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The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

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PART 1U.K.Preliminary

Citation and commencementU.K.

1.  These Regulations may be cited as the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 and come into force on 2nd January 2013.

InterpretationE+W+S

2.  In these Regulations—

[F1“2002 Directive” means Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment](2);

“2008 Regulations” means the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008(1);

“authorised person” means a person authorised by the market surveillance authority in accordance with regulation 35(2);

“authorised representative” means a person appointed in accordance with regulation 22(1);

“cables” means all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more items of EEE to each other;

F2...

“compliance notice” means a notice given under paragraph 1 of Schedule 3;

“conformity assessment” means the process demonstrating whether the requirements of these Regulations are met in relation to EEE;

[F3designated standard” has the meaning given in regulation 2A;]

“the Directive” means Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment(2) [F4, as last amended by [F5Commission Delegated Directive (EU) 2019/1846, and read in accordance with regulation 2B]];

“distributor” means a person in the supply chain, other than the manufacturer or the importer, who makes EEE available on the market;

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

“EEE” means electrical and electronic equipment as defined in regulation 4;

“enforcement notice” means a notice given under paragraph 2 of Schedule 3;

F6...

[F7“importer” means a person who is established in—

(a)

the United Kingdom, who places on the market EEE from a country outside of the United Kingdom; or

(b)

Northern Ireland, who places on the market EEE that has been supplied to that person 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;]

“industrial monitoring and control instruments” means monitoring and control instruments designed for exclusively industrial or professional use;

“infringing EEE” means EEE that does not comply with the requirements of these Regulations;

“make available on the market” means to supply in the course of a commercial activity (whether in return for payment or free of charge) for distribution, consumption or use [F8on the market of Great Britain], and related expressions are to be construed accordingly;

“manufacturer” means a person who manufactures EEE or who has EEE designed or manufactured, and markets it under that person’s name or trademark;

“market surveillance authority” has the meaning given in regulation 35(1);

“medical device”, “active implantable medical device”, and “in vitro diagnostic medical device” have the meanings given in regulation 2(1) of the Medical Devices Regulations 2002(3);

“notice” means a notice in writing;

“place on the market” means to make EEE available [F8on the market of Great Britain] for the first time, and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93(4);

“recall” means to take any measure aimed at achieving the return of EEE that has already been made available to the end user;

“recall notice” means a notice given under paragraph 4 of Schedule 3;

“spare part” means a separate part of an item of EEE that can replace a part of an item of EEE and—

(a)

the item of EEE cannot function as intended without that part; and

(b)

the functionality of the item of EEE is restored or upgraded when the part is replaced by the spare part;

[F9technical documentation” means the documentation referred to in paragraph 2 of Part 4 of Schedule 1;]

[F10UK marking” means a marking by which a manufacturer indicates that a product complies with the applicable requirements set out in these Regulations and which takes the form published in accordance with Article 30(1) of RAMS;]

“withdraw” means to take any measure aimed at preventing an item of EEE in the supply chain from being made available on the market.

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

InterpretationN.I.

2.  In these Regulations—

[F75“2002 Directive” means Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment]

“2008 Regulations” means the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008;

“authorised person” means a person authorised by the market surveillance authority in accordance with regulation 35(2);

“authorised representative” means a person appointed in accordance with regulation 22(1);

“cables” means all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more items of EEE to each other;

“CE marking” means a marking by which a manufacturer indicates that a product complies with the applicable requirements set out in these Regulations and which takes the form set out in Annex II of RAMS [F76as amended from time to time before or after IP completion day];

“compliance notice” means a notice given under paragraph 1 of Schedule 3;

“conformity assessment” means the process demonstrating whether the requirements of these Regulations are met in relation to EEE;

“the Directive” means Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment[F77, as last amended by [F78Commission Delegated Directive 2019/1846]];

“distributor” means a person in the supply chain, other than the manufacturer or the importer, who makes EEE available on the market;

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

“EEE” means electrical and electronic equipment as defined in regulation 4;

“enforcement notice” means a notice given under paragraph 2 of Schedule 3;

“harmonised standard” means a standard adopted by one of the European standardisation bodies listed in [F79Annex 1 to Regulation (EU) No 1025/2012 of the European Parliament and of the Council on European standardisation] on the basis of a request made by the European Commission in accordance with [F80Article 10 of that Regulation], the reference of which standard has been published in the Official Journal of the European Union;

“importer” means a person established [F81in a relevant state] who places EEE from a third country on the [F82relevant market];

“industrial monitoring and control instruments” means monitoring and control instruments designed for exclusively industrial or professional use;

“infringing EEE” means EEE that does not comply with the requirements of these Regulations;

[F83in vitro diagnostic medical device” has the meaning given in Article 2 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;]

“make available on the market” means to supply in the course of a commercial activity (whether in return for payment or free of charge) for distribution, consumption or use on the [F84relevant] market, and related expressions are to be construed accordingly;

“manufacturer” means a person who manufactures EEE or who has EEE designed or manufactured, and markets it under that person’s name or trademark;

“market surveillance authority” has the meaning given in regulation 35(1);

[F85“medical device” and “active implantable medical device” have the meanings given in regulation 2(1) of the Medical Devices Regulations 2002;]

“notice” means a notice in writing;

“place on the market” means to make EEE available on the [F86relevant] market for the first time, and related expressions are to be construed accordingly;

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

“recall” means to take any measure aimed at achieving the return of EEE that has already been made available to the end user;

“recall notice” means a notice given under paragraph 4 of Schedule 3;

[F87“relevant market” means the market comprised of the market in Northern Ireland and the markets of the EEA states;]

[F87“relevant state” means Northern Ireland or any EEA state;]

“spare part” means a separate part of an item of EEE that can replace a part of an item of EEE and—

(a)

the item of EEE cannot function as intended without that part; and

(b)

the functionality of the item of EEE is restored or upgraded when the part is replaced by the spare part;

“technical documentation” has the meaning given in Module A of Annex II to Decision 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products(5);

“withdraw” means to take any measure aimed at preventing an item of EEE in the supply chain from being made available on the market.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F11Interpretation: designated standardE+W+S

2A.(1) In these Regulations a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body [F12or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated and published by the Secretary of State in accordance with paragraphs (3) to (5).

