Report of Mission

Report of Mission 29 November to 7 October, 2005 Peter Ranum, Food Fortification Consultant Contract No. (SSA/GEOA/2005/00000273-0)

This mission was to assist the Government Ministries and State Agencies elaborate legal and normative acts on food fortification standards and QC/QA related to food fortification as per the recent Georgian Law on Vitamin Mineral Defiencies (VMDs) with particular reference to the iodization of salt and the iron/folic acid fortification of wheat flour. This mission was under the general supervision of Unicef Health & Nutrition Section and in coordination with the National Fortification Alliance (NFA).

The New Law of Georgia on VMDs

Georgia has a new Law Concerning the Prevention of Iodine, Other Micronutrients and Vitamin Deficiency Disorders, dated February 2005 and signed by the President of Georgia, Mickeil Saakashvili. (Attachment A). The immediate task is to draft new or revised normative documents, decrees or laws regarding food fortification necessary to achieve the requirements in this new law on VMDs and to have them reviewed by all affected government ministries including the Ministry of Labour, Health and Social Affairs, the Ministry of Agriculture, the Ministry of Economy and the Ministry of Environment and Natural Resources.

Salt Iodization

Georgia does not product salt. All salt is imported, with most (95%) coming from Ukraine and a small amount from Azerbijian. Excellent progress has been made in achieving salt iodization in Georgia with 85% of the salt being estimated to be iodized, up from only 15% in 2003. The current requirement is that salt contain 40  10 ppm iodine but there has been no mandatory requirement that all salt be iodized until this latest law.

It was understood that the only normative documents on salt specifications and quality are holdovers from the former Soviet Union. These need to be revised and adopted in accordance with current requirements.

After consulting with representatives from responsible Ministries, Unicef Georgia and Dr. Gregory Gerasimov, an expert on salt iodization with the International Council for Control of Iodine Deficiency Disorders and Unicef consultant, and based on WHO/UNICEF/ICCIDD document “Recommended Iodine Levels in Salt and Guidelines for Monitoring their Adequacy and Effectiveness”1 (WHO/NUT/96.13), it is recommended that the Georgian government set the following requirements for iodized salt:

1. All salt for human or animal consumption, whether imported to Georgia or produced locally, must contain 40 ppm  15 ppm iodine.

2. The use potassium iodate (KIO3) for salt fortification is required.

1 WHO, UNICEF, ICCIDD. Recommended iodine levels in salt and guidelines for monitoring their adequacy and effectiveness. Geneva, World Health Organization, 1996 (unpublished document WHO/NUT/96.13;available on request from Department of Nutrition for Health and Development, World Health Organization, 1211 Geneva 27, Switzerland). 3. A maximum 12 months shelf life period is established for iodized salt unless the manufacturer can show evidence that a longer shelf life up to 3 years is possible with their particular product. After the expiry of shelf life, iodized salt must be utilized for technical purposes only.

4. The salt must be sold in a sealed package that maintains the required iodine content under the indicated storage periods.

5. The salt must be identified as being iodized and show the date of production.

6. Importers of iodized salt must show a certificate that the salt has been properly iodized.

7. Shipments and imports of salt that was not properly labeled or iodized cannot be sold for food use. Nonconforming product will be returned to the producer or distributor and can be used for technical purposes only. Reiodization of this salt in order to meet food grade standards is not permitted.

8. Importers of non-iodized salt for non-food medical or technical purposes (non-food purposes) must get a special importation permit from the appropriated government office. Non iodized salt imported for reiodization is not permitted.

It is the position of Unicef and other groups that the reiodization of salt within Georgia should not be permitted owing to the difficulty in controlling the proper application of this procedure and the questionable need for allowing it.

Dr. Gerasimov, who is very familiar with the salt iodization practices in Ukraine, advised that any deviation from the standard practices used in that country on iodine levels, packaging and labeling would likely result in their having to produce a special product for Georgia that would command a higher price. A price increase would not be acceptable to the Ministry of Economy or importers. The above requirements are in conformance with Ukraine practices, as reviewed by Dr. Gerasimov.

Representatives from the Ministry of Environment and Natural Resources (Ms. Maia Javakhishvili – Director and Mr. Alverd Chankseliani – Head of Dept.) saw no problem with these regulations regarding their area of concern. In discussion with them it was established that non-conforming salt that was not properly iodized or expired could be used for technical purposes and would not have to be disposed of in a manner that would create an environmental problem.

