GB 29922: Evolution and historical versions
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National food safety standard - General rules for formula foods for special medical purposes
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GB 29922-2025
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National food safety standard - General principles for formula foods of special medical purpose
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GB 29922-2013
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Basic data | Standard ID | GB 29922-2025 (GB29922-2025) | | Description (Translated English) | National food safety standard - General rules for formula foods for special medical purposes | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53 | | Word Count Estimation | 18,182 | | Date of Issue | 2025-09-02 | | Issuing agency(ies) | National Health Commission; State Administration for Market Regulation | GB 29922-2013: National food safety standard - General principles for formula foods of special medical purpose
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Food Safety Standard - General Rules on Formula Food for Medical Use
National Standards of People's Republic of China
National standards for food safety
Special medical use formula General rules
2013-12-26 release
2014-07-01 implementation
People's Republic of China
National Health and Family Planning Commission released
National standards for food safety
Special medical use formula General rules
1 Scope
This standard applies to the special medical use of food for people over 1 year old.
2 terms and definitions
2.1 Special medical use formula food
In order to meet the specific needs of nutrient or dietary supplementation, digestion and absorption disorders, metabolic disorders or specific disease states,
Door processing made of formula food. Such products must be eaten by a doctor or clinical dietitian or with other food
edible.
2.1.1 full nutrition formula food
Can be used as a single source of nutrition to meet the nutritional needs of the target population of special medical use formula food.
2.1.2 specific full nutrition formula food
Can be used as a single source of nutrition to meet the target population in a particular disease or medical conditions nutritional needs of the special medical use formula
food.
2.1.3 non-nutritious formula food
Special medical use formula foods that meet the nutritional needs of the target population are not suitable for use as a single source of nutrition.
3 technical requirements
3.1 Basic requirements
Special medical use formula formula should be based on medical and/or nutritional research results based on its safety and clinical application (effect
Fruit) need to be scientifically confirmed.
Special medical use formula food production conditions should be consistent with the relevant provisions of the state.
3.2 Raw material requirements
Special medical uses The raw materials used in the prescription food should comply with the appropriate standards and/or regulations, prohibit the use of hazardous food users
Healthy substance.
3.3 sensory requirements
Special medical use of formula color, taste, smell, tissue state, the tone should be consistent with the characteristics of the corresponding product, should not have normal
Visible foreign body visible.
3.4 Nutritional Ingredients
3.4.1 applicable to 1 to 10 years of age the whole nutrition recipe food
3.4.1.1 Applicable to 1 to 10 years of age the whole nutrition formula food every 100mL (liquid products or liquid can be liquid in the ready-to-eat
State) or 100 g (direct consumption of non-liquid products) contained in the energy should be no less than 250kJ (60kcal). The calculation of energy per
100mL or 100g per product of protein, fat, carbohydrate content multiplied by the corresponding energy coefficient of 17kJ/g, 37kJ/g,
17kJ/g (the energy coefficient of dietary fiber, calculated according to 50% of the carbohydrate energy coefficient), the sum is kJ/100mL or
kJ/100g value, divided by 4.184 for kcal/100mL or kcal/100g values.
3.4.1.2 Applicable to 1 to 10 years of age in the whole nutrition formula food protein content should not be less than 0.5g/100kJ
(2g/100kcal), of which the proportion of high-quality protein not less than 50%. The method of testing the protein is referred to GB 5009.5.
3.4.1.3 Applicable to 1 to 10-year-old population of nutritious formula in the linoleic acid energy ratio should not be less than 2.5%; α-linolenic acid for energy ratio should not
Less than 0.4%. Determination of fatty acids with reference to GB 5413.27.
3.4.1.4 The content of vitamins and minerals in the whole nutritious formula for 1 to 10 years of age shall be in accordance with Table 1.
3.4.1.5 In addition to the ingredients specified in Table 1, if the addition or label label is selected in the product to contain one or more of the ingredients in Table 2,
The amount should be in accordance with Table 2.