(2) In this regulation, a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a product, including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b)production methods and processes relating to the product, where these have an effect on the characteristics of the product.

(3) Before designating the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F13such] technical specifications adopted by the other recognised standardisation bodies [F14or by international standardising bodies as the Secretary of State considers to be relevant.]

(4) The Secretary of State must publish a reference to a designated technical specification in a manner which the Secretary of State considers appropriate to draw the standard to the attention of any person who may have an interest in the standard.

(5) The Secretary of State may withdraw the designation of a technical specification, and as soon as reasonably practicable after doing so must publish notice of that withdrawal in a manner which the Secretary of State considers appropriate to draw that withdrawal to the attention of any person who may have an interest in it.

(6) In paragraph (2), a reference to a “product” is a reference to any materials, components and EEE to which these Regulations apply.

[F15(7) In this regulation—

(a)international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time);

(b)a “recognised standardisation body” means any one of the following—

(i)the European Committee for Standardisation (CEN);

(ii)the European Committee for Electrotechnical Standardisation (Cenelec);

(iii)the European Telecommunications Standards Institute (ETSI);

(iv)the British Standards Institution (BSI).]

Modifications to the DirectiveE+W+S

2B.(1) For the purposes of these Regulations, except regulation 34A, the Directive is to be read in accordance with this regulation.

(2) A term which is used in the Directive and which is defined in Part 1 of these Regulations is to be read as having the meaning given by Part 1.

(3) Article 3 is to be read as if points (1), (2), (5), (11), (12), (21), (22), (24) and (27) were omitted.

(4) Article 4 is to be read as if—

(a)in paragraph 1, for “Member States” there was substituted “ the Secretary of State ”;

(b)in paragraph 2, the second sentence were omitted.

(5) Annex 3 is to be read as if, in entry 41 of the table, in the second column, for the words “classes SH:1” to the end, substitute “category NRSh' of Article 4(1), point 3 of Regulation (EU) 2016/1628 of the European Parliament and of the Council on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile”.

(6) Annex 4 is to be read as if—

(a)in points 21 and 30, “EU” were omitted;

(b)in point 33, for the words from “Directive 93/42/EEC” to “defibrillators” there were substituted “mobile medical devices (other than portable emergency defibrillators) that are classified as belonging to Class IIa or IIb for the purposes of the Medical Devices Regulations 2002.]

Restriction on the use of certain hazardous substances in EEEE+W+S

3.—(1) Subject to paragraph (2) and (4) EEE placed on the market must not contain the substances listed in [F16Schedule A1].

(2) The presence of those substances in quantities no greater than the maximum concentration value by weight in homogeneous materials as specified in [F17Schedule A1], is allowed.

(3) In paragraph (2) “homogeneous material” means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.

(4) Paragraph (1) shall not apply to the applications listed in [F18Schedule A2].

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Restriction on the use of certain hazardous substances in EEEN.I.

3.—(1) Subject to paragraph (2) and (4) EEE placed on the market must not contain the substances listed in Annex II to the Directive, as amended from time to time [F88before or after IP completion day].

(2) The presence of those substances in quantities no greater than the maximum concentration value by weight in homogeneous materials as specified in that Annex, as so amended, is allowed.

(3) In paragraph (2) “homogeneous material” means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.

(4) Paragraph (1) shall not apply to the applications listed in Annex III and IV to the Directive, as amended from time to time [F89before or after IP completion day].

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Definition of EEEU.K.

4.—(1) “EEE” means electrical and electronic equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current.

(2) In paragraph (1) “dependent” means needing electric currents or electromagnetic fields to fulfil at least one intended function.

(3) References to EEE include references to cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity.

EEE to which these Regulations applyU.K.

5.—(1) Subject to paragraphs (2) and (3) F19..., these Regulations apply to EEE which falls within the categories set out in Part 1 of Schedule 1 and—

(a)is placed on the market on or after 2nd January 2013; or

(b)was placed on the market before 2nd January 2013 as set out in paragraph (2) of regulation 7.

(2) These Regulations do not apply to EEE which falls within the categories set out in Part 2 of Schedule 1.

(3) These Regulations apply to EEE which falls within the categories set out in Part 3 of Schedule 1 as set out in that Part.

Exclusion until 22nd July 2019 for EEE outside the scope of the 2008 RegulationsU.K.

F206.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation and transitional arrangementsU.K.

7.—(1) The following are revoked—

(a)the 2008 Regulations; and

(b)the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) Regulations 2009(6).

(2) Where EEE was placed on the market before 2nd January 2013—

(a)any obligations that arose under the 2008 Regulations may be enforced under Schedules 2 and 3 of these Regulations;

(b)obligations under these Regulations which arise after the placing on the market of the EEE apply.

(3) This regulation does not affect liability under the 2008 Regulations for any offences committed before 2nd January 2013.

Existing legislationE+W+S

8.  Nothing in these Regulations affects the application of [F21retained EU law] as regards requirements in relation to—

(a)safety and health;

(b)chemicals, in particular as set out in Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals(7); and

(c)specific [F22retained EU law on waste management].

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Existing legislationN.I.

8.  Nothing in these Regulations affects the application of existing EU legislation or legislation giving effect to EU legislation as regards requirements in relation to—

(a)safety and health;

(b)chemicals, in particular as set out in Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; and

(c)specific EU waste management legislation.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Presumption of conformity for EEEE+W+S

9.—(1) Any EEE which bears the [F23UK] marking is presumed to comply with the provisions of these Regulations.

(2) Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of regulation 3 have been performed, or which have been assessed, in accordance with [F24a designated standard], shall be presumed to comply with the requirements of these Regulations.

(3) The presumptions of conformity in paragraphs (1) and (2) are rebuttable.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Presumption of conformity for EEEN.I.

9.—(1) Any EEE which bears the CE marking is presumed to comply with the provisions of these Regulations.

(2) Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of regulation 3 have been performed, or which have been assessed, in accordance with harmonised standards, shall be presumed to comply with the requirements of these Regulations.

(3) The presumptions of conformity in paragraphs (1) and (2) are rebuttable.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 2U.K.Prohibitions and Obligations on Economic Operators

Manufacturers and their authorised representativesU.K.

Prohibitions on placing EEE on the marketE+W+S

10.—(1) A manufacturer must not place EEE on the market unless the EEE complies with the requirements of regulation 3 (restriction on the use of certain hazardous substances in EEE).

