Conclusion on the peer review of the pesticide risk assessment of the active substance Pythium oligandrum strain M1


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(1):3034 [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
Download Article (436.6 KB)

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 Sweden, for the pesticide active substance Pythium oligandrum strain M1 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 Pythium oligandrum as a fungicide on oil seed rape. 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.


Pythium oligandrum 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.

Pythium oligandrum strain M1 was 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 has 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.

Sweden being the designated rapporteur Member State submitted the DAR on Pythium oligandrum in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 26 June 2007. The peer review was initiated on 23 April 2008 by dispatching the DAR to the notifier Biopreparáty Co. Ltd. and on 17 March 2009 to the Member States for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the area of ecotoxicology and deliver its conclusions on Pythium oligandrum.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Pythium oligandrum as a fungicide on oil seed rape, 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, a more detailed explanation of the method of manufacture, investigation of toxin/secondary metabolite production, the pH, humidity, and nutrient requirements for the strain as well as the effect of UV light, validation of all the quantification methods for the technical/product, a specification for contaminating microorganisms with validated methods of analysis and batch analysis, storage stability data for the formulation.

In the area of mammalian toxicology, two data gaps were identified. Firstly, it should be demonstrated that the concentration of Pythium oligandrum (viable oospores) in the batches used for the toxicological studies is representative of the content of microorganisms in the technical specification. Secondly, information is needed on the mammalian toxins/secondary metabolites produced by this strain both in the product and after application to the crop. Consequently, the risk assessment for the operators, workers and bystanders cannot be finalised.

Pythium oligandrum strain M1 is not pathogenic to humans therefore the remaining issue for consumer exposure is the production of toxins/secondary metabolites. As this issue has not been addressed for this strain the consumer risk assessment cannot be finalised.

The available information in the environmental fate and behaviour section is not sufficient to conclude that, under the conditions of use, Pythium oligandrum M1 and/or its possible relevant metabolites/toxins will not persist in soil and in the aquatic compartment in concentrations considerably higher than the natural background levels. A data gap was also identified for information on the possible spread of Pythium oligandrum M1 and its degradation products in relevant environmental compartments.

The ecotoxicological risk assessment for secondary metabolites or toxins could not be finalised. A low risk to birds and wild mammals from infectivity and pathogenicity was concluded. Data gaps to address the risk from infectivity and pathogenicity for aquatic organisms, bees, non-target arthropods, earthworms and soil microorganisms were identified. A low risk to sewage treatment organisms for the representative use was concluded.

Pythium oligandrum strain M1, peer review, risk assessment, pesticide, fungicide
Print on demand
Number of Pages