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EFSA on the pesticide risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs:直鎖鱗翅目フェロモン) in light of confirmatory data

Straight Chain Lepidopteran Pheromones (SCLPs) was included in Annex I to Directive 91/414/EEC on 1 September 2009 by Commission Directive 2008/127/EC, and has 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 2014 the approval has been amended by Commission Implementing Regulation (EU) No 918/2014, following the peer review performed by EFSA (EFSA, 2014). It was a specific provision of the approval that the applicant was required to submit to the European Commission a second batch of confirmatory data as regards exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. EFSA finalised a technical report on the first batch of confirmatory data on 13 May 2016.

In accordance with the specific provision, the applicant, IBMA SCLP Task Force, submitted an updated dossier in December 2016, which was evaluated by the designated rapporteur Member State (RMS), Austria, in the form of a revision to the draft assessment report (DAR). In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the revised DAR to Member States, the applicant and EFSA for comments on 30 January 2017. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 22 March 2017. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table.

The current report summarises the outcome of the consultation process organised by the RMS, Austria, and presents EFSA’s scientific views and conclusions on the individual comments received.

For the representative product Isomate-CLR that is a retrievable passive dispenser and its associated straight chain lepidopteran pheromone active substances: (E,E)-8,10-dodecadien-1-ol, 1-tetradecanol, 1-dodecanol, (Z)-9-tetradecen-1-yl acetate, (Z)-11-tetradecen-1-yl acetate sufficient information was available to finalise the human and animal health and environmental risk characterisation. However the information provided did not address the confirmatory data requirement set, as the calculations only covered one way of application (passive dispenser). For the second representative formulation Checkmate CM-F (a microencapsulated spray application), an exposure assessment comparison with natural releases from the target lepidopteran insects was not available.