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. 2021 Mar 23;19(3):e06499. doi: 10.2903/j.efsa.2021.6499

Modification of the existing maximum residue levels for cyprodinil in blueberries, cranberries, currants and gooseberries

EFSA (European Food Safety Authority)✉, Maria Anastassiadou, Giulia Bellisai, Giovanni Bernasconi, Alba Brancato, Luis Carrasco Cabrera, Lucien Ferreira, Luna Greco, Samira Jarrah, Aija Kazocina, Renata Leuschner, Jose Oriol Magrans, Ileana Miron, Stefanie Nave, Ragnor Pedersen, Hermine Reich, Miguel Santos, Alessia Pia Scarlato, Anne Theobald, Benedicte Vagenende, Alessia Verani
PMCID: PMC7985993  PMID: 33777238

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 levels (MRL) for the active substance cyprodinil in blueberries, cranberries, currants and gooseberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blueberries, cranberries, currants and gooseberries. Adequate analytical methods for enforcement are available to control the residues of cyprodinil 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 uses of cyprodinil on blueberries, cranberries, currants and gooseberries according to the reported agricultural practices will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to present a risk to consumer health.

Keywords: cyprodinil, small fruits and berries, fungicide, MRL, consumer risk assessment

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 cyprodinil in blueberries, gooseberries, currants and cranberries. 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 10 November 2020. To accommodate for the intended uses of cyprodinil, the EMS proposed to raise the existing MRL from 3 to 8 mg/kg in blueberries, gooseberries, currants and cranberries.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 8 December 2020, the EMS submitted the requested information in a revised evaluation report, which replaced the previously submitted evaluation report.

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

The metabolism of cyprodinil following foliar application was investigated in crops belonging to the groups of fruit crops, root crops and cereals during the peer review. Studies investigating the effect of processing on the nature of cyprodinil (hydrolysis studies) demonstrated that cyprodinil is stable. As the proposed uses of cyprodinil are on permanent or semi‐permanent crops, investigations of residues in rotational crops are not required.

EFSA concluded that for the crops assessed in this application, metabolism of cyprodinil in primary crops and in processed products has been sufficiently addressed and that the previously derived residue definitions proposed as ‘cyprodinil’ are applicable.

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) and gas chromatography with mass spectrometry (GC–MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The method enables quantification of residues at or above 0.01 mg/kg (limit of quantification, LOQ) in the crops assessed. For enforcement purposes, the LOQ of 0.02 mg/kg for cyprodinil for the crops under assessment was proposed in the framework of the MRL review.

The available residue trials suffice to derive MRL proposals of 8 mg/kg for blueberries, cranberries, currants and gooseberries.

Specific processing studies were not submitted in the framework of the present MRL application and are not required considering the low contribution of the individual crops to the dietary intake of cyprodinil. Residues of cyprodinil in commodities of animal origin were not assessed since the crops under consideration in this MRL application are normally not fed to livestock.

The toxicological profile of cyprodinil was assessed in the framework of the European Union (EU) pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day. An acute reference dose (ARfD) was deemed unnecessary.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). No concerns from long‐term exposure to cyprodinil were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for a maximum 56% of the ADI (NL toddler diet). The individual contribution of residues in blueberries, cranberries, currants and gooseberries to the total consumer exposure was low, accounting for no more than the 1.13% of the ADI.

EFSA concluded that the proposed use of cyprodinil on blueberries, cranberries, currants and gooseberries will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers’ health.

It is to be noted that the peer review for the renewal of approval of cyprodinil in accordance with Regulation (EC) No 1107/2009 is ongoing and not yet finalised. Therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

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 MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification
Enforcement residue definition: cyprodinilF
154010 Blueberries 3 8 The submitted data suffice to derive an MRL proposal for the indoor EU use.
Risk for consumers unlikely.
154020 Cranberries 3 8
154030 Currants 3 8
154040 Gooseberries 3 8
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MRL: maximum residue level.

a

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

F

Fat soluble (Regulation (EU) 2020/1565).

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for cyprodinil in blueberries, gooseberries, currants and cranberries. The detailed description of the intended uses of cyprodinil, which are the basis for the current MRL application, is reported in Appendix A.

