Evaluation of confirmatory data following the Article 12 MRL review for cymoxanil

Abstract

The applicant DuPont de Nemours (Deutschland) GmbH submitted a request to the competent national authority in Austria to evaluate confirmatory data identified for cymoxanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 and implemented in the EU MRL Regulation. To address the data gap on table and wine grapes, lettuce and spinach, the applicant submitted new residue trials for cymoxanil on these commodities. The data gap was considered satisfactorily addressed. Confirmatory data on analytical methods for enforcement in hops and herbal infusions (dried flower), and storage stability data in dry matrices were not submitted with the present application. Based on the available information, a revision of the existing MRLs for table and wine grapes, spinach and pulses should be considered by risk managers.

Summary

In 2015, when the European Food Safety Authority (EFSA) reviewed the existing maximum residue levels (MRLs) for cymoxanil according to Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data but for which no risk to consumers was identified. The following data gaps were identified:

1. a confirmatory analytical method for enforcement in hops and herbal infusions (dried, flower);

2. a study investigating storage stability of cymoxanil in dry matrices;

3. additional residue trials supporting the authorisations on table and wine grapes (southern Europe (SEU) use), lettuce (SEU use), spinach (SEU use), sunflower seed (SEU use) and soyabean (SEU use).

Tentative MRL proposals have been implemented in the MRL legislation by Commission Regulation (EU) No 2016/1785, including footnotes related to data gaps number 1, 2 and 3, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 8 October 2018. The footnote related to data gap number 3 was introduced only for table and wine grapes, lettuces and spinaches. For sunflower seeds and soyabeans, data gap number 3 was not translated into a footnote in the MRL regulation because risk managers decided to set the MRL at the level of limit of quantification (LOQ) for these commodities.

Thus, in the framework of the current assessment, EFSA focused on the confirmatory data gaps number 1, 2 and 3, the latter one for table, wine grapes, lettuces and spinaches only.

In accordance with the agreed procedure set out in the working document SANTE/10235/2016, DuPont de Nemours (Deutschland) GmbH submitted an application to the competent national authority in Austria (rapporteur Member State, RMS) to evaluate confirmatory data on table and wine grapes, lettuces and spinaches identified under data gap number 3 during the MRL review. The applicant provided residue trials supporting the SEU uses for these crops. The RMS assessed the new information in an evaluation report which was submitted to the European Commission and forwarded to the EFSA on 11 March 2019. No information on data gaps number 1 and 2 was submitted in the context of the current application.

The summary table below provides an overview of the assessment of confirmatory data and the recommended MRL modifications to Regulation (EU) No 396/2005.

Codea	Commodity	Existing MRLb	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Cyproxanil
0151000	Grapes	0.3 ft 1	0.05	The data gap identified by EFSA concerning three additional trials from SEU in grapes has been addressed. The SEU residue trials suggest an MRL of 0.02 mg/kg. Considering that MRL proposed in the NEU residue trials for grapes evaluated in the MRL review is higher (0.05 mg/kg), a revision of the existing MRL in table and wine grapes from 0.3 to 0.05 mg/kg would be appropriate; the footnote can be deleted
0151010	Table grapes	0.3 ft 1	0.05
0151020	Wine grapes	0.3 ft 1	0.05
0251020	Lettuces	0.03 ft 1	0.03	The data gap identified by EFSA concerning two additional trials from SEU in lettuces has been addressed. The MRL is confirmed and the footnote can be deleted
0252010	Spinaches	1 ft 1	0.9	The data gap identified by EFSA concerning four trials from SEU in spinaches has been addressed. The SEU residue trials suggest an MRL of 0.9 mg/kg. Therefore, a revision of the existing MRL in spinaches from 1 to 0.9 mg/kg would be appropriate; the footnote can be deleted
0300000	Pulses	0.05* ft 2	0.01*	Information on storage stability in dry matrices requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on pulses Considering that the validated analytical method assessed in the MRL review reports an LOQ of 0.01 mg/kg for dry matrices, a revision of the existing MRL from 0.05* to 0.01* mg/kg and deletion of the footnote would be appropriate
0300010	Beans	0.05* ft 2	0.01*
0300020	Lentils	0.05* ft 2	0.01*
0300030	Peas	0.05* ft 2	0.01*
0300040	Lupins/lupini beans	0.05* ft 2	0.01*
0631000	Herbal infusions (dried flowers)	0.1* ft 3	0.1*	Information on storage stability and analytical methods for enforcement in herbal infusions from flowers requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on herbal infusions (dried flowers). A modification of the existing MRL is not required
0631010	Chamomile	0.1* ft 3	0.1*
0631020	Hibiscus/roselle	0.1* ft 3	0.1*
0631030	Rose	0.1* ft 3	0.1*
0631040	Jasmine	0.1* ft 3	0.1*
0631050	Lime/linden	ft 3	0.1*
0700000	Hops (dried)	0.1* ft 3	0.1*	Information on storage stability and analytical methods for enforcement in hops requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on hops. A modification of the existing MRL is not required

