Setting of an import tolerance for fenazaquin in almonds

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Ltd submitted a request to the competent national authority in Greece to set an import tolerance for the active substance fenazaquin in almonds. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for almonds. Adequate analytical methods for enforcement are available to control the residues of fenazaquin and its metabolites on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use fenazaquin according to the reported agricultural practices is unlikely to present a risk to European consumers. The chronic consumer risk assessment is affected by non‐standard uncertainties due to the lack of information on the occurrence of the metabolite 2‐(4‐tert‐butylphenyl) ethanol (TBPE) in crops where the use of fenazaquin is the authorised in Europe. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Gowan Crop Protection Ltd submitted an application to the competent national authority in Greece (evaluating Member State (EMS)) to set an import tolerance for the active substance fenazaquin in almonds. The EMS 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 the European Food Safety Authority (EFSA) on 25 January 2018. The EMS proposed to establish a maximum residue level (MRL) for almonds imported from the USA at the level of 0.02 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of fenazaquin following foliar applications was sufficiently investigated in crops belonging to the fruit crops group.

Studies investigating the effect of processing on the nature of fenazaquin (hydrolysis studies) demonstrated that the fenazaquin is cleaved at the ether bridge in the molecule, leading to the degradation product quinazolin‐4‐ol (4‐OHQ). Available studies do not investigate the fate of the phenyl ring moiety.

Investigations of residues in rotational crops are not required since almonds are a permanent crop and the MRL request concerns an import tolerance.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological significance of metabolites and degradation products, the residue definition for plant products proposed in the framework of the EU peer review was as fenazaquin (for enforcement); for risk assessment, fenazaquin and 2‐(4‐tert‐butylphenyl) ethanol (TBPE) were considered relevant. Due to different mode of action of both substances and different toxicological reference values, a separate risk assessment was conducted for the two residue compounds.

EFSA concluded that for the crops assessed in this application, metabolism of fenazaquin in primary and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at or above 0.01 mg/kg in the crops assessed (limit of quantification (LOQ)).

The available residue trials are sufficient to derive a calculated MRL of 0.02 mg/kg for almonds.

Specific studies investigating the magnitude of fenazaquin residues in processed commodities are not required, as the residue concentrations expected in raw agricultural commodities (RAC) are low.

Residues of fenazaquin in commodities of animal origin were not assessed since the crop under consideration in this MRL application is normally not fed to livestock.

The toxicological profile of fenazaquin was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.005 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.1 mg/kg bw. TBPE has been identified as the main metabolite and due to its toxicological relevance and different mode of action, toxicological reference values has been established for the metabolite. The ARfD and ADI of TBPE are 0.002 mg/kg bw (/day).

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). A separated consumer risk assessment has been performed for fenazaquin and for its metabolite TBPE. For fenazaquin, no long‐term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for 87.8% of the ADI (German, children), where the contribution of the residues in almonds to the total exposure accounting for 0.01% of ADI. No acute consumer risk was identified in relation to the MRL proposal for almonds; the highest calculated acute exposure was 0.04% of the ARfD.

In the absence of information on the concentration of TBPE in the crops for which authorised uses that exist in Europe, an indicative chronic exposure was calculated considering the existing MRLs according to Reg. No 833/2013, including several conservative assumptions, which introduce non‐standard uncertainties in the dietary risk assessment for TBPE. Using the approach described in detail in section 3 of the document, a long‐term risk to consumers from TBPE has not been identified. The total calculated intake of TBPE accounted for 81.7% of the ADI (WHO Cluster diet B), where the contribution of the residues in almonds to the total exposure accounting for 0.02% of ADI. No acute consumer risk was identified for TBPE residues in almonds (1.2% of the ARfD).

