On July 31, 2025, the National Institutes for Food and Drug Control (NIFDC) released six draft Technical Guidelines for public consultation, including the Technical Guidelines for the Study of Hair Dye Cosmetics (Trial). In terms of perm hair cosmetics, according to the relevant guidelines, the definition and classification of them have been clarified. Following content would also provide a comprehensive overview and interpretation in the following eight aspects, covering:
- Product name,
- Formulation,
- Manufacturing process,
- Quality control standards,
- Registration testing,
- Labeling and claims,
- Safety assessment, and
- Efficacy evaluation.
It aims to help enterprises stay informed of regulatory changes and ensure smooth compliance with evolving supervision requirements.
Definition and Classification
Perm hair cosmetics refer to cosmetic products used to alter the curvature of hair (either curling or straightening) and maintain the changed shape for a relatively stable period. These products are characterized by their ability to return the hair to its original form after washing.
In classification coding, the claimed efficacy must include “perm”, and the site of action must be limited to the hair. The target user group should not include infants or children.
I. Product Name
The Chinese product name generally consists of three parts: brand name, generic name, and attribute name. Additional information, such as fragrance or suitable hair type, may be indicated after the attribute name as needed. For commonly accepted or traditionally used cosmetic names, the generic or attribute name may be omitted.
Chinese product names must not include letters, Pinyin, numbers, symbols, or similar elements (except in cases where they are part of a registered trademark, indicate a series number, or are otherwise necessary). If such elements must be used, a valid trademark registration certificate should be provided, and the meaning must be clearly explained on the visible panel of the product’s sales packaging.
If the brand name, generic name, or attribute name is used individually and complies with relevant requirements, but their combination may cause consumer misunderstanding regarding product efficacy, an explanatory note must be provided on the visible panel of the sales packaging.
For imported products with foreign-language names, a reasonable explanation of the foreign name and its correspondence to the Chinese name must be included in the naming rationale.
II. Product Formula
1. Ingredients
The selection, use, and dosage of ingredients shall be consistent with the product’s formulation type and comply with the Safety and Technical Standards for Cosmetics and other relevant laws, regulations, and technical standards. The primary function of each ingredient shall be clearly defined based on its actual role in the product, and its intended use must align with its physicochemical properties, product characteristics, and formulation process.
(1) Ingredient Safety Information
The basic information, risk profile, and quality control measures of each ingredient shall be clearly identified through research to ensure the safety and efficacy of the ingredient, as well as the stability of product quality. Where technical standards or quality specifications for ingredients are clearly stipulated in the Safety and Technical Standards for Cosmetics or other relevant regulations, such requirements must be met.
(2) New Cosmetic Ingredients Under Monitoring
When using new cosmetic ingredients that are still within the monitoring period, the registrant shall obtain authorization from the registrant or filer of the new ingredient. The use of such ingredients must comply with the intended use, applicable scope, safe use level, and other restrictions and requirements as specified in the original registration or filing of the new ingredient.
(3) Active Ingredients for Perming Efficacy
The mechanism of action for perming cosmetics is based on a redox (reduction-oxidation) reaction. First, the disulfide bonds in keratin molecules of the hair are broken through a reduction reaction. Then, under the reshaped hair form (e.g., curled or straightened), the disulfide bonds are reformed via an oxidation reaction, thereby achieving the purpose of altering the hair’s curvature.
Active ingredients responsible for perming effects are typically thiol-containing agents, such as cysteamine hydrochloride, thioglycolic acid, thiolactic acid, and their corresponding salts and esters. Among them, the use levels of thioglycolic acid and its salts and esters must comply with the requirements specified in the Cosmetic Safety Technical Specification (CSTS):
For general-use perming products, the maximum allowed concentration is 8% (calculated as thioglycolic acid); For professional-use perming products, the maximum allowed concentration is 11% (calculated as thioglycolic acid).
2. Formulation
Perming cosmetics typically consist of two components. The waving (or straightening) agent formulation usually contains thioglycolic acid and its salts or esters as reducing agents, while the neutralizer formulation generally uses oxidizing agents such as hydrogen peroxide or sodium bromate. Various auxiliary ingredients such as fragrances, chelating agents, and thickeners are also added to complete the formulation.
The formulation should be scientifically and rationally designed and fully optimized to ensure the product’s safety, stability, and efficacy throughout its shelf life. For multi-component products that must be used in combination, comprehensive research should be conducted to justify the necessity, rationality, and scientific basis of their combined use.
For imported products specifically designed for the Chinese market (excluding those manufactured overseas under domestic commission), formulation development should include research tailored to Chinese consumers. Such research should demonstrate the necessity of designing the formulation specifically for the Chinese market, outline the relevant R&D efforts undertaken, and be consistent with the actual product development practices.
