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The Electromagnetic Compatibility Regulations 2005

Type Statutory-Instrument

Publication 2005-02-02

Last updated 2005-03-07

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 2nd February 2005

Laid before Parliament: 11th February 2005

Coming into force: 7th March 2005

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to apparatus which is liable to cause electromagnetic disturbance and to apparatus the performance of which is liable to be affected by such disturbance, in exercise of the powers conferred upon her by that section, hereby makes the following Regulations:

PART 1 — PRELIMINARY

Citation and commencement

1

These Regulations may be cited as the Electromagnetic Compatibility Regulations 2005, and shall come into force on 7th March 2005.

Repeal and disapplication

2

(1) The following Regulations are hereby revoked—

(a) the Electromagnetic Compatibility Regulations 1992 ;

(b) the Electromagnetic Compatibility (Amendment) Regulations 1994 ; and

(2) The regulations made under section 10 of the Wireless Telegraphy Act 1949 listed in Schedule 1, to the extent that they impose electromagnetic compatibility requirements which must be complied with if relevant apparatus is—

(a) to be supplied or taken into service and

(b) used for the purpose for which it was intended,

shall cease to have effect, but nothing in these Regulations shall affect the said regulations to the extent that they impose requirements for radio frequency spectrum planning or for the prevention of undue interference to wireless telegraphy from relevant apparatus in use.

Interpretation

3

(1) In these Regulations,

“the 1949 Act” means the Wireless Telegraphy Act 1949;

“the 1984 Act” means the Telecommunications Act 1984 ;

“the EMC Directive” means Council Directive 89/336/EEC on the approximation of the laws of the member States relating to electromagnetic compatibility as amended byCouncil Directive 92/31/EEC ; andArticles 5, 14.1 and 14.2 of Council Directive 93/68/EEC (the CE Marking Directive);

“affixed” in relation to the CE marking, or any inscription which is liable to be confused therewith, or which is likely to deceive third parties as to the meaning and form thereof, means affixed to one of the items mentioned in regulation 35 (2) below or to any other item such that it is referable to any apparatus;

“authorised representative” means a person established within the Community appointed by the manufacturer (whether or not established in the Community) to act on his behalf in fulfilling his obligations under the EMC Directive as implemented by these Regulations;

“business” includes a profession and an undertaking, and a supply in the course of a business includes any supply by a business;

“CE marking” and “CE conformity marking” shall be construed in accordance with regulation 35 below;

“the Commission” means the Commission of the European Communities;

“the Community” means the European Community;

“competent body” shall be construed in accordance with regulation 47 below;

“conformity assessment requirements” shall be construed in accordance with regulation 33 below;

“EC declaration of conformity” has the meaning given in regulation 36(1) below;

“EC type-examination certificate” in relation to the EC type-examination route to compliance in respect of radiocommunication transmission apparatus means an EC type-examination certificate issued by—a United Kingdom notified body pursuant to regulation 66 below; ora notified body of an EEA state other than the United Kingdom pursuant to Article 10.5 of the EMC Directive;

“the EC type-examination route to compliance” in relation to radiocommunication transmission apparatus shall be construed in accordance with regulation 33(b) below;

“education and training equipment” means any relevant apparatus (including a kit)—supplied or possessed for supply to education or training establishments or manufactured in such an establishment for the purposes of experimentation, learning or practical training; andthe usual electromagnetic environment of which is a classroom, laboratory, study area or similar such place;

“electrical apparatus” shall be construed in accordance with regulation 7(2) below;

“enforcement authority” in relation to any relevant apparatus means any person who is, pursuant to the provisions of regulation 75 below, authorised to act as an enforcement authority in relation to that relevant apparatus;

“end user” meansa manufacturer who first uses electrical apparatus which he has manufactured for the purpose for which it is designed, but excludes a manufacturer who uses the apparatus by incorporating it into other apparatus; andany other person who uses the electrical apparatus;

“excluded installation” has the meaning giving by regulation 12(2);

“immunity” means immunity to electromagnetic disturbance;

“kit” means a collection of all or substantially all the necessary components, for supply as a single commercial unit, required for the construction of an item of electrical apparatus and intended for such use, whether or not accompanied by instructions. For the purposes of the definition of “system” in this paragraph and of the application of regulation 7 below, a kit shall be considered to be a system with an intrinsic function intended for the end user notwithstanding that, when it is supplied, it is not yet assembled;

“manufacture” means manufacture in the course of a business, and includes—assembly;finishing;reconditioning;modification which substantially alters the electromagnetic compatibility characteristics of the apparatus;but does not include repair or the assembly of relevant apparatus from a kit;

“medical device” has the meaning given by regulation 22(3) below;

“notified body” shall be construed in accordance with regulation 63 below;

“OFCOM” means the Office of Communications established under the Office of Communications Act 2002 ;

“presumption of conformity” shall be construed in accordance with regulation 34 below;

“protection requirements” has the meaning given by regulation 5 below;

“radio amateur apparatus” means wireless telegraphy apparatus designed or adapted for use in the amateur service, but excludes citizens' band apparatus, and in this definition—“amateur service” has the meaning given by Article 1, definition 1.56 of the 2001 edition of the Radio Regulations annexed to the International Telecommunication Constitution 1992 pursuant to Articles 4 and 54 of that Constitution; and“citizen”s band apparatus' means wireless telegraphy apparatus designed or adapted exclusively for the provision of voice radiocommunication in the frequency bands 26.960 MHz to 27.410 MHz and 27.60125 MHz to 27.99125 MHz;

“radiocommunication transmission apparatus” has the meaning given by regulation 61(2) below;

“radio frequency spectrum” means that part of the electromagnetic spectrum at frequencies not exceeding 3,000 GHz; and requirements of regulations made under section 10 of the 1949 Act shall be taken to concern radio frequency spectrum planning if they concern the frequency allocation for any apparatus (whether wireless telegraphy apparatus or other apparatus which operates by emitting electromagnetic radiation in the radio frequency spectrum) and the necessary characteristics of any signal or emission authorised by such regulations;

“relevant apparatus” shall be construed in accordance with regulation 6 below;

“responsible person” in relation to relevant apparatus means—the manufacturer;the manufacturer's authorised representative; orwhere the manufacturer is not established in the Community and he has not appointed an authorised representative, the person who supplies the relevant apparatus;

“the standards route to compliance” in relation to relevant apparatus other than radiocommunication transmission apparatus shall be construed in accordance with regulation 33(a) (i) below;

“supply” means the first making available of relevant apparatus in the Community including, offering to supply, agreeing to supply, exposing for supply and possessing for supply such apparatus; but relevant apparatus shall not be regarded as having been supplied by reason only of its having been displayed at a trade fair or exhibition or advertised for supply when not available for supply;

“system” means an item of equipment, or a combination of items of equipment, containing—electrical components;electronic components; orboth (a) and (b),and includes a kit but excludes any such equipment containing a medical device;

“technical certificate” in relation to the technical construction file route to compliance in respect of relevant apparatus other than radiocommunication transmission apparatus means a technical certificate issued by—a United Kingdom competent body in accordance with regulation 52 below; ora competent body of an EEA State other than the United Kingdom pursuant to Article 10.2 of the EMC Directive;

“technical construction file” shall be construed in accordance with regulation 45 below;

“the technical construction file route to compliance” in relation to relevant apparatus other than radiocommunication transmission apparatus shall be construed in accordance with regulation 33(a)(ii) below;

“technical report” in relation to the technical construction file route to compliance in respect of relevant apparatus other than radiocommunication transmission apparatus means a technical report issued by—a United Kingdom competent body in accordance with regulation 52 below; ora competent body of an EEA State other than the United Kingdom pursuant to Article 10.2 of the EMC Directive;

“test apparatus” means relevant apparatus designed or adapted to generate or be susceptible to electromagnetic disturbance for the specific purpose of conducting any test or measurement in relation to—any relevant apparatus; orany other thing, matter or phenomenon;

“United Kingdom competent body” shall be construed in accordance with regulation 48 below;

“United Kingdom notified body” shall be construed in accordance with regulation 64 below; and

“wireless telegraphy”, “wireless telegraphy apparatus” and “station for wireless telegraphy” have the meanings given respectively by section 19(1) of the 1949 Act.

