Circular No. 17/2010/TT-BYT Issuing National Technical Regulations on substances used to supplement calcium in food

CIRCULAR

Issuing National Technical Regulations on substances used to supplement calcium in food

to be added to food

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006 Government Decree No. Decision No. 127/2007/NĐ-CP dated August 1, 2007, issued by the Government detailing the implementation of certain provisions of the Law on Standards and Technical Regulations;

Pursuant to the Ordinance on Food Safety and Hygiene dated August 7, 2003 and Decree No. 163/2004/NĐ-CP dated September 7, 2004 of the Government detailing implementation of certain provisions of the Ordinance on Food Safety and Hygiene;

Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Food Safety and Hygiene Administration, the Head of the Science and Training Department, and the Head of the Legal Affairs Department,

c) Enterprises may be granted permission for no more than one block out of the total three dual-frequency blocks (FDD) B

Article 1. 1. National Technical Regulation on Railway Traffic Signals, number QCVN 21:2025/BXD.

QCVN 3-4:2010/BYT - National Technical Regulation on substances used to supplement calcium in food.

Article 2. This Circular takes effect from January 1, 2011.

Article 3. The Director of the Food Safety and Hygiene Administration, Heads of units under the Ministry of Health, units directly under the Ministry of Health; Directors of Provincial Health Departments and central city health departments, and relevant organizations and individuals are responsible for implementing this Circular./.

 

