Modification of the existing maximum residue levels for lambda‐cyhalothrin in seed and fruit spices

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance lambda‐cyhalothrin in seed and fruit spices. The data submitted in support of the request were found to be sufficient to derive MRL proposals in seed spices and in fruit spices. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical enforcement methods are available to control the residues of lambda‐cyhalothrin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of lambda‐cyhalothrin on spices according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Agro GmbH submitted an application to the competent national authority in Germany (evaluating Member State (EMS)) to modify the existing maximum residue levels (MRLs) for the active substance lambda‐cyhalothrin in seed and fruit spices. 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 24 October 2019. To accommodate for the intended NEU outdoor use of lambda‐cyhalothrin, the EMS proposed to raise the existing MRL to 0.3 mg/kg. EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation.

Based on the conclusions derived in the framework of the original approval and its renewal, the review of the existing MRLs for lambda‐cyhalothrin with its revisions, the data evaluated under a previous MRL assessment and the additional data provided by the EMS in the framework of this application, the following conclusions were derived.

The metabolism of lambda‐cyhalothrin in primary and rotational crops was sufficiently investigated in four different crop category groups. Studies investigating the effect of processing on the nature of lambda‐cyhalothrin (hydrolysis studies) demonstrated that the active substance was stable under pasteurisation and baking, brewing and boiling but extensively degraded under sterilisation conditions, forming the degradation products Ia, IV and gamma‐lactone. Based on the results of the metabolism studies, the hydrolysis studies, the capability of the currently available enforcement analytical methods and taking into account that analytical methods do not allow to discriminate between lambda‐ and gamma‐cyhalothrin, which is also approved for use in plant protection products, the residue definitions for enforcement and risk assessment to all plant commodities have been set as ‘lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R,S‐ and S,R‐isomers)’. The residue definition was set on a provisional basis for processed products, pending the assessment of toxicological properties of compounds Ia, IV and gamma‐lactone, formed under conditions simulating sterilisation. These residue definitions are considered appropriate also for the crops assessed under this application.

Sufficiently validated analytical methods are available to quantify residues of lambda‐cyhalothrin in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at or above 0.1 mg/kg (limit of quantification (LOQ)) but do not allow distinguishing the different isomers of lambda‐cyhalothrin.

The available residue trials are sufficient to derive MRL proposals of 0.3 mg/kg for seed spices and, by extrapolation, for fruit spices. Since set at a higher level, a modification of the existing tentative EU MRL for cardamom is not required.

The general data gap identified in the framework of the MRL review for toxicological information on the compounds formed under sterilisation conditions applies to spices and it has not been addressed yet. Since the MRL application was received within the time period provided for submission of the confirmatory data, which have been requested for many food commodities, and in light of the low contribution of spices to the dietary exposure, EFSA considered acceptable the EMS proposal to amend the tentative MRL for seed and fruit spices while maintaining the current footnote in the legislation. This proposal is put forward for risk management consideration.

Based on the available information, the intended NEU use of lambda‐cyhalothrin in spices according to the proposed Good Agricultural Practice (GAP) is unlikely to result in significant residues in rotational corps. Residues of lambda‐cyhalothrin in commodities of animal origin were not assessed since spices are normally not fed to livestock.

The toxicological profile of lambda‐cyhalothrin was assessed in the framework of the EU pesticides peer review for renewal of the approval and the data were sufficient to derive an acceptable daily intake (ADI) of 0.0025 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.005 mg/kg bw.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The estimated long‐term intake was in the range of 7–90% of the ADI. The contribution of residues in seed and fruit spices to the overall consumer exposure was insignificant (≤ 0.02% of the ADI). The estimated short–term exposure conducted according to the currently agreed methodology did not exceed the ARfD for any of the crops under assessment and was individually the highest for fennel seed (2% of the ARfD).

EFSA concluded that the proposed northern Europe (NEU) outdoor use of lambda‐cyhalothrin on seed and fruit spices will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.

EFSA derived MRL proposals as reported in the summary table below. Since the general data gap identified in the framework of the MRL review has not yet been addressed, a risk management decision is required whether it is appropriate to take over the proposed MRLs in the MRL legislation.

The conclusions reported in this reasoned opinion and the consumer risk assessment might need to be reconsidered in light of the confirmatory data requested following the renewal of the approval and the review of the existing MRLs for lambda‐cyhalothrin.

