National Health and Family Planning Commission; China Food and Drug Administration
Issued on:
2016-12-23
Implemented on:
2017-6-23
Status:
valid
Language:
English
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Word Count:
3000 words
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Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
National Food Safety Standard
Food Nutritive Fortifier – Lactoferrin
1 Scope
This standard is applicable to lactoferrin, a food nutritive fortifier which is obtained from raw materials of milk and dairy products through separation, sterilization, extraction, refinement and drying.
2 Technical Requirements
2.1 Sensory requirements
Sensory requirements shall meet those specified in Table 1.
Table 1 Sensory Requirements
Item Requirement Inspection method
Color and luster Pink to red brown Take appropriate amount of specimen and put it in a clean and dry colorless glass beaker, and observe its color, luster and state in natural light.
State Powder
2.2 Physical and chemical indexes
Physical and chemical indexes shall meet those specified in Table 2.
Table 2 Physical and Chemical Indexes
Item Index Inspection method
Total protein, ω/% ≥ 93.0 GB 5009.5a
Percentage of lactoferrin in total protein, ω/% ≥ 95.0 A.2 in Annex A
Loss on drying, ω/% ≤ 4.5 Direct drying method in GB 5009.3b
Ash content, ω/% ≤ 2.0 GB 5009.4
Fe content/(mg/100g) ≤ 35 GB 5009.90
Solubility Pass the test A.3 in Annex A
pH 5.2~7.2 GB/T 9724c
Pb/(mg/kg) ≤ 1.0 GB 5009.75 or GB 5009.12
As/(mg/kg) ≤ 1.0 GB 5009.76
a Conversion coefficient of nitrogen to protein is 6.38.
b Drying temperature and duration are respectively 105±2℃ and 5h.
c 20g/L water solution is determined at 20℃.
2.3 Microorganism limits
Microorganism limits shall meet those specified in Table 3.
Table 3 Microorganism Limits
Item Limit Inspection method
Total bacterial count/(CFU/g) ≤ 1000 GB 4789.2
Molds and yeasts count/(CFU/g) ≤ 10 GB 4789.15
Coliform/(MPN/g) < 3.0 MPN counting method in GB 4789.3
Salmonella/25g Not detectable GB 4789.4
Staphylococcus aureus/25g Not detectable Qualitative inspection in GB 4789.10
Annex A
Inspection Method
A.1 General requirements
Unless otherwise specified in this standard, the purity of the adopted reagents shall be analytically pure; the adopted standard volumetric solutions, standard solutions for impurity determination, preparations and products shall be prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603; the test water shall be Class-III water specified in GB/T 6682. Solutions adopted for test shall be water solution, unless otherwise indicated.
A.2 Determination of percentage of lactoferrin in total protein
A.2.1 Method summary
Adopt high performance liquid chromatography, determine the lactoferrin through separating the chromatographic column with ultraviolet detector at 280nm position under selected operating conditions, and determine the quantity with area normalization method.
1 Scope
2 Technical Requirements
Annex A Inspection Method
Annex B Reference Chromatogram for Lactoferrin Reference Sample
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
National Food Safety Standard
Food Nutritive Fortifier – Lactoferrin
1 Scope
This standard is applicable to lactoferrin, a food nutritive fortifier which is obtained from raw materials of milk and dairy products through separation, sterilization, extraction, refinement and drying.
2 Technical Requirements
2.1 Sensory requirements
Sensory requirements shall meet those specified in Table 1.
Table 1 Sensory Requirements
Item Requirement Inspection method
Color and luster Pink to red brown Take appropriate amount of specimen and put it in a clean and dry colorless glass beaker, and observe its color, luster and state in natural light.
State Powder
2.2 Physical and chemical indexes
Physical and chemical indexes shall meet those specified in Table 2.
Table 2 Physical and Chemical Indexes
Item Index Inspection method
Total protein, ω/% ≥ 93.0 GB 5009.5a
Percentage of lactoferrin in total protein, ω/% ≥ 95.0 A.2 in Annex A
Loss on drying, ω/% ≤ 4.5 Direct drying method in GB 5009.3b
Ash content, ω/% ≤ 2.0 GB 5009.4
Fe content/(mg/100g) ≤ 35 GB 5009.90
Solubility Pass the test A.3 in Annex A
pH 5.2~7.2 GB/T 9724c
Pb/(mg/kg) ≤ 1.0 GB 5009.75 or GB 5009.12
As/(mg/kg) ≤ 1.0 GB 5009.76
a Conversion coefficient of nitrogen to protein is 6.38.
b Drying temperature and duration are respectively 105±2℃ and 5h.
c 20g/L water solution is determined at 20℃.
2.3 Microorganism limits
Microorganism limits shall meet those specified in Table 3.
Table 3 Microorganism Limits
Item Limit Inspection method
Total bacterial count/(CFU/g) ≤ 1000 GB 4789.2
Molds and yeasts count/(CFU/g) ≤ 10 GB 4789.15
Coliform/(MPN/g) < 3.0 MPN counting method in GB 4789.3
Salmonella/25g Not detectable GB 4789.4
Staphylococcus aureus/25g Not detectable Qualitative inspection in GB 4789.10
Annex A
Inspection Method
A.1 General requirements
Unless otherwise specified in this standard, the purity of the adopted reagents shall be analytically pure; the adopted standard volumetric solutions, standard solutions for impurity determination, preparations and products shall be prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603; the test water shall be Class-III water specified in GB/T 6682. Solutions adopted for test shall be water solution, unless otherwise indicated.
A.2 Determination of percentage of lactoferrin in total protein
A.2.1 Method summary
Adopt high performance liquid chromatography, determine the lactoferrin through separating the chromatographic column with ultraviolet detector at 280nm position under selected operating conditions, and determine the quantity with area normalization method.
Contents of GB 1903.17-2016
1 Scope
2 Technical Requirements
Annex A Inspection Method
Annex B Reference Chromatogram for Lactoferrin Reference Sample
