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


European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(11):4279 [66 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
22 October 2015
4 November 2015
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 Germany, for the pesticide active substance picolinafen 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 use of picolinafen as a herbicide on autumn sown cereals. 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 and establishes the list of those substances. Picolinafen is one of the active substances listed in the Regulation. 

The Rapporteur Member State (RMS) provided its initial evaluation of the dossier on picolinafen in the Renewal Assessment Report (RAR), which was received by EFSA on 15 May 2014.  The peer review was initiated on 20 May 2014 by dispatching the RAR for consultation of the Member States and the applicant BASF Belgium SA.

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, environmental fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether picolinafen 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 use of picolinafen as a herbicide on autumn sown cereals (winter wheat, winter barley, winter rye, winter triticale), as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

A data gap was identified for a complete search of the peer-reviewed open literature covering picolinafen and its relevant metabolites and impurities and dealing with side-effects on health, the environment and non-target species.

In the area of identity, physical/chemical/technical properties and methods of analysis no data gaps were identified.

In the mammalian toxicology area, a data gap was identified to address the relevance of non-significant impurities (present in the technical specification < 1 g/kg) as a carcinogenic potential could not be ruled out at least for one of these impurities.

In the area of residues and consumer exposure no data gaps or areas of concern were identified.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative use, with the notable exception that information is missing regarding the fate and behaviour of the aniline and fluoro-phenoxy portions of the molecule in soil under illuminated conditions, and the fluoro-phenoxy portion of the molecule in natural surface water and sediment systems. Consequently, the soil, groundwater, surface water and sediment exposure assessments for metabolites that have the potential to be formed from these portions of the molecule could not be finalised.

In the area of ecotoxicology data gaps for further refining the risk to mammals and algae were identified. This led to the identification of two critical areas of concern. In addition, a data gap was identified for providing valid ecotoxicological data on non-target terrestrial plants; due to the lack of valid studies, the risk assessment could not be finalised.

picolinafen, peer review, risk assessment, pesticide, herbicide
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