(2) For the purpose of these Regulations—

(a) “electromagnetic compatibility” (“EMC”) is the ability of relevant apparatus to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment;

(b) the electromagnetic (“EM”) characteristics of relevant apparatus comprise—

(i) the propensity of that apparatus to generate electromagnetic disturbance; and

(ii) the adequacy of the immunity of that apparatus to external electromagnetic disturbance;

(i) in the case of apparatus to which regulations 27 to 29 below apply, any EM characteristic thereof which falls within the scope of these Regulations; and

(ii) in the case of any other apparatus, any EM characteristic thereof;

(d) “applicable EMC standard”, “harmonised standard”, “recognised national standard” and “transposed harmonised standard” shall be construed in accordance with regulation 40 below;

(e) an electromagnetic environment is the totality of electromagnetic phenomena existing at a given location, and

(i) a reference to the immediate electromagnetic environment in relation to education and training equipment or test apparatus (“disturbance permissible apparatus”) is a reference to a sufficient space for that apparatus to—

(aa) operate as intended, where the object of the study or test as the case may be is that it should generate electromagnetic disturbance;

(bb) be subjected to electromagnetic disturbance, where the object of the study or test as the case may be is that it should be the victim of electromagnetic disturbance,

without preventing other relevant apparatus (other than any apparatus involved in the study or test) from operating as intended; and in this definition, “sufficient space” means a space no greater in size than is reasonably necessary having regard to all the circumstances, to enable the disturbance permissible apparatus to be so operated or so subjected, and having regard in particular to the steps which might reasonably be taken to insulate the site at which the disturbance permissible apparatus is being used against the escape of emissions therefrom;

(ii) a reference to a sealed electromagnetic environment is a reference to an electromagnetic environment which prevents relevant apparatus therein from causing electromagnetic disturbance to relevant apparatus outside that electromagnetic environment and includes an anechoic chamber, an electromagnetic anechoic room or a Faraday cage; and

(iii) a reference to the usual electromagnetic environment of apparatus is a reference to—

(aa) where the apparatus is manufactured or supplied for the purpose of being used at a specific location, the totality of electromagnetic phenomena which exist at that location under normal circumstances at the time when it is first used; or

(bb) where sub-paragraph (aa) above does not apply, the totality of electromagnetic phenomena which might reasonably be expected to exist at the usual range of locations at which that relevant apparatus might reasonably be expected to be used, having regard to all the circumstances, and in particular to—

(iv) the electromagnetic phenomena associated with that relevant apparatus and other relevant apparatus which might reasonably be expected to be in sufficient proximity to the first mentioned relevant apparatus to be affected thereby; and

(v) any indication by the manufacturer or supplier of the applications for which the first-mentioned relevant apparatus is suitable; and

(f) relevant apparatus other than a kit is taken into service when it is first used by the person who assembled it or the person who imported it from a country or territory other than a member State; but relevant apparatus shall not be regarded as having been taken into service by reason only of its having been operated by or on behalf of the manufacturer at a trade fair or exhibition or by a supplier for demonstration purposes.

(3) In these Regulations, with respect to matters arising on and after 1st January 1994, a reference to the Community includes a reference to the EEA States, and for the purposes of this paragraph an EEA state means a member State, Norway, Iceland or Liechtenstein .

Electromagnetic disturbance

4

In these Regulations, “electromagnetic disturbance” means, subject to paragraphs (2) to (6) below, any electromagnetic phenomenon which is liable to degrade the performance of relevant apparatus.

(1) Without prejudice to the generality of paragraph (1) above, the following phenomena shall be regarded as electromagnetic disturbance (being phenomena expressly stated to be such in Article 1.2 of the EMC Directive):—

(a) electromagnetic noise;

(b) unwanted signals; and

(2) Without prejudice to the generality of paragraph (1) above and in addition to the phenomena regarded as electromagnetic disturbance pursuant to paragraph (2) above, the phenomena and effects listed in Schedule 2 hereto may be regarded as electromagnetic disturbance.

(3) A signal or emission which is a necessary function, or consequence of the operation, of relevant apparatus shall not be taken to be electromagnetic disturbance if, in relation to that apparatus, that signal or emission is permitted, and does not exceed the limits specified, by—

(a) the applicable EMC standard;

(b) a condition of the technical report or technical certificate;

(i) a condition of the EC type-examination certificate; or

(ii) a term, provision or limitation of—

(aa) a licence granted under section 1 of the 1949 Act; or

(bb) regulations made under that section; or

(d) where the apparatus is—

(i) radiocommunication transmission apparatus; or

(ii) apparatus other than wireless telegraphy apparatus which operates by emitting electromagnetic radiation in the radio frequency spectrum,

any relevant provisions of regulations made under section 10 of the 1949 Act concerning radio frequency spectrum planning.

(4) A nuclear electromagnetic pulse (“NEMP”) shall not be regarded as electromagnetic disturbance.

(5) Without prejudice to the generality of the foregoing provisions of this regulation, the performance of relevant apparatus shall be taken to be degraded if any of the following types of interference with its function occur—

(a) permanent, temporary or intermittent—

(i) total loss of function;

(ii) significant impairment of function; or

(b) where the apparatus is information storage or retrieval equipment, destruction or corruption of information stored thereby.

Protection requirements

5

(1) A reference to “protection requirements” in relation to relevant apparatus is a reference to the requirements set out in the following provisions of this regulation.

(2) Subject to paragraphs (3) to (5) below, relevant apparatus shall be so constructed that—

(a) the electromagnetic disturbance it generates does not exceed a level allowing other relevant apparatus to operate as intended; and

(b) it has a level of intrinsic immunity which is adequate to enable it to operate as intended,

when it is—

(i) properly installed and maintained; and

(ii) used for the purpose for which it was intended.

(3) Nothing in paragraph (2) above shall be taken to require relevant apparatus, not being apparatus specifically designed for use at a given location, to be constructed in such a manner as to—

(a) prevent the generation of electromagnetic disturbance to, or

(b) provide for intrinsic immunity to electromagnetic disturbance generated by,

other relevant apparatus which would not reasonably be expected to be present in its usual electromagnetic environment.

(4) Without prejudice to the generality of paragraph (2)(a), the electromagnetic disturbance generated by relevant apparatus shall—

(a) not exceed a level allowing radio and telecommunications equipment to operate as intended; and

(b) be such as not to hinder the use of apparatus of any of the descriptions listed in Schedule 3 hereto (being descriptions listed in the illustrative list of the principal protection requirements in Annex III of the EMC Directive) where that apparatus is constructed in such a way that it has an adequate level of immunity in its usual electromagnetic environment so as to allow its unhindered operation taking into account the levels of electromagnetic disturbance generated by relevant apparatus complying with applicable EMC standards.

(5) Without prejudice to the generality of paragraph (2)(b)—

(a) relevant apparatus shall be constructed in such a way that it has an adequate level of immunity in its usual electromagnetic environment so as to allow its unhindered operation taking into account the levels of electromagnetic disturbance generated by other relevant apparatus which might reasonably be expected to be present in that environment and which complies with the protection requirements; and

(b) whether the level of intrinsic immunity of relevant apparatus is adequate is to be considered having regard to all the circumstances of the case, and in particular to—

(i) the level of performance reasonably expected of that apparatus having regard to its function or intended function;

(ii) any specification for an acceptable level of degradation of performance provided to the end user by the manufacturer;

(iii) the consequences of degradation of performance,

but nothing in this sub-paragraph shall authorise a level of intrinsic immunity which could permit the operation of the apparatus to be dangerous (either to persons or property) in any reasonably foreseeable circumstances.

