Cosmetic Regulations in China

With the implementation of Cosmetic Supervision Administration Regulation (CSAR) since 1st January 2021, the Chinese cosmetic market has begun a new epoch. New related measures or provisions have been published constantly in the last two years. Quality safety management system and cosmetic reverse reaction monitoring system play a very important role in the supervision of government. Here is an overview of the important provisions or legislations for the recent two years:

Measures for Supervision and Administration of Toothpaste

This Measure was published in March of 2023, will take effect from 1st December 2023 and contain the main contents: Toothpaste is defined as a paste product that is applied by friction to the surface of the human teeth for the primary purpose of cleaning. This means that tooth powder, mouthwash and other oral care products are excluded. The regulatory authority is National Medical Product Administration (NMPA). 

Toothpaste must be notified/registered before placing on the Chinese market after 1st December 2023. Up to now in China, imported toothpaste is regulated as general cosmetics but doesn’t need be notified/registered.

Strict restrictions on the use of terms in efficacy claims of toothpaste such as caries prevention, plaque inhibition, anti-dentin sensitivity, gum problem reduction, etc. are published. Toothpaste efficacy claims are permitted to be used in fixed combinations and may not be added, deleted or adjusted at will, and  should have sufficient scientific basis at the same time. 

Cosmetic Production Quality Management Code

The Management Code has 9 chapters and 67 articles, which clarify clearly the requirements for quality management departments and personnel, quality assurance and control, plant facilities and equipment, raw material and product, production process and product sales in cosmetic manufacturing enterprises.

The Chinese GMP specifies the main responsibilities to be assumed by the commissioning party, i.e. the cosmetic notifier and registrant:

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• A quality management system should be established, criteria for the selection of entrusted producers should be determined, and the production activities of entrusted producers should be supervised
• There should be a person responsible for quality and safety with corresponding responsibilities
• Samples should be retained and comply with relevant requirements
• To assume responsibility for the release of products to 
market
• A record management system should be established and implemented to supervise entrusted producers to keep records related to the implementation of production quality management practices

Furthermore,

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• the children’s cosmetics, eye cosmetics and toothpaste are the key regulated products.  Storage of half-finished products, filling, cleaning containers, etc. should be completed in the production clean area.
• the “double release” of products, i.e. the entrusted manufacturer fulfils the factory release obligation and the notifier/registrant fulfils the release to the market obligation.
• the number of product samples to be retained is at least twice the amount required for release inspection and should meet the product quality inspection requirements. If the product is a semi-finished product, the sample should be sealed and labelled.
• the parameters of the production process and the key control points of the process are clearly defined and the main production process should be validated.

Submission Code or Annex 14 – safety Information of raw material

The safety information of every raw material of cosmetic product which notifies or registers from the 1st January 2023 has to been submitted. The submission code will be applied by the manufacturer of the raw material.  A summary of safety information of cosmetic raw material in Chinese will be automatically generated after applying for the submission code. The problem now is only with the submission code one can’t check if the information regarding the trade name, the INCI Name and the percentage of a component which the submission code contains is exactly the same as the data in the formulation. If the information is not concordant, some more documents such as specification, MSDS, etc. about the raw material may be demanded, or an amended Annex 14 (safety information) is required.

If no submission code exists, annex 14 is an alternative and allowed to be filled in by the notifier/registrant. 

Because of the requirement on safety information of raw material, some producers or suppliers of raw materials haven’t applied for submission code or filled in Annex 14, the process of notification/registration is thus significantly slowed down. Because of this problem, on 27th March 2023 the NMPA published an announcement of optimisation of safety information management measures for cosmetic raw materials while notification/registration. Until 31st December 2023 the notifier/registrant has to submit only safety information of raw materials with high risk such as preservatives, sunscreen ingredients, coloring agents, hair dyes, raw materials for spot-lighting and whitening functions. Safety information of other raw materials used in the product formulation shall be made available for inspection by the competent authority at any time but a form doesn’t need to be submitted. From 1st January 2024 raw material safety information of every raw material in the formulation has to been submitted for notification/registration.

