Products covered under new approach directive

73/23/EEC

Low voltage (electrical equipment)

Electrical equipment

"Any equipment designed for use with a voltage rating of between 50 V and 1000 V for alternating current and between 75 V and 1500 V for direct current", other than the equipment and phenomena.

electrical domestic appliances, tools, cables, leading wires, machinery carrying primarily electrical risks.

electrical equipment for use in an explosive atmosphere, electrical equipment for radiology and medical purposes, electrical parts for goods and passenger lifts, electricity meters, plugs and socket outlets for domestic use, electric fence controllers, radio-electrical interference, specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

87/404/EEC

Simple pressure vessels

Welded vessels

The Directive applies to simple pressure vessels manufactured in series. For the purposes of this Directive, simple pressure vessel means: any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.

Moreover,

-the parts and assemblies contributing to the strength of the vessel under pressure shall be made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys,

-the vessel shall be made of:

-either a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part,

-or two dished ends revolving around the same axis,

-the maximum working pressure of the vessel shall not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS.V) shall not exceed 10 000 bar/litre,

-the minimum working temperature must be no lower than minus 50 °Cand the maximum working temperature shall not be higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels.

The following vessels shall be excluded from the scope of the Directive:

-vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity,

-vessels specifically intended for installation in or the propulsion of ships and aircraft,

-fire extinguishers.

88/378/EEC

Toys

Products or material

designed or clearly intended for use in play by children of less than 14 years of age

Christmas decorations; detailed scale models for adult collectors; equipment intended to be used collectively in playgrounds; sports equipment; aquatic equipment intended to be used in deep water; folk dolls and decorative dolls and other similar articles for adult collectors; "professional toys" installed in public places (shopping centres, stations, etc.); puzzles with more than 500 pieces or without picture, intended for specialists; air guns and air pistols; fireworks, including percussion caps; slings and catapults; sets of darts with metallic points; electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts; products containing heating elements intended for use under the supervision of an adult in a teaching context; vehicles with combustion engines; toy steam engines; bicycles designed for sport or for travel on the public highway; video toys that can be connected to a video screen, operated at a nominal voltage exceeding 24 volts; babies' dummies; faithful reproductions of real fire arms; fashion jewellery for children.

89/106/EEC

Construction products

Products

which are produced for incorporation in a permanent manner in construction works (i.e. building and civil engineering works)

Concrete and grout admixtures; glues, putty, pipe filling, fittings; sealers; metal anchors; plaster ; concrete et water activated binders; precast concrete units; chimney and chimney bricks; water and heat meters; stairs; safety hook; telescope cover boxes; devices for seismic risk protection; doors, windows and French windows; metal fittings; industrial doors and trellised gates; gas treatment plants; solar power units; rough plasterers and stucco plasterers; heat insulating materials; concrete pavements; linings; steel products; metal products for structural use; precast concrete units; water heater ; fire extinguishing systems; drinking water taps; glasses and vitroceramic glasses, etc.

89/336/EEC

Electromagnetic compatibility

Apparatus

i.e. all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components which are liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

Components such as fuses, transistors, integrated circuits, resistances, miniaturised condensers.

98/37/EC

Machinery

Machinery

i.e. an assembly of linked parts or components at least one of which moves, with the appropriate actuators, control and power circuits, etc.; joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material;

i.e. an assembly of machines which, in order to achieve the same end, are arranged and controlled to function as an integral whole;

i.e. interchangeable equipment modifying the function of a machine, and the purpose of which is to be assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool

Machinery used in the process for manufacturing products, vehicles used in the mining industry;

