Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization (Draft for Comments) and Drafting Instructions

On April 10, 2024, the China National Institutes for Food and Drug Control (NIFDC) unveiled six draft guidance documents concerning cosmetics safety assessment. 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

Main Content

The Guidelines is applicable to the skin sensitization assessment of cosmetic ingredients. The assessment employs toxicological tests capable of detecting the key events (KE1-KE3) within the skin sensitization Adverse Outcome Pathway (AOP), forming a "2 out of 3" integrated testing strategy (ITS). The scope of this strategy should be consistent with the suitability of all selected test methods.