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 |
钠Sodium |
GB 5413.21 |
|
31 |
钾Potassium |
GB 5413.21 |
|
32 |
铜Copper |
GB 5413.21 |
|
33 |
镁Magnesium |
GB 5413.21 |
|
34 |
铁Iron |
GB 5413.21 |
|
35 |
锌Zinc |
GB 5413.21 |
|
36 |
锰Manganese |
GB 5413.21 |
|
37 |
钙Calcium |
GB 5413.21 |
|
38 |
磷Phosphorus |
GB 5413.22 |
|
39 |
钙磷比值 |
GB 10765 |
|
40 |
碘Iodine |
GB 5413.23 |
|
41 |
氯
Chlorin |
GB 5413.24 |
|
42 |
硒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 |
铅
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 7718、GB
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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