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


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(7):3742 [84 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
19 June 2014
1 July 2014
Last Updated
26 August 2015. This version replaces the previous one/s.
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 France, for the pesticide active substance amitrole 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 amitrole as a herbicide in orchards, grapes, olives and non-crop uses. 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.


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 in Annex I to Council Directive 91/414/EEC and establishes the list of those substances. Amitrole is one of the active substances listed in the Regulation.

The RMS provided its initial evaluation of the dossier on amitrole in the Renewal Assessment Report (RAR), which was received by the EFSA on 2 April 2013. The peer review was initiated on 17 April 2013 by dispatching the RAR for consultation of the Member States and the applicant Nufarm SAS.

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, residues, environmental fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether amitrole 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 uses of amitrole as a herbicide on orchards (citrus fruits, pome and stone fruits, assorted fruits-edible or inedible peel, tree nuts), grapes, olives and non-crop uses, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for some physchem properties of the active substance, information on relevant impurities, validation of the plant method for dry commodities and a suitable method of analysis for air.

In the area of mammalian toxicology, two data gaps and four critical areas of concern were identified. The data gaps are related to the toxicological relevance of impurities in the technical specification, and to the toxicological assessment of the metabolite aminotriazolylalanine. The areas of concern are raised by exposure estimates exceeding the AOEL, by the classification as Repr. Cat. 1B proposed by the EFSA Peer Review, by the potential endocrine disruption of amitrole, and by the non representativeness of the batches used in toxicity studies with regard to the technical specification.

The consumer risk assessment for the representative uses on crops, according to the residue definition for risk assessment established by the peer review is not finalised, and data gaps were identified for storage stability data in crops with high water content and sufficient residue trials for the representative crop uses.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level, with the notable exception that satisfactory information on anaerobic route and rate of degradation in soil is not available that may be important for some uses (e.g. pome fruit orchards in some territories). Exposure assessments were provided for uses on crops where one third of the ground surface area is treated and the total annual dose is applied at the same time and additionally in the case of olives only one of the possible two applications originally requested was assumed. It should be noted that for the crop uses assessed, it is normal practice that up to one half of the ground surface area is treated and that splitting the annual dose is indicated as appropriate practice. In addition satisfactory surface water and sediment exposure assessments for parent amitrole are not available for geoclimatic situations where drainage will be a route of exposure to surface water. Data gaps are identified for these missing assessments. For the representative non-crop uses an environmental exposure assessment is available that was designed to cover the climatic and civil engineering situation in the UK. It is uncertain how applicable the available non-crop use assessment might be to other territories. The available crop use assessments where one third of the ground surface area is treated and the total annual dose is applied at the same time indicate a high potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/L for the relevant metabolite 1,2,4-triazole at all nine of the pertinent FOCUS groundwater scenarios.

In the area of ecotoxicology, a number of data gaps and two critical area of concern were identified as a high risk for soil non-target macro- and microorganisms could not be excluded for the soil metabolite 1,2,4-triazole and on the potential endocrine disruption of amitrole.

amitrole, peer review, risk assessment, pesticide, herbicide
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