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SAMR | Announcement on Matters Concerning the Product Formula Registration of Infant Formula Milk Powder


"National Food Safety Standard, Infant Formula" (GB 10765-2021), "National Food Safety Standard, Older Infant Formula" (GB 10766-2021) and "National Food Safety Standard, Young Children Formula" (GB 10767-2021) (hereinafter referred to as the new national standards) was released on March 22, 2021 and will be implemented on March 22, 2023. In order to do a good job in the product formula registration of infant formula milk powder after the issuance of the new national standard, the announcement regarding registration related matters is as follows:

1. From the date of the issuance of the new national standards, the applicant can apply for product formula registration (including change and renewal) according to the new national standard. After obtaining the registration, it can organize production according to the new national standard. From the date of implementation of the new national standards, producers should organize production according to the product formula registered in accordance with the new national standards. The products, produced according to the "National Food Safety Standard, Infant Formula" (GB 10765-2010) and "National Food Safety Standards, Older Infants and Young Children Formula" (GB 10767-2010), can be sold until the end of the shelf life.

2. For product formulas that has been registered, if the applicant adjusts the formula according to the new national standards, in principle, it shall be processed as change registration. If the applicant adjusts the types of formula raw materials (including food additives) and the nutrient composition table at the same time, which essentially constitutes a new product formula, the products should be handled as applying for the registration of the new formula and the original formula will be cancelled.

3. For product formulas that have been registered, applicants, who apply for registration according to the new national standards (including changes and renewals), should follow the "Application Materials and Requirements on Product Formula Registration of Infant and Young Children Formula Milk Powder (Trial) (2017 Revised Edition)" to submit the materials. Materials that have not changed will not be resubmitted. In the product formula research and development demonstration report, the research and development demonstration status of the formulation adjustment and the difference before and after the adjustment shall be explained in detail.

4. The applicant should submit research materials on the shelf-life stability of the product. Stability research should combine the physical and chemical properties of food raw materials (including food additives), product formula, process conditions and packaging materials. For details, please refer to the "Guidelines for Stability Research of Infant Formula Milk Powder (Trial)" (see attachments) to ensure product quality and safety.

Special announcement.

 
Attachment: Guidelines for Stability Research of Infant Formula Milk Powder Products (Trial)

State Administration for Market Regulation

March 24, 2021
 


Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net

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