China cosmetics quality and safety responsibilities regulations have been released by the National Medical Products Administration (NMPA).
The Regulations on the Supervision and Administration of Enterprises’ Implementation of the Main Responsibility for Quality and Safety of Cosmetics (No. 125 in 2022) come into force on March 1, 2023.
This final version of the legislation is largely unchanged from the draft legislation that was proposed for industry comment at the end of 2022. Below you will find the main provisions and the main changes between the draft and finalized legislation.
Persons responsible for quality, safety and efficacy claims
This is covered in Article 3: Cosmetics registrants and filers shall be responsible for the quality, safety and efficacy claims of cosmetics. The shall manage the quality and safety of the cosmetics registered or filed over the whole process of research and development, production and operation.
Where a cosmetics registrant/filer entrusts (outsources) the production of cosmetics, it shall supervise the entire process of production activities and be responsible for the quality and safety of the cosmetics commissioned for production. The entrusted production enterprise is responsible for the production activities and accepts the supervision of the entrusted party.
China cosmetics quality and safety responsibility system
This is covered in Article 4: Enterprises shall establish a cosmetics quality and safety responsibility system and clarify the responsibilities of cosmetics quality and safety related positions. The personnel of each position shall perform the corresponding cosmetics quality and safety obligations step by step in accordance with the requirements of their job responsibilities and implement the quality and safety of cosmetics responsibility.
Article 5 states that the legal representative (or main responsible person) of the enterprise is fully responsible for the quality and safety of cosmetics. Enterprises shall appoint a person in charge of quality and safety. The person in charge of quality and safety shall, in accordance with the requirements of the quality and safety responsibility system, assist the legal representative in organizing relevant quality and safety management personnel to perform quality and safety management duties in accordance with law.
And in the final version, the legal representative shall also be responsible for providing necessary resources, reasonably formulating and organizing the implementation of quality policies, and ensuring the achievement of quality objectives.
Article 6 specifies cases where the legal representative (LP) of a company entrusts other personnel of the company to carry out comprehensive management of the enterprise, the LP may entrust the quality and safety of the cosmetics accordingly subject to a power of attorney (POA) being signed with the entrusted person. The POA shall clarify the quality management duties that the entrusted person should perform and grants corresponding authority. Performance of duties conducted by the entrusted person must be traceable.
A new addition to article 6 is the legal representative shall supervise the entrusted person’s performance of duties on their behalf.
Requirements for the person in charge of quality and safety of cosmetics
The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics such as cosmetics, chemistry, chemical industry, biology, medicine, pharmacy, food, public health or law. They shall also be familiar with relevant laws and regulations, mandatory national standards and technical specifications, and have more than 5 years of experience in cosmetics production or quality management.
Articles 9 to 14 state specific duties of the person in charge of quality and safety cosmetics.
See below for duties concerning product release and self-inspection (Article 19).
In Article 21, it states that a company must establish an assessment system for the person in charge of quality and safety. And that the company shall periodically carry out assessment and assessment of the ability of the person in charge of quality and safety to perform his or her duties.
Moreover, Article 22 introduces a new requirement that the person in charge of quality and safety shall receive no less than 40 hours of relevant learning and training per year.
Article 26 specifies that the NMPA and local MPAs shall strengthen random inspections and assessments of the ability of persons responsible for quality and safety to perform their duties.
Importantly, in Article 28, new provisions are introduced if an enterprise does not have a person in charge of quality and safety, or the person in charge of quality and safety established by the enterprise does not meet the prescribed requirements for employment or does not have the corresponding ability to perform their duties. Sanctions in accordance with the provisions of Item 2 of the first paragraph of Article 61 of the Regulations on the Supervision and Administration of Cosmetics will be applied. This can involve fines, seizure of raw materials and goods, suspension of production and business, revoking of cosmetics licenses and potential bans of up to 5 years on cosmetics production and business activities.
China cosmetics quality and safety management
As part of the requirements in Article 15, a company must set up a dynamic management mechanism to prevent and control cosmetic quality and safety risks. Part of this involves a review system for cosmetics registration and filing materials.
In Article 16 this is newly clarified that before the registration or filing of products (including the first application for registration or filing, change of registration and filing, and renewal of registration), the person in charge of quality and safety shall review the legality, authenticity, scientificity, and completeness of the registration or filing materials such as:
- product name
- product formula
- product implementation standards
- product label
- product inspection report
- product safety evaluation
- efficacy declaration evaluation materials.
If any problem is found, it shall be rectified immediately, and no product registration application or filing shall be submitted before the rectification is completed.
Part of the cosmetics QMS requirements is the establishment of a system for releasing products batch-by-batch (Article 18). New requirements in this article state that if the person in charge of quality and safety finds that the product has quality and safety risks, they shall not release it. They shall immediately undertake risk control measures, and report in a timely fashion to the legal representative.
Furthermore, in Article 19, it is newly added that if the person in charge of quality and safety finds that the above situation involving product quality and safety is a major safety risk, he shall immediately report to the legal representative and put forward veto suggestions such as stopping the production and operation of relevant cosmetics. The legal representative shall organize research and take measures to deal with it.
In articles 15, 19 and 20 there are new requirements for companies to establish self-inspection systems.
In Articles 15 and 20, companies are required to establish a dynamic management mechanism to prevent and control cosmetic quality and safety risks including a new requirement for self-inspection of the quality management system and a review of said system.
In Article 19, companies shall establish a self-inspection system for initiating causes.
If the person in charge of quality and safety finds that the above situation involving product quality and safety is a major safety risk, he shall immediately report to the legal representative and put forward veto suggestions such as stopping the production and operation of relevant cosmetics. The legal representative shall organize research and take measures to deal with it.
Supervision and management by the NMPA and local MPAs
Article 25 explains that the NMPA shall regard the following as important parts of supervision and inspection of cosmetics registrants, filers and entrusted manufacturers:
- establishment and implementation of the cosmetics quality and safety responsibility system
- performance of duties by the person in charge of quality and safety
- implementation of the dynamic management mechanism for risk prevention and control.
Article 28 brings new provisions if the person in charge of quality and safety does not meet the requirements laid out (see above). And Article 29 sees an extension in the directly responsible personnel who commit illegal acts to also including the company’s production and operation management personnel or the employees of the company.
However, Article 30 newly specifies that when an enterprise is administratively punished for illegal acts, where there is sufficient evidence to prove that the relevant responsible personnel of the enterprise have fulfilled their cosmetics quality and safety obligations and there is no subjective fault, the relevant responsible personnel shall not be given administrative punishment.
Domestic Responsible Person (DRP)
A new article, Article 32, has been added to state that the Domestic Responsible Person designated by the overseas cosmetics registrant/filer shall, in accordance with laws and regulations and in its agreement with the registrant/filer, bear the corresponding responsibility for the quality and safety of cosmetics, and cooperate with the supervision and inspection work of the department responsible for drug supervision and administration.
Further information on China cosmetics quality and safety responsibilities
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