Definitions as Provided from the Guidelines  

Placing of an apparatus on the market. This means the first-time availability, against payment or free of charge, of an apparatus covered by the Directive, in the EEA market, for the purpose of distribution and/or use in the EEA. The Directive’s provisions and obligations concerning its placement on the market apply to each apparatus individually.  The Directive does not apply to a specific type, group or family nor is the date and place of manufacturing relevant.  It is the responsibility of the manufacturer to guarantee that each and all apparatus comply where the apparatus falls under the scope of the Directive.   

Taking an apparatus into service.This means the first time that the end-user uses an apparatus referred to in the Directive within the EEA territory.  An apparatus covered by the EMC Directive is put into service when it is first used.   

Manufacturer. This is the entity responsible for the design and construction of an apparatus covered by the Directive with a view to placing it on the EEA market on the entity’s own behalf. Whoever modifies substantially an apparatus resulting in an “as-new” apparatus, with a view to placing it on the EEA market, also becomes the manufacturer.  The manufacturer has sole and ultimate responsibility for the conformity of an apparatus. Manufacturers bear responsibility for:

• Designing and constructing the apparatus in accordance with protection requirements laid down in the Directive; and

• Following the procedures for the certification of conformity of the apparatus with the protection requirements laid down in the Directive  

Authorized representative. The manufacturer may appoint with a written mandate a person or persons to act on behalf of the manufacturer in respect to certain of the manufacturer’s obligations. This person(s) can be appointed to undertake the testing in the EEA territory, sign the declaration of conformity, affix the CE marking, and hold the declaration of conformity and the technical construction file at the disposal of the competent authorities.   

Importer. This is a person who places on the EEA market an apparatus that is covered by the Directive and imported from a third country.   

Finished product. A finished product is any device, or unit of equipment that has a direct function, its own enclosure, and if applicable, ports and connections intended for end-users. These products are fully subject to the provisions of the EMC Directive and must be CE marked (discussed later).   

Direct function. “Direct function” is defined as any function of a component or a finished product that fulfills the intended use specified by the manufacturer in the instructions for use by an end-user.

The Scope of the EMC Directive  

The Directive directly covers several sectors of electrical/electronic engineering, such as household appliances, consumer electronics, industrial manufacturing, information technology, radio communication, and telecommunications apparatus.   

The following is a non-restrictive list of apparatus explicitly covered by the scope of the EMC Directive:  

5.2.1) Electrical household appliances, portable tools and similar equipment (last recital of the EMC Directive and Annex III(g);
5.2.2) Fluorescent lighting luminaires fitted with starters (last recital of the EMC Directive);
5.2.3) Fluorescent lamps (partially Annex III(1);  
5.2.4) Industrial manufacturing equipment (Annex III(b) of the EMC Directive);  
5.2.5) Information technology equipment (Annex III(f);  
5.2.6) Domestic radio and television receivers;  
5.2.7) Radio and television broadcast transmitters (Annex III(k);  
5.2.8) Aeronautical and marine radio apparatus (Annex III(h);

etc. 

Key Articles Concerning the Scope of the EMC Directive  

Article 1.1. Apparatus means all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components.   

Article 1.2. Electromagnetic disturbance means any electromagnetic phenomenon which may degrade the performance of apparatus.  An electromagnetic disturbance may be an electromagnetic noise or unwanted signal, etc.  The EMC Directive intends to ensure that appliances and systems function without suffering degradation by an electromagnetic phenomenon.  A product is considered compliant when it is used as intended and does not degrade the performance of other products within its electromagnetic environment.  

Article 1.3. Immunity means the ability of an apparatus to perform satisfactorily against the performance criteria for the apparatus in the presence of an electromagnetic disturbance. The aim of this protection requirement is to ensure that the function of electrical/electronic appliance, equipment, and installation containing electrical and/or electronic components is immune to electromagnetic disturbance within its intended environment.  It does not expect the product to be immune to EM disturbances from outside of its intended environment.  The expected level of protection must be proportional to the objectives pursued.  