Importers of non-iodized salt for medical purposes must get a permit from the Ministry of Health to do so, and sell it as non-iodized salt in pharmacies. Dr. Frits Vanderhar, a salt iodization expert at Emory University, advises that the government should do the following when this law is being enacted (assuming that some grace period is observed): (a) Publish a notice in the local newspapers saying (1) This law will be effective by (date); and (2) Pharmacies desiring to obtain an exemption permit must apply to (the indicated government office) before (date); and (b) Route the same notice through the secretaries of the Georgia Association of Pharmacists and the Georgia Medical Association.

As to enforcement of the law (and prevention of leakage through pharmacies), the salt importers should be made to understand that only those pharmacies that have a Ministerial exemption will be eligible for supplies of non-iodized salt and the Ministry will periodically check for this.

Dr. Vanderhar’s experience with this situation in other countries is that most pharmacies stop ordering non-iodized salt after a year or so because they cannot sell it, since it is not being "prescribed" by physicians despite their prior insistence that "many people cannot consume iodized salt for medical reasons".

These suggestions allow for specially iodized and packaged salt that the manufacture can claim and prove has a shelf life greater than one year and up to three years. Without such proof and its acceptance the maximum shelf life allowed is one year. The current recommendation is to specify iodate only an dnot to allow iodide, which has a shorter shelf life.

Wheat Flour Fortification

Fortification of wheat flour with vitamins and minerals is currently not practiced in Georgia but has been proposed as part of a grant proposal to the Global Alliance for Improved Nutrition (GAIN). Flour fortification normally starts out as a voluntary practice to get the milling industry and consumers familiar and acceptant of the practice. Once that is accomplished it can be made mandatory, which makes it a true public health program.

Flour can be fortified with a number of micronutrients, but WHO and other authorities consider iron and folic acid a minimum practice. The GAIN proposal suggested adding 60 ppm iron as elemental “electrolytic” iron powder and 1.5 ppm folic acid. I would suggest instead that Georgia consider adding the same level of iron as ferrous sulfate and folic acid as that developed by the Kazakhstan Academy of Nutrition (KAN), which is the addition of 20 ppm iron from ferrous sulfate and 1.2 ppm folic acid to first grade flour. Premium grade flour can also be fortified with the same premix so as to add 25 ppm iron and 1.5 ppm folic acid. In addition, I would hope that Georgia consider adding the full array of micronutrients used in Central Asian countries provided by the KAP #2 premix, shown in Appendix D.

Note that the above recommendation for ferrous sulfate differs from the GAIN proposal that I originally endorsed. I now believe the lower level of iron from ferrous sulfate makes better sense for Georgia considering the high level of flour consumption and the relative rapidity of flour usage after milling. It would also help reduce the cost of flour fortification making it more acceptable to the industry.

Samples of the possible premixes should be provided to major milling companies and other interested parties for testing purposes, the results of which could influence which premixes are acceptable. It is understood that work in this area will likely not commence until the GAIN grant is realized. General Food Fortification

It was recommended that for general food fortification Georgia simply adopt the European Union (EU) standards on food fotification as shown in Attachment B. This allows the voluntary fortification of any processed, packaged food with certain restrictions made on the types and level of micronutrients added and the sources of micronutrients added. These are given in Attachment B. The only mandatory food fortification would be the iodization of salt.

Vitamin A deficiency is not believed to be a problem in Georgia. But if future studies show that more vitamin A is needed in the diet, foods that would be good vehicles for delivering vitamin A are listed in Attachment B along with suggested levels of both vitamin A and D to add to these foods.

It would be possible for Georgia to Standardize the fortification of food staples such as wheat flour, vegetable oil, margarine and milk. That is, to specify the types and levels of micronutrietns to add to such foods if they are to be fortified. I do not think it would be wise to do that at this time since it could restrict imports of fortified versions of these foods, but it may be something to consider at some future date.

There were people present at some of the meeting who were promoting iodization of foods other than salt, such as tea and bread. There is no reason presently to restrict them from doing this, just as there is no reason to prevent any similar voluntary fortification within the limits mentioned in Appendix B. On the other hand, they should not expect to receive indorsement or financial assistance for doing this from Unicef or the Government of Georgia, which may be what they are really after.