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

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

^bExisting EU MRL and corresponding footnote on confirmatory data.

^cThe European Food Safety Authority identified some information on residue trials as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 3).

^dThe European Food Safety Authority identified some information on storage stability as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 2).

ft 1 The European Food Safety Authority identified some information on storage stability and analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it. Footnote related to data gap No 1 and 2).

Assessment

The review of existing maximum residue levels (MRLs) for the active substance cymoxanil according to Article 12 of Regulation (EC) No 396/20051 (MRL review) has been performed in 2015 (EFSA, 2015). The European Food Safety Authority (EFSA) identified some information as unavailable (data gaps) and derived tentative MRLs for those uses not fully supported by data but for which no risk to consumers was identified. The list of Good Agricultural Practices (GAPs) assessed in the framework of the MRL review that were not fully supported by data and for which confirmatory data were requested are listed in Appendix A.

Following the review of existing MRLs, the legal limits have been modified by Commission Regulation (EU) No 2016/17852, including footnotes for tentative MRLs that specified the type of information that was identified as missing. Any party having an interest in maintaining the proposed tentative MRLs was requested to address the confirmatory data by 8 October 2018.

In accordance with the specific provisions set out in the working document of the European Commission SANTE/10235/2016 (European Commission, 2016), the applicant, DuPont de Nemours (Deutschland) GmbH, submitted an application to the competent national authority in Austria (designated rapporteur Member State, RMS) to evaluate some of the confirmatory data identified during the MRL review. To address the data gaps identified by EFSA, the applicant provided residue trials supporting the southern Europe (SEU) GAPs on table and wine grapes, lettuces and spinaches.

The RMS assessed the new information in an evaluation report, which was submitted to the European Commission and forwarded to EFSA on 11 March 2019 (Austria, 2019). EFSA assessed the application as requested by the European Commission in accordance with Article 9 of Regulation (EC) No 396/2005.

EFSA based its assessment on the evaluation report submitted by the RMS (Austria, 2019), the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 and an additional assessment on the modification of the existing MRL for cymoxanil in beans without pods performed after the MRL review (EFSA, 2015, 2017).

For this application, the data requirements established in Regulation (EU) No 544/20113 and the relevant guidance documents at the date of implementation of the confirmatory data requirements by Regulation (EU) No 2016/1785 are applicable. The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20114.

An updated list of end points, including the end points of relevant studies assessed previously and the confirmatory data evaluated in this application, is presented in Appendix B.

The evaluation report submitted by the RMS (Austria, 2019) is considered a supporting document to this reasoned opinion and, thus, is made publicly available as a background document to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

Not relevant for the current assessment.

1.1.2. Nature of residues in rotational crops

Not relevant for the current assessment.

1.1.3. Nature of residues in processed commodities

Not relevant for the current assessment.

1.1.4. Methods of analysis in plants

Data gap number 1 requested a confirmatory method for enforcement in hops and herbal infusions (dried, flower) (EFSA, 2015). No confirmatory method for the above‐mentioned commodities was submitted in the context of the current assessment.

1.1.5. Storage stability of residues in plants

Data gap number 2 requested a study investigating storage stability of cymoxanil in dry matrices. No new information was submitted on data gap number 2 in the context of the current assessment.

1.1.6. Proposed residue definitions

The previously derived residue definitions are still applicable.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In order to address data gap number 3, the applicant provided additional residue trials on grapes, lettuces and spinaches.

