Guidance

OPSS coronavirus (COVID-19) guidance for business and local authorities

Guidance on PPE, face coverings, face visors, and hand cleaning and sanitising products, for the protection of consumers during the COVID-19 pandemic.

The Office for Product Safety and Standards (OPSS) is focusing on the key issues surrounding Government measures to protect the public during the coronavirus (COVID-19) pandemic.

During this challenging period, we are working with business to understand where regulatory requirements are preventing them delivering the products the public and NHS need.

OPSS COVID-19 guidance for businesses

Placing hand cleaning and sanitising products on the UK market (PDF, 375KB, 5 pages) - version 3, 14 May 2020

Personal Protective Equipment (PPE) Regulations (PDF, 550KB, 19 pages) - version 4, 1 April 2021

Personal Protective Equipment (PPE) Regulations - Northern Ireland (PDF, 536KB, 19 pages) - version 4, 1 April 2021

Manufacturers and makers of face coverings (PDF, 145KB, 3 pages) - version 4, 23 September 2020

Manufacturers and makers of face visors (PDF, 137KB, 4 pages) - version 1, 2 December 2020 - also applicable to individuals

Resuming full conformity assessment of COVID-19 PPE (PDF, 490KB, 11 pages) - version 3, 1 April 2021 - for large and small-scale manufacturers, including individuals

Read technical specifications for PPE published by the Cabinet Office and Department of Health and Social Care.

OPSS COVID-19 guidance for local authorities

The enforcement guidance for local authorities on face masks and coverings published on 12 June 2020 was removed on 15 April 2021 as it was no longer applicable due to developments. A revised version is under consideration.

Letters OPSS has sent to stakeholders:

Letter to Notified Bodies concerning PPE (PDF, 205KB, 2 pages) - 25 March 2020

Letter to Health and Safety Executive concerning PPE (PDF, 193KB, 2 pages) - 25 March 2020

The letter to Local Authority Heads of Service, regional coordinators and National Product Safety Group members concerning PPE published on 27 March 2020 was removed on 15 April 2021 as it was no longer in line with our current advice.

OPSS has developed hand sanitisers and PPE guidance for Trading Standards, as well as businesses.

Email: opss.enquiries@beis.gov.uk for further information.

Published 27 March 2020
Last updated 1 April 2021 + show all updates
  1. Version 3 of the guidance for all manufacturers of PPE published, amended to reflect the end of the conformity assessment easing in relation to the placing on the GB market of COVID-19 related PPE.

  2. Guidance updated for the Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021 coming into force on Monday 1 February 2021.

  3. Updated guidance for all manufacturers of PPE published, clarifying the deadlines in relation to the temporary arrangements for the conformity assessment of products, and replacing the separate guidance for high-volume and small-scale manufacturers.

  4. Guidance for manufacturers and makers of face visors added on complying with the General Product Safety Regulations 2005.

  5. Updated Face Mask and Coverings Guidance.

  6. Version 7 of the guidance for new high-volume manufacturers of PPE and version 4 of the guidance for businesses and individuals on the small-scale manufacture of PPE published, amended to simplify the text concerning the Market Surveillance Authority approval of PPE.

  7. Version 4 of the guidance for manufacturers and makers of face coverings on complying with the General Product Safety Regulations 2005 published, amended in the light of the alignment of approach across the UK, and with a warning against claiming that face coverings containing particulate material 2.5 filters or other hygiene filters give protection from COVID-19.

  8. Version 4 of the guidance for businesses on the Personal Protective Equipment (PPE) Regulations, version 6 of the guidance for new high-volume manufacturers of PPE and version 3 of the guidance for businesses and individuals on the small-scale manufacture of PPE published, amended to take account of the new guidance on Recommendation 2020/403 issued by the European Commission. The main changes set out the role of the market surveillance authority in approving COVID-19 related PPE before it can be placed on the UK market, and clarify that non CE marked PPE cannot be placed on the EU market.

  9. Version 5 of the guidance for new high-volume manufacturers of PPE and version 2 of the guidance for businesses and individuals on the small-scale manufacture of PPE published, amended to: a) reflect the closure of the Government PPE offers portal and move to competitive tendering processes, b) align the traceability requirements for all manufacturers, and c) remove the need for the notified body number to be placed on each individual piece of PPE. In addition, version 3 of the guidance for manufacturers and makers of face coverings on complying with the General Product Safety Regulations 2005 published, now including a reference to avoiding or warning against allergenic materials.

  10. Second version of the enforcement guidance for local authorities on face masks and coverings published, with section 2 amended to clarify the remits of enforcing authorities.

  11. Enforcement guidance for local authorities added on face masks and coverings.

  12. Second version of the guidance for manufacturers and makers of face coverings on complying with the General Product Safety Regulations 2005 published, amended to reflect the latest government guidance on when a face covering should be worn.

  13. Guidance for manufacturers and makers of face coverings added on complying with the General Product Safety Regulations 2005.

  14. Version 3 of the guidance for businesses on the Personal Protective Equipment Regulations and version 4 of the guidance for new high-volume manufacturers of PPE published, the former clarifying the obligations of importers in the light of the easements, and the latter linking to the simplified PPE specifications issued by HSE (in section 4), updating the centralised PPE acquisition process by the Government (in section 6, previously section 7), and setting out importers’ duties in the light of the easements (in a new section 9).

  15. Version 3 of the guidance for businesses on hand sanitisers published, with an additional link to a technical specification for hand wash from the Department of Health and Social Care.

  16. Guidance for businesses and individuals added on the small-scale manufacture of Personal Protective Equipment (PPE).

  17. Version 3 of the guidance for new high-volume manufacturers of COVID-19 PPE published, containing amendments to: a) section 6.2, confirming the easement allowing placing on the market once conformity assessment has begun but before completion, providing Essential Safety Requirements are met, applies to COVID-19 PPE for all workers, not just healthcare, and b) section 8, clarifying that under that easement, before placing on the market, manufacturers must contact Notified Bodies via a formal application (an email is insufficient), must receive confirmation they have been accepted into the assessment process, and must be able to provide confirmation of of their accepted application.

  18. Second version of guidance for businesses on hand sanitisers published, with additional links for businesses in Northern Ireland.

  19. Second versions of guidance for businesses on the Personal Protective Equipment Regulations and the high volume manufacture of COVID-19 PPE published.

  20. Guidance for businesses added on the Personal Protective Equipment Regulations and the high volume manufacture of COVID-19 PPE.

  21. Guidance for businesses that are new to the manufacture or import of hand cleaning and sanitising products has been uploaded.

  22. First published.