REASONED OPINION APPROVED: 3 November 2016 doi: 10.2903/j.efsa.2016.4638
Setting of a temporary maximum residue level for chlorantraniliprole in hops European Food Safety Authority (EFSA)
Abstract In accordance with the Article 53 of the Regulation (EC) 1107/2009, the United Kingdom granted a 120-day emergency authorisation for the use of chlorantraniliprole in hops following an application by the British Hop Association. To accommodate for the use of chlorantraniliprole according to the authorised good agricultural practices, the United Kingdom asked to set a temporary maximum residue level (MRL) in line with Article 16(1) in conjunction with Article 14 of Regulation (EC) No 396/2005. The United Kingdom 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. EFSA has assessed the available data and performed a risk assessment as regards the risks to consumers related to the exposure of chlorantraniliprole residues in hops. EFSA has derived three options for temporary MRLs to be discussed by risk managers. © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Keywords: chlorantraniliprole, hops, MRL application, consumer risk assessment
Requestor: European Commission Question number: EFSA-Q-2016-00547 Correspondence:
[email protected]
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EFSA Journal 2016;14(11):4638
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Suggested citation: EFSA (European Food Safety Authority), 2016. Reasoned opinion on the setting of a temporary maximum residue level for chlorantraniliprole in hops. EFSA Journal 2016;14(11):4638, 16 pp. doi:10.2903/j.efsa.2016.4638 ISSN: 1831-4732 © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.
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Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Summary In accordance with Article 18(4) of Regulation (EC) No 396/2005, the United Kingdom (UK), hereafter referred as the evaluating Member State (EMS), authorised the placing on the market within its territory of treated hops not complying with the existing European Union maximum residue level (EU MRL) due to the authorisation for the emergency use of chlorantraniliprole in hops according to the Article 53 of the Regulation (EC) 1107/2009 following an application from the British Hop Association. To accommodate the emergency use in the United Kingdom, the EMS proposes to raise the existing EU MRL from the limit of quantification (LOQ) of 0.02 mg/kg to a temporary MRL of 40 mg/kg. The United Kingdom 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). EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance chlorantraniliprole, the Joint Meeting on Pesticide Residues (JMPR) Evaluation report as well as the conclusions from previous EFSA opinions on chlorantraniliprole. The toxicological profile of chlorantraniliprole was assessed in the framework of the peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 1.56 mg/kg body weight (bw) per day. The setting of an acute reference dose (ARfD) was concluded to be unnecessary. The metabolism of chlorantraniliprole in primary crops was investigated in the fruit, leafy and pulses/oilseeds crop groups using foliar applications and in cereals after soil application. From these studies, the peer review established a general residue definition for enforcement and risk assessment as chlorantraniliprole only. For the use in hops, EFSA concludes that the metabolism of chlorantraniliprole in primary crops is sufficiently addressed and the residue definitions covering only parent chlorantraniliprole are applicable. The supervised residue trials submitted under the current MRL application are not in compliance with the good agricultural practices (GAP) authorised in the United Kingdom for the emergency use. Although the submitted residue trials are not appropriate to derive a definitive MRL, EFSA has derived two proposals for temporary MRLs to accommodate the emergency use of chlorantraniliprole for further risk management decision. Adequate analytical methods to enforce the residues of chlorantraniliprole in hops are available. Studies investigating the nature of chlorantraniliprole residues in processed commodities were evaluated during the peer-review process and it was concluded that the residue definition for raw and processed commodities are as well applicable for enforcement and risk assessment as chlorantraniliprole only. Specific studies investigating the magnitude of chlorantraniliprole residues in processed commodities are not required since the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI. Since hops are semipermanent crops and hops and their by-products are not used to feed livestock, the residues on rotational crops and in livestock as result of the emergency use of chlorantraniliprole are not considered in the current MRL application. The consumer risk assessment was performed with the revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) and using those residue values derived for the two temporary MRL proposals. For both scenarios, no long-term consumer intake concern was identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for approximately 2% of the ADI (NL child) in both scenarios. The contribution of chlorantraniliprole residues in hops to the total consumer exposure was insignificant counting for less 0.01% (UK adult). Acute consumer risk assessment was not performed since acute toxicological reference value for chlorantraniliprole was not established previously. EFSA concludes that none of the MRL proposals will result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a health risk to consumers.
