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.
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).
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.
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
27 Sept
28 Sept
29 Sept
30 Sept
1 Oct
2 Oct
3Oct
4 Oct
5 Oct
6 Oct
7 Oct
Activity
Leave Buffalo, NY
En route
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
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
Weekend – Drafting a framework of recommendations on normative acts
Weekend – Prepared materials for presentations
Review of Draft Framework with UNICEF, Ms. Mariam Jashi - APO Health
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
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
Unicef, discussion of recommendations for NFA debriefing on Oct 7 with Ingrid
Kolb-Hindarmanto, Program coordinator and Maya Tsjutusgvuku.
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
8 Oct
Industry, Public Health Department, NGOs, International agencies - WHO,
ACTS Georgia.
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.
2
Brussels, 10.11.2003, COM(2003) 671 final, 2003/0262 (COD)
RDA, Recommended Daily Allowance as given by the Food Nutrition Board of the National
Academy of Sciences.
3
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 (nonfood 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
Margarine
Milk
30,000 IU/kg
20,000 IU/kg
4,000 IU/liter
1,000 IU/kg Vitamin D
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
Vitamin A (retinol)
Thiamine (Vitamin B1)
Riboflavin (Vitamin B2)
Niacin (Vitamin B3)
Pantothenic acid (Vitamin B5)
Vitamin B6
Vitamin B12
Vitamin C
Vitamin D
Vitamin E
Folacin
Biotin
Calcium
Phosphorus
Selenium
Iron
Zinc
Magnesium
Iodine
Fluoride
Potassium
5
Females
700 µg
1.1 mg
1.1 mg
14 mg
5 mg
1.3 mg
2.4 µg
75 mg
5 µg
15 mg
400 µg
30 µg
1000 mg
700 mg
55 µg
18 mg
8 mg
310 mg
150 µg
3 mg
2g
Males
900 µg
1.2 mg
1.3 mg
16 mg
same
same
same
90 mg
same
same
same
same
same
same
70 µg
10 mg
15 mg
400 mg
same
4 mg
same
Minimum
135 µg
0.18 mg
0.195 mg
2.4 mg
0.75 mg
0.195 mg
0.36 µg
13.5 mg
0.75 µg
2.25 mg
60 µg
4.5 µg
150 mg
105 mg
10.5 µg
2.7 mg
2.25 mg
60 mg
22.5 mg
0.6 mg
0.3 mg
Maximum
700 µg
1.1 mg
1.1 mg
14 mg
5 mg
1.3 mg
2.4 µg
75 mg
5 µg
15 mg
400 µg
30 µg
1000 mg
700 mg
55 µg
18 mg
8 mg
310 mg
150 µg
3 mg
2g
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
Ingredient
Thiamin Mononitrate
Riboflavin
Niacinamide
Folic Acid
Vitamin B12
Ferrous Sulfate **
Zinc Oxide
Free flow agent
Starch or maltodextrin *
Purity Requirements
Physical Properties
Addition rate to flour
Minimum Level
1.2 %
1.6%
6.67%
1.0%
0.00267% as Cyanocobalamine
16.6% as Fe, approximately 52% as ferrous sulfate
13.3% as Zn, approximately 16.6% as zinc oxide
quantity sufficient to make free flowing
quantity sufficient to make 100%
All ingredients used must meet Food Chemical Codex (Vol
IV) purity specifications
It must be free-flowing with no lumps or stickiness.
98% of offered product must pass through a 100 mesh
screen.
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
Level added to
Nutrient
flour
ppm @ 150 g/MT
Thiamin
Riboflavin
Niacin
Folic Acid
Vitamin B12
Iron
Zinc
1.8
2.4
10
1.5
0.004
25
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]