China NIFDC Solicits Comments on Cosmetics Ingredients and Testing Methods in STSC

On August 6, 2026, the National Institutes for Food and Drug Control (NIFDC) publicly solicited comments on nine cosmetic standards invloving eight cosmetic ingredients and one testing method in Safety and Technical Standards for Cosmetics (STSC). The deadline for comments is September 7, 2026. CIRS Group has compiled and summarized the core content of the nine standards and the key points of their drafting explanations for your reference.

1. Trisodium NTA (Draft for Comment)

Trisodium NTA, with the English name Trisodium nitrilotriacetate, INCI name Trisodium NTA, and CAS No. 5064-31-3, is currently included in the Inventory of Existing Cosmetic Ingredients in China (IECIC). This revision proposes to add Trisodium NTA to the List of Prohibited Ingredients in Cosmetic Products (Table 1) of the Safety and Technical Standards for Cosmetics (STSC). After the adjustment, it will be consistent with the relevant regulations of the EU, the UK, the US, ASEAN and other countries or regions.

2. Methyl Pyrrolidone (Draft for Comment)

Methyl Pyrrolidone, with the English name N-Methyl-2-pyrrolidone, INCI name METHYL PYRROLIDONE, and CAS No. 872-50-4, is included in the IECIC.

Relationship with international standards of the same type: Based on the possible risk of reproductive toxicity, the EU includes Methyl Pyrrolidone in Annex II (list of substances prohibited in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009. ASEAN also prohibits the use of Methyl Pyrrolidone in cosmetics.

Relationship with existing Chinese standards: This revision proposes to add Methyl Pyrrolidone to the List of Prohibited Ingredients in Cosmetic Products  (Table 1) of the STSC. After the adjustment, it will be consistent with the relevant regulations of the EU and ASEAN.

3. Ethyl Butylacetylaminopropionate (Draft for Comment)

Ethyl Butylacetylaminopropionate, with the INCI name ETHYL BUTYLACETYLAMINOPROPIONATE and CAS No. 52304-36-6, is included in the IECIC. At the same time, the substance is registered under the name “驱蚊酯” (a mosquito-repellent active) on the China Pesticide Information Network.

Relationship with international standards of the same type: Ethyl Butylacetylaminopropionate is included in the EU glossary of common ingredient names used in cosmetic products and in the International Cosmetic Ingredient Dictionary and Handbook. The EU and the US have approved Ethyl Butylacetylaminopropionate for use in mosquito-repellent products.

Relationship with existing Chinese standards: This revision proposes to add Ethyl Butylacetylaminopropionate to the List of Prohibited Ingredients in Cosmetic Products.

4. Kojic Acid (Draft for Comment)

Kojic Acid, with the INCI name KOJIC ACID, is included in the IECIC.

Relationship with international standards of the same type: Based on the possible risk of endocrine disruption, Kojic Acid is included in Annex III (list of substances restricted in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009, with a maximum allowable concentration of 1% in face and hand products. The relevant use and management requirements of the UK are consistent with those of the EU.

Relationship with existing Chinese standards: This revision proposes to add Kojic Acid to the List of Restricted Ingredients for Cosmetics (Table 3) of the STSC, with a maximum allowable concentration of 1% in face (including neck) and hand products. After the adjustment, it will be basically consistent with the relevant regulations of the EU, the UK and other countries or regions.

5. Free Formaldehyde (Draft for Comment)

Formaldehyde, with the INCI name FORMALDEHYDE and CAS No. 50-00-0, is stipulated by the STSC as a prohibited substance in cosmetics. Note (1) d of the List of Preservatives Allowed in Cosmetic Prodcuts (Table 4) currently stipulates that all cosmetic products containing formaldehyde-releasing substances listed in this table shall, when the formaldehyde concentration in the finished product exceeds 0.05% (calculated as free formaldehyde), bear the words “contains formaldehyde” on the product label, and are prohibited in spray products.

Relationship with international standards of the same type: Based on the potential risk of sensitization, Annex V (list of preservatives allowed in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009 stipulates that all cosmetic products containing formaldehyde-releasing substances listed in this Annex shall, regardless of whether the finished product contains one or more formaldehyde-releasing substances, bear the words “releases formaldehyde” on the product label when the concentration of released formaldehyde in the finished product exceeds 0.001% (10 ppm).

