I. Core Content of the New Regulations
On June 26, 2026, the National Medical Products Administration issued Announcement No. 59, formally publishing the Regulations on the Registration, Filing, and Documentation Management of New Cosmetic Ingredients (hereinafter referred to as the "New Regulations"), effective from July 15, 2026. The previous Announcement No. 31 of 2021 was simultaneously repealed.
Without lowering safety standards, the New Regulations systematically optimize the documentation requirements for the registration and filing of new cosmetic ingredients, mainly reflected in the following four aspects:
1. Adjusting New Ingredient Classification to Simplify Documentation Submission
The New Regulations reduce the scope of "higher risk" efficacy categories from the original 10 (preservative, sunscreen, coloring, hair dyeing, freckle removal and whitening, anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and deodorant) to 5 (preservative, sunscreen, coloring, hair dyeing, freckle removal and whitening), aligning with the efficacy scope requiring registration as stipulated in the Regulations on the Supervision and Administration of Cosmetics. After this adjustment, new ingredients with efficacy claims such as anti-hair loss, anti-acne, anti-dandruff, and anti-wrinkle are no longer broadly classified into the higher-risk category, and their registration and filing documentation requirements are correspondingly reduced.
2. Fully Utilizing Existing Data to Avoid Duplicate Testing
In the safety assessment of new ingredients, full consideration is given to the utilization of existing safety background information, as well as data such as a history of safe use and a history of safe consumption. Where tests have already been conducted using other Chinese national standards or internationally accepted methods, existing data may be utilized provided that the conclusions of the safety assessment of the new ingredient are not affected.
3. Fully Embracing Animal Alternative Methods
The application of new technologies and new methods such as animal alternative testing methods is encouraged. Enterprises may directly adopt alternative methods included by internationally authoritative institutions for testing, which helps reduce technical barriers to international trade and promotes the global expansion of Chinese beauty brands.
4. Separation of Management Requirements and Technical Requirements
The management requirements and technical requirements for new ingredients are separated. The management portion is incorporated into the New Regulations to highlight its management attributes, while the technical requirements are converted into the General Technical Rules for the Registration and Filing Documentation of New Cosmetic Ingredients to emphasize technical requirements, allowing for more flexible adaptation to industry development.
II. Industry Impact Analysis
According to the China Association of Fragrance, Flavour and Cosmetic Industries, new ingredients with a history of safe consumption or prior use may, upon meeting the corresponding conditions, apply for exemption or reduction of animal testing items
