Explanatory Memorandum to COM(2002)759 - Approximation of the laws of the Member States relating to electromagnetic compatibility - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)759 - Approximation of the laws of the Member States relating to electromagnetic compatibility. |
|---|---|
| source | COM(2002)759  |
| date | 23-12-2002 |
This proposal provides for a revision of Council Directive 89/336/EEC of 3 May 1989 on the approximation of laws of the Member States relating to electromagnetic compatibility (EMC Directive).
Directive 89/336/EEC has been amended by Directives 91/263/EEC, 92/31/EEC and 93/68/EEC. It became applicable on a voluntary basis on 1 January 1992. Since 1 January 1996 all electrical and electronic apparatus concerned must satisfy the requirements of the EMC Directive before being placed on the market within the European Community.
The objective of the EMC Directive is to guarantee the free movement of electrical equipment whilst creating an acceptable electromagnetic environment within the EU. The Directive therefore seeks to ensure that electromagnetic disturbances produced by electrical equipment do not affect the correct functioning of other such equipment, including telecommunication and electricity distribution networks, and that such equipment has an appropriate level of immunity to electromagnetic disturbances so that it can function as intended.
Since 1992 considerable experience has been gained with the application of the EMC Directive. In 1997, due to the need to clarify a number of issues and in order to ensure homogeneous application, the Commission issued an informal guide to the application of the Directive prepared with the assistance of national authorities and other relevant stakeholders.
Contents
- 2. BACKGROUND AND KEY ELEMENTS FOR THE REVISION
- 2.1. The SLIM process
- 2.2. Objectives of the revision
- 2.3. Content of the revision
- 2.3.1. Distinction between apparatus and fixed installations
- 2.3.2. Essential requirements
- 2.3.3. Conduct of conformity assessment for apparatus under the sole responsibility of the manufacturer
- 3. LEGAL BASIS
- 4. PROPORTIONALITY AND SUBSIDIARITY
- 5. CONTENT OF THE PROPOSAL
- 5.1. Chapter 1: general provisions
- 5.1.1. Article 1 - Scope
- 5.1.2. Article 2
- 5.1.3. Article 6
- 5.2. Chapter 2: apparatus
- 5.3. Chapter 3: fixed installations
- 5.4. Chapter 4: final provisions
- 5.5. Annex I: essential requirements
- 5.6. Annexes II to IV
- 5.7. Annex V
- 6. CONSISTENCY WITH OTHER COMMUNITY POLICIES
- 7. EXTERNAL CONSULTATIONS
- 8. EVALUATION
The EMC Guide has made a substantial contribution towards homogeneous application of the Directive. But it is informal and therefore cannot provide legal certainty to resolve the issues.
In 1997, as a first step towards providing clarity, and giving legal weight to agreed solutions, and also to reduce unnecessary regulatory burdens on industry, the Commission, together with Member States, identified the EMC Directive as a candidate for the SLIM (Simpler Legislation for the Internal Market) initiative.
During 1998 a panel composed of experts from Member States and stakeholders reviewed the Directive. At the end of this process the panel gave their opinion that for certain aspects its application was problematic, and recommended that it should be revised taking due account of the 1997 EMC Guide.
The Recommendations of the SLIM panel focussed on the following aspects:
-basic principles;
-treatment of large machines and installations;
-conformity assessment procedures;
-standards;
-EMC requirements in other Directives;
-consideration of the solutions provided by the EMC Guide.
In its Communication to the European Parliament and the Council (COM(1999)88), the Commission endorsed most of the SLIM panel's recommendations. The Commission then set up a working party consisting of experts from national administrations and relevant stakeholders (industry, network operators, conformity assessment and standardisation bodies, users) to help the Commission draft a proposal for revision of the Directive. During 1999 and 2000 several drafts were considered by this group and, in order to ensure transparency, were placed on the Commission web-site to attract comments from other interested parties. The current proposal for revision of the EMC Directive has been drafted taking due account of comments made during this extensive and wide-ranging consultation.
In general terms the proposal for revision maintains the objectives of the existing EMC Directive, and its field of application. It follows the regulatory concept of the New Approach and, for the most part, uses concepts already found in the current Directive.
