Ministério da Economia e da Inovação (Ministry of Economy and Innovation)
Decree-Law
The protection against electromagnetic disturbance requires obligations to be imposed on the various economic operators. This Decree-Law aims to regulate the electromagnetic compatibility of equipment, transposing to the national legal order Directive 2004/108/EChttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:390:0024:0037:EN:PDF of the European Parliament and of the Council, of 15 December, on the approximation of the laws of Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEChttp://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=389L0336&model=guichett&lg=en, transposed by Decree-Law no. 74/92, of 29 April, as amended by Decree-Law no. 98/95, of 17 May.
The equipment covered by this Decree-Law includes both apparatus and fixed installations. However, separate provision is made for each, because, whereas apparatus as such may move freely within the Community, fixed installations on the other hand are installed for permanent use at a predefined location, as assemblies of various types of apparatus and, where appropriate, other devices. The composition and function of such installations correspond in most cases to the particular needs of the respective operators.
The self-government bodies of the Autonomous Regions were heard.
The associations representing the sector were heard.
Therefore:
Pursuant to point a) of paragraph 1 of article 198 of the Constitution, the Government hereby decrees as follows:
CHAPTER I
General provisions
Article 1
Subject-matter
This Decree-Law transposes to the national legal order Directive 2004/108/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:390:0024:0037:EN:PDFof the European Parliament and of the Council, of 15 December 2004, on the approximation of the laws of the Member States relating to electromagnetic compatibility of equipment.
Article 2
Scope
1 - This Decree-Law applies to equipment as defined in article 3.
2 - This Decree-Law does not apply to:
a) Equipment covered by Decree-Law no. 192/2000, of 18 August, on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity;
b) Aeronautical products, parts and appliances as referred to in Regulation (EC) no. 1592/2002http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=302R1592&model=guichett&lg=en of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency;
c) Radio equipment used by radio amateurs, within the meaning of the Radio Regulations adopted in the framework of the Constitution and Convention of the International Telecommunication Union, unless the equipment is available commercially, kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs not being regarded as commercially available equipment;
d) Equipment the inherent nature of the physical characteristics of which is such that:
i) It is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment and other equipment to operate as intended;
ii) It will operate without unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use.
3 - Where, for any equipment, the essential requirements referred to in annex I are wholly or partly laid down more specifically by other statutory instruments, this Decree-Law shall not apply, or shall cease to apply, from the date of implementation of those statutory instruments.
4 - This Decree-Law shall not affect the application of legislation regulating the safety of equipment.
Article 3
Definitions
1 - For the purposes of this Decree-Law, the following definitions shall apply:
a) ''Equipment'' means any apparatus or fixed installation;
b) ''Apparatus'' means 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;
c) ''Fixed installation'' means 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;
d) ''Electromagnetic compatibility'' means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment;
e) ''Electromagnetic disturbance'' means any electromagnetic phenomenon which may degrade the performance of equipment, such as an electromagnetic noise, an unwanted signal or a change in the propagation medium itself;
f) ''Immunity'' means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance;
g) ''Safety purposes'' means the purposes of safeguarding human life or property;
h) ''Electromagnetic environment'' means all electromagnetic phenomena observable in a given location;
i) ''Harmonised standard'' means a technical specification adopted by a recognised European standardisation body under a mandate from the Commission in conformity with the procedures laid down in Directive 98/48/EChttp://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=398L0048&model=guichett&lg=en, laying down a procedure for the provision of information in the field of technical standards and regulations, transposed to the national legal order by Decree-Law no. 58/2000, of 18 April.
2 - For the purposes of this Decree-Law, the following shall be deemed to be an apparatus, within the meaning of point b) of the preceding paragraph:
a) ''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;
b) ''Mobile installations'' defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.
Article 4
Placing on the market and putting into service
1 - Equipment shall be placed on the market or put into service only if it complies with the requirements of this Decree-Law when properly installed, maintained and used for its intended purpose.
2 - Without prejudice to the preceding paragraph, equipment that fails to comply herewith may be displayed at trade fairs, exhibitions, demonstrations or similar events, provided that a visible sign clearly indicates that such equipment may not be placed on the market or put into service until it has been brought into conformity with this Decree-Law.
3 - During demonstrations, adequate measures must be taken to avoid electromagnetic disturbances.
