1. © Nino Binns 2009FDIN 8 th July 20091 Safe Claims for Healthy Middle Years Nino Binns BSc PhD NMB Consulting Ireland

2. © Nino Binns 2009FDIN 8 th July 20092 Outline What type of claims are being used now and can we still use them? The latest on the regulations that control nutrition and health claims How to get new health claims approved (not easy!) Other regulations to watch out for

3. © Nino Binns 2009FDIN 8 th July 20093 Regulatory Considerations Formulation CommunicationLabelling Packaging

4. © Nino Binns 2009FDIN 8 th July 20094 Regulatory Considerations Formulation Additives Novel foods Vitamins and minerals Botanicals Nutrient profiles CommunicationLabelling Packaging

5. © Nino Binns 2009FDIN 8 th July 20095 Regulatory Considerations Formulation CommunicationLabelling Packaging

6. © Nino Binns 2009FDIN 8 th July 20096 Regulatory Considerations Formulation Communication Labelling Food Information Nutrition labelling Front of pack Packaging

7. © Nino Binns 2009FDIN 8 th July 20097 Regulatory Considerations Formulation Communication Nutrition claims Health claims Commercial communications Labelling Packaging

8. Nutrition and Health Claims Regulation 1924/2006 Annex Content Comparative Nutrition Claims Health Claims (a) Function (b) Cognitive (c) Slimming Reduction of disease risk; children’s health/devlpt Based on new science or proprietary data Art 13.1 Health claims WHAT THE PRODUCT DOES WHAT THE PRODUCT CONTAINS Art 13.5 Health claims Nutrient profiles Labelling Consumer Understanding Art 14 Health claims

9. © Nino Binns 2009FDIN 8 th July 20099 Nutrition Claims With B vitamins Rich in calcium Low fat/saturates Rich in fibre Contains isoflavones Contains omega 3 Cholesterol free Nutrition Claims WHAT THE PRODUCT CONTAINS Annex Jan 2010 Now CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE]

10. © Nino Binns 2009FDIN 8 th July 200910 Proposed New Nutrition Claims Source of omega-3 fatty acids High omega-3 fatty acids High mono unsaturated fat High poly unsaturated fat High unsaturated fat

11. © Nino Binns 2009FDIN 8 th July 200911 Nutrition Claims WHAT THE PRODUCT CONTAINS Annex Contains antioxidants Contains probiotics = Health Claims

12. © Nino Binns 2009FDIN 8 th July 200912 Health Claims List of >4000 claims being evaluated by EFSA List supposed to be adoted by Jan 2010 but delay expected Latest info that EFSA opinions not till second half 2010 Legal use claims until list published (unless Article 13.5/14 dossier rejected) Dossiers being evaluated by EFSA Decisions on Art 14 (not 13.5) voted in Standing Committee (Member States) EFSA has set very high science hurdle Art 13.1 Health claims Art 13.5 New/prop claims Art 14 DRR/child claims

13. © Nino Binns 2009FDIN 8 th July 200913 Which claims will be approved?

14. © Nino Binns 2009FDIN 8 th July 200914 EFSA Opinions Approx Status 25 June 2009 ReceivedWithdrawnPublished"Approved" Children215*15439 (11) Disease38183 Art 13.520691 *approx 145 not completed registration

15. © Nino Binns 2009FDIN 8 th July 200915 Art 13 Bone health – calcium, vitamin D Fibre - transit time Probiotics - transit time Satiety LC omega 3 - heart/vascular health WSTC - normal platelet aggregation (approved) B vitamins - mental health related Weight control (rate and amount prohibited) Isoflavones – menopause Glycaemic index/load Beauty Risky? A safe bet?

16. © Nino Binns 2009FDIN 8 th July 200916 Phytostanol/sterol - LDL cholesterol reduction (approved) Oats/ soya – LDL-C Sodium - blood pressure Tri-peptide - blood pressure Cancer related claims (not yet!) Osteoporosis A safe bet? Art 14 Risky?

17. © Nino Binns 2009FDIN 8 th July 200917 What about these? Joint health –LC omega 3, zinc, boron –Chondroitin, glucosamine, MSM, isoflavones, GLA, botanicals –Lot of evidence on “treatment” of “symptoms” Insulin sensitivity –Fibre, carbs, bread etc,; protein; Mg,Cr,Zn; DHA/EPA, CLA; (pro) anthocyanidines; fenugreek, garlic, bilberry Fruits and vegetables –Based on observational studies

18. © Nino Binns 2009FDIN 8 th July 200918 Approval of Article 13.5 and Article 14 claims

19. © Nino Binns 2009FDIN 8 th July 200919 Reading Matter Regulations COMMISSION REGULATION 353/2008 -implementing rules for applications for approval of health claims per Article 15 of 1924/2006 –Re-iteration of parts of Council regulation and of EFSA technical guidance –Sets the high standard for science into legally binding text

20. © Nino Binns 2009FDIN 8 th July 200920 Reading Matter EFSA Detailed Guidance on dossiers plus the document templates on EFSA website: http://www.efsa.europa.eu/EFSA/efsa_locale- 1178620753812_1178623592471.htm Guidance is complicated –Read it carefully then read it again –Or find an expert! Read the EFSA opinions avidly

21. © Nino Binns 2009FDIN 8 th July 200921 Key Elements of EFSA Assessment Characterisation Relevance (benefit) to human health Substantiation of the claim Proposed wording Conditions of use

22. © Nino Binns 2009FDIN 8 th July 200922 The First Consideration! Nutrient Profiles Nutrition claim - one profile may be exceeded –but must state food is “high in xxx” Health claim - must respect all profiles Sodium Saturates Sugars Apply 24 months following adoption

23. © Nino Binns 2009FDIN 8 th July 200923 Thank you Nino M Binns BSc PhD Consultant in Nutrition and Food Regulation nino.binns@nbconsulting.eu Tel/fax: +353 41 983 4644

24. Proposed New Nutrition Claims "SOURCE OF OMEGA-3 FATTY ACIDS A claim that a food is a source in omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the product contains minimum 0,3g alpha-linolenic acid per 100g [and per 100kcal], or minimum 30mg of the sum eicosapentaenoic acid and docosahexaenoic acid per 100g [and per 100kcal]. HIGH OMEGA-3 FATTY ACIDS A claim that a food is high in omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where product contains minimum 0,6g alpha-linolenic acid per 100g [and per 100kcal], or minimum 60mg of the sum eicosapentaenoic acid and docosahexaenoic acid per 100g [and per 100kcal]. HIGH MONO UNSATURATED FAT A claim that a food is high in monounsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 10% of energy of the product. HIGH POLY UNSATURATED FAT A claim that a food is high in polyunsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 10% of energy of the product. HIGH UNSATURATED FAT A claim that a food contains high amount of unsaturated fat and any claim likely to have the same meaning for the consumer may only be made where the amount of unsaturated fat is 70% of the total fat content in the product under the condition that unsaturated fat provides more than 10% of energy of the product. "

25. © Nino Binns 2009FDIN 8 th July 200925 Front of Pack Labelling