The EMC Directive - 2004/108/EC, A Brief Summary

This section refers to the base text of the EMC Directive 2004/108/EC

Preamble

In the Preamble, the Commission recognises the following points in the decision to adopt the Directive:

1. The existing EMC Directive 89/336/EEC has been the subject of a review under the SLIM process and a need has been identified to complete, reinforce and clarify the framework introduced by that Directive.
2. Member States must ensure that radio communications, electrical supply networks, telecommunications networks and the equipment connected to them are protected from electromagnetic disturbances.
3. Provisions of national law regarding protection from electromagnetic disturbance must be harmonised.
4. Protection against electromagnetic disturbance requires fair and effective obligations to be imposed on operators within the Community.
5. The electromagnetic compatibility of equipment should be regulated to enable a market without internal frontiers to function.
6. That this Directive should encompass both 'apparatus' and 'fixed installations' but with separate provision for each. This is because apparatus is equally likely to be mobile as fixed in one location whereas installations are permanently fixed in one place. Installations are also more likely to be made up of a number of elements of apparatus.
7. Radio equipment and telecommunications terminal equipment should not be covered by this Directive as they are already covered by Directive 1999/5/EC.
8. Aircraft or equipment to be fitted in aircraft should not be covered by this Directive since they are already covered by special rules regarding electromagnetic compatibility.
9. This Directive need not apply to equipment which is electromagnetically benign.
10. This Directive should not deal with safety as that is covered by separate legislation.
11. This Directive regulates which is made commercially available for the first time. Also considered to be apparatus are certain components and sub-assemblies if made available to an end-user (as opposed to a manufacturer).
12. That this Directive is based on the principles of a New Approach Directive and as such equipment is subject to the essential requirements of electromagnetic compatibility. Those requirements are expressed by a series of harmonised standards to be adopted by the various standardisation bodies within the Community (CEN, CENELEC, ETSI).
13. Harmonised standards reflect the state of the art regarding electromagnetic compatibility within the EU. There should therefore be a series of these standards published in the OJ which should raise a presumption of conformity with the relevant essential requirements.
14. Manufacturers of equipment for connection to networks must ensure that there is no degradation of service when the equipment is used normally. Network operators must ensure that the networks are constructed to facilitate connection of such equipment without excessive burden. These factors must be taken into account by the European standardisation bodies when developing harmonised standards.
15. It should only be possible to place equipment on the market when it complies with the essential requirements and carries the CE marking. Although not mandatory, manufacturers may use the services of an independent conformity assessment body.
16. The conformity assessment should require a manufacturer to perform an electromagnetic compatibility assessment of apparatus to determine whether the protection requirements have been met.
17. Where the apparatus has different configurations, it is only necessary to perform a conformity assessment for what the manufacturer deems is the worst case scenario with respect to electromagnetic disturbances.
18. Fixed installations and apparatus may both cause electromagnetic disturbances harmful to each other. Therefore comprehensive sets of essential requirements are required for both cases. It should be possible to use harmonised standards in both cases.
19. Fixed installations need not be subject to CE Marking or require a DOC.
20. While it is not pertinent to apply conformity assessment for apparatus destined to be part of a fixed installation, where it is otherwise not available commercially, such apparatus must not degrade the conformity assessment of the installation into which it is incorporated. If the apparatus is used in several installations, the conformity assessment of each is sufficient.
21. A transitional period is necessary to allow concerned parties to adapt to the new regime.
22. The Directive only goes as far as is necessary to ensure the functioning of the internal market by requiring equipment to present an adequate level of electromagnetic compatibility.
23. Directive 89/336/EEC should be repealed.

Article 1 - Subject Matter and Scope

Article 1(1) states that the Directive regulates electromagnetic compatibility of equipment defined in Article 2 to ensure the functioning of the internal market.

