The New EMC Directive - Primary Differences

Introduction

From the date the EMC Directive 89/336/EEC became fully effective (1 January 1996), there has been much confusion and controversy surrounding it to the extent that the Commission has produced a set of guidelines which, at the third attempt, appears to have addressed most of the issues. Because the guide has no legal standing, the Directive was identified as a candidate for review under the SLIM initiative. A report was produced with some twenty recommendations which were taken into consideration by the Commission in communication COM(1999) 88 to the EU Council. We hope to post a copy of this document on the site for reference. As a result of extensive and wide ranging discussion, the new Directive 2004/108/EC was produced.

Although published in the OJ and in force, the new Directive does not require to be implemented into the legislation of the Member States until 20 July 2007. Until then, the current Directive is still in force and will remain so until its repeal on 20 July 2009. To provide background and a simple reference, the main points of the two Directives are presented in preceding sections. The text has been considerably condensed without losing too much of the meaning and intent of the Directives. In the revised version of the Directive, a cross reference table has been produced as Annex VII which shows which Articles relate to the Articles of the original Directive in its amended form.

Some of the complaints of the original Directive, addressed by the revised version were as follows:

1. Lack of clarity in the classification of equipment which was subject to the Directive through the use of the terms 'apparatus', 'systems' and 'installations'. It was, for example, not always clear which type of equipment constituted a system and which an installation, and was a system also an apparatus etc.
2. The process for the presumption of conformity with the Directive was complex, particularly at the time when the number of available harmonised standards was small. It fell to the use of either the generic standards or the use of existing non-harmonised standards with a Technical Construction File (TCF). This introduced the 'Competent Body' into the equation. Competent Bodies were generally attached to test facilities and were appointed by the DTI.
   
   Note: Competent Bodies differ from Notified Bodies which became more prevalent with the introduction of the R&TTE Directive and are used in the place of Type Examination Agencies for the certifying of radio transmission equipment.
   
3. With the exception of the TCF route and the DOC, there was no documentation relating to the manufacturer of the apparatus and no technical information relating to it, its intended use or instructions in order to achieve the protection requirements of the Directive at all, nor was there any requirement to provide this information.

Some of the areas that the new Directive was intended to address were as follows:

1. To redefine the classes of equipment which came under the scope of the Directive and improve the definitions of these equipments. Only two major classes are considered, namely apparatus and fixed installations. Apparatus, however, means finished apparatus commercially available for the first time and can include other categories such as components sub-assemblies if they have a direct function and are made available to an end-user.
2. To segregate out installations as a separate class with their own set of requirements. The reasons cited for this were that apparatus could move freely throughout the EEA whereas fixed installations were immovable and located at predefined locations.
3. To improve the detail of the essential requirements.
4. To simplify the route to demonstrate the presumption of conformity with the Directive by removing some of the options.
5. To redefine the circumstances where an external 'body' is required and put more onus and responsibility on the manufacturer to define the requirements and control the certification process.
6. Add requirements for the manufacturer to keep a technical file containing technical documentation and test records for each apparatus under all circumstances and not just where the original TCF route was followed (i.e. where harmonised standards were not applied or were applied only in part or where the apparatus did not meet the requirements of the harmonised standards).
7. To follow some of the practices used for the demonstration of conformity in more recent Directives such as the R&TTE Directive.

Scope (Article 1)

Article 1 equates to Article 2 of 89/336/EEC.