______Peter Ranum Schedule of Activities Date Activity 27 Sept Leave Buffalo, NY 28 Sept En route 29 Sept Arrive Tbilisi Meeting with Unicef: Review of the mission agenda, briefing on key legal & normative documents on USI/FF, Ms. Mariam Jashi, APO Health Ms. Giovanna Barberis – UNICEF Representative 30 Sept Meeting with NFA – National Fortification Alliance, Parliament of Georgia, Discussing current situtation, TOR and expected outcomes. Mr. Gigi Tsereteli - Chair, Parliamentary Committe for Health & Social Affairs Mr. Giorgi Gegelashvili – Deputy Chair, Parl. Committe for Health & Social Affairs, & NFA Chair Mr. Koka Pruidze – Deputy Minister of Labour, Health & Social Affairs Ms. Mariam Jashi - APO Health, UNICEF Mr. Zurab Sekhniashvili – Director, National Centre for Nutrition Mr. Zviad Gogochuri – Deputy Head, State Sanitary Inspectorate, MLHSA Mr. Shota Chkheidze – Head of Dept., Ministry of Agriculture Ms. Maia Javakhishvili – MoEvnironmnt & Natural Resources Discussing ToR & expected outcomes of the Mission 1 Oct Weekend – Drafting a framework of recommendations on normative acts 2 Oct Weekend – Prepared materials for presentations 3Oct Review of Draft Framework with UNICEF, Ms. Mariam Jashi - APO Health 4 Oct Review of Draft Framework on fortification standards with State Sanitary Inspectorate, MLHSA Mr. Zurab Sekhniashvili – Director, National Centre for Nutrition Mr. Zviad Gogochuri – Deputy Head, State Sanitary Inspectorate, MLHSA State Sanitary Inspectorate Representative 5 Oct Dissusion on suggested regulations on processing, re-iodization & waste mngt of expired FF , Venue: M of Environmnt & Natural Resources Ms. Maia Javakhishvili – Director Mr. Alverd Chankseliani – Head of Dept.

Discussion of fortification standards & options with private industry - focus on flour fortification, Venue: Parliament of Georgia Meeting with Private Sector - Milling Industry and Ministry of Economics representvie. Attendees included: Konstantin Osipov, Agrosystems Emzar Lomidze – Global-Agro, Chief of Inspection Public Health Department NFA Secretariat 6 Oct Unicef, discussion of recommendations for NFA debriefing on Oct 7 with Ingrid Kolb-Hindarmanto, Program coordinator and Maya Tsjutusgvuku. 7 Oct Revision and finalizing recommendations for NFA debriefing

General meeting on food fortification at Parliament of Georgia. Gave final debriefing on mission outcomes for NFA Partners. Discussing key recommendations & Possible amendments. Mr. Giorgi Gegelashvili – Deputy Chair, Parl. Committe for Health & Social Affairs, NFA Chair Mr. Koka Pruidze – Deputy Minister of Labour, Health & Social Affairs Ms. Ingrid Kolb Hindarmanto - Programme Coordinator, UNICEF Mr. Zurab Sekhniashvili – Director, National Centre for Nutrition Mr. Zviad Gogochuri – Deputy Head, State Sanitary Inspectorate, MLHSA Mr. Shota Chkheidze – Head of Dept., Ministry of Agriculture Ms. Maia Javakhishvili – MoEvnironmnt & Natural Resources Represenantives from Parliamentary Committee for Agriculture, Milling Industry, Public Health Department, NGOs, International agencies - WHO, ACTS Georgia. 8 Oct Departure Attachment A –

Law of Georgia

Concerning the Prevention of Iodine, Other Microelements and Vitamins Deficiency Disorders

The goal of this law is creation of supportive environment for prevention of iodine, other microelements and vitamins deficiency disorders in Georgia.

Chapter I General Provisions

Article 1. The Law of Georgia concerning prevention of iodine, other microelements and vitamins deficiency disorders. The Law of Georgia concerning the prevention of iodine, other microelements and vitamins deficiency disorders is based on the Constitution of Georgia, International Agreements and consists of current law, law of Georgia “Concerning Health Care” and other legislative and normative acts.

