The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021

Citation, commencement, application and interpretation

1.—(1) These Regulations may be cited as the Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021 and come into force on 1 February 2021.

(2) These Regulations apply in Scotland.

(3) In these Regulations—

“the 2018 Regulations” means the Personal Protective Equipment (Enforcement) Regulations 2018(1),

“Covid PPE” means PPE that—

(a)

is necessary for protection against the coronavirus disease, and

(b)

requires conformity assessment by an approved body in accordance with Article 19 of the PPE Regulation,

“CE marking” has the meaning given to it in Article 3(18) of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC(2) (as it has effect in EU law),

“EHSR” means the essential health and safety requirements applicable to the Covid PPE as set out in Annex 2 to the PPE Regulation,

“the HSE” means the Health and Safety Executive(3),

“notified body” means a conformity assessment body that is not an approved body, that has been assigned an identification number under Article 29 of Regulation 2016/425 (as it has effect in EU law),

“the PPE Regulation” means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC(4).

(4) Expressions in these Regulations which are not defined in paragraph (3) and which appear in the PPE Regulation have the same meaning in these Regulations as they have in the PPE Regulation.

Temporary arrangements for the making available of Covid PPE

2.—(1) This regulation applies to Covid PPE only.

(2) Notwithstanding the requirements of Articles 8(2), 10(2) and 11(2) of the PPE Regulation, where the conditions set out in paragraph (3) are met, Covid PPE may be made available on the market by a relevant economic operator before—

(a) the applicable conformity assessment procedure has been carried out, and

(b) the UK marking has been affixed.

(3) The conditions referred to in paragraph (2) are that before an economic operator makes the Covid PPE available—

(a) the Covid PPE has been submitted for conformity assessment to an approved body, and

(b) after the Covid PPE has been submitted to an approved body, the HSE—

(i) has assessed the Covid PPE as compliant with the EHSR relevant to the assessment process, and

(ii) has notified an economic operator at any time before 1 April 2021 of the assessment that the Covid PPE is compliant with the EHSR against which it has been assessed.

(4) Where an economic operator relies on regulation 2A of the 2018 Regulations and submits Covid PPE to a notified body, a reference in this regulation to—

(a) the UK marking is to be read as a reference to the CE marking,

(b) an approved body is to be read as a reference to a notified body.

Temporary arrangements for the making available of Covid PPE for healthcare and other frontline workers

3.—(1) This regulation applies to Covid PPE only.

(2) Notwithstanding the requirements of Articles 8(2), 10(2) and 11(2) of the PPE Regulation, where the conditions set out in paragraph (3) are met, Covid PPE may be made available by a relevant economic operator for the use of healthcare and other frontline workers, without—

(a) the applicable conformity assessment procedure having been carried out, and

(b) the UK marking having been affixed.

(3) The conditions referred to in paragraph (2) are that before an economic operator makes the Covid PPE available—

(a) the Covid PPE has been purchased by the Scottish Ministers or a health service body for use in the health service or other frontline services, and

(b) the HSE—

(i) has assessed the Covid PPE as compliant with the EHSR relevant to the assessment process, and

(ii) has notified an economic operator at any time before 1 July 2021 of the assessment that the Covid PPE is compliant with the EHSR against which it has been assessed.

(4) In this regulation—

“healthcare worker” means an individual working as part of the health service continued under section 1(1) of the National Health Service (Scotland) Act 1978(5),

“a health service body” means a body listed in section 17A(2)(a) to (e) of the National Health Service (Scotland) Act 1978(6),

“other frontline services” means the provision of social care and community or residential drug and alcohol services,

“other frontline workers” means any individual working in other frontline services,

“social care” includes all forms of personal care and other practical assistance provided for individuals who are by reason of age, illness, disability, pregnancy, childbirth, dependence on alcohol or drugs, or any other similar circumstances, are in need of such care or other assistance.

Enforcement

4.—(1) Where an economic operator has made Covid PPE available in reliance on regulations 2 or 3, the economic operator will not be treated as having contravened the requirements and obligations set out in Articles 8(2), 10(2) or 11(2) of the PPE Regulation for the purposes of regulation 7(1) of the 2018 Regulations if—

(a) the applicable conformity assessment procedure has not been completed in relation to the Covid PPE, or

(b) the UK marking has not been affixed to the Covid PPE.

(2) Paragraph (3) applies where an economic operator has made Covid PPE available in reliance on regulation 3 and—

(a) the applicable conformity assessment procedure has not been completed in relation to the Covid PPE, or

(b) the Covid PPE does not bear the UK marking.

(3) Where this paragraph apples, a failure by an economic operator to take the action required under Article 41(1)(b), (c) and (d) of the PPE Regulation will not be treated as non-compliance with the PPE Regulation and the economic operator will not be guilty of an offence for the purposes of regulation 7(3) of the 2018 Regulations.

(4) Where PPE has been assessed by the HSE before IP completion day, pursuant to the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat(7), these Regulations do not affect the validity of that HSE assessment.

JEANE FREEMAN

A member of the Scottish Government

St Andrew’s House,

Edinburgh

At 11.23 a.m. on 28th January 2021