Vse kar morate vedeti o CE direktivah

1 naročnik

tole zna biti evergreen :)

Ker se pogosto pojavljajo vprašanja o CE direktivi je tukaj na preprost in razumljiv način napisano bistvo z navedbo standardov in skupin izdelkov :

Avtor: Fredrik Grönkvist

Importing from China to the European Union. . If so, your product is likely required to be CE marked, and compliant with one or more European Union standards. Yet, many small businesses importing from China are unaware of how these regulations apply to their products – and who is ultimately responsible to ensure compliance.

In this article, we explain the basics of CE marking, including documentation, labeling requirements, regulated products and major EN / EC directives. What’s more, we also explain why companies importing from China, and other Asian countries, shall be cautious and never take CE compliance for granted.

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 highly specific products, e.g. finger paints, while others are more comprehensive and regulate large categories of products, e.g. electronics with an input or output voltage between 50 to 1000 volts. CE marking is not a product directive itself, but a conformity marking stating that the item is compliant with all applicable EC directives.

As each EC directive regulates specific products, their scope of regulation varies greatly. Some EC directives regulate substances, while other regulate energy efficiency and electrical safety. These directives also cover labeling requirements, applying to the product unit and its packaging and user instructions.

However, you can’t simply print a CE mark on your products, and assume that you’re good to go. You must ensure that the items comply with all technical requirements outlined in the applicable EN and EC directives. Selling non-compliant items in the EU is illegal, and may result in both a forced recall and serious fines – assuming that the items make it through customs in the first place.

Are non-EU based importers required to ensure CE compliance?

No, as CE marking is part of European Union directives, importers based in the United States, Australia, India and other countries are not required by law to ensure compliance. However, looking for previous CE compliance when selecting a Chinese manufacturer is still wise – even for non-European importers. Previous CE compliance does indicate a certain level of technical expertise. European compliance is also far more common in China, 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 CE compliance – as a way to determine if the supplier is capable to reach standards in their own countries.

CE marking is of course 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. Most big companies, including Apple and Samsung, tend to secure compliance with all relevant standards in major markets. That’s why your laptop chargers, sold worldwide, are also labeled with the CE mark.
Which products must be CE compliant?

Some EC and EN directives regulate specific products, but most are applicable to groups of products. We will look into the specific scopes of regulations for various directives later, but let’s begin by taking a look at the list products requiring CE marking.

However, if you can’t find your products in the list below, that is not implying your product is exempt from product standards and directives. There are various other regulations in the European Union, one of which is the REACH directive, regulating substances in all products sold in the EU.

Electronics

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)

Toys

Mechanical and physical properties
Flammability
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

Machinery (general)
Non-automatic weighing instruments
Measuring instruments
Cableway installations designed to carry persons
Lifts
Personal protective equipment
Pressure equipment
Pyrotechnics

Medical

Active implantable medical devices
In vitro diagnostic medical devices
Medical devices

Vehicles

Recreational craft
Bicycles
Electric bicycles

Other

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

Which party is responsible to ensure CE compliance?

When products are manufactured overseas (e.g. in China), the importer is responsible to ensure compliance with the applicable CE marking 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 I import non-compliant items?

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 those cases that the importer could not produce such documentation, the customs did not allow the cargo to pass through customs.

The most recent report we received, concerned a Spanish company not being allowed to bring their products through customs, as they failed to provide the necessary CE certificate. In this specific case, they had done part of their homework and ensured compliance with the EN 71, the EU Toy Safety Directive. However, as these toys were also electrical, additional CE directives also applied, of which they couldn’t prove compliance. We didn’t hear back from them, but I think this resulted in a complete loss.

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 EU regulators came knocking on their door – they couldn’t produce documents proving full compliance. Thus, they faced a forced recall, which means that you are not allowed to sell the items anywhere in the European Union – and refund all customers that have received items from that same batch. A financial nightmare, in other words.

In addition to this, you may also face major fines, counted in the millions of Euros. Assuming anyone gets hurt, or if property is damaged, you may also face criminal prosecution.

Are all Chinese manufacturers CE compliant?

No, they are not. It’s rather the opposite. In most industries, only 5 to 10% of the Chinese manufacturers are compliant. However, that is not saying that an entire factory can be “CE compliant”. CE marking only applies to specific products. Therefore, even those manufacturers that can show previous compliance, will not always make CE marked items.

Thus, when selecting suppliers, we always look at previous CE compliance in order to determine if the supplier has the knowledge and technical 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.

Declaration of Conformity

The Declaration of Conformity (DoC) 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.
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.
Labeling requirements

CE compliance label

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 CE marking requirements for your product. It’s critical that you provide your supplier with graphical files, 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 requiring CE marking

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.

Low Voltage Directive (LVD)

The LVD 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.

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.

Machinery directive (MD)

The MD 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.

Toy Safety Directive (EN71)

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 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.

Radio & Telecommunications Terminal Equipment Directive (R&TTE)

The R&TTE directive 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.

European Ecodesign Directive

The Ecodesign Directive was put in place to reduce greenhouse gases. As of today, more than 40 groups of products are covered by the Ecodesign Directive, including light bulbs and domestic electrical appliances. The directive also applies to non-electrical products, including windows and insulation materials.

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.