Scientific support for preparing an EU position in the 51st Session of the Codex Committee on Pesticide Residues (CCPR)

The EU toxicological reference values are in general lower than the JMPR values. In the EU assessment, a lower NOAEL of 0.2 mg diquat ion/kg bw per day for eye effects (cataracts) was set in the 2‐year study in rats compared to 0.6 mg/kg bw per day in the JMPR assessment

The basis for setting the ARfD was different in the EU and JMPR assessment, whereas in the JMPR the basis was the acute neurotoxicity study, the peer review considered appropriate to set the ARfD based on the NOAEL of 1 mg/kg bw per day for reduced body weight gain observed at 3 mg/kg bw per day in the developmental toxicity study in rabbits. An uncertainty factor of 100 was applied. The reference values as agreed during the peer review are supported

Under the MRL review, toxicological data for the major plant metabolite TOPPS were requested as confirmatory data (deadline for submission 24 June 2018)

Confirmatory data for Diquat (data gaps Article 12 assessment) were submitted to the RMS, co‐RMS, EFSA and the EU COM on 20 June 2018g. No new data on TOPPS was available. Syngenta considered that this was not necessary since in their opinion TOPPS is of no toxicological concern. The applicant proposed use a conversion factor of 1.5 for TOPPS to diquat residues, as a conservative approach. These confirmatory data have not yet been evaluated by UK

In the EFSA conclusion (EFSA, 2015r), toxicological information was also requested for diquat monopyridone and dipyridone. Considering that in October 2018 a decision on non‐approval was taken, it is unlikely that the requested toxicological data will be provided for diquat monopyridone and dipyridone. However, before new Codex MRLs are taken over in the EU legislation, this open point should be addressed

JMPR did not assess the toxicological profile of the metabolites, because they were considered as not relevant due to the low amount expected in plant and animal products (FAO, 2013)

EU Reg. 2016/1002: Diquat

MRL Review (EFSA, 2015a):

Sum of diquat and its salts, expressed as diquat

Peer‐review (EFSA, 2015r): Diquat

Diquat cation

The residue is not fat soluble

EU Reg. 2016/1002: Diquat

MRL Review (EFSA, 2015a): Sum of diquat and its salts, expressed as diquat

Peer‐review (EFSA, 2015r): Ruminant tissues and milk: Diquat dipyridone

Poultry tissues and eggs: Diquat

The residue is not fat soluble

MRL Review (EFSA, 2015a):

Peer‐review (EFSA, 2015r): Herbicide uses: Diquat; Desiccant uses:

1) Diquat &

2) TOPPS, to be considered separately (insufficient data to conclude on the toxicological profile of TOPPS)

Diquat cation

Sum of diquat, its salts and TOPPS expressed as diquat (tentative)

MRL Review (EFSA, 2015a): Sum of diquat, its salts and TOPPS expressed as diquat (tentative)

Peer‐review (EFSA, 2015r): Diquat, diquat monopyridone and diquat dipyridone

Whether residues of the two metabolites can be expressed as diquat is pending a conclusion on the toxicological properties of diquat monopyridone and diquat dipyridone

The current EU enforcement residue definitions implemented in the MRL legislation are comparable with the residue definitions of Codex

For risk assessment, the EU residue definitions are broader; however, in the EU, toxicological data are still missing for the metabolites TOPPS, diquat monopyridone, diquat dipyridone to conclude that they have toxicity comparable with the parent compound. Thus, at EU level, the data gaps related to the metabolites need to be addressed, before new MRLs are established

Critical GAP: AU, 600 g a.i./ha, no PHI defined, but worst case would be harvest after 4 days

Number of trials: 1 trial matching the GAP, 5 trials where residue concentration was interpolated from different PHIs

Sufficiently supported by data: No

Specific comments/observations: For barley at least 8 trials would be required

Conclusion: The proposed Codex MRL is not acceptable because of insufficient number of trials. The risk assessment value derived by JMPR does not reflect the EU residue definition

In the EU, MRLs are not established for feed items

The proposed Codex MRL was derived from the combined data set of trials in barley, oat and wheat (17 trials), reflecting the use of 600 g/ha shortly before harvest

Critical GAP: CA, 408 g a.i./ha for preharvest desiccation, no PHI defined, but worst case would be harvest after 4–5 days Number of trials: 9

Sufficiently supported by data: Yes

Specific comments/observations: The samples were analysed only for diquat; no information on the amount of TOPPS

Conclusion: The proposed Codex MRL is acceptable. However, the risk assessment values derived by JMPR do not reflect the EU residue definition

Beans dry: 0.2;

Soya bean: 0.3

Critical GAP: CA, 552 g a.i./ha for preharvest desiccation; no PHI defined, but worst case would be harvest after 4–5 days

Number of trials: 24 trials for beans and 3 trials in soya beans

Sufficiently supported by data: No

Specific comments/observations: Additional trials in soybeans (major crop) would be required. The samples were analysed only for diquat; no information on the amount of TOPPS

Conclusion: The proposed Codex MRL is not acceptable. However, the risk assessment values derived by JMPR do not reflect the EU residue definition

Critical GAP: CA, 552 g a.i./ha for preharvest desiccation, no PHI defined, but worst case would be harvest after 4–5 days. Number of trials: 8 trials in lentils, 21 trials in peas (dry). Since residue trials in lentils and peas differed significantly, the MRL proposal was derived from the lentil trials only

Sufficiently supported by data: Yes

Specific comments/observations: The samples were analysed only for diquat; no information on the amount of TOPPS

Conclusion: The proposed Codex MRL is acceptable. However, the risk assessment values derived by JMPR do not reflect the EU residue definition

From feeding studies performed with exaggerated dose rates JMPR concluded that no residues are expected in fat

Conclusion: The proposed Codex MRL is acceptable

From feeding studies performed with exaggerated dose rates, JMPR concluded that no residues are expected in fat

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: 600 g a.i./ha, PHI not defined

Number of trials: 6 trials in wheat; residues measured 2‐4 days after application

Sufficiently supported by data: Yes

Specific comments/observations: For rye, 5 trials are sufficient according to JMPR rules; extrapolation from wheat to rye is acceptable. At EU level, 8 trials would be required

Conclusion: The proposed Codex MRL is sufficiently supported by residue trials. The risk assessment value derived by JMPR does not reflect the EU residue definition. A chronic consumer intake concern was identified for rye

Critical GAP: 600 g a.i./ha, PHI not defined

Number of trials: 6 trials in wheat; residues measured 2–4 days after application

Sufficiently supported by data: Yes

Specific comments/observations: For triticale, 5 trials are sufficient according to JMPR rules; extrapolation from wheat to triticale is acceptable

Conclusion: The proposed Codex MRL is sufficiently supported by residue trials. The risk assessment value derived by JMPR does not reflect the EU residue definition

It is noted that 2013 JMPR recommended withdrawal of the CXL for barley, wheat, wheat bran, wheat flour and wheat wholemeal. Since no sufficiently supported alternative GAPs were provided, the CXL should be withdrawn in 2019 CCPR

2018 JMPR confirmed the draft MRLs for edible offal (mammalian) eggs, meat (from mammals other than marine mammals), milks, poultry meat, poultry edible offal which were maintained at step 4. If these MRL proposals are advanced, the old CXLs for these commodities should be withdrawn

EFSA (2010a)

European Commission (2011b)

Studies with parent imazalil assessed by JMPR:

It seems that not all of the studies reported in the JMPR report have been evaluated in the RAR or addendum to the RAR of imazalil (to be verified in the JMPR evaluation). However, according to the RMS, most of the new studies are not expected to influence the outcome of the evaluation in the RAR: e.g. acute tox results are in line with studies RAR and lead to same classification category; genotoxicity studies are negative, confirming the studies and conclusions reached in the RAR; mechanistic studies demonstrating liver enzyme induction and a CAR‐dependent mechanism for liver effects

Assessment of metabolites:

The JMPR Meeting concluded that, based on the structure of R014821, its acute toxicity profile as well as its detection in rats at significant levels, this metabolite would be covered by the health‐based guidance values for the parent compound. As regards R061000 (FK‐772) JMPR was of the opinion that the toxicity would be covered by the parent compound, given its toxicity profile as well as its detection in rats at significant levels. For R043449 (FK‐284) JMPR considered that the expected exposure was below the threshold Cramer Class III

In the JMPR evaluation, all in vitro genotoxicity assays were concluded to be negative

In 2018, EFSA concluded that insufficient data are available to conclude on the toxicological profile of metabolites formed in plants after post‐harvest treatment (R014821) and observed in animal metabolism (FK‐772 and FK‐284) (EFSA, 2018h, o). In the EU evaluation, one study for metabolite R14821 and one study for metabolite FK772 was considered to give equivocal results, as the findings did not comply to either negative or positive outcome as defined in the respective OECD guidelines. Furthermore, the genotoxic endpoint of aneugenicity was not sufficiently addressed for any of the metabolites as the in vitro studies provided are not specifically designed to address this endpoint. Therefore, it was concluded that additional data are required regarding genotoxicity. Furthermore, EFSA set a data gap for a repeated dose study to be able to set specific reference values for these three metabolites

Although the same studies were available for the metabolites, different conclusions were derived by JMPR and at EU level

Reg. (EU) No 750/2010: Imazalil

EFSA (2018h, o): Imazalil (any ratio of constituent isomers)

Imazalil

The residue is not fat soluble

Reg. (EU) No 750/2010: Imazalil

EFSA (2017h): Sum of imazalil and metabolite FK‐772 (any ratio of constituent isomers), expressed as imazalil (tentative, pending full assessment of toxicological properties of FK‐772) (not implemented in MRL legislation)

EFSA (2018h, o): Open

The residue is not fat soluble

EFSA (2018h, o): Open for post‐harvest use

Imazalil (any ratio of constituent isomers) for foliar treatment and seed treatment

It should be noted that the last EFSA recommendations derived under Article 43 (i.e. no residue definition for risk assessment can be derived for post‐harvest uses and for livestock commodities) will be discussed at PAFF meeting of February 2019

For all plant commodities for which the critical GAP is a post‐harvest use as well as for animal commodities, a comparison of the residue definition for risk assessment derived by JMPR with the EU residue definition is not appropriate, as long as the toxicological information requested for R014821, and FK‐772 and FK‐284 is not available

