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Infant Formula Milk Powder China CFDA Registration

I.        Introduction of Infant Formula CFDA Registration

On 1 October 2016, The Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (Administrative Measures) outlines CFDA’s new registration requirements for domestic and foreign infant formula manufacturers, has beed taken into force. In accordance with these Administrative Measures, all infant formula brands exported to China must be registered with CFDA prior to 1 January 2018, after get the approval of CFDA then can be marketing in china.

Only infant formula milk powder production enterprises satisfying the following requirements can apply for infant formula products registration: with appropriate capabilities in research and development, production and inspection, satisfying the powdered infant formula foods’ good manufacturing practice requirements, having implemented the hazard analysis and critical control point system, the products are manufactured in accordance with relevant laws, carrying out batch testing of products produced in accordance with relevant legal provisions and items stipulated by infant formula milk powder food safety standards.

The Administrative Measures require each company in principle can only apply at most for nine formula products within three series, One series includes infant formula (0-6 months, 1 stage), older infant formula (6-12 months, 2 stage), and young children formula (12-36 months, 3 stage). The rules allow a wholly-owned subsidiary to use registered formula products of another wholly-owned subsidiary subordinated to a single group company. 

Foreign applicant need entrust a Chinese Responsibility Agent (CRA) to conduct the registration procedure, the CRA can be the foreign applicant china branch or other 3th part consulting company.


II.    Infant Formula CFDA Registration Timeline:

No. Items Time line Note

1

CFDA Application documents prepare

1-2 months

 

2

Product Initial Testing

4-12 months

Time depend on the Lab.

3

CFDA Technical Evaluation

3-4 months

Time depend on CFDA

4

CFDA On-site Inspection

1- 6 months

Time depend on CFDA

5

CFDA Sample Inspection

1-2 months

Time depend on the Lab.

6

CFDA approval & issue certificate:

1 month

Time depend on CFDA

 

Total time

1~2 years

 



III.    Infant Formula CFDA Registration Cost:                                                      Curency:USD

Product Quantity Agent service fee CFDA official Cost Note

1 product

Enquire us for

About $ 30,000.00

CFDA official fees, in accordance with the actual charge, add 5% tax

3 products

Enquire us for

About $ 90,000.00

9 products

Enquire us for

About $ 27,000.00



IV.             Infant Formula CFDA Registration Application Documents List:

1.Application for Registration of Product Formula of Infant Formula Milk Powder;

2.Subject qualification certifications of the applicant;

3.Quality safety standard of raw materials and excipients;

4.Product formula;

5.Product formula R&D report;

6.Instruction for production process;

7.Product certificate of analysis; (Issued by CFDA designated Lab.)

8.Materials for certifying R&D capability, production capability and test capability;

9.Other materials indicating scientificity and safety of formula;

10.Label and package insert sample manuscript and the alleged instruction and certification documents.

 

V.  Infant Formula CFDA Registration Sample Test Items & GB standards:

At least test 3 batches products, and 1 batch Production site sampling when CFDA conduct site-audit.
The most time-consuming item is the stability test, usually need take 3-6 months.