Article 1.4. Electromagnetic compatibility means the ability of an electrical/electronic appliance, equipment, and installation containing electrical and/or electronic components to function satisfactorily[12] in its electromagnetic environment without introducing intolerable EM disturbances to anything in that environment.  

Article 2.1. This Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.  

Article 4. The apparatus referred to in Article 2 shall be so constructed that:

The EM disturbance it generates does not exceed a level allowing radio and telecommunications equipment and other apparatus to operate as intended.

The apparatus has an adequate level of intrinsic immunity to EM disturbance to enable it to operate as intended.

Technical Justification  

The Directive covers only three types of emitted disturbances:

• Conducted (continuous and intermittent) radio-frequency disturbance;

• Radiated radio frequency disturbance; and

• Harmonics, flicker and voltage fluctuations on the mains power supply.

Procedures for Assessment of the Conformity of Apparatus Intended to be Placed on the Market 

There are three procedures for assessment of the conformity of an apparatus specified in Article 10 of the EMC Directive. 

• Article 10.1 describes the procedure in the case of apparatus for which the manufacturer has applied harmonized standards;

• Article 10.2 describes the procedure where the manufacturer has not applied the standards, or has applied them only in part, or in the absence of relevant standards;

• Article 10.5 describes the specific procedure for apparatus designed for the transmission of radio communications” The EMC Directive does not refer directly to Council Decision 93/465, which established CE marking, the following information is based on this Decision.   

Article 10.1 describes how a manufacturer or his authorized representative can ensure or declare that a product conforms to the applicable harmonized standards.  When a product properly conforms, the manufacturer or his representative (established in the EEA) affixes the CE marking and draws up a written EC declaration of conformity (explained below).  The EC declaration of conformity needs to be retained for ten years after a product is placed on the market for purposes of inspection. The manufacturer is fully responsible for determining and documenting compliance of his products to the EMC Directive and the subsequent regulations.  However, this is a simple process since the only documentation required is the EC declaration of conformity.  There is no requirement for a technical file to demonstrate the steps taken to show compliance with the Directive.   

Article 10.2 describes how a manufacturer or his authorized representative may satisfy the protection requirements of the Directive when the manufacturer does not follow the harmonized standards or has applied them only in part in producing an apparatus.  Again, it is the manufacturer’s responsibility to determine compliance to the Directive and his responsibility to affix the CE label and to draw up a written EC declaration of conformity.   Also, from the time the apparatus is placed on the market, the manufacturer must keep a technical construction file at the disposal of competent authorities (explained below).  All the technical data needed to assess the apparatus’ EMC performance and a certificate or technical report obtained from a competent body must be included in the technical file. (For greater explanation and detail, please see the Guidelines on the Application of Council Directive 89/336/EEC of 3 May 1989 on the Approximation of the Laws of the Member States Relating to Electromagnetic Compatibility, pages 41-45.   

Article 10.5 is applicable only to apparatus designed for the transmission of radio communications, as defined in the International Telecommunication Union Convention.    
 

EC Declaration of Conformity  

Manufacturers or their authorized representatives within the EEA territory are responsible for drawing up the EC declaration of conformity.  When neither party is established within the EEA, the obligation to keep the EC declaration of conformity is the responsibility of the person who places the apparatus on the EEA market. Again, a copy is kept for inspection purposes by the competent authority.   

The content of the EC declaration of conformity, as described by paragraph 1 of Annex I, includes the following:

• description of the apparatus to which it refers,

• reference to the specifications (pursuant to Article 7) under which conformity is declared and, where appropriate, the internal measures implemented to ensure the conformity of the apparatus with the  provisions of the Directive,

• identification of the signatory empowered to bind the manufacturer or his authorized representative, established within the EEA,

• where appropriate, reference to the EC type-examination certificate issued by the notified body.

The declaration of conformity must be written in one of the languages of the EEA.  
   

Apparatus Marking  

“All apparatus covered by the Directive in accordance with the protection requirements and accompanied by one of the means of certification provided for in Article 10 must bear the CE marking.” The manufacturer affixes the CE marking to the apparatus or to the packaging or the instructions for use or guarantee certificate if there is no room on the apparatus itself. The application of a CE marking will imply that the apparatus complies to all other directives that may require the CE marking.   

