[Updated] CSAR Subsidiary Regulations: China Implements the Finalized Good Manufacturing Practices for Cosmetics

Editor’s Note: This article was originally published on Jan. 10, 2022, and was updated on Jul. 1, 2022, as per the latest developments.

In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as “Practices”). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and implemented it on July 1, 2022. ¹

Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices;
For enterprises that have obtained production licenses before July 1, 2022, if their facilities, equipment, etc., shall be upgraded according to the Practices, the upgrading and reconstruction shall be completed before July 1, 2023.

Main Contents

The Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The promulgation of the Practices indicates that cosmetics production in China enters a more standardized era.

Chapter I General Rules

Chapter II Institutions and Personnel

Chapter III Quality Assurance and Control

Chapter IV Plant Facilities and Equipment Management

Chapter V Materials and Products Management

Chapter VI Production Management

Chapter VII Entrusted Production Management

Chapter VIII Product Sales Management

Chapter IX Supplementary Rules

Annex I Electronic Record Requirements for Cosmetics Production

Annex II Environmental Requirements for Cosmetics Production Plant

Key Points

Based on the quality control requirements in Practice for Cosmetics Production Licensing issued in 2015, the Practices' formulation supplements and refines relevant contents combined with the problems found in regulatory and supervisory practice. The three key points of the Practices are as follows:

1. Finalizes the qualification requirements and duties of the person in charge of quality and safety

Cosmetic registrants, notifiers and entrusted product enterprises (hereinafter collectively referred to as the "enterprises") shall set up a person in charge of quality and safety to establish a production quality management system, put the product on the market, and be responsible for the product's quality, safety, and efficacy claims. The person in charge of quality and safety shall perform their duties independently without interference from other personnel from the enterprise, and shall not concurrently serve as the person in charge of the production department.

Qualification Requirements for the Person in Charge of Quality and Safety

Duties of the Person in Charge of Quality and Safety

1) Having cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health, legal science or other cosmetic quality and safety professional knowledge;

2) Being familiar with relevant laws, regulations, rules, mandatory national standards, and technical norms;

3) Having more than five years of experience in cosmetic production or quality management.

1) Establishing and organizing the enterprise’s production quality management system, fulfilling quality and safety management responsibilities, and regularly reporting the operation of the quality management system to the legal representative;

2) Making decisions on product quality and safety issues and issuing relevant documents;

3) Reviewing product safety assessment report, formulas, production techniques, material suppliers, product labels, and registration and notification documents;

4) Managing material release and product release;

5) Managing cosmetics adverse reactions monitoring.

The Practices also points out that, with the written consent of the legal representative, the person in charge of quality and safety is allowed to designate other personnel from the enterprise to assist in performing the duties of 3), 4), and 5) in the above table. However, the legal responsibility of the person in charge of quality and safety will not be transferred to the designated person. This means that once a product safety problem occurs, the first responsible person is still the person in charge of quality and safety.

The previous draft of Practices had qualification requirements for the person in charge of quality and safety in three aspects: education, professionalism, and work experience. Therefore, scarce people were able to meet the requirements. The finalized Practices removes the requirement for educational background. In addition, NMPA allowed the group company to appoint the same person in charge of quality and safety for different subsidiaries ², and recognized experience in drug, medical device, special food production or quality and safety management ³, which can alleviate the talent pressure faced by the industry to a certain extent.

2. Ensures the traceability of products from production to market and refine the requirements for sample retention

The Practices stipulates that enterprises shall establish and implement a traceability management system, and formulate the batch management rules for ingredients, primary packaging materials, semi-finished products, and finished products. All records related to the production should be interrelated to ensure the traceability of materials purchasing, production, quality control, storage, sales and recall.

In addition to the traceability management system, enterprises must establish and implement quality and safety responsibility system, self-inspection system, sample retention management system, material purchase and inspection system, labeling management system, product release system, etc.

The Practices also refines the requirements for sample retention. Enterprises shall retain samples for each batch of products that leaves the factory, and the number of samples should be at least twice the amount required for factory inspection. The retention period of the samples shall not be less than six months after the product expires. If the samples deteriorate within the shelf life, the enterprise must recall the product and analyze the reason.

	Requirements for Sample Retention
Finished product	Keep the original sales packaging
Product set	Enterprises can choose to keep the smallest sales unit or the overall sales packaged product; and Keep the outer packaging of the set
Semi-finished product	The samples shall be sealed and have label information.
Key ingredient	The retained ingredients shall have label information.

Notes: Other responsibilities of enterprises can be found in the English version.

3. Further clarifies the requirements for entrusted production

The Practices clarifies "Entrusted Production Management" as a separate chapter, indicating that NMPA attaches great importance to it. This chapter refines the management requirements for the entrusting party (brand) that entrust factories to produce cosmetics. The responsibilities of brands include:

1. Establishing quality management systems

Establishing organizational structure; clarifying the responsible departments of registration/notification, production quality and sales management; and allocating corresponding management personnel;
Establishing a quality and safety responsibility system, a quality management system, and setting up a person in charge of quality and safety;
Keeping samples of the product. For overseas enterprises, the RP in China shall keep the product samples;
Establishing and implementing cosmetic registration and notification management, employee health management, employee training, self-inspection, product release management, sample retention management, sales records, product storage and transportation management, product return records, product quality compliance management, product recall management, adverse reaction monitoring and evaluation, and record management system.

2. Supervising the production activities of the entrusted production enterprises

Establishing the selection criteria, as well as directory and management files for entrusted production enterprises;
Signing a contract with the entrusted production;
Establishing and implementing the production activity supervision system and the replacement system of entrusted production enterprises.

Previously, some brands that lacked a person in charge of quality and safety chose to authorize their entrusted factory as the registrant/notifier to register/notify cosmetics. The Practices clearly states that in entrusted production, the entrusting party (brand) should be the registrant/notifier; thus, authorizing the entrusted factory as the registrant/notifier may bring regulatory risks.

Industry Comments

"The introduction of the Practices will reshuffle the industry, and companies that cannot meet the requirements in the Practices will gradually be eliminated. Meanwhile, the Practices gives enterprises clear guidance, and can regulate the product manufacturing and sales, thereby promoting the development of cosmetic brands,” said an industry insider. ⁴

From the introduction of the person in charge of quality and safety, to the improvement of the sample retention system, the traceability chain, and the management of entrusted production, there is no doubt that "strictly ensuring product quality and safety" is the goal of carrying out the Practices. It also shows NMPA's determination to promote the standardized development of the cosmetics industry.