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

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(1):3032 [76 pp.].
doi
10.2903/j.efsa.2013.3032
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2009-00286
Approved
12 December 2012
Published
9 January 2013
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 Italy, for the pesticide active substance pyrethrins 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 uses of pyrethrins as an insecticide on tomato, pepper, cucumber, melons, strawberries, potatoes, lettuce and ornamentals. 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

Pyrethrins are 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.

Pyrethrins was included in Annex I to Directive 91/414/EEC on 1 September 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.

Italy being the designated rapporteur Member State submitted the DAR on pyrethrins in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 28 November 2007. The peer review was initiated on 18 June 2008 by dispatching the DAR to the notifiers, the Pyrethrum Board of Kenya represented by Kenya Pyrethrum Information Centre and COPYR S.p.A. as co-notifiers (PBK and COP), and the EU Pyrethrins 91/414 Task Force (also known as the EU Pyrethrum 91/414 Task Force) comprised of Botanical Resources Australia Pty Ltd. and McLaughlin Gormley King Company (BRA and MGK), and on 9 September 2011 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 mammalian toxicology and deliver its conclusions on pyrethrins.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of pyrethrins as an insecticide on tomato, pepper, cucumber, melons, strawberries, potatoes, lettuce and ornamentals, as proposed by the notifier. 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 a specification with supporting batch data and methods of analysis. Data gaps were identified for various physical and chemical properties of the active substance and formulation. For the residues methods further ILV data are required for the plant method. No methods were available for soil, water and air.

In the mammalian toxicology section, it could not be concluded on the toxicological relevance of the impurities and whether the batches used in the toxicological studies were representative of the technical specification. Due to local effects by inhalation at the low dose, and indications of local genotoxicity in an in vitro Comet assay without evidence of a threshold, the risk assessment for the operators, workers and bystanders cannot be concluded (data gap and critical area of concern). Additionally, the toxicological assessment of the hydroxylated chrysanthemic acid plant metabolites is missing (data gap).

The consumer risk assessment could not be finalised since information on the toxicity of the hydroxy-chrysanthemic acid metabolites and information on the metabolism of the cyclopropene moiety in plants are not available. Provisionally, the residue definitions for monitoring and risk assessment were set as "pyrethrins, sum of pyrethrin 1&2, cinerin 1&2 and jasmolin 1&2" and a conversion factor of 2 was proposed as the dietary toxicological reference values refer to plant extracts having a pyrethrins content of 57 % only.
 

Fate and behaviour studies are only available for pyrethrin 1. A data gap has been identified for scientific information or data to demonstrate the representativeness of pyrethrin 1 with respect to the environmental assessment of all the pyrethrin components. A data gap has been identified to address the fate and behaviour of the cyclopentelone moiety. In order to establish the active substance rate of degradation for environmental exposure assessment, aerobic dark experiments need to be performed in at least four distinct soils. A data gap has been identified for data on the degradation of pyrethrins in three additional soils under dark aerobic conditions. The field dissipation half-lives reported in the dossier are highly uncertain and likely to represent photolytic degradation of pyrethrins I. A data gap has been identified to specify the proportion of the individual pyrethrins components in the material used in the field dissipation studies. No exposure assessment has been presented for the uses on protected crops. A data gap is identified to address the aquatic exposure resulting from application of pyrethrins to protected crops. With respect to potential contamination of ground water, a data gap is identified in dossier B (BRA and MGK) for FOCUS GW calculations to address their proposed representative use with six annual applications to tomatoes. A data gap is identified in dossier A (PBK and COP) for FOCUS GW calculations with a second FOCUS GW model. The limit of 0.1 µg/L is not exceeded for any of the uses and scenarios for which modelling calculations are available. However, calculations were performed using pyrethrin 1 end points as surrogate for the end points of all the six pyrethrins components and no bridging data is available to ensure that assessment performed on basis of pyrethrin 1 end points actually addresses the assessment of the other known active components. Assessment of potential contamination of ground water by chrysanthemic acid (or its analogues) and the pyrethrolones metabolites may be necessary once the information on the route of degradation of all components of pyrethrins in soil is completed.

For the representative outdoor uses, data gaps were identified to address the risk to: birds and mammals via the consumption of contaminated water; earthworm-eating and fish-eating birds and mammals; herbivorous birds from major plant metabolites; aquatic organisms from pyrethrins and its metabolites; bees; non-target arthropods; earthworms from pyrethrins and its metabolites and soil microorganisms from soil metabolites. A low risk to herbivorous birds (from the parent substance via dietary exposure), insectivorous birds (via dietary exposure), herbivorous mammals (via dietary exposure) and non-target plants was concluded.

For the representative indoor uses, data gaps were identified to address the risk to fish-eating birds, and to aquatic organisms from pyrethrins and its metabolites. A low risk to birds and mammals (from other routes of exposure), bees, non-target arthropods, soil dwelling organisms, non-target plants and sewage treatment organisms was concluded.
 

Keywords
Pyrethrins, peer review, risk assessment, pesticide, insecticide
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Number of Pages
76