Regulation of Cosmetics in China

Cosmetics in China are regulated under an approval system. Chinese cosmetic companies with an I-commerce business license are required to undergo approval of a cosmetic manufacturer's production license and a license from the Ministry of Health, and production must meet the appropriate quality standards of testing before they can be licensed to produce cosmetics.

Currently, there are three main cosmetic authorities in China: the State Administration of Market Regulation (SAMR), the National Medicines and Drug Administration (NMPA) and the General Administration of Customs (GAC).

Laws that China Enforces for Cosmetics:

• Cosmetics Supervision and Administration Regulation (CSAR)

Main updated contents of CSAR (2021.01.01)

In view of the new CSAR requirements for cosmetic products, a five-year grace period has been granted to registered hair growth, hair removal, breast beauty, weight loss and deodorant cosmetics from the date of implementation of the regulation to ensure a smooth transition. The manufacture, import and sale of these products are prohibited after the transition period.

• Definition of Cosmetic Product: Cosmetics referred to in this regulation, refers to the application of rubbing, spraying or other similar methods, applied to the skin, hair, nails, lips and other human surfaces to clean, protect, beautify, decorate for the purpose of daily use of chemical industrial products. At the same time, it should be noted that the role of cosmetics is the surface of the human body, including the surface of the skin, hair surface and nail surface and other parts of the market or some beauty institutions use hyaluronic acid (for subcutaneous injection), whitening injections, botulinum toxin, etc. do not belong to the cosmetics category.
• Toothpaste and soap: Toothpaste with reference to the provisions of ordinary cosmetics for management. Toothpaste filer in accordance with national standards, industry standards for efficacy evaluation, you can claim that toothpaste has anti-caries, plaque, anti-dentin sensitivity, reduce gum problems and other effects. Specific management of toothpaste by the State Council drug supervision and management departments to develop, reported to the State Council market supervision and management departments for review and release. Soap does not apply to this regulation, but claims to have special cosmetic effects apply to this regulation.
• Filing/registration of new ingredients: High risk new ingredients must be registered with and approved by the NMPA. Other new ingredients must be filed with the NMPA prior to use. Applicants for registration and filers of new APIs and cosmetics should conduct a safety assessment or commission a professional body prior to registration and filing. With regard to the dossier, the information provided must include: 1) the name, address and contact information of the applicant for registration or the filer; 2) the name, address and contact information of the manufacturer; 3) the name of the product; 4) the product formulation or a complete list of ingredients; 5) the standards used; 6) a sample manuscript of the label; 7) the test report; 8) the safety assessment dossier; (ix) other documents required to demonstrate the safety of the product Registration The applicant or declaration must report information on the use and safety of new cosmetic ingredients to the NMPA every six months for a period of three years. Only new ingredients that are free of safety concerns before the expiry of the three-year observation period will be included in the IECIC.
• Cosmetic efficacy claims: Cosmetic efficacy claims must include sufficient scientific evidence, including relevant literature, research data or efficacy evaluation documents, and be made available to the public on the website of the State Drug Administration.
• Requirements for imported cosmetics: Imported cosmetics also require the submission of certificates relating to the production quality control of the overseas manufacturer, as well as supporting documents proving that the product has been placed on the market in the country (region) where it was produced. For products manufactured specifically for the Chinese market for which no supporting documentation is available, applicants must submit relevant research and test data for Chinese consumers.
• Transition period: The regulations have been registered before the implementation of the hair, hair removal, breast, bodybuilding, deodorant cosmetics from the date of implementation of these regulations set a five-year transition period, the transition period can continue to produce, import, sales, the transition period expires without production, import, sales of the cosmetics.

Classification of Cosmetic Product

China's cosmetics are divided into ordinary cosmetics and special cosmetics. State registration management of special cosmetics, the ordinary cosmetics for the record management. A product can belong to more than one category. Cosmetics used for hair dyeing, perming, spot whitening, sunscreen, anti-hair loss, and cosmetics claiming new effects for special cosmetics. Special cosmetics other than cosmetics for ordinary cosmetics. State Council drug supervision and management departments according to the efficacy of cosmetic claims, the role of parts, product dosage forms, the use of the population and other factors, the development and publication of cosmetics classification rules and classification catalog.

Management of cosmetic raw materials

China has established separate lists of active ingredients and hazardous ingredients for cosmetic ingredient control, such as a list of banned ingredients, a list of restricted ingredients, and a list of permitted uses for preservatives, UV sunscreens and colorants. China further distinguishes between "used cosmetic ingredients" and "new cosmetic ingredients". In addition, China has differentiated the risk levels of different ingredients. Ingredients with relatively high risks (e.g. preservatives, UC sunscreens, colorants, hair dyes and whitening agents) are only allowed to be used after registration with the NMPA, while ingredients with low risks can be used after filing with the NMPA.

Labels and Claims

China has also adopted the International Nomenclature of Cosmetic Ingredients (INCI) for the labels of ingredients. China has set out clear requirements for cosmetic efficacy claims in the New Cosmetics Supervision and Administration Regulations (CSAR), i.e. claims for cosmetic products need to be supported by scientific evidence, including literature documents, research data, test reports or efficacy evaluation reports, and the person in charge of the company concerned has to publish the scientific evidence for their product claims on a website designated by the NMPA for public scrutiny.

Responsibility

Cosmetics registrant, the person of record is responsible for the quality and safety of cosmetics and claims of efficacy.

Animal experiment

Animal testing has previously been mandatory for cosmetic products in China, and on 2021-05-01, China formally proposed an exemption from mandatory animal testing for common cosmetic products (both imported and domestic) provided they meet the relevant requirements. However, one of the prerequisites is that the cosmetic manufacturer has to obtain the relevant qualification certificate (GMP) from the country in which it is located, a condition that is difficult to achieve as many countries do not issue such certificates.

For R&D and Further Manufacturing ONLY.