Article 2. Explanation of terminology The terminologies used in the current law have the following meaning: A) Iodine, other microelements and vitamins deficiency disorders – pathological state of health reasoned by insufficiency of iodine, other microelements and vitamins in the human organism; B) Prevention of iodine, other microelements and vitamins deficiency disorders – system of state activities targeting at prevention of iodine, other microelements and vitamins deficiency disorders; C) Food fortification – enrichment of food products with microelements and vitamins for prevention of microelements and vitamins deficiency disorders; D) Iodized Salt – Salt enriched (fortified) with iodine; E) Fortificant – supplements (additive substances) used for food fortification; F) Re-iodization – repeated iodization of iodized salt or other fortified food.

Article 3. Main provisions for prevention of iodine, other microelements and vitamins deficiency disorders The main provisions for prevention of iodine, other microelements and vitamins deficiency disorders are the following:

A) Elaboration of National Policy on Food Fortification and promotion of implementation of respective programmes; B) Elaboration of standards of import, production and realization of iodized salt and other fortified food products in Georgia; C) Strengthening of the State supervision and inter-agency coordination over the import, production and realization of iodized salt and other fortified food products in Georgia; D) Determination of roles and responsibilities of governmental institutions entities, physical persons and juridical entities for ensuring that the standards of import, production and realization of iodized salt and other fortified food in Georgia are enforced; E) Promoting participation of the population, society and international organizations in implementation of the National Food Fortification Policy.

Chapter II Standards of Import, Production and Realization of Iodized Salt and other Fortified Food Products in Georgia

Article 4. Requirements to iodized salt and other fortified food products 1. Iodized salt and other fortified food (imported to Georgia or produced locally) should be compliant to the national standards. 2. The import and realization of non-iodized salt is banned in Georgia except for conditions (circumstances) defined by point 1 of article 5 of this law. 3. Salt for human and animal consumption should be iodized in accordance to the national standards.

Article 6. Import and realization of non-iodized salt to Georgia 1. Import and realization of non-iodized salt to Georgia is permitted for: A) Medical purposes; B) Technical and non-food production purposes.

2. The import of non-iodized salt to Georgia for medical purposes is permitted only on the basis of license issued by the Ministry of Labour, Health and Social Affairs of Georgia. 3. Non-iodized salt for medical purposes can be realized only through pharmacy network.

Article 6. Certification and Licensing of iodized salt and other fortified food products 1. Import of iodized salt and other fortified food products without obligatory certificate and production without the license is prohibited. 2. During the import of iodized salt and other fortified food products to Georgia the Customs Department along with the customs declaration should be provided by the certificate of conformity. 3. Licensing of iodized salt and other fortified food products is led by the Ministry of Agriculture of Georgia, while obligatory certification is processed by the Legal Person of Public Law – National Agency of Standardization, Metrology and Certification in accordance with the rule of law.

Article 7. Requirements for sorting, packaging, marking, transportation and storage of iodized salt and other fortified food products Sorting, packaging, marking, transportation and storage of iodized salt and other fortified food products should meet the requirements of the national standards.

Article 8. Safety and quality assurance of iodized salt and other fortified food products 1. Physical persons and juridical entities importing, producing and selling iodized salt and other fortified food products are responsible to the customers for safe and quality assurance of the iodized salt and other fortified food products in compliance with the national standards. 2. The population is provided with the information concerning certification of iodized salt and other fortified food products in accordance with the rule defined by the law “Concerning the Protection of the Consumer’s Rights”. 3. Realization of expired iodized salt and other fortified food products is prohibited and the products should be withdrawn from the realization network.

Chapter III Control

Article 9. Control over the compliance of the iodized salt and other fortified products with national standards The Ministry of Labour, Health and Social Affairs, Ministry of Agriculture and Customs Department of the Ministry of Finance of Georgia, within the frame of their competence, control the compliance of iodized salt and other fortified food products with the national standards.

Chapter IV Responsibilities of Physical Persons and Juridical Entities for Violation of the Law

Article 10. Responsibilities for violation of the law The level of responsibility for violation of this law is prescribed by the rule of law of Georgia.

