If you have been expanding your brand in China during the past few years, congratulations for having chosen to export in a country that was estimated to have the highest year-on-year growth rate among the five leading global markets according to Statista!
That also means that your products have passed successfully the registration process there, which is unique to this market. So, you know about a series of technical documents and tests you had to provide to the certification body to register your product in China. If you are interested in expanding yet into another promising market that is Europe, be prepared to start over a completely new process, although some of the actions that were required for the Chinese registration will not have to be done again for the EU.
In this article, we will detail the extra steps that are required to enter the EU, once a product is compliant in China.
1. What are the regulations for importing cosmetics from China to the EU?
The same that apply for any cosmetic product coming from outside of the European Union, meaning that each product must have:
* A Product Information File (PIF), including a Cosmetic Product Safety Report (CPSR) signed by a certified Safety Assessor
* Compliant labels with the requirements of the EU Regulation 1223/2009
* A CPNP number
* A Responsible Person based in one of the EU-27
2. Are there any restrictions on importing cosmetics from China to the EU?
Yes, Annex II of the EU Regulation details a series of substances that are prohibited while Annex III lists all the substances that are subject to restrictions. A long list of additional requirements and restrictions apply depending on the type of product, the exposure, the target population using it, etc. The only way to know if a product complies with the regulation is to have a Safety Assessment performed by a certified Safety Assessor or toxicologist, which will be part of the Product Information File (PIF).
3. Which additional documentation is required to import cosmetics from China to the EU?
First of all, it’s important to bear in mind that all documents related to your finished product or raw materials need to be in English so a Safety Assessor can understand them.
In addition to the documents, you will have prepared for the Chinese registration, you will also need to gather:
* The non-animal testing statement of each raw materials and of the finished product
* The IFRA certificate and allergen report for fragrances, natural extracts and oils
* MSDS and COA of the finished product
* The stability/compatibility test
* Information on microbiology (either available in the COA or thanks to a separate test)
* Information about CMR, nanomaterials, heavy metals, GMOs and Substances of Very High Concern (SVHC)
* Challenge (PET) test (unless the product has low microbiological risk)
* Undesirable effect statement
* Depending on the claims made on the packaging, efficacy tests to sustain the effect claimed
* Information on the packaging material and technical drawing
4. Are there any testing requirements for imported cosmetics from China to the EU?
Yes. For all product, two mandatory tests will be required:
(1) An accelerated stability/compatibility test of at least 3 months, including protocol, reasoning and shelf-life conclusion, performed at 40°C for 100 days in the final packaging. The results will later need to be backed up by a real-time stability test.
(2) A Challenge (PET) test according to ISO 11930:2019 is also needed, unless for:
* Products that do not contain water
* Products with pH above 10 or below 3
* Products with high alcohol content (≥ 20%)
* Products that are filled at a temperature above 65°C
* Products that contain raw materials that can create a hostile environment, such as strong oxidizing agents, propellant gases, polar organic solvents, etc.
* Products packed in packaging that does not allow contamination during use or single-use products.
Then, depending on the type of product, additional tests might be required, such as:
* UVB and UVA protection tests for Sun Protection products.
* Eye irritation test for products meant to be applied in the eye area.
* Patch test, for products using many essential oils that might be irritating.
* Efficacy tests to sustain the effects claimed on the labels
5. Can I export cosmetics from China directly to the EU or do I need a local distributor?
Once the products are registered in Europe, you may either ship your products directly to your customers via your website or find a distributor based in the market, which includes the 27 countries of the European Union, Norway, Iceland, Switzerland, and Lichtenstein.
Either way, you will need to bear in mind the requirements that are specific to your goods, your country, and the country in which you wish to sell.
To help you find your way through the maze of administration, we strongly advise you to take a look at Access2Markets, which is a free tool developed by the European Commission to assist companies in international trade by sharing much useful information such as:
* Custom fees
* Taxes
* Paperwork
* Rules of origin
* Trade barriers
* Etc.
All you need to do is to enter the customs code of your product (or keywords), the country of origin and the country of destination and the list of requirements you need to comply with will appear.
The same than for any other cosmetic product being sold in Europe, whether it has been manufactured there or imported into the community. We explain the requirements in detail in a separate blog article here, but here is a brief recap of the mandatory elements that need to appear:
* Name and address of the Responsible Person
* Nominal content
* Date of minimum duration or PAO
* Country of origin (if the product is imported into the community)
* Product function (unless it’s clear from its presentation)
* Warnings
* Batch number
* INCI list
7. What are the penalties for non-compliance with EU regulations for imported cosmetics from China?
Failing to comply with the regulation will irremediably lead to sanctions which can be translated in several ways according to the country and the severity of the non-compliance.
Article 37 in the Consolidated text of the EU Regulation (EC) No 1223/2009 describes the penalties as follows:
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided must be effective, proportionate, and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.
In France for example, the sanctions may be applied as such:
* If it’s a matter of safety, which is the worst-case scenario, you might be charged with a 2-year prison sentence and up to 30 000€ fine.
* If it’s a matter of non-compliance, such as failing to have updated the Product Information File following changes for example, a 1-year prison sentence and up to 15 000€ fine may be imposed on you.
Are you ready to take the leap and start registering your products in Europe? Don’t hesistate to contact us, we will be happy to help.
This article is the result of a collaboration between Anaïs Thys of Taobé Consulting and Yingying Pan of ZMUni.
If you are planning to export cosmetic products to the Chinese market, it is crucial to have a good understanding of the essential knowledge on placing cosmetics in China. This article From the EU to China: Understanding the Additional Steps for Cosmetics Regulatory Compliance will provide you with the necessary information to ensure a successful export.
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