1. Introduction to the STSC
The Safety and Technical Standards for Cosmetics (STSC) is the overarching technical standard governing cosmetic safety supervision and testing in China. Promulgated on December 23, 2015, and officially implemented on December 1, 2016, the standard establishes comprehensive technical requirements for cosmetic products in the Chinese market. The STSC is primarily structured into general safety requirements, lists of prohibited, restricted, and permitted ingredients (such as preservatives, UV filters, colorants, and hair dyes), as well as a comprehensive suite of testing methods covering physicochemical, microbiological, toxicological, human safety, and human efficacy evaluation tests.
Chapter 1: Explanations of technical terms and general safety requirements;
Chapters 2–3: Lists of prohibited, restricted, and permitted ingredients used in cosmetics;
Chapters 4–8: Testing methods covering physicochemical testing, microbiological testing, toxicological testing, human safety testing, and efficacy evaluation.
Rather than adopting a "major overhaul once, stable for a long time" model, the regulatory body National Medical Products Administration (NMPA) now employs a dynamic, high-frequency, and small-scale revision mechanism. This continuous updating process is driven by the need for enhanced risk control, advancements in scientific and toxicological research, and a strategic push to harmonize Chinese regulations with mainstream international frameworks (such as EU SCCS opinions and IFRA standards).
For international cosmetic enterprises, brand owners, and compliance teams, the dynamic nature of the STSC signifies a shift in compliance management. It necessitates a transition from passive response to proactive risk management. Enterprises must establish routine monitoring mechanisms for regulatory updates. Failure to keep pace with these updates can lead to market access barriers and increased compliance costs.
2. Revisions to STSC Ingredient Lists
The ingredient lists in the STSC have undergone multiple revisions to phase out substances with potential health risks and to align with new scientific findings. Below is a comprehensive overview of the revisions related to ingredient limits introduced in the STSC.
2.1 Prohibited Ingredients
The prohibited ingredients list has seen the most frequent updates to phase out substances with potential health risks:
1) Detailed Amendments
2021 (NMPA Announcement No. 74 of 2021): The NMPA completely updated and replaced the lists for prohibited chemical and plant/animal ingredients.
2023 (NMPA Announcement No. 41 of 2023): Added Benvimod as a prohibited ingredient and established a limit for Benzene as an impurity at 2mg/kg.
2024 (NMPA Announcement No. 12 of 2024): Added five prostaglandin analogues to the prohibited list, including Bimatoprost, Latanoprost, Tafluprost, Tafluprost ethyl amide, and Travoprost.
2026 (NMPA Announcement No. 6 of 2026):
Effective Jan. 1, 2027: 4-Methylbenzylidene Camphor and 6-Amino-m-cresol are transitioned to the prohibited list. PFOS (and its salts) and PFOA (and its salts) are newly added;
Effective Jan. 1, 2028: Zinc Pyrithione is transitioned to the prohibited list. Butylphenyl Methylpropional and Cyclotetrasiloxane are newly added;
2026 (NMPA Announcement No. 48 of 2026):
Effective July 1, 2026: Mercury and its compounds are prohibited for use in cosmetics, except for certain preservatives permitted in cosmetic products, including Thimerosal and Phenylmercuric salts (including borate). The revision removes this exemption, and reclassifies Thimerosal and Phenylmercuric salts (including borate) as prohibited ingredients.
2) Current Status: The lists currently contain a total of 1,406 prohibited ingredients (1,297 chemicals and 109 plant/animal ingredients).
2.2 Restricted Ingredients
1) Detailed Amendments
Historical Updates: In 2021 and 2026, several previously restricted ingredients were removed from this list and transitioned to entirely prohibited status due to safety concerns.
Ingredient Reference Number in the Prohibited List (After Revision) |
Ingredient |
Ingredient Reference Number in the Restricted List (Before Revision) |
|---|---|---|
1267 |
Borates and tetraborates |
3 |
1268 |
Boric acid |
3 |
1271 |
Dichloromethane; methylene chloride |
41 |
1272 |
Formaldehyde |
31 |
1274 |
Nitromethane |
33 |
1297 |
Zinc pyrithione (Effective Jan. 1, 2028) |
21 |
2026 (NMPA Announcement No. 6 of 2026): Adjusted the specific restriction requirements for Salicylic Acid (Effective Jan. 1, 2028).