Cyprodinil is the ISO common name for 4‐cyclopropyl‐6‐methyl‐N‐phenylpyrimidin‐2‐amine (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Cyprodinil was evaluated in the framework of Directive 91/414/EEC1 with France designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on apples and winter wheat. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (2006). Cyprodinil was approved2 for the use as a fungicide on 1 May 2007.

The process of renewal of the first approval is currently ongoing.

The EU MRLs for cyprodinil are established in Annexes II of Regulation (EC) No 396/20053. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2013) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA issued two reasoned opinions on the modification of MRLs for cyprodinil (EFSA, 2019a,d). The proposals from these reasoned opinions have been considered in recent MRL regulations.4 Certain Codex maximum residue limits (CXLs) for cyprodinil were assessed by EFSA (2014, 2016, 2018b, 2019c) and implemented in the European Union (EU) legislation.

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 cyprodinil in blueberries, gooseberries, currants and cranberries. 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 10 November 2020. To accommodate for the intended uses of cyprodinil, the EMS proposed to raise the existing MRLs from 3 to 8 mg/kg in blueberries, gooseberries, currants and cranberries.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 8 December, the EMS submitted the requested information in a revised evaluation report (Germany, 2020), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Germany, 2020), the DAR (France, 2003) and its addendum (France, 2009) prepared under Directive 91/414/EEC, the Commission review report on cyprodinil (European Commission, 2006), the conclusion on the peer review of the pesticide risk assessment of the active substance cyprodinil (EFSA, 2006), as well as the conclusions from previous EFSA opinions on cyprodinil (EFSA, 2019a,d), including the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2013).

For this application, the data requirements established in Regulation (EU) No 544/20115 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 546/20116.

As the EU pesticides peer review for the renewal of approval of cyprodinil in accordance with Regulation (EC) No 1107/2009 is not yet finalised, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.

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, is presented in Appendix B.

The evaluation report submitted by the EMS (Germany, 2020) 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 cyprodinil following foliar applications was investigated in the framework of the peer review under Directive 91/414/EEC (EFSA, 2006) and further assessed in the framework of the MRL review (EFSA, 2013) in the following crops: fruit crops (apple, peach and tomato), root crops (potato) and cereals (wheat). Cyprodinil was found to be rather persistent and remained the dominant residue up to 60 days after the last application in fruit crops and cereals. For potato tubers, a different metabolic pattern resulting from the uptake of soil metabolites was observed.

For the intended uses, the metabolic behaviour in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

Investigations of the nature of residues in rotational crops are not required as the proposed uses of cyprodinil are on permanent or semi‐permanent crops (FAO, 2016a).

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of cyprodinil residues was investigated under standard hydrolysis conditions indicating that cyprodinil is hydrolytically stable under the representative processing conditions of pasteurisation, baking, brewing, boiling and sterilisation (EFSA, 2006, 2013). The relevant residue definition for enforcement and risk assessment in processed commodities is therefore ‘cyprodinil’.

1.1.4. Methods of analysis in plants

Various analytical methods for enforcement purposes were assessed during the EU pesticides peer review (EFSA, 2006) and further discussed in the MRL review (EFSA, 2013). Multi‐residue methods are available using gas chromatography with mass spectrometry (GC–MS) (DFG S19) with a limit of quantification (LOQ) of 0.02 mg/kg and a QuEChERS method in combination with high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) and GC–MS, as described by CEN (2018), for enforcement of cyprodinil in high acid content matrices, with an LOQ of 0.01 mg/kg (EFSA, 2013). Considering the large number of residue trials evaluated during the MRL review (EFSA, 2013) which were conducted with an LOQ of 0.02 mg/kg, an LOQ of 0.02 mg/kg for cyprodinil in plant commodities was set in Reg. (EC) No 396/2005.

EFSA concluded that sufficiently validated analytical enforcement methods are available for the determination of cyprodinil residues in blueberries, cranberries, currants and gooseberries which allow quantification of residues at or above the validated LOQ of 0.01 mg/kg.

1.1.5. Storage stability of residues in plants

The storage stability of cyprodinil was investigated in the context of the peer review (EFSA, 2006) and the MRL review (EFSA, 2013). Residues of cyprodinil were found to be stable at ≤ –18°C for up to 26 months in high water content commodities (peaches, apples) and 24 months in high acid content commodities (grapes, strawberries) and in dry/high starch content commodities (wheat).

