Modification of the existing maximum residue level for fluazifop‐P in tomato

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Portugal to modify the existing maximum residue level (MRL) for the active substance fluazifop‐P in tomato. The data submitted in support of the request were found to be sufficient to derive MRL proposal for tomato. An adequate analytical method for enforcement is available to control the residues of fluazifop‐P in tomato 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 of fluazifop‐P according to the reported agricultural practice is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in Portugal (evaluating Member State (EMS)) to modify the existing maximum residue level (MRL) for the active substance fluazifop‐P in tomato. Portugal 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 31 October 2017. To accommodate for the intended use of fluazifop‐P, the EMS proposed to raise the existing MRL from the limit of quantification (LOQ) to 0.06 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, the data evaluated under previous MRL assessment and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

Based on the metabolic pattern identified in metabolism studies, hydrolysis data and the toxicological significance of metabolites, the residue definitions for plant products were proposed for fluazifop‐P as the sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop for enforcement and risk assessment. This residue definition is applicable to primary crops, rotational crops and processed products. EFSA concluded that for the crops assessed in this application, metabolism of fluazifop‐P in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.

A sufficiently validated analytical method is available to quantify residues in dry, acidic, high water content and high oil content commodities according to the enforcement residue definition. The method allows quantification of residues at or above 0.01 mg/kg in the crop assessed (LOQ).

Although the residue trials submitted in support of the MRL application were not exactly reflecting the intended Good Agricultural Practice (GAP), EFSA is of the opinion that the data are sufficient to derive a MRL proposal of 0.06 mg/kg for tomato. Due to these deficiencies of the residue trials, the MRL proposal is affected by a higher level of uncertainty than usual resulting from the fact that the residue trials were not exactly reflecting the most critical application conditions.

No processing studies were evaluated in this application. However, robust processing factors for juice, paste, purée and canned tomatoes were evaluated in a previous reasoned opinion and are available.

The occurrence of fluazifop‐P residues in rotational crops was investigated in the framework of the European Union (EU) pesticides peer review and by EFSA in the MRL review. Based on this available information on the nature and magnitude of residues, it is concluded that significant residue levels are unlikely to occur in rotational crops, provided that the active substance is used according to the proposed GAP.

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

The toxicological profile of fluazifop‐P 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 0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.017 mg/kg bw, both values expressed as racemic fluazifop in accordance with the residue definition for dietary risk assessment.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment performed for tomato did not exceed the ARfD when using the highest residue (HR). The estimated long‐term dietary intake ranged from 1% to 41% of the ADI. The contribution of residues expected in tomato assessed in this application to the overall long‐term exposure is of 0.3% of the ADI.

EFSA concluded that the proposed use of fluazifop‐P on tomato will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

EFSA proposes to amend the existing MRL as reported in the summary table below.

Full details of all endpoints and the consumer risk assessment can be found in Appendices Appendix B – List of end points, Appendix C – Pesticide Residue Intake Model (PRIMo)–D.

Codeb	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop
231010	Tomatoes	0.01a	0.06	The submitted data are considered sufficient to derive a MRL proposal for the SEU use. Risk for consumers unlikely The MRL proposal is affected by non‐standard uncertainties, resulting from the fact that the residue trials were not exactly reflecting the most critical application conditions

MRL: maximum residue level; SEU: southern Europe.

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

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

Assessment

The detailed description of the intended use of fluazifop‐P in tomato, which is the basis for the current MRL application, is reported in Appendix A.

Fluazifop‐P is the ISO common name for (R)‐2‐{4‐[5‐(trifluoromethyl)‐2‐pyridyloxy]phenoxy}propionic acid (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Fluazifop‐P was evaluated in the framework of Directive 91/414/EEC1 with France designated as rapporteur Member State (RMS) for the representative uses as a single foliar application on pome fruits, peas, beans, pulses, potatoes and rapeseeds. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by the European Food Safety Authority (EFSA, 2010, 2012). Following the first peer review, which was carried out by EFSA, a decision on non‐inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Decision 2008/934/EC2. A resubmission application was subsequently made in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No 33/20083. Following this second peer review, which was carried out by EFSA, fluazifop‐P was approved under Regulation (EU) No 1107/20094 in accordance with Regulation (EU) No 540/20115. This decision was published by means of Commission Implementing Regulation (EU) No 788/20116, which entered into force on 1 January 2012. It was a specific provision of the approval that only use as an herbicide for orchards (basal application) with one application may be authorised. After amendment to the conditions of approval of the active substance, the restriction was lifted and other uses as an herbicide were authorised under Commission Implementing Regulation (EU) No 201/20137.