QCVN 3-4:2010/BYT
NATIONAL TECHNICAL REGULATION
ON SUBSTANCES USED TO SUPPLEMENT CALCIUM
IN FOOD
National technical regulation
on substances that may be added for calcium fortification in food
Preamble
QCVN 3-4:2010/BYT was drafted by the National Technical Regulation Drafting Board on Nutrient-Fortified Foods, submitted for review by the Food Safety and Hygiene Administration, and issued pursuant to Circular No. 17/2010/TT-BYT dated May 20, 2010 of the Minister of Health.
National technical regulation
1. Scope of Application
This national technical regulation (hereinafter referred to as the Regulation) sets forth technical requirements and management requirements concerning quality and hygiene safety for substances used to supplement calcium in food.
NATIONAL TECHNICAL REGULATION
ON SUBSTANCES USED TO SUPPLEMENT CALCIUM
IN FOOD
2. Applicability
on substances that may be added for calcium fortification in food
I. GENERAL PROVISIONS
This Regulation applies to:
2.1 Organizations and individuals importing, exporting, producing, trading, and using substances to supplement calcium in food (hereinafter referred to as organizations and individuals).
2.2 Relevant state management agencies.
3. Definitions and Abbreviations
3.1 Substances used to supplement calcium in food: These are substances actively added to food with the purpose of supplementing calcium.
3.2 JECFA Monograph 1 - Vol. 4: JECFA Monographs 1 - Combined Compendium - JECFA Monograph 1 - Vol. 4 (JECFA Monographs 1 - Combined Compendium of Food Additive Specifications; Joint FAO/WHO Expert Committee on Food Additives; Volume 4 - Analytical Methods, Test Procedures and Laboratory Solutions Used by and Referenced in the Food Additive Specifications; FAO, 2006):
Technical requirements for food additives, Volume 4 - Analytical methods, test procedures, and laboratory solutions used (or referenced) in the technical requirements for food additives; compiled by JECFA and promulgated by FAO in 2006.
3.3 CAS number (Chemical Abstracts Service): Registration number for chemicals by the American Chemical Society.
3.4 TS (test solution): Test solution.
3.5 ADI (Acceptable Daily Intake): Acceptable daily intake.
3.6 INS (International Numbering System): International numbering system for food additives.
II. TECHNICAL REQUIREMENTS AND TESTING METHODS
1. Technical requirements and testing methods for substances used to supplement calcium in food are specified in the appendices accompanying this Regulation as follows:
1.1 Appendix 1: Technical requirements and testing methods for Calcium Carbonate.
1.2 Appendix 2: Technical requirements and testing methods for Calcium Gluconate.
1.3 Appendix 3: Technical requirements and testing methods for Calcium Dihydrophosphate.
1.4 Appendix 4: Technical requirements and testing methods for Calcium Dihydrodiphosphate.
2. The technical requirements set forth in this standard shall be tested according to JECFA Monograph 1 - Vol. 4, except for some specific tests described in the appendices; equivalent testing methods may also be used.
3. Sampling shall be conducted in accordance with Circular No. 16/2009/TT-BKHCN dated June 2, 2009 of the Ministry of Science and Technology on guidelines for state inspection of the quality of goods circulating in the market and other relevant legal provisions.
III. MANAGEMENT REQUIREMENTS
1. Declaration of Compliance
1.1 All substances used to supplement calcium in food must be declared in compliance with the provisions of this Regulation.
1.2 The method, procedure, and process for declaring compliance shall be carried out in accordance with the regulations on certification of conformity, declaration of conformity, and issuance of certificates of conformity and declarations of conformity issued together with Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007 of the Minister of Science and Technology and other relevant legal provisions.
2. Inspection of Substances Used to Supplement Calcium in Food
Quality and hygiene safety inspections of substances used to supplement calcium in food must be conducted in accordance with legal provisions.
1. Organizations and individuals must declare compliance in accordance with the technical requirements of this Regulation, register their declaration of compliance with the Food Safety and Hygiene Administration, and ensure quality and hygiene safety in accordance with the contents of the declaration.
75 
2. Organizations and individuals may only import, export, produce, trade, and use substances used to supplement calcium in food after completing registration of their declaration of compliance and ensuring quality, hygiene safety, and labeling in accordance with legal provisions.
1. The Food Safety and Hygiene Administration shall take the lead and coordinate with relevant functional agencies to guide implementation and organization of enforcement of this Regulation.
2. Based on management requirements, the Food Safety and Hygiene Administration shall have the responsibility to propose amendments and supplements to this Regulation to the Ministry of Health.
1. Technical requirements and testing methods for calcium supplements added to food are specified in the appendices attached to this standard as follows:
2. The technical requirements stipulated in this standard are tested according to JECFA monograph 1 - Vol. 4, except for certain specific tests described in the appendices; equivalent testing methods may be used.
