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Infant formula standard

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Infant formula standard

National Standard of the People's Republic of China

    GB 107651997

    National food safety standard

    Infant formula

Issued on 1997-03-26 Implemented on 2011-04-01

    Issued by the Ministry of Health of the People’s Republic of China Translated by Xuzhou Yitong Food Industry Co.Ltd.

    On 13 May 2010

    Foreword This standard is modified in relation to Codex Stan 72-1981 (Revision 2007) (Part A of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants) formulated by Codex Alimentarius Commission and by reference to Chinese Dietary Reference Intakes compiled by Chinese Nutrition Society in 2000.

    This Standard is an integration and amendment to GB 10765-1997, Infant Formula?,

    GB 10766-1997, Infant Formula II, III, and GB 10767-1997, General Technical Regulations for Infant Blended Milk Powder and Infant Completed Grain Flour. Compared with GB 10765-1997, GB 10766-1997 and GB 10767-1997, the following changes have been made to the Standard:

    ——Integrate the above three standards to one, titled as Infants Formula;

    ——Provisions therein are modified. Annex A and B of this present National Standard is normative.

    The original editions replaced by this present National Standard include: ——GB 10765-1997;

    ——GB 10766-1997;

    ——GB 10767-1997.

    GB107651997

    National food safety standard

    Infant Formula

    1 Scope

    This Standard applies to production, circulation, supervision and administration of formulas for infants.

    2 Normative References

    The following standards contain provisions which, through reference in this text, constitute provisions of this present standard. Note: As for the dated references, all the amendments or

    revisions after them except the corrigenda are not applicable to this present standard. As for the

    references that are not dated, their most recent editions are applicable to this present national

    standard.

    3 Terms and Definitions

    3.1 Infants

    Refers to persons of 0 ~ 12 months old.

    3.2 Formula for infants

    3.2.1 Milk-based infant formula: refers to liquid or powder products made only through

    physical methods, of which the main material is milk and its product, supplemented with

    a proper amount of vitamin, minerals and/or other supplementary materials, which are

    applicable to normal infants, where the energy and nutrition can satisfy the requirements

    of growth and development of normal infants of 0~6 months old. 3.2.2 Soybean-based infant formula: refers to liquid or powder products made only through

    physical methods, of which the main material is beans and its product, supplemented with

    a proper amount of vitamin, minerals and/or other supplementary materials, which are

    applicable to normal infants, where the energy and nutrition can satisfy the requirements

    of growth and development of normal infants of 0~6 months old. 4 Requirements

    4.1 Requirements for Raw Materials

    The raw and supplementary materials should comply with the related national or trade

    standards or regulations. The raw and supplementary materials should ensure the safety of infants

    and satisfy the requirements of nutrition. Hazardous substances in infant nutrition and health

    should not be used.

    Ingredients and food additives adopted should not contain gluten.

    Hydrogenated oil and fat should NOT be used.

    Raw and supplementary materials treated by irradiation should NOT be used.

    4.2 Sensory requirement: should meet the requirement of Table 1.

    Table 1 Sensory requirement

    Item Requirement

    Color Meet the requirement on the quality of related products

    Flavor , Smell Meet the requirement on the quality of related products

    Structure Meet the requirement on the quality of related products, foreign

    materials can not be seen under normal vision.

    Fast dissolvability Meet the requirement on the quality of related products 4.3 Essential components

    4.3.1 All essential components in infant formulas should be necessary for growth and

    development of infants.

    4.3.2 The energy in the ready-to-eat infant formulas per 100ml should be within the range of

    250 kJ (60 kcal) 295 kJ (70 kcal). Energy is calculated according to protein, fat and

    carbohydrate content per 100mL products, multiplied by energy coefficient of 17 kJ/g, 37 kJ/g, 17

    kJ/g, (the energy coefficient of dietary fiber is 50% of carbohydrate), then divide the result

    (kJ/100mL) by 4.184 to value of kcal/100mL.

    4.3.3 Protein, fat and carbohydrate contained per 100kJ (100kcal) infant formula must meet

    the requirement of Table 2.

    4.3.4 For infant formula based on milk, the preferred carbohydrate should be lactose or the

    polymer of lactose and glucose. Only after pregelatinization, the starch can be added into the

    infant formula. Fructose can NOT be used.