The process of renewal of the first approval has not yet been initiated.

The review of existing maximum residue levels (MRLs) according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2015b) and the proposed modifications have been implemented in the MRL legislation (Annexes II of Regulation (EC) No 396/20058). After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for fluazifop‐P. The proposals from these reasoned opinions have been considered in recent regulations9 for the European Union (EU) MRL legislation. It is noted that in 2017 EFSA assessed a MRL request for fluazifop‐P in tomatoes for a different Good Agricultural Practice (GAP); in its assessment EFSA did not recommend the raising of the existing MRL since the residue trials were found insufficient to support the intended GAP (EFSA, 2017).

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in Portugal (evaluating Member State (EMS)) to modify the existing MRL for the active substance fluazifop‐P in tomato. Portugal 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 EFSA on 31 October 2017. To accommodate for the intended uses of fluazifop‐P, the EMS proposed to raise the existing MRL from the limit of quantification (LOQ) to 0.06 mg/kg.

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

EFSA based its assessment on the evaluation report submitted by the EMS (Portugal, 2017), the DAR (France, 2007), prepared under Council Directive 91/414/EEC, the final addendum and its additional report to the DAR (France, 2010), the final addendum to the additional report (France, 2012), the revised European Commission review report on fluazifop‐P (European Commission, 2015), the conclusion on the peer review of the pesticide risk assessment of the active substance fluazifop‐P (EFSA, 2010, 2012), as well as the conclusions from previous EFSA opinions on fluazifop‐P including the review of existing MRLs according to Article 12 (EFSA, 2015a,b, 2016, 2017).

For this application, the data requirements established in Regulation (EU) No 544/201110 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a–1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 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 546/201111.

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

The evaluation report submitted by the EMS (Portugal, 2017) 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

The metabolism of fluazifop‐P‐butyl in primary crops belonging to the group of fruit crops (tomatoes), root crops, leafy crops and pulses/oilseeds was investigated in the framework of EU pesticides peer review and the MRL review (EFSA, 2012, 2015b). The predominant compound of the total residues was fluazifop, free and conjugated (20–70% of total radioactive residue (TRR) in all the different crops tested). Overall, a similar metabolic pattern was observed in all crops investigated. In tests using the single enantiomers and racemic fluazifop‐butyl, a significant change in the ratio of the R and S enantiomers of the residues was not observed (EFSA, 2012).

1.1.2. Nature of residues in rotational crops

Tomatoes can be grown in crop rotation. Fluazifop‐P has a DT₉₀ of over 100 days being therefore considered a persistent substance (EFSA, 2012).

Metabolism was investigated in three different crop groups (root crops, leafy crops and cereals) by means of a confined rotational crop metabolism study (EFSA, 2012). Only compound X, either free or hexose conjugated, was recovered at relevant levels in harvested wheat (forage, straw, grain) (30–70% TRR), lettuce (64% TRR) and carrot (foliage) (44–60% TRR) sown 60 days after a bare soil treatment with fluazifop‐P‐butyl. Compound X is the predominant metabolite in soil and it is assumed that its presence in the edible parts of the rotated crops is due to its uptake from the soil (EFSA, 2012). The MRL review concluded that considering the occurrence of compound X at insignificant levels in rotational crop trials (see also Section 1.2.2), the residue definition for the rotational crops can be set as the same as for the primary crops (EFSA, 2015b).

1.1.3. Nature of residues in processed commodities

The nature of residues in processed commodities was not investigated under standardised hydrolytic conditions for fluazifop‐P‐butyl. However, analytical methods reported for enforcement of residues include severe hydrolytic conditions. Under these conditions, conjugates and esters of fluazifop did not hydrolyse beyond the stable fluazifop moiety itself. It was therefore concluded that the metabolic pattern in processed commodities will not differ significantly from the metabolic pattern observed in raw commodities (EFSA, 2015b).

1.1.4. Methods of analysis in plants

An analytical method for the determination of fluazifop residues (including all fluazifop isomers, its esters and its conjugates) was assessed during the EU pesticides peer review (EFSA, 2012).

The method was validated for dry, acidic, high water content and high oil content commodities. It is based on the Quick, Easy, Cheap, Effective, Rugged, and Safe (QuECHERS) method involving an additional hydrolysis step under acidic conditions (using acetonitrile/concentrated hydrochloric acid solution (98:2 v/v)); the determination is performed using triple quadrupole high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS).

The method is applicable for tomatoes to quantify residues at or above the LOQ of 0.01 mg/kg (total residues of fluazifop‐P determined as fluazifop, its esters and its conjugates).