2) Current Status: The list currently contains 42 restricted ingredients.
2.3 Permitted Preservatives
1) Detailed Amendments
2020 (NMPA Announcement No. 141 of 2020): Ethyl Lauroyl Arginate HCl was approved and added as a permitted preservative.
2021 (NMPA Announcement No. 74 of 2021): Clorofene, Formaldehyde, and Paraformaldehyde were removed and transitioned to the prohibited list.
2026 (NMPA Announcement No. 6 of 2026): Zinc Pyrithione is removed and transitioned to the prohibited list (Effective Jan. 1, 2028). Furthermore, the usage restrictions and limits for Climbazole, Methylisothiazolinone (MIT), and Polyaminopropyl Biguanide have been revised and tightened (Effective Jan. 1, 2028).
2026 (NMPA Announcement No. 48 of 2026): Biphenyl-2-ol and its salts are currently regulated as permitted preservatives in cosmetics, with a maximum concentration of 0.2% (as phenol), without defined product category restrictions. The revision introduces category-specific concentration limits for rinse-off and leave-on products, as well as restrictions on use in applications with inhalation exposure risk and labeling requirements. The revised requirements will apply as of Jun. 1, 2028.
2) Current Status: The list currently contains 49 permitted preservatives.
2.4 Permitted UV Filters
1) Detailed Amendments
2021 (NMPA Announcement No. 74 of 2021): 3-Benzylidene Camphor was removed and transitioned to the prohibited list.
2026 (NMPA Announcement No. 6 of 2026): 4-Methylbenzylidene Camphor is removed and transitioned to the prohibited list (Effective Jan. 1, 2027). Additionally, the specific restriction requirements for Benzophenone-3, Homosalate, and Octocrylene have been revised (Effective Jan. 1, 2028).
2) Current Status: The list currently contains 25 permitted UV filters.
2.5 Permitted Colorants
With no recent deletions mentioned in the latest update, STSC currently maintains a stable list of 157 permitted colorants.
2.6 Permitted Hair Dyes
1) Detailed Amendments
2021 (NMPA Announcement No. 74 of 2021): 2-Chloro-p-phenylenediamine and its sulfate salts were removed and transitioned to the prohibited list.
2026 (NMPA Announcement No. 6 of 2026): 6-Amino-m-cresol is removed and transitioned to the prohibited list (Effective Jan. 1, 2027). The restriction requirements for Toluene-2,5-diamine and Toluene-2,5-diamine sulfate have also been revised (Effective Jan. 1, 2028).
2026 (NMPA Announcement No. 48 of 2026): Acid Violet 43 is permitted for use as a hair dye in cosmetics. The revision amends the maximum use level for non-oxidative hair dye products and updates the substance's purity specifications, with effect from Jun. 1, 2028.
2) Current Status: The list currently contains 72 permitted hair dyes.
2.7 Other Amendments
In addition, revisions have been made to the total bacterial count limits for eye cosmetics, lip cosmetics, and children's cosmetics, as well as the limit for dioxane, and remarks for mercury.
Indicator |
Limit |
Remark |
|---|---|---|
Total bacterial count (CFU/g or CFU/ml) |
≤500 (Current requirements: to be repealed on Jan. 1, 2027) |
Eye-applicable cosmetics, lip care and lip make-up and children's cosmetics |
≤100 (New requirements: to take effect on Jan. 1, 2027) | ||
≤1000 |
Other cosmetics |
|
Dioxane (mg/kg) |
30 (Current requirements: to be repealed on Jan. 1, 2027) |
/ |
10 (New requirements: to take effect on Jan. 1, 2027) |
/ |
|
Mercury (mg/kg) |
1 |
/ |
3. Revisions to STSC Testing Methods
3.1 Physical and Chemical Testing Methods for Cosmetics
The STSC has added 28 new and revised 26 physical and chemical testing methods for detecting prohibited, restricted, and permitted ingredients in cosmetics. This chapter currently includes 102 physical and chemical testing methods.