III. Manufacturing Process
The manufacturing process should be designed in accordance with the characteristics of the product dosage form, with full consideration given to the physicochemical properties of raw materials to ensure uniform mixing. The process description should be complete and clearly articulated, accurately reflecting the main steps of actual production. All ingredients listed in the formulation and the range of key process parameters must be explicitly specified within the production steps.
In addition, the process should highlight any characteristic steps based on the product type and actual manufacturing practices. For example, in the case of perming cosmetics in cream, lotion, or emulsion form, the emulsification step should be clearly identified and described in detail.
IV. Quality Control Standards
1. Items and Specifications
The established quality control items and specifications shall be clear and specific, and in principle, shall not be less than the testing items stipulated in the Specifications for Inspection Work Standards for the Registration and Filing of Cosmetics.
(1) Hazardous Substances
Physicochemical testing items and specifications for hazardous substances such as mercury, lead, arsenic, and cadmium shall be established in accordance with the Safety and Technical Standards for Cosmetics.
If the formula contains ethoxylated ingredients—such as phenoxyethanol, ethoxydiglycol, polyethylene glycols (PEGs), polyethers, or polysorbates—testing for 1,4-dioxane shall be included with appropriate limits. If the combined content of ethanol and isopropanol in the formula is equal to or greater than 10% (w/w), methanol shall be included as a testing item with specified limits.
(2) pH Value
Perm hair cosmetics typically consist of two components. According to the Specifications for Cosmetic Registration and Notification Testing, for multi-component products that require pH testing, pH values shall be measured not only for each individual component but also for the mixture prepared according to the instructions for use.
When the formula contains thioglycolic acid and/or its salts, the pH should be controlled within the range of 7.0 to 9.5. When the formula contains thioglycolic acid esters, the pH should be controlled within the range of 6.0 to 9.5.
To ensure product quality, the pH control range should not be excessively broad and should be reasonably set based on the actual characteristics of the product. For styling agents or other products used in conjunction with perm agents but applied separately, the lower limit of the pH specification shall be greater than 2.0 and shall not include 2.0, in order to avoid potential safety risks associated with strong acidity.
(3) Active Ingredients
The primary functional ingredient in perm hair cosmetics refers to the perming agent. When the product formula contains thioglycolic acid, thioglycolates (salts of thioglycolic acid), or thioglycolic acid esters, the specification for thioglycolic acid shall be controlled, and its upper content limit must comply with the requirements specified in the Safety and Technical Standards for Cosmetics (STSC).
In addition, the specific control range of thioglycolic acid should be clearly defined based on its usage level in the formulation. The control range should be reasonable and expressed in a standardized manner. For example, if the usage level of thioglycolic acid in a professional-use perm product is 10.5%, the control range may be set at 8.4% to 11%, corresponding to 80%-100% of the maximum permitted concentration under the STSC.
If the formula contains thioglycolates or thioglycolic acid esters and the controlled specification item is “thioglycolic acid”, appropriate conversion between these substances and thioglycolic acid must be applied.
Even for perm products that do not contain thioglycolic acid, its salts, or esters in the formulation, the content of thioglycolic acid in the final product shall still be tested.
(4) Other Items
In accordance with the manufacturing process and quality control characteristics of perm hair cosmetics, relevant items and specifications-such as heat resistance and cold resistance-should be included and controlled in the product's implemented standards.
2. Quality Management Measures
Each control indicator shall be supported by at least one quality management measure, with a brief explanation detailing the specific implementation plan. Quality management measures may include inspection-based or non-inspection-based approaches. Inspection-based measures include, but are not limited to, batch-by-batch inspection, type inspection, and comprehensive inspection, with clearly defined and reasonable inspection frequencies. Non-inspection-based measures include, but are not limited to, control of relevant raw material specifications and management of the production process.
(1) Testing Methods
When adopting testing approaches as quality management measures, appropriate test methods should be selected. Chapter 4, Section 3.9 of the Safety and Technical Standards for Cosmetics specifies three analytical methods for determining the content of thioglycolic acid, namely: Method I: Test method for thioglycolic acid and seven other raw materials in cosmetics; Method II: Ion chromatography; Method III: Chemical titration. The specific test method adopted shall be clearly specified in the quality management measures.
When using Method III (chemical titration), certain substances such as thiolactic acid and cysteine may interfere with the determination, leading to inaccurate results. Therefore, if such compounds are present in the product formulation, Method III should not be used. Instead, Method I (high-performance liquid chromatography) or Method II (ion chromatography) should be selected for the determination of thioglycolic acid content.
If a test method other than those specified in the Safety and Technical Standards for Cosmetics is adopted as a quality management measure, the method must be validated against the corresponding official method(s) described in the Standards. The validation results should meet relevant requirements, and the complete test method along with the method validation documentation shall be properly archived for future reference.
