On July 10, 2023, State Administration for Market Regulation (SAMR) unveiled the updated Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes, replacing the 2016 version. Major revisions include the definition of situations not approved for registration, labels, on-site inspection requirements, and measures to optimize business environment. The new version will come into force on October 1, 2023.Situations not allowed for registrationThe updated version clearly prohibits using the compound of raw materials in a disguised form and defines 8 other situations that are not approved for registration.It is not allowed to apply for the registration of formula whose raw materials are compound ingredients that have already met the national safety and nutritional requirements for infant formula.The new version defines 8 more situations that are not allowed for registration. Examples of the situations are shown in the table below.1The scientific and safety basis of the recipe is insufficient.2The recipe applied for registration by the same enterprise does not differ significantly from the recipe of the same age group that have already been registered.Updated labeling requirementsThe updated version specifies the requirements for including animal-derived terms in product names, and adjusts prohibitive requirements on labels and instructions.If a product name includes animal-derived terms, all sources of milk protein, such as raw milk, milk powder, and whey powder, should come from that species.The list of prohibited information on labels or instructions has been expanded from six to nine. For instance, vague information such as “original ecological milk source” or “non-polluted milk source'” must not be used.Clarified requirements for on-site inspectionThe new version specifies situations where an on-site inspection should be conducted.On-site inspections should occur when significant changes are made to the GB standards for infant formula and when applicants apply for registration or modification of product recipes.However, if the applicant has obtained administrative approval for all three product recipes in the same series after the GB standards change, on-site inspection may not be required for other series of product formulas with the same production process.The new version clarifies 7 more situations where an onsite inspection should be conducted. Examples of the situations are shown in the table below.1There is a change in the actual production address.2The applicant has concealed the true situation or provided false materials in previous registration applications.Significant revisions in optimizing the business environmentThe new version responds to the industry development trend and make important changes in optimizing the business environment.If a group company has an independent R&D organization, its controlled subsidiaries can share some of the group's R&D capabilities when they apply for registration. This is a change from the previous requirement that subsidiaries had to have their own R&D capabilities in their factories.When a parent company or its controlled subsidiary company within a group company has already obtained a registration certificate and production license for infant formula milk powder products, the parent company or its controlled subsidiary company may use the infant formula recipe registered by other subsidiary companies or the parent company within the same group company. Previously, only wholly-owned subsidiaries were allowed to use the formula interchangeably.The authority's processing time limits are shortened. For instance, the inspection time limit is reduced from 30 working days to 20 days. (ICE PECHINO)

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