China’s New Food Regulatory Authority Planning More Stringent Application of Infant Formula Registration Standard

On Apr. 10, 2018, State Administration for Market Regulation made its first major announcement detailing its supervision plan of foods, drugs and etc. Currently, previous requirements are still being used by authorities to assess infant formula registration. It is expected that the latest list of manufacturers and corresponding products granted approval will be announced soon.

However, the resumption of assessment of formula registration dossiers etc. under the new department will mean more stringent application of regulatory standards and a higher product approval threshold. Liu Xuecong, secretary general of China Nutrition and Health Food Association, said more stringent formula registration standards will be imposed on infant formula manufacturers after the institutional restructuring. Our own technical experts here at REACH2h have confirmed this fact, revealing that the competent authority is now stricter in terms of its application material requirements. (For more detailed information on practical requirements please contact the food technical division at REACH24h).

By Feb. 23, 2018, 102 domestic infant formula manufacturers with 864 formulae have been granted approval (check all in our Flist), and 274 formulae from 46 overseas manufacturers were approved. Looking at the number of China government accredited infant formula manufacturers (104 domestic plants, 94 overseas plants), we can see that most of the Chinese enterprises have completed formula registration, while overseas manufacturers seem to be struggling with regulatory compliance requirements.