4 - In addition to the compliance with requirements laid down in this Decree-Law, equipment may be subject also to the following special measures concerning the putting into service or use:
a) Measures to overcome an existing or predicted electromagnetic compatibility problem at a specific site;
b) Measures taken for safety reasons to protect public telecommunications networks or receiving or transmitting stations when used for safety purposes in well-defined spectrum situations.
Article 5
Essential requirements
The equipment covered by this Decree-Law shall meet the essential requirements set out in annex I hereto, which is deemed to be an integral part hereof.
Article 6
Presumption of conformity and harmonised standards
1 - Equipment that complies with the relevant harmonised standards whose references have been published in the Official Journal of the European Union shall raise a presumption of conformity with the essential requirements referred to in annex I hereto.
2 - The presumption of conformity shall be limited to the scope of the harmonised standards applied and the relevant essential requirements covered by such harmonised standards.
3 - The application of harmonised standards shall not be compulsory.
CHAPTER II
Apparatus
Article 7
Conformity assessment procedure for apparatus
1 - Compliance of apparatus with the essential requirements referred to in annex I shall be demonstrated by means of the procedure of internal production control described in annex II hereto, which is deemed to be an integral part hereof.
2 - Without prejudice to the preceding paragraph, the manufacturer or his authorised representative in the Community is also entitled to follow the procedure described in annex III hereto, which is deemed to be an integral part hereof.
Article 8
CE marking
1 - Apparatus whose compliance herewith has been established by means of the procedure laid down in article 7 shall bear the ''CE'' marking which attests to that fact.
2 - The affixing of the ''CE'' marking shall be the responsibility of the manufacturer or his authorised representative in the Community, and the respective model and conditions for the affixing must comply with the procedure laid down in annex V hereto, which is deemed to be an integral part hereof.
3 - The affixing to the apparatus, to its packaging, or to the instructions for its use, of marks which are likely to mislead third parties in relation to the meaning or graphic form of the ''CE'' marking shall be prohibited, however any other mark may be affixed to the apparatus, its packaging, or the instructions for its use, provided that neither the visibility nor the legibility of the ''CE'' marking is thereby impaired.
4 - Without prejudice to article 10, if supervisory bodies, provided for in paragraph 1 of article 16, establish that the ''CE'' marking has been unduly affixed, the manufacturer or his authorised representative in the Community shall bring the apparatus into conformity with the provisions concerning the ''CE'' marking under conditions imposed by the supervisory bodies.
Article 9
Other marks and information
1 - Each apparatus shall be accompanied by the name and address of the manufacturer and, if he is not established within the Community, the name and address of his authorised representative or of the person in the Community responsible for placing the apparatus on the Community market, and shall also be identified in terms of type, batch, serial number or any other information allowing for its identification.
2 - The manufacturer shall provide information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the protection requirements set out in paragraph 1 of annex I.
3 - Apparatus for which compliance with the protection requirements is not ensured in residential areas shall be accompanied by a clear indication of this restriction of use, where appropriate also on the packaging.
4 - The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be contained in the instructions accompanying the apparatus.
5 - Instructions referred to in the preceding paragraph shall be written in Portuguese.
Article 10
Safeguard clause
1 - Where supervisory bodies, provided for in paragraph 1 of article 16, ascertain that an apparatus bearing the ''CE'' marking does not comply with the requirements of this Decree-Law, all appropriate measures must be taken to withdraw the apparatus from the market, to prohibit its placing on the market or its putting into service, or to restrict the free movement thereof, by means of a ministerial order issued by the minister responsible for the economy area, which shall be duly substantiated.
2 - Where the non-compliant apparatus has been subject to the conformity assessment procedure referred to in annex III, appropriate action shall be taken in respect of the author of the statement referred to in point b) of annex III.
Article 11
Guarantee afforded to interested parties
1 - Any decision taken pursuant to this Decree-Law to withdraw an apparatus from the market, prohibit or restrict its placing on the market or its putting into service, or restrict the free movement thereof, shall be notified without delay to the party concerned, attaching the reasons for the decision, as well as the indication of legal remedies available and the time limits to which such remedies are subject.
2 - In the event of a decision as referred to in the preceding paragraph, the manufacturer, his authorised representative, or any other interested party shall have the opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular with respect to public interest requirements.
Article 12
Notified bodies
1 - Bodies responsible for performing or supervising conformity assessment procedures provided for in annex III shall be duly qualified for the purpose by an acknowledged body within the Portuguese Quality System, in compliance with minimum criteria provided for in annex VI hereof, which is deemed to be an integral part hereof.
2 - The designation of bodies notified to carry out the tasks referred to in annex III shall state whether it concerns all apparatus covered by this Decree-Law, and all essential requirements referred to in annex I or whether the scope of designation is limited to certain specific aspects and certain categories of apparatus.
3 - Bodies which comply with the assessment criteria established by the relevant harmonised standards shall be presumed to comply with the criteria set out in annex VI covered by such harmonised standards.
4 - Where it is ascertained that a notified body has ceased to be duly qualified, namely for no longer meeting the minimum criteria listed in annex VI hereof, its notification shall be withdrawn.
CHAPTER III
Fixed installations
Article 13
Fixed installations
1 - Apparatus which has been placed on the market and which may be incorporated into a fixed installation is subject to all relevant provisions for apparatus.
2 - Apparatus which is intended for incorporation into a given fixed installation and is otherwise not commercially available shall not be subject to compliance with provisions of articles 5, 7, 8 and 9.
3 - Documentation accompanying apparatus referred to in the preceding paragraph shall identify the fixed installation and its electromagnetic compatibility characteristics and shall indicate the precautions to be taken for the incorporation of the apparatus into the fixed installation in order not to compromise the conformity of that installation, as well as include the information referred to in paragraph 1 of article 9.
Article 14
Conformity of fixed installations
1 - Without prejudice to compliance with requirements set out in annex I, fixed installations need not be subject to the affixation of the ''CE'' marking or to the declaration of conformity.
2 - Where there are indications of non-compliance of the fixed installation, in particular, where there are complaints about disturbances being generated by the installation, supervisory bodies, provided for in paragraph 1 of article 16, may request evidence of compliance of the fixed installation, and, when appropriate, initiate an assessment.
3 - Where non-compliance is established, the competent authorities may impose appropriate measures to bring the fixed installation into compliance with the protection requirements set out in paragraph 1 of annex I.
4 - The identification of the person responsible for the establishment of compliance of a fixed installation with the relevant essential requirements, under specific legislation applied to fixed installations, shall be compulsory.
CHAPTER IV
Final provisions
Article 15
Monitoring the application of the Decree-Law
1 - The DGAE - Direcção-Geral das Actividades Económicas (General Directorate for Economic Activities) shall be responsible for monitoring the general application of this Decree-Law, as well as of draft measures necessary to further its objectives and to ensure the connection with the European Commission and with other Member States, and for this purpose may consult the Instituto de Comunicações de Portugal - Autoridade Nacional de Comunicações (ICP-ANACOM), namely as far as electronic communications equipment is concerned.
2 - For the purpose of the preceding paragraph, it is incumbent in particular upon DGAE:
a) To inform the European Commission and other Member States of measures taken under paragraph 4 of article 4;
b) To publish the list of titles and references of harmonised standards referred to in paragraph 1 of article 6;
c) To submit objections, duly substantiated, to harmonised standards which are deemed not to fully meet the essential requirements referred to in annex I to the Standing Committee set up by Directive 98/34/EChttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:204:0037:0048:EN:PDF;
d) To present measures to be taken under paragraph 1 of article 10 to the minister responsible for the economy area;
e) To exercise due diligence to ensure that the manufacturer or his authorized representative in the Community is informed of measures taken under paragraph 1 of article 10, indicating the precise reasons that justify them, as well as the possibility of legal remedies available and respective the time limits;
f) To inform the European Commission and other Member States of measures taken under paragraph 1 of article 10, indicating the respective grounds;
g) To take measures provided for in paragraph 2 of article 10;
h) To inform the European Commission and other Member States of measures taken under paragraph 2 of article 10;
i) To permanently inform the European Commission and other Member States of bodies designated under paragraph 2 of article 12 to take part in the conformity assessment procedures provided for in article 7;
j) To inform the European Commission and other Member States of bodies designated under paragraph 2 of article 12 whose notification has been withdrawn, pursuant to paragraph 4 thereof.
Article 16
Supervision
1 - Responsibility for overseeing observance of this Decree-Law shall lie with the Autoridade de Segurança Alimentar e Económica (ASAE) - Food and Economic Safety Authority -, without prejudice to powers granted by law to other entities, namely ICP-ANACOM, as far as electronic communications equipment is concerned.
