AO 4 S. 1995
AO 4 S. 1995
AO 4 S. 1995
Department of Health
BUREAU OF FOOD AND DRUGS
Filinvest Corporate City
Alabang, Muntinlupa City
Administrative Order
No. 4-A s. 1995
GUIDELINES ON MICRONUTRIENT
FORTIFICATION OF PROCESSED FOODS
SECTION I. AUTHORITY
This Order is issued pursuant to Article 7, 17, 21, and 22 of R.A. 7394 known as the Consumer
Act of the Philippines.
1. The Department of Health issues these guidelines to improve the nutritional quality of the
nation's food supply.
1.1. These guidelines shall serve as a basis for the rational addition of nutrient(s) to
processed foods, so that the nutritional quality of the Filipino diet can be improved and
maintained.
1.2. These guidelines are intended to avoid over-or-under fortification that may create
imbalance in the diet as well as avoid misleading label claims to gain competitive
marketing advantage.
1. Fortification shall mean the addition of nutrients to processed foods at levels above the
natural state.
2. Processed food shall refer to food that has been subjected to some degree of processing
(e.g. milling, drying, concentrating, canning, etc) which partially or completely changes the
physico-chemical and/or sensory characteristics of the raw material.
3. Unprocessed food shall refer to food that has not undergone any treatment resulting in
substantial change in the original state but which may have been divided, boned, skinned,
peeled, ground, cut, cleaned, trimmed, fresh frozen or chilled.
1. Food fortification shall be vital where there is a demonstrated need to increase the intake of
an essential nutrient by one or more population groups as manifested in dietary, biochemical
or clinical evidences of deficiency. It shall also be considered important to compensate for
nutrient losses due to processing storage.
2. The Department recognizes that the nutritional deficiency problems in the Philippines based
on recent nutrition surveys include deficiencies in energy, iron, vitamin A, thiamin, riboflavin,
and iodine (Annex A). The Filipino diet is also deficient in ascorbic acid, calcium and folate to
a minor extent Food fortification shall thus be mainly carried out to fill up these inadequacies
in Filipino diets, based on present-day needs as measured using the more recent RDAs
(Annex B)
3. Food fortification shall not be encouraged in alcoholic beverages and candies because
excessive consumption as a result of undue promotion of these fortified products may lead to
health problems.
4. Food fortification shall be highly encouraged for foods that are widely consumed particularly
by at-risk population groups. Examples of such foods are:
- cereals (e.g. wheat flour, milled rice, corn grits)
and cereal-based products
(e.g. snack foods, instant noodles) ………… with iron and B complex vitamins
5. Fortification shall be recommended for processed foods replace or simulate traditional foods
to compensate for nutritional inferiority due to use of substitute ingredients.
SECTION V. COVERAGE
These Guidelines shall apply to all fortified foods except dietary supplements and foods for which
established standards include specifications for nutrient composition or levels of fortification, e.g.
breastmilk substitutes, follow-up formula.
2. Processed foods may be fortified with nutrients that are not considered deficient in the
Filipino diet if the purpose is to restore losses in the food due to processing or to
preserve/maintain a balance of nutrients in the processed food.
3. Fortification is appropriate when essential nutrient(s) is (are) added in proportion to the total
caloric content of food.
Processed foods that contain at least 40 kilocalories per normal serving (that is, 2% of a daily
intake of 2000 kilocalories) may be fortified to balance the nutrient-caloric content of the food.
1
Food, Drug and Devices, and Cosmetic Act, as amended
4. Processed foods that are consumed not for its caloric contribution to the diet (e.g.
condiments, seasoning/spices) may be fortified only with essential nutrients that are deficient
in the Filipino diet, PROVIDED such foods are appropriate vehicles for the particular
nutrient(s) and are widely consumed by the general population or are intended for
intervention programs to address micronutrient deficiency in specific target populations.
5. The fortification level shall be in accordance with the following principles, unless otherwise
provided in a separate guideline/standard for specific processed food.
5.1. For essential nutrients that are deficient in the Filipino diet, the added nutrients shall
supply at least 1/3 of the RDA of the target consumer (refer to Annex E, Table 1), except
that vitamin C shall be supplied at not less than 100% of the RDA in fortified
juices/flavored drinks. These levels shall be uniformly distributed in the total number of
services likely to be consumed in a day.
Hence, the minimum fortification level shall be computed in the following manner:
To get fortification level per serving, divide A by B. In the case of processed foods that
will be cooked before consumption, the losses due to the prescribed cooking directions
may be compensated accordingly when determining the amount of nutrient(s) to be
added.