1.2.1.1. Table and wine grapes

In the MRL review for cymoxanil (EFSA, 2015), three additional residue trials compliant with the southern outdoor GAP on table and wine grapes were requested as confirmatory data.

Four additional residue trials on wine grapes in SEU were submitted to address the data gap identified for this commodity. Samples were stored in compliance with the demonstrated storage conditions and analysed with a sufficiently validated analytical method. Trials were found to be independent and compliant with the SEU critical GAP.

EFSA concluded that the data gap identified for table and wine grapes in the framework of the MRL review was addressed. The SEU residue trials suggest an MRL of 0.02 mg/kg.

Residue trials on table and wine grapes from northern Europe (NEU) have been submitted and assessed in the context of the MRL review (EFSA, 2015). Since the preharvest interval (PHI) for grapes in the SEU GAP (= 21 days) is different from the PHI for grapes in the NEU GAP (= 28 days), the SEU and NEU residue trials cannot be combined. Considering that MRL proposal from the NEU residue trials for grapes evaluated in the MRL review is higher (0.05 mg/kg) than the one from the SEU (0.02 mg/kg), a revision of the existing MRL in table and wine grapes from 0.3 to 0.05 mg/kg would be appropriate.

1.2.1.2. Lettuces

In the framework of the MRL review for cymoxanil (EFSA, 2015), two additional residue trials compliant with the SEU outdoor GAP on lettuce were requested as confirmatory data.

Three additional SEU residue trials on lettuce were submitted to address the data gap identified for this commodity. Samples were stored in compliance with the demonstrated storage conditions and analysed with a sufficiently validated analytical method. Trials were found to be independent and compliant with the critical GAP.

EFSA concluded that the data gap identified for lettuces in the framework of the MRL review was addressed. The estimated MRL for cymoxanil in lettuce was found to be 0.03 mg/kg. Therefore, the MRL set in lettuces is confirmed.

1.2.1.3. Spinaches

In the framework of the MRL review for cymoxanil (EFSA, 2015), four additional residue trials compliant with the SEU outdoor GAP on spinaches were requested as confirmatory data.

Five additional SEU residue trials on spinach were submitted to address the data gap identified for this commodity. Samples were stored in compliance with the demonstrated storage conditions and analysed with a sufficiently validated analytical method. Trials were found to be independent and compliant with the SEU critical GAP.

EFSA concluded that the data gap identified for spinaches in the framework of the MRL review was addressed. The SEU residue trials suggest an MRL of 0.9 mg/kg. Residue trials on spinach from NEU have been submitted and assessed in the context of the MRL review (EFSA, 2015). Since the PHI for spinach in the SEU GAP (= 7 days) is different from the PHI for spinaches in the Northern Europe GAP (= 14 days), the SEU and NEU residue trials cannot be combined. Considering that MRL proposal from the SEU residue trials for spinaches evaluated in the MRL review is higher (0.9 mg/kg) than the one from the NEU (0.07 mg/kg), a revision of the existing MRL in spinaches from 1 to 0.9 mg/kg would be appropriate.

1.2.2. Magnitude of residues in rotational crops

Not relevant for the current assessment.

1.2.3. Magnitude of residues in processed commodities

Not relevant for the current assessment.

2. Residues in livestock

Sunflower seeds and soyabeans may be fed to livestock. In the context of the EFSA MRL review of cymoxanil in 2015, the dietary burden for livestock was calculated including potatoes and potato by‐products; soyabeans and sunflower seeds were not considered in the estimation of the animal intake of cymoxanil residues due to the lack of residue data for cymoxanil in these commodities (EFSA, 2015). EFSA highlighted that this might underestimate the animal intake of the active substance. However, there was sufficient evidence to conclude that MRLs for cymoxanil in animal commodities are not required (EFSA, 2015).

The previous assessment of residues in livestock (EFSA, 2015) is still valid.

3. Consumer risk assessment

EFSA updated the previous risk assessment, taking into account information on beans without pods, submitted in the framework of the modification of the existing MRL for cymoxanil in this commodity (EFSA, 2017) and the new data on grapes, spinaches and lettuces submitted under this application. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo (EFSA, 2007). The toxicological reference values for cymoxanil have not changed since the MRL review (EFSA, 2015).

