Authoritative Answers to Core Questions about Cosmetic Toxicology Testing and Ingredient Safety

1. Can accelerated testing in stability experiments provide the basis for confirming the product shelf life?

A: Cosmetic Stability Test Assessment Technical Guide stipulate that long-term testing provides the basis for confirming products’ storage conditions, shelf life, etc. Cosmetic registrants can submit their registration application after completing the accelerated testing. The long-term testing report shall be retained by the enterprise for record.

2: Some ingredients have restriction principles in the CIR assessment conclusion, such as “when the formula is non-irritating”. How should proof be provided to meet such restriction principle?

A: It is necessary to provide proof that the product using the ingredients does not cause skin irritation. Product toxicology test reports can be used, such as acute/multiple skin irritation tests to prove that the product does not cause skin irritation.

3. What alternative methods for detecting skin sensitization are currently included in the Cosmetics Safety Technical Specifications?

A: At present, included alternative methods are as follows:

Skin Allergy: Test Method of Skin Sensitization: Local lymph node assay (LLNA:DA and LLNA: BrdU-ELISA); In Vitro Skin Allergy Tests: Direct Peptide Reactivity Assay (DPRA); Amino Acid Derivative Reactivity Assay (ADRA); Human Cell Line Activation Test (h-CLAT); U937 Cell Line Activation Test (U-SENS); Keratinosens Assay (LuSens - Keratinocyte Luciferase Reporter Gene Test)

4. How should the cosmetic safety assessment of flavors and fragrances in formulas be conducted?

A: (1) If only “Fragrance” is listed in the “Standard Chinese Name” column of the product formula, the fragrance should be assessed according to the principles and requirements of the Guidelines, or it should be clearly stated that the fragrance used complies with the International Fragrance Association (IFRA) Code of Practice or relevant Chinese national standards (for fragrances).

(2) If both “Fragrance” and specific fragrance components are listed in the “Standard Chinese Name” column of the product formula, each fragrance component must have safety assessments.

(3)When children’s cosmetics contain fragrance, botanical essential oils, or aromatic ingredients, all allergenic components within them must be identified and assessed.

5. Do components not included in the formula require safety assessment?

A: When assessing  ingredients, minimal traces of components not listed as formula ingredients (e.g., components added in extremely small quantities to ensure the overall quality of the cosmetic ingredients) must also be explained and have a thorough safety assessment to ensure such components do not compromise the quality and safety of the ingredients.

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