Modification of the existing maximum residue levels for imazalil in various commodities

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. 2018 Jun 27;16(6):e05329. doi: 10.2903/j.efsa.2018.5329

Code^a	Commodity	Existing EU MRL/MRL proposed in MRL review^b (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: imazalil (any ratio of constituent isomers)
0110010 0110020 0110030 0110040 0110050 0110990	Grapefruits Oranges Lemons Limes Mandarins Other citrus fruits	5/4^c 5/4^c 5/6^d 5/6^d 5/6^d 5/–	No proposals	The submitted data were sufficient to calculate the MRLs that would be required to cover the three different GAPs for citrus fruits (6 mg/kg for the post‐harvest dipping/drenching use, 4 mg/kg for the post‐harvest low volume spray and 2 mg/kg for the post‐harvest waxing use). However, EFSA did not derived MRL proposals, since the risk assessment for metabolite R014821 needs to be completed first, ruling out that the metabolite is genotoxic; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolite R014821. Lacking this information, a final decision on the residue definition for risk assessment for plant products cannot be derived, and consequently, the risk assessment cannot be completed
1000000	Products of animal origin	0.05^/0.03 (bovine and equine liver); 0.02^ (other products)	No proposals	EFSA did not derived MRL proposals for animal products, since the risk assessment for metabolites FK‐772 and FK‐284 needs to be completed first, ruling out that the metabolites are is genotoxic; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolites. Lacking this information, a final decision on the residue definition for risk assessment for animal products cannot be derived and consequently, the risk assessment cannot be completed

Code^a

Commodity

Existing EU MRL/MRL proposed in MRL review^b (mg/kg)

Proposed EU MRL (mg/kg)

Comment/justification

Enforcement residue definition: imazalil (any ratio of constituent isomers)

0110010

0110020

0110030

0110040

0110050

0110990

Grapefruits

Oranges

Lemons

Limes

Mandarins

Other citrus fruits

5/4^c

5/6^d

5/–

No proposals

The submitted data were sufficient to calculate the MRLs that would be required to cover the three different GAPs for citrus fruits (6 mg/kg for the post‐harvest dipping/drenching use, 4 mg/kg for the post‐harvest low volume spray and 2 mg/kg for the post‐harvest waxing use).

However, EFSA did not derived MRL proposals, since the risk assessment for metabolite R014821 needs to be completed first, ruling out that the metabolite is genotoxic; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolite R014821.

Lacking this information, a final decision on the residue definition for risk assessment for plant products cannot be derived, and consequently, the risk assessment cannot be completed

1000000

Products of animal origin

0.05^*/0.03 (bovine and equine liver); 0.02^* (other products)

No proposals

EFSA did not derived MRL proposals for animal products, since the risk assessment for metabolites FK‐772 and FK‐284 needs to be completed first, ruling out that the metabolites are is genotoxic; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolites.

Lacking this information, a final decision on the residue definition for risk assessment for animal products cannot be derived and consequently, the risk assessment cannot be completed

MRL: maximum residue level; GAP: good agricultural practice.

* Indicates that the MRL is set at the limit of quantification.

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

MRL proposals derived in the framework of the MRL review (EFSA, 2017a,b); not yet implemented in EU MRL legislation.

Tentative MRL derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; CXL is higher but it was also not sufficiently supported by data a risk to consumers cannot be excluded (EFSA, 2017a,b).

Tentative MRL derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; existing CXL is covered by the tentative MRL (EFSA, 2017a,b).