1.1.5. Stability of residues in plants

The stability of fluazifop‐P‐butyl was investigated in the framework of the peer review in high water content, high oil content and dry commodities stored under frozen conditions. The findings for fluazifop‐P‐butyl were considered sufficient to demonstrate storage stability for all constituent isomers of fluazifop, its esters and its conjugates (EFSA, 2012).

It is sufficiently demonstrated that residues of fluazifop (including all constituent isomers, its esters and conjugates) in tomatoes are stable for at least 18 months when stored at −18°C.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the toxicological significance of metabolites and degradation products and the capabilities of enforcement analytical methods, the following residue definitions were proposed under the MRL review (EFSA, 2015b):

• residue definition for risk assessment: sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop.

• residue definition for enforcement: sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop.

The same residue definitions are applicable to rotational crops and processed products.

The residue definition set in Regulation (EC) No 396/2005 for enforcement is equivalent to the enforcement residue definition mentioned above (i.e. fluazifop‐P (sum of all the constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop)).

Taking into account the proposed use assessed in this application, EFSA concludes that these residue definitions are appropriate and no modification is required.

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 on tomato. The samples were analysed for all constituents of the residue definitions for enforcement and risk assessment. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose and the sample integrity demonstrated for the storage stability of these residue trials (Portugal, 2017).

The residue trials were conducted in the south of France, Greece, Italy and Spain in the years 1999, 2001 and 2002 were provided.

The intended GAP for tomato is described as a single application at 312.5 g/ha at the growth stages before BBCH 61 (before first flower opens) and a preharvest interval (PHI) of 70 days.

Two of the eight trials match the application rate, whereas in the remaining six trials the application rate was below the intended GAP but within the acceptable deviation of 25%. In all residue trials, the samples were taken at a slightly longer or shorter PHIs (65–87 days) than the one described in the GAP of 70 days. Despite the general principle that trials may not deviate more than on one parameter (European Commission, 2017), the deviations on the PHI are not expected to have a significant impact on the final residue level as the intended interval between the last application and the harvest is long. The timing of the application did not fully match with the growth stage defined in the GAP (BBCH 51 instead of close to BBCH 61). Considering that the time between BBCH 51 and BBCH 61 is relatively short compared to the PHI and since fluazifop‐P is a systemic herbicide where the early timing of application should not impact greatly on the residues, the residue trials were considered acceptable to support the intended SEU outdoor use and to derive a MRL proposal for tomato. However, the MRL proposal is affected by a higher level of uncertainty compared to other cases where the residue trials would reflect the intended GAP exactly in terms of application rate, BBCH and PHI.

1.2.2. Magnitude of residues in rotational crops

Tomatoes can be grown in a crop rotation. The possible transfer of residues to crops that are grown in a crop rotation has been assessed in the framework of the EU pesticides review and the MRL review with fluazifop‐P‐butyl (EFSA, 2012, 2015b). The available studies demonstrated that significant residues are not expected in succeeding crops planted in soil treated once at a dose rate 375–475 g a.s./ha. Since the maximum annual application rate for the crops under consideration is lower (312 g/ha; 0.8N) than the lowest application rate tested in the rotational crop field trials, it is concluded that no residues are expected in rotational crops, provided that the active substance is applied according to the proposed GAP.

1.2.3. Magnitude of residues in processed commodities

No new processing studies were submitted in the framework of this application but robust processing factors for juice, paste, purée and canned tomatoes were derived in a previous reasoned opinion and recommended for inclusion in Annex VI of Regulation (EC) No 396/2005 (EFSA, 2017).

1.2.4. Proposed MRLs

Although the residue trials submitted in support of the MRL application were not exactly reflecting the intended GAP, EFSA is of the opinion that the data are sufficient to derive a MRL proposal of 0.06 mg/kg for tomato. Due to these deficiencies of the residue trials, the MRL proposal is affected by a higher level of uncertainty than usually resulting from the fact that the residue trials were not exactly reflecting the most critical application conditions.

In Section 3, EFSA assessed whether residues on tomato resulting from the intended use are likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as tomato is not used for feed purposes in Europe.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 2 of the EFSA PRIMo (EFSA, 2007). This exposure assessment model contains food consumption data for different sub‐groups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (EFSA, 2007).

The toxicological reference values used in the risk assessment (i.e. acceptable daily intake (ADI) and acute reference dose (ARfD) values) were derived in the framework of the EU pesticides peer review on fluazifop‐P (EFSA, 2012) and were expressed as racemic fluazifop in accordance with the residue definition for dietary risk assessment.

