In a significant move to enhance the safety and regulation of cosmetic products in the Chinese market, the National Medical Products Administration (NMPA) of China announced new requirements for cosmetics safety assessment in 2024. These guidelines, officially released on April 30, 2024, mark a pivotal shift in how cosmetic companies must approach safety assessments for their products in China.

The new guidelines, titled “Guidelines for Submission of Cosmetics Safety Assessment Dossiers,” introduce a comprehensive framework for evaluating and documenting the safety of cosmetic products. This article, the first in a three-part series, will focus on the scope of application of these guidelines, with particular emphasis on the classification of cosmetics under the new system.

Scope of Application

The NMPA’s new guidelines apply to all cosmetic products intended for the Chinese market, whether domestically produced or imported. This broad scope ensures a uniform standard of safety across the entire cosmetics industry in China.

Classification of Cosmetics

Under the new guidelines, cosmetics are categorized into two main groups based on various factors including the use of new ingredients, nanomaterials, high-risk ingredients, product efficacy claims, target users, and product dosage forms:

1. Category I Cosmetics
   • Special cosmetics
   • Infant and children’s cosmetics
   • Cosmetics containing new ingredients under safety monitoring period
2. Category II Cosmetics
   • All other cosmetics not falling under Category I

This classification system is crucial as it determines the level of scrutiny and the specific requirements for safety assessment submission.

Category I Cosmetics

Products in this category are subject to more rigorous safety assessment requirements due to their nature or target user group:

• Special Cosmetics: This includes products with specific functions such as hair dyes, perming agents, freckle-removing and whitening products, sunscreens, and anti-hair loss products.
• Infant and Children’s Cosmetics: Any cosmetic products designed for use by infants and young children.
• Cosmetics with New Ingredients: Products containing newly developed ingredients that are still under the safety monitoring period as mandated by NMPA.

Category II Cosmetics

This category encompasses all other cosmetic products not included in Category I. While still subject to safety assessment requirements, these products are further divided into two situations based on their risk level:

Situation 1: Higher Risk Category II Cosmetics

This situation includes:

1. Cosmetics using nanomaterials
2. Non-sunscreen cosmetics that use sunscreens not included in Table 5 of the Safety and Technical Standards for Cosmetics (STSC) as light stabilizers
3. Cosmetics with claims of acne-removing, anti-wrinkle (excluding physical anti-wrinkle), deodorization, anti-dandruff, depilating, exfoliating (excluding physical exfoliating) efficacies
4. Cosmetics in the form of patches, masks, cosmetics containing base materials (patches, masks, and base materials contain functional ingredients or colorants) or aerosols
5. Cosmetics to be used in conjunction with instruments or tools (excluding hairbrushes and air cushions that only assist in application, hair perming tools, etc.)

Situation 2: Lower Risk Category II Cosmetics

This situation includes all Category II general cosmetics that do not fall within Situation 1.

Importance of Classification

The classification of a cosmetic product significantly impacts the safety assessment process:

1. Submission Requirements: Category I products and Category II Situation 1 products generally require more comprehensive safety assessment documentation compared to Category II Situation 2 products.
2. Level of Scrutiny: Category I products undergo the most thorough examination, followed by Category II Situation 1 products, due to their potential higher risk or sensitive target users.
3. Documentation: The extent and depth of safety data required vary among the categories and situations.

Understanding this classification is crucial for cosmetic companies to ensure compliance with NMPA regulations and to streamline their product registration process in China.

Conclusion

The new NMPA guidelines represent a significant step forward in ensuring the safety of cosmetic products in the Chinese market. By clearly defining the scope of application and introducing a structured classification system, these guidelines provide a robust framework for cosmetic safety assessment.

In the subsequent parts of this series, we will delve deeper into the specific submission requirements for cosmetics (Part II) and the self-inspection points for safety assessment reports (Part III). These upcoming articles will provide essential information for cosmetic companies looking to navigate the complexities of the Chinese regulatory landscape successfully.

Stay tuned for Part II, where we will explore the detailed submission requirements for both Category I and Category II cosmetics under the new NMPA guidelines.