Article 1(2) lists equipment excluded from the Directive as follows:

• Equipment covered by the R&TTE Directive 1999/5/EC
• Aeronautical products, parts and appliances referred in Regulation (EC) No 1592/2002.
• Amateur radio equipment unless the equipment is available commercially. Kits to be assembled by radio amateurs and commercial equipment modified by and to be used by radio amateurs are excluded as they are not considered to be commercially available.

Article 1(3) excludes the following classes of equipment:

• equipment which, by its design, is incapable of generating levels of electromagnetic disturbance capable of interfering with radio and telecommunication equipment.
• equipment which, by its design, will operate in the presence of the electromagnetic disturbances it would experience in normal use.

Article 1(4) excludes equipment where the essential requirements of this Directive are covered more appropriately by other Directives. The exclusion starts from the date of publication of the other Directive(s) in the OJ.

Article 1(5) states that legislation relating to equipment safety is not affected by this Directive.

Article 2 - Definitions

Article 2(1) gives definitions for 'equipment', 'apparatus', 'fixed installation', 'electromagnetic compatibility', 'electromagnetic disturbance', 'immunity', 'safety purposes' and 'electromagnetic environment'.

Article 2(2) includes specific classes of equipment within the term 'apparatus' as defined in 2(1), as follows:

• 'components' or 'sub-assemblies' intended for incorporation into apparatus by an end-user which can cause or be affected by electromagnetic disturbances.
• 'mobile installations' which are a combination of apparatus and other devices intended to used in a range of locations.

Article 3 - Placing on the Market and/or Putting into Service

This Article covers the requirement to only place apparatus on the market which complies with the Directive when operated as intended.

Article 4 - Free Movement of Equipment

Article 4(1) states that Member States shall permit the free movement of goods compliant with this Directive.

Article 4(2) allows a Member State to override the Directive and take the following special measures:

• measures to overcome existing or predicted electromagnetic compatibility problems at a specific site or sites.
• safety measures to protect public telecommunications networks or transmitting/receiving stations used in well defined spectrum situations.

The special measures must be notified to the Commission and to the other Member States and must be published in the OJ.

Article 4(3) allows non-conforming equipment to be demonstrated at exhibitions, trade fairs eta. provided it is clearly marked and is in conformity with this Directive at the point of placing upon the market. Measures must however be taken to prevent electromagnetic disturbances.

Article 5 - Essential Requirements

The essential requirements are stated in Annex I of the Directive.

Article 6 - Harmonised Standards

Article 6(1) gives the definition of a 'harmonised standard' and states that compliance with a harmonised standard is not compulsory.

Article 6(2) states that conformance with harmonised standards raises a presumption of conformity with the essential requirements within the scope of the standards. The implication is that more than one harmonised standard may be necessary to conform to all the essential requirements of the Directive.

Article 6(3) mandates the Member States or the Commission to notify the Committee if a harmonised standard does not fully cover the essential requirements of Annex I. The Committee must deliver a prompt decision.

Article 6(4) lists the decision options for the Commission on receipt of the opinion of the Committee as follows:

1. not to publish
2. to publish with restrictions
3. to maintain the reference in the OJ
4. to withdraw the reference from the OJ

The Commission must inform the Member States promptly.

Article 7 - Conformity Assessment Procedure for Apparatus

Article 7 states that compliance with Annex I requirements shall follow the procedure of Annex II or, at the discretion of the manufacturer, Annex III.

Article 8 - CE Marking

Article 8(1) states that compliant apparatus must bear the CE Marking which shall be affixed by the manufacturer and shall be in accordance with Annex V.

Article 8(2) states that Member States shall prohibit the affixing of erroneous and misleading markings in relation to the graphic form or meaning of the CE Marking.

Article 8(3) prohibits the affixing of any other mark which may impair the meaning or legibility of the CE Marking.

Article 8(4) requires a manufacturer to bring apparatus into conformity if it is discovered by a competent authority that the CE Marking has been unduly affixed.

Article 9 - Other Marks and Information

Article 9(1) requires apparatus to be identified by type, batch, serial number or any other identification information.

