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GB 29922-2013 English PDF (GB29922-2013)

GB 29922-2013 English PDF (GB29922-2013)

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GB 29922-2013: National Food Safety Standard -- General Rules on Formula Food for Medical Use

This Standard is applicable to formula foods of special medical purpose for people older than 1 year old.
GB 29922-2013
GB
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
National food safety standard -
General principles for formula foods of special
medical purpose
ISSUED ON. DECEMBER 26, 2013
IMPLEMENTED ON. JULY 01, 2014
Issued by. National Health and Family Planning
Commission of the PEOPLE Republic of China
Table of Contents
1 Scope ... 3
2 Terms and definitions ... 3
3 Technical requirements ... 3
4 Others ... 11
Annex A Common specific whole nutrient formula foods ... 13
Annex B Applicable amino acid for formula foods of special medical purpose ... 14
National food safety standard -
General principles for formula foods of special
medical purpose
1 Scope
This Standard is applicable to formula foods of special medical purpose for people older than 1 year old.
2 Terms and definitions
2.1 Formula foods of special medical purpose
Formula foods specially processed and prepared in order to meet special needs for nutrient or diet of those suffering from food intake restriction, disorder of digestive absorption, disorder of metabolic or certain disease. Such foods must be used alone or together with other foods under the guidance of doctor or clinical nutritionist.
2.1.1 Whole nutrient formula foods
Formula foods of special medical purpose that may be used as single nutrition source to meet the nutritional requirements of the target group.
2.1.2 Specific whole nutrient formula foods
Formula foods of special medical purpose that may be used as single nutrition source to meet the nutritional requirements of the target group of certain disease or medical state.
2.1.3 Non-whole nutrient formula foods
Formula foods of special medical purpose that may meet the partial nutritional requirements of the target group and is not applicable to be regarded as single nutrition source.
3 Technical requirements
3.1 Basic requirements
The formula of formula foods of special medical purpose shall be based on the research results of medicine and/or nutrition, and their safety and clinical application (effectiveness) shall be scientifically verified.
The production condition of formula foods of special medical purpose shall meet the relevant national regulations.
3.2 Material requirements
The material adopted in formula foods of special medical purpose shall meet the corresponding standards and/or the relevant requirements, and any
substance endangering the health of eaters is forbidden.
3.3 Sensory requirements
The color and luster, taste, smell, texture state and reconstituability of formula foods of special medical purpose shall meet the characteristic of corresponding product which is free from the extrinsic impurity in normal sight.
3.4 Nutrient
3.4.1 Whole nutrient formula foods which are applicable to the group of 1 ~ 10 years old.
3.4.1.1 As for whole nutrient formula foods which are applicable to the group of 1 ~ 10 years old, the energy contained shall not be lower than 250 kJ (60 kcal) per 100 mL (liquid or dissolvable product under the instant state) or per 100 g (non-liquid product that can be eat directly). The energy shall be calculated by multiplying the contents of protein, fat and carbohydrates in 100 mL of product with the respective corresponding energy coefficients of 17 kJ/g, 37 kJ/g and 17 kJ/g (the energy coefficient of dietary fiber, which is calculated according to 50 % of the energy coefficient of carbohydrates) to obtain a sum expressed in kJ/100 mL or kJ/100 g, and this sum shall be divided by 4.184 to obtain a value expressed in kcal/100 mL or kcal/100 g.
3.4.1.2 As for whole nutrient formula foods which are applicable to the group of 1 ~ 10 years old, the content of protein shall not be lower than 0.5 g/100 kJ (2 g/100 kcal), where the proportion of high-quality protein shall not be lower than 50 %. The protein shall be inspected according to GB 5009.5.
3.4.1.3 As for whole nutrient formula foods which are applicable to the group of 1 ~ 10 years old, the energy supply ratio of linoleic acid shall not be lower than 2.5 % and the energy supply ratio of ??-linoleic acid shall not be lower than 0.4 %. The fatty acid shall be inspected according to GB 5413.27.
3.4.1.4 The contents of vitamins and mineral substances in whole nutrient formula foods that are applicable to the group of 1 ~ 10 years old shall be in The fatty acid shall be inspected according to GB 5413.27.
3.4.2.4 The contents of vitamins and mineral substances in whole nutrient formula foods which are applicable to the group of over 10 years old shall be in accordance with those specified in Table 3.