Measures for Management of Cosmetic Random Sample Testing

These measures came into force from 1st March 2023. Local medical products administration departments (MPAs) organise the random sample and the designated institutions complete the sample tests. The conformity of packaging and Chinese label will be proofed as well. The test includes chemical and physical values, microbiological and a heavy metal test. The target products are: children’s cosmetics and special cosmetics, cosmetics using new raw materials, problematic cosmetics which are once found via supervision, adverse reaction monitoring, safety risk monitoring, complaints and public opinion monitoring, a high failure rate in previous sampling tests, cosmetics with a wide circulation and high frequency of use, cosmetics with higher safety risks, etc.

The random samples will be taken on-site or bought online anonymously. Once the tests are finished and the test result is negative, the test result will be published on the website of NMPA. 

Cosmetics e-commerce is a very important sales channel in China. An online sample test is becoming more frequent. The main testing cosmetics are from flagship shops in the mall,and via influencers/ live streaming, etc. 

Implementation of Cosmetics Quality and Safety Main Responsibility

Enterprises in this Provision stand for the notifier, registrant and entrusted manufacturer. 

In order to urge enterprises to implement the main responsibility for the quality and safety of cosmetics, strengthen the awareness of enterprise quality and safety responsibility, standardise the quality and safety of cosmetics management, ensure the quality and safety of cosmetics, this Provision has been made according to CSAR, “Cosmetic Registration and Notification Management”, “Cosmetics Production and Management Supervision”, “Cosmetics Production Quality Management Practices,” etc.

The notifier or registrant of cosmetics is responsible for the quality and safety of cosmetics and its efficacy claims as well, and manages the whole process of quality and safety of notified or registered cosmetics from research and development of formulation, production and sales as well.

The notifier or registrant of cosmetics commissions the manufacturer to produce cosmetic products and is responsible for quality and safety of products. The entrusted manufacturer is responsible for the production activities and accepts the supervision of the notifier or registrant.

The enterprises should establish cosmetic quality and safety responsibility system, clarify the responsibilities of cosmetic quality and safety-related positions, the personnel in each position should be in accordance with the requirements of job responsibilities, the corresponding level of cosmetic quality and safety obligations, the implementation of the main responsibility for cosmetic quality and safety.

The Provision contain the chapters, such as key position requirements of quality and safety, quality and safety management mechanism, supervision and management, etc.

I take several abstracts from the Provisions and present the details:

The person in charge of quality and safety should have expertise in cosmetics, chemistry, chemical engineering, biology, medicine, pharmacy, food, public health or law or other cosmetics quality and safety-related fields, familiar with relevant laws and regulations, mandatory national standards, technical specifications, and has more than 5 years of experience in cosmetic production or quality management. The qualification requirements for head of quality and safety (QS) are so high and there are not so many heads of QS to meet the requirements, so that Chinese cosmetics companies have begun a battle for qualified head of QS.

Because of this reason, on 27th April 2022, the NMPA published a response letter on issue related to the qualification of the head of QS, which was posted on its official website. According to the letter, the principles of production, quality and safety management of health-related products such as pharmaceuticals, medical devices, and special foods are largely similar to those of cosmetics. Therefore, experiences in the production, quality and safety management of health-related products can be regarded as relevant experience for the head of QS in the cosmetic industry. 

The enterprises should provide the necessary conditions for the study and training of the head of QS to ensure that he or she is continuously updated with professional knowledge and legal knowledge of quality and safety management and to improve his or her ability to perform his or her duties. The head of QS shall have no less than 40 hours of relevant learning and training every year.

The head of QS set up by an enterprise engaged in cosmetic production activities shall assist the legal representative in assuming the following corresponding responsibilities for product quality and safety management and product release:

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1. establishing and organising the implementation of the enterprise’s quality management system, and reporting regularly to the legal representative on the operation of the quality management system
2.  decision-making on product quality and safety issues and the issuance of relevant documents
3.  management of product safety assessment reports, formulations, production processes, material suppliers, product labelling, etc., and the review of documents of cosmetic notification and registration
4. management and release of materials such as raw material, packaging, etc. and release of finished product as well
5.  cosmetic adverse reaction monitoring management.