MINISTRY OF HEALTH
RESOLUTION No. 393 EXEMPT
Published in the Official Gazette, March 1, 2002
ISSUES NUTRITIONAL INSTRUCTIONS ON USE OF VITAMINS AND MINERALS IN FOOD
No. 393 Exempt. Santiago, February 20, 2002
Having had before me:
The provisions contained in articles 108 and 109 of the Health Code, approved under Decree with Force of Law No. 725, of 1967, issued by the Ministry of Health; article 114 of the Sanitary Food Regulations, approved under Decree No. 977, of 1996, issued by the Ministry of health, and in Resolution No. 520, of 1996, issued by the Office of the Comptroller-General of the Republic:
The maximum limits for fortifying food with vitamins and minerals, set forth under Exempt resolution No. 1.844/1998, issued by the Ministry of Health, and amendments thereto, have been reviewed and examined on the basis of new scientific and technical information; and
Bearing in mind the authority granted to me under article 4 b) and 6 of Decree-Law No. 2,763, of 1979, I hereby issue the following
1 – The following maximum limits are hereby set for fortifying food with vitamins and minerals per serving:
Nutrient Unit % of reference DRD Absolute value
Vitamins value per serving per serving
Vitamin A mcg ER 25 200.0
Vitamin D mcg 40 2.0
Vitamin E mg ET 100 20.0
Vitamin K mcg 100 80.0
Vitamin C mg 100 60.0
Tiamin (B1) mg 50 0.7
Riboflavin (B2) mg 50 0.8
Niacin mg EN 25 4.5
Vitamin B6 mg 50 1.0
Folate mcg 50 100.0
Vitamin B12 mcg 100 1.0
Pantotenic acid mg 50 5.0
Biotin mcg 10 30.0
Colin mg 50 275.0
Calcium mg 50 400.0
Chrome +3 mcg 50 17.5
Copper mg 25 0.5
Iron mg 25 3.5
Magnesium mg 25 75.0
Phosphorus mg 50 400.0
Zinc mg 25 3.8
Selenium mcg 25 17.5
- To prevent loss from degradation that might affect vitamins and minerals during the period between the fortified food processing date to the expiry date of such product shelf life, and to ensure that at the end of such period such product shall retain at l east thelevel of vitamins or minerals stated on the label thereof, the following excess dosage will be accepted:
– for vitamins, the limits stated on the label may be exceeded by up to 40%:
– for minerals, the limits stated on the label may be exceeded by up to 35%,
3.Maximum limits specified hereunder shall not apply to Foods for Special Diets, dealt with under Title XXVIII of the Sanitary Food Regulations.
4 Also excepted from the provisions hereunder are foods to be fortified with different levels of a specific nutrient, pursuant to the Sanitary Food Regulations, in order to resolve a specific public health problem, and also foods involved in public health programs, which are governed by special fortification standards individually defined and specified in the program concerned.
5 The following products shall no be fortified or enriched with vitamins and minerals:
– Milk formulas, milk desserts, milk beverages and milk substitutes, where milk proteins are less than 35% of the total proteins in dry extract.
– Confectionery and similar products, such as chocolates, candy, sweets, chewing-gum, cookies, and ice cream.
– Preserves and similar products, such as jams, jellies, and candied fruit.
– Sugar, honey, syrup.
– Carbonated soft drinks.
– Tea, coffee, mate, and herb teas based on aromatic herbs.
– Spices, condiments, and sauces.
– Cocktail crackers
– Processed fruit.
– Meat, meat products, fish, and shellfish.
– The above limitation shall not apply to Food for Athletes regulated under Title XXIX of Supreme Decree No.977 of 1996, issued by the Ministry of health, which approved the Food Sanitary Regulations.
6 Fortification or enrichment of fruit or vegetable nectars is hereby permitted, provided that:
– The label on fruit and vegetable nectars shall state % m/m soluble solids in the constituent fruit(s) or vegetable(s).
7 Fortification or enrichment of non-carbonated non-alcoholic beverages and powders for preparing soft drinks is hereby permitted under the following condition:
– such fortification or enrichment shall include at least three of the nutrients listed below:
8 Juice fortification is hereby permitted. Juices no fortifies shall not carry the denomination “pure juice”, as provided under article 482 of the Food Sanitary Regulations, Supreme Decree No. 977/06, issued by the Ministry of Health.
9 Control of food fortification with vitamins and minerals shall be conducted according to an inspection plan that contemplates a composite sample made up of five equal samples of the product taken at random, analyzed three times. To such end the methods of analysis used shall be those of the Chilean Institute of Public Health, domestic reference lab for such purposes.
10 Reference bases for fortifying or enriching food products in Chile are listed below:
Daily reference dose (DRD) for adults and children over 4 years of age, stated as nutritional information on the label of food products in Chile
Energy kcal 2300
Protein g 50
Vitamin A mcg ER 800
Vitamin D mcg 5
Vitamin E mg ET 20
Vitamin K mcg* 80
Vitamin C mg 60
Tiamin (B1) mg 1.4
Riboflavin (B2) mg 1.6
Niacin mg EN 18
Vitamin B6 mg 2
Folate mcg 200
Vitamin B12 mcg 1
Pantotenic acid mg* 10
Biotin mcg* 300
Colin mg** 550
Calcium mg 800
Phosphorus mg 800
Magnesium mg 300
Iron mg 14
Zinc mg 15
Copper mg* 2
Selenium mcg* 70
Chrome+3 mcg** 35
| 1 ER = retinal equivalent
2 as mcg of tocoferol
3 ET = alpha tocoferol equivalent
4 EN = niacin equivalent
Ref. Codex guidelines on nutritional labeling Rev. 1 (1993), except for nutrients marked with an asterisk (*, **)
*RDI values obtained from the FDA
** Adequate intake values, AI
11 Exempt Resolutions No. 1.844/98 and amendments thereto, and No. 9/96, all issued by the Ministry7 of health, are hereby revoked.
12 Ministerial resolutions under which enrichment of specific food products has been individually authorized using elements not contemplated hereunder or in percentages exceeding the limits approved hereby, shall remain in effect for six months after the effective date hereof, following which the contents thereof shall be adjusted as specified in the preceding paragraphs.
13 This resolution shall become effective thirty days after publication thereof in the Official Gazette
To be noted and published. L. Gonzalo Navarrete Muñoz, Acting Minister of Health
Which I hereby transcribe for your information. Sincerely, Luis Gonzalo Navarrete Muñoz, Under Secretary for Health.
 ER = Retinol equivalent
 mcg of tocoferol
 ET 0 alpha tocoferol equivalent
 EN = niacin equivalent