The Electromagnetic Compatibility Regulations 2016

Made: 15th November 2016

Laid before Parliament: 16th November 2016

Coming into force: 8th December 2016

The Secretary of State is 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 could be affected by such disturbance.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of EU instruments to be construed as references to those provisions as amended from time to time.

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972.

PART 1

Citation and commencement

1

These Regulations may be cited as the Electromagnetic Compatibility Regulations 2016 and come into force on 8th December 2016.

Interpretation

2

• (1) In these Regulations—

• the “1987 Act” means the Consumer Protection Act 1987 ;

• the “2006 Regulations” means the Electromagnetic Compatibility Regulations 2006 ;

• ...

• ...

• “approved body” has the meaning given in regulation 43 (approved bodies);

• “apparatus” means any finished appliance or combination thereof made available on the market 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 and includes—components or sub-assemblies intended for incorporation into an apparatus by an end-user, which are liable to generate or be affected by electromagnetic disturbance;a mobile installation defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations;

• “authorised representative” means a person established within the United Kingdom appointed in accordance with regulation 38 (appointment of an authorised representative);

• ...

• ...

• “conformity assessment” means the process demonstrating whether the essential requirements relating to apparatus have been fulfilled;

• “conformity assessment body” means a body that performs conformity assessment activities;

• “conformity assessment procedure” means a procedure referred to in regulation 40;

• “declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 10(1)(a) (declaration of conformity and UK marking);

• “designated standard” has the meaning given to it in regulation 2A;

• “the Directive” means Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of laws of the Member States relating to electromagnetic compatibility (recast) ...;

• “distributor” means any person in the supply chain, other than the manufacturer, authorised representative or importer, who makes apparatus available on the market;

• “district council” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972 ;

• “economic operator” means a manufacturer, authorised representative, importer or distributor;

• “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;

• “electromagnetic disturbance” means any electromagnetic phenomenon which may degrade the performance of equipment; an electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself;

• “electromagnetic environment” means all electromagnetic phenomena observable in a given location;

• “enforcing authority” is to be interpreted in accordance with regulation 52 (designation of enforcing authorities);

• “equipment” means any apparatus or fixed installation;

• “essential requirements” means the requirements set out in Schedule 1;

• ...

• ...

• “European Commission” means the Commission of the European Union;

• “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;

• ...

• “immunity” means the ability of equipment to perform as intended without degradation in the presence of electromagnetic disturbance;

• “importer” means a person who—is established in the United Kingdom and places apparatus from a country outside of the United Kingdom on the market; oris established in Northern Ireland and places apparatus on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

• “make available on the market” means any supply of apparatus for distribution or use on the market of Great Britain in the course of a commercial activity, whether in return for payment or free of charge, and related expressions must be construed accordingly;

• “manufacturer” means a person who—manufactures apparatus or has apparatus designed or manufactured; andmarkets that apparatus under that person's name or trademark;

• “market surveillance authority” has the meaning given in regulation 53 (designation of market surveillance authorities);

• “mobile installation” means a combination of apparatus and, where applicable, other devices, which are intended to be moved and operated in a range of locations;

• ...

• ...

• ...

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

• ...

• “place on the market” means the first making available of apparatus on the market of Great Britain, and related expressions must be construed accordingly;

• “put into service” means the first use of equipment in the United Kingdom market by its end-user for the purposes for which it was intended, and related expressions must be construed accordingly;

• “RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 ;

• “recall” means any measure aimed at achieving the return of apparatus that has already been made available to the end-user, and related expressions must be construed accordingly;

• “relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 40 (conformity assessment procedures);

• “relevant economic operator” means, in relation to apparatus, an economic operator with obligations in respect of that apparatus under Part 2;

• “technical specification” means a document that prescribes technical requirements to be fulfilled by the equipment;

• “UK marking” means the marking in the form set out in Annex 2 of RAMS;

• “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

• “weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 ;

• “withdrawal” means any measure aimed at preventing apparatus in the supply chain from being made available on the market, and related expressions must be construed accordingly.

• (2) In these Regulations, a reference to apparatus or equipment being “in conformity with Part 2” means that—

• (a) the apparatus or equipment is in conformity with the essential requirements; and

• (b) each relevant economic operator has complied with the obligations imposed on them under Part 2 which must be satisfied at or before the time at which they make the apparatus or equipment available on the market.

• (3) In these Regulations, “risk” means a risk to the protections against electromagnetic disturbance referred to in these Regulations.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application

3

• (1) Subject to paragraphs (2) to (4) and regulations 4 to 6, these Regulations apply to all equipment.

• (2) These Regulations do not apply to—

• (a) equipment to which the Radio Equipment Regulations 2017 apply;

• (b) aeronautical apparatus, parts and appliances as referred to in Regulation (EC) 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC ;

• (c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution of the International Telecommunication Union and the Convention of the International Telecommunication Union ;

• (d) equipment the inherent nature and 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; and

• (ii) it operates without an unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use;

• (e) custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

• (3) These Regulations do not apply to kits of components to be assembled by radio amateurs and equipment made available on the market and modified by and for the use of radio amateurs.

