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China CFDA Details Registered Infant Formula Label Change Requirements and Criteria

Dec 06, 2017
Yilia Ye
Certain changes to a label which deviate from the information provided during formula registration, will require prior application to CFDA.

On December 5, 2017, China CFDA released an announcement detailing conditions that require a label change application. Generally speaking, if there are changes relate to product formula within the registration validity period, manufacturers are obliged to apply for label change to CFDA; otherwise, they can update the label themselves based on relevant regulations.

Cases requiring application

Cases not requiring application

changes in:

changes in:

  • Product name

  • Enterprise name, production address

  • Ingredients list, nutrition facts

  • Allowable content claim

  • Registered trademark

  • Others involving consistency with formula registration

  • production date, expiration date, usage method, dosage, storage condition, notice, product tracing, alert, after-sales service

  • claims of raw materials’ origin, including lactogenesis, raw milk powder

  • content place (excluding trademark and product name) on principal display panel; content place on non-principal display panel

  • Trademark holders, agent, production license No. (registration No. of overseas manufacturer) , contact information (QR code, telephone, etc.)

  • color of certification mark, label

  • product specification (net content)

  • Others not involving consistency with formula registration

Manufacturers shall follow the procedures specified in article 26 of Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes to apply for label changes.

Tags : Chinese MainlandInfant FormulaLabeling
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