China NMPA Incorporates 18 Revised Cosmetics Standards Into 2015 Technical Framework

On January 12, 2026, China’s National Medical Products Administration (NMPA) issued “Announcement No. 6 of 2026,” formally incorporating 18 standards development and revision projects — including the “Total Bacterial Colony Count Limits in Eye Cosmetics, Lip Cosmetics, and Children’s Cosmetics” — into the “Safety and Technical Standards for Cosmetics (2015 Edition).” The measures introduce phased implementation dates of January 1, 2027, and January 1, 2028, representing another material tightening of China cosmetics regulation.

At a policy level, the 18 revisions pursue two core regulatory objectives: tightening controls over higher-risk categories and substances, and standardizing oversight by clarifying previously under-defined requirements. These objectives are most immediately visible in the area of microbiological safety.

Strengthened Microbiological Requirements for High-Risk Categories

One of the most consequential updates is the introduction of differentiated microbial limits for eye cosmetics, lip cosmetics, and children’s cosmetics.

Separate Microbial Limits for Sensitive Product Categories

Previously, unified microbiological limits applied broadly to general cosmetics. The revised standards now establish separate thresholds for higher-risk product categories due to:

• Direct mucosal contact
• Increased exposure sensitivity
• Weaker skin barriers, particularly for children

By distinguishing these categories, the NMPA has raised the safety threshold for products that present greater physiological vulnerability.

While microbiological controls address product safety at the category level, ingredient regulation forms the second major pillar of this update.

Expansion and Tightening of Prohibited and Restricted Ingredients

In parallel with microbial revisions, the announcement expands and refines China’s ingredient control framework. The changes include both newly prohibited substances and modifications to existing restricted ingredients.

Newly Prohibited Substances: PFOS and PFOA

Perfluorooctane sulfonate (PFOS) and its salts, as well as perfluorooctanoic acid (PFOA) and its salts, are now explicitly listed as prohibited ingredients.

These persistent organic pollutants are known for environmental persistence and potential health risks. With similar restrictions already established in other major jurisdictions, Their formal inclusion in the prohibited list confirms zero-tolerance expectations under China’s cosmetics compliance regime.

For overseas companies, the primary compliance challenge lies in supply chain verification. Manufacturers should conduct comprehensive audits and obtain updated supplier declarations confirming the absence of PFOS, PFOA, and related derivatives in both raw materials and finished formulations.

Revisions to Restricted Substances

Beyond new prohibitions, multiple existing ingredient standards have been revised, including:

• UV filters such as Benzophenone-3, Homosalate, and Octocrylene
• Preservatives such as Methylisothiazolinone, Climbazole, and Polyaminopropyl Biguanide
• Anti-dandruff agent Zinc Pyrithione
• Hair dye ingredient Toluene-2,5-diamine and its sulfate

Revisions may involve adjusted maximum concentration limits, restrictions on specific product types, or updated warning label requirements. For example, certain preservatives may face lower allowable concentrations or restrictions in leave-on products. Overseas companies should therefore conduct clause-by-clause reviews of each revised provision to determine whether reformulation or label updates are required.

Introduction of New Ingredient Standards

The NMPA has also introduced new standards for specific substances to close regulatory gaps and align with international oversight trends.

• Butylphenyl Methylpropional - A fragrance ingredient.
• Cyclotetrasiloxane (D4) - a widely used volatile silicone, has also been included under new regulatory specifications.

Although commonly used as a carrier or volatile component, D4 has attracted environmental scrutiny in other jurisdictions. Its inclusion signals heightened regulatory attention within China's cosmetics compliance system. Companies should examine technical requirements carefully and ensure supporting documentation is available.

With the scope of technical changes clarified, timing becomes the next critical consideration.

Implementation Timeline and Transitional Arrangements

The NMPA has adopted a phased enforcement schedule, allowing for structured adjustment while maintaining regulatory momentum.

• Effective January 1, 2027: Six standards — primarily involving microbiological safety and certain high-risk chemical controls — will take effect. Companies have approximately one year to align products and documentation.
• Effective January 1, 2028: The remaining 12 standards — largely addressing revised restricted ingredients — will take effect, allowing roughly two years for preparation.

Products manufactured or imported before the applicable effective date may continue to be sold until the end of their shelf life.

However, this transitional allowance does not eliminate risk. Products planned for launch in 2027 or later must comply with the new standards from the outset. For existing products with extended shelf life, companies should assess inventory management and production adjustment strategies in advance.

Given the breadth of the revisions, structured compliance planning is essential.

Compliance Priorities for Overseas Cosmetics Companies

The revised standards affect the full compliance chain — from formulation and raw material control to safety assessments and manufacturing systems. The new microbiological limits and ingredient restrictions require coordinated, portfolio-level action.

Overseas companies should prioritize:

• Portfolio-wide formulation review, focusing on eye, lip, and children’s cosmetics, as well as products containing newly prohibited or revised restricted substances such as PFOS, PFOA, and D4
• Upstream quality reassessment, including raw material microbiological specifications, environmental monitoring standards, preservative system performance, and packaging integrity
• Supplier documentation updates, obtaining revised technical specifications and formal compliance declarations
• Safety assessment report revisions, aligning microbial limits, ingredient concentrations, and supporting validation data with the amended standards
• Structured reformulation timelines, synchronized with the January 1, 2027, and January 1, 2028, enforcement deadlines

Early coordination across regulatory, R&D, quality, and supply chain functions will be essential to maintain uninterrupted access to the China cosmetics market.

Strategic Outlook for the China Cosmetics Market

The incorporation of 18 standards into the “Safety and Technical Standards for Cosmetics” underscores the continued scientific strengthening of China’s cosmetics regulatory system.

For overseas manufacturers, the update presents clear compliance challenges but also reinforces a predictable, data-driven regulatory environment. Companies that proactively adapt formulations, strengthen quality systems, and align documentation with evolving NMPA requirements will be better positioned for long-term stability in the China market.

Cisema supports international cosmetics companies with regulatory interpretation, formulation compliance review and optimization recommendations, supply chain compliance management, and full regulatory representation services covering NMPA filing and registration. For suppot in assessing how the new standards affect your product portfolio and to develop a clear, compliance strategy aligned with the 2027 and 2028 enforcement timelines, contact Cisema today.

Further Information

To understand how these regulatory updates may affect your China cosmetics registration strategy, explore Cisema’s services for cosmetics registration in China.

References

“Announcement of NMPA on Incorporating 18 Standards Development and Revision Projects, Including ‘Total Bacterial Colony Count Limits in Eye Cosmetics, Lip Cosmetics, and Children's Cosmetics’, into the Safety and Technical Standards for Cosmetics (2015 Edition) (No. 6 of 2026)”