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Conclusion on the peer review of the pesticide risk assessment of the active substance Fatty acids C7 to C18 (approved under Regulation (EC) No 1107/2009 as Fatty acids C7 to C20)

EFSA Journal 2013;11(1):3023 [62 pp.]. doi:10.2903/j.efsa.2013.3023
European Food Safety Authority Contact pesticides.peerreview@efsa.europa.eu
Type: Conclusion on Pesticides On request from: European Commission Question number: EFSA-Q-2009-00279 Approved: 07 December 2012 Published: 07 January 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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 Ireland, for the pesticide active substance fatty acids C7 to C18 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 fatty acids C7 to C18 as a herbicide, acaricide, insecticide or plant growth regulator on a variety of crops. 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.

© European Food Safety Authority, 2013

Summary

Fatty acids C7 to C18 is 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.

Fatty acids C7 to C18 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.

Ireland being the designated rapporteur Member State submitted the DAR on fatty acids C7 to C18 in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 10 September 2007. The peer review was initiated on 9 September 2011 by dispatching the DAR to the Member States and on 13 June 2008 to the notifiers W. Neudorff GmbH KG, The Fatty acid Task Force & Oleon n.v. 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 ecotoxicology and deliver its conclusions on fatty acids.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of fatty acids as a herbicide, acaricide, insecticide or plant growth regulator on a variety of crops, as proposed by the notifiers. 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 the specification, physchem properties of both the active substances and the formulations as well as for methods of analysis.

Exposure to fatty acids derived from the use as plant protection products would be considered of low toxicological concern and no reference values would be needed if the different groups of fatty acids can be considered of food grade quality. However, this assumption could not be confirmed and therefore operator, worker and bystander risk assessment cannot be concluded leading to an issue that could not be finalised. The potential exposure risk assessment to methanol from the use of fatty acid methyl esters is considered inconclusive.

No data gap was identified in the residue section. However, if the technical material does not comply with the food grade specification and raises potential toxicological issues, further data may be required.

Fate and behaviour of fatty acids C7-C18 in the environment was assessed on the basis of a limited data set. Although associated with a high uncertainty, the exposure assessment presented may be regarded to represent a realistic worst case for the representative uses proposed with the exception of the field and greenhouses uses on azalea (application rate 73.8 kg/ha) and the aquatic exposure assessment for the use in pome fruits/stone fruits. A data gap has been identified to provide Step 4 FOCUS PEC SW calculations to refine the risk assessment for the aquatic environment.

For pelargonic acid, data gaps to address the following aspects of the ecotoxicological risk assessment were identified: aquatic organisms, bees, in-field populations of non-target arthropods, earthworms, soil microorganisms and non-target plants (seedling emergence). A low risk to birds, mammals and sewage treatment organisms was concluded. A risk was identified for earthworms and in-field populations of non-target arthropods.

For potassium salts of fatty acids, data gaps to address the following aspects of the ecotoxicological risk assessment were identified: aquatic organisms, bees, non-target arthropods, earthworms and soil microorganisms. A low risk to birds, mammals, non-target plants and sewage treatment organisms was concluded. A risk was identified for aquatic organisms and bee for the outdoor uses.

For fatty acid/salt and C7-C10 methyl esters, data gaps to address the following aspects of the ecotoxicological risk assessment were identified: aquatic organisms, bees, non-target arthropods, earthworms, soil microorganisms and non-target plants. A low risk to birds, mammals and sewage treatment organisms was concluded.
 

Keywords

Fatty acids C7 to C18, peer review, risk assessment, pesticide, herbicide, acaricide, insecticide, plant growth regulator

Background documents
Additional information is available in the Assessment report
Background documents are available in the Register of Questions