2 - The investigation stage of breach proceedings shall be incumbent upon the body that has drawn up the respective notice.
3 - It is incumbent upon supervising bodies to supply the DGAE with grounds for measures taken under paragraph 1 of article 10, indicating the reasons and specifying, in particular, whether non-compliance is due to:
a) Failure to satisfy the essential requirements referred to in annex I, where the apparatus does not comply with the harmonised standards referred to in article 6;
b) Incorrect application of the harmonised standards referred to in article 6;
c) Shortcomings in the harmonised standards referred to in article 6.
Article 17
Breaches
1 - The following infringements shall be deemed as breaches liable to fines between (Euro) 498 and (Euro) 2493, where committed by natural persons, and between (Euro) 3740 and (Euro) 44 890, where committed by legal persons:
a) Failure to affix the ''CE'' marking and affixing of marks which are likely to mislead third parties in relation to the meaning or graphic form of the ''CE'' marking, under article 8;
b) Failure to comply with essential requirements referred to in article 5;
c) Non-compliance with the provision of paragraph 1 of article 7, as regards the procedure of internal production control;
d) Failure to affix the ''CE'' marking under article 8;
e) Non-compliance with the provision of article 9, of paragraph 3 of article 13 and paragraphs 3 and 4 of article 14.
2 - Negligent behaviour shall be punishable, amounts of fines referred to in the preceding paragraph being reduced by one-half.
Article 18
Application of fines
Responsibility for application of fines and additional sanctions shall lie with the Comissão de Aplicação de Coimas em Matéria Económica e Publicidade (Commission for the Imposition of Fines in Economic or Advertising Matters).
Article 19
Distribution of proceeds from fines
Proceeds from the application of fines provided for in article 17 shall revert at:
a) 60% to the State;
b) 30% to the body that draws up the notice;
c) 10% to the DGAE.
Article 20
Autonomous Regions
1 - This Decree-Law shall apply to the Autonomous Regions of the Azores and Madeira, its administrative implementation being incumbent upon the competent services of the respective regional administrations.
2 - Proceeds from fines applied in the Autonomous Regions shall be deemed as resources of their own.
Article 21
Transitional provision
The placing on the market or the putting into service before 20 July 2009 of equipment which is in compliance with the provisions of Decree-Law no. 74/92 of 29 April, as amended by Decree-Law no. 98/95 of 17 May, shall be allowed.
Article 22
Repealing provision
The following statutory instruments are hereby repealed:
a) Decree-Law no. 74/92 of 29 April, as amended by Decree-Law no. 98/95 of 17 May;
b) Administrative Rule no. 767-A/93, of 31 August, as amended by Administrative Rules nos. 935/95, of 24 July, and 1160/97, of 14 November.
Article 23
Entry into force
This Decree-Law shall enter into force on the day following that of its publication.
Checked and approved in the Council of Ministers of 2 August 2007. - José Sócrates Carvalho Pinto de Sousa - Luís Filipe Marques Amado - António José de Castro Guerra - Mário Lino Soares Correia.
Promulgated on 17 September 2007.
Let it be published.
The President of the Republic, Aníbal Cavaco Silva.
Counter-signed on 18 September 2007.
The Prime Minister, José Sócrates Carvalho Pinto de Sousa.
ANNEX I
Essential requirements referred to in article 5
1 - Protection requirements - Equipment shall be so designed and manufactured, having regard to new technical developments, as to ensure that:
a) The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
b) It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
2 - Specific requirements for fixed installations - Installation and intended use of components - A fixed installation shall be installed applying good engineering practices and respecting the information on the intended use of its components, with a view to meeting the protection requirements set out in paragraph 1. Those good engineering practices shall be documented and the documentation shall be held by the person(s) responsible at the disposal of the relevant entities for inspection and supervision purposes for as long as the fixed installation is in operation.
ANNEX II
Conformity assessment procedure referred to in article 7
(Internal production control)
1 - The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the protection requirements set out in paragraph 1 of annex 1. The correct application of all the relevant harmonised standards whose references have been published in the Official Journal of the European Union shall be equivalent to the carrying out of the electromagnetic compatibility assessment.
2 - The electromagnetic compatibility assessment shall take into account all normal intended operating conditions. Where the apparatus is capable of taking different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus meets the protection requirements set out in paragraph 1 of annex I, in all the possible configurations identified by the manufacturer as representative of its intended use.