3. Sampling shall be conducted in accordance with Circular No. 16/2009/TT-BKHCN dated June 2, 2009, issued by the Ministry of Science and Technology on state inspection guidelines for goods circulating in the market and other relevant laws.
1.1 Appendix 1: Technical requirements and testing methods for Calcium carbonate.
carbonate. 
1.2 Appendix 2: Technical requirements and testing methods for Calcium gluconate.
gluconate. 
1.3 Appendix 3: Technical requirements and testing methods for Calcium dihydrophosphate.
phosphate. 
1.4 Appendix 4: Technical requirements and testing methods for Calcium dihydropyrophosphate.
diphosphate. 
2. The technical requirements set forth in this standard shall be tested according to JECFA monograph 1 - Vol. 4, except for certain specific tests described in the appendices; equivalent testing methods may be used.
Monograph 1 - Vol. 4, except for certain tests described in the appendices. 
3. Sampling shall be conducted in accordance with Circular No. 16/2009/TT-BKHCN dated June 2, 2009, issued by the Ministry of Science and Technology on state inspection guidelines for goods circulating in the market and other relevant laws.
3. Sampling shall be carried out in accordance with Circular No. 16/2009/TT-BKHCN dated June 2, 2009. 
III. MANAGEMENT REQUIREMENTS
1. Declaration of conformity
1.1 All calcium supplements added to food must be declared in compliance with the provisions of this standard.
III. MANAGEMENT REQUIREMENTS. 
1.2 The method, procedure, and process for declaring conformity shall be carried out in accordance with the regulations on certification, declaration of conformity, and announcement of conformity promulgated together with Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007, issued by the Minister of Science and Technology and other relevant laws.
1.1 All calcium food supplements must be announced in compliance with regulations on conformity certification, conformity declaration, and conformity announcement. 
2. Inspection of calcium supplements added to food
Quality and hygiene safety inspections of calcium supplements added to food must be conducted in accordance with the provisions of the law.
provisions set forth in Decision No. 28/2007/QD-BKHCN dated September 28, 2007 of the Minister of Science and Technology and other relevant regulations. 
1. Organizations and individuals must declare conformity in compliance with the technical requirements of this standard, register the declaration of conformity at the Food Safety Agency, and ensure quality and hygiene safety in accordance with the contents announced.
2. Inspection of calcium food supplements. 
2. Organizations and individuals are only allowed to import, export, produce, trade, and use calcium supplements added to food after completing the registration of the declaration of conformity and ensuring quality, hygiene safety, and labeling in compliance with the provisions of the law.
Food supplements must be conducted in accordance with the provisions of the law. 
1. The Food Safety Agency shall take the lead and coordinate with relevant agencies to guide the implementation and organization of the enforcement of this standard.
This standard, registration of the conformity declaration at the Food Safety Agency. 
IV. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
2. Based on management requirements, the Food Safety Agency has the responsibility to propose amendments and supplements to this standard to the Ministry of Health.
2. Organizations and individuals are only permitted to import, export, produce, trade, and circulate calcium food supplements that comply with quality standards, food safety, and labeling requirements. 
apply according to the new document.
1. The Food Safety Agency shall take the lead and coordinate with relevant agencies. 
within JECFA monograph 1-Vol. 4 section analytical tools.
2. Based on management requirements, the Food Safety Agency has the responsibility. 
Weigh approximately 200 mg (accurate to 0.1 mg) of the dried sample, transfer it to a 400 ml beaker, add 10 ml of water, and stir to form a thick mixture. Cover the beaker with a watch glass and use a pipette (the pipette is placed between the edge of the beaker and the rim of the watch glass) to add 2 ml of dilute hydrochloric acid solution (TS). Shake the beaker to dissolve the sample. Rinse the inside of the beaker, the outside of the pipette, and the watch glass, then dilute to 100 ml with distilled water. While stirring (preferably using a magnetic stirrer), add 30 ml of 0.05 M sodium ethylenediaminetetraacetate, then add 15 ml of sodium hydroxide solution (TS) and 300 mg of hydroxynaphthol blue indicator, and continue titration until the solution turns blue.
V. IMPLEMENTATION
Composition formula. 
Each milliliter of 0.05 M sodium ethylenediaminetetraacetate is equivalent to 5.004 mg CaCO3.
Solubility. 
Appendix 2
3. In case international guidance on testing methods and the legal provisions cited in this Standard are amended, supplemented, or replaced, the new provisions shall apply.
TECHNICAL REQUIREMENTS AND TESTING METHODS FOR CALCIUM CARBONATE
GLUCONATE
Appendix 1
1. Other names, index number
2. Definition
Chemical name
CAS number
Chemical formula
Molecular weight
3. Sensory characteristics
