Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR)

European Food Safety Authority (EFSA)

doi:10.2903/j.efsa.2021.6766

. 2021 Aug 17;19(8):e06766. doi: 10.2903/j.efsa.2021.6766

Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR)

European Food Safety Authority (EFSA)^✉

PMCID: PMC8370139 PMID: 34429776

Abstract

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to provide support for the preparation of the EU position for 52nd session of the Codex Committee on Pesticide Residues (CCPR). In 2019, JMPR evaluated 20 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment (acetochlor, boscalid, chlorothalonil, cyprodinil, dicamba, mesotrione, metaflumizone, thiabendazole, afidopyropen, buprofezin, clethodim, dimethoate, metconazole, omethoate, pyflubumide, pyridate, pyrifluquinazon, tolclofos‐methyl, triflumuron, valifenalate) and 47 active substance regarding the setting of Maximum Residue Limits (MRLs) (acetochlor, azoxystrobin, boscalid, chlorantraniliprole, chlorothalonil, cyantraniliprole, cyprodinil, dicamba, fenazaquin, flonicamid, flupyradifurone, fosetyl‐Al, glyphosate, mesotrione, metaflumizone, S‐methoprene, pendimethalin, spirotetramat, tebuconazole, thiabendazole, acetamiprid, afidopyropen, benzovindiflupyr, bifenthrin, buprofezin, carbendazim, clethodim, cyclaniliprole, cypermethrins, dimethoate, fluazifop‐p‐butyl, fluensulfone, kresoxim‐methyl, mandestrobin, metconazole, omethoate, penthiopyrad, picoxystrobin, pydiflumetofen, pyflubumide, pyrifluquinazon, pyriofenone, pyriproxyfen, tolclofos‐methyl, tolfenpyrad, triflumuron, valifenalate). EFSA prepared comments on the Codex MRL proposals and the proposed toxicological reference values. In addition, EFSA provided the views on follow‐up assessments of JMPR on pesticides where specific concerns were raised in the previous CCPR meetings. The current report should serve as the basis for deriving the EU position for the CCPR meeting.

Keywords: consumer risk assessment, toxicological evaluation, residue definitions, MRL setting, 52nd CCPR meeting

Summary

For the preparation of the 52nd session of the Codex Committee on Pesticide Residues (CCPR meeting), the European Commission asked EFSA to provide comments on the individual active substances assessed in the Joint FAO/WHO Meetings on Pesticide Residues (JMPR) (extraordinary meeting of May and regular meeting of September), in particular on the recommended toxicological reference values and the proposed MRLs at steps 3 and 6 of the Codex procedure.

In the two meetings held in 2019, JMPR evaluated in total 20 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment (acetochlor, boscalid, chlorothalonil, cyprodinil, dicamba, mesotrione, metaflumizone, thiabendazole, afidopyropen, buprofezin, clethodim, dimethoate, metconazole, omethoate, pyflubumide, pyridate, pyrifluquinazon, tolclofos‐methyl, triflumuron, valifenalate). EFSA compared the acceptable daily intake (ADI) and acute reference dose (ARfD) values derived by JMPR with the values derived at EU level and, in case differences were identified, EFSA provided further explanations for the reasons of the differences.

Regarding the setting of Maximum Residue Limits (MRLs), JMPR assessed 47 substances (acetochlor, azoxystrobin, boscalid, chlorantraniliprole, chlorothalonil, cyantraniliprole, cyprodinil, dicamba, fenazaquin, flonicamid, flupyradifurone, fosetyl‐Al, glyphosate, mesotrione, metaflumizone, S‐methoprene, pendimethalin, spirotetramat, tebuconazole, thiabendazole, acetamiprid, afidopyropen, benzovindiflupyr, bifenthrin, buprofezin, carbendazim, clethodim, cyclaniliprole, cypermethrins, dimethoate, fluazifop‐p‐butyl, fluensulfone, kresoxim‐methyl, mandestrobin, metconazole, omethoate, penthiopyrad, picoxystrobin, pydiflumetofen, pyflubumide, pyrifluquinazon, pyriofenone, pyriproxyfen, tolclofos‐methyl, tolfenpyrad, triflumuron, valifenalate). EFSA provided comments on the proposed Codex MRLs as well as on active substances that were re‐assessed by JMPR following specific concerns raised in the previous years and on general issues discussed in the 2019 JMPR meetings.

It is highlighted that the EFSA comments were derived based on the information provided in the JMPR reports. Since the JMPR reports do not contain the full detailed information on the studies submitted to JMPR, the EFSA comments are restricted to the specific questions specified in the Terms of Reference. Hence, the conclusions reached on Codex MRL proposals reported in this report should be considered as indicative and might have to be reconsidered in a more detailed assessment when needed. The comments presented in this report have to be seen in the context of the currently applicable guidance documents and the MRL legislation applicable at the time of commenting. The comments may not be valid any more or may have to be modified, if the legal or scientific framework changes.

1. Introduction

1.1. Background

Manufacturers of pesticides who are interested in the setting of Codex Maximum Residue Limits (CXLs) submit data to the Joint Meeting on Pesticide Residues (JMPR) for assessment. The most recent JMPR evaluations of the toxicological data and the residue studies are summarised in the Extra and Regular JMPR Reports 2019 (FAO, 2019, 2020). It comprises in total 49 active substances: 20 of them were assessed for both toxicological reference values and residues, 47 active substances were assessed in view of setting new CXLs and 8 active substances were assessed for specific concerns raised by the official delegations.

On 13 August 2019, the European Commission requested EFSA to provide support for the preparation of the EU‐coordinated position for the 52nd session of the Codex Committee on Pesticide Residues (CCPR). In particular, EFSA was asked to give advice and to provide comments on the recommendations of the 2019 Joint FAO/WHO meeting on pesticide residues (JMPR). Additionally, the European Commission requested EFSA to give its comments on other proposed Codex MRLs that were retained at Step 4 or 7, respectively, in previous years and are likely to be discussed in the 52nd CCPR meeting, in case that such new advice from EFSA is needed and appropriate.

Furthermore, the European Commission asked for comments on the general chapters of the JMPR 2019 report, where relevant for risk assessment as well as other comments on the proposed crop groupings, the JMPR priority list and documents related to the revision of the IESTI equation.

For reasons of transparency and traceability, EFSA has created separate questions for each of the active substances covered by the mandate with the following reference numbers and subjects:

Question number	Subject
EFSA‐Q‐2019‐00551	Thiabendazole (65) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00552	Chlorothalonil (81) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00553	S‐Methoprene (147) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00554	Glyphosate (158) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00555	Tebuconazole (189) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00556	Cyprodinil (207) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00557	Boscalid (221) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00558	Azoxystrobin (229) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00559	Spirotetramat (234) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00560	Metaflumizone (236) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00561	Dicamba (240) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00562	Chlorantraniliprole (263) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00563	Mesotrione (277) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00564	Acetochlor (280) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00565	Flonicamid (282) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00566	Flupyradifurone (285) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00567	Pendimethalin (292) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00568	Fosetyl‐Al (302) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00569	Fenazaquin (297) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00706	Dimethoate (027) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00707	Omethoate (055) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00708	Cypermethrins (118) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00709	Propiconazole (160) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00710	Buprofezin (173) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00711	Bifenthrin (178) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00712	Clethodim (187) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00713	Tolclofos‐methyl (191) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00714	Kresoxim‐methyl (199) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00715	Pyriproxyfen (200) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00716	Cyclaniliprole (296) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00717	Pyraclostrobin (210) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00718	Penthiopyrad (253) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00719	Fluxapyroxad (027) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00720	Picoxystrobin (256) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00721	Benzovindiflupyr (261) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00722	Fluensulfone (265) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00723	Tolfenpyrad (269) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00724	Fluazifop‐p‐butyl (283) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00725	Isofetamid (290) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00726	Mandestrobin (307) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00727	Pydiflumetofen (309) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00728	Pyriofenone (310) – EFSA comments on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00729	Afidopyropen (312) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00730	Metconazole (313) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00731	Pyflubumide (314) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00732	Pyridate (315) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00733	Pyrifluquinazon (316)‐ EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00734	Triflumuron (317)‐ EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019
EFSA‐Q‐2019‐00735	Valifenalate (318) – EFSA comments on the toxicological reference values and on the proposed Codex MRLs evaluated by JMPR in 2019

		Comments, references
JMPR assessment	JMPR meeting September 2019
Type of JMPR evaluation	Periodic review
RMS	IT
Approval status	Not approved	Commission Implementing Regulation (EU) 2019/1090^a
EFSA conclusion available	Yes, see comments	(EFSA, 2018x)
MRL review performed	Yes, see comments	(EFSA, 2009a) (MRLs of concern) (EFSA, 2016r) (prioritised review)
MRL applications/assessments	Yes, see comments	(EFSA, 2012f) (olives) (EFSA, 2011e) (various crops) (EFSA, 2010c) (various crops) (EFSA, 2010b) (cauliflower, broccoli, Brussels sprouts and lettuce)
Classification of a.s. – cut‐off criteria	No
Endocrine effects of a.s.	Not assessed/not concluded

