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Overview of the regulatory requirements for new cosmetic raw materials under the Regulations on the Supervision and Administration of Cosmetics and the Measures for the Registration and Administration of Cosmetics (Draft for Comment)
Release time:
2020-07-27 11:46
Following the issuance of the Regulations on the Supervision and Administration of Cosmetics on June 29, 2020 (the "Regulations"), on July 21, 2020, the State Drug Administration publicly solicited comments on the Regulations supporting the Regulations, the Measures for the Registration and Administration of Cosmetics (Draft for Comments) (hereinafter referred to as the "Draft for Comments").
In the content of the regulations and the draft for comments, the regulatory system framework for new raw materials has been basically established. On the basis of the contents of the above two documents, Xinanrun Consulting summarized the regulatory system of new cosmetic raw materials in the future for the reference of customers and friends.
* Classification management
The State implements classified management of new raw materials for cosmetics:
Registration: new raw materials with high safety risk with anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening functions. The applicant for new raw material registration shall submit the declaration data in accordance with the requirements of the new raw material registration filing data specification, which can be used for cosmetics production after acceptance, technical review, supplementary information (if applicable), review application (if applicable), administrative approval and other steps.
§ Filing: Other raw materials. The new raw material filing person shall submit the information for filing in accordance with the requirements of the new raw material registration filing data specification, and complete the filing after submitting the information.
* Filing/registration information requirements
According to the provisions of Article 12 of the Regulations, the materials required for the registration of new cosmetic raw materials include
§ The name, address and contact information of the registration applicant and the filing person;
§ New raw material development report;
§ Research information on the preparation process, stability and quality control standards of new raw materials;
§ Safety assessment information for new raw materials.
In view of the fact that the specifications for registration and filing materials for new raw materials under the regulations and the draft for comments (articles 14 and 16 of the draft for comments) have not yet been issued, Xiao 'an speculates that the requirements for registration and filing materials for new raw materials for cosmetics under the current guidelines for declaration and review of new raw materials for cosmetics (Guo Food and Drug Administration [2011] No. 207) are as follows:
§ New raw material development report
Raw material research and development background, process and related technical information.
Name, source, relative molecular mass, molecular formula, chemical structure, physical and chemical properties of raw materials.
The purpose of using raw materials in cosmetics, the scope of use, the use limit and basis based on safety, precautions, warnings, etc.
Description of whether the raw materials are used in cosmetics abroad (region).
§ Research information on the preparation process, stability and quality control standards of new raw materials
Process Flow Diagram and Description
Stability Study Report
Quality control standards (should include possible safety risk substances and their control measures)
New raw material safety assessment data (mainly for health toxicology research data, this data requirements due to the raw material function and the use of different at home and abroad)
Acute oral toxicity (exempt if there is a history of safe consumption or a substance that is both food and medicine announced by the administrative department of the State Council)
Acute transdermal toxicity (exempt if there is a history of safe consumption or a substance that is both a food and a drug as announced by the administrative department of the State Council)
Eye irritation
Skin Irritation/Corrosivity
Skin allergy
skin phototoxicity
light sensitivity test
Ames test
chromosome aberration test
subchronic toxicity
Teratogenicity test (prediction is only applicable to registered raw materials, that is, new raw materials with higher safety risks with anti-corrosion, sun protection, coloring, hair dyeing, freckle and whitening functions, the same below)
Combined Chronic Toxicity/Carcinogenicity Test (Predictions only for registered materials)
Toxicokinetics (prediction only for registered raw materials)
*
Use of new raw materials
New raw materials for cosmetics may be used in the production of cosmetics only by the filing/registrant or with the permission of the filing/registrant.
* Safety monitoring
Monitoring period: 3 years
Responsible subject: new raw material filing/registrant; new raw material user (I. e. corresponding cosmetics filing/registrant)
Monitoring responsibility: the new raw material filing/registrant establishes a safety risk monitoring and evaluation system; the user monitors the safety of the new raw material in real time and responds to the new raw material filing/registrant.
Report:
Annual report: the new raw material filing/registrant shall submit an annual report (summary and analysis of the use and safety of new raw materials) to the adverse reaction monitoring department and the technical review department within three years after the first filing/registration is successful and within 30 days of each full year.
Safety report: when it is found that the safety of cosmetics involving new raw materials or using new raw materials (including the following situations), the new raw material filing/registrant shall carry out safety assessment, and if the safety risk of the new raw material is assessed, it shall take immediate measures to control the risk and report to the technical review department:
Serious cosmetic adverse reactions, cosmetic adverse reactions that may cause greater social impact, or other safety problems occur in (I) cosmetics that use new raw materials;
(II) there is evidence that the new raw material may have safety problems;
(III) found in other countries (regions) suspected of serious cosmetic adverse reactions or group adverse reactions caused by the raw materials;
(IV) the cosmetic regulations and standards of other countries (regions) to raise the use standards, increase the use restrictions or prohibit the use of the raw materials;
(V) other cases involving new raw materials and the safety of cosmetics using new raw materials.
§ Product report: When an adverse reaction is found in cosmetics using new raw materials, the user of the new raw materials shall report the adverse reaction in a timely manner in accordance with the relevant provisions of the adverse reaction report; if there is evidence that cosmetics using new raw materials may have safety problems, immediately take risk Control measures and report to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government.
* Listing
The State Drug Administration organizes the evaluation of new raw materials that have been monitored for safety for 3 years. New raw materials that have not found safety problems are included in the catalog of used cosmetic raw materials, and other same new raw materials that are still under safety monitoring are terminated together; there are safety For new raw materials with problems, the filing or registration shall be canceled.
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