CFDA ‘Administrative Measures on Product Formula Registration of Infant Formula Milk Powder’, will come into force on 1 October 2016, After then, all Infant Formula Milk Powder must apply CFDA registration, after get the approval of CFDA, then can be imported to china.
Pre-market Approval Item Name
Infant Formula Milk Powder CFDA Registration
Applicable Product Scope
infant formula milk powder
there are at most 3 series 9 kinds of formulas for one company in principle.
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).
One wholly-owned subsidiary who has get the formula registration license and production license is allowed to produce the registered product from another wholly-owned subsidiary in the same group company.
License / Certificate Name
CFDA Registration certificate for Infant Formula Milk Powder
License / Certificate Sample
License / Certificate Valid Time
CFDA - China Food and Drug Administration
Requirements of Applicant
Only the infant formula milk powder manufacturers who meet below requirements can apply for product formula registration:
a). have qualified R&D, production, testing capacities;
b). meet the good manufacturing practises (GMP) requirements for infant formula powder food;
c). conduct hazard analysis and critical control point (HACCP) system;
d). conduct lot by lot inspection on infant formula milk powder before they are out of factory on the basis of relevant law and national food safety standard.
Application Procedure Flow Chart
Applicant Entrust a China Responsibility Agent (CRA)
Note: CRA isn't a distributor of Applicant
China Responsibility Agent filing
Time: 1-2 weeks
2.Qualification certificate of applicant.
3.Quality and safety standards of raw materials
4.Formula research report
5.Production process specification
6.Product testing report
7.Evidentiary materials of the production, research and testing capabilities
8.Other materials to prove the scientificity and safety of the formula
The above is only part of application documents
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