Cosmetic products marketed in China need to have approval from the CFDA/SAMR or from provincial FDAs. The rules and requirements differ depending on whether the cosmetic product is for special use or non-special use and they also differ for imported and domestic products. All imported products require pre-market registration. The only exception is non-SUC products imported through the Shanghai Pudong pilot area that are also sold within that area. These are only subject to the same filing management as domestic non-SUC products, whereas other imported non-SUC products require registration.
Foreign manufacturers that want to import cosmetics into China need to assign a Chinese Responsible Agent (similar to the EU Responsible Person) who would then take care of the product registration procedures. The Chinese Responsible Agent can be a local importer, a third party specializing in providing such services or a local subsidiary of the importer.
Before the registration process is undertaken it is advisable to check the formula to see whether it complies with the Chinese legislation. The CFDA/SAMR maintains an Inventory of Existing Cosmetic Ingredients in China (IECIC – current version 2015). The ingredients listed in this inventory have already been approved for use in cosmetic products. Furthermore, the Hygiene Standard for Cosmetics 2007 lists the restrictions for ingredients, their maximum permitted concentration, warnings, etc. It also lists the permitted preservatives, UV filters, colourants and hair dyes. New ingredients that are not listed in the IECIC need to undergo a stringent and time-consuming pre-market registration procedure. If approved by the CFDA/SAMR, the applicant will be granted a “new cosmetic ingredient trial use certificate” that enables the applicant to use the ingredient in the products for four years. If no adverse effects are observed during that period, the ingredient will be added to the IECEC.
The next step is product testing. Even if cosmetic products have already been tested abroad, they will have to be tested again in one of the 21 CFDA/SAMR authorized laboratories in China. The test items, duration and cost depend on whether the product is non-SUC or SUC. However, in both cases, toxicological tests are performed using animals. Animal testing can only be waived for domestic-manufactured non-SUC products. SUC products have to meet stricter requirements and the tests also include human safety tests.
A registration dossier must then be submitted to the CFDA/SAMR for review. The content of the dossier again depends on whether the product is non-SUC or SUC. The CFDA/SAMR will first conduct a format review or completeness check and then a technical review. The format review takes five days to complete, while the technical review generally takes around three months and a further 20 days for the CFDA/SAMR to issue an approval certificate. The information required for the CFDA/SAMR review includes:
- CFDA registration form
- Quantitative and qualitative formulation
- Indication of active ingredients and their functions
- Method of manufacture
- Test certificates (from CFDA/SAMR accredited laboratory)
- Product specification and test methods
- Toxicity testing
- Free sales certificate
- Authorization letter for the local agent to apply for registration on the company’s behalf
- Chinese label copy
- Declaration of the absence of ingredients with BSE risk
More extensive documentation is required for SUC products, including a safety assessment that includes acute toxicity, animal skin and mucous tests, mutagenic and short-term biological screening tests, etc.
The CFDA/SAMR will also extensively review the product label. The China Inspection and Quarantine Bureau (CIQ) will also check the product name and labels when the products arrive in China. Cosmetics must be labelled according to the National Standard GB 5296.3-2008.
The whole registration process takes approximately six to eight months for non-SUC and nine to 14 months for SUC products. The CFDA/SAMR does not charge administration fees but they do charge for the obligatory testing at the CFDA laboratories.
Below is a short summary of the registration requirements for various types of cosmetic products.