3.1. Short‐term (acute) dietary risk assessment

The short‐term risk assessment was performed only for the commodities under assessment and for which new residue trials were submitted: table and wine grapes, lettuces and spinaches. The estimation of the exposure is based on the highest residue (HR) derived from the supervised field trials on the above‐mentioned commodities (see Appendix D). The international estimated short‐term intake (IESTI) accounted for 13.8% of the acute reference dose (ARfD) in spinaches (BE children), 4.1% of the ARfD in table grapes (DE children), 1.5% of the ARfD in wine grapes (UK adult) and 0.7% of the ARfD in lettuce (DE children).

3.2. Long‐term (chronic) dietary risk assessment

The long‐term exposure assessment was performed based on the existing uses of cymoxanil at EU level. EFSA updated the previous exposure assessment (EFSA, 2017), with the supervised trials median residue value (STMR), derived from the new trials available in grapes, lettuce and spinach (Austria, 2019). The complete list of input values is reported in Appendix D. The contributions of commodities for which no GAP was reported in the framework of the MRL review (EFSA, 2015) or for which the confirmatory data requested remain unavailable (i.e. sunflower seeds, soyabeans, herbal infusions (dried flowers) and hops (dried)) were not included in the calculation.

The estimated long‐term exposure to cymoxanil accounted for up to 1.9% of the acceptable daily intake (ADI) for WHO Cluster diet B. The contribution of residues expected in (i) table grapes is up to the 0.5% of the ADI for DE child, (ii) wine grapes up to the 1.5% of the ADI for FR all population, (iii) lettuces up to the 0.04% of the ADI for ES adult and (iv) spinaches up to the 0.1% of the ADI for FR toddler.

4. Conclusion and Recommendations

To address data gaps identified in the framework of the MRL review (EFSA, 2015), the following confirmatory data on data gap number 35 were submitted by the applicant:

• – Four residue trials on wine grapes in SEU to support the authorisations on table and wine grapes;
• –Three residue trials on lettuces in SEU and
• –Five additional residue trials on spinaches in SEU.

The above data gaps were sufficiently addressed. Based on the available information, a revision of the existing MRLs for table and wine grapes and spinaches would be appropriate. The MRL for lettuces is confirmed.

For sunflower seeds and soyabeans, the data gap number 3 was not translated into footnote in the MRL regulation because risk managers decided to set the MRL at the level of LOQ for these commodities. Thus, these crops are not subject to the current assessment.

No new information was submitted on data gap number 1 requesting a confirmatory analytical method for enforcement in hops and herbal infusions (dried, flower). Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on hops and herbal infusions (dried flowers). A modification of the existing MRLs is not required.

No new information was submitted on data gap number 2 requesting a study investigating storage stability of cymoxanil in dry matrices. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on pulses. Considering that the validated analytical method assessed in the MRL review reports an LOQ of 0.01 mg/kg for dry matrices, a revision of the existing MRL from 0.05* mg/kg to 0.01* mg/kg and deletion of the footnote would be appropriate. The overview of the assessment of confirmatory data and the recommended MRL modifications are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

DAT

days after treatment

DT₉₀

period required for 90% dissipation (define method of estimation)

Eq

residue expressed as a.s. equivalent

GAP

Good Agricultural Practice

GC‐NPD

gas chromatography with nitrogen/phosphorous detector

HPLC‐MS/MS

high performance liquid chromatography with tandem mass spectrometry

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

NEU

northern Europe

PBI

plant back interval

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SEU

southern Europe

STMR

supervised trials median residue

WG

water‐dispersible granule

WHO

World Health Organization

WP

wettable powder

Appendix A – Summary of GAPs assessed in the evaluation of confirmatory data

1.

