Paragraph 15

The Personal Protective Equipment (Enforcement) Regulations^f1 are amended as follows.

After Part 3 insert—

“PART 4

Provisions in respect of the UK(NI) indication

Interpretation

20.

In this Part “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.

UK(NI) indication

21.

(1)

Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the PPE, in accordance with this regulation.

(2)

The UK(NI) indication must be affixed—

(a)

visibly, legibly and indelibly; and

(b)

before PPE is placed on the market in Northern Ireland.

(3)

The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with Article 17.

(4)

The UK(NI) indication must be affixed by—

(a)

the manufacturer; or

(b)

the manufacturer’s authorised representative.

(5)

When placing PPE on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

United Kingdom notified bodies

22.

(1)

The reference in Article 28(5) to “objections” does not include objections on the grounds that—

(a)

the conformity assessment body is established in the United Kingdom; or

(b)

the accreditation certificate was issued by the United Kingdom’s national accreditation body.

(2)

Where a notified body established in the United Kingdom is involved in a conformity assessment procedure pursuant to Article 19, the notified body identification number referred to in Article 17(3) is the notified body identification number assigned to the notified body pursuant to regulation 23.

Register of notified bodies established in the United Kingdom

23.

(1)

The Secretary of State must ensure that—

(a)

each notified body established in the United Kingdom is assigned an identification number; and

(b)

there is a register of—

(i)

notified bodies established in the United Kingdom;

(ii)

their notified body identification number;

(iii)

the activities for which they have been notified;

(iv)

any restrictions on those activities.

(2)

The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3)

The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Offence in relation to the UK(NI) indication

24.

(1)

Where an enforcement authority finds that the UK(NI) indication—

(a)

has not been affixed, in contravention of regulation 21; or

(b)

has been affixed otherwise in accordance with regulation 21

it must require a manufacturer to put an end to the non-compliance within such reasonable period as the authority specifies.

(2)

Until the specified period has elapsed, the enforcement authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the manufacturer in respect of the non-compliance referred to in paragraph (1).

(3)

Where the non-compliance referred to in paragraph (1) persists beyond the specified period, the enforcement authority must take appropriate measures to—

(a)

restrict or prohibit the PPE being available on the market;

(b)

ensure that the PPE is withdrawn;

(c)

ensure that the PPE is recalled.

(4)

It is an offence for any person to contravene or fail to comply with any requirement of a withdrawal or recall notice that relates to the UK(NI) indication served on that person under these Regulations.

(5)

A person guilty of an offence under paragraph (4) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(6)

This regulation does not apply where PPE presents a risk.”.