2012 No. 3032
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
Made
Laid before Parliament
Coming into force
The Secretary of State is a Minister designated1 for the purposes of section 2(2) of the European Communities Act 19722 in respect of measures relating to the restriction of the use of hazardous substances in electrical and electronic equipment.
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of an EU instrument to be construed as a reference to those provisions as amended from time to time.
The Secretary of State, in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 makes the following Regulations.
PART 1Preliminary
Citation and commencement1
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.
InterpretationE72
In these Regulations—
F77“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 equipment4;
“2008 Regulations” means the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 20083;
“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;
F94...
“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;
F10“designated 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 equipment4F27, as last amended by F84Commission 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;
F64...
F45“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;
- a
“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 F93on 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 20026;
“notice” means a notice in writing;
“place on the market” means to make EEE available F93on 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 339/937;
“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;
- a
F79“technical documentation” means the documentation referred to in paragraph 2 of Part 4 of Schedule 1;
F34“UK 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.
InterpretationE232
In these Regulations—
F116“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 RAMSF87as 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 equipmentF110, as last amended by F60Commission 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 F114Annex 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 F117Article 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 F100in a relevant state who places EEE from a third country on the F16relevant 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;
F118“in 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 F33relevant 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);
F119“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 F35relevant 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;
F56“relevant market” means the market comprised of the market in Northern Ireland and the markets of the EEA states;
F56“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;
- a
“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 products8;
“withdraw” means to take any measure aimed at preventing an item of EEE in the supply chain from being made available on the market.
F47Interpretation: designated standard2A
1
In these Regulations a “designated standard” means a technical specification which is—
a
adopted by a recognised standardisation body F40or 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 F102such technical specifications adopted by the other recognised standardisation bodies F86or 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.
F787
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 Directive2B
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 EEEE193
1
Subject to paragraph (2) and (4) EEE placed on the market must not contain the substances listed in F62Schedule A1.
2
The presence of those substances in quantities no greater than the maximum concentration value by weight in homogeneous materials as specified in F23Schedule 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 F21Schedule A2.
Restriction on the use of certain hazardous substances in EEEE233
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 F113before 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 F111before or after IP completion day.
Definition of EEE4
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 apply5
1
Subject to paragraphs (2) and (3) F6..., 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 RegulationsF376
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation and transitional arrangements7
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 20099.
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 legislationE88
Nothing in these Regulations affects the application of F58retained 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 Chemicals10; and
c
specific F8retained EU law on waste management.
Existing legislationE238
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.
Presumption of conformity for EEEE59
1
Any EEE which bears the F95UK 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 F46a 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.
Presumption of conformity for EEEE239
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.
PART 2Prohibitions and Obligations on Economic Operators
Manufacturers and their authorised representatives
Prohibitions on placing EEE on the marketE610
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);
d
regulation 17 (compliance procedures for series production); and
e
regulation 18 (information identifying EEE and manufacturer).
Prohibitions on placing EEE on the marketE2310
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 EEE11
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 documentationE912
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 F53Part 4 of Schedule 1.
2
Where other applicable F80retained 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 documentationE2312
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.
F44... Declaration of conformity and F15UK markingE1113
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—
EU declaration of conformity and CE markingE2313
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.
E1414
1
The F105... 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
3
The manufacturer must keep up to date the F105... declaration of conformity drawn up in relation to EEE.
F924
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
6
By drawing up the F105... declaration of conformity, the manufacturer assumes responsibility for the compliance of the EEE.
E2314
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 F85EU declaration of conformity15
A manufacturer must keep the technical documentation and the F89EU 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 F52UK markingE1316
1
F182
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 F2seven years beginning with IP completion day.
EEE to bear CE markingE2316
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 productionE317
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
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 productionE2317
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 manufacturerE1718
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 F5retained 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 manufacturerE2318
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 EEE19
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 EEEE1820
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 F97... with information about the non-compliance and any such corrective measures taken.
Non-compliant EEEE2320
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 F17relevant states in which they made the EEE available with information about the non-compliance and any such corrective measures taken.
Co-operation with the authorities21
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.
3
The manufacturer must comply with a request made under paragraph (1).
Manufacturers’ authorised representativesE1022
1
A manufacturer may, by written mandate, appoint a person established within the F83United 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
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 representativesE2322
1
A manufacturer may, by written mandate, appoint a person established within F26a 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.
Importers
Prohibition on placing EEE on the marketE2223
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);
F32iii
complied with regulation 18 (information identifying EEE and manufacturer).
F59iv
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 marketE2323
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);
F115iii
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 importersE1524
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.
F392
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 F106seven 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 F69retained 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 importersE2324
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 EEE25
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 EEEE226
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 F20... with information about the non-compliance and any corrective measures taken in accordance with sub-paragraph (a).
Non-compliant EEEE2326
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 F76relevant 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 authorities27
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 F11EU 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.
4
The importer must comply with a request under paragraph (2).
Duty in certain circumstances to comply with manufacturers’ duties in place of importers’ duties28
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.
Distributors
Duty to act with due care and prohibition on making EEE available on the marketE129
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 F70UK 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 F90United 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 marketE2329
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 F66relevant 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 EEEE1630
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 F4... with information about the non-compliance and any corrective measures taken under sub-paragraph (a).
Non-compliant EEEE2330
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 F54relevant 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 authorities31
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.
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’ duties32
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 operators
Identification of economic operators to the market surveillance authority33
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 F14UK markingE2134
1
A person must not affix a F61UK marking in relation to EEE unless—
a
the person is—
i
the manufacturer; or
2
A person must not affix any marking in relation to EEE which—
a
is not a F61UK 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 F61UK 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 F61UK marking is not thereby impaired.
Protection of CE markingE2334
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
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.
F24Obligations which are met by complying with obligations in the Directive34A
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).
F13Expiry of regulation 34A34B
1
Subject to paragraphs (2) and (3), regulation 34A ceases to have effect at the end of the period of F73four 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 goods34C
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 3Enforcement
Market surveillance authority35
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 powers36
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).