	JMPR evaluation		EU evaluation		TRV comparable
	Value	Comments	Value	Comments	TRV comparable
ADI	0.001 mg/kg bw per day	JMPR (2019) Based on the NOAEL for RBC AChE inhibition in female pups on PND 21 in a developmental special study designed to assess the effects of dimethoate on AChE activity in pregnant rats, preweaning rats and young adult rats; applying an UF of 100	–	(EFSA, 2018x) A genotoxicity potential could not be ruled out in vivo and TRVs were not established	No
ARfD	0.02 mg/kg bw	JMPR (2003, 2019) Based on an overall acute NOAEL for RBC AChE inhibition in an acute neurotoxicity study and a special study in preweaning females and in young adult females, applying an UF of 100	–	(EFSA, 2018x) A genotoxicity potential could not be ruled out in vivo and TRVs were not established	No
Conclusion/comment	Parent: The submitted studies provided some evidence for dimethoate being weakly genotoxic in bacterial and mammalian cells in in vitro assays. The JMPR considered the rate of phosphorylation of acetylcholinesterase to be the predominant reaction of dimethoate, whereas mutations resulting from reactions with DNA would only be detected at much higher concentrations and concluded that dimethoate is unlikely to be genotoxic in vivo; accordingly to the JMPR established toxicological reference values for the parent dimethoate. In contrast, the EU peer review considered that in the absence of adequate in vivo follow up to contravene the positive genotoxicity results in vitro, a genotoxic potential could not be ruled out and no toxicological reference values were established. Metabolites: Omethoate: Considering that omethoate showed genotoxic potential in vivo the setting of reference values was not considered appropriate by both the JMPR and EU peer review. Metabolite III (Dimethoate Carboxylic Acid): The JMPR considered that the metabolite is a major rat metabolite and as such its toxicity is covered by the toxicological reference values established for the parent dimethoate. The EU assessment derived an ADI of 0.09 mg/kg bw per day, based on a 28‐day study in rats, UF of 1,000 applied; ARfD was not established as not needed. While the JMPR could not conclude on the genotoxicity potential of other metabolites due to lack of studies, the EU peer review appears to have had access to additional toxicological studies, including genotoxicity studies on metabolites and concluded the following: Metabolite X (O‐Desmethyl dimethoate): Read across from metabolite XI. Metabolite XI (O‐Desmethyl omethoate): The EU assessment derived an ADI of 0.1 mg/kg bw per day, based on a 28‐day study in rats, applying an UF of 1,000; ARfD was not established as not needed. Metabolite XII (Des‐O‐methyl isodimethoate): The EU assessment derived an ADI of 0.015 mg/kg bw per day based on the parental NOAEL of the reproductive/developmental toxicity study in rats, UF of 1,000 applied; ARfD was not established as not needed. Metabolite XX (O‐Desmethyl omethoate carboxylic acid): The EU assessment derived an ADI of 0.1 mg/kg bw per day, based on the parental and offspring's NOAEL of the reproductive/developmental toxicity study in rat, supported by the 28‐day study in rats, UF of 1000 applied; ARfD was not established as not needed. Metabolite XXIII (O‐Desmethyl N‐desmethyl Omethoate): The EU assessment derived an ADI of 0.075 mg/kg bw per day from the parental NOAEL of the reproductive/developmental toxicity study in rats, UF of 1,000 applied; ARfD was not established as not needed.

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Dimethoate and omethoate (measured and reported separately)	Reg. 396/2005: separate residue definitions were set for dimethoate and omethoate. Peer review (EFSA, 2018x): dimethoate and omethoate, to be considered separately.	Yes
RD enf	Animal products	Dimethoate and omethoate (measured and reported separately) The residue is not fat soluble	Reg. 396/2005: separate residue definitions were set for dimethoate and omethoate. Peer review (EFSA, 2018x): dimethoate and omethoate, to be considered separately. The residue is not fat soluble	Yes
RD RA	Plant products	The Meeting was unable to recommend a definition for dietary risk assessment	Peer review (EFSA, 2018x): Provisionally, the residue definition for risk assessment is proposed as dimethoate and omethoate	Not appropriate
RD RA	Animal products	The Meeting was unable to recommend a definition for dietary risk assessment	Peer review (EFSA, 2018x): Provisionally, the residue definition for risk assessment is proposed as dimethoate and omethoate	Not appropriate
Conclusion/comments	–

Commodity	Codex MRL proposal^(a)	EU MRL Dimethoate/omethoate	Comment
Artichoke, globe	0.05 (W)	0.01^/0.01^	All existing Codex MRLs established for dimethoate were proposed for withdrawal, following the considerations that An ADI or an ARfD for omethoate were not recommended by the WHO panel, due to concerns regarding its genotoxicity; Due to genotoxicity concerns relating to omethoate and other related metabolites, a conclusion on a residue definition for dietary risk assessment could not be derived; Consequently, a long‐term and acute dietary risk assessment could not be conducted.
Asparagus	0.05 ^* (W)	0.01^/0.01^
Barley	2 (W)	0.02^/0.01^
Brussels sprouts	0.2 (W)	0.1^/0.01^
Cabbage, Savoy	0.05 ^* (W)	0.01^/0.01^
Cattle, Edible offal of	0.05^*(W)	–/–
Cauliflower	0.2 (W)	0.01^/0.01^
Celery	0.5 (W)	0.01^/0.01^
Cherries	2 (W)	0.01^/0.01^
Citrus fruits	5 (W)	0.01^/0.01^
Eggs	0.05^*(W)	0.01^–/0.01^
Lettuce, Head	0.3 (W)	0.01^/0.01^
Mammalian fats (except milk fats)	0.05^* (W)	0.01^/0.01^
Mango	1 (Po) (W)	0.01^/0.01^
Meat of cattle, goats, horses, pigs and sheep	0.05^*(W)	0.01^/0.01^ (muscle)
Milk of cattle, goats and sheep	0.05^* (W)	0.01^/0.01^
Pear	1 (W)	0.01^/0.01^
Peas (pods and succulent = immature seeds)	1 (W)	0.01^/0.01^
Peppers Chilli, dried	3 (W)	–/–
Peppers, sweet (including pimento or pimiento)	0.5 (W)	0.01^/0.01^
Potato	0.05 (W)	0.01^/0.01^
Poultry fats	0.05^* (W)	0.01^0.01^
Poultry meat	0.05^* (W)	0.01^/0.01^ (muscle)
Poultry, edible offal of	0.05^* (W)	0.01^*/0.01
Sheep, edible offal of	0.05^* (W)	0.01^*/0.01
Spices, fruits and berries	0.5 (W)	0.05^/0.05^
Spices, roots and rhizomes	0.1^* (W)	0.05^/0.05^
Spices, seeds	5 (W)	0.05^/0.05^
Sugar beet	0.05 (W)	0.01^/0.01^
Table olives	0.5 (W)	0.01^/0.01^
Turnip greens	1 (W)	Chinese cabbage: 0.01^/0.01^
Turnip, Garden	0.1 (W)	0.01^/0.01^(turnips from other root and tuber vegetables except sugar beets)
Wheat	0.05 (W)	0.01^/0.01^
Wheat straw and fodder, dry	1 (W)	–/–
General comments	(a): The Codex MRLs that are proposed for withdrawal refer to the previous residue definition which covered only dimethoate.

Commodity	Codex MRL proposal^(a)	EU MRL	Comment
Spices, fruits and berries	0.01 (W)	0.05^*	All existing Codex MRLs established for omethoate were proposed for withdrawal, following the considerations that – An ADI or an ARfD for dimethoate were not recommended by the WHO panel, due to concerns regarding its genotoxicity; – Due to genotoxicity concerns relating to omethoate and other related metabolites, a conclusion on a residue definition for dietary risk assessment could not be derived; – Consequently, a long‐term and acute dietary risk assessment could not be conducted.
Spices, roots and rhizomes	0.05 (W)	0.05^*
General comments	(a): The Codex MRLs that are proposed for withdrawal refer to the previous residue definition which covered only omethoate.

		Comments, references
JMPR assessment	Extraordinary JMPR meeting May 2019
Type of JMPR evaluation	New use
RMS	ES
Approval status	Approved	Commission Implementing Regulation (EU) 2017/157^a
EFSA conclusion available	Yes, see comments	(EFSA, 2014p)
MRL review performed	Yes, see comments	(EFSA, 2014k) (EFSA, 2016n) (Art. 43)
MRL applications/assessments	Yes, see comments	(EFSA, 2021h)^b (various crops)
Classification of a.s. – cut‐off criteria	No
Endocrine effects of a.s.	Not assessed/not concluded	The confirmatory data requirements established by Commission Implementing Regulation (EU) 2017/157 requesting information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine‐mediated effects have not been addressed. Therefore, in line with the ECHA and EFSA guidance (ECHA and EFSA, 2018) on the identification of endocrine disruptors, additional data are still required before a final conclusion on the endocrine disrupting properties of thiabendazole can be derived ECHA and EFSA guidance (ECHA and EFSA, 2018).

