On May 15, 2026, the National Medical Products Administration (NMPA) issued an announcement incorporating three revised standards — “o-Phenylphenol and Its Salts,” “Acid Violet 43 (CI 60730),” and “Mercury and Its Compounds” — into the Safety and Technical Standards for Cosmetics (2015 Edition), replacing the original relevant provisions. CIRS Group now provides a detailed interpretation of the revised content.
Summary of 3 Revision Projects
| No. | Project Name | Type | Chapter/Section Incorporated into the Technical Specification for Cosmetic Safety | Corresponding Original Chapters/Sections in the Technical Specification for Cosmetic Safety Being Repealed |
| 1 | o-Phenylphenol and its salts | Revised and replaced original provisions | Chapter III, Part 1: Preservatives Allowed in Cosmetics (Table 4), Serial No. 34 | Chapter III, Part 1: Preservatives Allowed in Cosmetics (Table 4), Serial No. 34 |
| 2 | Acid Violet 43 (CI 60730) | Chapter III, Part 4: Hair Dyes Allowed in Cosmetics (Table 7), Serial No. 37 | Chapter III, Part 4: Hair Dyes Allowed in Cosmetics (Table 7), Serial No. 37 | |
| 3 | Mercury and Its Compounds | Chapter I, Section 3.4: Limits for Hazardous Substances Chapter II, Part 1: List of Prohibited Cosmetic Ingredients (Table 1), Serial No. 888 |
Chapter I, Section 3.4: Limits for Hazardous Substances Chapter II, Part 1: List of Prohibited Cosmetic Ingredients (Table 1), Serial No. 888 Chapter III, Part 1: Preservatives Allowed in Cosmetics (Table 4), Serial No. 43 Chapter III, Part 1: Preservatives Allowed in Cosmetics (Table 4), Serial No. 47 |
Revised Content and CIRS Interpretation
1. o-Phenylphenol and Its Salts
o-Phenylphenol and its salts are currently listed in the Permitted Preservatives List of the Safety and Technical Standards for Cosmetics (2015 Edition) (hereinafter referred to as the “Safety and Technical Standards”).
The original provision states: the maximum permitted concentration when used in cosmetics is 0.2% in total (expressed as phenol).
The revised content is as follows:
(1) The scope of application and restrictions are classified by “leave-on products” and “rinse-off products,” with the corresponding maximum permitted concentrations specified respectively;
(2) The warning statement “avoid contact with eyes” must be printed on the label.
| Chapter and Section | Serial No. | Substance Name | Maximum concentration in ready for use preparation | Scope of Application and Restrictions | Wording of conditions of use and warnings | ||
| Chinese Name | English Name | INCI Name | |||||
| Chapter III, Part 1: Preservatives Allowed in Cosmetics (Table 4) | 34 | 邻苯基苯酚及其盐类 | o-Phenylphenol and its salts | (a) 0.2% total (calculated as phenol) | (a) Rinse-off products: shall not be used in products with potential inhalation risk | Avoid contact with eyes | |
| (b) 0.15% total (calculated as phenol) | (b) Leave-on products: shall not be used in products with potential inhalation risk | ||||||
o-Phenylphenol is currently listed as Entry 7 in Annex V (Permitted Preservatives List) of the EU Cosmetics Regulation (EC) No 1223/2009, with a maximum permitted concentration of 0.2% (expressed as phenol) for rinse-off products and 0.15% (expressed as phenol) for leave-on products, and the label must bear the warning “avoid contact with eyes.” Following this adjustment, China’s requirements for the use of o-phenylphenol are largely consistent with the relevant EU regulations.
2. Acid Violet 43 (CI 60730)
Acid Violet 43 (CI 60730) is currently listed in the Permitted Hair Dye List of the Safety and Technical Standards. Compared with the original provisions, the revisions this time are as follows:
(1) The maximum permitted concentration for use in non-oxidative hair dye products has been reduced from the original 1% to 0.5%;
(2) Among other restrictions and requirements, “insoluble matter in water shall not be less than 0.4%” has been corrected to “insoluble matter in water shall not be greater than 0.4%.”