(6) The information required to enable use in accordance with the intended purpose of the relevant apparatus must be contained in the manufacturer's instructions accompanying the apparatus.

PART II — APPLICATION

General Application

Relevant apparatus

6

(1) Subject to paragraph (2) below, this Part shall have effect for the purposes of providing for the application of these Regulations, and apparatus to which these Regulations apply shall be relevant apparatus.

(2) In addition to applying to relevant apparatus, the following provisions of these Regulations apply as follows:—

(a) Part I, and regulations 35(6), 36(4), 76 to 79, 82, 83, 84(c) and (d), 86 to 88, 91 to 93 and 95 to 99, apply to electrical apparatus other than relevant apparatus; and

(b) Part I and regulations 7(2), 82, 83, 86, 92, 93, 95, and 99 apply to an excluded installation as a unit (without prejudice to the application of the provisions referred to in sub-paragraph (a) above to such installation or any part thereof on the ground that it is electrical apparatus).

General conditions of application

7

(1) Subject to regulations 8 and 9 below, these Regulations apply to electrical apparatus unless, pursuant to regulations 10 to 29 below, it falls outside the scope of these Regulations.

(2) For the purposes of these Regulations, electrical apparatus consists of a product —

(a) with an intrinsic function intended for the end user; and

(b) supplied or intended for supply or taken into service or intended to be taken into service as a single commercial unit,

which is—

(i) an electrical appliance;

(ii) an electronic appliance; or

(iii) a system.

Modified application

Education and training equipment

8

(1) This regulation applies to education and training equipment which would not, except for the provisions of this regulation, conform with the protection requirements under normal conditions of use in its usual electromagnetic environment.

(2) Education and training equipment to which this regulation applies shall be deemed to conform with the protection requirements if it satisfies the following conditions—

(a) in relation to supply, the apparatus is accompanied by a declaration in English stating that the use of the apparatus outside the classroom, laboratory, study area or similar such place invalidates conformity with the protection requirements of the EMC Directive and could lead to prosecution; and

(b) the equipment when operated does not cause electromagnetic disturbance to apparatus situated outside its immediate electromagnetic environment.

Test apparatus

9

In the application of these Regulations to test apparatus, a reference to the protection requirements—

(a) insofar as it relates to the electromagnetic disturbance generated by that apparatus shall be construed as a reference to that disturbance capable of preventing relevant apparatus situated outside the immediate electromagnetic environment of that apparatus from operating as intended; and

(b) insofar as it relates to the immunity of that apparatus, shall not be taken to refer to any susceptibility to electromagnetic disturbance which is a necessary feature of that apparatus to facilitate the conducting of the test.

Exclusions

Apparatus supplied or taken into service before 28th October 1992

10

These Regulations do not apply to an item of electrical apparatus supplied or taken into service in the Community before 28th October 1992.

Apparatus for export to a third country outside the Community

11

(1) Subject to paragraph (2) below, these Regulations do not apply to any apparatus which the supplier believes (with reasonable cause) will not be used either in the United Kingdom or elsewhere in the Community.

(2) Paragraph (1) above shall not apply if the CE mark or any inscription liable to be confused therewith is affixed to the apparatus.

Excluded installations

12

(1) These Regulations do not apply to excluded installations; but the extent to which any apparatus or system comprised or to be comprised therein is relevant apparatus shall be determined in accordance with the provisions of this Part.

(2) In this regulation “excluded installation” means two or more combined items of relevant apparatus or systems put together at a given place (whether or not in combination with any other item) to fulfil a specific objective but not designed by the manufacturer (or manufacturers, where the items are made by different manufacturers) for supply as a single functional unit.

Spare parts

13

(1) Subject to paragraph (2), these Regulations do not apply to spare parts.

(2) Nothing in this regulation shall be taken to affect the application of these Regulations to apparatus into which a spare part has been incorporated.

(3) In this regulation, “spare part” means a component or combination of components intended for use in replacing parts of electrical apparatus.

Supply to the authorised representative

14

These Regulations do not apply to the supply of apparatus by the manufacturer thereof to his authorised representative.

Second-hand apparatus

15

(1) Subject to paragraph (2) below, these Regulations do not apply to second-hand apparatus.

(2) Nothing in paragraph (1) above shall be taken to disapply these Regulations to—

(a) the supply of second-hand apparatus which has, since it was last used, been subjected to further manufacture within the meaning of sub-paragraphs (c) or (d) of the definition of manufacture in regulation 3(1) above;

(b) the supply or taking into service of such apparatus following such further manufacture; or

(c) the supply or taking into service in the Community of apparatus which has previously been supplied or used in a country or territory outside the Community.

(3) In this regulation, “second-hand apparatus” means apparatus which has previously been used by an end user.

Electromagnetically benign apparatus

16

These Regulations do not apply to apparatus the inherent qualities of which are such that neither is it liable to cause, nor is its performance liable to be degraded by, electromagnetic disturbance.

Apparatus for use in a sealed electromagnetic environment

17

These Regulations do not apply to—

(a) the supply of any apparatus—

(i) for which the usual electromagnetic environment is a sealed electromagnetic environment; and

(ii) which is accompanied by instructions which state that the apparatus is suitable for use only in a sealed electromagnetic environment; or

(b) the taking into service of any apparatus in such an environment.

Radio amateur apparatus

18

(1) These Regulations do not apply to radio amateur apparatus which is not available commercially.

(2) In this regulation, “available commercially” means manufactured in the course of a business of manufacture of relevant apparatus.

Military equipment

19

(1) These Regulations do not apply to military equipment.

(2) In this regulation, “military equipment” means apparatus which is designed for use as arms, munitions or war material within the meaning of Article 223.1(b) of the Treaty establishing the European Community (notwithstanding that it may be capable of other applications), but does not include apparatus which is designed both for such use and for other applications.

Apparatus covered by other Directives

Active implantable medical devices

20

(1) These Regulations do not apply to active implantable medical devices.

(2) In this regulation “active implantable medical device” has the meaning given by Article 1.2(c) of Council Directive 90/385/EEC on the approximation of laws of the member States relating to active implantable medical devices.

In vitro medical devices

21

(1) These Regulations do not apply to in vitro medical devices and their accessories.

(2) In this regulation “in vitro medical device” has the meaning given by Article 1.2(b) of Directive 98/79/EC concerning in vitro medical devices and “accessory” has the meaning given in Article 1. 2(c) of that Directive.

Medical devices

22

(1) These Regulations do not apply to medical devices.

(2) Insofar as the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963 impose electromagnetic compatibility requirements which must be complied with if a relevant medical device is to be supplied, used or taken into service, those Regulations shall cease to apply except where the manufacturer elects to comply with the Wireless Telegraphy (Control of Interference from Electro Medical Apparatus) Regulations 1963 if applicable.

(3) In this regulation “medical device” has the meaning given by Article 1.2(a) of Directive 93/42/EEC concerning medical devices.

Vehicles, components and separate technical units

23

(1) These Regulations do not apply to vehicles, components or separate technical units.

(2) In this regulation, in accordance with Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles as adapted to technical progress and amended by Commission Directive 95/54/EC , “vehicle”, “component” and “separate technical unit” have the meanings respectively given to them by Article 2 of Council Directive 70/156/EEC on the approximation of the laws of the member States relating to the type-approval of motor vehicles and their trailers , as amended by Council Directive 92/53/EEC .

Agricultural or forestry tractors

24

(1) These Regulations do not apply to agricultural or forestry tractors insofar as the electromagnetic disturbance generated by them is liable to cause radio interference.