Machinery that is particularly "hazardous" (see exhaustive list in annex IV): circular saws (single or multi-blade), sawing machines of various types; machines of the types for working with wood and analogous materials; machines for working with meat and analogous materials; machines for underground working ( for example, machinery on rails, locomotives and brake-vans); presses, including bending machines for cold metal working; plastic injection or compression moulding machinery with manual loading or unloading; rubber injection or compression moulding machinery with manual loading or unloading; tree protection systems; vehicles servicing lifts; devices for the lifting of persons involving a risk of falling from a vertical height of more than three metres; machines for the manufacture of pyrotechnics…

machinery whose only power source is directly applied manual effort: machinery for medical use used in direct contact with patients; special equipment for use in fairgrounds and/or amusement parks; steam boilers, tanks and pressure vessels; machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity; radioactive sources forming part of a machine; firearms ; storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances; means of transport, i.e. vehicles and their trailers intended solely for transporting passengers; seagoing vessels and mobile offshore units together with equipment on board such vessels or units; cableways, including funicular railways, for the public or private transportation of persons; agricultural and forestry tractors (see Directive 74/150/EEC); machines specially designed and constructed for military or police purposes; lifts; means of transport of persons using rack and pinion rail mounted vehicles; mine winding gear; theatre elevators; construction site hoists (See Article 1)

Safety components

placed on the market separately to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons, provided that the component is not an interchangeable equipment

89/686/EEC

Personal protective equipment

Devices or appliances

designed to be worn or held by an individual for protection against one or more health and safety hazards

protective goggles, waistcoat to provide protection, helmets, forearm protectors; lower-leg protector; breathing masks, safety harness, climbing hooks, etc.

PPE specifically mentioned in the list included in the Directive, such as:

PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.),

PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.),

PPE designed and manufactured for private use against adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas), etc. (See Annex 1)

Units of several devices or appliances

which have been integrally combined by the manufacture for the protection of an individual against one or more potentially simultaneous risks

Protective devices or appliances

combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity

Interchangeable components

essential to the satisfactory functioning of the personal protective equipment, and used exclusively for such equipment

90/384/EEC

Non-automatic weighing instruments

Measuring instruments

serving to determine the mass of a body by using the action of gravity on that body, or to determine other mass related magnitudes, quantities, parameters or characteristics; and which require the intervention of an operator during weighing

90/385/EEC

Medical devices: Active implantable

Instruments, apparatus, appliances, material or other article, whether used alone or in combination (including any accessories or software necessary for its proper application)

which are intended by the manufacturer to be used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring, treatment of disease); which rely for their functioning on an external source of power; which are intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice; and which are intended to remain after the procedure

phials, bottles, spatulas, glass plates, etc.

Devices intended for clinical investigation or custom-made are covered by the Directive but cannot feature the CE marking.

93/42/EEC

Medical devices: General

Instrument, apparatus, appliances, materials or other article, whether used alone or in combination (including the software necessary for its proper application)

which are intended by the manufacturer to be used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring, treatment of disease); and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means

The Directive specifies four classes of products such as:

Class I: bands, elastic bands, elastic stocking, glasses, etc.

Class IIa: syringes, contact lenses, hearing aids, etc

Class IIb: internal orthopaedic aids, solutions and liquids for contact lenses, medical equipment for X-rays, medical appliances for high-frequency surgery, etc.

Category III : heart valves, absorbable surgical materials, etc.

In vitro diagnostic devices, active implantable devices, medicinal products (including medicinal products derived from blood), cosmetic products, human blood, human blood, organs and tissues of human origin,…covered by other directives.

Accessories

i.e. an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device

98/79/EC

Medical devices: In vitro diagnostic

Instruments, apparatus, appliances, materials or other articles, whether used alone or in combination (including the software necessary for its proper application)

which are intended by the manufacturer to be used for human beings for certain defined purposes (e.g. diagnosis, prevention, monitoring, treatment or alleviation of disease); and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means; and which are reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body for the purpose of providing information

implantable cardiac pacemakers, implantable defibrillators, electrodes and adapters for the aforementioned products, implantable nerve stimulators, bladder stimulators, etc.

This Directive does not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity.

Accessories

i.e. an article intended specifically by its manufacturer to be used together with others for in vitro diagnostic examination

90/396/EEC

Appliances burning gaseous fuels

Appliances

i.e. appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 °C; or forced draught burners and heating bodies to be equipped with such burners

appliances specially designed to be used in an industrial process are excluded. "Gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15° under a pressure of 1 bar.