4. Function
5. Technical requirements
5.1. Qualitative analysis
Solubility
Calcium
Carbonate
Barium
Fluoride
Free alkali
Arsenic
Lead
Calcium carbonate, powder
INS 170i
ADI "Unlimited"
Calcium carbonate; calcium salt of carbonic acid.
CaCO3
White fine crystal powder, odorless. - Nutrient supplement: calcium supplementation. - Food additive: anti-caking agent.
471-43-1 
Insoluble in water and ethanol.
100,09 
Must exhibit characteristic reactions of calcium.
Must exhibit characteristic reactions of carbonate.
Loss on drying must not exceed 2.0% (dried at 200°C for 4 hours).
Non-soluble substances in
acid
Not more than 0.2%.
Not more than 0.03%.
Not more than 50.0 mg/kg.
Not more than 0.05%.
Magnesium salts and
alkali
Not more than 1.0%.
Not more than 3.0 mg/kg.
Not more than 3.0 mg/kg.
5.3. Content must not be less than 98.0% after drying.
6. Testing methods
6.1. Purity
Weigh 5 g (accurate to mg) of the sample, disperse it in
78 
1. Organizations and individuals must declare compliance in accordance with the technical requirements of this Regulation, register their declaration of compliance with the Food Safety and Hygiene Administration, and ensure quality and hygiene safety in accordance with the contents of the declaration.
25 ml of water. Carefully add 25 ml of hydrochloric acid solution
(1 in 2), stirring continuously, then add
Not more than 0.03%.
Not more than 50.0 mg/kg.
Free alkali
Arsenic
Lead
Not more than 3.0 mg/kg.
Not more than 3.0 mg/kg.
water and dilute to 200 ml. Boil the mixture, cover the container,
immerse it in a water bath for 1 hour, cool it down and filter. Wash the precipitate with water until
the washings no longer contain chloride when tested with silver nitrate solution (TS). Dry the precipitate, cool it, weigh it, and calculate the result (%).
The weight of the residue obtained must not exceed 10 mg.
Weigh 1 g (accurate to mg) of the sample, mix it with 10 ml
of water. Add 15 ml of diluted hydrochloric acid solution
(TS), further dilute to 30 ml with water and filter. Take
20 ml of the filtrate, add 2 g of sodium acetate, 1 ml of diluted acetic acid solution
(TS), 0.5 ml of potassium chromate solution (TS) and let stand for 15 minutes. The resulting solution
must not be more turbid than the control solution containing
1 mg of barium/ml. To prepare the control solution, add
20 ml of distilled water to 0.3 ml of standard barium solution (1.799 g
of barium chloride/1 l), then add 2 g of sodium acetate, 1 ml of diluted acetic acid solution
(TS), 0.5 ml of potassium chromate solution (TS). - Sample: 1 g (accurate to mg). - Test according to JECFA monograph 1 - Vol. 4 (limit test for fluoride - method III).
Weigh 3 g of the sample, place it in 30 ml of freshly boiled and cooled water, stir for 3 minutes and filter. Add 2 drops of phenolphthalein solution (TS) to 20 ml of the filtrate.
The solution turns red and loses color upon addition of
0.2 ml of 0.1 N hydrochloric acid.
Mix 1 g of the sample with 40 ml of water, carefully add 5 ml
of hydrochloric acid, shake the mixture well and boil it for 1
minute. Immediately add 40 ml of oxalic acid solution
(TS), stir vigorously until a precipitate forms. Immediately add 2 drops of methyl red solution (TS), then add
drops of ammonia solution (TS) until the solution begins to show alkalinity, cool the solution. Transfer the mixture to a 100 ml measuring cylinder, dilute with water
to 100 ml, let stand for 4 hours or overnight, then decant the clear supernatant through dry filter paper. Take 50 ml of the filtrate into a platinum dish, add 0.5 ml of sulfuric acid, evaporate the mixture on a water bath
until only a small amount of liquid remains. Carefully evaporate the remaining liquid over a flame until dry and continue heating until all ammonium salts are destroyed and completely volatilized. Finally, calcine the residue to constant weight. Cool it, weigh it, and calculate the result. (The weight of the residue obtained must not exceed 5 mg).
6.2. Quantitative analysis
Test according to JECFA monograph 1 - Vol. 4 (arsenic limit test - method II).
Test according to JECFA monograph 1 - Vol. 4. Determine using suitable atomic absorption techniques for the specified content. Select sample size and sample preparation method based on the principles described in JECFA monograph 1-Vol. 4 section instrumental analytical methods.
Weigh 200 mg (accurate to 0.1 mg) of the dried sample, transfer it to a 400 ml beaker, add 10 ml of water and
stir to form a thick mixture. Cover the beaker with a watch glass and use a pipette (the pipette is placed between
the edge of the beaker and the rim of the watch glass) to add 2 ml of diluted hydrochloric acid solution (TS). Shake the beaker to dissolve the sample. Rinse the inside of the beaker, outside of the pipette, and the watch glass, dilute to 100 ml with distilled water.
While stirring (preferably with a magnetic stirrer), add
30 ml of 0.05 M disodium ethylenediaminetetraacetic acid, then add 15 ml of sodium hydroxide solution (TS) and 300 mg of blue naphthol indicator and titrate until the solution turns blue.
1. Organizations and individuals must declare compliance in accordance with the technical requirements of this Regulation, register their declaration of compliance with the Food Safety and Hygiene Administration, and ensure quality and hygiene safety in accordance with the contents of the declaration.
