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 first guideline (the next six ones related to the second guideline will be presented in the next article). 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 History of Safe Consumption of New Cosmetic Ingredients (Trial)?

A: According to the Cosmetics Supervision and Administration Regulations, when applying for the registration or notification of new cosmetic ingredients, safety assessment data of the new ingredient shall be submitted. Among these, for new ingredients with a well-established history of safe consumption, certain toxicological testing items may be exempted.

To implement the Provisions on Supporting Innovation of 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 History of Safe Consumption of New Cosmetic Ingredients (Trial) (hereinafter referred to as the “Guideline”), which provides technical guidance for the collection, determination, and application of data related to the history of safe consumption in safety assessments.

Q2: What are the requirements for the sources of evidence supporting the history of safe consumption?

A: Evidence supporting the history of safe consumption shall originate from regulatory authorities in relevant fields such as food, agriculture, and health, or from technical institutions with functions or technical capabilities related to food safety risk assessment. The sources shall possess a certain level of authority and, in general, should be publicly available data or information (e.g., announcements, notices, technical standards, etc.). Specifically, regulatory authorities in China shall be at the provincial or ministerial level or above; foreign regulatory authorities shall be at the national level; and technical institutions shall be internationally recognized authoritative institutions or organizations.

In addition, when using evidence supporting the history of safe consumption, a comprehensive

analysis shall be conducted on the background of the referenced materials, the specific content of the data, and relevant food safety regulatory requirements, in order to fully explain the circumstances under which the ingredient can be considered safe for consumption.

Q3: What consistency or relevance should exist between the new cosmetic ingredient intended for registration or notification and the food ingredient described in the history of safe consumption?

A: The new cosmetic ingredient intended for registration or notification shall exhibit consistency or relevance with the food ingredient described in the supporting evidence of the history of safe consumption. The registrant or notifier of the new ingredient (hereinafter referred to as the “applicant”) shall conduct an analysis based on both the evidence of the history of safe consumption and the specific characteristics of the new cosmetic ingredient.

It should be noted that if the processing method differs from that used for food consumption (e.g., extraction using alternative solvents), an analysis shall be conducted based on the specific type of process, including the composition and enrichment of constituents, residual solvents, etc. For new ingredients derived from biological fermentation, relevant supporting evidence shall be provided to demonstrate that the final fermentation product is safe for consumption.

Q4: What are the common types of evidence supporting the history of safe consumption?

A: The common sources of evidence for a history of safe consumption primarily include general food ingredients, region-specific traditional food ingredients, novel food ingredients, substances with both medicinal and edible uses, and health food ingredients. To guide applicants in collecting and utilizing relevant information, the Guideline outlines several common types of supporting evidence along with their basic requirements.

In cases where certain general food ingredients may lack officially issued supporting documentation, applicants may provide an explanation of the situation and submit relevant materials demonstrating that the ingredient has been marketed and sold within China as a general food ingredient. An analysis of its history of safe consumption should also be included. The submitted evidence should be relevant, traceable, and capable of accurately reflecting consistency or relevance with the new cosmetic ingredient intended for registration or notification.

Q5: Can supporting evidence issued by foreign regulatory authorities or technical institutions be used?

A: Supporting evidence issued by foreign regulatory authorities or recognized technical institutions regarding ingredients deemed safe for consumption may be used to demonstrate a

history of safe consumption. However, such evidence must comply with relevant principles and requirements. In addition, applicants should provide contextual background information, including: The country or region of issuance; Background information on the regulatory authority or technical institution; Date of issuance; Full content of the published information; Specific applications of the information within the food safety regulatory framework; Supporting materials related to the safety assessment.

Q6: How should safety risk assessments be conducted for cosmetic ingredients with a history of safe consumption?

A: For ingredients with clearly defined intake limits or other restrictions in food use, safety assessments for cosmetic applications should be conducted based on factors such as the intended scope of use, safe usage levels, and applicable conditions for the new ingredient. For ingredients without explicitly defined intake limits, a reasonable assessment may be conducted by taking into account dietary habits, typical consumption levels, and other relevant information. If the raw material has undergone further processing-such as being used in the form of a plant extract-appropriate conversion calculations should be considered during the assessment.

If the established intake limits or typical consumption levels are insufficient to support the intended use of the new ingredient in cosmetics, additional data-such as repeated dose toxicity study results and other necessary information-should be provided to assess the ingredient’s scope of application and safe usage levels. A complete and standardized toxicological study report must be submitted concurrently.

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