3.4.2.5 Except for those ingredients listed in Table 3, if one or more ingredients listed in Table 4 are added into the products or indicated in the label, the content shall be in accordance with those specified in Table 4.
Table 3 -- Indexes of vitamins and
mineral substances (group of over 10 years old)
Nutrient Per 100 kJ Per 100 kcal Inspection method Min. Max. Min. Max.
Vitamin A/(??gRE)a 9.3 53.8 39.0 225.0 GB 5413.9 or GB/T 5009.82
Vitamin D/??gb 0.19 0.75 0.80 3.14 GB 5413.9
Vitamin E/(mg ??-TE)c 0.19 N.S.e 0.80 N.S. GB 5413.9 or GB/T 5009.82
Vitamin K1/??g 1.05 N.S. 4.40 N.S. GB 5413.10 or GB/T 5009.158
Vitamin B1/mg 0.02 N.S. 0.07 N.S. GB 5413.11 or GB/T 5009.84
Vitamin B2/mg 0.02 N.S. 0.07 N.S. GB 5413.12
Vitamin B6/mg 0.02 N.S. 0.07 N.S. GB 5413.13 or GB/T 5009.154
Vitamin B12/??g 0.03 N.S. 0.13 N.S. GB 5413.14
Nicotinic acid
(niacinamide)/mgd 0.05 N.S. 0.20 N.S. GB 5413.15 or GB/T 5009.89
Folic acid/??g 5.3 N.S. 22.2 N.S. GB 5413.16 or GB/T 5009.211
Pantothenic acid/mg 0.07 N.S. 0.29 N.S. GB 5413.17 or GB/T 5009.210
Vitamin C/mg 1.3 N.S. 5.6 N.S. GB 5413.18
Biotin/??g 0.5 N.S. 2.2 N.S. GB 5413.19
Sodium/mg 20 N.S. 83 N.S. GB 5413.21 or GB/T 5009.91
Potassium/mg 27 N.S. 111 N.S. GB 5413.21 or GB/T 5009.91
Cuprum/??g 11 120 44 500 GB 5413.21 or GB/T 5009.13
Magnesium/mg 4.4 N.S. 18.3 N.S. GB 5413.21 or GB/T 5009.90
Ferrum/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/??g 6.0 146.0 25.0 611.0 GB 5413.21 or GB/T 5009.90
Calcium/mg 13 N.S. 56 N.S. GB 5413.21 or GB/T 5009.92
Phosphorus/mg 9.6 N.S. 40.0 N.S. GB 5413.22 or GB/T 5009.87
Iodine/??g 1.6 N.S. 6.7 N.S. GB 5413.23
Chlorine/mg N.S. 52 N.S. 218 GB 5413.24
Selenium/??g 0.8 5.3 3.3 22.2 GB 5009.93
a RE is retinol equivalent. 1 ??g of RE = 3.33 IU of Vitamin A = 1 ??g of alltrans retinol (Vitamin A). Only the preformed retinol shall be included in Vitamin A, any carotenoid ingredient shall be excluded in calculating and declaring the activity of Vitamin A.
b Calciferol, 1 ??g of Vitamin D = 40 IU of Vitamin D.
Table 9 -- Limit for microorganism
Item
Sampling schemea and limit (otherwise provided, both of
them shall be represented in CFU/g) Inspection method
n c m M
Aerobic bacteria countb,c 5 2 1000 10000 GB 4789.2
Coliform bacteria 5 2 10 100 GB 4789.3 Plate count method
Salmonella bacteria 5 0 0/25 g ?€? GB 4789.4
Staphylococcus aureus 5 2 10 100 GB 4789.10 Plate count method
a The analysis and treatment of sample shall be implemented according to GB 4789.1. b Not applicable to the products added with activated microbial strain (aerobic and facultative anaerobic probiotics) [The viable count of the activated probiotics in the product shall ??? 106 CFU/g (mL)]. c Only applicable to the group of 1 ~ 10 years old.
3.8 Food additive and nutrient supplement
3.8.1 For products which are applicable to the group of 1 ~ 10 years old, the variety and usage amount of food additive may refer to those specified in baby formula foods of GB 2760; for products which are applicable to the group of over 10 years old, the variety and usage amount of food additive may refer to those of the same or closed product specified in GB 2760.
3.8.2 The nutrient supplement shall be used according to the requirements of GB 14880.
3.8.3 The quality specification of food additive and nutrient supplement shall meet the relevant standard and requirements.