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

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

Codea	Commodity	Existing EU MRLb (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R,S‐ and S,R‐isomers)(F)
0810000	Seed spices	0.01* (ft)	0.3 (ft) Further risk management considerations necessary	The submitted data are sufficient to derive an MRL proposal for the intended NEU use Risk for consumers unlikely A risk management decision is required whether it is appropriate to take over the MRL in the MRL legislation, despite the lack of toxicological data for certain degradation products (compounds Ia, IV and gamma lactone) observed in standard hydrolysis studies representative for sterilisation conditions
0820000, except 0820040	Fruit spices, except cardamom	0.03 (ft)	0.3 (ft) Further risk management considerations necessary	The submitted data are sufficient to derive an MRL proposal by extrapolation from spice seeds for the intended NEU use Risk for consumers unlikely A risk management decision is required whether it is appropriate to take over the MRL in the MRL legislation, despite the lack of toxicological data for certain degradation products (compounds Ia, IV and gamma lactone) observed in standard hydrolysis studies representative for sterilisation conditions
0820040	Cardamon	2 (ft)	2 (ft) (No change required)	The submitted data are sufficient to derive an MRL proposal of 0.3 mg/kg by extrapolation from spice seeds for the intended NEU use, which is lower than the existing tentative MRL

MRL: maximum residue level; NEU: northern Europe.

^*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.

(F): Fat soluble.

(ft): The European Food Safety Authority identified some information on certain metabolites (compounds Ia, IV and gamma‐lactone) formed under sterilisation conditions 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 6 July 2020, or, if that information is not submitted by that date, the lack of it.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for lambda‐cyhalothrin in spices. The detailed description of the intended northern Europe (NEU) outdoor use of lambda‐cyhalothrin in seed and fruit spices, which is the basis for the current MRL application, is reported in Appendix A.

Lambda‐cyhalothrin is the ISO common name for (R)‐α‐cyano‐3‐phenoxybenzyl (1S)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate and (S)‐ α‐cyano‐3‐phenoxy‐benzyl (1R)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate (IUPAC). It represents a 1:1 mixture of two of the four components of the insecticide cyhalothrin: the R,S‐ and the S,R‐isomers. The isomer S,R alone is the active substance gamma‐cyhalothrin, which is also approved for use in plant protection products. The chemical structures of the active substance and main metabolites are reported in Appendix E.

Lambda‐cyhalothrin was included in Annex I to Directive 91/414/EEC on 1 January 2002 by Commission Directive 2000/80/EC1 and is deemed to be approved under Regulation (EC) No 1107/2009 in accordance with Commission Implementing Regulation (EU) No 540/2011.2 The approval has been renewed by Commission Implementing Regulation (EU) 2016/1463 which entered into force on 1 April 2016. The representative uses evaluated in the peer review for renewal were foliar spraying applications on wheat, potato, plum, peach and tomato. The renewal assessment report (RAR) has been peer reviewed by EFSA (2014b). Sweden acted as rapporteur Member State (RMS) in both the original and renewal approval procedures. Lambda‐cyhalothrin was approved for the use as insecticide, but the applicant was requested to submit confirmatory information to the Commission, the Member States and EFSA by 1 April 2018.4 The peer review of the confirmatory data assessment has not yet been initiated. Lambda‐cyhalothrin has been included in the list of candidates for substitution.

The EU MRLs for lambda‐cyhalothrin are established in Annex II of Regulation (EC) No 396/2005.5 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2014a) and revised in 2015 (EFSA, 2015) and the proposed modifications have been implemented in the MRL legislation. In 2017, EFSA issued a focused review on the assessment of the existing MRLs for lambda‐cyhalothrin which might lead to consumers intake concerns on the basis of the new toxicological reference values for gamma‐cyhalothrin and of the data currently available to EFSA for lambda‐cyhalothrin (EFSA, 2017). After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of MRLs for lambda‐cyhalothrin (EFSA, 2019b). The proposals from these reasoned opinions have been considered in recent MRL regulation(s).6 Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation_. 7 ^, 8 ^, 9

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Agro GmbH submitted an application to the competent national authority in Germany (evaluating Member State (EMS)) to modify the existing MRLs for the active substance lambda‐cyhalothrin in seed and fruit spices. 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 EFSA on 24 October 2019. To accommodate for the intended NEU outdoor use of lambda‐cyhalothrin, the EMS proposed to raise the existing MRL to 0.3 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 (Germany, 2019), the RAR and its addendum (Sweden, 2013, 2014) prepared under Directive 91/414/EEC, the revised Commission review report on lambda‐cyhalothrin (European Commission, 2015), the conclusion on the peer review of the pesticide risk assessment of the active substance (EFSA, 2014b) and the reasoned opinions related to the review of the existing MRLs for lambda‐cyhalothrin (EFSA, 2014a, 2015, 2017, 2019b) and in the EFSA scientific report (EFSA, 2016).

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, 1997 g, 2000, 2010a, 2015, 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 546/2011.11

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

The evaluation report submitted by the EMS (Germany, 2019) 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 lambda‐cyhalothrin in primary crops belonging to the group of fruit crops, leafy crops, cereals/grass, pulses/oilseeds has been investigated in the framework of the EU pesticides peer review and the MRL review (EFSA, 2014a,b).

