A New EMC Directive 2004/108/EC
Chris Marshman BEng, MPhil, CEng, MIEE, York EMC Services Ltd, University of Yor
The long awaited New EMC Directive was published in the Official Journal of the European Union on 31/12/04, 2004/108/EC.
The EMC Directive 89/336/EEC as amended, became fully effective from 01 January 1996. In 1997 the Commission issued an informal guide to clarify a number of issues and in order to ensure a homogenous application of the Directive. This guide has no legal standing and therefore the Commission identified the EMC Directive as a candidate for the SLIM (Simpler Legislation for the Internal Market) initiative.
During 1998 the SLIM panel presented their opinion, taking account of the 1997 guide and presented a report making 20 recommendations. The Commission endorsed most of these recommendations in its communication (COM(1999)88) to the Council. The Commission then set up a working party to help it draft a proposal for revision of the EMC Directive. During 1999 and 2000 several drafts were produced and circulated for comment and consultation. The new EMCD 2004/108/EC has been drafted taking account of this extensive and wide ranging consultation.
This article aims to identify he main changes to 89/336/EEC, if not specifically addressed then it may be assumed that the provisions of 89/336/EEC are substantially unaltered.
It should be remembered that at this stage this is a Directive to the Member States (MS) and not imple-mented legislation and that the implementations of 89/336/EEC remain legally binding. The New EMCD is to be implemented by the MS by 20 July 2007. Compliance with 89/336/EEC remains valid until 20 July 2009.
For full details the reader is referred to the Official Journal of the European Union (OJEU) L 390 dated 31.12.2004, pp24 - 36.
1.1.1 Objectives of the new EMCD
In general terms 2004/108/EC maintains the objectives of 89/336/EEC and follows the same regulatory concept of the New Approach. It does however seek to:
- Clarify the scope by improved definitions and more clearly defined exclusions
- To treat fixed installations under a different regulatory approach
- To enhance the clarity by more detailed essential requirements
- Clarify the role of harmonised standards
- Simplify the Conformity Assessment procedure by reducing it to a single route
- Cut “red tape” and increase manufacturer’s choice by removing compulsory use of a Competent Body (CB) where harmonised standards cannot be used, but allowing manufacturers to voluntarily use a Notified Body (NB or NoBo)
- Allow better market surveillance through better traceability of the manufacturer, by defined documentation
- Some of the changes reflect the practices used in more recent New Approach Directives, for example the R&TTE Directive, which allows the voluntary use of Notified Bodies.
Chris Marsman, Managing Director, York EMC Services Ltd, subsidiary of the University of York since 1995. Authored ’The guide to the EMC Directive’, EPA Press.
1.1.2 Essential requirements (Article, 5 ANNEX I)
The protection requirements remain unchanged apart from minor changes to the words and apply to equipment. They are however prefaced by the statement that ‘Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:’. The interpretation of this should prove interesting! Specific requirements are identified for ‘fixed installations’ (FI), these are covered in the following sections.
The scope of the EMCD is revised under 2004/108/EEC. Particularly it is identified that:
- equipment within the scope of the R&TTED is excluded from the EMCD. [It is noted that the R&TTED (1999/5/EC) refers to the EMCD and since the new EMCD has different Article Numbers to 89/336/EEC a correlating table is provided in Annex VII.]
- Aircraft and aircraft equipment is excluded as it has been concluded that EMC protection for aircraft is met by aircraft specific regulations, EC No. 1592/2002.
- Benign equipment is specifically excluded, examples given are: wristwatches or greetings cards incorporating electronic devices.
- Equipment within the scope of other more specific Community legislation is excluded eg the Medical Devices Directive.
- The EMCD is defined as not covering safety of equipment, since safety is dealt with by separate community or national legislation eg the Machinery Safety Directive.
