On April 15, 2026, China's National Institute for Food and Drug Control (NIFDC) issued the Technical Guideline for Research on Hair Perming Cosmetics (Trial) and the Technical Guideline for Research on Quality Control Requirements for Hair Perming Cosmetics (Trial).
Based on both guidelines and the cosmetics regulatory framework, CIRS provides a thorough analysis of the technical essentials across nine key areas for hair-perming cosmetics: definitions, classification, product naming, formulation, quality control standards, registration testing, labeling claims, safety assessment, and efficacy evaluation, assisting enterprises in achieving precise registration and compliant market entry.
I. Definitions and Classification
Hair-perming cosmetics refer to cosmetics intended to alter the curl degree of hair (curling or straightening) and maintain a relatively stable result. Products that restore the original hair shape upon washing are not classified in this category.
In the classification coding, the efficacy claim must include at least "hair perming"; the application site must correspond exclusively to hair; and the target population must not include infants or children.
II. Product Naming
The Chinese product name must generally consist of three parts: trademark name, generic name, and attribute name. Information such as fragrance and applicable hair type may be added after the attribute name. Conventional names may omit the generic name or attribute name.
Chinese names must not use letters, pinyin, numerals, or symbols for naming purposes (except for registered trademarks, series numbers, or other necessary applications). The use of terms that do not comply with the requirements of the Measures for the Administration of Cosmetic Labels must be avoided, such as "French Perm," "Quick Perm," "Botanical Conditioning Type," or "Protein Nourishing Type."
Where the trademark name, generic name, or attribute name is compliant when used individually but may cause ambiguity when combined, an explanatory note must be provided on the visible surface of the sales packaging.
For imported products with foreign-language names, the correspondence between the foreign name and the Chinese name must be explained in the product naming basis.
III. Product Formulation
1. Ingredients
The selection, use, and dosage of ingredients must be consistent with the product dosage form characteristics and comply with the requirements of the Safety and Technical Standards for Cosmetics and other relevant regulations and technical standards. The intended use must be consistent with the physicochemical properties of the ingredients and the product attributes.
(1) Ingredient Safety Information
Adequate research must be conducted on key aspects of the ingredients used, including basic information, risk information, and quality control. All ingredients used must comply with the technical standards or quality specifications set forth in the Safety and Technical Standards for Cosmetics and relevant mandatory national standards.
(2) New Cosmetic Ingredients Under Monitoring Period
When using new cosmetic ingredients that are still within the monitoring period, authorization from the registrant/filer of the new ingredient must be obtained. The application of the ingredient must be consistent with the intended use, applicable scope, safe usage level, and other restrictions and requirements as declared during the registration or filing of the new ingredient.
(3) Efficacy Ingredients for Hair Perming
Hair perming cosmetics alter hair curl degree through a reduction reaction that breaks the disulfide bonds of hair keratin, followed by an oxidation reaction that reconnects them after the hairstyle is adjusted.
The primary efficacy ingredients are thiol-containing perming agents (e.g., cysteamine hydrochloride, mercaptopropionic acid, and thioglycolic acid and its salts and esters). According to the Safety and Technical Standards for Cosmetics, the maximum permitted concentrations of thioglycolic acid and its salts and esters are: 8% (calculated as thioglycolic acid) for general-use perming products, and 11% (calculated as thioglycolic acid) for professional-use perming products.
2. Formulation
Hair perming cosmetics typically consist of two components: a curling/straightening agent (using thioglycolic acid derivatives as reducing agents) and a neutralizing/fixing agent (using hydrogen peroxide or sodium bromate as oxidizing agents), supplemented with fragrances, chelating agents, and thickeners.
The formulation design must be scientifically sound, ensuring the safety, stability, and efficacy of the product throughout its shelf life. For products composed of multiple components used in combination, the necessity, rationality, and scientific validity must be adequately studied.
