Conclusion regarding the peer review of the pesticide risk assessment of the active substance aclonifen

Aclonifen is one of the 84 substances of the third stage Part B of the review programme covered by Commission Regulation (EC) No 1490/2002 1 .This Regulation requires the European Food Safety Authority (EFSA) to organise upon request of the EU-Commission a peer review of the initial evaluation, i.e. the draft assessment report (DAR), provided by the designated rapporteur Member State and to provide within six months a conclusion on the risk assessment to the EU-Commission.Germany being the designated rapporteur Member State submitted the DAR on aclonifen in accordance with the provisions of Article 10(1) of the Regulation (EC) No 1490/2002, which was received by the EFSA on 11 September 2006.The peer review was initiated on 24 November 2006 by dispatching the DAR for consultation of the Member States and the sole applicant Bayer CropScience AG.Subsequently, the comments received on the DAR were examined and responded by the rapporteur Member State in the reporting table.This table was evaluated by EFSA to identify the remaining issues.The identified issues as well as further information made available by the applicant upon request were evaluated in a series of scientific meetings with Member State experts in March-April 2008.A final discussion of the outcome of the consultation of experts took place during a written procedure with the Member States in June-July 2008 leading to the conclusions as laid down in this report.The conclusion was reached on the basis of the evaluation of the representative uses as a preemergence herbicide as proposed by the applicant.Full details of the GAP can be found in the attached list of end points.The representative formulated product for the evaluation was "Bandur", a suspension concentrate formulation (SC). 1 OJ No L 224, 21.08.2002,p. 25, as amended by Regulation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19) EFSA Scientific Report (2008) 149, 1-80, Conclusion on the peer review of aclonifen http://www.efsa.europa.eu of 80Adequate methods are available to monitor all compounds given in the respective residue definition.Residues in food of plant origin can be determined with a multi-method (The German S19 method has been validated).For the other matrices only single methods are available to determine residues of aclonifen.Sufficient analytical methods as well as methods and data relating to physical, chemical and technical properties are available to ensure that some quality control measurements of the plant protection product are possible.The exception to this is the relevant impurity phenol where there is no method to monitor it in the formulation.It was concluded during the peer review process that the specification is not supported and a data gap has been identified.In addition it was considered by the meeting of experts mammalian toxicology that phenol is a relevant impurity.The meeting of experts discussed that as the technical material is a wet cake a TK specification should be required but no conclusion was reached on this in the meeting.Mammalian toxicology of aclonifen was assessed in a series of investigations.Aclonifen is absorbed rapidly to an extent of about 80% and is distributed widely in the body.It has no potential for accumulation.It is excreted rapidly and almost completely and it is extensively metabolised.Aclonifen is of very low acute toxicity.It is neither a skin nor an eye irritant but has skin sensitising properties.A classification as Xi; R43 "Irritant; May cause sensitisation by skin contact" is proposed.Short term studies were carried out with dogs, mice and rats and the lowest NOAEL of 3.6 mg/kg bw/d was obtained in rats (effects on body weight, liver and kidney).Aclonifen is not genotoxic.Two chronic rat studies and a carcinogenicity study with mice have been carried out.While the thyroid tumours seen in rats and the bladder tumours observed in mice were considered not relevant for human risk assessment the brain tumours seen in the rat could not be dismissed and a classification as Xn; Carc.Cat. 3 R40 "Harmful; Limited evidence of a carcinogenic effect" was proposed.Aclonifen did not exert specific effects on reproduction and was neither teratogenic in rats nor in rabbits.The acceptable daily intake (ADI) and the acceptable operator exposure level (AOEL) were set at 0.07 mg/kg bw/d.An acute reference dose (ARfD) was not allocated.Operator exposure amounted to 16.1% of the AOEL when wearing personal protective equipment (PPE) in the German model.When no PPE is worn in the German model and in all scenarios in the UK POEM exposures exceeded the AOEL.Exposure of bystanders and unprotected re-entry workers was estimated to amount to 4.6% and 2.9% of the AOEL respectively.The metabolism of aclonifen was investigated in wheat, peas and potatoes.However in the meeting of experts PRAPeR 45 no conclusion could be reached on the cereal and potato metabolism studies because there were no GAPs for these crops in the representative uses evaluated.So only the pea study was considered further.The pea study is representative of the relevant metabolism group for sunflowers which is the supported crop.This study showed that there are no significant residues in peas or in podded peas the major residue in the vinings was aclonifen.The residue definition for pulses and oilseeds was set as aclonifen only.The rotational crop metabolism study showed that in the majority of crops no significant residues would occur.However, for root and tuber crops it showed that residues could be expected.A data gap was set for a rotational crop residue study.

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