Strategies for Enterprises in Response to New Infant Formula Registration Regulations in China

The Administrative Measures for the Registration of Infant Formula Products (hereinafter referred to as the Administrative Measures) was revised and issued on July 10, 2023, and came into effect on October 1, 2023. Following the implementation of the new national standards, the new registration regulations have further tightened the requirements for infant formula registration. How should enterprises make adjustments to cope with the new circumstances?

1. Major revisions to the Administrative Measures

Tighten formula registration and refine inspection requirements

1) Specify the circumstances and requirements for carrying out on-site inspection and, when necessary, extended inspections shall be conducted on raw material manufacturers;

2) Clarify the principle of dynamic production sampling inspection. The variety of dynamic production samples for sampling inspection is determined based on risk. For instance, within the same series of three products, select the formula that is relatively complex and representative for sampling; and

3) Specify 8 scenarios where registration will not be granted.

Further standardize labeling to protect consumers’ rights and interests

1) Three new prohibitions have been introduced regarding what labels and instructions must not contain: the use of ambiguous information such as “imported milk source”, “sourced from foreign pastures”, “ecological ranch”, “imported ingredients”, “pristine milk source”, “pollution-free milk source”, etc., is not permitted; the depiction or use of infants and women, as well as the phrases such as “humanized”, “breast milk-like” or other similar terms, is prohibited; they must not contain any other content that does not comply with laws, rules and regulations, and national food safety standards. This includes any explicit or implied health claims associated with the product; and

2) It is specified that if the product name contains terms indicating an animal origin, all sources of raw milk, milk powder, whey powder, and other whey proteins shall be derived from that particular species.

Encourage research and development to facilitate the business environment

1) The industry is encouraged to engage in formula research and development and innovation of infant formula products, optimizing formulations in line with the latest findings in human milk research to enhance the quality of infant formula;

2) Fundamental research activities are supported. For corporate groups possessing independent R&D institutions, it is permissible for holding subsidiaries to act as applicants and share a collective portion of R&D capabilities. This includes research into human milk nutritional components, clinical application outcomes, and certain aspects of R&D design;

3) Corporate responsibility shall be duly implemented, allowing for the exchange and utilization of formulas among the parent company and its holding subsidiaries;

4) Reduce the processing time limits. The time frames for testing and issuance of replacement certificates are to be shortened to 20 and 10 working days, respectively; and

5) The legal validity of electronic certificates is strengthened and the details specified in the registration certificates are simplified for clarity and efficiency.

2. Major revisions to the new National Food Safety Standards for Infant Formulas

• The standards for follow-on formula are being aligned more closely with those for infant formula;
• Changes to the maximum limits for nutrient content;
• Components that were previously optional are now considered essential; and
• New requirements for raw materials have been added.

3. Strategic responses for infant formula enterprises

Available options

Under the provision that the validity period of infant formula registration certificates is five years, enterprises that secured their registrations in 2017 will need to reapply. With the introduction of the new national standards and the new Administrative Measures, infant formula enterprises have the following options:

Apply for a new formula

Companies may develop new formulas according to the requirements of the new national standards and submit these for registration. The previous formulas will be deemed expired and automatically canceled.

Substantive formula changes

For products that have already been registered, if companies adjust the formula according to the new national standards—such as adding choline to Stage 1 products, and adding choline, selenium, manganese, and adjusting the compound sources of vitamins and minerals, and the functional components content of food additive preparations—they may proceed with the registration change process.

Cancel the original formula and apply for a new one

If a company intends to add or remove optional components from a product formula that has been registered, it can cancel the original formula and apply for registration of a new formula. It is important to note that when it comes to three types of raw materials—dietary fibers, nucleotides, and strains that can be used in infants and young children food—this approach is only applicable when adding or removing a certain category of raw materials. In such cases, the company should handle it as a cancellation of the original formula and proceed with the registration of a new formula.

Key technical issues that enterprises should pay attention to

The new Administrative Measures, from a legislative perspective, further tighten formula registration, optimize the approval process, promote formula research and development, and encourage corporate innovation. Higher requirements are set for the R&D, production, and testing capabilities of enterprises. This is conducive to raising the entry threshold, improving product quality, and making proactive adjustments by enterprises, thus facilitating long-term development.

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