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. H ow 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

Requirements	Details
In terms of raw materials and excipients
Compound food additives and food additive preparations	The difference between compound food additives and food additives preparations.
	Compliance, functional components and safety indicators control.
Proportion of whey protein in protein content	Stage 1 products are required to be presented using both testing and calculation methods.
	Stage 2 products can either choose the testing or the calculation methods.
Base powder	Commercialized production process (main production steps, work area division, and critical control points).
	The quality safety standards for the raw materials and excipients used in the base powder.
	Full-item inspection report of the base powder and conformity assessment with the National Standards for Infant Formula.
Product labeling for animal source (Sheep)	Control indicators and test reports for sheep-origin components in milk protein raw materials sourced from sheep.
	Provide control measures to ensure that raw milk or milk powder is sourced from sheep milk.
Active probiotics	Source of the active probiotics raw materials.
	The strain identification report shall be accurate to the strain level.
	Preventive and control measures for potential contamination of the product with miscellaneous bacteria due to the use of active probiotics.
Hydrolyzed protein	Manufacturers
	Source of the raw materials used for producing hydrolyzed protein.
	The conformity of enzyme for hydrolysis purposes with GB 2760.
	The controllability of the degree of hydrolysis of hydrolyzed proteins, safety, and control measures.
In terms of formula R&D
Rationale for adjustments to the formula composition and dosage, nutrition facts, and ingredients	Clarify the details of  the adjustments
	Explain the reasons for adjustments, including changes in the types of raw materials and excipients, dosages, and label value indications.
The basis for determining label indicated value	Taking raw material variability, nutrient enhancement levels, production process losses and shelf life degradation into consideration.
	Data support, conformity determination and necessary control measures.
Formula requirements for using base powder	The nutrient content range in the internal control standards for base powder.
	The necessity of adding nutrients besides the base powder.
Formula differentiation (when the same enterprise applies for two or more product formulas for the same age group)	There should be significant differences between the product formulas, which should be scientifically verified, such as in macro-nutritional components, optional components, and cow/sheep milk powder raw materials.
Product stability research	Sampling times and testing times shall reflect the trend of changes in stability test data.
	The testing methods and testing agencies for the same project at different time points must be consistent.
	Projects with significant attenuation, analysis of the causes of abnormal data, and control measures.
In terms of the production process
Information on the input of raw materials and excipients for commercial production	The quantities, batch numbers, dates and sample batch numbers of each raw material and excipient during the trial production.
	Theoretical yield, actual yield, material balance accounting, etc.
Sample consistency	Sample consistency analysis indicators.
	Validation of sample consistency in dry mixing using base powder (or semi-finished products produced by wet processes), etc.
Process stability	Stability analysis among different batches.
	Stability analysis of the process parameters for the main production procedures.
Nutritional components compliance	Analysis of the compliance of nutrient components in at least one batch of trial production samples to determine adherence to label/standard requirements.
In terms of risk materials prevention and control
Chlorate, perchlorate and chloropropanol ester	Limit requirements, control measures for raw materials and finished products, and the frequency of regular testing.
	Quality management documents or mechanisms and their execution.
	Inspection requirements
Plasticizer	Plasticizer risk analysis and relevant control measures.
	The plasticizer test report for the commercial trial production samples.

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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