(2) A manufacturer must not place EEE on the market without having complied with—

(a)regulation 11 (design and manufacture of EEE);

(b)regulation 12 (conformity assessment procedure and drawing up of technical documentation);

(c)regulation 13 (F25... declaration of conformity and [F26UK] marking);

(d)regulation 17 (compliance procedures for series production); and

(e)regulation 18 (information identifying EEE and manufacturer).

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Prohibitions on placing EEE on the marketN.I.

10.—(1) A manufacturer must not place EEE on the market unless the EEE complies with the requirements of regulation 3 (restriction on the use of certain hazardous substances in EEE).

(2) A manufacturer must not place EEE on the market without having complied with—

(a)regulation 11 (design and manufacture of EEE);

(b)regulation 12 (conformity assessment procedure and drawing up of technical documentation);

(c)regulation 13 (EU declaration of conformity and CE marking);

(d)regulation 17 (compliance procedures for series production); and

(e)regulation 18 (information identifying EEE and manufacturer).

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Design and manufacture of EEEU.K.

11.  A manufacturer must ensure that the EEE has been designed and manufactured to comply with the requirements of regulation 3.

Conformity assessment procedure and drawing up of technical documentationE+W+S

12.—(1) A manufacturer must—

(a)draw up technical documentation; and

(b)carry out, and comply with their obligations under, the internal production control procedure,

in relation to the EEE, in line with [F27Part 4 of Schedule 1].

(2) Where other applicable [F28retained EU law] requires the EEE to be subject to a conformity assessment procedure which is at least as stringent as that required under paragraph (1), compliance with the requirements of regulation 3 may be demonstrated within the context of that procedure and a single set of technical documentation may be drawn up.

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Conformity assessment procedure and drawing up of technical documentationN.I.

12.—(1) A manufacturer must—

(a)draw up technical documentation; and

(b)carry out, and comply with their obligations under, the internal production control procedure,

in relation to the EEE, in line with Module A of Annex II to Decision 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC.

(2) Where other applicable EU legislation or legislation giving effect to EU legislation requires the EEE to be subject to a conformity assessment procedure which is at least as stringent as that required under paragraph (1), compliance with the requirements of regulation 3 may be demonstrated within the context of that procedure and a single set of technical documentation may be drawn up.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

F29... Declaration of conformity and [F30UK] markingE+W+S

13.  Where the compliance of the EEE with the requirements of regulation 3 has been demonstrated by the procedure referred to in regulation 12, a manufacturer must—

(a)draw up [F31a] declaration of conformity in accordance with regulation 14; and

(b)affix the [F32UK] marking in relation to the EEE in accordance with regulation 16.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU declaration of conformity and CE markingN.I.

13.  Where the compliance of the EEE with the requirements of regulation 3 has been demonstrated by the procedure referred to in regulation 12, a manufacturer must—

(a)draw up an EU declaration of conformity in accordance with regulation 14; and

(b)affix the CE marking in relation to the EEE in accordance with regulation 16.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

14.—(1) The F33... declaration of conformity must state that it has been demonstrated that the requirements specified in Article 4 of the Directive have been met in relation to the EEE.

(2) The F33... declaration of conformity must also follow the structure, and include the information, specified in [F34Schedule 1A].

(3) The manufacturer must keep up to date the F33... declaration of conformity drawn up in relation to EEE.

F35(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) [F36A] F33... declaration of conformity in relation to EEE which is made available on the market F37... must be drawn up in or translated into English [F38or any other language agreed by the market surveillance authority].

(6) By drawing up the F33... declaration of conformity, the manufacturer assumes responsibility for the compliance of the EEE.

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

14.—(1) The EU declaration of conformity must state that it has been demonstrated that the requirements specified in Article 4 of the Directive have been met in relation to the EEE.

(2) The EU declaration of conformity must also follow the structure, and include the information, specified in Annex VI to the Directive.

(3) The manufacturer must keep up to date the EU declaration of conformity drawn up in relation to EEE.

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

(5) An EU declaration of conformity in relation to EEE which is made available on the market in the United Kingdom must be drawn up in or translated into English.

(6) By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the EEE.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Duty to keep technical documentation and [F39EU] declaration of conformityU.K.

15.  A manufacturer must keep the technical documentation and the [F40EU] declaration of conformity for EEE available for inspection by the market surveillance authority for a period of ten years from the day on which the EEE was placed on the market.

EEE to bear [F41UK] markingE+W+S

16.—(1) The [F42UK] marking which a manufacturer must affix under regulation 13 must be affixed visibly, legibly and indelibly.

[F43(2) The UK marking must be affixed to—

(a)the EEE;

(b)a data plate affixed to the EEE; or

(c)where paragraph (2A) applies—

(i)a label affixed to the EEE; or

(ii)a document accompanying the EEE.

(2A) This paragraph applies to EEE that is placed on the market within a period of [F44seven years] beginning with IP completion day.]

(3) Where due to the nature of the EEE it is not possible or not warranted for the [F42UK] marking to be affixed in accordance with paragraph (2), the manufacturer must instead affix the [F42UK] marking to—

(a)the packaging of the EEE; and

(b)any documents that accompany the EEE.

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EEE to bear CE markingN.I.

16.—(1) The CE marking which a manufacturer must affix under regulation 13 must be affixed visibly, legibly and indelibly.

(2) The CE marking must be affixed to—

(a)the EEE; or

(b)a data plate affixed to the EEE.

(3) Where due to the nature of the EEE it is not possible or not warranted for the CE marking to be affixed in accordance with paragraph (2), the manufacturer must instead affix the CE marking to—

(a)the packaging of the EEE; and

(b)any documents that accompany the EEE.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Compliance procedures for series productionE+W+S

17.—(1) A manufacturer of EEE which is manufactured by means of series production must ensure that procedures are in place to ensure that any EEE so manufactured complies with the requirements of regulation 3.

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

(a)any changes in the design or characteristics of the EEE; and

(b)any changes to any [F45designated standards] or technical specifications referred to in the F46... declaration of conformity drawn up in relation to the EEE.

(3) In this regulation “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process or service.

Extent Information

E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Compliance procedures for series productionN.I.

17.—(1) A manufacturer of EEE which is manufactured by means of series production must ensure that procedures are in place to ensure that any EEE so manufactured complies with the requirements of regulation 3.

