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Last updated: 28/09/2020

When the Covid-19 pandemic spread across the world, it led to a surge in the demand for hand cleaning and sanitising products. Many retailers struggled to keep up with the demand, switching to alternative suppliers. It led to distilleries switching production to assist with the response to the pandemic by making ethanol to be used in making hand cleaning products. It also saw new manufacturers and importers of hand gels and foams.

The Health and Safety Executive (HSE) who are the UK Competent Authority for the EU Biocidal Products Regulation 528/2012 (BPR), responded to the situation by issuing a derogation enabling hand sanitiser products, using the World Health Organisation specified hand rub formulation, based on Isopropanol alcohol (propan-2-ol), to be quickly made available on the UK market, on a temporary basis. This enabled a broad number of businesses to be able to supply and use the formulation, provided they met certain conditions.

During the Covid-19 Local Authority Trading Standards Services have seen alcohol based hand sanitisers and alcohol-free hand sanitisers placed on the market, some of which have been compliant but others have either been labelled, packaged and/or advertised incorrectly, found to be ineffective with regards to claims made, unauthorised in certain circumstances, and some have contained active substances which have not been supported  for use in human hygiene (hand cleaning) products.

The legislation surrounding hand cleaning and sanitising products is complex and the aim of this series of bulletins is to assist new and existing businesses understand and navigate the applicable regulations.

What is a biocide and how does it differ to a cosmetic product or a medicine?

Determining whether a hand cleaning or sanitising product is a biocide, cosmetic or medicine depends on its intended use, function, composition or how it is described/advertised. Therefore, this will be determined on a case by case basis:

  • Products primarily claiming to kill germs, disinfect or sanitise or prevent cross-contamination, consisting of, containing or generating one or more active substances, are likely to be classed as a biocidal product.
  • Products used to primarily clean and/or moisturise hands (even if they claim to provide a secondary antimicrobial/antibacterial effect) such as a liquid soap or solid soap bars are likely to be classed as a cosmetic product.

Further guidance on cosmetic products

For more information see: European Commission guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)

  • Products presented as principally preventing or treating a disease or adverse condition, e.g. Covid-19, MRSA, SARS are likely to be classed as a medicinal product and will require authorisation from the Medicines & Healthcare products Regulatory Agency before they can be placed on the market.

The following guides have been produced to help businesses within the different sectors supplying biocide hand cleaning products: (click on each one takes you to each guide)

  • Manufacturers – including own branders
  • Importers - responsible for import (placing on the market) into the customs territory of the Community
  • Distributors - including wholesalers and retailers

It should be read in conjunction with the Health & Safety Executive guidance on manufacturing and supplying hand sanitisers

Biocide advertisement requirements

Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008 (CLP), include the sentences ‘Use biocides safely. Always read the label and product information before use.’

The sentences shall be clearly distinguishable and legible in relation to the whole advertisement.

Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.

Adverts for biocidal hand sanitiser products must not be misleading in respect of the risks from the product to human health, animal health or the environment, or in relation to its efficacy.
 
Adverts must not mention the terms ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications, or include any medicinal claims.

What about the implication of Brexit? Please note that during this time of Covid-19 the EU Biocidal Products Regulation 528/2012 applies to the UK whilst we are still  in the Transition period of withdrawal from the EU.  

Further information

If you are manufacturing or supplying biocides to be used by consumers, and require further advice, contact your local Trading Standards Service.

If you are manufacturing or supplying biocides to be used in the workplace, and require further advice, contact Health & Safety Executive.

For further advice on BPR advertising requirements, visit HSE's website or contact your local Trading Standards Service.

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