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| GB 29922-2025 | English | 260 |
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National food safety standard - General rules for formula foods for special medical purposes
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| GB 29922-2013 | English | 85 |
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National food safety standard - General principles for formula foods of special medical purpose
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GB 29922-2025: National food safety standard - General rules for formula foods for special medical purposes
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB29922-2025
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard - General rules for formula
foods for special medical purposes
Issued on: SEPTEMBER 02, 2025
Implemented on: SEPTEMBER 02, 2027
Issued by. National Health Commission of the People’s Republic of China;
State Administration for Market Regulation.
Table of Contents
Foreword... 3
1 Scope... 4
2 Terms and definitions... 4
3 Technical requirements... 5
4 Others... 17
Appendix A Partially nutritionally modified complete nutritional formula foods for
some people aged 1 ~ 10 years... 19
Appendix B Common specific complete nutritional formula foods)... 20
Appendix C Amino acids that can be used in formula foods for special medical purposes
... 21
National food safety standard - General rules for formula
foods for special medical purposes
1 Scope
This Standard applies to formula foods for special medical purposes for people aged 1
year and older.
2 Terms and definitions
2.1 Formula foods for special medical purposes
Formula foods specially processed and prepared to meet the special nutritional or
dietary needs of people with restricted food intake, digestive and absorption disorders,
metabolic disorders, or specific disease states. These products must be consumed alone
or in combination with other foods under the guidance of a doctor or clinical nutritionist.
2.2 Complete nutritional formula foods
Formula foods for special medical purposes that can serve as a single source of nutrition
to meet the nutritional needs of the target population, including complete nutritional
formula foods for people aged 1 ~ 10 years, complete nutritional formula foods for
people aged 10 years and older, and partially nutritionally modified complete nutritional
formula foods.
2.3 Specific complete nutritional formula foods
Formula foods for special medical purposes that can serve as a single source of nutrition
to meet the nutritional needs of target population under specific diseases or medical
conditions.
2.4 Incomplete nutritional formula food
Formula foods for special medical purposes that can meet some of the nutritional needs
of the target population, which are not suitable as a single source of nutrition, including
incomplete nutritional components (nutrient components, thickening components,
dietary fiber components), incomplete nutritional formulas (electrolyte formulas, liquid
formulas, preoperative carbohydrate formulas, amino acid metabolism disorder
formulas), incomplete nutritional formulas for specific diseases, and other categories.
3 Technical requirements
3.1 Basic requirements
3.1.1 The formulation of formula foods for special medical purposes shall be based on
the medical and/or nutritional research results, and their safety and clinical application
(effects) shall be scientifically proven.
3.1.2 The production conditions of formula foods for special medical purposes shall
comply with relevant national regulations.
3.2 Raw material requirements
3.2.1 The raw materials used in formula foods for special medical purposes shall
comply with the relevant safety standards and/or regulations, and the use of substances
that endanger the health of consumers is prohibited.
3.2.2 Hydrogenated oils shall not be used in products intended for people aged 1 ~ 10
years.
3.3 Sensory requirements
Sensory requirements shall be in accordance with Table 1.
3.4 Nutritional components
3.4.1 Complete nutritional formula foods
3.4.1.1 Complete nutritional formula foods suitable for people aged 1 ~ 10 years
3.4.1.1.1 The energy content of complete nutritional formula foods suitable for people
aged 1 ~ 10 years shall not be less than 250 kJ (60 kcal) per 100 mL (liquid products or
products that can be dissolved into liquid in a ready-to-eat state) or per 100 g (solid or
semi-solid products for direct consumption). The calculation of energy is based on the
value obtained by multiplying the protein, fat, carbohydrate, and dietary fiber content
per 100 mL or per 100 g of product by their respective energy coefficients of 17 kJ/g,
37 kJ/g, 17 kJ/g, and 8 kJ/g – in kJ/100 mL or kJ/100 g for the sum of the results – then
dividing by 4.184 in kcal/100 mL or kcal/100 g. If other substances provide 5% or more
of the total energy, they shall be included in the total energy.
3.4.1.1.2 The protein content in complete nutritional formula foods suitable for people
aged 1 ~ 10 years shall not be less than 0.5 g/100 kJ (2 g/100 kcal), of which the
proportion of high-quality protein shall not be less than 50% (not applicable to complete
nutritional formula foods with amino acid formula). For the inspection method of
proteins, refer to GB 5009.5.
3.4.1.1.3 In complete nutritional formula foods suitable for people aged 1 ~ 10 years,
the energy contribution ratio of linoleic acid shall not be less than 2.5% and the energy
contribution ratio of α-linolenic acid shall not be less than 0.4%. For the inspection
method of fatty acids, refer to GB 5009.168.