The text of the proposal is recommended in pursuit of the following objectives:
-Clarification of scope by means of improved definitions, more clearly defined exclusions and inclusion of ready-made connecting devices;
-Treatment of fixed installations by means of a more appropriate regulatory regime;
-Enhanced clarity through more detailed essential requirements;
-Clarification of the role of harmonised standards;
-Simplification of the conformity assessment procedure, reduced to a single procedure for apparatus;
-Cutting 'red tape' and increasing manufacturers' choice by abolishing compulsory third-party intervention where harmonised standards have not been applied but allowing in all cases for voluntary involvement of conformity assessment bodies for apparatus;
-Improved market surveillance through better traceability of the manufacturer.
The structure and text of the proposal have been adapted to the state of the art introduced by other New Approach Directives adopted since 1989.
In view of these modifications, it is proposed that Directive 89/336/EEC be replaced by the proposal below.
In accordance with the New Approach concept, the proposal for revision lays down the electromagnetic compatibility requirements for electrical equipment which must be satisfied before it is placed on the market and/or put into service.
Equipment is the key term of reference to which the Directive applies. It includes two sub-sets: apparatus and fixed installations. A number of provisions of the Directive apply in common to both apparatus and fixed installations. This is the case for generic electromagnetic protection requirements, and for the principle that these protection requirements can be given technical expression in voluntary harmonised standards. Harmonised standards are to be adopted by the European standardisation bodies CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute). Harmonised standards must be elaborated on the basis of remits addressed by the Commission to the European standards bodies in accordance with the procedure laid down in Directive 98/34/EC. Harmonised standards, once published in the Official Journal of the EC, confer presumption of conformity with the essential protection requirements of the Directive, in so far as they are covered by them.
One of the main reasons for the revision of the EMC Directive is the need for different regulatory regimes tailored for apparatus and for fixed installations. Apparatus means goods which, once they comply with the Directive, can be placed on the market and/or put into service anywhere within the European Union. It is therefore up to the manufacturer to carry out, under his responsibility, a conformity assessment to show that the apparatus complies with the requirements of the Directive. Apparatus which complies must bear the CE marking.
However, the concept of a conformity assessment procedure and the affixation of the CE marking are not felt to be appropriate for fixed installations. Fixed installations are assemblies of various apparatus and other devices installed and intended to be used permanently at a pre-defined location within the EU (e.g. electricity distribution networks, telecommunication networks, large machinery and assemblies of machinery on manufacturing sites). The justification for a different regime is that such fixed installations may be the subject of continuous alterations, coupled with the difficulties experienced in applying a formal conformity assessment procedure to such an installation, due to its size, its complexity, undefined and variable external EMC conditions, operational needs etc...
This viewpoint is given additional weight by the fact that competent authorities can, following the identification of a fixed installation that might be the source of an unacceptable emission, request that the responsible person brings it into compliance.
During the consultation process it was found that stakeholders strongly support the application of a particular regime for fixed installations within the Directive. Such installations, as a source or object of potential electromagnetic disturbances, are part of the electromagnetic environment.
In addition, it is in the interest of the free circulation of equipment to establish a coherent set of harmonised EMC requirements for equipment, including fixed installations, which provide a coherent set of rules defining all the aspects of an acceptable electromagnetic environment.
Furthermore, the rapidly changing technologies used in such installations need to be provided with a solid regulatory base and harmonised standards as tools to ensure that they can be fully exploited throughout the EU.
The proposals lays down in Annex I a coherent and comprehensive regime of essential requirements which equipment, i.e. both apparatus and fixed installations, must comply with.
The essential requirements consist of generic protection requirements covering the emission and immunity characteristics of equipment. In addition, more specific requirements are given separately for apparatus and for fixed installations.
In the case of apparatus the manufacturer will need to perform an electromagnetic compatibility assessment, in which all relevant phenomena are identified and addressed with a view to meeting the protection requirements. If all relevant harmonised EMC standards applicable to a given apparatus are met, it is deemed to have met the obligation for an EMC assessment.
