GB 10765-2021 (GB10765-2021) & related versions
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GB 10765-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard - Infant formula
ISSUED ON: FEBRUARY 22, 2021
IMPLEMENTED ON: FEBRUARY 22, 2023
Issued by: National Health Commission of PRC;
State Administration for Market Regulation.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Terms and definitions ... 4
3 Technical requirements ... 4
4 Others ... 10
Appendix A Recommended content of essential and semi-essential amino acids
in infant formula ... 11
Appendix B Monomer amino acids that can be used in infant formula ... 12
National food safety standard - Infant formula
1 Scope
This standard applies to formula foods, which are consumed by infants aged 0
~ 6 months.
2 Terms and definitions
2.1 Infant formula
A formula food, suitable for normal infants, whose energy and nutrients can
meet the normal nutritional needs of infants aged 0 ~ 6 months.
2.1.1 Milk-based infant formula
The product which, taking milk and milk protein products as the main source of
protein, by adding appropriate amount of vitamins, minerals and (or) other raw
materials, is processed and produced by only the physical methods.
2.1.2 Soy-based infant formula
The product which, taking soybeans and soybean protein products as the main
source of protein, by adding appropriate amount of vitamins, minerals and (or)
other raw materials, is processed and produced by only the physical methods.
3 Technical requirements
3.1 Raw material requirements
3.1.1 The raw materials, which are used in the product, shall comply with the
corresponding safety standards and/or relevant regulations. It shall ensure the
safety of infants; meet their nutritional needs. It shall not use the substances
that endanger the nutrition and health of infants.
3.1.2 The raw materials and food additives used shall not contain gluten.
3.1.3 Hydrogenated grease shall not be used.
3.1.4 Raw materials, that have been irradiated, shall not be used.
3.2 Sensory requirements
4 Others
4.1 Labels
4.1.1 The product label shall comply with GB 13432 and/or relevant regulations.
For the content label of essential and optional ingredients, it shall add the
indication of "100 kilojoule (100 kJ)" content.
4.1.2 In the label, it shall indicate the product category, attributes (such as milk-
based or soy-based products, as well as product status), applicable age.
4.1.3 For the infant formula, it shall be indicated that: "The most ideal food for
infants aged 0 ~ 6 months is breast milk. This product can be used, when breast
milk is insufficient or absent."
4.1.4 There must be no images of babies and women on the label. It shall not
use such expressions as “human emulsification”, “breast emulsification” or
similar terms.
4.2 Instructions for use
4.2.1 For the information on product use, preparation instructions, illustrations,
storage conditions, it shall be clearly stated on the label. When the maximum
surface area of the package is less than 100 cm2, OR the mass of the product
is less than 100 g, the illustration may not be indicated.
4.2.2 The instructions shall give warnings about the health hazards, that may
be caused by improper preparation and improper use.
4.3 Packaging
It may use the carbon dioxide and (or) nitrogen, that meet the national food
safety standards, as packaging media.
Appendix A
Recommended content of essential and semi-essential amino acids in
infant formula
A.1 Refer to the published representative data of essential and semi-essential
amino acids in Chinese human milk AND data on nitrogen content and/or
protein content, considering a certain range of variation, to calculate the
recommended lower limit of essential and semi-essential amino acids in infant
formula (mg/gN).
A.2 According to the low limit of each amino acid in human milk in China
(mg/gN), calculate the amino acid content per 100 kcal of infant formula, when
the protein content is the lowest (1.8 g/100 kcal); the calculation method is that:
The milligrams of amino acids per gram of nitrogen in human milk, is divide by
the nitrogen conversion factor of 6.25, then multiplied by 1.8. At the same time,
refer to the provisions in the corresponding standards of the Codex Alimentarius
Commission. The results are as shown in Table A.1. It is recommended that the
content of essential and semi-essential amino acids, which are contained in
infant formula, shall not be lower than the recommended value in Table A.1.