    Table 2 Index of Protein, Fat and Carbohydrate

    Per 100 kJ Per 100 kcal Test Nutrient method Minimum Maximum Minimum Maximum a Protein Milk-based infant formula/ (g) 0.45 0.70 1.88 2.93 GB 5009.5 Soybean-based infant formula/(g) 0.50 0.70 2.09 2.93

    bFat /(g) 1.05 1.40 4.39 5.86 GB 5413.3 in which: linoleic acid 0.07 0.33 0.29 1.38 GB5413.27 ccα- linolenic acid 12 N.S. 50 N.S.

    linoleic acid /α-linolenic acid ratio 5:1 15:1 5:1 15:1

    d,e Total carbohydrate /(g) 2.2 3.3 9.2 13.8 a For infant formulas based on milk protein and its processed products, the content of lactalbumin should be over or equal to 60%. The content of protein should be calculated as nitrogen (N) × 6.25. b In the finished products, the total content of lauric acid and myristic acid (tetradecanoic acid)

    should not exceed 20% of the total fatty acid; the maximum content of trans fatty acid should not

    exceed 3% of the total fatty acid; the erucic acid content should not exceed 1% of the total fatty acid.

    During calculation of total fatty acid, C4 ~ C24 fatty acid should be involved. c N.S.: No specification

    d The content of lactose in total carbohydrate should be over or equal to 90%; for infant formulas

    based on milk, when calculate the content of lactose in total carbohydrate, no oligosaccharide and polysaccharide shall be included; requirement of lactose content does not apply to soybean-based formula.

    e The mass fraction A1 of carbohydrate is calculated as per formula (1):

    A = 100(AAAAA).......................(1) 123456

    A1——Mass fraction of carbohydrate, g/100g;

    A2——Mass fraction of protein, g/100g;

    A3——Mass fraction of fat, g/100g;

A4——Mass fraction of water, g/100g;

    A5——Mass fraction of ash, g/100g;

    A6——Mass fraction of dietary fiber, g/100g;

    4.3.5 Vitamin: should meet the requirement of Table 3.

    Table 3 Indices of Vitamin

    aPer 100 kJ Per 100 kcal 14 43 59 180 Nutrient Test method bMinimum Maximum Minimum Maximum Vitamin D/(μg) GB 5413.9 0.25 0.60 1.05 2.51 Vitamin A/(μg RE) cVitamin E/(mg α-TE) 0.12 1.20 0.50 5.02 Vitamin K/(μg) 1.0 6.5 4.2 27.2 GB 5413.10 1

    Vitamin B/(μg) 14 72 59 301 GB 5413.11 1

    Vitamin B/(μg) 19 119 80 498 GB 5413.12 2

    Vitamin B/(μg) 8.5 45.0 35.6 188.3 GB 5413.13 6

    Vitamin B/(μg) 0.025 0.360 0.105 1.506 GB 5413.14 12dNiacin(niacinamide)/(μg) 70 360 293 1506 GB 5413.15 Folic acid/(μg) 2.5 12.0 10.5 50.2 GB 5413.16 Pantothenic acid/(μg) 96 478 402 2000 GB 5413.17 Vitamin C/(mg) 2.5 17.0 10.5 71.1 GB 5413.18 Biotin/(μg) 0.4 2.4 1.5 10.0 GB 5413.19 a RE is retinol equivalent. 1 ug RE= 1ug All trans retinol (Vitamin A)=3.33 IU Vitamin A.

    Ingredients of Vitamin A shall come from preformed retinol. When calculating or claiming

    activities of Vitamin A, no carotenoids ingredient shall be included.

    b Calciferol, 1μg Vitamin D = 40 IU Vitamin D.

    c 1 mg a-TE (α-tocopherol equivalent)=1 mg d-α-tocopherol. The content of Vitamin E should

    be at least 0.5mg of α-TE per gram of polyunsaturated fatty acid. The minimum of Vitamin E

    content should be regulated according to the number of double bonds in polyunsaturated fatty

    acids in the formula as follows: 0.5 mg of α-TE per gram of linoleic acid (18:2 n-6); 0.75 mg of α-TE per gram of α-linolenic acid (18:3 n-3); 1.0 mg of α-TE per gram of arachidonic acid (20:4 n-6); 1.25mg of α-TE per gram of Eicosapentaenoic Acid (20:5 n-3); 1.5mg of α-TE per gram of docosahexenoic acid (22:6 n-3).

    d Niacin: excludes precursor form.