In the crops tested, lambda‐cyhalothrin was the predominant residue (37–95% total radioactive residue (TRR)) while compound Ia was identified as a significant metabolite in soya bean and cotton leaves only (17–25% TRR). Based on the chiral analysis on residue trial samples assessed in the framework of the EU pesticides peer review renewal, EFSA concluded that the impact of the change in the ratio of the isomers of the active substance on the toxicological burden the consumer is exposed to, was of low concern (EFSA, 2014a,b).

For the intended use assessed in this application, the metabolic behaviour in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

The crops under consideration may be grown in a crop rotation. The metabolism of lambda‐cyhalothrin in rotational crops has been previously investigated (EFSA, 2014a,b). Parent compound extensively degraded and was only detected in negligible proportions in wheat straw (< 1% TRR). Compound Ia was the major residue (34–52% TRR).

For the intended use assessed in this application, no further information is required.

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of lambda‐cyhalothrin was investigated in the framework of the EU pesticides peer review and the MRL review (EFSA, 2014a,b).

Lambda‐cyhalothrin remained stable under hydrolytic conditions representative of pasteurisation and baking, brewing and boiling (82–91% TRR), while a significant degradation occurred under conditions simulating sterilisation. Hydrolytic cleavage of the parent molecule to form compound Ia, compound IV and gamma‐lactone was noted. The toxicity of these compounds has not been sufficiently addressed. Therefore for all crops which may be consumed after processing that were assessed in the MRL review, a general data gap was implemented in the EU legislation by Regulation (EU) 2018/960 as confirmatory data to be submitted by 6 July 2020.

Since new studies, investigating the toxicity of degradation products Ia, IV and gamma‐lactone were not provided in the framework of the current assessment, the data gap identified by the MRL review is relevant also for the use under assessment.

1.1.4. Methods of analysis in plants

Analytical methods for the determination of lambda‐cyhalothrin residues in all four plant matrix groups were assessed during the EU pesticides peer review, the MRL review and its revision (EFSA, 2014a,b, 2015). The methods enable quantification of residues at or above the LOQ of 0.01 mg/kg, but do not allow distinguishing the different isomers of lambda‐cyhalothrin.

The applicant has not submitted validation data for an enforcement method to determine lambda‐cyhalothrin in spices. Spices are not included in any group12 and could be considered as a commodity difficult to analyse (European Commission, 2010b).

However, since the multi‐residue Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) method using gas chromatography with tandem mass spectrometry (GC–MS/MS) and/or liquid chromatography with tandem mass spectrometry (LC‐MS/MS) provided acceptable recoveries for lambda‐cyhalothrin at the LOQ of 0.1 mg/kg (lowest concentration tested) in seeds of spices and cardamom (FAO, 2015) and since the same method was successfully validated in all four major matrices (EFSA, 2014a,b, 2015), there is a sufficient evidence to conclude that the proposed MRLs can be enforced at a LOQ of 0.1 mg/kg in the crops under consideration.

1.1.5. Storage stability of residues in plants

The storage stability of lambda‐cyhalothrin in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review and the MRL review (EFSA, 2014a,b). It was demonstrated that in high water content, high oil content and dry matrices residues were stable for at least 26 months when stored at −18°C.

At present, a clear classification of spices regarding storage stability is not available. They have been often considered as dry commodity, but the Organisation for Economic Co‐operation and Development (OECD) included these products in the high oil content group (OECD, 2007b). The available storage stability data cover either way.

1.1.6. Proposed residue definitions

In the framework of the MRL review, based on the results of the metabolism studies, the hydrolysis studies and the capability of the currently available enforcement analytical methods, the residue definition for enforcement and risk assessment in all plants was set as:

• Residue definition for enforcement: lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R,S‐ and S,R‐isomers).

• Residue for risk assessment: lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R,S‐ and S,R‐isomers).

The residue definitions are applicable to primary crops. A specific residue definition for rotational crops is not deemed necessary (EFSA, 2014a). For processed commodities the same residue definitions were proposed on a provisional basis, pending the assessment of the toxicological properties of the degradation products formed under sterilisation conditions, i.e., compounds Ia, IV and gamma‐lactone (EFSA, 2014a, 2015).

The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition. It is noted that the definition is not specific to lambda‐cyhalothrin and covers also residues arising from the use of gamma‐cyhalothrin, isomer S,R alone, which is also approved for use in plant protection products (EFSA, 2017).

