It may look innocuous but a CE marking is very important for distributors, importers and manufacturers trading on European markets. It is obligatory to have the CE marking on several non-food products listed in the CE Directive. The CE marking is a guarantee that the product conforms to the regulations of the European Union (EU) and the European Economic Area or EEA.
Not all products are required to carry the CE marking but each regulation and directive covers a specific product category wherein a different set of conformity rules apply. It is considered an economic offense if a product does not bear the CE mark or the CE mark is placed on products that are not included in the list. Both offenses are punishable. The type of penalty varies depending on the member state of the EU.
The CE Marking
The CE Marking refers to “Conformité Européene,” a French phrase that translates to ”European Conformity” that is covered by the 1993 Directive 93/68/EEC and used in all official documents of the EU.
Affixing the CE Marking on each specific product means that the manufacturer warrants that the product abides by the important requirements of the environmental, safety and health protection laws that are relevant to Europe. These products are covered by the Product Directives that include the Harmonized Standards and Performance Levels/Essential Requirements that the products must follow.
The Harmonized Standards or the European Standards are the technical specifications that are established by several standard agencies in Europe, such as CENELEC (European Committee for Electro-technical Standardization) and CEN (European Committee for Standardization).
The CE Marking is a bit similar to the U.S. Federal Communications Commission (FCC) Declaration of Conformity.
Placing the CE Marking means:
- Assuring the officials of the government of each EU country that the product can be sold in their county legally.
- Assurance that the product can move freely within the EU single market, which includes EEA and European Free Trade Association (EFTA) member countries.
- Granting permission to EEA customs and other related authorities to remove products that to do not conform to the CE Marking guidelines.
The European Economic Area or the EEA includes member countries of the EU as well as Norway, Liechtenstein and Iceland. Switzerland is not a member of the EU or EEA but is a member of EFTA, thus it is a part of the single market of the EFTA.
With the effectiveness of the CE Marking directives, more products are now required to have the required marking in order for them to access the EU and EFTA markets.
Many people think that the CE Marking indicates the quality of the product. In reality, it is a mark of safety. Affixing the CE Marking is a sign that the product has been evaluated and found compliant with the EU requirements.
Many exporters who are not from the European Union are still not aware of how this single mark can greatly affect their business.
General principles covering its use
The CE Marking can only be affixed by the product manufacturer or its authorized representative. It should be affixed on the specific products listed in the particular Community Harmonization legislation. The CE marking indicates that the manufacturer will take responsibility that the product conforms to the requirements covered by each Community Harmonization legislation that provides the directive for its inclusion in the product label.
This means that the only marking that ensures that the product conforms to the ruling of the relevant legislation is the CE Marking. Manufacturers should ensure that no other inscriptions, signs or marking should be included in the label that may mislead consumers and relevant parties. Other essential markings may be included, provided that the CE marking is legible and visible and the meaning of the marking is not obscured.
Each member state of the EU must see to the correct implementation of the CE Marking, The member states have the right to set the penalties for any infringement, including criminal punishments, which should be in proportion to the seriousness of the infringement.
All member states of the EU and the EFTA, as well as Liechtenstein, Norway and Iceland now require CE Marking. It is also required to be affixed on products that are produced outside of the EU and sold in the European Economic Area.
Countries requiring CE Marking:
|Czech Republic||Ireland||Poland||United Kingdom|
Member countries of the Central European Free Trade Agreement or CEFTA such as Albania, Bosnia and Herzegovina, Moldova and Kosovo do not require CE Markings, although countries that are candidates for membership to the EU such as Serbia, Montenegro and Macedonia may require them as well.
Products requiring CE Marking
Twenty-two product categories require CE Marking right now. These include medical, electrical and machinery products that can cause harm due to improper use. Some of these include active implantable medical devices, explosives (for civilian use), hot water boilers, elevators, measuring devices, medical devices, pyrotechnics, recreational craft and safety of toys.
The responsibility for the CE Marking falls on the manufacturer. In some cases, a private labeler that establishes itself as the product’s producer or a company that changes the product enough to render it as a new one may be responsible for the conformity to the CE Marking directives. The responsibility for the product and the translation of its required documents fall on the original manufacturer of the product or on the producer that adds the CE Marking on the product.
Some manufacturers enter into an agreement with their end user, agent or distributor so that they would be responsible for the translation of the required documentation. However, the liability for the product itself remains with the manufacturer and not the entity that ordered the translation.
No particular languages are specified by the EU directives although it is mandatory for the CE Marking to be translated in the official languages of each specific EU member country.
Member countries are allowed to specify the language/s they require. For products sold in France, the CE marking should be translated in French. If the manufacturer sells products to Belgium, they have to translate it to German, Dutch and French. Luxembourgish, German and French translations are needed for products to be sold in Luxembourg.
Manufacturers must contact the designated Competent Authority of every country where their products are going to be sold to get the appropriate guidance for translation into other languages.
Broadly, the importing countries must receive translations of the following:
- Product documentation and materials related to product safety
- User manuals
- Instructions for use of the product
- User interface
- Marketing materials
- Guidelines for users/caregivers
Specifically, the translation requirement can be grouped into three and should be translated into all the required languages of each country where the products are to be marketed:
- Declaration of conformity. This is conformity to the various directives, such as Machinery, Low Voltage, EMC, ATEX, Radio Equipment, Pressure Equipment, Medical Devices and RoHS.
- Maintenance and operations manuals. This is for all products that fall under the directives mentioned above.
- Technical files. These are for all the materials and devices that are included in the eight directives.
The translation services provider must ask specific questions regarding the language/s to be used. The requirements for each directive are also different.
Official languages of the EU
The EU has 23 official languages: Latvian, Dutch, French, German, Bulgarian, English, Greek, Czech, Danish, Estonian, Swedish, Finnish, Hungarian, Irish, Italian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, and Spanish.
There is a caveat to the languages. For some of the member states that have more than one official language, one language can be used for the translation provided the product is to be sold only in the areas that use the specific language. Other states such as Ireland, Malta and Cyprus accept English.
With regard to the Machinery Directive in the EEA, it should be translated into the language/s of the member countries, i.e., Norwegian (Norway), Turkish (Turkey), German (Liechtenstein), Italian, German and French (Switzerland) and Icelandic (Iceland).
Manufacturers have to work with professional translation companies to ensure that the translation of all the required documents is accurate. They need to contact the Competent Authorities of each EU member country where they intend to make their products available to get the required translation checklist.
For high quality and accurate translations to conform to the CE Marking directives, get in touch with Day Translations, Inc. by phone (1-800-969-6853) or email (email@example.com) anytime of the day. We have expert and professional native-speaking translators who work with more than 100 languages. We are open 24/7 from Monday to Sunday. Our translators are located all over the world, so it is easy for you to connect with one.
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