Citation, commencement, application and interpretation

1. —(1) These Regulations may be cited as the Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (England) Regulations 2020 and come into force on IP completion day.

(2) These Regulations apply in relation to England only.

(3) In these Regulations—

(a) “the PPE Regulation” means Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC 2 );

(b) expressions in these Regulations which appear in the PPE Regulation have the same meaning as in the PPE Regulation;

(c) “the 2018 Regulations” means the Personal Protective Equipment (Enforcement) Regulations 2018( 3 ).

(4) In these Regulations—

“Covid PPE” means PPE that—

“CE marking” has the meaning given to it in Article 3(18) of Regulation 2016/425 (pre-exit);

“coronavirus” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

“coronavirus disease” means COVID-19 (the official designation of the disease which can be caused by coronavirus);

“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( 4 );

“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 (pre-exit).

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 1st 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—

(i) the applicable conformity assessment procedure having been carried out; and

(ii) 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 Secretary of State or an NHS 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 1st 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 Act 2006( 5 );

“NHS body” has the meaning given in section 275 of the National Health Service Act 2006( 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 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 applies, 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 HSE before IP completion day, pursuant to the European 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.