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On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on the draft Instructions for Cosmetic Registration and Notification Dossiers [1], one of the subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR). Cosmetic stakeholders with any suggestions can send to us at [email protected] before September 14. We will submit them to NIFDC on your behalf.
General Information of the Instruction
The Instruction consists of 7 chapters with 65 articles. The 7 chapters are as follows:
Basic Requirements
Format requirements
The opening and maintenance of user permissions
Requirements for registration and notification dossiers
Requirements for modifications
Requirements for registration renewal and cancellations
Supplementary provisions
The Instruction is designed to standardize cosmetic registration and notification, shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management, and promote the industry's development.
Highlights of the Instruction
1. Dossiers for First Imported or Notified Cosmetics: Same Category, Detailed Requirements
CSAR issued on June 29 revealed that the dossiers necessary for the registration of special cosmetics or notification of general cosmetics are same, which includes the items listed below:
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In this Instruction, the requirements for the dossiers mentioned above are further modified and refined. Among them, the following will have a significant influence on the industry.
1) Product Testing Report
As per the draft, general cosmetics manufactured under certified GMP conditions and with substantiated safety as defined by risk assessment will be exempted from relevant toxicology tests, except in one of the following circumstances:
The product is claimed to be used by children;
The product uses a new ingredient that is in the monitoring period;
The notifier, the responsible person and the manufacturer are listed as the key regulatory objects according to the quantitative grading results;
The notifier, the responsible person, and the manufacturer were investigated and punished for cosmetics' quality and safety issues.
Notably, compared with the Administration Measures for Filing of Non-Special Use Cosmetics (Draft) issued on May 27, 2019, the requirements for GMP certificates in this draft are further specified, which stress that its license issuing agency shall be the government and not associations or third parties.
Administration Measures for Filing of Non-Special Use Cosmetics | Instructions for Cosmetic Registration and Notification Dossiers | |
Provisions related to toxicological test exemption | If the production enterprise of filing product has obtained relevant qualification certification on the production quality management system by the regulatory agency and the product safety risk assessment results can fully confirm the safety of the product, the product may be exempted from relevant toxicological test items, except in the following situations… | If the production enterprise of general product has obtained relevant qualification certification on the production quality management system by the local cosmetics regulatory department in his country, and the product safety risk assessment results can fully confirm the safety of the product, the product may be exempted from relevant toxicological test items, except in the following situations… |
Given this, the exemption is still subject to great limitations as currently there are very few overseas government agencies can issue GMP or ISO certification. Stakeholders with any comments or suggestions on this article can send to ChemLinked, we’ll submit to the NIFDC.
Additionally, the following two requirements concerning efficacy evaluation shall also be noted:
Special cosmetics claiming sunscreen, freckle whitening, anti-hair loss, and new efficacy shall provide corresponding efficacy test reports issued by the testing institutions that meet the requirements of the Working Rules for Cosmetic Registration and Filing Testing.
Freckle-removing and whitening products of the same company can apply for the read-across assessment of whitening effects provided that they meet the requirements regulations.
2) Product Safety Assessment
One of the most important requirements concerning product safety assessment is that special cosmetics shall submit abstracts of safety assessment and toxicological test reports when applying for registration. While for general cosmetics, they can either submit these two documents or apply for exemption from toxicological tests and submit abstracts of safety assessment when applying for notification.
3) Product Formula
To strengthen cosmetic raw materials' traceability management, the applicant shall provide ingredient manufacturers and suppliers' information for all ingredients, coupled with the quality specifications signed/sealed by the ingredient manufacturer’s legal representative or by the authorized person. The supplier’s signature or official seal is required if the quality specification issued by the ingredient manufacturer is a photocopy or a scan.
For cosmetic products to use new ingredients in the monitoring period, obtaining the authorization from the new ingredient registrant, notifier, or the responsible person is the prerequisite for a successful registration or notification.
In cases where ingredients used require the addition or change of information (of ingredient supplier/manufacturer) but others details (types and proportions of ingredient, formula) remains unchanged, the cosmetic registrant or notifier shall timely update the information of ingredient supplier/manufacturer via online platforms.
4) Standard that the Product Complies with
This standard includes the original regulatory requirements such as: "Production Process" and "Product Quality and Safety Conrol Requirements" and adds the following:
New Packaging Material Requirements;
The actual quality control for the micro-organisms and physical/chemical indicators.
2. Requirements for Registration Renewal, Cancellation, etc. Dossiers
Under CSAR, a 5-year transitional period was granted for already registered hair growth, hair removal, breast beauty, slimming, and deodorant cosmetics from this regulation's implementation date. The production, import, and sale of such cosmetics are prohibited after the transition period [2].
As per this draft, products that have obtained the original registration certificates and will still be included in the category of special cosmetics should apply for registration renewal after the validity expires. The dossers such as the registration renewal application form, the product self-inspection commitment report, and the product inspection report (when necessary) shall be submitted when renewing the registration certificate. Products that no longer belong to special cosmetics but will be categorized as general cosmetics should conduct notification.
For example, the original hair growth products were categorized as special cosmetics. But under the new regulatory scheme, the management of these products will be divided into three situations based on their mechanism of action:
Products that prevent hair loss by improving hair quality will be changed to general cosmetics, which are subject to notification;
Products that prevent hair loss by improving the condition of the scalp will continue to be managed according to the anti-hair loss category of special cosmetics;
Products that promote hair growth through hormone regulation will fall under the oversight of drugs, and shall not be produced, imported, or sold per cosmetic regulations.
Related Resources:
News 5: CSAR Subsidiary Regulations: China Releases the Draft Cosmetic Classification Rules and Catalog
Webinar: Understanding China's New Draft Subsidiary Measures of CSAR
Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)
English Translation: Supervision and Administration Measures on Cosmetics Manufacture and Operation
English Translation: Administrative Measures on Cosmetic Registration
English Translation: Cosmetic Classification Rules and Catalog
English Translation: Technical Guidelines for Cosmetic Safety Assessment
Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
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