Case Study: Navigating Product Classification under China's Cosmetic Supervision and Administration Regulation (CSAR)

Introduction

China’s Cosmetic Supervision and Administration Regulation (CSAR), implemented in 2021, established a framework for classifying cosmetic products into Special Use Cosmetics and Ordinary Cosmetics. This classification is essential for determining the regulatory pathway a product must follow, including safety, efficacy, and documentation requirements. However, the classification process often involves nuanced considerations, particularly for borderline products like hair dyes. This case study explores these nuances to highlight the importance of carefully analyzing product functions and intended effects under Chinese regulations.

Special Use Cosmetics and Ordinary Cosmetics: Core Differences

CSAR defines Special Use Cosmetics as products with specific intended effects that may impact health or require additional safety assurances. These include categories such as hair dyes, sunscreens, anti-hair loss products, and skin-whitening products. They must undergo pre-market approval by the National Medical Products Administration (NMPA), supported by robust safety and efficacy data (CSAR, Article 16).

In contrast, Ordinary Cosmetics encompass general skincare, hygiene, and decorative products without claims that would categorize them as Special Use. Ordinary Cosmetics only require a notification process with the NMPA, which involves less stringent requirements for safety and efficacy testing (CSAR, Article 15).

Hair Dyes: A Case Study in Special Use Classification

Under CSAR, hair dyes are categorized as Special Use Cosmetics because their primary function is to alter the natural color of hair through chemical or physical means. This classification applies regardless of whether the product achieves its effect through oxidative or non-oxidative methods. Below are the key reasons why hair dyes are regulated as Special Use Cosmetics:

1. Intended Effect: Permanent or Semi-Permanent Color Change

The Classification Rules and Catalog of Cosmetics (2021) specifies that any product with the primary function of altering hair color falls under the Special Use category, as this effect involves a targeted and prolonged change to the hair's appearance (Section 1.4.2 of the Catalog).

• Oxidative Hair Dyes: These products rely on chemical reactions between oxidizing agents (e.g., hydrogen peroxide) and dye precursors to produce permanent or semi-permanent color changes. These interactions alter hair structure, necessitating higher regulatory scrutiny.

• Non-Oxidative Hair Dyes: Products using direct dyes or temporary pigments also fall under Special Use if they deliver a visible color change that persists for multiple washes. Despite the absence of oxidative reactions, the intended outcome of lasting color alteration meets the regulatory criteria for Special Use Cosmetics.

  
  

2. Safety and Risk Assessment

Hair dyes often include active ingredients such as p-phenylenediamine (PPD) and resorcinol, which may pose risks of allergic reactions or skin irritation. Both oxidative and non-oxidative dyes involve synthetic or natural dyes that require safety assessments for potential dermal penetration or toxicity. These safety concerns align with the Technical Guidelines for Cosmetic Safety Assessment (2021), which mandate comprehensive toxicological evaluation for products with prolonged contact or physiological interaction (Section 5.3.2).

3. Uniformity in Regulatory Approach

CSAR’s regulatory framework ensures that all products intended to change hair color—regardless of the mechanism—are classified consistently to avoid loopholes. This uniform approach aligns with the principle that products with similar intended effects should face comparable safety and efficacy requirements (CSAR, Article 14).

Comparison: Hair Dyes vs. Ordinary Cosmetics (e.g., Mascara)

The distinction between Special Use and Ordinary Cosmetics hinges on the level of interaction with body structures and the nature of claims. A comparison between hair dyes and mascara illustrates why CSAR places hair dyes in a higher regulatory category:

1. Intensity and Permanence of Effect

   • Hair dyes produce a lasting transformation in the natural pigmentation of hair, which may involve chemical penetration or binding to hair fibers. Mascara, by contrast, offers a temporary enhancement to eyelashes through coating without altering their structure or pigmentation.

2. Safety Profile

   • Hair dyes often use ingredients with allergenic potential, such as oxidative dyes, requiring toxicological testing under CSAR. Mascara relies on pigments, waxes, and polymers that remain on the surface of eyelashes, posing minimal risk under normal use.

These distinctions underline the functional and safety-related differences that justify separate regulatory pathways under CSAR.

Nuanced Classification: Non-Oxidative Hair Dyes

An important nuance is that non-oxidative hair dyes, despite their milder formulations, are still classified as Special Use Cosmetics.

1. Focus on Intended Effect

The Classification Rules and Catalog of Cosmetics (2021) emphasize that the defining factor is the intended outcome—lasting hair color change—rather than the formulation method. Products achieving this effect through non-oxidative means, such as direct dyes, meet the same regulatory criteria as oxidative dyes (Section 1.4.2).

2. Safety Concerns

Non-oxidative dyes use direct dye molecules or semi-permanent pigments that may still carry allergenic risks. The Technical Guidelines for Cosmetic Safety Assessment (2021) require safety evaluations of prolonged exposure to synthetic dyes, even in the absence of oxidative reactions (Section 6.1.1).

Conclusion: The Importance of Regulatory Nuance

This case study demonstrates that product classification under CSAR requires careful consideration of intended effects, formulation methods, and safety profiles. In China, the classification of hair dyes as Special Use Cosmetics—whether oxidative or non-oxidative—highlights the regulatory focus on the function and potential risks of a product rather than its formulation alone.

For companies navigating the Chinese market, understanding these nuances is crucial. Regulatory frameworks like CSAR emphasize principles over rigid rules, meaning that products with similar outcomes will face similar scrutiny regardless of technical differences in formulation. This approach ensures consistent safety and quality standards, ultimately protecting consumers and fostering a more reliable cosmetics market.

References

1. Cosmetic Supervision and Administration Regulation (CSAR), National Medical Products Administration (NMPA), 2021.

2. Classification Rules and Catalog of Cosmetics, NMPA, 2021.

3. Technical Guidelines for Cosmetic Safety Assessment, NMPA, 2021.

4. Measures for the Administration of Cosmetic Registration and Notification, NMPA, 2021.