For blueberries, cranberries, currants and gooseberries, classified as crops with high acid content, sufficient storage stability data are available.

1.1.6. Proposed residue definitions

Based on the primary and rotational crop metabolism studies, and the results of the hydrolysis studies, the residue definitions for both enforcement and risk assessment purposes were proposed as ‘cyprodinil’ in the context of the peer review and MRL review (EFSA, 2006, 2013). The residue definition set for cyprodinil in Regulation (EC) No 396/2005 is aligned with the EFSA recommendations.

In the framework of the MRL review, EFSA highlighted that for root and tuber vegetables the residue definition might need to be reconsidered, if new uses are requested for cyprodinil in these crops in the future (EFSA, 2013). This is however not relevant for the uses under assessment, namely, blueberries, cranberries, currants and gooseberries, which belong to the category of fruits.

Future proposals to revise the residue definitions for cyprodinil in the framework of the on‐going renewal of the approval of cyprodinil might result in the reconsideration of the MRL proposal and risk assessment derived in this opinion.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the intended EU indoor use, the applicant submitted six Good Agricultural Practice (GAP)‐compliant indoor trials (3 × 375 g/ha, preharvest interval 7 days) on black currants (four trials) and blueberries (two trials) which were all performed in Germany from 2016 to 2017. Half of the trials submitted was designed as decline studies. The residue trial data are summarised in Appendix B.1.2.1.

The samples were analysed for the parent compound according to 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. The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated.

The number of trials is sufficient to derive an MRL proposal of 8 mg/kg for currants and blueberries. The applicant proposes to combine available residue data on currants and blueberries and to extrapolate results to gooseberries and cranberries. According to the EU guidance document (European Commission, 2017), such an extrapolation is acceptable and is sufficiently supported by residue data. An MRL proposal of 8 mg/kg is thus derived also for gooseberries and cranberries.

It is to be noted that residues of cyprodinil above the LOQ were observed in untreated samples of the two trials on currants during the 2016 growing season (0.017 and 0.038 mg/kg) and in the decline trial on currants of 2017 (0.029–0.033 mg/kg). EFSA requested the EMS explanation concerning those observed residues. While no further information could be retrieved from the study reports to justify the findings, the EMS expressed the view that the impact of the contamination of the untreated samples would be very minor if any with regard to the proposed MRL amendment.

It is concluded that an MRL of 8 mg/kg would be required to support the indoor use of cyprodinil on blueberries, cranberries, currants and gooseberries.

1.2.2. Magnitude of residues in rotational crops

Blueberries, cranberries, currants and gooseberries represent semi‐permanent crops and are not expected to be grown in rotation with other plants (FAO, 2016a). Therefore, investigations of residues of cyprodinil in rotational crops are not required in the framework of this application.

1.2.3. Magnitude of residues in processed commodities

Studies investigating the magnitude of cyprodinil residues in processed blueberries, cranberries, currants and gooseberries have not been submitted and are not required, considering the low contribution of residues in crops under assessment to the total consumer exposure.

1.2.4. Proposed MRLs

The submitted data suffice to propose an MRL of 8 mg/kg for cyprodinil in blueberries, cranberries, currants and gooseberries in support of the intended indoor GAP. In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

2. Residues in livestock

Blueberries, cranberries, currants and gooseberries are not used for feed purposes. Therefore, the nature and magnitude of cyprodinil residues in livestock are not assessed in the framework of this application.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2019b). 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, 2018a).

The toxicological profile of cyprodinil was assessed in the framework of the EU pesticides peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day. Currently, no acute reference dose (ARfD) is set for cyprodinil (European Commission, 2010a,b).

For the calculation of the chronic exposure to cyprodinil from blueberries, cranberries, currants and gooseberries, EFSA used the median residue (STMR) values derived from the residue trials submitted (see Sections 1.2.1 and B.1.2.1). For the remaining crops, the STMR values as reported in the MRL review (EFSA, 2013) and in previous EFSA reasoned opinions (EFSA, 2019a,d) were used as input values; for Codex MRLs implemented in the EU MRL legislation, the STMR values derived by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) were taken into account in the risk assessment process (FAO, 2014, 2016a,b, 2019). The details on the input values are presented in Appendix D.1.

