GB 25596-2010 PDF in English
GB 25596-2010 (GB25596-2010) PDF English
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National Food Safety Standard -- General Standard for Infant Formula for Special Medical Purposes
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Standards related to (historical): GB 25596-2010
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GB 25596-2010: PDF in English GB 25596-2010
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard -
General Standard for Infant Formula for Special
Medical Purposes
ISSUED ON. DECEMBER 21, 2010
IMPLEMENTED ON. JANUARY 1, 2012
Issued by. Ministry of Health of the PRC
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Technical requirements ... 4
5 Others ... 11
Appendix A (Normative) Common infant formula for special medical purposes
... 13
Appendix B (Normative) Monomeric amino acids which can be used in infant
formula for special medical purposes ... 15
National Food Safety Standard -
General Standard for Infant Formula for Special
Medical Purposes
1 Scope
This Standard applies to infant formula for special medical purposes.
2 Normative references
The documents cited in this Standard are indispensable for the application of
this Standard. For the dated references, only the versions with the dates
indicated are applicable to this Standard. For the undated references, the latest
version (including all the amendments) are applicable to this Standard.
3 Terms and definitions
3.1 Infant
People of 0 months ~ 12 months of age.
3.2 Infant formula for special medical purposes
A powdered or liquid formula designed for the nutritional needs of infants with
special medical conditions, such as special disorders, diseases, or medical
conditions. Under the guidance of a doctor or clinical dietitian, when consumed
alone or in combination with other foods, the energy and nutritional ingredient
can meet the growth and development needs of infants with special medical
conditions of 0 months ~ 6 months of age.
4 Technical requirements
4.1 General requirements
Formulations for infant formula for special medical purposes shall be based on
research results of medical and nutritional studies. The safety, nutritional
adequacy, and clinical effects need to be scientifically proven. When consumed
alone or in combination with other foods, the growth and development needs of
infants with special medical conditions of 0 months ~ 6 months of age can be
and nutritional needs of certain infants, the energy can be adjusted accordingly.
The energy is calculated by multiplying the protein, fat, and carbohydrate
content per 100mL of product by the energy coefficients of 17 kJ/g, 37 kJ/g, and
17 kJ/g (the energy coefficient of dietary fiber, calculated according to 50% of
energy coefficient of carbohydrate). The sum obtained is the value of kJ/100mL,
and divided by 4.184, to obtain the value of kcal/100mL.
4.4.3 In general, the amount of protein, fat, and carbohydrate contained per
100kJ (100 kcal) of infant formula for special medical purposes shall meet the
requirements of Table 2.
4.4.4 For infant formula for special medical purposes, except for special needs
(such as lactose intolerance), the preferred carbohydrate shall be lactose and
(or) glucose polymer. Only pre-gelatinized starch can be added to infant formula
for special medical purposes. Fructose shall not be used.
Table 2 -- Indexes for protein, fat, and carbohydrate
Nutrients
Per 100 kJ Per 100 kcal Inspection
method Minimum
Maxim
um
Minimu
Maxim
um
Proteina 0.45 0.70 1.88 2.93 GB 5009.5
Fatb/ (g)
Of which. Linoleic acid/ (g)
α-linolenic acid/ (mg)
Ratio of linoleic acid to
α-linolenic acid
1.05 1.40 4.39 5.86 GB 5413.3
0.07 0.33 0.29 1.38
GB 5413.27
12 N.S.c 50 N.S.c
5.1 15.1 5.1 15.1 -
Carbohydrated/ (g) 2.2 3.3 9.2 13.8 -
a The protein content shall be calculated by multiplying nitrogen (N) ×6.25.
b The total amount of lauric acid and myristic acid (tetradecanoic acid) in the final product
fat < 20% of total fatty acids. The maximum content of trans-fatty acids < 3% of total
fatty acids. Erucic acid content < 1% of total fatty acids. Total fatty acids refer to the
sum of C4 ~ C24 fatty acids.
c N.S. means no special instructions.
d The carbohydrate content A1 shall be calculated according to the formula (1).