Table 1 Vitamin and Mineral Indicators (1 to 10 years old)
Nutrient
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Vitamin A/(μgRE) a 17.9 53.8 75.0 225.0 GB 5413.9 or GB/T 5009.82
Vitamin D/μgb 0.25 0.75 1.05 3.14 GB 5413.9
Vitamin E/(mgα-TE) c 0.15 NSe 0.63 NSGB 5413.9 or GB/T 5009.82
Vitamin K1/μg 1 NS4 NSGB 5413.10 or GB/T 5009.158
Vitamin B1/mg 0.01 NS0.05 NSGB 5413.11 or GB/T 5009.84
Vitamin B2/mg 0.01 NS0.05 NSGB 5413.12
Vitamin B6/mg 0.01 NS0.05 NSGB 5413.13 or GB/T 5009.154
Vitamin B12/μg 0.04 NS0.17 NSGB 5413.14
Niacin (nicotinamide)/mgd 0.11 NS0.46 NSGB 5413.15 or GB/T 5009.89
Folic acid/μg 1.0 NS4.0 NSGB 5413.16 or GB/T 5009.211
Pantothenic acid/mg 0.07 NS0.29 NSGB 5413.17 or GB/T 5009.210
Vitamin C/mg 1.8 NS7.5 NSGB 5413.18
Biotin/μg 0.4 NS1.7 NSGB 5413.19
Sodium/mg 5 20 21 84 GB 5413.21 or GB/T 5009.91
Potassium/mg 18 69 75 289 GB 5413.21 or GB/T 5009.91
Copper/μg 7 35 29 146 GB 5413.21 or GB/T 5009.13
Magnesium/mg 1.4 NS5.9 NSGB 5413.21 or GB/T 5009.90
Iron/mg 0.25 0.50 1.05 2.09 GB 5413.21 or GB/T 5009.90
Zinc/mg 0.1 0.4 0.4 1.5 GB 5413.21 or GB/T 5009.14
Table 1 (continued)
Nutrient
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Manganese/μg 0.3 24.0 1.1 100.4 GB 5413.21 or GB/T 5009.90
Calcium/mg 17 NS71 NSGB 5413.21 or GB/T 5009.92
Phosphorus/mg 8.3 46.2 34.7 193.5 GB 5413.22 or GB/T 5009.87
Iodine/μg 1.4 NS5.9 NSGB 5413.23
Chlorine/mg NS52 NS218 GB 5413.24
Selenium/μg 0.5 2.9 2.0 12.0 GB 5009.93
aRE is retinol equivalent. 1 μgRE = 3.33IU Vitamin A = 1 μg Total Reverse Retinol (Vitamin A). Vitamin A only includes pre-formed
Of retinol, in the calculation and claim that vitamin A activity does not include any carotenoid components.
b Calculated alcohol, 1 μg Vitamin D = 40IU Vitamin D.
c1 mgα-TE (α-tocopherol equivalent) = 1 mg d-α-tocopherol.
d nicotinic acid does not include precursor form.
eN.S. is not specifically stated.
Table 2 Selectable component indicators (1 to 10 years old)
Selectable ingredient a
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Chromium/μg 0.4 5.7 1.8 24.0 GB/T 5009.123
Molybdenum/μg 1.2 5.7 5.0 24.0 -
Fluorine/mg NSb 0.05 NS0.20 GB/T 5009.18
Choline/mg 1.7 19.1 7.1 80.0 GB/T 5413.20
Inositol/mg 1.0 9.5 4.2 39.7 GB 5413.25
Taurine/mg NS3.1 NS13.0 GB 5413.26 or GB/T 5009.169
L-carnitine/mg 0.3 NS 1.3 NS-
Docosahexaenoic acid/(% total fatty acid c) NS0.5 NS0.5 GB 5413.27 or GB/T 5009.168
Eicosatetraenoic acid/(% total fatty acids c) NS1 NS1 GB 5413.27
Nucleotide/mg 0.5 NS 2.0 NS-
Dietary fiber/g NS0.7 NS2.7 GB 5413.6 or GB/T 5009.88
a Fluoride compounds are sources of sodium fluoride and potassium fluoride, nucleotides and dietary fiber sources. References GB 14880 Table 16.2 Available sources of use, other
Of the source of the compound reference GB 14880.
b NS is not specifically stated.
c total fatty acids refers to the sum of C4 ~ C24 fatty acids.
3.4.2 applicable to people over the age of 10 full nutrition formula food
3.4.2.1 Applicable to all-nutritious formula for people over 10 years of age Each 100mL (liquid product or liquid-
State) or per 100 g (direct consumption of non-liquid products) contained in the energy should not be less than 295kJ (70kcal). Calculation of energy by
Per 100mL or per 100g of protein, fat, carbohydrate content multiplied by the corresponding energy coefficient of 17kJ/g, 37kJ/g,
17kJ/g (the energy coefficient of dietary fiber, calculated according to 50% of the carbohydrate energy coefficient), the sum of kJ/100mL or kJ/100g
Value, divided by 4.184 for kcal/100mL or kcal/100g values.
