Conclusion on the peer review of the pesticide risk assessment of the active substance pencycuron1
Pencycuron is one of the 79 substances of the third stage part A of the review programme covered by Commission Regulation (EC) No 1490/20023, as amended by Commission Regulation (EC) No 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as „the Commission), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by the Netherlands, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant‟s decision, in accordance with Article 11e, to withdraw support for the inclusion of pencycuron in Annex I to Council Directive 91/414/EEC.
Following the Commission Decision of 5 December 2008 (2008/934/EC)5 concerning the non-inclusion of pencycuron in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Bayer CropScience AG made a resubmission application for the inclusion of pencycuron in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR.
In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, the Netherlands, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 4 November 2009.
In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 13 November 2009. The EFSA collated and forwarded all comments received to the Commission on 4 January 2010.
In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology, and deliver its conclusions on pencycuron.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of pencycuron as a fungicide on potatoes, as proposed by the applicant. Full details of the representative use can be found in Appendix A to this report.
A data gap is identified in the section physical and chemical properties of the formulation.
No data gaps or critical areas of concern are identified in the mammalian toxicology section.
In the residues area, for the specific use on potatoes at planting, the pertinent issues for consumer risk assessment have been reasonably addressed and no data gaps or critical areas of concern are identified.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative use, with the notable exception that information is missing regarding the fate and behaviour of the chlorophenyl and cyclopentyl portions of the molecule in soil, and the chlorophenyl and phenyl portions of the molecule in natural surface water and sediment systems. Consequently, the soil, groundwater, surface water and sediment exposure assessments for metabolites that have the potential to be formed from these portions of the molecule could not be finalised.
A high long-term risk to large omnivorous mammals (wild boar) was indicated in the refined risk assessment. This issue has been regarded as a critical area of concern and a data gap has been identified. The risk assessments for non-target organisms in relation to metabolites in soil, groundwater when it becomes surface water, surface water and sediment could not be finalised in view of the data gaps for further information on the nature and level of the metabolites in these environmental matrices.
Pencycuron is one of the 79 substances of the third stage part A of the review programme covered by Commission Regulation (EC) No 1490/20023, as amended by Commission Regulation (EC) No 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as „the Commission), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by the Netherlands, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant‟s decision, in accordance with Article 11e, to withdraw support for the inclusion of pencycuron in Annex I to Council Directive 91/414/EEC.
Following the Commission Decision of 5 December 2008 (2008/934/EC)5 concerning the non-inclusion of pencycuron in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Bayer CropScience AG made a resubmission application for the inclusion of pencycuron in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR.
In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, the Netherlands, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 4 November 2009.
In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 13 November 2009. The EFSA collated and forwarded all comments received to the Commission on 4 January 2010.
In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology, and deliver its conclusions on pencycuron.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of pencycuron as a fungicide on potatoes, as proposed by the applicant. Full details of the representative use can be found in Appendix A to this report.
A data gap is identified in the section physical and chemical properties of the formulation.
No data gaps or critical areas of concern are identified in the mammalian toxicology section.
In the residues area, for the specific use on potatoes at planting, the pertinent issues for consumer risk assessment have been reasonably addressed and no data gaps or critical areas of concern are identified.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative use, with the notable exception that information is missing regarding the fate and behaviour of the chlorophenyl and cyclopentyl portions of the molecule in soil, and the chlorophenyl and phenyl portions of the molecule in natural surface water and sediment systems. Consequently, the soil, groundwater, surface water and sediment exposure assessments for metabolites that have the potential to be formed from these portions of the molecule could not be finalised.
A high long-term risk to large omnivorous mammals (wild boar) was indicated in the refined risk assessment. This issue has been regarded as a critical area of concern and a data gap has been identified. The risk assessments for non-target organisms in relation to metabolites in soil, groundwater when it becomes surface water, surface water and sediment could not be finalised in view of the data gaps for further information on the nature and level of the metabolites in these environmental matrices.
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