Imported products specifically designed for the Chinese market (excluding those commissioned by domestic entities for overseas production) must conduct formulation studies targeting Chinese consumers.
IV. Manufacturing Process
The manufacturing process must be designed based on the product dosage form characteristics, with full consideration of the physicochemical properties of the ingredients, ensuring uniform mixing of materials. The process description must be complete and clear, reflecting the main steps of actual production and specifying key process parameters.
Characteristic steps must be highlighted in conjunction with product features and actual production processes. For example, for emulsion-type hair perming cosmetics such as creams and lotions, the emulsification step must be clearly specified.
V. Quality Control Standards
In light of the actual conditions of product manufacturing, quality control, formulation, manufacturing process, and stability, scientifically sound, reasonable, and feasible items and indicators that reflect product safety and quality controllability must be established under the "Microbiological and Physicochemical Indicators and Quality Control Measures" section of the product standards document.
1. Items and Indicators
In principle, the items must be no fewer than the testing items specified in the Measures for the Administration of Cosmetic Registration and Filing Testing.
(1) Harmful Substances
Indicators for mercury, lead, arsenic, and cadmium, must be established in accordance with the Safety and Technical Standards for Cosmetics. When the formulation contains ingredients with ethoxylated structures (e.g., ethoxy diglycol, polyethers, polysorbates, etc.), a dioxane indicator must be established; when the combined content of ethanol and isopropanol is ≥10% (w/w), a methanol indicator must be established.
(2) pH Value
A scientifically sound control range must be determined based on the formulation and actual manufacturing process of the hair perming cosmetic, and must comply with the requirements of the Safety and Technical Standards for Cosmetics.
When the product contains thioglycolic acid and its salts, the pH must be controlled within 7.0–9.5; when the product contains thioglycolic acid esters, the pH must be controlled within 6.0–9.5. The control range must not be excessively broad.
For neutralizing/fixing agents used in conjunction with perming agents, as they are used separately from the perming agents, to avoid safety risks associated with strong acidity, the lower limit of the pH control range must be greater than 2.0 and must not include 2.0.
(3) Efficacy Ingredients
When the product contains thioglycolic acid, thioglycolate salts, or thioglycolic acid esters, the thioglycolic acid indicator must be controlled. The maximum permitted concentration must comply with the requirements of the Safety and Technical Standards for Cosmetics: the total maximum allowed concentration for general-use perming products is 8% (calculated as thioglycolic acid), and for professional-use perming products is 11% (calculated as thioglycolic acid). The control range must be specified based on the formulated usage level – for example, if the formulated level is 10.5%, the control range may be set at 8.4%–11%. If the indicator is set as "thioglycolic acid" while the formulation contains salts/esters, appropriate conversion must be noted.
(4) Other Items
Additional indicators may be established based on manufacturing process and quality control characteristics to ensure product quality and efficacy.
2. Quality Management Measures
All quality control indicators must be subject to at least one quality management measure, and the specific implementation plan must be further elaborated in the "Brief Description" section of the product standards document. Measures may be implemented through testing or non-testing approaches.
(1) Testing Approaches
Testing approaches include, but are not limited to, batch-by-batch testing, type testing, and full-item testing, with reasonable testing frequencies to be specified.
The Safety and Technical Standards for Cosmetics specifies three methods for the determination of thioglycolic acid content, namely "Method I: High-Performance Liquid Chromatography (HPLC)," "Method II: Ion Chromatography," and "Method III: Chemical Titration." The specific testing method must be clearly specified in the quality management measures.
When using chemical titration, certain substances such as mercaptopropionic acid and cysteine may interfere with the determination, leading to inaccurate results. Therefore, when the product formulation contains such compounds, chemical titration must not be selected; HPLC or ion chromatography must be used instead.
When using testing methods other than those specified in the Safety and Technical Standards for Cosmetics, method validation must be conducted, and the data must be archived for future reference.
