CMS Expert Guide on Beauty in China

According to the Regulations on the Supervision and Administration of Cosmetics issued by the State Council of the People’s Republic of China (“PRC”) (“Cosmetics Regulation”) (effective as of 1 January 2021), cosmetic products refer to those daily chemical products applied on the surface of the human body such as skin, hair, nails and lips by way of smearing, spraying or other similar methods for cleaning, protection, beautification and modification purposes. Note that according to the Cosmetics Regulation, toothpastes are also regulated as non-special purpose cosmetics.  

Cosmetics are classified into special purpose cosmetics and non-special purpose cosmetics. Special purpose cosmetics include the cosmetics used for hair colouring, hair perming, freckle removal and whitening, anti-suntan and anti-hair loss and the cosmetics that claim new efficacies. Others shall be treated as non-special purpose cosmetics. In this regard, the National Medical Product Administration (“NMPA”) released a Cosmetics Classification Rules and Classification Catalogue (effective as of 1 May 2021) to help to identify what products shall be regulated as special purpose cosmetics. Pursuant to the Cosmetic Regulation, special purpose cosmetics are subject to registration, while non-special purpose cosmetics are subject to a filing. The NMPA is the competent authority for the administration, registration and filing of cosmetic products.

According to the PRC Drug Administration Law (revised in 2019), medical products or usually called "pharmaceuticals" or "drugs" shall refer to any substance used for preventing, treating and diagnosing human diseases as well as purposely regulating human physiological functions with specified indications or functions, usage and dosage, including traditional Chinese medicines, chemical drugs and biological products. Before listed on the market, a medical product must be approved by and registered with the NMPA, except traditional Chinese medicines (“TCM”) materials and TCM decoction pieces not yet subject to management upon approval.

Cosmetics are prohibited to mark the content expressing or implying medical efficacy on their labels. Therefore, from the regulatory perspective, there is no middle ground where a product is a cosmetic product and at the same time, also a drug. Accordingly, there is no such thing as “cosmeceutical products” in the current regulatory system. For products registered or filed according to the Cosmetic Regulation, claiming the concept of "medicinal cosmetics", "medicated cosmetics" and "medical skincare products" is illegal.

Key national laws and regulations for cosmetics are as follows:

1. Regulations on the Supervision and Administration of Cosmetics, effective as of 1 January 2021;
2. Measures for the Supervision and Administration of the Manufacturing and Distribution of Cosmetics, effective as of 1 January 2022;
3. Measures for the Administration of the Registration and Filing of Cosmetics, effective as of 1 May 2021;
4. Regulations on the Administration of Information for Registration and Filing of Cosmetics, effective as of 1 May 2021;
5. Administrative Measures for the Labelling of Cosmetics, effective as of 1 May 2022;
6. Measures on the Supervision and Administration of the Inspection and Quarantine of Import and Export  Cosmetic Products, 23 November 2018;
7. Regulations on Supervision and Administration of Enterprises Implementing the Principal Responsibility for the Quality and Safety of Cosmetics, effective as of 1 March 2023;
8. Specification for Evaluation of Cosmetic Efficacy Claims, effective as of 1 May 2021;
9. Technical Code for Cosmetic Safety (2015 Edition);
10. National Standard GB 5296.3-2008, Instruction for Use of Consumer Products - General Labelling for Cosmetics, effective as of 1 October 2009.                                                           

“New ingredients” in cosmetics products shall be subject to regulation by the NMPA. The term “new ingredients” refers to the natural or synthetic ingredients used for the first time in cosmetics in China. NMPA has issued a Catalogue of Used Cosmetics Ingredients (2021 Edition) (“Ingredients Catalogue”) to identify whether an ingredient is already used in cosmetics in China. If the new ingredient could be used for (1) anti-corrosion, (2) sun protection, (3) coloring, (4) hair dyeing, (5) spot removal and (6) whitening, they shall be registered with the NMPA before use for safety concerns. For other new ingredients, a record-filing is sufficient.

Regardless of registration or record-filing, applicants for new ingredients shall submit, among other documents,  (1) a research & development report, (2) research data on the production process, stability, and quality control standards of the new ingredient; and (3) safety assessment data. New ingredients will be included into the Ingredients Catalogue if there is no safety issue during a three-year observation period after it has completed registration or record-filing.  

Any addition of a substance in cosmetic products shall follow the Technical Code for Cosmetic Safety (2015 Edition) (“Cosmetics Technical Code”). The Cosmetics Technical Code lists the following matters:

1. The substances prohibited to be used as cosmetic raw materials. List I and List II are promulgated in this regard. List I is for certain chemical substances and List II is for plant/animal components. For example, the tretinoin (INN) (retinoic acid) (CAS No. 302-79-4) and its salts, are prohibited to use by the List I. Others, such as retinol, its esters, and vitamin C are not prohibited.
2. The substances to be used only in restricted conditions. The Cosmetics Technical Code has a List III for restricted substances. Conditions covered include:
   1. allowed product scope,
   2. the maximum allowed concentration,
   3. labelling caveats, and
   4. other conditions.
      For example, salicylic acid is a popular substance used in acne control cosmetic products. According to the List III, salicylic acid shall only be added in two kinds of products: (1) residual products and rinse-off skincare products, with a maximum concentration of 2.0%, and (2) rinse-off hair products, with a maximum concentration of 3.0%. Salicylic acid shall not be used in products intended for use by children under 3 except for in shampoos. And the labels for concerned products shall indicate: (1) “含水杨酸” (in English: contains salicylic acid); (2) “三岁以下儿童勿用” (in English: do not use on children under 3 years old).
   5. The allowed preservatives (List IV), sunscreen substances (List V), colorants (List VI), and hair dyes (List VII). All these substances are also under certain restrictions, including related to maximum concentration, product scope and labelling.