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Thiabendazole	Reg. 396/2005: Thiabendazole	Yes
RD enf	Animal products	Sum of thiabendazole and 5‐hydroxythiabendazole The residue is not fat soluble	Reg. 396/2005: Sum of thiabendazole and 5‐hydroxythiabendazole MRL review Art. 43 (EFSA, 2016n): Milk: Sum of thiabendazole, 5–hydroxythiabendazole and its sulfate conjugate, expressed as thiabendazole Other animal commodities: Sum of thiabendazole and 5–hydroxythiabendazole expressed as thiabendazole Peer review (EFSA, 2014p): Milk: Thiabendazole, 5–hydroxythiabendazole and its sulfate conjugate, sum expressed as thiabendazole All other animal commodities: Thiabendazole and 5–hydroxythiabendazole, sum expressed as thiabendazole The residue is not fat soluble	Yes (the RD proposed by EFSA in the MRL review for milk has not been implemented). See comments below.
RD RA	Plant products	Thiabendazole	MRL review Art. 43 (EFSA, 2016n): Post‐harvest treatment: Thiabendazole (relevant to the authorised uses on citrus fruit, apple, pear, avocado, mango, banana, papaya and consumption potato); this RD is provisional for potatoes and witloof, because of lack of metabolism study. Preharvest treatment and rotational crops: RD 1) Thiabendazole; RD 2) Total benzimidazole (tentative, data gap identified) Peer review (EFSA, 2014p): Post‐harvest treatment: Thiabendazole (relevant to the representative uses on citrus and on apple and pear); Preharvest treatment and rotational crops: Thiabendazole, and total benzimidazole (i.e. free and conjugated) (provisional, data gap identified) Processed plant commodities: pending (data gap identified)	No, see comments below
RD RA	Animal products	Sum of thiabendazole, 5‐hydroxythiabendazole and its sulfate conjugate	MRL review Art. 43 (EFSA, 2016n): Milk: Sum of thiabendazole, 5–OH–thiabendazole and its sulfate conjugate, expressed as thiabendazole; Total benzimidazole (tentative, data gap identified) Other animal commodities: Sum of thiabendazole and 5–OH–thiabendazole, expressed as thiabendazole; Total benzimidazole (tentative, data gap identified) Peer review (EFSA, 2014p): Milk: Thiabendazole, 5–hydroxythiabendazole and its sulfate conjugate, sum expressed as thiabendazole, and benzimidazole (provisional; data gap identified) All other animal commodities: Thiabendazole and 5–hydroxythiabendazole, sum expressed as thiabendazole, and benzimidazole (provisional; data gap identified)	No, see comments below
Conclusion, comments	The enforcement residue definitions for plant products derived by the JMPR and EU evaluations are comparable. It is noted that JMPR did not assess metabolism studies representative for the post‐harvest use in root crops (sweet potatoes). Hence, the appropriateness of the current residue definitions for post‐harvest uses in root crops should be verified. In an ongoing EU import tolerance application, a metabolism study for post‐harvest use in root crops was requested, which should provide information on the formation of metabolites over time (it is not enough to characterise and identify the nature of residues immediately after the treatment, but nature of residues need to be investigated after an appropriate storage period). The enforcement residue definition for animal products derived by the JMPR evaluation is comparable with the residue definition established in the EU Reg. 396/2005. The EU Peer review and the EFSA MRL review under Art. 43 proposed to include the sulfate conjugate of 5–hydroxythiabendazole in the enforcement residue definition for milk. Risk managers decided not to implement this residue definition. The risk assessment residue definition for plant products derived by the JMPR evaluation is comparable with the residue definition derived by the EU evaluation for plant products post‐harvest treatment (relevant to the EU authorised uses on fruits) based on metabolism studies in oranges. The residue definitions derived by the EU evaluation for plant products (preharvest treatment and rotational crops) and for animal products are both wider than the respective JMPR residue definitions, covering also the metabolite benzimidazole and its conjugates (provisional, data gap identified). In the MRL legislation, confirmatory data were requested on the magnitude of residues of benzimidazole for citrus fruit, apples, potatoes and animal products (deadline for submission: 1 July 2019).

Commodity	Codex MRL proposal	EU MRL	Comment
Beans with pods (includes all commodities in this subgroup)	0.01^*	0.01^* beans (with pods)	cGAP: USA succulent beans, except soyabean: 0.55 kg a.i./tonne seed treatment; soyabean: 0.20 kg a.i./tonne seed treatment Number of trials: 6 trials in succulent beans with pods Sufficiently supported by data: Yes Specific comments/observations: Levels of thiabendazole in beans with pods were < 0.01 mg/kg (six trials). JMPR proposed a Codex MRL for the subgroups of succulent beans with pods. The description of the commodity related to the code VP 2060 should be corrected (to include the suffix ‘(includes all commodities in this subgroup’)). Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs. It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None.
Dry beans, subgroup of (includes all commodities in this subgroup)	0.01^*	0.01^* (dry beans, dry lupins)	cGAP: USA dry beans, except soyabean: 0.55 kg a.i./tonne seed treatment; soyabean: 0.20 kg a.i./tonne seed treatment Number of trials: 9 in dry beans Sufficiently supported by data: Yes Specific comments/observations: Levels of thiabendazole in dry beans were < 0.01 mg/kg (nine trials). Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None
Dry peas, subgroup of (includes all commodities in this subgroup)	0.01^*	0.01^* dry peas, dry lentils	cGAP: USA 0.33 kg a.i./tonne seed treatment Number of trials: 10 overdosed trials (≥ 2.4N rate) Sufficiently supported by data: Yes Specific comments/observations: Levels of thiabendazole in dry peas were < 0.01 mg/kg (five trials) and < 0.05 mg/kg (five trials). Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None
Mango	7 (Po)	0.01^*	cGAP: Central American GAP 0.24 kg a.i./hL dip solution; Brazil GAP 0.19 kg a.i./hL dip solution. Number of trials: 4 Sufficiently supported by data: No Specific comments/observations: The residue trials assessed in the JMPR evaluation were previously submitted to EFSA in support of an import tolerance application for mango (EFSA‐Q‐2018‐00334). The JMPR evaluation derived an STMR and a HR for residues in the pulp. According to information available to EFSA from an ongoing IT application, the residue trials determined thiabendazole residues in mango pulp on the day of treatment only (DAT = 0). However, translocation of residues from the peel to the pulp cannot be excluded during shipping/storage/ripening. These studies may underestimate the magnitude of residues in the edible portion (mango pulp) following a suitable waiting period under typical shipping/storage/ripening conditions. An EU import tolerance application for mangos is currently on clock‐stop due to the lack of a valid study investigating the possible transfer of residues to the pulp after a time period which is realistic for shipment of treated mangoes to Europe. Conclusion: The proposed Codex MRL is not acceptable because of a potential acute intake concern identified in scenario 1 (see below). Follow‐up action: None
Peas with pods, subgroup of (includes all commodities in this subgroup)	0.01^*	0.01^*	cGAP: USA 0.33 kg a.i./tonne seed treatment Number of trials: 6 trials in beans with pods (overdosed) Sufficiently supported by data: Yes, by extrapolation from beans with pods Specific comments/observations: Levels of thiabendazole in beans with pods were < 0.01 mg/kg (six trials). Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None
Succulent beans without pods, subgroup of (includes all commodities in this subgroup)	0.01^*	0.01^*	cGAP: USA succulent beans, except soyabean: 0.55 kg a.i./tonne seed treatment; soyabean: 0.20 kg a.i./tonne seed treatment Number of trials: 1 trial in beans, 9 trials in peas (overdosed) Sufficiently supported by data: Yes, based on combined trials in beans and peas. Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None
Succulent peas without pods, Subgroup of (includes all commodities in this subgroup)	0.01^*	0.01^*	cGAP: USA 0.33 kg a.i./tonne seed treatment Number of trials: 9 overdosed trials (3–4N rate) Sufficiently supported by data: Yes Specific comments/observations: Information on benzimidazole (tentative second EU residue definition for preharvest uses) is not reported in the JMPR report. Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that the risk assessment for benzimidazole could not be performed. Follow‐up action: None
Sweet potato	9 (Po)	0.01^*	cGAP: USA 0.16 kg a.i./hL dip solution or spray (on a conveyor belt) at 0.006 kg a.i./tonne post‐harvest treatment Number of trials: Spray application GAP: seven trials; dip application GAP: eight trials. Sufficiently supported by data: Yes Specific comments/observations: JMPR evaluation based on dip trials, which gives the highest residues. The residue trials were previously submitted to EFSA in support of an import tolerance application for sweet potato (EFSA‐Q‐2018‐01013). The residue levels of benzimidazole in sweet potatoes were reported in the residue trials (dip and spray application) at PHI 0 days only. The EU evaluation MRL review Art. 12, revised in 2016 (EFSA, 2016n) proposed the residue definition for risk assessment for post‐harvest treatment as thiabendazole (provisional). However, further information on the metabolism of thiabendazole in root and tuber vegetables following post‐harvest treatment covering a suitable waiting period relevant to the storage period and storage conditions was requested that would allow to confirm the suitability of the residue definition for risk assessment for post‐harvest uses for root and tuber group commodities. For a currently ongoing import tolerance application for the post‐harvest use on sweet potatoes, this data gap leads to a clock‐stop. Conclusion: The proposed Codex MRL is not acceptable because of a potential acute intake concern (see below). In addition, it should be highlighted that a suitable metabolism study in root crops (post‐harvest use) would be required to verify the appropriateness of the residue definition for sweet potatoes. Follow‐up action: None
General comments	Further background information Data gaps identified in the Art. 43 (EFSA, 2016n): a detailed and reproducible evaluation of the study investigating the nature of residues after pasteurisation, cooking, brewing and sterilisation in order to judge the validity of the study (data gap relevant for all authorisations reported); data to address the potential for consumer exposure and toxicological properties for the metabolite benzimidazole (data gap relevant for commodities of animal origin and for the authorisations on citrus fruits, apples, potatoes and witloof); Reg. (EU) 2017/1164^a: Confirmatory data requirement (citrus, apples, potatoes, witloofs, products of animal origin): information on the magnitude of residues of the metabolite benzimidazole (to be submitted by 1 July 2019).

