Importing products from China to the European Union? Depending on the product, importers are required to ensure full compliance with all relevant CE directives – a process that is far more complex than requesting a test report from your supplier.
In this guide, we explain what you must know about CE marking as an importer:
- What is CE Marking?
- Documentation Requirements
- Labeling Requirements
- List of CE Marking Directives
- Laboratory testing requirements
- Notified Bodies
- Fake CE Certificates
We also answer frequently asked questions about CE marking:
- Are non-EU companies and exporters required to comply with CE marking rules?
- Which products must be CE Marked?
- Must all products sold in the EU carry the CE mark?
- Is the importer or manufacturer responsible for ensuring CE compliance?
- What can happen if I importer non-CE compliant products?
- Are all Chinese manufacturers able to produce CE compliant products?
What is CE Marking?
‘CE marking” is not a product standard, but a conformity mark signaling compliance with all applicable EC directives. The specific directives and technical standards, differ depending on the product type.
For example, electronic devices with a certain input voltage must comply with the Low Voltage Directive while finger paint must comply with EN 71 substance restrictions. While these products are very different, they must both carry the CE mark to signal compliance with all mandatory directives.
As each EC directive regulates specific products, their scope of regulation varies. Some EC directives regulate substances, while others regulate energy efficiency and electrical safety. Some directives also cover product and packaging labeling, other than the CE mark itself.
Product compliance requires more than a printed CE mark. You must ensure that the items comply with all technical standards and requirements, as outlined in the applicable EN and EC directives.
Importing and selling non-compliant items in the EU is illegal, and may result in both a forced recall and major fines, assuming that the goods make it past the customs check in the first place.
Are non-EU companies and exporters required to comply with CE marking rules?
CE marking is only required if you are either importing or exporting to an EU member state. CE marking is not required when selling into the United States, Australia, or any other market.
Previously, enforcement only targeted EU-based importers. That said, things are changing as the EU is flooded by non-compliant and unsafe products originating from cross border eCommerce companies.
As a countermeasure, the EU has now implemented legislation forcing third party economic operators in the supply chain, such as freight forwarders and fulfillment centers, to check whether an importer or exporter has the relevant CE documents.
As a result, CE compliance is therefore critical for both EU-based companies importing goods, and exporters selling to the EU – either as traditional B2B exporters or B2C cross-border eCommerce sellers.
Which products must be CE Marked?
Some EC and EN directives only regulate specific products, but most are applicable to wider groups of products. We introduce the scopes of regulations for various directives further down in this article, but let’s begin by taking a look at the product categories for which CE marking is required.
Essentially all electronic products are covered by one or more CE directives. Here are a few examples:
- Battery-powered devices
- Power sockets
- Power banks
- Tablet computers
- Video game consoles
- TVs and computer screens
- Household electronics
- Soft toys
- Finger paint
- Electronic toys
- Wooden toys
- Plastic toys
- Other children’s products
- Machinery (general)
- Non-automatic weighing instruments
- Measuring instruments
- Cableway installations designed to carry persons
- Personal protective equipment
- Pressure equipment
d. Medical Devices
- Medical Face Masks
- Active implantable medical devices
- In vitro diagnostic medical devices
- Medical laser devices
- Recreational craft
- Electric bicycles
f. Protective equipment
- Protective Face Masks
g. Other Products
- Cableway installations designed to carry persons
- Equipment and protective systems intended for use in potentially explosive Atmospheres
- Explosives for civil uses
- Hot-water boilers
- Noise emission in the environment
- Simple pressure vessels
Must all products sold in the EU carry the CE mark?
Only products covered by one or more ‘CE directives’ should carry the CE mark. All other products should not be CE marked.
Here are some products for which CE marking is not applicable:
- Home textiles
- Non-electric kitchen utensils
Is the importer or manufacturer responsible for ensuring CE compliance?
When products are manufactured overseas, for example in China or Vietnam, the importer is responsible to ensure compliance with the applicable directive. This often comes as a surprise to European importers, as most EU authorities, and their websites, tend to refer to the “manufacturer” as the party responsible to ensure CE compliance.
However, when items are manufactured overseas, the importer is considered being the ‘legal manufacturer’. Thus, the responsibility to ensure ‘CE compliance’ cannot be shifted to a Chinese manufacturer.
What this means in practice is that the importer is responsible for the following:
- Book lab testing
- Create label files
- Create the Declaration of Conformity
- Create the technical file
- Create the user manual
What can go wrong if I import non-CE compliant products?
Importing non-CE compliant products to the EU is illegal and can result in fines, a forced recall, or even persecution. Here are some scenarios:
Customs Check: The customs authorities and hold, seize and destroy incoming shipments that are not correctly labeled, or in case the importer cannot provide the required documentation. In recent years, customs authorities also work closely with consumer safety authorities to keep track of certain high-risk product categories.