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Setting of a tMRL for the emergency use of chlorantraniliprole in hops
The table below summarises all the possible MRL options presented in the current reasoned opinion: Code(a)
Commodity
Existing EU MRL (mg/kg)
Proposed EU tMRL (mg/kg)
Comment/justification
Enforcement residue definition: Chlorantraniliprole(F) 0700000
Hops
0.02*
No MRL proposal
40 (temporary)
10 (temporary)
Option 1: Residue trials were not conducted according to the critical use authorised in the UK under Article 53 of Regulation (EC) No 1107/2009 (1 9 35 g/ha, PHI 21 day); none of the trials was performed in NEU Considering the emergency authorisation granted in the UK for 120 days, EFSA derived two options for temporary MRLs to be considered by risk managers (option 2 and 3) Option 2: The proposal for the temporary MRL is based on the submitted overdosed US residue trials No risk for consumer has been identified with regard to chlorantraniliprole residues in hops related to the GAP tested in the supervised field trials (overdosed trials, shorter PHI) Option 3: The proposed temporary MRL is based on the scaled residue trials (scaling down by a factor of 3), taking into account that the supervised field trials were overdosed. The MRL proposal is still expected to overestimate the residues compared with the authorised UK GAP, since the samples were taken at shorter PHIs (between 0 and 14 days), while the GAP defines the PHI of 21 days No risk for consumer has been identified in relation to the MRL proposed as option 3
MRL: maximum residue level; tMRL: temporary maximum residue level; PHI: preharvest interval; NEU: northern Europe; GAP: good agricultural practice. (a): Commodity code number according to Annex I of Regulation (EC) 396/2005. *: Indicates that the MRL is set at the limit of analytical quantification (LOQ). (F): Fat soluble.
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Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Table of contents Abstract..................................................................................................................................................... Summary................................................................................................................................................... Background ............................................................................................................................................... The active substance and its use pattern ..................................................................................................... Assessment................................................................................................................................................ 1. Method of analysis ........................................................................................................................ 1.1. Methods for enforcement of residues in food of plant origin ............................................................. 1.2. Methods for enforcement of residues in food of animal origin ........................................................... 2. Mammalian toxicology ................................................................................................................... 3. Residues....................................................................................................................................... 3.1. Nature and magnitude of residues in plant ...................................................................................... 3.1.1. Primary crops................................................................................................................................ 3.1.1.1. Nature of residues......................................................................................................................... 3.1.1.2. Magnitude of residues ................................................................................................................... 3.1.1.3. Effect of industrial processing and/or household preparation ............................................................ 3.1.2. Rotational crops ............................................................................................................................ 3.2. Nature and magnitude of residues in livestock ................................................................................. 4. Consumer risk assessment ............................................................................................................. Conclusions and recommendations .............................................................................................................. References................................................................................................................................................. Abbreviations ............................................................................................................................................. Appendix A – Good Agricultural Practice (GAPs) ............................................................................................ Appendix B – Used compound codes ...........................................................................................................
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1 3 6 6 7 7 7 7 8 8 8 8 8 8 11 11 11 11 12 13 14 15 16
EFSA Journal 2016;14(11):4638
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Background The United Kingdom granted a 120-day emergency authorisation for the use of chlorantraniliprole in hops in accordance with Article 53 of the Regulation (EC) 1107/20091 following an application from the British Hop Association.2 Since the emergency use is expected to lead to residues exceeding the existing maximum residue level (MRL), the United Kingdom has, in accordance with Article 18(4) of Regulation (EC) No 396/20053 (hereinafter referred to as ‘the MRL Regulation’), authorised the placing on the market within its territory of treated hops not complying with the existing European Union (EU) MRL. In addition, the United Kingdom has submitted an application in the framework of Article 16 of the MRL Regulation to set a temporary MRL for chlorantraniliprole in hops. A temporary MRL is according to the United Kingdom justified since it is based on an emergency authorisation under Article 53, the concerned products constitute a minor component of consumer’s diet and the expected residues following the emergency use do not pose an unacceptable risk to consumers. In support of the request to set a temporary MRL, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), prepared an Evaluation Report which was submitted to the European Commission and to the European Food Safety Authority (EFSA). On 5 September 2016, the European Commission formally asked EFSA to assess the MRL request and to deliver a reasoned opinion according to Article 10 of the MRL Regulation. The application was included in the EFSA Register of Questions with the reference number EFSA-Q-2016-00547 and the following subject: Chlorantraniliprole: MRL in hops The United Kingdom asked to set the temporary MRL for chlorantraniliprole in hops according to Article 16(1) in conjunction with Article 14 of the MRL Regulation at the level of 40 mg/kg in hops. EFSA proceeded with the assessment of the application and the evaluation report. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall assess the application and the evaluation report and give a reasoned opinion on the risks to the consumers associated with the modification of the MRL. The opinion shall in particular include:
• • • • •
an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes; the anticipated limit of quantification (LOQ) for the pesticide/product combination; an assessment of the risks of the acceptable daily intake (ADI) and the acute reference dose (ARfD) being exceeded as a result for the modification of the MRL; the contribution to the intake due to the residues in the product for which the MRL was requested; any other element relevant to the risk assessment.
