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:
Whereas
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
Resolution
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
Minerals
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
2. 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 the level 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.
-
Pickles.
-
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:
iron
vitamin
C
fiber
zinc
vitamin
E
calcium
vitamin
B12
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[1] 800
Vitamin D mcg[2] 5
Vitamin E mg ET[3] 20
Vitamin K mcg* 80
Vitamin C mg 60
Tiamin (B1) mg 1.4
Riboflavin (B2) mg 1.6
Niacin mg EN[4] 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.