EFSA concludes that residues resulting from the use of fenazaquin on almonds assessed in this reasoned opinion will not result in a consumer exposure exceeding the toxicological reference values of fenazaquin. However, the consumer risk assessment for TBPE is characterised by several uncertainties linked to the missing information on the levels of this metabolite associated to the existing authorised uses in Europe for which data are required. Information on the expected residue concentrations for metabolite TBPE should therefore be provided to EFSA to be assessed in the framework of the MRL review for fenazaquin under Article 12 of Regulation (EC) No 396/2005 which has been recently initiated.

Full details of all endpoints and the consumer risk assessment can be found in Appendices B–D.

Codea	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: fenazaquin
0120010	Almonds	0.01*	0.02	The submitted data are sufficient to derive a calculated MRL of 0.02 mg/kg for the import tolerance from USA. Residues in almonds related to the use of fenazaquin in accordance with the assessed GAP are not expected to pose a risk to EU consumers.

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

* 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.

Assessment

The detailed description of the existing use of fenazaquin authorised in the USA in almonds, which is the basis for the current MRL application, is reported in Appendix A.

Fenazaquin is the ISO common name for 4‐tert‐butylphenethyl quinazolin‐4‐yl ether (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Fenazaquin was evaluated in the framework of Directive 91/414/EEC1 with Greece designated as rapporteur Member State (RMS). The draft assessment report (DAR) prepared by the RMS has been peer reviewed by the European Food Safety Authority (EFSA, 2010b). Fenazaquin was approved2 for the use as an acaricide on ornamentals in greenhouses only on 1 June 2011. In 2011, Greece received an application for amendment to the conditions of approval of the active substance fenazaquin in the framework of Regulation (EC) No 1107/2009, in order to lift the restriction and allow uses on grapes and citrus (uses for which RMS previously applied for) as well as uses on pome fruit and stone fruit (additional uses) to be authorised. The addendum to the DAR prepared by the RMS under this framework has been peer reviewed by EFSA (2013).

The European Union (EU) maximum residue levels (MRLs) for fenazaquin are established in Annexes III of Regulation (EC) No 396/20053. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) is currently ongoing. A reasoned opinion on the modification of MRLs for fenazaquin in tea has been issued (EFSA, 2010a) and the proposals from this reasoned opinion have been considered in regulation4 for EU MRL legislation.

EFSA based its assessment on the evaluation report submitted by the EMS (Greece, 2018), the DAR and its addenda (Greece, 2006, 2010, 2012, 2013) prepared under Council Directive 91/414/EEC and in the framework of Regulation (EC) No 1107/20095 for amendment to the conditions of approval of fenazaquin, the Commission review report on fenazaquin (European Commission, 2011), the conclusions on the peer review of the pesticide risk assessment of the active substance fenazaquin (EFSA, 2010b, 2013), as well as the conclusions from a previous EFSA opinion on fenazaquin (EFSA, 2010a).

For this application, the data requirements established in Regulation (EU) No 544/20116 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017; OECD, 2011). 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 546/20117.

As the review of the existing MRLs under Article 12 of Regulation 396/2005 is not yet finalised, the conclusions reported in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the MRL review.

A selected list of end points of the studies assessed by EFSA in the framework of the this MRL application, including the end points of relevant studies assessed previously, are presented in Appendix B.

The evaluation report submitted by the EMS (Greece, 2018) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents 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

Metabolism studies were evaluated at EU level in a previous reasoned opinion (EFSA, 2010a) and during the EU pesticide peer‐review processes (EFSA, 2010b, 2013). Only a metabolism study in grapes was considered suitable to derive the residue definitions for enforcement and risk assessment. A major proportion of the total residue was present as parent fenazaquin. The levels of individual metabolites or fractions did not exceed 5% of the total radioactive residue (TRR) at harvest of the mature crop. There were indications of a cleavage of the fenazaquin molecule at the ether bridge that lead to the formation of quinazolin‐4‐ol (4‐OHQ) and 2‐(4‐tert‐butylphenyl) ethanol (TBPE).

1.1.2. Nature of residues in rotational crops

Metabolism data in rotational crops was not triggered during the peer review (representative uses on permanent crops only) and is not triggered by the current assessment since the MRL application is to accommodate an import tolerance from the USA.