The evaluation report submitted by the United Kingdom (2016) 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. The deadline for providing the finalised reasoned opinion for the request is 5 December 2016.
The active substance and its use pattern Chlorantraniliprole is the ISO common name for 3-bromo-40 -chloro-1-(3-chloro-2-pyridyl)-20 -methyl6 -(methylcarbamoyl)pyrazole-5-carboxanilide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix B. Chlorantraniliprole is an insecticide belonging to the anthranilic diamide chemical class. The details of the authorised good agricultural practice (GAP) in the United Kingdom for the emergency use of chlorantraniliprole in hops are given in Appendix A. Chlorantraniliprole was evaluated in the framework of Directive 91/414/EEC with Ireland designated as rapporteur Member State (RMS). Chlorantraniliprole is approved under Regulation (EC) No 1107/2009 0
1
2 3
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1–50. British Hop Association (UK), Brown Thorne Cottage, Hereford, HR1 4ED, United Kingdom. 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.
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Setting of a tMRL for the emergency use of chlorantraniliprole in hops
by means of Commission Implementing Regulation (EU) No 1199/20134, which entered into force on 1 May 2014 for use as an insecticide. The representative uses evaluated in the peer review were field spray applications on apples, pears, peaches, apricots, citrus, grapes, tomatoes, aubergines, potatoes, pepper and lettuce, and glasshouse spray applications on tomatoes, aubergines, pepper, cucurbits and lettuce. The draft assessment report (DAR) of chlorantraniliprole has been peer reviewed by EFSA (2013a). The EU MRLs for chlorantraniliprole are established in Annex IIIA of Regulation (EC) No 396/2005. Since the entry into force of this regulation, EFSA has issued several reasoned opinions on the modification of MRLs for chlorantraniliprole (EFSA, 2010, 2011, 2012a,b, 2013b, 2015) which have been implemented in the MRL Regulation. In 2015, a number of Codex maximum residue limits (Codex MRLs; CXLs) adopted by the Codex Alimentarius Commission (CAC) in 2014 were implemented in the EU legislation by Regulation (EU) 2015/8455. It is noted that the CXL for hops set at the level of 40 mg/kg has not been taken over in the EU legislation due to different policy on extrapolation.6
Assessment EFSA bases its assessment on the evaluation report submitted by the United Kingdom (2016), the DAR prepared under Directive 91/414/EEC (Ireland, 2010), the Codex Commission in Pesticide Residues report (CCPR) (CAC, 2013), the Joint Meeting on Pesticide Residues (JMPR) (FAO, 2014) and the conclusion on the peer review of the pesticide risk assessment of the active substance chlorantraniliprole (EFSA, 2013a) as well as the conclusions from the latest EFSA reasoned opinion on chlorantraniliprole (EFSA, 2015). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20117 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a–g, 2000, 2010a,b, 2015; FAO, 2009; OECD, 2011).
1.
Method of analysis
1.1.