Chapter V Transitional Provisions

Article 11. Activities for putting this law into force 1. The following legal acts should be elaborated within 3 months after the law comes into force: A) Decree of the Minister of Labour, Health and Social Affairs of Georgia “Concerning the list of food products due to fortification”; B) Decree of the Minister of Labour, Health and Social Affairs of Georgia “Concerning the requirements for import and realization of non-iodized salt for medical purposes”; C) Joint Decree of the Minister of Economy, Minister of Environment and Natural Resources and Minister of Labour, Health and Social Affairs of Georgia “Concerning the rule for processing, re-iodization, usage for technical purposes and destruction of expired iodized salt and other fortified food products”; D) Joint Decree of the Minister of Labour, Health and Social Affairs and the Minister of Agriculture “Concerning the content of fortificants and methods of fortification for iodized salt and other fortified food products”. 2. Request the Legal Person of Public Law – National Agency for Standardization, Metrology and Certification to elaborate and approve the national standards of sorting, packaging, marking and transportation of iodized salt for human and animal consumption. 3. With reference to the Decree of the Minister of Labour, Health and Social Affairs of Georgia “Concerning the list of food products due to fortification” request the legal person of Public Law - National Agency for Standardization, Metrology and Certification to elaborate and approve the national standard for food products due to fortification (imported to Georgia or produced locally).

Chapter VI Final Provision Article 12. Law in force The current law to be in force after 6 months since its publication

President of Georgia Mickeil Saakashvili

Tbilisi, February 2005.

Attachment B Suggestions for Regulations on Food Fortification for Georgia Prepared by Peter Ranum, Unicef consultant, October, 2005

Recognizing that the fortification of foods with micronutrients (vitamins and minerals) is a widely practiced, effective and well accepted method for promoting optimal health, compensating for the loss of nutrients due to processing and/or storage of food and preventing known micronutrient inadequacies in the diet, the following regulations regarding food fortification are proposed.

VOLUNTARY FOOD FORTIFICATION Processed foods, whether imported to Georgia or produced locally, may be fortified with vitamins and minerals provided that:

1. The type and source of the micronutrients added be those approved by the EU2. (See Appendices A and B for current listing of approved micronutrients)

2. The food is processed. It cannot be fresh meat, poultry, fish, fruits or vegetables.

3. The amount of each micronutrient added is high enough so that one serving of the food provide at least an additional 15% RDA3 of the micronutrient over the unfortified version of the food. (See Appendix C for list of RDAs)

4. The amount of each micronutrient added must not resulting in one serving of the food to contain more than 100% or the RDA for the total level of the micronutrient.

5. The food is sold in a sealed package that retains the claimed level of vitamin activity if a level claim is made.

6. The food is identified as being fortified.

MANDATORY FOOD FORTIFICATION

Recognizing that certain foods are preferred vehicles for delivering micronutrients known to be deficient in the Georgian populations to the extent that they constitute a serious public health problem, the following regulations regarding mandatory food fortification is proposed.

Iodized salt

Based on WHO/UNICEF/ICCIDD document “Recommended Iodine Levels in Salt and Guidelines for Monitoring their Adequacy and Effectiveness” (WHO/NUT/96.13), it is recommended to the Georgian government to set the following requirements for iodized salt:

1. All salt for human or animal consumption, whether imported to Georgia or produced locally, must contain 40 ppm  15 ppm iodine.

2. The use potassium iodate (KIO3) for salt fortification is required.

3. A maximum 12 months shelf life period is established for iodized salt unless the manufacturer can show evidence that a longer shelf life up to 3 years is possible with their particular product. After the expiry of shelf life, iodized salt must be utilized for technical purposes only.

4. The salt must be sold in a sealed package that maintains the required iodine content under the indicated storage periods.

5. The salt must be identified as being iodized and show the date of production.

2 Brussels, 10.11.2003, COM(2003) 671 final, 2003/0262 (COD) 3 RDA, Recommended Daily Allowance as given by the Food Nutrition Board of the National Academy of Sciences. 6. Importers of iodized salt must show a certificate that the salt has been properly iodized.

7. Shipments and imports of salt that was not properly labeled or iodized cannot be sold for food use. Nonconforming product will be returned to the producer or distributor and can be used for technical purposes only. Reiodization of this salt in order to meet food grade standards is not permitted.

8. Importers of non-iodized salt for non-food medical or technical purposes (non- food purposes) must get a special importation permit from the appropriated government office). Non iodized salt imported for reiodization is not permitted.

STANDARDIZED FOOD FORTIFICATION

Fortified Wheat Flour Recognizing that wheat flour is the preferred vehicle for delivering minerals and B vitamins to the general population, the following optional fortification standards are proposed:

1. Wheat flour of premium/supreme, whether imported to Georgia or produced locally, may be fortified with addition of 25 ppm iron from ferrous sulfate and 1.5 ppm folic acid, or with the flour fortification premix given in Appendix D used at a rate of 150 grams/ton of flour. Wheat flour of first grade, whether imported to Georgia or produced locally, may be fortified with addition of 20 ppm iron from ferrous sulfate and 1.2 ppm folic acid, or with the flour fortification premix given in Appendix D used at a rate of 120 grams/ton of flour.