    4.3.6 Minerals: should meet the requirement of Table 4.

    Table 4 Indices of Minerals

    Per 100 kJ Per 100 kcal Nutrient Test method Minimum Maximum Minimum Maximum Sodium/(mg) 5 14 21 59

    Potassium/(mg) 14 43 59 180 Copper/(μg) 8.5 29.0 35.6 121.3 GB 5413.21 Magnesium/(mg) 1.2 3.6 aa 5.0 15.1

    Iron/(mg) 0.10 0.36 0.42 1.51

    Zinc/(mg) 0.12 0.36 0.50 1.51

    aa 25 100 GB 5413.22 Manganese/(μg) 1.2 24.0 5.0 100.4

    Calcium/phosphorus ratio 1:1 2:1 1:1 2:1 Calcium/(mg) 12 35 50 146

    Iodine/(μg) 2.5 14.0 10.5 58.6 GB 5413.23 Phosphorus/(mg) 6 24

    Chloride/(mg) 12 38 50 159 GB 5413.24

    Selenium/(μg) 0.48 1.90 2.01 7.95 GB 5009.93 a Only applicable to formulas based on milk.

4.4 Optional components

4.4.1 In addition to the essential components in 4.3, one or more nutrients listed in Table 5 can

    be selected, whereas the content of such nutrients should meet the specification of Table 5.

    4.4.2 Individual L type amino acids listed in Annex A can be added ONLY for the purpose of

    improving the protein quality or raising the nutritional value of infant formulas. Sources of the

    individual L type amino acid used should meet the specification of GB14880 or Annex B.

    4.4.3 Other nutrients not shown in Table 5 and Annex B can also be added to infant formulas,

    whereas such nutrients should comply with related regulations.

    Table 5 Indices of Optional Components

    Per 100 kJ Per 100 kcal Optional Components Test 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.

    aa 3 N.S. 13 GB 5413.26

    aaL-Carnitine/(mg) 0.3 N.S. 1.3 N.S.

    Docosahexaenoic acid aa 0.5 N.S. 0.5 GB 5413.27 N.S.b,c/(%total fatty acid )

    Arachidonic acid aa 1 N.S. 1 GB 5413.27 N.S.b,c/(%total fatty acid )

    a NS: No specification.

    b If docosahexaenoic acid (22:6 n-3) is supplemented to the infant formula, at least the same amount of Arachidonic acid (20:4 n-6) should be supplemented. Eicosapentaenoic acid (20:5 n-3) may exist in long chain unsaturated fatty acids, of which the total content should not exceed that

    of docosahexaenoic acid.

    c During calculation of total fatty acid, C4 ~ C24 fatty acid should be involved.

4.5 Other indices: should meet the requirement of Table 6.

     aTable 6 Other Indices ? 5.0 GB 5009.3 Item Index Test method Ash

    Water/(%)Powder milk-based products/(%) ? 4.0

    Liquid milk-based products 4.2 (calculated based on total dry matter)/(%) ? GB 5009.4 Powder bean-based products/(%) ? 5.0

    Liquid bean-based products 5.3 (calculated based on total dry matter)/(%) ?

    Impurities(for milk based infant formula ONLY)

    Powder product/(mg/kg) ? 12 GB 5413.30 Liquid product/(mg/kg) ? 2

    a Only for powder infant formula.

4.6 Hygienic requirements: should meet the specification of Table 7.

    Table 7 Indices of Contaminants (calculated based on powder products)

    Item Index Test method Lead, mg/kg ? 0.15 GB 5009.12 Nitrate (based on NaNO3), mg/kg ? 100 GB 5009.33 Nitrite (based on NaNO2) a, mg/kg ? 2 a Only for milk based infant formula.

    4.7 Mycotoxin requirements: should meet the specification of Table 8.

    Table 8 Indices of Mycotoxin(calculated based on powder products)

    Item Index Test method

    a Aflatoxin M or Aflatoxin B μg ? 0.5 GB 5009.24 11

    a Indice of Aflatoxin M is for milk based infant formula; Indice of Aflatoxin B is for bean 11

    based infant formula.

