Peer Review of the pesticide risk assessment of the active substance azoxystrobin
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EFSA Journal 2010; 8(4):1542
T
HE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT
Azoxystrobin is the ISO common name for methyl (
E
)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl}-3-methoxyacrylate (IUPAC).
The representative formulated product for the evaluation was "Amistar", a suspension concentrate
(SC), containing 250 g/L azoxystrobin, registered under different trade names in Europe.
The representative uses are as a fungicide applied to broccoli, cauliflower, Brussels sprouts, kale,
barley and wheat. Full details of the GAP can be found in the list of end points in Appendix A to this
conclusion.
C
ONCLUSIONS OF THE EVALUATION
1.
Identity, physical/chemical/technical properties and methods of analysis
The minimum purity of azoxystrobin as manufactured should not be less than 965 g/kg, which is in
compliance with the FAO Specification 571/TC (August 2009).
QC data on the analysis of the technical material are required to support finalisation and agreement of
the technical material specification. During the peer review appropriate levels of some impurities
could not be agreed on. Toluene was considered as an impurity of toxicological relevance based
on its
hazards, however the assessment of its maximum level was not finalised.
Besides the specification, the assessment of the data package revealed no issues that need to be
included as critical areas of concern with respect to the identity, physical, chemical and technical
properties of azoxystrobin or the respective formulation. The main data regarding the identity of
azoxystrobin and its physical and chemical properties are given in Appendix A of this conclusion.
Adequate analytical methods are available for the determination of azoxystrobin in the technical
material and in the representative formulation, as well as for the determination of the relevant
impurities in the technical material.
The multi-method DFG-S19 is applicable to determine residues of azoxystrobin in dry crops, fruits
with high acid content and commodities with high water content. Adequate LC-MS/MS methods are
also available to monitor azoxystrobin residues in food of plant origin. Residues of azoxystrobin in
animal matrices can be monitored by GC-NPD. Monitoring of residues of azoxystrobin in
groundwater, drinking water and surface water can be done by GC-MSD. Pending on the data gap
identified in section 4, the residue definition for water might change and therefore further methods
could be required in the future. Adequate methods are available for the determination of residues of
azoxystrobin in soil and air.
According to the currently agreed classification under Annex I of Directive 67/548/EEC
5
,
azoxystrobin is classified as T, and as a consequence, a data gap was identified for adequate analytical
methods for body fluids and tissues.
2.
Mammalian toxicity
Azoxystrobin was discussed at the PRAPeR 71 meeting of experts on Mammalian Toxicology
(October 2009). The experts concluded that the specification is covered by the toxicological
assessment if it complies with the rapporteur Member State‟s proposal from May 2009 (Volume 4,
Table C.1.2-3; The United Kingdom, 2009a); in the notifier‟s proposal for the Annex I renewal, which
reduces the levels of a number of impurities compared to the specification agreed for Annex I
inclusion, two impurities are not covered by the toxicological assessment. The technical specification
5
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous substances. OJ 196 , 16/08/1967 p. 0001 – 0098.