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Importing from China to the European Union? Then CE marking, and compliance with at least one EN directive, may be mandatory. Yet, many small businesses importing from China remain unaware of how to determine whether CE marking is required for their products, and which party is required to ensure compliance.
In this article, we explain the basics of CE marking, including documentation, labeling requirements, regulated products and relevant EN / EC directives.
What’s more, we also explain why companies importing from China, and other Asian countries, must never assume that their manufacturer is able to ensure compliance with EU standards and regulations.
What is CE Marking?
Many products sold in the European Union must be compliant with one or more EC or EN directives. Some EC directives apply to specific products, e.g. finger paints, while others are more comprehensive and include a wider scope of products, e.g. Electronics with an input or output voltage, between 50 to 1000 volts. ‘CE marking” is not a product directive, but a conformity marking signaling compliance with all applicable EC directives.
As each EC directive regulates specific products, their scope of regulation varies. Some EC directives regulate substances, while other regulate energy efficiency and electrical safety. Some directives also cover product and packaging labelling, other than the CE mark itself.
As such, compliance requires more than a printed CE mark. You must ensure that the items comply with all technical standards (which in turn are often based on IEC and ISO 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 serious fines. Assuming that the goods make it through customs in the first place.
Are Non-EU Based Importers Required to Have Their Products CE Marked?
No, as CE marking is part of European Union directives, importers based outside of the European Union are not required to ensure compliance with EU regulations. However, looking for previous ‘CE compliance’ when selecting a Chinese manufacturer is still wise – even for non-European importers.
Previous CE compliance indicate a certain level of technical expertise. European compliance is also far more common among Chinese manufacturers, as compared to compliance with American, Australian and Indian standards.
Thus, buyers in these countries often have no choice but to primarily look for suppliers able to show compliance with EU regulations (i.e., previously issued product certificates and test reports), as a way to determine if the supplier is capable to comply with technical standards and regulations in their own countries (i.e., FCC Part 15).
CE marking is also required for items, not only shipped from China, but for products sold from any country to an EU member state. Therefore, it is indeed highly relevant to ensure CE compliance, if you are a non-EU company looking to re-export items to the European Union.
Which Products must be CE Marked?
Some EC and EN directives regulate specific products, but most are applicable to 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 products, for which CE marking is required.
- Appliances burning gaseous fuels
- Household refrigerators and freezers
- Ecodesign of energy related products
- Electromagnetic Compatibility
- Low voltage
- Radio and Telecommunications Terminal Equipment
- RoHS 2 (Part of CE, starting in 2013)
- Mechanical and physical properties
- Specification for migration of certain elements
- Experimental sets for chemistry and related activities
- Chemical toys (sets) other than experimental sets
- Graphical symbols for age warning labelling
- Finger paints
- Swings, slides and similar activity toys for indoor and outdoor family domestic use
- Organic chemical compounds – Requirement
- Organic chemical compounds – Sample preparation and extraction
- Organic chemical compounds – Methods of analysis
- N-Nitrosamines and N-Nitrosatable Substances
- Machinery (general)
- Non-automatic weighing instruments
- Measuring instruments
- Cableway installations designed to carry persons
- Personal protective equipment
- Pressure equipment
d. Medical Devices
- Active implantable medical devices
- In vitro diagnostic medical devices
- Medical devices
- Recreational craft
- Electric bicycles
f. 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
Note: CE marking is not mandatory for all products imported the the EU. In addition, there are product regulations which apply to items for which the CE mark is required, and for which it is not. REACH is one such regulations, restricting substances (i.e., Lead and Cadmium) in all consumer products.
Which Party is Responsible to Ensure Compliance with All Applicable EN Directives?
When products are manufactured overseas (e.g. in China), the importer is responsible to ensure compliance with the applicable EN 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 manufacturer. Thus, the responsibility to ensure ‘CE compliance’ cannot be shifted to a Chinese manufacturer.
What Can Happen if We Import Non-Compliant Products From Overseas?
We have received several notifications of EU customs requesting CE certification documents, to prove that the imported items are compliant with all applicable CE directives. In cases when the importer could not produce the requested documentation (i.e., Product Certificates and Technical Documentation), the Customs authorities have refused to shipment to enter.
A few years ago we also received a similar report from a Swedish company, also importing toys. The difference in this case was that the items arrived several months ago, but when local authorities came knocking on their door – they couldn’t produce documents proving full compliance.
