Conclusion on the peer review of the pesticide risk assessment of the active substance Phlebiopsis gigantea


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(1):3033 [31 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
11 December 2012
9 January 2013
European Food Safety Authority (EFSA), Parma, Italy
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The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Estonia, for the pesticide active substance Phlebiopsis gigantea are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative use of Phlebiopsis gigantea as a fungicide in pine and spruce forests. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.


Phlebiopsis gigantea is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007.

Phlebiopsis gigantea strains VRA 1835,VRA 1984, VRA 1985, VRA 1986, FOC PG B20/5, FOC PG SP log 6, FOC PG SP log 5, FOC PG BU 3, FOC PG BU 4, FOC PG 410.3, FOC PG97/1062/116/1.1, FOC PG B22/SP1287/3.1, FOC PG SH 1 and FOC PG B22/SP1190/3.2 were included in Annex I to Directive 91/414/EEC on 1 May 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as ‘the Regulation’) and have subsequently been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report.

Estonia being the designated rapporteur Member State submitted the DAR on Phlebiopsis gigantea in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 30 April 2007. The peer review was initiated on 23 April 2008 by dispatching the DAR for consultation of the Member States and the notifier the Phlebiopsis gigantea Task Force (PGT; formed by Verdera Oy, Finland and Forest Research, UK). Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should deliver its conclusions on Phlebiopsis gigantea.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Phlebiopsis gigantea as a fungicide in pine and spruce forests, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.

In the areas of identity of the microorganism, biological properties, physical and technical properties and methods of analysis, the following data gaps remain: validated method of analysis to strain level, investigation of toxin production, pH range of growth, evidence that when used the formulation ‘Rotstop’ can be evenly applied and no nozzles are blocked, Annex III data package for the formulation PG suspension, validation of all the quantification methods for the technical/product and a specification for contaminating microorganisms for all strains with validated methods of analysis and batch analysis.

Operator exposure risk assessment could not be finalised due to a data gap on the identification of secondary metabolites/toxins potentially produced in the formulated product.

As there are no edible crop uses a consumer risk assessment is not necessary.

The information on fate and behaviour in the environment is sufficient to characterise the competitiveness/persistence of Phlebiopsis gigantea (various strains) and its dispersion characteristics in the context of the representative use assessed for the product ‘Rotstop’.

A data gap was identified in the ecotoxicology section for further information to address the toxicity, infectiveness or pathogenicity Phlebiopsis gigantea on non-target arthropods.

Phlebiopsis gigantea, peer review, risk assessment, pesticide, fungicide
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