The RMS proposed to discuss with MS in the PAFF committee (February 2019) to set the residue definition for risk assessment (plant commodities) tentatively as the sum of imazalil and R014821, expressed as imazalil. For animal products, the RMS proposed to set the residue definition for risk assessment as the sum of imazalil and all identified/characterised metabolites observed in the goat metabolism study. CF from enforcement to risk assessment can be derived tentatively from the metabolism study

Critical GAP: USA, post‐harvest application (dip or drench) at 0.075 kg a.i./hl + post‐harvest wax application at 0.2 kg a.i./hl (total: 0.275 kg a.i./hl); withholding period: 0 day

Number of trials: 9 on lemons

Sufficiently supported by data: Yes

Specific comments/observations: See general comment for post‐harvest applications and RMS proposal to re‐discuss the residue definitions

Conclusion: The proposed Codex MRL is not acceptable because the toxicity of metabolite R014821 (released after post‐harvest treatment) is not sufficiently addressed

USA, post‐harvest application (dip or drench) at 0.075 kg a.i./hl + post‐harvest wax application at 0.2 kg a.i./hl (total: 0.275 kg a.i./hl); withholding period: 0 day

Number of trials: 12 on oranges

Sufficiently supported by data: Yes

Specific comments/observations: See general comment for post‐harvest applications

Conclusion: The proposed Codex MRL is not acceptable because the toxicity of metabolite R014821 (released after post‐harvest treatment) is not addressed

See also proposal of RMS below (General comments)

Critical GAP: FR, post‐harvest dip application at 0.0375 kg a.i./hl; withholding period: 0 day

Number of trials: 13 trials available

Sufficiently supported by data: Yes

Specific comments/observations: See general comment for post‐harvest applications. It is expected that following the recent EFSA assessment under Art. 43, the French GAP will be withdrawn

Conclusion: The proposed Codex MRL is not acceptable because the toxicity of metabolite R014821 (released after post‐harvest treatment) is not addressed

Critical GAP: EU post‐harvest application at 0.015 kg a.i./tonne; with‐holding period of 0 day

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: In the framework of the MRL review, EFSA assessed the post‐harvest use reported to JMPR, resulting in a similar MRL proposal (9 mg/kg). However, since intake concerns were identified, the EU MRL was derived for an alternative GAP; thus the GAP assessed by JMPR is no longer valid in the EU. See general comment for post‐harvest applications. See also results of acute risk assessment

Conclusion: The proposed Codex MRL is not acceptable because it is based on a GAP that is no longer valid for the EU and because of acute intake concerns. In addition, the comments regarding the toxicity of metabolite R014821 (released after post‐harvest treatment) are not addressed

Critical GAP: Belgium, foliar (indoor) 3 × 0.02 kg a.i./hL; PHI 1 day (corresponding to 3 × 300 g a.i./ha assuming 1,500 L water/ha is applied)

Number of trials: 6

Sufficiently supported by data: No

Specific comments/observations: 2 additional trials would be required. However, in the EU assessment (art. 43), the critical EU use (indoor, 3 × 300 g /ha, PHI 1 day) was fully supported by data and lead to similar MRL. It is noted that for the EU assessment in total 8 trials were provided

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs

Critical GAP: seed treatment at 0.1 kg a.i./tonnes

Number of trials: 5 trials on barley (all < LOQ) + 5‐fold overdosed metabolism study on spring wheat (all < LOQ)

Sufficiently supported by data: Yes

Specific comments/observations: acceptable as no‐residue situation is expected

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: seed treatment at 0.1 kg a.i./tonnes

Number of trials: 5 on barley (all < LOQ)

Sufficiently supported by data: Yes

Specific comments/observations: acceptable as no‐residue situation is expected and similar residue behaviour expected in barley and wheat straw

Conclusion: The proposed Codex MRL is acceptable

Max estimated burden for beef cattle: 28.9 ppm (EU)

Feeding study available that covers the estimated burden for imazalil; samples were analysed for parent, R043449 and R061000

Sufficiently supported by data: Yes

Specific comments/observations: The feeding studies seem acceptable. See also general comment

Conclusion: The proposed Codex MRL is acceptable

Conclusion: The proposed Codex MRL is not acceptable because of the lack of toxicological studies for metabolite FK‐772 and FK‐284

The RMS proposed to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs

Max estimated burden for poultry: 2.3 ppm (EU)

Feeding study available that covers the estimated burden for imazalil; samples were analysed for parent, R042639 (FK‐284), R043449 (FK‐772) and R044085

Sufficiently supported by data: Yes

Specific comments/observations: The feeding studies seem acceptable

Conclusion: The proposed Codex MRL is acceptable

The proposed Codex MRLs for post‐harvest uses are not acceptable because the toxicity of metabolite R014821 (formed after post‐harvest treatment) is not sufficiently addressed. This recommendation is in line with the recommendations derived in the recently published reasoned opinions of EFSA (2018h, o) which were supported by MS in a MS consultation

The RMS proposed to discuss with MS whether the proposed Codex MRLs are compatible with the EU policy on setting MRLs although the toxicity of metabolite R014821 is not sufficiently addressed. The recommendations to be updated for lemons, oranges, bananas, after the PAFF meeting

Although toxicological data for metabolites expected in animal commodities are also missing, the Codex MRL proposals for livestock commodities except edible offal might be acceptable, considering that at the relevant feed levels the total imazalil residues (sum of imazalil, R061000 (FK‐772) and R043449 (FK‐284) in animal matrices (except liver and kidney) were below the LOQ. The MRL proposal for edible offal mammalian is not supported since the occurrence of FK‐772 and FK‐284 cannot be excluded

Multigeneration rat study (cyhalothrin),

EFSA (2014a) confirmed in European Commission (2015c)

At EU level, the toxicological reference values were lowered in the framework of the renewal of the approval of the active substance. Compared to the JMPR toxicological reference values, the EU ADI/ARfD are significantly lower. The available data on cyhalothrin and lambda‐cyhalothrin were interpreted differently by the JMPR and at EU level. The EU assessment considered that lambda‐cyhalothrin is about twice as toxic as cyhalothrin while the JMPR concluded on a similar level of toxicity of the two a.s. The EU peer review applied an additional uncertainty factor of 2 (overall 200) on studies performed with cyhalothrin to derive the toxicological reference values for lambda‐cyhalothrin (i.e. the ADI) while the JMPR used a reduced uncertainty factor of 25 based on toxicokinetic considerations. The point of departure to derive the ADI was the same for the two assessments although based on different studies

Regarding the ARfD setting, the point of departure was the same value based on the same study, however a different uncertainty factor was applied (100 in the EU vs. 25 in the JMPR assessment) resulting in different ARfDs. In the EU dossier toxicological data (acute oral toxicity and genotoxicity studies) were provided on metabolites 1a, II, III, VI and XIII showing that these metabolites are less acutely toxic than lambda‐cyhalothrin and are unlikely to be genotoxic. Metabolite V (PBA) was shown to be less acutely toxic than the parent, but no genotoxicity or repeated dose toxicity data are available for this metabolite. Confirmatory data have been required by the EC for the applicant to address the toxicological profile (including the genotoxicity potential) of the metabolites V (3‐phenoxybenzoic acid or PBA) and XXIII (3‐(4‐hydroxyphenoxy)benzoic acid or PBA(OH)) that are relevant to consumer exposure, and to clarify sperm effects reported upon lambda‐cyhalothrin administration in the published literature; these data are currently being peer reviewed

In 2018, JMPR assessed new toxicological studies with lambda‐cyhalothrin (biliary elimination and biotransformation study in rats, 21‐day dermal toxicity study, 21‐day toxicity study by inhalation, two bacterial gene mutation assays and a preliminary developmental neurotoxicity study

Furthermore, toxicological studies R119890, R41207 and R110649 (all three are plant metabolites) were assessed

According to JMPR, these studies did not have an impact on the ADI and ARfD established in 2007

The new toxicological studies assessed by JMPR were probably not all made available at EU level

Cyhalothrin (sum of all isomers).

The residue is fat soluble

EU Reg. 2019/50:

lambda‐cyhalothrin

Art. 43 (EFSA, 2017e): lambda‐cyhalothrin

The residue is fat soluble

Art. 43 (EFSA, 2017e):

Lambda‐cyhalothrin

0.4 mg/kg bw

per day

EFSA (2006b);

European Commission (2007a)

(52‐week rat study, UF 100)

EFSA (2006b);

European Commission (2007a)

(28‐day gavage study in rats, UF 100)

The currently agreed ADI and ARfD values reported in the table above were recalculated to propamocarb free base

Peer review ongoing – The toxicological reference values proposed by the RMS will be discussed in April experts’ meeting

The proposed ADI from the draft RAR is 0.29 mg propamocarb hydrochloride/kg bw per day based on the NOAEL of 29 mg/kg bw per day from a 52‐week rat study and a safety factor of 100 The proposed ARfD is 1.0 mg propamocarb hydrochloride/kg bw per day, based on the NOAEL of 100 mg/kg bw from a 28‐day rat gavage study and a safety factor of 100

Also, the ADI and ARfD of JMPR are expressed for propamocarb free base

In 2005, JMPR derived an ADI of 0.4 mg/kg bw per day is set based on a NOAEL of 39 mg/kg bw per day, on the basis of vacuolisation observed in a range of organs in a 52‐week study in dogs, and using a safety factor of 100. An ARfD of 2 mg/kg bw is set based on a NOAEL of 200 mg/kg bw, on the basis of a decreased in activity in rats 1 h after dosing from the rat acute neurotoxicity study and using a safety factor of 100

EU Reg. 2018/832:

Propamocarb (Sum of propamocarb and its salts, expressed as propamocarb)

Propamocarb

The residue is not fat soluble

EU Reg. 2018/832:

N‐oxide propamocarb (products of animal origin, except poultry/birds eggs)

N‐desmethyl propamocarb (poultry, birds eggs)

The residue is not fat soluble

MRL review (EFSA, 2013e):

Sum of propamocarb and its salts, expressed as propamocarb

MRL review (EFSA, 2013e):

Sum of propamocarb, N‐oxide propamocarb, oxazolidin‐2‐one propamocarb and 2‐hydroxypropamocarb, expressed as propamocarb (ruminants, pigs);

Sum of propamocarb and N‐desmethyl propamocarb, expressed as propamocarb (poultry)

Plant commodities: The residue definition set for enforcement and risk assessment by JMPR and at EU level are substantially the same