As a result, the authorities forced a recall. Hence, the importer had to issue refunds to their retailers, essentially buying back the entire batch of ‘non-compliant’ goods. We’ve never heard from them since.
Are all Chinese Manufacturers Able to Ensure Compliance With EN Directives and CE Mark Our 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 to specific products. Therefore, even the manufacturers that can show previous compliance (i.e., previously issued certificates and 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. Neither of these are to be taken for granted in China. Remember, previous compliance is an indication, not a guarantee that your items will be compliant.
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 EC directives apply to their products is an extremely risky strategy.
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 (DoC) (See sample) is a document issued by the manufacturer, stating that the item is compliant with all applicable EN or EC directives. The DoC shall also list the specific EN or EC directives of which the product is compliant.
Apart from this, the manufacturers company name, address and product information shall also be present on the DoC.
For some products, the manufacturer is allowed to issue the DoC without the need for third party testing verifying compliance. This setup works fine, when it regards European, American and Japanese manufacturers. But what about Chinese manufacturers?
Fake product certificates and test reports are not unheard of in China, to say the least. Many Chinese suppliers issue DoC, claiming compliance, while they have not made any effort whatsoever to ensure compliance.
A few months ago we received a DoC, issued by a Chinese supplier, claiming that their ball bearings were compliant with the Electromagnetic Compatibility (EMC) Directive.
The EMC directive regulates electronics, that may interfere with other electronics in its proximity. The problem here is that a ball bearing doesn’t have any electrical components, and is therefore unable to interfere with electronics.
Thus, the EMC directive is not even applicable to a ball bearing. In essence, the Chinese supplier simply went online and copy pasted the first EN directive they could find on Wikipedia, hoping it would solve their compliance problems.
In the end, it’s the importer’s responsibility to ensure that the items are compliant. If the authorities find that your imported items are non-compliant, you will be held responsible – not the supplier.
This is why third party testing, verifying that the DoC is actually valid, is important, even though such testing may not always be required by law.
However, in some cases, third party testing is required by law. This means that the Declaration of Conformity, issued by the supplier, must be based on third party testing from an authorized testing company.
b. Technical file
In addition to the DoC, the manufacturer 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 (if electrical), 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 labelling copies
- User instruction copies
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 published or made available to retailers, or direct customer. 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.
This opens up a world of problems, as the importer is facing the risk of first paying a supplier, only to find out that they don’t really have a technical file.
How do I get these documents from my supplier?
In order to complete a technical file, you must obtain the bill of materials, design drawings and other documents. Many suppliers hesitate, or outright refuse, to provide these documents – citing needs to protect their IP.
So, what can you do if your supplier reject to provide documents that are mandatory for importing the product to the EU? First, you may want to consider to change supplier. Without the right documentation, you cannot import the product legally anyway.
For more simple products, however, you can consider to ‘reverse engineer’ the bill of materials, and recreate the design drawings on your own. This should not be attempted for more complex products though.
Can’t I just use my supplier’s declaration of conformity and technical file?
Using the supplier’s documentation is actually accepted by most EU member states, as long as the product brand is owned by the supplier. And, that you can provide a technical file upon request by authorities in the EU.
Keep in mind that this only works in theory. Extremely few suppliers in China even have a technical file, so if something ‘goes wrong’, you will be left holding the bag – as you will not be able to present a technical file.
In the end, you will need to create the DoC and the technical file.
Further, if you import products with your own brand name, or design, you are classified as the manufacturer. Hence, you will need to issue the DoC and technical file in your name.
The CE mark is essentially a label showing that the item is compliant with all applicable EN or EC directives. On the other hand, products that are not regulated by such directives, shall not be CE marked.
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 Chinese supplier.
That said, don’t expect that they are aware of the specific labeling requirements applicable to your product. It’s critical that you provide your supplier with graphical files (i.e., in .ai or .eps format), dimensions and affixing position on the product.
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. Naturally, the CE mark shall also be permanent, so a sticker is not enough.
EU Directives For Which CE Marking is Required
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 don’t interfere with other electronics, and signals, in its proximity. While it’s impossible to completely eliminate electromagnetic emittance, the EMC directive sets strict limits – which in turn depend on the type of product, its usage and intended environment. However, products covered by the R&TTE Directive, are not regulated by the EMC directive.
c. Machinery directive (MD)
The Machinery Directive is applicable to machinery, interchangeable equipment and parts. The machinery directive primarily regulates mechanical design and electrical design, 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. It’s not one uniform 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 replacing R&TTE, and 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. European 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 few exceptions.
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