Methods for enforcement of residues in food of plant origin
Analytical methods for the determination of chlorantraniliprole residues in plant commodities were assessed during the peer review under Directive 91/414/EEC (EFSA, 2013a). The DFG S19 multiresidue method based on liquid chromatography and tandem mass detection (LC–MS/MS) was sufficiently validated at the LOQ of 0.01 mg/kg for the determination of chlorantraniliprole residues in high water, high acid and high oil content matrices and in dry/starch commodities. An independent laboratory validation (ILV) was available (EFSA, 2013a, 2015). Hop is a matrix which is normally difficult to analyse and therefore specific validation data are required to prove the applicability of analytical methods for enforcement in this matrix. According to the information available in the database of the EU Reference Laboratories for Residues of Pesticides, residues of chlorantraniliprole can be determined in hops at the LOQ of 0.1 mg/kg using the LC–electrospray ionisation (ESI) method (EURL-DataPool).
1.2.
Methods for enforcement of residues in food of animal origin
Analytical methods for the determination of chlorantraniliprole residues in food of animal origin were not assessed in the current application, as no MRL proposals were derived for feed commodities. 4
5
6
7
Commission Implementing Regulation (EU) No 1199/2013 of 25 November 2013 approving the active substance chlorantraniliprole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 315, 26.11.2013, p. 69–73. Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products. The residue trials submitted in support of the CXL request were found to be not representative for the GAP for which the Codex MRL was requested. 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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Setting of a tMRL for the emergency use of chlorantraniliprole in hops
2.
Mammalian toxicology
The toxicological profile of the active substance chlorantraniliprole was assessed in the framework of the peer review under Directive 91/414/EEC (Ireland 2010; EFSA, 2013a). The data were sufficient to derive the toxicological reference value compiled in Table 1. Table 1:
Overview of the toxicological reference values Source
Year
Value
Study
Safety factor
Rat, 2-year study, supported by mouse, 18-month study
Chlorantraniliprole ADI
EFSA
2013
1.56 mg/kg bw per day
ARfD
EFSA
2013
Not necessary
100
ADI: acceptable daily intake; ARfD: acute reference dose; bw: body weight.
It is noted that JMPR established an ADI of 2 mg/kg bw per day for chlorantraniliprole (FAO, 2009). The difference is resulting from a different rounding policy.
3.
Residues
3.1.
Nature and magnitude of residues in plant
3.1.1.
Primary crops
3.1.1.1. Nature of residues The metabolism of chlorantraniliprole in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC in the fruit, leafy, pulses/oilseeds and cereals crop groups (Ireland, 2010). The data of metabolism studies have been reported in the previous EFSA reasoned opinion (EFSA, 2013b) and the results were discussed in the EFSA peer-review conclusion (EFSA, 2013a). The overview of the metabolism studies is presented in the Table 2. Table 2:
Summary of available metabolism studies in plants Application
Crop group
Crop
Fruit Leafy Pulses/ oilseeds Cereals
Sampling(a)
Method, rate
Growth stage
Apple
Foliar: 3 9 100 g/ha
BBCH 71,75, 77
15, 30 DALA
Tomato Lettuce
Foliar: 3 9 100 g/ha Foliar: 3 9 100 g/ha
BBCH 61, 73, 81 BBCH 13, 19, 19
7, 15 DALA 7, 15 DALA
Cotton
Foliar: 1 9 150 g/ha Foliar: 1 9 150 g/ha
41 days seedling 57 days seedling
8, 15, 22, 86, 126 DAT 8, 21, 48 DAT
Excised foliage
50 mg/kg
After 4 days incubation
Soil drench: 1 9 300 g/ha
BBCH 11/12
14, 28, 56 and 132 DAT
Rice
Remark
BBCH: growth stages of mono- and dicotyledonous plants. (a): DALA: days after last application; DAT: day(s) after treatment.
Based on these metabolism studies, the residue definition for monitoring and risk assessment was proposed as chlorantraniliprole in the conclusion of the peer review (EFSA, 2013a). The current residue definition set in Regulation (EC) No 396/2005 is identical to the residue definition for enforcement derived in the peer review. For the use on hops, a crop belonging to the group of leafy crops, EFSA concludes that the metabolism of chlorantraniliprole is sufficiently addressed and the residue definitions for enforcement and risk assessment agreed during the peer review as ‘chlorantraniliprole’ only are applicable. 3.1.1.2. Magnitude of residues The details of the GAP of chlorantraniliprole in hops authorised in the United Kingdom as emergency use are given in Appendix A (UK critical good agricultural practice (cGAP), 1 9 35 g/ha, preharvest interval (PHI) 21 days).
