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CE Marking - The Directives:

Given below are a list of the directives (and regulations) associated with CE marking. These are provided here to give an impression of the scope of the directives and to help you before talking to us. Before applying these please check the currently validity. Note that amendments are not included in the list given below.

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Statement: Petts Consulting Ltd will provide an Organization with the knowledge of the Directives and an appropriate process which, when applied correctly will demonstrate due-diligence. However, the CE-marking is the manufacturers claim that the product meets the essential requirements of all relevant European Directives. In many cases the process to be carried out is a self-declaration process and the responsibility for any decisions lie with the management of the Company. During the course of the project Petts Consulting Limited will provide guidance and advice but ultimately it cannot be held responsible for such decisions.

Low Voltage 2014/35/EU

The LVD applies to electrical equipment with a voltage rating ranging from 50V – 1000V A.C. and 75V – 1500V D.C. and covers all risks arising from the use of the equipment (including mechanical and chemical risks).     
 
Equipment and phenomena listed below are explicitly excluded 
 

  • 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  

  • Specialized electrical equipment, for use on ships, aircraft or railways.

 

Examples:

  • "White goods" 

  • Heaters 

  • Gaming machines 

  • Computers 

  • TV and Audio 

  • Scientific instruments 

  • Etc. etc. 

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Machinery 2006/42/EC

This Directive applies to the following products: 
 

  • machinery 

  • inter changeable equipment 

  • safety components 

  • lifting accessories 

  • chains, ropes and webbing 

  • removable mechanical transmission devices 

  • partly completed machinery. 

 
‘Machinery’ means: 
 

  • an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application  

  • an assembly missing only the components to connect it on site or to sources of energy and motion,  

  • an assembly , ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,  

  • assemblies of machinery as above or partly completed machinery referred to in point which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,  

  • an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort.  

 
It shall also apply to safety components placed on the market separately. ‘safety components’ mean a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons. 
 
The following are excluded from the scope of this Directive: 
 

  • safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery  

  • specific equipment for use in fairgrounds and/or amusement parks  

  • machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity  

  • weapons, including firearms  

  • the following means of transport — agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles, — motor vehicles and their trailers subject to type-approval of motor vehicles and their trailers with the exclusion of machinery mounted on these vehicles, Type-approved two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles, — motor vehicles exclusively intended for competition, and — means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport  

  • seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units  

  • machinery specially designed and constructed for military or police purposes  

  • machinery specially designed and constructed for research purposes for temporary use in laboratories  

  • mine winding gear

  • machinery intended to move performers during artistic performances  

  • electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 2006/05/EC  —    household appliances intended for domestic use, —    audio and video equipment, —    information technology equipment, —    ordinary office machinery, —    low-voltage switchgear and control gear, —    electric motors  

  • the following types of high-voltage electrical equipment: —    switch gear and control gear, —    transformers. 

Examples:

  • Hand held power tools

  • Larger power tools (lathes, saws, presses)

  • Conveyor systems

  • Fork-lift trucks

  • Automated factory lines

  • Off-road vehicles (quad bikes etc.)

  • Safety curtains

  • Lawn mowers, garden equipment (powered)

  • Interchangeable tools for equipment (i.e strimmer heads, saw blades)

  • Etc. etc.

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Electromagnetic compatibility (EMC) 2014/30/EU

The EMC directive applies in principle to all electrical and electronic equipment and is intended to minimise the contamination of the EM spectrum and supply and to reduce problems arising from external interference. The provisions of the directive that are to be applied depend both on the functional characteristics of the product and its method of commercial distribution.  This directive is not considered to be a “Safety directive” but is mandatory to ensure that the levels of EM “contamination” are kept with acceptable limits.  
 
It should be noted that this directive applies to both equipment (appliances) and Fixed installations (such as large scale factory-scale machines , building data networks etc)
 
Note:   This directive does not apply to the parts of the product that contains “intentional transmitters/receivers”

Examples:

  • Computers, peripherals etc. 

