China New Regulations for Cosmetics Testing are Coming Now!

If the cosmetic raw material is used in a product with a risk of inhalation exposure, the possibility of inhalation exposure should be clearly mentioned, and the health hazard effect of inhalation exposure should be considered.

On April 13, the National Institutes for Food and Drug Control issued the Technical Guidelines for 28-day/90-day Repeated Dose Inhalation Toxicity Test (exposure draft)(hereinafter referred to as Guidelines), which formulated guidelines for issues related to repeated dose inhalation toxicity tests of cosmetics. corresponding technical guidelines.

The Guidelines pointed out that cosmetics are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods, due to the influence of some dosage forms and using methods or the feature of the raw materials some cosmetic raw materials may have inhalation exposure risks.

According to the requirements of Technical Guidelines for Safety Assessment of Cosmetics and Regulations on the Administration of Registration and Filing Data of New Cosmetics Raw Materials, For cosmetic products that may have a risk of inhalation exposure, the possible health hazard effects of inhalation exposure on the human body should be evaluated. When the cosmetic raw materials or risky substance may be absorbed through the respiratory tract, the inhalation toxicity test data shall be provided.

If the cosmetic raw material is used in a product with a risk of inhalation exposure, the possibility of inhalation exposure should be clearly mentioned, and the health hazard effect of inhalation exposure should be considered.

Hazardous effects and the toxicology test data required in the registration and filing materials for new raw materials include "inhalation toxicity test (the test must be done when the raw material may be exposed to inhalation).

Therefore, it is necessary to carry out systematic research and discussion on relevant technical issues, and formulate corresponding technical guidelines to standardize and guide the research and evaluation of repeated inhalation toxicity of cosmetics.

The purpose of the Guidelines is to provide scientific recommendations for the repeated dose inhalation toxicity test research of cosmetic raw materials. The test results can provide a basis for repeated inhalation toxicity evaluation of cosmetics.

The Guidelines apply to repeated dose inhalation toxicity test studies of cosmetic raw materials that may pose a risk of inhalation exposure.

At the same time, it provides two test methods with different exposure periods: 28-day repeated dose inhalation toxicity test and 90-day repeated dose inhalation toxicity test. The principle of "concrete analysis of specific issues" should be followed, and according to the expected service life of the test substance, select the 28-day repeated dose inhalation toxicity test for short-term exposure, and the 90-day repeated dose inhalation toxicity test for long-term exposure.

It is required to design an appropriate test method, and conduct a comprehensive evaluation of the test results in combination with other toxicological research information.