(2) In this regulation, “agricultural or forestry tractor” has the meaning given to “vehicle” in Article 1 of Council Directive 75/322/EEC on the suppression of radio interference produced by agricultural or forestry tractors (electromagnetic compatibility) as amended by Commission Directive 2000/2/EC of 14 January 2000 .

Two and three-wheel motor vehicles

25

(1) These Regulations do not apply to two and three-wheel motor vehicles.

(2) In this regulation, in accordance with Directive 97/24/EC on certain components and characteristics of two and three-wheel motor vehicles , “two and three-wheel motor vehicles” has the meaning given to two or three-wheel motor vehicles referred to in Article 1 of Directive 2002/24/EC relating to the type approval of two and three-wheel vehicles.

Marine Equipment

26

(1) These Regulations do not apply to marine equipment.

(2) In this regulation, “marine equipment” has the meaning given to “equipment”, as defined in Article 2 (b) of Directive 96/98/EC on marine equipment, for use on board as provided for in Article 3 of that Directive.

Electrical Energy Meters

27

(1) These Regulations do not apply to electrical energy meters as regards the immunity thereof.

(2) In this regulation, “electrical energy meter” means any new directly connected induction meter, with single or multiple tariffs, designed to measure active energy single-phase or polyphase current at 53 Hz frequency mentioned or referred to in Article 2 of Council Directive 76/891/EEC on the approximation of the laws of the member States relating to electrical energy meters .

Non-automatic weighing instruments

28

(1) These Regulations do not apply to non-automatic weighing instruments as regards the immunity thereof.

(2) In this regulation, “non-automatic weighing instrument” has the meaning given by the second indent of Article 1.1 read in conjunction with Article 1.2(a) of Council Directive 90/384/EEC on the harmonisation of the laws of the member States relating to non-automatic weighing instruments .

Radio equipment and telecommunications terminal equipment

29

These Regulations do not apply to telecommunications terminal equipment and radio equipment as defined in regulation 2(1) of the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 .

PART III — GENERAL REQUIREMENTS

General duty for supply

30

No person shall supply relevant apparatus unless the requirements of regulation 32 below are complied with in relation to such apparatus.

General duty for taking into service

31

No person shall take into service relevant apparatus unless that apparatus conforms with the protection requirements.

Requirements for supply

32

The requirements of this regulation are that—

(a) the relevant apparatus conforms with the protection requirements;

(b) the conformity assessment requirements have been complied with;

(c) the CE marking has been properly affixed by the manufacturer or his authorised representative in relation to the relevant apparatus in accordance with regulation 35 below; and

(d) the manufacturer or his authorised representative has properly issued an EC declaration of conformity in respect of the relevant apparatus in accordance with the requirements of regulation 36 below.

Conformity assessment requirements—the three routes to compliance

33

The conformity assessment requirements are that—

(a) in the case of relevant apparatus other than radiocommunication transmission apparatus, the requirements of—

(i) Part IV (in these Regulations referred to as “the standards route to compliance”); or

(ii) Part V (in these Regulations referred to as “the technical construction file route to compliance”)

of these Regulations are complied with; and

(b) in the case of radiocommunication transmission apparatus, the requirements of Part VI (in these Regulations referred to as “the EC type-examination route to compliance”) of these Regulations are complied with.

Presumption of conformity

34

Where in relation to any relevant apparatus—

(a) such apparatus conforms to the applicable EMC standard, or all applicable EMC standards, which make provision for that apparatus; or

(b) the conformity assessment requirements are complied with pursuant to the technical construction file route to compliance,

there shall be a presumption (“the presumption of conformity”) that, until the contrary is proved, that relevant apparatus complies with the protection requirements.

The CE marking

35

(1) For the purposes of these Regulations, the CE marking shall be regarded as properly affixed in relation to relevant apparatus if the requirements of this regulation are complied with.

(2) The CE marking shall be affixed in relation to any relevant apparatus by being affixed to one of the following—

(a) the apparatus; or

(b) the apparatus'—

(i) packaging;

(ii) instructions for use; or

(iii) guarantee certificate.

(3) Subject to paragraph (4) below, where the apparatus is the subject of other Community Directives covering other aspects and which also provide for the CE conformity marking, the latter shall indicate that the apparatus is also presumed to conform to those other Directives.

(4) Where one or more of the other Directives referred to in paragraph (3) above allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying such apparatus.

(5) No person shall affix to relevant apparatus, its packaging, the instructions for use or the guarantee certificate any marking which is likely to deceive third parties as to the meaning and form of the CE marking. Any other marking may be affixed to the apparatus, its packaging, the instructions for use or the guarantee certificate provided that the visibility and legibility of the CE marking are not thereby reduced.

(6) No person shall affix the CE marking, or any other inscription liable to be confused with it, in relation to any relevant apparatus, unless—

(a) the apparatus complies with the protection requirements; and

(b) the conformity assessment requirements have been complied with.

(7) Except as provided in paragraph (3) above, no person shall affix the CE marking, or any other inscription liable to be confused with it, to any electrical apparatus other than relevant apparatus.

(8) The CE marking shall comply with the form requirements set out in Schedule 4 to these Regulations.

(9) In these Regulations, “CE marking” means the CE conformity marking, being a mark—

(a) consisting of the initials “CE”;

(b) taking the form set out in paragraph 1 of Schedule 4 hereto; and

(c) which, when used in relation to the EMC Directive, indicates conformity to all the provisions of that Directive, including the conformity assessment requirements.

EC declaration of conformity

36

(1) For the purposes of these Regulations, an EC declaration of conformity is a declaration which indicates that apparatus conforms with the protection requirements of the EMC Directive (howsoever expressed).

(2) For the purposes of these Regulations, an EC declaration of conformity shall be regarded as properly issued in relation to relevant apparatus if the following requirements are complied with—

(a) the apparatus conforms with the protection requirements;

(b) the conformity assessment requirements are complied with;

(i) in the case of a declaration issued pursuant to the standards route to compliance, it complies with the requirements of regulation 42 below;

(ii) in the case of a declaration issued pursuant to the technical construction file route to compliance, it complies with the requirements of regulation 59 below;

(iii) in the case of a declaration issued pursuant to the EC type-examination route to compliance, it complies with the requirements of regulation 72 below;

(d) in the case of a declaration issued other than in the United Kingdom, the declaration is issued by the manufacturer or his authorised representative and contains the following—

(i) a description of the apparatus to which it refers;

(ii) reference to the specifications or harmonised standards or both under which conformity is declared, and where appropriate, to the national measures or recognised national standards or both, as the case may be, implemented to ensure the conformity of the apparatus with the provisions of the EMC Directive;

(iii) identification of the signatory empowered to bind the manufacturer or his authorised representative; and

(iv) where appropriate, reference to the EC type-examination certificate issued by a notified body.

(3) No person shall (in the United Kingdom) issue an EC declaration of conformity in relation to relevant apparatus unless—

(a) the apparatus to which it relates conforms with the protection requirements;

(b) the conformity assessment requirements have been complied with; and

(4) No person shall (in the United Kingdom) issue an EC declaration of conformity in relation to any electrical apparatus other than relevant apparatus.

Retention of documentation

37

(1) A responsible person shall hold an EC declaration of conformity in relation to relevant apparatus at the disposal of the Secretary of State for ten years beginning with the date on which the latest item of relevant apparatus to be supplied in the Community to which the declaration relates was so supplied.

(2) Where the EC declaration of conformity is made pursuant to Part V or VI of these Regulations, the responsible person shall hold the technical construction file, or EC type-examination certificate, as the case may be, at the disposal of the Secretary of State for ten years beginning with the date on which the latest item of relevant apparatus to be supplied in the Community to which the technical construction file or EC type-examination certificate relates was so supplied.

(3) Any documentation to be retained by the responsible person pursuant to the requirements of paragraphs (1) and (2) above may be kept by recording the matters in question in any form, provided that adequate precautions shall be taken for guarding against falsification.