In addition to the above general restrictions, for cosmetics for children, Regulations on the Supervision and Administration of Cosmetics for Children (effective as of 1 January 2022) list some special requirements on their ingredients:

1. Cosmetics for children should choose the ingredients with a long history of safe use, shall not use new ingredients that are still in the observation period. It is prohibited to use the ingredients made with gene technology, nanotechnology and other new technologies. Where there are no alternative ingredients, the reasons for the use shall be explained and the safety evaluation for children shall be carried out.
2. It is prohibited to use ingredients for the purpose of spot whitening, acne removal, hair removal, deodorant, dandruff, anti-hair loss, hair colouring, perming, etc. If ingredients that may have the above effects are used for other purposes, the necessity of their use shall be evaluated as well as the safety of their use for  cosmetics for children.
3. The scientific nature and necessity of ingredients, especially fragrances and flavours, colouring agents, preservatives and surfactants and other raw materials, shall be evaluated based on the safety, stability, function and compatibility of ingredients, as well as the children's physiological characteristics.

There is no statutory differentiation between home and professional use in China.

Registrants, record-filing entities and entrusted manufacturers shall respectively be responsible for the quality and safety of their cosmetic products on the market. The legal representative and main person in charge of each of the aforementioned entities shall be fully responsible for the cosmetics safety.  

According to the Cosmetics Regulation and the Measures for the Administration of the Registration and Filing of Cosmetics, foreign cosmetics registrants and record-filing entity shall designate a Chinese enterprise as domestic responsible agent (“DRA”) to handle the following matters:

1. The registration and record-filing, in the name of the foreign registrant and record-filing entity;
2. Assisting the registrant and record-filing entity to carry out adverse reaction monitoring, monitoring and reporting of new ingredients’ safety;
3. Assisting the registrant and record-filing entity in recalling cosmetics and new ingredients;
4. assuming the corresponding quality and safety responsibilities for the cosmetic products and new ingredients placed on the domestic market, in accordance with their own agreements; and
5. Cooperating with the supervision and inspection of the government’s Medical Products Administration.

It should be noted that such DRA can only be a Chinese enterprise legal entity and cannot be the representative office of a foreign registrant or record-filing entity. In addition, pursuant to Article 32 of the Cosmetics Regulation, cosmetics registrants, record-filing entities, entrusted manufacturers should designate a person responsible for the product quality and safety management and product release. For one type of product, only one DRA can be entrusted. The change of the DRA is subject to its consent or a court decision in case of dispute.

The DRA shall be responsible for carrying out annual report of non-special cosmetics that have been filed for more than one year, failing which the DRA will be ordered for rectification, and if the filing entity still fails to rectify during specified term, the authority will cancel the relevant product filing.

Before the registration and record-filing of new raw materials and cosmetics, the applicants shall conduct safety assessments on their own or through a contracted specialized institution.

The NMPA released the Technical Guideline for the Safety Assessment of Cosmetics (2021 Edition) on 8 April 2021. Cosmetics safety assessment must be conducted in accordance with the requirements in this guideline, and product safety assessment materials must be submitted to NMPA. Starting from 1 May 2024, for all applications for registration or record-filing of cosmetics and new raw materials, in principle a complete version of safety assessment report will be needed, while there are still exceptional cases and appliable transitional period policies till 1 May 2025.

Cosmetics for children are subject to particular requirements. The safety assessment shall take into account the physiological characteristics of children in terms of hazard identification, exposure calculation, etc. The application documents for cosmetics for children are thus under stricter examination.

In addition to the final cosmetic products, according to the Announcement of the NMPA on Matters Related to the Further Optimization of Safety Information Management Measures for Cosmetic Raw Materials, the registrants or record-filing entities shall submit raw material safety information through the official platform of NMPA regarding those raw material used in their products. The manufacturers of raw material can also register the safety information of the raw material that they produce (especially appendix 14 of the Administrative Provisions on Registration and Record-filing Materials for Cosmetics) and reference codes will be generated on such platform, so that registrants or record-filing entities can make reference to such information during their own registration or record-filing process. The deadline to complete this shall be 1 January 2024.

Cosmetic products shall follow packaging requirements outlined by various laws and regulations.

According to Article 27 of the PRC Product Quality Law (“PQL”), the following mandatory content must be indicated on the label of all products, including cosmetic products:

• a product quality inspection certificate;
• product name, manufacturer name, and address indicated in Chinese;
• the product specifications, grades, names and contents of the main ingredients indicated in Chinese, if necessary according to the characteristics and using requirements of the product;
• the information that consumers need to be informed of in advance shall be indicated on the outer packaging, or shall be provided to consumers in advance;
• the production date and safe use period or expiration date shall be indicated in a prominent position for the products with a limited use period;
• warning signs or Chinese warning instructions shall be indicated for the products that are prone to damage or may endanger personal or property safety due to improper use. 