Relationship with existing Chinese standards: This revision proposes to amend Note (1) d of the List of Preservatives Allowed in Cosmetic Products (Table 4) to read: “All cosmetic products containing formaldehyde-releasing substances listed in this table shall, when the formaldehyde concentration in the finished product exceeds 0.001% (calculated as free formaldehyde), bear the words ‘releases formaldehyde’ on the product label, and shall not be used in products that may present an inhalation risk.” After the adjustment, it will be basically consistent with the relevant EU regulations.

6. CI 42090 (Draft for Comment)

CI 42090, with the INCI name ACID BLUE 9. The STSC stipulates that it may be used as a colorant permitted for use in cosmetics, with the C.I. generic Chinese name “Food Blue 2” (食品蓝2) and a use scope of all types of cosmetics. The other restrictions and requirements are: the total amount of 2-, 3- and 4-Formyl benzene sulfonic acids shall not exceed 1.5%; 3-(Ethyl(4-sulfophenyl)amino)methyl benzene sulfonic acid shall not exceed 0.3%; Leuco base shall not exceed 5.0%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline).

Relationship with existing Chinese standards: This revision proposes to add CI 42090 to the List of Hair-dyes Allowed in Cosmetic Prodcuts (Table 7) of the STSC, with a maximum allowable concentration of 0.5% when used in non-oxidative hair dye products. The other restrictions and requirements are: the purity of the dye used shall be not less than 85%; the total amount of 2-, 3- and 4-Formyl benzene sulfonic acids shall not exceed 1.5%; 3-(Ethyl(4-sulfophenyl)amino)methyl benzene sulfonic acid shall not exceed 0.3%; Leuco base shall not exceed 5.0%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline).

Relationship with international standards of the same type: CI 42090 is included in both Annex III (list of substances restricted in cosmetic products) and Annex IV (list of colorants allowed in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009. Annex III stipulates a maximum concentration of 0.5% in non-oxidative hair dye products. Annex IV stipulates that its purity shall meet the relevant requirements of the former European Commission Directive 95/45/EC, namely: the dye purity shall be not less than 85%; the total amount of 2-, 3- and 4-Formyl benzene sulfonic acids shall not exceed 1.5%; 3-(Ethyl(4-sulfophenyl)amino)methyl benzene sulfonic acid shall not exceed 0.3%; Leuco base shall not exceed 5.0%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline), etc. The relevant purity requirements of the US are basically consistent with those of the EU.

7. CI 42520 (Draft for Comment)

CI 42520, with the INCI name BASIC VIOLET 2. The STSC stipulates that it may be used as a colorant permitted for use in cosmetics, with the C.I. generic Chinese name “Basic Violet 2” (碱性紫2).

Relationship with existing Chinese standards: This revision proposes to add CI 42520 to the List of Hair-dyes Allowed in Cosmetic Products (Table 7) of the STSC, with a maximum allowable concentration of 1.0% in oxidative hair dye products and 0.5% in non-oxidative hair dye products. After the adjustment, it will be consistent with the relevant regulations of the EU, ASEAN and other countries or regions.

Relationship with international standards of the same type: CI 42520 is included in both Annex III (list of substances restricted in cosmetic products) and Annex IV (list of colorants allowed in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009. The use and management requirements for CI 42520 in Annex III are: a maximum allowable concentration of 1.0% in oxidative hair dye products and 0.5% in non-oxidative hair dye products. The relevant ASEAN use and management requirements are consistent with those of the EU.

8. CI 19140 (Draft for Comment)

CI 19140, with the INCI name ACID YELLOW 23. The STSC stipulates that it may be used as a colorant permitted for use in cosmetics, with the C.I. generic Chinese name “Food Yellow 4” (食品黄4).

Relationship with existing Chinese standards: CI 19140 is already included in the List of Colorants Allowed in Cosmetic Products (Table 6) of the STSC, with the C.I. generic Chinese name “Food Yellow 4” (食品黄4), a use scope of all types of cosmetics, and the following other restrictions and requirements: the total amount of 4-Hydrazinobenzene sulfonic acid, 4-Aminobenzene-1-sulfonic acid, 5-Oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid, 4,4’-Diazoaminodi(benzene sulfonic acid) and Tetrahydroxy succinic acid shall not exceed 0.5%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline). 