(2) Non-Testing Approaches
Non-testing approaches include, but are not limited to, ingredient-related indicator control, and manufacturing process control. The ingredient control approach must be consistent with the quality specification documents; the manufacturing process control must be consistent with the relevant indicators.
For hair perming cosmetics containing thioglycolic acid and its salts or thioglycolic acid esters, the quality management measures must not rely solely on "ingredient-related indicator control." However, "manufacturing process control" or a combination of non-testing and testing approaches can be adopted.
3. Other Requirements
When conducting product quality control studies, sensory indicators (such as color, appearance, and odor), storage conditions, and shelf life must also be considered to ensure stable and controllable quality.
VI. Product Testing
The testing institutions, testing procedures, testing items, testing methods, testing reports, and report format must all comply with the requirements of the Safety and Technical Standards for Cosmetics, the Measures for the Administration of Cosmetic Registration and Filing Testing, and other relevant documents. The testing items must be no fewer than those required by the Measures. The basic information in the testing reports, such as the product Chinese name, enterprise name, and manufacturing address, must be consistent with the information in the Cosmetic Registration and Filing Information Form.
VII. Labeling and Claims
The labels of hair perming cosmetics must comply with the requirements of the Regulations on the Administration of Cosmetics, the Measures for the Administration of Cosmetic Labels, the Standards for the Evaluation of Cosmetic Efficacy Claims, the Safety and Technical Standards for Cosmetics, and other relevant regulations and national standards.
The labels must at least include: the product Chinese name, special cosmetics registration certificate number, relevant information of the registrant/domestic responsible person/manufacturer, product standards number, full ingredient list, net content, shelf life, directions for use, necessary safety warnings, and other information required by laws, administrative regulations, and mandatory national standards.
For imported products with affixed Chinese labels, the content on the Chinese labels relating to product safety and efficacy claims must correspond to the relevant content on the original labels. If inconsistent, packaging and labels specifically designed for the Chinese market must be used.
Efficacy claims must be scientifically sound and avoid exaggeration; claims regarding ingredient efficacy or mechanisms of action must be consistent with the supporting evidence for the relevant ingredients. Medical terminology or implications of medical effects must not be used; exaggerated or absolute claims must not be made.
VIII. Safety Assessment
Product safety assessment must be conducted in accordance with the Technical Guidelines for Safety Assessment of Cosmetics, based on all ingredients and known risk substances in the declared formulation, taking into account information such as the method of use, site of application, and exposure level. The safety assessment report must be complete and standardized. The types of evidence for safety assessment must comply with the requirements of the Guideline on the Use of Data for Cosmetic Ingredients and other relevant documents.
Under the current cosmetics regulatory and safety assessment framework, in addition to the routine safety assessment of ingredient usage levels and harmful substances, three key supporting studies must be conducted: stability testing, preservative challenge testing, and packaging compatibility testing. The NIFDC has already issued three technical documents in July 2024 – the Technical Guide for the Evaluation of Cosmetic Stability Testing, the Technical Guide for the Evaluation of Cosmetic Preservative Challenge Testing, and the Technical Guide for the Evaluation of Cosmetic and Packaging Compatibility Testing – providing clear technical guidance for the above studies.
IX. Efficacy Evaluation
Efficacy studies for hair perming cosmetics must be conducted in conjunction with the product formulation design and manufacturing process, ensuring that the product achieves the intended effects under conditions of use. Hair perming cosmetics generally consist of two components. Single-component hair perming cosmetics must be evaluated for their perming efficacy based on the perming mechanism.