    4.8. Indices of Microorganisms: Indices of Microorganism in powder infant formulas

    should meet the specification of Table 9; the liquid infant formulas should meet the

    requirement of commercial sterilization, test method is GB/T 4789.26.

    Table 9 Indices of Microorganisms

    Sampling plan a and limit (Unless

    specified otherwise, it should be Item Test method expressed in CUF/g or CUF/mL)

    n c m M

    bTotal colony count 5 2 1000 10000 GB 4789.2 Coliform bacteria 5 2 10 100 GB4789.3(plate count) Staphylococcus ureus 5 2 10 100 GB 4789.10(plate count)

    c 3 0 0/100 g - GB 4789.40(plate count) Salmonella 5 0 0/25 g - GB 4789.4 Enterobacter sakazakii a Comply with GB 4789.1 and GB 4789.18.

    b Not applicable to products supplemented with probiotic bacteria(aerobic and facultative

    6anaerobe probiotics). [Total colony of probiotics bacteria should ?10CFU/ g (mL)]. c Only applicable to formulas for infants of 0-6 months old.

    4.9 Food Additives and Nutrient compounds

    4.9.1 The quality of food additives and nutrient compounds should comply with related

    regulations.

    4.9.2 Food additives and nutrient compounds should comply with GB 2760 and GB 14880.

    4.10 Urease: The activity of urease for bean-based product should meet the specification of

    Table 10.

    Table 10 Indices of activity of urease

    Item Index Test method Activity of urease(Qualitative determination) Negative GB/T 5413.31a a Liquid infant formula should be calculated based on dry matter content. 5 Others

    5.1 Labels

    5.1.1 Contents indicated on the label should be subject to specifications of GB 13432. In

    addition, nutrient ingredients and optional components should be indicated as ―content per 100 kJ or 100 kcal.

    5.1.2 On the label, product type(e.g. milk-based or bean-based products) applicable infant age

    should be indicated. Label of the formula applicable to infants over 6 months old should be

    indicated with ―”If this product serves infants elder than 6 month, supplementary foods should

    also be used”

    5.1.3 Label of the infant formula should be indicated with ―”the most ideal food for infants is breast milk; when breast milk is absent or not enough, this product can be used. 5.1.4 Images of infants or women cannot appear on the labels. It is not allowed to use the

    expressions such as ―”like human milk, “like breast milk or similar terms.

    5.2 Directions for use

    5.2.1 The directions for use, proper preparation and illustration as well as storage condition of

    the product should be clearly indicated on the label. If maximum surface area of the package is

    less than 100 cm2 or if the quality of product is less than 100 g, illustration is not necessary.

    5.2.2 The directions indicated should cover warning on the hazard to health resulting from

    incorrect preparation or application.

    5.3 Packaging

    Carbon dioxide and/or nitrogen (food-grade or purity?99.9%) may serve as packaging medium.

     Annex A (Normative index)

    Essential and Semi-essential Amino Acids in infant formula

A.1 By reference to the representative data that have been published related to nitrogen content

    and/or protein content in human milk in China, the content of essential and semi-essential amino

    acids in infant formula can be calculated, and expressed in milligram per gram of nitrogen(mg/g

    N).

    A.2 In Attached table A.1 to this national standard, the amino acid content in 100 kcal of infant

    formula, of which the lower limit level of protein is 1.88g/100kcal, can be calculated according to

    the mean content of each amino acid in human milk (mg/g nitrogen): The amino acid level (in

    milligram) per gram of nitrogen in human milk is divided by the nitrogen conversion factor, 6.25,

    and then multiplied by 1.88. Recommendable content of amino acid in infant formula should not

    lower than recommendation in table A1.

    A3. In the calculations, content of tyrosine and phenylalanine can be summed; if the proportion

    of methionine and cysteine is less than 2:1, the content of them can also be summed.

    Table A1: Recommendable Content of Amino Acid in infant formula

    Amino Acid Mg/g N Mg/100 kcal Cystine 80 24.1 Histidine 120 36.1 Isoleucine 300 90.2 Leucine 540 162.4 Lysine 350 105.3 Methionine 65 19.6 Phenylalanine 180 54.1 Threonine 250 75.2 Tryptophan 110 33.1 Tyrosine 200 60.2 Valine 310 93.2

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