  • Electronic games 

  • TV, audio 

  • Gaming machines 

  • Scientific instruments 

  • Power tools 

  • Motorised machines 

  • Digital cameras 

  • LED and Fluorescent lighting 

  • Etc. etc. etc. 

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Radio Equipment Directive 2014/53/EU

This directive applies radio equipment. In this context radio equipment means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as an antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination. 
 
Radio waves means EM waves with a frequency lower than 3000GHz, propagated in space without artificial guide. Note that there is no lower limit to frequency.
 
Products that fall within the scope of this directive are excluded from the scope of the EMC directive with the exception of the essential protection and safety requirements. 
 
It should also be noted that products that fall within the scope of the RED are subject to the essential protection requirements of the Low voltage directive, irrespective of the voltages involved.

Examples:

  • Mobile phones 

  • Bluetooth units 

  • Wireless networking 

  • GPS systems 

  • Radio receivers 

  • Walkie-Talkies 

  • Radio-controlled toys and models 

  • Etc.

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Construction Products Regulation(EU) No 305/2011

Construction Products Regulation (the CPR) is to ensure reliable information on construction products in relation to their performances. 
 
For the purposes of the regulation, ‘construction product’ means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. It provides performance criteria for building under six general topics, 
 

  • Mechanical resistance and stability  

  • Safety in case of fire  

  • Hygiene, health and the environment  

  • Safety in use  

  • Protection against noise  

  • Energy economy and heat retention 

 
Unlike other CE Marking directives the CPR does not apply to a product until a harmonized standard has been developed for it and ratified. Once a standard is in place a date is specified by which all products sold must conform. 

Examples

  • Bricks 

  • Cement 

  • Building boards 

  • Steelworks 

  • Security shutters 

  • RSJs 

  • Etc. etc. 

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Medical Devices: Directive (MDD) 93/42/EEC and Regulation (MDR) 2017/745

These apply to medical devices and their accessories. Accessories are treated as medical devices in their own right.   


The following definitions apply: ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the  software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: 
 

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,  

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,  

  • investigation, replacement or modification of the anatomy or of a physiological process,  

  • control of conception, 

 
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. 
 
An ‘accessory’ means an article which whilst not being a 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.  
 
Some devices are excluded from the scope of this directive, i.e. in-vitro and active implantable devices. 

Examples

  • Bandages 

  • Spectacle frames 

  • Wheelchairs 

  • Walking sticks 

  • Hearing aids 

  • Surgical instruments 

  • Medical monitoring equipment 

  • Hospital beds 

  • Contraceptives 

  • Etc. etc. 

The new MDR came  into force on 25th May 2017 , however most of the requirements will not fully apply until 26th May 2020, during the three year transition period both the MDD and MDR can be used for CE Marking. 

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In-vitro diagnostic medical devices: Directive (IVDD) 98/79/EC and Regulation (IVDR) 2017/746

These apply to in-vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in-vitro diagnostic medical devices in their own right. Both in-vitro diagnostic medical devices and accessories shall hereinafter be termed devices. An ‘in-vitro diagnostic medical device’ means any medical device which is a reagent, 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, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: 
 

  • concerning a physiological or pathological state or  

  • concerning a congenital abnormality or  

  • to determine the safety and compatibility with potential recipients or  

  • to monitor therapeutic measures. 

Examples

  • Some analytical equipment 

  • Reagents 

  • Pregnancy test kits 

  • Blood testing kits 

  • Etc. etc. 

The new IVDR came  into force on 25th May 2017 , however most of the requirements will not fully apply until 26th May 2022, during the five year transition period both the IVD and IVDR can be used for CE Marking.

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Active implantable medical devices 90/385/EEC and Medical Devices Regulation 2017/745

These apply to active implantable medical devices. An ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity; An ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. 

Examples

  • Pacemakers

  • Ocular implants

  • Etc.

The new MDR came  into force on 25th May 2017 , this will eventually replace 90/385/EEC however most of the requirements will not fully apply until 26th May 2020.

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Equipment and protective systems for potentially explosive atmospheres (ATEX) 2014/34/EU

This Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres. 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 are also covered by the scope of this Directive. 
The following definitions apply:  
 

  • ‘Equipment'’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition.  