OffencesE2037
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);
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
6
In any proceedings for an offence under paragraph (1)(a) in respect of a failure to affix the F48UK marking in accordance with regulation 16 (EEE to bear F48UK 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 F48UK marking to be affixed in accordance with regulation 16(2).
OffencesE2337
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).
Obstruction, etc.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.
Penalties39
Remediation orders40
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 enforcement41
1
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 offences42
F311
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.
F412
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)12 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 F36(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 diligence43
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 F81(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 offender44
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 documents45
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 4Miscellaneous
Review46
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 F19other 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 amendments47
1
In Schedule 1 to the Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 200413 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 200714 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”.
F96SCHEDULE A1Restricted substances referred to in regulation 3 and maximum concentration values tolerated by weight in homogeneous materials
Words in Sch. A1 substituted (4.5.2021) by The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) Regulations 2021 (S.I. 2021/422), regs. 1(2), 2
Words in Sch. A1 omitted (1.7.2022) by virtue of The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) (No. 2) Regulations 2021 (S.I. 2021/1395), regs. 1(3), 2(2)
Words in Sch. A1 omitted (1.7.2022) by virtue of The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) (No. 2) Regulations 2021 (S.I. 2021/1395), regs. 1(3), 2(2)
Lead (0.1%)
Mercury (0.1%)
F38Cadmium (0.01%)
Hexavalent chromium (0.1%)
Polybrominated biphenyls (PBB) (0.1%)
Polybrominated diphenyl ethers (PBDE) (0.1%)
Bis (2-ethylexyl) phthalate (DEHP) (0.1%)
Butyl benzyl phthalate (BBP) (0.1%)
Dibutyl phthalate (DBP) (0.1%)
Diisobutyl phthalate (DIBP) (0.1%)
The restriction of DEHP, BBP, DBP and DIBP does not apply to—
The restriction of DEHP, BBP and DBP does not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex 17 to Regulation (EC) No 1907/2006.
C1F101SCHEDULE A2Applications exempted from the restriction in regulation 3(1)
Sch. A2 inserted (E.W.S.) (31.12.2020) by The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1647), reg. 1(3), Sch. 2
Sch. A2: power to amend conferred (31.12.2020) by The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1647), regs. 1(3), 5
The tables of exempted applications1
In this Schedule—
a
Table 1 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in EEE, F42...
b
Table 2 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in spare parts for EEE F65with no expiry date.
Interpretation of the tables
2
The following provisions apply for the purposes of interpreting Tables 1 and 2.
3
In Table 1, in the column headed “corresponding EU exemption”, a reference to a numbered Annex, followed by another number, is a reference to the exemption with that number in that Annex to Directive 2011/65/EU.
4
In Tables 1 and 2, in the column headed “categories of EEE to which exemption applies”, the entries indicate the categories of EEE to which an exemption applies, as follows—
a
a number from 1 to 11, which is not followed by any letters, means the category of EEE with that number in Part 1 of Schedule 1;
b
“8iv” and “8x” are sub-categories of category 8 (medical devices) with the following meanings—
i
8iv means in vitro diagnostic medical devices;
ii
8x means medical devices, other than in vitro diagnostic medical devices;
c
“9ind” and “9x” are sub-categories of category 9 (monitoring and control instruments) with the following meanings—
i
9ind means industrial monitoring and control instruments;
ii
9x means monitoring and control instruments, other than for industrial use.
5
In Table 1, in the column headed “expiry date or status”—
a
a date, in relation to an exemption and a category of EEE, is the expiry date of the exemption for that category of EEE, that is, the date on which the exemption expires subject to regulation 5(8) of the 2020 Regulations;
b
“transitional case”, in relation to an exemption and a category of EEE, means that the exemption for that category of EEE is a transitional case for the purposes of regulation 10 of the 2020 Regulations.
6
For the purposes of entries 1 to 9 in Table 1 (entries related to lighting) a lamp is for “general lighting purposes” if it is designed for the purpose of illuminating a room or space in order to provide or improve visibility, and it is for “special purposes” if it is designed for any other purpose.
7
In paragraph 5, “the 2020 Regulations” means the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020.
No. | Application | Maximum quantity exempted (if any) | Corresponding EU exemption | Categories of EEE to which exemption applies | Expiry date or status |
|---|---|---|---|---|---|
1 | Mercury in single capped (compact) fluorescent lamps: | ||||
1.1 | For general lighting purposes < 30 W | 2.5 mg per burner | Annex 3, 1(a) | all categories | transitional case |
1.2 | For general lighting purposes ≥ 30 W and < 50 W | 3.5 mg per burner | Annex 3, 1(b) | all categories | transitional case |
1.3 | For general lighting purposes ≥ 50 W and < 150 W | 5 mg per burner | Annex 3, 1(c) | all categories | transitional case |
1.4 | For general lighting purposes ≥ 150 W | 15 mg per burner | Annex 3, 1(d) | all categories | transitional case |
1.5 | For general lighting purposes with circular or square structural shape and tube diameter ≤ 17 mm | 7 mg per burner | Annex 3, 1(e) | all categories | transitional case |
1.6 | For special purposes | 5 mg per burner | Annex 3, 1(f) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
1.7 | For general lighting purposes < 30 W with a lifetime equal or above 20,000 h | 3.5 mg per burner | Annex 3, 1(g) | all categories | transitional case |
2 | Mercury in double-capped linear fluorescent lamps for general lighting purposes: | ||||
2.1 | Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter < 9 mm (e.g. T2) | 4 mg per lamp | Annex 3, 2(a)(1) | all categories | transitional case |
2.2 | Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5) | 3 mg per lamp | Annex 3, 2(a)(2) | all categories | transitional case |
2.3 | Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 17 mm and ≤ 28 mm (e.g. T8) | 3.5 mg per lamp | Annex 3, 2(a)(3) | all categories | transitional case |
