What European Directives Say About Language Requirements
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What European Directives Say About Language Requirements

In an effort to promote free movement of goods within the single European market the European Commission has issued New Approach Directives that contain mandatory requirements for 18 product areas. Language is included in the specifications laid out in the New Approach Directives for the following product areas. (This list is intended as a guideline for decisions concerning language strategies. It does not replace a legal analysis of current European directives.)

Directive Product Area Language Requirements

90/396/EEC

Gas appliances used for cooking, heating, hot water production, refrigeration, washing and more

Instructions and warning notices must be in the official language(s) of the Member States of destination. See Annex I (1.2)

Documentation relating to certification of conformity must be in the language of the certifying body’s country or in a language accepted by it. See Article 8(6)

89/106/EEC

Construction products, such as doors, windows, tiles, sanitary fixtures, ceiling material, wall coverings, fire detectors, etc.

Certificates and declarations of conformity must be presented in the official language(s) of the country in which the product is to be used. See Annex III(4.4)

94/9/EC

Equipment used in potentially explosive atmospheres such as fans, pumps, engines, packaging machines, printing, textile, wood working machinery, etc. (see exclusions)

Instructions must be translated in the language(s) of the country in which the equipment is to be used (excluding specialist maintenance instructions). See Annex II(1.0.6)

93/15/EEC

Explosives for civil uses, such as ammunition and pyrotechnic articles

Instructions and, where necessary, markings about safe handling, storage, use and disposal must be in the official language(s) of the recipient Member State. See Annex I(II/1/k)

95/16/EC

Elevators (see exclusions)

Safety instruction manual and logbook must be published in an official language of the European Community. See Annex I(6)

93/42/EEC

General medical devices: any instrument, apparatus, appliance and substance intended by the manufacturer to be used for human beings (see exclusions)

User and/or patient information may be required to be in the Member State’s national language(s) or in another Community language, regardless of whether it is for professional or other use. See Article 4(4)

Records and correspondence relating to conformity assessment must be in the official language of the Member State in which the procedures will be carried out and/or in a language acceptable to the official body assessing conformity. See Article 11(9)

90/385/EEC

Active, implantable medical devices: medical devices which rely on an additional source of power

Records and correspondence relating to conformity assessment of devices not custom-made or intended for clinical investigations must be in the official language of the Member State in which the procedures will be carried out and/or in a language acceptable to the official body assessing conformity. See Article 9(4)

Operating instructions, package labeling and instructions for use may be required in the national language(s) of Member States. See Article 4(4)

Harmonized symbols should preferably be used on packaging. See Annex I(14)

98/79/EC

In vitro diagnostic medical devices, reagents, calibration and control substances, instruments, equipment and systems for the examination of samples derived from the human body.

Instructions for use and labels may be required in the Member State’s official language(s) when a device reaches the final user. If the safe and correct use of the device is ensured, Member States may authorize this information to be in one or more other official Community language(s). See Article 4(4)

Where appropriate, the information to be supplied should take the form of symbols. See Annex I,B(8.2)

Records and correspondence relating to conformity assessment must be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. See Article 9(11)

90/384/EEC

Non-automatic weighing instruments

Documents and correspondence relating to conformity assessment must be in an official language of the Member State where the assessment is to be carried out, or in a language accepted by the assessing body. See Article 8(2)

89/686/EEC

Personal protective equipment, such as helmets, shields, headgear, gloves, footwear, umbrellas

Required manufacturer’s information must be provided at least in the official language(s) of the Member State of destination. See Annex II(1.4/g)

Health and safety information should preferably be in the form of harmonized pictograms or ideograms: when such information contains words or sentences, the latter must appear in the official language(s) of the Member State where the equipment is to be used. See Annex II(2.12)

97/23/EC

Pressure equipment and related parts, such as flanges, piping, valves, castings, fasteners and more (see exclusions)

Safety requirements may be required in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State in which the equipment or assembly reaches the final user. See Article 4(2)

Records and correspondence relating to conformity assessment must be in the official language(s) of the Community determined in accordance with the Treaty by the Member State where the assessing body is established, or in a language accepted by that body. See Article 10(4)

94/25/EC

Recreational boats of any type from 2, 5 to 24 m hull length (see exclusions)

Owner's manual must be in the official language(s) of the European Community as determined by the Member State in which it is marketed. See Annex I(2.5)

88/378/EEC

Toys

Warnings, precautions may be required in the national language(s) of the Member State in which the toy is marketed. See Article 11(5)

87/404/EEC

Simple pressure vessels intended to contain air or nitrogen (see exclusions)

Records and correspondence relating to certification procedures must be in an official language of the Member State in which the certifying body is established or in a language accepted by that body. See Article 8 (3)

Instructions must be in the official language(s) of the Member State of destination. See Annex II (2)

98/13/EC

Telecommunications terminal equipment and satellite earth station equipment

Records and correspondence relating to conformity procedures must be in an official language of the Member State where the procedure will be carried out or in a language acceptable to the assessing body involved. See Articles 10(3) and 21(2)

 
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