A1 =100-(A2+A3+A4+A5+A6) ... (1)
Where.
A1 - Carbohydrate content, g/100g;
A2 - Protein content, g/100g;
A3 - Fat content, g/100g;
A4 - Moisture content, g/100g;
Table 5 (continued)
Optional ingredients
Per 100 kJ Per 100 kcal Inspection
method Minimum Maximum Minimum Maximum
Choline/ (mg) 1.7 12.0 7.1 50.2 GB/T 5413.20
Inositol/ (mg) 1.0 9.5 4.2 39.7 GB 5413.25
Taurine/ (mg) N.S.a 3 N.S.a 13 GB 5413.26
L-carnitine/ (mg) 0.3 N.S..a 1.3 N.S.a -
Docosahexaenoic acid/
(% total fatty acid b, c) N.S.
a 0.5 N.S.a 0.5 GB 5413.27
Eicosatetraenoic acid/ (%
total fatty acid b, c) N.S.
a 1 N.S.a 1 GB 5413.27
a N.S. means no special instructions.
b If docosahexaenoic acid (22.6 n-3) is added to the infant formula for special medical
purposes, at least the same amount of eicosatetraenoic acid (20.4 n-6) shall be added.
The amount of eicosapentaenoic acid (20.5 n-3) in long-chain unsaturated fatty acid
shall not exceed that of docosahexaenoic acid.
c Total fatty acids refer to the sum of C4 ~ C24 fatty acids.
4.6 Other indexes. It shall meet the requirements of Table 6.
Table 6 -- Other indexes
Items Indexes Inspection method
Moisture/ (%) a ≤ 5.0 GB 5009.3
Ash
Powdered product/(%) ≤
5.0 GB 5009.4
Liquid product (based on total dry matter)/(%) ≤ 5.3
Impurity degree
Powdered product/ (mg/kg) ≤
12 GB 5413.30
Liquid product/ (mg/kg) ≤ 2
a It is limited to powdered infant formula for special medical purposes.
4.7 Contaminant limits. It shall meet the requirements of Table 7.
4.10 Food additives and nutrient supplements
4.10.1 The quality of food additives and nutrient supplements shall comply with
the relevant safety standards and relevant regulations.
4.10.2 The use of food additives and nutrient supplements shall comply with
the provisions of GB 2760 and GB 14880.
4.11 Urease activity. The urease activity in products containing soybean
ingredients shall meet the requirements of Table 10.
Table 10 -- Urease activity index
Item Index Inspection method
Qualitative determination of urease activity Negative GB/T 5413.31a
a The sampling amount of liquid infant formula for special medical purposes shall
be converted according to the dry matter content.
5 Others
5.1 Label
5.1.1 The product label shall comply with the provisions of GB 13432. The
nutrients and optional ingredients shall be marked with an indication of the
content of “per 100kJ”.
5.1.2 The label shall clearly indicate the type of infant formula for special
medical purposes (e.g., lactose-free formula) and the applicable special
medical conditions. Formulas for premature/low birth weight infants shall be
marked with the osmotic pressure of the product. The formula for special
medical purposes, which can be eaten by infants over 6 months of age, shall
be marked “When infants with special medical conditions above 6 months of
age take this product, supplementary food shall be added”.
5.1.3 The label shall clearly identify “Please use under the guidance of a doctor
or clinical dietitian”.
5.1.4 There must be no image of infants and women on the label.
“Humanization”, “breast milk-simulated”, or similar terminology cannot be used.
5.2 Use instructions
5.2.1 The product use, preparation instructions and illustrations, storage
conditions shall be clearly stated on the label. When the maximum surface area
of the package is less than 100cm2 or the product mass is less than 100g, the
illustration may not be indicated.
Appendix A
(Normative)
Common infant formula for special medical purposes
Table A.1 -- Common infant formula for special medical purposes
Product category Applicable special medical conditions Main technical requirements of the formula
Lactose-free or
low-lactose
formula
Lactose
intolerance infants
1. The lactose is completely or partially replaced by
other carbohydrates in the formula;
2. The protein in the formula is provided by milk
protein.