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The applicant submitted four residue trials conducted in the USA with two applications of 112–115 g/ha. All the samples were taken at PHI 0 days; in two out of the four residue trials, the hop samples were also collected at PHI 1, 3, 7–8 and 13–14 days. In all the samples, residues of chlorantraniliprole were detected above the LOQ of 0.02 mg/kg. The submitted residue trials are not in compliance with the legal data requirements since the following deficiencies were noted:
• • •
the application rate and the number of applications are not matching with the United Kingdom GAP (the trials are significantly overdosed, the number of applications does not match with the GAP); the sampling time is not in accordance with the PHI defined in the United Kingdom GAP; the trials were not performed in the geographical region representative for the United Kingdom.
However, EFSA has assessed the data available and proposes the following MRL options to facilitate the risk managers’ decision-making: Option 1: No MRL proposal Taking into account the deficiencies of the trials, the trials would not be acceptable in a routine MRL application, and no MRL proposal would be derived. At least four GAP-compliant residue trials performed in a geographical region representative for the country where the authorisation is envisaged, would be required to support the setting of the MRL in hops. However, considering the emergency situation (Article 53 of Regulation (EC) No 1107/2009) and the request to set an MRL in hops on a temporary basis in accordance with the provisions of Article 18 (4) in conjunction with Article 16 of Regulation (EC) No 396/2005, EFSA derived two additional options for risk management consideration (option 2 and option 3 below). Option 2: MRL proposal based on the submitted residue trials Based on the results of the four submitted residue trials (residues at PHI that is closest to the authorised PHI of 21 days), EFSA calculated a MRL of 40 mg/kg using the OECD MRL calculator. The supervised trials median residue (STMR) to be used for the long-term dietary risk assessment is 9.3 mg/kg. Option 3: MRL proposal based on scaled residue trials, applying the proportionality principle Since the MRL proposal presented as option 2 is grossly overestimating the residues expected at the authorised GAP (the trials were overdosed in terms of number of applications with two applications instead of one, the application rate per hectare was overdosed by a factor of 3, seasonal application is overdosed by a factor of ca 6, the samples were taken at significantly shorter PHI of 0 days and 13/14 days after the last application instead of 21 days), EFSA calculated an additional option by applying the proportionality principle (CAC, 2013). In this option 3, the results of the trials are scaled down by a factor of 3. The MRL proposal derived in option 3 would still overestimate the expected residues following the treatment according to the authorised GAP since the samples were taken at a shorter PHI. It is noted that the criteria for using the proportionality principle are not completely fulfilled,8 but the MRL proposal of option 3 is based on data set that is corrected for one of the parameters that is not compliant with the authorised GAP and would therefore be more in line with the as low as reasonably achievable (ALARA) principle. The three options for the MRL proposal above described are summarised in Table 3.
8
The proportionality concept can be applied to data from field trials conducted within a rate range of between 0.39 and 49 the GAP rate. This is only valid when quantifiable residues occur in the data set. Scaling is acceptable if the application rate is the only deviation from critical GAP (cGAP) (CAC, 2013, Appendix VIII).
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USA
Scaled residue trials (scaling down by a factor of 3): 1.7(f); 1.8(g); 3.8(h); 5.3(h)
5.6(f); 6.1(g); 12.50(h); 17.50(h)
No residue trials compliant with the cGAP
Residue levels observed in the supervised residue trials(b) (mg/kg)
Option 3: Based on scaled residue trials submitted (scaled down by a factor of 3), EFSA calculated a MRL proposal using the OECD calculator MRLOECD: 10.07/10
Option 1: No MRL proposal is derived Option 2: Based on the residue trials submitted, EFSA calculated an MRL using the OECD calculator MRLOECD: 33.1/40 Noted that the MRL proposal above and the residue values were derived from the submitted data set and none of the residue trials was conducted according to the UK cGAP (1 9 35 g/ha, PHI 21 days) authorised for the emergency use of chlorantraniliprole in hops
The submitted residue trials are not compliant with the UK GAP Based on the trials, three options are derived for risk management consideration, as follows:
Recommendations/comments(c)
10
No proposal 40
MRL proposal (mg/kg)
5.3
– 17.5
2.8
– 9.3
HR(d) STMR(e) (mg/kg) (mg/kg)
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GAP: good agricultural practice; PHI: preharvest interval; cGAP: critical good agricultural practice; MRL: maximum residue level; OECD: Organisation for Economic Co-operation and Development. (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): Individual residue levels considered for MRL calculation are reported in ascending order. (c): Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values). (d): HR: Highest residue level. (e): STMR: Median residue level. (f), (g): Sample taken 13, 14 days after the last treatment, respectively. (h): Samples taken at the day of the last treatment.
Hops (2 9 115 g/ha, PHI 0 days)
Region/ indoor(a)
Overview of the available residues trials data
Crop (trial GAPs)
Table 3:
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
The stability of chlorantraniliprole residues in plant matrices under frozen conditions prior to analysis was assessed during the peer review under Directive 91/414/EEC (EFSA, 2013a). Residues of chlorantraniliprole were found to be stable at ≤ 20°C at least 24 months in high water (apple, tomato, lettuce, and cauliflower), high acid (grape), high starch (wheat grain, potato) and high oil content matrices (cotton seed). As the residue trial samples were stored for less than 12 months prior to analysis under conditions for which integrity of the samples was demonstrated, it is concluded that the residue data are valid with regard to storage stability. According to the United Kingdom, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for the purpose (United Kingdom, 2016). 3.1.1.3. Effect of industrial processing and/or household preparation The effect of processing on the nature of chlorantraniliprole was investigated in the framework of the peer review in standard hydrolysis studies representative of pasteurisation, boiling and sterilisation (Ireland, 2010; EFSA, 2013a). The compound was hydrolytically stable under the conditions representative of pasteurisation and sterilisation. However, under boiling conditions chlorantraniliprole was slightly degraded, forming the IN-F6L99, IN-EQW78 and IN-ECD73 metabolites (11–14% of applied radioactivity). Since the metabolites were detected at low levels (0.016 mg/kg) and the magnitude of the parent compound residues was always significantly higher (87–86% of the total radioactive residue (TRR)), the peer review concluded that for processed commodities the same residue definition for enforcement and risk assessment as for raw agricultural commodities (RAC) is applicable (EFSA, 2013a). Specific studies to assess the magnitude of chlorantraniliprole residues during the processing of hop cones to processed commodities have not been submitted and are not necessary as the total theoretical maximum daily intake (TMDI) is expected to be below the trigger value of 10% of the ADI (European Commission, 1997d).
3.1.2.
Rotational crops
As the proposed use of chlorantraniliprole is on semipermanent crops, the investigation of residues in rotational crops is not required and therefore is not considered in the current reasoned opinion.
3.2.
Nature and magnitude of residues in livestock
Under the current assessment, the nature and magnitude of chlorantraniliprole residues in livestock was not considered since hops and their by-products are not used to feed livestock and therefore no impact is expected in food of animal origin (European Commission, 1996).
4.
Consumer risk assessment
The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population9 (EFSA, 2007). To calculate the chronic exposure, the STMR derived from the residue trials (option 2 and option 3 of Table 3) was used as input value for hops. For the other commodities, the existing MRLs as established under Regulation (EU) No 2016/56710 were used as input values. Acute consumer exposure assessment was not performed since the setting of an ARfD was not necessary for chlorantraniliprole (Table 1). The input values used for the dietary exposure calculation are summarised in Table 4. The estimated exposure was then compared with the toxicological reference value derived for chlorantraniliprole (see Table 1). The results of the intake calculation using the EFSA PRIMo is a key supporting document and is made publicly available as a background document to this reasoned opinion. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for 2% of the ADI (NL child) for both scenarios calculated (STMR option 2 and STMR option 3 of Table 3). The contribution of 9
10
The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from Member State (MS) surveys plus one regional and four cluster diets from the WHO GEMS Food database; for the acute exposure assessment the most critical large portion consumption data from 19 national diets collected from MS surveys is used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007). Commission Regulation (EU) 2016/567 of 6 April 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen in or on certain products. C/2016/1879. OJ L 100, 15.4.2016, p. 1–60.
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chlorantraniliprole residues in hops to the total consumer exposure was insignificant counting for less than 0.01% (UK adult) for both options. Table 4:
Input values for the consumer dietary exposure assessment Acute exposure assessment
Chronic exposure assessment Commodity
Input Comment (mg/kg)
Input (mg/kg)
Comment
Risk assessment residue definition: Chlorantraniliprole Hops
9.3 2.8
STMR (option 2 of Table 3) Acute risk assessment was not STMR (option 3 of Table 3) undertaken since the setting of an ARfD was considered not necessary (Table 2)
Other plants and animal commodities
MRL
MRLs in Regulation (EU) No 2016/567
MRL: maximum residue level; STMR: supervised trials median residue; ARfD: acute reference dose.