The short‐term exposure assessment performed for tomato did not exceed the ARfD when using the highest residue (HR).

The long‐term exposure assessment was performed using the supervised trials median residue (STMR) values of the previous reasoned opinion (EFSA, 2017), including the STMR values for certain Codex MRLs (FAO, 2016) that were taken over in the EU legislation recently, as well as the STMR value derived for tomato under this application. The estimated long‐term dietary intake ranged from 1% to 41% of the ADI. The contribution of residues expected in tomato assessed in this application to the overall long‐term exposure is of 0.3% of the ADI.

Therefore, EFSA concludes that neither the short‐ nor the long‐term intake of residues resulting from the existing uses of fluazifop‐P and the new use in tomato is unlikely to present a risk to consumer health.

For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive a MRL proposal for tomato, noting that the derived MRL may not cover the most critical application conditions (treatment at BBCH between 51 and 61).

EFSA concluded that the proposed use of fluazifop‐P on tomato will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

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

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

DT₉₀

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

EC

emulsifiable concentrate

EMS

evaluating Member State

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GS

growth stage

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

MS

mass spectrometry detector

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

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SEU

southern Europe

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

TRR

total radioactive residue

WHO

World Health Organization

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

1.

				Preparation		Application				Application rate per treatment
Crop and/or situation	NEU, SEU, MS or country	F G or Ia	Pests or group of pests controlled	Typeb	Conc. a.s.	Method kind	Range of growth stages and seasonc	Number min–max	Interval between application (min)	g a.s./hL min–max	Water L/ha min–max	Rate	Unit	PHI (days)d	Remarks
Tomato	SEU	F	Annual and perennial grasses	EC	125 g/L	Foliar spray	Before any flowers open (< BBCH 61)	1	–	78.125–312.5	100–400	312.5	g a.s./ha	70	Application rate expressed as fluazifop‐P‐butyl

NEU: northern European Union; SEU: southern European Union; MS: Member State; GAP: Good Agricultural Practice; MRL: maximum residue level; a.s.: active substance; EC: emulsifiable 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	Soil, 670 + 160 g a.s./ha	14, 30	Study carried out with fluazifop‐P‐butyl, labelled both on the phenyl and pyridyl moieties/EFSA (2012)
	Root crops	Carrot	Foliar, 1 × 250 g a.s./ha	45	Study includes a comparative assessment of fluazifop‐P‐butyl labelled on the phenyl moiety (low application rate) and fluazifop‐butyl labelled on both moieties (high application rate)/EFSA (2012)
			Foliar, 1 × 500 g a.s./ha	45
		Sugar beet	Foliar, 1 × 250 g a.s./ha	90	Study includes a comparative assessment of fluazifop‐P‐butyl labelled on the phenyl moiety (low application rate) and fluazifop‐butyl labelled on both moieties (high application rate)/EFSA (2012)
			Foliar, 1 × 500 g a.s./ha	90
	Leafy crops	Celery	Foliar, 1 × 250 g a.s./ha	30	Study carried out with fluazifop‐P‐butyl, labelled both on the phenyl and pyridyl moieties/EFSA (2012)
		Lettuce	Foliar, 1 × 500 g a.s./ha	27	Study carried out with fluazifop‐butyl (R and S enantiomers separately), labelled on the phenyl moiety/EFSA (2012)
	Pulses/oilseeds	Soya bean	Foliar, 1 × 560 g a.s./ha	BBCH 61 and Maturity	Study carried out with fluazifop‐P‐butyl, labelled both on the phenyl and pyridyl moieties/EFSA (2012)
			Foliar, 560 + 211 g a.s./ha	Maturity
		Cotton	Foliar, 1 × 450 g a.s./ha	27	Study carried out with fluazifop‐butyl (R and S enantiomers separately), labelled on the phenyl moiety/EFSA (2012)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/source
	Root/tuber crops	Carrot	Soil, 1 × 470 g a.s./ha	30	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)
			Soil, 1 × 970 g a.s./ha	90, 270	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)
	Leafy crops	Lettuce	Soil, 1 × 470 g a.s./ha	30	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)
			Soil, 1 × 970 g a.s./ha	90, 270	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)
	Cereal (small grain)	Wheat	Soil, 1 × 470 g a.s./ha	30	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)
			Soil, 1 × 970 g a.s./ha	90, 270	14C‐phenyl and 14C‐pyridinyl fluazifop‐P EFSA (2012)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/source
	Pasteurisation (20 min, 90°C, pH 4)	Inconclusive	Study not available
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Inconclusive	Study not available
	Sterilisation (20 min, 120°C, pH 6)	Inconclusive	Study not available
	Other processing conditions	Yes	Severe hydrolytic conditions were evaluated under the analytical enforcement method demonstrating stability to hydrolysis 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 water content	Sugar beet	−18	12	Months	Fluazifop‐butyl	Additional studies lasting 9 and 4 months are also available for cauliflower and tomatoes, respectively/EFSA (2015b)
	High water content	Fresh beans	−18	12	Months	Fluazifop‐butyl	EFSA (2015b)
	High oil content	Oilseed rape	−18	9	Months	Fluazifop‐butyl	EFSA, (2015b)
	High acid content	Strawberries	−18	9	Months	Fluazifop‐butyl	EFSA (2015b)
	High water content	Onions	−18	28	Months	Fluazifop‐P‐butyl	Additional study lasting 18 months is also available for potatoes, lettuce, cabbage and tomatoes/EFSA (2015b)
	High oil content	Soya bean	−18	18	Months	Fluazifop‐P‐butyl	EFSA (2015b)
	Dry/high protein	Dry beans	−18	18	Months	Fluazifop‐P‐butyl	EFSA (2015b)