As a general rule, apparatus will be required to meet the protection requirements without recourse to additional external devices (such as filtering or shielding) placed separately on the market. Apparatus must be accompanied by information enabling the product to be clearly identified (e.g. by means of type number, batch code, etc.) and indicating the name and address of the manufacturer. Where the manufacturer or his authorised representative is not established within the EU, the person established within the EU responsible for placing the apparatus on the market will be indicated. These provisions aim at strengthening the means available to market surveillance authorities to verify the compliance of apparatus and to take any enforcement measures considered necessary.
The manufacturer will need to provide information on any specific precautions to be taken before installation, assembly and use of the apparatus to ensure it complies with protection requirements.
In cases where apparatus will not comply with the protection requirements in residential areas, this restriction of use must be indicated. This requirement has its origin in the discussions of the SLIM panel, which came to the conclusion that the revised Directive should define certain classes of EMC environment and the conditions for intended use. The feedback from the consultation process following the SLIM recommendations did not confirm this necessity. Even so, when because of its EMC characteristics an apparatus is not suitable for use in residential areas, it was considered essential to indicate explicitly such a restriction of use.
2.3.3. Conduct of conformity assessment for apparatus under the sole responsibility of the manufacturer
In cases where the manufacturer has not applied harmonised standards or has applied them only in part, the current EMC Directive requires a technical construction file including a technical report or certificate issued by a competent body.
Harmonised standards now exist for almost all apparatus. The self-declaration procedure by means of applying harmonised standards is now used in 95% of cases. In practice, bodies which are also competent bodies are often asked to confirm compliance with harmonised standards. The proposal will make the manufacturer's obligations clearer. Experience has also shown that the non-application of harmonised standards cannot be considered as an appropriate criterion for requiring the involvement of a third party. Therefore, the proposal removes the obligation to rely on a competent body. This represents a streamlining of the Directive. However, in accordance with Council Decision 93/465/EEC on the modular concept, the manufacturer must always establish and maintain technical documentation which confirms that the apparatus complies with the essential requirements, whether harmonised standards apply or not.
The proposal will leave with the manufacturer the decision whether to involve a third party, and if so to what extent. As in other New Approach Directives, conformity assessment bodies will be called 'Notified Bodies'. This change of name will not, however, imply any additional new re-assessment of bodies already designated under the current Directive.
Nor will this change of name affect the current sectoral practice that, under certain conditions, an assessment body owned by a manufacturer may become a Notified Body for the purpose of the EMC Directive.
This proposal is based on Article 95 of the EC Treaty. It aims at ensuring the free circulation of equipment throughout the European Internal Market by laying down harmonised electromagnetic compatibility requirements. Article 95 also covers the EMC requirements for fixed installations. The functioning of the Internal Market can only be ensured if both apparatus and fixed installations are designed and constructed in accordance with a coherent and homogeneous set of EMC requirements.
The proposal has relevance for the European Economic Area.
The main objective of the proposed action is to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty, this measure is proposed since the objectives laid down above cannot be sufficiently achieved by Member States acting alone and can therefore, by reason of their scale and effects, be better achieved at Community level.
Directive 89/336/EEC follows the principles set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards. In accordance with that approach, the essential requirement laid down in this proposal are given technical expression by harmonised European standards, to be adopted by the various European standardisation bodies. During its ten years of applicability, the directive has proven its accordance with the principle of proportionality as set out in Article 5 of the Treaty. Based on this experience, this proposal follows exactly the same principles, and thus, does not go beyond what is necessary in order to achieve those objectives.
The main body of the revision proposal consists of four chapters:
-Chapter 1: general provisions;
-Chapter 2: apparatus;
-Chapter 3: fixed installations;
-Chapter 4: final provisions.
The provisions of the proposal are set out in further detail where they substantially deviate from the current Directive.
Radio and telecommunication terminal equipment covered by Directive 1999/5/EC is excluded from the scope of the EMC Directive. However, the R&TTE Directive (1999/5/EC) refers explicitly to a number of specific provisions of the EMC Directive and renders them applicable. Due to the modification of the EMC Directive, changes in referencing to the EMC Directive can be identified with the help of the correlation table in Annex VI of the proposal.