2.4 | Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 28 mm (e.g. T12) | 3.5 mg per lamp | Annex 3, 2(a)(4) | all categories | transitional case |
2.5 | Tri-band phosphor with long lifetime (≥ 25,000 h) | 5 mg per lamp | Annex 3, 2(a)(5) | all categories | transitional case |
3 | Mercury in other fluorescent lamps: | ||||
3.1 | Non-linear tri-band phosphor lamps with tube diameter > 17 mm (e.g. T9). | 15 mg per lamp | Annex 3, 2(b)(3) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
3.2 | Lamps for other general lighting and special purposes (e.g. induction lamps). | 15 mg per lamp | Annex 3, 2(b)(4) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
4 | Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for special purposes: | ||||
4.1 | Short length (≤ 500 mm) | 3.5 mg per lamp | Annex 3, 3(a) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
4.2 | Medium length (> 500 mm and ≤ 1500 mm) | 5 mg per lamp | Annex 3, 3(b) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
4.3 | Long length (> 1500 mm) | 13 mg per lamp | Annex 3, 3(c) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
5 | Mercury in other low pressure discharge lamps. | 15 mg per lamp | Annex 3, 4(a) | 1-7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
6 | Mercury in High Pressure Sodium (vapour) lamps for general lighting purposes in lamps with improved colour rendering index Ra > 60: | ||||
6.1 | P ≤ 155 W | 30 mg per burner | Annex 3, 4(b)-I | all categories | transitional case |
6.2 | 155 W < P ≤ 405 W | 40 mg per burner | Annex 3, 4(b)-II | all categories | transitional case |
6.3 | P > 405 W | 40 mg per burner | Annex 3, 4(b)-III | all categories | transitional case |
7 | Mercury in other High Pressure Sodium (vapour) lamps for general lighting purposes: | ||||
7.1 | P ≤ 155 W | 25 mg per burner | Annex 3, 4(c)-I | all categories | transitional case |
7.2 | 155 W < P ≤ 405 W | 30 mg per burner | Annex 3, 4(c)-II | all categories | transitional case |
7.3 | P > 405 W | 40 mg per burner | Annex 3, 4(c)-III | all categories | transitional case |
8 | Mercury in metal halide lamps. | Annex 3, 4(e) | 1–7, 10 | transitional case | |
8x, 9x | 21st July 2021 | ||||
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
9 | Mercury in other discharge lamps for special purposes not specifically mentioned in another entry in this Table. | Annex 3, 4(f) | 1-7, 8x, 9x, 10 | transitional case | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
10 | Lead in glass of cathode ray tubes. | Annex 3, 5(a) | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
11 | Lead in glass of fluorescent tubes. | 0.2% lead by weight | Annex 3, 5(b) | 1–7, 10 | transitional case |
8x, 9x | 21st July 2021 | ||||
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
12 | Lead as an alloying element in steel for machining purposes and in galvanised steel. | 0.35% lead by weight | Annex 3, 6(a) | 8, 9 | transitional case |
11 | 21st July 2024 | ||||
13 | Lead as an alloying element in steel for machining purposes. | 0.35% lead by weight | Annex 3, 6(a)-I | 1-7, 10 | transitional case |
14 | Lead as an alloying element in batch hot dip galvanised steel components. | 0.2% lead by weight | Annex 3, 6(a)-I | 1-7, 10 | transitional case |
15 | Lead as an alloying element in aluminium. | 0.4% lead by weight | Annex 3, 6(b) | 8, 9 | transitional case |
11 | 21st July 2024 | ||||
16 | Lead as an alloying element in aluminium, provided it stems from lead-bearing aluminium scrap recycling. | 0.4% lead by weight | Annex 3, 6(b)-I | 1-7, 10 | transitional case |
17 | Lead as an alloying element in aluminium for machining purposes. | 0.4% lead by weight | Annex 3, 6(b)-II | 1-7, 10 | transitional case |
18 | Copper alloy containing lead. | 4% lead by weight | Annex 3, 6(c) | 1-10 | transitional case |
11 | 21st July 2024 | ||||
19 | Lead in high melting temperature type solders, i.e. lead-based alloys containing 85% by weight or more lead. This entry does not apply to applications covered by entry 42. | Annex 3, 7(a) | 1-10 | transitional case | |
11 | 21st July 2024 | ||||
20 | Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission, and network management for telecommunications. | Annex 3, 7(b) | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
21 | Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound. This entry does not apply to applications covered by entry 49. | Annex 3, 7(c)-I | 1-10 | transitional case | |
11 | 21st July 2024 | ||||
22 | Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher. This entry does not apply to applications covered by entry 21 or 23. | Annex 3, 7(c)-II | 1 – 10 | transitional case | |
11 | 21st July 2024 | ||||
23 | Lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors. | Annex 3, 7(c)-IV | 1-7, 8x, 9x, 10 | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
24 | Cadmium and its compounds in electrical contacts. | Annex 3, 8(b) | 8, 9 | transitional case | |
11 | 21st July 2024 | ||||
25 | Cadmium and its compounds in electrical contacts used in: — circuit breakers, — thermal sensing controls, — thermal motor protectors (excluding hermetic thermal motor protectors), — AC switches rated at:
— DC switches rated at 20 A and more at 18 V DC and more, and — switches for use at voltage supply frequency ≥ 200 Hz. | Annex 3, 8(b)-I | 1-7, 10 | transitional case | |
26 | Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75 % by weight in the cooling solution. | Annex 3, 9 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
27 | Lead in bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications. | Annex 3, 9(b) | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
28 | Lead in white glasses used for optical applications. | Annex 3, 13(a) | all categories | transitional case | |
29 | Cadmium and lead in filter glasses and glasses used for reflectance standards. | Annex 3, 13(b) | 8, 9, 11 | transitional case | |
30 | Lead in ion coloured optical filter glass types. | Annex 3, 13(b)-(I) | 1-7, 10 | transitional case | |
31 | Cadmium in striking optical filter glass types. | Annex 3, 13(b)-(II) | 1-7, 10 | transitional case | |
32 | Cadmium and lead in glazes used for reflectance standards. | Annex 3, 13(b)-(III) | 1-7, 10 | transitional case | |
33 | Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages. | Annex 3, 15 | 8, 9 | transitional case | |
11 | 21st July 2024 | ||||
34 | Lead in solders to complete a viable electrical connection between the semiconductor die and carrier within integrated circuit flip chip packages where at least one of the following criteria applies: — a semiconductor technology node of 90 nm or larger; — a single die of 300 mm² or larger in any semi-conductor technology node; — stacked die packages with die of 300 mm² or larger, or silicon interposers of 300mm2 or larger. | Annex 3, 15(a) | 1–7, 10 | transitional case | |
