Designated standard2A

1

Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is—

a

adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and

b

designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

2

For the purposes of paragraph (1), 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

For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

a

the European Committee for Standardisation (CEN);

b

the European Committee for Electrotechnical Standardisation (Cenelec);

c

the European Telecommunications Standards Institute (ETSI);

d

the British Standards Institution (BSI).

4

When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5

Before publishing 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 technical specifications adopted by the other recognised standardisation bodies.

6

The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

7

Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

8

In this regulation, a reference to a “product” is a reference to machinery to which these Regulations apply.

9

The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

10

Regulations made under paragraph (9) are to be made by statutory instrument.

11

A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Obligations which are met by complying with obligations in the Directive12A

1

In this regulation—

a

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

b

“CE marking” means the marking referred to in Article 16(1);

c

“harmonised standard” means a harmonised standard within the meaning of Article 2(l), the reference to which has been published in the Official Journal of the European Union.

2

Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing machinery on the market or putting machinery into service, the responsible person—

a

ensures that the machinery satisfies the essential health and safety requirements set out in Annex I;

b

ensures that the technical file referred to in Annex VII, part A is available to the enforcement authorities on request;

c

provides the necessary information, referred to in Article 5(1)(c);

d

carries out the appropriate procedures for assessing conformity in accordance with Article 12;

e

ensures that the technical file, necessary information and records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

f

draws up the EC declaration of conformity in accordance with Annex II, part I, Section A and ensure that it accompanies the machinery;

h

ensures that the EC declaration of conformity is prepared in or translated into English; and

i

affixes the CE marking in accordance with Article 16.

3

Where this paragraph applies—

a

the requirements of regulation 7(2)(a), (b), (c), (e)(i) and (f) are to be treated as being satisfied;

b

regulations 7(2)(e)(ii), 15 and 21 apply subject to the modifications in paragraph (8);

c

Part 8 of Schedule 2 does not apply.

4

Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing partly completed machinery on the market, the responsible person ensures that—

a

the relevant technical documentation referred to in Annex VII part B is prepared in or translated into English;

b

the assembly instructions referred to in Annex VI are prepared in or translated into English; and

c

a declaration of incorporation referred to in Annex II part 1, Section B has been drawn up in or translated into English.

5

Where this paragraph applies the requirements of regulation 8(1) are to be treated as being satisfied.

6

This paragraph applies to machinery listed in Annex IV where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 7(2).

7

Where paragraph (6) applies, paragraph (2)(d) is to be read as requiring the responsible person to have carried out the conformity assessment procedure in Article 12(4).

8

The modifications referred to in paragraph (3)(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.

F11Expiry of regulation 12A12B

1

Subject to paragraph (2), regulation 12A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

2

Notwithstanding the expiry of regulation 12A—

a

any machinery or partly completed machinery which was placed on the market or put into service pursuant to regulation 12A may continue to be made available on the market on or after the expiry of regulation 12A;

b

any obligation to which a person was subject under regulation 12A(2) in respect of machinery or partly completed machinery placed on the market or put into service pursuant to regulation 12A continues to have effect after the expiry of regulation 12A, in respect of that machinery or partly completed machinery.

Qualifying Northern Ireland Goods12C

1

Where paragraph (2) applies the requirements of Part 3, other than those in regulations 12A, 12B and this regulation, are treated as being satisfied.

2

This paragraph applies where—

a

the responsible person has complied with the requirements of Part 3, as that Part applies in Northern Ireland; and

b

the machinery or partly completed machinery is qualifying Northern Ireland goods.

3

In this regulation “qualifying Northern Ireland goods has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Approved bodies16A

1

An approved body is a person who—

a

on or after F13 IP completion day has been designated to carry out conformity assessment in accordance with regulation 16B, to the extent that the designation remains in effect; or

b

immediately beforeF13 IP completion day was a UK notified body.

2

Paragraph (1) is subject to regulation 17.

3

In this Part a “UK notified body” means a person who immediately before F13 IP completion day was a UK notified body as defined in regulation 16(3) of these Regulations as they had effect immediately before F13 IP completion day.

