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
II.Infant Formula CFDA Registration Timeline:
Application documents prepare
Product Initial Testing
on the Lab.
1- 6 months
on the Lab.
approval & issue certificate:
III.Infant Formula CFDA Registration Cost: