A Revised EMC Directive from Europe

TÜV America Inc. Phone: (978) 739-7000 5 Cherry Hill Drive Fax: (978) 777-8441 Danvers, MA 01923 E-mail: info@tuvam.com www.tuvamerica.com A Revised EMC Directive from Europe INTRODUCTION The Commission of European Communities has published a proposal on REVISING the Electromagnetic Compatibility (EMC) Directive, which was first released in 1989. The existing EMC Directive has been mandatory for all electrical and electronic apparatus since January 1, 1996. Pertinent products must comply with the EMC Directive before being placed on the market within the European Community. Directives are the European Union s equivalent of laws and are enforced by the individual countries in the European Union. The revision of the EMC Directive arose as a result of the commission s efforts to clarify a number of issues in the EMC Directive and as a further result of the commission s program called SLIM (Simpler Legislation for the Internal Market). The efforts to clarify the EMC Directive were codified in an informal Guide to the Application of the EMC Directive released in 1997. The following year, 1998, a SLIM panel reviewed the EMC Directive and recommended its revision. The recommended revision focused on the following aspects: 1. Basic Principles 2. Treatment of Large Machines and Installations 3. Conformity Assessment Procedures 4. Standards 5. EMC Requirements in Other Directives 6. Consideration for the Solutions Provided by the EMC Guide The actual proposal may be downloaded from the European Commission s Web Site at http://europa.eu.int/comm/enterprise/electr_equipment/emc/revision/proposal.htm. It is expected that the revised Directive could be published in early 2004. MAJOR CHANGES One of the major changes of the proposed revision is the elimination of the Competent Body designation from the original EMC Directive. Instead, Conformity Assessment Bodies will be called Notified Bodies as in other New Approach Directives. The Notified Body designation also allows easy migration for the European Union for its Mutual Recognition Agreement (MRA) activities with other countries including the United States. For example, an MRA exists between the USA and the European Union where both parties recognize one another s Conformity Assessment Bodies (Notified Bodies). However, a second major change in the EMC Directive is that the proposed revision recognizes that the self-declaration (EC Declaration of Conformity or Manufacturer s Declaration of Conformity) process (utilizing harmonized standards) is used 95% of the time and further recognizes that for the other 5% of the cases that use of non-harmonized standards is not sufficient reason to require a Notified Body. However, the proposed revision clearly allows the manufacturer the option of involving a third party (Notified Body) in whole or in part for any of the conformity assessment requirements. Thus, a third-party Certificate of Conformity is still allowed and subtly encouraged. Of course, the manufacturer is ultimately responsible for his product and must always establish and maintain technical documentation, which confirms that the apparatus complies with the essential requirements of the EMC Directive. Yet another major change in the proposed revision allows electrical equipment to be divided into two categories: Apparatus and Fixed Installations. Page 1 of 1

Many provisions of the Directive apply to both Apparatus and Fixed Installations. This is especially true for the generic EMC requirements and the principle of the use of harmonized standards to show compliance with the essential requirements. However, there are differences. For example, consistent with the original EMC Directive, once an Apparatus complies with the EMC Directive it can be placed onto the market. But, Fixed Installations do not fit cleanly into a conformity assessment procedure. This is usually because of their large size, their complicated structures, variable external EMC conditions, and their unusual operational needs. Examples are telecommunication networks, large machinery such as papermaking machines, and assemblies of machinery on a manufacturing site. So, these Fixed Installations are allowed to avoid some of the testing and marking requirements of the EMC Directive. But, they must still not interfere with licensed telecommunications services when operational, and the manufacturer may have to make modifications of the Fixed Installation on site to prevent interference problems. Details of the Proposed Revised Directive Chapter 1 General Provisions Article 1 Subject Matter and Scope This Directive regulates the EMC of equipment. It aims to assure the functioning of the internal market of the European Community by requiring equipment to comply with an adequate level of EMC. SCOPE Radio and Telecommunication Terminal Equipment covered by Directive 99/5/EC is excluded from the scope of the EMC Directive. Aircraft and equipment fitted into aircraft will be excluded from the EMC Directive. The needs of protection for EMC for aircraft will be met by specific regulations for the aircraft. The EMC Directive will also not apply to very small equipment such as greeting cards incorporating small electronic devices and specialized wristwatches using electronics. The EMC Directive will also not apply to radio equipment which is not commercially available, including kits of components to be assembled by radio amateurs, within the meaning defined in the Radio Regulations adopted in the framework of the Constitution and Convention of the International Telecommunication Union as well as commercial equipment modified by and for the use of such radio amateurs. The EMC Directive shall not affect the application of European Community or national legislation regulating the safety of equipment. Article 2 Definitions Apparatus 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. Page 2 of 2

