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SFDA.FD 000:2020

الفيتامينات والمعادن المسموح باستخدامها في المواد الغذائية

Vitamins and Minerals permitted for use in foodstuff

لمواصفة قياسية سعودية تم هذه الوثيقة مشروع

، لذلك فإنها توزيعها لإبداء الرأي والملحوظات بشأنها

ولا يجوز الرجوع إليها عرضة للتغيير والتبديل،

. كمواصفة قياسية سعودية إلا بعد اعتمادها من الهيئة

This document is a draft Saudi Standard

Circulated for comments. It is, therefore,

subject to alteration and modification and

may not be referred to as a Saudi Standard

Until approved by SFDA.

ICS: 67.040

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Foreword

Saudi Food and Drug Authority (SFDA) is an independent organization

with purpose of regulating and monitoring of foods, drugs and medical

devices. One of SFDA functions is to issue national Standards /Technical

Regulation in the fields of foods, drugs and medical devices, whether

imported or manufactured locally. SFDA food sector has updated Standard

No. SFDA.FD 2539 “Vitamins and Minerals permitted for use in

Foodstuff”. This Technical Regulation has been approved by His Highness

the CEO of SFDA as per Decision No (………) Held on (……….. AH),

(……….).

*It hereby shall nullify and replace SFDA.FDGSO 2359.

This Regulation repeals Clause (15.5) of Technical Regulation

SFDA.FD/GSO 194:2015 "Wheat flour."

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Vitamins and minerals permitted for use in foodstuffs

1- Domain and scope of application

This standard is concerned with vitamins and minerals

permitted for use in foodstuffs.

2 - Complementary References

2/1 SFDA.FD GSO 9 "Labeling of Prepackaged Foodstuffs."

2/2 SFDA.FD 2233 "Requirements on nutrition labeling"."

2/3 SFDA.FD 2333 " Requirements for nutrition and health claim in

the food.

2/4 SFDA.FD GSO 1069 "General principles for the addition of

essential nutrients to foods"

2/5 SFDA.FD 5003 "Infant formula, follow-up formula and milk for

special medicinal uses"

2/6 SFDA.FD GSO 194 "Wheat flour”.

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3 - General Requirements

3/1 This standard is derived from the requirements related

to vitamins and minerals mentioned in the approved regulations and

specifications and does not contradict with them in any way.

3/2 Vitamins and minerals may be added to food products in a form

that is bio-available to the human body.

3/3 Vitamins and minerals may not be added to foodstuffs unless these

vitamins and minerals are added to the product specification.

3/4 Vitamins and minerals may not be added to unprocessed foodstuffs

including, fruit, vegetables, meat, poultry, and fish.

4. vitamins and minerals permitted for use in foodstuffs.

4.1 Vitamins and minerals are added in the quantities mentioned in

the table without prejudice to what is stipulated in the technical

regulations and standard specifications for the following food

products:

Quantity Minerals /Vitamins Food

product

1200- 2500 lU /Kg. Vitamin A Milk (Laban)

Minimum level 400 IU. Vitamin D

1200- 2500 IU/Liter.

Vitamin A Flavored milk

300 – 400 IU/Liter.

Vitamin D

2000 IU of Vitamin A /Liter.

Vitamin A Sterilized milk

400 IU of Vitamin D /Liter.

Vitamin D

2000 IU /Liter.

Vitamin A

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400 IU /Liter. Vitamin D Pasteurized

milk

Vitamin A content may be added

to Low-Fat and skimmed milk and

shall be between 1200 -IU/Liter

2500 IU /Liter. It is optional to add

the same amount of Vitamin A to

full- fat milk.

Vitamin A UHT Milk

( long life)

Vitamin D content may be

added to full – fat milk, Low-Fat

milk, and skimmed milk shall be

between

300 – 400 IU/Liter.

Vitamin D

2000 IU/ Liter. Vitamin A Dairy products

– Pasteurized

camel milk 400 IU / Liter. Vitamin D

8000μg/Liter. Vitamin A Skimmed

evaporated

milk mixed

with vegetable

oil

600μg/Liter.

