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CSAR Subsidiary Regulations: China to Implement Supervision and Administration Measures on Cosmetics Manufacture and Operation

The Measures refines the responsibilities of cosmetics registrants, notifiers, and entrusted production enterprises, such as establishing production quality management practices, quality and safety management systems, purchase inspection and recording systems, product sales record systems, etc.; Companies engaged in cosmetic preparation or content filling are required to obtain production licenses; The qualification requirements for the person in charge of quality and safety are relaxed; Cosmetic operators in e-commerce platforms should display the labeling information on the product page.

On Aug. 2, 2021, China State Administration for Market Regulation released the finalized Supervision and Administration Measures on Cosmetics Manufacture and Operation (hereafter referred to as “Measures”), which will come into force on Jan. 1, 2022. 1

The Measures consists of 7 chapters with 66 provisions, detailing cosmetic manufacture and operation management. Highlights include:

  • Optimizing production license management system;

  • Refining and clarifying the production management requirements;

  • Refining and clarifying the operation management requirements;

  • Strengthening the supervisory responsibilities of the administration department.

In addition, detailed requirements have been made for issues of concern, such as the responsibilities and qualification requirements for the person in charge of quality and safety, the requirements for operators in e-commerce platforms, etc.

1. Production License Management

1) A production license is required for cosmetics preparation and content filling.

To engage in cosmetics production activities, stakeholders shall apply to the local medical product administration department (hereafter referred to as “administration department”) for production licenses. After the dossiers review and on-site inspection, the production license will be issued within 35 working days, valid for five years.

The Measures stipulates that the preparation and filling of cosmetic contents should also obtain a production license. It means enterprises that subpackage products or manufacture semi-finished products should obtain a production license.

The labeling process shall be conducted by the enterprise that complete the last step in the production process of contacting cosmetic contents.

2) Soap is added to the licensing categories of the production license.

Cosmetic production licensing items are classified into:

general liquid unit, cream emulsion unit, powder unit, aerosol and organic solvent unit, wax-based unit, toothpaste unit, soap-based unit, and other units

In China, soap does not belong to cosmetics, but those claiming the efficacy of special cosmetics (e.g., whitening soap) shall comply with cosmetic regulations. The addition of soap to the licensing categories leaves a channel for soap companies to apply for production licenses.

For manufacturers who meet the production conditions of children’s skin care or eye-care products, the production qualification shall be indicated in the licensing categories.

3) The notification and commitment system is implemented for production license renewal.

Step 1: 30-90 working days before the license’s expiration: The production enterprises submit the license renewal application and make commitments that they meet the cosmetic production licensing conditions;

Step 2: 5 working days after receiving the renewal application: The administration department conducts a format review of the application documents and accepts qualified applications;

Step 3: 10 working days from the date of acceptance: The administration department renews the production license;

Step 4: The administration department supervises the application documents and commitments submitted by the production enterprises.

2. Cosmetics Production Management

1) Responsibilities of the registrants, notifiers, and entrusted production enterprises are refined.

Cosmetic registrants, notifiers, and entrusted production enterprises shall:

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