35 | Lead halide as radiant agent in high intensity discharge (HID) lamps used for professional reprography applications. | Annex 3, 17 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
36 | Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used as sun tanning lamps. | 1% lead by weight or less | Annex 3, 18(b) | 1–7, 8x, 9x, 10 | transitional case |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
37 | Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment. This entry does not apply to applications covered by entry 88. | 1% lead by weight or less | Annex 3, 18(b)-I | 5, 8 | transitional case |
38 | Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses. | Annex 3, 21 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
39 | Cadmium when used in colour printed glass to provide filtering functions, used as a component in lighting applications installed in displays and control panels of EEE. | Annex 3, 21(a) | 1–7, 10 | 21st July 2021 | |
40 | Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses. | Annex 3, 21(b) | 1–7, 10 | 21st July 2021 | |
41 | Lead in printing inks for the application of enamels on other than borosilicate glasses. | Annex 3, 21(c) | 1–7, 10 | 21st July 2021 | |
42 | Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors. | Annex 3, 24 | 1–10 | transitional case | |
11 | 21st July 2024 | ||||
43 | Lead oxide in surface conduction electron emitter displays (SED) used in structural elements, notably in the seal frit and frit ring. | Annex 3, 25 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
44 | Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC(1). | Annex 3, 29 | 1–7, 10, 11 | transitional case | |
8x, 9x | 21st July 2021 | ||||
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
45 | Cadmium alloys as electrical/mechanical solder joints to electrical conductors located directly on the voice coil in transducers used in high-powered loudspeakers with sound pressure levels of 100 dB (A) and more. | Annex 3, 30 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
46 | Lead in soldering materials in mercury free flat fluorescent lamps (which e.g. are used for liquid crystal displays, design or industrial lighting). | Annex 3, 31 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
47 | Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes. | Annex 3, 32 | 1–7, 8x, 9, 10 | transitional case | |
8iv | 21st July 2023 | ||||
11 | 21st July 2024 | ||||
48 | Lead in solders for the soldering of thin copper wires of 100 μm diameter and less in power transformers. | Annex 3, 33 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
49 | Lead in cermet-based trimmer potentiometer elements. | Annex 3, 34 | 1–10 | transitional case | |
11 | 21st July 2024 | ||||
50 | Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass body. | Annex 3, 37 | 1–7, 8x, 9x, 10 | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
51 | Cadmium and cadmium oxide in thick film pastes used on aluminium bonded beryllium oxide. | Annex 3, 38 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind, 11 | 21st July 2024 | ||||
52 | Cadmium selenide in downshifting cadmium-based semiconductor nanocrystal quantum dots for use in display lighting applications (< 0.2 μg Cd per mm² of display screen area). | Annex 3, 39(a) | all categories | transitional case | |
53 | Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (category NRSh in Regulation (EU) 2016/1628 of the European Parliament and of the Council(2)). | Annex 3, 41 | 1–7, 10, 11 | 31st March 2022 | |
8x, 9x | 21st July 2021 | ||||
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
54 | Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment: — with engine total displacement ≥ 15 litres; or — with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications. This entry does not apply to applications covered by entry 18. | Annex 3, 42 | 8x, 9x | transitional case | |
11 | 21st July 2024 | ||||
55 | Bis(2-ethylhexyl) phthalate in rubber components in engine systems, designed for use in equipment that is not intended solely for consumer use and provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin. This entry applies where the concentration value of bis(2-ethylhexyl) phthalate does not exceed: 30 % by weight of the rubber for: gasket coatings; solid-rubber gaskets; or rubber components included in assemblies of at least three components using electrical, mechanical or hydraulic energy to do work, and attached to the engine. 10% by weight of the rubber for rubber-containing components not referred to in point (a). For the purposes of this entry, ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day. | Annex 3, 43 | 9ind | 15th July 2023 | |
11 | 21st July 2024 | ||||
56 | Lead in solder of sensors, actuators, and engine control units of combustion engines within the scope of Regulation (EU) 2016/1628 of the European Parliament and of the Council, installed in equipment used at fixed positions while in operation which is designed for professionals, but also used by non-professional users. | Annex 3, 44 | 11 | 21st July 2024 | |
57 | Lead, cadmium and mercury in detectors for ionising radiation. | Annex 4, 1 | 8x, 9x, 9ind | transitional case | |
8iv | 21st July 2023 | ||||
58 | Lead bearings in X-ray tubes. | Annex 4, 2 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
59 | Lead in electromagnetic radiation amplification devices: micro-channel plate and capillary plate. | Annex 4, 3 | 8, 9 | transitional case | |
60 | Lead in glass frit of X-ray tubes and image intensifiers and lead in glass frit binder for assembly of gas lasers and for vacuum tubes that convert electromagnetic radiation into electrons. | Annex 4, 4 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
61 | Lead in shielding for ionising radiation. | Annex 4, 5 | 8x, 9 | transitional case | |
8iv | 21st July 2023 | ||||
62 | Lead in X-ray test objects. | Annex 4, 6 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
63 | Lead stearate X-ray diffraction crystals. | Annex 4, 7 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
64 | Radioactive cadmium isotope source for portable X-ray fluorescence spectrometers. | Annex 4, 8 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
65 | Lead and cadmium in ion selective electrodes including glass of pH electrodes. | Annex 4, 1a | 8x, 9 | transitional case | |
8iv | 21st July 2023 | ||||
66 | Lead anodes in electrochemical oxygen sensors. | Annex 4, 1b | 8x, 9 | transitional case | |
8iv | 21st July 2023 | ||||
67 | Lead, cadmium and mercury in infra-red light detectors. | Annex 4, 1c | 8, 9 | transitional case | |
68 | Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate and mercury oxide. | Annex 4, 1d | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
69 | Cadmium in helium-cadmium lasers. | Annex 4, 9 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