1.1.3. Nature of residues in processed commodities

Standard hydrolysis studies evaluated during previous EFSA assessments (EFSA, 2010b, 2013) have shown that fenazaquin is highly degraded, leading to the formation of 4‐OHQ under pasteurisation conditions. Since the fate of phenyl ring moiety was not investigated under simulated processing conditions, no information is available whether TBPE, the second cleavage product, will occur in significant amount in processed products or whether further degradation of this moiety is likely to occur.

Additional studies investigating the fate of the molecule under standard hydrolysis conditions would be desirable and should be provided in the framework of the MRL review. Considering the low residues expected in almonds and the low almond consumption, the additional uncertainty introduced to the risk assessment resulting from the lack of these study is considered acceptable (see also risk assessment approach used for TBPE).

1.1.4. Methods of analysis in plants

Analytical methods for the determination of fenazaquin and its residues in plant commodities were assessed in the framework of the peer review for amendment of approval conditions. EFSA concluded that adequate analytical methods are available to monitor residues of fenazaquin in high water, high oil and high acid content commodities and in starch/dry commodities at the limit of quantification (LOQ) of 0.01 mg/kg. Analytical methods are also available to monitor 4‐OHQ and TBPE at 0.01 mg/kg in high acid and high water content commodities (EFSA, 2013).

Additional information has been provided in the framework of the current application that confirm the sufficiently validation of the existing analytical methods to monitor the residues of fenazaquin and its metabolites (TBPE and 4‐OHQ) in almond nutmeat (high oil content commodities) (Greece, 2018).

1.1.5. Stability of residues in plants

Fenazaquin and its metabolites (TBPE, 4‐OHQ) were found to be stable for 12 months under frozen conditions in high acid content matrices (orange, grapes) (EFSA, 2013). Storage stability information for high oil content matrices (almonds) has been submitted under the current MRL application (Greece, 2018) and residues of fenazaquin and its metabolites (TBPE and 4‐OHQ) were found to be stable for 17 and 20 months respectively when stored under frozen condition at least in a minimum of −10°C.

1.1.6. Proposed residue definitions

Based on the available metabolism data in a crop from the same metabolism crop group that the one assess in the current MRL application and the existing toxicological characterisation of the active substance and its metabolites, the residue definitions applicable under the current MRL application only valid for the fruit crop group and processed commodities are as follows:

• Residue definition for enforcement: fenazaquin;

• Residue definition for risk assessment: fenazaquin and TBPE, considered separately.

Fenazaquin parent compound has been considered a good marker and was concluded for the enforcement residue definition, whereas the need to set a separate residue definition for risk assessment covering TBPE was based on toxicological considerations. Toxicological studies concluded that this metabolite is more toxic than the parent fenazaquin (EFSA, 2013).

The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the one mentioned above.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted eight residue trials performed in California during 2012 and 2014 in almond trees compliant with the USA good agricultural practice (GAP). In six out of the eight residue trials, the samples were analysed for fenazaquin and TBPE, while two trials that were analysed only for TBPE. Additionally, five GAP‐compliant residue trials were submitted in which only the parent fenazaquin was analysed (Greece, 2018). Detailed information of the residue levels can be found in Table B.1.2.1. The data were sufficient to calculate a MRL proposal.

Considering that TBPE was not found in quantifiable concentrations in any of the trials in which TBPE was analysed, EFSA derived risk assessment values for TBPE in almonds at the LOQ of 0.01 mg/kg to be considered for exposure calculations.

The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated (max. 12 months for fenazaquin and for a maximum of 20 months for its metabolites). Thus, the residue trials were considered valid with regard to the storage stability.

1.2.2. Magnitude of residues in rotational crops

Not triggered by the current assessment (see also Section 1.1.2).

1.2.3. Magnitude of residues in processed commodities

Not triggered by the current application. Specific studies to assess the magnitude of residues of fenazaquin and its residues during the processing of almonds are not considered necessary as the residue levels in RAC did not exceed the trigger value of 0.1 mg/kg (European Commission, 1997d).