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was performed using PRIMo rev. 3.1 for the commodities, for which the Codex MRL proposal is higher than the existing EU MRL (i.e. sweet potatoes and mangoes). For mango, EFSA calculated two scenarios: scenario 1 is based on the HR for the whole fruit (4.5 mg/kg); scenario 2 is based on HR edible part of the crop measured immediately after the treatment (DAT 0 days) (0.03 mg/kg). The risk assessment was performed with the EU ARfD. The calculations are indicative, because information is required on (1) confirmation of the residue definition for risk assessment, (2) the nature of residues after processing (standard hydrolysis studies) and (3) data to address the potential for consumer exposure and toxicological properties for the metabolite benzimidazole. The risk assessment calculations are indicative, because data for the metabolite benzimidazole (toxicological studies and information on magnitude of residues in the crops under assessment) are not available.	RA assumptions: A long‐term dietary risk assessment was performed using PRIMo rev. 3.1. The input values of the most recent long‐term risk assessment (EFSA, 2016n) were updated, including the STMR values derived by JMPR for the crops for which the proposed Codex MRL is higher than the EU MRL. For mango, the risk assessment used the STMR whole fruit because information is not available to derive a reliable processing factor for peeling after a suitable waiting period. The risk assessment was performed with the EU ADI. The risk assessment calculations are indicative, because data for the metabolite benzimidazole (toxicological studies and information on magnitude of residues in the crops under assessment) are not available. The calculations are indicative, because information is required on (1) confirmation of the residue definition for risk assessment, (2) the nature of residues after processing (standard hydrolysis studies) and (3) data to address the potential for consumer exposure and toxicological properties for the metabolite benzimidazole. The risk assessment calculations are indicative, because data for the metabolite benzimidazole (toxicological studies and information on magnitude of residues in the crops under assessment) are not available.	Specific comments: The JMPR exposure assessment does not include the potential for consumer exposure to the metabolite benzimidazole, which is included in the EU residue definition for risk assessment for plant products (tentative, relevant to preharvest treatment and rotational crops, data gap identified). Information is required on the nature of residues after processing (standard hydrolysis studies). For mango, the JMPR exposure assessment is based on residues in mango pulp (edible potion) on the day of treatment (DAT = 0).
Results: The calculated short‐term exposure exceeded the ARfD for one/several crops under assessment. Mangoes: scenario 1: 354% of ARfD (NL toddler) scenario 2: 2.4% of ARfD (NL toddler) Sweet potatoes: 145% of ARfD (IE adult)	Results: No long‐term consumer health risk was identified. The overall chronic exposure accounted for 39% of the ADI (NL toddler). Among the crops under consideration, sweet potato was identified as the main contributor, accounting for up to 17% of the ADI (IE adult).	Results: Long‐term exposure: Max. 2–10% of the JMPR ADI. Short‐term exposure: Highest results for sweet potatoes: 4–20% (child) and 1–7% (adult) of ARfD for general population; 3–9% of ARfD for women of child‐bearing age.

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Chlorothalonil	Reg. 396/2005: Chlorothalonil Peer review (EFSA, 2018a): 1) Chlorothalonil 2) R182281(SDS‐3701) 3) R611965 (SDS‐46851) for rotational crops (provisional)	Yes (compared with current RD in legislation)
RD enf	Animal products	SDS‐3701 (2,5,6‐trichloro‐4‐hydroxyisophthalonitrile) The residue is not fat soluble	Reg. 396/2005: 2,5,6‐trichloro‐4‐hydroxyphtalonitrile (SDS‐3701) Peer review (EFSA, 2018a): R182281(SDS‐3701) (provisional) The residue is not fat soluble	Yes (compared with current RD in legislation)
RD RA	Plant products	1) Chlorothalonil 2) SDS 3701 (2,5,6‐trichloro‐4‐hydroxyisophthalonitrile)	Peer review (EFSA, 2018a): 1) Chlorothalonil and its conjugates 2) R182281 (SDS‐3701) and its conjugates 3) R613636 (SDS‐19221) for processed commodities 4) R611965 (SDS‐46851)/R417888 and conjugates of metabolites R613636, R613800 (C15) and R611968 (for rotational crops) Residue definitions provisional MRL review: 1) Chlorothalonil 2) R182281(SDS‐3701)	No
RD RA	Animal products	SDS‐3701 (2,5,6‐trichloro‐4‐hydroxyisophthalonitrile)	MRL review: 1) R182281(SDS‐3701) (ruminants and poultry) Peer review (EFSA, 2018a): R182281(SDS‐3701) (provisional)	Yes
Conclusion, comments	The existing EU enforcement residue definitions in plant and animal commodities are comparable with those recommended by JMPR. For plant commodities, a separate risk assessment RD has been derived in the MRL review and by JMPR to cover SDS‐3701 residues; in the EU also the conjugates were included. Also for parent chlorothalonil the proposed EU risk assessment residue definition includes chlorothalonil conjugates. In addition, the EU peer review proposed separate residue definitions in rotational crops and in processed commodities (not yet implemented). The residue definitions will have to be modified, considering the conclusions on the toxicological profile for SDS‐3707.

Commodity	Codex MRL proposal	EU MRL	Comment
Cranberry	15	0.01^*	cGAP: USA, 3 × 5.5 kg/ha, PHI 50 days Number of trials: 5 Sufficiently supported by data: Yes Specific comments/observations: The information on SDS‐3701 residues was provided (< 0.01 (4)–0.019 mg/kg). The samples prior to analysis were stored frozen for 22 days (relevant to assess validity of SDS‐3701 data). Residue data on SDS‐3701 are reported separately (4 < 0.01, 0.019). In 2015/2016 JMPR assessed the use of chlorothalonil in cranberries. Due to low storage stability for chlorothalonil and SDS‐3701 after 10 months, no MRL proposal was made, as the validity of the residue trials in cranberries was questionable. The residue trials assessed in 2019 were stored for up to 22 days. The EU MRL for cranberries was recently lowered from 5 to 0.01 mg/kg, following the decision on non‐renewal of the approval. Following the assessment of confirmatory data, it was decided that separate MRLs for SDS‐3701 should not be established. Conclusion: Considering that for SDS‐3701 a risk assessment could not be performed (inconclusive results on genotoxicity), the proposed MRL for cranberries is not acceptable. Follow‐up action: None
General comments

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was performed for chlorothalonil residues, using PRIMo rev. 3.1 The ARfD was updated to most recent value of 0.05 mg/kg derived by European Commission in 2019 (European Commission, 2019a). The exposure to SDS‐3701 was estimated using PRIMo rev. 3.1. with TRV as set by the European Commission in 2006 (European Commission, 2006b). No acute consumer intake concerns were identified. The peer review (EFSA, 2018a), due to a number of data gaps, could not conclude on the TRV for SDS‐3701. The risk assessment for parent chlorothalonil was performed with the EU ARfD. For SDS‐3701 an indicative risk calculation of the expected exposure was calculated. Lacking an EU ARfD for this metabolite, no risk assessment was possible. For SDS‐46851 (provisional residue definition for rotational crops) no exposure/risk assessment could be performed, lacking information on the expected concentration of this metabolite in processed cranberries. However, considering that the ARfD is significantly higher than the ARfD for the parent compound, it is not expected that the exposure to SDS‐4651 would exceed the ARfD. It is noted that exposure assessment does not take into consideration conjugates of chlorothalonil and of SDS‐3701. Data on conjugates not available for EU uses assessed in the MRL review as RD for risk assessment did not include conjugates. For cranberries data on conjugates not available, as JMPR RD for risk assessment does not include conjugates.	RA assumptions: A long‐term dietary risk assessment was performed using PRIMo rev. 3.1 The input values of the most recent long‐term risk assessment (EFSA, 2020p), were updated, including the STMR values derived by the JMPR for cranberries. The risk assessment was performed with the EU ADI derived for chlorothalonil. The exposure to SDS‐3701 from the intake of cranberries (and commodities of animal origin) was estimated using PRIMo rev. 3.1. A full risk assessment is not possible, since no EU ADI could be derived for this metabolite, due to a number of data gaps, identified in the peer review (2018).	Specific comments: Exposure assessment was done separately for chlorothalonil and SDS‐3701, considering TRVs set individually for each compound. For metabolite R613636 (relevant in processed commodities undergone sterilisation process), the TTC approach was applied to consider exposure from the intake sterilised foods. Concern was unlikely. The same approach and conclusion were taken for metabolites SYN548764 and R611968 (rotational crop metabolite).
Results: No short‐term consumer health risk was identified for the crops under assessment. Cranberries: 69% of ARfD for chlorothalonil SDS‐3701: the acute exposure accounted for 0.09 μg/kg bw.	Results: No long‐term consumer health risk was identified. Chlorothalonil: the overall chronic exposure accounted for 0.8% of the ADI. The contribution of residues in cranberries is low (< 1% of the ADI). SDS‐3701: the overall chronic exposure accounted for 0.00020 μg/kg bw per day.	Results: Long‐term exposure: Max 10–50% of the JMPR ADI for chlorothalonil; Max 4–10% of the JMPR ADI for SDS‐3701 Short‐term exposure: Cranberries: 9% of ARfD (children) for chlorothalonil; 0% of ARfD for SDS‐3701