1.2 Distinction between Apparatus and Fixed Installations
Apparatus is defined as ‘goods’ which, once they comply with the EMCD can be placed on the market and/or put into service anywhere within the EU (EEA). It is the responsibility of the manufacturer to carry out a conformity assessment to show that the apparatus complies with the ‘essential requirements’ of the EMCD. Apparatus is defined as ‘any finished appliance, or combination thereof [a system] made commercially available as a single functional unit, intended for the end user, and liable to generate EM disturbance, or the performance of which is liable to be affected by such disturbance.’
Apparatus also includes:
“components” or “sub-Assemblies” apparatus under certain conditions if they are made available to an end user.
Compliant apparatus must carry the CE marking.
Residual radio transmitting equipment outside the scope of the R&TTED eg air traffic management equipment [type examination will no longer be required]
1.2.2 Apparatus Conformity Assessment
Compliance with the essential requirements, the protection requirements described in Annex I is demonstrated by the procedure described in Annex II (internal production control) or at the manufactuer’s discretion Annex III. The only difference is that under Annex III a manufacturer may choose to seek an opinion from a Notified Body [the old Competent body].
A manufacturer is required to perform an EMC assessment, in which all relevant EM phenomena are identified and addressed in order to meet the protection requirements. There is a presumption of conformity if all relevant harmonised EMC standards applicable to the apparatus are met; this is equivalent to the EMC assessment.
Where apparatus can take different configurations, the EMC assessment should confirm that the apparatus meets the protection requirements in the configurations foreseeable by the manufacturer as representative of normal use in the intended applications; in such cases it should be sufficient to perform an assessment on the basis of the configuration likely to cause the maximum disturbance and the configuration most susceptible to disturbance.
The conformity has to be demonstrated through ‘technical documentation’ (TD) as described in Annex IV [this is in effect the old Technical Construction File used under 89/336/EEC], regardless of whether or not products are manufactured in compliance with harmonised standards, and attested by issuing a Declaration of Conformity (DoC). The technical documentation may include a report from a Notified Body (Annex III) confirming the compliance of the apparatus with the essential requirements. The TD and DoC should be available upon request to the Competent authorities for up to 10 years after the last date of manufacture of the product.
Compliance with a harmonised standard means conformity with its provisions eg limits and using the methods the standard describes, eg the use of receivers meeting CISPR 16 requirements. Presumption of conformity is limited to the scope of the standard(s) applied and the relevant essential requirements covered by the standard(s).
Equipment must be accompanied by information clearly identifying the product (eg type number, batch code, etc), and the name and address of the manufacturer or his EU authorised representative. Where the manufacturer or authorised representative is outside the EU then the person responsible for placing the apparatus on the EU market must be identified. These provisions are to strengthen the means available to the market surveillance [enforcement] authorities to verify conformance of apparatus and take enforcement measures considered necessary.
The manufacturer will also need to provide information on any specific precautions to be taken at installation, assembly, maintenance or use of the apparatus to ensure that it complies with the protection requirements.
A specific restriction must be explicitly stated where apparatus is not suitable for use in residential areas. This requirement is already in place for ITE complying with EN 55022 ie Class A, but is in effect now extended to all industrial equipment.
Where standards are not available or have only been applied in part by the manufacturer, under 89/336/EEC a manufacturer is required to produce a TCF and have this assessed by a third party, a Competent Body appointed by the Competent authorities. Under the new EMCD involvement of a third-party is no longer obligatory. However manufacturers are required to establish and maintain TD that confirms that the apparatus complies with the protection requirements, whether harmonised standards apply or not [ie a TCF!].
This proposal allows the manufacturer to decide whether to involve a third-party and if so to what extent. The Conformity assessment bodies are to be renamed as Notified Bodies to align them with recent new approach directives and remove anomalies. As for existing CB appointment, manufacturers will be allowed to own a NB if they can demonstrate its independence. Requirements for NoBos are largely as for existing CBs; Article 12 and Annex VI.
