Conclusion on the peer review of the pesticide risk assessment of the active substance fish oil

No abstract available

Fish oil 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.

Fish oil was included in Annex I to Directive 91/414/EEC on 18 December 2008 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.

Greece being the designated rapporteur Member State submitted the DAR on fish oil in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 3 April 2008. The peer review was initiated on 31 July 2008 by dispatching the DAR for consultation of the notifier (Fluegel GmbH). The commenting period with Member States was launched on 16 December 2010. Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should deliver its conclusions on fish oil. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of fish oil as a game repellent in deciduous and coniferous forests and orchards, 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 and supporting data. Data gaps were also identified for further physical- chemical properties of the active substance and the formulation and a translation of some studies. A method of analysis is also required for the formulation.

No agreed technical specification is available and a data gap is identified in the mammalian toxicology section on the presence and maximum level of impurities and/or contaminants of potential toxicological concern; this issue could not be finalised.

No critical areas of concerns or data gaps were identified in the residue section.

Fish oil is a natural compound produced from fresh fish. Fate and behaviour of fish oil is expected to follow the normal pathways of dissipation and degradation common to naturally occurring residues of biological origin. Considering the nature of the substance and the limited usage a definition of residue in the environment for risk assessment is deemed to be unnecessary for fish oil.

The risk to non-target organisms is considered as low for the representative uses.

Fish oil, peer review, risk assessment, pesticide, repellent