Ready-to-eat flour-based products (e.g. bread, snack food) fortified with iron and B-
complex vitamins - assuming 2 servings are like to be consumed by a male adult (20-39y,
56 kg) in a day, and at 30 grams/serving, shall be fortified as follows:
Margarine fortified with vitamin A and thiamin - assuming 2 servings are likely to be
consumed by a male adult (20-39y, 56 kg) in a day, and at 15 grams/serving, shall be
fortified as follows:
Packaged fruit-flavored drinks fortified with vitamin C - assuming 2 servings are likely to
be consumed by a male adult (20-39y, 56 kg) in a day, and at 250 mL per serving, shall
be fortified as follows:
Vitamin C - 38 mg/serving
(=30 mg/200 mL serving)
5.2. For nutrients that are essential but have not been established to be deficient in the
Filipino diet, the added nutrients shall supply at least 1/5 (or 20%) of the RDA of the
target consumer (refer to Annex E, Table 2)
5.3. For nutrients that are essential but have no established RDA, the added nutrients shall
supply at least 20% of the estimated safe and adequate levels for daily intake as
recommended by the Food and Nutrition Board of the U.S. National Research Council.
(refer to Annex E, Table 2)
5.4. For processed foods to be fortified with nutrient(s) with known toxicity (e.g. vitamins A, D,
E, K, Zn, Se), the level of such nutrient(s) in the food shall not exceed 150% of the RDA
for the target consumer per prescribed serving(s) likely to be consumed per day.
5.5. For essential amino acids, fortification levels shall be in accordance with the
recommendations of the Joint FAO/WHO/UNU Expert Consultation on Energy and
Protein Requirements. (WHO TRS 724, 1985) Food manufacturers who wish to fortify
their products with amino acids are required to consult a qualified professional with
expertise in human nutrition and shall submit a certificate of such consultation.
5.6. For nutrients that have not been established as essential for humans fortification with
such nutrients shall be at a significant level above the natural state as determined by the
precision of the analytical method at its lowest detection limit.
5.7. The reference RDAs to be used in compliance with the above fortification guidelines are
shown in the tables in Annex E.
5.8. For nutrients with Philippine RDA, the reference RDA shall be those of a Filipino male
adult, 20-39y, 56 kg.
5.9. For nutrients without established Philippine RDA, the USRDA shall be used, particularly
of the male adult, 19-24, 72 kg.
5.10. For processed foods specifically intended for children (after infancy and below 10
years), the reference RDA shall be that of a child in the 4 to 6 years age group.
5.11. Where no RDA has been prescribed for a nutrient, safety considerations shall be applied
and the safety of the use of such nutrient in a particular food shall be supported by the
user/claimant (producer/distributor)
The following label declarations shall be required for fortified processed foods, in addition to other
requirements under BFAD's food labeling regulations.
1. Only when the levels of fortification provided in Section 6 are met and when the nutrient
content analysis, at any point in time within the shelf-life of the product, show at least 80% to
90% of the claimed fortification level depending on the nutrient analyzed and the precision of
the analytical methods used, shall the claim "FORTIFIED" be considered valid.
2. Fortification claims shall be based on the processed food as packaged and purchased by the
consumer.
3. The fortification level shall be appropriately presented on the label indicating the following
information:
*by weight for solid food and volume for liquid food
3.1. If the food as packaged is not ready-to-eat and will be consumed after simply mixing
with water (or other edible liquid), the amount of nutrient fortificant shall be declared
in terms of %RDA per the specified amount needed to make one serving of the
ready-to-eat food.
3.2. If the food is not ready-to-eat as packaged and is used as an ingredient for the
preparation of another food, the amount of the nutrient fortificant added shall be
declared as %RDA per 100 grams of the packaged food and, optionally, as %RDA
per specified amount used in a given product recipe.
3.3. The %RDA per 100 kcal of the packaged food may also be declared on the label
when such food contains at least 40 kcal per serving.
4. The terms "enriched", "added with", "supplemented with" and other similar terms shall be
equivalent to the term "fortified". Descriptive terms like "rich in", "good source of", "excellent
source of" shall not necessarily imply fortification and shall be used in accordance with
BFAD's food labeling regulations.
1. These guidelines shall be applied in the registration of fortified processed food products in the
BFAD.
2. The BFAD itself or BFAD in coordination with the recognized agencies or institutions listed in
Annex "F" shall monitor the micronutrient of fortified processed food.
3. A processed food claiming fortification shall be considered mislabelled unless the fortification
levels comply with these guidelines except when the deviation from the fortification levels
herein set are just and are properly declared in the labelling.
4. The BFAD, after notice and hearing, may impose any or all of the following administrative
sanctions in cased of non-compliance with these guidelines.