2. Such flour must be identified as being fortified. This can include using a special logo indicating a food fortified to Georgian standards.

3. Importers of fortified flour must provide a certificate that the flour has been properly fortified.

4. Local producers of fortified flour must maintain records showing proper fortification. These records must be available to government audit.

5. The total iron content of the fortified flour by quantitative spectrophotometric analysis must be no less than 30 mg/kg and no greater than 80 ppm.

Vitamin A Fortified Food Staples Recognizing that there may be a need for additional vitamin A in the Georgian diet, the following food staples are identified as being good vehicles for delivering vitamin A to the diet and can be optionally fortified to the following standards. Foods so fortified can use the special logo showing foods fortified to Georgian standards. Fortification of these foods may be made mandatory if there is sufficient evidence of continuing, serious vitamin A deficiency in the Georgian population.

Fortified Food Minimum Vitamin A level Other optional fortification Vegetable oil 30,000 IU/kg Margarine 20,000 IU/kg 1,000 IU/kg Vitamin D Milk 4,000 IU/liter 500 IU/liter Vitamin D Appendix A - Vitamins and minerals that may be added to foods according to proposed E.U. standards4

VITAMINS Vitamin A Vitamin D Vitamin E Vitamin K Vitamin B1 Vitamin B2 Niacin Pantothenic acid Vitamin B6 Folic acid Vitamin B12 Biotin Vitamin C

MINERALS Calcium Magnesium Iron Copper Iodine Zinc Manganese Sodium Potassium Selenium Chromium Molybdenum Fluoride Chloride Phosphorus

4 COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 10.11.2003 COM(2003) 671 final 2003/0262 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the addition of vitamins and minerals and of certain other substances to foods Appendix B - Vitamins and minerals souces that may be used to fortify foods according to proposed E.U. standards3

VITAMIN SOURCES VITAMIN A - retinol - retinyl acetate - retinyl palmitate - beta-carotene VITAMIN D - cholecalciferol - ergocalciferol VITAMIN E - D-alpha-tocopherol - DL-alpha-tocopherol - D-alpha-tocopheryl acetate - DL-alpha-tocopheryl acetate - D-alpha-tocopheryl acid succinate VITAMIN K - phylloquinone (phytomenadione) VITAMIN B1 - thiamin hydrochloride - thiamin mononitrate VITAMIN B2 - riboflavin - riboflavin 5'-phosphate, sodium NIACIN - nicotinic acid - nicotinamide PANTOTHENIC ACID - D-pantothenate, calcium - D-pantothenate, sodium - dexpanthenol VITAMIN B6 - pyridoxine hydrochloride - pyridoxine 5'-phosphate - pyridoxine dipalmitate FOLIC ACID - pteroylmonoglutamic acid 27 VITAMIN B12 - cyanocobalamin - hydroxocobalamin BIOTIN - D-biotin VITAMIN C - L-ascorbic acid - sodium-L-ascorbate - calcium-L-ascorbate - potassium-L-ascorbate - L-ascorbyl 6-palmitate MINERAL SOURCES calcium carbonate calcium chloride calcium salts of citric acid calcium gluconate calcium glycerophosphate calcium lactate calcium salts of orthophosphoric acid calcium hydroxide calcium oxide magnesium acetate magnesium carbonate magnesium chloride magnesium salts of citric acid magnesium gluconate magnesium glycerophosphate magnesium salts of orthophosphoric acid magnesium lactate magnesium hydroxide magnesium oxide magnesium sulphate manganese carbonate ferrous carbonate ferrous citrate ferric ammonium citrate ferrous gluconate ferrous fumarate ferric sodium diphosphate ferrous lactate ferrous sulphate ferric diphosphate (ferric pyrophosphate) ferric saccharate elemental iron powder (carbonyl, electrolytic or hydrogen reduced) cupric carbonate cupric citrate cupric gluconate cupric sulphate copper lysine complex sodium iodide sodium iodate potassium iodide potassium iodate zinc acetate zinc chloride zinc citrate zinc gluconate zinc lactate zinc oxide zinc carbonate zinc sulphate Appendix C - Recommended Dietary Allowances (RDAs)5 with minimum and maximum RDA added per serving.