3.4.2.2 The content of the protein contained in the whole nutritious formula for persons over 10 years of age shall be not less than 0.7g/100kJ (3g/100kcal)
Which the proportion of high-quality protein not less than 50%. The method of testing the protein is referred to GB 5009.5.
3.4.2.3 applicable to the population over the age of 10 full-nutritious formula in the linoleic acid energy ratio should not be less than 2.0%; α-linolenic acid energy ratio should be
Not less than 0.5%. Determination of fatty acids with reference to GB 5413.27.
3.4.2.4 The amount of vitamins and minerals contained in the whole nutritious formula for people over 10 years of age shall comply with the requirements in Table 3.
3.4.2.5 In addition to the ingredients specified in Table 3, if the addition or label is selected in the product to contain one or more of the ingredients listed in Table 4,
The amount shall be in accordance with Table 4.
Table 3 Vitamin and Mineral Indicators (Population over 10 years old)
Nutrient
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Vitamin A/(μgRE) a 9.3 53.8 39.0 225.0 GB 5413.9 or GB/T 5009.82
Vitamin D/μgb 0.19 0.75 0.80 3.14 GB 5413.9
Vitamin E/(mgα-TE) c 0.19 NSe 0.80 NSGB 5413.9 or GB/T 5009.82
Vitamin K1/μg 1.05 NS4.40 NSGB 5413.10 or GB/T 5009.158
Vitamin B1/mg 0.02 NS0.07 NSGB 5413.11 or GB/T 5009.84
Vitamin B2/mg 0.02 NS0.07 NSGB 5413.12
Vitamin B6/mg 0.02 NS0.07 NSGB 5413.13 or GB/T 5009.154
Vitamin B12/μg 0.03 NS0.13 NSGB 5413.14
Niacin (nicotinamide)/mgd 0.05 NS0.20 NSGB 5413.15 or GB/T 5009.89
Folic acid/μg 5.3 NS22.2 NSGB 5413.16 or GB/T 5009.211
Pantothenic acid/mg 0.07 NS0.29 NSGB 5413.17 or GB/T 5009.210
Vitamin C/mg 1.3 NS5.6 NSGB 5413.18
Biotin/μg 0.5 NS2.2 NSGB 5413.19
Sodium/mg 20 NS83 NSGB 5413.21 or GB/T 5009.91
Potassium/mg 27 NS111 NSGB 5413.21 or GB/T 5009.91
Copper/μg 11 120 44 500 GB 5413.21 or GB/T 5009.13
Magnesium/mg 4.4 NS18.3 NSGB 5413.21 or GB/T 5009.90
Iron/mg 0.20 0.55 0.83 2.30 GB 5413.21 or GB/T 5009.90
Zinc/mg 0.1 0.5 0.4 2.2 GB 5413.21 or GB/T 5009.14
Manganese/μg 6.0 146.0 25.0 611.0 GB 5413.21 or GB/T 5009.90
Calcium/mg 13 NS56 NSGB 5413.21 or GB/T 5009.92
Phosphorus/mg 9.6 NS40.0 NSGB 5413.22 or GB/T 5009.87
Iodine/μg 1.6 NS6.7 NSGB 5413.23
Table 3 (continued)
Nutrient
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Chlorine/mg NS52 NS218 GB 5413.24
Selenium/μg 0.8 5.3 3.3 22.2 GB 5009.93
aRE is retinol equivalent. 1 μgRE = 3.33IU Vitamin A = 1 μg Total Reverse Retinol (Vitamin A). Vitamin A only includes pre-formed
Of retinol, in the calculation and claim that vitamin A activity does not include any carotenoid components.
b Calculated alcohol, 1 μg Vitamin D = 40IU Vitamin D.
c1 mgα-TE (α-tocopherol equivalent) = 1 mg d-α-tocopherol.
d nicotinic acid does not include precursor form.
eN.S. is not specifically stated.
