Detailing China’s Requirements for Cosmetic Quality and Safety Directors

Background

Under China's new cosmetic regulations, cosmetic companies are required to appoint a quality and safety director to be responsible for product quality and safety management.  When applying for cosmetic notification and registration, the company shall provide the director's resume. If any company fail to appoint a director or appoint a disqualified director, the company, the legal representative, or other directly responsible persons will face severe punishments. The director will also be punished if failing to undertake his or her responsibilities.

In May 2021, Guangdong MPA disclosed a punishment on a cosmetic quality and safety director as he deliberately provided false sales prices and false recall documents to MPA. Different from the past, the punishment fell on an individual apart from the company. This is the first time that China has publicly imposed penalties on quality and safety directors of cosmetics companies as well as an individual after the implementation of China's new overarching regulation-Cosmetic Supervision and Administration Regulation (CSAR).

The punishment reflects that the quality and safety director is a key position for cosmetics companies under China's new regulations. Quality and safety directors and cosmetics companies are a community sharing the risks and shouldering the responsibilities. Cosmetic companies are advised to attach greater importance to the cultivation of quality and safety directors or deliberatively recruit a qualified person to undertake the work. 

Responsibilities of Quality and Safety Directors 

The CSAR regulates that the quality and safety director (hereinafter referred to as the director) shall undertake the responsibilities of product quality and safety management and product release. According to the draft of Good Manufacturing Practices for Cosmetics, the director's main responsibilities include:

1. To establish and improve the enterprise's quality management system, ensure that the enterprise activities meet the requirements of these Practices, and regularly report the quality management system's operation situation to the legal representative of the enterprise;

2. To make decisions on product quality and safety problems and issue relevant documents;

3. To assess and approve product formulas, ingredients and production processes;

4. Responsible for managing the release of new materials and products;

5. To select, assess and approve material suppliers (including material production enterprises and distributors, the same below);

6. To assess and supervise entrusted production and entrusted testing.

To ensure that the director performs his responsibilities independently and is not interfered with by other personnel, cosmetic companies are required to establish a corresponding internal management system.

If the director fails to undertake his responsibilities, he or she may be fined up to five times the income received from the company in the previous year and banned from engaging in cosmetics production for life. If a crime is constituted, the director shall be prosecuted for criminal responsibility.

Qualification of Quality and Safety Directors

The CSAR briefly stipulates that the director shall have the following two qualifications:

1. Have professional knowledge related to cosmetics quality and safety

2. Have more than five years of experience in cosmetics production or quality and safety management

The draft of Good Manufacturing Practices for Cosmetics further clarifies that the director shall have a junior college diploma or above in cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, public health, food or other related majors. Mastering cosmetics professional and regulatory knowledge related to quality and safety is also a must for this position.

The requirements for professional and regulatory knowledge are not explained clearly in the draft. The industry estimates that the director should not only be familiar with all cosmetics-related regulations but also understand cosmetic formulations, production processes, raw materials, safety assessment, hazard identification, etc. In addition, the director might be expected to master the knowledge related to management, statistics, verification principles, product traceability system establishment, etc.

It should be noted that if a company fails to appoint a director or appoints an unqualified director, even if the products meet the requirements, the company will still be subject to administrative penalties such as fines, and confiscation of illegal income and illegal cosmetics. For serious circumstances, the following punishments will be imposed:

• Suspension of cosmetic production and operation

• Cancellation of the notification and registration certificates

• The legal representative, the main responsible person, the person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than one time and less than two times the income last year they obtained from the unit and shall be prohibited from engaging in cosmetics production and operation activities in five years. 

Industry Comments 

• The setting up of quality and safety director is an important regulatory innovation to ensure the quality and safety of cosmetic products and a healthy development of the cosmetic industry. In the past, product safety and quality management were not completely unified, and the nominal person in charge of product quality could not fully manage product quality and safety. Such a new approach will further strengthen product quality and safety management, promote the professional expertise of technical personnel, and give full play to the role of internal supervision.

• Due to the strict requirements for quality and safety directors, there are very few qualified persons in the industry. As a result, the position is in short supply with a rising salary. Since the director is a key position with heavy responsibilities, hiring a part-time person or sharing the director with other companies should also not be accepted by the government. Therefore, the shortage of talents is a difficult problem faced by cosmetic companies. It is expected that the government may introduce corresponding measures to solve this problem.