No. Test items Test GB Standards

1

色泽 Color

GB 10767

2

滋味及气味 Taste and odor

GB 10767

3

组织形态 Form

GB 10767

4

冲调性dilution

GB 10767

5

蛋白质Protein

GB 5009.5

6

脂肪Fat

GB 5413.3

7

亚油酸Linoleic acid

GB 5413.27

8

α-亚麻酸α-linolenic acid

GB5413.27

9

月桂酸Α-linolenic acid

GB5413.27

10

肉豆蔻酸Lauric acid

GB5413.27

11

总脂肪酸Myristic acid

GB5413.27

12

芥酸Total fatty acids

GB5413.27

13

反式脂肪酸Erucic acid

GB 5413.36

14

乳糖trans fat

GB 5413.5

15

碳水化合物 lactose

GB 10765

16

乳清蛋白Carbohydrates

GB/T 5413.2

17

维生素A Vitamin AWhey protein

GB 5413.9

18

维生素D Vitamin D

GB 5413.9

19

维生素E Vitamin E

GB 5413.9

20

维生素K1 VitaminK1

GB 5413.10

21

维生素B1 VitaminB1

GB 5413.11

22

维生素B2 VitaminB2

GB 5413.12

23

维生素B6 VitaminB6

GB 5413.13

24

维生素B12 VitaminB12

GB 5413.14

25

烟酸(烟酰胺)Niacin

GB 5413.15

26

叶酸Folic acid

GB 5413.16

27

泛酸 Pantothenic acid

GB 5413.17

28

维生素C Vitamin C

GB 5413.18

29

生物素Biotin

GB 5413.19

30

Sodium

GB 5413.21

31

Potassium

GB 5413.21

32

Copper

GB 5413.21

33

Magnesium

GB 5413.21

34

Iron

GB 5413.21

35

Zinc

GB 5413.21

36

Manganese

GB 5413.21

37

Calcium

GB 5413.21

38

Phosphorus

GB 5413.22

39

钙磷比值

GB 10765

40

Iodine

GB 5413.23

41

Chlorin

GB 5413.24

42

Selenium

GB 5009.93

43

胆碱Choline

GB/T 5413.20

44

肌醇Inositol

GB 5413.25

45

牛磺酸Taurine

GB 5413.26

46

左旋肉碱L-carnitine

GB 10765

47

二十二碳六烯酸Docosahexaenoic acid

GB 5413.27

48

二十碳四烯酸Eicosatetraenoic acid

GB 5413.27

49

总脂肪酸Total fatty acids

GB 5413.27

50

水分Moisture

GB 5009.3

51

灰分Ash

GB 5009.4

52

杂质度 Impurity

GB 5413.30

53

Lead

GB 5009.12

54

硝酸盐(以NaNO3计)

GB 5009.33

55

亚硝酸盐(以NaNO2计)

GB 5009.33

56

黄曲霉毒素M1Aflatoxin M1

GB 5009.24

57

菌落总数Total colony count

GB 4789.2

58

大肠菌群 Coliform

GB 4789.3

59

金黄色葡萄球菌Staphylococcus aureus

GB 4789.10

60

阪崎肠杆菌Enterobacter sakazakii

GB 4789.40

61

沙门氏菌Salmonella

GB 4789.4

62

商业无菌检验Commercial sterility testing

GB/T 4789.26

63

脲酶活性定性测定

Qualitative determination of urease activity

GB/T 5413.31

64

三聚氰胺Melamine

GB 22388

65

食品标签Labeling

GB 7718GB 13432


 

VI.    Infant Formula CFDA Registration On-site inspection items

CFDA examination expert panel will conduct the on-site inspection from below aspects to evaluate the manufacturer production and quality management capacity.

No. Category Items

1

Production conditions

Production workshop

Production distribution

2

Quality control

Organization structure

Quality management system

Quality control system

Handling with unqualified situation

Production control and process file

Key control point

Purchase system

Purchase file

3

Inspection capacity

Organization structure

Examining system

Lab layout

Examination facility, instrument and equipment

4

Development capacity

Development institution

Development system

5

Small trail capacity

Operator requirement

Sample development situation

Pilot production equipment

Inspection equipment

Food raw material and food additives

Consistency of pilot production

Relevant regulation and GB standards:

1.      Rules for the Inspection of Infant Formula Milk Powder Production.

2.      The Key Points for On-site Inspection and Judgment Principles of Product Formula Registration of Infant Formula Milk Powder

3.      GB 12693-2010  Good Manufacturing Practice for Dairy Products

4.      GB 23790-2010  Good Manufacturing Practice for Powdered Formulae for Infants and Young Children


 

VII.     Relevant China regulations and GB standards about Infant Formula

RJS provide these regulations and GB standards english translation, and the product formula, quality, labeling CFDA regulation and GB standards compliance Pre-review services, the price enquire us for.

