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. 2024 Feb 26;22(2):e8560. doi: 10.2903/j.efsa.2024.8560
Code a Commodity Existing MRL b Data gap(s) Art. 12 Review Proposed MRL Conclusion/recommendation
Enforcement residue definition: Quizalofop (sum of quizalofop, its salts, its esters [including propaquizafop] and its conjugates, expressed as quizalofop [any ratio of constituent isomers])
0151010 Table grapes 0.02* Art. 10 MRL application 0.02* No change proposed. The submitted data are not sufficient to support the MRL proposal of 0.04 mg/kg, based on the NEU use of quizalofop‐P‐tefuryl. The existing MRL of 0.02 mg/kg (LOQ) is still deemed appropriate considering that all the residue trials submitted for table grapes indicated residue values below the LOQ. Risk for consumers unlikely
0251000 Lettuces and salad plants 0.2 (ft 4)

Footnote related to data gap No. 7

[Some information on residue trials unavailable for propaquizafop]

0.15

The data gap identified by EFSA concerning the lack of residue trials to support the GAP reported in the MRL review for propaquizafop on lettuces and salad plants is not addressed. Therefore, the MRL of 0.2 mg/kg is not supported

However, an alternative MRL of 0.15 mg/kg, fully supported by data, can be proposed based on a GAP on propaquizafop assessed in the context of a previous MRL application for lettuces and salad plants

Risk for consumer is unlikely

0252010 Spinaches 0.2 (ft 2)

Footnote related to data gap No. 4

[Some information on analytical methods unavailable for quizalofop‐P‐ethyl]

0.01* or 0.15 (Risk management decision)

The data gap identified by EFSA concerning the lack of information on analytical methods for quizalofop‐p‐ethyl on spinaches has not been addressed

However, sufficient data are available to support an MRL proposal of 0.15 mg/kg based on the existing SEU GAP on spinach for propaquizafop

Risk for consumers unlikely

Risk manager decision is needed on whether lowering the existing MRL to the LOQ of 0.01 mg/kg or to consider the MRL of 0.15 mg/kg

0252030 Chards/beet leaves 0.04 (ft 2)

Footnote related to data gap No. 4

[Some information on analytical methods unavailable for quizalofop‐P‐ethyl]

0.01*

The data gap identified by EFSA concerning the lack of information on analytical methods for quizalofop‐p‐ethyl on spinaches and chards/beet leaves has not been addressed. No fall‐back option has been identified for this crop

Risk managers may consider lowering the existing MRL to the LOQ of 0.01 mg/kg

0401050 Sunflower seeds 0.8 Art. 10 MRL application 1.5

The submitted data are sufficient to derive an MRL proposal, based on NEU use of quizalofop‐P‐tefuryl

Risk for consumers unlikely

0401070 Soyabeans 0.2 Art. 10 MRL application 0.3

The submitted data are sufficient to derive an MRL proposal, based on NEU use of quizalofop‐P‐tefuryl

Risk for consumers unlikely

0631000 Herbal infusions from flowers 0.8 (ft 1) Footnote related to data gap No. 3 [Some information on storage stability unavailable for quizalofop‐P‐ethyl] and data gap No. 2 and 4 [Some information on analytical methods unavailable for quizalofop‐P‐ethyl] 0.05*

The data gaps identified by EFSA concerning the lack of information on storage stability and analytical methods to support the GAPs reported for quizalofop‐p‐ethyl on herbal infusions from flowers has not been addressed

Risk managers may consider lowering the existing MRL to the LOQ of 0.05 mg/kg

0632000 Herbal infusions from herbs 0.8 (ft 1) Footnote related to data gap No. 3 [Some information on storage stability unavailable for quizalofop‐P‐ethyl] and data gap No. 2 and 4 [Some information on analytical methods unavailable for quizalofop‐P‐ethyl] 0.05*

The data gaps identified by EFSA concerning the lack of information on storage stability and analytical methods to support the GAPs reported for quizalofop‐p‐ethyl on herbal infusions from leaves and herbs has not been addressed

Risk managers may consider lowering the existing MRL to the LOQ of 0.05 mg/kg

0810000 Seed spices 0.05* (ft 5) Footnote related to data gap No. 2, 3, 4, 5 [Some information on residue trials, analytical methods and storage stability unavailable for quizalofop‐P‐ethyl] 0.05*

The data gaps identified by EFSA concerning the lack of information on residue trials, storage stability and analytical methods to support the GAPs reported for quizalofop‐p‐ethyl on seed spices has not been addressed

EFSA recommends keeping the MRLs at the LOQ

Risk for consumers unlikely

0820000 Fruit spices (except caraway) 0.05* (ft 5) Footnote related to data gap No. 2, 3, 4, 5 [Some information on residue trials, analytical methods and storage stability unavailable for quizalofop‐P‐ethyl] 0.05*

The data gaps identified by EFSA concerning the lack of information on residue trials, storage stability and analytical methods to support the GAPs reported for quizalofop‐p‐ethyl on fruit spices has not been addressed. New residue trials on seed spices or fruit spices have not been submitted

EFSA recommends keeping the MRLs at the LOQ

Risk for consumers unlikely

0820030 Caraway 0.04 (ft 5) Footnote related to data gap No. 2, 3, 4, 5 [Some information on residue trials, analytical methods and storage stability unavailable for quizalofop‐P‐ethyl] 0.04

