Modification of the existing maximum residue levels for difenoconazole in wheat and rye

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. 2023 Aug 14;21(8):e08207. doi: 10.2903/j.efsa.2023.8207

Code ^(a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Difenoconazole
0500070	Rye	0.1	0.3 (further risk management consideration required)	The submitted data are sufficient to derive an MRL proposal for the intended NEU/SEU use. The dietary exposure to difenoconazole residues from the intended uses on wheat and rye is low, noting that the impact of the intended uses on the residue levels in animal commodities and the consumer exposure could not be properly assessed. A very narrow margin of safety is noted for the overall chronic exposure which is considered provisional pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and animals and the impact of isomerisation on the toxicity of difenoconazole. The consumer exposure assessment is also affected by uncertainties associated with the toxicity of animal metabolite CGA205375 and, additionally, it does not take into consideration triazole derivative metabolites (TDMs).
0500090	Wheat	0.1

Code ^(a)

Commodity

Existing EU MRL (mg/kg)

Proposed EU MRL (mg/kg)

Comment/justification

Enforcement residue definition: Difenoconazole

0500070

Rye

0.1

0.3 (further risk management consideration required)

The submitted data are sufficient to derive an MRL proposal for the intended NEU/SEU use.

The dietary exposure to difenoconazole residues from the intended uses on wheat and rye is low, noting that the impact of the intended uses on the residue levels in animal commodities and the consumer exposure could not be properly assessed. A very narrow margin of safety is noted for the overall chronic exposure which is considered provisional pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and animals and the impact of isomerisation on the toxicity of difenoconazole. The consumer exposure assessment is also affected by uncertainties associated with the toxicity of animal metabolite CGA205375 and, additionally, it does not take into consideration triazole derivative metabolites (TDMs).

0500090

Wheat

0.1

MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe; GAP: Good Agricultural Practice.

^(a)

Commodity code number according to Annex I of Regulation (EC) No 396/2005.