70 | Lead and cadmium in atomic absorption spectroscopy lamps. | Annex 4, 10 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
71 | Lead in alloys as a superconductor and thermal conductor in MRI. | Annex 4, 11 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
72 | Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. | Annex 4, 12 | 8x, 9 | transitional case | |
8iv | 30th June 2021 | ||||
73 | Lead in counterweights. | Annex 4, 13 | 8x, 9x | transitional case | |
38iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
74 | Lead in single crystal piezoelectric materials for ultrasonic transducers. | Annex 4, 14 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
75 | Lead in solders for bonding to ultrasonic transducers. | Annex 4, 15 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
76 | Mercury in very high accuracy capacitance and loss measurement bridges and in high frequency RF switches and relays in monitoring and control instruments. | 20mg of mercury per switch or relay | Annex 4, 16 | 8x, 9x | 21st July 2021 |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
77 | Lead in solders in portable emergency defibrillators. | Annex 4, 17 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
78 | Lead in solders of high performance infrared imaging modules to detect in the range 8-14 μm. | Annex 4, 18 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
79 | Lead in liquid crystal on silicon (LCoS) displays. | Annex 4, 19 | 8x, 9x | 21st July 2021 | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
80 | Cadmium in X-ray measurement filters. | Annex 4, 20 | 8x, 9x | transitional case | |
8iv | 21st July 2023 | ||||
9ind | 21st July 2024 | ||||
81 | Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment. | Annex 4, 22 | 8, 9 | 30th June 2021 | |
82 | Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. | Annex 4, 23 | 8, 9 | 30th June 2021 | |
83 | Lead in the surface coatings of pin connector systems. requiring nonmagnetic connectors which are used durably at a temperature below –20 °C under normal operating and storage conditions. | Annex 4, 25 | 8, 9 | 30th June 2021 | |
84 | Lead in the following applications that are used durably at a temperature below –20 °C under normal operating and storage conditions:
Lead in solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below –150 °C. | Annex 4, 26 | 8x, 9 | transitional case | |
8iv | 30th June 2021 | ||||
85 | Lead in: — solders, — termination coatings of electrical and electronic components and printed circuit boards, — connections of electrical wires, shields and enclosed connectors, which are used in:
| Annex 4, 27 | 8, 9x | transitional case | |
86 | Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices or in industrial monitoring and control instruments. | Annex 4, 29 | 8x | transitional case | |
8iv, 9ind | 30th June 2021 | ||||
87 | Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. | Annex 4, 31a | 8, 9x | transitional case | |
9ind | 21st July 2024 | ||||
88 | Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. | Annex 4, 34 | 8, 9 | 22nd July 2021 | |
89 | Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017. | Annex 4, 35 | 9ind | 21st July 2024 | |
90 | Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:
| Annex 4, 37 | 8, 9 | 31st December 2025 | |
91 | Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:
| Annex 4, 39 | 8, 9 | transitional case | |
92 | Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. | Annex 4, 41 | 8iv | 31st March 2022 | |
93 | Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation. | Annex 4, 42 | 8x, 9x | F6730th June 2026 | |
94 | Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required. | Annex 4, 43 | 9ind | 15th July 2023 | |
95 | Cadmium in radiation tolerant video camera tubes designed for cameras with a centre resolution greater than 450 TV lines which are used in environments with ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy. | Annex 4, 44 | 8x, 9 | 31st March 2027 | |
F10396 | Lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide in electric and electronic initiators of explosives for civil (professional) use and barium chromate in long time pyrotechnic delay charges of electric initiators of explosives for civil (professional) use | Annex 3, 45 | 11 | 20th April 2026 | |
F197 | Bis(2-ethylhexyl) phthalate (DEHP) in ion selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids. | Annex 4, 45 | 8 | 21st July 2028 | |
98 | Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils. | Annex 4, 46 | 8 | 1st January 2024 | |
99 | Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. | Annex 4, 47 | 8 | 21st July 2028 | |
(1) OJ No L 326, 19.12.1969, p.36, as last amended by Council Directive 2006/96/EC (OJ No L 363, 20.12.2006, p.81). | |||||
(2) EUR 2016/1628. | |||||
No. | Application | Categories of EEE to which exemption applies |
|---|---|---|
1 | Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for EEE placed on the market before 1st January 2013. | all categories |
2 | Cadmium and its compounds in one shot pellet type thermal cut-offs, where used in spare parts for EEE placed on the market before 1st January 2012. | all categories |
3 | Lead used in C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 24th September 2010. | all categories |
4 | Lead used in other than C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 1st January 2013. | all categories |
5 | Lead as a coating material for the thermal conduction module C-ring, where used in spare parts for EEE placed on the market before 24th September 2010. | all categories |
6 | Lead in solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80% and less than 85% by weight, where used in spare parts for EEE placed on the market before 1st January 2011. | all categories |
7 | Lead in finishes of fine pitch components other than connectors with a pitch of 0.65 mm and less, where used in spare parts for EEE placed on the market before 24th September 2010. | all categories |
8 | Cadmium in phosphor coatings in image intensifiers for X-ray images, in spare parts for X-ray systems placed on the market before 1st January 2020. | 8, 9 |
9 | Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers, where used in spare parts for X-ray systems placed on the market before 1st January 2020. | 8, 9 |
10 | Lead used in other than C-press compliant pin connector systems, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021. | 9ind |
11 | Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021. | 9ind |
SCHEDULE 1
Words in Sch. 1 inserted (E.W.S.) (31.12.2020) by The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/188), regs. 1(2)(b), 18(25)(a) (as amended by S.I. 2020/1540, regs. 1(2), 11(2)); 2020 c. 1, Sch. 5 para. 1(1)
PART 1Categories of EEE to which these Regulations apply
1
Large household appliances.
2
Small household appliances.
3
IT and telecommunications equipment.
4
Consumer equipment.
