Takehome:
Agrana Stärke GmbH, a CNCA-approved infant formula manufacturer in Austria, has had its export accreditation revoked and is banned from exporting IF products to China. It’s the first case where CNCA has revoked a registered manufacturer China accreditation.
Registration of overseas dairy manufacturers with CNCA has been implemented for over 2 years. Since the promulgation of this requirement 73 foreign infant formula manufacturers have successfully passed CNCA registration. However, according to a CNCA update on 16 May CNCA the following suspension notice has been issued.
The main reason for this punishment is that Hei Longjiang FDA found one batch of Holle organic infant formula produced by this manufacturer contained enterobacter sakazakii during a spot check. This is not compliant with the Chinese national standard. A few days later, the official website of Holle published a statement that they have sent the sample of the same batch to three labs. All results show the product is fully qualified. No matter which result is more reliable, CNCA has already sanctioned the manufacturer. Imports of IF products from this manufacturer are no longer allowed during the suspension period.
As outlined in the China 2016 Food Supervision Focus, infant formula products as a product type under special control will receive full inspection. That means CFDA and various local FDAs will initiate rounds of random checks on infant formula available on the Chinese market. Overseas approved manufacturers should maintain good manufacturing practices and ensure product quality and compliance.