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, and supported by traceable supporting documents.

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

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.

China | What are the requirements regarding the marketing duration and usage quantity of marketed cosmetics?

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.

China | What are the requirements for marketed cosmetics cited in safety use history documentation?

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.

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

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.

China | 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)?

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.

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

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.

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