Animal commodities: The residue definition set for enforcement and risk assessment by JMPR and at EU level EU are quite different

EFSA proposed to limit the residue definition for enforcement to the best marker compound, identified as N‐oxide propamocarb in tissues of ruminants (and pigs) and in milks and as N‐desmethyl propamocarb in poultry tissues and eggs (details are reported below as background information)

For risk assessment, the EU residue definition is more comprehensive and includes the major plant and animal metabolites. Based on metabolism studies, tentative conversion factors for risk assessment were proposed during the MRL review (4.25 for milk; 2.2 for ruminant kidney, 1.7 for ruminant liver and muscle; 1 for ruminant fat; 1.3 for all poultry tissues and eggs)

Overall, the residue definitions for animal products derived at EU level and by JMPR are not compatible

Both assessments concluded residues in products of animal origin are not fat soluble

According to the MRL review, in ruminants, metabolite N‐oxide propamocarb was the predominant metabolite of the total residues found in kidney (41% TRR – 0.044 mg/kg), liver (49% TRR – 0.203 mg/kg), muscle (40.5% TRR – 0.008 mg/kg) and also in milk (21% TRR – 0.012 mg/kg). Oxazolidine‐2‐one propamocarb occurred in significant amounts in kidney, liver and milk (14–23% TRR; 0.014–0.09 mg/kg). 2‐hydroxy propamocarb was the major metabolite of the total residues in milk (37.5% TRR – 0.022 mg/kg) but was also identified at a lower level in liver (5% TRR) and kidney (13% TRR). Parent propamocarb accounted for 24.6% TRR in muscle (0.005 mg/kg), 23.5% TRR in kidney (0.025 mg/kg), 6.2% TRR in liver (0.026 mg/kg) and 6.0% TRR in milk (0.003 mg/kg)

In poultry, the predominant compound of the total residues was the N‐desmethyl propamocarb in eggs (45% TRR), liver (22% TRR), muscle (29% TRR) and to a minor extend in fat (6% TRR) while the parent compound occurred at a lower level in all matrices (2–12% TRR). Bis desmethyl propamocarb and N‐oxide propamocarb accounted for less than 10% TRR. It is noted that a significant fraction of the radioactive residues remained uncharacterised in liver and muscle (32% and 41% TRR, respectively)

Edible offal, liver from

– ruminants, equine, others: 0.2 –swine: 0.1

Kidney from

– ruminants, equine, others: 0.05

– swine: 0.2

In 2014, JMPR calculated the maximum dietary burden using the OECD diets listed in the 2009 Edition of the FAO manual. The maximum and mean dietary burden was identified for Australian Dairy cattle (31.55 ppm DM and 10.7 ppm DM; the dietary burden is expressed as free base)

In 2018, JMPR assessed a new feeding study with dairy cows administered propamocarb‐HCl with feed levels equivalent to 13.6, 26.3 and 138 ppm propamocarb equivalents in feed

The Codex MRL proposal refers to propamocarb residues only

Conclusion: The proposed Codex MRL is not acceptable because it is not compatible with the EU residue definition for enforcement

See comment on mammalian edible offal

Conclusion: The proposed Codex MRL is not acceptable because derived according to a different residue definition

Meat from mammals

(other than marine mammals)

See comment on mammalian edible offal

Although Codex MRL proposal refers to meat, samples of muscle tissue were analysed

Conclusion: The proposed Codex MRL is not acceptable because derived according to a different residue definition

See comment on mammalian edible offal

Conclusion: The proposed Codex MRL is not acceptable because derived according to a different residue definition

The proposed Codex MRLs for tissues and milks cannot be taken over in EU legislation because of incompatible residue definitions

In 2014, the proposed Codex MRLs for cabbages, head and kale were retained on step 4, awaiting the livestock feeding study

In 2014, JMPR also recommended withdrawal of the CXLs for animal products that were derived by Codex in 2007, (once the CXLs are replaced with new Codex MRL proposals)

EFSA (2017e)

(developmental study in rat with uncertainty factor of 300)

In the framework of the renewal of the approval (EFSA, 2017e), EFSA proposed to lower the ARfD; the new value is not yet formally adopted. The ADI has been confirmed

Propiconazole is proposed to be classified as toxic for reproduction category 1B by the Risk Assessment Committee of ECHA (2016), in accordance with the provisions of Regulation (EC) No 1272/2008, and toxic effects on the endocrine organs have been observed in the available data

Due to classification (ECHA, 2016), a non‐approval decision was taken in 2018

Propiconazole

The residue is fat soluble

EU Reg. 2017/626: Propiconazole (sum of isomers)

Peer review (EFSA, 2017e): CGA91305 (free and conjugated) ((1RS)‐1‐(2,4‐dichlorophenyl)‐2‐(1H‐1,2,4‐triazol‐1‐yl) ethanol)

The residue is fat soluble

MRL review(EFSA, 2015b): Propiconazole and all the metabolites convertible to the 2,4‐dichlorobenzoic acid, expressed as propiconazole (sum of isomers)

Peer review (EFSA, 2017e):

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) TDMs (EFSA, 2018m)

MRL review (EFSA, 2015b ):

Parent propiconazole and all the metabolites convertible to the 2,4‐dichlorobenzoic acid, expressed as propiconazole (sum of isomers)

Peer review (EFSA, 2017e ):

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) TDMs (EFSA, 2018m)

The enforcement RD for plants established in Reg. 2017/626 is comparable with the RD of JMPR. For the risk assessment residue definitions, JMPR covers the common moiety (2,4‐dichlorobenzoic acid); in the MRL review, the same risk assessment residue definitions were derived

In the framework of the peer review, data gaps on the genotoxicity potential and toxicological profile of metabolite CGA118244 and CGA91305 were identified

JMPR did not set specific residue definitions for the TDMs (TAA and TA).

Due to the different risk assessment residue definitions for plant commodities and the open questions as regards the toxicological properties of some of the metabolites, only a tentative risk assessment can be performed

Critical GAP: US post‐harvest GAP: 1 × 12.9 g a.s./100 L (in‐line dip/drench)

Number of trials: 5

Sufficiently supported by data: Cherries are a major crop according the JMPR and at EU level. Thus, additional residue trials would be required. Last year, the EU did not make a formal reservation on the lack of residue trials

The recalculation of the MRL using mean residue + 4 SD resulted in the same MRL proposal as suggested last year

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: US post‐harvest GAP: 2 × 52.7 g a.s./100 L (dip/drench)

Number of trials: 16

Sufficiently supported by data: Yes

Specific comments/observations: See assessment for the subgroup of oranges

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: US post‐harvest GAP: 2 × 52.7 g a.s./100 L (dip/drench)

Number of trials: 16

Sufficiently supported by data: Yes

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: USA, post‐harvest GAP: 2 × 52.7 g a.s./100 L (dip/drench),

Number of trials: 16 (8 trials on oranges, 4 trials on mandarins and 4 trials on lemons)

Sufficiently supported by data: Yes

Specific comments/observations: The CF for risk assessment was derived from residue trials in cherries. The validity of this extrapolation is not questionable, but formally the EU did not make a reservation on that point

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: US post‐harvest GAP: 1 × 0.54 g a.s./1,000 kg (in‐line aqueous/fruit‐coating spray)

Number of trials: 3

Sufficiently supported by data: No

Specific comments/observations: Peaches are a category 3 crop for JMPR; therefore, at least 5 trials would be required. Last year, the EU did not make a formal reservation on the lack of residue trials

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480. Furthermore, a acute intake concern was identified for peaches

Critical GAP: US post‐harvest GAP: 1 × 25.8 g a.s./100 L (drench) + 1 × 25.8 g a.s./100 L (directed peduncle spray)

Number of trials: 4

Specific comments/observations: According the JMPR, pineapples are a category 3 crop, thus, at least 5 residue trials would be required. Last year, the EU did not make a formal reservation on the lack of residue trials

UK is evaluating an import tolerance application from USA on behalf Finland (agreed at PAFF June 2018 meeting). The application concerns also pineapples. The GAP and residue data for pineapple seems to be the same as the ones considered by JMPR

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: US post‐harvest GAP: 1 9 0.54 g a.s./1,000 kg (in‐line aqueous/fruit‐coating spray)

Number of trials: 5

Sufficiently supported by data: Yes

Specific comments/observations: Sufficient number of trials according to JMPR rules, but at EU level 8 trials would be required

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

Critical GAP: US post‐harvest GAP: 2 9 52.7 g a.s./100 L (dip/drench)

Number of trials: 4

Sufficiently supported by data: Yes

Conclusion: It is recommended to discuss with MSs whether the proposed Codex MRL is acceptable considering the fact that propiconazole is proposed to be classified as toxic for reproduction category 1B in accordance with that Regulation. Commission Regulation (EU) 2018/1480

2018 CCPR Meeting agreed that more refined maximum residue levels are possible for the post‐harvest uses considered by the 2017 JMPR using the mean + 4 SD. The residue data assessed by the 2017 JMPR for post‐harvest uses are suitable for estimating maximum residue levels, and for estimating STMR and HR for long‐term and acute dietary exposure assessments. The Meeting recommended the following maximum residue levels based on the mean + 4 SD for the post‐harvest uses of propiconazole on the crops considered in the 2017 Meeting

In the light of the recent decision on non‐approval of the a.s. and the lowering of the ARfD in 2017, the existing EU MRLs should be reviewed. Finland has screened the existing EU MRLs in the light of the new toxicological reference values. The assessment was based on the existing RD for RA. STMR, HR and CFs were taken from the previous EFSA assessment on the complete MRL review (EFSA, 2015b) and JMPR reports. Calculations by PRIMO rev. 3 resulted in the ARfD exceedance for the following crops: oranges, peaches, grapefruits, mandarins, lemons and tomatoes. In all cases, the GAPs are based on post‐harvest uses (consequently, a CF of 1 was used in the assessment). MRLs for orange, peach and tomatoes are based on CXLs, implemented in the EU legislation. The results of the screening exercise will be presented to the PAFF‐Residues meeting February 2019