(4) The power conferred on a responsible person in paragraph (3) above includes power to keep the documentation by recording those matters otherwise than in legible form, so long as the recording is capable of being reproduced in a legible form.

(5) If the responsible person records the documentation in question otherwise than in a legible form, any duty imposed on him by these Regulations to allow inspection of, or to furnish a copy of, the documentation or any part of it is to be treated as a duty to allow inspection of, or to furnish, a reproduction of the document or of the relevant part of it in legible form.

PART IV — THE STANDARDS ROUTE TO COMPLIANCE

Application of Part IV

38

(1) Subject to paragraph (2) below, this Part shall have effect for the purposes of providing for the manner in which the conformity assessment requirements may be complied with where the manufacturer has chosen the standards route to compliance.

(2) This Part does not, save for regulation 40, apply to radiocommunication transmission apparatus.

The standards route to compliance

39

The conformity assessment requirements are complied with pursuant to the standards route to compliance if the manufacturer has applied an applicable EMC standard which makes, or all applicable EMC standards which make, complete provision in respect of the apparatus.

Applicable EMC standards

40

(1) This regulation shall have effect for the purpose of making provision in respect of the standards which are to be recognised for the purposes of Article 7 of the EMC Directive.

(2) Except for regulation 49(4) below, a harmonised standard is a technical specification (European standard or harmonisation document)—

(a) adopted for the purposes of Article 7.1(a) of the EMC Directive by the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI) upon a remit from the Commission in accordance with the provisions of Council Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations or Directive 98/34/EC as amended by Directive 98/48/EC ;

(b) the reference number of which has been published in the Official Journal of the European Communities pursuant to that sub-article.

(3) A transposed harmonised standard is a national standard of a Member State—

(a) which transposes a harmonised standard; and

(b) the reference number of which has been published—

(i) by the relevant member State pursuant to Article 7.1(a) of the EMC Directive; or

(ii) in the case of a transposed harmonised standard of the United Kingdom, pursuant to regulation 41(1) below.

(4) A recognised national standard is a standard of a member State—

(a) which applies to relevant apparatus for which no harmonised standard has been adopted;

(b) which is recognised as a national standard for the purposes of Article 7.1(b) of the EMC Directive, the Commission having notified the member States pursuant to Articles 7.2 and 8.2 of that Directive that that standard enjoys the presumption of conformity with the protection requirements for the time being and published its reference number in the Official Journal pursuant to Article 7.2 of the Directive; and

(i) a member State other than the United Kingdom, the reference number of which has been published by the relevant member State pursuant to the said Article 7.2;

(ii) the United Kingdom, the reference number of which has been published (and not withdrawn) pursuant to regulation 41(2) below.

(5) In relation to any description of relevant apparatus, an applicable EMC standard is either a transposed harmonised standard or a recognised national standard within the scope of which that description of relevant apparatus falls.

Publication of reference numbers of standards

41

(1) The Secretary of State shall from time to time publish pursuant to this paragraph, lists of the reference numbers of standards which are to be regarded as the transposed harmonised standards of the United Kingdom for the time being for the purposes of Article 7.1(a) of the EMC Directive.

(2) The Secretary of State shall from time to time publish pursuant to this paragraph lists of the reference numbers of standards which are to be regarded as the recognised national standards of the United Kingdom for the time being for the purposes of Article 7.1(b) of the EMC Directive.

(3) The Secretary of State shall from time to time publish lists of the reference numbers of standards which are for the time being transposed harmonised standards and recognised national standards of the member States other than the United Kingdom.

EC declaration of conformity pursuant to the standards route to compliance

42

(1) This regulation shall have effect for prescribing the form of an EC declaration of conformity issued in the United Kingdom in respect of relevant apparatus in relation to which the conformity assessment requirements have been complied with pursuant to the standards route to compliance.

(2) An EC declaration of conformity to which this regulation applies shall—

(a) be in English;

(b) give the name and address—

(i) of the responsible person;

(ii) where that person is not the manufacturer, of the manufacturer;

(d) bear the date of issue;

(e) give particulars of the relevant apparatus to which it relates sufficient to identify it;

(f) state the numbers and titles of the applicable EMC standards applied by the manufacturer; and

(g) certify that the apparatus to which it relates conforms with the protection requirements of the EMC Directive.

PART V — THE TECHNICAL CONSTRUCTION FILE ROUTE TO COMPLIANCE

General

Application of Part V

43

This Part shall have effect for the purposes of providing for—

(a) the circumstances and manner in which the conformity assessment requirements may be complied with pursuant to the technical construction file route to compliance; and

(b) the appointment of United Kingdom competent bodies to exercise functions in relation thereto, and matters incidental to such appointment and exercise.

Applicability of the technical construction file route to compliance

44

(1) Subject to paragraph (2) below, the conformity assessment requirements may be complied with pursuant to the technical construction file route to compliance where—

(a) there are applicable EMC standards which make complete provision in respect of the apparatus, but the manufacturer has chosen not to apply all or any of those standards either as regards the whole or part thereof;

(b) there is no applicable EMC standard; or

(c) there are applicable EMC standards and the manufacturer has applied all or any of them as regards the whole or part thereof, but they do not make complete provision in respect of the apparatus.

(2) The technical construction file route to compliance shall not apply in respect of radiocommunication transmission apparatus.

Technical construction files

45

(1) A technical construction file is a file which—

(a) describes the apparatus to which it relates;

(b) contains information about the design, manufacture and operation thereof;

(c) sets out the procedures used to ensure the conformity of the apparatus with the protection requirements in respect of the applicable EM characteristics of the apparatus in respect of which the manufacturer has not applied an applicable EMC standard; and

(d) includes a technical report or technical certificate.

(2) A technical construction file may be composed in relation to—

(a) a single item of apparatus;

(b) where a number of items are to be produced, a specimen representative of the production envisaged (a “representative”); or

(c) a number of items of apparatus or representatives of each such item or representative being variants of the same basic design (each such item or representative being referred to as a “variant”).

(3) Without prejudice to the generality of paragraph (1) above, a technical construction file composed in the United Kingdom shall—

(a) be in material form;

(b) be in—

(i) English where application for the technical report or technical certificate is made to a United Kingdom competent body; or

(ii) any official Community language acceptable to the competent body where such application is made to a competent body of another member State;

(i) of the responsible person;

(ii) where that person is not the manufacturer, of the manufacturer;

(d) contain such information as is sufficient, in all the circumstances of the case, to enable the enforcement authority to—

(i) identify the apparatus to which it relates; and

(ii) ascertain whether the apparatus to which it relates conforms with the protection requirements;

(e) state the numbers and titles of the applicable EMC standards, and any other standards, specifications or codes of practice, applied by the manufacturer; and

(f) contain particulars of the electromagnetic environment for which the apparatus is suitable.

The technical construction file route to compliance

46

The conformity assessment requirements are complied with in relation to relevant apparatus pursuant to the technical construction file route to compliance if the manufacturer or his authorised representative has composed a technical construction file in respect of the apparatus.

Competent bodies

47

For the purposes of these Regulations, a competent body is a body responsible for issuing technical reports and technical certificates pursuant to Article 10.2 of the EMC Directive either for all descriptions of relevant apparatus (other than radiocommunication transmission apparatus) or for specific descriptions thereof, and which is for the time being—

(a) a United Kingdom competent body pursuant to appointment under regulation 48 below;

(b) a competent body of a member State other than the United Kingdom; or

(c) recognised for the purpose of carrying out those functions by inclusion in a mutual recognition agreement relating to the EMC Directive or a similar agreement (including a Protocol to the Europe Agreement, or other Agreement, on Conformity Assessment and Acceptance of Industrial Products) which has been concluded between the Community and a State other than an EEA State.

United Kingdom competent bodies

Appointment

48

(1) Subject to regulation 49 below, the Secretary of State may appoint a person as a United Kingdom competent body in accordance with the following provisions of this regulation.

