If you are importing into Italy from China, it is likely that your products must comply with one or more EU regulations and be marked with the CE marking: the importer is the final responsible and has the task of ensuring compliance.
Here’s what we’ll talk about in this article:
– The fundamental principles of CE
marking
– the documentation- the labeling
requirements- the regulated
products- the main directives
– how not to take risks and never take compliance for granted
What is CE marking?
Many products sold in the European Union must comply with one or more EU or EN directives. Some CE regulations apply to very specific products, such as finger paints, while other directives are more comprehensive and regulate large categories of products such as electronic systems with an input or output voltage between 50 and 1000 volts.
The CE marking is not a product directive, but a conformity mark certifying that the article complies with all current EC directives that apply to a given product.
As each EC Directive regulates specific products, the scope of the regulation varies considerably. Some EC directives regulate substances, while others regulate energy efficiency and electrical safety. These directives also cover the labelling requirements that apply to the product unit, the packaging instructions and the user manual.
It is not just a matter of printing the CE mark on your products, but the importer must ensure that the goods comply with all the technical requirements described in the current EU directives. The sale of non-compliant goods in the European Union is illegal and can result in both the seizure of the products and serious penalties, assuming that the goods first manage to pass customs.
Products that must comply with the CE marking
Some EC directives regulate specific products, but most of these directives are applicable to product groups. We will look at the specific areas of application of the regulations later, but let’s start by taking a look at the list of products that require CE marking.
If your products are not on this list, it does not mean that your goods do not have to comply with product regulations and directives. There are several other regulations in the European Union, including the REACH Directive, which regulate the substances present in all products sold within the EU.
Here are the products:
Electronic systems
Gas appliances
Domestic refrigerators and freezers
Ecodesign of energy-related products
Electromagnetic compatibility
Low voltage
Radio equipment and telecommunications terminal equipment
RoHS 2 (Part of CE, as of 2013)
Toys
Mechanical and physical properties
Inflammability
Specifications for the diffusion of certain elements
Toy boxes for chemical experiments and related activities
Chemical toys (toy boxes), excluding experimental toys
Pictograms relating to the age warnings of the children for whom the game is intended
Paints for painting with your fingers
Swings, slides and toys for similar indoor and outdoor activities for domestic use
Organic Chemical Compounds – Requirements
Organic Chemical Compounds – Sample Preparation and Extraction
Organic Chemical Compounds – Methods of Analysis
N-Nitrosamines and N-Nitrosatable Substances
Hardware
Machinery (in general)
Non-automatic weighing instruments
Measuring equipment
Cableway installations for the transport of persons
Lifts
Personal protective equipment
Pressure Equipment
Fireworks
Medical devices
Active implantable medical devices
In vitro diagnostic medical devices
Medical devices
Vehicles
Pleasure boats
Bicycles
Electric Bicycles
Other
Cableway installations for the transport of persons
Equipment and protective systems intended for use in potentially explosive atmospheres
Explosives for civil use
Hot water boilers
Noise emissions into the environment
Simple pressure vessels
The person responsible for ensuring CE conformity
When products are manufactured outside the European Union (e.g. in China), it is the importer who is responsible for ensuring compliance with the current CE marking directive, although most relevant EU bodies and their websites tend to refer to the “manufacturer” as the one responsible for ensuring CE conformity.
However, when the goods are produced outside the European Union, the importer and the manufacturer are considered as one and the same person. Therefore, the responsibility for ensuring CE conformity cannot be placed on a Chinese manufacturer.
What happens if you import non-compliant goods
There are many cases where EU customs have required CE certification documents to prove that the imported goods comply with all applicable EC directives and when the importer could not produce such documentation, customs did not allow the goods to transit.
A recent example concerned a Spanish company that was not authorised to transit its products through customs, as it had failed to provide the necessary CE certificate. In this specific case, the company had carried out part of its task by ensuring compliance with the EU directive on the safety of toys, but since these toys were also electric, additional EC regulations applied which the company could not demonstrate compliance with consequent loss at an economic level.
Another example is a Swedish company that also imports toys. In this case, the difference was that the goods arrived several months earlier, but when the European Union regulators forwarded their requests, this company could not produce the documents proving full compliance with the directives. Therefore, the company faced a seizure, which means that you are not allowed to sell the goods throughout the European Union and that you have to reimburse all customers who received the goods belonging to that same batch. In other words: a financial nightmare.
