China Cosmetic Regulations
China is introducing new cosmetic regulations a little at a time and this will be a rapidly changing situation.
Cosmetic Supervision and Administration Regulation (CSAR) is the new regulatory structure. Currently there is no English translation for the implementing Regulations.
Old regulation was CHMR
For finished cosmetics, companies who plan to place cosmetics on Chinese market must apply for and obtain hygiene license or record-keeping certificate from the China Food & Drug Administration (CFDA). Foreign companies shall appoint a Chinese responsible agent to deal with registration and obtain such certificate. Manufacturers shall also register a new cosmetic ingredient prior to using it for cosmetics production.
Definition of Cosmetics and Classification
Cosmetics are defined as daily used industrial chemicals which can be spread on the outer surface of human body (e.g. skin, hair, nails. lips etc) for the purpose of cleaning, deodorizing, providing skin care, beauty and make – up, by way of smearing, spraying or other similar means.
Imported cosmetics are divided into two classes: ordinary cosmetics and special use cosmetics. Each class requires different type of license from CFDA. Please note that imported ordinary use cosmetics are approved by food & drug administration authorities at provincial level while imported special use cosmetics are approved by CFDA in Beijing.
How Much Does Application Cost Per Product?
The total costs of application consist of three parts: Testing fee, risk evaluation fee charged by approved inspection authorities and consulting fee. The total costs vary among different service providers, quoted prices in various inspection authorities, and test items for the distinct usages of cosmetics.
Requirements of Ingredients in Cosmetics
Companies shall also check if there is any new ingredient in their product. A new ingredient that is not currently listed on the Inventory of Existing Cosmetic Ingredients in China (IECIC) also requires registration with SFDA. However, a new ingredient might not require registration if there is proof that the ingredient has been used in approved cosmetics in China before. It can be very difficult and expensive to register a new ingredient. More info about registration of new cosmetic ingredient can be found here.
Generally speaking, the total application cost of record-keeping certificate for imported ordinary cosmetics is between 10,000 and 30,000 RMB per product.
The total application cost of hygience license for imported specific use cosmetics is between 20,000 and 60,000 RMB per product.
The total application cost of hygiene license for new cosmetic ingredient is between 80000 and 100000 RMB per ingredient.
Please note the above cost estimation does not include risk evaluation fee and human body test.
NOTE: With the introduction of the new regulations, CSAR, some of the requirements may be changed, added to or eliminated to make way for different requirements.