The scope of the new Directive has been expanded compared to the scope of the original Directive to take into account the introduction of new Directives. In particular the Directive does not apply to the following classes of equipment:

1. equipment covered by the R&TTE Directive 1999/5/EC. (Note however that the R&TTE Directive makes reference to the EMC Directive 89/336/EEC)
2. aeronautical products, parts and appliances covered by Regulation (EC) No 1592/2002.
3. radio equipment used by radio amateurs. This class of equipment was excluded under Directive 89/336/EEC also but has been expanded to include kits to be assembled by radio amateurs and commercial equipment modified by and to be used by radio amateurs. There is however a caveat that the radio equipment and kits to be used by radio amateurs must not be available commercially. If they are, then they come under the R&TTE Directive if they contain transmitters or the EMC Directive if they are purely receiving equipment.
4. equipment which, due to its inherent physical characteristics (referred to generally as electromagnetically benign):
   1. is incapable of generating or contributing to electromagnetic emissions exceeding a level which could impede the operation of radio and telecommunication equipment and other equipment.
   2. will operate without unacceptable degradation in the presence of electromagnetic disturbances consequent upon its use.
5. equipment where the essential requirements (Annex I) are wholly or partly specified by other Directives. Where the Directives which more accurately specify the essential requirements are not yet in force, this Directive shall apply until the date of implementation of these Directives.

This Article, under Article 1(5), states that the Directive does not prevent the application of Community or national legislation which regulates the safety of equipment.

Definitions (Article 2)

Article 2 equates to Article 1 of 89/336/EEC.

Compared to 89/336/EEC, the range of definitions has been extended and some have been redefined slightly as follows:

1. The definition of 'equipment' has been added, meaning any 'apparatus' or 'fixed installation'. Previously 'equipment' and 'installations' (not specifically fixed) were classed as 'apparatus' with the added confusion that they contained electrical and/or electronic components where the term 'component' was not defined. Treatment of components was left to the guidelines.
2. The definition of 'apparatus' has been changed from "all electrical and electronic appliances including equipment and installations containing electrical and/or electronic components" to "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"
3. The definition of 'fixed installation' has been added meaning "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". This definition helps to clarify the confusion between systems which could be fixed and installations which could in theory be moved. Installations were considered exempt from the Directive because they were 'assembled' from a range of constituent parts possibly by a number of different people and so no one person could be held responsible for compliance with the Directive and the signing of a DOC.
4. The definition of 'electromagnetic compatibility' has only changed to reflect the change in terminology to 'equipment'.
5. The definition of 'electromagnetic disturbance' has been added meaning "any electromagnetic phenomenon which may degrade the performance of equipment. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself"
6. The definition of 'immunity' has been added meaning "the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance".
7. The term 'safety purposes' has been added meaning "the purposes of safeguarding human life or property". This term has been added in recognition of the potential hazards of having poor performance with respect to electromagnetic compatibility.
8. The definition of 'electromagnetic environment' has been added meaning "all electromagnetic phenomena observable in a given location".

The term 'apparatus' has been expanded to include the following:

• 'components' or 'sub-assemblies' intended for incorporation into an apparatus by the end user (rather than a manufacturer), which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance.
• 'mobile installations' defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.

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

This Article correlates with Article 3 of 89/336/EEC. It has been simplified slightly with the removal of references to CE Marking and to the conformity procedures of Article 10, and refers to equipment rather than apparatus.

Free Movement of Equipment (Article 4)

Articles 4(1) and 4(2) equate to Articles 5 and 6 of 89/336/EEC respectively.

Article 4(1) is virtually identical in words and meaning to Article 5 of 89/336/EEC. Article 4(2) is very similar to Article 6 of 89/336/EEC but slanted towards the taking into service and use of equipment rather than apparatus. It is emphasised that special measures taken to protect radio transmitting and receiving stations and telecommunications networks are for safety reasons where the equipment is used for safety purposes.

Essential Requirements (Article 5) Including Annex I

As Article 5 refers directly to Annex I for the essential requirements, it is included here. The corresponding part of 89/336/EEC is Article 4 which refers to Annex III for a list of examples of apparatus which must not be affected by electromagnetic disturbances.

The essential requirements of Annex I are divided into two parts covering protection requirements (Point 1) and specific requirements for fixed installations (Point 2). Parts (a) and (b) of the protection requirements in both versions of the Directive say essentially the same. Part (b) in the new version expands the immunity criteria to state that equipment must have a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation.

The new version of the Directive also includes the qualifying statement that equipment shall be so designed and manufactured, having regard to the state of the art, as to ... This replaces the original statement apparatus shall be so constructed that...