(2) An appointment under this regulation shall be in writing and shall, subject to regulations 50(5) and 51(3) below, be subject to such conditions as the Secretary of State may impose for the time being, and such conditions may include conditions which are to apply on or following the termination or expiry of the appointment.

(3) Subject to regulation 49(2) below, an appointment under this regulation shall have effect in respect of such descriptions of relevant apparatus as the Secretary of State may for the time being authorise, and in this Part, “authorised” shall be construed accordingly.

(4) In exercising the power conferred by paragraph (1) above, the Secretary of State may (in addition to the matters of which she is required to satisfy herself pursuant to regulation 49(2) below) have regard to any matter appearing to her to be relevant, and, without prejudice to the generality of the foregoing, she may have regard to any standards relating to the accreditation of laboratories or certification bodies appearing to her to be appropriate.

(5) Subject to regulation 50 below, an appointment under this regulation may be for—

(a) the time being; or

(b) such period as may be specified in the appointment.

(6) The Secretary of State shall from time to time publish lists of United Kingdom competent bodies indicating the descriptions of relevant apparatus in respect of which each body is authorised; and such lists may include information concerning any condition to which the appointment of any competent body is for the time being subject.

Eligibility and verification

49

(1) Subject to paragraph (2) below, the following persons shall be eligible for appointment as United Kingdom competent bodies—

(a) the Secretary of State; and

(b) any person resident, incorporated, or carrying on a business in the United Kingdom.

(2) The criteria listed in Schedule 5 hereto (being the criteria for the assessment of the bodies to be notified listed in Annex II of the EMC Directive and the criteria which competent bodies are required by Article 1.5 of that Directive to meet) (“the minimum criteria”) must be satisfied in relation to any person if that person is to be appointed or remain a United Kingdom competent body, and accordingly the Secretary of State shall not—

(a) make an appointment under regulation 48(1) above unless she is satisfied that the person concerned meets the minimum criteria; or

(b) authorise under regulation 48(3) above the appointment to have effect in relation to any description of relevant apparatus unless she is satisfied that the body meets the minimum criteria in respect of that description of apparatus.

(3) The Secretary of State shall from time to time verify that each United Kingdom competent body meets the minimum criteria listed in paragraphs 1 and 2 of Schedule 5 hereto.

(4) A person who complies with the assessment criteria fixed by a standard which is a relevant harmonised standard within the meaning of Article 10.6 of the EMC Directive shall be presumed to meet the minimum criteria.

(5) An appointment under regulation 48 above may be subject to the condition that only a defined part of the undertaking of the appointed person may exercise the functions of a competent body, and where an appointment is, or is to be, subject to such a condition—

(a) a reference in these Regulations to a person's meeting the minimum criteria shall be construed in relation to that person as a reference to the part of that person's undertaking so defined meeting those criteria; and

(b) the conditions of the appointment shall include provision for ensuring that the confidentiality of confidential information held by the part of the undertaking so defined in pursuance of its function as a United Kingdom competent body is protected from disclosure to other parts of the undertaking.

(6) Upon the expiry of an appointment under regulation 48 above, the United Kingdom competent body shall be eligible for re-appointment.

Termination of appointment and transfer of functions

50

(1) The Secretary of State, by notice in writing (a “notice of termination”)—

(a) shall terminate the appointment of a United Kingdom competent body where—

(i) the body so requests; or

(ii) it appears to the Secretary of State that—

(aa) the body no longer satisfies the minimum criteria; or

(bb) it is necessary in the interests of manufacturers, suppliers or end users of relevant apparatus to terminate the body's appointment; and

(b) may terminate such appointment if the body is in breach of a condition of appointment.

(2) Where the Secretary of State exercises the power conferred by paragraph (1) above—

(a) the notice of termination shall take effect on such date as shall be specified therein; and

(b) the Secretary of State shall inform the appropriate authorities of the other member States and the Commission.

(3) Where the Secretary of State—

(a) withdraws the authorisation of a United Kingdom competent body to exercise functions in relation to any description of apparatus pursuant to regulation 48(3) above; or

(b) terminates the appointment of such a body pursuant to paragraph (1) of this regulation,

she may give such directions (either to the body the subject of the withdrawal or termination, as the case may be, or to another authorised United Kingdom competent body) for the purposes of making such arrangements for the determination of outstanding applications as she considers appropriate.

(4) Without prejudice to the generality of the power conferred by paragraph (3) above, such directions may include the manner in which fees already received pursuant to regulation 51 below in respect of outstanding applications by the body the subject of the withdrawal or termination, as the case may be, are to be disposed of, having regard to the work already done on such applications by that body.

(5) The Secretary of State shall, where she takes an action referred to in paragraph (3)(a) or (b) above in relation to a United Kingdom competent body, give such directions as she considers appropriate to provide for the exercise by another United Kingdom competent body or herself of the powers conferred by regulations 56(3) and 57 below exercisable by the first mentioned United Kingdom competent body, and where such directions have been given, a reference in those provisions to the United Kingdom competent body which issued a technical certificate or technical report shall be construed as a reference to that other United Kingdom competent body or to the Secretary of State, as the case may be.

Power of competent body other than the Secretary of State to charge fees

51

(1) Without prejudice to the power of the Secretary of State, where she is a United Kingdom competent body, to charge fees pursuant to regulations made under section 56 of the Finance Act 1973 and subject to paragraphs (2) and (3) below, a United Kingdom competent body other than the Secretary of State may charge applicants for technical reports or technical certificates such fees in connection with or incidental to the consideration of applications therefor as the body may determine; and such fees may include an amount on account of profit which is reasonable in the circumstances having regard to—

(a) the character and extent of the work done or to be done by the body in the determination of such applications; and

(b) the commercial rate normally charged on account of profit for that work or similar work.

(2) The power in paragraph (1) above includes power to require the payment of fees or a reasonable estimate thereof with the application.

(3) Without prejudice to the generality of regulation 48(2) above, the conditions to which an appointment under regulation 48(1) may be subject may include a requirement to publish from time to time the scale of fees which the United Kingdom competent body charges pursuant to this regulation, or such information about the basis of calculation thereof as may be specified in the condition.

Applications for technical reports and technical certificates

52

(1) Subject to regulation 53 below, a United Kingdom competent body shall determine applications made thereto for the issue of technical reports and technical certificates in respect of relevant apparatus of authorised descriptions.

(2) In determining such applications, the United Kingdom competent body—

(a) shall have regard to the actual or usual electromagnetic environment of the apparatus; and

(b) may have regard to any standards (whether applicable EMC standards or otherwise) or other technical criteria appearing to it to be relevant.

(3) Where in the opinion of the United Kingdom competent body the apparatus to which an application relates conforms with the protection requirements, it shall issue a technical report or technical certificate, as the case may be, which complies with the requirements of regulation 55 below.

(4) Subject to regulation 58 below, where in the opinion of the United Kingdom competent body the apparatus to which the application relates does not conform with the protection requirements, it shall refuse to issue a technical report or technical certificate, as the case may be, giving written reasons for the refusal.

Limitations on duty to exercise functions

53

(1) A United Kingdom competent body shall not accept any application for a technical report or technical certificate in respect of any apparatus unless the application—

(a) is in writing;

(b) is accompanied by a draft technical construction file, that is to say, a file containing such information as will, when the technical report or technical certificate as the case may be is added thereto, be sufficient to constitute the file as a technical construction file;

(c) includes particulars of which applicable EMC standards the manufacturer has applied or proposes to apply in respect of the apparatus, and in respect of which applicable EM characteristics; and

(d) contains a declaration by the applicant that no application to another competent body for a technical report or technical certificate in respect of that apparatus is outstanding.

