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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 registration
The 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.
1 | The scientific and safety basis of the recipe is insufficient. |
2 | The 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 requirements
The 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 inspection
The 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.
1 | There is a change in the actual production address. |
2 | The applicant has concealed the true situation or provided false materials in previous registration applications. |
Significant revisions in optimizing the business environment
The 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.
Changes to the punishment regulations
The new version strengthens punishment for illegal activities that cause harm, such as increasing the maximum fine to 200,000 yuan for applicants who obtain registration certificates through deception, bribery, or other improper means that result in harmful consequences.
It reduces the punishment for minor violations. Applicants who fail to apply for changes in matters that do not affect the scientificness and safety of the product formula shall be ordered to make corrections within a specified time limit. Instead of a fine between 10,000 and 30,000 yuan, failure to do so will result in a fine ranging from 1,000 to 10,000 yuan.
Other noteworthy changes
Enterprises that submit alteration applications shall submit a justification report on the recipe alteration.
The new version refines the procedures, such as adding the process that should be followed if the applicant withdraws the recipe application for infant formula milk powder.
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