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 |
|
|