Fixed Installation 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. For the purposes of the new EMC Directive, the following shall be deemed to be an apparatus: Components or sub-assemblies intended for incorporation into an apparatus by the end user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; Ready-made connecting devices intended for connection to an apparatus by an end user for the transmission of signals, which are placed on the market separately from such apparatus, and which are liable to generate or transmit electromagnetic disturbance when connected to it. Article 3 Placing on the market, putting into service Member States shall take all appropriate measures to ensure that equipment is placed on the market and/or put into service only if it complies with the requirements of the Directive when properly installed, maintained and used for its intended purpose. Article 4 Free Circulation of Equipment Member States shall not impede, for reasons relating to EMC, the placing on the market and/or the putting into service in their territory of equipment, which complies with the EMC Directive. Article 5 Essential Requirements The equipment referred to in Article 1 shall meet the essential requirements set out in Annex I. Article 6 Harmonized Standards It is in the interest of the functioning of the internal markets to have standards for EMC of equipment, which have been harmonized at the Community level. Once a reference to the standard has been published in the Official Journal (harmonized), then, compliance of an apparatus with it should satisfy the essential requirements criteria. Chapter 2 Apparatus Article 7 Conformity Assessment Procedure for Apparatus Manufacturers (or their authorized representative established within the community) will have to assess the compliance of apparatus with the essential requirements. The conformity can be shown through the development of a Technical File and attested to by a Manufacturer s Declaration of Conformity. Of course, a Notified Body could always be asked to become involved and the NB could issue a Third-Party Certificate of Conformity to satisfy the essential requirements of the EMC Directive. The Manufacturer s Declaration of Conformity shall be held at the disposal of the competent authorities for a period of at least ten years after the date on which such apparatus was last manufactured. The technical documentation and the Manufacturer s Declaration of Conformity shall be drawn up in accordance with the requirements outlined in Annex II of the EMC Directive. Page 3 of 3

CONFIGURATIONS Where apparatus can take different configurations, the EMC assessment should confirm that the apparatus meets the protection requirements in the normal configurations. The assessment can be performed on the basis of a configuration most likely to cause maximum disturbance and the configuration most susceptible to disturbance. Article 8 CE Marking Apparatus whose compliance with the EMC Directive has been established by the procedure laid down in Article 7 shall bear the CE marking which attests to that fact. The affixing of the CE marking shall be the responsibility of the manufacturer or his authorized representative established within the Community. The CE marking shall be affixed in accordance with the provisions set out in Annex III. Article 9 Safeguards Where a Member State ascertains that an apparatus bearing the CE marking does not comply with the requirements of the EMC Directive, it shall take all appropriate measures (1) to withdraw the apparatus from the market, (2) to prohibit its placing on the market or putting into service, and (3) to restrict its free movement. The Member State concerned shall immediately inform the Commission and the other Member States of its actions. The Commission shall consult the parties concerned as soon as possible, following which it shall inform the member States whether or not it finds the measure to be justified. Where the non-compliant apparatus is accompanied by the report referred to in Article 7(2), the Member State concerned shall take appropriate action with respect to the author of that report, and shall inform the Commission and the other Member States accordingly. Article 10 Decisions with respect to the withdrawal, prohibition or restriction of free movement of apparatus Any decision taken pursuant to this Directive to withdraw an apparatus from the market, prohibit or restrict its placing on the market or its putting into service, or restrict its free movement, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. Article 11 Notified Bodies Member States shall designate the bodies competent to draw up the reports referred to in Article 7(2) and shall notify them (Notified Bodies) to the Commission and to the other Member States. Member States shall apply the criteria listed in Annex IV for the assessment of Notified Bodies. The Commission shall publish in the Official Journal of the European Communities a list of Notified Bodies. If a Member State finds that a Notified Body no longer meets the criteria listed in Annex IV, it shall inform the Commission and the other Member States accordingly. The Commission shall withdraw the reference to that body from the published list. Chapter 3 Fixed Installations Article 12 Fixed Installations Where such installations are built or modified using apparatus, which are generally available on the market, the apparatus can be qualified under the usual apparatus procedures. However, if the general Page 4 of 4