A. China Rules and Regulations:

1.        The Administrative Measure for Overseas Manufacturer Registration of Imported Food

2.        The Administrative Measure of Imported and Exported Food Safety

3.        The Administrative Measure of Inspection, Quarantine, and Supervision of Imported and Exported Dairy Products

4.        The Administrative Measures on the Formula  Registration of Infant Formula Milk Powder

5.        The AQSIQ Notice about Strengthening the Management of Imported Infant Formula Milk Powder

6.        The AQSIQ Notice of the Implementation Requirements about “The Administrative Measure of Inspection, Quarantine, and Supervision of Imported and Exported Dairy Products”

7.        The Food Safety Law of the People's Republic of China

8.        The Items and Requirements of Product Formula Registration Application Documents of Infant Formula Milk Powder

9.        The Key Points for On-site Inspection and Judgment Principles of Product Formula Registration of Infant Formula Milk Powder

10.    The Measures for the Management of Product Formula Registration of Infant Formula Milk Powder

11.    Technical guidelines for Study on Stability of Formula Registration for Infant Formula

12.    Rules for the Inspection of Infant Formula Milk Powder Production.

B. China national GB standards

No. Standard Code Standard name

1

GB 10770-2010

Canned Complementary Foods for Infant and Young Children

2

GB10770-2010

Canned complementary foods for infant and young children

3

GB 10769-2010

Cereal-Based Complementary Foods for Infants and Young Children

4

GB10769-2010

Cereal-based complementary foods for infants and young children

5

GB5420-2010

Cheese

6

GB 22570-2014

Complementary Food Supplement

7

GB19646-2010

Cream, butter and anhydrous milkfat

8

GB5413.21-2010

Determination  of  calcium,  iron,  zinc,  sodium,  potassium, magnesium, copper and manganese in foods  for infants  and young children, milk and dairy products

9

GB5413.34-2010

Determination of acidity in raw milk and dairy products

10

GB22031-2010

Determination of added citrate content in cheese and processed cheese products

11

GB5413.37-2010

Determination of aflatoxin M  in milk and dairy products

12

GB5009.24-2010

Determination of aflatoxins M1 and B1 in foods

13

GB5009.4-2010

Determination of ash in foods

14

GB21703-2010

Determination of benzoic and sorbic acid in milk and dairy products

15

GB5413.24-2010

Determination of chlorine in foods for infants and young children, milk and dairy products

16

GB5413.3-2010

Determination of fat in foods for infants and young children, milk and dairy products

17

GB5413.27-2010

Determination of fatty acids in foods for infants and young children, milk and dairy products

18

GB5413.16-2010

Determination of folic acid (folate activity) in foods for infants and young children, milk and dairy products

19

GB5413.19-2010

Determination of free biotin content in foods for infants and young children, milk and dairy products

20

GB5413.38-2010

Determination of freezing point in raw milk

21

GB5413.30-2010

Determination of impurities in raw milk and dairy products

22

GB5413.25-2010

Determination of inositol in foods for infants and young children, milk and dairy products

23

GB5413.6-2010

Determination of insoluble dietary fiber in foods for infants and young children, milk and dairy products

24

GB5413.23-2010

Determination of iodine in foods for infants and young children, milk and dairy products

25

GB5413.5-2010

Determination of lactose and sucrose in foods for infants and young children, milk and dairy products

26

GB5009.12-2010

Determination of lead in foods

27

GB5009.3-2010

Determination of moisture in foods

28

GB5009.33-2010

Determination of nitrite and nitrate in foods

29

GB5413.39-2010

Determination of nonfat total milk solids in milk and milk products

30

GB5413.17-2010

Determination of pantothenic acid in foods for infants and young children, milk and dairy products

31

GB5413.22-2010

Determination of phosphorus in foods for infants and young children, milk and dairy products

32

GB5009.5-2010

Determination of protein in foods

33

GB5009.93-2010

Determination of selenium in foods

34

GB5413.29-2010

Determination of solubility in foods for infants and young children, milk and dairy products

