China Issues New Production Licensing Rules for Infant Formula Liquid Milk

China’s State Administration for Market Regulation (SAMR) has released new detailed rules governing the production licensing review of infant formula liquid milk, further strengthening regulatory oversight in China’s special foods sector. The announcement, issued on January 29, 2026, publishes the Detailed Rules for the Review of Production Licenses for Infant Formula Liquid Milk (hereinafter, the “new rules”)and took effect immediately upon release.

The new rules, formulated by the Department of Special Food Safety Supervision and Administration under SAMR, establish clearer and more standardized requirements for enterprises seeking to manufacture infant formula liquid milk in China. As a category subject to stringent supervision due to its direct impact on infant health and nutrition, infant formula products remain one of the most tightly regulated segments within China’s food industry.

The issuance of these detailed review rules signals continued efforts by Chinese regulators to refine licensing procedures, strengthen production controls, and enhance product safety standards in the infant nutrition market. For domestic producers and foreign-invested food manufacturers alike, the new framework underscores the importance of compliance readiness, facility standards, and quality management systems when entering or expanding within this highly sensitive sector.

Regulatory background

The issuance of the new rules is part of a broader regulatory push to enhance food safety governance in China’s special foods sectors, including infant nutrition products, pre-prepared meals, and live-streaming e-commerce food safety oversight.

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This reflects a shift from reactive enforcement toward preventive, standardized control mechanisms, consistent with recent amendments to the Food Safety Law and expanded product registration systems.

China’s regulatory framework for infant formula has evolved into one of the most demanding food safety regimes globally, grounded in the new rules. Historically, infant formula powder (the dominant product format) has been subject to rigorous registration and licensing controls, requiring manufacturers to register product formulas with the SAMR and comply with strict production and quality requirements.

See also: Key Regulatory Developments in China’s F&B Sector: Implications for Industry Stakeholders

In 2025, the regulatory landscape broadened to encompass infant formula liquid milk (in Chinese, 婴幼儿配方液态乳), reflecting a strategic shift toward expanded oversight of product types beyond traditional powdered formulas. A significant amendment to the Food Safety Law (hereinafter, the “amended law”)adopted by China’s National People’s Congress Standing Committee in September 2025 formally brought infant formula liquid milk into the national registration management system, a framework previously applied only to powdered formula products.

Under the amended law, effective from December 1, 2025, liquid infant formula must be registered in the same way as powdered formula, and manufacturers are required to adhere to registered formulas and technical standards in production. This legal change also prohibits production through sub-packaging and aligns transportation controls for liquid foods under enhanced safety oversight.

Before these developments, infant formula liquid milk existed largely on the periphery of China’s regulatory system, with a relatively low market share compared with powdered formula. However, growing consumer demand for ready-to-feed products, combined with safety considerations linked to the higher microbiological risks of liquid formats, prompted regulators to incorporate liquid products into formal safety and licensing regimes. Integrating liquid formula into the established formula registration and licensing structure brings clarity to compliance expectations and closes a regulatory gap that had previously complicated market entry and oversight.

The new rules build directly on this legal foundation by specifying how licensing authorities should assess facility standards, quality control systems, and production capabilities for liquid formula manufacturers. Together with the amended Food Safety Law and related registration requirements, these measures mark a major milestone in China’s systematic strengthening of special food supervision.

Scope of the new detailed rules

The new rules apply specifically to the production licensing review processes for infant formula liquid milk in China. These rules are designed to guide market supervision authorities in assessing applications for initial production licenses, changes to existing licenses, and license renewals for manufacturers of this product category.

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Under the new rules, infant formula liquid milk is defined as a liquid infant formula food product made primarily from cow’s or goat’s milk and milk protein ingredients, supplemented with vitamins, minerals, and other approved raw materials, and produced solely through physical processing methods for consumption by infants aged zero to thirty-six months. The definition also establishes three age-based product categories: formula for infants aged 0–6 months (stage 1), older infants aged 6–12 months (stage 2), and young children aged 12–36 months (stage 3).

