On March 13th, China Certification and Accreditation Commission (CNCA) issued an announcement about the registration extension for overseas  infant formula manufacture, which is estimated to create lots of challenges for oversea infant formula manufacturers.

1) Tight timeline for manufacturers to go through the extension registration process and lots of dossiers for CNCA to review

The regulation for oversea infant formula registration in CNCA was issued in 2014. It is estimated that about 40% of current approved manufacturers (about 100 manufactures from 19 countries) were approved at that time. Since the registration valid duration is 4 years. All of the manufactures approved in 2014 should submit extension registration dossiers by the end of 2018. Otherwise, it shall be not allowed to export infant formula to China.

2) Manufacturers are unable to reach the latest update from CNCA and hard to move forward

The one who got CNCA certificate has already experienced that it was impossible to control the CNCA registration process by manufacturer itself. Due to the process is more like a government to government communication process. It seems that the manufacturers can do nothing but just wait for the final approval announcement. Therefore, if the manufacture extension registration is not finished by the end of 4 years valid time, the formula will be forbidden to export to China even the formula registered by CFDA.

3) China’s food regulation structure will be adjusted soon and responsibility of each department will be re-defined.

On March 13th, 2018, the State Council institutional reform scheme was reviewed during the meeting. The reform scheme draft indicated that CNCA will be under the General Administration of Market Supervision and Management (will be newly established). Therefore, responsibility of each department will be re-defined, and the process will be not clear in a short time, which may be difficult and confused for enterprises to go through manufacture extension registration process.

Suggestions:

Foodmate suggests that infant formula manufactures registered in 2014 and 2015 should prepare and submit the extension registration dossier ASAP.