Smoother sailing for sanitisers

31.03.2020

COVID-19 has resulted in a shortage of hand sanitiser. As well as the risk this presents to healthcare professionals and the general public, many businesses are reliant on sanitiser for their operations. The shortage presents a threat of serious commercial disruption to essential food production. In order to increase the availability of sanitisers generally, the UK Health and Safety Executive (HSE) has relaxed the regulatory requirements for placing sanitiser on the market.[1]

Hand sanitiser is generally regulated as a biocide, in accordance with the EU Biocidal Products Regulation 528/2012 (BPR)[2]. The requirements of the BPR involve two stages of authorisation, the first relating to the “active substance” and the second relating to the product or family of products. Product authorisations are mandatory for supply (whether for payment or free) and commercial use. In addition, active substances must be obtained from suppliers approved in accordance with Article 95 of the BPR (Article 95 Suppliers).

These requirements present barriers to manufacturers preparing their own sanitisers for commercial purposes or those wishing to manufacture and donate hand sanitiser. Regardless, a number of cosmetic and alcohol manufacturers have reported an intention to manufacture and distribute sanitiser.

In a pragmatic and proactive response, the HSE intends to grant a derogation[3] from authorisation requirements for sanitisers which:

  1. are prepared in accordance with the World Health Organisation formulary for hand sanitiser[4]; and
  2. have isopropyl alcohol as their active ingredient.

No product authorisation (and therefore no derogation) is required for the commercial use of ethanol based sanitisers. However, there are specific HMRC requirements in regards to the use of ethanol, which manufacturers will need to consider.[5]

In addition to the derogations, the HSE has stated that it intends to take a “sensible and proportionate approach” to the Article 95 Supplier requirements. The HSE reinforced that the primary obligation on manufacturers is to obtain active ingredients which are safe and effective.

The HSE cautions manufacturers to obtain derogation certificates before placing sanitiser on the market. Further, certain labelling and other BPR requirements will continue to apply. It is also important to note that if specific medical claims are made in regards to sanitiser (such as it preventing infection with COVID-19) it will be regulated as a medicinal product, requiring a marketing authorisation.

It is heartening to see regulators responding quickly to ensure that the increased demand for essential products can be met, while seeking to maintain baseline safety and efficacy thresholds.

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[1] https://www.hse.gov.uk/news/hand-sanitiser-manufacture-supply-coronavirus.htm.

[2] In certain instances (e.g. use in a surgical suites to prevent infection with specific antigens), hand sanitiser may be regulated as a medicinal product. Products primarily used to clean or moisturise skin while providing a secondary antimicrobial effect, such as a liquid soap, are classed as a cosmetic.

[3] Article 55 of the BPR enables derogations in emergency public health situations.

[4] Guide to Local Production: WHO-recommended Handrub Formulations, April 2010.

[5] HMRC is also relaxing certain requirements in regards to COVID-19.

Alex Denoon

Author

Zac Fargher

Author