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.)
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Directive
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Product Area
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Language Requirements
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90/396/EEC
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Gas appliances used for cooking, heating, hot water production,
refrigeration, washing and more
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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)
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89/106/EEC
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Construction products, such as doors, windows, tiles, sanitary
fixtures, ceiling material, wall coverings, fire detectors, etc.
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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)
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94/9/EC
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Equipment used in potentially explosive atmospheres such as fans,
pumps, engines, packaging machines, printing, textile, wood working machinery,
etc. (see exclusions)
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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)
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93/15/EEC
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Explosives for civil uses, such as ammunition and pyrotechnic
articles
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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)
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95/16/EC
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Elevators (see exclusions)
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Safety
instruction manual and logbook must be published in an official
language of the European Community. See Annex I(6)
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93/42/EEC
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General medical devices: any instrument, apparatus, appliance and
substance intended by the manufacturer to be used for human beings (see
exclusions)
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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)
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90/385/EEC
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Active, implantable medical devices: medical devices which rely on an
additional source of power
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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)
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98/79/EC
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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)
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90/384/EEC
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Non-automatic weighing instruments
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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)
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89/686/EEC
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Personal protective equipment, such as helmets, shields, headgear,
gloves, footwear, umbrellas
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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)
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97/23/EC
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Pressure equipment and related parts, such as flanges, piping, valves,
castings, fasteners and more (see exclusions)
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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)
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94/25/EC
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Recreational boats of any type from 2, 5 to 24 m hull length (see
exclusions)
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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)
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88/378/EEC
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Toys
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Warnings,
precautions may be required in the national language(s) of the Member
State in which the toy is marketed. See Article 11(5)
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87/404/EEC
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Simple pressure vessels intended to contain air or nitrogen (see
exclusions)
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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)
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98/13/EC
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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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