Chapter 4 Physical and Chemical Testing Methods for Cosmetics | |||
|---|---|---|---|
Method Name |
Status |
NMPA Announcement No. |
|
General Principles of Physical and Chemical Testing | |||
General Principles of Physical and Chemical Testing |
Revised |
||
Determination of Li and 42 kinds of elements in cosmetics |
Revised |
||
Nd and 14 kinds of elements |
Replaced |
||
Determination of pH in cosmetics (W/O) |
Added |
||
Determination of pH in toothpastes |
Added |
||
Determination of Mercury in toothpaste |
Added |
||
Determination of Lead in toothpaste |
Added |
||
Determination of Arsenic in toothpaste |
Added |
||
Determination of Cadmium in toothpaste |
Added |
||
Determination of Li and 42 Kinds of Elements in toothpaste |
Revised |
||
Determination of Hard Particles in toothpaste |
Added |
||
Determination of Prohibited Ingredients in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Fluconazole and other 8 kinds of components |
Replaced |
||
Minocycline hydrochloride and other 6 kinds of components |
Replaced |
||
Enoxacin and other 9 kinds of components |
Replaced |
||
Estriol and the other 6 kinds of components |
To be replaced on Jan. 1, 2027 |
||
Minoxidil and other 6 kinds of components |
To be replaced on Jan. 1, 2027 |
||
Determination of Cantharidin and Chlormethine in cosmetics |
Revised |
||
Determination of Acrylamide in cosmetics |
Revised |
||
Chlormethine |
Replaced |
||
Determination of Desloratadine and other 50 kinds of components in cosmetics |
Revised |
||
Determination of Dioxane in cosmetics |
Revised |
||
Determination of Procainamide and other 22 kinds of ingredients in cosmetics |
Revised (Effective Jan. 1, 2027) |
||
Hydroquinone and phenol |
Replaced |
||
Determination of Asbestos in cosmetics |
Revised |
||
Determination of Tretinoin and other 7 kinds of components in cosmetics |
Revised |
||
Determination of 6α-Methyl hydrocortisone and Other 123 Kinds of Ingredients in Cosmetics |
Revised (Effective Jan. 1, 2027) |
||
Determination of Dimetridazole and other 119 kinds of components in cosmetics |
Revised |
||
Determination of Ethyl Acrylate and other 39 kinds of components in cosmetics |
Added |
||
Determination of Dioxane in toothpaste |
Added |
||
Determination of Methanol in toothpaste |
Added |
||
Determination of Phenacetin in Cosmetics |
Added |
||
Determination of Diethylene Glycol and Glycol in toothpaste |
Added |
||
Determination of Cannabidiol and other 5 kinds of components in cosmetics |
Added |
||
Determination of Diethylene Glycol in cosmetics |
Added |
||
Determination of Trivalent Chromium and Hexavalent Chromium in Cosmetics |
Added (Effective Mar. 1, 2027) |
||
Determination of Restricted Ingredients in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Determination of Glucuronic Acid and other 13 kinds of components in cosmetics |
Revised |
||
Determination of Selenium Disulfide |
Revised |
||
Boric Acid and Borate |
Revised |
||
Determination of Thioglycollic Acid and other 7 kinds of components in cosmetics |
Revised (Only the first method in the original method) |
||
Determination of Hydroxycapric Acid in cosmetics |
Added |
||
Determination of Soluble/Free Fluoride in toothpastes |
Added |
||
Determination of total fluoride in toothpaste |
Added |
||
Determination of Preservatives in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Methyl Isothiazolinone and other 22 kinds of components |
Revised |
||
Zinc Pyrithione and other 18 kinds of components |
Revised |
||
Hexamidine Diisethionate and other 6 kinds of components |
Revised |
||
Poly (aminopropylbiguanide) |
Revised |
||
Hexetidine |
Revised |
||
Phenylmercury Borate |
Revised |
||
Formic Acid and other 8 kinds of components |
Revised |
||
Formaldehyde |
Revised |
||
Determination of Free Formaldehyde in cosmetics |
Revised |
||
Determination of Free Formaldehyde in toothpaste |
Added |
||
Determination of Ethyl Lauroyl Arginate HCl in Cosmetics |
Added (Effective Mar. 1, 2027) |
||
Determination of Sunscreens in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Determination of 3-Benzylidene Camphor and other 21 kinds of sunscreens in cosmetics |
Added |
||
Determination of Colorants in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
CI 10020 and other 10 kinds of components |
Added |
||
CI 11920 and other 12 kinds of components |
Added |
||
Determination of Hair Dyes in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Determination of p-Phenylenediamine and other 32 kinds of components in cosmetics |
Revised |
||
Determination of 5-(2-Hydroxyethylamino)-2-Methoxylaniline Sulfate and other 14 kinds of components |
Added |
||
Determination of 1-hydroxyethyl-4,5-diaminopyrazole Sulfate and Other 10 Kinds of Ingredients in Cosmetics |
Added (Effective Mar. 1, 2027) |
||
Determination of Other Ingredients in Cosmetics | |||
Method Name |
Status |
NMPA Announcement No. |
|
Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and other 10 components in cosmetics |
Added |
||
α-Arbutin and other 3 kinds of components |
Revised |
||
Disodium Distyrylbiphenyl Disulfonate and other 4 kinds of components |
Added |
||
Determination of Azelaic Acid and its salts in cosmetics |
Added |
||
3.2 Methods of Microbiological Test
To strengthen microbiological safety controls, 6 new methods related to toothpaste have been added. This chapter currently includes 2 general principles and 10 microbiological testing methods.