Table 4 Selectable component indicators (people over 10 years old)
Selectable ingredient a
Per 100kJ per 100kcal
Min Max Max Min Max
Testing method
Chromium/μg 0.4 13.3 1.8 55.6 GB/T 5009.123
Molybdenum/μg 1.3 12.0 5.6 50.0 -
Fluorine/mg N.Sb.0.05 NS 0.20 GB/T 5009.18
Choline/mg 5.3 39.8 22.2 166.7 GB/T 5413.20
Inositol/mg 1.0 33.5 4.2 140.0 GB 5413.25
Taurine/mg NS4.8 NS20.0 GB 5413.26 or GB/T 5009.169
L-carnitine/mg 0.3 NS1.3 NS-
Nucleotide/mg 0.5 NS2.0.NS-
Dietary fiber/g NS0.7 NS2.7 GB 5413.6 or GB/T 5009.88
a Fluoride compounds are sources of sodium fluoride and potassium fluoride, nucleotides and dietary fiber sources. References GB 14880 Table 16.2 Available sources of use, other
Of the source of the compound reference GB 14880.
b NS is not specifically stated.
3.4.3 specific full nutrition formula food
The energy and nutrient content of a particular nutritious formula should be based on 3.4.1 or 3.4.2 full nutritious formula, but may be based on
Disease or medical condition The specific requirements for nutrients are appropriately adjusted to meet the nutritional needs of the target population. Common specific nutritious formula
See Appendix A for food.
3.4.4 non-nutritious formula food
Common non-nutritious prescription foods include nutrient components, electrolyte formulations, thickening components, fluid formulations and amino acid metabolic disorders
Such as recipes. The technical specifications of the products should meet the requirements of Table 5 and Table 6. Since such products can not be met as a single source of nutrition
The nutritional needs of the target population, the need to use with other food, so the nutrient content is not required. Non-whole nutrition special medical use with
The food should be used under the guidance of a doctor or clinical dietitian, depending on the particular condition or need of the patient's individual.
Table 5 common non-nutrient formula food main technical requirements
Product category recipe main technical requirements
Protein (amino acid) component 1. consists of protein and/or amino acid;
2. Protein source can choose one or more amino acids, protein hydrolysates, peptides or high quality whole protein
Fat (Fatty Acid) Components 1. Composed of fat and/or fatty acids;
2. You can use long chain triglycerides (LCT), medium chain triglycerides (MCT) or other laws and regulations approved by the fat
Fat (acid) source
Carbohydrate components 1. Composed of carbohydrates;
2. Carbohydrate sources can be used monosaccharides, disaccharides, oligosaccharides or polysaccharides, maltodextrins, glucose polymers or
Other laws and regulations approved raw materials
Electrolyte formulations 1. Based on carbohydrates;
2. Add an appropriate amount of electrolyte
Thickening components 1. Based on carbohydrates;
2. Add one or more thickeners;
3. Can add dietary fiber
Liquid formula 1. Based on carbohydrate and protein;
2. Can add a variety of vitamins and minerals;
3. Can add dietary fiber
Amino Acids Metabolic Barrier 1. Amino acids as the main raw material, but does not contain or contain only a small amount of amino acids associated with metabolic disorders. Common ammonia
Base acid metabolic disorders in the formulation of food should limit the amino acid species and content requirements in Table 6;
2. Add the right amount of fat, carbohydrates, vitamins, minerals and/or other ingredients;
3. Meet the patient part of the protein (amino acid) needs at the same time, should meet the patients on some vitamins and minerals
The demand
Table 6 common amino acid metabolic disorders in the formula should limit the amino acid species and content
Common amino acid metabolic disorders in formula foods should limit the amount of amino acids
Ingredients should limit the amino acid content of food
mg/g protein equivalent
Phenylketonuria phenylalanine ≤1.5
Maple urine leucine, isoleucine, valine ≤ 1.5a
Propionic acid/methylmalonic acid
Methionine, threonine, valine ≤ 1.5a
Isoleucine ≤5
Tyrosine, phenylalanine, tyrosine ≤ 1.5a
High cystineuria methionine ≤ 1.5
Glutaric acid type Ⅰ
Lysine ≤ 1.5
Tryptophan ≤ 8
Isovalerate leucine ≤ 1.5
Urea circulatory disturbance
Non-essential amino acids (alanine, arginine, aspartic acid, asparagine
Amine, glutamic acid, glutamine, glycine, proline, serine)
≤1.5a
a refers to a single amino acid content.
3.5 Contaminant limits
The pollutant limit should be in accordance with Table 7.