Code	Crop name	Region/country	Outdoor/indoora	Pests controlled	Active substance (a.s.)	Formulation typeb	a.s. conc. in formulation (g/kg)	Appl. method	Growth stagec	No of appl.	Interval (days) Minim.	Water amount (L/ha)	Max. appl. rate (g a.s./ha)	PHI (days)d	Comments
151010	Table grapes	NEU/AT	Outdoor	Plasmopara viticola, Downy mildew	Cymoxanil	WG	45	Foliar treatment – broadcast spraying	BBCH 11–71	1–4	10	Not specified	90	28
151010	Table grapes	SEU/IT	Outdoor	Plasmopara viticola, Phomopsis viticola	Cymoxanil	WP	200	Foliar treatment – broadcast spraying	BBCH 15–85	1–4	7	Not specified	170	21	Assessed for confirmatory data
151020	Wine grapes	NEU/DE	Outdoor	Plasmopara viticola	Cymoxanil	WG	330	Foliar treatment – broadcast spraying	BBCH 14–89	1–5	7	Not specified	150	28
151020	Wine grapes	SEU/IT	Outdoor	Plasmopara viticola, Phomopsis viticola	Cymoxanil	WP	200	Foliar treatment – broadcast spraying	BBCH 15–85	1–4	7	Not specified	170	21	Assessed for confirmatory data
251020	Lettuces	SEU/IT	Outdoor	Bremia lactucae	Cymoxanil	WP	200	Foliar treatment – broadcast spraying	BBCH 19–49	1–4	5	Not specified	240	7	Assessed for confirmatory data
252010	Spinaches	NEU/BE	Outdoor	Downy mildew	Cymoxanil	WG	250	Foliar treatment – broadcast spraying	N/A	1–2	10	Not specified	150	14
252010	Spinaches	SEU/IT	Outdoor	Downy mildew	Cymoxanil	WP	200	Foliar treatment – broadcast spraying	BBCH 19–49	1–4	7	Not specified	180	7	Assessed for confirmatory data

NEU: northern European Union; SEU: southern European Union; MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide formulation types and international coding system.

^cGrowth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

^dPHI: minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

B.1.1. Nature of residues and methods of analysis in plants

B.1.1.1. Metabolism studies, methods of analysis and residue definitions in plants

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Fruit crops	Tomatoes	Foliar, 3 × 0.63 kg a.s./ha	3	EFSA (2015)
		Tomatoes	Foliar, 4 × 0.24 kg a.s./ha	13	EFSA (2015)
		Tomatoes	Foliar, 7 × 0.14 kg a.s/ha	7, 14, 21, 35	EFSA (2015)
		Grapes	Foliar, 8 × 0.21 kg a.s./ha	0, 1, 4, 10, 18	EFSA (2015)
	Root crops	Potatoes	Foliar, 8 × 0.24 kg a.s./ha	10	EFSA (2008)
		Potatoes	Foliar, 3 × 0.40 kg a.s./ha	3	EFSA (2008)
	Leafy crops	Lettuces	Foliar, 3 × 0.24 kg a.s./ha	11	EFSA (2008)
		Lettuces	Foliar, 4 × 0.84 kg a.s./ha	3	EFSA (2008)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/source
	Root/tuber crops	Sugar beet	Bare soil, 1.2 kg a.s./ha	30, 120	A ‘no residue’ situation in rotational crops was established (EFSA, 2008)
	Leafy crops	Lettuces	Bare soil, 1.2 kg a.s./ha	30, 120	A ‘no residue’ situation in rotational crops was established (EFSA, 2008)
	Cereal (small grain)	Wheat	Bare soil, 1.2 kg a.s./ha	30, 120	A ‘no residue’ situation in rotational crops was established (EFSA, 2008)
	Other	–	–	–	–

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/source
	Pasteurisation (20 min, 90°C, pH 4)	Not investigated	In the context of the MRL review for cymoxanil, a study investigating the nature of residues in processed commodities through standard hydrolytic conditions was considered desirable but not essential (EFSA, 2015)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Not investigated
	Sterilisation (20 min, 120°C, pH 6)	Not investigated
	Other processing conditions	Not investigated

B.1.1.2. Storage stability

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compound covered	Comment/source
				Value	Unit
	High water content	Tomatoes	−18	≤ 18	Months	cymoxanil	Study performed on several crops investigating storage periods of up to 873 days. However, an unexplained decline of residues was observed in tomatoes between 18 and 24 months. (EFSA, 2015)
	High acid content	Grapes	−18	24	Months	cymoxanil
	High oil content	Sunflower seed	−18	18	Months	cymoxanil
	Dry content	–	–	–	–	–	A confirmatory study investigating storage stability of cymoxanil in dry matrices was requested in the framework of the MRL review under Article 12 of Reg. (EC) No 396/2005 (EFSA, 2015), but was not provided