National Consumer Safety Authorities: Each EU member state has its own government organizations tasked with implementing and enforcing compliance with EU directives. Here are some measures they take to check non-compliance:
- Request DoC and test reports from importers
- On-site inspections
- Making purchases from eCommerce stores to test product samples
- Investigate non-compliance reports from consumers
Personal injury or property damage: While CE compliance can seem overly bureaucratic, these directives and standards are in place for a reason. Products, such as phone chargers or toys, that are not made in conformity with safety standards can be extremely unsafe. Importers are financially liable in case someone is injured or if property is damaged as a result of their non-compliant and unsafe products.
Are all Chinese manufacturers able to produce CE compliant products?
Short answer, no. It’s rather the opposite. In most industries, only 5 to 10% of the Chinese manufacturers are able to produce compliant goods. However, that is not saying that an entire factory can be “CE compliant”. CE marking only applies on a ‘product basis’.
Therefore, even the manufacturers that can show previous compliance, such as previously issued test reports, does not always make ‘CE marked items’ by default.
Thus, when selecting suppliers, we always look at ‘previous CE compliance’ in order to determine if the supplier has the technical expertise and manufacturing capability to manufacture compliant products. That said, this only serves as an indication of their technical capability.
There is no such thing as “compliance by default”. Before you place an order, you must make your supplier aware of “your” compliance requirements. If Chinese manufacturers do anything “by default”, it’s manufacturing items that are non-compliant with any foreign standard whatsoever.
But simply referring to “CE compliance” and assuming that the supplier will know exactly which directives and EN apply to their products is almost certain to result in severe compliance issues.
You must confirm exactly which CE directives your products, and communicate this to the Chinese supplier. In order to verify compliance, you must also implement a testing and certification procedure. In most cases, importers cannot rely on ‘existing certification’, but must submit reference samples or prototypes to a testing company, before mass production.
a. Declaration of Conformity (DoC)
The Declaration of Conformity is a document issued by either the importer or the manufacturer, which includes the following information:
- Product identification/SKU
- Product features
- Name and address of the manufacturer/importer
- List of EN standards or directives
- Responsible individual
The DoC is the primary document used to demonstrate compliance to government bodies, retailers, and even end-consumers.
Warning: Fake CE Certificates
Many Chinese manufacturers buy official-looking “CE Certificates” from unscrupulous service providers in China and the EU. Here are some typical examples:
- CE Certificate
- CE Certificate of Conformity
- CE Compliance Assessment
- Attestation of Conformity
These documents are supposedly issued based on the review of the technical file and test report. The problem is that many of these documents are issued without any such review.
Further, even if such a review has taken place – it still doesn’t change the fact that a third-party “CE Certificate” is not a replacement for a DoC, lab test report, and technical file.
b. Technical file
In addition to the DoC, the importer is also required to set up a technical file. This document regards the technical aspects of a product, combined with testing and quality control procedures and documents. Below follows an overview of the information the technical file shall at a minimum include:
- Description of the items
- Concept designs, drawings, wiring and circuit diagrams, component schemes, sub-assemblies, part lists, etc.,
- List of standards applied in full or in part
- Testing (in-house or made by third parties) and quality control procedures
- Test reports and quality control records
- Marking and labeling copies
- Risk assessment
However, the specific information a technical file shall include is outlined in the applicable EN or EC directive. The technical file, unlike the Declaration of Conformity, must not be made public or shared with retailers, or direct customers. The importer is required to present the technical file, only if requested by EU or local authorities.
Thus, the importer is legally required to obtain copies of the technical file from the Chinese manufacturer. But, as the technical file contains detailed product information such as circuit diagrams, virtually no suppliers are willing to hand it over prior to the buyer placing an order.
As such, the only workable way to create a technical file is for you to create it entirely on your own. This is not an issue when concerning custom-designed products, but technical files for private label products require a certain degree of reverse engineering.
c. User Manual
You must create a user manual including the following information:
1. Instructions on how to install the product
2. An overview of the relevant parts and part names of the product
3. Safety instructions
4. Instructions on how to use the product
5. instructions on how to recharge and/or refill the product and
6. Instructions on how to dispose of the product in an environmentally friendly manner
d. Test report
While the test report is part of the technical file, I also want to highlight that you cannot rely on test reports issued by the buyer. While lab testing is not mandatory for most products, it’s the only way to verify that a product is compliant.
Further, test reports are ‘de facto’ mandatory in the sense that the customs authorities and national consumer market surveillance authorities often request test reports to verify if the product is compliant. They have the legal right to seize and order a recall for any product they deem unsafe.
For most products, the CE marking process is self-managed. This means that there is no “approval” from a third-party involved. However, for some products, a Notified Body is mandatory. The role of the Notified Body is to review the DoC, technical file, and lab test report – and issue an EC Certificate if they approve the documentation.
For example, this requirements apply to the following product categories:
- PPE Class II
- PPE Class III
- Medical Devices Class II
- Medical Devices Class III
How do I get these documents from my supplier?