5
Lighting equipment.
6
Electrical and electronic tools.
7
Toys, leisure and sports equipment.
8
Medical devices.
9
Monitoring and control instruments including industrial monitoring and control instruments.
10
Automatic dispensers.
11
Other EEE not covered by any of the categories above.
PART 2EEE to which these Regulations do not apply
E1212
Equipment which is necessary for the protection of the essential interests of the security of F108the United Kingdom, including arms, munitions and war material intended for specifically military purposes.
E412
Equipment which is necessary for the protection of the essential interests of the security of F112the United Kingdom or member States, including arms, munitions and war material intended for specifically military purposes.
13
Equipment designed to be sent into space.
14
Equipment which is specifically designed, and is to be installed, as part of another type of equipment to which these Regulations do not apply, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment.
15
Large-scale stationary industrial tools being a large-scale assembly of machines, equipment, and/or components—
a
functioning together for a specific application;
b
permanently installed and de-installed by professionals at a given place; and
c
used and maintained by professionals in an industrial manufacturing facility or research and development facility.
16
Large-scale fixed installations being a large-scale combination of several types of apparatus and, where applicable, other devices, which are—
a
assembled and installed by professionals;
b
intended to be used permanently in a pre-defined and dedicated location; and
c
de-installed by professionals.
17
Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved.
18
Non-road mobile machinery made available exclusively for professional use, being machinery, with an on-board power source F9or with a traction drive powered by an external power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use.
19
Active implantable medical devices.
20
Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications.
21
Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.
F9821A
Pipe organs.
PART 3Categories of EEE with special rules of application
22
Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply—
a
to medical devices and monitoring and control instruments placed on the market before 22nd July 2014;
b
to in vitro diagnostic medical devices placed on the market before 22nd July 2016; F74...
c
to industrial monitoring and control instruments placed on the market before 22nd July 2017; F29and
d
to all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019.
23
1
Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following—
a
EEE placed on the market before 1st July 2006;
b
medical devices placed on the market before 22nd July 2014;
c
in vitro diagnostic medical devices placed on the market before 22nd July 2016;
d
monitoring and control instruments placed on the market before 22nd July 2014;
e
industrial monitoring and control instruments placed on the market before 22nd July 2017;
F3ea
all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019;
f
EEE which benefited from an exemption listed in the Directive or the F512002 Directive and which was placed on the market before that exemption expired, provided that the specific exemption concerned those cables or spare parts.
F252
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F8224
Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer, regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to reused spare parts—
a
recovered from EEE placed on the market before 1st July 2006 and used in EEE placed on the market before 1st July 2016;
b
recovered from medical devices or monitoring and control instruments placed on the market before 22nd July 2014 and used in EEE placed on the market before 22nd July 2024;
c
recovered from in vitro diagnostic medical devices placed on the market before 22nd July 2016 and used in EEE placed on the market before 22nd July 2026;
d
recovered from industrial monitoring and control instruments placed on the market before 22nd July 2017 and used in EEE placed on the market before 22nd July 2027;
e
recovered from all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019, and used in EEE placed on the market before 22nd July 2029.
F7PART 4Internal Production Control Procedure
Sch. 1 Pt. 4 inserted (E.W.S.) (31.12.2020) by The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/188), regs. 1(2)(b), 18(25)(c) (as amended by S.I. 2019/1078, regs. 1, 4(5) and S.I. 2020/1540, regs. 1(2), 11(2)); 2020 c. 1, Sch. 5 para. 1(1)
25
The internal production control procedure is a conformity assessment procedure whereby a manufacturer must ensure EEE is manufactured in compliance with the technical documentation and with the applicable requirements of these Regulations.
26
The technical documentation must—
a
make it possible to assess the EEE's conformity with the applicable requirements of these Regulations, and must include an adequate analysis and assessment of the risks;
b
specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the EEE;
c
contain, where applicable, at least the following elements—
i
a general description of the EEE;
ii
conceptual design and manufacturing drawings and schemes of components, sub-assemblies;
iii
descriptions and explanations necessary for the understanding of those drawings and schemes, and the operation of the EEE;
iv
a list of the designated standards applied in full or in part (where applicable specifying the parts which have been applied);
v
where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied;
vii
results of design calculations made, examinations carried out and
viii
test reports.
F107SCHEDULE 1ADeclaration of conformity
Sch. 1A inserted (E.W.S.) (31.12.2020) by The Waste (Miscellaneous Amendments) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/188), regs. 1(2)(b), 18(26) (as amended by S.I. 2020/1540, regs. 1(2), 11(2)); 2020 c. 1, Sch. 5 para. 1(1)
1
Declaration of conformity (unique identification of the EEE):
2
Name and address of the manufacturer or, where applicable, authorised representative:
3
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4
Object of the declaration (identification of EEE allowing traceability: it may include a photograph, where appropriate):
5
The object of the declaration described above is in conformity with relevant statutory requirements:
6
Where applicable, references to the relevant designated standards used or references to the technical specifications in relation to which conformity is declared:
7
Additional information:
Signed for and on behalf of:
place and date of issue:
name, function) (signature:
SCHEDULE 2Test purchases, powers of entry etc and warrants
Test purchases1
1
The market surveillance authority may purchase EEE for the purpose of ascertaining whether the requirements of these Regulations have been complied with in respect of it.
2
If—
a
EEE which has been purchased under sub-paragraph (1) or seized under paragraph 3(1)(c) of this Schedule is submitted to a test;
b
the test leads to the bringing of proceedings for an offence under regulation 37 or the serving of a compliance, enforcement or recall notice; and
c
a person—
i
from whom the EEE was purchased;
ii
who is a party to the proceedings; or
iii
who has an interest in EEE which is identified as an infringing EEE in a compliance enforcement or recall notice,
requests the market surveillance authority to allow that person to have the EEE tested,
the authority must, if it is practicable for such a test to be carried out, allow that person to have the EEE tested.
Power to enter premises2
1
An authorised person may enter premises, except any premises used wholly or mainly as a private dwelling, at any reasonable hour, for the purpose of enforcing these Regulations.