(ft) In the framework of the MRL review, certain information was considered for lemons, lime, mandarins and grapefruit; deadline for submission of the missing data: 30 March 2018. Finland received an MRL application concerning Art. 12 confirmatory data. The submission included studies on the toxicological properties of the metabolites convertible to 2,4‐dichlorobenzoic acid and new residue trials on barley, wheat, maize and sugar beet; and a processing study on cereals. Studies on magnitude of residues were also requested to confirm MRLs for grapefruits, lemon, limes, mandarins, apples, apricots, grapes, bananas and rice, but not submitted. Evaluation of residue data has not been started yet, but the tox. part is going to be finalised during spring and can be submitted earlier, if needed

JMPR (2007)

(dog: 90 days, 6 months and 1 year studies)

German evaluation of 2001

(dog 1‐year study. Toxicological evaluation at EU level performed in the framework of setting MRLs under Council Directive 90/642/EEC^a)

JMPR (2007)

(rat acute neurotoxicity)

The German ADI is based on the LOAEL 1 mg/kg bw per day with an UF of 200

The ARfD is based on the NOAEL for the inhibition of brain cholinesterase activity

Due to the limited details available in the JMPR Report and the German evaluation, a final conclusion on the acceptability of the toxicological reference values derived by the two bodies cannot be made

Profenofos

The residue is not fat soluble

EU Reg. 2017/978: Profenofos

The residue is fat soluble

Critical GAP: Brazil, 2 × 400 g/ha, 30‐day interval, PHI 7 days

Number of trials: 7

Sufficiently supported by data: No

Specific comments/observations: According to the JMPR criteria, the number of trials is not sufficient because coffee beans are classified as a major crop and a minimum of 8 trials are normally required. The number of trials is not sufficient according to the EU data requirements. The limited number of trials is of low relevance since the Codex MRL proposal is lower than the current EU MRL at the LOQ of 0.05 mg/kg. Further consideration may be required in case the LOQ is in future lowered

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs. The long‐term risk assessment indicated a potential consumer health risk in the scenario where the toxicological reference value (ADI) derived by the EU evaluation was used

EFSA (2015i)

(rat, 2‐year study with an UF of 100) conformed in European Commission (2018c)

EFSA (2015i)

(rat developmental toxicity study, 100 UF) conformed in European Commission (2018c)

Regarding the setting of the ADI, both the JMPR and EU assessments are based on the same NOAEL of 9 mg/kg bw per day from the same two‐year toxicity study in rats and applying an uncertainty factor of 100

The ARfD established by the JMPR is based on an acute neurotoxicity study in rats that was not available to the EU peer review; this study should be reviewed in the EU peer review to re‐visit the established ARfD

In the opinion of the EU peer review, the toxicological reference values of the parent, bentazone, are applicable to the metabolite 8‐hydroxy‐bentazone, however according to the EFSA conclusion, insufficient toxicological information is available to establish reference values for metabolite 6‐hydroxy‐bentazone

In the Review report for the active substance bentazone finalised in the Standing Committee, the following statement for the bentazone metabolites (6‐OH and 8‐OH bentazone) was made:

According to the JMPR review of bentazone (Bentazone 31‐98, JMPR 2012) the 8‐hydroxy and 6‐hydroxy metabolites of bentazone are of comparable toxicity by the oral route of administration and are both less toxic than the parent compound. In addition the RMS informed that even if 6‐OH bentazone would not be regarded as toxicologically equivalent to 8‐OH‐bentazone, the consumer exposure falls below 1.5 μg/kg bw/day (TTC Cramer Class III for non‐genotoxic substances). The TTC approach was recommended in the Scientific Opinion (EFSA, 2012c )

According to the RMS NL, the EU Commission Review Report (2018c) closed the EFSA data gap. The reference values of the parent should also be applicable to 6‐hydroxy‐bentazone

For the 8‐hydroxy‐bentazone, the peer review concluded that it is less toxic than parent compound and the reference values of parent can be applied to this metabolite. The peer review did not consider this metabolite relevant for the inclusion in the residue definitions. Actual levels of this metabolite in plants are low

Following the setting of an ARfD by JMPR in 2016, JMPR re‐assessed the previously derived CXLs as regards possible acute intake concerns

Bentazone

The residue is not fat soluble

MRL review 2012c and Reg. (EC) No 1146/2014: Sum of bentazone, its salts and 6‐hydroxy (free and conjugated) and 8‐hydroxy bentazone (free and conjugated), expressed as bentazone

Peer review (2015i) proposal: Bentazone

MRL review 2012c and Reg. (EC) No 1146/2014: Sum of bentazone, its salts and 6‐hydroxy (free and conjugated), expressed as bentazone

Not fat soluble

Peer review (2015i) (provisional):

6‐hydroxy‐bentazone, expressed as bentazone (all animal commodities, except milk)

6‐hydroxy‐bentazone (sulphate) conjugates, expressed as bentazone (milk only)

MRL review (2012c): same as RD for enforcement

Peer review (2015i): Sum of bentazone, 6‐hydroxy‐bentazone and its conjugates, expressed as bentazone (provisional)

The EU and JMPR residue definitions for bentazone are not comparable. The metabolite 6‐hydroxy‐bentazone is included in the currently applicable enforcement and risk assessment residue definitions in the EU. For plant commodities, additionally, the 8‐hydroxy‐metabolite is included in the enforcement and risk assessment residue definitions. Thus, as long as the EU residue definitions are not modified, the Codex MRL proposals are not compatible with the EU enforcement residue definitions. Furthermore, a common understanding regarding the data gap on toxicological information for metabolite 6‐hydroxy‐bentazone should be derived (see Conclusion/comments on toxicological reference values)

The enforcement residue definition for plant commodities as proposed by the peer review (not yet enforced) complies with the residue definition derived by the JMPR, but this residue definition is not yet implemented

0.1

Soya beans: 0.03*

Critical GAP: USA, foliar, 2 × 1.12 kg/ha, PHI 30 days

Number of trials: 8

Sufficiently supported by data: No

Specific comments/observations: Extrapolation from peas. The Codex MRL proposal would also cover soya beans; residue trials on soybeans would be also required

Conclusion: The proposed Codex MRL is not acceptable because the Codex residue definition is not compatible with the EU residue definition (occurrence of 6‐hydroxy and 8‐hydroxy‐bentazone has not been investigated)

Critical GAP: USA, foliar, 2 × 1.12 kg/ha, PHI 30 days

Number of trials: 8

Sufficiently supported by data: Yes

Specific observations: The CXL derived in 1997 has been taken over in the EU. 2013 JMPR recommended withdrawal of this old CXL; since JMPR derived a new MRL proposal, the CXL for Field peas (dry) VD0561) should be withdrawn

Conclusion: The proposed Codex MRL is not acceptable because the Codex residue definition is not compatible with the EU residue definition (occurrence of 6‐hydroxy and 8‐hydroxy‐bentazone has not been investigated). Risk managers to discuss the replacement of the existing EU MRL, considering that the previous CXL will be withdrawn

The Codex MRL proposal is based on the maximum dietary burden calculated by 2013 JMPR based on the OECD feeding tables of 2009, and the new cow feeding study submitted for the current meeting. The CXL for edible offal derived on the basis of estimated residues in kidney at the calculated DB

The new use on beans/peas does not have an impact on the DB

The existing EU MRL is currently assessed for the Article 12 confirmatory data. The same cow feeding study was provided in the EU assessment for the Article 12 confirmatory data gap/EU peer review data gap

Considering the different residue definitions, the proposed Codex MRL would not be compatible with the EU legislation

The CXL proposal is based on the maximum dietary burden calculated for Australian dairy cattle by the 2013 JMPR, and the new cow feeding study submitted for the current meeting. The new use on beans/peas does not have an impact on the DB

The existing EU MRL is currently assessed for the Article 12 confirmatory data. The same cow feeding study was submitted for EU assessment. Considering the different residue definitions, the proposed Codex MRL would not be compatible with the EU legislation

0.001 mg/kg

bw per day

EFSA (2008b);

European Commission (2008)

(18‐ and 53‐week dog study, UF 100)

EFSA (2008b);

European Commission (2008)

(acute neurotoxicity rat, UF 100)

The toxicological reference values derived by JMPR are lower than the ones derived at EU level. It is noted that the ADI/ARfD of JMPR applies also to the 8,9‐Z‐isomer and the 24‐hydroxymethyl metabolite of abamectin

The developmental neurotoxicity study in rats was not peer reviewed by EFSA (2008b). EFSA would consider appropriate to use this study as a point of departure for setting the ADI. The use of the dog studies for setting the ARfD would be also consider appropriate since the effects described by JMPR were observed during the first week of treatment

Regarding metabolites, EFSA (2008b) also concluded that 8,9‐Z‐isomer showed a similar profile to abamectin. EFSA (2008b) did not discuss the toxicological profile of 24‐hydroxymethyl metabolite of abamectin; however, being a major rat metabolite as described by JMPR, EFSA would support the view that it could be considered covered by parent and then the reference values of abamectin would apply to this metabolite

EU Reg. 2018/1514:

Abamectin (sum of avermectin B1a, avermectin B1b and delta‐8,9‐isomer of avermectin B1a, expressed as avermectin B1a)

Avermectin B1a

The residue is fat soluble

EU Reg. 2018/1514:

Avermectin B1a

(except honey; for honey, see plant RD)

The residue is fat soluble

Plant commodities: The residue definitions set for enforcement and risk assessment by JMPR and at EU level in plant commodities are not comparable

In the EU, the residue definitions are more comprehensive. Beside the minor abamectin component avermectin B1b (≤ 20% of abamectin mixture), the photodegradate (8,9‐Z‐isomer, identified also as delta‐8,9‐isomer or NOA427011) of avermectin B1a was included, since it is found in plant metabolism studies in concentrations three times higher than avermectin B1a. The three compounds can be determined with the enforcement analytical method simultaneously. In addition, the formation of the photodegradate during the sample analysis cannot be excluded as well

Overall, the enforcement residue definitions established by JMPR and at EU level are not compatible

Animal commodities: The residue definition set for enforcement by JMPR and at EU level are comparable. NB: The residue definition for enforcement reported in EU Reg. 2018/1514 was taken over from the legislation on veterinary medicinal products (marker substance avermectin B1a). The current uses of abamectin as pesticide does not lead to residues in animal products.