A new GAP for quizalofop‐p‐ethyl was reported and assessed under Article 10 of Regulation (EC) No 396/2005. In the framework of the previous MRL application, the requirements on residue trials, analytical methods and storage stability were considered sufficiently addressed for caraway

An enforcement method with an LOQ at 0.01 mg/kg is available for caraway

Risk for consumers unlikely

1011010 Swine muscle 0.02* (ft 3) Footnote related to data gap No. 8 [Some information on analytical methods being unavailable for quizalofop‐P‐tefuryl] 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not needed since MRLs are set at the LOQ. The MRL is confirmed. Risk for consumers unlikely

1,011,020 Swine fat 0.02* (ft 3) 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is partially addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not demonstrated

EFSA recommends keeping the MRL at the LOQ. Risk for consumers unlikely

1011030 Swine liver 0.02* (ft 3) 0.02* (Risk management decision)

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is demonstrated in poultry liver and risk managers might accept the validation of the extraction of efficiency on poultry liver as sufficient to cover both swine liver and kidney (covering also edible offal). Risk managers decisions are needed. Risk for consumers unlikely

1011040 Swine kidney 0.1 (ft 3) 0.1 (Risk management decision)
1011050

Swine

Edible offals (other than liver and kidney)

0.1 (ft 3) 0.1 (Risk management decision)

1012010

1013010

1014010

1015010

Bovine muscle Sheep muscle Goat muscle Equine muscle 0.02* (ft 3) Footnote related to data gap No. 8 [Some information on analytical methods being unavailable for quizalofop‐P‐tefuryl] 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not needed since MRLs are set at the LOQ. The MRLs are confirmed. Risk for consumers unlikely

1012020

1013020

1014020

1015020

Bovine fat

Sheep fat

Goat fat

Equine fat

0.02* (ft 3) 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is partially addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not demonstrated

EFSA recommends keeping the MRLs at the LOQ. Risk for consumers unlikely

1012030

1013030

1014030

1015030

Bovine liver

Sheep liver

Goat liver

Equine liver

0.03 (ft 3) 0.03 (Risk management decision)

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is demonstrated in poultry liver and risk managers might accept the validation of the extraction of efficiency on poultry liver as sufficient to cover both bovine liver and kidney (covering also edible offal). Risk managers decisions are needed. Risk for consumers unlikely

1012040

1013040

1014040

1015040

Bovine kidney

Sheep kidney

Goat kidney

Equine kidney

0.3

(ft 3)

0.3

(Risk management decision)

1012050

1013050

1014050

1015050

Bovine

Sheep

Goat

Equine

Edible offals (other than liver and kidney)

0.3

(ft 3)

0.3

(Risk management decision)

1016010 Poultry muscle 0.02* (ft 3) Footnote related to data gap No. 8 [Some information on analytical methods being unavailable for quizalofop‐P‐tefuryl] 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not needed since MRLs are set at the LOQ. The MRL is confirmed. Risk for consumers unlikely

1016020 Poultry fat 0.04 (ft 3) 0.02*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is partially addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not demonstrated

Risk managers may consider lowering the existing MRL to the LOQ

1016030 Poultry liver 0.04 (ft 3) 0.04

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is demonstrated in poultry liver and Risk Managers might accept the validation of the extraction of efficiency on poultry liver as sufficient to cover both liver and kidney (covering also edible offal). EFSA proposes maintaining the MRL for poultry liver, while risk managers decisions are needed for kidney and edible offal. Risk for consumers unlikely

1016040 Poultry kidney 0.04 (ft 3) 0.04 (Risk management decision)
1016050

Poultry

Edible offals (other than liver and kidney)

0.04 (ft 3) 0.04 (Risk management decision)
1020000 Milk 0.015 (ft 3) Footnote related to data gap No. 8 [Some information on analytical methods being unavailable for quizalofop‐P‐tefuryl] 0.01*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is partially addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not demonstrated

Risk managers may consider lowering the existing MRL to the LOQ

1030000 Birds eggs 0.01* (ft 3) Footnote related to data gap No. 8 [Some information on analytical methods being unavailable for quizalofop‐P‐tefuryl] 0.01*

The general data gap on analytical methods (validation data demonstrating the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock) is addressed

The efficiency of the hydrolysis step is demonstrated. The extraction efficiency is not needed since MRLs are set at the LOQ

The MRLs are confirmed at the LOQ of 0.01* mg/kg. Risk for consumers unlikely

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

*

Indicates that the MRL is set at the limit of analytical quantification (LOQ).

a

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

b

Existing EU MRL and corresponding footnote on confirmatory data.

ft 1

The European Food Safety Authority identified some information on analytical methods and storage stability as unavailable for quizalofop‐P‐ethyl. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.

ft 2

The European Food Safety Authority identified some information on analytical methods as unavailable for quizalofop‐P‐ethyl. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.

ft 3

The European Food Safety Authority identified some information on analytical methods as unavailable for quizalofop‐P‐tefuryl. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.

ft 4

The European Food Safety Authority identified some information on residue trials as unavailable for propaquizafop. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.

ft 5

The European Food Safety Authority identified some information on residue trials, analytical methods and storage stability as unavailable for quizalofop‐P‐ethyl. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.