1.2.4. Proposed MRLs

EFSA concludes that sufficient information was provided to calculate an MRL of 0.02 mg/kg in support of the import tolerance of almonds from the USA. In Section 3 of this Reasoned Opinion, the risk to consumers related to the calculated MRL is assessed.

2. Residues in livestock

No relevant for the current assessment.

3. Consumer risk assessment

The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. The PRIMo model contains the relevant European food consumption data for different sub‐groups of the EU population (EFSA, 2007). The exposure calculations were performed separately for fenazaquin and TBPE, assuming that the two compounds do not share a common mode of action.

The estimated exposure for fenazaquin and TBPE were then compared with the toxicological reference values derived for fenazaquin and its metabolite TBPE (EFSA, 2013).

As the MRL review of fenazaquin in accordance with Regulation (EC) No 396/2005 is ongoing, the conclusions reported in this reasoned opinion should be taken as provisional and should be reconsidered in the light of the outcome of the MRL review process.

The short‐term exposure assessment has been performed using the highest residue (HR) for fenazaquin and TBPE observed in the supervised residue trials for almonds. No acute consumer risk was identified in relation to the MRL proposal for almonds, the highest calculated acute exposure being less than 0.05% of the acute reference dose (ARfD) of fenazaquin and less than 2% of the ARfD of TBPE.

For the chronic risk assessment of fenazaquin, supervised trial median residues (STMR) were used for all those commodities previously assessed by EFSA,8 including the use in almond trees. For the other commodities, the existing MRLs set in Regulation (EU) No 893/20109 have been used for exposure calculations. The calculated exposure was then compared with the toxicological reference values as derived for fenazaquin (EFSA, 2013). No long‐term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for 87.8% of the acceptable daily intake (ADI; German, children), where the contribution of the residues in almonds to the total exposure accounting for 0.01% of ADI.

For the chronic risk assessment of TBPE, EFSA performed a conservative risk assessment screening, based on the STMR values derived for almonds and for previously assessed commodities. For the other crops, where the existing MRL is above the LOQ, TBPE residues relevant for consumer exposure might be expected. For those plant commodities, the existing MRLs for fenazaquin, multiplied by a molecular weight conversion factor10 were used to derive a conservative input value for the exposure calculation. Crops where the fenazaquin MRL is established at the LOQ and food of animal origin were excluded from this calculation, taking into account the TBPE was not observed in livestock metabolism studies. The underlying assumption is that residues of TBPE may be present at the level of the MRL (expressed as TBPE). The chronic exposure of TBPE did not exceed the ADI (81.7% of the ADI; WHO Cluster diet B) and the contribution of the residues in almonds to the total exposure accounting for 0.02% of ADI.

The input values used for the dietary exposure calculation are summarised in Appendix D and for further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

EFSA concludes that the proposed use of fenazaquin on almonds will not result in a consumer exposure exceeding the toxicological reference values of fenazaquin. However, EFSA emphasises that the consumer risk assessment for TBPE is characterised by several uncertainties linked to the missing information on the levels of this metabolite associated to the existing authorised uses in Europe for which data are required.

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for almonds.

EFSA concluded that the proposed use of fenazaquin in almonds is unlikely to pose a risk to consumers’ health; however, considering the high toxicity of the metabolite TBPE in comparison to fenazaquin and the lack of information in the current consumer exposure scenario for this metabolite according to the authorised uses in Europe, EFSA stresses the need for a revision of the existing authorised used in order to provide a refined risk assessment and guarantee that the MRLs in place do not pose a consumer health concern.

The MRL recommendation is summarised in Appendix B.4.

