Requirements

Cosmetic products marketed in China need to get approval from NMPA or provincial MPAs. Rules and requirements differ depending on whether the product is special use or non-special use cosmetic and they are also different for imported and domestic products.

Imported SUC products require a pre-market registration and can only be imported after getting approval from NMPA. On the other hand, non-SUC products require a pre-market filing and can be imported after the filing has been finished while the technical review is carried out during post-market surveillance.

Registration process – SUC

Imported SUC, domestic SUC and new cosmetic ingredients require a pre-market registration with NMPA.

Foreign manufacturers that want to import SUC products into China need to assign a Chinese Responsible Agent who would then take care of the SUC product registration procedures. The Chinese Responsible Agent can be any legal entity registered in China.

Before the registration process is undertaken it is advisable to check the formula to see whether it complies with the Chinese legislation or not. NMPA maintains an Inventory of Existing Cosmetic Ingredients in China (IECIC – current version 2015). Furthermore, the Hygiene Standard for Cosmetics 2007 lists the restrictions for ingredients, their maximum permitted concentration, warnings etc. it lists the permitted preservatives, UV filters, colorants and hair dyes. New ingredients, which aren’t listed in IECIC, need to undergo a stringent and time-consuming pre-market registration procedure. If approved by NMPA, the applicant will be granted a “new cosmetic ingredient trial use certificate”, enabling the applicant to use the ingredient in their products for 4 years. If no adverse effects are observed during that period, the ingredient will be added to 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 NMPA authorized laboratories in China. Toxicological tests are performed using animals. SUC products have to meet strict requirements and the testing part also includes human safety tests.

A registration dossier must then be submitted to NMPA for review. NMPA will conduct format review or completeness check first and then a technical review. Information required for NMPA review include:

• NMPA registration form
• Quantitative and qualitative formulation
• Indication of active ingredients and their functions
• Method of manufacture
• Test certificates (from NMPA 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 absence of ingredient with BSE risk
• Sample

It is also required to provide the safety assessment that includes acute toxicity, animal skin and mucous tests, mutagenic and short-term biological screening tests etc.

NMPA will extensively review the product label. Product name and labels will also be checked by CIQ (China Inspection and Quarantine Bureau) when products arrive to China. Cosmetics must be labelled according to the national standard GB 5296.3-2008.

Filing process – non-SUC

Imported non-SUC are subject to pre-market filing with NMPA and domestic non-SUC are subject to pre-market filing with provincial MPAs.

Foreign manufacturers that want to import non-SUC products into China need to assign a Chinese Responsible Person who would take care of the non-SUC product filing procedures. The Chinese Responsible Person must have cosmetic business licence and importation qualification and needs to be the importer. After assigning the RP and applying for NMPA account, the next step is testing the product, which must be conducted in NMPA accredited labs in China. After obtaining the testing reports, the dossier can be compiled and submitted online by the RP.

RPs that are registered in Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan or Shanxi can file to provincial MPAs. RPs that are registered outside the 11 Free-Trade Zones, need to file to NMPA.

NMPA or provincial MDA will first conduct administrative review. After the approval, the RP can obtain E-Filing certificate (with no expiry date) online and start importing the products through the local ports. Technical review is carried out within 3 months after filing. The authorities can then approve or demand supplementary data, which has to be provided within 30 days.