provisions for apparatus are not applied because of the specificity of the equipment, then, the apparatus will have to be accompanied by qualified information indicating the site of intended use and the precautions to be used in the installation of the apparatus. A formal conformity assessment procedure is not required for fixed installations prior to putting them into service. However, where there are indications of non-compliance (such as interference complaints from parties around the installation), public authorities may request evidence of compliance and initiate a suitable assessment. The public authorities may also determine the responsible party for the final compliance with the relevant essential requirements. In other words, fixed installations should be designed and constructed in accordance with good engineering practices to assure their successful integration into their final electromagnetic environment. Due to their specific characteristics, fixed installations need not be subject to the requirements of CE marking or the Declaration of Conformity. Chapter 4 Final Provisions Article 13 Repeal The original EMC Directive, Directive 89/336/EEC, will be repealed. References to Directive 89/336/EEC shall be construed as references to the New EMC Directive and be read in accordance with the correlation table set out in Annex VI of the new EMC Directive. Article 14 Transitional Provisions A transitional period is necessary in order to ensure that manufacturers and other concerned parties are able to adapt to the new regulatory scheme. Member States shall not impede the placing on the market and/or putting into service of equipment which is in compliance with the provisions of Directive 89/336/EEC and which was placed on the market before the date of application of the new EMC Directive plus two years. Article 15 Transposition Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with the new EMC Directive by the date of application minus 6 months at the latest. Member States shall communicate to the Commission the texts of the provisions of national law, which they adopt in the field covered by the new EMC Directive. Article 16 Entry into Force The new EMC Directive shall enter into force on the twentieth day after its publication in the Official Journal of the European Communities. Article 17 Addressees The new EMC Directive is addressed to the Member States. Page 5 of 5

Annex I Essential Requirements This Annex goes into detail on the design and manufacturing requirements for EMC protection. It outlines the specific requirements for Apparatus including an EMC assessment, a warning about external devices, information requirements, and more information on ready-made connecting devices. It also has a recommendation on the specific requirements for Fixed Installations. Annex II Technical Documentation, EC Declaration of Conformity This Annex informs the manufacturer that the technical documentation must enable the conformity of the apparatus with the essential requirements to be assessed. It must cover the design and manufacture of the apparatus. This Annex also details what the EC Declaration of Conformity must contain, e.g., reference to the EMC Directive, identification of the apparatus, name and address of the manufacturer, dated reference to the specifications under which conformity is declared, date and place of issue of the declaration, and identification and signature of the person empowered to bind the manufacturer or his authorized representative. Annex III CE Marking This Annex covers the basics on the CE mark; size, where it should be affixed, indication that it meets other directives (if appropriate), and documentation hints for special situations. Annex IV Criteria for the Assessment of the Bodies to be Notified Lists the minimum conditions that a Notified Body must comply with and the fact that these conditions must be verified at intervals by the competent authorities of the Member States. Annex V Application of Harmonized Standards The correct application of all the relevant harmonized standards whose references have been published in the OJ shall be equivalent to the carrying out of the EMC assessment referred to in Point 2 of Annex I. Compliance with a harmonized standard means conformity with its provisions (e.g., limits) and demonstration thereof by the methods the harmonized standard describes or refers to. Presumption of conformity via application of harmonized standards is limited to the scope of the harmonized standards applied and the relevant essential requirements covered by such harmonized standards. Harmonized standards are to be selected and used in accordance with the provisions of the relevant standardization documents. The reference to those documents shall be published in the OJ. Annex VI Correlation Table A correlation of paragraphs and their respective requirements between Directive 89/336/EEC (the old EMC Directive) and the new Proposed EMC Directive. LEGAL BASIS The proposed revision is based on Article 95 of the European Commission Treaty. Its intent is to assure the easy circulation of equipment throughout the European Market by having apparatus and fixed installations comply with the intent of the harmonized standards thus assuring a compatible electromagnetic environment. For more information, contact us at 800-TUV-0123 or info@tuvam.com. Page 6 of 6