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Safe Claims for Healthy Middle Years

Safe Claims for Healthy Middle Years. Nino Binns BSc PhD NMB Consulting Ireland. 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!)

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Safe Claims for Healthy Middle Years

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  1. Safe Claims for Healthy Middle Years Nino Binns BSc PhD NMB Consulting Ireland 1

  2. 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 2

  3. Regulatory Considerations Formulation Packaging Labelling Communication 3

  4. Regulatory Considerations Formulation Additives Novel foods Vitamins and minerals Botanicals Nutrient profiles Packaging Labelling Communication 4

  5. Regulatory Considerations Formulation Packaging Labelling Communication 5

  6. Regulatory Considerations Formulation Packaging Labelling Food Information Nutrition labelling Front of pack Communication 6

  7. Regulatory Considerations Formulation Packaging Communication Nutrition claims Health claims Commercial communications Labelling 7

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

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

  10. 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 10

  11. Nutrition Claims Nutrition Claims WHAT THE PRODUCT CONTAINS • Contains antioxidants • Contains probiotics Annex = Health Claims 11

  12. 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 Health Claims Art 13.1 Health claims Art 13.5 New/propclaims Art 14 DRR/child claims 12

  13. Which claims will be approved? 13

  14. EFSA OpinionsApprox Status 25 June 2009 *approx 145 not completed registration 14

  15. 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 Art 13 A safe bet? Risky? 15

  16. Phytostanol/sterol - LDL cholesterol reduction (approved) Oats/ soya – LDL-C Sodium - blood pressure Tri-peptide - blood pressure Cancer related claims (not yet!) Osteoporosis Art 14 A safe bet? Risky? 16

  17. 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 17

  18. Approval of Article 13.5 and Article 14 claims 18

  19. Reading MatterRegulations • 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 19

  20. 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 20

  21. Key Elements of EFSA Assessment • Characterisation • Relevance (benefit) to human health • Substantiation of the claim • Proposed wording • Conditions of use 21

  22. The First Consideration!Nutrient Profiles • Sodium • Saturates • Sugars • Nutrition claim - one profile may be exceeded –but must state food is “high in xxx” • Health claim - must respect all profiles Apply 24 months following adoption 22

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

  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. Front of Pack Labelling 25

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