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

(a)any changes in the design or characteristics of the EEE; and

(b)any changes to any harmonised standards or technical specifications referred to in the EU declaration of conformity drawn up in relation to the EEE.

(3) In this regulation “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process or service.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Information identifying EEE and manufacturerE+W+S

18.—(1) A manufacturer must ensure that a type, batch or serial number or other element allowing the EEE to be identified is marked—

(a)on the EEE; or

(b)where the size or nature of the EEE does not allow this, on the packaging of the EEE or in a document accompanying the EEE.

(2) A manufacturer must indicate the manufacturer’s name, registered trade name or registered trade mark and a single address at which they can be contacted—

(a)on the EEE; or

(b)where that is not possible, on the packaging of the EEE or in a document accompanying the EEE.

(3) Where other applicable [F47retained EU law] contains provisions for the affixing of the manufacturer’s name and address to the EEE which are at least as stringent as those set out in this regulation, the provisions of this regulation may be met by satisfying the provisions of that other legislation.

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Information identifying EEE and manufacturerN.I.

18.—(1) A manufacturer must ensure that a type, batch or serial number or other element allowing the EEE to be identified is marked—

(a)on the EEE; or

(b)where the size or nature of the EEE does not allow this, on the packaging of the EEE or in a document accompanying the EEE.

(2) A manufacturer must indicate the manufacturer’s name, registered trade name or registered trade mark and a single address at which they can be contacted—

(a)on the EEE; or

(b)where that is not possible, on the packaging of the EEE or in a document accompanying the EEE.

(3) Where other applicable EU legislation or legislation giving effect to EU legislation contains provisions for the affixing of the manufacturer’s name and address to the EEE which are at least as stringent as those set out in this regulation, the provisions of this regulation may be met by satisfying the provisions of that other legislation.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Register of EEEU.K.

19.  A manufacturer must keep a register of any EEE placed on the market that the manufacturer has manufactured, or had designed and manufactured,—

(a)in relation to which any provision of these Regulations has not been complied with; or

(b)which has been recalled,

and keep distributors informed of these matters.

Non-compliant EEEE+W+S

20.  Where a manufacturer has placed EEE on the market and has reason to believe that any provision of these Regulations has not been complied with by the manufacturer in relation to the EEE, the manufacturer must immediately—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)provide the market surveillance authority F48... with information about the non-compliance and any such corrective measures taken.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Non-compliant EEEN.I.

20.  Where a manufacturer has placed EEE on the market and has reason to believe that any provision of these Regulations has not been complied with by the manufacturer in relation to the EEE, the manufacturer must immediately—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)provide the market surveillance authority and the competent national authorities of any other [F90relevant states] in which they made the EEE available with information about the non-compliance and any such corrective measures taken.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Co-operation with the authoritiesU.K.

21.—(1) The market surveillance authority may, during the period of 10 years from the day on which EEE was placed on the market, request the manufacturer who placed EEE on the market to—

(a)provide it within such period as the authority may specify with all the information and documentation necessary to demonstrate that the provisions of these Regulations have been complied with in relation to the EEE; and

(b)co-operate with that authority on any action taken or to be taken to ensure that the provisions of these Regulations are complied with in relation to the EEE.

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

(3) The manufacturer must comply with a request made under paragraph (1).

(4) The information and documentation supplied pursuant to a request under paragraph (1)(a) must be drawn up in or translated into English.

Manufacturers’ authorised representativesE+W+S

22.—(1) A manufacturer may, by written mandate, appoint a person established within the [F49United Kingdom] as their authorised representative to act on the manufacturer’s behalf in relation to specified tasks.

(2) The mandate must allow the authorised representative to do at least the following in relation to EEE covered by the mandate—

(a)perform the manufacturer’s obligations under regulation 15 (duty to keep technical documentation and F50... declaration of conformity); and

(b)perform the manufacturer’s obligations under paragraph (4) of regulation 21 (cooperation with the authorities).

(3) An authorised representative may not be appointed to perform the manufacturer’s obligations under regulation 11 (design and manufacture of EEE ) or paragraph (1)(a) of regulation 12 (conformity assessment procedure and drawing up of technical documentation).

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and, accordingly—

(a)as far as those duties are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative; and

(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer’s behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Manufacturers’ authorised representativesN.I.

22.—(1) A manufacturer may, by written mandate, appoint a person established within [F91a relevant state] as their authorised representative to act on the manufacturer’s behalf in relation to specified tasks.

(2) The mandate must allow the authorised representative to do at least the following in relation to EEE covered by the mandate—

(a)perform the manufacturer’s obligations under regulation 15 (duty to keep technical documentation and EU declaration of conformity); and

(b)perform the manufacturer’s obligations under paragraph (4) of regulation 21 (cooperation with the authorities).

(3) An authorised representative may not be appointed to perform the manufacturer’s obligations under regulation 11 (design and manufacture of EEE ) or paragraph (1)(a) of regulation 12 (conformity assessment procedure and drawing up of technical documentation).

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and, accordingly—

(a)as far as those duties are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative; and

(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer’s behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

ImportersU.K.

Prohibition on placing EEE on the marketE+W+S

23.  An importer must not place EEE on the market unless—

(a)the EEE complies with the requirements of regulation 3;

(b)the importer has ensured that the manufacturer has done all of the following in relation to the EEE—

(i)carried out the conformity assessment procedure and drawn up the technical documentation in accordance with paragraph (1) of regulation 12 (conformity assessment procedure and drawing up of technical documentation);

(ii)affixed the [F51UK] marking in accordance with regulation 16 (EEE to bear [F51UK] marking);

[F52(iii)complied with regulation 18 (information identifying EEE and   manufacturer).]

F53(iv). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the EEE is accompanied by the required documents; and

(d)the importer has complied with regulation 24 (information identifying importers).

Prohibition on placing EEE on the marketN.I.

23.  An importer must not place EEE on the market unless—

(a)the EEE complies with the requirements of regulation 3;

(b)the importer has ensured that the manufacturer has done all of the following in relation to the EEE—

(i)carried out the conformity assessment procedure and drawn up the technical documentation in accordance with paragraph (1) of regulation 12 (conformity assessment procedure and drawing up of technical documentation);

(ii)affixed the CE marking in accordance with regulation 16 (EEE to bear CE marking);

[F92(iii)complied with regulation 18 (information identifying EEE and   manufacturer).]