No concerns from long‐term exposure to cyprodinil were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for a maximum 56% of the ADI (NL toddler diet). The individual contribution of residues in blueberries, cranberries, currants and gooseberries to the total consumer exposure was low, i.e. 0.11% (NL toddler), 0.07% (GEMS/Food G10), 1.13% (NL toddler) and 0.15% (PL general) of the ADI respectively.

EFSA concluded that the long‐term intake of residues of cyprodinil resulting from the existing and the intended uses 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 an MRL proposal for blueberries, cranberries, currants and gooseberries.

EFSA concluded that the proposed use of cyprodinil on blueberries, cranberries, currants and gooseberries will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers’ health.

As the peer review on the renewal of the approval of cyprodinil in accordance with Regulation (EC) No 1107/2009 is currently ongoing, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.

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

CAC

Codex Alimentarius Commission

CF

conversion factor for enforcement to risk assessment residue definition

CXL

Codex maximum residue limit

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

HPLC–MS/MS

high‐performance liquid chromatography with tandem mass spectrometry

HPLC‐UVD

high‐performance liquid chromatography with ultra‐violet detector

HR

highest residue

IEDI

international estimated daily intake

ILV

independent laboratory validation

InChiKey

International Chemical Identifier Key

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

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

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SEU

southern Europe

STMR

supervised trials median residue

UV

ultraviolet (detector)

WG

water‐dispersible granule

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–max) g a.s./hL
(max) Water L/ha (max) Rate (max) Unit
Currants (red, black and white) EU (DE) G Botrytis cinerea, other fungi WG 375 g/kg Foliar treatment – broadcast spraying From BBCH 59 1–3* 7–10 < 37.5 1,000 375 g a.s/ha 7 1,125 g a.s./ha as max seasonal rate.
Gooseberries (green, red and yellow) EU (DE) G Botrytis cinerea, other fungi WG 375 g/kg Foliar treatment – broadcast spraying From BBCH 59 1–3* 7–10 < 37.5 1,000 375 g a.s/ha 7 1,125 g a.s./ha as max seasonal rate.
Blueberries EU (DE) G Botrytis cinerea, other fungi WG 375 g/kg Foliar treatment – broadcast spraying From BBCH 59 1–3* 7–10 < 37.5 1,000 375 g a.s/ha 7 1,125 g a.s./ha as max seasonal rate.
Cranberries EU (DE) G Botrytis cinerea, other fungi WG 375 g/kg Foliar treatment – broadcast spraying From BBCH 59 1–3* 7–10 < 37.5 1,000 375 g a.s/ha 7 1,125 g a.s./ha as max seasonal rate.
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*

A maximum of two treatments per season has to be considered against grey mould (Botrytis cinerea) only.

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; WG: water‐dispersible granule.

a

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

b

CropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

c

Growth 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.

d

PHI: minimum pre‐harvest 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 Apple Foliar, 3 × 0.05 kg/hL (8, and 5 weeks intervals) 61 (fruits, foliage at harvest) Radiolabelling: 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Peach Foliar, 4 × 0.27 kg/ha, and 4 × 2.7 kg/ha 1 (fruits, foliage) Application to individual branches of separate fruit trees, 21 to 1 day PHI (7 day interval).
Radiolabelling: U‐14C‐phenyl or 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Tomato Foliar, 2 × 0.75 kg/ha 14 (fruits, foliage at harvest) First application when fruits 2 cm diameter; second application 28 days later. Radiolabelling: U‐14C‐phenyl or 2‐14C‐pyrimidine cyprodinil (EFSA, 2013).
Root crops Potato Foliar, 3 × 0.56 kg/ha (19–20 days interval) 14 (tuber, foliage at harvest) Radiolabelling: U‐14C‐phenyl or 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Cereals/grass Wheat Foliar, 1 × 0.75 kg/ha (5–6 leaf stage) 0‐35 (whole plant) Radiolabelling: U‐14C‐phenyl cyprodinil (EFSA, 2006, 2013).
Foliar, 1 × 0.75 + 1 × 0.50 kg/ha (22 days interval) 41 (straw, husk, grain at harvest) Radiolabelling: U‐14C‐phenyl or 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Rotational crops (available studies) Crop groups Crop(s) Application(s) PBI (DAT) Comment/Source
Root/tuber crops Sugar beet Foliar on wheat, 0.75 + 0.5 kg/ha 272 Radiolabelling: U‐14C‐phenyl and 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Radish Soil, 1.25 kg/ha 29, 124, 365 Radiolabelling: 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Leafy crops Lettuce Foliar on wheat, 0.75 + 0.5 kg/ha 43 Radiolabelling: U‐14C‐phenyl and 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Soil, 1.25 kg/ha 29, 124, 365 Radiolabelling: 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Cereal (small grain) Wheat Foliar on wheat, 0.75 + 0.5 kg/ha 106 Radiolabelling: U‐14C‐phenyl and 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Soil, 1.25 kg/ha 29, 180, 365 Radiolabelling: 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Maize Foliar on wheat, 0.75 + 0.5 kg/ha 302 Radiolabelling: U‐14C‐phenyl and 2‐14C‐pyrimidine cyprodinil (EFSA, 2006, 2013).
Processed commodities (hydrolysis study) Conditions Stable? Comment/Source
Pasteurisation (20 min, 90°C, pH 4) Yes EFSA (2006, 2013)
Baking, brewing and boiling (60 min, 100°C, pH 5) Yes EFSA (2006, 2013)
Sterilisation (20 min, 120°C, pH 6) Yes EFSA (2006, 2013)
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B.1.1.1.