According to the Cosmetic Regulation below are mandatory content that must be indicated on cosmetic products:

• product name, registration certificate code of a special-purpose cosmetic product;
• name and address of the registrant, record-filing entity and contract manufacturer;
• manufacturing license code;
• number of the standards that the product implements;
• all ingredients;
• net content;
• using period, using methods and necessary safety warnings;
• other mandatory content as provided for in laws, regulations and national standards (such as the Administrative Measures for the Labeling of Cosmetics, and the National Standard GB 5296.3-2008 Instruction for Use of Consumer Products - General Labelling for Cosmetics).

Cosmetics for children are further subject to special packaging requirements. For example, “Caution” or “Warning” shall be used as introductory words, and “Should be used under adult supervision” shall be indicated on the label. Words or signs related to “food grade” and “edible” are prohibited. Moreover, the cosmetics for children sign (see below the picture) must be indicated on the packaging.

Imported cosmetics may use Chinese labels directly or attach Chinese labels on original labels. It should be noted that if Chinese labels are attached, the content should be consistent with the original label.

The national mandatory standard GB 23350-2021 Requirements for Limiting Excessive Packaging of Commodities - Food and Cosmetics applies to the packaging of cosmetics to prevent excessive packaging.  

On the packaging the barcodes of the products shall be affixed in accordance with the Measures for the Administration of Commodity Barcodes and relevant national standards.

Advertisement of cosmetics shall be true and lawful. There are some clear prohibitions for advertising of cosmetics. According to the Cosmetics Regulation, labels of cosmetics shall not include the following content:

• the content that explicitly or implicitly relates to medical effects;
• false or misleading content;
• content that offends public order and good morals;
• other content prohibited by laws and administrative regulations from being labeled. 

Based on these general efficacies of cosmetics, the NMPA issued the Cosmetics Classification Rules and Classification Catalogue which further provides for 26 efficacies allowed to be claimed for cosmetic products. Other claims covered are related to the application area, dosage, target people and etc. Registrants and record-filing entities shall be responsible for efficacies claimed on their products. For those already been filed, no change of efficacy claim shall be made without solid scientific evidence. For registered products, a change of efficacy claim will incur a change of registration with the NMPA.

The efficacy of cosmetics shall be evaluated and claimed based on sufficient scientific basis. An evaluation of efficacy claims shall be conducted when registering or filing the product. On 9 April 2021, the NMPA promulgated the Specification for Evaluation of Cosmetic Efficacy Claims (“Efficacy Specification”) with a view to regulating the evaluation of cosmetic efficacy claims and making all evidence available to consumers. According to the Efficacy Specification, depending on the efficacy claimed, different evaluation requirements, including (1) human efficacy evaluation test, (2) consumer use test, (3) laboratory experiment, and (4) literature and research date, may apply. Cosmetics registrants and record-filing entities shall publish the literature and research date, and the abstracts of efficacy evaluation materials on websites designated by the NMPA so as to be supervised by the public.

According to the Technical Guidelines for Cosmetics for Children,in terms of cosmetics for infants and young children (0-3 years of age, including 3 years of age), the efficacy claims are limited to cleaning, moisturizing, hair care, sunscreen, soothing and toning. In terms of cosmetics for children (3-12 years of age, including 12 years of age), the efficacies of claims are limited to cleansing, make-up removing, moisturizing, cosmetic modification, aroma, hair care, sunscreen, repair, soothing, toning.  Cosmetics for children that do not meet the above efficacy claims should apply for registration as cosmetics with new efficacy.

The NMPA and local drug administration authorities are competent authorities for the enforcement. They are allowed to take the following measures in their daily supervision and administration:

• entering the business premises to implement on-site inspection;
• sampling and testing the cosmetics;
• accessing, copying the contracts, bills, books and other relevant information;
• seizing cosmetics, their ingredients and packaging materials with direct contact with the cosmetics that do not meet the mandatory national standards, technical specifications or endanger human health according to evidence, and seizing the tools and equipment used for illegal business;
• Closing the premises associated with illegal business activities.

Furthermore, the NMPA and local drug administration authorities are also empowered by other enforcement measures, such as the adverse reaction monitoring system, safety risk monitoring and evaluation system, emergency suspension on production, operation and importation and etc.

If there are potential safety hazards in the operation process and no measures were taken to eliminate such hazards in a timely manner, the legal representative or person-in-charge of the concerned enterprises shall be subject to a regulatory talk. The enterprises shall immediately take measures to rectify and eliminate any potential dangers. Regulatory talks and rectification should be included in the credit files of the concerned cosmetics production and operation enterprises.

The following activities related to the production and/or supply of cosmetics may subject to criminal liabilities:

• import unregistered special-purpose cosmetic products;
• supply cosmetic products that do not meet the mandatory national standards, technical specifications or do not meet technical requirements contained in the cosmetic registration, record information;
• change the shelf life of cosmetic products;
• produce cosmetics products without permits, supply deteriorated or expired cosmetics;
• refuses to recall after being ordered to do so by medical products administrations, or refuses to stop or suspend supply after being ordered to do so by medical products administrations;
• false or misleading advertising etc.

