China Adds Safety Assessment Data for 999 Cosmetic Ingredients

On April 10, 2025, China’s National Institutes for Food and Drug Control (NIFDC) released a document titled Information on the Use of Some Ingredients Included in the International Cosmetic Safety Assessment Data Index, accompanied by a related FAQ.

This release marks a major supplement to the International Cosmetic Safety Assessment Data Index (the “Index”), which was initially launched on April 30, 2024—then referred to as the Index of Cosmetics Safety Assessment Data from Authoritative Organizations. The Index is an objective compilation of 3,651 cosmetic ingredients that have been used in Chinese cosmetics but are not listed in China’s Safety and Technical Standards for Cosmetics (STSC). These ingredients have been assessed by internationally recognized bodies such as the EU’s Scientific Committee on Consumer Safety (SCCS) and the U.S. Cosmetic Ingredient Review (CIR), which have published corresponding safety assessment reports.

While the Index provides a valuable reference for cosmetic registrants and notifiers when conducting safety assessments, it has certain limitations. Not all included ingredients have clearly defined safe usage limits, and some are subject to specific conditions or restrictions. As a result, not all ingredient data in the Index may be directly applicable for use by cosmetic registrants and notifiers in their safety assessments. To address these gaps, the NIFDC has introduced targeted improvements and refinements to the Index, aiming to enhance its practical value for industry stakeholders.

Key Highlights of the Update

1. Expanded Safety Data for 999 Ingredients

The newly released document provides detailed safety data for 999 ingredients already included in the Index, covering 2,879 specific usage entries. These ingredients—either lacking safety conclusions or having restricted use conditions—are widely used in registered and/or notified cosmetic products in China.

Each usage entry now includes the following detailed information:

• Application sites (e.g., body, face, eyes)

• Methods of use (e.g., leave-on or rinse-off)

• Usage limits

For instance, 10-hydroxydecanoic acid is listed as a leave-on ingredient for whole-body and eye-area use, with respective usage concentrations of 0.15% and 0.187%. 

Importantly, this new dataset does not duplicate data from the Ingredient Usage Information of Marketed Products and thus significantly expanding the available reference data for enterprises conducting cosmetic safety assessments.

2. Consistent Reference Principles

This document applies the same principles as the Ingredient Usage Information of Marketed Products for handling the ingredients’ application sites, methods, and concentration levels. Key principles include:

1. For the same ingredient applied to the same area, if only a leave-on concentration is recorded, it can also serve as a reference for rinse-off products.

2. For the same ingredient used in the same way but applied to different areas, reference priority follows this order: whole body → trunk → face (including neck) → hands & feet → head → hair → lips → eyes → nails (fingers and toes). The ingredient use amount for the former areas can serve as a reference for later areas.

3. Moreover, when the product is applied to eyes and the use amount for other areas is referenced, the ingredient must be assessed for eye irritation separately. Specifically:

• The usage levels for hands and feet, head, or hair cannot serve as the reference for lips and eyes.

• For ingredients intended for body hair, only the usage level for the whole body or trunk can serve as the reference.

• If the application area includes both the head and hair, the use amount for the head can be referenced.

• If the application area includes the face (including neck), eye area, and/or lips, the use amount for the face (including the neck) can be referenced. If the eye area is included, additional assessment of eye irritation is required.

• For ingredients used in products targeting multiple areas, the use amount for the former area with the same application method should be referenced.

3. Considerations for Data Use

The NIFDC emphasizes that the document is solely an objective collection of international authoritative data and domestic registration and notification records. The 999 ingredients listed have not undergone systematic evaluation by Chinese regulatory authorities. It remains the responsibility of cosmetic registrants and notifiers to ensure compliance with all applicable national laws, regulations, and technical standards by conducting thorough safety assessments and assuming full accountability for product quality and safety.

The ingredient usage limits in the document may serve as helpful references in safety assessments. Registrants and notifiers should evaluate the relevance of the data based on the intended use and site of application, and apply the usage limits appropriately. If new safety assessment conclusions become available for any listed ingredient, registrants and notifiers must determine the appropriate data to support their assessment based on scientific validity, rationality, and in accordance with the principles of scientific rigor, fairness, and case-by-case evaluation.

Industry Implications

As per China’s Guidelines for Use of Cosmetic Ingredient Data, safety assessment conclusions from international authoritative agencies are among the seven recognized categories of evidence for conducting cosmetic safety assessments. This update significantly expands the pool of available reference data, offering cosmetic companies an opportunity to reduce both the time and cost of gathering data for safety assessments.

Nonetheless, challenges persist. Over 2,000 ingredients in the Index still lack sufficient safety conclusions or usage limits, remaining inadequate for reference purposes and may requiring further toxicological assessment. It is therefore essential for regulatory authorities to accelerate the collection and refinement of ingredient data, continue updating the Index, and provide more detailed technical guidance to support industry compliance and safety assessment efforts.