2
Before entering the premises an authorised person must give reasonable notice, unless the authorised person has a reasonable suspicion of a failure to comply with these Regulations.
3
An authorised person must, if requested to do so, produce a written authorisation document.
4
An authorised person may—
a
be accompanied by—
i
such other persons as the authorised person considers necessary,
F55ii
any representative of the European Commission; and
b
bring on to the premises such equipment as the authorised person considers necessary.
Power to inspect, seize and detain EEEetc3
1
An authorised person may—
a
in order to ascertain if any provision of these Regulations has not been complied with—
i
inspect any EEE, products, goods, substances, records, documents or information;
b
in order to ascertain if any provision of these Regulations has not been complied with, require any person carrying on or employed in connection with a business to produce any EEE, products, goods, substances, records, documents or information and take copies of—
i
any document or record; or
ii
any entry in any document or record;
c
in order to ascertain by testing or otherwise if any provision of these Regulations has not been complied with, and reasonably suspecting such non-compliance, seize and detain any EEE, products, goods, substances, records, documents or information;
d
seize and detain any EEE, products, goods, substances, records, documents or information which may be required as evidence in any proceedings under these Regulations;
e
for the purposes of exercising any powers or duties under these Regulations or RAMS, but only if and to the extent reasonably necessary in order to secure that the provisions of these Regulations are complied with, require any person having authority to do so to break open any container and, if that person does not comply or if there is no person present having authority to open it, break it open using reasonable force.
2
An authorised person may require information stored electronically to be made available in printed form.
3
An authorised person entering any premises whether under a power of entry under paragraph 2 or under a warrant under paragraph 4 must, if the occupier is present, give to the occupier or, if the occupier is absent, leave in a prominent place a notice—
a
summarising the authorised person’s powers of seizure and detention of EEE, products, goods, substances, records, documents and information;
b
disclosing at which office of the market surveillance authority and within which hours a copy of these Regulations is available to be consulted.
4
An authorised person entering any premises which are unoccupied or from which the occupier is temporarily absent must leave them as effectively secured against unauthorised entry as they were before entry.
5
An authorised person exercising any power of seizure and detention must—
a
give to the person against whom the power has been exercised a notice stating what has been seized and detained;
b
detain those things only for as long as is necessary for the market surveillance authority to ascertain whether any provision of these Regulations has not been complied with and, if required, to present the evidence at court.
6
Nothing in this paragraph compels the production by any person of a document which that person would be entitled to withhold production of in any proceedings in any court on the grounds that it is the subject of legal professional privilege or, in Scotland, that it contains a confidential communication made by or to an advocate or solicitor in that capacity.
Warrants4
1
A justice of the peace may by signed warrant permit an authorised person or any other person to enter any premises in the exercise of the powers and duties under these Regulations or Article 19 of RAMS, if necessary by reasonable force, if the justice in England and Wales on sworn information in writing, in Northern Ireland on a complaint on oath, or in Scotland by evidence on oath is satisfied—
a
that there are reasonable grounds to enter those premises for the purposes of enforcing these Regulations; and
b
that any of the conditions in sub-paragraph (3) is met.
2
Reference to a justice of the peace—
a
in Scotland includes a sheriff;
b
in Northern Ireland is a reference to a lay magistrate.
3
The conditions are—
a
entry to the premises has been, or is likely to be, refused and notice of the intention to apply for a warrant has been given to the occupier;
b
asking for admission to the premises, or giving such a notice, would defeat the object of the entry;
c
entry is required urgently;
d
the premises are unoccupied or the occupier is temporarily absent.
4
A warrant under sub-paragraph (1) is valid for one month.
SCHEDULE 3Compliance, enforcement and recall notices
Compliance notice1
1
The market surveillance authority may serve a notice under this paragraph on an economic operator who makes EEE available on the market if the authority has reasonable grounds for believing—
a
the EEE is an infringing product; or
b
the economic operator has failed to comply with its obligations under regulation 15, 19, 25 or 27(1).
2
A compliance notice must—
a
describe the alleged infringing EEE (the “specified EEE”) or alleged failure to comply with the obligations set out in sub-paragraph 1(b) (the “alleged breach”) in a manner sufficient to identify it; and
b
state the exact grounds on which the notice is based.
3
A compliance notice may—
a
require the economic operator in an appropriate case, and having regard to the economic operator’s ability to take the measures in light of that person’s position in the supply chain, to remedy the situation or matters which gave rise to the authority’s belief that the specified EEE was an infringing EEE or an alleged breach had occurred; or
b
where it is not possible for the specified EEE to cease to be an infringing EEE, require the economic operator to secure that the specified EEE is withdrawn or that its being made available on the market is prohibited or restricted.
4
A compliance notice must tell the economic operator—
a
what compliance is required and the period within which it must be completed;
b
to give the authority evidence that the economic operator has complied with the notice;
c
the consequences of failing to comply with the notice; and
d
the rights of appeal against the notice under these Regulations and any time limits for their exercise.
5
Proceedings must not be commenced against a person under regulation 37 in respect of an alleged contravention of a requirement of these Regulations where—
a
a compliance notice has been served on that person in respect of the alleged contravention; and
b
the specified compliance period in that notice has not come to an end.
Enforcement notice2
1
Where the market surveillance authority serves a compliance notice on an economic operator and, at the end of the compliance period specified in the notice—
a
it appears to the authority that that person has failed to comply with the notice; and
b
the authority has reasonable grounds for considering that the specified EEE is an infringing EEE or that an alleged breach has occurred,
the authority may serve an enforcement notice on that person.
2
An enforcement notice must—
a
describe the specified EEE or alleged breach in a manner sufficient to identify it; and
b
state the exact grounds on which the notice is based.
3
An enforcement notice may—
a
require the economic operator in an appropriate case, and having regard to the economic operator’s ability to take the measures in light of that person’s position in the supply chain, to remedy the situation or matters which gave rise to the authority’s belief that the specified EEE was an infringing EEE or that an alleged breach has occurred; or
b
require the economic operator to secure that the specified EEE is withdrawn or that its being made available on the market is prohibited or restricted.
