China Amends the Safety and Technical Standards for Cosmetics 2015: 5 Prohibited Ingredients and 14 Testing Methods Involved

On March 21, 2024, China National Medical Products Administration (NMPA) announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC), involving changes to prohibited ingredients and testing methods for cosmetics. The ingredient list was updated with immediate effect, while the revised testing methods are scheduled to take effect on December 1, 2024.

The key amendments are as follows:

1. Adding the following five prostaglandin analogs to the “List of Prohibited Ingredients Used in Cosmetics” in STSC.

Entry No.	English Name	CAS No.
1286	Bimatoprost	155206-00-1
1287	Latanoprost	130209-82-4
1288	Tafluprost	209860-87-7
1289	Tafluprost ethyl amide, (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-Difluoro-4-phenox y-1-buten-1-yl]-3,5-dihydroxycyclopentyl}-N-ethyl-5- heptenamide	1185851-52-8
1290	Travoprost	157283-68-6

2. Releasing three testing methods to replace the original methods outlined in "Chapter 4 Physical and Chemical Testing Methods for Cosmetics" in STSC

No.	The Superseded Original Testing Methods	Replacement
1	2. Testing Methods of Prohibited Ingredients: 2.19 Dioxane	Determination of Dioxane in Cosmetics
2	2. Testing Methods of Prohibited Ingredients: 2.1 Fluconazole and Other 8 kinds of Components 2.2 Minocycline Hydrochloride and Other 6 Kinds of Components 2.3 Enoxacin and Other 9 Kinds of Components 2.35 Determination of Anti-infective Drug in Cosmetics (NMPA No. 66 in 2019)	Determination of Dimetridazole and Other 119 Kinds of Components in Cosmetics
3	3. Testing Methods of Restricted Ingredients: 3.2 Selenium Disulfide	Determination of Selenium Disulfide

3. Introducing 11 new testing methods into "Chapter 6 Methods of Toxicological Test" in STSC

Section No.	New Testing Methods	Range of Application
33	General Rule for Pretreatment of Cosmetic in Toxicological Experiments	This Rule is applicable to toxicological tests of cosmetic ingredients and products.
34	Acute Inhalation Toxicity Study	This specification is applicable to the toxicological test of single-component cosmetic ingredients.
35	Acute Inhalation Toxicity-Acute Toxic Class Method	This testing method is applicable to single-component cosmetic ingredients. If non-single-component ingredients are evaluated through this method, more scientific basis needs to be provided to illustrate its feasibility. This testing method is not suitable for testing certain special materials, such as insoluble isometric or fibrous materials, and manufactured nanomaterials.
36	Reactive Oxygen Species (ROS) Assay for Photoreactivity	This method is applicable to the prediction of potential phototoxicity of chemical ingredients used in cosmetics.
37	U937 Cell Line Activation Test	This testing method is applicable to the evaluation of potential sensitization of chemical ingredients used in cosmetics.
38	Skin Absorption: in Vivo Method	This testing method is applicable to the in vivo test of percutaneous absorption of single-component cosmetic ingredients. If non-single-component ingredients are evaluated using this method, more scientific basis needs to be provided to illustrate its feasibility.
39	Repeated Dose 28-Day Oral Toxicity Study	This specification is applicable to the evaluation of 28-day repeated dose inhalation toxicity of cosmetic ingredients.
40	28-Day Inhalation Toxicity Study	This testing method is applicable to the evaluation of 28-day repeated dose inhalation toxicity of single-component cosmetic ingredients.
41	90-Day Inhalation Toxicity Study	This testing method is applicable to the inhalation toxicity evaluation of 90-day repeated dose of single-component cosmetic ingredients.
42	Extended One-Generation Reproductive Toxicity Study	This testing method is used for the detection of reproductive and developmental toxicity of cosmetic ingredients.
43	Two-Generation Reproductive Toxicity Study	This testing method is used for the detection of reproductive and developmental toxicity of cosmetic ingredients.