Formula of
partially
hydrolyzed milk
protein
Infants with high
risk of milk protein
allergy
1. The milk protein shall be processed and
decomposed into small molecular milk proteins,
peptides, and amino acids;
2. The lactose may be completely or partially
replaced by other carbohydrates in the formula.
Formula of
deeply
hydrolyzed milk
protein or amino
acid formula
Food protein-
allergic infants
1. Food protein shall be not included in the formula;
2. The source of the amino acid used shall comply
with the provisions of GB 14880 or Appendix B of
this Standard;
3. The content of some minerals and vitamins can
be adjusted appropriately.
Formula for
premature/low
birth weight
infants
Premature/low
birth weight infants
1. The content of energy, protein, and certain
minerals and vitamins shall be higher than that
specified in 4.4;
2. The formula for premature/low weight infants
shall use medium-chain fat which is easily
digested and absorbed as a partial source of fat,
but medium-chain fat shall not exceed 40% of
total fat.
Breast milk
nutritional
supplement
Premature/low
birth weight infants
Essential ingredients and optional ingredients in 4.4
and 4.5 can be optionally added. The content can
be adjusted appropriately according to the
nutritional needs of premature/low birth weight
infants and the recognized breast milk data.
Combined with breast milk, the growth and
development needs of premature/low birth weight
infants can be met.
Appendix B
(Normative)
Monomeric amino acids which can be used in infant formula for special
medical purposes
Table B.1 -- Monomeric amino acids which can be used in infant formula
for special medical purposes a
No. Amino acids
Compound
source Chemical name
Molecular
formula
Molecul
ar
weight
Specific
rotation
[α]D, 20°C
pH
Purit
(%)
Moist
ure
(%)
Ash
(%)
Lead
(mg/kg)
Arsenic
(mg/kg
1 Aspartic acid
L-aspartic
acid
L-aminosuccinic
acid C4H7NO4 133.1
+24.5 ~
+26.0
2.5 ~
3.5 98.5 0.2 0.1 0.3 0.2
L-
magnesium
aspartate
L-magnesium
aminosuccinate
2(C4H6NO
4).Mg 288.49
+20.5 ~
+23.0 - 98.5 0.2 0.1 0.3 0.2
2 Threonine L-threonine
L-2-amino-3-
hydroxybutyric
acid
C4H9NO3 119.12 -26.5 ~ -29.0
5.0 ~
6.5 98.5 0.2 0.1 0.3 0.2
3 Serine L-serine
L-2-amino-3-
hydroxypropionic
acid
C3H7NO3 105.09 +13.6 ~ +16.0
5.5 ~
6.5 98.5 0.2 0.1 0.3 0.2
4 Glutamate
L-glutamate α-aminoglutaric acid C5H9NO4 147.13
+31.5 ~
+32.5 3.2 98.5 0.2 0.1 0.3 0.2
L-
potassium
glutamate
α-potassium
aminoglutarate
C5H8KNO
4·H2O 203.24
+22.5 ~
+24.0 - 98.5 0.2 0.1 0.3 0.2
5 Glutamine L-glutamine
2-amino-4-
amidobutyric
acid
C5H10N2O
3 146.15
+6.3 ~
+7.3 - 98.5 0.2 0.1 0.3 0.2
6 Proline L-proline
Pyrrolidine-2-
carboxylic acid C5H9NO2 115.13
-84.0 ~ -
86.3
5.9 ~
6.9 98.5 0.2 0.1 0.3 0.2
7 Glycine Glycine
Amino acetic
acid C2H5NO2 75.07 -
5.6 ~
6.6 98.5 0.2 0.1 0.3 0.2
8 Alanine L-alanine
L-2-
aminopropionic
acid
C3H7NO2 89.09 +13.5 ~ +15.5
5.5 ~
7.0 98.5 0.2 0.1 0.3 0.2
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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