Table 7 Contaminant limits (in solid products)
Item Index Test Method
Lead/(mg/kg) ≤ 0.15 0.5a GB 5009.12
Nitrate (in terms of NaNO3)/(mg/kg) b ≤ 100
Nitrite (in terms of NaNO2)/(mg/kg) c ≤ 2
GB 5009.33
a Only for people over 10 years of age.
b does not apply to the addition of vegetables and fruits.
c only for milk-based products (no bean ingredients).
3.6 Mycotoxins limit
The limit of mycotoxin should be in accordance with Table 8.
Table 8 Limit of mycotoxins (based on solid products)
Item Index Test Method
Aflatoxin M1/(μg/kg) a ≤ 0.5
Aflatoxin B1/(μg/kg) b ≤ 0.5
GB 5009.24
a Only applicable to dairy and milk protein products as the main raw material products.
b only for beans and soy protein products as the main raw material products.
3.7 Microbiological limits
The microbiological limits for the use of solid-state special medical preparations should comply with the provisions of Table 9, the liquid special medical use formula microbes
Material indicators should meet the requirements of commercial sterility, according to the provisions of GB/T 4789.26 test.
Table 9 Microbial limits
project
Sampling scheme a and limit (if not specified, both in CFU/g)
ncm M
Testing method
Total number of colonies b, c 5 2 1000 10000 GB 4789.2
Coliforms 5 2 10 100 GB 4789.3 Plate counting method
Salmonella 5 0 0/25g - GB 4789.4
Staphylococcus aureus 5 2 10 100 GB 4789.10 Plate counting method
a sample analysis and treatment according to GB 4789.1 implementation.
b is not suitable for the addition of active strains (aerobic and facultative anaerobic probiotics) products [the number of live probiotics in the product should be ≥ 106 CFU/g (mL)].
c only for 1 to 10 years of age products.
3.8 Food Additives and Nutrition Enhancers
3.8.1 The use of food additives in products for 1 to 10 years of age may be determined by reference to GB 2760 infant formula
The types of additives and the amount used, for the use of food additives in products over 10 years of age can refer to GB 2760 in the same or similar
The types and amounts of additives that are allowed in the product.
3.8.2 The use of nutrition enhancers shall comply with the provisions of GB 14880.
3.8.3 The quality specifications of food additives and nutrition enhancers shall comply with the relevant standards and relevant regulations.
3.8.4 Depending on the particular nutritional requirements of the population used, one or more amino acids may be selected for use in special medical foods.
The source of the amino acid should be in accordance with Appendix B and/or GB 14880.
3.8.5 If other substances are added to the special medical use formula, it shall comply with the relevant provisions of the State.
4 other
4.1 tags
4.1.1 The product label shall comply with the provisions of GB 13432. Nutrient and optional ingredient content should be added "per 100 kJ
(/ 100kJ) "content.
4.1.2 The labeling characteristics or nutritional characteristics of the product should be described in the label and the product category and applicable population should be indicated.
Should be marked "does not apply to non-target population use".
4.1.3 The label should be marked in the eye-catching position "Please use it under the guidance of a doctor or clinical dietitian."
4.1.4 Labeling should be marked "This product is prohibited for parenteral nutrition support and intravenous injection".
4.2 Instructions for use
4.2.1 The use of the product, preparation instructions and illustrations, storage conditions should be clearly stated on the label. When the maximum surface area of the package is less than
100cm2 or product quality is less than 100g, may not indicate the diagram.
4.2.2 Guidance Note A warning note should be given to the health hazards that may arise from improper preparation and improper use.
4.3 Packaging
You can use food grade and/or purity ≥99.9% carbon dioxide and/or nitrogen as the packaging medium.
Appendix A
Common specific nutritious formula
A.1 Diabetes Whole Nutrition Formula Food.
A.2 Respiratory System All Nutritional Formula Food.
A.3 kidney disease full nutrition formula food.
A.4 Tumor full nutrition formula food.
A.5 liver disease full nutrition formula food.
A.6 muscle attenuated syndrome full nutrition formula food.
A.7 Trauma, Infection, Surgery and Other Stress State Nutritional Formula Food.
A.8 Inflammatory Bowel Disease Whole Nutrition Formula Food.
A.9 Food Protein Allergy Nutritional Formula Food.
A.10 refractory epilepsy full nutrition formula.
A.11 gastrointestinal tract absorption disorders, pancreatitis full nutrition formula food.
A.12 Fatty Acid Metabolic Abnormal Nutritional Formula Food.
A.13 obesity, fat reduction surgery full nutrition formula food.
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