The Administrative Measures for the Monitoring of Safety Risks of Cosmetics is released on 14 September 2024 for public comment. The Measures outline procedures for administrative authorities to monitor, analyze, assess, and effectively manage potential risk that may impact the quality and safety of cosmetics. The primary focus of this monitoring is to detect and address hazardous substances that could threaten human health. Sampling will be conducted discreetly, without prior notification to operators. If the authority identifies potential safety hazards in the cosmetics, it will proceed with an investigation. If necessary, the cosmetics registrant or record filing entity may be required to conduct a self-inspection of the product quality and safety hazards and the enterprise's production quality management system. In cases where cosmetics are found to pose a risk to human health or have already caused harm, the authorities will implement necessary risk control measures, including suspending production and operations, issuing safety warning information, and suspending importation for imported cosmetics. These Measures are open for public comments until 8 October 2024 and are expected to be finalised and implemented soon after.

Supplements are classified as health food in China according to the Food Safety Law (effective as of 29 April 2021). Health food must go through complex registration or record-filing procedures before it can be marketed. Further, products marketed can only claim health functions within the fixed scope of the Catalog of Permitted for Health Food Claims ("Catalog of Health Functions"). Currently, the effective and promotable functions include: (1) for non-nutrient supplements, 24 health benefits according to the Catalog of Health Functions – Non-Nutrient Supplements (2023 Edition); and (2) for nutrient supplements, 1 health benefit (i.e., “supplementing vitamins/minerals and etc.”) according to the Catalog of Health Functions – Nutrient Supplements (2023 Edition).

Among the 24 health benefits allowed to be promoted by non-nutrient supplements, some of the following functions may have relevance with beauty:

• Helps with antioxidant;
• Helps improve acne;
• Helps improve melasma;
• Helps improve skin hydration;
• Supplementary protection against the hazards of ionising radiation.

In addition, some vitamin’s functions may also be claimed to have benefits for beauty. For example, it is allowed to state on the supplement products that Vitamin C helps maintain the health of the skin and mucous membranes and has antioxidant properties.

Health food in China is subject to, among others, the following laws and regulations, including but without limitation:

1. Food Safety Law, effective as of 29 April 2021;
2. Administrative Measures for Health Food, effective as of 1 June 1996;
3. Regulations on the Labeling of Health Food, 18 July 1996;
4. Administrative Measures for the Registration and Filing of Health Food, effective as of 23 October 2020;
5. Administrative Measures for the Catalog of Health Food Raw Materials and the Catalog of Health Functions, effective as of 1 October 2023；
6. Interim Measures for the Administration of Advertising Review of Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes, effective as 1 March 2020.

Supplement products are subject to strict restriction with regard to permitted ingredients. Pursuant to the Food Safety Law, in principle, supplement products are only permitted to use the ingredients that are included in the Catalog of Health Food Raw Materials. Currently, there are three batches of Catalog of Health Food Raw Materials, i.e.

1. Catalog of Health Food Raw Materials - Nutrient Supplements, Catalog of Health Food Raw Materials - Soybean Isolated Protein, and Catalog of Health Food Raw Materials - Whey Protein;
2. Catalog of Health Food Raw Materials - Coenzyme Q10 and Other Four Raw Materials;
3. Catalog of Health Food Raw Materials - Ginseng, Catalog of Health Food Raw Materials -  Western Ginseng, and Catalog of Health Food Raw Materials - Lingzhi.

For the supplement products that use the ingredients not included in the above catalogs and the supplement products that are imported into China for the first time, a mandatory registration process with the SAMR (State Administration for Market Regulation) shall be required (however, the products imported into China for the first time that supplement vitamins, minerals and other nutrients, they are only subject to a record-filing procedure with the SAMR). Other supplement products are subject to a record-filing with the provincial Market Supervision Administration (“MSA”). These supplement products shall fulfill the following basic requirements for health food:

It has been proved by necessary animal and/or human functional tests that it has a clear and stable health care effect;

1. All raw materials and their products must comply with food hygiene requirements and not pose any acute or chronic hazards to the human body;
2. The composition and dosage of the formula must have scientific basis and clear functional ingredients. 
3. If the active ingredients cannot be clearly identified under existing technological conditions, the names of the main raw materials related to health functions should be determined;
4. Labels, instructions, and advertisements shall not promote therapeutic effects.

Specifically, for a new ingredient to be listed in aforesaid catalogs, the following requirements will apply:

1. Having a history of consumption both domestically and internationally, and the safety of the ingredient is confirmed, and they have been added in registered health foods;
2. The corresponding efficacy of the ingredient has been included in the current health function catalog;
3. The technical requirements for the ingredient and their dosage range, corresponding efficacy, production process, testing methods, etc. can be standardized to ensure the consistency of product quality recorded according to the catalog.

