Conclusion on the peer review of the pesticide risk assessment of the active substance pymetrozine

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(9):3817 [102 pp.].
doi
10.2903/j.efsa.2014.3817
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00908
Approved
22 August 2014
Published
9 September 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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 Germany, for the pesticide active substance pymetrozine are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of pymetrozine as an insecticide on tomato, aubergine, potato and oilseed 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.

Summary

Commission Regulation (EU) No 1141/2010, as amended by Commission Implementing Regulation (EU) No 380/2013, (hereinafter referred to as ’the Regulation’) lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances.  Pymetrozine is one of the active substances listed in the Regulation. 

The RMS provided its initial evaluation of the dossier on pymetrozine in the Renewal Assessment Report (RAR), which was received by the EFSA on 28 June 2013.  The peer review was initiated on 7 July 2013 by dispatching the RAR for consultation of the Member States and the applicant Syngenta Crop Protection AG.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether pymetrozine can be expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of pymetrozine as an insecticide on tomato, aubergine, potato and oilseed rape, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

No data gaps were identified in the area of identity, physical and chemical properties and analytical methods.

In the area of mammalian toxicology, one data gap was identified for an assessment of the toxicological relevance of one impurity. Considering the harmonised classification of pymetrozine as carcinogen category 2 and the proposed classification as reproductive toxicant category 2, a critical area of concern was identified with regard to Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 interim provisions for active substances that shall be considered to have endocrine disruption properties. As limited investigations have been performed to clarify a possible endocrine-mediated mode of action of pymetrozine, a data gap has been identified for the Level 2 tests currently indicated in the OECD Conceptual Framework. Due to both the harmonised classification and the proposed classification of pymetrozine, all groundwater metabolites that occur above the parametric drinking water limit are considered relevant according to the guidance document on the assessment of the relevance of metabolites in groundwater (European Commission, 2003).

In the area of residues and consumer risk data gaps were identified for further data on rotational crops for the glasshouse uses and for residue trials on tomato and aubergine. The risk assessment for tomato and aubergine could not be finalised.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses, with the notable exception that in relation to the representative use on oilseed rape, soil, natural surface water system and groundwater exposure estimates are not available for the anaerobic soil metabolites CGA180777 and GS23199 and soil and groundwater exposure estimates are not available for anaerobic soil metabolite CGA249257. Consequently the potential for impacts on groundwater quality regarding these three metabolites are not available. There is a critical area of concern due to the potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/L by the relevant metabolite CGA371075 in all the pertinent groundwater scenarios for all four representative uses assessed.

In the area of ecotoxicology no transparent evaluation of the aquatic endpoints (excluding aquatic invertebrates) could be performed and a data gap was identified. A data gap was also identified for the groundwater metabolite M3MF, the surface water and soil metabolites CGA180777, GS23199 and CGA249257. A data gap has been identified for further data on the residues decline of pymetrozine in oilseed rape to characterise the interval between the application of pymetrozine and the pre-flowering period for a safe application to bees for the representative use on oilseed rape. Pending on the outcome of the data gap in section 2, further ecotoxicological tests might be necessary to address the potential endocrine disrupting properties of pymetrozine.

Keywords
pymetrozine, peer review, risk assessment, pesticide, insecticide
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Number of Pages
102