Both assessments concluded that residues in products of animal origin are fat soluble

0.08

(blackberries, raspberries)

0.01^*

(dewberries, other cane berries)

Critical GAP: USA, 2 × 0.0213 kg/ha, interval 7 days, PHI 7 days

Number of trials: 7

Sufficiently supported by data: Yes

Specific comments/observations: Trials conducted on blackberry and raspberry, all with 3 instead of 2 applications. Based on decline trials results, JMPR concluded that number of applications do not had an impact on the final residue concentrations of avermectin B1a. Information on the magnitude and the decline behaviour of avermectin B1b and of the delta‐8,9‐isomer of avermectin B1a in cane berries not reported. The Codex MRL proposal refers to avermectin B1a residues only and would cover blackberries, raspberries and dewberries

Conclusion: The proposed Codex MRL for cane fruits is not acceptable because residue definitions for enforcement are not compatible

Critical GAP: not reported in the summary report

Number of trials: 1

Sufficiently supported by data: No

Specific comments/observations: PF of 5 refers to avermectin B1a residues only. It is noted that in the EU the MRL is set for the fresh product, but not for dried chives

Critical GAP: information assessed by JECFA in 2015

Number of trials: 3

Sufficiently supported by data: Yes

Specific comments/observations: median PF of 2.8 refers to avermectin B1a residues only. It is noted that in the EU the MRL is set for the fresh product, but not for dried grapes

Critical GAP: information assessed by JECFA in 2015

Number of trials: 3

Sufficiently supported by data: Yes

Specific comments/observations: best estimate of 1.4 refers to avermectin B1a residues only. It is noted that in the EU the MRL is set for the fresh product, but not for grape juice

0.01^*

(table grapes, wine grapes)

Critical GAP: Brazil, 2 × 0.0108 kg/ha, interval 7 days, PHI 7 days

Number of trials: 6

Sufficiently supported by data: No

Specific comments/observations: all trials overdosed (0.0144 or 0.018 kg/ha) and with higher number of applications (3‐5), proportionally scaled to the GAP rate (scaling factor: 0.75 or 0.60). Based on decline trials results, JMPR concluded that number of applications does not have an impact on the final residue concentrations of avermectin B1a. Information on the magnitude and the decline behaviour of avermectin B1b and of the delta‐8,9‐isomer of avermectin B1a in crops not reported in the JMPR report. Considering the decline (half‐lives of abamectin in grape were 2.1–3.7 days), the higher number of applications is unlikely to affect significantly the final residues at harvest

Grapes are major crop both for JMPR and EU and a minimum of 8 trials is required. The Codex MRL proposal refers to avermectin B1a residues only

Conclusion: The proposed Codex MRL for grapes is not acceptable because (1) number of trials not sufficient to derive an MRL proposal; (2) residue definitions for enforcement are not compatible; and (3) the proportionality approach should not be applied when more than one parameter is deviating from critical GAP (3)

0.01^*

(spring/green/welsh onion)

0.01^*

(leeks)

2

(Chives, leaves and bulbs)

Critical GAP: USA, 2 × 0.0213 kg/ha, interval 7 days, PHI 7 days

Number of trials: 6 trials in spring onions; additional 3 trials in chives (not used to calculate the MR proposal)

Sufficiently supported by data: Yes

Specific comments/observations: all trials on spring onions conducted with 4 instead of 2 applications. Based on two decline trials on onions, JMPR concluded that number of applications do not had an impact on the final residue concentrations of avermectin B1a. Information on the magnitude and the decline behaviour of avermectin B1b and of the delta‐8,9‐isomer of avermectin B1a in spring onions not reported. The Codex MRL proposal refers to avermectin B1a residues only

Conclusion: The proposed Codex MRL may be acceptable, despite the incompatibility of the residue definitions, considering the level of the MRL. The proposed Codex MRL would also cover leeks. See also general comments

2

(herbs and edible flowers, except celery leaves)

0.09 (ft)

(celery leaves)

Critical GAP: USA, 2 × 0.0213 kg/ha, interval 7 days, PHI 14 days

Number of trials: 5

Sufficiently supported by data: Yes

Specific comments/observations: Trial on basil (3) and mint (2) with 3 instead of 2 applications. For the extrapolation to the whole group (which includes mint in the basil subgroup), a minimum of 6 trials would be required in the EU. However, for JMPR, 5 trials are sufficient. None of the trials designed as decline. Based on decline trials results from other crops, JMPR concluded that number of applications do not had an impact on the final residue concentrations of avermectin B1a. Information on the magnitude and the decline behaviour of avermectin B1b and of the delta‐8,9‐isomer of avermectin B1a in herbs not reported

The Codex MRL proposal refers to avermectin B1a residues only

Conclusion: The proposed Codex MRL for herbs and edible flowers is not acceptable because the residue definitions are not compatible

Critical GAP: not reported in the summary report

Number of trials: 3

Sufficiently supported by data: Yes

Specific comments/observations: median PF 5.5 refers to avermectin B1a residues only. It is noted that in the EU the MRL is set for the fresh product, but not for orange oil

Critical GAP: USA, 2 × 0.0261 kg/ha, interval 7 days, PHI 112 days

Number of trials: 6

Sufficiently supported by data: Yes

Specific comments/observations: Residues of avermectin B1a < LOQ of 0.002 mg/kg in all 6 trials. Number of trials is in line with JMPR rules

The Codex MRL proposal refers to avermectin B1a residues only, but avermectin B1b and of the delta‐8,9‐isomer of avermectin B1a are not expected to be found in the edible part of the fruit at the long PHI of the cGAP

Conclusion: The proposed Codex MRL is acceptable, despite the incompatibility of the residue definitions, considering the level of the MRL. See also general comments

Critical GAP: USA, 2 × 0.0213 kg/ha (foliar application), interval 6 days, PHI 28 days

Number of trials: 19

Sufficiently supported by data: Yes

Specific comments/observations: Trails conducted with a seed treatment followed by 2 foliar applications with residues of avermectin B1a < LOQ of 0.002 mg/kg. The Codex MRL proposal refers to avermectin B1a residues only, but avermectin B1b and of the delta‐8,9 isomer of avermectin B1a are not expected to be found in the seed at the long PHI of the cGAP

Conclusion: The proposed Codex MRL is acceptable, despite the incompatibility of the residue definitions, considering the level of the MRL. See also general comments

0.01^*

(beans w/out pod)

Critical GAP: USA, 2 × 0.0213 kg/ha, interval 6 days, PHI 7 days

Number of trials: 7

Sufficiently supported by data: Yes

Specific comments/observations: All trials on beans w/out pods with 3 or 4 instead of 2 applications with residues of avermectin B1a < 0.002 mg/kg. Based on decline trials results from other crops, JMPR concluded that number of applications do not had an impact on the final residue concentrations of avermectin B1a. Information on the magnitude and the decline behaviour of avermectin B1b and of the delta‐8,9 isomer of avermectin B1a in beans not reported. The Codex MRL proposal refers to avermectin B1a residues only

Conclusion: The proposed Codex MRL is acceptable, despite the incompatibility of the residue definitions, considering the level of the MRL. See also general comments

Critical GAP: USA, 2 × 0.0213 kg/ha, interval 7 days, PHI 7 days

Number of trials: 12

Sufficiently supported by data: Yes

Specific comments/observations: GAP‐compliant trials with residues of avermectin B1a < LOQ of 0.002 mg/kg. Information on the magnitude of avermectin B1b and of the delta‐8,9 isomer of avermectin B1a in sweet corns not reported. The Codex MRL proposal refers to avermectin B1a residues only

Conclusion: The proposed Codex MRL is acceptable, despite the incompatibility of the residue definitions, considering the level of the MRL. See also general comments

Overall, the residue definitions for plant products derived at EU level and by JMPR are not compatible

Risk managers to discuss whether this is a sufficient reason: to make a reservation for all crops or whether a reservation is only justified for crops with MRL proposals higher than the existing EU MRL or a reservation is appropriate only for crops with MRL proposals > LOQ

JMPR (2017)

Rat, 2‐year study

EFSA (2013j)

Rat, 2‐year study

JMPR (2017)

Dog, 1‐day and 13‐week studies

EFSA (2013j)

Dog, 1‐ and 5‐day study

For the derivation of the ADI, the JMPR considered the NOAEL of 1 mg/kg bw per day in the 2‐year rat study, applying an uncertainty factor (UF) of 100. The same derivation was adopted at EU level

In 2017, the JMPR withdrew the ARfD of 0.02 mg/kg bw from 2008 and established an ARfD of 0.01 mg/kg bw on the basis of the LOAEL of 2 mg/kg bw for the induction of diarrhoea seen in a newly submitted single bolus gavage study and 13‐week study of toxicity in dogs. A safety factor of 200 was used since no NOAEL was identified

In the EU assessment, an ARfD of 0.02 mg/kg bw was established in 2008 on the same basis as conclusion reached by the JMPR in 2007 (1‐ and 5‐day toxicity study in dogs presenting a NOAEL of 2 mg/kg bw per day for the occurrence of diarrhoea, applying an UF of 100)

It appears that the JMPR had access to a new acute toxicity study in dogs in 2017 resulting in a LOAEL at 2 mg/kg bw

The RMS informed EFSA that for the renewal of fenpyroximate an additional single dose study in dogs has been submitted, which was not available for the first approval. In this study, dogs showed diarrhoea already after acute exposure to 2 mg/kg bw. No NOAEL could be determined and the LOAEL of the study is set at 2 mg/kg bw. The RMS will propose to lower the ARfD from 0.02 mg/kg bw to 0.01 mg/kg bw, on the basis of the LOAEL of 2 mg/kg bw from the single oral dose study in dogs and application of a uncertainty factor of 200 (for LOAEL)

For the metabolites, the JMPR concluded that M‐1, M‐3, M‐5, M‐21, M‐22 and Fen‐OH would be covered by the reference values of the parent compound since these metabolites were also detected in rats at significant levels

During the EU evaluation, the metabolites M‐1 and M‐12 were concluded of equal or lower acute toxicity than the parent compound

EU Reg. 2019/552: Fenpyroximate

Peer review (2013l): Fenpyroximate (fruit crops, pulses and oilseeds, only)

Sum of fenpyroximate, 2‐hydroxymethyl‐2‐propyl (E)‐4‐[(1,3‐dimethyl‐5‐ phenoxypyrazol‐4‐yl)‐methylenaminooxymethyl]benzoate (Fen‐OH), and (E)‐4‐[(1,3‐dimethyl‐5‐phenoxypyrazol‐4‐yl)methyleneaminooxymethyl]benzoic acid (M‐3), expressed as fenpyroximate

