CE marking, essential requirement to sell in Europe

 

The new approach is a regulation method set by the European Community in order to reconcile the legislation of the different Member State, especially for electrical and electronic products.

 

There are 3 objectives :

• Ensure the free circulation of the product within the internal market of the European Union
• Guarantee the safety of consumers and users,
• Restrict the environmental impact of the product placed on the market.

The "New Approach" directives leave to the manufacturer the choice of the approval procedure to certify the product conformity, and especially the use of harmonized European standards. It is different from the previous approaches which impose strict and precise technical means.

 

 

Placing on the market means making an equipment available for the first time on the Community market with a view to its distribution or use within the Community whether for reward or free of charge.

 

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Scope

 

The directive concerns equipments, it means apparatus and any finished appliance or combination thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance fixed installations [a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location]. Member States shall take all appropriate measures to ensure that equipment is placed on the market and/or put into service only if it complies with the requirements of this Directive. Besides, Member States shall not impede, for reasons relating to electromagnetic compatibility, the placing on the market and/or the putting into service in their territory of equipment which complies with this Directive.

 

The EMC directive shall not apply to:

• equipment covered by directive 1999/5/EC related to radio and telecommunications terminal equipment,
• aeronautical products, parts and appliances as referred to in regulation 1592/2002/EC,
• radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution and Convention of the ITU,
• equipment for which the inherent nature is incapable of generating or contributing to electromagnetic emissions to interfere with other equipments and which operates without unacceptable degradation in the presence of electromagnetic disturbance (ex : passive antenna, quartz watch, battery,wire, ...)
• equipment covered by specific directive setting EMC requirements (ex : medical devices, automotive vehicle related to rules of the road, farm and forestry tractors, ...)

 

 

 

Essential requirements

 

Some clauses of the directive are applicable to apparatus as well as to fixed installations. These are mainly clauses on essential requirements in terms of general electromagnetic protection. They stipulate that equipments shall be design and manufacture in order to guarantee that :

• electromagnetic disturbance generated will not exceed the level allowing radio and telecommunication equipment to operate as intended,
• they have an immunity level to electromagnertic disturbance which allow to operate without unacceptable degradation upon its intended use.

 

 

Conformity assessment

 

There is a difference between apparatus and fixed installations more particularly for what concerns the procedure of conformity assessment to the essential requirement of the directive.

 

For apparatus, it is to the manufacturer to assess the conformity to the requirement, following a specific procedure. Conformity shall be demonsatrate by a technical file and certified by a conformity declaration. Complying apparatus which can be placed into the european market shall affix the CE marking.

 

Manufacturer are free to ask for Notified Body services. Notified Body may deliver qualified notice to confirm the essential requirements to the directive are met.

 

For fixed installations (as example, electricity supply network and telecommunications network) such formal procedure to assess the conformity are not appropriate. They don't require to affix the CE marking.

However, these fixed installations shall be assembled following good engineering practice and documentation shall be available to national competent authorities.

When some element indicate the non-conformity of a fixed installation (when there are complain about disturbance generated), competent national authorities may ask for the conformity proof, or may proceed to an assessement. When a non-conformity is established, competent authorities may impose appropriate measure in order for the fixed installation to comply with the essential requirements.

 

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Objective and scope

 

Provisions of the directive aim to harmonise the laws of Member States relating to the design and manufacturing of electrical equipment designed for use within:

• a voltage rating [the voltage rating refers to the voltage at the input and at the output of the equipment, and not the voltage inside the equipment] of between 50 and 1000 V for alternating current,
• a voltage rating of between 75 and 1500 V for direct current.

Some electrical equipment are outside the scope of this directive. These are equipment covered by other european directives (radio equipment and telecommunications terminal equipment, electrical medical device or electricity meter as example), but also plugs and socket outlets for domestic use, electric fence controllers and specialised electrical equipment, for use on ships, aircraft or railways.

 

 

 

Essential requirement

 

Design and manufacturing of electrical equipment are subjected to essential requirement in terms of saferty.

The directive sets out the "safety objectives" which are the essential requirements. The requirements includes electrical, mechanical and chemical risks, but also tacitly noise and vibration aspects linked to health.

 

 

Conformity assessment

 

The manufacturer of electrical equipment or its mandatory shall ensure and declare that electrical equipment complies with the provisions of the directive

The compliance of electrical equipment to the safety requirement of the directive are presumed when equipment has been produced in accordance with :

• european harmonised standards applicable to the product.
• international rules published by the International Commission on Rules for the approval of electrical equipment (CEE) or by the International Electrotechnical Commission (IEC), if the european harmonised standards have not been set or published.
• without any european harmonised or international standards, the directive forecast the mutual recognition of the national standards of the manufacturer's Member States.
  