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 Peaches, apples –18 26 Months cyprodinil EFSA (2006, 2013)
Dry/High starch Wheat –18 24 Months cyprodinil EFSA (2006, 2013)
High acid content Grapes, strawberries –18 24 Months cyprodinil EFSA (2006, 2013)
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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
Blueberries, Cranberries, Currants, Gooseberries Indoor 0.33; 1.70; 2.3; 4.10e Combined dataset of GAP‐compliant indoor residue trials on black currants (four) and blueberries (two). Extrapolation to derive an MRL proposal for blueberries, cranberries, currants and gooseberries is possible. 8 4.1 1.02 1
0.17; 0.26
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MRL: maximum residue level; GAP: Good Agricultural Practice.

a

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.

b

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

c

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

d

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

e

A higher residue was reported at a longer PHI of 10 days.

B.1.2.2. Residues in rotational crops

B.1.2.2.

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

Short‐term (acute) risk assessment: Not relevant since no ARfD has been considered necessary (European Commission, 2010a,b).

B.3.

B.4. Recommended MRLs

Codea Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification
Enforcement residue definition: cyprodinilF
154010 Blueberries 3 8 The submitted data suffice to derive an MRL proposal for the indoor EU use.
Risk for consumers unlikely.
154020 Cranberries 3 8
154030 Currants 3 8
154040 Gooseberries 3 8
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MRL: maximum residue level.

a

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

F

Fat soluble (Regulation (EU) 2020/1565).

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

1.