Vitamin D

2000 IU /kg

Vitamin A Skimmed

Powdered milk

mixed with

vegetable oil 400 IU/kg

Vitamin D

2000 IU / Liter Vitamin A Juices with

milk 400 IU / Liter Vitamin D

Not less than 2000 lU/ Liter Vitamin A

Yogurt Not less than 400 IU /Liter Vitamin D

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2000 IU / Liter. Vitamin A Flavored

Yogurt 400 IU / Liter. Vitamin D

70- 114 (μg RE /100 kcal)

16.7- 27.2 (μg RE /100 kJ)

Vitamin A

Infants

Formula and

Formula for

Special

Medical

Purposes

Intended for

Infants

2- 3 (μg/100 kcal)

0.48- 0.72 (μg/100 kJ)

Vitamin D₃

0.6- 5 (mg α-TE /100 kcal)

0.14-1.2 ) mg α-TE /100 kJ)

Vitamin E

1-25 ) μg / 100 kcal)

0.24-6 (μg/100 kJ )

Vitamin K

40- 300 (μg/100 kcal )

9.6- 72 (μg/100 kJ)

B₁ Vitamin

(Thiamin )

60-400 ) μg / 100 kcal)

14.3-95.6 (μg/ 100 kJ)

Vitamin B2

(Riboflavin)

Quantity Vitamins/ minerals Food

product

0.4- 1.5 (mg /100 kcal)

0.1- 0.36 (mg / 100 kJ)

Vitamin B3

Niacin

(Nicotinic

acid)

Infants

Formula and

Formula for

Special

Medical

Purposes

Intended for

Infants

20- 175 (μg /100 kcal)

4.8- 41.8 (μg / 100 kJ)

Vitamin B₆

(Pyridoxine)

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0.1- 0.5 (μg/100 kcal)

0.02- 0.12 (μg / 100 kJ)

(B₁₂)Vitamin

0.4- 2 (mg/100 kcal)

0.1- 0.48 (mg / 100 kJ ( Pantothenic

acid

15- 47.6 (μg/100 kcal)

3.6- 11.4 ( μg /100 kJ)

Folic acid

4- 30 ) mg/100 kcal)

0.96- 7.2 (mg / 100 kJ (

Vitamin C

1.5- 7.5 (μg/100 kcal (

0.24- 1.8 ( μg / 100 kJ) Biotin

0.3- 1.3 (mg /100 kcal )

0.07- 0.31(mg/ 100 kJ) Iron

50 - 140( mg/100 kcal)

12- 33.5( mg/100 kJ)

Calcium

25- 90 ( mg / 100 kcal )

6- 21.5( mg / 100 kJ)

Phosphor

5- 15 (mg/100 kcal)

1.2- 3.6 (mg / 100 kJ)

Magnesium

Quantity Vitamins/minerals Food

product

25- 60 ( mg/ 100 kcal)

6- 14.3 ( mg/100 kJ)

Sodium Infants Formula

and Formula for

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60- 160 ) mg/100 kcal)

14.3- 38.2 (mg/ 100 kJ)

Chloride Special Medical

Purposes

Intended for

Infants 80- 160 (mg/ 100 kcal)

19.1- 38.2(mg/ 100 kJ)

Potassium

1-100(μg/100 kcal)

0.24- 24 (μg / 100 kJ)

Manganese

15- 29(μg/100 kcal)

3.6- 6.9 (μg / 100 kJ) Iodine

3-8.6 (μg/ 100 kcal)

0.72-2 (μg / 100 kJ) Selenium

60-100 (μg/ 100 kcal)

14.3-24 (μg / 100 kJ)

Copper

0.5-1 (mg/100 kcal)

0.12- 0.24 (mg/ 100 kJ) Zinc

Sodium shall not exceed 100 mg/100

kcal (25 mg /100 kJ) in the product

intended for consumption. Sodium

Processed

cereal-based

foods for

infants and

young

children

calcium content in

Protein-fortified cereals shall not

be less than 80 mg /100 kcal (20

mg/100 kJ)

Calcium

Quantity Vitamins/minerals Food

product

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Calcium content in biscuits and

rusks, processed with the

addition of milk as it is, shall not

be less than 50 mg /100 kcal (12

mg/100 kJ)

Calcium

Processed

cereal-based

foods for

infants and

young children

Content of Vitamin B₁(Thiamin)

shall not be less than 25 μg/ 100 kJ

(100 μg / 100 kcal)

B₁ Vitamin

(Thiamin )

60-180 (μg α-TE /100 kcal)

14-43 (μg / 100 kJ)

Vitamin A

1- 3 (μg/100 kcal)

0.25- 0.75 (μg / 100 kJ)

Vitamin D

600 μg VitaminA

Foods for

use in

weight

control

diets.