(2) Non-Testing Methods
When non-testing approaches are adopted as quality management measures, specific and reasonable implementation plans shall be clearly defined to ensure that the product complies with the applicable product standards.
If raw material control is used, the implementation plan shall be consistent with the quality and safety information of the raw materials. If production process control is used, the implementation plan shall align with the relevant quality control items and specifications.
As thioglycolic acid is an efficacy ingredient, it should not be managed solely through “control of raw material-related specifications” as the quality management measure. Instead, a combination of non-testing-based and testing-based measures should be adopted, such as combining “production process control” with testing methods, or combining “control of raw material-related specifications” with testing methods.
3. Other Requirements
In conducting product quality control studies, additional factors such as sensory attributes (e.g., color, appearance, odor), storage conditions, and shelf life should also be taken into consideration to ensure the stability and controllability of product quality.
V. Registration Testing
The testing institution, procedures, items, methods, test reports, and formatting involved in product registration testing shall comply with the requirements of relevant documents such as the Safety and Technical Standards for Cosmetics and the Testing Specifications. The testing items shall be no fewer than those required in the Testing Specifications. Basic information included in the test report-such as the product’s Chinese name, company name, and manufacturing address-shall be consistent with the information provided in the Cosmetic Registration and Notification Information Form.
VI. Labeling and Claims
The product name and labeling claims of perm (hair waving) cosmetics shall comply with the requirements of relevant regulations and national standards, including the Regulations on the Supervision and Administration of Cosmetics, the Measures for Administration of Cosmetics Labeling, the Safety and Technical Standards for Cosmetics, and the Standard for the Evaluation of Cosmetic Efficacy Claims.
The label shall include the Chinese product name, the special cosmetics registration certificate number, information on the registrant, domestic responsible person, and manufacturer, the standard number implemented for the product, full ingredients list, net content, shelf life, directions for use, necessary safety warning statements, and other content required to be indicated in accordance with laws, administrative regulations, and mandatory national standards.
For imported products with affixed Chinese labels, the content related to product safety and efficacy claims on the Chinese label shall be consistent with the corresponding information on the original label. If inconsistencies exist, packaging and labeling specifically designed for the Chinese market shall be used.
Any efficacy claims made for the product shall be scientific, reasonable, and not exaggerated. Claims regarding ingredient efficacy or mechanisms of action shall be supported by relevant evidence for those ingredients. The use of medical terminology or implications that the product has medical effects is prohibited. Exaggerated or absolute claims are also not permitted.
VII. Safety Studies
1. Safety Assessment Report
A product safety assessment shall be conducted in accordance with the Technical Guidelines for Cosmetic Safety Assessment. The assessment must be based on all ingredients in the declared formula and known risk substances, and should take into account relevant factors such as the product’s usage method, application area, and exposure level to ensure accurate conclusions. The safety assessment report shall be complete and standardized. The types of evidence used in the assessment shall comply with relevant documents such as the Guidelines on the Use of Cosmetic Ingredient Data. The assessment may refer to technical documents including the Guidelines for Submission of Cosmetic Safety Assessment Data, Information on the Use of Ingredients in Marketed Products, Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Approach, and Technical Guidelines for the Application of the Read-Across Method.
2. Stability Study
The stability study shall focus on parameters that are prone to change during the shelf life and may affect product quality, safety, or efficacy. These include, but are not limited to, observations of product appearance and the content of functional ingredients (e.g., active ingredients in perm products). The study should evaluate how these parameters change over time under different conditions such as temperature, humidity, and light exposure.
VIII. Efficacy Evaluation
Efficacy studies for perm cosmetics shall be conducted based on the product formulation design, manufacturing process, and other relevant factors to ensure that the product can achieve the intended effect under conditions of use. Perm cosmetics are generally composed of two components. For single-agent perm products, a comprehensive efficacy evaluation shall be carried out based on the product’s perming mechanism.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
Cosmetic services in China:
- China Cosmetic Registration and Filing;
- China New Cosmetic Ingredient Registration and Filing;
- China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
- China Cosmetics Efficacy Evaluation;
- Hair Care Products Efficacy Evaluation;
- In-vitro Efficacy and Safety Evaluation;
- China Cosmetic Safety Assessment Report;
- China Toothpaste Filing;
- China Disinfectant Notification;
- China Cosmetic Formula/Label/Claim Review; and
- Customs Clearance
If you need any assistance or have any questions, please get in touch with us via kexinbio@cirs-group.com.
Further Information
https://www.nifdc.org.cn//nifdc/bshff/hzhpjssp/hzpsptzgg/202507310840431663213.html
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