On April 15, 2026, the NIFDC published two technical guidelines related to hair dye cosmetics: the Technical Guideline for Research on Hair Dye Cosmetics (Trial) and the Technical Guideline for Research on Quality Control Requirements for Hair Dye Cosmetics (Trial), providing normative technical basis and compliance guidance for the research and quality control of hair dye cosmetics.
The two newly issued guidelines cover core requirements for research and quality control of hair dye cosmetics. Compared to the draft for public comment, multiple provisions have been deleted, added, or reworded. CIRS Group has compiled the core content and compliance key points for enterprise reference.
Part I: Interpretation of the Technical Guideline for Research on Hair Dye Cosmetics (Trial)
Scope of Application
Hair dye cosmetics refer to cosmetics intended to change hair color, where the original color cannot be restored by immediate washing after use.
General Principles
Research covers technical aspects including safety, quality, efficacy, and label claims.
Main Content
(I) Research on Mechanism of Action
Key Point 1: Hair dye cosmetics are classified into oxidative hair dye cosmetics (typically composed of two components: a colorant and an oxidant/developer, involving oxidation-reduction reactions) and non-oxidative hair dye cosmetics (no oxidation reactions occur).
Key Point 2: Hair bleaching cosmetics generally contain only an oxidant without colorants and fall under the category of oxidative hair dye cosmetics. The coloring process of non-oxidative hair dye cosmetics does not involve oxidation-reduction reactions.
Note: Compared to the draft for public comment, the regulatory description stating "non-oxidative hair dye cosmetics typically color hair through mechanisms such as penetration and adsorption of hair dye agents" has been deleted.
Key Point 3: For novel hair dye cosmetics (e.g., single-component oxidative hair dye cosmetics), in-depth research should be conducted in conjunction with the formulation to elucidate the hair dyeing mechanism.
(II) Research on Quality Controllability
1. Raw Materials
Key Point 1: All raw materials used shall comply with the relevant requirements of mandatory national standards and the Technical Specifications regarding technical standards or quality specifications for raw materials.
Note: Compared to the draft for public comment, examples of specific raw material requirements such as "N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate, p-phenylenediamine" have been deleted.
Key Point 2: The use of new cosmetic ingredients under monitoring period requires authorization, and shall comply with the intended use purpose, applicable or scope of use, safe usage amount, and other restrictions and requirements for registered/filed new ingredients.
Key Point 3: Efficacy-related raw materials for hair dyeing mainly include hair dye agents and oxidants. Hair dye agents in oxidative hair dye cosmetics shall be selected from those listed in Table 7, Chapter III of the Technical Specifications that are permitted for use in oxidative hair dye cosmetics. Hair dye agents in non-oxidative hair dye cosmetics shall be selected from those listed in Table 7 that are permitted for use in non-oxidative hair dye cosmetics. Common oxidants include hydrogen peroxide. Usage shall comply with the limit requirements of the Technical Specifications. For example, the maximum permitted concentration of hydrogen peroxide and other hydrogen peroxide-releasing compounds or mixtures in hair products is 12% in total (calculated as present or released H₂O₂).
Note: Compared to the draft for public comment, the example "oxidants are typically sodium perborate" has been deleted.
Key Point 4: In principle, colorants prohibited for use in hair dye products under the Technical Specifications shall not be used. If permitted colorants are used, it must be clearly demonstrated that they do not participate in the hair dyeing process. For oxidative hair dye products, the stability of organic colorants under oxidative conditions should be specifically studied.
2. Formulation
Key Point 1: Formulations include base formulations and efficacy-related raw materials. The compatibility between base formulations and efficacy-related raw materials should be considered. Since hair dye agents are easily oxidized, an appropriate amount of antioxidants (e.g., ascorbic acid) should typically be added to the colorant formulation.
Note: Compared to the draft for public comment, the description regarding "including oil phase and water phase" has been deleted.
Key Point 2: The colorant formulation typically includes hair dye agents, antioxidants/reducing agents, chelating agents, pH adjusters, etc. The oxidant formulation generally includes strong oxidants (e.g., hydrogen peroxide), chelating agents, pH adjusters, etc. Non-oxidative hair dye cosmetics typically consist of only the colorant component. When GALLA RHOIS extract is used as a hair dye agent in hair dye cosmetics, it must be used in combination with ferrous sulfate.
Key Point 3: Imported products specifically designed for the Chinese market (excluding those manufactured overseas entrusted by domestic entities) shall conduct formulation design research targeting Chinese consumers.
