1. 1 STANDARDS, LEGISLATION, REGULATION AND REGISTRATION OF HOME FORTIFICATION PRODUCTS Jonathan Siekmann, PhD Technical Advisor, Multi-Nutrient Supplements Initiative (MSI) Secretariat, Home Fortification Technical Advisory Group (HF-TAG)

2. 2 Introduction Several international regulations are relevant for the classification of and communication around home fortification products (MNP and SQ-LNS) For home fortification programs at scale it will be important to understand the applicable international and national regulations While complying with relevant regulations, aim to ensure maximum and sustained access to information on the purpose and appropriate use of home fortification products

3. 3 Example from European Union Food supplements: foodstuffs to supplement the normal diet and which are concentrated sources of nutrients …marketed in dose form…such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles…designed to be taken in and measured small unit quantities; Nutrients means the following substances: (i)vitamins, (ii) minerals. EC Directive 2002/46

4. 4 Example from United Kingdom (England) Food supplements: food sold in dose form…to supplement the normal diet…a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination. Food supplements are not required to demonstrate their efficacy before marketing, nor are they subject to prior approval unless they are genetically modified or are “novel”. It is the responsibility of the manufacturer, importer or distributor to ensure that their product complies with the necessary legislation. THE FOOD SUPPLEMENTS REGULATIONS 2007 No. 330

5. 5 Overview Pharmaceuticals/ Medicines FoodFood Supplements/ Dietary Supplements Legislation (e.g.) EC Directive 2001/83 (EU) Medicine Act (UK) EC Directive 2002/178 (EU) Food Safety Act (UK) EC Directive 2002/46 and 2006/37 (EU) Food Supplement Regulation (England) StandardsPharmacopoeiaCodex AlimentariusPharmacopoeia RegulationsRegistration Manufacturing Labeling Advertisement Manufacturing Labeling Safety List of Allowed Vitamins and Minerals and their forms Manufacturing Labeling RegistrationMUSTNOT NECESSARY

6. 6 Registration Important to register home fortification products (MNP or SQ-LNS) in country For MNP: pharmaceutical? nutritional supplement? food? For SQ-LNS: food? nutritional supplement? Potential challenges If pharmaceutical, only medical staff can handle; storage and handling conditions more stringent; higher costs Need to be able to accommodate the home fortification product within national categories of products Might need to create new national standard for this category of products if one does not exist

7. 7 MNP Registration Category: Home Fortification Global Assessment 2011

8. 8 SQ-LNS Registration Category: Home Fortification Global Assessment 2011

9. 9 Relevant regulations and standards International International Code of Marketing of Breast-milk Substitutes (BMS) and subsequent World Health Assembly resolutions Codex Alimentarius standards and guidelines for nutrition and health claims and labeling National National laws, regulations and other measures

10. 10 The Code & Subsequent WHA Resolutions 1.The International Code of Marketing of Breast-milk Substitutes (the Code) Ensuring the appropriate marketing of breast-milk substitutes, teats and feeding bottles. These products should not be advertised or promoted. World Health Assembly (WHA) resolutions 2.Subsequent relevant World Health Assembly (WHA) resolutions: Same status as the Code Clarify or strengthen the Code Also provides guidance on the marketing of complementary foods.

11. 11 National laws, regulations and other measures Over 80 countries have implemented the Code National laws govern advertising and promotion of foods for IYC, including Information and educational materials on infant and young children not coming from health professionals Labeling of relevant products WHA 63.23 calls on Governments to ensure that nutrition and health claims shall not be made for foods for infants and young children unless specifically allowed under Codex or National Legislation

12. Main Concern: Misleading or Unsubstantiated Health Claims Support your baby’s natural immune system

13. 13 The Code and WHA resolutions: relevance to home fortification MNP Not food or breast milk substitute so clearly outside the scope of the Code and subsequent WHA resolutions Except where interpreted by National legislation SQ-LNS Not a breast milk substitute (if used from age 6+ months) Studies show it does not displace or negatively impact breast milk intake Complementary food for older infants and young children If classified as a food, it comes under the scope of the Code and subsequent WHA resolutions