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

The results of six Good Agricultural Practice (GAP)‐compliant residue trials were provided where caraway, anise and fennel were treated with lambda‐cyhalothrin. All trials were conducted within the same region in Germany. Considering that cultivation is limited to few areas and that the trials were conducted over two seasons, EFSA accepted the deviation in the geographical representation of the trials for these very minor crops.

The number of submitted trials is sufficient to derive an MRL proposal of 0.3 mg/kg for lambda‐cyhalothrin in seed spices. The proposed extrapolation from seed spices to fruit spices is accepted and is in line with the EU guidance document (European Commission, 2017).

According to the assessment of the EMS, the analytical methods used were sufficiently validated and fit for purpose (Germany, 2019). The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated.

1.2.2. Magnitude of residues in rotational crops

Based on the results of the confined rotational crop metabolism studies, which were conducted at a maximum total application rate significantly higher (about 66N) than the intended rate on the crops under assessment (7.5 g/ha), significant residue levels (> 0.01 mg/kg) are not expected in the edible parts of the succeeding crops.

EFSA concluded that no residues of lambda‐cyhalothrin 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

Studies investigating the magnitude of residues in processed spices were not submitted in this MRL application. Although such studies are not required considering low contribution of spices to the total dietary intake (< 0.02% of the acceptable daily intake (ADI)), due to the high toxicity of the active substance and pending a final decision on the residue definition in processed products, the investigation on magnitude of residues in processed spices might become relevant.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals and, noting the lack of studies investigating the toxicity of degradation products Ia, IV and gamma‐lactone that are formed under sterilisation, risk assessment values for the commodities under evaluation (see Appendix B). In Section B.3, EFSA assessed whether residues on these crops resulting from the intended use is likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as spices are not used for feed purposes.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019a). This exposure assessment model contains food consumption data for different subgroups 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 (FAO, 2016).

The toxicological reference values for lambda‐cyhalothrin used in the risk assessment (ADI of 0.0025 mg/kg body weight (bw) per day and acute reference dose (ARfD) of 0.005 mg/kg bw) were derived in the framework of the EU pesticides peer review (European Commission, 2015).

Since no GAP for gamma‐cyhalothrin in spices was reported to EFSA, the assessment of exposure from this active substance in spices is not relevant under the current assessment.

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed for the commodities assessed in this application. The calculations were based on the highest residue derived from supervised field trials and the list of input values can be found in Appendix D.1.

The short‐term exposure did not exceed the ARfD for any of the crops assessed in this application (see Appendix B). The highest acute exposure to residues of lambda‐cyhalothrin was identified for fennel seed (2% of the ARfD) and were lower for the other spices, for which consumption data were provided to EFSA.

It is noted that the estimated short‐term exposure to lambda‐cyhalothrin residues in a number of commodities related to the authorised uses (table grapes, pears, peaches, apples) and to adopted CXL (swine meat) exceeded the ARfD while the exposure calculated in the framework of the MRL review and its revisions, where the MRL recommendations for these crops were derived, was below the ARfD. The different results are due to the higher large portion consumption data used in PRIMo revision 3.1 compared to the previously used version of the risk assessment model (PRIMo rev. 2). Further refinements of the acute risk assessment for these crops may be possible.

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level and the acceptable CXLs (EFSA, 2014a). EFSA updated the calculation with the relevant supervised trials median residue (STMR) values derived from the residue trials submitted in support of this MRL application for seed and fruit spices; in addition, STMRs derived in EFSA opinions issued after the MRL review (EFSA, 2015, 2017, 2019b) and Codex MRL implemented in the EU legislation (FAO, 2015) were considered to refine the calculation. The input values used in the exposure calculations are summarised in Appendix D.1.

The long‐term exposure did not exceed the ADI; the maximum calculated long‐term exposure accounted for 90% of the ADI (NL toddler) (see Appendix B).

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

EFSA pointed out that the consumer risk assessment presented has to be regarded as provisional and might need to be reconsidered in the light of the outcome of the evaluation of the confirmatory data on the toxicological properties of the compounds Ia, IV and gamma‐lactone formed under sterilisation conditions identified following the review of the existing MRLs for lambda‐cyhalothrin.

4. Conclusion and Recommendations

The residue data submitted in support of the intended NEU use of lambda‐cyhalothrin on spices were found to be sufficient to derive an MRL proposal in seed and fruit spices. Since set at a higher level, a modification of the existing tentative EU MRL for cardamom is not required.

The general data gap identified in the framework of the MRL review for toxicological information on the compounds formed under sterilisation conditions applies to spices and it has not been addressed yet. Since the MRL application was received within the time period provided for submission of the confirmatory data, which have been requested for many food commodities, and in the light of the low contribution of spices to the dietary exposure, EFSA considered acceptable the EMS proposal to amend the tentative MRL for seed and fruit spices while maintaining the current footnote in the legislation. This proposal is put forward for risk management consideration.

EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of lambda‐cyhalothrin on spices according to the intended agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional and might need to be reconsidered in light of the outcome of the evaluation of the confirmatory data requested following the renewal of the approval and the review of the existing MRLs for lambda‐cyhalothrin.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

a.i.

active ingredient

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CCPR

Codex Committee on Pesticide Residues

CF

conversion factor for enforcement to risk assessment residue definition

CS

capsule suspension

CXL

Codex maximum residue limit

DALA

days after last application

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

GC‐MS

gas chromatography with mass spectrometry

GC‐MS/MS

gas chromatography with tandem mass spectrometry

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

InChiKey

International Chemical Identifier Key

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

LC–MS/MS

liquid chromatography with tandem mass spectrometry

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

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

RA

risk assessment

RAR

renewal assessment report

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

TAR

total applied radioactivity

TRR

total radioactive residue

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	Unit
Anise/ aniseed	NEU	F	Sucking insects, biting insects	CS	100 g/L	Foliar treatment – broadcast spraying	65	1			400–600	7.50	g a.i./ha	n.a.	Growth stage: at beginning of infestation and/or when first symptoms become visible until shortly before flowering of the main umbel PHI is defined by the application stage at last treatment
Dill seed	NEU	F	Sucking insects, biting insects	CS	100 g/L	Foliar treatment – broadcast spraying	65	1			400–600	7.50	g a.i./ha	n.a.	Growth stage: at beginning of infestation and/or when first symptoms become visible until shortly before flowering of the main umbel PHI is defined by the application stage at last treatment
Caraway	NEU	F	Sucking insects, biting insects	CS	100 g/L	Foliar treatment – broadcast spraying	65	1			400–600	7.50	g a.i./ha	n.a.	Growth stage: at beginning of infestation and/or when first symptoms become visible until shortly before flowering of the main umbel. PHI is defined by the application stage at last treatment

GAP: Good Agricultural Practice; MRL: maximum residue level; NEU: northern European Union; SEU: southern European Union; MS; Member State; a.s.: active substance; a.i.: active ingredient; CS: capsule suspension; n.a.: not applicable.

^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	Crops	Applications	Sampling	Comment/Source
	Fruit crops	Apple	Spotting onto fruit, 33 μg/fruit	0, 7, 14, 28, 56 DAT	[cyclopropyl‐14C]‐cyhalothrin (EFSA, 2014a)
		Tomato	Foliar, 4 × 100 g/ha	3 DALA	[cyclopropyl‐14C] and [phenoxy‐14C]‐ lambda‐cyhalothrin (EFSA, 2014a)
	Leafy crops	Cabbage	Spotting onto crop, 26 μg/leaf	2, 4, 5, 6, 7 weeks after application	[cyclopropyl‐14C]‐cyhalothrin (EFSA, 2014a)
			Foliar, 4‐8 × 55 g/ha	7 DALA	[cyclopropyl‐14C]‐cyhalothrin (EFSA, 2014a)
	Cereals/grasses	Wheat	Foliar, 2 × 224 g/ha	14, 85 DALA	[cyclopropyl‐14C] and [benzyl‐14C]‐ lambda‐cyhalothrin (EFSA, 2014a)
			Foliar, 3 × 224 g/ha	30 DALA
	Pulses/oilseeds	Soya bean	Foliar, 2 × 20 g/ha	39, 51 DALA	[cyclopropyl‐14C] and [benzyl‐14C]‐ lambda‐cyhalothrin (EFSA, 2014a)
		Cotton	Foliar, 3 × 66 g/ha	30, 50 DALA	[cyclopropyl‐14C] and [benzyl‐14C]‐ lambda‐cyhalothrin (EFSA, 2014a)
Rotational crops (available studies)	Crop groups	Crop(s)	Application (s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Carrot	Bare soil, 1 × 470 g/ha	30, 60, 120	[cyclopropyl‐14C] and [phenyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
			Bare soil, 1 × 110 g/ha	30, 120	[cyclopropyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
	Leafy crops	Lettuce	Bare soil, 1 × 470 g/ha	30, 60, 120	[cyclopropyl‐14C] and [phenyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
			Bare soil, 1 × 110 g/ha	30, 120	[cyclopropyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
	Cereal (small grain)	Wheat	Bare soil, 1 × 470 g/ha	30, 60, 120	[cyclopropyl‐14C] and [phenyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
			Bare soil, 1 × 110 g/ha	30, 120	[cyclopropyl‐14C]‐lambda‐cyhalothrin (EFSA, 2014a)
Processed commodities (hydrolysis study)	Conditions		Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)		Yes	[cyclopropyl‐14C]‐ and [phenyl‐14C]‐lambda‐cyhalothrin. Extensive degradation of the parent to form compounds Ia (59% TRR), IV (63% TRR) and gamma‐lactone (15% TRR) (EFSA, 2014a)
	Baking, brewing and boiling (60 min, 100°C, pH 5)		Yes
	Sterilisation (20 min, 120°C, pH 6)		No