The conformity assessment procedure to the directive has three steps. First, the manufacturer may submit a technical report. Then the manufacturer or its authorised mandatory established in the community, present a conformity declaration. And the electrical equipment affixed the CE marking before its placing on the market.

 

The article 8 of the Low Voltage Directive describe the role and function of the Notified Body.

In case of contestation from the market supervisory authorities, a report provided by a Notified Body is consider as a proof. The service of the Notified Body may intervene before the report made up which will be the base of the conformity declaration.
It can be used in case of lack of technical standards applicable to a new product (the Notified Body set the test campaign required to check the conformity) or when the conformity declaration is based on the checking of the essential requirements without using the applicable harmonised stanadards. In this last case, the manufacturer shall join to the technical report a description of the solutions used to comply with the safety requirements of the directive and the Notified Body intervene to validate these solutions.

 

 

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Scope

 

Except for radio equipment and for [product or relevant component capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication]telecommunications terminal equipment[a product or component which is intended to be connected directly or indirectly by any means to interfaces of public telecommunications networks], the directive is also applicable when an apparatus [any equipment that is either radio equipment or telecommunications terminal equipment or both] :

• incorporates, as an integral part, or as an accessory, a medical device within the meaning of Directive 93/42/EEC concerning medical devices ;
• incorporates, as an integral part, or as an accessory an active implantable medical device within the meaning of the directive 90/385/EEC relating to active implantable medical devices ;
• constitutes a component or a separarte technical unit of a vehicle within the meaning of Directive 72/245/EEC relating to the radio interference of vehicles ;
• constitutes a component or a separate technical unit of a vehicle within the meaning of directive 92/61/EEC relating to the type-approval of two or three-wheel motor vehicles.

 

This directive shall not apply to apparatus exclusively used for activities concerning public security, defence, State security and the activities of the State in the area of criminal law.

other equipment not covered by this directive :

• radio equipment used by radio amateurs unless the equipment is available commercially ;
• equipment falling within the scope of directive 96/98/EC on marine equipment ;
• cabling and wiring ;
• receive only radio equipment intended to be used solely for the reception of sound and TV broadcasting services ;
• products, appliances and components within the meaning of Council regulation (EEC) nº 3922/91 in the field of civil aviation.

 

 

 

 

Essential requirement and european harmonised standards

 

Member States shall ensure that apparatus is placed on the market only if it complies with the appropriate essential requirements of this directive when it is properly installed and maintained and used for its intended purpose.

The following essential requirements are applicable to all apparatus :

• the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in the Low Voltage Directive concerning electrical device to be used with limited voltage (but with no bottom line voltage) ;
• the protection requirements with respect to electromagnetic compatibility contained in the EMC directive ;
• radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.

 

 

Conformity assessment

 

The directive precise the conformity assessment procedure to follow for the different types of equipment, depending on the choice of the manufacturer.ssentielles à suivre pour les différents types d'équipements selon le choix des fabricants.
Member States shall notify the Commission of the bodies which they have designated to carry out the relevant conformity assessment procedure.

At the choice of the manufacturer,compliance of the apparatus with the essential requirements may be demonstrated using the procedures specified in Directive 73/23/EEC and EMC Directive respectively, where the apparatus is within the scope of those Directives.

Where an apparatus complies with harmonised standards, Member States presume that the requirements of the directive are respected.

Where harmonised standard applicable to radio equipment don't covered the entire essential requirement, the responsible person for placing product on the market shall ask for a Notified Body notice. The Notified Body has 4 weeks to issue an opinion about the test to be carrying out to check the conformity to the essential requirement. The procedure set the issue of a technical file. This file must be kept by the person responsible for placing the apparatus on the market at the disposal of the relevant national authorities.

 

 

 

Informations and notification

 

Member States shall ensure that the manufacturer or the person resonsible for placing the apparatus on the market provides information for the user on the intended of the apparatus, together with the declaration of conformity.

Where is concerns radio equipment, such information shall be sufficient to identify on the packaging and the instructions for use of the apparatus the Member States or the geographical area where the equipment is intended to be used.

Where it concerns telecommunications terminal equipment, such information shall be sufficient to identify interfaces of the public telecommunications networks to which the equipment is intended to be connected.

 

 

 

CE marking and restrictions

 

Apparatus complying with all relevant essential requrements shall bear the CE marking. Apparatus shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer or the person responsible for placing the apparatus on the market.

If a Notified Body has been consulted, the CE marking shall be accompanied by the identification number of the notified body.

In the decision 2000/299/CE of 6 April 2000, Commission has established the initial classification of radio equipment and telecommunications terminal equipment which can't be used everywhere in the Community (case of non-harmonised national frequency plans). This type of equipment shall bear near the Ce marking a relevant warning mark.

