China Clarifies Requirements for Proof Materials on the Safe Use and Consumption History of New Cosmetic Ingredients

On May 31, 2024, the China National Institutes for Food and Drug Control (NIFDC) released the draft Guidelines for the Research and Determination of the Safe Use History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the "Safe Use History Guidelines") and the draft Guidelines for the Research and Determination of the Safe Consumption History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the "Safe Consumption History Guidelines"). ¹

Subsequently, on June 24, 2025, NIFDC officially issued and implemented the finalized versions of the Safe Use History Guidelines and the Safe Consumption History Guidelines ², along with corresponding Q&A. ³⁴

Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial)

The Safe Use History Guidelines is applicable to the research and determination of the safe use history of NCIs in Situation 3 and Situation 4. It mainly outlines the overview, application scope, general principles, basic requirements for safe use history proof materials, proof material format requirements, and safety assessment requirements. Key points include:

1) Basic Proof Material Requirements: Materials should be able to fully describe the use situation of the NCIs to be registered or notified in the marketed cosmetics, as well as include the listing time, the amount of use, safety, and other related information. The information collection work can be carried out from the aspects of ingredient consistency, the type, information and time of the listing of the marketed cosmetics, the use amount of the marketed cosmetics, and safety usage analysis, etc.

2) Ingredient Consistency: Emphasis is placed on verifying that ingredients used in the marketed cosmetics recorded in the proof materials match those of the NCIs to be registered or notified, ensuring all-aspect consistency in ingredient source, production process, ingredient composition, and quality specification.

3) Type and Information of Marketed Cosmetics: The marketed cosmetics referenced in the safe use history materials should conform to the definition of cosmetics under Chinese laws and regulations.

If a product is not regulated as a cosmetic in its country of origin but falls within the scope of the cosmetic definition in China, relevant information—such as the overseas regulatory framework, applicable regulatory requirements, product efficacies, and mechanism of action—should be provided. A detailed analysis should also be conducted to demonstrate how the product aligns with the cosmetic definition in China.

In addition, the ingredient concentration, application site, and method of use of the marketed product should be sufficient to support the intended application scope, safe usage level, and other relevant information submitted in the NCI registration or notification dossier.

4) Listing Time and Use Amount of Marketed Cosmetics: The cosmetics cited should have been on the market for at least three consecutive years. This may refer to a single product sold continuously for three years or more, or to multiple related products that have been marketed continuously for three years or more. If the product was launched earlier, the reliability and traceability of the supporting information should be carefully assessed.

In addition, it must be ensured that the products have been used by consumers in sufficient quantities. In principle:

• If terminal retail sales data (i.e., actual consumer purchases) are used, the cumulative sales volume over three years should be no less than 10,000 pieces, with at least 3,000 pieces sold per year;

• If indirect sales data are used (e.g., factory volume of cosmetic manufacturers or sales volume of distributors), the cumulative sales over three years should be no less than 100,000 pieces, with at least 30,000 pieces sold per year.

Guidelines for Research and Determination of Safe Consumption History of New Cosmetic Ingredients (Trial)

The Safe Consumption History Guidelines applies to the research and determination of the safe consumption history for NCIs in Situation 5. Its main text consists of 6 parts, including the overview, application scope, general principles, basic requirements for safe consumption history proof materials, common proof materials, as well as safety assessment requirements. Key highlights include:

1) Basic Requirements for Proof Materials: The proof materials should be obtained from supervisory and management authorities or authoritative technical institutions in relevant fields. The NCI registrant/notifier is required to conduct a detailed analysis based on the specific NCIs to be registered or notified, in order to ensure that the NCI—or the raw materials used in its preparation—demonstrates characteristics of safe consumption and can be used as a basis for safety assessment.

In particular, the information should be evaluated and its applicability analyzed from the following aspects: the source of the proof materials, the consistency or relevance of the NCI, consumption conditions, and any applicable restriction requirements.