It is not clear what regard to the state of the art means, but the Commission recognises that the expertise provided by the bodies tasked with producing the harmonised standards reflects the current state of the art in their areas.

Point 2, covering fixed installations, refers to the use of good engineering practice and respecting the information on the intended use of its components as a requirement for demonstrating conformity. This refers to the requirement for manufacturers to supply sufficient information for equipment covering its use and installation to conform with the Directive. The engineering practices must be included in the documentation and held for the period of time the installation is in service.

Harmonised Standards (Article 6)

Articles 6(1) and 6(2) equate to Article 7(1)(a) of 89/336/EEC and Articles 6(3) and 6(4) equate to Article 8(1).

Article 6(1) defines a 'harmonised standard' as a technical specification adopted by a recognised European standardisation body under a mandate from the Commission (i.e. CENELEC, ETSI etc.). It quotes the procedural Directive 98/34/EC and makes the assertion that compliance with a harmonised standard is not compulsory. The existing Directive does not give a definition of a harmonised standard nor does it state that compliance is not compulsory, although the options available if harmonised standards are not used are given.

Article 6(2) covers the compliance of equipment with relevant harmonised standards with the caveat that the presumption of conformity is limited to the scope of the harmonised standard(s) applied and the relevant essential requirements covered by such harmonised standards.

In the current Directive, Article 7 refers of course to apparatus rather than equipment and gives provision for the use of national standards transposing the harmonised standards provided the reference numbers of these standards have been published in the OJ. Also covered is the situation where no equivalent harmonised standard exists and so the required national standard must be used instead. In order to use national standards instead of harmonised standards, the Directive requires that the text be forwarded to the Commission and the other Member states and the reference numbers be published in the OJ. Article 7 also asserts that Member States accept the apparatus as compliant using the TCF route of Article 10(2), a process which ceases to exist in the same form under the new Directive.

Article 6(3) mandates the Standing Committee to be notified by either a Member State or the Commission if a harmonised standard is considered not to satisfy the essential requirements of the Directive. The Committee must deliver an opinion without delay and action taken by the Commission to either (a) not publish, (b) publish with restrictions, (c) maintain the reference in the OJ or (d) withdraw the reference from the OJ. The Member States must be notified of the decision without delay (Article 6(4)). The text of Articles 6(3) and 6(4) is more or less identical to that of Article 8(1).

Article 8(2) deals with the response of the Commission and the Committee to communication from a Member State regarding national standards. These are not considered under the new Directive and so there is no equivalent Article. This is presumably because there has been sufficient time to replace most if not all of the national standards by harmonised standards which have been transposed into national standards by the Member States.

Conformity Assessment Procedure for Apparatus (Article 7 plus Annexes II and III)

Article 7, in conjunction with Annexes II and III, equates to Articles 10(1) - part of, 10(2) and 10(5) of 89/336/EEC.

Article 7 merely states that the essential requirements of Annex I be demonstrated by the procedures of either Annex II (internal production control) or by Annex III (Annex II plus a Notified Body assessment).

Annex II

Annex II is the replacement process for self certification as specified in Article 10(1) of the existing Directive but with the following differences which expand and clarify the requirements:

1. The manufacturer must perform an electromagnetic compatibility assessment, on the basis of the relevant phenomena, aimed at meeting the protection requirements. This means that the manufacturer is responsible for identifying all the requirements based on the apparatus and its intended use and ensuring that the correct harmonised standards are applied. The implication is that merely applying the product specific standard may not be sufficient but the application of all harmonised standards deemed relevant is sufficient to satisfy the requirements for the assessment.
   
   This differs from the current Directive where a formal assessment is not required and it has been assumed that it is only necessary to meet the requirements of the product standard. There have been cases where meeting the requirements of the product standard have still resulted in the prosecution of a manufacturer because the standard did not fully address the emission characteristics of the apparatus.
   