3.4.1.1.4 The vitamin and mineral content in complete nutritional formula foods
suitable for people aged 1 ~ 10 years shall comply with the provisions of Table 2.
3.4.1.1.5 In addition to the components specified in Table 2, if one or more components
from Table 3 are selected to be added to the product or are indicated on the label, their
content shall comply with the provisions of Table 3.
protein accounting for ≥20% of the energy; high-energy-density complete nutritional
formula foods are suitable for people with high-energy-density dietary needs. For liquid
products or products that can be reconstituted into liquids, in ready-to-eat form, the
energy density of high-energy-density complete nutritional formula foods for people
aged 1 ~ 10 years is ≥5.0 kJ/mL (1.2 kcal/mL), and the energy density of high-energy-
density complete nutritional formula foods for people aged 10 years and more is ≥6.28
kJ/mL (1.5 kcal/mL).
The categories and main technical requirements of partially nutritionally modified
complete nutritional formula foods for some people aged 1 ~ 10 years shall comply
with the provisions of Appendix A of this Standard; the essential fatty acids (linoleic
acid, α-linolenic acid), vitamins and minerals, and optional component indicators in
partially nutritionally modified complete nutritional formula foods for other people
aged 1 ~ 10 years shall comply with the corresponding technical requirements for
complete nutritional formula foods for people aged 1 ~ 10 years.
The essential fatty acids (linoleic acid, α-linolenic acid), vitamins, minerals and
optional components in partially nutritionally modified complete nutritional formula
foods for people aged 10 years and older shall meet the corresponding technical
requirements for complete nutritional formula foods for people aged 10 years and older.
3.4.2 Specific complete nutritional formula food
The energy and nutrient content of specific complete nutritional formula foods shall be
based on the complete nutritional formula foods in 3.4.1.1 or 3.4.1.2, but may be
appropriately adjusted according to the special requirements of diseases or medical
conditions to meet the nutritional needs of the target population. See Appendix B for
common specific complete nutritional formula foods.
3.4.2.1 For nutritional formulas that meet the requirements of the corresponding
specific complete nutritional formula food standards, their safety and clinical
application (effects) in specific disease or medical condition populations shall be
scientifically proven.
3.4.2.2 For nutritional formulas for which there are no specific standards for complete
nutritional formula foods, their safety and clinical application (effects) in specific
disease or medical condition populations shall be scientifically proven based on the
medical and/or nutritional research results.
3.4.3 Incomplete nutritional formula food
3.4.3.1 Common incomplete nutritional formula foods mainly include nutrient
components, thickening components, dietary fiber components, electrolyte formulas,
liquid formulas, preoperative carbohydrate formulas, amino acid metabolism disorder
formulas, incomplete nutritional formulas for specific diseases, and others. These types
of products cannot be used as a single source of nutrition to meet the nutritional needs
of the target population and need to be used in combination with other foods.
3.8 Food additives and nutritional fortification substances
3.8.1 For products applicable to people aged 1 ~ 3 years, the use of food additives shall
comply with the requirements of GB 2760 on the types and amounts of additives
permitted in infant formula; for products applicable to other populations, the use of food
additives shall comply with the types and amounts of additives permitted in the same
or similar products in GB 2760.
3.8.2 The use of nutrient fortifiers shall comply with the provisions of GB 14880.
3.8.3 The mass specifications of food additives and nutritional fortifiers shall comply
with the relevant standards and regulations.
3.8.4 Depending on the specific nutritional needs of the target population, one or more
amino acids may be added to various formula foods for special medical purposes. The
sources of the amino acids used shall comply with Appendix C, GB 14880 and other
relevant regulations.
3.8.5 If live bacteria and/or other substances are added to formula foods for special
medical purposes, they shall comply with relevant national regulations.
4 Others
4.1 Labels
4.1.1 Product labels shall comply with the provisions of GB 13432.The labeling of
nutrient and optional component content shall include the content “per 100 kilojoules
(kJ/100 kJ)”.
4.1.2 The label shall describe the product's formulation characteristics or nutritional
features. If dietary fiber is added to the formulation, its type (soluble/insoluble) shall be
indicated. The product category and target population shall also be indicated.
Additionally, it shall state "Not suitable for use by non-target populations".
4.1.3 The label shall indicate "Please use under the guidance of a doctor or clinical
nutritionist".
4.1.4 The label shall indicate that "This product is prohibited from being used for
parenteral nutrition support and intravenous injection".
4.1.5 Thickening component products shall indicate the corresponding swallowing
disorder food classification, mixing temperature, and standing time after the product is
mixed with water.
4.1.6 Liquid formulas, electrolyte formulas, preoperative carbohydrate formulas, and
amino acid metabolism disorder formulas shall indicate the osmotic pressure of the
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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