New Standards for FSMP Infant Formula in China: Key Compliance Deadlines and Registration Guidance

China has officially introduced a new mandatory national standard for foods for special medical purposes (FSMP) for infants—GB 25596-2025 Food Safety National Standard: General Rules for FSMP Infant Formula (the “new standard” or “new GB standard”). Set to take effect on March 16, 2027, this new standard will replace the current 2010 version (GB 25596-2010).

Under China’s strict FSMP regulatory system, products must be individually registered before entering the market. This means that during the upcoming two-year transition period, all FSMP infant formula products holding existing registrations must reapply for approval under the new standard to continue manufacturing and selling after the new rules take effect. The transition demands extensive efforts from businesses, including product R&D updates, production adjustments, compliance testing, regulatory filings, and packaging redesigns.

On April 23, 2025, the State Administration for Market Regulation (SAMR) released a Q&A document offering critical guidance on how companies should handle registration renewals and changes under the new FSMP framework. This article summarizes the key takeaways foreign businesses need to know for compliance.

What is FSMP infant formula?

FSMP infant formula refers to specially formulated products designed to meet the unique nutritional needs of infants (0 to 12 months old) who experience feeding restrictions, digestive and absorption disorders, metabolic imbalances, or specific disease conditions. Given their medical importance, FSMP infant formula products are subject to stricter supervision than regular infant formula and other general food categories.

Key changes under China’s new FSMP infant formula standard (GB 25596-2025)

The new FSMP infant formula standard (GB 25596-2025) introduces important updates in ingredient requirements, product categories, and labeling rules, reflecting the latest scientific understanding of infant nutrition. Companies must carefully assess these changes to ensure timely compliance.

Adjustments to essential and optional ingredients

Choline has been reclassified from an optional ingredient to a mandatory component for FSMP infant formulas, emphasizing its critical role in infant development.
Building on the previous ban on fructose as a carbohydrate source, the new standard also prohibits the addition of sucrose, aligning with updated global nutrition guidelines to minimize unnecessary sugar intake for infants.

Expansion of product categories

Previously, FSMP infant formulas were mainly categorized under formulations such as amino acid metabolism disorder formulas and formulas for preterm or low birthweight infants. The new standard expands the list to include six additional specialized categories:

Ketogenic formulas
Anti-reflux formulas
Fat metabolism disorder formulas
High-energy formulas
Protein modular components
Medium-chain triglyceride (MCT) modular components

This expansion allows for a broader range of clinically targeted nutritional products to better serve infants with specific medical needs.

New labeling requirements

The updated standard introduces clearer and more detailed labeling requirements to improve clinical use and consumer guidance:

Anti-reflux formulas must display specific mandatory label information regarding their intended use.
The requirement to declare osmolarity, previously applied to certain FSMP products, is now extended to all categories of FSMP infant formulas.

These enhanced labeling rules help healthcare professionals and clinical nutritionists quickly identify product features and make more informed recommendations to caregivers and consumers.

How to implement FSMP registration under the new standards

When can companies submit FSMP registration applications under the new standards?

Companies are allowed to submit FSMP registration (including change applications) in accordance with the new standards immediately after their release. Once the registration is approved, production must comply with the updated product formulas, manufacturing processes, and technical requirements defined under the new standards.

Important deadlines:

Before the new standards take effect: Companies may continue selling products manufactured according to the previous 2010 standard (GB 25596-2010) until the product’s expiry date.
After the new standards take effect: All production must comply with the technical specifications outlined in the new standards.

Companies are strongly encouraged to develop a detailed project timeline and start the re-registration process as early as possible. Key workstreams include formula research and adjustment, production process updates, product testing, regulatory submission, and packaging label redesign. External steps such as testing and submission can be time-consuming. Therefore, it is advisable to reserve at least six to 10 months specifically for regulatory review and approval before the new standards come into force.

How to determine if a change is a product amendment or a new product registration?

When applying for registration under the new standards:

If a company only adjusts the product formula to align with the new standards, this will generally be treated as a change registration.
If both the product formula and manufacturing process are adjusted, resulting in a substantively different product, the company must cancel the old product registration and apply for new product registration.