2.5 μg Vitamin D

10 mg Vitamin E

30 mg Vitamin C

0. 8 mg B₁ Vitamin

(Thiamin)

Quantity Vitamins/minerals Food

product

10

1.2 mg

B₂ vitamin

(Riboflavin )

Foods for use

in weight

control diets.

11 mg Niacin

2 mg Vitamin B₆

1 μg Vitamin B₁₂

200 μg Folate

500 mg Calcium

500 mg Phosphor

16 mg Iron

140 μg Iodine

350 mg magnesium

1.5 mg Copper

6 mg Zinc

1.6 mg Potassium

1.0 gram Sodium

(ppm) 4.4 -8.8 Thiamin Rice cereal

2.6- 5.3 (ppm)

Riboflavin

35-70 (ppm)

Niacin

(ppm) 29-57

Iron

Quantity Vitamins / minerals Food

product

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15–40 mg / kg expressed as Iodine.

Iodine

Salt

4.2 Wheat flour (flour) in a way that does not contradict what is stated in Item

No. (6.2), the amount of nutrients that should be fortified in wheat flour

(flour) should not be less than the following:

Nutrient The rate

of wheat

extraction

compound The amount of the added

nutrient calculated in parts of

a million (PPM) according to

the estimated level of wheat

flour availability per person (g

/ day).

Low

than

75

gram/

day

75-

150

gram/

day

150-

300

gram/

day

More

than

300

gram/

day

Iron Low (NaFeEDTA)

Ferrous sulfate

Ferrous fumarate

Electrolytic iron

40

60

60

NR

40

60

60

NR

20

30

30

60

15

20

20

40

High NaFeEDTA 40 40 20 15

Folic

acid

Low or

High

Folic acid

5 2.6 1.3 1.0

Vitamin

(B12)

Low or

High

Cyanocobalamin

0.04 0.02 0.01 0.008

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Vitamin

A

Low or

High

Vitamin A

Palmitate

5.9 3 1.5 1

Zink

Low

Zinc oxide 95 55 40 30

High

Zinc oxide 100 100 80 70

Vitamin

D

The amount of the nutrient

per 100 grams Limits

551.15 IU Minimum

5 LABELLING

Without violating, the provisions of the Technical Regulation mentioned in

Section No. 2/1.

5.1 In case of stating any health or nutritional claim concerning vitamins

and minerals on the labelling of the food products , it must be in accordance

with the standard mentioned in Section No 2/3 .

5/2 The labelling of the food product to which vitamins and minerals

have been added shall not include any statement or claim implying that a

balanced and varied diet cannot provide appropriate quantities of nutrients

5/3 The foodstuffs shall not be described or presented with a label or

explanatory information regarding vitamins and minerals in a manner that

involves falsehood, misinformation, deception or in any way that may lead

to a false impression of their characteristics in any way.

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5/4 The labelling of foods to which vitamins and minerals have been

added shall not mislead or deceive the consumer as to the nutritional

value of a food that may result from the addition of these nutrients.

5/5 Without violating what is stated in the technical regulations

mentioned in Section No. 2/2, the digital information of vitamins and

minerals shall be expressed in metric units and / or the percentage of the

reference value of the nutrient for every 100 g or 100 ml or for each

package if it contains a piece. This information may also be clarified for

each amount of food according to what is indicated quantitatively on the

label or for each piece in the package, on the basis of indicating the

number of pieces in the package.

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References

REGULATION (EC) No 1925/2006 on the addition of vitamins and

minerals and of certain other substances to foods.

Standard 1.3.2 Vitamins and Minerals (Australia).

WHO | Fortification of wheat and maize flours