Note: Compared to the draft for public comment, the description stating "the research content should demonstrate the necessity of designing formulations specifically for the Chinese market and the relevant R&D work conducted, consistent with actual conditions" has been deleted.
3. Production Process and Quality Control
Key Point 1: Production process should focus on the accuracy of hair dye agent dosing, controllability of key parameters such as temperature and time, etc.
Note: Compared to the draft for public comment, the description stating "the manufacturing process should highlight characteristic steps, such as emulsification steps for cream/emulsion/lotion dosage forms of hair dye cosmetics" has been deleted.
Key Point 2: Quality control indicators shall at minimum include the physicochemical and microbiological test items specified in the Testing Specifications.
(III) Safety Research
1. Product Registration Testing
Key Point: Test items shall be no fewer than those required by the Testing Specifications. [Note: Compared to the draft for public comment, the description stating "for oxidative hair dye cosmetics, microbiological testing is not required" has been deleted.]
2. Safety Assessment
Key Point 1: Based on all raw materials and known risk substances in the declared formulation, in combination with relevant information such as product usage method, application site, and exposure level.
Key Point 2: Organic colorants may participate in oxidation-reduction reactions; research should be conducted on whether their chemical structure and content change under the conditions of use in oxidative hair dye products.
Key Point 3: For products consisting of two or more components that must be used in combination, the content of raw materials after mixing should be assessed according to the usage instructions. If multiple usage ratios exist, the actual amount of each raw material should be assessed under each ratio, and combined with literature or experimental data, the safety risks potentially arising from chemical and/or biological interactions between raw materials should be analyzed. Attention should also be paid to risk substances that may be generated within the shelf life of the colorant and the product after mixing according to usage instructions, and safety assessments of risk substances should be conducted.
Note: Compared to the draft for public comment, the description regarding "attention to shelf life" has been added.
(IV) Efficacy Evaluation Research
Key Point: Conduct adequate efficacy research in conjunction with factors including product formulation design, hair dyeing mechanism, and production process.
(V) Label Claims
1. Classification Code
Key Point: The classification code shall at least include "hair dye"; the application site shall correspond only to hair; the target user population shall not include infants and children.
2. Product Name
Key Point 1: If the combination use of products may cause consumer confusion regarding product efficacy, explanatory notes shall be provided on the visible surface of the sales packaging. When different products share the same trademark name, generic name, and attribute name, other required labeling information should be noted after the attribute name, including color or shade number, fragrance, applicable hair type, or specific user population.
Key Point 2: Misleading product names shall not be used; product names that mislead consumers into believing that hair dye products are general cosmetics shall not be used.
Note: Compared to the draft for public comment, examples such as "plant-based hair dye", "shampoo", and "conditioner" have been deleted.
3. Label Claims
Key Point 1: "Net content" shall specify the exact net content of each component; usage instructions shall clearly state the mixing ratio of each component during use.
Key Point 2: Where skin allergy testing is involved, it shall be conducted at least 48 hours before product use.
Key Point 3: Misleading claims such as "plant-based hair dye", "perm and dye", or "wash-in black" shall not be used. Oxidative hair dye products should not make claims related to "mild" or "safe".
Note: Compared to the draft for public comment, the example "wash and dye" has been deleted.
Part II: Interpretation of the Technical Guideline for Research on Quality Control Standards for Hair Dye Cosmetics (Trial)
Scope of Application
The product execution standards are intended to guide the cosmetics industry in implementing the "one product, one standard" approach. Specifically, they include test items, indicators, quality management measures, and brief descriptions.
General Principles
Quality control measures should be compatible with production processes, demonstrate good operability and reproducibility, and effectively ensure the stability and consistency of product quality between batches, thereby safeguarding the quality and safety of hair dye cosmetics.
Main Content
Research on quality control requirements for hair dye cosmetics mainly covers stability, quality control items and indicators, and quality management measures.
(I) Stability Research
Key Point 1: Items that may affect product safety, quality, or efficacy should be selected as indicators, such as product appearance/properties and active ingredient content, to study their variation patterns over time under different temperature and humidity conditions.
Note: Compared to the draft for public comment, the example of "light" as a parameter has been deleted.
Key Point 2: The impact of packaging materials on product stability and quality should be considered.
Note: Compared to the draft for public comment, a description regarding "stability" has been added.
(II) Research on Quality Control Items and Indicators
Quality control items and indicators shall be no fewer than those specified in the Testing Specifications, including harmful substances, microbiology, and hair dye agent components. Hair dye agent component indicators should be set with reasonable content control ranges based on the addition amounts in the product formulation, ensuring stability and consistency of product quality between different batches. For products consisting of two or more components for mixed use, corresponding quality control items and indicators should be set for each component according to their respective formulations.
