In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from Monsanto Europe NV to set import tolerances at the level of 0.6 mg/kg for the active substance acetochlor in soya bean and cotton seed imported from the USA. This proposal included a change in the residue definition set for acetochlor at European level. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 February 2012. EFSA identified some data gaps, which prevented EFSA from concluding on the consumer risk assessment. On 10 June 2014, the EMS provided a revised evaluation report, including an assessment of the reply from the applicant on these gaps.
EFSA bases its assessment on the evaluation report submitted by the EMS (Spain, 2014), the Draft Assessment Report (DAR) (and its addenda) prepared under Council Directive 91/414/EEC Spain, 2005, 2007, 2010, 2011), the Commission Review Report on acetochlor (European Commission, 2011b), the conclusion on the peer review of the pesticide risk assessment of the active substance acetochlor (EFSA, 2011), as well as the conclusions from the previous EFSA reasoned opinion on acetochlor carried out according to article 12 of Regulation (EC) No 396/2005.
The toxicological profile of acetochlor was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.0036 mg/kg bw per day and an acute reference dose (ARfD) of 1.5 mg/kg bw applicable to acetochlor and some specifically listed transformation products.
In the framework of the peer review, the metabolism of acetochlor in primary crops was investigated in the cereal group only (maize) and the residue definition for enforcement was proposed as “all compounds forming EMA and HEMA on hydrolysis expressed as acetochlor”. In addition, the N-oxamic acid (68) metabolite was included in the residue definition for risk assessment. The residue definition for enforcement placed in the legislation Regulation (EC) No 396/2005 is limited to acetochlor.
Further metabolism studies on the pulses/oilseeds crop group (soya bean and cotton) were submitted in the framework of this MRL application. Several plant metabolites above 0.01 mg/kg in beans of soya bean remained unidentified and it was therefore not possible to conclude on their toxicological profile. Since concerns on the genotoxic and carcinogenic properties of an identified metabolite could not be excluded on the basis of the available data, EFSA concludes that appropriate residue definitions for monitoring and risk assessment cannot be proposed for the pulses/oilseeds crop group, whilst all components present in beans of soya bean above 0.01 mg/kg have not been fully identified.
Residues trials on soya bean and cotton conducted in the USA according to the US GAPs were submitted. Tentative MRLs were derived according to the residue definition for enforcement proposed in the conclusion of the peer review taking into account all components forming EMA and HEMA on hydrolysis. Note the peer review only considered metabolism in the cereals crop group. Since the residue definitions applicability to the pulses/oilseeds crop group could not be concluded, EFSA does not recommend the setting of import tolerances for soya bean and cotton seed.
Studies investigating the nature and magnitude of acetochlor residues in processed commodities were assessed in the framework of this application for MRL modification. Residues from acetochlor that form EMA and HEMA on hydrolysis were lower in soya and cotton seed oil than in beans and seeds. Concentration of these residues was found in soya bean meal but not cotton seed meal.
Since the proposed use of acetochlor is on imported crops, investigations of residues in rotational crops are not required.
Provisionally, livestock dietary burden calculations were conducted based on acetochlor residues forming EMA and HEMA on hydrolysis. Estimated intakes were below the trigger value of 0.1 mg/kg (dry matter) for all relevant species, and therefore the transfer of acetochlor residues to livestock has not been reconsidered.
Whilst it is not possible to conclude what would be appropriate, applicable toxicological reference values for the unidentified components that are present in beans of soya bean and seed of cotton seed, a valid consumer risk assessment could not be performed.