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Cypermethrin (sum of isomers)	Reg. 396/2005 and Peer review (EFSA, 2018s): Cypermethrin including other mixtures of constituent isomers (sum of isomers)	Yes
RD enf	Animal products	Cypermethrin (sum of isomers) The residue is fat soluble	Reg. 396/2005 and Peer review (EFSA, 2018s): Cypermethrin including other mixtures of constituent isomers (sum of isomers) The residue is fat soluble	Yes
RD RA	Plant products	Cypermethrin (sum of isomers)	Peer review (EFSA, 2018s): Cypermethrin (sum of isomers) Provisional, pending finalisation of the assessment of the genotoxic potential of 3‐phenoxybenzoic acid (3‐PBA) and review of the preliminary conclusions in toxicology on the whole group of related metabolites bearing the 3‐phenoxybenzoyl moiety (besides 3‐PBA also, e.g. PBAldehyde, 4‐OH‐PBA) once the confirmatory data on lambda‐cyhalothrin have been peer reviewed.	Yes, when compared with provisional RD
RD RA	Animal products	Cypermethrin (sum of isomers)	Peer review (EFSA, 2018s): Cypermethrin including other mixtures of constituent isomers (sum of isomers) Provisional, pending clarification on the relative toxicity of individual cypermethrin isomers and finalisation of the assessment of the genotoxic potential of 3‐phenoxybenzoic acid (3‐PBA) and review of the preliminary conclusions in toxicology on the whole group of related metabolites bearing the 3‐phenoxybenzoyl moiety once the confirmatory data on lambda‐cyhalothrin have been peer reviewed.	Yes, when compared with provisional RD.
Conclusion, comments	The residue definitions for monitoring for products of plant and animal origin are the same whilst the residue definitions for risk assessment are regarded as provisional pending the outcome of the assessment of the outstanding toxicological data.

Commodity	Codex MRL proposal	EU MRL	Comment
Ginseng	0.03 ^*	–	cGAP: Republic of Korea, Foliar, 3 × 0.005 kg a.s./hL, PHI 45 days Number of trials: 6 trials compliant with the cGAP Sufficiently supported by data: Yes Specific comments/observations: In the EU, MRLs are not set for fresh ginseng; ginseng is classified in the class of herbal infusions from roots for which the MRLs refer to dried products. Conclusion: The proposed Codex MRL is acceptable. Follow‐up action: None
Ginseng, dried including red ginseng	0.15	0.1^* (0633020, ginseng)	cGAP: Republic of Korea, Foliar, 3 × 0.005 kg a.s./hL, PHI 45 days Fresh ginseng samples from residue trials reported above were dried or steamed (to produce red ginseng). The results refer to dried ginseng (washed or steamed), which would be the commodity for which EU MRLs are established. Conclusion: The proposed Codex MRL is acceptable. Follow‐up action: None
Ginseng, extracts	0.06^*	–	For processed products no EU MRLs are established.
General comments	–

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was performed using PRIMo rev. 3.1 for ginseng only. The calculations are indicative, because in the EU a final residue definition for risk assessment could not be derived. The risk assessment was performed with the EU ARfD for cypermethrin.	RA assumptions: For ginseng, no chronic consumption data are available in PRIMo rev. 3.1. Since ginseng is not expected to be consumed in significant amounts, the overall dietary exposure situation will not be impacted by the proposed Codex MRL for ginseng. It is noted that the comprehensive MRL review for cypermethrin and its isomers will be performed in the near future (depending on the agreement on prioritisation). In this framework, a reliable, comprehensive risk assessment will be performed for cypermethrin, including existing Codex MRLs.	Specific comments: –
Results: No short‐term consumer health risk was identified for the crops under assessment. The exposure accounted for 1% of ARfD for the adults	Results: –	Results: Long‐term exposure: previous risk assessment not affected by the new use in ginseng. Short‐term exposure: Ginseng: 0% of ARfD

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Methoprene	Reg. 396/2005: Methoprene	Yes
RD enf	Animal products	Methoprene The residue is fat soluble	Reg. 396/2005: Methoprene The residue is not fat soluble	Yes
RD RA	Plant products	Methoprene	–	Not applicable
RD RA	Animal products	Methoprene	–	Not applicable
Conclusion, comments	EU: In the framework of the EU pesticide legislation, methoprene and S‐methoprene were never evaluated. The current residue definition was introduced in 2008, when temporary MRLs were established for the first time under Regulation 396/2005; the residue definition was set by default as the parent compound. An EU assessment for the appropriate residue definitions has not been performed. Methoprene and S‐methoprene have not been authorised for use as pesticide at EU level under Council Directive 91/414^a or Regulation 1107/2009.^b  JMPR: The residue definition is set as methoprene for plant and animal commodities, for both enforcement and dietary risk assessment. The definition is not specific to S‐methoprene and covers also residues arising from the use of methoprene. The residue definition of JMPR was based on pant metabolism studies conducted with radiolabelled methoprene in wheat (post‐harvest treatment), alfalfa and rice (leaf painting application). A metabolism in pulses and oilseeds after post‐harvest treatment (or other appropriate foliar metabolism studies) is not available. JMPR concluded that residue is fat‐soluble (based on log P_ow of 4 for methoprene and approximate 6 for S‐methoprene).

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was not performed since no ARfD has been allocated to the a.s. Not relevant since no ARfD was allocated.	RA assumptions: The long‐term dietary risk assessment was performed using PRIMo rev. 3.1.; EFSA used the MRLs as reported in Reg. (EU) No 899/2012^a and the STMR (5 mg/kg, equal to the CXL) proposed by JMPR for S‐methoprene in peanuts. The risk assessment was performed with the JMPR ADI for S‐methoprene. The calculations are indicative, because methoprene was never assessed at EU level. The calculations are affected by additional, non‐standard uncertainties, related to the lack of information on the existing MRLs above the LOQ (cereals, swine, bovine, sheep fat and edible offal). Further refinements could not be performed as no detailed information is available for these uses.	Specific comments: JMPR used the ADI for S‐methoprene is 0–0.05 mg/kg bw in the risk assessment.
Results: Not relevant	Results: The calculated long‐term exposure exceeded the ADI set by JMPR for methoprene. The overall chronic exposure accounted for 136% of the ADI set by JMPR for S‐methoprene. The main contributors to the overall exposure were the existing MRLs on wheat (up to 72% of the ADI) and maize (up to 70% of the ADI). MRLs at the LOQ covered 8% of the ADI. The maximum contribution to the chronic exposure of the peanuts (expressed as percentage of the ADI) was 3% (NL child)	Results: Long‐term exposure: Max 60% of the JMPR ADI set for s‐methoprene. Short‐term exposure: Not relevant (JMPR did not derive an ARfD).

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Soyabean, maize and rape: Sum of glyphosate and N‐acetyl glyphosate, expressed as glyphosate Other crops: glyphosate	Reg. 396/2005: Glyphosate MRL review Art. 12 (EFSA, 2018i) (not yet implemented in EU MRL legislation): Two different options proposed by EFSA for further considerations by risk managers: Main RD‐enforcement: – For plants with glyphosate tolerant genetically modified varieties currently available on the market (sweet corn, cotton seeds, sugar beets, rapeseeds, maize and soybeans): sum of glyphosate, AMPA and N‐acetyl glyphosate, expressed as glyphosate – For all other plant commodities: glyphosate Optional RD‐enforcement: – For all plant commodities (including plants with glyphosate tolerant genetically modified varieties currently available on the market): sum of glyphosate, AMPA and N‐acetyl‐glyphosate, expressed as glyphosate Peer review (EFSA, 2015x): Sweet corn, oilseed rape, soyabeans and maize (non‐tolerant and tolerant, all modifications): sum of glyphosate and N‐acetyl‐glyphosate, expressed as glyphosate Other plant commodities: glyphosate	Yes, for RD implemented in MRL Regulation, except for soyabeans, maize, rapeseed
RD enf	Animal products	Sum of glyphosate and N‐acetyl glyphosate, expressed as glyphosate The residue is not fat soluble	Reg. 396/2005: Glyphosate MRL review Art. 12 (EFSA, 2018i): Sum of glyphosate, AMPA and N‐acetyl‐glyphosate, expressed as glyphosate Peer review (EFSA, 2015x): Sum of glyphosate and N‐acetyl‐glyphosate, expressed as glyphosate The residue is not fat soluble	No
RD RA	Plant products	Glyphosate, N‐acetyl glyphosate, AMPA and N‐acetyl AMPA, expressed as glyphosate	MRL review Art. 12 (EFSA, 2018i): Sum of glyphosate, AMPA, N‐acetyl‐glyphosate and N‐acetyl‐AMPA, expressed as glyphosate Peer review (EFSA, 2015x): Sum of glyphosate, AMPA, N‐acetyl‐glyphosate and N‐acetyl‐AMPA, all expressed as glyphosate	Yes
RD RA	Animal products		MRL review Art. 12 (EFSA, 2018i): Sum of glyphosate, AMPA, N‐acetyl‐glyphosate and N‐acetyl‐AMPA, expressed as glyphosate Peer review (EFSA, 2015x): Sum of glyphosate, AMPA, N‐acetyl‐glyphosate and N‐acetyl‐AMPA, all expressed as glyphosate	Yes
Conclusion, comments	For the commodities under assessment (conventional crops), the residue definitions are comparable. In case the optional residue definition for enforcement will be legally implemented in the EU legislation, the residue definitions for the crops under consideration will not be comparable.