At the same time, new ingredients shall not be listed if they have the following circumstances:

1. They pose risks to food safety and the safety of the ingredient is uncertain;
2. Technical requirements are unable to be established for standardized management and lacking the conditions for industrial large-scale production;
3. Prohibited by laws and regulations, as well as relevant departments of the State Council, or other situations that do not comply with ecological environment and resource laws and regulations.

For health products, there are no specific requirements on the safety and quality responsibility. As a general provision for all food products, according to the Food Safety Law, food producers and operators are responsible for the safety of their food production and operation. It is further required that for any food production/operation enterprises, there shall be full- or part- time staff responsible for food safety.

As mentioned under Question 11, health food products that use ingredients not in the catalogs and health foods imported for the first time (except health food which is for the purpose of supplementing vitamins, minerals, and other nutrients), shall be registered before they are placed on the market. For other health food products, a record filing is sufficient. Both in the registration and record-filing process, applicants must submit the safety and health function assessment documents, including: (1) safety and health function test evaluation, population consumption evaluation materials for the ingredients and products outside the catalogs, (2) testing reports on functional ingredients or signature ingredients, hygiene, stability, strain identification, strain toxicity, as well as (3) testing reports related to stimulants, prohibited drug ingredients, etc.

These safety and health function assessments must be conducted in accordance with the Technical Guidelines for Function Inspection and Evaluation of Health Food (2023 Edition) and Function Testing and Evaluation Methods for Health Food (2023 Edition) released by the SAMR, National Health Commission and State Administration of Traditional Chinese Medicine. Safety and health function assessments shall follow certain procedures, conditions, indicators as outlined in the above technical specifications.

The Food Safety Law establishes a comprehensive record system for food products for all enterprises involved in the production and operation of food products and food additives.

Firstly, according to the Food Safety Law, food and food additives production enterprises shall establish a system for inspecting and recording the purchase of food raw materials, food additives, and food related products, truthfully recording the name, specifications, quantity, production date or batch number, shelf life, purchase date, supplier name, address, contact information, and other relevant documents of food raw materials, food additives, and food related products. The records and vouchers shall be kept for no less than six months after the expiration of the product's shelf life. If there is no clear shelf life, records shall be kept for no less than two years.

The operation enterprises shall also follow the record requirements for the purchase of food products.

Secondly, food and food additives production enterprises shall establish a food ex-factory inspection record system, to inspect the inspection certificate and safety status of the food leaving the factory, truthfully record the name, specifications, quantity, production date or batch number, shelf life, inspection certificate number, sales date, as well as the purchaser's name, address, contact information, etc. and keep relevant vouchers. The records and vouchers shall comply with the same safekeeping period mentioned in the above.

As provided by the Food Safety Law, the labels and instructions of health food shall not involve disease prevention or treatment functions, and the content shall be truthful and consistent with the registered or filed content, indicating suitable and unsuitable populations, functional or signature ingredients and their contents, and declaring that "this product cannot replace drugs". The functions and ingredients of health food should be consistent with the labels and instructions.

Advertising and promotion of supplements is allowed but under strict restrictions. As a general principle for all food products, the content of food advertisements shall be truthful and legal, and must not contain false information or involve disease prevention or treatment functions. Specifically for health food products, the mention "this product cannot replace drugs" must be indicated on the advertisements.

To legally advertise and promote health food products, the content of advertisements must be approved by competent provincial MSA and the approved content will be timely disclosed to the public.

On 1 March 2020, the Interim Administrative Measures on the Censorship of Advertisements for Drugs, Medical Devices, Health Food, Formulas for Special Medical Purposes, took effect in order to clarify advertising and promotion standards, including:

1. The content of health food advertisements shall be based on the registration certificate or filing certificate approved by the market supervision administrations, as well as the content of the registered or filed product manual, and shall not involve disease prevention or treatment functions.
2. If health food advertisements involve health functions, product efficacy ingredients or iconic ingredients and their contents, suitable populations or consumption amounts, etc., they shall not exceed the scope of the registration certificate or filing certificate, or the product manual registered or filed.
3. Health food advertisements shall prominently indicate the mention that “保健食品不是药物，不能代替药物治疗疾病” ("health food is not a drug and cannot replace drugs for treating diseases"), declare that this product cannot replace drugs, and prominently indicate the health food logo (see below), suitable and unsuitable populations.

1. Health food advertisements should prominently indicate the advertising approval number.
2. The content that should be prominently displayed in advertisements must have clear and easily recognizable fonts and colors, and should be continuously displayed in video advertisements.
3. It is prohibited to engage in the following practice in advertisements:
   1. Using or disguising the names or images of state organs, state organ staff, military units, or military personnel, or using military equipment, facilities, etc. for advertising and promotion;
   2. Using the names or images of research institutions, academic institutions, industry associations, experts, scholars, physicians, pharmacists, clinical nutritionists, patients, etc. as recommendations or proofs;
   3. Violating scientific laws, explicitly or implicitly stating that all diseases can be treated, the product can adapt to all symptoms and all populations, or is necessary for normal life and treatment of illnesses;
   4. Causing unnecessary concerns and fears among the public about their health condition and diseases, or leading to misunderstandings that not using the product will lead to certain illnesses or worsen the condition;
   5. Containing "safe", "safe without toxic side effects", and "minimal toxic side effects"; explicitly or implicitly indicating that the ingredients are "natural", thus ensuring safety;
   6. Containing inducing content such as "hot selling, snapping up, trial", "essential items for families, free treatment, free gifts", comprehensive evaluation content such as "evaluation, sorting, recommendation, designation, selection, award", and guaranteed content such as "refund if not working, insured by insurance company", which encourages consumers to use health foods arbitrarily or excessively;
   7. Containing the name, address, contact information, diagnosis and treatment items, diagnosis and treatment methods of medical institutions, as well as relevant medical services such as free clinics, medical consultation telephone numbers, and the establishment of special clinics.