The residue is fat soluble

EU Reg. 2019/552: Fenpyroximate for all animal products, except liver and kidney of ruminants:

Liver and kidney of ruminants: metabolite M‐3

Peer review (2013l):

Metabolite M‐3 expressed as fenpyroximate

The residue is fat soluble

Plant:

Residue definitions for enforcement and risk assessment in plant commodities are comparable. Additional metabolism studies with fenpyroximate following foliar application to citrus, apples, grapes, snaps beans, cotton and Swiss chard were evaluated by the JMPR. These studies allowed deriving a general residue definition

Animal:

RD enf: Fen‐OH is not included in the residue definition for enforcement established at EU level. However, according to the results of the metabolism and livestock‐feeding studies, at the calculated dietary burden, residues in livestock consist mainly of metabolite M‐3 (liver and kidney) and fenpyroximate (fat). Therefore, the difference in the residue definitions for enforcement in animal commodities can be considered as minor

RD‐RA: In 2018, JMPR revised the definition for risk assessment considering that M‐5 and its conjugates were only detected in liver and kidney and only below or equal to 10% TRR. Thus, these metabolites were excluded

In the EU residue definition, the Z‐isomers of parent fenpyroximate, Fen‐OH and M‐3 are also included in the residue definition. JMPR considered not necessary to include them in the residue definition since there was no evidence in the goat metabolism study of significant levels of Z‐isomers

The process on the renewal of the approval is currently ongoing; the RMS informed EFSA that the RD enf animal might be revised (M‐3 expressed as fenpyroximate)

Max dietary burden: 3.503 mg/kg DM (Australian diet after refinement excluding bean forage)

The feeding study covered the max DB

Sufficiently supported by data: Yes

Specific comments/observations: MRL proposal reflects the

residue definition of JMPR which is different than the EU RD

Conclusion: The proposed Codex MRL is not fully compatible

with the EU residue definition

Max dietary burden: 3.503 mg/kg DM (Australia diet after

refinement excluding bean forage)

Number of trials: 1 feeding study with highest dose level

(10 ppm) covering the max DB

Sufficiently supported by data: Yes

Specific comments/observations: MRL proposal reflects the

residue definition of JMPR which is different than the EU RD.

HR in fat is 0.089 mg/kg; thus, a MRL proposal of

0.09 mg/kg should be enough

Conclusion: The proposed Codex MRL is not fully compatible

with the EU residue definition

Since the residue definition is fat soluble, according to the Codex rules, an MRL proposal was derived for fat only

Considering the result of the feeding study assessed by JMPR, the existing EU MRL for muscle may not be sufficient, since at the expected dietary burden, the maximum residues measured in muscle are 0.02 mg/kg

Max dietary burden: 3.503 mg/kg DM (Australia diet after

refinement excluding bean forage)

1 feeding study with highest dose level (10 ppm) covering the max DB

Sufficiently supported by data: Yes

Specific comments/observations: See comments on residue

definitions

Conclusion: The proposed Codex MRL is acceptable, despite the difference in the RD, considering the level

Tomatoes, subgroup of (includes

all commodities in this subgroup)

Critical GAP: 2 × 117 g a.i./ha; PHI 1 day

Number of trials: 19 trials on tomatoes conducted in the USA

Sufficiently supported by data: Yes

Specific comments/observations: As residues in cherry tomato is normally higher than that in tomato, the Meeting estimated a maximum residue level, STMR and HR of 0.3, 0.10 and 0.17 mg/kg, respectively, for cherry tomato and tomato

Conclusion: The proposed Codex MRL is acceptable

Considering that the JMPR residue definition for animal products (enforcement) is more comprehensive than the EU residue definition, the proposed MRLs for animal commodities may be slightly higher than required according to the EU residue definition. However, it is not expected that this difference has a major impact on the MRL

The RMS informed EFSA that in the framework of the renewal of the approval for fenpyroximate some EU MRLs will be modified, but since the EU MRL assessment is not related to crops/commodities assessed by JMPR, the future modification of existing EU MRLs does not affect the EU position for CCPR

EFSA (2010c) (2‐yr oral rat with a uncertainty factor of 100)

European Commission (2014)

EU Reg. 2016/486:

Kresoxim‐methyl

Sum of metabolites (2E)‐(methoxyimino){2‐[(2‐methylphenoxy)methyl]phenyl}acetic acid (490M1), and (2E)‐{2‐[(4‐hydroxy‐2‐methylphenoxy)methyl]phenyl}(methoxyimino)acetic acid (490M9) expressed as kresoxim‐methyl

The residue is not fat soluble

EU Reg. 2016/486:

Milk: 490M9, expressed as kresoxim‐methyl

Other animal products: 490M1, expressed as kresoxim‐methyl

The residue is not fat soluble

Art.12 (EFSA, 2014b):

Sum of kresoxim‐methyl and the metabolites BF 490‐2 (490M2) and BF 490‐9 (490M9), free and conjugated, expressed as parent

Art.12 (EFSA, 2014b):

Sum of metabolites BF 490‐1, BF 490‐2 (490M2) and BF 490‐9 (490M9), expressed as parent

Peer‐review (EFSA, 2010c):

Ruminant matrices, milk: Sum of BF 490‐1 (490M1), BF 490‐2 (490M2) and BF 490‐9 (490M9);

No residue definition is proposed for poultry matrices

The metabolite codes BF 490‐1, BF 490‐2 and BF 490‐9, which were at some occasions used in the EU residue definitions, correspond to metabolites with codes 490M1, 490M2 and 490M9 (used by JMPR), respectively

The EU risk assessment RD for plant products is different from the one of JMPR. JMPR did not include metabolite BF 490‐2. BF 490‐2 (490M2) was found as a major residue in the metabolism studies in grapes (unconjugated and conjugated, up to 14% TRR), but was not present in significant amounts in apple, wheat and sugar beet metabolism studies. BF 490‐2 was found at significant levels in field residue trials (fruit crops). Thus, the risk assessment values derived by JMPR are likely to underestimate the exposure

RD for processed products: Considering that kresoxim‐methyl is significantly hydrolysed to kresoxim acid (BF 490‐1), the RD for processed products (enforcement) was defined as the sum of kresoxim‐methyl and BF 490‐1, expressed as kresoxim; RD for risk assessment of processed products: sum of kresoxim‐methyl, BF 490‐1 (490M1), BF 490‐2 (490M2) and BF 490‐9 (490M9), free and conjugated, expressed as parent (EFSA, 2014b)

For animal products, the residue definitions are not fully compatible. The EU residue definition for enforcement is restricted to the most relevant metabolite for the respective matrix, while JMPR established a comprehensive residue definition that covers all metabolites observed in animal products

Thus, the residue definitions for animal products proposed by JMPR differ from the current EU residue definitions, both for enforcement and for risk assessment

0.1 (barley and oats)

0.01^* (buckwheat)

Critical GAP: UK, 2 foliar applications at 125 g a.i./ha (RTI not given) PHI not needed (last application up to BBCH 59)

Number of trials: 10

The proposed Codex MRL would be also applicable to oats and buckwheat. At EU level, the extrapolation of residue trials in barley to buckwheat would not be acceptable

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: German GAP for beet root in Germany allows two foliar applications of kresoxim‐methyl at 125 g a.i./ha with a RTI of 10 days and a PHI of 28 days

Number of trials: 10 trials in sugar beet

Sufficiently supported by data: Yes

Specific comments/observations: –

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: UK, 3 × 100 g a.i./ha, RTI of 10 days, PHI of 14 days, foliar use

Number of trials: 5

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

JMPR calculated the dietary burden, including the feed items sufficiently supported by data. Maximum dietary burden in Australia 3.2 ppm

Feeding studies (7, 21 and 77 ppm) on lactating cow, corrected for maximum dietary burden of 3.2 ppm

Conclusion: The maximum residue expected in kidney is 0.02 mg/kg. The proposed Codex MRL was derived by rounding up; according to EFSA a lower MRL of 0.02 mg/kg would be sufficient. Further discussion with MS recommended, whether the proposed MRL is acceptable, taking into account that the residue definitions are not fully compatible

JMPR calculated the dietary burden, including the feed items sufficiently supported by data. Maximum dietary burden in EU (0.33 ppm)

No feeding study available; MRL proposal were derived from metabolism study which is about 500 times overdosed compared to the expected maximum dietary burden

Conclusion: The proposed Codex MRL is acceptable; a MRL of 0.01 mg/kg would be sufficient. Considering the proposed level of the MRL, the difference of the residue definition may not be relevant

Critical GAP: Cucumber, summer squash, melon: USA: 4 × 168 g a.i./ha, RTI 7 days, PHI 0 days

Number of trials: 8 cucumber, 5 summer squash and 5 melon

Sufficiently supported by data: No; according to EFSA's interpretation of the JMPR rules, additional 3 trials on melons (major crop in Codex classification) would be required to derive a group MRL for cucurbits

Specific comments/observations: JMPR proposes an MRL for the whole group of fruiting vegetables (including edible and non‐edible peel). According to the agreement on extrapolation, trials on cucumbers and summer squash and/or gourd and melon would be required. Since this condition is not fulfilled, and the number of trials for melons is not sufficient, it would be possible to derive a group MRL for the subgroup fruiting vegetables, cucurbits‐ cucumber and summer squashes (0.3 mg/kg)

For melons, the number of trials is insufficient (melons are classified as major crop)

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs

Critical GAP: BR GAP: 4 × 70 g a.i./ha, RTI 10 days, 7 days PHI

Number of trials: 4

Sufficiently supported by data: Yes

Specific comments/observations: The existing EU MRL is based on a more critical GAP (DE, NL, 3 × 200 g/ha, 7 days PHI)

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 4 × 224 g a.i./ha, RTI 7 days, PHI of 14 days, foliar

Number of trials: 18

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

The existing CXL was proposed to be withdrawn since insufficient data were provided to support the GAPs reported to JMPR

The existing EU MRL was derived from the CXL; in the framework of the MRL review, no EU GAPs were reported for citrus

Conclusion: It is recommended to discuss with MS to revise the existing EU MRL

Critical GAP: NL GAP: 3 × 375 g a.i./ha, RTI 10 days, PHI 14 days

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: The existing EU MRL was derived from the same data and on the basis of the same cGAP

Conclusion: The proposed Codex MRL is acceptable

See comments on edible offal (mammalian)