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	Apple, peach, sugar beet root, cabbage, potato, peas	−18	26	Months	Parent	EFSA (2014a)
	High oil content	Cotton seed, rape seed	−18	26	Months	Parent	EFSA (2014a)
		hops	−18	8	Months	Parent	EFSA (2014a)
	Dry/High starch	Wheat grain	−18	26	Months	Parent	EFSA (2014a)

B.1.2. Magnitude of residues in plants

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

Commodity	Region/ Indoor a	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRa (mg/kg)	CFb
Spice seeds, Spice fruits	NEU	2 × < 0.010; 0.011; 0.019; 0.031; 0.130	Residue trials on anise (2), caraway (2) and fennel (2) compliant with GAP. Extrapolation to spice fruits possible	0.3	0.130	0.015	n.a.

MRL: maximum residue level; GAP: Good Agricultural Practice; OECD: Organisation for Economic Co‐operation and Development; n.a.: not applicable.

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

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

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

^bConversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment. n/a, not applicable.

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.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing EU MRLb (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R,S and S,R isomers)(F)
0810000	Seed spices	0.01* (ft)	0.3 (ft) Further risk management considerations necessary	The submitted data are sufficient to derive an MRL proposal for the intended NEU use Risk for consumers unlikely A risk management decision is required whether it is appropriate to take over the MRL in the MRL legislation, despite the lack of toxicological data for certain degradation products (compounds Ia, IV and gamma lactone) observed in standard hydrolysis studies representative for sterilisation conditions
0820000, except 0820040	Fruit spices, except cardamom	0.03 (ft)	0.3 (ft) Further risk management considerations necessary	The submitted data are sufficient to derive an MRL proposal by extrapolation from spice seeds for the intended NEU use Risk for consumers unlikely A risk management decision is required whether it is appropriate to take over the MRL in the MRL legislation, despite the lack of toxicological data for certain degradation products (compounds Ia, IV and gamma lactone) observed in standard hydrolysis studies representative for sterilisation conditions
0820040	Cardamon	2 (ft)	2 (ft) (No change required)	The submitted data are sufficient to derive an MRL proposal of 0.3 mg/kg by extrapolation from spice seeds for the intended NEU use, which is lower than the existing tentative MRL

MRL: maximum residue level; NEU: northern Europe.

^*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.

(F): Fat soluble.

(ft): The European Food Safety Authority identified some information on certain metabolites (compounds Ia, IV and gamma‐lactone) formed under sterilisation conditions 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 6 July 2020, or, if that information is not submitted by that date, the lack of it.