EFSA concludes that the emergency use of chlorantraniliprole in hops will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health.
Conclusions and recommendations The table below summarises all the possible MRL options presented in the current reasoned opinion as follows: Code(a)
Commodity
Existing EU MRL (mg/kg)
Proposed EU tMRL (mg/kg)
Comment/Justification
Enforcement residue definition: Chlorantraniliprole(F) 0700000 Hops 0.02* No MRL proposal
Option 1: Residue trials were not conducted according to the critical use authorised in the UK under Article 53 of Regulation (EC) No 1107/2009 (1 9 35 g/ha, PHI 21 day); none of the trials was performed in NEU Considering the emergency authorisation granted in the UK for 120 days, EFSA derived two options for temporary MRLs to be considered by risk managers (option 2 and 3)
40 (temporary)
Option 2: The proposal for the temporary MRL is based on the submitted overdosed US residue trials No risk for consumer has been identified with regard to chlorantraniliprole residues in hops related to the GAP tested in the supervised field trials (overdosed trials, shorter PHI)
10 (temporary)
Option 3: The proposed temporary MRL is based on the scaled residue trials (scaling down by a factor of 3), taking into account that the supervised field trials were overdosed. The MRL proposal is still expected to overestimate the residues compared with the authorised UK GAP, since the samples were taken at shorter PHIs (between 0 and 14 days), while the GAP defines the PHI of 21 days No risk for consumer has been identified in relation to the MRL proposed as option 3
MRL: maximum residue level; tMRL: temporary maximum residue level; PHI: preharvest interval; NEU: northern Europe; GAP: good agricultural practice. (a): Commodity code number according to Annex I of Regulation (EC) 396/2005. *: Indicates that the MRL is set at the limit of analytical quantification (LOQ). (F): Fat soluble.
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References CAC (Codex Alimentarius Commission), 2013. Report of the 45th Session of Codex Committee on pesticide residues. REP13/PR, Beijing, China, 6–11 May 2013. EFSA (European Food Safety Authority), 2007. Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. Available online: www.efsa.europa.eu EFSA (European Food Safety Authority), 2010. Modification of the existing MRL for chlorantraniliprole in carrots. EFSA Journal 2010;8(10):1859, 27 pp. doi:10.2903/j.efsa.2010.1859 EFSA (European Food Safety Authority), 2011. Reasoned opinion on the modification of the existing MRLs for chlorantraniliprole in various crops and in products of animal origin. EFSA Journal 2011;9(3):2099, 45 pp. doi:10.2903/j.efsa.2011.2099 EFSA (European Food Safety Authority), 2012a. Reasoned opinion on the modification of the existing MRLs for chlorantraniliprole in various crops. EFSA Journal 2012;10(1):2548, 38 pp. doi:10.2903/j.efsa.2012.2548 EFSA (European Food Safety Authority), 2012b. Reasoned opinion on the modification of the existing MRLs for chlorantraniliprole in carrots, parsnips, parsley root and celeriac. EFSA Journal 2012;10(11):2988, 24 pp. doi:10.2903/j.efsa.2012.2988 EFSA (European Food Safety Authority), 2013a. Conclusion on the peer review of the pesticide risk assessment of the active substance chlorantraniliprole. EFSA Journal 2013; 11(6):3143, 107 pp. doi:10.2903/j.efsa.2013.3143 EFSA (European Food Safety Authority), 2013b. Reasoned opinion on the modification of the existing MRLs for chlorantraniliprole in several root and tuber vegetables and oilseeds. EFSA Journal 2013;11(7):3296, 25 pp. doi:10.2903/j.efsa.2013.3296 EFSA (European Food Safety Authority), 2015. Reasoned opinion on the modification of MRLs and the setting of import tolerances for chlorantraniliprole in various crops. EFSA Journal 2015;13(9):4216, 20 pp. doi:10.2903/ j.efsa.2015.4216 European Commission, 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. European Commission, 2000. Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99-rev.4. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010. European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. European Commission, 2015. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. FAO (Food and Agriculture Organization of the United Nations), 2009. Chlorantraniliprole. In: Pesticide residues in food – 2008. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 193, p. 127–143. FAO (Food and Agriculture Organization of the United Nations), 2014. Chlorantraniliprole. In: Pesticide residues in food – 2013. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 219, p. 402–403. Ireland, 2010. Draft assessment report on the active substance chlorantraniliprole prepared by the rapporteur Member State Ireland in the framework of Council Directive 91/414/EEC, December 2008. OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide Publications/Publications on Pesticide Residues. Available online: http://www.oecd.org United Kingdom, 2016. Evaluation report on the setting of tMRL for chlorantraniliprole in hops prepared by the evaluating Member State United Kingdom under Article 18(4) of Regulation (EC) No 396/2005, 15 August 2016, 26 pp.