3 - In accordance with the provisions set out in annex IV, the manufacturer shall draw up technical documentation providing evidence of the conformity of the apparatus with the essential requirements of this Decree-Law.
4 - The manufacturer or his authorised representative in the Community shall hold the technical documentation at the disposal of the competent authorities for at least 10 years after the date on which such apparatus was last manufactured.
5 - The compliance of apparatus with all relevant essential requirements shall be attested by an EC declaration of conformity issued by the manufacturer or his authorised representative in the Community, written in Portuguese.
6 - The manufacturer or his authorised representative in the Community shall hold the EC declaration of conformity at the disposal of the competent authorities for a period of at least 10 years after the date on which such apparatus was last manufactured.
7 - If neither the manufacturer nor his authorised representative is established within the Community, the obligation to hold the EC declaration of conformity and the technical documentation at the disposal of the competent authorities shall lie with the person who places the apparatus on the Community market.
8 - The manufacturer must take all measures necessary to ensure that the products are manufactured in accordance with the technical documentation referred to in paragraph 3 and with the applicable provisions of this Decree-Law.
ANNEX III
Conformity assessment procedure referred to in article 7
This procedure consists of applying annex II, completed as follows:
a) The manufacturer or his authorised representative in the Community shall present the technical documentation to the notified body referred to in article 12 and request the notified body for an assessment thereof. The manufacturer or his authorised representative in the Community shall specify to the notified body which aspects of the essential requirements must be assessed by the notified body;
b) The notified body shall review the technical documentation and assess whether the technical documentation properly demonstrates that the requirements that it is to assess have been met. If the compliance of the apparatus is confirmed, the notified body shall issue a statement to the manufacturer or his authorised representative in the Community confirming the compliance of the apparatus. That statement shall be limited to those aspects of the essential requirements which have been assessed by the notified body;
c) The manufacturer shall add the statement of the notified body to the technical documentation.
ANNEX IV
Technical documentation and EC declaration of conformity
1 - Technical documentation - 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, in particular:
a) A general description of the apparatus;
b) Evidence of compliance with the harmonised standards, if any, applied in full or in part;
c) Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements of this Decree-Law, including a description of the electromagnetic compatibility assessment set out in paragraph 1 of annex II, results of design calculations made, examinations carried out, test reports, etc.;
d) A statement from the notified body, when the procedure referred to in annex III has been followed.
2 - EC declaration of conformity - the EC declaration of conformity must contain, at least, the following:
a) A reference to Directive 2004/108/CEhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:390:0024:0037:EN:PDF;
b) An identification of the apparatus to which it refers, as set out in paragraph 1 of article 9;
c) The name and address of the manufacturer and, where applicable, the name and address of his authorised representative in the Community;
d) A dated reference to the specifications under which conformity is declared to ensure the conformity of the apparatus with the provisions of this Decree-Law;
e) The date of the declaration;
f) The identity and signature of the manufacturer or his authorised representative.
ANNEX V
CE marking
The CE marking shall consist in the initials ''CE'' taking the following form:
(see original document)
The CE marking must have a height of at least 5 mm, and if it is reduced or enlarged the proportions given in the above graduated drawing must be respected.
The CE marking must be affixed to the apparatus or to its data plate. Where this is not possible or not warranted on account of the nature of the apparatus, it must be affixed to the packaging, if any, and to the accompanying documents.
Where the apparatus is the subject of other directives covering other aspects and which also provide for the CE marking, the latter shall indicate that the apparatus also conforms to those other directives.
Where one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only with the directives applied by the manufacturer. In that case, particulars of the directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the directives and accompanying such apparatus.
ANNEX VI
Criteria for the assessment of the bodies to be notified
1 - The bodies shall fulfil the following minimum conditions:
a) Availability of personnel and of the necessary means and equipment;
b) Technical competence and professional integrity of personnel;
c) Independence in preparing the reports and performing the verification function provided for in this Decree-Law;
d) Independence of staff and technical personnel in relation to all interested parties, groups or persons directly or indirectly concerned with the equipment in question;
e) Maintenance of professional secrecy by personnel;
f) Possession of civil liability insurance unless such liability is covered by the State under national law.
2 - Fulfilment of the conditions laid down in paragraph 1 shall be verified at intervals by an acknowledged body within the Portuguese Quality System.