Abbreviations

4‐OHQ

quinazolin‐4‐ol

a.s.

active substance

ADI

acceptable daily intake

AR

applied radioactivity

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CF

conversion factor for enforcement to risk assessment residue definition

DAR

draft assessment report

DAT

days after treatment

EMS

evaluating Member State

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

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

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

LOQ

limit of quantification

MRL

maximum residue level

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

TBPE

2‐(4‐tert‐butylphenyl) ethanol

TRR

total radioactive residue

WHO

World Health Organization

Appendix A – Summary of intended GAP triggering the amendment of existing EU MRLs

1.

Crop and/or situation	NEU, SEU, MS or country	F G or Ia	Pests or Group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) d	Remarks
				Typeb	Conc a.s.	Method kind	Range of growth stages & seasonc	Number min–max	Interval between application (min)	g a.s./hL min–max	Water L/ha min–max	Rate min‐max	Unit
Almonds (0120000/TN 0660)	USA/ Outdoor	F	Tetranychidae (mites)	SC	200 g/L	Foliar spray	At infestation	1	n.a	36–54	935	336–504	g a.s./ha	7	GWN‐1708F (formulated product) may be tank mixed with non‐ionic surfactants

NEU: northern European Union; SEU: southern European Union; MS: Member State; GAP: good agricultural practice; MRL: maximum residue level; a.s.: active substance; SC: suspension concentrate.

^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	Grapes	F, 1 × 15 g/ha 2‐3 weeks after BBCH 68	0, 46, 76	Radiolabelled active substance: 14C‐fenazaquin labelled in quinazoline (Q‐fenazaquin) and in phenyl ring (P‐fenazaquin) (EFSA, 2010a)
	Fruit crops	Grapes	F, 1 × 15 g/ha + 1 × 150 g/ha 9‐10 weeks after BBCH 68	0, 28	Radiolabelled active substance: 14C‐fenazaquin labelled in quinazoline (Q‐fenazaquin) and in phenyl ring (P‐fenazaquin) (EFSA, 2010a)
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Not available and not triggered
Processed commodities (hydrolysis study)	Conditions		Stable?		Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)		No		Fenazaquin is significantly degraded to 4‐OHQ particularly during pasteurisation (EFSA, 2013)
	Baking, brewing and boiling (60 min, 100°C, pH 5)		Inconclusive		–
	Sterilisation (20 min, 120°C, pH 6)		Inconclusive		–
	Other processing conditions		–		–

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High oil content	Almond nutmeat	−10	17	Months	Fenazaquin TBPE/4‐OHQ	Temperatures range during storage between −10°C and −25°C Storage stability for TBPE/4‐OHQ for 20 months (Greece, 2018)
	High acid content	Oranges Grapes	−15	12	Months	Fenazaquin	EFSA (2013)
	High acid content	Orange pulp Grapes	–	12	Months	TBPE/4‐OHQ	Storage temperatures reported as frozen conditions (EFSA, 2013)
	Processed products	Raisins	–	12	Months	TBPE/4‐OHQ	Storage temperatures reported as frozen conditions (EFSA, 2013)

TBPE: 2‐(4‐tert‐butylphenyl) ethanol; 4‐OHQ: quinazolin‐4‐ol.

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)	CFd
Almonds	Import tolerance	Fenazaquin: 9× < 0.01; 0.0155, 0.0155	Residue trials on almonds compliant with the US GAP	0.02	0.0155	0.01	–
		TBPE: 8 × < 0.01 mg/kg		–	0.01	0.01	–

MRL: maximum residue level; GAP: good agricultural practice; TBPE: 2‐(4‐tert‐butylphenyl) ethanol.

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

^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 according to the residue definition for risk assessment.

^cSupervised trials median residue according to the residue definition for risk assessment.

^dConversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

Underlined values show that the residue situation was more critical at longer PHI than the PHI for the GAP under assessment (PHI 21 days).