Appendix: Comparison Between the Official Versions and the Drafts for Comments of the Two Technical Guidelines
Technical Guideline for Research on Hair Perming Cosmetics
| Official Version (Trial) | Draft for Comments (July 2025 Version) |
| (I) Quality Controllability Studies 1. Ingredients The selection, use, and dosage of ingredients must be consistent with the product dosage form characteristics and comply with the Technical Standards and other relevant regulations and technical standards. The primary intended use must be specified based on the main role the ingredient actually plays in the product, ensuring that the intended use is consistent with the physicochemical properties of the ingredient and the product attributes. |
(I) Quality Controllability Studies 1. Ingredients The selection, use, and dosage of ingredients must be considered in conjunction with the product dosage form and comply with the Technical Standards and other relevant regulations and technical standards. The primary intended use must be specified based on the main role the ingredient actually plays in the product, ensuring that the intended use is consistent with its physicochemical properties, product attributes, formulation process, etc. |
| (1) Ingredient Safety Information Adequate research must be conducted on key aspects of the ingredients used, including basic information, risk information, and quality control. Ensuring that the ingredients are safe, effective, and that product quality is stable. All ingredients used must comply with the relevant requirements for technical standards or quality specifications set forth in mandatory national standards and the Technical Standards. |
(1) Ingredient Safety Information The registrant must, through research, clarify key aspects of the ingredients used, including basic information, risk information, and quality control, ensuring the safety, efficacy, and stability of product quality. Where the Technical Standards and relevant regulations have specific requirements for the technical standards or quality specifications of ingredients, such requirements must be complied with. |
| 3. Manufacturing Process and Quality Control (1) Manufacturing Process The manufacturing process must be designed based on the product dosage form characteristics, with full consideration of the physicochemical properties of the ingredients, ensuring uniform mixing of materials. The process description must be complete and clear, reflecting the actual production's main steps, with key process parameters clearly specified; characteristic steps must be highlighted in conjunction with product features and actual production processes, such as for emulsion-type hair perming cosmetics such as creams and lotions, the emulsification step must be clearly specified. |
3. Manufacturing Process and Quality Control (1) Manufacturing Process The manufacturing process must be designed based on the product dosage form characteristics, with full consideration of the physicochemical properties of the ingredients, ensuring uniform mixing of materials. The process description must be complete and clear, reflecting the actual production's main process; all formulation ingredients and key process parameter ranges must be clearly specified in the production steps; characteristic steps must be highlighted in conjunction with product features and actual production processes, such as for emulsion-type hair perming cosmetics such as creams and lotions, the emulsification step must be clearly specified. |
| 3. Manufacturing Process and Quality Control (2) Quality Control In principle, quality control indicators must include at least the physicochemical testing items specified in the Testing Measures. |
3. Manufacturing Process and Quality Control (2) Quality Control In principle, the items established must be no fewer than the testing items required by the Testing Measures. |
| (II) Safety Studies 2. Safety Assessment The types of evidence for safety assessment must comply with the requirements of the Guideline on the Use of Data for Cosmetic Ingredients and other relevant documents. Assessment may be conducted with reference to the Technical Guidelines and their supporting guideline documents. |
(II) Safety Studies 2. Safety Assessment The types of evidence for safety assessment must comply with the requirements of the Guideline on the Use of Data for Cosmetic Ingredients and other relevant documents. Assessment may be conducted with reference to the Guidelines for Submission of Cosmetic Safety Assessment Data, Information on Ingredient Use in Marketed Products, Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Method, and Technical Guidelines for the Application of the Read-Across Method and other relevant technical documents. |
| (III) Efficacy Studies Single-component hair perming cosmetics must be studied for their perming efficacy based on the perming mechanism. |
(III) Efficacy Evaluation Studies Single-component hair perming cosmetics must undergo thorough evaluation of product efficacy based on the perming mechanism. |
| 3. Labeling and Claims Efficacy claims must be scientifically sound and avoid exaggeration; |