4.1. Order the recall of the products declared/found as mislabelled fortified food
4.2. Order the correction of the labeling of the fortified food products
4.3. Impose administrative fines provided for by existing laws
4.4. Suspend or cancel the registration of the product.
1. All the manufacturers or food processors are given six (6) months from effectivity to comply
with these guidelines.
2. All food products that are not otherwise adulterated or mislabelled produced before the
expiration of this 6-month period shall be allowed to stay in the market up to the expiration of
their shelf-life.
SECTION X. EFFECTIVITY
This Order shall be effective after its publication in two newspapers of general circulation at least
once a week for a period of not less than one (1) month pursuant to Art. 8 of RA 7394.
RECOMMENDING APPROVAL
Department of Agriculture
Department of Health
Institute of Chemistry
Analytical Services Laboratories
VITAMINS/PROVITAMINS
Vitamin B2 : Riboflavin
Riboflavin-5-phosphate (sodium salt of)
Vitamin D2 : Ergocalciferol
Vitamin D3 : Cholecalciferol
Vitamin E : DL-alpha-tocopherol
D-alpha-tocopherol
DL-alpha-tocopheryl acetate
D-alpha-tocopheryl acetate
Tocopherols, mixed concentrate
Vitamin H : Biotin
Vitamin K : Phytonadione
MINERALS
Table 2. Essential nutrients that have not been established as deficient in the Filipino diet
RDA 1/5 RDA RDA 1/5 RDA
NUTRIENT (Adult) (20%) (Child) (20%)
Niacin, mg 25 5 12 2.4
Vitamin B6, mg 2 0.4 1.1 0.22
Vitamin B12, ug 2 0.4 1.0 0.20
Vitamin D, ug CF 10 2 10 2.0
Vitamin E, mg TE 10 2 7 1.4
Vitamin K, ug 70 14 20 4.0
Magnesium, mg 350 70 120 24
Zinc, mg 15 3 10 2.0
Selenium, ug 70 14 30 14
Note: Vitamins D, E, K, zinc and selenium are nutrients with known toxicity.
Table 3. Estimated safe and adequate daily intake of essential nutrients that have no
established RDA*
Age Group Biotin (ug) Pantothenic Copper Manganese
(years) Acid (mg) (mg) (mg)
Infants 0 - 0.5 10 2 0.4-0.6 0.3-0.6
0.5 - 1.0 15 3 0.6-0.7 0.6-1.0
Children/Adolescents
1-3 20 3 0.7-1.0 1.0-1.5
4-6 25 3-4 1.0-1.5 1.5-2.0
7 - 10 30 4-5 1.0-2.0 2.0-3.0
11+ 30-100 4-7 1.5-2.5 2.0-5.0
Adults 30-100 4-7 1.5-3.0 2.0-5.0
th
*Reference: Recommended Dietary Allowances, 10 edition
Food and Nutrition Board, National Research Council, Washington, D.C.
Annex F
Recognized agencies or institutions with analytical laboratories
that offer services for nutrient analysis to the food industry
DEPARTMENT OF AGRICULTURE
DEPARTMENT OF HEALTH
Institute of Chemistry
Analytical Services Laboratories
Designed to maintain health and provide reasonable levels of reserves in body tissues of nearly all healthy persons in the population.
Age (y) Weight kg Energy Protein Vit. A Vit. C Thiamin Riboflavin Niacin Folate Calcium Iron Iodine
(Kcal) g ug RE mg mg mg mg NE ug mg mg ug
Infants: 3-<6 mo. 6 620 8 325 30 0.3 0.3 5 20 300 10 40
6-<12 mo. 9 880 14 325 30 0.4 0.4 8 30 400 15 50
Children: 1-3 yrs. 13 1350 27 350 35 0.7 0.7 13 40 600 9 55
4-6 18 1600 32 375 45 0.8 0.8 15 60 600 10 65
7-9 24 1740 35 400 55 0.9 0.9 17 80 600 12 70
Males: 10-12 32 2090 45 425 65 1.0 1.0 20 100 700 16 85
13-15 44 2340 60 475 75 1.2 1.2 22 140 700 18 105
16-19 55 2580 69 525 90 1.3 1.3 25 170 700 17 120
20-39 56 2570 60 525 75 1.3 1.3 25 170 500 12 120
40-49 56 2440 60 525 75 1.2 1.2 23 170 500 12 120
50-59 56 2320 60 525 75 1.2 1.3 22 170 500 12 120
60-69 56 2090 60 525 75 1.0 1 20 170 500 12 120
70+ 56 1880 60 525 75 0.9 0.9 18 170 500 12 120
Females: 10-12 35 1910 49 400 70 1.0 1 18 110 700 17 80
13-15 44 2010 56 425 75 1.0 1 19 140 700 (21)b 100
16-19 48 2020 56 450 80 1.0 1 19 150 700 (25)b 100
20-39 49 1900 52 450 70 1 1 18 150 500 (26)b 100
40-49 49 1800 52 450 70 0.9 0.9 17 150 500 (26)b 100
50-59 49 1710 52 450 70 0.8 0.8 16 150 500 11 100
60-69 49 1540 52 450 70 0.8 0.8 15 150 500 11 100
70+ 49 1390 52 450 70 0.7 0.7 13 150 500 11 100
Pregnancy
1st trimester +000 +9 +25 +10 +0.0 +0.0 +0 +200 +400 (41)b +25
2nd trimester +300 +9 +25 +10 +0.3 +0.6 +3 +200 +400 (41)b +25
3rd trimester +300 +9 +25 +10 +0.3 +0.6 +3 +200 +400 (41)b +25
Lactation:
1st 6 mo +500 +16 +325 +35 +0.4 +0.4 +0.5 +100 +400 (23)b +50
2nd 6 mo +500 +12 +275 +30 +0.4 +0.4 +0.5 +100 +400 (23)b +50
a- Will be met if energy needs are met. See text.
