Overview:
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing. They also clarify the obligations of the manufacturer and applicant for cosmetic registration in china.
Cosmetic definition and classification
Definition
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’’.
Changes of the New Definition:
The new definition does not include products, which eliminate unpleasant odor.
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.
Classification
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.
Registration
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.
Imported Cosmetics
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).
Local Manufacture
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 colorants.
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 & 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.
Animal testing rule
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.
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.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.