2) Proof Material Sources: Materials should be obtained from reputable sources, such as supervision and management departments in relevant fields (e.g., food, agriculture, and health), or technical institutions with relevant functions or capabilities in food safety risk assessment, and with certain authority.

These materials should consist of publicly available data and information, such as official announcements, notices, or technical standards.

If the proof materials are provided by Chinese supervision and management departments, these departments should be at the provincial or ministerial level or above.

For materials from foreign supervision and management departments, the departments should be at least at the national level. If the materials are from technical institutions, they should come from internationally recognized authoritative organizations or institutions. Relevant background information should also be provided, including the country or region of issuance, an introduction to the regulatory authorities or technical institutions, the date of issuance, the complete content of the released information, its specific application in food safety supervision, and the background of the safety assessment.

In addition, when using safe consumption history proof materials, a comprehensive analysis should be conducted on the background of the cited material, the specific content of the material, as well as the relevant food safety regulatory requirements, to thoroughly demonstrate the basis for safe consumption.

3) Ingredient Consistency/Relevance: The NCI to be registered or notified should be consistent with—or closely related to—the food ingredient listed in the safe consumption history proof materials.

It is important to note that if the processing method differs from that used in food processing (e.g., extraction with alternative solvents), an analysis should be conducted based on the specific process type, covering aspects such as composition, enrichment status, and potential residual solvents. For NCIs produced through biological fermentation, proof materials must demonstrate that the final fermentation products are safe for human consumption.

4) Common Proof Materials: The common sources of safe consumption history include general food ingredients, region-specific food ingredients, new food ingredients, ingredients with both medicinal and edible uses, and ingredients used in health foods.

Among these, considering that some general food ingredients may lack official documentation, the registrant/notifier may explain the relevant situation and provide supporting materials demonstrating that the ingredient has been marketed as a general food ingredient in China, along with an analysis of its safety for consumption. All submitted materials should be relevant and traceable, and should clearly demonstrate the consistency or relevance between the ingredient cited and the NCI to be registered or notified.

The two guidelines also highlight the following key points:

• For NCIs with freckle-removal or whitening functions, it is not possible to exclude the potential safety risks associated with long-term use on human skin. Therefore, supporting information should be provided to demonstrate the long-term safe use of cosmetics containing the NCI by no fewer than 100 consumers over a period of at least one year, or alternatively, long-term human trial data should be submitted;

• In addition to the materials specified in the guidelines, registrants and notifiers may submit other scientifically sound and effective data based on actual circumstances. However, such data must be supported by a reasonable scientific rationale and must clearly demonstrate that the NCI has a sufficient history of safe use or consumption. This provision allows for a certain degree of flexibility in how registrants and notifiers present their supporting evidence.

Industry Comments

Previously, when preparing materials for NCI under situations 3 to 5, registrants and notifiers often faced confusion or inconsistent interpretations—particularly regarding how to demonstrate ingredient consistency, whether the ingredient had been used by a sufficient number of consumers, and whether it had an established history of safe consumption. The newly issued guidelines address these concerns by refining the consistency requirements based on different ingredient sources, optimizing documentation requirements for general food ingredients, incorporating health food ingredients as an acceptable source of safe consumption history, and requiring long-term use data for NCI with freckle-removal or whitening functions. These updates aim to enhance the clarity and effectiveness of regulatory implementation.

The China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI) also reminds registrants and notifiers that a demonstrated history of safe use or consumption is an important basis for exemptions from systemic toxicological studies. However, possessing adequate proof of safe use or consumption does not eliminate or reduce the registrant's or notifier’s responsibility to conduct safety assessment. Registrants and notifiers must thoroughly evaluate the historical data, assess the applicability of the proof materials, and remain fully accountable for the quality and safety of the NCI while benefiting from relevant regulatory support. ⁵

Further Reading

• Breaking! China Introduces Two-Tier IECIC System and Implements Dynamic Management Mechanism

• China NIFDC Seeks Feedback on Nine Draft Cosmetic Standards