(2) A United Kingdom competent body shall not be required to—

(a) accept an application for a technical report or technical certificate where—

(i) the application, and the draft technical construction file, are not in English or another language acceptable to that body;

(ii) the applicant has not submitted with the application the amount of the fee which the competent body (not being the Secretary of State) requires to be submitted with the application pursuant to regulation 51(2) above; or

(iii) the body reasonably believes that, having regard to the number of applications for technical reports or technical certificates made to it which are outstanding, it will be unable to determine the application within three months of receiving the application;

(b) determine an application for a technical report or technical certificate where the manufacturer has not—

(i) granted the body access to the apparatus to which the application relates or the production facilities for the apparatus (including where applicable the production envisaged in relation to a representative) to the extent that the body reasonably requests; and

(ii) made available to the body such information as it may reasonably require to determine the application; or

(c) having determined the application, inform the applicant of the result thereof or, in the case of a successful application, issue the technical report or technical certificate, unless the applicant has paid any fees chargeable pursuant to regulation 51 above or in accordance with regulations made under section 56 of the Finance Act 1973, as the case may be.

Contractors etc.

54

(1) Subject to paragraphs (2) and (3) below, a United Kingdom competent body may, in exercising its functions—

(a) arrange for some other person to carry out any test, assessment or inspection on its behalf; or

(b) require the applicant to satisfy another person with respect to any matter at the applicant's expense.

(2) Nothing in paragraph (1) above authorises a United Kingdom competent body to rely on the opinion of another person with regard to whether any relevant apparatus conforms with the protection requirements.

(3) Nothing in these Regulations shall preclude a person referred to in paragraph (1)(a) or (b) above from charging any fee in respect of any work undertaken by him in pursuance of those sub-paragraphs.

Form of technical reports and technical certificates

55

A technical report or technical certificate issued by a United Kingdom competent body shall be in writing and shall—

(a) be in English;

(b) give the name and address—

(i) of the applicant;

(ii) where that person is not the manufacturer, of the manufacturer;

(d) bear—

(i) the date of issue; and

(ii) the number of the report or certificate;

(e) give particulars of the relevant apparatus (where applicable, in relation to each variant) to which it relates sufficient to identify it, and shall state whether the apparatus to which it relates is a single item or a representative, or a number of variants thereof, as the case may be;

(f) certify that the apparatus to which it relates conforms with the protection requirements of the EMC Directive.

Conditions of technical reports or technical certificates

56

(1) Subject to regulation 58 below and paragraphs (2) and (3) of this regulation, a technical report or technical certificate issued by a United Kingdom competent body may be unconditional or subject to such conditions, which must be complied with if the report or certificate as the case may be is to apply, as the body considers appropriate.

(2) Without prejudice to the generality of paragraph (1) above, such conditions may include—

(a) a limitation on the electromagnetic environment for which the apparatus may be stated to be suitable; or

(b) a limitation that the apparatus is only to be installed at a specific site.

(3) The conditions imposed pursuant to paragraph (1) above may be varied by the United Kingdom competent body which issued the technical report or technical certificate, and a variation under this paragraph may include the imposition of new conditions or the removal of conditions.

Withdrawal of technical reports or technical certificates

57

(1) Subject to regulation 58 below and paragraph (2) of this regulation, the United Kingdom competent body which issued a technical report or technical certificate shall withdraw that report or certificate as the case may be if it appears that the apparatus to which it relates does not conform with the protection requirements.

(2) A withdrawal of a technical report or technical certificate shall be by notice in writing stating the reasons for the withdrawal.

Procedure where United Kingdom competent body is minded to make an unfavourable decision

58

Before making an unfavourable decision in respect of an applicant, that is to say—

(a) refusing to grant a technical report or technical certificate pursuant to regulation 52(4) above;

(b) the imposition of a condition of a technical report or technical certificate or the making of a restrictive variation of a condition thereof pursuant to regulation 56 above in circumstances where the applicant has not indicated in writing that the apparatus concerned is suitable for use subject to that condition;

the United Kingdom competent body shall—

(i) give notice in writing to the applicant, or holder of the technical report or technical certificate concerned, as the case may be (“the person concerned”), of the reasons why it proposes to make the unfavourable decision; and

(ii) give the person concerned the opportunity of making representations within a period of 28 days of the notice being given as to why that body should make a favourable decision, and consider any representations which are made by that person within that period.

EC declaration of conformity

EC declaration of conformity where conformity assessment requirements are complied with by reference to a technical construction file

59

(1) This regulation shall have effect for prescribing the form of an EC declaration of conformity issued in the United Kingdom in respect of relevant apparatus in relation to which the conformity assessment requirements have been complied with pursuant to the technical construction file route to compliance.

(2) An EC declaration of conformity to which this regulation applies shall—

(a) be in English;

(b) give the name and address—

(i) of the responsible person;

(ii) where that person is not the manufacturer, of the manufacturer;

(d) bear the date of issue;

(e) give particulars of the relevant apparatus to which it relates sufficient to identify it;

(f) identify the technical construction file relating thereto, and give the name and address of the competent body which issued the technical report or technical certificate, and the date and any number thereof;

(g) state the numbers and titles of the applicable EMC standards, if any, applied by the manufacturer; and

(h) certify that the apparatus to which it relates conforms with the protection requirements of the EMC Directive.

Final provisions

Interpretation of Part V

60

(1) In this Part—

“authorised” in relation to any description of apparatus shall be construed in accordance with regulation 48(3);

“minimum criteria” shall be construed in accordance with regulation 49(2);

“representative” shall be construed in accordance with regulation 45(2)(b); and

“variant” shall be construed in accordance with regulation 45(2)(c).

PART VI — THE EC TYPE-EXAMINATION ROUTE TO COMPLIANCE FOR RADIOCOMMUNICATION TRANSMISSION APPARATUS

General

Application of Part VI

61

(1) This Part shall have effect for the purposes of providing for—

(a) the manner in which the conformity assessment requirements shall be complied with in relation to radiocommunication transmission apparatus pursuant to the EC type-examination route to compliance; and

(b) United Kingdom notified bodies to exercise functions in relation thereto, and matters incidental to such exercise.

(2) For the purposes of these Regulations, “radiocommunication transmission apparatus” is wireless telegraphy apparatus for—

(a) transmitting; or

(b) both transmitting and receiving,other than—

(i) radio amateur apparatus designed, and intended by the manufacturer, for use exclusively by radio amateurs;

(ii) apparatus neither designed nor intended by the manufacturer to be used for transmitting in conjunction with other wireless telegraphy apparatus; or

(iii) apparatus which is dependent for its operation on a magnetic as distinct from an electromagnetic field.

The EC type-examination route to compliance

62

The conformity assessment requirements are complied with in relation to radiocommunication transmission apparatus pursuant to the EC type-examination route to compliance if there is in force an EC type-examination certificate obtained by the responsible person from a notified body in respect of the applicable EM characteristics of the apparatus.

Notified bodies

63

For the purposes of these Regulations, a notified body is a body responsible for issuing EC type-examination certificates pursuant to Article 10.5 of the EMC Directive either for all descriptions of radiocommunication transmission apparatus or for specific descriptions thereof, and which is—

(a) a United Kingdom notified body pursuant to regulation 64 below;

(b) for the time being a notified body of a member State other than the United Kingdom having been notified as a notified body by the member State concerned to the Commission and the other member States pursuant to Article 10.6 of the EMC Directive; or

(c) recognised for the purpose of carrying out those functions by inclusion in a mutual recognition agreement relating to the EMC Directive or a similar agreement (including a Protocol to the Europe Agreement, or other Agreement, on Conformity Assessment and Acceptance of Industrial Products) which has been concluded between the Community and a State other than an EEA State.

United Kingdom notified bodies

Bodies and scope of authority

64

The following shall be United Kingdom notified bodies in relation to the descriptions (“authorised descriptions”) of radiocommunication transmission apparatus referred to in relation thereto in Schedule 6—

(a) the Civil Aviation Authority (“the CAA”);

(b) OFCOM.

