Change in virus claims for disinfectants

For dossiers submitted as of 30 May 2016, the Ctgb assesses the efficacy of disinfectants in PT01 to PT04 according to the relevant EU guidance. This new assessment framework applies not only to product applications submitted under the Biocidal Products Regulation, but also to applications falling under transitional legislation in the Netherlands.

Regarding the virus claims, a number of important changes have been made relative to the previous assessment framework in the Netherlands. This has consequences regarding how virus claims are formulated on the labels (Draft legal instructions for use – WG/GA – and Summaries of Product Characteristics – SPCs) of disinfectants.
Under the previous assessment framework in the Netherlands, for example for hand and skin disinfectants (PT01, human hygiene), only full virus claims were authorised. The full virus claim for these products was formulated on the legal instructions for use (WG/GA) as ‘a product to control bacteria, yeasts,… and viruses’. In practice, we assumed that these products are active against all known viruses. Under the currently prevailing assessment framework, however, three gradations of efficacy are distinguished for PT01 products:

  • full virus claim (full virucidal activity)
  • limited virus claim (limited spectrum virucidal activity)
  • activity against enveloped viruses only.

In terms of efficacy, the limited virus claim lies between the full virus claim and the claim of being active against enveloped viruses only. The products for hygienic hand disinfection with a virus claim that are authorised under the new assessment framework are effective in 30-120 seconds. Previously, this was 30 seconds. For surgical hand disinfection, longer contact times up to 5 minutes are permitted.

For more information, also about other product types, click here.