From the EU to China: Understanding the Additional Steps for Cosmetics Regulatory Compliance

 

Expanding your business to new markets can be a great way to grow your brand and increase your revenue. However, selling products in different regions often requires additional steps to ensure regulatory compliance. If you're already selling cosmetics that are compliant with the EU regulations and are looking to expand to the Chinese market, you may be wondering what extra steps you need to take to ensure compliance. This article will explore the key considerations and steps you need to take to ensure your products meet regulatory requirements in China.

1. What is the supervision model for cosmetics in China?

Unlike in the EU, where cosmetics are generally regulated under a single framework, cosmetics are divided into two categories in China, namely general cosmetics and special cosmetics.  Special cosmetics refer to cosmetic products with claims of hair dye, hair perm, anti-hair loss, sunscreen, spot-removing, whitening, and other new efficacy claims. All the other cosmetic products are deemed as general cosmetics. Special cosmetics are subject to registration, while general cosmetics are subject to notification. Generally, compared to notification of general cosmetics, registration of special cosmetics requires a more extensive set of documents and testings, and therefore takes longer time and higher expense to finish the regulatory procedure. 

2. Is animal testing mandatory for cosmetics to enter the Chinese Market?

Previously, China required all cosmetic products to conduct animal testing. However, after the Measures on the Administration of Registration and Notification Dossier of Cosmetics came into force as of May 2021, animal testing can be exempted under certain conditions. 

Table 1 Conditions for Animal Exemption in China

Conditions
A	It is general cosmetics.
B	Manufacturers have obtained a certificate issued by the government to prove their qualification to produce qualified products, such as Good Manufacturing Practices.
C	The safety assessment results can substantiate the safety of products.
D	It does not involve New Cosmetic Ingredients.
E	It is not intended for kids or infants.
F	Domestic responsible persons, notifiers, and manufacturers of products have no bad records in China.

As for cosmetic products that can not be exempted from animal testing, some alternative testing methods can be adopted to substantiate the safety of cosmetics. Table 2 lists officially permitted alternatives to animal testing in China.

Table 2 Alternatives to Animal Testing Permitted in China

Testing	Application Field	Testing Purpose	Does it involve animals?
In vitro 3T3 NRU phototoxicity test	Cosmetic ingredients	To assess the phototoxicity of cosmetic ingredients	No
Short Time Exposure In Vitro Test Method (STE)	Cosmetic ingredients	To assess the eye irritation of cosmetic ingredients	No
In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)	Cosmetic ingredients	To assess the skin sensitization of cosmetic ingredients	No
Bacterial Reverse Mutation Assay	Cosmetic ingredients or products	To assess the gene mutation of Cosmetic ingredients or products	No
In Vitro Mammalian Cells Chromosome Aberration Test	Cosmetic ingredients or products	To assess the mutagenicity o Cosmetic ingredients or products	No
In Vitro Mammalian Cell Gene Mutation Test	Cosmetic ingredients or products	To assess the mutagenicity o Cosmetic ingredients or products	No
In Vitro Mammalian Cells Micronucleus Test	Cosmetic ingredients or products	To assess the mutagenicity o Cosmetic ingredients or products	No

3. Are there any restrictions on exporting cosmetics from the EU to China?

In the EU, all cosmetic products are subject to EU Regulation 1223/2009. In this regulation, it details a series of substances that are prohibited (Annex II) and lists all the substances that are subject to restrictions (Annex III). Similarly, China has lists of ingredients allowed to be used, prohibited to be used, and allowed to be used under certain conditions, which are listed in the Safety and Technical Standards for Cosmetics. However, these allowed, prohibited or restricted ingredients are not identical to the EU regulation. In other words, some ingredients that are allowed to be used in the EU might be prohibited in China, and vice versa; or the ingredients are under different restrictions, e.g. the maximum concentrations. Thus, To ensure compliance with Chinese regulations, it is advisable to refer to the lists of ingredients in the Safety and Technical Standards for Cosmetics before introducing your products to the market.

4. Which additional documentation is required to export cosmetics from the EU to China?

As is shown in Table 3, it’s obvious that the EU and China require a different set of documents. However, the core part of the documents is similar, for instance, the general information of the company and the product, the qualification of manufacturers, substantiation to prove the safety and efficacy, the safety of packaging and compliant labeling, etc. However, the documents need to be compiled in the form compliant with Chinese requirements and in Chinese.

On top of this, several documents need to be prepared before exporting products to China, i.e. certificate of free sale, power of attorney, product specification standards, a summary of the adverse event monitoring system, a summary of the quality management system, product classification code, Chinese label, etc. 

