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China Infant Formula: CFDA Drafts Provisions for Labeling and Stability Research for Infant Formula Recipe Registration

  •   7 Feb 2017
  •    Rachel Shen

    Takehome:

    • Two supplementary documents for infant formula registration relating to labeling and stability research have been released for public consultation.

    On Jan. 26, 2017, China CFDA released two supplementary documents pertaining to infant formula recipe registration, namely “Technical Guidance for Labeling of Infant Formula Recipe Registration” and “Technical Guidance for Stability Research of Infant Formula Recipe Registration”. The period for public consultation will end Feb. 20, 2017.

    The requirements on contents and format of infant formula labeling as well as the prohibited labeling items have been detailed in the draft regulation. As required in “Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial)”, stability research results of all infant formula packaging specifications should be included into the product R&D report and submitted to CFDA during the registration application to prove the scientificity and safety of the formula. The research method mainly includes influencing factor trial, acceleration trial and long-term trial.

    Reference link

    China CFDA Draft Regulation

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