ZMUni Compliance Centre

In recent years, ingredient-conscious consumers and the rapid growth of the functional skincare market have significantly reshaped the competitive landscape of the cosmetics industry in China. Consumers are increasingly demanding higher standards of product safety and efficacy. Since the implementation of the Cosmetics Supervision and Administration Regulation (CSAR) in 2021, China's National Medical Products Administration (NMPA) has introduced a series of regulatory documents, including the Cosmetic Classification Rules and Catalogs, as well as the Standards for Cosmetic Efficacy Claim Evaluation. Together with national, industry, and group standards, these regulations form a comprehensive framework that provides clear guidelines for substantiating cosmetic efficacy claims.

This article will focus on the key compliance essentials for cosmetic efficacy and ingredient claims in China. It aims to help international businesses navigate these requirements and mitigate potential risks associated with efficacy claims.

Efficacy Claims for Cosmetic Products  

According to the CSAR , cosmetic registrants and notifier are responsible for the quality, safety, and efficacy claims of their products. These claims must be supported by sufficient scientific evidence.  

Product Naming and Efficacy Claims  

The Chinese name of a cosmetic product typically consists of three parts: the brand name, generic name, and attribute name. For commonly recognized or conventionally used names, the generic or attribute name may be omitted.  

The generic name must be accurate and objective, describing either the product's ingredients, purpose, or application area. When specific ingredient names or ingredient categories are used, they must align with the product’s formulation. Additionally, the claimed efficacy of these ingredients must correspond to the product's stated efficacy claims.  

Product Labeling and Efficacy Claims  

Cosmetic product labels include the text, symbols, numbers, images, or other markers on the packaging that provide basic product information, features, and safety warnings. These labels may also include packaging containers, boxes, or instructions that carry the labeling information.  

Efficacy claims must adhere to the categories listed in the Cosmetic Classification Rules and Catalogs. Each claim must be substantiated with adequate scientific evidence.

To further explore cosmetic labeling in China, check our previous webinar.

Classification of Cosmetic Efficacy Claims (26+1) 

The Cosmetic Classification Rules and Catalogs outlines 26 categories of efficacy claims for cosmetics. Claims that do not fall within these 26 categories are considered "new efficacy claims." Details of the classification are as follows:  

• Special Cosmetics  

  Products used for hair dyeing, perming, freckle removal and whitening, sunscreen, anti-hair loss, or those claiming new efficacy are categorized as special cosmetics. Refer to Table 1, entries labeled as A and 01–05.  

• General Cosmetics

  Cosmetics that do not fall under the category of special cosmetics are classified as general cosmetics. Refer to Table 1, entries labeled as 06–26.  

Table 1: Efficacy Claims Classification Catalogue

Evaluation Requirements of Cosmetic Efficacy Claims in China

The Standards for Cosmetic Efficacy Claim Evaluation (hereinafter referred to as the Standards) define efficacy claim evaluation as the process of scientifically testing and reasonably assessing cosmetic efficacy claims under normal usage conditions. This is achieved through literature research, analysis of research data, or efficacy claim evaluation tests, culminating in an evidence-based conclusion. All cosmetics manufactured or marketed within the territory of the People’s Republic of China must undergo efficacy evaluation in accordance with the Standards.  

Cosmetic registrants or notifiers may conduct the evaluation themselves or entrust capable institutions to perform the efficacy claim evaluations based on the requirements outlined in the Standards.  

• Exceptions for Visual and Physical Effects

According to Article 7 of the Standards, claims that are visually or sensory-detectable (e.g., cleansing, makeup removal, beautifying, parfum, hair dye, perm, hair color care, hair removal, depilation, or assisted shaving) or those achieved through simple physical mechanisms (e.g., physical coverage for whitening, physical exfoliation, or blackhead removal) may be exempt from providing a summary of supporting evidence if the label clearly indicates that the claim is based solely on physical effects.  

• Efficacy Claims Requiring Supporting Evidence Summaries

For other claims, efficacy evaluations must be conducted according to the Standards, and a summary of supporting evidence must be uploaded during product registration or notification. The claims requiring supporting evidence summaries include:  

a) New Efficacy Claims  

b) Special Efficacy Claims: Freckle removal and whitening, sunscreen, anti-hair loss, anti-acne.  

c) Functional Claims: Nourishment, repair, anti-wrinkle, firming, soothing, oil control, exfoliation, anti-hair break, anti-dandruff, moisturizing, hair care.  

d) Specific Claims: Suitable for sensitive skin, tear-free formula, ingredient-based efficacy, gentle/non-irritating claims.  

e) Quantifiable Claims: Claims involving measurable metrics such as time, statistical data, or other quantitative indicators.  

This regulatory framework ensures that cosmetic efficacy claims in China are scientifically substantiated and transparent, promoting consumer confidence and product credibility.

Efficacy Claims for Cosmetic Ingredients in China

The efficacy of cosmetics is inherently linked to the functional ingredients they contain. For example, freckle-removal and whitening products typically include active ingredients with such efficacy, and cosmetics claiming sun protection must incorporate sunscreen agents.

However, the efficacy claims for ingredients do not directly equate to the efficacy claims for the final cosmetic product. For instance, while a cosmetic product may claim moisturizing or soothing benefits, the corresponding ingredients are often categorized as skin protectants. If a company intends to make specific efficacy claims for an ingredient, it must provide adequate supporting evidence.

According to the Standards, if product efficacy claims are based on the efficacy of specific ingredients, companies must conduct literature reviews, analyze research data, or perform efficacy evaluation tests to substantiate the claimed benefits of those ingredients. Furthermore, the efficacy claims for ingredients must have a clear and direct correlation with the efficacy claims of the final product. This ensures that ingredient-based claims are scientifically validated and aligned with the product's marketed benefits, safeguarding both regulatory compliance and consumer trust.

ZMUni Reminder

Cosmetic companies must ensure that ingredient selection is based on comprehensive research and validation to support innovation and maintain market competitiveness. This approach ensures that product efficacy claims are both legally compliant and scientifically substantiated. Adhering strictly to regulations and staying updated on regulatory changes are essential for sustaining a competitive advantage in the dynamic cosmetics market.

If you have any questions regarding efficacy claims for cosmetic products or ingredients, or if you need further assistance, please don't hesitate to contact us at info@zmuni.com.