Article 9(2) requires apparatus to carry the name and address of the manufacturer or agent.

Article 9(3) requires the manufacturer to provide any safety and installation instructions to ensure the conformity of the apparatus.

Article 9(4) requires apparatus not suitable for use in residential areas to be clearly marked to that effect.

Article 9(5) requires the apparatus to be supplied with sufficient instructions as to its intended use.

Article 10 - Safeguards

Article 10(1) requires a Member State to withdraw from the market and prohibit from use, apparatus which does not comply with the requirements of the Directive.

Article 10(2) requires a Member State to inform the Commission and the other Member States if the action of Article 10(1) is taken. The reasons for the action must be given especially if due to any of the following:

• failure to satisfy the essential requirements by non-compliance with the harmonised standards
• incorrect application of the harmonised standards
• shortcomings in the harmonised standards

Article 10(3) requires the Commission to investigate the actions of Article 10(1) and advise the Member States if the actions are justified or not.

Article 10(4) requires the Commission to refer the actions of Article 10(1) to the Committee if the Member State upholds the measure and it is due to shortcomings in the harmonised standards.

Article 10(5) deals with the situation where the apparatus found to be non-compliant has been subjected to the conformity assessment of a Notified Body (Annex III). In this case, the Member State must take action with regard to the Notified Body and inform the Commission and the other Member States.

Article 11 - Decisions to Withdraw, Prohibit or Restrict the Free Movement of Apparatus

Article 11(1) requires any decision to withdraw equipment from or restrict its placing on the market to state the exact grounds for so doing and to communicate these to the party concerned along with options available within the Member State to remedy the situation. Time limits for such remedies shall also be given to the party.

Article 11(2) gives the party concerned in Article 11(1) the opportunity to state his point of view unless prevented by the urgency due to public interest requirements.

Article 12 - Notified Bodies

Article 12 (1) requires Member States to notify the Commission of the bodies designated as Notified Bodies to carry out the tasks of Annex III and who have been selected according to the criteria of Annex VI. The scope of designation with respect to the apparatus covered by the Directive shall be stated.

Article 12(2) states that bodies complying with the assessment procedure established by the harmonised standards are presumed to meet the requirements of Annex VI. This presumably refers to UKAS accreditation relating to the harmonised product standards and the basic standards which define the tests. The standards involved shall be published in the OJ by the Commission.

Article 12(3) requires the Commission to publish an up to date list of Notified Bodies in the OJ.

Article 12(4) requires Member States to notify the Commission and other Member States when a Notified Body no longer meets the criteria of Annex VI.

Article 13 - Fixed Installations

Article 13(1) states that apparatus placed on the market and which may form part of a fixed installation comes under the Directive. Apparatus which is intended only for a given fixed installation and not generally for the market is exempt provided that the documentation for the apparatus identifies the installation, identifies the electromagnetic compatibility characteristics and precautions to be taken so as not to compromise the conformity of the installation.

Article 13(2) indicates that the competent authorities of a Member State may request evidence of compliance of a fixed installation in the event of complaint. An assessment may be initiated in such cases. If a non-compliance is subsequently established, then appropriate measures may be imposed to achieve compliance.

Article 13(3) requires Member States to identify persons responsible for establishing the compliance of fixed installations.

Article 14 - Repeal

This Article repeals the EMC Directive 89/336/EEC as from 20 July 2007.

References to Directive 89/336/EEC are to be construed as references to this Directive with reference to the correlation table of Annex VII.

Article 15 - Transitional Provisions

This Article sets out a transitional period for conformance to Directive 89/336/EEC until 20 July 2009.

Article 16 - Transposition

Article 16(1) allows Member States to introduce legislation transposing this Directive into national law by 20 January 2007. The Commission must be advised when this is complete and the legislation must be in force by 20 July 2007.

Article 16(2) requires the Member States to communicate the text of the national legislation to the Commission.

Article 17 - Entry into Force

The entry into force of this Directive is the 20th day after publication in the OJ, i.e. 20 January 2005.