4
An enforcement notice must tell the economic operator—
a
what compliance is required and the period within which it must be completed;
b
to give the authority evidence that the economic operator has complied with the notice;
c
the consequences of failing to comply with the notice; and
d
the rights of appeal against the notice under these Regulations and any time limits for their exercise.
5
Proceedings must not be commenced against a person under regulation 37 (Offences) in connection with any specified EEE which it is alleged is an infringing EEE where—
a
an enforcement notice has been served on that person in respect of the specified EEE; and
b
the compliance period specified in that notice has not come to an end.
6
In this paragraph “specified EEE” means the alleged infringing EEE that has been identified in a compliance notice in accordance with paragraph 1(2)(a).
Supplementary provisions in relation to compliance and enforcement notices3
1
The market surveillance authority must comply with the provisions of Article 21 of RAMS in relation to the serving of a compliance or enforcement notice which imposes any requirements to secure that EEE is withdrawn from the market or that its being made available on the market is prohibited or restricted.
2
Where the market surveillance authority has served a compliance notice or enforcement notice under this Schedule, the authority—
a
must keep the notice under review and may withdraw or revoke it at any time;
b
may vary the notice, provided it is not made more restrictive for the economic operator or more onerous for that person to comply with.
Recall notices4
1
The market surveillance authority may serve a recall notice on an economic operator if the authority has reasonable grounds for believing that EEE is—
a
an infringing EEE presenting a serious risk by reason of that infringement; and
b
that it has already been supplied or made available to end users.
2
A recall notice is a notice which requires the economic operator to use reasonable endeavours to organise the return of the EEE from end users to the economic operator or another person specified in the notice.
3
The provisions of—
a
regulation 15 of the General Product Safety Regulations 200516 (“GPSR”); and
b
Article 21 of RAMS,
apply in relation to the serving of a recall notice under these Regulations.
4
For the purposes of serving a recall notice under this paragraph, regulation 15 of the GPSR applies as if—
a
references to the provisions of the GPSR were references to those provisions as modified by this paragraph and to these Regulations;
b
references to an “enforcement authority” were references to the market surveillance authority;
c
references to the product being “a dangerous product” were references to the EEE being an infringing EEE presenting a serious risk by reason of that infringement;
d
references to risks to the health and safety of persons were references to the serious risk presented by the EEE;
e
paragraphs (9) and (10) were omitted.
5
In this paragraph—
a
“serious risk” means a serious risk to health, safety, the environment, consumers, or security, requiring rapid intervention, including a serious risk the effects of which are not immediate;
b
The decision whether or not an EEE presents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of an occurrence;
c
The feasibility of obtaining higher levels of safety or the availability of other EEEs presenting a lesser degree of risk shall not constitute grounds for considering that an EEE presents a serious risk.
Action by the market surveillance authority5
1
The market surveillance authority may itself take action which an economic operator could have been required to take by a compliance, an enforcement or recall notice where the conditions for serving such a notice are met and either—
a
the authority has been unable to identify any economic operator on whom to serve such a notice; or
b
the person on whom such a notice has been served has failed to comply with it.
2
If the market surveillance authority has taken action under paragraph (1) following the failure of an economic operator to comply with a compliance, enforcement or recall notice, the authority may recover from that person as a civil debt any costs or expenses reasonably incurred by the authority in taking the action.
3
A civil debt recoverable under the preceding paragraph may be recovered summarily—
a
in England and Wales by way of complaint pursuant to section 58 of the Magistrates’ Courts Act 198017;
b
in Northern Ireland in proceedings under article 62 of the Magistrates’ Court (Northern Ireland) Order 198118.
Compensation provisions relating to compliance, enforcement and recall notices6
Where the market surveillance authority serves a compliance, enforcement or recall notice, the authority is liable to pay compensation to a person in respect of any loss or damage suffered by that person by reason of the notice if—
a
the EEE is not an infringing EEE or the alleged breach is not a breach; and
b
the exercise by the authority of the power to serve the notice was not attributable to neglect or default by the person.
Appeals against compliance, enforcement and recall notices7
1
An application for an order to vary or set aside the terms of a compliance, enforcement or recall notice may be made—
a
in the case of a compliance, enforcement or recall notice, by the economic operator on whom the notice has been served; and
b
in the case of a compliance or enforcement notice, by a person having an interest in the product in respect of which that notice has been served.
2
An application must be made before the end of the period of 21 days beginning with the day on which the notice was served.
3
The appropriate court (as determined in accordance with paragraph 8) may only make an order setting aside a compliance, enforcement or recall notice if satisfied—
a
that the EEE is not an infringing EEE;
b
that the alleged breach is not a breach; or
c
that the serving of the notice was not proportionate.
4
On an application to vary the terms of a compliance, enforcement or recall notice, the appropriate court may vary the terms of the notice as it considers appropriate.
Appropriate court for appeals against notices etc and further appeals8
1
In England and Wales or Northern Ireland the appropriate court for the purposes of paragraph 7 is—
a
b
in any other case a magistrates’ court in England and Wales or Northern Ireland.
2
In Scotland the appropriate court for the purposes of paragraph 7 is the sheriff for a sheriff court district in which a compliance, enforcement or recall notice has been served on an economic operator.
3
A person aggrieved by an order made by a magistrates’ court in England, Wales or Northern Ireland19 pursuant to an application under paragraph 7(1), or by a decision of such a court not to make such an order, may appeal against that order or decision—
a
in England and Wales, to the Crown Court;
b
in Northern Ireland, to the county court.
Offences and penalties9
1
It is an offence for any person to contravene or fail to comply with any of the requirements of—
a
an enforcement notice; or
b
a recall notice.
2
A person convicted of an offence under sub-paragraph (1) is liable—
a
on summary conviction, to a fine not exceeding the statutory maximum;
b
on conviction on indictment, to a fine.
(This note is not part of the Regulations)
Sch. A1 inserted (E.W.S.) (31.12.2020) by The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1647), reg. 1(3), Sch. 2