China NIFDC | Q&A on Guideline for the Study and Determination of the History of Safe Consumption of New Cosmetic Ingredients (Trial)

On June 24, 2025, the National Institutes for Food and Drug Control (NIFDC) released two technical guidelines-Guideline for the Study and Determination of the History of Safe Consumption of New Cosmetic Ingredients (Trial) and Guideline for the Study and Determination of the History of Safe Use of New Cosmetic Ingredients (Trial)-along with related Q&As. Following six questions together with the corresponding answers are related to the second guideline. CIRS Group has compiled and translated them into English for your reference.

Q1: What is the background for the development of the Guideline for the Study and Determination of the Safety Use History of New Cosmetic Ingredients (Trial)?

A: According to the Cosmetics Supervision and Administration Regulations, applicants for the registration or notification of new cosmetic ingredients are required to submit safety assessment data. For new ingredients that have a well-established history of safe use in cosmetics, certain toxicological study requirements may be waived.

To implement the Provisions on Supporting Innovation in Cosmetic Ingredients issued by the National Medical Products Administration (NMPA) and to enhance the utilization of existing data, the National Institutes for Food and Drug Control (NIFDC) organized the development of the Guideline for the Study and Determination of the Safety Use History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the "Guideline"). This Guideline provides technical guidance on the collection, evaluation, and application of historical safety use data in the safety assessment of new cosmetic ingredients.

Q2: Does the new ingredient intended for registration or notification need to be completely identical to the ingredient referenced in the safety use history?

A: Applicants for the registration or notification of new cosmetic ingredients (hereinafter referred to as "applicants") shall conduct a consistency analysis of the ingredient based on its source, manufacturing process, composition, and quality specifications.

For new ingredients with a clearly defined single chemical structure, key information such as molecular formula and structural formula must be consistent. If modifications to the manufacturing process are made-for example, to improve ingredient quality or enhance environmental sustainability-a comprehensive analysis must be conducted to assess any resulting changes in ingredient content (purity), impurity profile, and other potentially affected characteristics. For other types of new ingredients, such as plant extracts, microbial fermentation products, and polymeric substances, it is essential to ensure that the ingredient referenced in the safety use history documentation is consistent with the new ingredient intended for registration or notification.

In addition, if the ingredient is actually marketed in a compound (mixture) form, the potential impact of other components in the mixture on efficacy and safety must be analyzed. The scientific validity of using the historical safety data as the basis for the safety assessment of the new ingredient should be thoroughly evaluated.

Q3: What are the requirements for marketed cosmetics cited in safety use history documentation?

A: The marketed cosmetics referenced in safety use history documentation must fall within the scope of the definition of cosmetics under Chinese regulations. If a product is not regulated as a cosmetic in its country of origin but meets the definition of a cosmetic under Chinese law, relevant information must be provided, including the regulatory context in the country of origin, applicable regulatory requirements, product claims, and mechanisms of action. An analysis should also be conducted to demonstrate how the product aligns with the definition of cosmetics in China. Furthermore, the concentration of the ingredient in the marketed product, its site of application, and method of use should be sufficient to support the applicable scope, usage conditions, and safe use levels as indicated in the registration or notification dossier.

Q4: What are the requirements regarding the marketing duration and usage quantity of marketed cosmetics?

A: The marketed cosmetics should have been available on the market for no less than three years. This can be demonstrated either by continuous sales of a single product for three years or more, or by cumulative continuous sales of multiple products over a period of three years or more. For products that were launched earlier, the reliability and traceability of the relevant information should be thoroughly considered.

In addition, the products must have sufficient usage quantity. In principle, if end-user retail sales data (i.e., actual consumer purchases) are used, the cumulative sales volume over three years should be no less than 10,000 units, with annual sales of no less than 3,000 units. If indirect sales data are used, such as factory shipment volumes from cosmetic manufacturers or distributor sales volumes, the cumulative sales volume over three years should be no less than 100,000 units, with annual sales of no less than 30,000 units.

Q5: How should the notifier of a new cosmetic ingredient conduct an analysis of its safe use?

A: The notifier of a new cosmetic ingredient should conduct a comprehensive investigation and clearly describe the channels and methods for collecting adverse event reports. They should also indicate whether any adverse reactions or other reports of potential harm to human health have been associated with cosmetics containing the ingredient since their launch, and perform a necessary analysis of such information. Based on this, and in conjunction with the overall market use of the ingredient, the notifier should conduct a scientific and rational assessment of the ingredient’s history of use. This assessment should lead to a clear conclusion as to whether the ingredient has caused any serious adverse reactions or widespread adverse events, and whether it may pose a risk to human health.

For new ingredients with skin-whitening or spot-removal functions, particular attention should be paid to the safety risks of long-term application to human skin. For example, information should be provided on no fewer than 100 consumers who have continuously used the same product for a long period (one year or more). If such information cannot be provided, long-term human safety trials may be conducted as an alternative, and relevant research data should be submitted.

Q6: What are the format requirements for documentation proving the history of use?

A: The notifier of a new cosmetic ingredient should collect, organize, analyze, and summarize relevant information in accordance with the basic requirements for documentation proving the history of safe use. A comprehensive summary of the ingredient’s history of safe use should be prepared, accompanied by relevant annexes (see sample Tables 1 to 3 in the Guideline), and supported by traceable supporting documents.

Considering that different countries have varying regulations and practices regarding product sales records and traceability, the Guideline does not impose specific restrictions on the format of supporting documents. The notifier should have a thorough understanding of the actual circumstances and independently compile supporting documentation based on the specific methods of sales and use. The submitted documentation must be relevant, traceable, and reflect key information related to production and business operations. If the marketed cosmetics were not manufactured by the notifier of the new ingredient, the source of the information should be clearly stated, and appropriate authorization should be obtained.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Safety and Efficacy Test;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; and
• China Cosmetic Formula/Label/Claim Review

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://www.nifdc.org.cn//nifdc/bshff/hzhpjssp/hzhpspcjwtjd/zhpspcjwtjdqt/202506241609041614725.html