  • ‘Protective systems’ means devices other than components of the equipment defined above which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately placed on the market for use as autonomous systems.  

  • Components'’ means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. . 

Examples

  • Petrol pumps 

  • Fall-off protection for tankers 

  • Chemical plant machinery 

  • Etc. etc. 

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Pressure equipment 2014/68/EU

This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar. ‘Pressure equipment’ means vessels, piping, safety accessories and pressure accessories. Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc. The Pressure Equipment is split into 4 categories depending on a combination of the fluids involve, volume (or DN) and operating pressures.  Effectively the risks involved increase as the category increases. The PED excludes "simple pressure vessels" 

Examples

  • Pneumatic and hydraulic systems

  • Gas handling systems

  • Heat-pumps and large Refrigeration systems 

  • Fittings

  • Etc. etc 

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Simple Pressure Vessels 2014/29/EU

This 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 − 50 ºC and the maximum working temperature shall not be higher than 300 ºC for steel and 100 ºC 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. 

Example

  • Compressed air storage systems

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Personal protective equipment (PPE) Regulation 2016/425/EU

This regulation applies to personal protective equipment, ‘PPE’. For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. PPE shall also cover:  
 

  • Units constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks  

  • Protective devices or appliances combined with personal non-protective equipment worn or held by an individual for the execution of a specific activity  

  • Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.  

 
Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure. 
 
This Directive does not apply to PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety or the PPE classes specified in the list below 
 

  • 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.), damp and water (dish-washing gloves, etc.), heat (gloves etc.).  

  • PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time. 

  • Helmets and visors intended for users of two- or three-wheeled motor vehicles. 

Examples

  • Ear protectors , plugs

  • Goggles

  • Hard hats 

  • Welding gloves and aprons 

  • Breathing gear 

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Non-automatic weighing instruments 2014/31/EU

This Directive applies to all non-automatic weighing instruments. A weighing instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. A non-automatic weighing instrument is defined as a weighing instrument requiring the intervention of an operator during weighing. 

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Measuring instruments 2014/32/EU

This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes i.e.  
 

  • Water meters (MI-001  

  • Gas meters and volume conversion devices (MI-002), Active electrical energy meters (MI-003)

  • Heat meters (MI-004)  

  • Measuring systems for continuous and dynamic measurement of quantities of liquids other then water (MI-005)  

  • Automatic weighing instruments (MI-006)  

  • Taximeters (MI-007)  

  • Material measures (MI-008),  

  • Dimensional measuring instruments (MI-009)  

  • Exhaust gas analysers (MI-010). 

Note: This directive only applies to the limited set of equipment above (effectively "weights and measures"), it does not applied to all equipment that carries out a measurement 

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Safety of toys 2009/48/EC

This Directive shall apply to toys. A ‘toy' shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age. 
 
Is does not apply to the following specific products. 
 

  • Decorative objects for festivities and celebrations 

  • Products for collectors, provided that the product or its packaging bears a visible and legible indication that it is intended for collectors of 14 years of age and above. Examples of this category are: 

o    detailed and faithful scale models; 
o    kits for the assembly of detailed scale models; 
o    folk dolls and decorative dolls and other similar articles; 
o    historical replicas of toys; and 
o    reproductions of real fire arms. 

  • Sports equipment, including roller skates, inline skates, and skateboards intended for children with a body mass of more than 20 kg 

  • Bicycles with a maximum saddle height of more than 435 mm, measured as the vertical distance from the ground to the top of the seat surface, with the seat in a horizontal position and with the seat pillar set to the minimum insertion mark 

  • Scooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways 

  • Electrically driven vehicles which are intended to be used for travel on public roads, public pathways, or the pavement thereof 

  • Aquatic equipment intended to be used in deep water, and swimming learning devices for children, such as swim seats and swimming aids 

  • Puzzles with more than 500 pieces 

  • Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery over 120 cm long 

  • Fireworks, including percussion caps which are not specifically designed for toys 

  • Products and games using sharp-pointed missiles, such as sets of darts with metallic points 

  • Functional educational products, such as electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision 

  • Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor, such as science equipment 

  • Electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals, unless the electronic equipment or the associated peripherals are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels 

  • Interactive software, intended for leisure and entertainment, such as computer games, and their storage media, such as CDs 

  • Babies’ soothers 

  • Child-appealing luminaires 

  • Electrical transformers for toys 

  • Fashion accessories for children which are not for use in play 

 
It does not apply to the following general categories, 
 

  • playground equipment intended for public use; 

  • automatic playing machines, whether coin operated or not intended for public use. 