(iv). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the EEE is accompanied by the required documents; and

(d)the importer has complied with regulation 24 (information identifying importers).

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Information identifying importersE+W+S

24.—(1) An importer must ensure that the following information is marked on the EEE—

(a)the importer’s name, registered trade name or registered trade mark; and

(b)an address at which the importer can be contacted.

[F54(2) Paragraph (1) does not apply where—

(a)either—

(i)it is not possible to set out the information referred to in paragraph (1) on the EEE; or

(ii)the importer has imported the EEE from the EU and places it on the market within the period of [F55seven years] beginning with IP completion day; and

(b)before placing the EEE on the market, the importer sets out the information referred to in paragraph (1) on the packaging of the EEE or in a document accompanying the EEE.]

(3) Where the importer complies with other applicable [F56retained EU law], containing provisions for the affixing of the importer’s name and address which are at least as stringent as those set out in this regulation, it is sufficient to satisfy this regulation.

Extent Information

E15This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Information identifying importersN.I.

24.—(1) An importer must ensure that the following information is marked on the EEE—

(a)the importer’s name, registered trade name or registered trade mark; and

(b)an address at which the importer can be contacted.

(2) Where it is not possible to mark the information on the EEE the information may instead be marked on the packaging of the EEE or in a document accompanying the EEE.

(3) Where the importer complies with other applicable EU legislation, or legislation giving effect to EU legislation, containing provisions for the affixing of the importer’s name and address which are at least as stringent as those set out in this regulation, it is sufficient to satisfy this regulation.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Monitoring of EEEU.K.

25.  An importer must keep a register of any EEE which they have placed on the market—

(a)in relation to which any provision of these Regulations has not been complied with; or

(b)any EEE which has been recalled,

and keep distributors informed of these matters.

Non-compliant EEEE+W+S

26.—(1) If an importer has reason to believe that EEE which the importer was intending to place on the market does not comply with the requirements of regulation 3, the importer must inform the manufacturer and the market surveillance authority of the non-compliance.

(2) An importer who has placed EEE on the market and has reason to believe that any provision of these Regulations has not been complied with in relation to the EEE must immediately—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)provide the market surveillance authority F57... with information about the non-compliance and any corrective measures taken in accordance with sub-paragraph (a).

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Non-compliant EEEN.I.

26.—(1) If an importer has reason to believe that EEE which the importer was intending to place on the market does not comply with the requirements of regulation 3, the importer must inform the manufacturer and the market surveillance authority of the non-compliance.

(2) An importer who has placed EEE on the market and has reason to believe that any provision of these Regulations has not been complied with in relation to the EEE must immediately—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)provide the market surveillance authority and the competent national authorities of any other [F93relevant states] in which they made the EEE available with information about the non-compliance and any corrective measures taken in accordance with sub-paragraph (a).

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Retention of documentation and co-operation with the authoritiesU.K.

27.—(1) An importer must for a period of ten years from the day on which they placed an item of EEE on the market—

(a)keep a copy of the [F58EU] declaration of conformity for the EEE; and

(b)ensure that the technical documentation is available for inspection by the market surveillance authority on request by the authority.

(2) The market surveillance authority may during the ten year period mentioned in paragraph (1) request an importer who has placed EEE on the market to—

(a)provide it within such period as the authority may specify with all the information and documentation necessary to demonstrate that the provisions of these Regulations have been complied with in relation to the EEE; and

(b)co-operate with that authority on any action taken or to be taken to ensure that the provisions of these Regulations are complied with in relation to the EEE.

(3) A request under paragraph (2)(a) must be accompanied by the reasons for making the request.

(4) The importer must comply with a request under paragraph (2).

(5) The information and documentation supplied pursuant to a request under paragraph (2)(a) must be drawn up in or translated into English.

Duty in certain circumstances to comply with manufacturers’ duties in place of importers’ dutiesU.K.

28.—(1) An importer who places EEE on the market under the importer’s name or trademark must comply with all of the duties imposed by these Regulations on manufacturers, and in such a case, a reference to the manufacturer in these Regulations is to be taken as being a reference to the importer.

(2) Such an importer is not required to comply with the duties imposed by these Regulations on importers.

DistributorsU.K.

Duty to act with due care and prohibition on making EEE available on the marketE+W+S

29.—(1) When making EEE available on the market, a distributor must act with due care in relation to the requirements applicable, in particular by verifying that—

(a)the EEE bears the [F59UK] marking;

(b)the EEE is accompanied by the required documents in a language which can be easily understood by consumers and other end-users in the [F60United Kingdom];

(c)the manufacturer has complied with regulation 18 (information identifying EEE and manufacturer);

(d)the importer has complied with regulation 24 (information identifying importers).

(2) A distributor must not make EEE available on the market if the distributor has reason to believe that the EEE does not comply with the requirements of regulation 3.

Extent Information

E17This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to act with due care and prohibition on making EEE available on the marketN.I.

29.—(1) When making EEE available on the market, a distributor must act with due care in relation to the requirements applicable, in particular by verifying that—

(a)the EEE bears the CE marking;

(b)the EEE is accompanied by the required documents in a language which can be easily understood by consumers and other end-users in the [F94relevant state] in which the EEE is to be made available on the market;

(c)the manufacturer has complied with regulation 18 (information identifying EEE and manufacturer);

(d)the importer has complied with regulation 24 (information identifying importers).

(2) A distributor must not make EEE available on the market if the distributor has reason to believe that the EEE does not comply with the requirements of regulation 3.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Non-compliant EEEE+W+S

30.—(1) If a distributor has reason to believe that EEE which the distributor was intending to make available on the market does not comply with the requirements of regulation 3, the distributor must inform the following to that effect—

(a)the importer (if there is one);

(b)the manufacturer (if there is no importer); and

(c)the market surveillance authority.

(2) A distributor who has reason to believe that EEE which the distributor has made available on the market is not in conformity with these Regulations must—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)immediately provide the market surveillance authority F61... with information about the non-compliance and any corrective measures taken under sub-paragraph (a).

Extent Information

E18This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Non-compliant EEEN.I.

