CSAR Subsidiary Regulations: China NMPA Consults on the Second Draft of Good Manufacturing Practices for Cosmetics

On Sep. 28, 2020, China NMPA released the first draft of Good Manufacturing Practices (GMP) for Cosmetics. On Sep. 8, 2021, China NMPA consults on the second draft Good Manufacturing Practices for Cosmetics (the Practices). ¹ The number of articles in the second draft is reduced from 77 to 64, and some standards are relaxed. Any suggestions can be mailed to NMPA ([email protected]) before Sep. 28, 2021.

Domestic cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with Good Manufacturing Practices for Cosmetics. The Practices are divided into nine chapters and two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. As the second draft mentions that the Practices' effective date is Jan. 1, 2022, it is expected that its finalized version will be issued before 2022.

Compared with the first draft, some adjustments are as follows:

1. Relax the qualification requirements for the person in charge of quality and safety, the person in charge of the quality management department and the person in charge of the production management department.

Cosmetic production enterprise should appoint the person in charge of quality and safety, person in charge of the quality management department and person in charge of the production management department.

The second draft of the Practices neither restricts the education background of the person in charge of quality and safety any longer, nor impose restrictions on the education background and working years of the person in charge of the quality management department and the person in charge of the production management department.

	Qualifications	Amendments
Person in charge of quality and safety	Have cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health, legal science or other cosmetic quality and safety professional knowledge; Be familiar with relevant laws, regulations, rules, mandatory national standards, and technical practices; Have more than five years of experience in cosmetic production or quality management.	No more education background requirements; "Legal science" is added to the professional knowledge scope.
Person in charge of the quality management department	Have cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health, legal science or other cosmetic quality and safety professional knowledge; Have cosmetics production or quality management experience.	No more education background and working years requirements; "Legal science" is added to the professional knowledge scope.
Person in charge of the production management department	Have cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health, legal science or other cosmetic quality and safety professional knowledge; Have cosmetics production or quality management experience.
Notes: 1. The person in charge of quality and safety should perform his/her duties independently and shall not be disturbed by other personnel; 2. The person in charge of the quality management department and the production management department cannot be the same; 3. The person in charge of quality and safety and the person in charge of the production management department cannot be the same.

With the relaxation of the qualification requirements, the current talent shortage in China is expected to be improved.

Although the qualifications are relaxed, the scope of responsibilities of the person in charge of quality and safety is expanded. New responsibilities for label review, adverse reaction monitoring, and product recall management are added. The specific main responsibilities specifically include:

Establish and implement production quality management system, fulfill quality and safety management responsibilities, and regularly report the operation of the quality management system to the legal representative of the enterprise;
Make decisions on product quality and safety problems and issue relevant documents;
Review product formulas, production processes, material suppliers, product labels, etc.;
Responsible for the release management of materials and products;
Manage adverse reaction monitoring;
Manage product recall.

2. Refine the management requirements for brands that entrust factories to produce cosmetics.

The second draft clearly states that in entrusted production, the entrusting party (brand) should be the registrant or notifier. The responsibilities of brands that entrust factories to produce cosmetics include:

1	Establish quality management systems	Establish organizational structure; clarify the responsible departments of registration/notification, production quality and sales management; and allocate corresponding management personnel; Establish a quality and safety responsibility system, quality management systems, and set up a person in charge of quality and safety; Keep samples of the product. For overseas registrant/notifier, the RP in China shall keep the product samples; Establish and implement a record management system.
2	Supervise the production activities of the entrusted production enterprises	Establish the selection criteria, as well as directory and management files for entrusted production enterprises; Sign a contract with the entrusted production; Establish and implement the production activity supervision system and the replacement system of entrusted production enterprises.

Since the new registration and notification regulations came into effect on May 1, some brands that lack quality and safety personnel chose to authorize their entrusted factory as the registrant/notifier to register/notify cosmetics. The second draft clarifies that the entrusting party should be the registrant/notifier; thus, the approach of authorizing the entrusted factory as the registrant/notifier may bring regulatory risks.

NMPA intends to raise industry entry barriers through CSAR and its subsidiary regulations. Brands that entrust factories to produce cosmetics should conform to the spirit of the new regulations and establish standardized product quality management systems as early as possible to avoid possible risks.

The second draft also revised the enterprise self-inspection system, testing capability management, production plant's environmental requirements, employee's health file retention period, etc. Detailed requirements of cosmetic production management in China can be found in the English translation of the Practices.