At the same time, this revision proposes to add CI 19140 to the List of Hair Dyes Permitted for Use in Cosmetics (Table 7) of the STSC, with a maximum allowable concentration of 0.5% in non-oxidative hair dye products, and the following other restrictions and requirements: the purity of the dye used shall be not less than 85%; the total amount of 4-Hydrazinobenzene sulfonic acid, 4-Aminobenzene-1-sulfonic acid, 5-Oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid, 4,4’-Diazoaminodi(benzene sulfonic acid) and Tetrahydroxy succinic acid shall not exceed 0.5%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline). After the adjustment, it will be basically consistent with the relevant EU regulations.

Relationship with international standards of the same type: CI 19140 is included in both Annex III (list of substances restricted in cosmetic products) and Annex IV (list of colorants allowed in cosmetic products) of the EU Cosmetic Regulation (EC) No 1223/2009. Annex III stipulates a maximum allowable concentration of 0.5% in non-oxidative hair dye products, and the relevant ASEAN use and management requirements are consistent with those of the EU. Annex IV stipulates that its purity shall meet the relevant requirements of the former European Commission Directive 95/45/EC: the dye purity shall be not less than 85%; water-insoluble matter shall not exceed 0.2%; the total amount of 4-Hydrazinobenzene sulfonic acid, 4-Aminobenzene-1-sulfonic acid, 5-Oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid, 4,4’-Diazoaminodi(benzene sulfonic acid) and Tetrahydroxy succinic acid shall not exceed 0.5%; and unsulfonated primary aromatic amines shall not exceed 0.01% (calculated as aniline), etc.

9. Skin Sensitization Test Method (Draft for Comment)

Scope

This method specifies the basic principles, requirements and procedures of the animal skin sensitization test. This method is applicable to the safety toxicological testing of cosmetic ingredients and their products.

Relationship with existing relevant standards in China

Existing skin-sensitization-related standards published in China include Chapter 6 Toxicological Test Method No. 6 “Skin Sensitization Test” of the STSC; the national standard GB/T 21608-2025 “Chemicals - Skin Sensitization Test Method”; and Chapter 6 Toxicological Test Methods Nos. 22 “Skin Sensitization: Local Lymph Node Assay: DA”, 23 “Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA”, 24 “In Vitro Skin Sensitization of Cosmetic Ingredients: Direct Peptide Reactivity Assay”, 26 “In Vitro Skin Sensitization: Human Cell Line Activation Test Method”, 27 “In Vitro Skin Sensitization: Amino Acid Derivative Reactivity Assay Method”, 37 “In Vitro Skin Sensitization: U937 Cell Activation Test Method”, 45 “In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test Method”, 46 “In Vitro Skin Sensitization: Kinetic Direct Peptide Reactivity Assay Method” and 50 “Skin Sensitization: Local Lymph Node Assay: BrdU-FCM” of the STSC.

During the drafting of this method, the “Skin Sensitization Test” in the STSC was revised with reference to the above existing relevant Chinese standards.

Comparison with the original method in the STSC

Compared with the original method, the main revisions include: (1) refining the relevant requirements for the reliability check of the test method — for the occluded (closed) patch application method, the positive rate was changed from 30% to 15%, and for the intradermal injection method, the positive rate was changed from 60% to 30%; unnecessary positive control substances were deleted; (2) clarifying the observation time-point requirements separately in the result evaluation; (3) specifying the number of animals in the positive control group; and (4) revision and refinement of some textual expressions.

Relevant international standards

In July 2022, the Organisation for Economic Co-operation and Development (OECD) released an update to TG 406 Skin Sensitisation. To align with international standards, this project referenced OECD TG 406 when revising the “Skin Sensitization Test” in the STSC, and the technical content remains basically consistent.

CIRS Reminder

This consultation on the nine cosmetic standards covers revisions in areas including ingredient prohibitions and restrictions, label warnings, and skin sensitization test methods, with many technical requirements benchmarked against overseas regulations such as those of the EU and ASEAN.

Specifically, Trisodium NTA and Methyl Pyrrolidone are proposed to be added to the prohibited list; a maximum concentration limit is set for Kojic Acid; the labeling threshold for free formaldehyde is lowered; several CI colorants gain new hair dye uses; and the judgment criteria of the skin sensitization toxicological test are updated.

It is recommended that cosmetic enterprises promptly review their existing product formulations, assess the impact on ingredient substitution, formulation adjustment and label compliance, and make early arrangements for formulation optimization, product filing documentation updates and other related work.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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