3.8.4 One or several s of amino acids may be selected to be added into the foods of special medical purpose according to the special dietary demand of the target group and the source of the amino acids used shall be in accordance with those specified in Appendix B and (or) GB 14880.
3.8.5 Where other substances are added into the formula foods of special medical purpose, the national relevant requirements shall be met.
4 Others
4.1 Label
4.1.1 The product label shall meet those specified in GB 13432. The ?€?per 100 kilojoule (/100 kJ)?€? shall be added in the content indication of nutrient and optional ingredient.
Annex A
Common specific whole nutrient formula foods
A.1 Whole nutrient formula foods for diabetic patient.
A.2 Whole nutrient formula foods for patient with respiratory system diseases. A.3 Whole nutrient formula foods for nephrotic patient.
A.4 Whole nutrient formula foods for tumor patient.
A.5 Whole nutrient formula foods for hepatopathy.
A.6 Whole nutrient formula foods for muscle attenuation syndrome patient. A.7 Whole nutrient formula foods for injured, infected or surgery patient and other patient with stress state.
A.8 Whole nutrient formula foods for patient with inflammatory bowel disease. A.9 Whole nutrient formula foods for people allergic to food protein.
A.10 Whole nutrient formula foods for intractable epilepsy patient.
A.11 Whole nutrient formula foods for patients with gastrointestinal tract malabsorption or pancreatitis.
A.12 Whole nutrient formula foods for patient with metabolic disorder of fatty acid.
A.13 Whole nutrient formula foods for patient of fat or having liposuction surgery. 13 Isoleucine L-Isoleucine L-2-Amino-3-Methylpentanoic acid C6H13NO2 131.17 +38.6 ~ +41.5 5.5 ~ 7.0 98.5 0.2 0.1 0.3 0.2 14 Tyrosine L-Tyrosine
S-Amino-3 (4-
hydroxyphenyl)-propionic
acid
C9H11NO3 181.19 -11.0 ~ -12.3 ?€? 98.5 0.2 0.1 0.3 0.2
15 Phenylalanine L-Phenylalanine L-2-Amino-3-Phenylpropionic acid C9H11NO2 165.19 -33.2 ~ -35.2 5.4 ~ 6.0 98.5 0.2 0.1 0.3 0.2 16 Lysine
L-Lysine
hydrochloride
L-2,6-Diaminocaproic
acid hydrochloride C6H14N2O2 ??? HCl 182.65 +20.3 ~ +21.5 5.0 ~ 6.0 98.5 0.2 0.1 0.3 0.2 L-Lysine acetate L-2,6-Diaminocaproic acid acetate C6H14N2O2 ??? C2H4O2 206.24 +8.5 ~ +10.0 6.5 ~ 7.5 98.5 0.2 0.1 0.3 0.2 L-Lysine L-2,6-Diaminocaproic acid C6H14N2O2 ??? H2O 164.2 +25.5 ~ +27.0 9.0 ~ 10.5 98.5 0.2 0.1 0.3 0.2 L-Lysine-L-
Glutamic acid
L-2,6-Diaminocaproic
acid ??-Glutamic acid salt C11H23N3O6 ??? 2H2O 329.35 +27.5 ~ +29.5 6.0 ~ 7.5 98.0 0.2 0.1 0.3 0.2 L-Lysine-Aspartic
acid
L-2,6-Diaminocaproic
acid L-Aminosuccinic acid
salt
C10H21N3O6 279.30 +24.0 ~ +26.5 5.0 ~ 7.0 98.0 0.2 0.1 0.3 0.2
17 Arginine
L-Arginine L-2-Amino-5-Guanidine valeric acid C6H14N4O2 174.2 +26.0 ~ +27.9 10.5 ~ 12.0 98.5 0.2 0.1 0.3 0.2 L-Arginine
hydrochloride
L-2-Amino-5-Guanidino
valeric acid hydrochloride C6H14N4O2 ??? HCl 210.66 +21.3 ~ +23.5 ?€? 98.5 0.2 0.1 0.3 0.2 L-Arginine-Aspartic
acid
L-2-Amino-5-Guanidino-
Pentanoic acid-L-
Aminosuccinic acid
C10H21N5O6 307.31 +25.0 ~ +27.0 6.0 ~ 7.0 98.5 0.2 0.1 0.3 0.2

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