Fittings

i.e. safety devices, controlling devices or regulating devices and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners, if they are separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance

92/42/EEC

Hot-water boilers

Combined boiler-body units

with a rated output of no less than 4 kW and no more than 400 kW; which are fired with liquid or gaseous fuels and which are designed to transmit to water the heat released from burning

Hot-water boilers capable of being fired by different fuels including solid fuels, equipment for the instantaneous preparation of hot water, boilers designed to be fired by fuels the properties of which differ appreciably from the properties of the liquid and gaseous fuels commonly marketed (industrial waste gas, biogas, etc), cookers and appliances designed mainly to heat the premises in which they are installed and, as a subsidiary function, to supply hot water for central heating and sanitary hot water, appliances with rated outputs of less than 6 kW using gravity circulation and designed solely for the production of stored sanitary hot water, boilers manufactured on a one-off basis. (See Article 3)

Appliances

i.e. the boiler-body designed to have a burner fitted, or the burner designed to be fitted to a boiler-body

93/15/EEC

Explosives for civil uses

Materials and articles

considered to be explosives in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations

pyrotechnical articles, ammunition (partial application), explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police.

94/9/EC

Potentially explosive atmospheres

Equipment

i.e. machines, apparatus, fixed or mobile devices, control components (i.e. items essential to the safe functioning of equipment and protective system, without autonomous function) and instrumentation thereof; and detection or prevention systems intended for use in potentially explosive atmospheres (i.e. atmospheres that could become explosive due to local and operational conditions), and intended, separately or jointly, for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material, and capable of causing an explosion through their own potential sources of ignition

Examples of items excluded from the scope of the directive:

- medical devices intended for use in a medical environment; equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances, equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas, personal protective equipment covered by Directive 89/686/EEC, seagoing vessels and mobile offshore units together with equipment on board such vessels or units (vehicles intended for use in a potentially explosive atmosphere are not excluded. (See Article 1).

Protective Systems

i.e. design units intended for use in potentially explosive atmospheres; intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures; and separately placed on the market for use as autonomous systems

Safety devices, controlling devices and regulating devices

intended for use outside potentially explosive atmospheres, but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion

94/25/EC

Recreational craft

Boats

from 2.5m to 24m hull length, measured according to the appropriate harmonised standards; and intended for sports and leisure purposes

boats; ignition-protected equipment for inboard and stern drive engines; start-in-gear protection devices for outboard engines; steering wheels, steering mechanisms and cable assemblies; fuel tanks and fuel hoses: prefabricated hatches and portlights. (See Annex II)

Craft intended solely for racing, including rowing racing boats and training rowing boats labelled as such by the manufacturer; canoes and kayaks, gondolas and pedalos; sailing surfboards; powered surfboards, personal watercraft and other similar powered craft; original, and individual replicas of, historical craft designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer; experimental craft, provided that they are not subsequently placed on the Community market; craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years; craft specifically intended to be crewed and to carry passengers for commercial purposes; submersibles; air cushion vehicles; hydrofoils. (See Article 1)

Partly completed boats

i.e. boats consisting of a hull and/or components

Components

referred to in Annex II of the Directive when separate and when installed

95/16/EC

Lifts

Appliances

permanently serving specific levels in buildings and constructions; having a car moving along guides that are rigid and inclined at an angle of more than 15 degrees to the horizontal; and intended for the transport of persons and/or goods, the car being in each case accessible

Those excluded include lifts specially designed and constructed for military or police purposes, mine winding gear, theatre elevators, etc.

Safety components

used in lifts and referred to in Annex IV of the Directive

97/23/EC

Pressure equipment

Vessels*

i.e. housings designed and built to contain fluids under pressure including their direct attachments up to the coupling point connecting it to other Equipment

Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.… ".