30.—(1) If a distributor has reason to believe that EEE which the distributor was intending to make available on the market does not comply with the requirements of regulation 3, the distributor must inform the following to that effect—

(a)the importer (if there is one);

(b)the manufacturer (if there is no importer); and

(c)the market surveillance authority.

(2) A distributor who has reason to believe that EEE which the distributor has made available on the market is not in conformity with these Regulations must—

(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and

(b)immediately provide the market surveillance authority and the competent national authorities of any other [F95relevant states] in which they made the EEE available with information about the non-compliance and any corrective measures taken under sub-paragraph (a).

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Co-operation with the authoritiesU.K.

31.—(1) The market surveillance authority may request a distributor who has made EEE available on the market to—

(a)provide it within such period as the authority may specify with all the information and documentation within the distributor’s knowledge or possession which demonstrate that the provisions of these Regulations have been complied with in relation to the EEE; and

(b)co-operate with that authority on any action taken or to be taken to ensure that the provisions of these Regulations are complied with in relation to the EEE.

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

(3) The distributor must comply with a request under paragraph (1).

(4) A request for information or documents may not be made more than 10 years after the day on which the EEE is placed on the market.

Duty in certain circumstances to comply with manufacturers’ duties in place of distributors’ dutiesU.K.

32.  A distributor who modifies EEE already placed on the market in such a way that compliance with the requirements of regulation 3 may be affected must comply with all of the duties imposed by these Regulations on manufacturers, and in such a case, a reference to the manufacturer in these Regulations is to be taken as being a reference to the distributor.

All economic operatorsU.K.

Identification of economic operators to the market surveillance authorityU.K.

33.—(1) The market surveillance authority may, for ten years following the placing on the market of the EEE, request an economic operator to identify to the authority, within such period as the authority may specify—

(a)any economic operator who has supplied it with EEE; and

(b)any economic operator to whom it has supplied EEE.

(2) The economic operator must comply with the request.

Protection of [F62UK] markingE+W+S

34.—(1) A person must not affix a [F63UK] marking in relation to EEE unless—

(a)the person is—

(i)the manufacturer; or

(ii)an authorised representative of the manufacturer who has been appointed by the manufacturer in accordance with regulation 22(1) to affix the [F63UK] marking on the manufacturer’s behalf; and

(b)it has been demonstrated by performance of the conformity assessment procedure referred to in regulation 12 (conformity assessment procedure and drawing up of technical documentation) that the EEE complies with the requirements of regulation 3.

(2) A person must not affix any marking in relation to EEE which—

(a)is not a [F63UK] marking; but

(b)purports to attest that the EEE satisfies the requirements of regulation 3.

(3) A person must not affix in relation to EEE any marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F63UK] marking affixed in relation to the EEE.

(4) Any other marking may be affixed in relation to EEE provided that the visibility, legibility and meaning of the [F63UK] marking is not thereby impaired.

Extent Information

E19This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Protection of CE markingN.I.

34.—(1) A person must not affix a CE marking in relation to EEE unless—

(a)the person is—

(i)the manufacturer; or

(ii)an authorised representative of the manufacturer who has been appointed by the manufacturer in accordance with regulation 22(1) to affix the CE marking on the manufacturer’s behalf; and

(b)it has been demonstrated by performance of the conformity assessment procedure referred to in regulation 12 (conformity assessment procedure and drawing up of technical documentation) that the EEE complies with the requirements of regulation 3.

(2) A person must not affix any marking in relation to EEE which—

(a)is not a CE marking; but

(b)purports to attest that the EEE satisfies the requirements of regulation 3.

(3) A person must not affix in relation to EEE any marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the CE marking affixed in relation to the EEE.

(4) Any other marking may be affixed in relation to EEE provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F64Obligations which are met by complying with obligations in the DirectiveE+W+S

34A.(1) This regulation makes provision for obligations on manufacturers, importers and distributors in these Regulations for placing, or making available, EEE on the market to be met by complying with obligations in the Directive for placing, or making available, EEE on the market.

(2) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b)CE marking” has the meaning given to it in Article 3(15);

(c)harmonised standard” has the meaning given to it in Article 3(13).

(3) Paragraph (4) applies where, before placing EEE on the market, the manufacturer—

(a)ensures the EEE has been designed and manufactured in accordance with the requirements set out in Articles 4 and 7;

(b)ensures that the conformity assessment procedure that applies to the EEE in accordance with Article 7(b) has been carried out;

(c)affixes a CE marking, in accordance with Article 7(c), 15(1) and (2);

(d)draws up an EU declaration of conformity, in accordance with Article 13; and

(e)ensures that the EU declaration of conformity is prepared in or translated into English.

(4) Where this paragraph applies—

(a)the requirements of regulations 12(1), 13 and 14(1), (2), (5) and (6) are satisfied in respect of that EEE;

(b)regulations 12(1), 13, 14(1), (2), (5) and (6) apply to that EEE subject to the modifications in paragraph (9).

(5) Paragraph (6) applies where, before placing EEE on the market, the importer ensures that—

(a)the conformity assessment procedure that applies to that EEE in accordance with Article 7(b) has been carried out;

(b)the manufacturer has drawn up the technical documentation referred to in Article 7(b); and

(c)the EEE bears the CE marking and inscriptions referred to in Article 13.

(6) Where this paragraph applies—

(a)the requirements of regulation 23(b) are satisfied in respect of that EEE;

(b)regulation 23(b) applies to that EEE subject to the modifications in paragraph (9).

(7) Paragraph (8) applies where, before making EEE available on the market, a distributor ensures that the EEE bears the CE marking and inscriptions referred to Article 13.

(8) Where this paragraph applies—

(a)the requirements of regulation 29(1)(a) are satisfied in respect of that EEE;

(b)regulation 29(1)(a) applies to that EEE subject to the modifications in paragraph (9).

(9) The modifications referred to in paragraphs (4)(b), (6)(b) and (8)(b) are that—

(a)any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b)any reference to “UK marking” is to be read as a reference to the CE marking;

(c)any reference to “designated standard” is to be read as a reference to a harmonised standard;

(d)any reference to an “internal control procedure” is to be read as a reference to Module A of Annex 2 to Decision 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products as it has effect in EU law, as amended from time to time;

(e)any reference to “technical documentation” is a reference to the technical documentation referred to in Article 7(b).]