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity Existing/proposed MRL Source of input values Chronic risk assessment
Input value (mg/kg) Comment
Risk assessment residue definition: Cyprodinil
Blueberries 8 Proposed MRL 1.02 STMR‐RAC
Cranberries 8 Proposed MRL 1.02 STMR‐RAC
Currants (red, black, white) 8 Proposed MRL 1.02 STMR‐RAC
Gooseberries (green, red, yellow) 8 Proposed MRL 1.02 STMR‐RAC
Almonds 0.02* EFSA (2013) 0.02 STMR‐RAC
Brazil nuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Cashew nuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Chestnuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Coconuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Hazelnuts/cobnuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Macadamia 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Pecans 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Pine nut kernels 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Walnuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Other tree nuts 0.04 CXL (FAO, 2018) 0.02 STMR‐RAC
Apples 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Pears 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Quinces 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Medlar 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Loquats/Japanese medlars 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Other pome fruit 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Apricots 2 CXL (FAO, 2014) 0.68 STMR‐RAC
Cherries (sweet) 2 CXL (FAO, 2014) 0.68 STMR‐RAC
Peaches 2 CXL (FAO, 2014) 0.68 STMR‐RAC
Plums 2 CXL (FAO, 2014) 0.68 STMR‐RAC
Other stone fruit 2 CXL (FAO, 2014) 0.68 STMR‐RAC
Table grapes 3 EFSA (2013) 0.68 STMR‐RAC
Wine grapes 3 EFSA (2013) 0.67 STMR‐RAC
Strawberries 5 EFSA (2013) 0.99 STMR‐RAC
Blackberries 3 EFSA (2013) 0.81 STMR‐RAC
Raspberries (red and yellow) 3 EFSA (2013) 0.81 STMR‐RAC
Rose hips 3 EFSA (2013) 0.69 STMR‐RAC
Mulberries (black, white) 3 EFSA (2013) 0.69 STMR‐RAC
Azarole/Mediter. medlar 3 EFSA (2013) 0.69 STMR‐RAC
Elderberries 3 EFSA (2013) 0.69 STMR‐RAC
Other small fruit & berries 3 EFSA (2013) 0.69 STMR‐RAC
Kaki/Japanese persimmons 2 CXL (FAO, 2014) 0.48 STMR‐RAC
Avocados 1 CXL (FAO, 2014) 0.265 STMR‐RAC
Granate apple/pomegranates 5 CXL (FAO, 2019) 3.3 STMR‐RAC
Guavas 1.5 CXL (FAO, 2018) 0.485 STMR‐RAC
Potatoes 0.02* CXL (FAO, 2018) 0.02 STMR‐RAC
Beetroots 1.5 EFSA (2013) 0.45 STMR‐RAC
Carrots 1.5 EFSA (2013) 0.45 STMR‐RAC
Celeriacs/ turnip rooted celeries 0.3 EFSA (2013) 0.08 STMR‐RAC
Horseradishes 1.5 EFSA (2013) 0.45 STMR‐RAC
Parsnips 1.5 EFSA (2013) 0.45 STMR‐RAC
Parsley roots/Hamburg roots parsley 1.5 EFSA (2013) 0.45 STMR‐RAC
Radishes 0.3 CXL (FAO, 2014) 0.01 STMR‐RAC
Salsifies 1.5 EFSA (2013) 0.45 STMR‐RAC
Garlic 0.07 EFSA (2013) 0.02 STMR‐RAC
Onions 0.3 EFSA (2013) 0.07 STMR‐RAC
Shallots 0.07 EFSA (2013) 0.02 STMR‐RAC
Spring onions/green onions and Welsh onions 0.8 EFSA (2013) 0.17 STMR‐RAC
Tomatoes 1.5 EFSA (2013) 0.17 STMR‐RAC
Sweet peppers/bell peppers 1.5 EFSA (2013) 0.24 STMR‐RAC
Aubergines/ eggplants 1.5 EFSA (2013) 0.17 STMR‐RAC
Cucumbers 0.5 EFSA (2013) 0.13 STMR‐RAC
Gherkins 0.5 EFSA (2013) 0.13 STMR‐RAC
Courgettes 0.5 EFSA (2013) 0.13 STMR‐RAC
Other cucurbits ‐ edible peel 0.5 EFSA (2013) 0.13 STMR‐RAC
Melons 0.6 EFSA (2013) 0.08 STMR‐RAC
Pumpkins 0.6 EFSA (2013) 0.08 STMR‐RAC
Watermelons 0.6 EFSA (2013) 0.08 STMR‐RAC
Other cucurbits – inedible peel 0.6 EFSA (2013) 0.08 STMR‐RAC
Broccoli 2 CXL (FAO, 2014) 0.27 STMR‐RAC
Cauliflowers 2 CXL (FAO, 2014) 0.27 STMR‐RAC
Other flowering brassica 2 CXL (FAO, 2014) 0.27 STMR‐RAC
Head cabbages 0.7 CXL (FAO, 2014) 0.03 STMR‐RAC
Lamb's lettuce/corn salads 15 EFSA (2013) 3.1 STMR‐RAC
Lettuces 15 EFSA (2013) 3.1 STMR‐RAC
Escaroles/broad‐leaved endives 15 EFSA (2013) 3.1 STMR‐RAC
Cress and other sprouts and shoots 15 EFSA (2013) 3.1 STMR‐RAC
Land cress 15 EFSA (2013) 3.1 STMR‐RAC
Roman rocket/rucola 15 EFSA (2013) 3.1 STMR‐RAC
Red mustards 15 EFSA (2013) 3.1 STMR‐RAC
Baby leaf crops (including brassica species) 15 EFSA (2013) 3.1 STMR‐RAC
Other lettuce and other salad plants 15 EFSA (2013) 3.1 STMR‐RAC
Spinaches 15 EFSA (2013) 3.1 STMR‐RAC
Purslanes 15 EFSA (2013) 3.1 STMR‐RAC
Chards/beet leaves 15 EFSA (2013) 3.1 STMR‐RAC
Other spinach and similar 15 EFSA (2013) 3.1 STMR‐RAC
Witloofs/Belgian endives 0.06 EFSA (2013) 0.02 STMR‐RAC
