Cosmetic products that are also subject to the requirements of Chapter V of the FD&C Act (i.e., requirements for drugs or devices) are not subject to section 611, but these products may be subject to other mandatory recall authorities. (See section 613 of the FD&C Act)

U.S. | What cosmetics are subject to FDA’s mandatory recall authority?

All articles that meet the definition of “cosmetic” in section 201(i) the FD&C Act are subject to FDA’s mandatory cosmetic recall authority. The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

China | What are the format requirements for documentation proving the history of use?

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.

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