 

 

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Context and scope

 

The EuP directive does not create immediate legal binding requirements for the manufacturer.

Compulsory requirements come with the implementing measures.

 

 

 

 

Implementing measures

 

Coming from self-regulation measures, they should only be adopted

• to confirm technological measures and measures kept (by professional field) to improve environmental performances of the product
• to accelerate these measures if there is no consensus (or not enough quickly) between concerned parts

 

Product families which can be concerned are those which :

• represent a significant business volume in the Community (indicative limit of 200 000 units /year) ;
• have significant environmental consequences considering the quantities placed on the market ;
• have a high potential of improvement without generating high cost compensation for manufacturers.

See the 24 families potentially concerned

 

The EuP directive also concerned the energy consumption of equipment in stand-by or off-mode.

This executive measure concerns household electrical appliances,information processing system for household use, electronic products for household use, toys, sport and leisure equipments,...

See the requirements

 

 

 

 

Essential requirements

 

There are 2 types :

• Generic requirements aim to improve the global environmental performance. They are based on the ecological profile of the product and they don't impose fixed limit value.
  Environmental characteristics like : selection and use of raw material, packaging, transport, distribution, installation and maintenance, end of life, expectable consumption of raw and energy, air, water and ground emission, quantity of waste generated, possibility for re-use or recycling, use of substance classified as hazardous.
• Specific requirements set up precise environmental charactéristics, quantified and measurable with limited value.

 

 

Conformity assessment

 

Before placing an EuP covered by implementing measures on the market, the CE marking shall be affixed and supported by :

• a conformity assessment which ensures that the product is complying with all the requirement of the applicable implementing measures ;
• a technical file with a general description of the product and its use, the results of the impact assessment, the ecological profile, the element concerning the design of the product and related to the eco-design requirements.

 

 

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Yes, because a product may generate different types of risks.
As example, an electronic control appliance powered by a network is covered by :

• the "machinery" directive for mechanical risks,
• the "electromagnetic compatibility" directive for electromagnetic disturbances it can cause or which can affect the product,
• the "low voltage" directive for electrical risks.

 

NO. A single CE marking attests the conformity to the essential requirements of the applicable directives. However, in the conformity declaration, the manufacturer ot its mandatory shall specified and named the directives which their product comply with. They also have to prepare for each directive the document to prove this marking (technical file,...).

 

The CE marking is mandatory at the first placing on the market of the concerned product. "First placing on the market" means making a product available for the first time on the Community market with a view to its distribution or use within the Community. CE marking is not mandatory for second-hand products placing on the market before the directive entry into force, nor for products shown during fairs and trade show, nor for products exclusively intended for export markets.

 

The person responsible for the placing on the market, it means the manufacturer, its mandatory establish in the European Community or the importer.

 

Yes, according to the mutual recognition principle, it is possible to ask any notified body located in one of the EU contries (for other country please check if there are mutual recognition agreement).
The NANDO-IS base allows a search by directive, product or contry of european notified body as well as body from other country (like future Member States).

 

In the frame of the new approach, harmonised standards translate the essential requirements of a directive in technical instructions.
Compliance with european harmonised standard provide a presumption of conformity with the essential requirements of the relevant directive.
These standards are named harmonised when their references are published in the Official Journal of the European Union (OJEU).
In the frame of it mission, a notified body may recommend the use of a standard plan to integrate in the conformity demonstration the requirements which will be to follow as soon as the standard will be harmonised.

 

This may be for example for custom products or very innovative products, or products with new technologies.
In this case, the procedure to follow depends on the directives.
Some directives forecast the use of a conformity assessement body (Notified Body), some authorize the manufacturer to use non european standard (international standards as example), or to build its own standard in which the manufacturer will describe the technical solutions set in place to achieve the essential requirement.
Don't hesitate to contact a notified body.

 

For each of these directives, the person responsible for the CE marking have to
1° follow the conformity assessment procedure describes in the directive
2° gather documents testifying the product conformity : technical instructions, CE conformity declaration, certificate, report and/or qualified notice from a botified body
3° affix the CE marking

 

There is no single answer. Time may vary depending on : the number of applicable directives, the choosen procedures, the technical documents given by the manufacturer, or if the requirements have been taken into account from the design of the product*.
* Essentail to avoid extra time and costs.

CE marking is mandatory and so is part of a certification process. The legislator has excluded the obligatory use of a third part body for the conformity demonstration and keep the internal checking of the production to the manufacturer and without obligation to use a third party.
We talk about self certification in the frame of the CE marking in which the the responsibility of the CE marking is not given to a third body in opposition to a certification mark.

 

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