2. As part of the assessment, the manufacturer must identify all the possible intended uses of the apparatus and all the different configurations which it can take (e.g. through the use of adapters, upgrades or add-on circuit cards etc.). This should even apply to the use of different sources of plug-top power modules. From this analysis, the manufacturer must identify the worst case scenario and use this configuration for the demonstration of conformity with the Directive.
   
   Although not specifically stated in the existing Directive, it was nevertheless taken as good practice for the worst case configuration to be used for compliance.
   
3. The manufacturer must produce technical documentation which provides the necessary evidence that the product conforms to the essential requirements of the Directive. The requirements for the documentation are provided in Annex IV of the Directive. This requirement does not exist in the current Directive under the self-certification process where a manufacturer need only declare conformance to the harmonised standards, affix the CE Mark and produce a DOC. It does however reflect the TCF route to compliance under the old Directive.
4. The requirement to retain the technical documentation for at least ten years after the date the equipment was last manufactured has not changed from the current Directive.
5. The requirement for the manufacturer to produce an EC Declaration of Conformity and to retain this for a period of at least ten years has not changed from the current Directive.
6. The requirement for the person who places the equipment on the market within the EU to retain the documentation at the disposal of the competent authorities, where neither the manufacturer nor the authorised representative is established within the community, has not changed from the current Directive.
7. The requirement for the manufacturer to take steps to ensure that the product is manufactured in accordance with the technical documentation is new in that it is not specifically stated as a requirement in the current Directive. Even with the TCF route to compliance, which should include all the information regarding the design and construction of the product, there is no mandatory requirement for the product to be manufactured in accordance with this information. The Competent Body is not required to verify the manufacturing process, only to assess that there is demonstration of conformity with the essential requirements of the Directive.
8. The requirement to draw up the technical documentation and EC DOC in accordance with Annex IV, is in effect not new. The requirements for the technical documentation reflect the requirements for a TCF, and the EC marking and DOC requirements are present in the current Directive. There are however small differences which will be covered later.

'CE' Marking (Article 8)

Article 8 equates to the second sub-paragraph of Article 10(1) of 89/336/EEC

Although there is a difference in wording between the two Directives, there is no significant difference in meaning and therefore no further comment is required.

Other Marks and Information (Article 9)

Article 9 has no direct equivalent in the current Directive, with the exception of Article 9(5) which equates to Annex III - last paragraph.

This Article requires more detailed information regarding the apparatus and the ability to identify the apparatus and also information on its intended use. In the existing Directive, the only requirement which is common to the new version is the inclusion of instructions as to the intended use of the apparatus. In summary, the requirements are as follows:

1. The inclusion of identification in terms of type, batch and serial number plus any other identifying information (Article 9(1)).
2. The inclusion of the name and address of the manufacturer, authorised representative or person responsible within the community.
3. The inclusion of any specific precautions to be taken when the apparatus is assembled, maintained or used to preserve the conformity to the protection requirements.
4. The inclusion of clear information regarding the restriction of use in residential areas if compliance with the protection requirements is not ensured.

Safeguards (Article 10)

Article 10 has a somewhat tortuous relationship with the current Directive. Articles 10(1) and 10(2) relate to Article 9(1) of 89/336/EEC, Article 10(3) relates to Articles 9(2) and 9(4), Article 10(4) relates to Article 9(2) and Article 10(5) relates to Article 9(3) - easy really!!

The text and meaning of Articles 10(1) and 10(2) is virtually identical to Article 9(1) of the current Directive and therefore requires no further comment.

Article 10(3) deals with the consultation of the Commission to the Member States in the event of a non-compliance and the need to inform the Member States if the measures taken are justified. This action is dealt with under Article 9(2) first paragraph of the current Directive.

Article 10(4) deals with the situation where the measures taken by a Member State are due to shortcomings in the harmonised standards and correlates with Article 9(2) second paragraph of the current Directive.

Article 10(5) is identical in meaning to Article 9(3) of the current Directive, with suitable rewording to cover changes to the conformity assessment procedure.

