FAQ Vol. 27 | Can the IECIC Still Be Used as a Reference for Safety Assessment?

After May 1, 2025, general cosmetics that meet certain conditions may still submit the basic conclusion of the safety assessment.

According to the Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management (No. 50 of 2024) and the Guidelines for Submission of Cosmetic Safety Assessment Dossiers, the National Medical Products Administration (NMPA) has adopted a classified management approach for cosmetic safety assessment documentation. Under this approach, for eligible general cosmetics, submission of the basic conclusion of the safety assessment remains permitted, while the full safety assessment report must be retained by the enterprise for future reference and regulatory inspection.

According to the Guidelines for Use of Cosmetic Ingredient Data, the highest historical use concentrations of ingredients, as announced by cosmetic regulatory authorities, are not included among the accepted data types for safety assessment. The main types of ingredient data include:

(I) The restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes included in the Safety and Technical Standards for Cosmetics (STSC).

(II) Assessment conclusions published by international authoritative cosmetic safety assessment institutions.

(III) Safety limits or conclusions published by authoritative institutions such as the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO).

(IV) Information on ingredient use of marketed products published by administration departments.

(V) 3-Year use history of ingredients.

(VI) History of safe consumption.

(VII) High-molecular polymers with stable structures and properties (except for ingredients with higher bioactivity).

The submitted information should clearly indicate the source of the relevant regulations or documents, and include key details such as the safety assessment dose of the risk substances. If the documents are in a foreign language, a Chinese translation must be provided for all submitted content.

In the IECIC, "fragrance" refers to a general term for a class of ingredients. For safety assessment purposes, the product should provide evidence that the fragrances used comply with the International Fragrance Association (IFRA) standards or meet relevant national standards of China.

If both "fragrance" and its specific components are listed in the product formula, a complete list of all components and their concentrations—issued by the fragrance manufacturer—must be submitted. A safety assessment should be conducted on each individual fragrance component.

If ingredients such as Lavandula Hybrida Oil, Rosa Rugosa Flower Oil, or similar are directly listed as fragrance ingredients in the formula, they should be assessed as general cosmetic ingredients.

The recommended national and industry standards for cosmetic categories such as facial cleansers, skincare lotions, and perm agents generally define a broad pH value range to ensure universal applicability. These ranges may cover both acidic and alkaline zones, and in some cases, may even extend to levels considered strongly acidic or strongly alkaline.

However, when determining the pH control range for a specific product, enterprises should not directly copy or rely solely on the values specified in these standards. Instead, they should establish a product-specific pH range that serves as a safety control parameter, based on factors such as the product formulation, manufacturing process, and intended application method.