Infant Formula: New Registration Guidelines Will Enter into Force in October 2023

On 10 July 2023, SAMR released the revised Administrative Measures of Product Formulation Registration of Infant Formula Milk Powder, which will enter into force on 1 October 2023. Compared with the previous version illustrated in the EU SME Centre report on China’s Dairy Sector, these revised guidelines will:

• Expand the legal basis for rejecting the registration of infant formula products, e.g. when the application materials submitted are untrue or fraudulent, when the scientific and safety basis of the product formula is deemed as not sufficient, or when the applicant is considered not to have the R&D, production or supervision capabilities necessary for ensuring the product quality and safety. 
  
• Expand, from 6 to 9, the elements that cannot be specified on product labels and instructions, such as the use of vague and fuzzy statements including “imported milk source”, “derived from foreign pastures”, “ecological pasture”, “imported raw materials”, “original ecological milk source”, “pollution-free milk source”, etc. Images of babies and women cannot be used, together with wording such as “human emulsification” or “mother emulsification”. 
  
• Include cases in which on-site inspection of production establishments may be required, including in case of major changes in the product formula, in the address of the production facility, or in any case further verification is required by the technical evaluators. 

Click here to access the revised measures in Chinese on SAMR’s website.