Special Issue Item
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Animal health & welfare
Evidence Management (DATA)
Assessment and methodological support
Conclusion on the peer review of the pesticide risk assessment of the active substance acetic acid
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 acetic acid 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 and Commission Regulation (EU) No. 114/2010. The conclusions were reached on the basis of the evaluation of the representative uses of acetic acid as a herbicide in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns. 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
Acetic acid 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.
Acetic acid 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.
Germany being the designated rapporteur Member State submitted the DAR on acetic acid in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 17 September 2007. The peer review was initiated on 13 June 2008 by dispatching the DAR to the notifier, the Task Force for Acetic Acid, and on 24 February 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 areas of mammalian toxicology and environmental fate and behaviour and deliver its conclusions on acetic acid.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of acetic acid as a herbicide in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns, 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 a data gap was identified for a specification with supporting batch analysis and methods of analysis. Data gaps were identified for some physical/chemical properties of the active substance as well as specific methods for the active substance in the technical and the formulated product. Data gaps were also identified for the representative formulations. As a residue definition is set for environmental compartments a data gap has been identified for methods of analysis.
In the section mammalian toxicology, no data gap and no critical area of concern were identified.
No significant residues of acetic acid are expected to be present in edible crops and a quantitative risk assessment is not necessary.
The information on environmental fate and behaviour in the environment is sufficient to carry out the necessary environmental exposure assessments at the EU level, with the exception that information is missing on volatilisation and re-deposition of acetic acid in the short range, that is needed to complete the aquatic exposure assessment for all the representative uses except for the representative use on turf grass, where application is by watering. The potential for groundwater exposure from the representative uses by acetic acid and its salts above the parametric drinking water limit of 0.1 µg/L was concluded to be high in geoclimatic situations that are represented by 5 out of 9 FOCUS groundwater scenarios for the representative use on pome fruits, stone fruits and ornamental shrubs at 4x40.8 kg a.s./ha, 4 out of 9 FOCUS scenarios for the representative use on trees and ornamental shrubs at 2x60 kg a.s./ha and 3 out of 9 FOCUS scenarios for the representative use on turf, lawn at 2x102 kg a.s./ha. Acetic acid has the potential for long-range atmospheric transport.
The acute and long-term risk assessments for birds and the acute risk assessment for mammals could not be finalised. A high long-term risk was identified for mammals for all representative uses. A low risk for aquatic organisms could only be concluded for the representative uses on turf and lawns, for the other representative uses either a high risk was identified or the assessments could not be finalised. The risk to honeybees and non-target arthropods was also assessed as high for all representative uses. The risk to soil-dwelling organisms was assessed as low, however data on carbon mineralisation are outstanding. The risk assessment for non-target plants could not be finalised. The risk to biological methods of sewage treatment was considered to be low for all representative uses, except roads and paths for which a data gap was identified.
Acetic acid, peer review, risk assessment, pesticide, herbicide