Businesses should carefully evaluate the gap between their existing product formulation and the requirements of the New GB Standards. They should decide whether to perform minimal adaptive adjustments to complete a faster change registration or take the opportunity to upgrade the product comprehensively and apply for new product registration. Regardless of the path chosen, companies must strictly follow the official procedures to ensure that both the product and submission materials meet the regulatory requirements.

What application materials are required under the new FSMP standards?

For products already registered under the previous standard, companies submitting for change or re-registration must prepare materials according to the 2017 revised version of the Special Medical Purpose Formula Food Registration Application Materials and Requirements (Trial).

To be noted:

Materials that remain unchanged from the original application do not need to be resubmitted, but their status must be clearly explained in the new submission.
The product development report must detail the research, scientific basis, and justification for any adjustments to the product formula or production process. It must also compare the new version of the product to the old version to highlight differences.

When preparing the R&D report, companies should clearly and specifically explain the necessity and scientific rationale for all changes made. Vague or unsupported statements may lead to additional inquiries or delays in the approval process.

Is stability study data required for registration under the new FSMP standards?

Yes. Applicants must conduct a stability study in accordance with the Special Medical Purpose Formula Food Stability Study Requirements (Trial) – 2017 Revision. Full records of stability studies must be properly maintained and made available for inspection if requested by the regulatory authorities.

Although companies are generally not required to submit the complete stability study report during the initial application, it is recommended to briefly describe the stability testing activities, including testing timelines and results, within the application documents. Providing such information may positively influence the approval process.

Are production site inspections and product sampling required?

The requirement for production site inspections and product sampling will depend on food safety risk assessments conducted by the review authority:

For products that only adjust formulas in line with the new standards without substantial changes to production processes, site inspections and sampling are generally not required.
For products that involve significant process changes or are subject to heightened scrutiny due to past compliance issues, inspections and sampling may still be initiated.

Companies must ensure that their submitted materials are truthful, accurate, and fully consistent with on-site operations. If a company is introducing a substantively new product or has a history of non-compliance or customer complaints, it should be fully prepared for potential site inspections and product sampling activities as part of the regulatory review.

FAQ: New FSMP Infant Formula Registration in China

Q1: When do the new FSMP standards officially take effect?

The new standards are effective from the date of their official implementation. Until then, products produced under the 2010 standards (GB 25596-2010) can continue to be sold until they expire.

Q2: If only minor formula adjustments are made, is a new registration necessary?

No. If only the formula is adjusted to align with the new standards (without significant process changes), a change registration is sufficient.

Q3: What happens if the manufacturing process also changes?

If both the formula and manufacturing process change significantly, companies must cancel the old registration and apply for a new product registration.

Q4: Are stability studies mandatory even if the formula change is minimal?

Yes. All products registered under the new FSMP standards require a stability study according to the 2017 revised guidelines.

Q5: Will every application require a production site inspection?

Not necessarily. If no major changes are made to the manufacturing process, site inspections and product sampling are generally waived, but authorities may still request them based on food safety risk assessments.

How can businesses prepare for the new FSMP standards?

The transition to the new FSMP national standards marks a critical compliance milestone for companies involved in China’s specialized infant formula market. Timely adjustment of registration documents, manufacturing processes, and stability testing protocols will be essential for maintaining market access. Foreign-invested enterprises should closely monitor application deadlines, regulatory expectations, and potential food safety reviews to ensure a smooth transition under the new framework.

Quick compliance checklist for FSMP manufacturers and sellers

Submit change or new registration applications under the new FSMP standards immediately if ready.
Align product formula and production processes with the technical specifications of the new standards.
Prepare updated documentation according to the 2017 revised registration material requirements.
Clearly describe research and development differences between old and new formulations.
Conduct and maintain stability study records even if changes are minimal.
Prepare for potential production site inspections or sampling if requested.
Sell out inventory produced under GB 25596-2010 before product expiration.

The implementation of the new FSMP standards is not just a regulatory update — it is also a major reshuffling of commercial opportunities in the industry. Businesses should treat this transition period as a strategic window. By securing registration under the new standards earlier than competitors, companies can gain a valuable first-mover advantage in the market.