The latest advice for those supplying Sanitiser and PPE to the NHS and other front-line organisations.
The UK Government have issued faster routes to achieve approval. This can be found at https://www.hse.gov.uk/news/hand-sanitiser-manufacture-supply-coronavirus.htm
The Health and Safety Executive have used their power under law to issue Derogation to the previous rules/standard. Please see the site for more detail, but here is a summary.
Biocidal hand sanitiser products containing Propan-2-ol (also known as isopropanol or isopropyl alcohol/IPA), will not be required to obtain a product authorisation if they meet the relevant WHO-specified formulation II (PDF).
Manufacturers wishing to place products that meet the WHO specified formulation onto the UK Market must contact HSE via email@example.com using ‘Propan-2-ol Article 55’ as the subject title of the email. HSE will respond quickly to request details about the products being manufactured and once provided, issue a derogation certificate.
Products should not be placed on the market until HSE has confirmed that the derogation applies to you and issued you with the certificate.
Hand sanitisers containing Propan-1-ol or Ethanol
WHO does not specify a formulation for hand sanitisers containing propanol-1-ol. Therefore, although Article 55 derogations may be possible for hand sanitisers containing propan-1-ol, these will require more information from applicants to enable HSE to determine their efficacy and the risks associated with their use. Such applications will take longer to process than those for hand sanitisers containing propan-2-ol.
There is a WHO-specified formulation I (PDF) for hand sanitiser containing ethanol. Under the transition arrangements in the biocidal product regulations manufacturers do not require product authorisations to place hand sanitiser products containing ethanol on to the UK Market.
For PPE, the matter is more clear, this is a HSE matter.
UK Government Guindance: Technical Specifications for Personal Protective Equipment (PPE) covering the technical and regulatory standards for Personal Protective Equipment.
We have published these documents in order for new suppliers and manufacturers to understand our requirements. Where new suppliers have product that meets these requirements we welcome offers of support through a smart survey.
The document covers these products can be seen below, identifying scope and standards expected to be maintained.
Any company seeking to supply PPE equipment must comply with HSE rules. (this includes Face Visors, FFP1/2/3, TypeIIR masks,etc).
There is a fast route to this but only through a company’s Notified Body. (For example : Such as : BSI Assurance UK Ltd Kitemark Court Davy Avenue Knowlhill Milton Keynes MK5 8PP United Kingdom (Full list available by emailing firstname.lastname@example.org – LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 89/686/EEC Personal protective equipment).
Reminder for offer of support – links to fast track are as follows:
Medical devices /vital signs/screening/POC testing email@example.com
Infection control /PPE/Face masks/Sanitiser–firstname.lastname@example.org
Social isolation and loneliness email@example.com
Digital/AI/ML/Apps – firstname.lastname@example.org
For WG support – https://businesswales.gov.wales/coronavirus-advice
If you have read this far and haven’t found a box that you fit into but design and make things in Wales from injection moulding, tools, polymer products, fabrication, Precision engineering, Laser cutters, 3D, material stockists, etc – please make sure you are on Industry Wales’ database for the next call outs for materials and components irrespective of industry sector!