35

GB5413.33-2010

Determination of specific gravity in raw milk

36

GB5413.26-2010

Determination of taurine in foods for infants and young children, milk and dairy products

37

GB5413.36-2010

Determination of trans fatty acids in foods for infants and young children, milk and dairy products

38

GB5413.9 -2010

Determination of vitamin A, D, E in foods for infant and young children, milk and dairy products

39

GB5413.11-2010

Determination of vitamin B1 in foods for infants and young children, milk and dairy products

40

GB5413.14-2010

Determination of vitamin B12 in foods for infants and young children, milk and dairy products

41

GB5413.12-2010

Determination of vitamin B2 in foods for infants and young children, milk and dairy products

42

GB5413.13-2010

Determination of vitamin B6 in foods for infants and young children, milk and dairy products

43

GB5413.18-2010

Determination of vitamin C in foods for infants and young children, milk and dairy products

44

GB5413.10-2010

Determination of vitamin K1 in foods for infants and young children, milk and dairy products

45

GB5413.15-2010

Determination of vitamin niacin and niacinamide in foods for infants and young children, milk and dairy products

46

GB5413.35-2010

Determination of β-carotene in foods for infants and young
children, milk and dairy products

47

GB13102-2010

Evaporated milk, sweetened condensed milk and formulated condensed milk

48

GB19302-2010

Fermented milk

49

GB4789.1-2010

Food microbiological examination: General guidelines

50

GB 29922-2013

Formulas for Special Medical Purposes

51

GB 24154-2015

General Standard for Sports Nutritional Food

52

GB 25596-2010

General Standard of Formulas for Special Medical Purposes Intended for Infants

53

GB 12693-2010

Good Manufacturing Practice for Dairy Products

55

GB 23790-2010

Good Manufacturing Practice for Powdered Formulae for Infants and Young Children

57

GB10765-2010

Infant Formula

58

GB 2762-2012

Maximum Levels of Contaminants in Foods

59

GB 2761-2011

Maximum Levels of Mycotoxins in Foods

60

GB 2763-2016

Maximum Residue Level of Pesticides in Foods34

61

GB4789.2-2010

Microbiological examination in foods - Aerobic plate count

62

GB4789.10-2010

Microbiological examination in foods - Detection of
Staphylococcus aureus

63

GB4789.3-2010

Microbiological examination in foods - Enumeration of coliforms

64

GB4789.35-2010

Microbiological examination in foods - Examination of lactic acid bacteria in foods

65

GB4789.18-2010

Microbiological examination in foods - Examination of milk and milk products

66

GB4789.15-2010

Microbiological examination in foods - Examination of moulds and yeasts

67

GB4789.40-2010

Microbiological examination in foods - Examination of
Enterobacter sakazakii

68

GB4789.30-2010

Microbiological examination in foods - Examination of
Listeria monocytogenes

69

GB4789.4-2010

Microbiological examination in foods - Examination of
Salmonella

70

GB19644-2010

Milk powder

71

GB25191-2010

Modified milks

72

GB 31601-2015

Multi-nutrient supplementary food for pregnant and lactating women

73

GB 10767-2010

Older infants and young children formula

74

GB19645-2010

Pasteurized milk

75

GB 29921-2013

Pathogen Limits for Food

76

GB25192-2010

Process(ed) cheese

77

GB19301-2010

Raw milk

78

GB 28050-2011

Standard for Nutrition Labelling of Prepackaged Foods

79

GB 7718-2011

Standard for the Labelling of Prepackaged Foods

80

GB 14880-2012

Standard Regarding Nutritional Fortification Substances in Foods

81

GB 2760-2011

Standards for Uses of Food Additives

82

GB25190-2010

Sterilized milk

83

GB 13432-2013

The Labelling of Pre-packaged Foods for Special Dietary Uses

84

GB11674-2010

Whey powder and whey protein powder

 

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