Takehome:
The requirements for infant formula base powder production have been clarified. Stipulations relating to companies that manufacture both infant formula and base powders (e.g whey protein concentrates) for the Chinese market have also been clarified. Additionally requirements relating to production license have been detailed.
On Dec. 2, 2016, China CFDA released “Notice on Further Strengthening the Supervision of Infant Formula”, which clarifies the requirements on infant formula base powder and change of production license.
Requirements for infant formula base powder:
Under the new notice infant formula manufacturers could use the base powder produced from domestic or overseas production facilities which are part of the company or group. Under these circumstances, a full-item batch by batch inspection should be conducted by the infant formula manufacturers to guarantee the safety of the base powder.
In situations where an infant formula manufacturer use the base powder produced from domestic or overseas production facilities which are part of the company or group, CFDA will place special emphasis on inspecting the production license or permission extension of the infant formula manufacturers. The production license of “infant formula (dry-wet composite processes)” will be issued for qualified manufacturers, and a designation of “dry process” will be assigned in the second sheet of the production license.
Requirements for change of infant formula production license:
The “Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes” were implemented in Oct. 1, 2016 with a grace period until until Jan. 1, 2018. In cases where the production license for infant formula manufacturers was obtained before Oct. 1, 2016 and will expire before Jan. 1, 2018, a change of production license in accordance with “Administrative Measures for Food Production License” (see CL report on Sep. 2, 2015) can be applied for. In cases were the production license will expire after Jan. 1, 2018, infant formula recipe registration certificate should be provided during the application for change of production license.
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