Commodity	Codex MRL proposal	EU MRL/proposed EU MRL^(a)	Comment
Dry beans, Subgroup of (includes all commodities in this subgroup) (except soyabeans)	15	Beans (dry): 2/15 Lupins (dry): 10/10	cGAP: UK, one application at 1.44 kg a.i./ha preharvest with a PHI of 7 days Number of trials: 13 Sufficiently supported by data: Yes Specific comments/observations: Residue trials on dry beans performed in USA at an application rate of 4.20 kg a.i./ha pre‐emergence and an application rate of 1.71 kg a.i./ha preharvest with harvest 7 DALA. The Meeting considered that the pre‐emergence applications would not contribute significantly to residue levels at harvest. This conclusion is supported by EFSA. Residues were analysed for both glyphosate and AMPA. Conclusion: The proposed Codex MRL is acceptable. Follow‐up action: None
Dry peas, Subgroup of (includes all commodities in this subgroup)	10	Peas (dry): 10/15 Lentils (dry): 10/10	cGAP: USA, 2 applications at 4.2 kg a.i./ha pre‐emergence and 2.5 kg a.i./ha preharvest with a PHI of 7 days. Number of trials: 16 Sufficiently supported by data: Yes Specific comments/observations: Combined data set of trials on dry lentils (11) and dry peas (5) approximating the GAP. Residues were analysed for both glyphosate and AMPA. Conclusion: The proposed Codex MRL is acceptable. Follow‐up action: None
General comments	The Codex MRL proposals for dry beans, dry peas and dry lentils are expected to be covered by the MRLs derived during the MRL review. For dry lupins, the Codex MRL proposal is higher than the MRL derived during the Article 12 review. It is underlined that the legal implementation of the MRL review is still pending. (a): MRL proposal derived in the MRL review (EFSA, 2019m) for the residue definition glyphosate.

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions:  In the framework of the Article 12 MRL review, EFSA calculated the acute risk assessment with the HR values, which were higher than the HR values derived from the trials assessed by JMPR (22 mg/kg for dry beans and peas, 15.2 mg/kg for dry lentils and lupins). Considering that for pulses the acute exposure calculation should be performed according to IESTI case 3, a second scenario was calculated, using the STMR values derived in the MRL review (see chronic RA). The risk assessment was performed with the EU ARfD and the EFSA PRIMo rev. 2.	RA assumptions: The most recent risk assessment performed by EFSA in the framework of the Art. 12 MRL review was updated, by including the STMR values for the crops under consideration for which a higher STMR was derived by the JMPR (lentils and lupins). The results reported below are based on the STMR values derived during the MRL review (0.92 for dry beans and peas) and derived by the JMPR (1.7 for dry lentils and 0.32 for dry lupins). The risk assessment was performed with the EU ADI and the EFSA PRIMo rev. 2.	Specific comments: –
Results: No short‐term consumer health risk was identified for the crops under assessment. Results considering the HR (as performed during the MRL review): Dry beans: 80.4% of ARfD Dry peas: 18.5% of the ARfD Dry lentils: 18.7% of the ARfD Dry lupins: not reported Results considering the STMR: Dry beans: 3.4% of ARfD Dry peas: 0.8% of the ARfD Dry lentils: 2.1% of the ARfD Dry lupins: not reported	Results: No long‐term consumer health risk was identified. The overall chronic exposure accounted for 18.8% of the ADI. Among the crops under consideration, beans were identified as the main contributor, accounting for up to 0.14% of the ADI.	Results: Long‐term exposure: Max 4% of the JMPR ADI. Short‐term exposure: Not relevant (JMPR did not derive an ARfD).

PERMALINK

Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR)

Abstract

Summary

1. Introduction

1.1. Background

1.2. Terms of Reference

2. Assessment

3. General Consideration items

3.1. Extraordinary 2019 JMPR meeting

3.1.1. Extra JMPR Meetings

3.2. Regular 2019 JMPR meeting

3.2.1. Update to Chapter 5 of the Environmental Health Criteria (EHC) 240: Dose–response assessment and derivation of health‐based guidance values

3.2.2. Combined exposure to multiple chemicals

3.2.3. Guidance for the evaluation of genotoxicity of chemical substances in food

3.2.4. Results for probabilistic modelling of acute dietary exposure to evaluate the IESTI equations

3.2.5. Need for a guidance on toxicological interpretation due to the shift from maximum tolerated dose (MTD)‐based to kinetically‐derived maximum dose (KMD)‐based evaluation of pesticide residues

3.2.6. Comments on chlorpyrifos

3.2.7. Possible need for amendments to the Environmental Health Criteria (EHC) 240 guidance on appropriate use of toxicological historical control data (HCD)

3.2.8. Use of monitoring data for the estimation of maximum residue levels

4. Responses to specific concerns raised by the Codex Committee on Pesticide Residues (CCPR)

4.1. Buprofezin (173)

4.2. Diflubenzuron (130)

4.3. Fluxapyroxad (256)

4.4. Iprodione (111)

4.5. Isofetamid (290) – Reconsideration of the maximum residue levels for bush berries, dry beans and dry peas

4.6. Picoxystrobin (258)

4.7. Propiconazole (160) – Reconsideration of the maximum residue level for peach

4.8. Pyraclostrobin (210)

4.9. Request from CCPR concerning okra

5. Comments on JMPR report chapter 5 (individual substances assessed)

5.1. Dimethoate (027) R/T

5.1.1. Background information

Table 1.

5.1.2. Toxicological reference values

Table 2.

5.1.3. Residue definitions

Table 3.

5.1.4. Codex MRL proposals

Table 4.

5.1.5. Consumer risk assessment

5.2. Omethoate (055) R/T

5.2.1. Background information

Table 5.

5.2.2. Toxicological reference values

Table 6.

5.2.3. Residue definitions

5.2.4. Codex MRL proposals

Table 7.

5.2.5. Consumer risk assessment

5.3. Thiabendazole (65) R/T

5.3.1. Background information

Table 8.

5.3.2. Toxicological reference values

Table 9.

5.3.3. Residue definitions

Table 10.

5.3.4. Codex MRL proposals

Table 11.

5.3.5. Consumer risk assessment

Table 12.

5.4. Chlorothalonil (81) R/T

5.4.1. Background information

Table 13.

5.4.2. Toxicological reference values

Table 14.

5.4.3. Residue definitions

Table 15.

5.4.4. Codex MRL proposals

Table 16.

5.4.5. Consumer risk assessment

Table 17.

5.5. Cypermethrin (including alpha and zeta‐cypermethrin) (118) R

5.5.1. Background information

Table 18.

5.5.2. Toxicological reference values

Table 19.

5.5.3. Residue definitions

Table 20.

5.5.4. Codex MRL proposals

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Propiconazole	Reg. 396/2005: Propiconazole (sum of isomers)	Yes
RD enf	Animal products	Propiconazole The residue is fat soluble	Reg. 396/2005: Propiconazole (sum of isomers) Peer review (EFSA, 2017h): CGA91305 (free and conjugated) ((1RS)‐1‐(2,4‐dichlorophenyl)2‐(1H‐1,2,4‐triazol‐1‐yl) ethanol) The residue is fat soluble	Yes, compared with the current residue definition in Reg. (EU) No 396/2005
RD RA	Plant products	Propiconazole plus all metabolites convertible to 2,4‐dichloro‐benzoicacid, expressed as propiconazole.	MRL review (EFSA, 2015a): Parent propiconazole and all the metabolites convertible to the 2,4‐dichlorobenzoic acid, expressed as propiconazole (sum of isomers) Peer review (EFSA, 2017h): Primary crops (For all categories of crops): 1) Propiconazole (sum of isomers) 2) CGA 118244 (3,5‐dideoxy‐1,2‐O‐[(1RS)‐1‐(2,4‐dichlorophenyl)‐2‐(1H‐1,2,4‐triazol‐1‐yl)ethylidene]‐D,L‐pentitol) free and glucoside conjugated. Whether the parent compound and CGA 118244 have to be considered together or separately is pending upon the submission of toxicological data to address the toxicity profile on CGA118244). 3) CGA142856 (TAA, 1H‐1,2,4‐triazol‐1‐ylacetic acid) and CGA131013 (TA,3‐(1H‐1,2,4‐triazol‐1‐yl)‐d,l‐alanine)	Yes, compared with the current residue definition in Reg. (EU) No 396/2005
RD RA	Animal products	Propiconazole plus all metabolites convertible to 2,4‐dichloro‐benzoicacid, expressed as propiconazole.	MRL review (EFSA, 2015a): Parent propiconazole and all the metabolites convertible to the 2,4‐dichlorobenzoic acid, expressed as propiconazole (sum of isomers) Peer review (EFSA, 2017h): 1) Propiconazole, CGA91305 (free and conjugated) and CGA118244 (The way the residue definition will be expressed is pending upon the requested toxicological profile on CGA91305 and CGA118244) 2) CGA71019 (1,2,4‐triazole)	Yes, compared to the RD derived in the MRL review
Conclusion, comments	–