Micronutrient Females Males Minimum Maximum

Vitamin A (retinol) 700 µg 900 µg 135 µg 700 µg Thiamine (Vitamin B1) 1.1 mg 1.2 mg 0.18 mg 1.1 mg Riboflavin (Vitamin B2) 1.1 mg 1.3 mg 0.195 mg 1.1 mg Niacin (Vitamin B3) 14 mg 16 mg 2.4 mg 14 mg Pantothenic acid (Vitamin B5) 5 mg same 0.75 mg 5 mg Vitamin B6 1.3 mg same 0.195 mg 1.3 mg Vitamin B12 2.4 µg same 0.36 µg 2.4 µg Vitamin C 75 mg 90 mg 13.5 mg 75 mg Vitamin D 5 µg same 0.75 µg 5 µg Vitamin E 15 mg same 2.25 mg 15 mg Folacin 400 µg same 60 µg 400 µg Biotin 30 µg same 4.5 µg 30 µg Calcium 1000 mg same 150 mg 1000 mg Phosphorus 700 mg same 105 mg 700 mg Selenium 55 µg 70 µg 10.5 µg 55 µg Iron 18 mg 10 mg 2.7 mg 18 mg Zinc 8 mg 15 mg 2.25 mg 8 mg Magnesium 310 mg 400 mg 60 mg 310 mg Iodine 150 µg same 22.5 mg 150 µg Fluoride 3 mg 4 mg 0.6 mg 3 mg Potassium 2 g same 0.3 mg 2 g

5 Recommended Dietary Allowances (RDA) of the Food and Nutrition Board of the U.S. Institute of Medicine, 2001, NATIONAL ACADEMY PRESS, Washington, D.C. (http://www.nap.edu/books/0309071836/html/) Appendix D - Flour Fortification Premix (KAP #2) for use on Supreme and First Grade wheat flour, or any flour with ash content less than 1.00%

Specifications

Descriptions Requirements Product Composition Minimum Level Ingredient Thiamin Mononitrate 1.2 % Riboflavin 1.6% Niacinamide 6.67% Folic Acid 1.0%

Vitamin B12 0.00267% as Cyanocobalamine Ferrous Sulfate ** 16.6% as Fe, approximately 52% as ferrous sulfate Zinc Oxide 13.3% as Zn, approximately 16.6% as zinc oxide Free flow agent quantity sufficient to make free flowing Starch or maltodextrin * quantity sufficient to make 100% Purity Requirements All ingredients used must meet Food Chemical Codex (Vol IV) purity specifications Physical Properties It must be free-flowing with no lumps or stickiness. 98% of offered product must pass through a 100 mesh screen. Addition rate to flour 150 grams per metric ton (1000 kg) to premium grade flour and 120 grams per metric ton to first grade flour.

* Calcium salts or wheat flour are not permitted as fillers ** Must be dried ferrous sulfate of very fine particle size, white to light tan in color

Micronutrient Levels Added to Flour Nutrient Level added to flour ppm @ 150 g/MT Thiamin 1.8 Riboflavin 2.4 Niacin 10 Folic Acid 1.5

Vitamin B12 0.004 Iron 25 Zinc 20 Appendix E United Stated Food & Drug Regulations Code of Federal Regulations, Title 21

