Explanation of virus claims for disinfectants

For dossiers submitted as of 30 May 2016, the Ctgb assesses the efficacy of disinfectants in PT01 to PT05 according to the EU guidance. This new assessment framework applies not only to product applications under the Biocidal Products Regulation, but also to applications falling under transitional legislation in the Netherlands. Regarding the virus claims in PT01. PT02, PT03 and PT04, a number of important changes have been made relative to the previous assessment framework in the Netherlands. This has consequences for how virus claims are worded on the labels for disinfectants: legal instructions for use (WG/GA) and Summaries of Product Characteristics (SPCs). Below is an explanation of which virus claims are authorised in the Netherlands for the various types of disinfectants.

Virus claims for hand and skin disinfectants (PT01)

Under the previous assessment framework in the Netherlands, only full virus claims were authorised for hand and skin disinfectants (PT01, human hygiene). On the legal instructions for use (WG/GA), the full virus claim for these products is worded as ‘a product to control bacteria, yeasts,… and viruses’. For the full virus claim, the efficacy of these products against the adenovirus and poliovirus must be demonstrated as a minimum. In practice, we assumed that these products are active against all known viruses.
The PT01 products for hygienic hand disinfection with a virus claim authorised under the previous assessment framework were found to be effective within 30 seconds (reported on the label as exposure time or contact time). For surgical hand disinfection, longer contact times up to 5 minutes were authorised.

Under the currently prevailing assessment framework for PT01 products, three gradations of efficacy are distinguished:

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

In terms of efficacy, the limited virus claim lies between the full virus claim and the claim of being effective against enveloped viruses only. Table 1 below provides a summary of the current three claims as described in the EU guidance and test norm EN 14885, including the corresponding test viruses against which efficacy must be demonstrated, the wording of these claims on WG/GAs and SPCs in the Netherlands and the efficacy in practice as currently estimated. This estimated efficacy in practice is based on information from the CEN (European Committee for Standardization TC 216/WG5); as more information becomes available in the future, the limited virus claims may be expanded.
The PT01 products for hygienic hand disinfection with a virus claim that are authorised under the new assessment framework are effective in 30-120 seconds. For surgical hand disinfection, longer contact times up to 5 minutes are permitted.

Table 1: Virus claims for PT01 products submitted as of 30-5-2016

Virus claims for PT01 products as described in the EU Guidance and EN 14885 (test organisms)	WG/GA: Products to control… SPC: Target organisms:….	Efficacy in practice
Full virucidal activity (tested against: Adenovirus type 5, strain Adenoid 75, ATCC VR-5 ; Poliovirus type 1, LSc-2ab (Picornavirus); and Murine Norovirus, strain S99 Berlin)	viruses (enveloped and non-enveloped viruses)	Activity against all viruses
Limited spectrum virucidal activity (tested against: Adenovirus type 5, strain Adenoid 75, ATCC VR-5 and Murine Norovirus, strain S99 Berlin)	enveloped viruses and a limited number of non-enveloped viruses	Activity against enveloped viruses, Adenovirus and Norovirus
Activity against enveloped viruses (tested against: Modified Vaccinia Virus Ankara, ATCC VR-1508)	enveloped viruses	Activity against enveloped viruses¹

¹ Enveloped viruses are viruses with a viral envelope consisting of lipids. Enveloped viruses are relatively easy to inactivate with biocidal products. Examples of enveloped viruses include corona viruses, influenza viruses, herpes viruses, HIV and ZIKA. For more information about viruses, see: Fauquet, C.M. et al., Eds.: Virus Taxonomy, eighth report of the international committee on taxonomy of viruses. Elsevier Academic Press, San Diego, 2005

Virus claims disinfectants not intended for direct application to humans or animals (PT02)

For disinfectants used in healthcare and non-healthcare areas (e.g. hotels, public sanitary, homeless shelters, public transport or clean rooms for production of pharmaceuticals) by professional users in addition to the currently accepted full virucidal claim, also the limited spectrum virucidal activity and the activity against enveloped viruses can be claimed;
For disinfectants used in non-healthcare areas by the general public only a full virucidal activity and activity against enveloped viruses can be claimed.

Virus claims for veterinary uses (PT03)

Under the previous assessment framework in the Netherlands, the efficacy of disinfectants for veterinary uses (PT03, veterinary hygiene) was tested against various viruses. For use in animal transport vehicles, the disinfectants must be tested, as a minimum, against quarantine viruses (mandatory: classical swine fever virus, Aujeszky's disease (Pseudorabies virus) and Foot and Mouth Disease (FMD virus); optional: Swine Vescular Disease virus). The PT03 products for animal transport vehicles that were authorised under the previous assessment framework were determined to be effective in less than 5 minutes. For use on surfaces/materials, depending on the claim, the products are tested on bovine enterovirus Type 1 or on quarantine viruses. The viruses against which the products have been tested are specified on the WG/GAs.

Under the currently prevailing assessment framework, the efficacy of PT3 products for surfaces/materials, including animal transport vehicles, are tested against bovine enterovirus Type 1. Efficacy against this virus is sufficiently representative for efficacy against quarantine viruses. The full virus claim for these products is therefore formulated on the label (WG/GA) as ‘product to control bacteria, yeasts,… and viruses’, and on the SPC as 'Target organisms: bacteria, yeasts,… and viruses’. For PT3 products to be used on surfaces/materials, only a full virus claim will be authorised. An exception is made for products for disinfecting teats and udders prior to or after milking. For these uses, a virus claim against enveloped viruses is permitted; similar to PT01, the product is tested against Modified Vaccinia Virus Ankara.

Virus claims for disinfection in Food and feed area (PT04)

For the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals used by professional and non-professional users, an enveloped virus claim is now allowed in addition to the currently accepted full virus claim. For enveloped viruses testing is done against Modified Vacciniavirus Ankara as with PT01 & PT02.

Virus claims for drinkingwater disinfectants (PT05)

The virus claims for PT05 remains unchanged; only full virus claim is authorised. These full virus claims are formulated on the label (WG/GA) as ‘product to control bacteria, yeasts,… and viruses’, and on the SPC as 'Target organisms: bacteria, yeasts,… and viruses’. See the EU guidance for the test organisms.