Aircraft and equipment fitted into aircraft will be explicitly excluded from the EMC Directive. This exclusion is a result of the conclusions of a study carried out by CENELEC under a mandate from the Commission and with the help of experts on EMC and aircraft specifications. Aircraft can be considered as a very specific environment with regard to EMC. The needs of protection in terms of EMC can be entirely met by specific regulations relating to aircraft.
Furthermore, the EMC Directive shall not apply to equipment which, due to the inherent nature of its physical characteristics, is from an EMC point of view, benign. For example, this might be the case for certain wristwatches or greeting cards incorporating electronic devices.
This Article contains legal definitions for the most important technical terms, such as apparatus, fixed installations and electromagnetic compatibility. It should be noted that only components or sub-assemblies, which are intended to be incorporated by the end-user and are either liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance are deemed to be apparatus in terms of the Directive.
Ready-made connecting devices intended for the transmission of signals are, under certain conditions, deemed to be apparatus and subject to the essential requirements, the conformity assessment regime and the CE marking provisions of the Directive. It should be noted that this does not apply to cables as such but only to ready-made devices placed on the market separately from apparatus. A technical study carried out for the Commission as well as the practical experience of Member States confirmed the need to include ready-made connecting devices within the scope of the Directive. By such an inclusion, national regulations potentially affecting the free circulation of such devices will be avoided.
This article explains that equipment, to which harmonised standards have been applied, shall benefit from a presumption of conformity to the essential requirements. Harmonised standards become the further technical expression of the essential requirements for equipment falling under their scope. The coverage of fixed installations by the essential requirements and harmonised standards will prevent national regulations on EMC matters, which currently go beyond the level of specification detailed in the Directive.
According to Article 7, manufacturers have to assess, under their own responsibility, the compliance of apparatus with the essential requirements, regardless of whether or not products are manufactured in compliance with harmonised standards. The conformity has to be demonstrated through a technical file and attested through the issue of a declaration of conformity. The technical file and the declaration of conformity shall be made available to the Competent Authorities, upon request, during ten years after the last apparatus has been manufactured. The involvement of a notified body is left to the discretion of manufacturers. Notified bodies may issue certificates confirming full compliance with the essential requirements or only in part with given requirements, upon a manufacturer's request (see section 2.3.1). The procedure for the notification of notified bodies and the publication provisions (Article 11) generally follow the requirements to be found in other New Approach Directives.
Given the advent of the R&TTE Directive (1999/5/EC), which now provides the regulatory EMC provisions for almost all radio transmitters, it is considered disproportionate to continue a mandatory third-party regime for those remaining within the scope of the EMC Directive. Residual radio transmitting equipment remaining within the scope will therefore be subject to the same provisions as other apparatus.
Article 12 provides for a particular regime for fixed installations.
Where such installations are built or modified using apparatus which are generally available on the market, the provisions for such apparatus are detailed in Chapter 2. However, if the apparatus used are specifically designed for a given fixed installation and are otherwise not commercially available, the manufacturer may decide whether or not to follow the provisions of Chapter 2.
However, if the general provisions for apparatus (Articles 5, 7 and 8) are not applied to apparatus designated for a specific installation, such apparatus will need to be accompanied by more specific information indicating the site of intended use and the precautions to be observed in view of the installation.
Article 12 does not require the conduct of a formal conformity assessment procedure for fixed installations prior to their putting into service. As noted above, it was identified by the SLIM panel and during the subsequent consultation process that the application of a conformity assessment procedure may be difficult or even impossible, as well as disproportionate taking account of the technical complexity of installations and the modifications they can be subject to during their lifetime. Where there are indications of non-compliance, for example due to complaints about disturbances being generated by such installations, public authorities may request evidence of compliance and, where appropriate, initiate a proper assessment. Article 12 leaves it to Member States to determine under national law the person(s) to be held responsible for the compliance of the fixed installation with the relevant essential requirements.
Directive 89/336/EEC will need to be repealed. In accordance with the correlation table of Annex VI, references to Directive 89/336/EEC, for example in harmonised standards, need to be read as referring to the revised Directive.