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

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

B.2. Residues in livestock

Not relevant for the current assessment.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: fenazaquin
0120010	Almonds	0.01*	0.02	The submitted data are sufficient to derive a calculated MRL of 0.02 mg/kg for the import tolerance from USA. Residues in almonds related to the use of fenazaquin in accordance with the assessed GAP are not expected to pose a risk to EU consumers

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

* 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.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment for fenazaquin

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Almonds	0.01	STMR (Table B.1.2.1)	0.0155	HR (Table B.1.2.1)
Citrus fruits	0.17	STMR (EFSA, 2013)
Grapes (table and wine grapes)	0.04	STMR (EFSA, 2013)
Tea	3.79a	STMR (EFSA, 2010a)
All other commodities	EU MRLs	Reg. (EU) No 893/2010

STMR: supervised trials median residue; HR: highest residue.

^aResidues only for the parent compound fenazaquin were considered from being the only compound in the residue definition for risk assessment at that time (EFSA, 2010a).

D.2. Consumer risk assessment for TBPE metabolite

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Almonds	0.01	STMR (Table B.1.2.1)a	0.01	HR (Table B.1.2.1)a
Citrus fruits	0.003	STMR (EFSA, 2013)b	Acute risk assessment was undertaken only with regard to the crop under consideration in the current MRL application.
Grapes (table and wine grapes)	0.01	STMR (EFSA, 2013)b
Tea	2.30	STMR(EFSA, 2010a) × MW factor (0.58)c
All plant origin commodities	Several values	Reg. (EU) No 893/2010See footnoted

TBPE: 2‐(4‐tert‐butylphenyl) ethanol; STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level.

^aResidues of TBPE were not detected in the supervised residue trials submitted under the current application (Greece, 2018).

^bFor those uses previously assessed (EFSA, 2013) and for which TBPE values were reported, the STMR values of TBPE were used for the chronic exposure calculation.

^cAs mentioned in footnote (a), Table D.1. For the use of fenazaquin in tea (EFSA, 2010a), only fenazaquin was analysed as relevant compound. Considering that the median residue value is available from the supervised residue trials in tea, a conversion of residues by using the MW correction factor (0.58) was used in order to perform more refined exposure scenario.

^dDue to the lack of information of the occurrence of TBPE and the authorised used in Europe, where MRLs of fenazaquin are above the LOQ, a hypothetical residue situation where the MRL was converted into TBPE residues by multiplied the existing MRL by a molecular weight correction factor has been considered for exposure calculations. The MRLs at the LOQ (0.01 mg/kg) and the MRLs in food items of animal origin were not considered in the exposure calculation.

Appendix E – Used compound codes

1.

Code/trivial name	IUPAC name/SMILES notation/InChiKeya	Structural formulab
Fenazaquin	4‐tert‐butylphenethyl quinazolin‐4‐yl ether CC(C)(C)c1ccc(cc1)CCOc1ncnc2ccccc21 DMYHGDXADUDKCQ‐UHFFFAOYSA‐N
TBPE	2‐(4‐tert‐butylphenyl)ethanol CC(C)(C)c1ccc(CCO)cc1 NZGMMENPUKHODD‐UHFFFAOYSA‐N
4‐OHQ	quinazolin‐4‐ol Oc1ncnc2ccccc21 QMNUDYFKZYBWQX‐UHFFFAOYSA‐N

IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system.

^aACD/Name 2015 ACD/Labs 2015 Release (File version N20E41, Build 75170, 19 December 2014).

^bACD/ChemSketch 2015 ACD/Labs 2015 Release (File version C10H41, Build 75059, 17 December 2014).

Suggested citation: EFSA (European Food Safety Authority) , Brancato A, Brocca D, Carrasco Cabrera L, De Lentdecker C, Erdos Z, Ferreira L, Greco L, Jarrah S, Kardassi D, Leuschner R, Lythgo C, Medina P, Miron I, Molnar T, Pedersen R, Reich H, Riemenschneider C, Sacchi A, Santos M, Stanek A, Sturma J, Tarazona J, Theobald A, Vagenende B and Villamar‐Bouza L, 2018. Reasoned opinion on the setting of an import tolerance for fenazaquin in almonds. EFSA Journal 2018;16(7):5330, 23 pp. 10.2903/j.efsa.2018.5330