Interpretation! Historical evidence for the safe use of new cosmetic raw materials in China

Release time:

2024-06-13 15:25

May 31, 2024, issued by the Central ProcuratorateNotice on publicly soliciting opinions on the "Guidelines for the Research and Determination of the Safe Use of New Cosmetic Raw Materials (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Solicitation of Comments").On the basis of the "Regulations on the Administration of Registration and Filing Materials of New Cosmetics Raw Materials" (hereinafter referred to as the "Regulations"), the draft for comments further clarifiesInformation requirements related to the safe use history of new raw materialsof the details. The following is a summary of the contents of the regulations and a sharing of our views for your reference.

The content of the draft for comments mainly focuses on the following points:

1. Which enterprises may provide supporting materials to meet the requirements?

It is generally considered that onlyForeign Enterprise/Domestic Branch/Joint VentureRelevant information can be provided. The draft of the opinion limits the consistency of raw material technology and quality specifications. It is not an enterprise that already has corresponding cosmetic raw material business abroad, and it is basically impossible to provide the above information.

2. Who will provide the supporting materials

Enterprises that have obtained authorization to use the data of cosmetics enterprises listed abroad.

The most important information in the certification materials is the sales volume of relevant cosmetics, the monitoring of adverse reactions, and the use information of raw materials in the formula (purpose of use and addition amount).

3. Whether it meets the safe use history of more than 3 years can be exempted from the sub-chronic toxicity test.

The data of sub-chronic toxicity test is designed to meet the calculation of MoS value in the safety assessment report. If the safety of raw materials used in cosmetics cannot be fully evaluated according to the relevant data information of safe use history, necessary toxicology test data shall be supplemented. The necessary toxicology tests here are considered by individuals as long as they are repeated dose toxicity (e. g. 28-day sub-acute test).

The following is a description of the historical proof materials for safe use in the draft for your reference.

According to the Exposure Draft, the safe use history certification materials for new raw materials should cover the following

(I)Raw material consistency

The person who notes the new raw materials shall fully grasp the production and use of the new raw materials, and ensure that the raw materials used in the listed cosmetics in the certification materials are the same as the new raw materials to be registered for the record.Raw material composition, quality specification and production processetc. are consistent.

The supporting materials provided shall reflect the specific information of the raw materials actually used in the listed cosmetics, so as to judge the consistency with the new raw materials to be registered for the record, such:Raw material name, molecular formula, structural formula, relative molecular mass; raw material source, production process; raw material actual composition, purity or content; sensory indicators, physical and chemical constants; impurity types and control indicators.

(II)alreadyListingCosmetic type and time to market

Cosmetics already on the market in the supporting materials providedShould comply with the definition of cosmetics in China's laws and regulations. When the products using new raw materials are not managed in accordance with cosmetics outside the country, but meet the definition of cosmetics in China, the regulatory situation, regulatory documents, product efficacy and mechanism of action of the relevant products outside the country shall be submitted.

New raw materials in marketed cosmeticsPurpose of use, application or scope of useetc., should be consistent with the relevant content in the registration filing materials;The amount of new raw materials used in cosmetics already on the market shall not be less than the safe amount of use reported in the registration filing materials..

Cosmetics containing new raw materials that meet the above requirementsHas been on the market for not less than three years, andAt least one product has been sold continuously for three years or more.

(III)Cosmetics used on the marketQuantity

Focus on marketed cosmetics containing new ingredients that have been sold continuously for three years or more to ensure that they arehave sufficient quantities to use: such as the use of terminal retail cosmeticsSales Quantity(I. e., the number of actual purchases by consumers), then threeThe annual cumulative sales quantity shall not be less than 10000 pieces, of which the annual sales quantity shall not be less than 3000 pieces.; if adoptedCosmetics production enterprise factory quantitybased on, thenThe cumulative ex-factory quantity in three years shall not be less than 100000 pieces, of which 30000 pieces shall not be less than each year..

For havingNew raw materials for anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), dandruff removal and deodorization functions, in addition to the above requirements, shallHave an accurate knowledge of the long-term (1 year or more) continuous use of the same product by no less than 100 consumers. Should be based on the structure or function of raw materials easy to cause adverse reactions, targeted to consumersRetrospective and return visit investigation, and standardized records of implementation, cosmetic use and adverse reactions.

(IV)Safe use and adverse reaction monitoring

The new raw material injection person should carry out a comprehensive investigation to understand whether the raw material will cause harm to human health and the adverse reactions of the listed cosmetics using the raw material. Adverse reactions should include the channels and methods used by cosmetics manufacturers to collect adverse reactions of cosmetics containing the raw material, and whether there is a record of adverse reactions of cosmetics used by consumers since the cosmetics containing the raw material were put on the market. If so, the incidence of adverse reactions should be calculated, the types of adverse reactions should be determined, and the causes of adverse reactions should be analyzed to form an analysis report. The new raw material injection person should be based on the investigation, the formation of the raw material has been marketed cosmetics adverse reactions summary.

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