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)
Tomato	SEU	Trials performed at 1 × 313 g a.s./ha; PHI: 67 days 0.015d Trial performed at 1 × 313 g a.s./ha; PHI: 86 days < 0.01 Trials performed at 1 × 250 g a.s./ha; PHI: 65–69 days 2 × 0.03 Trials performed at 1 × 250–275 g a.s./ha; PHI: 75–87 days 3 × < 0.01; 0.02	Sufficient number of trials to derive a MRL. The MRL proposal is affected by non‐standard uncertainties, resulting from the fact that the residue trials were not exactly reflecting the most critical application conditions	0.06	0.03	0.01

MRL: maximum residue level; a.s.: active substance; PHI: preharvest interval.

^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.

^dMean of a replicate trial.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

No new processing studies were submitted in the framework of this application but robust processing factors for juice, paste, puree and canned tomatoes were evaluated in previous reasoned opinion (EFSA, 2017)

B.2. Residues in livestock

Not relevant

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codeb	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop
231010	Tomatoes	0.01a	0.06	The submitted data are sufficient to derive a MRL proposal for the SEU use. Risk for consumers unlikely The MRL proposal is affected by non‐standard uncertainties, resulting from the fact that the residue trials were not exactly reflecting the most critical application conditions

MRL: maximum residue level; SEU: southern Europe.

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

^bCommodity 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

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop
Tomato	0.01	STMR	0.03	HR
Strawberries, peas (with pods) and cotton seeds	STMR	FAO (2016)	Acute risk assessment was performed only for the crop under consideration
Other products of plant and animal origin	STMR	EFSA (2017)

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

Appendix E – Used compound codes

1.

Code/trivial name	IUPAC name/SMILES notation/InChiKeya	Structural formulab
Fluazifop‐P	(R)‐2‐{4‐[5‐(trifluoromethyl)‐2‐pyridyloxy]phenoxy}propionic acid O=C(O)[C@@H](C)Oc1ccc(cc1)Oc2ccc(cn2)C(F)(F)F YUVKUEAFAVKILW‐SECBINFHSA‐N
Fluazifop	(RS)‐2‐{4‐[5‐(trifluoromethyl)‐2‐pyridyloxy]phenoxy}propionic acid O=C(O)C(C)Oc1ccc(cc1)Oc2ccc(cn2)C(F)(F)F YUVKUEAFAVKILW‐UHFFFAOYSA‐N
Fluazifop‐butyl	butyl (RS)‐2‐{4‐[5‐(trifluoromethyl)‐2‐pyridyloxy]phenoxy}propionate O=C(OCCCC)C(C)Oc1ccc(cc1)Oc2ccc(cn2)C(F)(F)F VAIZTNZGPYBOGF‐UHFFFAOYSA‐N
Fluazifop‐P‐butyl	butyl (R)‐2‐{4‐[5‐(trifluoromethyl)‐2‐pyridyloxy]phenoxy}propionate O=C(OCCCC)[C@@H](C)Oc1ccc(cc1)Oc2ccc(cn2)C(F)(F)F VAIZTNZGPYBOGF‐CYBMUJFWSA‐N
Compound X	5‐(trifluoromethyl)‐2(1H)‐pyridinone FC(F)(F)C1=CNC(=O)C=C1 BYRJSCNPUHYZQE‐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 modification of the existing maximum residue level for fluazifop‐P in tomato. EFSA Journal 2018;16(4):5253, 21 pp. 10.2903/j.efsa.2018.5253