CODEX PROPOSAL FOR READY TO USE THERAPEUTIC FOODS
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1 CODEX PROPOSAL FOR READY TO USE THERAPEUTIC FOODS International Regulation for foods used in CMAM contexts Alison Fleet Supply Division, 1 July 2015
2 WHAT IS THE CODEX ALIMENTARIUS? Type your title in this FOOTER area and in CAPS
3 Mission: Codex aims to set regulation to ensure safe, good foods for International trade Committees and Subcommittees Codex Alimentarius consists of numerous committees that are responsible for the work of establishing guidelines or standards. is working with: CCNFSDU (Codex Committee for Nutrition and Foods for Special dietary uses) & CCFH (Codex Committee for Food Hygiene) Codex Proposal for Ready to use Therapeutic Foods
4 THE CODEX PROCESS Proposal by a country Plenary reaches consensus for each step Progress in steps Codex Guideline, Standard or Code Committee plenary consider Plenary reach a consensus Work begins (EWG)
5 Safety of global supply of RUTF Smooth importing and exporting building regulatory capacity Assist manufacturers Resolution of disputes (trade and safety) Purpose of Codex for RUTF
6 UPDATE : CCFH CCFH 16 th - 19 th November 2014 Request that RUF for acute malnutrition are included in the ongoing codex work on a Code of Hygienic practice for Low Moisture Foods. Electronic working group The committee agreed to include the foods as an example in the Code, and SD are now part of the electronic working group of the committee. This work will cover the microbiological specification only.
7 UPDATE : CCNFSDU Proposal presented CCNFSDU 16 th - 19 th November 2014 SD presented a discussion paper on a proposal for a commodity codex standard for RUF in acute malnutrition on 26 th of November 2014 at the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU). Redraft proposal for CCNFSDU November 23 rd - 27 th November 2015 After much debate, the committee agreed that the document should be redrafted to address country member s comments
8 Codex standard for RUF will not change the lack of regulation in many countries (EU) examples of recipes for RUF developed for Vietnam, Bangladesh, Ethiopia, and Pakistan that incorporate local ingredients sustainability RUF is not widely consumed and has trade low value (EU) Focus should be on affordable culturally appropriate foods Regulatory status is unclear: Medicine or Food? Medicines are outside the scope of Codex.. (Nigeria and India) Guideline to encompass local, endogenous foods as nutrition is a cultural phenomenon. (Senegal, Bangladesh, Tanzania, Nigeria, Rwanda
9 EVIDENCE Cochrane 2013
10 Evidence The recent Cochrane review published in 2013 concluded that there is a lack of evidence to demonstrate superiority of RUTF over flour porridge as an intervention for SAM. This review was based on just 3 trials, all done in one country (Malawi) The argument was made that flour porridge is more akin to indigenous foods, and much cheaper and therefore preferable The citation of this review hindered the acceptance of RUTF as a superior product in the treatment of SAM, that needed a standard or guideline
11 Regulation The doses of micronutrients are high because many of these children have had a very bland, low diversity diet for a long time, leading to many nutrient deficiencies. The basis for the formulation is that the children need all nutrients to be fortified for a short period of time, in order to address multiple nutrient deficiencies. The high dose of micronutrients will mean that many countries will have difficulty categorizing RUTF as a food, as the regulatory systems for high dose nutrient products are often classified as drugs.
12 STRATEGY FOR THE REDRAFTING Focus on relevance of a guideline for current and future products Limit work to RUTF, inclusion of RUSF too politically sensitive Explore the possibility of an additional annex to the Foods for Special Medical Purposes with FAO (not recommended by WHO) Include relevant research that supports the use of a finished product in the treatment of SAM Keep in communication with those countries with concerns, and lobby groups
13 STRATEGY FOR NEXT CCNFSDU MEETING Gain support from EU, American and African Union delegations Collaborate closely with Sengal as the main contact for the African nations Run side sessions to educate attending delegates for the CCNFSDU meeting in Germany Type your title in this FOOTER area and in CAPS
14 WHAT CAN SUPPLIERS DO TO ASSIST? Contact your national Codex contact point and CCNFSDU representative Express your support and justification for wanting a guideline developed Type your title in this FOOTER area and in CAPS
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