According to the Food Safety Law, MSAs at the county level or higher shall develop an Annual Food Safety Supervision and Administration Plan. The following key points related to the health food will be included in this plan:

• the addition of ingredients in health food production process;
• the production of health food in accordance with the registered or filed technical requirements;
• the health functions claimed in health food labels, instructions and promotional materials.

MSAs at the county level or higher have the power to take the following measures in relation to food safety supervision and administration:

1. to enter production or operation premises to perform on-site inspections;
2. to take samples from the food, food additives and food-related products being produced or traded in;
3. to review and copy relevant contracts, notes, books and other relevant materials;
4. to seize and hold food, food additives and food-related products that are proved to be non-conforming to the food safety standards, or have potential safety hazards, or be used in illegal production and operation; and
5. to seize premises that are used in the illegal production or operation.

According to the PRC Criminal Law (amended in 2023), two crimes are in place to outlaw the following activities:

• supplying food that does not meet food safety standards, enough to cause serious food poisoning accidents or other serious foodborne illnesses;
• mixing the food produced or supplied with toxic, harmful non-food raw materials, or knowingly supplying the food mixed with toxic, harmful non-food raw materials.

None at the moment.

Under PRC laws, cosmetics devices and cosmetics products are subject to different regulatory regimes.

The definition of cosmetic products under the Regulations on the Supervision and Administration of Cosmetics has already excluded cosmetic devices from cosmetic regulation regime.

A part of cosmetic devices are regulated as medical devices. Pursuant to the Regulations on the Supervision and Administration of Medical Devices (Revised 2021), medical devices refer to the instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the required computer software. Based on this definition, efficacy of medical devices is obtained mainly by physical means, not by pharmacological, immunological or metabolic means, or it is involved in these means but only in a complementary way. Therefore, if a cosmetic device falls within this definition and correspond to items listed in the Medical Device Catalogue, for instance focused ultrasound fat reduction device, self-adhesive silicone film dressing, then it shall be regulated as medical devices subject to categorisation management based on its risk. NMPA and the local drug administration authorities are the competent regulation authorities of all medical devices.

In recent years, the NMPA has strengthened control and management of cosmetic devices, by which certain cosmetic devices which were not regulated as medical devices before are now under the regulation applying to medical device. For instance, the NMPA issued notice to adjust the Medical Device Catalogue in 2022 (Order No. 30 of year 2022) , stipulating that starting from 1 April 2024, radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products shall not be manufactured, imported and sold without obtaining the registration certificate for medical devices in accordance with the law.

Under the medical device regulation regime, the registrant or record-filing entity of the medical devices shall be responsible for the safety and quality of their products. Overseas medical device registrant or record-filing entity  must designate a domestic enterprise legal person as the domestic registration agent to fulfil the obligations set out by law, including:

1. establish a quality management system appropriate to the product and maintain its effective operation;
2. develop post-marketing research and risk management plan and ensure its effective implementation;
3. carry out adverse event monitoring and re-evaluation according to law;
4. establish and implement the product traceability and recall system.

Additionally, for production enterprises, according to the Measures for the Supervision and Administration of the Production of Medical Devices (effective as of 1 May 2022), the legal representative, main responsible person shall assume the quality and safety responsibility of their medical devices. The legal representative, main responsible person shall entrust a management representative to fulfil the obligations in developing, implementing the quality management system. For the operation enterprises, they shall be equipped with full- or part-time staffs responsible for after-sales management, and ascertaining causes for quality issues complained by customers, responding timely and taking effective measures.

According to the Regulations of the Supervision and Administration on Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices (effective as of 1 March 2023), key personnel for quality and safety of production enterprises include: (1) the legal representative, (2) main responsible person, (3) management representative, and (4) principal of the quality management department. For the operation enterprises, such key personnel include: (1) main responsible person, (2) quality responsible person, (3) quality management personnel.

For those cosmetic devices for home-use which are not regulated as medical devices, they shall comply with the relevant national standards applicable to home-used electronic devices.

For those cosmetic devices regulated as medical devices as mentioned above in point 1, they shall follow the safety assessment standards for medical devices. Pursuant to the Regulations on the Supervision and Administration of Medical Devices (revised 2021), before a medical device product is registered or filed, clinical evaluation shall be carried out to assess the product’s safety. Clinical evaluation of medical devices can be conducted in two ways: (1) analysing and evaluating clinical literature and clinical data on the same variety of medical devices, or (2) a clinical trial. If clinical literature, clinical data is not enough to confirm the safety and effectiveness, a clinical trial shall become mandatory.