A.3 When calculating, it may add the concentrations of tyrosine and
phenylalanine. If the ratio of methionine to cysteine is less than 2:1, it may also
add the two.
Table A.1 -- The recommended content of essential and semi-essential
amino acids in the infant formula
......
GB 10765-2010
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard
Infant Formula
ISSUED ON. MARCH 26, 2010
IMPLEMENTED ON. APRIL 1, 2010
Issued by. Ministry of Health of the People’s Republic of China
Table of Contents
1 Scope ... 3
2 Normative references ... 3
3 Terms and Definitions ... 3
4 Technical requirements ... 3
5 Others ... 9
Annex A ... 10
Annex B ... 11
National Food Safety Standard
Infant Formula
1 Scope
This Standard is applicable to infant formula.
2 Normative references
Documents referenced in this Standard are indispensable for application of this Standard.
For dated references, only the dated edition is applicable to this Standard. For undated
references, the latest edition (including all amendments) is applicable to this Standard.
3 Terms and Definitions
3.1 Infants
Babies at the age of 0 - 12 months.
3.2 Infant formula
3.2.1 Milk-based infant formula. It refers to the liquid or powdered products that are made
mainly from milk and milk protein products, with addition of adequate amount of vitamins,
mineral substances and/or other ingredients, and produced and processed by physical
methods only, suitable for normal infants. Their energy and nutrition ingredients can meet
normal nutritional requirements of infants 0 - 6 months.
3.2.2 Soybean-based infant formula. It refers to the liquid or powdered products that are made
mainly from soybean and soybean protein products, with addition of adequate amount of
vitamins, mineral substances and/or other ingredients, and produced and processed by
physical methods only, suitable for normal infants. Its energy and nutrition ingredients can
meet normal nutritional requirements of infants 0 - 6 months.
4 Technical requirements
4.1 Requirements for raw materials
Raw materials used in the products shall conform to appropriate safety standards and/or
related regulations. It shall ensure the safety of infants and satisfy nutritional requirements.
And it shall not contain substances harmful to nutrition and health of infants.
Raw materials and food additives used shall not contain glutelin.
Hydrogenated oil and fat shall not be used.
Radiation-treated raw materials shall not be used.
4.2 Sensory requirements. It shall comply with the provisions in Table 1.
5 Others
5.1 Label
5.1.1 Product labels shall be in accordance with the provisions of GB 13432. The content “per
100 kJ” shall be additionally labelled for content labelling of nutrients and optional
ingredients.
5.1.2 Labels shall clearly indicate category, attribute (e.g. milk-based and/or soybean-based
products and product status) and applicable age of the products. Formula for infants at the
age more than 6 months shall be labelled with “Complementary food shall be added for
infants older than 6 months”.
5.1.3 Infant formula shall be labelled with “The ideal food for babies at the age of 0 – 6 months
is breast milk. This product can be used in case of lack or loss of breast milk”.
5.1.4 Labels must not have the images of infants and women. It must not use “Humanized” or
approximate terminology.
5.2 Instructions for use
5.2.1 Use and preparation guidance, illustrations and storage conditions of products shall be
clearly stated on the labels. Illustrations may not be marked when the maximum surface
area of packages is less than 100 cm2 or the product weight is less than 100 g.
5.2.2 Guidance shall give warning explanation on health hazards caused by improper preparation
and use.
5.3 Package
Carbon dioxide and (or) nitrogen at food grade or those whose purity is not less than
99.9% may be taken as a packaging medium.
B.6 L-Lysine
B.6.1 Name and source
Name. L-histidine α-amino-β – imidazolyl propionic acid
Source. non-animal derived raw-material
Food-grade
B.6.2 Chemical structure, molecular formula and molecular weight
Chemical structure.
Molecular formula. C6H9N3O2
Molecular weight. 155.15
B.6.3 Physiochemical properties. White crystal free-flowing or crystalline powder
B.6.4 Physiochemical indexes. It shall comply with the provisions in Table B.6.