Power of CAA and OFCOM to charge fees

65

(1) Subject to paragraph (2) below, the CAA and OFCOM may charge applicants for EC type-examination certificates such fees as they may determine provided that such fees shall not exceed the sum of the following –

(a) the costs incurred or to be incurred by the notified body in performing the relevant function; and

(b) an amount on account of profit which is reasonable in the circumstances having regard to—

(i) the character and extent of the work done or to be done by the body on behalf of the applicant; and

(ii) the commercial rate normally charged on account of profit for that work or similar work.

(2) The power in paragraph (1) above includes power to require the payment of fees or a reasonable estimate thereof with the application.

(3) The CAA and OFCOM shall each publish from time to time the scale of fees charged by it, or such information about the basis of calculation thereof as the Secretary of State may direct.

Applications for EC type-examination certificates

66

(1) It shall be the function of a United Kingdom notified body to determine applications made to it in writing for the issue of EC type-examination certificates from the manufacturer or his authorised representative in respect of authorised descriptions of radiocommunication transmission apparatus.

(2) Subject to regulation 67, a United Kingdom notified body shall, following receipt of an application in respect of an authorised description of apparatus—

(a) examine the apparatus and the design thereof;

(b) subject the apparatus or cause it to be subjected to such tests as the body considers appropriate to determine whether or not the apparatus conforms with the protection requirements in all the circumstances (having regard, without prejudice to the generality of the foregoing, to the actual or usual electromagnetic environment in which the apparatus is to be used), and, where there is a relevant transposed harmonised standard or a recognised national standard and the body considers it appropriate to apply that standard, such tests as may be provided for thereby.

(3) Following examination and testing pursuant to paragraph (2) above, the United Kingdom notified body shall determine whether or not the apparatus to which the application relates conforms with the protection requirements.

(4) Where in the opinion of the United Kingdom notified body the apparatus to which an application relates conforms with the protection requirements, it shall issue an EC type-examination certificate in respect thereof.

(5) Subject to regulation 71 below, where in the opinion of the United Kingdom notified body the apparatus to which the application relates does not conform with the protection requirements, it shall refuse to issue the EC type-examination certificate, giving written reasons for the refusal.

(6) An EC type-examination certificate may relate to—

(a) a single item of apparatus;

(b) where a number of items are to be produced, a specimen representative of the production envisaged (a “representative”); or

Limitations on duty to exercise functions

67

(1) Nothing in these Regulations shall require a United Kingdom notified body to determine a relevant application—

(a) which is not in English or another language acceptable to that body; or

(b) where the applicant has not—

(i) granted the body access to the radiocommunication transmission apparatus to which the application relates or the production facilities for the apparatus (including where applicable, the production envisaged in relation to a representative) to the extent that the body reasonably requests; and

(ii) made available to the body such information as it may reasonably require to determine the application.

(2) Nothing in these Regulations shall require a United Kingdom notified body to—

(a) determine a relevant application; or

(b) having determined the application, inform the applicant of the result thereof or, in the case of a successful application, issue the EC type-examination certificate,

unless the applicant has paid the fees charged pursuant to regulation 65 above.

Contractors etc.

68

(1) Subject to paragraphs (2) and (3) below, a United Kingdom notified body may, in exercising its functions—

(a) arrange for some other person to carry out any test, assessment or inspection on its behalf; or

(b) require the applicant to satisfy another person with respect to any matter at the applicant's expense.

(2) Nothing in paragraph (1) above authorises a United Kingdom notified body to rely on the opinion of another person with regard to whether any radiocommunication transmission apparatus conforms with the protection requirements.

(3) Nothing in these Regulations shall preclude a person referred to in sub-paragraph (1)(a) or (b) above from charging any fee in respect of any work undertaken by him in pursuance of those sub-paragraphs.

Conditions of EC type-examination certificates

69

(1) Subject to regulation 71 below and paragraphs (2) and (3) of this regulation, an EC type-examination certificate issued by a United Kingdom notified body may be unconditional or subject to such conditions, which must be complied with if the certificate is to apply, as the body considers appropriate.

(2) Without prejudice to the generality of paragraph (1) above, such conditions may include—

(a) a limitation on the electromagnetic environment for which the apparatus may be stated to be suitable; or

(b) a limitation that the apparatus is only to be installed at a specific site.

(3) The conditions imposed pursuant to paragraph (1) above may be varied by the United Kingdom notified body which issued the EC type-examination certificate, and a variation under this paragraph may include the imposition of new conditions or the withdrawal of conditions.

Withdrawal of EC type-examination certificates

70

(1) Subject to regulation 71 below and paragraph (2) of this regulation, the United Kingdom notified body which issued an EC type-examination certificate shall withdraw that certificate if it appears that the apparatus to which it relates does not conform with the protection requirements.

(2) A withdrawal of an EC type-examination certificate shall be by notice in writing stating the reasons for the withdrawal.

Procedure where United Kingdom notified body is minded to make a decision unfavourable to the applicant

71

Before making an unfavourable decision in respect of an applicant, that is to say—

(a) refusing to grant an EC type-examination certificate pursuant to regulation 66(5) above;

(b) the imposition of a condition of an EC type-examination certificate or the making of a restrictive variation of a condition thereof pursuant to regulation 69 above in circumstances where the applicant has not indicated in writing that the apparatus concerned is suitable for use subject to that condition;

the United Kingdom notified body shall—

(i) give notice in writing to the applicant, or holder of the EC type-examination certificate concerned, as the case may be (“the person concerned”), of the reasons why it proposes to make the unfavourable decision; and

(ii) give the person concerned the opportunity of making representations within a period of 28 days of the notice being given as to why that body should make a favourable decision, and consider any representations which are made by that person within that period.

EC declaration of conformity

EC declaration of conformity for radiocommunication transmission apparatus

72

(1) This regulation shall have effect for prescribing the form of an EC declaration of conformity issued in the United Kingdom in respect of radiocommunication transmission apparatus.

(2) An EC declaration of conformity to which this regulation applies shall—

(a) be in English;

(b) give the name and address—

(i) of the responsible person;

(ii) where that person is not the manufacturer, of the manufacturer;

(d) bear the date of issue;

(e) give particulars of the relevant apparatus to which it relates sufficient to identify it;

(f) identify the EC type-examination certificate relating thereto, and give the name and address of the notified body which issued it, and the date and any number thereof; and

(g) certify that the apparatus to which it relates conforms with the protection requirements of the EMC Directive.

Final provisions

Savings

73

(1) For the avoidance of doubt, it is hereby declared that nothing in this Part shall be construed as dispensing with any requirement—

(a) of a licence granted under—

(i) section 1 of the 1949 Act to establish and use any station for wireless telegraphy or to install and use any wireless telegraphy apparatus;

(ii) Part I of the Broadcasting Act 1990 ;

(iii) Part III of the Broadcasting Act 1990 to provide independent radio services within the meaning of that Part; or

(iv) the Broadcasting Act 1996 ;

(b) that apparatus be approved under section 84 of the 1984 Act;

(d) of an order made under—

(i) section 7of the Wireless Telegraphy Act 1967 ; or

(ii) section 85 or 86 of the 1984 Act; or

(e) of a continuation notice under paragraph 9 of Schedule 18 to the Communications Act 2003 given to a person who was a holder of a licence granted under section 7 of the 1984 Act.

(2) Nothing in this Part shall affect the validity of an EC-type examination certificate lawfully issued by a notified body pursuant to regulation 60 of the Electromagnetic Compatibility Regulations 1992.

Interpretation of Part VI

74

In this Part—

“authorised description” shall be construed in accordance with regulation 64 above;

“examine” includes, where a UK notified body considers appropriate, the disassembly of apparatus.

PART VII — ENFORCEMENT

Enforcement authorities and powers

Enforcement authorities

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