| Chapter and Section | Serial No. | Substance Name | Maximum concentration in ready for use preparation | Scope of Application and Restrictions | Wording of conditions of use and warnings | ||
| Chinese Name | INCI Name | Oxidative hair dye products | Non-oxidative hair dye products | ||||
| Chapter III, Part 4: Hair Dyes Allowed in Cosmetics (Table 7) | 37 | 酸性紫 43 号 (CI 60730) | Acid Violet 43 | 0.5% | The purity of the dye used shall not be less than 80%, and its impurity content must meet the following requirements:Volatile components (at 135°C), chlorides and sulfates (calculated as sodium salts): less than 18%Water-insoluble matter: not more than 0.4%1-hydroxy-9,10-anthracenedione: less than 0.2%p-Toluidine: less than 0.1%;p-toluidine sulfonic acids, sodium salts less than 0.2%, subsidiary colors less than 1%, lead less than 20 mg/kg, arsenic less than 3 mg/kg, mercury less than 1 mg/kg. | ||
3. Mercury and Its Compounds
Compared with the original provisions, the revisions this time are as follows:
(1) In Section 3.4 Hazardous Substance Limits of Chapter 1 of the Safety and Technical Standards, the original note for the hazardous substance mercury- “except eye cosmetics containing organic mercury preservatives”-has been deleted;
| Chapter | Hazardous Substance | Limit (mg/kg) | Notes |
| Chapter 1 Overview 3.4 Hazardous Substance Limit Requirements | Mercury | 1 | / |
(2) In the name of the prohibited ingredient list in Chapter 2 of the Safety and Technical Standards, “Mercury and Its Compounds (except mercury compounds in permitted preservatives),” the phrase “except mercury compounds in permitted preservatives” has been deleted, and the English name has been adjusted to “Mercury (CAS No. 7439-97-6) and its compounds”;
Note: The content in the original version of the Safety and Technical Standards for Cosmetics (2015 Edition) has not yet been modified. According to the “Announcement on Updating the Prohibited Ingredient List for Cosmetics (Announcement No. 74 of 2021)” issued by the NMPA on May 28, 2021, the original entry for mercury and its compounds in the prohibited ingredient list for cosmetics was as follows:
| Serial No. | Chinese Name | English Name |
| 888 | 汞及其化合物（化妆品准用防腐剂中的汞化合物除外） |
Mercury (CAS No. 7439-97-6) and its compounds, except those special cases included in preservatives allowed in cosmetic products |
(3) Entries No. 43 and No. 47 in Table 4 (Permitted Preservatives) of Chapter 3 of the Safety and Technical Standards have been abrogated. That is, two permitted preservatives for cosmetics — “Phenylmercury salts including Phenylmercuric Borate” and “Thimerosal” — have been reclassified as prohibited ingredients.
Effective Dates
- o-Phenylphenol and Its Salts, and Acid Violet 43 (CI 60730): effective from June 1, 2028;
- Mercury and Its Compounds standard: effective from July 1, 2026.
CIRS Reminder
In light of the revisions to the Safety and Technical Standards for Cosmetics, CIRS Group reminds relevant enterprises to pay attention to the following:
(1) Pay attention to the effective dates of the above standards. Before the standards take effect, cosmetics that have been manufactured or imported may continue to be sold until their expiration dates. Cosmetic registrants, filers, and manufacturers are encouraged to implement the above standards in advance.
(2) Focus on key changes including the differentiated concentration limits for o-phenylphenol and its salts, the addition of label warnings, the reduction of Acid Violet 43 concentration in non-oxidative hair dye products, the prohibition of mercury and its compounds, and the abrogation of relevant preservative entries. Enterprises should promptly assess product formulations to ensure that ingredients and products comply with regulatory requirements.
CIRS Group will continue to monitor revisions to the Safety and Technical Standards for Cosmetics and changes in Chinese cosmetics regulations, and will promptly release the latest updates.
Our Services
- China Cosmetic Registration and Filing (including Taiwan, China)
- China New Ingredient Registration and Filing
- China Toothpaste Filing
- China Cosmetic Safety and Efficacy Testing
- Domestic Responsible Person
- Safety Assessment Report
- Cosmetic Ingredient Safety Information Reporting Code Application
- Formula/Label/Ingredient Review
- Regulatory Consulting/Reports/Training
- Cosmetic Customs Clearance
Further information:
