The global cosmetics industry, valued at $511 billion in 2021, is highly lucrative and China has become one of the largest consumers in this industry, being second only after the USA; making it an attractive target market to sell your cosmetics products. But before you jump at the opportunity to enter this huge market, there are certain regulations that you should be aware of first.
Some Data about the Cosmetics industry in China
- China’s beauty and personal care market has a value of over $38 billion USD.
- In 2019, the online retail sales value of cosmetic products in China amounted to approximately RMB 194.4 billion.
- This extremely profitable industry in fact is forecasted to exceed RMB 350 billion by 2024.
- Around 70% of the purchases will be made via e-commerce, largely on Tmall and JD.com from Alibaba Group Holdings Limited or Jumei Incorporated respectively.
- The Chinese men’s skincare market is forecast to hit $1.9 billion USD this year, and is projected to reach around $2.8 billion USD by 2025.
- In recent years, The Chinese cosmetic industry is the fastest-growing market in the world.
- The main consumer groups for cosmetic products are between the post-80 and post-90 generations, who are highly aware of product updates and have a strong inclination towards appearance and trends. As a result, several cosmetic brands have witnessed the collaboration with KOL and beauty bloggers and have incorporated advertisements to increase cosmetic sales.
While the Chinese market is flourishing, there are still some tricky aspects about this opportunity, namely the regulatory compliance for cosmetic manufacturing, importation, and special rules governing the sales and promotion of such products.
New and Existing Cosmetic Regulations in China
Chinese cosmetics manufacturers are getting ready for a brand new array of regulations that went into effect this year. The National Medical Products Administration (NMPA) has issued a list of new rules that manufacturers should abide by:
- Cosmetics Efficacy Claim Evaluation Standards
- The Technical Guidelines for Cosmetics Safety Assessment
- Cosmetics Classification Rules and Catalog
- Provisions on Management of Registration and Notification Dossiers for Cosmetics and Cosmetic Ingredients
All of the above rules are designed to guide the implementation of Cosmetics Supervision and Administration Regulations (CSAR). Cosmetics manufacturers and brands are eager to have their products registered in the NMPA system, due to much stricter new requirements for product registration and notification.
Regulation regarding cannabis extracts in cosmetics was also announced. The following cannabis-based ingredients were marked as to be prohibited :
- BD / Cannabidiol
- Cosmetics
- Cannabis Sativa kernel fruit
- Cannabis Sativa seed oil
- Cannabis Sativa leaf
- Hemp
In the past few years, while a number of CBD-based cosmetics have managed to enter China through cross border e-commerce channels, it has been confirmed now that the ban will apply to all brands selling on the Chinese market.
Currently, cosmetic regulations in China are supervised by 2 main competent authorities:
- State Administration for Market Regulation (SAMR)
- National Medical Products Administration (NMPA), which is under the governance of SAMR.
The NMPA, as an Independent Drug Administration Bureau, 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 (non-SUC) and the 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 have been multiple laws that have been 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.
In China, the most important cosmetic legislation is Regulations Concerning Hygiene Supervision over Cosmetics. Both domestic and imported cosmetic products require pre-market approval or notification before they can be placed on the Chinese market.
What are considered “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) categories.
- Non-special use cosmetics include skin care products, hair care products, nail care products, make-up and perfumes.
- Special use cosmetics are 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 considered to be cosmetics and they can be imported directly into China after customs clearance.
Source: Reach24H
Registration & Filing 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. Non-SUC products require a pre-market filing and can be imported after the filing has been finished while the technical review process is carried out during post-market surveillance.
Registration Process for 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.
Appoint a Chinese Responsible Agent
A foreign company must appoint a Chinese agent to apply for the NMPA license in a written power of attorney. In fact, the company cannot register its cosmetic products on its own. The responsible Chinese agent may be a Chinese subsidiary, distributor, or third party (e.g. a consultancy). It is essential to consider the pros and cons before choosing your agent.