1. Physicochemical Items and Indicators
Key Point-Harmful Substances: Mercury, lead, arsenic, cadmium, etc. shall comply with the Technical Specifications; products containing ethoxylated structures should establish dioxane items and control indicators; when the combined content of ethanol and isopropanol is ≥10% (w/w), methanol items and indicators should be established.
Key Point-Active Ingredients (Hair Dye Agents): The upper content limits shall comply with the requirements of the Technical Specifications. If the content exceeds a reasonable control range, adequate research should be conducted to ensure the stability of the production process and the controllability of product quality. For two-component mixed-use products, there are two expression methods: (1) set the control range of hair dye agent indicators based on the concentration of each hair dye agent in Component I or the colorant; or (2) set the control range based on the concentration of each hair dye agent at the time of mixed use, clearly indicating that the control range represents the concentration of hair dye agents upon mixing and the mixing ratio.
Key Point-Other Items: If the formulation contains thioglycolic acid and its salts, the execution standards should control items and indicators such as pH value and oxidant content.
2. Microbiological Items and Indicators
Key Point: Non-oxidative hair dye cosmetics should establish microbiological control items and indicators.
Note: Compared to the draft for public comment, the description stating "oxidative hair dye cosmetics contain ingredients that inhibit microorganisms and may not require microbiological item control" has been deleted.
(III) Research on Quality Management Measures
All quality control indicators shall be subject to at least one quality management measure. The "quality management measures" and "brief descriptions" for the same item and indicator should be correspondingly linked.
Quality management measures may adopt testing methods or non-testing methods. Testing methods should specify reasonable testing frequencies. Non-testing methods include, but are not limited to, raw material-related indicator control, production process control, etc. A combination of testing and non-testing methods may be used as quality management measures, such as combining raw material control with testing methods, or combining production process control with testing methods.
1. Testing Methods
Key Point: In principle, the methods specified in the Technical Specifications should be adopted, with scientifically reasonable testing frequencies established. When adopting testing methods already included in the Technical Specifications, the specific name of the testing method adopted should be clearly specified in the quality management measures.
Key Point: When adopting testing methods outside the Technical Specifications, two scenarios apply: (1) for items that already have testing methods in the Technical Specifications, the adopted testing method should be validated against the testing methods specified in the Technical Specifications, and the validation results should meet requirements; (2) for items that do not yet have established testing methods in the Technical Specifications, adequate methodological validation should be conducted on the adopted method to ensure its accuracy, reliability, and applicability.
2. Non-Testing Methods
Key Point 1: If raw material control is adopted, the implementation plan should be consistent with technical documentation such as quality specification files. If production process control is adopted, the implementation plan should be consistent with the corresponding quality control items and indicators.
Key Point 2: As efficacy-related ingredients, hair dye agents should not rely solely on "raw material-related indicator control"; "production process control" or a combination of non-testing and testing methods may be adopted as quality management measures.
Note: Compared to the draft for public comment, examples such as "production process control and testing methods, raw material-related indicator control and testing methods" have been deleted.
Key Point 3: For hair dye agents that have testing methods in the Technical Specifications and hair dye agents that have colorant testing methods, it is encouraged to include testing methods in their quality management measures. For hair dye agents where the Technical Specifications have not yet established corresponding testing methods, non-testing methods (such as production process control) may be adopted. When the hair dye agent content is below the quantitative limit of the testing method, testing methods should not be adopted, and other methods such as production process control may be used instead.
Note: Compared to the draft for public comment, "encouraged to include at least testing methods in quality management measures" has been changed to "encouraged to include testing methods in quality management measures", and "should not solely adopt testing methods" has been changed to "should not adopt testing methods".
Other Requirements
Product quality control research should consider sensory indicators (color, appearance/properties, odor, etc.), storage conditions, product shelf life, etc.
CIRS Reminder
The official implementation of the two hair dye cosmetics guidelines establishes detailed specifications for product mechanism research, raw material and formulation control, safety assessment, etc., while also incorporating multiple deletions, additions, and wording adjustments compared to the draft for public comment. It is recommended that hair dye cosmetics enterprises promptly benchmark against the new regulatory requirements, accurately grasp key policy revisions and compliance boundaries, and proactively plan compliance measures in advance. This can effectively mitigate operational risks such as product delisting, market recalls, trade disruptions, and compliance penalties. If you have any needs related to hair dye cosmetics compliance or regulatory monitoring, please feel free to contact us!
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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