Official Registration Q&A | Special Topics on the Safe Use History of New Cosmetic Ingredients
Beijing Food and Drug Administration General Cosmetics Registration Q&A (Issue 48)
Problem 1: What is the background for the formulation of the two documents, “Guidelines for Historical Research and Determination of Safe Use of New Cosmetic Ingredients (Trial)” and “Guidelines for Historical Research and Determination of Safe Consumption of New Cosmetic Ingredients (Trial)”?
A: According to the Regulations on the Supervision and Administration of Cosmetics, when applying for registration or filing a new cosmetic ingredient, you must submit safety assessment information for the new ingredient. New ingredients with a sufficient history of safe use and safe consumption in cosmetics may be exempted from certain toxicology testing requirements. To implement the National Medical Products Administration's "Several Provisions on Supporting Innovation in Cosmetic Ingredients" and strengthen the utilization of existing data, the China National Institute for Inspection and Quarantine (CNIC) has developed the "Guidelines for Research and Determination of the Safe Use History of New Cosmetic Ingredients (Trial)" (hereinafter referred to as the "Guidelines"), which provide technical guidance for the collection, determination, and application of data related to safe use and safe consumption histories in safety assessments.
Problem 2： Do new raw materials to be registered need to be exactly the same as the raw materials with a history of safe use?
A: Registrants and recorders of new raw materials (hereinafter referred to as recorders) should conduct a consistency analysis of the raw materials, including their source, production process, composition, and quality specifications. For new raw materials with a clear, single chemical structure, consistency of key information such as the molecular formula and structural formula should be ensured. If the production process is adjusted to improve raw material quality or promote environmental friendliness, a comprehensive analysis of the raw material content (purity), impurity composition, and other potential changes should be conducted in conjunction with the process adjustments. For other new raw materials, such as plant extracts, microbial fermentation products, and high-molecular-weight polymers, the raw materials cited in the safety history documentation should be consistent with the new raw materials to be registered and filed.
In addition, for products sold in a compounded form, the potential impact of other ingredients in the compounded raw materials on efficacy and safety should be analyzed, and the scientific rationale for the safety history used as the basis for the new raw materials to be registered and filed should be fully considered.
Problem 3： What are the requirements for the safety use history certification of new raw materials to be registered and filed for cosmetics that have already been marketed?
A: The marketed cosmetics documented in the safe use history documentation must comply with the definition of cosmetics under Chinese regulations. If a product is not regulated as a cosmetic abroad but meets the Chinese definition of cosmetics, relevant information such as the product's overseas regulatory background, regulatory requirements, product efficacy, and mechanism of action should be provided, along with an analysis and explanation of the circumstances that support compliance with the Chinese definition of cosmetics. Furthermore, the concentration of raw materials, application site, and method of use of the marketed cosmetics should support the applicable or scope of use, safe usage amount, and other relevant information reported in the registration and filing materials.
Problem 4： What are the requirements for the safety use history certification of new raw materials to be registered and filed regarding the time of market launch and usage quantity of cosmetics that have already been marketed?
A: Cosmetics that have been on the market should be on the market for no less than 3 years. This can mean that the same product has been sold continuously for 3 years or more, or that multiple products have been sold continuously for 3 years or more. If the product was launched earlier, the reliability and traceability of the relevant information should be fully considered. In addition, it should be ensured that the relevant products have sufficient usage. In principle, if the sales volume of cosmetics at terminal retail stores (i.e. the actual purchase volume by consumers) is used, the cumulative sales volume over 3 years shall not be less than 10,000 units, of which no less than 3,000 units per year shall be used; if indirect sales data is used, such as the factory output of cosmetics manufacturers and the sales volume of distributors, the cumulative sales volume over 3 years shall not be less than 100,000 units, of which no less than 30,000 units per year shall be used.