3. Labeling and Claims Where product efficacy is claimed, such claims must be scientifically sound and avoid exaggeration; |
Technical Guideline for Research on Quality Control Requirements for Hair Perming Cosmetics
| Official Version (Trial) | Draft for Comments (July 2025 Version) |
| (I) Stability Studies Stability studies must, in light of product characteristics, select items that are susceptible to change during storage and may affect product quality, safety, and efficacy, such as the patterns of change over time of indicators including product appearance and efficacy ingredient (perming agent) content under the influence of conditions such as temperature and humidity. In addition, the impact of packaging materials on product quality must be fully considered. |
(I) Stability Studies Stability studies must select items that are susceptible to change during storage and may affect product quality, safety, and efficacy, including but not limited to observing the patterns of change over time of indicators such as product appearance and efficacy ingredient (perming agent) content under the influence of conditions such as temperature, humidity, and light. |
| (II) Quality Control Items and Indicators Studies 3. Efficacy Ingredients When the formulation contains thioglycolate salts, thioglycolic acid esters, etc., and the controlled item indicator in the "Microbiological Indicators and Physicochemical Indicators" of the product standards is "thioglycolic acid," attention must be paid to the conversion between the two. |
(II) Quality Control Items and Indicators Studies 3. Efficacy Ingredients When the formulation contains thioglycolate salts, thioglycolic acid esters, etc., and the controlled item indicator in the "Microbiological Indicators and Physicochemical Indicators" of the product standards is "thioglycolic acid," attention must be paid to the conversion between the two. For perming products whose formulations do not contain thioglycolic acid and its salts or esters, the thioglycolic acid content in the product must also be tested. |
| (II) Quality Control Items and Indicators Studies 4. Other Items Relevant items and indicators may be controlled in the product standards based on the manufacturing process and quality control characteristics of hair perming cosmetics, ensuring product quality and efficacy. |
(II) Quality Control Items and Indicators Studies 4. Other Items The registrant may control relevant items and indicators in the product standards based on the manufacturing process and quality control characteristics of hair perming cosmetics, such as heat resistance/cold resistance performance, ensuring product quality and efficacy. |
| (III) Quality Management Measures Studies 1. Testing Approaches When adopting testing approaches as quality management measures, appropriate testing methods must be selected. Section 3.9, Chapter IV of the Technical Standards specifies three methods for the determination of thioglycolic acid content, namely "Method I: High-Performance Liquid Chromatography (HPLC)," "Method II: Ion Chromatography," and "Method III: Chemical Titration." The specific testing method must be clearly specified in the quality management measures. |
(III) Quality Management Measures Studies 1. Testing Approaches When adopting testing approaches as quality management measures, appropriate testing methods must be selected. Section 3.9, Chapter IV of the Technical Standards specifies three methods for the determination of thioglycolic acid content, namely "Method I: Test Method for Thioglycolic Acid and 7 Other Ingredients in Cosmetics," "Method II: Ion Chromatography," and "Method III: Chemical Titration." The specific testing method must be clearly specified in the quality management measures. |
| (III) Quality Management Measures Studies 2. Non-Testing Approaches For hair perming cosmetics containing thioglycolic acid and its salts or thioglycolic acid esters, the quality management measures must not rely solely on "ingredient-related indicator control." However, "manufacturing process control" or a combination of non-testing and testing approaches may be adopted as quality management measures. |
(III) Quality Management Measures Studies 2. Non-Testing Approaches As an efficacy ingredient, thioglycolic acid must not rely solely on "ingredient-related indicator control" as its quality management measure. A combination of non-testing and testing approaches may be adopted as quality management measures, such as "manufacturing process control" combined with testing approaches, or "ingredient-related indicator control" combined with testing approaches, etc. |
CIRS Reminder
Compared with the drafts for comments, the official versions of the two technical guidelines for hair perming cosmetics have been refined and adjusted in multiple key areas, including the expression of ingredient safety information, manufacturing process parameter requirements, and efficacy evaluation requirements. Relevant enterprises are advised to promptly monitor the key revisions, precisely manage compliance risks, ensure products meet the latest regulatory requirements, and steadily advance the compliant market entry process.
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