Registration process for all imported SUC and non-SUC includes:
- Appoint a responsible agent in China
- Product dossier
- Submit dossier to NMPA for administrative review
- Technical review
- Registration certificate
- Importation
Check Your Product Formula
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 2021). 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.
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
- Product 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 for 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 (RP) 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 Free-Trade Zones can file to provincial MPAs. RPs that are registered outside the 11 Free-Trade Zones, need to file to NMPA.
From here, NMPA or provincial MDA will first conduct an 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.
The filing process includes:
- Appoint a responsible person in China
- The responsible agent applies for NMPA account
- Prepare dossier
- Submit dossier to NMPA for administrative review
- E-filing certificate
- Importation
- Technical review
Cosmetic Labelling Requirements
As is the case in many other countries, labelling is a very important part of ensuring compliance with the relevant cosmetics legislation in China. The applicable national standard for cosmetic products labelling is GB 5296.3-2008.
Cosmetic labels, including claims, are checked during the process of pre-market product registration and they are also checked by the CIQ when the products arrive in Chinese ports. Failing to place compliant labels on the products when exporting cosmetics to China may result in product rejection or in the products being destroyed at the port.
Product labels have to be written in Chinese. Companies can either design special labels with the aim of being compliant with the rules of the Chinese cosmetics legislation or they can use their original packaging with China compliant over-labels.
The following information has to appear on the labels:
- Product name
- Name and address of the manufacturer
- Net content
- List of ingredients, which have to be written according to their Chinese INCI names, in descending order of concentration, at least for ingredients with a concentration above 1%
- Shelf life and production date
- Manufacturer’s license, product standard or administrative approval code that is received when the product is successfully registered
- Safety marks, any possible precautions for use
- Country of origin of imported products
- Name and address of the distributor in China for imported cosmetics
- Instructions for use and storage conditions if inadequate storage conditions will impact product safety.
According to China’s 2010 Naming Requirements for Cosmetics, the name of a cosmetic product should be concise and easily understandable. It must not intentionally mislead or deceive consumers.
The Cosmetics Naming Guidelines list expressions prohibited in cosmetic product names. Banned expressions include:
- “Special effect”
- “Total effect”
- “Powerful effect”
- “Absolutely natural”, etc.
Product names must not explicitly or implicitly indicate a false medical effect by using expressions such as:
- “anti-bacterial”
- “bacteria-inhibiting”
- “anti-allergic”
- “hair-regenerating”
- “face-slimming”, etc.
In addition, the names of celebrities in the medical field are not allowed to be used in product names.
Claims made on the cosmetic product labels have to be true and have to be in line with the Chinese definition of cosmetic products.
Exaggerated claims regarding the performance or efficiency of the products, their composition, etc., are not allowed, as is also the case for any therapeutic claims, medical claims or comparisons that denigrate competitor products.
Further, claims such as hypoallergenic, dermatologically tested or 100% natural will be challenged by the CFDA/SAMR expert panel.
Cosmetic Formula Compliance
One of the first steps in the cosmetic product registration process in any country is checking if the formula is compliant with the relevant cosmetics regulation. China has strict requirements regarding the cosmetic ingredients, which includes lists of prohibited and restricted ingredients for use in cosmetics.
Even if your cosmetics have been tested overseas, you still need to send your cosmetics to a designated NMPA testing institute in China for testing. For all cosmetics, hygiene safety tests are mandatory. Tests might include a sanitary chemical test, microbiological test, toxicological test, and human safety tests.
Animal testing is required for imported cosmetics products but has been waived for domestic non-special use cosmetics since 2014. China is reducing the requirements for animal testing for cosmetics and is working on establishing alternative methods and verification institutions.
In addition, the regulation also provides guidance on the use of correct ingredient nomenclature. It is important to make sure that the product formula does not contain any prohibited substances and that any restricted substances fall within the required restriction limits. Any deviations found in the formula will result in rejection by the competent authority during the technical review of the Chinese cosmetics registration process.