PART 104—NUTRITIONAL QUALITY GUIDELINES FOR FOODS Subpart B—Fortification Policy §104.20 Statement of purpose. (a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nation's food supply is an important public health objective. The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food. It is reasonable to anticipate that the Reference Daily Intakes (RDI's) as delineated in §101.9 of this chapter and in paragraph (d) of this section will be amended from time to time to list additional nutrients and/or to change the levels of specific RDI's as improved knowledge about human nutrient requirements and allowances develops. The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable in other countries. (b) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to correct a dietary insufficiency recognized by the scientific community to exist and known to result in nutritional deficiency disease if: (1) Sufficient information is available to identify the nutritional problem and the affected population groups, and the food is suitable to act as a vehicle for the added nutrients. Manufacturers contemplating using this principle are urged to contact the Food and Drug Administration before implementing a fortification plan based on this principle. (2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions. (Other Federal regulations include, but are not limited to, standards of identity promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act, nutritional quality guidelines established in subpart C of this part, and common or usual name regulations established in part 102 of this chapter.) (c) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to restore such nutrient(s) to a level(s) representative of the food prior to storage, handling, and processing, when: (1) The nutrient is shown by adequate scientific documentation to have been lost in storage, handling, or processing in a measurable amount equal to at least 2 percent of the Daily Reference Value (DRV) of protein and of potassium and 2 percent of the Reference Daily Intake (RDI) in a normal serving of the food. (2) Good manufacturing practices and normal storage and handling procedures cannot prevent the loss of such nutrient(s), (3) All nutrients, including protein, iodine and vitamin D, that are lost in a measurable amount are restored and all ingredients of the food product that contribute nutrients are considered in determining restoration levels; and (4) The food is not the subject of any other Federal regulation that requires or prohibits nutrient addition(s), or the food has not been fortified in accordance with any other Federal regulation that permits voluntary nutrient additions. (d) A nutrient(s) listed in paragraph (d)(3) of this section may be added to a food in proportion to the total caloric content of the food, to balance the vitamin, mineral, and protein content if: (1) A normal serving of the food contains at least 40 kilocalories (that is, 2 percent of a daily intake of 2,000 kilocalories); (2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions; and (3) The food contains all of the following nutrients per 100 calories based on 2,000 calorie total intake as a daily standard: ------DRV or Amount Nutrient Unit of measurement RDI[SU]1[/ per 100 SU] calories ------Protein...... grams (g)...... 50 2.5 Vitamin A...... International Unit (IU). 5,000 250 Vitamin C...... milligrams (mg)...... 60 3 Calcium...... g...... 1 0.05 Iron...... mg...... 18 0.9 Vitamin D...... IU...... 400 20 Vitamin E...... do...... 30 1.5 Thiamin...... mg...... 1.5 0.08 Riboflavin...... do...... 1.7 0.09 Niacin...... do...... 20 1 Vitamin B[INF]6[/INF]... do...... 2.0 0.1 Folate...... micrograms (μg)...... 400 20 Vitamin B[INF]12[/INF].. do...... 6.0 0.3 Biotin...... mg...... 0.3 0.015 Pantothenic acid...... do...... 10 0.5 Phosphorus...... g...... 1.0 0.05 Magnesium...... mg...... 400 20 Zinc...... do...... 15 0.8 Iodine...... μg...... 150 7.5 Copper...... mg...... 2.0 0.1 Potassium...... do...... 3,500 175 ------\1\ RDI's for adults and children 4 or more years of age.

(e) A nutrient(s) may appropriately be added to a food that replaces traditional food in the diet to avoid nutritional inferiority in accordance with §101.3(e)(2) of this chapter. (f) Nutrient(s) may be added to foods as permitted or required by applicable regulations established elsewhere in this chapter. (g) A nutrient added to a food is appropriate only when the nutrient: (1) Is stable in the food under customary conditions of storage, distribution, and use; (2) Is physiologically available from the food; (3) Is present at a level at which there is a reasonable assurance that consumption of the food containing the added nutrient will not result in an excessive intake of the nutrient, considering cumulative amounts from other sources in the diet; and (4) Is suitable for its intended purpose and is in compliance with applicable provisions of the act and regulations governing the safety of substances in food. (h) Any claims or statements in the labeling of food about the addition of a vitamin, mineral, or protein to a food shall be made only if the claim or statement is not false or misleading and otherwise complies with the act and any applicable regulations. The following label claims are acceptable: (1) The labeling claim “fully restored with vitamins and minerals” or “fully restored with vitamins and minerals to the level of unprocessed &lowbarm;&lowbarm;&lowbarm;” (the blank to be filled in with the common or usual name of the food) may be used to describe foods fortified in accordance with the principles established in paragraph (c) of the section. (2) The labeling claim, “vitamins and minerals (and “protein” when appropriate) added are in proportion to caloric content” may be used to describe food fortified in accordance with the principles established in paragraph (d) of this section. (3) When labeling claims are permitted, the term “enriched,” “fortified,” “added,” or similar terms may be used interchangeably to indicate the addition of one or more vitamins or minerals or protein to a food, unless an applicable Federal regulation requires the use of specific words or statements. (i) It is inappropriate to make any claim or statement on a label or in labeling, other than in a listing of the nutrient ingredients as part of the ingredient statement, that any vitamin, mineral, or protein has been added to a food to which nutrients have been added pursuant to paragraph (e) of this section. [45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]