Take home
- China CNCA has reinstated the China infant formula export accreditation of NUTRIBIO, a French infant formula manufacturer which had their registration suspended since 1 Jun 2016 due to non-compliant level of vitamin A.
Early in May this year, one batch of infant formula made by NUTRIBIO was tested by Heilongjiang FDA against China’s national food safety standard. The concentration of vitamin A was lower than Chinese national standard (see CL Food News on 2 Jun 2016). The registration of NUTRIBIO was then revoked temporarily starting on 1 Jun which meant it was not allowed to export infant formula products to China until the ban was lifted.
After the issue occurred, CNCA initiated re-audit of this manufacturer by notifying the French competent authority of investigations on the factory’s capacity to meet registration requirements and implement adequate risk identification and prevention measures.
According to the feedback from the French competent authority, NUTRIBIO has probed into the cause by analyzing the source of raw materials, production process control, packaging, product storage condition and test methods and rectified the problem after self-check.
The authority further confirmed that NUTRIBIO can in future guarantee that the level of vitamin A will be in conformity with China’s national standard. It has optimized its production and formulation process and will use metal cans which are better at maintaining vitamin A levels and will also label the product storage condition on the can. On 18 July, CNCA announced that NUTRIBIO exports to China are permitted again.
Since 1 May 2014, CNCA has conducted stringent audit of overseas infant formula manufacturers and will also strengthen post-registration surveillance. Registered companies are faced with stringent pre-market entry inspection by CIQ and frequent post-market spot-checks by local FDAs. So far, 74 infant formula manufacturers from 18 countries have been approved by CNCA.
Reference Link
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