Chervil 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Chives 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Celery leaves 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Parsley 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Sage 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Rosemary 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Thyme 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Basil and edible flowers 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Laurel/bay leaves 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Tarragon 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Other herbs 40 CXL (FAO, 2014) 5.05 STMR‐RAC
Beans (with pods) 2 EFSA (2013) 0.6 STMR‐RAC
Beans (without pods) 0.08 EFSA (2013) 0.02 STMR‐RAC
Peas (with pods) 2 EFSA (2013) 0.6 STMR‐RAC
Peas (without pods) 0.08 EFSA (2013) 0.02 STMR‐RAC
Lentils (fresh) 0.2 EFSA (2010) 0.07 STMR‐RAC
Asparagus 0.02* EFSA (2013) 0.02 STMR‐RAC
Celeries 30 CXL (FAO, 2018) 8.45 STMR‐RAC
Florence fennels 4 EFSA et al. (2019b, 2019d) 0.77 STMR‐RAC
Globe artichokes 4 CXL (FAO, 2018) 1.2 STMR‐RAC
Rhubarbs 2 EFSA (2019d) 0.43 STMR‐RAC
Beans 0.2 EFSA (2013) 0.06 STMR‐RAC
Peas 0.1 EFSA (2013) 0.02 STMR‐RAC
Lupins/lupini beans 0.1 EFSA (2013) 0.02 STMR‐RAC
Rapeseeds/canola seeds 0.02* CXL (FAO, 2016b) 0.02 STMR‐RAC
Barley 4 EFSA (2013) 0.75 STMR‐RAC
Oat 4 EFSA (2013) 0.75 STMR‐RAC
Rye 0.5 EFSA (2013) 0.13 STMR‐RAC
Wheat 0.5 EFSA (2013) 0.13 STMR‐RAC
Valerian root 1.5 EFSA (2013) 0.45 STMR‐RAC
Ginseng root 1.5 EFSA (2013) 0.45 STMR‐RAC
Other herbal infusions (dried roots) 1.5 EFSA (2013) 0.45 STMR‐RAC
Liquorice 1.5 EFSA (2013) 0.45 STMR‐RAC
Ginger 1.5 EFSA (2013) 0.45 STMR‐RAC
Turmeric/curcuma 1.5 EFSA (2013) 0.45 STMR‐RAC
Horseradish, root spices 10.5 EFSA (2013) 0.45 STMR‐RAC
Other spices (roots) 1.5 EFSA (2013) 0.45 STMR‐RAC
Risk assessment residue definition: Sum of cyprodinil and CGA 304075, expressed as cyprodinil.
Swine: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Swine: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Swine: Liver 0.02* EFSA (2013) 0.02 STMR‐RAC
Swine: Kidney 0.02* EFSA (2013) 0.02 STMR‐RAC
Swine: Edible offal (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Bovine: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Bovine: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Bovine: Liver 0.05 EFSA (2013) 0.02 STMR‐RAC
Bovine: Kidney 0.05 EFSA (2013) 0.02 STMR‐RAC
Bovine: Edible offal (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Sheep: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Sheep: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Sheep: Liver 0.05 EFSA (2013) 0.02 STMR‐RAC
Sheep: Kidney 0.05 EFSA (2013) 0.02 STMR‐RAC
Sheep: Edible offals (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Goat: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Goat: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Goat: Liver 0.05 EFSA (2013) 0.02 STMR‐RAC
Goat: Kidney 0.05 EFSA (2013) 0.02 STMR‐RAC
Goat: Edible offals (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Equine: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Equine: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Equine: Liver 0.05 EFSA (2013) 0.02 STMR‐RAC
Equine: Kidney 0.05 EFSA (2013) 0.02 STMR‐RAC
Equine: Edible offal (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Poultry: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Poultry: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Poultry: Liver 0.02* EFSA (2013) 0.02 STMR‐RAC
Poultry: Kidney 0.02* EFSA (2013) 0.02 STMR‐RAC
Other farmed animals: Muscle/meat 0.02* EFSA (2013) 0.02 STMR‐RAC
Other farmed animals: Fat tissue 0.02* EFSA (2013) 0.02 STMR‐RAC
Other farmed animals: Liver 0.05 EFSA (2013) 0.02 STMR‐RAC
Other farmed animals: Kidney 0.05 EFSA (2013) 0.02 STMR‐RAC
Other farmed animals: Edible offal (other than liver and kidney) 0.02* EFSA (2013) 0.02 STMR‐RAC
Eggs: Chicken 0.02* EFSA (2013) 0.02 STMR‐RAC
Eggs: Duck 0.02* EFSA (2013) 0.02 STMR‐RAC
Eggs: Goose 0.02* EFSA (2013) 0.02 STMR‐RAC
Eggs: Quail 0.02* EFSA (2013) 0.02 STMR‐RAC
Eggs: Others 0.02* EFSA (2013) 0.02 STMR‐RAC
Risk assessment residue definition: Sum of cyprodinil and CGA 304075 (free and conjugated), expressed as cyprodinil.
Milk: Cattle 0.02* EFSA (2013) 0.02 STMR‐RAC
Milk: Sheep 0.02* EFSA (2013) 0.02 STMR‐RAC
Milk: Goat 0.02* EFSA (2013) 0.02 STMR‐RAC
Milk: Horse 0.02* EFSA (2013) 0.02 STMR‐RAC
Milk: Others 0.02* EFSA (2013) 0.02 STMR‐RAC
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*