The rules are targeted at domestic production facilities that seek to obtain or modify a production license for infant formula liquid milk. While imported infant formula liquid milk products are not subject to China’s domestic production licensing regime, they remain subject to other regulatory requirements, including China’s formula registration system and import supervision administered by customs authorities and SAMR’s formula evaluation body.

By clarifying the product definition and delineating the licensing review scope, the rules bring greater regulatory certainty for enterprises planning to enter or scale up in the infant formula liquid milk segment, an area that, until recently, has lacked detailed regulatory guidance compared with the well-established licensing framework for infant formula powder products.

Key requirements under the new licensing review measures

The new rules set forth detailed criteria that enterprises must meet to qualify for a production license for infant formula liquid milk, with a strong emphasis on safety, hygiene, and production integrity. Key elements include:

Production facility standards and full-process capability

Manufacturers must operate complete wet-process production lines capable of receiving raw milk, formulating the product, homogenization, sterilization, filling, and post-production handling.

Merely having packaging facilities, partial equipment, or packaging operations without full production capability is not sufficient for licensing.

Compliance with good manufacturing practices (GMP) and HACCP systems

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Firms must implement the Good Manufacturing Practices for Infant Formula Foods and a Hazard Analysis and Critical Control Points (HACCP) system. This includes: documented risk analysis, defined critical control points, and consistent application of quality management standards across all production stages.

Prohibitions on collateral production models
The rules expressly prohibit several practices that could compromise product safety or traceability:

• Contract manufacturing and simple repackaging arrangements are not permitted. Production must be conducted under the licensee’s direct operational control.
• A single enterprise may not use the same formula to produce and market different brands of infant formula liquid milk, reinforcing product differentiation and accountability.
• Manufacturers may not produce liquid formula by reconstituting powdered formula or formula bases; liquid products must be produced through fresh or processed liquid milk workflows.

Defined product characteristics and controls

While the public text of the rules does not list all specific testing and quality protocols, the overarching requirement for HACCP implementation implies effective systems for:

• In-house or third-party quality testing, including microbiological and compositional checks;
• Traceability and batch-level documentation;
• Raw material approval and ongoing supplier management; and
• Alignment between registered formula specifications and actual production outputs.

This reflects how China’s broader formula product regulation, such as formula registration and product specification requirements that took effect with liquid formula registration starting December 1, 2025, interacts with licensing review expectations.

Implementation and transitional arrangements

Although the rules apply from the date of publication, regulators have concurrently updated related frameworks, such as formula registration procedures for liquid infant formula, which began on December 1, 2025. Companies already operating in the infant formula liquid milk space should closely assess how the new licensing criteria interact with registration obligations and compliance timelines.

Implications for industry stakeholders

Domestic dairy and infant formula producers

Domestic manufacturers may need to invest in facility upgrades, enhance quality systems, and align production processes with the new licensing criteria. These changes could lead to increased compliance costs but also improve overall product quality and regulatory certainty.

Foreign-invested food manufacturers in China

Foreign food producers planning to enter the liquid infant formula market will now face clearly defined production licensing pathways. Aligning product formulas, production capabilities, and quality systems with China’s specific standards will be essential prior to filing for licenses and registrations. However, successful compliance could enhance credibility in a high-value, high-trust market segment.

Market outlook

The introduction of these licensing review measures is likely to strengthen consumer confidence in domestically produced liquid infant formula products and promote industry consolidation. Aligning regulatory requirements across powdered and liquid formula products also supports China’s broader strategy of tightening oversight in special foods and protecting infant health.

Conclusion

The newly issued licensing review measures formalize and standardize approval criteria for infant formula liquid milk production in China, offering both clarity and predictability for regulators and enterprises. Manufacturers and investors seeking to operate or expand in this sensitive segment must carefully evaluate facility readiness, compliance systems, and alignment with China’s evolving regulatory framework before applying for production licenses.

This regulatory evolution underscores China’s continued commitment to strengthening infant food safety and supporting high-quality industry development.