B.1.2. Magnitude of residues in plants

B.1.2.1. Summary of residues data from the supervised residue trials

Commodity	Region/indoora	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)
Table and wine grapes	NEU	EFSA (2015): 2 × < 0.001; 6 × < 0.01; < 0.04; 14 × < 0.05	Residue trials on wine grapes compliant with GAP. Extrapolation to table grapes for which the GAP is less critical is possible because residue levels are < LOQ (EFSA, 2015)	0.05 *	0.05	0.05
	SEU	EFSA (2015): 4 × < 0.01; 0.015 Austria (2019): 4 × < 0.01	Residue trials on wine grapes compliant with GAP. Extrapolation to table grapes is possible (EFSA, 2015)	0.02	0.015	0.01
Lettuces	SEU	EFSA (2015): 4 × < 0.01; 0.01; 0.02 Austria, (2019): 3 × < 0.01	Residue trials on lettuces compliant with GAP	0.03	0.02	0.01
Spinaches	NEU	EFSA (2015): 4 × < 0.02; 0.04	Residue trials on spinaches compliant with GAP	0.07	0.04	0.02
	SEU	EFSA (2015): Unscaled residues: 2 × < 0.01; 0.01; 0.02; 0.04; 0.05; 0.65 Scaled residues (sf 0.75): 2 × < 0.01; 0.0075; 0.15; 0.03; 0.0375; 0.488 Austria (2019): 2 × < 0.01; 0.021; 0.049; 0.47	Residue trials on spinaches compliant with GAP. Trials evaluated in the framework of the MRL review (EFSA, 2015) were overdosed (240 g a.s./ha instead of 180 g a.s./ha). A scaling factor (sf) of 0.75 was applied to derive the scaled residue values for these trials which were used in the present assessment	0.9	0.49	0.02

* Indicates that the MRL is proposed at the limit of quantification (EFSA, 2015). Values in bold are the final MRL proposals.

^aNEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non‐EU trials.

^bHighest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^cSupervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

Supervised trials median residue according to the residue definition for monitoring.

B.1.2.2. Residues in rotational crops

B.1.1.3. Processing factors

No processing studies were submitted in the framework of the present MRL application.

B.2. Residues in livestock

No additional data were submitted on sunflower seeds and soyabeans which may be fed to livestock; grapes, lettuces and spinaches are not expected to be fed to livestock.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing MRLb	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Cyproxanil
0151000	Grapes	0.3 ft 1	0.05	The data gap identified by EFSA concerning three additional trials from SEU in grapes has been addressed. The SEU residue trials suggest an MRL of 0.02 mg/kg. Considering that MRL proposed in the NEU residue trials for grapes evaluated in the MRL review is higher (0.05 mg/kg), a revision of the existing MRL in table and wine grapes from 0.3 mg/kg to 0.05 mg/kg would be appropriate; the footnote can be deleted
0151010	Table grapes	0.3 ft 1	0.05
0151020	Wine grapes	0.3 ft 1	0.05
0251020	Lettuces	0.03 ft 1	0.03	The data gap identified by EFSA concerning two additional trials from SEU in lettuces has been addressed. The MRL is confirmed and the footnote can be deleted
0252010	Spinaches	1 ft 1	0.9	The data gap identified by EFSA concerning four trials from SEU in spinaches has been addressed. The SEU residue trials suggest an MRL of 0.9 mg/kg. Therefore, a revision of the existing MRL in spinaches from 1 to 0.9 mg/kg would be appropriate; the footnote can be deleted
0300000	Pulses	0.05* ft 2	0.01*	Information on storage stability in dry matrices requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on pulses Considering that the validated analytical method assessed in the MRL review reports an LOQ of 0.01 mg/kg for dry matrices, a revision of the existing MRL from 0.05* mg/kg to 0.01* mg/kg and deletion of the footnote would be appropriate
0300010	Beans	0.05* ft 2	0.01*
0300020	Lentils	0.05* ft 2	0.01*
0300030	Peas	0.05* ft 2	0.01*
0300040	Lupins/lupini beans	0.05* ft 2	0.01*
0631000	Herbal infusions (dried flowers)	0.1* ft 3	0.1*	Information on storage stability and analytical methods for enforcement in herbal infusions from flowers requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on herbal infusions (dried flowers). A modification of the existing MRL is not required
0631010	Chamomile	0.1* ft 3	0.1*
0631020	Hibiscus/roselle	0.1* ft 3	0.1*
0631030	Rose	0.1* ft 3	0.1*
0631040	Jasmine	0.1* ft 3	0.1*
0631050	Lime/linden	0.1* ft 3	0.1*
0700000	Hops (dried)	0.1* ft 3	0.1*	Information on storage stability and analytical methods for enforcement in hops requested as confirmatory data was not provided. Since the data gap was not addressed, risk management action would be appropriate, e.g. revocation of the existing uses on hops. A modification of the existing MRL is not required