On 19 September 2021, the NMPA issued five technical guidelines for clinical evaluation, including:

1. Technical Guidelines for Clinical Evaluation of Medical Devices;
2. Technical Guidelines on the Decision-Making Regarding Whether to Carry out Clinical Trials of Medical Devices;
3. Technical Guidelines for the Demonstration of Equivalence in Medical Device Clinical Evaluation;
4. Technical Guidelines on the Declaration of Clinical Evaluation Report in Medical Device Registration;
5. Technical Guidelines on the Comparative Description of the Medical Devices Included in the Catalogue of Medical Devices Exempted from Clinical Evaluation.

Clinical evaluation shall be conducted following these technical guidelines.

Clinical trials are under stricter supervision. Clinical trials shall be carried out by qualified and field medical institutions in accordance with the Good Clinical Practice of Medical Devices Trials and shall obtain a prior approval (for Class III medical device clinical trials that pose a high risk to humans) or record-filing. Medical institutions carrying out the clinical trials are also subject to other obligations regarding informed consent from participants, ethical review, adverse events and etc.

In the cases where the function mechanism is clear, the design is finalised, the production process is mature, the listed medical devices of the same kind have been clinically applied for many years and there is no record of serious adverse events, and the routine use is not changed, such medical device may be exempted from a clinical evaluation before registration/record-filing. If other non-clinical evaluation can prove that the medical device is safe and effective, the exemption will also apply. Despite these general exceptions, there is a Catalogue of Medical Devices Exempted from Clinical Evaluation released on 20 July 2023 which clearly lists those medical devices that are exempted.

For those cosmetic devices for home-use which are not regulated as medical devices, they shall comply with the relevant national standards applicable to home-used electronic devices. 

For those cosmetic devices regulated as medical devices as mentioned above in point 1, they shall follow the statutory requirements regarding the advertising of medical devices.

According to Regulations on the Supervision and Administration of Medical Devices (Revised 2021), the contents of medical device advertisements shall be true and lawful, limited to the information in the registration or record-filing certificate and the registered/filed product instruction for use, and shall not contain false, exaggerated or misleading contents. Advertisement of medical devices shall be checked by advertisement examination authorities determined by provincial-level drug administration authorities and obtain approval document number before it can be publicized.

In addition, the Interim Administrative Measures on the Censorship of Advertisements for Drugs, Medical Devices, Health Food, Formulas for Special Medical Purposes also apply. Notably, for medical devices that are for personal use purpose, the advertisement shall prominently indicate that “please read the product instructions carefully or purchase and use under the guidance of medical personnel.” If there is any contraindication or precaution in registration certificate, the advertisement shall be prominently marked with “please refer to instructions for contraindications and precautions.”

Drug administration authorities are the competent authorities for the enforcement related to the supply of cosmetics products which are regulated as medical devices. In enforcement activities, drug administration authorities are empowered to take the following measures:

1. Enter the scene to carry out inspections and take samples;
2. Access, copy, seal, seize the relevant contracts, bills, books and other relevant information;
3. Seizure and detention of medical devices that do not meet the legal requirements, spare parts and raw materials used in violation of the law, as well as tools and equipment used in the illegal business of medical devices;
4. Seizure of business premises where the activities in violation of laws and regulations take place.

For potential quality and safety hazards that are not eliminated in a timely manner, drug administration authorities may take measures, such as warning, regulatory talks, rectification letter and etc. According to the Measures for the Supervision and Administration of the Distribution of Medical Device, drug administration authorities may also conduct unannounced inspections against distribution enterprises.

The PRC Criminal Law outlaws the following activity: producing medical devices or medical sanitary materials that do not meet the national or industrial standards for safeguarding human health, supplying medical devices, medical sanitary materials, knowing that they do not meet the national and industrial standards for the protection of human health, enough to seriously endanger human health.

None at the moment. 

The services listed above largely fall within the definition of “medical cosmetics” and thus shall be subject to the Administrative Measures for Medical Cosmetics Services (effective as of 19 January 2016) and relevant laws and regulations. For the purposes of the Administrative Measures for Medical Cosmetics Services, medical cosmetics refer to the use of surgery, drugs, medical devices and other traumatic or invasive medical technology to repair and reshape human appearance and the shape of various parts of the human body.

Except the Administrative Measures for Medical Cosmetics Services, other important relevant laws and regulations for medical cosmetics include:

1. Medical Practitioners Law (effective as of 1 March 2022);
2. Administrative Regulations on Medical Institutions (effective as of 1 May 2022);
3. Implementing Rules for the Administrative Regulations on Medical Institutions (effective as of 1 April 2017);
4. Catalogue of Hierarchical Management of Medical Cosmetic Services (effective as of 11 December 2009);
5. Enforcement Guidelines for Medical Cosmetic Advertising (effective as of 1 November 2021).

In recent years, complaints from consumers against the medical cosmetic industry have been surging. Some authorities, such the SAMR and the National Health Commission, have been releasing policies for the strengthened enforcement campaign.

The medical cosmetics as above-mentioned include both plastic surgery and other non-surgical medical cosmetics services to be explained in point 4 below under the PRC law. It is worth noting that for certain kinds of surgical operations which are regulated as medical service they may also have cosmetic effect.

