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

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:

Organize the production of cosmetics in accordance with production quality management practice, establish production quality management system and ensure its continuous and effective operation;
Establish and implement management systems such as supplier selection, ingredient check before acceptance, production process, quality control, equipment management, product inspection and sample retain;
Establish a cosmetic quality and safety responsibility system;
Establish and implement the health management system of the employees, and establish health archives for employees;
Formulate annual training plans for employees;
Keep samples and records of the cosmetics that leave the factory. The registrant/notifier needs to have enough space to store the samples;
Establish and implement the purchase inspection and recording system and product sales recording system for ingredients and packaging materials in direct contact with cosmetics.

2) Qualification requirements for the person in charge of quality and safety are relaxed.

The person in charge of quality and safety shall assist the registrant, notifier, legal representative and main responsible person of the entrusted production enterprise to undertake the following product quality and safety management and product release responsibilities:

The establishment and implementation of the enterprise’s quality management system;
Review the management of product formulas, production processes, material suppliers, etc.;
Material release management and product release;
Adverse reaction monitoring management;
Supervision of production activities of entrusted production enterprises.

The person in charge of quality and safety have cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health or legal science and other cosmetic quality and safety related professional knowledge; and be familiar with relevant laws, regulations, rules, mandatory national standards, and technical practices; and have more than five years of experience in cosmetic production or quality management.

The previous draft Measures stipulated that the person in charge of quality and safety should have at least a college degree or a corresponding technical title. Considering the talent shortage, the finalized Measures no longer restricts the education background and specialty of the person in charge of quality and safety, but pays more attention to the master of professional knowledge and work experience.

3) Cosmetic labeling requirements are refined.

The smallest sales unit of cosmetics should have Chinese labels;
Children cosmetics should be labeled with children cosmetics’ logo designated by National Medical Products Administration (NMPA). Enterprises that produce and sell toys and appliances for children shall indicate precautions on the packaging, and take measures to prevent the products from being misused as children cosmetics. Find all the requirements for children cosmetics in Cosmepedia;
For label defects that do not affect product quality and safety and will not mislead consumers, the administration department can order the enterprise to make corrections;
Cosmetic registrants, notifiers, and entrusted production enterprises shall take measures to avoid the confusion of cosmetics with food and drugs in product properties, appearance, etc. This provision implies a ban on cosmetics claiming “food-grade” or "edible."

For all the requirements of cosmetic labeling, please refer to CL News.

3. Cosmetic Operation Management

1) The cosmetic operators shall establish and implement the purchase inspection and recording system, check the market entity registration certificate of the direct supplier, the registration certificate of special cosmetics, the notification information of general cosmetics, and product quality inspection certificate. The cosmetic operators should keep relevant certificates, and truthfully record related information.

2) The Measures strengthens the supervision of products operated on e-commerce platforms.

E-commerce platform operators

1. Register the real names of the cosmetic operators who apply for entering the platform, and establish registration files;

2. Set up a cosmetic quality management agency or be staffed with management personnel, establish and effectively implement cosmetic quality and safety management systems, including daily inspections of cosmetics, stoppage and reporting of illegal acts, and handling of complaints and reports.

If serious illegal acts are found, platforms shall immediately stop providing services to illegal operators who are:

Sentenced to criminal punishment by the court for crimes related to cosmetics quality and safety;
Detained by public security organs or given other public security administration punishment due to an illegal act on cosmetics quality and safety;
Lawfully given punishment by the administration department such as the revocation of the license or being ordered to suspend production and operation, etc.;

3. E-commerce platform operators are encouraged to carry out sampling inspections;

4. Assist and cooperate with administration department in supervision, inspection and case investigation.

Cosmetic operators in the platforms

Fulfill the obligations of cosmetics operators;
Fully, truly and accurately display cosmetic labels and other information consistent with the cosmetic registration or notification documents on the product page.

3) Cosmetics used in beauty salons and hotels, cosmetics provided to consumers in the form of a free trial, gift, or exchange, shall also comply with Cosmetic Supervision and Administration Regulation (CSAR) and the obligations stipulated in the Measures.

The cosmetics used in beauty salons and hotels shall comply with the label provisions for the minimum sales unit, which means that beauty salons and hotels are not allowed to subpackage cosmetics by themselves.

Beauty and hair salons shall display the sales packaging of the cosmetics they used in operation in a prominent place at the site for business operation.

4. Supervision and Administration

NMPA will later formulate main inspection points on cosmetic production quality management practices, and clarify the key items and general items for supervision and inspection as well as the judgment principle.

When necessary, the administration departments can conduct extended inspections on suppliers and production enterprises regarding to cosmetic ingredients, and packaging materials in direct contact with cosmetics.