In addition, you may also have to deal with severe penalties of millions of euros. Assuming someone gets hurt, or the goods are damaged, you may also face criminal prosecution.
Are all Chinese manufacturers CE marked?
No. In most industries, only 5 to 10% of Chinese manufacturers comply with CE marking. However, this does not mean that an entire factory can comply with the CE mark. This marking applies only to specific products. Therefore, even those manufacturers who can demonstrate prior compliance will not always produce goods with the CE mark.
For these reasons, when selecting suppliers, we always look for prior CE conformity to determine whether the supplier has the capacity and technical knowledge to produce compliant products. None of this can be taken for granted in China. Remember: prior conformity is an indication, but not a guarantee, of the conformity of your goods.
There is no such thing as ‘default compliance’. Before placing an order, you must make the supplier aware of your compliance requirements. If Chinese manufacturers do nothing by default, it is the production of the goods that does not comply with all foreign regulations.
But simply referring to ‘CE compliance’ and assuming that the supplier will know exactly what EU directives apply to its products is an extremely risky strategy.
You need to confirm exactly which EC directives apply to your products and you need to communicate them to the Chinese supplier. To verify compliance, you must also implement a testing and certification procedure.
What is the Declaration of Conformity?
The Declaration of Conformity (DoC) is a document issued by the manufacturer certifying that the goods comply with all current EU directives. The Declaration of Conformity must also list the specific EU directives with which the product conforms.
In addition to this, the manufacturer’s company name, address and product information must also be present on the Declaration of Conformity.
For some products, the manufacturer is authorized to issue the Declaration of Conformity without a third-party company verifying the conformity of the goods. Everything is going well when it comes to European, American and Japanese manufacturers. But what about Chinese manufacturers?
Fake product certificates and test reports are not uncommon in China, to put it mildly. Many Chinese suppliers issue a Declaration of Conformity stating compliance with regulations, while they have made no effort to ensure compliance.
Let’s take the example of a Declaration of Conformity issued by a Chinese supplier in which they claimed that their ball bearings comply with the Electromagnetic Compatibility (EMC) Directive.
The Electromagnetic Compatibility (EMC) Directive regulates electronic systems that may interfere with other electronic devices located nearby. The problem here is that a ball bearing does not contain any electronic components, therefore, it cannot interfere with electronic devices.
For this reason, the EMC directive is not applicable to a ball bearing. Essentially, the Chinese provider simply went to the web and copied/pasted the first directive found on Wikipedia, hoping to solve its compliance issues.
Finally, it is the importer’s responsibility to ensure that the goods are compliant. If the authorities believe that your imported products do not comply with the regulations, you will be held responsible, not the supplier.
This is why tests carried out by third-party companies, which verify the validity of the Declaration of Conformity, are important, even if this type of control cannot always be required by law.
However, in some cases, tests carried out by third-party companies are required by law. This means that the Declaration of Conformity issued by the supplier must be based on tests carried out by a third-party company authorized to control.
What is the technical file?
In addition to the Declaration of Conformity, the manufacturer is also required to create a technical file. This document covers the technical aspects of a product that are related to testing and quality control procedures and documents. The following is a general list of the information that the technical file must at least include:
Products description
Design schematic, drawings, electrical circuits and circuit diagrams (if electrical), component diagrams, subassemblies, parts list, etc
List of regulations applied in whole or in part
Tests and quality control procedures (to be carried out on-site or by third-party companies)
Test reports and quality control records
Marking and labelling of copies
Copies of the operating instructions
However, the specific information contained in a technical dossier is outlined in the current EC Directive. Unlike the Declaration of Conformity, the technical file does not have to be published or made available to dealers or the direct customer. The importer must submit the technical dossier only if requested by the Community or local authorities.
Therefore, the importer is legally required to receive a copy of the technical file from the Chinese manufacturer. But, since the technical file contains detailed product information such as circuit diagrams, virtually no supplier will be willing to hand over the technical file to the buyer before they place an order.
This creates a whole host of problems, as the importer risks paying a supplier only to find out later that the supplier does not actually have any technical files.
Labeling requirements
The CE marking is basically a label certifying that the product complies with all current EN or EU directives. On the other hand, products not covered by these directives do not have to be CE marked.