Commodity	Codex MRL proposal	EU MRL/proposed EU MRL^(a)	Comment
Peaches	4	0.01^*	cGAP: USA, one post‐harvest in‐line dip/drench treatment to peach application of 0.014 kg a.i./hL; Number of trials: 4 Sufficiently supported by data: No Specific comments/observations: Peaches are a category 3 crop for JMPR; therefore, at least 5 trials would be required. The MRL proposal was derived using the Mean + 4SDs. STMR: 1.7 mg/kg; HR: 2.5 mg/kg. Conclusion: The proposed Codex MRL is not acceptable because of an acute intake concern (see below) and because of the insufficient number of residue trials. Follow‐up action: None
General comments	–

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Buprofezin	Reg. 396/2005: Buprofezin Peer review (EFSA, 2015n): Buprofezin	Yes
RD enf	Animal products	Buprofezin The residue is not fat soluble	Reg. 396/2005: Buprofezin Peer review (EFSA, 2010h): Not RD proposed, since not considered necessary for the representative uses The residue is fat soluble	Yes
RD RA	Plant products	Buprofezin	Peer review (EFSA, 2015n): Sum of buprofezin and BF4 conjugates analysed as BF9 + BF12 under acidic conditions and expressed as buprofezin	No
RD RA	Animal products	Buprofezin	Peer review (EFSA, 2015n): Not necessary	Not appropriate
Conclusion, comments	–

Commodity	Codex MRL proposal	EU MRL	Comment
Citrus pulp, dry	5	–	14 processing studies in oranges pulp, dry; PF ranged from 1.1 to 4.8, best estimate for PF: 2.9.
Citrus oil, edible	6	–	10 processing studies in oranges oil; PF ranged from 0.88 to 8.9, best estimate for PF: 5.4.
Olive oil, crude	20	–	8 processing studies in olive oil (crude); PF ranged from 0.9 to 4.1, best estimate for PF: 3.5. It is noted that JMPR derived a Codex MRL proposal for crude olive oil, although no MRL proposal is made for unprocessed olives for oil production (SO 0305).The MRL proposal is probably derived by recalculating the existing CXL for table olives (FT 0305) (5 mg/kg) to olive oil, using the PF. However, it is our understanding that a CXL needs to be established for the RAC olives for oil production.
Group of tree nuts	0.05 ^*	0.01^*	cGAP: USA, 1 × 2.24 kg a.i./ha, PHI 60 days Number of trials: 11 (6 in almonds and 5 in pecan nuts) Sufficiently supported by data: Yes Specific comments/observations: In none of the residue trials quantifiable residues were found. Conclusion: The proposed Codex MRL is sufficiently supported by data. To discuss with RM whether the concerns of the EU were sufficiently addressed by JMPR. Follow‐up action: None
Almond hulls	3	–	In the EU, no MRLs are set for almond hulls. JMPR derived the MRL proposal from 7 residue trials approximating the US GAP for almonds (see above).
Almond	0.05^* (W)	0.01^*	Existing CXL is withdrawn; to be replaced with Codex MRL proposal for the group of tree nuts
Mammalian fats except milk fats	0.01^*	0.01^*	In cattle feeding study conducted at exaggerated dose rates (12N and 35N the estimated dietary burden) no quantifiable residues were found in tissues and milk. Codex MRLs have been established for other animal products except mammalian fat in 2010. Sufficiently supported by data: Yes Conclusion: The proposed Codex MRL is acceptable. Follow‐up action: None
Eggs	0.01^*	0.01^*	The dietary burden for poultry was very low (0.002 ppm). No feeding study for poultry is available. JMPR derived the MRL proposal for poultry products, considering the findings of the feeding study in cattle. Sufficiently supported by data: No Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable although no feeding study is available, considering the low dietary burden for poultry. Follow‐up action: None
Poultry, edible offal of	0.01^*	0.01^*	See eggs.
Poultry fats	0.01^*	0.01^*	See eggs.
Poultry meat	0.01^*	0.01^*	See eggs.
General comments:

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was performed for parent buprofezin using PRIMo rev. 3.1 tree nuts. The risk assessment was performed with the EU/Codex ARfD. The calculations are indicative, because no information is available on the magnitude of residues for metabolites included in the EU residue definition (BF4 conjugates analysed as BF9 + BF12 under acidic conditions) Exposure to aniline residues expected in processed products was not calculated, since no aniline concentrations were reported for the crops under consideration.	RA assumptions: A long‐term dietary risk assessment was performed using PRIMo rev. 3.1 (normal mode). The calculations were performed with the STMR values derived by JMPR for tree nuts and the existing EU MRLs for the remaining crops. The risk assessment was performed with the EU ADI. The calculations are indicative, because no information is available on the magnitude of residues for metabolites included in the EU residue definition (BF4 conjugates analysed as BF9 + BF12 under acidic conditions) Exposure to aniline residues expected in processed products was not calculated, since no aniline concentrations were reported for the crops under consideration.	Specific comments: JMPR calculated the long‐term exposure for buprofezin and the short‐term exposure for parent buprofezin and for aniline.
Results: No short‐term consumer health risk was identified for the crops under assessment. All ≤ 0.1% of ARfD	Results: No long‐term consumer health risk was identified. The overall chronic exposure accounted for 13% of the ADI. Among the crops under consideration, coconut was identified as the main contributor, accounting for up to 0.25% of the ADI.	Results: Buprofezin: Long‐term exposure: Max 4–40% of the JMPR ADI. Short‐term exposure (including all crops for which CXLs were established/proposed in 2019 JMPR: Highest result for apples and grapes: 10% of ARfD, respectively. Aniline: Long‐term exposure: The long‐term dietary risk for buprofezin adequately addresses long‐term dietary risk to aniline (from uses of buprofezin). Short‐term exposure (including all crops for which CXLs were established/proposed in 2019 JMPR: Highest result for apples and grapes: 0% of ARfD, respectively.

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Bifenthrin (sum of isomers)	Reg. 396/2005 and MRL review Art. 12 (EFSA, 2015j): Bifenthrin (sum of isomers) Peer review (EFSA, 2011f): bifenthrin (sum of isomers)	Yes
RD enf	Animal products	Bifenthrin (sum of isomers) The residue is fat soluble	Reg. 396/2005 and MRL review Art. 12 (EFSA, 2015j): Bifenthrin (sum of isomers) Peer review (EFSA, 2011f): bifenthrin (sum of isomers) The residue is fat soluble	Yes
RD RA	Plant products	Bifenthrin (sum of isomers)	MRL review Art. 12 (EFSA, 2015j): Bifenthrin (sum of isomers) Peer review (EFSA, 2011f): bifenthrin (sum of isomers)	Yes
RD RA	Animal products	Bifenthrin (sum of isomers)	MRL review Art. 12 (EFSA, 2015j): Bifenthrin (sum of isomers)	Yes
Conclusion, comments	The residue definitions are comparable.

Commodity	Codex MRL proposal	EU MRL/assessment of confirmatory data	Comment
Strawberry	3	1 (ft)/further risk management considerations required	cGAP: USA, 0.045–0.22 kg a.i./ha, total seasonal rate: 0.56 kg a.i./ha; PHI: not specified. Number of trials: 19 (4 × 0.22 kg a.i./ha, RTI 14 days) Sufficiently supported by data: Yes Specific comments/observations: In 2019, JMPR also received a new US GAP for strawberries (4 × 0.11 kg a.i./ha, PHI 3 days). Since the previously assessed, more critical GAP is still authorised in the USA, the JMPR confirmed its previous MRL proposal of 3 mg/kg. Conclusion: Although the proposed Codex MRL is sufficiently supported by residue trials, it is not acceptable because a short‐term consumer risk was identified by JMPR and by EFSA (see below). It is noted that JMPR has not recommended withdrawal of the current CXL of 1 mg/kg. It is proposed to include a recommendation in the EU comments to discuss the withdrawal of the current CXL of 1 mg/kg on strawberries. Follow‐up action: None
Straw and fodder (dry) of cereal grains	1 (dw)	–	cGAP (for barley, assessed by JMPR in 2010): Switzerland, 2 × 0.016 kg a.i./ha; PHI 42 days. Number of trials: 13 The JMPR derived an MRL proposal based on trials on cereal straws from barley, oats, triticale and wheat. Trials were carried out with ˜ 2 × lower application rates and were scaled to comply with the GAP. The maximum dietary burdens calculated based on 2018 OECD Feed diets was less than 10% of the maximum total dietary burden estimated by JMPR in 2010 and did not change the estimated residues in animal commodities. Follow‐up action: Switzerland to verify whether the use in cereals still exists.
General comments	In 2016, CCPR agreed to retain proposed MRLs for strawberries, celery and lettuce at step 4, in light of acute intake risk identified in the 2015 JMPR and await an alternative GAP for review by 2017 JMPR which was then further postponed to 2019 JMPR. In 2010, JMPR recommended withdrawal of the CXL of 0.05 mg/kg* for barley and the CXL of 0.5 mg/kg for barley straw and fodder. Since the manufacturer committed to submit supporting data for barley, barley straw and fodder, CCPR 2011 agreed to retain these CXLs under 4 years periodic review procedure. In 2016, CCPR agreed to retain the existing CXL for barley and barley straw and fodder dry, awaiting the outcome of the 2018 JMPR (CCPR 48–60). Data for barley straw were now submitted (see table). In 2017 CCPR agreed to hold the draft MRL for okra at step 7 awaiting data from India. Additional data were submitted, but since the number of trials was insufficient to derive an MRL proposal for okra, the previous draft MRL proposal of 0.2 mg/kg should be withdrawn. Since no data were submitted to 2019 JMPR for celery and lettuce, a decision on withdrawal of the MRL proposal needs to be taken in CCPR 52.