A. Check if ingredients are allowed for use in China
Firstly, it is important to check if the ingredients can be found on any of the lists published in the Chinese cosmetics regulation.
In order to assure your formula contains only the ingredients allowed for use in cosmetics in China, they have to be found on the Inventory of existing cosmetic ingredients (IECIC).
If the ingredient cannot be found, it means you have a new cosmetic ingredient, which has not been used in China before. This means that in order to use this new ingredient, you will have to undergo the time-consuming process of new ingredient registration.
If the ingredient is found to be safe by the competent authority, you will get a certificate with 4-year validity. If no adverse effects are observed during this time, the ingredient will be added to the IECIC.
If your ingredients can be found on the list of existing cosmetic ingredients, you also have to check the following lists:
- List of prohibited substances
- List of restricted substances
- List of allowed preservatives
- List of allowed UV filters
- List of allowed colorants
- List of allowed hair dyes
If your product contains a restricted ingredient, it is important to follow the restrictions provided in the Safety and Technical Standards for Cosmetics 2015.
B. Check the ingredient nomenclature
Cosmetic ingredients in the formula and on the label of the products that are sold in China have to be listed according to their Chinese INCI names. Therefore, it is important to make sure that you are using the correct nomenclature by checking the Catalogue of Standard Chinese Name of International Cosmetic Ingredients (INCI Chinese version).
It is possible that there is no INCI name for your ingredient. In this case, you can adopt its chemical name, botanical name or the name written in the Chinese Pharmacopoeia.
C. Check if the mixtures are written correctly
In China, it is important to write the whole composition of the mixture used in the formulation. If you have a raw material that is composed of different substances, you have to list all of them by their Chinese INCI name and also provide the percent of each ingredient in this mixture, as well as the percent of this raw material (mixture) in the finished cosmetic product.
D. Choose the appropriate ingredient function
According to the Chinese cosmetics regulation, there are only 69 cosmetic ingredient functions, which are allowed to be listed in the formula. It is important to choose only among those 69 functions and to choose the most appropriate one for your ingredient.
The competent authority will check if the selected function corresponds to the ingredient. In case you have a mixture, the function should be applied to the mixture and not the individual substances.
Source: CE.way
Custom Clearance for Cosmetics goods in China
After you’ve completed all the above steps, your products are ready to be imported into China. There is a chance that they will have their documents inspected and go through quarantine at the port of entry.
The importer needs to show the hard copy of the NMPA license and provide the port Certificate of inspection with:
- Licenses and hygiene certificates
- Safety assessment data on materials with potential safety risks
- Certification that allows production and sale in the country of origin
- Certificate of origin
- Digital code
- Sample of Chinese label and foreign label
- Information on the quantity and weight of the product
Imported cosmetics are subject to tariffs when they enter China and the amount of import duty varies on what kind of cosmetic product it is. For example, skin care products have a 1% tariff rate while makeup has 5%.
About CE.way
CE.way was established in the quest of changing the industry by implementing our own ideas. We rely on our knowledge and experience to bring the best possible service to the clients in a way that is as easy as possible for them. We make the processes and the regulatory requirements simple and easy to understand. We are providing all of the necessary regulatory and testing services at one single place, so you can go through the whole process with one contact person. And we keep the costs below the industry average, because we know what matters to the clients the most.
Services Offered
- Product classification
- Formula review to ensure compliance with the cosmetics legislation
- Labelling Review & Translation into Chinese
- Preparation of the documentation for product registration and registration submission
- Laboratory testing at NMPA laboratories
- Chinese Responsible Agent (Third-party legal agent service)
About GMA
Gentlemen Marketing Agency (GMA) provides a wide choice of marketing and promotion solutions to help you grow your business in China. We offer a complete panel of solutions: digital, marketing, and distribution services for consumer goods, in beauty, cosmetics, healthcare products, and fragrance. Contact us!