See Section 2.3.2
These annexes include standard provisions of the New Approach Directives.
This Annex establishes that the correct application of relevant harmonised standards shall be equivalent to the carrying out of an EMC assessment as referred to in Annex I. Furthermore reference is made to standardisation documents which provide information for manufacturers about the selection and use of harmonised standards. These documents should be of help to manufacturers in particular in cases where the presumption of conformity to the requirements implies the simultaneous applicability of several standards.
The consistency with other Community policies is particularly ensured by the fact that the principles on which this Directive is based are those set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards. Additionally, interface with other Community legislation has been particularly considered, by excluding from the scope of the directive specific equipment, as specified in Article 1, point 2 of this proposal.
As indicated in section 2.1, the process of revision of the Directive was started following a Communication to the European Parliament and the Council (COM(1999)88), where the Commission endorsed most of the Recommendations of the SLIM panel, composed of independent experts.
The preparation of a proposal for the revision of the EMC Directive was assisted by an EMC SLIM Working Group, made up of Member States and Industry representatives (manufacturers, utility operators, certification bodies, etc).
As a result of the work of this group, several drafts of the future EMC Directive have been prepared for discussion and published on the Internet site of the Commission, in order to reach the widest possible audience of interested parties.
In order to provide the Commission and all other interested parties with the relevant technical information, an independent study was carried out during the year 2000 under contract from the European Commission. Based on the technical findings of this study, the proposal to include ready-made connecting devices within the scope of the Directive and to regulate specifically fixed installations has been added.
Similarly, the evaluation detailed in section 8 was supported by an independent study carried out in 2001 whose objective was to perform a cost benefit analysis on the proposed revision of the Directive.
The assessment of what impact a revision of the Directive will have on the European economy is based on a study carried out by an outside body.
The purpose of the study is to quantify the impact of the changes introduced by the proposed text on the various interested parties. This represents a pilot case of the new orientation of the Commission, whose intention is to use impact assessment as a tool to improve the quality and coherence of the policy development process, as expressed in a recent Communication from the Commission i.
The study was therefore conducted on the basis of an enquiry with interested parties, which included manufacturers, installers, certification bodies, private and professional users and the public authorities responsible for EMC. The final report of the study is available on the web site of the Commission.
The major points considered in this assessment are the following:
-Improving the legal certainty of the text by making available to those responsible for observing and enforcing the Directive a clearer and more detailed text which provides an answer to the varying interpretations of the existing text,
-A coherent and more detailed definition of the aspects covered by the Directive,
-Scope for action by certification bodies,
-Specifying the essential requirements and clarifying the application of harmonised standards,
-Special arrangements for fixed installations.
It emerges from the study that most of those involved in this area believe that the proposal for a Directive will formalise the mechanisms implemented at present, and the study recommends the directive to be revised. At the moment, the Directive is supplemented by a guide. The major qualitative advantage will be to provide a legal basis for the users of this guide. A second qualitative advantage will be the anticipated reduction in the level of electromagnetic interference, chiefly benefiting users and operators of electricity and telecommunication networks.
According to the study, the overall typical net cost for all affected parties in the EU will be EUR 2.4 billion discounted over the 8 years that the amended Directive is expected to remain in force. This amounts to less than 0.1% of the EU output of EMC products during the same period. This net cost will be mainly (90%) borne by the manufacturers. The sensitivity analysis indicates reasonably stable results: the typical cost coincides with the average and median costs; the lowest estimate is - EUR 1.3 billion, the 25% quartile - EUR 1.9 billion, the 75% quartile - EUR 2.9 billion and the highest estimate - EUR 3.5 billion. The main uncertainties in the cost/benefit estimates are caused, following the study, by lack of clarity in the use of standards and diverging interpretations of the product scope, product definitions and regime for fixed installations. The Commission is of the opinion that the provisions of Articles 1 and 2 (Scope and definitions) and of Annex V (application of harmonised standards) will reduce the uncertainties. These provisions have received a large support in the consultation process.