Chapter 5 Methods of Microbiological Test | ||
|---|---|---|
Method Name |
Status |
NMPA Announcement No. |
General Guidelines in Toothpaste |
Added |
|
Aerobic Plate Count in Toothpaste |
Added |
|
Detection of Thermotolerant Coliform Bacteria in Toothpaste |
Added |
|
Detection of Pseudomonas Aeruginosa in Toothpaste |
Added |
|
Detection of Staphylococcus Aureus in Toothpaste |
Added |
|
Molds and Yeasts Count in Toothpaste |
Added |
|
3.3 Methods of Toxicological Test
In line with the global trend towards reducing animal testing, the STSC has added 31 and revised 6 toxicological test methods. This chapter currently includes 1 general principle and 50 toxicological testing methods.
Chapter 6 Methods of Toxicological Test | ||
|---|---|---|
Method Name |
Status |
NMPA Announcement No. |
Bacterial Reverse Mutation Assay |
Revised |
|
Teratogenicity Test |
Revised |
|
In-vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Chemicals Used in Cosmetics |
Added |
|
In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) for Chemicals Used in Cosmetics |
Added |
|
Skin Photoallergy Test |
Added |
|
Short Time Exposure In Vitro Test Method (STE) |
Added |
|
Skin Sensitization: Local Lymph Node Assay: DA (LLNA: DA) |
Added |
|
BrdU-ELISA Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA: BrdU-ELISA) |
Added |
|
In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA) |
Added |
|
In Vitro Mammalian Cells Micronucleus Test |
Added |
|
In Vitro Skin Sensitization: Human Cell Line Activation Test (h-CLAT) |
Added |
|
In Chemico Skin Sensitization: Amino acid Derivative Reactivity Assay (ADRA) |
Added |
|
Fluorescein Leakage in Vitro Test Method |
Added |
|
Acute Oral Toxicity Test: Up-and Down Procedure |
Added |
|
Acute Oral Toxicity Test: The Fixed-Dose Procedure |
Added |
|
Acute Oral Toxicity: Acute Toxic Class Method |
Added |
|
In Vivo Mammalian Alkaline Comet Assay |
Added |
|
General Rule for Pretreatment of Cosmetic in Toxicological Experiments |
Added |
|
Acute Inhalation Toxicity Study |
Added |
|
Acute Inhalation Toxicity-Acute Toxic Class Method |
Added |
|
Reactive Oxygen Species (ROS) Assay for Photoreactivity |
Added |
|
U937 Cell Line Activation Test |
Added |
|
Skin Absorption: in Vivo Method |
Added |
|
Repeated Dose 28-Day Oral Toxicity Study |
Added |
|
28-Day Inhalation Toxicity Study |
Added |
|
90-Day Inhalation Toxicity Study |
Added |
|
Extended One-Generation Reproductive Toxicity Study |
Added |
|
Two-Generation Reproductive Toxicity Study |
Added |
|
In Chemico Skin Sensitization The ARE-Nrf2 Luciferase LuSens Test |
Added |
|
Bovine Corneal Opacity and Permeability (BCOP) Assay |
Added |
|
In Chemico Skin Sensitization: Kinetic Direct Peptide Reactivity Assay (kDPRA) |
Added |
|
Skin Absorption: In vitro Method |
Added |
|
Immunotoxicity Test |
Added |
|
Oral Mucous Irritation Test |
Added |
|
Skin Sensitization: Local Lymph Node Assay: BrdU-Flow Cytometry Method (LLNA: BrdU-FCM) |
Added |
|
Toxicokinetics Test |
Added |
|
Bacterial Reverse Mutation Test |
Revised (Effective on Mar. 1, 2027) |
|
In Vitro Mammalian Cells Chromosome Aberration Test |
Revised (Effective on Mar. 1, 2027) |
|
90-day Oral Toxicity Test |
Revised (Effective on Mar. 1, 2027) |
|
90-day Dermal Toxicity Test |
Revised (Effective on Mar. 1, 2027) |
|
3.4 Human Body Safety Testing Method
2 human body safety testing methods have been revised and 1 human body safety testing method has been added. This chapter currently includes 1 general principle and 3 human body safety testing methods.