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
Citrus fruits	0.003	STMR × PF (EFSA, 2015)	Acute risk assessment performed only for the crops under consideration
Tree nuts	0.01	STMR (EFSA, 2015)
Apples	0.02	STMR (EFSA, 2015)
Pears	0.02	STMR (EFSA, 2015)
Medlar	0.08	STMR (EFSA, 2015)
Loquat	0.08	STMR (EFSA, 2015)
Quinces	0.08	STMR (EFSA, 2015)
Apricots	0.03	STMR (EFSA, 2015)
Cherries	0.13	STMR (EFSA, 2015)
Peaches	0.03	STMR (EFSA, 2015)
Plums	0.02	STMR (EFSA, 2015)
Table grapes	0.02	STMR x PF (EFSA, 2017)a
Wine grapes	0.02	STMR (EFSA, 2015)
Cane fruits	0.02	STMR (EFSA, 2015)
Blueberries, Cranberries	0.02	STMR (EFSA, 2015)
Currants	0.06	STMR (EFSA, 2015)
Gooseberries, Rose hips	0.02	STMR (EFSA, 2015)
Mulberries	0.02	STMR (EFSA, 2015)
Azaroles, Elderberries	0.02	STMR (EFSA, 2015)
Table olives	0.13	STMR (EFSA, 2015)
Kaki/Japanese persimmons	0.02	STMR (EFSA, 2015)
Kiwi	0.01	STMR (EFSA, 2015)
Bananas	0.02	STMR x PF (EFSA, 2015)
Mangoes	0.01	STMR x PF (EFSA, 2015)
Potatoes	0.01	STMR (EFSA, 2015)
Tropical roots and tuber veg	0.01	STMR (EFSA, 2015)
Beetroot	0.01	STMR (EFSA, 2015)
Carrots	0.01	STMR (EFSA, 2015)
Celeriac	0.03	STMR (EFSA, 2015)
Horseradish Jerusalem artichokes Parsnips Parsley root Salsify Swedes Turnips	0.01	STMR (EFSA, 2015)
Radishes	0.02	STMR (EFSA, 2015)
Bulb vegetables	0.05	STMR (EFSA, 2015)
Tomatoes	0.02	STMR (EFSA, 2015)
Peppers	0.02	STMR (EFSA, 2015)
Aubergines	0.03	STMR (EFSA, 2015)
Okra	0.03	STMR (EFSA, 2015)
Cucumbers	0.01	STMR (EFSA, 2015)
Gherkins	0.04	STMR (EFSA, 2015)
Courgettes	0.04	STMR (EFSA, 2015)
Cucurbits with inedible peel	0.01	STMR x PF (EFSA, 2015)
Sweet corn	0.01	STMR (EFSA, 2015)
Flowering brassica	0.02	STMR (EFSA, 2015)
Brussels sprouts	0.02	STMR (EFSA, 2015)
Head cabbages	0.03	STMR (EFSA, 2015)
Chinese cabbages	0.08	STMR (EFSA, 2015)
Kohlrabi	0.01	STMR (EFSA, 2015)
Lamb's lettuces	0.34	STMR (EFSA, 2015)
Lettuces	0.03	STMR (EFSA, 2015)
Escarole	0.02	STMR (EFSA, 2015)
Cresses, Land cresses	0.23	STMR (EFSA, 2015)
Roman rocket	0.23	STMR (EFSA, 2015)
Baby leaf crops	0.23	STMR (EFSA, 2015)
Spinach	0.20	STMR (EFSA, 2015)
Chards/Beet leaves	0.05	STMR (EFSA, 2015)
Herbs and edible flowers	0.23	STMR (EFSA, 2015)
Beans with pods	0.11	STMR (EFSA, 2015)
Beans without pods	0.02	STMR (EFSA, 2015)
Peas with pods	0.02	STMR (EFSA, 2015)
Peas without pods	0.02	STMR (EFSA, 2015)
Lentils	0.02	STMR (EFSA, 2015)
Asparagus	0.01	STMR (EFSA, 2015)
Celeries	0.05	STMR (EFSA, 2019b)
Fennel	0.11	STMR (EFSA, 2019b)
Globe artichokes	0.04	STMR (EFSA, 2015)
Leeks	0.02	STMR (EFSA, 2015)
Wild fungi	0.17	STMR (EFSA, 2015)
Pulses	0.01	STMR (EFSA, 2015)
Oilseeds	0.01	STMR (EFSA, 2015)
Olives for oil production	0.11	STMR (EFSA, 2015)
Barley	0.09	STMR (EFSA, 2015)
Maize/corn	0.01	STMR (EFSA, 2015)
Oats	0.09	STMR (EFSA, 2015)
Rice	0.04	STMR (EFSA, 2019b)
Sorghum	0.01	STMR (EFSA, 2015)
Wheat, Rye	0.01	STMR (EFSA, 2015)
Coffee	0.01	STMR (FAO, 2015)
Hops	3.30	STMR (EFSA, 2015)
Seed spices	0.02	STMR	0.13	HR
Fruit spices, except cardamom	0.02	STMR (seed spices)	0.13	HR
Cardamom	0.28	STMR (FAO, 2015)
Root and rhizome spices	0.05	STMR (EFSA, 2015
Sugar beet roots	0.01	STMR (EFSA, 2015)
Sugar canes	0.02	STMR (EFSA, 2015)
Chicory roots	0.01	STMR (EFSA, 2015)
Swine, meat	0.23	STMR (EFSA, 2015)b
Swine, fat	1.00	STMR (EFSA, 2015)
Swine, liver	0.008	STMR (EFSA, 2015)
Swine, kidney	0.03	STMR (EFSA, 2015)
Swine, edible offal	0.03	STMR (EFSA, 2015)c
Ruminant, meat	0.23	STMR (EFSA, 2015)b
Ruminant, fat	1.00	STMR (EFSA, 2015)
Ruminant, liver	0.008	STMR (EFSA, 2015)
Ruminant, kidney	0.03	STMR (EFSA, 2015)
Ruminant, edible offal	0.03	STMR (EFSA, 2015)c
Poultry meat	0.01	STMR (EFSA, 2015)
Poultry fat	0.01	STMR (EFSA, 2015)
Poultry liver	0.01	STMR (EFSA, 2015)
Equine, other farmed, meat	0.23	STMR (EFSA, 2015)b
Equine, other farmed, fat	1.00	STMR (EFSA, 2015)
Equine, other farmed, liver	0.008	STMR (EFSA, 2015)
Equine, other farmed, kidney	0.03	STMR (EFSA, 2015)
Equine, other farmed e.offal	0.03	STMR (EFSA, 2015)c
Ruminant milk	0.01	STMR (EFSA, 2015)
Bird's eggs	0.01	STMR (EFSA, 2015)

STMR: supervised trials median residue; PF: processing factor; HR: highest residue.