The CE mark must be affixed to the product unit, the packaging instructions and the user manual, if any. It is the Chinese manufacturer’s job to take care of this during the production phase, but it is essential that you give your supplier the graphic files, dimensions and position of application on the product of the CE mark.
The dimensions of the CE mark must also comply with the official layout established by the European Union which is equal to a minimum diameter of 5 mm. That said, there are also exceptions. Of course, the CE mark must also be indelible, so a sticker is not enough.
Do non-EU importers need to ensure CE compliance?
No, because the CE marking is part of the European Union directives, importers based in the United States, Australia, India and other non-European countries are not required by law to ensure such compliance.
However, it is still advisable for you to look for prior CE compliance when selecting a Chinese manufacturer, and this also applies to non-European importers. Prior CE conformity does not indicate a certain level of technical competence. In China, moreover, compliance with European regulations is much more common than with American, Australian and Indian directives.
Therefore, buyers in these countries often have no choice but to seek out sellers who can demonstrate CE compliance to determine whether these suppliers can comply with their countries’ regulations.
The CE marking is of course necessary not only for items shipped from China, but also for products sold from any country to a member state of the European Union. Therefore, it is really very important to ensure CE compliance if you are a non-EU company looking to re-export products to the European Union.
Most large groups, including Apple and Samsung, tend to ensure compliance with all regulations in force in the main markets. That’s why your laptop chargers, which are sold worldwide, are also marked with the CE mark.
EU directives requiring CE marking
We offer you an overview of the directives applicable to electronic equipment, machines and toys, but remember that this is not the complete list of directives requiring CE marking.
Low Voltage Directive (LVD)
The Low Voltage Directive (LVD) applies to electronic systems and components that have an input or output, which have an alternating voltage of 50 to 1000 Volts and/or a direct current of 75 to 1500 Volts. Therefore, the scope of the Low Voltage Directive covers a wide range of products, including chargers, cables, household appliances and power sockets.
However, this directive is not applicable to battery-powered devices and other electronic devices that have an input or output that is outside the specified voltage range.
Electromagnetic compatibility (EMC)
The Electromagnetic Compatibility (EMC) Directive is applicable to stationary electronic equipment such as LED displays. The purpose of this regulation is to ensure that electrical equipment does not interfere with other electronic devices and signals in the vicinity.
Since it is impossible to completely eliminate electromagnetic emissions, the EMC Directive sets strict limits which, in turn, depend on the type of product, its use and the environment for which it is intended to be used. However, the products covered by the RED regulation are not regulated by the Electromagnetic Compatibility Directive.
The Machinery Directive (MD)
The Machinery Directive is applicable to machinery, interchangeable equipment and parts thereof. This directive mainly regulates mechanical and electrical design, but also cables, chains and other aspects related to the safety of machinery. That said, motor vehicles and many types of consumer appliances are not regulated by the Machinery Directive. Click here to read more about importing machines from China.
Radio Equipment Directive (RED)
The RED Directive (which replaces the old R&TTE Directive) applies to radio equipment and telecommunications equipment. The scope of the Directive covers both final products and individual components. Therefore, products with radio, WiFi and Bluetooth transmitters and receivers must comply with this directive. This includes, but is not limited to, Android tablets, smartphones, and WiFi routers.
Toy Safety Directive
The Toy Safety Directive regulates toys and other children’s products. It is not a uniform directive, but is divided into 13 different standards (called EN 71). In most cases, in addition to the EN 71 standards, several other regulations also apply. The Toy Safety Directive regulates the different characteristics of toys and children’s products including, but not limited to: flammability, mechanical and physical properties, chemicals and heavy metals.
In addition, the Directive also sets out requirements for graphic symbols (e.g. the age notice of the children for whom the products are intended) and other labelling requirements. Click here to learn more about the European Toy Safety Directive.
Ecodesign Directive
The Ecodesign Directive was implemented to reduce greenhouse gases. To date, more than 40 product groups fall under this regulation, including light bulbs and household appliances. The Directive also applies to non-electrical products, including windows and insulating materials.
Restriction on the Use of Hazardous Substances (RoHS 2)
The RoHS Directive limits the amount of certain substances, including lead, cadmium, and mercury, in electronic systems. As of January 2013, RoHS is part of the CE Marking Directive. Therefore, RoHS compliance is mandatory for all CE-marked electrical items. However, there are exceptions.
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