Chapter 7 Human Body Safety Testing Method | ||
|---|---|---|
Method Name |
Status |
NMPA Announcement No. |
Human Skin Patch Test |
Revised |
|
Cosmetic Safety In-use Test |
Revised |
|
Safety Evaluation of Long-term Using Tests of Cosmetics on Human Body |
Added (Effective Mar. 1, 2027) |
|
3.5 Human Body Efficacy Evaluation Testing Method
To substantiate product claims and protect consumers, specific test methods for evaluating the efficacy of whitening and anti-hair loss cosmetics have been officially incorporated. This chapter currently includes 1 general principle and 5 human body efficacy evaluation testing methods.
Chapter 8 Human Body Efficacy Evaluation Testing Method | ||
|---|---|---|
Method Name |
Status |
NMPA Announcement No. |
Test Method for Efficacy Measurement of Skin Whitening Cosmetic Products |
Added |
|
Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products |
Added |
|
4. Implementation Rules for STSC Revisions (Draft)
To facilitate the transition to the updated STSC, the NMPA released a draft Announcement on Matters Relating to the Implementation of STSC Revisions. The draft clarifies compliance procedures for updating ingredient lists, microbiological and harmful substance limits, and testing methods.
4.1 Ingredient List Adjustments
For cosmetics registered or notified prior to the revisions, companies can apply to modify their formulas and labels before the official implementation date:
Minor Adjustments: If replacing related ingredients with base materials (like solvents or fillers) or reducing their usage, companies only need to provide an explanation and a safety assessment without new testing. However, if the change affects product efficacy, a new efficacy evaluation is required to update the product name and label sample.
Fragrance Changes: Companies must conduct a safety assessment and provide proof that the new fragrance complies with national standards or International Fragrance Association (IFRA) standards.
Other Adjustments: Any other formula changes require new testing and safety assessments.
4.2 Microbiological and Harmful Substance Limits
Registrants and notifiers must conduct self-assessments on marketed products. If original test reports and safety assessments meet the revised STSC, companies can independently update their product execution standards and keep files on record. If they do not meet the new requirements, companies must adjust production processes or quality control measures, re-test the products, and apply for a modification.
4.3 Testing Method Updates
Companies must self-assess whether their marketed products comply with the updated quality and safety testing methods. If products meet the revised STSC requirements, companies can independently update their product execution standards and keep safety assessment and testing reports on record. For products requiring sunscreen, freckle-removing, whitening, or anti-hair loss efficacy testing, previously registered products do not need to be re-tested using the newly adjusted efficacy testing methods.
4.4 Products Under Technical Review or Proposed for Application
Test reports completed before the implementation of STSC revisions remain valid for registration and notification. For products currently under technical review, applicants are allowed to adjust prohibited, restricted or permitted ingredients during the supplementary documentation phase. Similar to marketed products, adjustments to base materials or reducing ingredient usage require a safety assessment but no re-testing (unless efficacy is impacted), while non-base material adjustments require new testing and safety assessments. If the change affects product efficacy, a new efficacy evaluation is required.
Please refer to China Mainland Cosmetic Regulation for a comprehensive overview.
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