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Abbreviations a.s. ADI ALARA ARfD BBCH bw CAC CCPR cGAP CXL DALA DAT DAR EMS ESI FAO GAP HR ISO IUPAC JPMR LC LOQ MRL MS MS/MS MW OECD PHI PRIMo RMS SC SEU STMR TMDI TRR
active substance acceptable daily intake as low as reasonably achievable acute reference dose growth stages of mono- and dicotyledonous plants body weight Codex Alimentarius Commission Codex Commission in Pesticide Residues report critical good agricultural practice Codex maximum residue limit (Codex MRL) days after last application days after treatment draft assessment report evaluating Member State electrospray ionisation Food and Agriculture Organization of the United Nations good agricultural practice highest residue International Organisation for Standardisation International Union of Pure and Applied Chemistry Joint Meeting on Pesticide Residues liquid chromatography limit of quantification maximum residue level Member State tandem mass spectrometry detector molecular weight Organisation for Economic Co-operation and Development preharvest interval (EFSA) Pesticide Residues Intake Model rapporteur Member State suspension concentrate southern Europe supervised trials median residue theoretical maximum daily intake total radioactive residue
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UK
Crop
Hops
Type
SC Insects (Lepidoptera sp.)
Pests or group of pests controlled
(b)
200 g/L
Conc. a.s.
Airassisted sprayer
Method kind
BBCH 35-74 June– August
Range of growth stages and season(c) g/hL min– max 2.3–1.75
Interval between application –
1
200–1,500
Water L/ha min– max 35
g/ha min– max
Application rate per treatment
Number min– max
Application
21
PHI (days)(d)
Authorised GAP in the UK according to the emergency use of chlorantraniliprole granted in hops (United Kingdom, 2016)
Remarks
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NEU: northern European Union; SEU: southern European Union; MS; Member State; a.s.: active substance; SC: suspension concentrate. (a): Outdoor or field use (F), greenhouse application (G) or indoor application (I). (b): CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide. (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 preharvest interval.
F
NEU, FG SEU, or I(a) MS or country
Preparation
Appendix A – Good Agricultural Practice (GAPs)
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Setting of a tMRL for the emergency use of chlorantraniliprole in hops
Appendix B – Used compound codes Code/trivial name
Chemical name/SMILES notation
Chlorantraniliprole DPX E-2Y45
3-Bromo-40 -chloro-1-(3-chloro-2-pyridyl)-20 -methyl60 -(methylcarbamoyl)pyrazole-5-carboxanilide MW: 483.15 g/mol CNC(=O)c3cc(Cl)cc(C)c3NC(=O)c2cc(Br) nn2c1ncccc1Cl
Structural formula Cl
CH3 O
N
O
N
NH Br
H3C
IN-EQW78
2-[3-Bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one Cc4cc(Cl)cc3c4N=C(c2cc(Br)nn2c1ncccc1Cl)N(C) C3=O
O
CH3
Br
N Cl
N
N N
CH3
IN-ECD73
Cl
N
NH
2,6-Dichloro-4-methyl-11H-pyrido[2,1-b] quinazolin-11-one Cc3cc(Cl)cc2c3N=C1C(Cl)=CC=CN1C2=O
N Cl
Cl
CH3 N N
Cl O
IN-F6L99
3-Bromo-N-methyl-1H-pyrazole-5-carboxamide Brc1cc(nn1)C(=O)NC
Br
CH3 HN O
N H
N
SMILES: simplified molecular-input line-entry system.
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