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

Article 11 is new to the Directive and has no equivalent in the current version. It covers the situation where apparatus has been withdrawn from the market or subjected to the restrictions imposed by the Directive. It states the requirement to notify to the parties concerned without delay of the exact grounds for imposing the restriction, the options available to the parties to remedy the situation under national law, and the time limits to which the remedies are subject.

The Article also makes allowances for the parties concerned to state their points of view unless prevented by the urgency of taking the measure in the interests of public safety.

Notified Bodies (Article 12)

Article 12 equates to Article 10(6) of 89/336/EEC.

In essence the requirements for Notified Bodies under the new Directive are identical to the requirements under the current Directive although the sub-clauses have been rearranged a little. Article 10(6) of the current Directive is referred to in Article 10(5) which is the part dealing with radio transmission equipment. As radio transmission equipment, along with telecommunications terminal equipment and satellite earth station equipment, now come under the R&TTE Directive there is no requirement for Notified Bodies for these products. Under the new Directive however, there is a change from the use of Competent Bodies to vet the TCF (used as a route to conformance under Article 10(2) of the current Directive) to the use of the more formal Notified Body to vet all or parts of the Technical File at the request of the manufacturer. This is the process used under the R&TTE Directive.

Fixed Installations (Article 13)

Article 13 has no equivalent under the current Directive 89/336/EEC as fixed installations were not given separate treatment. It makes the following provisions.

1. Apparatus placed on the market and which may be incorporated into fixed installations must be treated as apparatus under the Directive.
2. If the apparatus is incorporated in a fixed installation and is not otherwise commercially available, then the following provisions are not compulsory:
   1. Article 5 - essential requirements of Annex I.
   2. Article 7 - the conformity assessment procedure for apparatus (Annex II or Annex III).
   3. Article 8 - the CE Marking procedure for apparatus.
   4. Article 9 - other markings identifying the apparatus and supplying information as to its use.
3. Apparatus intended for incorporation into fixed installations and not commercially available must have documentation identifying the fixed installation, its electromagnetic compatibility characteristics and installation information for the apparatus so that these characteristics are not compromised.
4. Although stating that the requirements of Article 9 were not compulsory, Article 13(1) requires that information about the manufacturer or the importer within the Community be included along with information about the product (type, batch, serial number etc) as per Articles 9(1) and 9(2).
5. Where there are indications of possible non-compliance, e.g. by complaints received about disturbances, the competent authorities may request evidence of compliance of the fixed installation and may also initiate an assessment.
6. The competent authorities may then impose measures to bring the installation into compliance.
7. Member States shall have a procedure for identifying the person or persons responsible for establishing compliance with the provisions of the Directive.

Article 13 imposes a series of provisions on equipment which is not controlled at all under the current Directive as installations are exempt. There was confusion as to whether a large collection of apparatus working together was a system or an installation and therefore bounded by the Directive or exempt from it. Under the new Directive this has been clarified considerably but results in the imposition of the protection requirements on hitherto exempt equipment. The inclusion of fixed installations must increase the burden on manufacturers and operators of such installations as they now have to ensure that there is proof of conformance to the essential requirements of the Directive.

Repeal (Article 14)

Article 14 equates to Article 11 of the current Directive and requires no further comment.

Transitional Provisions (Article 15)

Article 15 has no equivalent in the current Directive and does not require any comment. It merely states that equipment which is in conformance with the current Directive may be placed on the market until 20 July 2009.

Transposition (Article 16)

Article 16 equates to Article 12 in the current Directive.

The wording of the new version is slightly different but conveys the same meaning as in the current version of the Directive. The only real difference is the removal of the option to place on the market apparatus which is in conformance with national regulations as this option is no longer appropriate.

Entry into Force (Article 17)

Article 17 has no direct equivalent in the current version. It merely states the date on which the Directive comes into force. This is 20 days after publication in the OJ as opposed to the more normal date of publication in the OJ.

Addressees (Article 18)

Article 18 equates to Article 13 in the current Directive and requires no comment.

