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

21A

Pipe organs.

Interpretation: designated standard

2A

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

• (a) adopted by a recognised standardisation body or 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 such technical specifications adopted by the other recognised standardisation bodies or 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.

• (7) In this regulation—

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

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

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

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

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

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

Modifications to the Directive

2B

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

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

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

• (4) Article 4 is to be read as if—

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

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

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

• (6) Annex 4 is to be read as if—

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

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

Restriction on the use of certain hazardous substances in EEE

Definition of EEE

EEE to which these Regulations apply

Exclusion until 22nd July 2019 for EEE outside the scope of the 2008 Regulations

Revocation and transitional arrangements

Existing legislation

Presumption of conformity for EEE

... Declaration of conformity and UK marking

Duty to keep technical documentation and EU declaration of conformity

EEE to bear UK marking

Compliance procedures for series production

Information identifying EEE and manufacturer

Register of EEE

Non-compliant EEE

Co-operation with the authorities

Manufacturers’ authorised representatives

Protection of UK marking

Obligations which are met by complying with obligations in the Directive

34A

• (1) In this regulation—

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

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

• (2) Paragraph (3) 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 Articles 7(c) and 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.

• (3) Where this paragraph applies—

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

• (b) regulation 14(3), (5) and (6) apply to that EEE subject to the modifications in paragraph (8).

• (4) Paragraph (5) 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 referred to in Article 7(c).

• (5) Where this paragraph applies, regulation 23(b) applies to that EEE subject to the modifications in paragraph (8).

• (6) Paragraph (7) applies where, before making EEE available on the market, a distributor ensures that the EEE bears the CE marking referred to in Article 7(c).

• (7) Where this paragraph applies, regulation 29(1)(a) applies to that EEE subject to the modifications in paragraph (8).

• (8) The modifications referred to in paragraphs (3)(b), (5) and (7) 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 “technical documentation” is to be read as a reference to the technical documentation referred to in Article 7(b);

• (c) any reference to “UK marking” is to be read as a reference to the CE marking.

• (9) Nothing in this regulation is to be taken to affect the prohibition in regulation 3(1) on placing, or making available, EEE on the market containing the substances listed in Schedule A1, subject to any exemptions as listed in Table 1 or Table 2 of Schedule A2.

• (10) Where an exemption continues to apply by virtue of regulations 6(4), 7(3) or (4) or 10(4) of the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020, Table 1 and Table 2 of Schedule A2 are to be read in accordance with those Regulations.

Expiry of regulation 34A

34B

• (1) In this regulation—

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

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

• (2) Paragraph (3) 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; and

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

• (3) Where this paragraph applies—

• (a) the requirements of regulation 12(1) are treated as being satisfied in respect of that EEE;

• (b) regulations 15 and 17(2) and paragraphs 25 and 26 of Schedule 1 and paragraph 6 of Schedule 1A apply to that EEE subject to the modifications in paragraph (6).

• (4) Paragraph (5) 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).

• (5) Where this paragraph applies—

• (a) the requirements of regulation 23(b)(i) are treated as being satisfied in respect of that EEE;

• (b) regulation 27(1)(b) applies to that EEE subject to the modifications in paragraph (6).

• (6) The modifications referred to in paragraphs (3)(b) and (5)(b) are that—

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

• (b) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 7(b).

• (7) Nothing in this regulation is to be taken to affect the prohibition in regulation 3(1) on placing, or making available, EEE on the market containing the substances listed in Schedule A1, subject to any exemptions as listed in Table 1 or Table 2 of Schedule A2.

• (8) Where an exemption continues to apply by virtue of regulations 6(4), 7(3) or (4) or 10(4) of the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020, Table 1 and Table 2 of Schedule A2 are to be read in accordance with those Regulations.

Qualifying Northern Ireland goods

34C

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

• (2) This paragraph applies where—

• (a) the goods which are EEE—

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

• (ii) are qualifying Northern Ireland goods; and

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

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

• (a) complies with regulation 21; and

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

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

• (ii) drawn up the technical documentation; and

• (iii) affixed the CE marking.

• (4) For the purposes of this regulation—

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

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

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

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

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

SCHEDULE A1 — Restricted substances referred to in regulation 3 and maximum concentration values tolerated by weight in homogeneous materials

• Lead (0.1%)

• Mercury (0.1%)

• Cadmium (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—......cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22nd July 2019.

• 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.

SCHEDULE A2 — Applications exempted from the restriction in regulation 3(1)

The tables of exempted applications

1

In this Schedule—

• (a) Table 1 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in EEE, ...

• (b) Table 2 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in spare parts for EEE with 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.