Acute exposure assessment	Chronic exposure assessment	Comments on JMPR exposure assessment
RA assumptions: A short‐term dietary risk assessment was performed using PRIMo rev. 3.1 for strawberries. Two scenarios were calculated, using the EU ARfD (scenario 1) and the JMPR ARfD (scenario 2).	RA assumptions: A long‐term dietary risk assessment was performed using PRIMo rev. 3.1. The input values of the most recent long‐term risk assessment (EFSA, 2015j) were updated, including the STMR value derived by JMPR for strawberries. In addition, for CXLs implemented in the EU MRL legislation in 2018 the corresponding STMR values were included in the calculation model. Two scenarios were calculated, using the EU ADI (scenario 1) and the JMPR ADI (scenario 2)	Specific comments: JMPR concluded that the estimated acute dietary exposure to residues of bifenthrin for the consumption of strawberries may present a public health concern.
Results: The calculated short‐term exposure exceeded the ARfD in both scenarios. Scenario 1, considering ARfD derived by (EFSA, 2008b, 2011f): Short‐term exposure concern was identified (max 125% ARfD for strawberries). Scenario 2: considering ARfD derived by JMPR (2009): Short‐term exposure concern was identified (max 376% ARfD for strawberries)	Results: No long‐term consumer health risk was identified. Scenario 1, considering ADI derived by (EFSA, 2008b, 2011f): The overall chronic exposure (refined mode) accounted for 43% of the ADI. Strawberries contribution accounting for up to 1.5% of the ADI. Scenario 2, considering ADI derived by (JMPR, 2009): The overall chronic exposure (refined mode) accounted for 64% of the ADI.	Results: Long‐term exposure: Max 10–40% of the JMPR ADI. Short‐term exposure: Highest result for children: 380% of ARfD

	Commodity group	JMPR evaluation	EU evaluation	RDs comparable
RD enf	Plant products	Sum of clethodim and its metabolites convertible to dimethyl 3‐[2‐(ethylsulfonyl)propyl]‐pentanedioate (DME) and dimethyl 3‐[2‐(ethylsulfonyl)propyl]‐3‐hydroxy‐pentanedioate (DME‐OH), expressed as clethodim	MRL review Art. 12 (EFSA, 2019e): For raw plant commodities: Sum of clethodim, clethodim sulfoxide and clethodim sulfone, expressed as clethodim For processed commodities: inconclusive (pending on submission of additional hydrolysis studies) Peer review (EFSA, 2011m): Root/tuber vegetable and Oilseeds/Pulses group: Sum of clethodim, clethodim sulfoxide and clethodim sulfone expressed as clethodim	No
RD enf	Animal products	Sum of clethodim and its metabolites convertible to dimethyl 3‐[2‐(ethylsulfonyl)propyl]‐pentanedioate (DME), expressed as clethodim The residue is fat soluble	MRL review Art. 12 (EFSA, 2019e): Sum of clethodim, clethodim sulfoxide and clethodim sulfone, expressed as clethodim (tentative) Peer review (EFSA, 2011m): Not proposed and not required for sugar beet use, since residues in food of animal origin were assessed to be insignificant and MRLs were not proposed. The residue is not fat soluble	No
RD RA	Plant products	A conclusion could not be reached	MRL review Art. 12 (EFSA, 2019e): Residue definition for risk assessment one (tentative): Sum of clethodim, clethodim sulfoxide, clethodim sulfone and metabolites M14R/M15R, M16R/M17R and M18R/M19R, expressed as clethodim is tentatively proposed Residue definition for risk assessment two (tentative): M14A/M15A For processed commodities: inconclusive Peer review (EFSA, 2011m): Root/tuber vegetables and Oilseeds/Pulses groups: Sum of clethodim, clethodim sulfone, clethodim sulfoxide and metabolites M15R, M17R and M18R expressed as clethodim	No
RD RA	Animal products	A conclusion could not be reached	MRL review Art. 12 (EFSA, 2019e): Sum of clethodim, clethodim sulfoxide and clethodim sulfone, expressed as clethodim (tentative)Peer review (EFSA, 2011m): Not proposed and not required for sugar beet use, since residues in food of animal origin were assessed to be insignificant and MRLs were not proposed.	No
Conclusion, comments	Since JMPR was unable to conclude on the toxicological relevance of metabolites clethodim sulfone (relevant for plant and animal commodities), M19R, M15A and clethodim oxazole sulfoxide (relevant for plant products), residue definition for dietary risk assessment could not be derived. JMPR used the TTC approach for genotoxicity for clethodim sulfone, M19R and M15A and the TTC approach for Cramer Class III for clethodim oxazole sulfoxide. However, the estimated chronic exposure exceeded the TTC for clethodim sulfone, M19R and M15A.

Commodity	Codex MRL proposal	EU MRL	Comment
Alfalfa fodder	10 (W)	–	EU MRLs are not established for feed items.
Beans fodder	10 (W)	–	EU MRLs are not established for feed items.
Beans (dry)	2 (W)	2	JMPR withdrew the previous recommendation for dry beans of 2 mg/kg (EU GAP) because residue trials did not measure all analytes in the clethodim residue definition.
Beans, except broad bean and soyabean	0.5^* (W)	0.5	JMPR withdrew the previous recommendation since no residue data were provided.
Cotton seed	0.5 (W)	0.5	JMPR withdrew the previous recommendation since no residue data were provided.
Cotton seed oil, crude	0.5^* (W)	–	EU MRLs are not established for processed products.
Cotton seed oil, edible	0.5^* (W)	–	EU MRLs are not established for processed products.
Edible offal (Mammalian)	0.2^* (W)	0.2	The dietary burden, considering that the only potential feed item was apple wet pomace, was calculated to be 0 ppm. JMPR did not derive a recommendation to replace the previous CXL. It is noted that the MRL proposal for pome fruit (LOQ of 0.2 mg/kg) was not put in the recommendations, probably because of the open toxicological questions related to the residue definition for risk assessment.
Eggs	0.05^* (W)	0.05^*	See edible offal (mammalian)
Field pea (dry)	2 (W)	2	EU MRLs are not established for feed items.
Fodder beet	0.1^* (W)	–	JMPR withdrew the previous recommendation since no residue data were provided.
Garlic	0.5 (W)	0.5	JMPR withdrew the previous recommendation; the data submitted in support of the cGAP (NL) since the trials did not match the GAP.
Meat (from mammals other than marine mammals)	0.2^* (W)	0.2	See edible offal (mammalian)
Milks	0.05^* (W)	0.05^*	See edible offal (mammalian)
Onion, Bulb	0.5 (W)	0.5	JMPR withdrew the previous recommendation; the data submitted in support of the cGAP (NL) since the trials did not match the GAP.
Peanut	5 (W)	5	JMPR withdrew the previous recommendation since no residue data were provided.
Potato	0.5 (W)	0.5	JMPR withdrew the previous recommendation since no residue data were provided.
Poultry meat	0.2^* (W)	0.2	See edible offal (mammalian)
Poultry, Edible offal of	0.2^* (W)	0.2	See edible offal (mammalian)
Rape seed	0.5 (W)	1	JMPR withdrew the previous recommendation; the data submitted in support of the GAPs (cGAP SK; fall‐back GAP UK) since the trials did not match the cGAP or were insufficient (4 trials for UK GAP).
Rape seed oil, Crude	0.5^* (W)	–	EU MRLs are not established for processed products.
Rape seed oil, Edible	0.5^* (W)	–	EU MRLs are not established for processed products.
Soyabean (dry)	10 (W)	10	JMPR withdrew the previous recommendation since no residue data were provided.
Soyabean oil, crude	1 (W)	–	EU MRLs are not established for processed products.
Soyabean oil, refined	0.5^* (W)	–	EU MRLs are not established for processed products.
Sugar beet	0.1 (W)	0.5	JMPR withdrew the previous recommendation since no residue data were provided.
Sunflower seed	0.5 (W)	0.5	JMPR withdrew the previous recommendation since no residue data were provided.
Sunflower seed oil, crude	0.1^* (W)	–	EU MRLs are not established for processed products.
Tomato	1 (W)	1	JMPR withdrew the previous recommendation since no residue data were provided.
General comments	In the recently performed MRL review (Art. 12 of Regulation (EC) No 396/2005), EFSA did not derive MRL proposals, because no conclusion on the toxicological properties of the metabolite could be reached, and therefore, the residue definition for risk assessment cannot be derived which is a prerequisite to perform a reliable dietary risk assessment.