Essential Requirements Referred to in Article 5 (Annex I)

Annex I equates to Article 4 and therefore requires no further comment.

Conformity Assessment Procedure Referred to in Article 7 (Annex II and Annex III)

Annex II, in combination with Article 7, equates in part to Articles 10(1), 10(2) and 10(5) of 89/336/EEC and therefore requires no further comment.
Annex III in combination with Article 7, equates in part to Articles 10(1), 10(2) and 10(5) of 89/336/EEC and therefore requires no further comment.

Technical Documentation and EC Declaration of Conformity (Annex IV)

Annex IV only relates to the current Directive in respect of Annex IV(2) which equates to Annex I(1) (EC Declaration of Conformity).

Annex IV(1) defines the requirements for the technical documentation. They are very similar to the requirements for the content of a TCF as detailed in the latest version of the guidelines to Directive 89/336/EEC. The following table offers a comparison.

Annex IV(2) is very closely related to Annex I(1) of the current Directive. The main differences are as follows:

1. The requirement to reference national measures implemented as part of the demonstration of conformity has been removed.
2. The requirement to reference the EMC Directive 2004/108/EC has been added. Although not specifically stated, the requirement to state all applicable Directives was always understood.
3. The description of the apparatus has been expanded to include the identification of the apparatus including type, batch, serial number etc. It should be noted that a DOC can cover several products.
4. The requirement for the name and address of the manufacturer, or the representative within the EU, has been added. This was always understood to be a requirement although not specifically stated except in guidelines and samples of a DOC.
5. The requirement for a dated reference to the standards used has been added. It was always understood that if no date is given then the latest version is in effect. However, with standards changing at the rate they are, the only way of ensuring that the conditions under which the presumption of conformity was demonstrated is to provide the precise dated version of the standards used.
6. The requirement to date the DOC has been added. This has always been understood to be a requirement!!.

'CE' Marking Referred to in Article 8 (Annex V)

Annex V equates to Annex I(2) of 89/336/EEC.

The two 'versions' are virtually identical in layout and identical in meaning and therefore require no further comment.

Criteria for the Assessment of the Bodies to be Notified (Annex VI)

Annex VI equates to Annex II of the current Directive. The two versions are identical and therefore require no comment.

Conclusions

The new version of the Directive has gone a long way to address problems associated with the current version. The classes of equipment covered have been reduced, partly by the introduction of other Directives, and better defined. The means of demonstrating conformity with the essential requirements have been reduced and simplified, partly as a result of an increased number of harmonised standards covering the extensive product range and the consequent removal of reliance on national provisions. Better control over the technical aspects of the product have been introduced and there is an increased burden on manufacturers to produce the additional technical information required.

In summary therefore:

1. Manufacturers must use harmonised standards where they exist and are appropriate. Manufacturers must also perform an EMC assessment relating to the apparatus although evidence of the correct and appropriate application of the harmonised standards is deemed to be equivalent to performing the assessment.
2. Manufacturers must prepare a technical file which contains sufficient information to demonstrate conformity. The file does not have to be vetted by a Competent Body as is the case for the TCF under the current Directive. The file, however, may be vetted in whole or in part by a Notified Body at the request of the manufacturer. The role of Competent Body will disappear under the new version of the Directive.
3. Manufacturers are required to produce a Declaration of Conformity which in itself is not new. However there are additional stipulations which were most likely taken for granted under the current system. In particular manufacturers must provide information on any specific precautions that need to be taken in respect of assembly, installation and use of the apparatus to maintain its EMC performance.
4. Fixed installations, which were previously exempt, now have to conform to the essential requirements but to not have to follow the assessment procedure and therefore do not require a CE mark. It is reasonable to produce technical documentation and test results for a room or factory full of equipment, but does leave one wondering where to affix the CE Mark!! Fortunately this is not a requirement.

The current version of the EMC Directive required extensive explanatory guidelines, it will be interesting to see if the revised version requires such guidelines and whether they will be so extensive.

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Page last updated 28 October 2007