one serving of 100% fruit juice counts as a portion of fruit is however in practice not sufficient incorporated /reflected in the existing 5-a-Day programmes or is even being questioned in certain EU member states The official recognition that one serving of 100% fruit juice counts as a portion of fruit is however in practice not sufficient incorporated /reflected in the existing 5-a-Day programmes or is even being questioned in certain EU member states

22. 22 Why are fruit juices absent? Contributing factors Depending upon the countries the 5-a-Day schemes may be governmental, semi governmental or private. Depending upon the countries the 5-a-Day schemes may be governmental, semi governmental or private. Often the private schemes or run by bodies representing fresh fruit and vegetables growers which apply different rules e.g. Finland – Finnish Horticultural Products Society excludes fruit juices because the raw material is mostly imported Spain – Association which owns the logo limits promotion to consumption of fresh fruits – even direct juice is not in

23. 23 Why are fruit juices absent? Contributing factors Wide spread scepticism that 100 % fruit juices really exist Wide spread scepticism that 100 % fruit juices really exist Lack of understanding and knowledge of the different product categories Lack of understanding and knowledge of the different product categories - 100 % Juice (NFC & FC), Nectar and Juice drinks General disbelief with labelling declarations (hidden ingredients) General disbelief with labelling declarations (hidden ingredients) Disbelief is re-enforced by misleading presentation and labelling of “juice impersonators” and …by Disbelief is re-enforced by misleading presentation and labelling of “juice impersonators” and …by

24. 24 Why are fruit juices absent? Contributing factors The use of non regulated descriptions like “100%”, “pure”, “authentic”, “premium”, “traditional”, “directly pressed” for different products within the fruit juice category and the use of negative claims without reference to legislation The use of non regulated descriptions like “100%”, “pure”, “authentic”, “premium”, “traditional”, “directly pressed” for different products within the fruit juice category and the use of negative claims without reference to legislation Fruit Juices get framed in the “sugar debate” Fruit Juices get framed in the “sugar debate” Resulting in fruit juices being discriminated with traffic light labelling due to the quantity of natural intrinsic sugars Resulting in fruit juices being discriminated with traffic light labelling due to the quantity of natural intrinsic sugars e.g. Swedish Food Administration rules for keyhole labelling to be used for foods low in fat and sugar, high in fibres exclude juices

25. 25 Why are fruit juices absent? Contributing factors Complaints by fresh fruit producers at official level on the way smoothies / drinks with real fruit pieces are marketed Complaints by fresh fruit producers at official level on the way smoothies / drinks with real fruit pieces are marketed

26. 26 Issues to be adressed 1.Defend the officially acknowledged inclusion of fruit juices within existing 5-a-Day programmes at EU and National level 2.Counter sceptical opinions that 100% fruit juices do not exist and those challenging fruit juices in 5-a-Day programmes

27. 27 Actions proposed Defend inclusion juices in 5-a-Day Request EU Commission (DG AGRI & SANCO) to ensure that coherent and clear messages are given to the consumers in relation to 5-a-Day Request EU Commission (DG AGRI & SANCO) to ensure that coherent and clear messages are given to the consumers in relation to 5-a-Day - development of common rules (on products and portions) portions) - clarify discrimination based upon origine of fruit - inclusion in school programmes - European logo - organise round table with all stakeholders in F&V sector F&V sector

28. 28 Actions proposed Defend inclusion juices in 5-a-Day AIJN with its members to lobby National Governments & organisations that do not include 100% fruit juices AIJN with its members to lobby National Governments & organisations that do not include 100% fruit juices Use existing AIJN position papers on Use existing AIJN position papers on - Fruit Juice Nutrition Policy - Fruit Juice and Obesity. Contribution of fruit juice to a healthy diet Use the results of a new American study which links 100% juice consumption to a healthier diet Use the results of a new American study which links 100% juice consumption to a healthier diet

29. 29 JPA’s 100% Juice Consumption Analysis Selected Dr. Victor Fulgoni, independent researcher Selected Dr. Victor Fulgoni, independent researcher Used USDA’s “What We Eat in America” database (1999-2002) Used USDA’s “What We Eat in America” database (1999-2002) Evaluated kids ages 2-18 Evaluated kids ages 2-18 –Amounts 100% juice consumed –Overall dietary patterns in juice consumers vs non-consumers –Effect on body weight – BMI- Z-scores (CDC) Courtesy of the Juice Products Association (US)

30. 30 PURPOSE: To examine the impact of 100% fruit juice consumption by children ages 2-18 years on food and nutrient intake, body weight status and risk of being overweight. SUBJECTS: 1999-2002 NHANES participants, which included children ages 2 to 18 years of age (N=7,557) with reliable 24-hour recall dietary interviews meeting minimum criteria. Courtesy of the Juice Products Association (US)

31. 31Conclusions Children who drank 100% juice had healthier dietary patterns: –Significantly more total fruit – a threefold increase in total fruit consumption versus non juice consumers –Significantly less total fat, saturated fat, sodium and added sugar in their diet than non-consumers –Significantly more nutrients relative to non- consumers – 140% more vitamin C, 25% more potassium, 15% more folate, 11% more magnesium and 9% more dietary fiber –Significantly more nutrients relative to non- consumers – 140% more vitamin C, 25% more potassium, 15% more folate, 11% more magnesium and 9% more dietary fiber Courtesy of the Juice Products Association (US)

32. 32 Conclusions (cont’d.) Overall, body weight status variables did not differ between juice consumers and non-consumers, with 2 exceptions : –In children 12-18 years of age, BMI was significantly lower in juice consumers versus non-juice consumers; no difference seen in children 2-11 –Juice consumers had an 18% lower risk for being overweight. Courtesy of the Juice Products Association (US)

33. 33Significance Concur with previous studies that suggest that fruit juice consumption is not associated with overweight in children and may be associated with a reduced risk of being overweight when consumed at recommended levels. Concur with previous studies that suggest that fruit juice consumption is not associated with overweight in children and may be associated with a reduced risk of being overweight when consumed at recommended levels. 100% juice consumption makes an important contribution to meeting daily fruit serving requirements. 100% juice consumption makes an important contribution to meeting daily fruit serving requirements. Children who consume 100% juices also consume higher levels of key nutrients including potassium, magnesium, and vitamin C. Children who consume 100% juices also consume higher levels of key nutrients including potassium, magnesium, and vitamin C. Courtesy of the Juice Products Association (US)

34. 34 New Data Analysis is consistent with US 2005 Dietary Guidelines Findings supportive of statements in the 2005 Dietary Guidelines Advisory Committee report which states that fruit juices provide higher, more substantial contributions of several vitamins and minerals than whole fruit. Findings supportive of statements in the 2005 Dietary Guidelines Advisory Committee report which states that fruit juices provide higher, more substantial contributions of several vitamins and minerals than whole fruit. With the exception of fiber, these include vitamin C, potassium, folate and magnesium. With the exception of fiber, these include vitamin C, potassium, folate and magnesium. Courtesy of the Juice Products Association (US)

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36. 36 THANK YOU FOR YOUR ATTENTION