[F65Expiry of regulation 34AE+W+S

34B.(1) Subject to paragraphs (2) and (3), regulation 34A ceases to have effect at the end of the period of [F66four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 34A—

(a)any EEE which was placed on the market pursuant to regulation 34A may continue to be made available on the market on or after the expiry of regulation 34A;

(b)any obligation to which a person was subject in respect of EEE placed on the market pursuant to regulation 34A continues to have effect after the expiry of regulation 34A, in respect of that EEE.

(3) Regulation 34A continues to apply to EEE that—

(a)was available on the market in the EU prior to IP completion day; and

(b)is placed on the market on or after IP completion day.

(4) Where EEE is placed on the market pursuant to paragraph (3), regulation 24(1) does not apply where—

(a)the importer has imported the EEE from the EU; and

(b)before placing the product on the market, the importer sets out the information referred to in regulation 24(1) in a document accompanying the EEE.

Qualifying Northern Ireland goodsE+W+S

34C.(1) Where paragraph (2) applies, EEE is to be treated as being in conformity with these Regulations.

(2) This paragraph applies where—

(a)the goods which are EEE—

(i)are in conformity with these Regulations as they apply in Northern Ireland; and

(ii)are qualifying Northern Ireland goods; and

(b)an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the EEE on the market, the importer—

(a)complies with regulation 21; and

(b)ensures that the manufacturer has done all of the following in relation to the EEE, in accordance with these Regulations as they apply in Northern Ireland—

(i)carried out the conformity assessment procedure in accordance with regulation 12(1);

(ii)drawn up the technical documentation; and

(iii)affixed the CE marking.

(4) For the purposes of this regulation—

(a)“in conformity with these Regulations” means, in relation to EEE, that—

(i)the EEE is not prohibited by regulation 3 from being placed on the market; and

(ii)each person who has obligations under this Part in respect of the EEE has complied, or is complying, with those obligations;

(b)“CE marking” and “technical documentation” have the meanings given in regulation 2 of these Regulations as they apply in Northern Ireland;

(c)“qualifying Northern Ireland goods” has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.]

PART 3U.K.Enforcement

Market surveillance authorityU.K.

35.—(1) It is the duty of the Secretary of State to enforce these Regulations and the Secretary of State is the market surveillance authority for the purposes of these Regulations and RAMS in its application to EEE.

(2) The market surveillance authority may authorise in writing any person who appears suitable to act on its behalf to carry out any of its functions and to exercise any of the powers and duties conferred on it by these Regulations or RAMS.

(3) The market surveillance authority must not commence proceedings for an offence in Scotland.

Market surveillance powersU.K.

36.  Where the market surveillance authority considers that there may be a breach of these Regulations it may—

(a)exercise the powers set out in Schedule 2 (test purchases, powers of entry etc and warrants); and

(b)take the actions set out in Schedule 3 (compliance, enforcement and recall notices).

OffencesE+W+S

37.—(1) It is an offence for a manufacturer to contravene or fail to comply with any of the requirements of—

(a)regulation 10 (prohibitions on placing EEE on the market);

(b)regulation 15 (duty to keep technical documentation and F67... declaration of conformity);

(c)regulation 19 (register of EEE);

(d)regulation 20 (non-compliant EEE); or

(e)regulation 21 (co-operation with the authorities).

(2) It is an offence for an importer to contravene or fail to comply with any of the requirements of—

(a)regulation 23 (prohibition on placing EEE on the market);

(b)regulation 25 (monitoring of EEE);

(c)regulation 26 (non-compliant EEE); or

(d)regulation 27 (retention of documents and co-operation with authorities).

(3) It is an offence for a distributor to contravene or fail to comply with any of the requirements of—

(a)regulation 29 (duty to act with due care and prohibition on making EEE available on the market);

(b)regulation 30 (non-compliant EEE); or

(c)regulation 31 (co-operation with authorities).

(4) It is an offence for an economic operator to contravene or fail to comply with regulation 33(2) (identification of economic operators to the market surveillance authority).

(5) It is an offence for any person to contravene or fail to comply with any of the requirements of regulation 34 (protection of [F68UK] marking).

(6) In any proceedings for an offence under paragraph (1)(a) in respect of a failure to affix the [F69UK] marking in accordance with regulation 16 (EEE to bear [F69UK] marking), where the accused seeks to rely on regulation 16(3), it is for the accused to show that it was not possible, or (as the case may be) not warranted, for the [F69UK] marking to be affixed in accordance with regulation 16(2).

Extent Information

E20This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

OffencesN.I.

37.—(1) It is an offence for a manufacturer to contravene or fail to comply with any of the requirements of—

(a)regulation 10 (prohibitions on placing EEE on the market);

(b)regulation 15 (duty to keep technical documentation and EU declaration of conformity);

(c)regulation 19 (register of EEE);

(d)regulation 20 (non-compliant EEE); or

(e)regulation 21 (co-operation with the authorities).

(2) It is an offence for an importer to contravene or fail to comply with any of the requirements of—

(a)regulation 23 (prohibition on placing EEE on the market);

(b)regulation 25 (monitoring of EEE);

(c)regulation 26 (non-compliant EEE); or

(d)regulation 27 (retention of documents and co-operation with authorities).

(3) It is an offence for a distributor to contravene or fail to comply with any of the requirements of—

(a)regulation 29 (duty to act with due care and prohibition on making EEE available on the market);

(b)regulation 30 (non-compliant EEE); or

(c)regulation 31 (co-operation with authorities).

(4) It is an offence for an economic operator to contravene or fail to comply with regulation 33(2) (identification of economic operators to the market surveillance authority).

(5) It is an offence for any person to contravene or fail to comply with any of the requirements of regulation 34 (protection of CE marking).

(6) In any proceedings for an offence under paragraph (1)(a) in respect of a failure to affix the CE marking in accordance with regulation 16 (EEE to bear CE marking), where the accused seeks to rely on regulation 16(3), it is for the accused to show that it was not possible, or (as the case may be) not warranted, for the CE marking to be affixed in accordance with regulation 16(2).

Extent Information

E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Obstruction, etc.U.K.

38.  It is an offence for any person—

(a)intentionally to obstruct an authorised person acting in pursuance of their powers and duties under these Regulations or Article 19 (which provides for market surveillance measures) of RAMS; or

(b)knowingly or recklessly to—

(i)make a statement; or

(ii)provide any information, document or record,

which is false or misleading in a material respect, in purported compliance with any requirement imposed under these Regulations or Article 19 of RAMS.

