Technical Guidelines for Skin Allergy Testing

The China Institute for Food and Drug Control drafted the "Technical Guidelines for Skin Allergy Testing (Draft for Comment)" on May 4, 2023, in order to further standardize and direct the safety evaluation of cosmetics and new raw materials in accordance with the "Regulations on the Supervision and Administration of Cosmetics", "Measures for the Administration of Cosmetics Registration and Filing", and other pertinent regulations and supporting documents.

Skin allergy testing is used to assess the potential for allergic reactions in mammals after repeated exposure to cosmetic chemicals or goods. It also serves as a critical component of toxicological tests for product safety.

The necessary information in this guiding concept will be regularly refined and updated in accordance with scientific research, according to the advancement of research as well as current legislation, standards, and levels of scientific understanding.

A normative test is conducted, and the test findings are examined based on the properties of the test material. Complete a thorough study and evaluation. Randomized, controlled, and repeated toxicological studies' fundamental tenets should be adhered to in the experimental design. The test data must then be authentic, comprehensive, accurate, and traceable.

This recommendation solely covers the skin allergy test that has to be prioritized. Throughout the test, the issue must be examined case by case. Evaluation of results on the partial closed skin test (Buehler Test, BT) and Guinea Pig Maximina Tm Test is available in this guideline. The basic contents are mentioned below:
• Selection and management of experimental animals
• Number of experimental animals
• Preparation of the test substance
• Design of the dose of the test substance
• Setting of the control group
• Inducing contact and provoking contact
Relevant stakeholders can give feedback before May 20, 2023.