As for the language of the documents, all of them are required to be submitted in Chinese. For the documents that require original documents, such as GMP, Certificate of Free Safe, original documents, and power of attorney, they shall be translated into Chinese and attached after the original documents.

It is required to use standard Chinese characters, except registered trademarks, website addresses, patent names, names and addresses of overseas companies, or commonly used professional terms (such as SPF, PFA, PA, UVA, UVB, vitamin C, etc.).

 

Table 3 Mandatory Documents Required in the EU and China for Cosmetics Compliance

Type of Document	EU	China
General Part
Company information form	√	√
Product Information and formula	√	√
GMP certificate	√	√
Method of manufacture	√	√
Samples	√	√
Product classification code		√
Power of attorney (original document)		√
Certificate of Free Sale (original document)		√
Summary of adverse event monitory system		√
Summary of quality management system and resume of the person in charge of safety and quality		√
Raw Material Part
Material Safety Data Sheet (MSDS) of raw material	√
Certificate of Analysis (COA) of raw material	√
IFRA certificate and allergen report for fragrances and natural oils	√
Finished Product Part
Challenge test result	√
Stability and compatibility test result	√
MSDS/COA of finished product	√
Non-animal testing statement	√
Undesirable effect statement (if any)	√
Safety assessment report and safety assessor resume	√	√
Product specification standards		√
Substantiation of the efficacy claims (if any)	√	√
Packaging and Labeling Part
Packaging info	√	√
Product labeling	√	√

5. Which additional testing is required to export cosmetics from EU to China?

Generally for products introduced into the Chinese market, substantiation is required to prove the safety and efficacy of products. 

Safety testings covers microbiological testing, physiochemical testing, toxicity testing (animal testing), and safety test on humans. It is worth noting that different products are required to conduct different testings. In other words, your products might only need several of the above-mentioned testings. However, all the testings related to safety shall be conducted in China and follow the standards set in China. 

As for efficacy testings, some reports of testings conducted outside China can be accepted, such as the efficacy claim of moisturizing, etc. However, as it is specified in the Standard for the Evaluation of Cosmetics Efficacy Claims, for cosmetics with efficacy claims of freckle-removing, whitening, sun-protecting, and anti-hair loss effects, efficacy evaluation testings on humans shall be conducted under the requirements of mandatory national standards and technical specifications, and issue a report. That is to say, these efficacy testings are required to be conducted in China. 

If you intend to check what testings are required for your products, please refer to the article Cosmetics Testing Required for Registration and Notification in China(hyperlink). 

6. What are the labeling requirements for imported cosmetics in China?

Cosmetic products placed on the Chinese market shall have Chinese labels under the Cosmetics Supervision and Administration Regulation and Measures for the Administration of Cosmetics Labeling. 

Cosmetics labels in Chinese should use standard Chinese characters. In cases where other words or symbols are used, standard Chinese characters should be used for the explanation on the same visible surface of the product.

In cases where the registered trademark in the Chinese name of the product uses letters, Chinese pinyin, numbers, symbols, etc., its meaning shall be explained on the same visual surface.

Except for registered trademarks, the font size of other characters on the same visible surface of the Chinese label should be smaller than or equal to the font size of the corresponding standardized Chinese characters.

Where a Chinese label is affixed to the original package in a foreign language, the Chinese label shall comply with the above requirements.

7. What are the timeline and procedures for registration/notification of cosmetics in China?

Normally it takes around 4-6 months for the notification of general cosmetics, and around 12-16 months for the registration of special cosmetics. As for the regulatory procedure, please refer to Table 2 Notification Process of General Cosmetics, and Table 3 Registration Process of Special Cosmetics.

 

Table 4 Notification Process of General Cosmetics

Table 5 Registration Process of Special Cosmetics

Navigating the regulations for cosmetics in China can be a complex and daunting task. With so many rules and requirements to follow, it can be difficult to ensure that your products are fully compliant. However, with our expert guidance and support, you can rest assured that your cosmetics will meet all necessary regulations and standards.

Our team of experienced professionals is well-versed in the intricacies of Chinese cosmetics regulations, and we can help you navigate the process with ease. From registration and notification to labeling and packaging, we have the knowledge and expertise to ensure that your products are fully compliant and ready for the Chinese market. So if you're looking to expand your cosmetics business in China, let us help you achieve success by ensuring that your products meet all necessary regulations and standards.

This article is the result of a collaboration between Anaïs Thys of Taobé Consulting and Yingying Pan of ZMUni.