At a more detailed level, certain specific points need clarifying:
Changing the scope: The proposal for a Directive excludes from its scope apparatus with a low level of emission but specifically includes ready-made connecting devices intended for connection to an apparatus by an end user for the transmission of signals. The study showed that the inclusion of the latter made up a major cost item (approximately 60% of the overall gross cost), which is largely to be borne by the manufacturers, particularly in the field of information technologies. In the Commission's opinion, however, this must be qualified by the fact that inclusion of this type of equipment, which was also recommended by an independent technical study, will avoid potentially divergent national legislation. As it will ensure the smooth operation of the internal market for the targeted products, this will be a move towards an overall medium-term reduction in costs. On the other hand, the inclusion of this type of ready-made connecting device could increase the workload of the certification bodies, but to a lesser extent. By contrast, both the end users and the operators identified a gain resulting from the anticipated reduction in electromagnetic interference. The exclusion of low-emission apparatus should not produce any change.
Fixed installations: The proposal for a Directive explicitly covers equipment designed specifically to be incorporated in a fixed installation and requires that fixed installations be constructed in accordance with good engineering practice. As a result, a reduction in manufacturers' costs has been identified, accompanied by a foreseeable reduction in the activities of certification bodies. Nonetheless, complaints may generate substantial costs, since the Directive requires that it be possible to demonstrate conformity with the requirements in this case, which may offset the anticipated benefits.
Intervention by notified bodies: The current Directive requires, in some cases, the intervention of a 'Competent Body' which issues a certificate/technical report placed in the technical file which proves conformity with the essential requirements. In the proposed Directive, the name of such bodies has been changed to 'Notified Body' to make it consistent with other New Approach Directives. The intervention of such a body is no longer mandatory and the proposal leaves it up to the manufacturer to ask for the intervention of such a body if he considers such an intervention appropriate. The study shows that there might be fewer cases of recourse to notified bodies, thereby reducing the costs borne by manufacturers, whereas the market supervision authorities would have to invest more in technical expertise.
Revision of the essential requirements
(a) Electromagnetic compatibility assessment: Some manufacturers in the information technology sector stressed that a maximalist interpretation of the requirement to ensure conformity in all configurations would require the actual testing of all such configurations, thus leading to substantial additional costs. Taking note of this finding of the impact assessment study, the proposal for a Directive has been amended in order to clarify its interpretation by introducing a more reasonable arrangement which does not require the testing of all configurations. Therefore, a possible source of additional social utility loss has been suppressed.
(b) Conformity without external devices: The proposal for a Directive requires apparatus to conform to the principal requirements without the aid of external devices. The associated one-off design costs are borne by the manufacturers and limited to the first two years of implementation of the Directive.
(c) Making information available: Manufacturers pointed to high costs (approximately 30% of the overall gross cost) due to the requirements for specific information to be provided with the apparatus, as set out in Annex I to the proposal for a Directive, as a result of the need to change the documentation process and, possibly, the production process. This stricter line on documentation compared with the present documentation requirements will fill a gap in the current Directive and will align the requirements with those of other New Approach Directives. The proposed regime would enable the market surveillance authorities to identify cases of non-conformity more easily and thus support them in taking measures against manufacturers who do not comply with the Directive.
Application of harmonised standards: The proposal for a Directive clarifies the concept of conformity to standards. Some manufacturers expressed fears that a literal application of the standards might impose further constraints as regards the testing methods and instruments to be used, thereby generating substantial costs. Nevertheless, it is fundamental, in the interests of equity, that standards, whose application remains voluntary, be applied identically by all manufacturers, an aspect which this proposal clarifies.
The Impact Assessment study has proved to be extremely useful. The findings of the study have led to improvement of the text of the directive, avoiding possible sources of social utility losses. According to the study, the proposal of directive involves extremely low costs for those concerned with respect to market volume. The study also concludes that the proposal of directive can bring qualitative benefits that are difficult to quantify, in particular concerning the achieved protection level.
The major cost factors identified should thus be viewed against the benefits brought by the proposal. These benefits will include improved operation of the internal market, greater flexibility for the actors of the market, for given aspects an improved level of protection and the improvement of the tools made available to the competent authorities to perform market surveillance.