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COVID-19:  EU Regulatory Response to Disinfectant Products

The rapid spread of COVID-19 has fostered panic in the public and in turn caused a scramble for protective equipment such as masks, hand sanitisers and wipes, resulting in a global shortage of these products. Businesses are now responding to demand for these products in the context of the current crisis. As a result, guidance on the relevant legislative requirements for bringing these products to market is urgently needed.

Alcohol based products containing substances such as ethanol, propan-2-ol or propan-1-ol at concentrations >70% are generally effective against the virus. These products may be subject to either Cosmetic Products or Biocidal Products Regulation (BPR), depending on their functional purpose and the active substance present.

Cosmetic Regulations applies to such products when the main purpose involves cleaning / cleansing the skin. Product classification can also be indicated by the types of claims made. Relevant claims in line with cosmetic product regulations would include ‘’physically clean/ visually clean’’ and ‘’hand cleaner’’.

On the other hand, BPR applies when the product contains an active substance and claim sto control infectious organisms. Examples of Biocidal product claims include the following:

  • ‘’Antibacterial”
  •  “Unique antibacterial formulation.”
  • ‘’Disinfecting’’
  • “Kills bacteria”
  • “Kill bacteria/a wide range of germs and words having the same meaning”
  • “Antiviral” and words having the same meaning
  • “Kills viruses, Virokill” and words having the same meaning
  • “Effective against flu virus H1N1”
  • “Effective against coronavirus”

Article 55 of Biocidal Products Regulation contains a public health danger provision which allows Member States to put aside standard BPR authorisation requirements in public health emergencies such as this one. Businesses wishing to quickly market products containing previously approved active substances such as propan-1-ol and propan-2-ol are advised to use the Article 55 provision in seeking market approval from their national authority. This provision enables Member States to apply derogations to BPR and grant emergency permits for products where they deem it necessary.

For products containing active substances still under ‘’review’’, set out in Regulation (EU) No 1062/2014 (see Annex II), they must be placed on the market in the Member States subject to compliance with the national rules (and possible exemptions).

In normal circumstances, biocidal products containing active substances which are either approved or under review are not permitted for market unless the active substance / product type is from a supplier registered on the European Chemicals Agency (ECHA). With current climate, national authorities have applied derogations such that Article 95 requirements do not have to be met.

The rapid spread of COVID-19 requires rapid regulatory responses from public authorities. Thankfully, the European Chemicals Agency (ECHA) is providing support for businesses wishing to meet product demand during the pandemic, so that consumers can have access to required equipment such as sanitisers and disinfectants as soon as possible.

#coronavirus  #covid-19  #biocidalproducts