PenaltiesU.K.

39.—(1) A person who is guilty of an offence under—

(a)regulation 37(1)(a);

(b)regulation 37(2)(a); or

(c)regulation 37(3)(a),

is liable on summary conviction, to a fine not exceeding the statutory maximum and on conviction on indictment, to a fine.

(2) A person who is guilty of—

(a)any other offence under regulation 37; or

(b)an offence under regulation 38,

is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Remediation ordersU.K.

40.—(1) This regulation applies where a person commits an offence under these Regulations in respect of a matter which appears to the court to be a matter which it is in the person’s power to remedy.

(2) The court may specify in an order (“a remediation order”)—

(a)the steps that the person must take to remedy any of the matters for which that person has been convicted; and

(b)the period within which those steps must be taken.

(3) A period specified in a remediation order may be extended if an application is made to the court within that period.

(4) If a person is ordered to remedy a matter, that person is not liable under regulation 37 (offences) in respect of that matter during the period or the extended period.

(5) A remediation order may be made in addition to, or instead of, any other penalty.

Recovery of expenses of enforcementU.K.

41.—(1) This regulation applies where a person commits an offence under regulation 37(1)(a), (2)(a) or (3)(a) or paragraph 9 of Schedule 3.

(2) The court may (in addition to any other order it may make as to costs or expenses) order the person to reimburse the market surveillance authority for any expenditure which the authority has reasonably incurred in investigating the offence, including in purchasing or in testing or examining any EEE, or any part of it, in respect of which the offence was committed.

Time limit for prosecution of offencesU.K.

42.[F70(1) In England and Wales an information relating to an offence that is triable by a magistrates’ court may be so tried if it is laid within twelve months after the date on which evidence sufficient in the opinion of the prosecutor to justify the proceedings comes to the knowledge of the prosecutor.]

[F71(2) In Scotland

(a)summary proceedings for an offence may be commenced before the end of twelve months from the date on which evidence sufficient in the Lord Advocate’s opinion to justify the proceedings came to the Lord Advocate’s knowledge, and

(b)section 136(3) of the Criminal Procedure (Scotland) Act 1995 (time limit for certain offences)(8) applies for the purpose of this paragraph as it applies for the purpose of that section.]

(3) In Northern Ireland summary proceedings for an offence may be instituted within twelve months after the date on which evidence sufficient in the opinion of the prosecutor to justify proceedings comes to the knowledge of the prosecutor.

(4) No proceedings are to be brought more than three years after the commission of the offence.

(5) For the purposes of this regulation a certificate of the prosecutor [F72(or in Scotland, the Lord Advocate)] as to the date on which such evidence as is referred to above came to their knowledge is conclusive evidence.

Defence of due diligenceU.K.

43.—(1) In proceedings for an offence under these Regulations, it is a defence for a person to show that they took all reasonable steps and exercised all due diligence to avoid committing the offence.

(2) A person is not, without the leave of the court, entitled to rely on the defence if it involves an allegation that the commission of the offence was due—

(a)to the act or default of another; or

(b)to reliance on information supplied by another;

unless, not less than seven clear days before the hearing of the proceedings [F73(in England, Wales and Northern Ireland), or the trial diet (in Scotland)], the person has served a notice on the person bringing the proceedings.

(3) The notice must give the information in the possession of the person (“A”) serving the notice which identifies or assists in identifying the person (“B”) who—

(a)committed the act or default; or

(b)supplied the information which was relied on.

(4) A may not rely on the defence by reason of reliance on information supplied by B, unless A shows that it was reasonable in all the circumstances to have relied on the information, having regard in particular—

(a)to the steps that A took and those which might reasonably have been taken for the purpose of verifying the information; and

(b)to whether A had any reason to disbelieve the information.

Liability of persons other than the principal offenderU.K.

44.—(1) Where the commission by a person of an offence under these Regulations is due to anything which another person did or failed to do in the course of a business, that other person is guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against the first person.

(2) Where a body corporate commits an offence and it is proved that the offence was committed—

(a)with the consent or connivance of a relevant person; or

(b)as a result of the negligence of a relevant person,

that person, as well as the body corporate, is guilty of the offence.

(3) A “relevant person” means—

(a)a director, manager, secretary or other similar officer of the body corporate;

(b)in relation to a body corporate managed by its members, a member of that body performing managerial functions;

(c)in relation to a Scottish partnership, a partner;

(d)a person purporting to act as a person described in (a), (b) or (c).

Service of documentsU.K.

45.—(1) Any document required or authorised by these Regulations to be served on a person may be served by—

(a)delivering it to that person in person;

(b)leaving it at that person’s proper address; or

(c)sending it by post or electronic means to that person’s proper address.

(2) In the case of a body corporate, a document may be served on a director of that body.

(3) In the case of a partnership, a document may be served on a partner or a person having control or management of the partnership business.

(4) For the purposes of this regulation, “proper address” means—

(a)in the case of a body corporate or its director—

(i)the registered or principal office of that body; or

(ii)the email address of the secretary or clerk of that body;

(b)in the case of a partnership, a partner or person having control or management of the partnership business—

(i)the principal office of the partnership; or

(ii)the email address of a partner or a person having that control or management;

(c)in any other case, a person’s last known address, which includes an email address.

(5) If a person to be served with a document has specified an address in the United Kingdom (other than that person’s proper address) at which that person or someone on that person’s behalf will accept service, that address must also be treated as that person’s proper address.

(6) In this regulation “partnership” includes a Scottish partnership.

PART 4U.K.Miscellaneous

ReviewU.K.

46.—(1) The Secretary of State must from time to time—

(a)carry out a review of these Regulations;

(b)set out the conclusions of the review in a report; and

(c)publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in [F74other] member States.

(3) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations;

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(4) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Consequential amendmentsU.K.

47.—(1) In Schedule 1 to the Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004(9) for the words “The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008” substitute “The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012”.

(2) In Part 2 of the Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007(10) under the heading “Weights and measures” omit the entry “Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008” and after the last entry insert “The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012”.

Michael Fallon

Minister of State for Business and Enterprise

Department for Business, Innovation and Skills

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