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

MRL: maximum residue level; STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; CXL: Codex maximum residue limit.

Appendix E – Used compound codes

1.

Code/trivial name IUPAC name/SMILES notation/InChiKeya Structural formulab
cyprodinil 4‐cyclopropyl‐6‐methyl‐N‐phenylpyrimidin‐2‐amine
Cc1cc(nc(Nc2ccccc2)n1)C3CC3
HAORKNGNJCEJBX‐UHFFFAOYSA‐N graphic file with name EFS2-19-e06499-g002.jpg
CGA321915 4‐cyclopropyl‐6‐methylpyrimidin‐2(1H)‐one
CC1=CC(=NC(=O)N1)C2CC2
QODMYONMGSMOCI‐UHFFFAOYSA‐N graphic file with name EFS2-19-e06499-g003.jpg
NOA422054 (2‐amino‐6‐cyclopropylpyrimidin‐4‐yl)methanol
Nc1nc(cc(CO)n1)C2CC2
SPGFTSNGXQXBSO‐UHFFFAOYAM graphic file with name EFS2-19-e06499-g001.jpg
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IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

a

ACD/Name 2019.1.3 ACD/Labs 2019 Release (File version N05E41, Build 111418, 3 September 2019).

b

ACD/ChemSketch 2019.1.3 ACD/Labs 2019 Release (File version C05H41, Build 111302, 27 August 2019).

Suggested citation: European Food Safety Authority (EFSA) , Anastassiadou M, Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Santos M, Scarlato AP, Theobald A, Vagenende B and Verani A, 2021. Reasoned opinion on the modification of the existing maximum residue levels for cyprodinil in blueberries, cranberries, currants and gooseberries. EFSA Journal 2020;19(3):6499, 24 pp. 10.2903/j.efsa.2021.6499

Requestor: European Commission

Question number: EFSA‐Q‐2020‐00731

Declarations of interest: The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.

Acknowledgments: EFSA wishes to thank: Stathis Anagnos, Laszlo Bura and Silvia Ruocco for the support provided to this scientific output.

Adopted: 25 February 2021

Notes

1

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1–32.

2

Council Directive 2006/64/EC of 18 July 2006, amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac as active substances. OJ L 206, 27.7.2006, p. 107–111.

3

Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1–16.

4

For an overview of all MRL Regulations on this active substance, please consult: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as

5

Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. OJ L 155, 11.6.2011, p. 1–66.

6

Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.6.2011, p. 127–175.

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