Applicable legislation

Cosmetic regulations in China are supervised by two main competent authorities: the State Administration for Market Regulation (SAMR)/China Food and Drug Administration (CFDA) and the Administration of Quality Supervision, Inspection & Quarantine (AQSIQ). The current regulatory system in China is based on the 1989 Regulations Concerning the Hygiene Supervision over Cosmetics. There are multiple laws that have to be followed and taken into account in China but the most important is the Technical Safety Standard for Cosmetics 2015, which replaced the Hygiene Standard for Cosmetics 2007.

What type of products are cosmetics?

Cosmetic products are defined as “Products which can be spread on the outer surface of the human body (e.g. skin, hairs, nails, lips etc.), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means”.

Cosmetic products are then further divided into non-special use cosmetics (non-SUC) and special use cosmetics (SUC). Non-special use cosmetics include skin care products, hair care products, nail care products, make-up and perfumes. Special use cosmetics, on the other hand, include products such as hair growth products, hair dyes, hair perming products, depilating products, breast beauty products, slimming products, deodorants, freckle-removing products, sunscreens and whitening products. Some products may fall into both categories and their classification depends on their composition.

Soaps, toothpaste and oral cleansers are not, however, considered cosmetics and they can be imported directly into China after customs clearance.

Requirements

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
  • Sample.

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.

OriginCategoryObligationsCertificateWho applies?Competent authority
Foreignnon-SUCPre-market online filingFiling certificateChinese responsible agentShanghai FDA
Foreignnon-SUCPre-market online registrationRegistration certificateChinese responsible agentCFDA/SAMR
ForeignSUCPre-market administrative licensingAdministrative certificateChinese responsible agentCFDA/SAMR
Domesticnon-SUCPre-market online filingNo certificateChinese manufacturerProvincial FDA
DomesticSUCPre-market administrative licensingAdministrative licensingChinese manufacturerCFDA/SAMR

Below is a summary of the registration process.

  • Appoint a responsible agent in China
  • Responsible agent applies for a username and password to access CFDA registration system
  • Review the formula
  • Send products for testing to CFDA authorized laboratories
  • Prepare and submit the dossier for CFDA check
  • Dossier completeness check by CFDA
  • Dossier technica review by CFDA
  • Approval license

Services offered

  • Product classification
  • Formula review to ensure compliance with the cosmetics legislation
  • Labelling review
  • Label translation into Chinese
  • Preparation of the documentation for product registration and registration submission
  • Laboratory testing at CFDA laboratories
  • Third-party legal agent (Chinese Responsible Agent) service

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