b - These recommended dietary allowance cannot be met by the usual diet, thus, supplementation is recommended.
Annex C
FOOD AND NUTRITION BOARD, NATIONAL ACADEMY OF SCIENCES-
NATIONAL RESEARCH COUNCIL, RECOMMENDED DIETARY ALLOWANCES, Revised 1989
Designed for maintenance of good nutrition of practically all healthy people in the United States
Category Age (y)/ Weight Height Protein Fat-Soluble Vitamins Water-Soluble Vitamins Minerals
Condition
Vit
(kg) (lbs) (cm) (in) (g) Vit. A Vit. D Vit. E Vit. K Vit. C Thiamin Riboflavin Niacin B6 Folate Vit. B12 Calcium Phosphorus Magnesium Iron Zinc Iodine Selenium
(mg
(mcg RE) (mcg) (mcg TE) (mcg) (mcg) (mg) (mg) NE) (mg) (mcg) (mcg) (mg) (mg) (mg) (mg) (mg) (mcg) (mcg)
Infants 0.0-0.5 6 13 60 24 13 375 7.5 3 5 30 0.3 0.4 5 0.3 25 0.3 400 300 40 6 5 40 10
0.5-1.0 9 20 71 28 14 375 10 7 10 35 0.4 0.5 6 0.6 35 0.5 600 500 60 10 5 50 15
Children 1-3 13 29 90 35 16 400 10 6 15 40 0.7 0.8 9 1 50 0.7 800 800 80 10 10 70 20
4-6 20 44 112 44 24 500 10 7 20 45 0.9 1.1 12 1.1 75 1 800 800 120 10 10 90 20
7-10 28 62 132 52 28 700 10 7 30 45 1 1.2 13 1.4 100 1.4 800 800 170 10 10 120 30
Males 11-14 45 99 157 62 45 1000 10 10 45 50 1.3 1.5 17 1.7 150 2 1200 1200 270 12 15 150 40
15-18 66 145 176 69 59 1000 10 10 65 60 1.5 1.8 20 2 200 2 1200 1200 400 12 15 150 50
19-24 72 160 177 70 58 1000 10 10 70 60 1.5 1.7 19 2 200 2 1200 1200 350 10 15 150 70
25-50 79 174 176 70 63 1000 5 10 80 60 1.5 1.7 19 2 200 2 800 800 350 10 15 150 70
51+ 77 170 173 68 63 1000 5 10 80 60 1.2 1.4 15 2 200 2 800 800 350 10 15 150 70
Females 11-14 46 101 157 62 46 800 10 8 45 50 1.1 1.3 15 1.4 150 2 1200 1200 280 15 12 150 45
15-18 55 120 163 64 44 800 10 8 55 60 1.1 1.3 15 1.5 180 2 1200 1200 300 15 12 150 50
19-24 58 128 164 65 46 800 10 8 60 60 1.1 1.3 15 1.6 180 2 1200 1200 280 15 12 150 55
25-50 63 138 163 64 50 800 5 8 65 60 1.1 1.3 15 1.6 180 2 800 800 280 15 12 150 55
51+ 65 143 160 63 50 800 5 8 65 60 1 1.2 13 1.6 180 2 800 800 280 10 12 150 55
Pregnant 60 800 10 10 65 70 1.5 1.6 17 2.2 400 2.2 1200 1200 300 30 15 175 65
Lactating 1st 6 mos 65 1300 10 12 65 95 1.6 1.8 20 2.1 280 2.6 1200 1200 355 15 19 200 75
2nd 6 mos 62 1200 10 11 65 90 1.6 1.7 20 2.1 260 2.6 1200 1200 340 15 16 200 75