EUROPE – COM: Update of the Guidance Document for virus-containing PPP Authorisation

The Commission has published an update of guidance document SANCO/0253/2008 for the authorisation of plant protection products (PPP) containing viruses, in the framework of Regulation (EC) No 1107/2009. This 3rd version applies to applications submitted from 11 March 2026 onwards.

This new version complies with Regulation (EU) No 283/2013. 

This guidance document describes a proportionate regulatory approach which considers the biological characteristics of viruses and allows for an efficient updating of the (mixtures of) viral isolates used in plant protection products, while guaranteeing safety for human health and the environment, based on the latest scientific knowledge. As of the date of publication of this guidance document, the viral isolates update procedures are described for the two types of viruses for which applications for approval were submitted: baculoviruses and bacteriophages.

For baculoviruses, risk assessment conclusions apply at species level. Thus, the approval/renewal of an active substance that is a baculovirus must refer to the species level, and, as the approval of the active substance is granted at species level, the authorisation of plant protection products containing such approved baculovirus must refer to the baculovirus at species level too.

Consequently, each baculovirus isolate composed of multiple (highly similar) genotypes of the respective already-approved baculovirus species may be used in authorised plant protection products, provided that it is demonstrated that (i) material produced from that isolate is equivalent in terms of specification and risk profile to the material assessed at approval, and that (ii) the new isolates are proven to be sufficiently effective and to belong to the same already-approved species. The corresponding regulatory procedures are those linked to Article 38 of Regulation (EC) No 1107/2009 together with SANCO/12823/2012 (i.e. assessment of an equivalence) to ensure the identity of the new isolate, and to Article 33 of this Regulation (i.e. amendment of an authorisation) to ensure its efficacy and traceability.

For bacteriophages, risk assessment conclusions apply at isolate level, and a case-by-case approach is most appropriate.

The guidance document describes the regulatory approach for bacteriophages for (i) application for approval or renewal, (ii) assessment in case of update of mixture of bacteriophage isolates and (iii) risk management in case of update of mixture of bacteriophage isolates.   

Moreover, new templates for the evaluation and confidential reports of new baculovirus and bacteriophage isolates have been added to the guidance document.

To download: 

SANCO/0253/2008 (11/03/2026)

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