• (4) These Regulations do not apply to equipment covered by the Measuring Instruments Regulations 2016.

• (5) Each provision of these Regulations applies to equipment in so far as there are no specific provisions in ... any enactment governing the conformity of the equipment with the essential requirements, other than these Regulations. Where equipment is subject to essential requirements imposed by ... any enactment other than these Regulations, these Regulations only apply insofar as the equipment is not covered by the other provisions of that enactment.

Application of safety legislation

4

Nothing in these Regulations affects the application of any enactment regulating the safety of equipment.

Exhibition at trade fairs

5

Nothing in these Regulations prevents the display or demonstration at a trade fair, exhibition or similar event of equipment which does not comply with these Regulations provided that a visible sign clearly indicates that the equipment—

• (a) is not in conformity with Part 2; and

• (b) will not be made available on the market or put into service until it has been brought into conformity with Part 2.

Making available or putting into service

6

Nothing in these Regulations prevents the making available on the market, or the putting into service in the United Kingdom, of equipment which is in conformity with Part 2 when the equipment is properly installed, maintained and used for its intended purpose.

PART 2 — Obligations of economic operators

Essential requirements

7

A person must not make equipment available on the market or put equipment into service unless it complies with the essential requirements.

Manufacturers

Duty to ensure apparatus complies with the essential requirements

8

Before placing apparatus on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Technical documentation and conformity assessment

9

Before placing apparatus on the market, a manufacturer must—

• (a) carry out a relevant conformity assessment procedure in respect of the apparatus or have such a procedure carried out; and

• (b) draw up—

• (i) the technical documentation referred to in Schedule 2 (module A: internal production control) or Schedule 3 (module B: EU-type examination and module C: conformity to type based on internal production control); and

• (ii) any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the apparatus complies with the essential requirements.

EU declaration of conformity and CE marking

10

• (1) Where the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the apparatus on the market—

• (a) draw up a declaration of conformity in accordance with regulation 41 ...; and

• (b) affix the UK marking in accordance with regulation 42 (UK marking).

• (2) The manufacturer must keep the ... declaration of conformity up-to-date.

• (3) Where apparatus is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment concerned by its title.

Retention of technical documentation and EU declaration of conformity

11

A manufacturer must keep the technical documentation and the EU declaration of conformity (as referred to in regulation 41) drawn up in respect of the apparatus for a period of 10 years beginning on the day on which the apparatus is placed on the market.

Compliance procedures for series production

12

• (1) A manufacturer of apparatus which is manufactured by series production must ensure that, before placing apparatus on the market, procedures are in place to ensure that any apparatus will be in conformity with Part 2.

• (2) In doing so, the manufacturer must take adequate account of—

• (a) any change in the design or characteristics; and

• (b) any change in a designated standard or in another technical specification by reference to which the ... declaration of conformity was drawn up.

Information identifying manufacturer

13

• (1) Before placing apparatus onto the market, a manufacturer (“M”) must ensure that the following appear on the apparatus—

• (a) a type, batch or serial number or an element which identifies M as the manufacturer of the apparatus;

• (b) the name, registered trade name or registered trade mark of the manufacturer; and

• (c) a postal address at which the manufacturer can be contacted.

• (2) The manufacturer must include the relevant information specified in paragraph (1) on the packaging of the apparatus or in a document accompanying the apparatus where—

• (a) due to the size or nature of the apparatus, it is not possible for the information in paragraph (1)(a) to appear on the apparatus; or

• (b) it is not possible for the information in paragraphs (1)(b) or (1)(c) to appear on the apparatus.

• (3) The postal address in paragraph (1)(c) must indicate a single point at which the manufacturer can be contacted.

• (4) The information specified in paragraphs (1)(b) and (1)(c) must be clear, legible and in easily understandable English.

Instructions and information

14

When placing apparatus on the market, a manufacturer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which are clear, legible and in clearly understandable English.

Manufacturer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity

15

• (1) A manufacturer who considers, or has reason to believe, that apparatus which the manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

• (a) bring the apparatus into conformity;

• (b) withdraw the apparatus; or

• (c) recall the apparatus.

• (2) Where the apparatus presents a risk, the manufacturer must immediately inform the market surveillance authority, ... giving details of, in particular—

• (a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

• (b) any corrective measures taken.

Provision of information and co-operation

16

• (1) A manufacturer must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

• (2) A request made under paragraph (1) must be accompanied by the reasons for making the request.

• (3) The information and documentation referred to in paragraph (1)—

• (a) may be provided in paper or electronic form; and

• (b) must be in a language that can be easily understood by the enforcing authority.