China State Council released the final version of the long-awaited Cosmetics Supervision and Administration Regulation (CSAR) on 29 June 2020. CSAR will replace the existing Cosmetics Hygiene Supervision Regulations, which was first released in 1989.
The new regulation will come into force on 1 January 2021. Following the release of CSAR, China will publish a series of supporting documents and administrative rules, which will further establish China’s cosmetic regulatory framework.
The new regulation brings many changes, below are the most important updates, which we will look at closely in this article:
- Cosmetic definition and classification
- New cosmetic ingredient application
- Claims and claim substantiation
- Safety assessment and requirements for safety assessors
- Enterprise obligations.
Cosmetic definition and classification
CSAR defines cosmetics as ‘’ daily chemical products intended to be applied on human skin, hair, nails, lips, mouth, etc., by spreading, spraying or other similar ways for cleansing, protecting, beautifying, or grooming purposes’’.
The new definition does not include products, which eliminate unpleasant odour.
Toothpaste is now regulated by CSAR and claims such as ‘anti-caries’, anti-plaque’, etc. are permitted, given that their efficacy was evaluated in accordance with national and industry standards.
However, soaps remain outside of the scope of CSAR. The only exceptions are soaps with special cosmetic efficacies.
Cosmetic products are classified into special cosmetics and general cosmetics. The first group contains five categories with one special category:
- Hair dyes
- Hair perms
- Whitening products
- Sunscreen products
- Anti-hair loss
- Products with new efficacy.
Other cosmetic products fall under general cosmetics.
Categories, which were previously under special use cosmetics – depilating, breast beauty, slimming, hair growth products, and deodorants, have a five-year transition period during which they can still be produced, imported, and sold. After that, such products will be prohibited.
Special cosmetics require registration with the National Medical Products Administration (NMPA), and the general cosmetics are subject to filing procedure. Registration certificates are valid for five years, and filing certificates do not have an expiry date.
For imported cosmetic products it is necessary to submit good manufacturing certificate of the overseas manufacturers as well as documents, that prove those products have been sold in the country of origin (certificate of free sale).
For products, manufactured specifically for China, the applicants must provide research and test data, which were carried out for the Chinese market.
New cosmetic ingredient application
Cosmetic ingredients are divided into new ingredients and existing ingredients. New cosmetic ingredients with higher risk are subject to registration with the NMPA, and other new cosmetic ingredients have to be filed with the NMPA.
New cosmetic ingredients that represent high risk are preservatives, UV filters, hair dyes, whitening agents, and colourants.
Within three years after the registration or filing of the new cosmetic ingredient, it is necessary to provide annual reports on the safety and usage of the new ingredient.
New ingredients without any safety concerns will be added to the Inventory of Existing Cosmetic Ingredients (IECIC). For ingredients with safety issues, the NMPA will cancel their registration or filing certificate.
Cosmetic efficacy claims
Cosmetic claims must be substantiated by sufficient scientific evidence, which applicant has to make publicly available on the NMPA’s website. Claims may be substantiated by literature, research data or product efficacy evaluation data.
Safety assessment and requirements for safety assessors
For registering or filing of cosmetics as well as new cosmetics ingredients, it is necessary to conduct a safety assessment. Safety assessors must have professional knowledge of cosmetics quality and safety and have more than five years of relevant work experience.
Enterprise obligations
An applicant for cosmetic registration or filing has to be an enterprise or other organization established according to the law.
It has to have a quality management system and the ability to monitor and assess any adverse reactions of the cosmetic products. The applicant is responsible for the quality, safety, and efficacy of cosmetics.
The end of animal testing?
CSAR does not provide any explanation regarding mandatory animal testing in China. However, it is expected that the clarification on this issue will come in the next few months.
According to the previously published draft Administration Measures for Filing of Non-Special Use Cosmetics, general cosmetics will no longer be subject to mandatory animal testing, whether they are produced domestically or imported into China.
Safety assessments will be accepted in place of animal testing, with certain restrictions.