  • toy vehicles equipped with combustion engines; 

  • toy steam engines 

  • slings and catapults.

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Appliances burning gaseous fuels 2016/426/EU

This Regulation applies to appliances and fittings. For the purposes of this Regulation, an appliance is considered to be ‘normally used’ where the following conditions are met:

(a) it is correctly installed and regularly serviced in accordance with the manufacturer's instructions;

(b) it is used with a normal variation in the gas quality and a normal fluctuation in the supply pressure as set out by Member States

(c) it is used in accordance with its intended purpose or in a way which can be reasonably foreseen.

 

This Regulation does not apply to appliances specifically designed:

(a) for use in industrial processes carried out on industrial premises;

(b) for use on aircrafts and railways;

(c) for research purposes for temporary use in laboratories.

 

For the purposes of this paragraph, an appliance is considered to be ‘specifically designed’ when the design is only intended to address a specific need for a specific process or use.

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Hot Water Boliers 92/32/EEC

This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no less than 4 kW and no more than 400 kW..

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Explosives for civil uses 2014/28/EU

This Directive applies to explosives for civil uses.  'Explosives' shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations.   
 
This Directive does not apply to:  
 

  • explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police,  

  • pyrotechnical articles,  

  • ammunition .

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Recreational craft 2013/53/EU

This directive applies to the design and construction, 
 

  • Recreational craft and partly completed boats;  

  • Personal watercraft  

  • Certain components 

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Lifts 2014/33/EU

This Directive applies to lifts permanently serving buildings and constructions. It shall also apply to the safety components for use in such lifts. For the purposes of this Directive, ‘lift’ shall mean an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of: 
 

  • persons,  

  • persons and goods,  

  • goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. 

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Cableway installations designed to carry persons 2016/424/EU

This directive applies to cableway installations intended to carry persons and covers installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons. i.e. funicular railways, cable cars and drag lifts. 

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Pyrotechnic articles 2013/29/EU

This Directive establishes rules designed to achieve the free movement of pyrotechnic articles. ‘Pyrotechnic article’ means any article containing explosive substances or an explosive mixture of substances designed to produce heat, light, sound, gas or smoke or a combination of such effects through self-sustained exothermic chemical reactions. It covers Fireworks and Theatrical pyrotechnics and other articles.. 

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Noise Emissions - Outdoors 2000/14/EC

This Directive is related to the levels of sound emission produced by 57 types of machinery that are operated outdoors. Two lists of equipment are included, if included within the first list the equipment is subject to limitations on the sound power level emitted, equipment included in the 2nd list do not have defined power limits but must be marked with the Guaranteed Sound Power Level.
 
Note: Noise associated with "general machinery" (not included in the 57 types) is covered under the requirements of the Machinery Directive. 

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RoHS 2011/95/EU

This Directive restricts placing on the EU market Electrical and Electronic Equipment containing more than the agreed levels of .
 

  • Lead   

  • Cadmium  

  • Mercury  

  • Hexavalent Chromium,  

  • Polybrominated biphenyls,  

  • Polybrominated diphenyl ethers 

Additional materials are currently under investigation including HBCDD (Hexabromocyclododecane), DEHP (Bis (2- ethylhexyl) phthalate), BBP (Butyl benzyl phthalate) and DBP (Dibutyl phthalate).

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Ecodesign requirements for energy-related products 2009/125/EC

This Directive provides for the setting of requirements which the energy-related products covered by implementing measures must fulfil in order to be placed on the market and/or put into service. It contributes to sustainable development by increasing energy efficiency and the level of protection of the environment, while at the same time increasing the security of the energy supply

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