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Chinese authorities have recently identified that a significant number of infant formula powder labels are in violation of food safety laws and regulations. This finding has been identified during routine food safety inspections done by local food and drug regulatory authorities. Key incompliances identified include product name, label content, ingredient content and function claims.

In order to further standardize the infant formula label, set solid foundation for the registration of infant formulas and safeguard public safety, Chinese Food and Drug Authority has issues a notice stating its intention to carry out additional inspections regarding compliance of labels on infant formula products.

Inspection timeline

The notice was released on December 7, 2016. In accordance with the notice, local manufacturers and importers of infant formula milk powder shall conduct self-assessment 3 months following the publication of the notice; they are also requested to submit a self-assessment report to local FDA 15 days following the completion of the self-assessment.  Local FDA shall submit the inspection report to central office of FDA before June 30, 2017.

Laws & regulations applicable to infant formula

  • Food safety law
  • Dairy quality safety supervision management regulation (State council Order No. 536)
  • Food label management rules (AQSIQ Order Year 2009 No.123)
  • Measures for the Registration of Infant formula Recipes (CFDA Decree No.26) and its related documents
  • GB 7718-2011 General Rules for the Labeling of Prepackaged Foods
  • GB 28050-2011 General Rules for Nutrition Labeling of Prepackaged Foods
  • GB 13432-2013 Labelling of Pre-packaged Foods for Special Dietary Uses
  • GB 10765-2010 Infant formula
  • GB 10767-2010 Elder infants and young children formula

What will the inspections cover?

  • Product name: The label should be true and accurate, without using font size or color to mislead consumers.
  • Source of raw materials: vague sayings like “imported milk source”, “originated from foreign meadow”, “ecological meadow” is prohibited.
  • Ingredient list and nutrition content table: The labelling should be in accordance with GB13432-2013 and other relevant requirements for labeling.
  • Labeling content: Infant formula powder label shall state food manufacture license number and other necessary information;
  • Content claim: Claims like “zero added”, “does not contain” shall not be labeled to materials which according to food safety standards shall not be contained in product formula.
  • Function claim: Label shall not express or implies product have functions like develop intelligence, enhance resistance or immunity, protect intestinal tract.
  • Exaggerate, misleading or other unconfirmed aspects.
  • Label shall not use “human milk equivalent”, “breast milk equivalent” or other similar terms.

Useful links

More info on the CFDA notice can be found here (in Chinese).

Posted by Annie He on Dec 16, 2016

Regulatory and Scientific Affairs Specialist

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