1. Parliamentary Portfolio Committee on Health Medicines and Related Substances Amendment Bill Comment by Danone Clover (Pty) Ltd Presented by Jane Badham, M.Sc Nutrition, Consultant Dietitian

2. Introducing Danone Clover Bringing Health through food to as many people as possible Danone globally is the leading producer of fresh dairy products (yoghurt & fresh cheese) Danone globally is present in 46 countries South Africa’s leading processor of yoghurt, cultured milk (maas) and desserts Local brands include Nutriday, Activia, Danino, Danao, Inkomazi, Vitalinea, Ultramel, Yogi Sip

3. Key Concern DEFINITION The DEFINITION of ‘Foodstuff’ in the Bill and the implications this potentially has for the food business and the promotion of health for all South Africans INCLUSION The INCLUSION of Foodstuffs in the Medicines and Related Substances Amendment Bill Support ALL products sold requiring to be SAFE, good QUALITY & EFFICACIOUS

4. Highlight Points 1.Global foodstuff definition and standards for Health Claims – CODEX Alimentarius 2.Local foodstuff definition and regulations for Health Claims – Regulations Relating to the Labelling and Advertising of Foodstuffs 3.Implications of the proposed Medicines and Related Substances Amendment Bill

5. CODEX ALIMENTARIUS Created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. Key purposes: –Protecting the health of consumers –Ensuring fair practices in food trade –Promoting coordination of all food standards work. www.codexalimentarius.net

6. CODEX and Health Claims 2 of the 12 CODEX Committees include health claims in their mandate CODEX Committee on Food Labelling (CCFL) CODEX Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) SOUTH AFRICA represented & active on both Committees through DOH

7. CODEX DEFINITION OF FOODSTUFF “any substance, whether processed, semi- processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs.” FOODS & MEDICINES clearly separated

8. CODEX Committee on Food Labelling NUTRITION AND HEALTH CLAIMS “Health claims should be consistent with national health policy, including nutrition policy, and support such policies where applicable. Health claims should be supported by a sound scientific body of evidence to substantiate the claim, provide truthful and non-misleading information to aid consumers in choosing healthful diets and be supported by specific consumer education…”

9. CODEX Committee on Food Labelling NUTRITION AND HEALTH CLAIMS Nutrient Content Claim Nutrient Comparative Claim Nutrient Function Claim Other Function Claim Reduction of Disease Risk Claim CLEAR definitions & guidelines

10. CODEX Committee on Food Labelling GENERAL GUIDELINES – PROHIBITED CLAIMS that any given food will provide an adequate source of all essential nutrients, except …. implying that a balanced diet or ordinary foods cannot supply adequate amounts of all nutrients which cannot be substantiated to the suitability of a food for use in the prevention, alleviation, treatment or cure of a disease, disorder, or particular physiological condition unless they are: (a) in accordance with the provisions of CODEX standards or guidelines for foods under jurisdiction of the Committee on Foods for Special Dietary Uses, or (b) permitted under the laws of the country in which the food is distributed.

11. FOODS FOR SPECIAL DIETARY USES “Those foods which are specifically processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such. The composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist.” CODEX Committee on Nutrition and Foods for Special Dietary Uses CLEAR definitions & guidelines

12. Work in progress –Re-evaluating –Revising –Considering WHO/FAO documents (Global Strategy on Diet, Nutrition and the Prevention of Chronic Diseases) and how they can be incorporated CODEX

13. Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972)Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972) –Regulations Relating to the Labelling and Advertising of Foodstuffs Current in-force [R2034 of 29 th October 1993] Proposed second draft [R642 of 20 th July 2007] SOUTH AFRICA Significantly aligned with CODEX Comments have been submitted (102)

14. Foodstuffs, Cosmetics & Disinfectants Act DEFINITION OF A FOODSTUFF “any article or substance (except a medicine as defined in the Medicine and Related Substances Act 1965 [Act no.101 of 1965]) ordinarily eaten or drunk by a person or purporting to be suitable, or manufactured or sold, for human consumption, and includes any part or ingredient of any such article or substance, or any substance used or intended or destined to be used as a part or ingredient of any such article or substance”