Approved body designation16B

1

The Secretary of State may only designate a person to carry out conformity assessment if that person qualifies for approval.

2

A person qualifies for approval if the Secretary of State—

a

is satisfied that the person meets the criteria specified in Annex XI (Part 11 of Schedule 2) (“approved body criteria”); and

b

makes a designation in respect of that person (an “approved body designation”).

3

Where a person meets the assessment criteria laid down in a designated standard (or part of such a standard) the Secretary of State is to presume that the person meets the approved body criteria covered by that standard (or that part of that standard).

4

Where the Secretary of States makes an approved body designation, that designation—

a

must be in writing;

b

must specify the conformity assessment procedures that the person designated may carry out;

c

may relate to all the categories of machinery listed in Annex IV (Part 4 of Schedule 2) or to such of those categories as are specified in the designation;

d

may designate a person for a specified period; and

e

may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.

5

In making an approved body designation the Secretary of State may have regard (in addition to the approved body criteria) to any other matter which appears to the Secretary of State to be relevant.

6

Where an approved body was a UK notified body immediately before F14IP completion, an “approved body designation” means a notified body designation within the meaning of regulation 16(2) and (4) of these Regulations, as they had effect immediately before F14IP completion.

Monitoring16C

1

The Secretary of State must, from time to time, carry out an inspection of each approved body with a view to verifying that it—

a

meets the approved body criteria;

b

complies with any condition to which its designation is subject—

i

in accordance with regulation 16B(4)(e);

ii

in the case of an approved body which was a UK notified body immediately before F15IP completion, in accordance with regulation 16(8)(e) as it applied before F15IP completion; and

c

complies with these Regulations.

2

An approved body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the approved body criteria, these Regulations, or any condition to which its designation is subject.

Register of approved bodies19A

1

The Secretary of State must—

a

assign an approved body identification number to each approved body; and

b

compile and maintain a register of—

i

approved bodies;

ii

their approved body identification numbers;

iii

the activities for which they have been approved: and

iv

any restriction on those activities.

2

The register referred to in paragraph (1) must be made publicly available.

Transitional provisions in relation to EU Exit30

1

In this regulation—

• “pre-exit period” means the period beginning with 29 December 2009 and ending immediately before F17IP completion day;

• “product” means machinery to which these Regulations apply.

2

Where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 12 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 M1, any obligation to which a person was subject under these Regulations as they had effect immediately before F17IP completion day, continues to have effect as it did immediately before F17IP completion day, in relation to that product.

3

Where during the pre-exit period—

a

a product has not been placed on the market; and

b

a manufacturer has taken any action to comply with regulations 10 to 12 as they had effect immediately before F17IP completion day in relation to that product

that action has effect as if it had been done under regulations 10 to 12 as they have effect on and after F17IP completion day.

31

1

In this regulation—

“information requirements” means the requirements set out in—

1. a

   section 1.7.3 of Schedule 2, Part 1 that all machinery must be marked visibly, legibly and indelibly with the business name and full address of the manufacturer and where applicable the manufacturer's authorised representative; and

2. b

   section 4.3.1 of Schedule 2, Part 1 that each length of lifting chain, rope or webbing not forming part of an assembly must bear a mark or, where this is not possible, a plate or irremovable ring bearing the name and address of the responsible person and the identifying reference of the relevant certificate.

2

The information requirements do not apply to a person who—

a

falls within paragraph (b) of the definition of manufacturer in regulation 2(2);

b

has imported machinery from an EEA state and places it on the market within a period of F1924 months beginning with F18IP completion day; and

c

before placing the machinery on the market, sets out the information referred to in sections 1.7.3 and 4.3.1 of Schedule 2, Part 1 in a document accompanying the machinery.

Part 3Annex III UK marking

The UK marking must be affixed in the immediate vicinity of the name of the responsible person, using the same technique.

Where the full quality assurance procedure prescribed in Annex X (Part 10 of this Schedule) has been applied, the UK marking must be followed by the identification number of the approved body.