Q&A About Guidelines for Safe Usage History of New Cosmetic Ingredients

1.What is the background for formulating the Guidelines for Research and Determination of Safe Usage History of New Cosmetic Ingredients (Trial)?

According to the Cosmetic Supervision and Management Regulations, when applying for registration or filing of new cosmetic ingredients, safety assessment materials for new ingredients shall be submitted. Among them, for new ingredients that have sufficient history of safe use in cosmetics, some toxicology test items can be exempted.

With the purpose of implementing Several Provisions on Supporting Cosmetic Ingredient Innovation issued by the NMPA and enhancing the utilization of existing data, the NIFDC organized the formulation of the Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the Guidelines). These Guidelines will provide technical guidance on the collection and determination of data related to safe use history and its application in safety assessments.

2. Does the new ingredient intended for registration/filing need to be completely identical to the ingredient in the safe usage history?

The registrant or filer of the new ingredient (hereinafter referred to as the applicants) must conduct an analysis of ingredient consistency regarding source, manufacturing process, composition, and quality specifications. When a new ingredient has a clearly defined single chemical structure, key information such as molecular formula and structural formula must be identical. If manufacturing process adjustments are made for reasons like quality improvement or environmental friendliness, a comprehensive analysis of changes in ingredient content (purity), impurity composition, and other potential variations must be analyzed. If there are other types of new ingredients, such as plant extracts, microbial fermentation products, and polymers, the applicant must ensure that the ingredient referenced in the safe use history report is identical to the new ingredient intended for registration or filing.

Furthermore, if the ingredients that are actually sold in a compounded form, an analysis of the potential impact of other components in the compounded ingredient on efficacy and safety must be conducted. The scientific rationality of using such compounded ingredients as evidence of safe use history for the new ingredient intended for registration or filing must be fully considered.

3.What are the requirements for the marketed cosmetics cited in the safe usage history proof materials?

The information of the marketed cosmetics cited in the safe use history evidence must fall within the definition of cosmetics under Chinese regulations. When products that are not regulated as cosmetics overseas but meet the Chinese definition of cosmetics, relevant documents must be provided. This includes the product’s regulatory background and requirements in the overseas market, as well as data on its efficacy and mechanism of action. An analysis must also be provided explaining how the product meets the Chinese definition of a cosmetic. Additionally, the usage concentration, application area, and method of use of the ingredient in the marketed cosmetics must support the applicable scope, safe usage levels, and other relevant information submitted in the registration or filing dossier.

4. What are the requirements regarding the market time and usage quantity of the marketed cosmetics?

The marketed cosmetics must have been on the market for no less than 3 years. This can be demonstrated by a single product continuously sold for 3 years or more, or by multiple products cumulatively sold continuously for 3 years or more. If the product was marketed earlier, the reliability and traceability of the relevant information must be fully considered.

Furthermore, sufficient usage quantity of the relevant products must be ensured. In principle, if the report use the terminal retail sales data (i.e., the actual quantity purchased by consumers), the cumulative sales quantity over 3 years must not be lower than 10,000 units, with annual sales in each year not lower than 3,000 units.

If the report use the indirect sales data, such as the manufacturer’s ex-factory quantity or distributor sales volume, the cumulative sales quantity over 3 years must not be lower than 100,000 units, with annual sales in each year not lower than 30,000 units.

5. How to conduct the analysis of safe usage history for the new ingredient applicant?

Applicants must conduct comprehensive research to detail the channels and methods used to collect adverse reaction reports. They must provide records of any adverse reactions reported since the market launch of cosmetics containing the ingredient, or any other relevant reports concerning harm to human health, accompanied by necessary analysis. Based on this, combined with the overall market usage of the ingredient, the applicant must conduct a scientific and reasonable assessment of the ingredient’s use history. This assessment must form a clear conclusion on whether the ingredient has ever caused serious adverse reactions or adverse reactions in populations, or whether it poses a potential risk to human health.

If the new ingredient has spot-removing and whitening functions, safety risks associated with long-term application on human skin must also be considered. For example, the applicant should provide information on no fewer than 100 consumers who have used the same product containing the ingredient continuously for a long period (1 year or more). If such information is unavailable, long-term human safety-in-use trials may be conducted instead, providing the relevant research data.

6. What are the formal requirements for the usage history proof materials?

The applicant must collect, organize, analyze, and summarize relevant data and information according to the basic requirements for safe use history evidence. This should be presented as a comprehensive overview of the safe use history of the new ingredient, accompanied by the relevant appendix tables (see sample tables Appendix 1 - Table 3 in the Guidelines), and supported by traceable supporting reports.

Recognizing that different countries have varying regulations and practices regarding the retention and traceability of product sales records, the Guidelines do not impose specific restrictions on the format of supporting documents. The applicant must fully understand the actual circumstances and reorganize the information based on the specific methods of sales and use. The provided information must be relevant, traceable, and reflect key information such as necessary production and operation details. If the marketed cosmetics were not produced by the applicant themselves, the source of the information must be clearly stated, and appropriate authorization must be obtained.

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