Cosmetics legislation and product registration in China

China

Applicable legislation

Cosmetic regulations in China are supervised by 2 main competent authorities: State Administration for Market Regulation (SAMR) and the independent Drug Administration Bureau called National Medical Products Administration (NMPA), which is under the governance of SAMR. Furthermore, NMPA consists of 9 subordinate departments, including Cosmetic Safety Supervision department. At provincial level and under NMPA, there are Medical Products Administrations (MPAs), which are in charge of filing of domestic non-special use cosmetics and issuance of cosmetics manufacturers' production license.

The current regulatory system in China is founded on the Regulations concerning the Hygiene Supervision over Cosmetics from 1989. 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 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.

Registration process - SUC

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:

According to article 11, the product information file must contain the following information and data:

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.

Below is a summary of the registration process for SUC products.

Below is a summary of the registration process for non-SUC products.

Below is a short summary of the registration requirements for various types of cosmetic products.

Origin	Catrgory	Obligations	Certificate	Who applies?	Competent authority
Foreign	non-SUC	Pre-market online filing	E-filing certificate	Chinese responsible person	NMPA or MPAs in the 11 Free-Trade Zones
	SUC	Pre-market registration	Administrative permit certificate	Chinese responsible agent	NMPA
Domestic	non-SUC	Domestic filing	No certificate	Chinese manufacturer	Provincial MPAs
	SUC	Pre-market registration	Administrative permit certificate	Chinese manufacturer	NMPA

Services offered

Product classification

Formula review to ensure compliance with the cosmetics legislation

Labelling review

Preparation of the documentation for product registration and registration submission

Laboratory testing at NMPA laboratories

Third-party legal agent (Chinese Responsible Agent) service

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

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Pharmaplast

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Alpure

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IBP

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Nash Corporation

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Curly Hair Solutions

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Funkitup

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RA Cosmetics

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Nuvision

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VB cosmetics

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SBBM

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MT Cosmetics, Inc.

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NCLA