14. 14 WHA Resolution 63.23 Article 1 (4) - May 2010 Calls on governments: To end inappropriate promotion of food for infants and young children and To ensure that nutrition and health claims shall not be permitted for foods for infants and young children, Except where specifically provided for, in: Relevant Codex Alimentarius standards OR National legislation

15. 15 Codex GUIDELINES FOR USE OF NUTRITION AND HEALTH CLAIMS Shown: page 1 of 8

16. Claim Definitions (CODEX) beneficial nutritional properties NUTRITION CLAIM: States, suggests or implies that a food has beneficial nutritional properties. Nutrient content claim: “contains iron”; “micronutrient fortified”; “contains essential fatty acids”; “enriched”; “fortified”; Nutrient content claim: “contains iron”; “micronutrient fortified”; “contains essential fatty acids”; “enriched”; “fortified”; Nutrient comparative claim: “reduced fat compared to X”; “less sodium than Y”; “fewer micronutrients than X”; “increased micronutrient content compared to Y”; “more iron than X” Nutrient comparative claim: “reduced fat compared to X”; “less sodium than Y”; “fewer micronutrients than X”; “increased micronutrient content compared to Y”; “more iron than X” Level of a nutrient in a food Compares the nutrient levels of two or more foods.

17. Claim Definitions (CODEX) relationship exists food and health HEALTH CLAIM: any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health. Nutrient function claims "Vitamin A is important for the maintenance of good vision and normal growth. Food X is a source of/ high in nutrient A " Nutrient function claims "Vitamin A is important for the maintenance of good vision and normal growth. Food X is a source of/ high in nutrient A " Other function claims “Omega 3 fatty acids are vital for brain development in children thereby enhancing intelligence. Product X contains Y EPA+DHA” Other function claims “Omega 3 fatty acids are vital for brain development in children thereby enhancing intelligence. Product X contains Y EPA+DHA” Reduction of disease risk “Iron may treat and prevent anaemia” Reduction of disease risk “Iron may treat and prevent anaemia” Describes the physiological role of the nutrient in growth, development and normal functions of the body. Specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet on normal functions or biological activities of the body Relating the consumption of a food or food constituent, in the context of the total diet, to the reduced risk of developing a disease or health-related condition

18. 18 Common Claims Prohibited for Complementary Foods High in calcium Good source of iron and zinc Aids in your baby's healthy growth and development Contains vitamins for healthy growth With DHA 8 Vitamins CalciumIron CalciumIron

19. Prohibited health and nutrition claims

20. What is ‘Inappropriate Promotion’? Are all claims inappropriate? Claims on breast milk substitutes are always inappropriate Promotion for use before 6 months is always inappropriate SQ-LNS≠ breastmilk substitutes – but if classified as food, claims not allowed unless permitted in national legislation WHA Resolution 63.23 "to end inappropriate promotion of food for infants and young children and to ensure that nutrition and health claims shall not be permitted for foods for infants and young children, except where specifically provided for, in relevant Codex Alimentarius standards or national legislation“

21. 21 Example from Zambia Design for labeling and packaging developed in the preparatory phase of pilot study Formative research findings shaped design Consultation with the National Fortification Alliance, partners & government representatives to develop Zambia-specific packaging

22. 22 Initially proposed package design

24. 24 Revisions to initial design Law-enforcers as guardians of the Code, who were not included in initial discussions, learned of proposed packaging design Purpose of MNP misunderstood Forced to change design in final stages IMPORTANT: Early engagement & active dialogue with all relevant groups throughout the package design process to prevent misunderstandings & ensure compliance with national legislation.

25. 25 Final Sachet Design Final Box Design

26. 26 Latest developments (2012) …WHA 65.6 Adopts the Comprehensive Implementation Plan on Maternal, Infant and Young Child Nutrition Requested that the Director-General “provide clarification and guidance on the inappropriate promotion of foods for infants and young children cited in resolution WHA63.23, taking into consideration the ongoing work of the Codex Alimentarius Commission.” WHO currently setting up a technical advisory group to look at the above

27. 27 Conclusion For labeling, marketing, manufacture and registration of MNP and SQ-LNS Important to consider national laws, the Code, and subsequent WHA resolutions Aim to ensure that target beneficiaries have maximum and sustained access to information on the purpose and appropriate use of home fortification products

28. 28 THANK YOU FOR YOUR ATTENTION jsiekmann@gainhealth.org