According to the PRC Civil Code, an individual under the age of 18 but above the age of 8 are considered as a minor and has limited civil capacity to enter medical cosmetic agreements with medical institutions, unless he/she has reached the age of 16 and lives mainly from his or her own labour income. Medical cosmetic agreement signed by such individual, therefore, shall obtain the consent of his/her guardian. The Administrative Measures for Medical Cosmetics Services also provide that medical cosmetic services shall not be carried out for persons having no or limited capacity for civil conducts without the consent of their guardians.

If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?

Botulinum toxin (BT) is a prescription only drug in China. BT shall only be prescribed by qualified practitioner in qualified medical cosmetic institutions. For details, please refer to Question 4 as below.

Medical cosmetics is a licensed business in China, which requires that the institutions and practitioners are registered.

According to the Administrative Measures for Medical Cosmetics Services, enterprises or individuals intended to establish medical cosmetic institutions shall go through an approval and registration procedure in accordance with the Administrative Regulations on Medical Institutions and the Implementing Rules for the Administrative Regulations on Medical Institutions. Depending on whether the number of beds, they shall apply to the health commission of the people's government at the county level (for those who have less than 100 beds) or at the provincial level (for those who have more than 100 beds) respectively. If successfully approved and registered, the Approval for the Establishment of Medical Institutions and the Licence for the Practice of Medical Institutions will be issued.

The medical cosmetic institution or medical cosmetic department within a medical institution must meet the following basic requirements:

1. Have the ability to assume civil liability;
2. Have a clear scope of medical cosmetic services;
3. In line with the “Basic Standards for Medical Institutions (for Trial Implementation)”;
4. Other conditions required by the health administrative department of provincial people's governments or above.

According to the Basic Standards for Medical Institutions (for Trial Implementation), there are three types of institutions allowed for medical cosmetics, including (1) beauty hospital, (2) medical cosmetic clinical department and  (3) medical cosmetic clinic. Different types of institutions are subject to different standards for beds, units, personnel, building, equipment, capital and etc. Medical cosmetic institutions must choose one or more service programmes from the four, i.e., Plastic Surgery, Cosmetic Dermatology, Cosmetic Dentistry, Cosmetic TCM. For the time being, except for the Plastic Surgery, other three subjects are not under the hierarchy management, which means relevant medical cosmetic programmes can be carried out by any type of medical cosmetic institutions mentioned above. Nevertheless, each specific medical cosmetic programmes must be certified by a designated professional academic society and filed with the competent health commission.

Practitioners in medical cosmetic institutions shall also be qualified and registered. The attending physician responsible for carrying out the medical cosmetic programmes must have the following qualifications:

1. Qualified as a medical practitioner and registered by the registration authority of medical practitioners;
2. Have working experience in related clinical disciplines;
3. Trained and qualified in medical cosmetics., or has been engaged in medical cosmetic clinical work for more than 1 year;
4. Other conditions stipulated by the health administrative department of the provincial people's government.

Practitioners who do not satisfy these conditions may engage in clinical and technical services of medical cosmetics under the guidance of attending physicians.

Persons engaged in medical cosmetic nursing shall also have the following conditions:

1. Have the qualification of nurse and be registered by the nurse registration authority;
2. Have more than two years of nursing work experience;
3. Have undergone and passed professional training or further training in medical cosmetic care, or have been engaged in clinical nursing work in medical cosmetic care for more than six months.

According to the Administrative Measures for Complaints against Medical Institutions (effective as of 10 April 2019), the health commissions of the people's government at the county level or above does not directly handle complaints in relation to non-surgical cosmetic services. They only supervise the complaints management activities of medical institutions.  

Health commissions of the people's government at the county level or above  are responsible for the supervision and administration of all medical institutions engaging in medical cosmetics. Health Commissions are empowered to (1) examine the approval, registration/record-filing, verification matters of medical institutions, (2) inspect the operation of medical institutions, (3) review the service quality of medical institutions, and (4) impose paneities, including warning, fine, rectification order, suspension etc. for illegal acts.

If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?

Advertising of non-surgical cosmetic services is subject to the requirements set forth in the PRC Advertising Law, Measures for the Administration of Medical Advertisements. Specifically, the State Administration for Market Regulation issued the Enforcement Guidelines for Medical Cosmetic Advertising on 1 November 2021. Third party booking platforms shall also follow these laws and regulations.

Market administration authorities combat certain activities in relation to advertising of non-surgical cosmetic services, including without limitation the following:

1. Contrary to the good customs of the society, creating ‘appearance anxiety’ by inappropriately associating poor appearance with negative evaluating factors such as ‘incompetence’, ‘laziness’ and ‘poverty’ or positive evaluating factors such as ‘high quality’, ‘diligence’ and ‘success’;
2. Violation of laws on drugs, medical devices, or other medical equipment;
3. Violating laws and regulations on medicines, medical devices and advertisements, and advertising medicines and medical devices that have not been approved or recorded by the drug administration authorities;
4. Promoting diagnostic and therapeutic subjects and services that have not been approved or recorded by the health administration authorities; and
5. Publishing medical beauty advertisements in the form of introduction of health and wellness knowledge, personal interviews, news reports and other forms in disguise.

None at the moment.