You should not expect your supplier to provide or assist in the creation of the DoC, technical file, or user manual. It’s your responsibility as an importer to ensure that the product is technically compliant and that all CE documents are in place.
Manufacturers in China, Vietnam and elsewhere in Asia, are not product compliance experts and should not be expected to act as such.
Can I use a test report issued by my supplier?
Test reports issued in the name of the supplier can in some cases be accepted. That said, this is only the case if the test reports match the following:
- Product name/SKU
- Manufacturer identity
- Applicable directive/EN standard
However, it’s extremely rare that a supplier can provide a complete set of verifiable test reports. In virtually all cases, the importer has no choice but to book a lab test.
The CE mark is essentially a label demonstrating compliance with all mandatory EN standards or EC directives. On the other hand, products that are not regulated by such directives, shall not be CE marked.
1. The CE mark shall be affixed to the product unit and its packaging and user instructions if any. This shall be done during production, by the manufacturer.
2. You must create a CE label file (e.g. in .ai format) and submit it to your supplier, along with specifications detailing the print position and dimensions of the CE mark.
3. The proportions of the CE mark itself shall also be according to the official layout set by the European Union, and a minimum diameter of 5 mm. That said, there are also exceptions. The CE mark shall also be permanent, so a sticker is not enough.
List of CE Marking Directives
As explained previously in this article, CE marking is meant to show compliance with all applicable EN or EC directives. Below follows an overview of directives applicable to electronics, machinery, and toys. However, keep in mind that this is not the full list of directives requiring CE marking.
a. Low Voltage Directive (LVD)
The Low Voltage Directive applies to electronics, and components, with an input, or output, ranging between 50 to 1000 volts AC, and 75 to 1500 volts DC. Thus, the Low Voltage Directive scope of regulations covers a wide range of products, including chargers, cables, home appliances, and socket outlets. However, LVD is not applicable to battery-powered devices, and other electronics with an input, or output, that falls outside of the specified voltage range.
b. Electromagnetic compatibility (EMC)
The EMC Directive is applicable to fixed electronic appliances, such as LED displays. The purpose is to ensure that electrical equipment doesn’t interfere with other electronic devices, and signals, in its proximity. While it’s impossible to completely eliminate electromagnetic emittance, the EMC directive sets strict limits – which in turn depends on the type of product, its usage, and the intended environment.
c. Machinery Directive (MD)
The Machinery Directive is applicable to machinery, interchangeable equipment, and parts. The machinery directive primarily regulates mechanical properties and electrical safety, but also ropes, chains, and other safety aspects of machinery. That said, motor vehicles and many types of consumer electronic appliances, are not regulated by the Machinery Directive.
d. Toy Safety Directive (EN 71)
EN 71 regulates toys and other children’s products. EN 71 not one single standard but divided into 13 different EN 71 standards. In most cases, more than one EN 71 standard is applicable. EN 71 regulates various aspects of toys and children’s products, including, but not limited to flammability, mechanical and physical properties, chemicals and heavy metals. In addition, EN 71 also stipulates requirements for graphical symbols (e.g., age warnings) and other labeling requirements.
e. Radio Equipment Directive (RED)
The Radio Equipment Directive (RED) is applicable to radio and telecommunication equipment. The scope of regulations includes both final products and individual components. Therefore, products with radio, WiFi, and Bluetooth transmitters and receivers are required to comply. This includes, but is not limited to, Android tablets, Smartphones and WiFi routers.
f. Eco-Design Directive
The Eco-design Directive was put in place to reduce greenhouse gases. As of today, more than 40 groups of products are covered by the Eco-design Directive, including light bulbs and domestic electrical appliances. The directive also applies to non-electrical products, including windows and insulation materials.
g. Restriction of Hazardous Substances (RoHS 2)
The RoHS directive restricts the amounts of certain substances in electronics, including lead, cadmium, and mercury. Starting in January 2013, RoHS is now part of the CE marking directive. Therefore, RoHS compliance is mandatory for all CE marked electrical items. However, there are a few exceptions.
h. Personal Protective Equipment (PPE)
The PPE directive is applicable to helmets, sunglasses, protective gloves, work shoes, protective face masks, and other related products used for protecting the user. Further, PPE is classified as class I, II, and III. Class II and III require the involvement of a Notified Body.
i. Medical Devices Directive
The Medical Devices Directive applies to products meant to protect the patient rather than the wearer. This includes medical masks and a range of other medical devices. Further, Medical Devices is classified as class I, II, and III. Class II and III require the involvement of a Notified Body.
Laboratory testing requirements
While lab testing is not necessarily mandatory for most products within the scope of the various ‘CE marking directives’, it’s the only way to verify that the product is compliant. Further, testing companies can also help you assess which standards and directives apply to a certain product.
Here’s an overview of compliance testing companies that can help with ‘CE testing’:
- Bureau Veritas
Note that the importer is expected to carry all testing costs, which can vary from a few hundred to tens of thousands of dollars.