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

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

^bExisting EU MRL and corresponding footnote on confirmatory data.

ft 1 The European Food Safety Authority identified some information on residue trials as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it (footnote related to data gap No 3).

ft 2 The European Food Safety Authority identified some information on storage stability as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it (footnote related to data gap No 2).

ft 3 The European Food Safety Authority identified some information on storage stability and analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 8 October 2018, or, if that information is not submitted by that date, the lack of it (footnote related to data gaps No 1 and 2).

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

1.

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Table grapes	0.05	STMR	0.05	HR
Wine grapes	0.05	STMR	0.05	HR
Lettuces	0.01	STMR	0.02	HR
Spinaches	0.02	STMR	0.49	HR
Potatoes	0.01	STMR (EFSA, 2015)	Acute risk assessment only for the crops under consideration
Garlic	0.01	STMR (EFSA, 2015)
Onions	0.01	STMR (EFSA, 2015)
Tomatoes	0.01	STMR (EFSA, 2015)
Aubergines (egg plants)	0.05	STMR (EFSA, 2015)
Cucumbers	0.01	STMR (EFSA, 2015)
Gherkins	0.01	STMR (EFSA, 2015)
Courgettes	0.01	STMR (EFSA, 2015)
Melons	0.002	STMR x PF (EFSA, 2015)
Pumpkins	0.002	STMR x PF (EFSA, 2015)
Watermelons	0.002	STMR x PF (EFSA, 2015)
Broccoli	0.01	STMR (EFSA, 2015)
Cauliflower	0.01	STMR (EFSA, 2015)
Beans (fresh, with pods)	0.05	STMR (EFSA, 2015)
Beans (fresh, without pods)	0.05	STMR (EFSA, 2017)
Peas (fresh, with pods)	0.05	STMR (EFSA, 2015)
Peas (fresh, without pods)	0.05	STMR (EFSA, 2015)
Globe artichokes	0.01	STMR (EFSA, 2015)
Leek	0.01	STMR (EFSA, 2015)
Beans (dry)	0.02	STMR (EFSA, 2015)
Lentils (dry)	0.02	STMR (EFSA, 2015)
Peas (dry)	0.02	STMR (EFSA, 2015)
Lupins (dry)	0.02	STMR (EFSA, 2015)
Sunflower seeds	–	Not considered in the risk assessment since the confirmatory data requested in the framework of the MRL review (EFSA, 2015) remain unavailable
Soyabeans	–
Herbal infusions (dried, flowers)	–
Hops (dried), including hop pellets and unconcentrated powder	–

Appendix E – Used compound codes

1.

Code/trivial name	Chemical name/SMILES notationa	Structural formulaa
cymoxanil	1‐[(EZ)‐2‐cyano‐2‐methoxyiminoacetyl]‐3‐ethylurea N#C\C(=N\OC)C(=O)NC(=O)NCC PSOONIQXVGMYIU‐JIBDQCPFSA‐N

^a(ACD/ChemSketch, Advanced Chemistry Development, Inc., ACD/Labs Release: 12.00 Product version: 12.00 (Build 29305, 25 Nov 2008).

Suggested citation: EFSA (European Food Safety Authority) , Anastassiadou M, Brancato A, Carrasco Cabrera L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Rojas A, Sacchi A, Santos M, Stanek A, Theobald A, Vagenende B and Verani A, 2019. Evaluation of confirmatory data following the Article 12 MRL review for cymoxanil. EFSA Journal 2019;17(10):5823, 23 pp. 10.2903/j.efsa.2019.5823