China Consults on Cosmetic Ingredient Safety Data Catalogs and Guidelines for Stability, Preservative Challenges, Packaging Compatibility, and Skin Sensitization Testing

Background

According to the Technical Guidelines for Cosmetic Safety Assessment, until May 1, 2024, cosmetics registrants and notifiers have the option to submit a simplified product safety assessment report during the registration or notification process. However, starting from May 1, 2024, the full version of the assessment report must be submitted. This transition presents challenges for the industry due to factors like the lack of toxicological data for various ingredients and limited safety assessment personnel.

National Medical Products Administration (NMPA) may troduce a six-month transition period for the submission of the full assessment report, as reported in the official industry newspaper on March 15, 2024. Additionally, NMPA will implement measures to optimize the management of safety assessment.

To support enterprises in submitting the full assessment reports, in March and April 2024, China released 5 draft guidelines related to safety assessment:

On April 10, 2024, the China National Institutes for Food and Drug Control (NIFDC) unveiled six draft guidance documents concerning cosmetics safety assessment. ¹ These documents specifically address stability testing, preservative challenge testing, packaging compatibility testing, skin sensitization testing, and ingredient safety data, aiming to enhance the overall safety assessment process for cosmetics. These documents are:

1. Technical Guidelines for Stability Evaluation of Cosmetics

2. Technical Guidelines for Cosmetic Preservative Challenge Testing

3. Technical Guidelines for Compatibility Evaluation of Cosmetics with Packaging Materials

4. Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization

5. Index of Cosmetics Safety Assessment Data from Authoritative Organizations

6. Information on Cosmetic Ingredient Usage

These draft documents are open for public feedback until April 17, 2024. Interested parties are encouraged to provide their comments and relevant documents to hzpbwh@nifdc.org.cn before the deadline.

1. Technical Guidelines for Cosmetic Stability Testing, Preservative Challenge Testing, Packaging Compatibility Testing, and Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization

In the full version of the safety assessment report, it is essential to include stability testing, preservative challenge testing, and packaging compatibility testing. Previously, there was a lack of unified standards for these tests issued by cosmetic regulatory authorities. As a result, most enterprises conducted these tests based on their own methods or by referring to standards from other product categories, such as drugs.

The introduction of these Guidelines brought about a unification of testing methods for stability, preservative challenge, and packaging compatibility. This development is beneficial for enterprises, as it provides standardized procedures for conducting these tests.