15. Proposed Regulations Relating to the Labelling & Advertising of Foodstuffs PROHIBITED STATEMENTS Words, pictorial representations, marks of descriptions which create an impression that such a foodstuff is supported by, endorsed by, complies with or has been manufactured in accordance with recommendations by –Medical or dental practitioners, psychologists or other persons who carry on a supplementary health service referred in the Health Professions Act, individually or through any professional or consumer advisory organisations consisting of one or more health practitioner –Organisations, associations, foundations and other entities, unless approved by the DG and can then provide proof of the fact that they are involved in generic health promotion which will improve the nutritional status of the people… –an individuals endorsement or testimonial in the form of a picture, written or verbal statement or in any other form, unless it is based on an evidence based nutrition motivation and submitted for pre- market approval by the DG

16. Proposed Regulations Relating to the Labelling & Advertising of Foodstuffs PROHIBITED STATEMENTS –the words ‘health’ or ‘healthy’ or other words or symbols implying that the foodstuff in and of itself has health giving properties in any manner including the name or trade name –the words ‘wholesome’ or ‘nutritious… –a claim that the foodstuff provides complete or balanced nutrition… –Subject to the Medicines and Related Substances Act 1965 (Act 101 of 1965), the word ‘cure’ or any other medicinal claim, except those health claims permitted in terms of these regulations.”

17. Proposed Regulations Relating to the Labelling & Advertising of Foodstuffs DEFINITION OF A HEALTH CLAIM “Means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health, and include but are not limited to nutrient function claims, enhanced function claims, reduction of disease risk claims, prebiotic claims, probiotic claims and slimming claims”

18. Proposed Regulations Relating to the Labelling & Advertising of Foodstuffs HEALTH AND NUTRITION CLAIMS Nutrient Content Claims Nutrient Function Claims Enhanced Function Claims Reduction of Disease Risk Claims Other claims… Detailed requirements and conditions

19. Medicine and Related Substances Amendment Bill NOW includes Foodstuffs “A foodstuff as defined in the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), in respect of which a medicinal claim is made” What is the definition of ‘medicinal claim’?

20. Medicine and Related Substances Amendment Bill Definition of Medicine (Act 101 of 1965) “any substance or mixture of substances used or purporting to be suitable for use or manufacture or sale for use in - (a)the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or (b)restoring, correcting or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine”

21. Medicine and Related Substances Amendment Bill Can we then say that any food that makes certain nutrition & health claims is making a ‘medicinal claim’?

22. Medicine and Related Substances Amendment Bill Example: Example: Proposed nutrient function claim for CALCIUM: “Helps maintain healthy bones and teeth, & a healthy nervous system. Important for healthy regular heartbeat. Needed for muscular growth & contraction & prevents muscle cramps. Essential in blood clotting.” Mitigation Disease prevention Treatment Modifying Correcting Restoring

23. Medicine and Related Substances Amendment Bill Will a yoghurt that makes an approved calcium nutrient function claim be required to register ?

24. Medicine and Related Substances Amendment Bill Example: Example: Existing health claim for mandatory fortified foods: Treatment Restoring Correcting Modifying Disease prevention

25. Medicine and Related Substances Amendment Bill Will bread & maize meal be required to register ?

26. Medicine and Related Substances Amendment Bill MISUNDERSTANDINGCONFUSION What requires registration? What is the purpose behind this amendment to the Bill? Stakeholder consultationIMPLICATIONS Logistics Costs Health impact Barrier to trade (WTO)

27. Conclusion We feel strongly that globally and locally foods should be regarded and regulated independently from medicines We urge the Committee to remove foods from this Bill as health and nutrition claims are being addressed in the Regulations Relating to the Labelling and Advertising of Foodstuffs