Competent Authorities 

The administrations of the Member States of the EEA responsible for fulfilling the obligations of market control are the competent authorities.  It is possible to find a list of the names and addresses of the competent authorities known to the Commission in Annex IV of the directive.   

Competent Bodies 

According to the EMC Directive, if a body fulfills the criteria set out in Annex II of the Directive, it is considered to be competent.  Bodies that present a certificate of accreditation or other means of documentary proof to their Competent Authorities and the Commission are considered competent and conform to the requirements of the Directive. 

A competent body may be a manufacturer’s laboratory.  However, to be recognized as such, it must prove that it satisfies the above criteria and that it can assure its independence and impartiality from the design and production processes. 

The following bodies can recognize a body as competent:  

• an accreditation body recognized as such by the competent authority of a Member State of the EEA; or

• a body representing the supervisory authority of a Member State of the EEA.  

A provisional list of the competent bodies as well as their area of competence is reproduced in Annex 5 and may be used as a guide.  

Standards Published in the Official Journal  

A reference list of which standards have been published in the EC’s Official Journal is included in Annex VII of the Directive. Once a manufacturer applies the appropriate harmonized standards to an apparatus, it confers that the apparatus conforms to the protection requirements of the Directive. In case an apparatus is challenged, it is the national authority’s responsibility to prove that the product is not in conformity.   

European standards are available from:

• CENELEC, rue de Stassart, 35, 1050 Brussels,

• ETSI, 650 Route des Lucioles F-06921 Sophia Antipolis CEDEX – France, and

• CEN, rue de Strassart, 36, 1050 Brussels.

National transpositions of harmonized standards are available from the national standardization bodies (see Annex 9).  

The list of harmonized standards published in the Official Journal is also available at the following Internet Address: http://www2.echo.lu/nasd.

APPENDIX C

 INFORMATION TECHNOLOGY AGREEMENT (ITA)    

During the 1996 World Trade Organization Ministerial meeting in Singapore, 28 countries or customs territories, including the U.S., signed the Information Technology Agreement.  This agreement addresses barriers to trade in the information technology industry.  Since October 1998, the agreement has expanded to include 44 countries that represent approximately 93 percent of world trade in IT products.[1] The overall purpose and result of this agreement is the elimination of tariffs on a non-discriminatory basis on a specific list of IT products by January 1, 2000. These products include computer software, computer hardware, telecommunications equipment, semiconductors, and other electronic components and equipment.[2]     

Although the ITA has increased market-access opportunities, there are still issues that need to be addressed, including standards-related issues. As tariffs are eliminated, non-tariff barriers emerge and are proving a greater obstacle.  For example, market access for foreign products remains low in countries like Japan even though Japan has a zero tariff on IT products. Non-tariff measures that are of specific concern to IT industry representatives are: 

• discriminatory certification, testing, conformity assessment, and other standards-related measures,

• unfair marking and labeling requirements, and

• proliferation of quality-system-registration requirements.”[3]   

An annex to the agreement prescribes that signatories to the agreement meet periodically in order to consult on non-tariff barriers to trade in IT products. There have been at least four of these meetings.  The first was on September 30, 1997. The next three were in July, October, and on November 20, 1998.  During the last meeting signatories decided to resolve a few remaining tariff issues and to embark on some “serious work on non-tariff measures, in particular with respect to standards.”[4] 

There is also talk of extending the Information Technology Agreement to cover more products for tariff reduction.  This new agreement would be called the Information Technology Agreement II.  Hundreds of IT product categories have been proposed, including printed-circuit-board-manufacturing equipment; flat-panel-display manufacturing equipment; capacitor manufacturing equipment, audio, radio, television and video apparatus; electrical/electronic machines; and many more (WTO).  The ITA II is not expected to come into fruition soon, but negotiations in this area may provide an opportunity to discuss technical regulations, such as those pertaining to low frequency emissions.[5] 

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