79 
Each ml of 0.05 M disodium ethylenediaminetetraacetic acid corresponds to 5.004 mg of CaCO3.
Appendix 2
GLUCONATE
Molecular formula
Structural formula
5. Technical requirements
Solubility
Gluconate
Loss on drying
Reducing compounds
Calcium gluconate
INS 578
ADI "Unlimited".
Calcium di-D-gluconate monohydrate.
Calcium carbonate, powder
INS 170i
C12H22CaO14.H2O
White granular or crystalline powder, odorless, stable in air. - Nutrient supplement: calcium supplementation. - Food additive: acid regulator, firming agent, metal chelating agent.
Soluble in water, insoluble in ethanol.
Must exhibit characteristic reactions of calcium.
Must exhibit characteristic reactions of gluconate.
Not more than 2.0%. (dried at 105°C for 16 hours).
Not more than 1.0% calculated on D-glucose.
Molecular formula
Structural formula
5. Technical requirements
Solubility
Gluconate
Loss on drying
Reducing substances
Calcium gluconate
INS 578
ADI "Unlimited".
Calcium di-D-gluconate monohydrate.
C12H22CaO14.H2O
White crystalline powder or granules, odorless, stable in air. - Nutrient supplement: calcium supplementation. - Food additive: acid adjustment, firming agent, metal chelating agent.
Soluble in water, insoluble in ethanol.
Must have the characteristic reaction of calcium.
Must have the characteristic reaction of gluconate.
Not more than 2.0% (dried at 105°C for 16 hours).
80 
1. Organizations and individuals must declare compliance in accordance with the technical requirements of this Regulation, register their declaration of compliance with the Food Safety and Hygiene Administration, and ensure quality and hygiene safety in accordance with the contents of the declaration.
Not more than 1.0% based on D-glucose.
1. Other names, index number
analytical tool.
Chemical name
CAS number
Chemical formula
Molecular weight
6.2 Quantitative analysis Weigh approximately 0.5 g (accurate to mg) of the sample, dissolve it in 5 ml of dilute hydrochloric acid solution. Add 50 ml of water, 25 ml of sodium hydroxide solution (TS), and about 0.1 g of 2-hydroxy-1-(2'-hydroxy-4'-sulfo-1'-naphtylazo)-3-naphthoic acid. Titrate immediately with 0.05 M EDTA solution until the color of the solution changes from red to blue.
Gluconate. 
4. Function
5. Technical requirements
5.1. Qualitative analysis
Each milliliter of 0.05 M EDTA solution is equivalent to 22.42 mg C12H22CaO14.H2O.
Calcium
Loss on drying. 
Barium
Reducing compounds. 
acid
Calcium gluconate. 
INS 578. 
INS 170i
ADI "Unlimited." 
Calcium di-D-gluconate monohydrate. 
C12H22CaO14.H2O. 
White granular or crystalline powder form, odorless, stable in air. - Nutrient supplement: calcium supplementation. - Food additive: pH adjustment, firming agent, metal chelating agent. 
299-28-5 
Soluble in water, insoluble in ethanol. 
448,39 
Must exhibit the characteristic reaction of calcium. 
Must exhibit the characteristic reaction of gluconate. 
Not more than 2.0%. (dried at 105°C for 16 hours). 
Not more than 1.0% calculated on the basis of D-glucose. 
instrumental analysis. 
6.2 Quantification Weigh approximately 0.5 g (accurate to mg) of the sample, dissolve it in 5 ml of dilute hydrochloric acid solution. 
Add 50 ml of water, 25 ml of sodium hydroxide solution (TS), and about 0.1 g of 2-hydroxy-1-(2'-hydroxy-4'-sulfo-1'-naphthylazo)-3-naphthoic acid. 
Titrate immediately with 0.05 M EDTA solution until the color of the solution changes from red to blue. 
Not more than 2.0 mg/kg.
5.3. Content Not less than 98.0% and not more than
102.0% calculated on the dried preparation.
1. Organizations and individuals must declare compliance in accordance with the technical requirements of this Regulation, register their declaration of compliance with the Food Safety and Hygiene Administration, and ensure quality and hygiene safety in accordance with the contents of the declaration.
81 
25 ml of water. Carefully add 25 ml of hydrochloric acid solution
(1 in 2), stirring continuously, then add
INS 578. 
Lead
Test according to JECFA monograph 1 - Vol. 4 (discussing the determination of reducing compounds - Method I).
Test according to JECFA monograph 1 - Vol. 4. Determine using suitable atomic absorption technique for the specified content. Select sample size and sample preparation method based on the principle described in JECFA
monograph 1 - Vol. 4 section analytical methods.
6.2. Quantitation Weigh approximately 0.5 g (accurate to mg) of the test sample,
dissolve in 5 ml of dilute hydrochloric acid solution.
Add 50 ml of water, 25 ml of sodium hydroxide solution (TS), and about 0.1 g of 2-hydroxy-1-(2'-hydroxy-4'-sulfo-1'-naphthylazo)-3-naphthoic acid.
Titrate immediately with 0.05 M EDTA solution until the color of the solution changes from red to blue.
Each ml of 0.05 M EDTA solution is equivalent to 22.42 mg of C12H22CaO14.H2O.
Each milliliter of 0.05 M EDTA solution is equivalent to 22.42 mg of C12H22CaO14.H2O. 
6.2. Định lượng Cân khoảng 0,5 g (chính xác đến mg) mẫu thử, 
hòa tan trong 5 ml dung dịch acid hydrocloric 
loãng. Thêm 50 ml nước, 25 ml dung dịch natri 
hydroxyd (TS) và khoảng 0,1 g acid 2-hydroxy
1-(2'-hydroxy-4'sulfo-1'-naphtylazo)-3-naphthoic. 
Chuẩn độ ngay với dung dịch EDTA 0,05 M đến 
khi màu của dung dịch chuyển từ màu đỏ sang 
màu xanh. 
Mỗi ml dung dịch EDTA 0,05 M tương đương 
với 22,42 mg C12H22CaO14.H2O.