Table B.6 Physical and chemical indexes of L-histidine
Item Index
Specific rotation [α] / (D20) 11.5 – 13.5
Content (based on dry substances) / (%) ≥ 98.5
Moisture / (%) ≤ 0.2
pH value 7.0－8.5
Ash content / (%) ≤ 0.2
Lead (based on Pb) / (mg/kg) ≤ 0.3
Arsenic (based on As) / (mg/kg) ≤ 0.2
......
| Standard ID | GB 10765-2021 (GB10765-2021) | | Description (Translated English) | National food safety standard - Infant Formula | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53 | | Word Count Estimation | 12,121 | | Date of Issue | 2021-02-22 | | Date of Implementation | 2021-08-22 | | Older Standard (superseded by this standard) | GB 10765-2010 | | Regulation (derived from) | National Health Commission Announcement No. 3 of 2021 | | Standard ID | GB 10765-2010 (GB10765-2010) | | Description (Translated English) | National food safety standard - Infant formula | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53;X82 | | Classification of International Standard | 67.100.10 | | Word Count Estimation | 13,120 | | Date of Issue | 2010-03-26 | | Date of Implementation | 2011-04-01 | | Older Standard (superseded by this standard) | GB 10765-1997; GB 10766-1997; GB 10767-1997 | | Quoted Standard | GB 5413.9; GB 5413.31; GB 5413.30; GB 5413.3; GB 5413.27; GB 5413.26; GB 5413.25; GB 5413.24; GB 5413.23; GB 5413.22; GB 5413.21; GB 5413.20; GB 5413.19; GB 5413.18; GB 5413.17; GB 5413.16; GB 5413.15; GB 5413.14; GB 5413.13; GB 5413.12; GB 5413.11; GB 5413.10; GB 5009.93; GB 5009.5; GB 5009.4; GB 5009.33; GB 5009.3; GB 5009.24; GB 5009.12; GB 4789.40; GB 4789.4; GB 4789.3; GB 4789.26; GB 4789.2; GB 4789.18; GB 4789.10; GB 4789.1; GB 2760; GB 14880; GB 13432 | | Adopted Standard | Codex Stan 72-1981, NEQ; Chinese Dietary Reference Intakes nutrition (2000 ed.) | | Regulation (derived from) | Circular of the Ministry of Health (2010)7 | | Issuing agency(ies) | Ministry of Health of People's Republic of China | | Summary | This Chinese standard applies to infant formula. | | Standard ID | GB 10765-1997 (GB10765-1997) | | Description (Translated English) | Infant formula I | | Sector / Industry | National Standard | | Classification of Chinese Standard | X82 | | Classification of International Standard | 67.100.10 | | Word Count Estimation | 8,828 | | Date of Issue | 1997/5/28 | | Date of Implementation | 1998/9/1 | | Older Standard (superseded by this standard) | GB 10765-1989 | | Quoted Standard | GB 317.1-1991; GB 1352-1986; GB 2760-1996; GB 4789.18-1994; GB/T 5009.11-1996; GB/T 5009.12-1996; GB/T 5009.24-1996; GB 6914-1986; GB 13432-1992; GB 14880-1994; GB/T 5413-1997; ZB X31 005-1989; SB 108-1983 | | Adopted Standard | CAC/CODEX STAN 72-1981 | | Regulation (derived from) | Announcement of Newly Approved National Standards 2010 No. 5 (No. 160 overall) | | Proposing organization | China Light Industry Association and the People Republic of China Ministry of Health | | Issuing agency(ies) | State Bureau of Technical Supervision | | Summary | This Standard specifies the technical requirements of an infant formula milk powder, test methods, inspection rules and product labeling, packaging, storage, transportation requirements; This Standard is applicable to order fresh milk (or goat), sugar, soy, caramel for The main raw material, adding the right amount of vitamins and minerals, processed into powder products for babies; |
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