Several exclusions are provided for such as:

piping; networks for the supply, distribution and discharge of water; equipment, appliances and machines covered by other directives; etc.(See Article 1)

Piping*

i.e. piping components intended for the transport of fluids, when connected together for integration into a pressure system

Special accessories*

i.e. devices designed to protect pressure equipment against the allowable limits being exceeded

Pressure accessories*

i.e. devices with an operational function and having pressure-bearing housings

Assemblies*

i.e. several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole*

99/5/EC

Radio and Telecommunications terminal equipment

Equipment

intended to be connected to the public telecommunications network in order to transmit, process or receive data capable of being used either for transmission only, or for transmission and reception, or for reception only, of radio communications signals by means of satellites or other space-based systems

Numerous exclusions are provided for such as:

Radio equipment used by radio amateurs unless the equipment is available commercially; kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment; marine equipment; cabling and wiring; receive only radio equipment intended to be used solely for the reception of sound and TV broadcasting services; air traffic-management equipment and systems. (See Annex I)

2000/9/EC

Cableway installations designed to carry persons

Installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.

These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel.

(a) funicular railways and other installations with vehicles mounted on wheels or on other suspension devices where traction is provided by one or more cables; (b) cable cars where the cabins are lifted and/or displaced by one or more carrier cables; this category also includes gondolas and chair lifts; (c) drag lifts, where users with appropriate equipment are dragged by means of a cable.

cable-operated tramways of traditional construction, installations used for agricultural purposes, on-site or mobile equipment for use in fairgrounds and/or amusement parks which are designed for leisure purposes and not as a means for transporting persons, mining installations or on-site installations used for industrial purposes, cable-operated ferries, rack railways, chain-driven installations..

2004/22/EEC

Measuring instruments

Equipment

94/62/EEC

99/652/EC

Packaging and packaging waste

All packaging placed on the market in the Community and all packaging waste, whether it is used or released at industrial, commercial, office, shop, service, household or any other level, regardless of the material used.

Directives based on the principles of the New Approach and the Global Approach but which do not provide for CE Marking

96/98/EC

Marine equipment

Equipment

Equipment for use on board ships for which safety certificates have been issued by the Member States or on their behalf under international agreements.

Equipment for which detailed test standards already exist in international instruments (See Annex A)

99/36/EC

Transportable pressure equipment

Equipment

Transportable pressure equipment approved for inland transport of dangerous goods by road and rail (relating to the free movement in the Community, the placing on the market, the commissioning and repeated use of this equipment).

And more specifically:

- all receptacles (cylinders, tubes, pressure drums, cryogenic receptacles, bundles of cylinders as defined in Annex A to Directive 94/55/EC),

- all tanks, including demountable tanks, tank containers (mobile tanks), tanks of tank wagons, tanks or receptacles of battery vehicles or battery wagons, tanks of tank vehicles used for the transport of Class 2 gases in accordance with the Annexes Directives 94/55/EC and 96/49/EC and for the transport of certain dangerous substances of other classes indicated in Annex VI to this Directive, including their valves and other accessories used for transport..

96/57/EC

Refrigeration equipment

Equipment

Electric mains-operated refrigerators, frozen food storage cabinets, food freezers, combinations of these

Appliances which can also use other energy sources, particularly accumulators, and household refrigeration appliances working on the absorption principle and appliances manufactured on a one-off basis shall be excluded.

2000/14/EC

Noise emission in the environment by equipment for use outdoors

Equipment

Equipment for use outdoors. This Directive only covers equipment that is placed on the market or put into service as an entire unit suitable for the intended use.

aerial access platform with combustion engines, brush cutter, building site hoist, building site circular saw bench, motor compressor, lawnmower, etc…

Non-powered attachments that are separately placed on the market or put into service shall be excluded, except for hand-held concrete-breakers and picks and for hydraulic hammers..

96/48/EC

Interoperability of the Trans-European high-speed rail system

Components and accessories

The "…aim of this Directive is to establish the conditions to be met in order to achieve interoperability within Community territory of the trans-European high-speed rail system…"

" … These conditions concern projects for and the construction, upgrading and operation of the infrastructures and rolling stock which will contribute to the functioning of the system…. "

"Trans-European high-speed rail system" means the structure composed of the railway infrastructures comprising lines and fixed installations, of the trans-European transport network, constructed or upgraded to be travelled on at high speeds, and rolling stock designed for travelling on those infrastructures