^aSTMR derived from the approved use of gamma‐cyhalothrin multiplied by a potency factor of 2 to take into account the hazard contribution of gamma‐cyhalothrin to lambda‐cyhalothrin (EFSA, 2017).

^bConsumption figures in the EFSA PRIMo are expressed as meat. Input values for mammals are calculated considering a 80%/90% muscle/fat content (FAO, 2016).

^cFor edible offal of mammals, the input values derived for liver were included in the calculation.

Appendix E – Used compound codes

1.

Code/trivial name	Chemical name/SMILES notation/InChiKeya	Structural formulab
Lambda‐cyhalothrin	A 1:1 mixture of: (R)‐α‐cyano‐3‐phenoxybenzyl (1S,3S)‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate and (S)‐α‐cyano‐3‐phenoxybenzyl (1R,3R)‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate or a 1:1 mixture of: (R)‐α‐cyano‐3‐phenoxybenzyl (1S)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate and (S)‐α‐cyano‐3‐phenoxybenzyl (1R)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate Cl\C(=C/[C@@H]3[C@H](C(=O)O[C@@H](C#N)c2 cccc(Oc1ccccc1)c2)C3(C)C)C(F)(F)F.N#C[C@@H](OC(=O)[C@@H]1[C@H](/C=C(\Cl)C(F)(F)F)C1(C)C)c3cccc(Oc2ccccc2)c3 BFPGVJIMBRLFIR‐GUCBCRIZSA‐N
Gamma‐cyhalothrin	(S)‐α‐cyano‐3‐phenoxybenzyl (1R,3R)‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate or (S)‐α‐cyano‐3‐phenoxybenzyl (1R)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate CC1([C@H]([C@H]1C(=O)O[C@H](C#N)c2cccc(c2)Oc3ccccc3)/C=C(/C(F)(F)F)\Cl)C BFPGVJIMBRLFIR‐GUCBCRIZSA‐N
Cyhalothrin	(RS)‐α‐cyano‐3‐phenoxybenzyl (1RS,3RS)‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate or (RS)‐α‐cyano‐3‐phenoxybenzyl (1RS)‐cis‐3‐[(Z)‐2‐chloro‐3,3,3‐trifluoropropenyl]‐2,2‐dimethylcyclopropanecarboxylate Cl\C(=C/[C@H]3[C@@H](C(=O)OC(C#N)c2cccc(Oc1ccccc1)c2)C3(C)C)C(F)(F)F.FC(F)(F)C(/Cl) = C/[C@@H]3[C@H](C(=O)OC(C#N)c2cccc(Oc1ccccc1)c2)C3(C)C OOAOVGPMANECPJ‐RWEUCVCFSA‐N
Compound Ia	(1RS,3RS)‐3‐[(1Z)‐2‐chloro‐3,3,3‐ trifluoro‐1‐propen‐1‐yl]‐2,2‐dimethylcyclopropanecarboxylic acid Cl\C(=C/[C@H]1[C@@H](C(=O)O)C1(C)C)C(F)(F)F.FC(F)(F)C(/Cl) = C/[C@@H]1[C@H](C(=O)O)C1(C)C DPUIEEBDWOJPHB‐OBDQHKNMSA‐N
Compound IV	3‐phenoxybenzaldehyde O=Cc2cc(Oc1ccccc1)ccc2 MRLGCTNJRREZHZ‐UHFFFAOYSA‐N
Gamma‐lactone (R947650)	(1RS,4RS,5SR)‐4‐[(1RS)‐1‐chloro‐2,2,2‐trifluoroethyl]‐6,6‐dimethyl‐3‐oxabicyclo[3.1.0]hexan‐2‐one (Unstated stereochemistry) CC2(C)C1C(=O)OC(C(Cl)C(F)(F)F)C12 ZSSZFVGRINYCPY‐UHFFFAOYSA‐N

SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^aACD/Name 2018.2.2 ACD/Labs 2018 Release (File version N50E41, Build 103230, 21 July 2018).

^bACD/ChemSketch 2018.2.2 ACD/Labs 2018 Release (File version C60H41, Build 106041, 7 December 2018).

Suggested citation: EFSA (European Food Safety Authority) , Anastassiadou M, Bernasconi G, 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, 2020. Reasoned opinion on the modification of the existing maximum residue levels for lambda‐cyhalothrin in seed and fruit spices. EFSA Journal 2020;18(6):6110, 28 pp. 10.2903/j.efsa.2020.6110