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

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 (F1... declaration of conformity and [F2UK] marking);

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

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

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).

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 [F3Part 4 of Schedule 1].

(2) Where other applicable [F4retained 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.

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.

F5... Declaration of conformity and [F6UK] 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 [F7a] declaration of conformity in accordance with regulation 14; and

(b)affix the [F8UK] marking in relation to the EEE in accordance with regulation 16.

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.

14.—(1) The F9... 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 F9... declaration of conformity must also follow the structure, and include the information, specified in [F10Schedule 1A].

(3) The manufacturer must keep up to date the F9... declaration of conformity drawn up in relation to EEE.

F11(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) [F12A] F9... declaration of conformity in relation to EEE which is made available on the market F13... must be drawn up in or translated into English [F14or any other language agreed by the market surveillance authority].

(6) By drawing up the F9... declaration of conformity, the manufacturer assumes responsibility for the compliance of the EEE.

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.

Duty to keep technical documentation and [F15EU] declaration of conformityU.K.

15.  A manufacturer must keep the technical documentation and the [F16EU] 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 [F17UK] markingE+W+S

16.—(1) The [F18UK] marking which a manufacturer must affix under regulation 13 must be affixed visibly, legibly and indelibly.

[F19(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 [F20seven years] beginning with IP completion day.]

(3) Where due to the nature of the EEE it is not possible or not warranted for the [F18UK] marking to be affixed in accordance with paragraph (2), the manufacturer must instead affix the [F18UK] marking to—

(a)the packaging of the EEE; and

(b)any documents that accompany the EEE.

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.

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 [F21designated standards] or technical specifications referred to in the F22... 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.

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.

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 [F23retained 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.

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.

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 F24... with information about the non-compliance and any such corrective measures taken.

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 [F43relevant states] in which they made the EEE available with information about the non-compliance and any such corrective measures taken.

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 [F25United 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 F26... 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.

Manufacturers’ authorised representativesN.I.

22.—(1) A manufacturer may, by written mandate, appoint a person established within [F44a 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.

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 [F27UK] marking in accordance with regulation 16 (EEE to bear [F27UK] marking);

[F28(iii)complied with regulation 18 (information identifying EEE and   manufacturer).]

F29(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);

[F45(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).

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.

[F30(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 [F31seven 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 [F32retained 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.

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.

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 F33... with information about the non-compliance and any corrective measures taken in accordance with sub-paragraph (a).

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 [F46relevant 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).

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 [F34EU] 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 [F35UK] 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 [F36United 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.

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 [F47relevant 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.

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 F37... with information about the non-compliance and any corrective measures taken under sub-paragraph (a).

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 [F48relevant states] in which they made the EEE available with information about the non-compliance and any corrective measures taken under sub-paragraph (a).

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 [F38UK] markingE+W+S

34.—(1) A person must not affix a [F39UK] 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 [F39UK] 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 [F39UK] 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 [F39UK] 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 [F39UK] marking is not thereby impaired.

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.

[F40Obligations 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).]

[F41Expiry 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 [F42four 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.]