Cosmetics testingCosmetics testingCosmetics testing

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.

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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.


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.

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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


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.

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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.

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

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

OriginCatrgoryObligationsCertificateWho applies?Competent authority
Foreignnon-SUCPre-market online filingE-filing certificateChinese responsible personNMPA or MPAs in the 11 Free-Trade Zones
SUCPre-market registrationAdministrative permit certificateChinese responsible agentNMPA
Domesticnon-SUCDomestic filingNo certificateChinese manufacturerProvincial MPAs
SUCPre-market registrationAdministrative permit certificateChinese manufacturerNMPA
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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.

Mena, Egypt


We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland


We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA


We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece


It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA


CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA


This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA


CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA


Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA



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