Article 18 - Addressees

Requires no further explanation.

Annex I - Essential Requirements Referred to in Article 5

Annex I(1) details the protection requirements which are that equipment shall be designed, having regard to the state of the art, to ensure that:

• generated electromagnetic disturbances are not at a level which prevents radio and telecommunications equipment or other equipment from operating as intended.
• the equipment has a level of immunity to electromagnetic disturbances to be expected from its use such that it cannot operate as intended.

Annex I(2) details the specific requirements for fixed installations which are that:

A fixed installation shall be installed following good engineering practice and respecting the use of its components with a view to meeting the protection requirements. The engineering practices must be documented and held by a responsible person for the service life of the installation.

Annex II - Conformity Assessment Procedure of Article 7, Internal production Control

Annex II lists the following requirements:

1. that a manufacturer perform an electromagnetic compatibility assessment of the apparatus, taking into consideration the phenomena relevant to the apparatus, in order to satisfy the protection requirements. Application of the appropriate harmonised standards is taken as equivalent to performing the assessment.
2. that all normal operating conditions are taken into consideration and that the worst case operating configuration and mode of operation of the apparatus is used for the assessment.
3. that the manufacturer produces technical documentation which respects the requirements of Annex IV and which provides evidence that the apparatus conforms with the essential requirements.
4. that the manufacturer holds the documentation of point (3) for a period of a least ten years from the date of last manufacture of the apparatus.
5. that a manufacturer issue an EC Declaration of Conformity for apparatus which conforms to the requirements of the Directive.
6. that a manufacturer holds the EC Declaration of Conformity for a period of at least ten years from the date of last manufacture of the apparatus.
7. that, if the manufacturer is not established within the Community, the EC Declaration of Conformity and the documentation must be held by whoever places the apparatus on the market within the community.
8. that the manufacturer must ensure that the apparatus is manufactured in accordance with the documentation and with the applicable provisions of this Directive.
9. that the documentation and the EC Declaration of Conformity are drawn up in accordance with Annex IV.

Annex III - Conformity Assessment Procedure Referred to in Article 7

Annex III defines a procedure which comprises the procedure of Annex II with the following additional points as follows:

1. the manufacturer must present the technical documentation to a Notified Body and request the Notified Body to carry out an assessment. The manufacturer must specify to the Notified Body which aspects of the essential requirements are to be assessed.
2. the Notified Body must review the documentation with respect to the requirements that it has to assess to see if they have been met. The Notified Body must issue a statement if it finds that the requirements have been met which confirms this where the statement is confined to those areas the Notified Body has assessed.
3. the manufacturer shall add the statement to the technical documentation.

Annex IV - Technical Documentation and EC Declaration of Conformity

Annex IV(1) - Technical Documentation

This part requires that the technical documentation be sufficiently detailed to enable the conformity of the apparatus to be assessed. The following minimum contents are listed:

Annex IV (2) - EC Declaration of Conformity

This part list the following minimum requirements for the EC Declaration of Conformity:

Annex V - CE Marking Referred to in Article 8

This Annex contains the details of the CE Mark itself, the dimensions and scaling of the mark, where it can be affixed, all the Directives that apply to the apparatus and the caveat that only Directives where transitional provisions are not implemented can be referred to on the apparatus or its documentation.

Annex VI - Criteria for the Assessment of Notified Bodies

The Annex lists the following criteria for the assessment of Notified Bodies:

• availability of personnel and the necessary means and equipment
• technical competence and integrity of personnel
• independence in reporting and verification as required by the Directive
• independence from interested parties directly concerned with the apparatus
• maintenance of professional secrecy
• possession of civil liability insurance unless provided by the law of the Member State

The Annex states that the above criteria shall be subject to periodic verification by the competent authorities of the Member State.

Annex VII - Correlation Table

This Annex provides a correlation between the Articles of the existing EMC Directive 89/336/EEC and the replacement 2004/108/EC as follows:

< Top

Page last updated 28 October 2007