CSAR Subsidiary Regulations: China Cosmetics Manufacture and Operation Supervision and Management Measures Unveiled

On July 21, 2020, China Ministry of Justice released the draft Supervision and Administration Measures on Cosmetics Manufacture and Operation for public consultation ^[1], one of the subsidiary measures of CSAR. The public consultation will last until August 20, 2020. Any suggestions can be submitted to the Chinese Government Legal Information Website or mail [email protected].

The draft consists of 8 chapters with 100 provisions with many details about production license management, production quality management, operation quality management, network operation management, and legal responsibilities. The main contents are as follows.

1. Refine the Main Responsibilities of the Registrants and Filers

The cosmetic registrants and filers serve as the bodies responsible for product quality and safety during production and operation. They shall:

Organize production in accordance with the requirements of cosmetics production quality management standard
Establish a cosmetics production quality management system
Perform post-market obligations of adverse reaction monitoring, risk control, product recall, product and ingredient safety re-assessment, etc.

For oversea registrants and filers, a corporate legal person in China shall be designated as a domestic responsible person. The domestic responsible person shall assist the cosmetic registrant and filer in fulfilling the obligation of adverse reactions monitoring, product recall, and cooperating with the drug administration department's supervision and inspection work.

2. Optimize the Production License Management System

1) Production License Application

To engage in cosmetics production activities, an application shall be submitted to the local provincial drug administration department. After the dossiers review and on-site inspection, the production license will be issued, valid for 5 years.

For the preparation, filling of cosmetic content, labeling, and packaging products in contact with cosmetic contents, a cosmetic production license shall be obtained.

Dossiers Necessary for Production License Application

1. Application form

2. Copy of business license

3. Copies of identity certificate of the legal representative and main responsible person

4. Copies of the resume and qualification certificate of the person in charge of quality and safety, such as identity, major, academic qualification or professional title

5. Proof of legal use of the production site

6. The production workshop air cleanliness and production water sanitation test report issued by a qualified inspection and testing institution within 1 year, and the production of eye skincare, infant and children skincare cosmetics, should meet the cosmetics production quality management standard regarding the environment of the clean area of the production workshop indices requirements

7. The general plan of the production site and plan of the production workshop (including the layout of each functional workshop)

8. Brief description and diagram of the production process

9. Production quality management system document catalog and main equipment catalog

10. Agency authorization letter

Note:

Requirements, procedures, the time required, dossiers necessary and the sample application form shall be disclosed on the website and offices of the administrative agency
Information that can be obtained and checked online is not required to submit in the form of paper document

2) Production License Renewal

The notification and commitment system shall be implemented for the renewal of cosmetic production licenses.

Step 1: 3 months before the expiration of the license: The manufacturer conducts a comprehensive self-inspection

Step 2: 30 working days before the license expiration: The manufacturer submits the license renewal application and self-inspection commitment report

Step 3: Before the expiration of the license: The original license-issuing department decides to approve the renewal

Step 4: Carry out post-market supervision and inspection.

3) Production License Information Alteration

The alterations are divided into the alteration of licensing items and registration items.

Category	Scope	Required time	Remarks
Licensing items alteration	The substantive alterations of the person in charge of quality and safety, licensing items, and production site relocation, reconstruction, and expansion	30 working days (alteration of the person in charge of quality and safety: 10 working days)	Conduct on-site inspection when necessary (the alteration of the person in charge of quality and safety can be exempted from on-site inspection) If a comprehensive on-site inspection is conducted, the validity period of the renewed production license shall be recalculated for 5 years from the date of renewal
Registration items alteration	Alteration of enterprise name, address, unified social credit code, legal representative or main responsible person, peripheral warehouse address and textual alteration of production address	5 working days	/

4) Principle of “One Production Site, One Cosmetic Production Enterprise”

Only one cosmetic production enterprise can be established in one production site.

Situation	Requirement
The cosmetic production enterprise sets up branch factories in different locations in the same province, autonomous region or municipality	Add the address of the production site to the original production license
The branch factory is a separate enterprise The cosmetic production enterprise sets up production sites across provinces, autonomous regions and municipalities	Apply for another cosmetic production license

3. Strengthen Production Quality Management

Cosmetic registrants, filers, and entrusted production enterprises shall establish a cosmetics production quality management system and organize the cosmetic production following the requirements of cosmetics production quality management standard. A comprehensive self-inspection of the implementation of cosmetics production quality management standards shall be conducted annually.

Entrusted Production

The draft clarifies the qualification requirements of the entrusting and entrusted parties, the entrusted contract requirements, and details the responsibilities of the entrusting party and the entrusted party, requirements for material management and procedures related to entrusted production alteration.

	Responsibility
Cosmetic registrants and filers	Responsible for the quality and safety of the entrusted product
The entrusted production enterprise	Responsible for the production activities and bear corresponding responsibilities for the entrusted product quality and safety.

4. Refine Operation Management

Cosmetic operators shall establish an operation quality management system and assist in monitoring adverse reactions and product recalls.
The draft prohibits operators from illegally preparing cosmetics, such as cosmetics sub-packaging in contact with contents. It also clarifies 8 types of products prohibited from operation.
Providing cosmetics to consumers in the form of free trials, gifts, etc. belongs to cosmetics operation activities.
The draft puts forward requirements for the business activities of beauty salons, hotels, and centralized trading markets.
The draft clarifies requirements for network operation management. The network operators are divided into 2 categories, cosmetics e-commerce platform operators, and cosmetics network operators.

Cosmetics e-commerce platform operators

Fulfill the obligations of cosmetics operators and ensure the traceability of cosmetics

Cosmetics e-commerce platform operators

Undertake the responsibility of reviewing and managing the operators on the platform.
To find cosmetics operators on the platform who seriously violate the provisions, the e-commerce platform operator shall immediately stop providing e-commerce platform services and fulfill the obligations of complaints and reports, adverse reaction reports, record keeping, cooperation in investigations, and evidence collection and cooperation in stopping violations.

5. Clarify Multiple Regulatory Measures and Refine Penalties

The draft details multiple regulatory measures such as supervision and inspection, sampling inspection, supplementary inspection, adverse reaction monitoring, risk monitoring and evaluation, risk control measures, responsibility interviews, credit files, bad credit records, the publication of prohibited business lists.
The draft puts forward specific obligations or requirements and stipulates legal responsibilities for cosmetic registrants, filers, domestic responsible persons, entrusted production enterprises, operators, e-commerce platforms, regulatory agencies, and monitoring agencies.
The draft refines the penalties for various illegal acts.

Related Resources:

News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration Regulation
News 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic Sector
News 3: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)
News 4: Chinese Cosmetic Officials Disclose the Content and Release Schedule of Subsidiary Regulations of CSAR
News 5: Will China Remove Mandatory Animal Testing for Imported General Cosmetics?
News 6: CSAR Subsidiary Regulations: China Consults on the Draft Administrative Measures on Cosmetic Registration
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 Supervision and Administration Regulation 2020
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