1.2.3 Fixed Installations
Fixed installations are identical to the ‘excluded installation’ defined in the 1991 Guidelines and the UK EMC Regulations. Fixed installations are assemblies of various apparatus and other devices, carrying the CE Marking, installed/constructed ‘applying good engineering practices’ (Annex I specific requirements) and intended to be used permanently at a pre-defined location within the EU (eg. electricity distribution networks, telecoms networks, large machinery and assemblies of machinery on manufacturing sites). A fixed installation is not subject to conformity assessment it must, however, meet the protection requirements. The good engineering practices shall be documented and the documentation held by ‘person (s) responsible’ for inspection by the national authorities for as long as the FI is in operation.
The Competent authority may request evidence of compliance of the FI with the protection requirements and when appropriate initiate an assessment. Member States are required to set out the provisions for the identification of the person(s) responsible for the compliance of a FI. If a fixed installation is identified as an unacceptable source of emissions, a Competent Authority can request that the responsible person brings it into compliance with the protection requirements.
Since the constituent apparatus of the fixed installation will conform to the EMCD and this conformance is likely to have been demonstrated by compliance with harmonised standards, then the Commission argue, the EM environment of the fixed installation is defined allowing for addition of apparatus employing ‘rapidly changing technologies’ itself conforming to harmonised standards.
Where apparatus is designed and built for incorporation into a specific fixed installation and is not otherwise commercially available, it is not required to undergo formal conformity assessment procedures. The manufacturer may choose to either follow conformity assessment procedures or to provide accompanying documentation detailing the name and site of the FI and the EMC precautions to be taken for the incorporation of the apparatus in order to maintain the conformity of the installation. The manufacturer must also provide identification of the apparatus and his name and address, or the name and address of his authorised representative [if the manufacturer is outside the EEA] or the person within the Community responsible for placing the equipment on the market.
1.2.4 Transitional Provisions and timescales
Member States are required to implement the new EMCD into regulations by 20 January 2007 and these are to be applied from 20 July 2007(Article 16).
Directive 89/336/EEC will be repealed as from 20 July 2007 (Article 14).
A transition period of 2 years allowed for the introduction of the new requirements. Equipment compliant with 89/336/EEC can continue to be placed on the market until 20 July 2009 (Article 15).
- Manufacturers are required to perform an EMC assessment; application of harmonised standards is deemed to be equivalent to performing the assessment.
- Manufacturers are required to produce Technical Documentation to demonstrate conformity. In effect this is the same as the Technical Construction File, but without the mandatory requirement for a third party Competent Body Report.
- Manufacturers may choose to obtain an independent conformity statement from a Notified Body (new name for the CB); the manufacturer specifies to the NoBo the parts of the essential requirements/protection requirements that the NoBo is to assess.
- Manufacturers are required to make a DoC and to supply information on any specific EMC precautions to be taken when the apparatus is assembled, installed, maintained or used.
- Fixed installations at a pre-defined location are required to conform to the essential requirements but do not have to follow the conformity assessment procedure and therefore do not have to carry the CE marking. The FI will consist of equipment carrying the CE marking installed as specified by the manufacturers; specific equipment not otherwise commercially available can be incorporated, accompanied by documentation which indicate precautions to be taken for incorporation into the FI; the installation shall follow good engineering practices which must be documented.
- The new EMCD 2004/108/EC will have an accompanying Guidance Document, which like the previous 1997 guidelines will have no legal status but is expected to provide some guidance on the interpretation of terms such as ‘state of the art’, ‘good engineering practices’ and perhaps when a large machine can be judged a fixed installation or equipment.
Managing Director, York EMC Services Ltd, subsidiary of the University of York since 1995. Authored ‘The guide to the EMC Directive’, EPA Press.
YES Ltd is a Dti appointed CB under SI 1992 No.2372, and has assessed over 300 TCFs.
Previously 10 years with Brush Traction: thyristor converters for 25kV ac EMUs, Australian XPT, DC switchgear, oil cooled covertors for 25kV ac electric locos.
York Electronics Centre, University of York, 1984 and from 1986 developed commercial EMC Services: EMC Consultancy and Testing. Developed EMC short course and training provision.
Leads the EMC Management Module to the Masters Degree Course in EMC and RF Communications.
Contact details: email@example.com,
tel. +44 (0)1904 434440
YES Ltd Website: www.yorkemc.co.uk