At the expected maximum dietary burden, the residues in fat were < 0.01 mg/kg

Conclusion: The proposed Codex MRL is acceptable. Considering the proposed level of the MRL, the difference of the residue definition may not be relevant

Critical GAP: BR, 2 × 120 g a.i./ha, RTI 15 days, PHI 7 days

Number of trials: 5

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

See comments on edible offal (mammalian)

At the expected maximum dietary burden, the residues in muscle were < 0.01 mg/kg

Conclusion: The proposed Codex MRL is acceptable; a MRL of 0.01 mg/kg would be sufficient. Considering the proposed level of the MRL, the difference of the residue definition may not be relevant

See comments on edible offal (mammalian)

At the expected maximum dietary burden, the residues in milk were < 0.002 mg/kg

Conclusion: The proposed Codex MRL is acceptable; a MRL of 0.01 mg/kg would be sufficient. Considering the proposed level of the MRL, the difference of the residue definition may not be relevant

Critical GAP: France, 3 × 100 g a.i./ha, PHI of 30 days

Number of trials: 5

Sufficiently supported by data: No

Specific comments/observations: Since olives for oil production are a major crop (in the EU and in Codex), at least 8 trials are required. In the MR review, the same cGAP was assessed which was sufficiently supported by data. Thus, additional trials were available in the EU which were not made available to JMPR

Conclusion: To discuss with RMS, whether the proposed Codex MRL is acceptable

The existing CXL was proposed to be withdrawn since insufficient data were provided to support the GAPs reported to JMPR

The existing EU MRL was derived from the CXL; in the framework of the MRL review, no EU GAPs were reported for citrus

Conclusion: It is recommended to discuss with MS to revise the existing EU MRL

Critical GAP: Japan, 3 × 25 g a.i./hL, PHI of 1 day, RTI not specified, foliar use.

Number of trials: 6

Sufficiently supported by data: Yes

Specific comments/observations: According to Codex classification, peaches are a crop for which at least 5 trials are required to derive a MRL proposal. At EU level, 8 trials would be required

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 3 × 168 g a.i./ha, RTI 14 days, PHI 45 days.

Number of trials: 6

Sufficiently supported by data: Yes

Specific comments/observations: The same USA cGAP and trial data had been considered in the framework of the EU MRL review; the same MRL was derived as proposed by JMPR

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: BR, 4 × 100 g a.i./ha, RTI 10 days, PHI 3 days.

Number of trials: 4 according GAP + 2 overdosed proportionality corrected (0.4 scaling factor)

Sufficiently supported by data: No

Specific comments/observations: For peppers, at least 8 trials would be required, since it is classified as a major crop in Codex

The EU MRL was derived from a more critical GAP (ES, CY, 4 × 250 g/ha, 3 d PHI). The EU GAP was not reported the JMPR

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs. Furthermore it should be highlighted that data for a more critical EU GAP are available that have not been notified to JMPR

The existing CXL was proposed to be withdrawn since insufficient data were provided to support the GAPs reported to JMPR

The existing EU MRL was derived from the CXL; in the framework of the MRL review, EU GAPs were reported for pome fruits (apples, pears, quinces, medlar, loquat) and an MRL of 0.15 mg/kg was proposed for the EU uses

Conclusion: It is recommended to discuss with MS to ask for maintaining the current CXL under the 4‐years rule and to encourage the applicant to provide the EU GAPs and EU residue data to JMPR for evaluation

United Kingdom GAP for wheat and barley:

Number of trials: 22

Sufficiently supported by data: Yes

It is noted that in the EU no MRLs are set for feed products

Critical GAP: Germany, 1 × 125 g a.i./ha, PHI of 28 days.

Number of trials: 10

Sufficiently supported by data: Yes

Specific comments/observations: –

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: France 3 × 100 g a.i./ha, PHI 30 days

Number of trials: 5

Sufficiently supported by data: No

Specific comments/observations: According to JMPR criteria, table olives are considered a major crop and therefore at least 8 trials would be required. In the EU, table olives are a minor crop and therefore 5 trials would be sufficient

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering that at EU level the number of trials would be sufficient and that the MRL proposal relates to a EU GAP

MRL proposal was derived by extrapolation from sugar beets (see comments on sugar beets)

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: UK: GAP for wheat, rye and triticale, 2 × 125 g a.i./ha, no PHI (last application up to BBCH 65)

Number of trials: 12

Sufficiently supported by data: Yes

The proposed Codex MRL would be also applicable to rye.

Conclusion: The proposed Codex MRL is acceptable

JMPR (1999)

(1‐year dog, safety factor 100)

EFSA (2009b)

(1‐year, dog with a safety factor of 100)

Confirmed in

European Commission (2010b)

EFSA (2009b) confirmed in

European Commission (2010b)

In the framework of the EU peer review for renewal (expert meeting January, 2019), the TRV for pyriproxyfen were proposed to be changed:

• –
  the ADI was lowered to 0.05 mg/kg bw per day based on the LOAEL of 16.4 mg/kg bw per day from the 18‐month mouse study and applying an uncertainty factor of 300;
• –
  an ARfD was set at 1 mg/kg bw based on an increased incidence of malformations in the developmental rabbit study, applying an uncertainty factor of 100.

In relationship with the ADI, the EU peer review reconsidered the assessment of the 18‐month mouse study in which the decreased survival in males at the low dose was considered to be an adverse effect. JMPR has not considered this dose‐related increase in mortality rate relevant at the low‐dose level

In relationship with the ARfD, the EU peer review reconsidered the assessment of one developmental rabbit study in which multiple visceral malformations in one animal and single visceral malformation in 2 animals at 300 mg/kg bw per day were concluded to be treatment‐related and adverse, leading to a lower NOAEL of 100 mg/kg bw per day

Pyriproxyfen

The residue is fat soluble

EU Reg. 2016/1902: Pyriproxyfen

Peer‐review (EFSA, 2009b):

Not relevant for notified uses. (No significant intake; no accumulation of residues in edible animal products expected)

The residue is fat soluble

Peer‐review (EFSA, 2009b):

Not relevant for notified uses. (No significant intake; no accumulation of residues in edible animal products expected)

In the framework of the peer‐review process, no investigation of the residues of pyriproxyfen in animal origin commodities has been performed (representative use on tomatoes and cotton seed – residues in cotton seeds at LOQ)

In succeeding MRL applications, no need for setting MRLs in animal commodities was identified (intended uses on fruits and tea)

JMPR 1999 assessed animal commodities and derived the residue definition for animal products which covers only parent compound

Residue definitions for plant commodities identical

Critical GAP: Europe (Italy, Greece, France, Spain) 2 × 0.12 kg a.s./ha, RTI 14 days, PHI 3 days

Number of trials: 8

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Europe (Italy), 2 × 0.12, RTI 14 days, PHI 3 days

Number of trials: 8 trials in peppers were used to derive MRL proposal by extrapolation

At EU level an extrapolation from peppers to eggplants would not be appropriate. However, this extrapolation was proposed by JMPR in the general considerations

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Europe (Italy, Greece, France, Spain) 2 × 0.12 kg a.s./ha, RTI 14 days, PHI 3 days

Number of trials: 8 residue trials in cucumbers, used to derive MRL proposal by extrapolation

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 2 × 0.075 kg a.i./ha, RTI 14 days, PHI 7 days

Number of trials: 7

Sufficiently supported by data: No

Specific comments/observations: Since melons are classified as a major crop in Codex and at EU level, a minimum of 8 residue trials would be required

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering the fact that 1 additional trial would be required

Critical GAP: Philippines, 2 × 0.1 kg a.s./ha, RTI 14 days, PHI 1 day

Number of trials: 6

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Europe (Italy), 2 × 0.12, RTI 14 days, PHI 3 days

Number of trials: 8

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Proposed MRL was derived from residue trials in peppers, applying the default dehydration factor of 10

At EU level, MRLs are set only for fresh products, but not for processed chili peppers

Critical GAP: USA, 2 × 0.06 kg a.s./ha, RTI 21 days, PHI 1 day

Number of trials: 6

Sufficiently supported by data: Yes

Specific comments/observations: Although for pineapples a minimum of 8 residue trials would be required in the EU, according to Codex classification, 5 trials are sufficient to derive a Codex MRL

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Europe (Italy, Greece, France, Spain) 2x 0.12 kg a.s./ ha, RTI 14 days, PHI 3 days

Number of trials: 8 residue trials in cucumbers, used to derive MRL proposal by extrapolation

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Italy, 2 × 0.12 kg a.s./ha, RTI 14 days, PHI 3 days

Number of trials: 8

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

PF (best estimate or mean): 0.08

Individual processing factors: 0.08, 0.08

Number of studies to derive the PF: 2

PF (best estimate or mean): < 0.18

Individual processing factors: < 0.17, < 0.2

Number of studies to derive the PF: 2

PF (best estimate or mean): < 0.18

Individual processing factors: < 0.17, < 0.2

Number of studies to derive the PF: 2

PF (best estimate or mean): 1.2

Individual processing factors: 0.67, 1.8

Number of studies to derive the PF: 2

PF (best estimate or mean):0.67

Individual processing factors: 0.67

Number of studies to derive the PF would not be sufficient in the EU

According to the information reported, pyriproxyfen is stable under standard hydrolysis studies. This was also concluded by EFSA in the framework of the peer‐review process

Additionally, the processing factors for tomato processed commodities in the JMPR report are the same that the ones assessed by EFSA during the peer‐review process

JMPR (2003)

(2‐year rat, SF 100)

EFSA (2006a)

(2‐year rat, UF 100)

^(a) Confirmed for the renewal of the approval (not yet finalised in an EFSA conclusion)

^(b) In the French RAR, an ARfD was proposed (1.5 mg/kg bw); in the expert meeting, the ARfD was agreed to be set at a level of 2 mg/kg bw. The conclusion is not yet published

During the EU peer review meeting (September 2018), several metabolites were discussed:

• –
  NOA422054: not concluded since genotoxicity potential could not be concluded due to lack of data and repeat‐dose toxicity had not been investigated
• –
  CGA232449: not concluded since genotoxicity potential could not be concluded due to lack of data and repeat‐dose toxicity had not been investigated
• –
  CGA249287: ADI is 0.08 mg/kg bw per day based on the 90‐day rat study, applying an uncertainty factor of 1000 to take into account the limited data package.
• –
  CGA263208: ADI is 0.02 mg/kg bw per day based on the 90‐day rat study, applying an uncertainty factor of 1000 to take into account the limited data package.
• –
  CGA304075: the ADI and ARfD of cyprodinil can be applied to this major rat metabolite.
• –
  CGA304076: not concluded since genotoxicity potential could not be concluded due to lack of data and repeat‐dose toxicity had not been investigated
• –
  I13C and I13b: not concluded since genotoxicity potential could not be concluded due to lack of data and repeat‐dose toxicity had not been investigated
• –
  CGA275535: no genotoxic potential, use of TTC value (Cramer class III) was proposed
• –
  CGA321915: no genotoxic potential, use of TTC value (Cramer class III) was proposed

For the TTC approach, the sum of the exposure for all non‐toxicological characterised metabolite should be compared to the TTC. It is noted that currently the TTC is not used at European Level for assessing residues metabolites since there is no agreement yet on how this tool should be used

Cyprodinil

The residue is fat soluble

EU Reg. 2019/552: Milk: Cyprodinil (sum of cyprodinil and CGA 304075 (free and conjugated), expressed as cyprodinil)

Other animal products:

Cyprodinil (sum of cyprodinil and CGA 304075 (free), expressed as cyprodinil)

The residue is fat soluble

Milk: Cyprodinil (sum of cyprodinil and CGA 304075 (free and conjugated), expressed as cyprodinil)

Other animal products:

Cyprodinil (sum of cyprodinil and CGA 304075 (free), expressed as cyprodinil)

Plant products: The residue definition for enforcement and risk assessment derived by the JMPR and at EU level is identical

Animal products: For animal products, the EU residue definition for enforcement and risk assessment is wider as comprises the metabolite CGA304075 (4‐[(4‐cyclopropyl‐6‐methylpyrimidin‐2‐yl)amino)]phenol) for tissues. In the framework of the MRL review also, the conjugates of CGA 304075 were also included in the residue definition for milk. However, this difference is of no relevance for the current MRL proposal

The RMS informed EFSA that in the framework of the renewal of the approval, residue definitions may be revised (e.g. residue definition for animal products (risk assessment and enforcement): sum of cyprodinil and CGA 304075 (free form and glucuronide), expressed as cyprodinil; residue definition for plant products (risk assessment) – fruit crops: cyprodinil and CGA232449 (free and conjugated) (pending submission of toxicity data on CGA232449 to be decided whether a separate residue definition for the metabolite would be more appropriate); cereals: cyprodinil by default (cereal) (provisional); rotational crops: NOA422054 (free and conjugated) (provisional)

However, since the modification of new residue definitions has not yet been implemented, the ongoing discussions at EU level do not affect the conclusions on Codex MRL proposals

Critical GAP: US post‐harvest (dip/drench) GAP, 1 × 54 g/hL before storage + 1 × 54 g/hL before trading, PHI 0 days

Number of trials: 1 storage facility, 4 trials at different dates

Sufficiently supported by data: to be discussed with MS. AT EU level the trials would not be considered independent

Specific comments/observations: Residue data were submitted for the 2017 JMPR, who proposed a CXL of 10 mg/kg

The EU made a reservation due to uncertainty over the relevance of the foliar metabolism study used to support the post‐harvest treatments and because for post‐harvest use the MRL should be calculated using mean + 4SD instead of CF × 3 Mean. The CXL proposal for pomegranates was maintained at step 4

2018 JMPR derived a revised MRL proposal calculated as proposed by the EU (5 mg/kg instead of 10 mg/kg)

2018 JMPR confirmed the metabolism studies are appropriate since post‐harvest treatment is unlikely to result in a more extensive metabolism than observed from foliar treatments

As regards question on the independence of residue trials and the lack of clarity of the GAP raised last year by the EU (see EFSA report on preparing EU position for the 50th CCPR), new information was not provided to 2018 JMPR

A risk management decision to be taken on the acceptability of the CXL proposal

The proposed Codex MRL is supported by the RMS

European Commission (2004)

(2‐year rat study, uncertainty factor of 100)

European Commission (2004)

(Rabbit developmental study, with an uncertainty factor of 100

JMPR assessment:

The previous ARfD of 0.05 mg/kg bw (JMPR, 2003), based on embryo and fetal toxicity in a developmental toxicity study in rabbits (SF 100), has been withdrawn. Based on additional studies, the meeting concluded that the effects secondary to local irritation following gavage dosing in rabbits were not relevant to human dietary risk assessment. Therefore, the meeting established a new ARfD of 0.7 mg/kg bw based on vomiting and diarrhoea seen during the first week of dosing of dogs (90‐day and 1‐yr studies), and applying a safety factor of 8 since the critical effects are considered to be secondary to a direct local effect on the gastrointestinal tract, which is independent of absorption and metabolism

Additional toxicological information on certain metabolites/degradation products was assessed by JMPR, e.g. degradation product formed under high temperature conditions, (see olives for oil production). The conclusions were:

• –
  for 500M04: No evidence of genotoxicity, oral LD₅₀ > 2,000 mg/kg bw (rats), 3‐month oral toxicity study NOAEL 100 mg/kg bw per day (rats),
• –
  for 500M49: no evidence of genotoxicity in vitro

EU peer review assessment:

Peer review for the renewal is ongoing – The same toxicological reference values established during the first assessment (European Commission, 2004) are proposed by the RMS. To be discussed at the experts’ meeting

The agreed ARfD of the first peer review was based on maternal toxicity (body weight losses) during the initial phase of the treatment in the rabbit developmental toxicity studies

Pyraclostrobin

The residue is fat soluble

EU Reg. 2017/1016: Pyraclostrobin

The residue is fat soluble

Art.12 (EFSA, 2011e): Sum of pyraclostrobin and its metabolites containing the 1‐(4‐chlorophenyl)‐1H‐pyrazole moiety or the 1‐(4‐chloro‐2‐hydroxyphenyl)‐1H‐pyrazole moiety, expressed as pyraclostrobin

Conversion factor of 4 for ruminant liver

Conversion factor of 6.8 for milk

The residue definitions for enforcement are compatible

The difference in the residue definition for animal products (risk assessment) can be compensated by using the conversion factors derived in the EU

Critical GAP: Germany, 2 foliar applications (BBCH > 69, after harvest of spears) at 0.1 kg a.i./ha, PHI not specified

Number of trials: 7

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 2 foliar applications of 0.166 kg a.i./ha, PHI 0 days

Number of trials: 4

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA (for whole subgroup of beans with pods), 3 applications of 0.16 kg a.i./ha, PHI 7 days

Number of trials: 7 trials with 2 × 0.23 kg/ha, PHI 7 days; trials were scaled (scaling factor 0.7). Scaling was considered acceptable, considering that decline trials demonstrated that the first application does not significantly contribute to the final residues

Sufficiently supported by data: Yes

Specific comments/observations: EFSA proposes to set only one MRL for beans with pods, subgroup (VP2060) at the level of 0.6 mg/kg derived from the EU trials (see below)

Conclusion: The proposed Codex MRL is acceptable. However, preferably only one MRL for the whole subgroup should be set. The proposed Codex MRL of 0.6 mg/kg derived for common beans (poroto) would be the appropriate level for the code VP 2060

Critical GAP: France, 2 applications of 0.1 kg a.i./ha and PHI 7 days

Number of trials: 8 (all at 0.01^*)

Sufficiently supported by data: Yes

Specific comments/observations: The proposed Codex MRL refers to the code VP 0523 (Vicia faba). A separate MRL proposal of 0.3 mg/kg was derived for Phaseolus beans (common beans without pods (succulent seeds, VP 2845)

Conclusion: The proposed Codex MRL is acceptable. See comments below on common beans without pods (succulent seeds)

Critical GAP: Brazil, 3 foliar applications of 0.2 kg a.i./ha, PHI 14 days

Number of trials: 3

Sufficiently supported by data: No

Specific comments/observations: Cocoa beans are a crop of consumption category 2; thus at least 4 trials would be required. At EU level 8 trials would be requested (if residues < LOQ, 4 trials would be sufficient)

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable, considering the level of the MRL proposal. If the proposed Codex MRL is found acceptable, it should be proposed to label it with an asterisk, indicating that the MRL is at the LOQ

Critical GAP: Poland, 2 foliar applications at 0.1 kg a.i./ha, PHI 14 days

Number of trials: 9

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: France, 2 applications of 0.1 kg a.i./ha, PHI 7 days

Number of trials: 17 trials

Sufficiently supported by data: Yes

Specific comments/observations: NEU and SEU residue trials were merged. The proposed Codex MRL refers to code VP2060 (Vicia faba)

Conclusion: The proposed Codex MRL is acceptable. However, it would be preferable to set the MRL for the whole subgroup of beans with pods (VP2060) at this level. (See also comments on Beans with pods, subgroup of, except common beans (poroto)

Critical GAP: France, 2 applications of 0.1 kg a.i./ha and PHI = 7 days

Number of trials: 11

Sufficiently supported by data: Yes

Specific comments/observations: The proposed Codex MRL refers to the code VP 2845 (Phaseolus vulgaris). A separate MRL proposal of 0.01 mg/kg was derived for fava beans (Broad beans without pods (succulent seeds, VP 0523)

Conclusion: Since in the EU, the two commodities (Phaseolus beans and fava beans (codex code VP) are covered by the same code (260020), the MRL proposal of 0.3 mg/kg would be relevant. It is sufficiently supported by data and therefore acceptable. See also comments on broad beans without pods (succulent seeds)

Critical GAP: Canada, 2 foliar applications at 0.15 kg a.i./ha, PHI 30 days

Number of trials: 9 overdose trials, scaled down (scaling factor of 0.67) and 5 trials in lentils

Sufficiently supported by data: Yes

Specific comments/observations: The proposed Codex MRL covers peas and lentils

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: in USA of 0.23 kg a.i./ha and PHI = 0

Number of trials: 6

Sufficiently supported by data: Yes

Specific comments/observations: Although at EU level, 8 trials would be required, the number of trials is acceptable at Codex level, since lettuce is not a major crop

2006 JMPR assessed the same trials, but due to an exceedance of the ARfD, the MRL proposal was not advanced. With the higher ARfD value established by 2018 JMPR, the proposed MRL did not exceed the TRV

JMPR withdrew previous recommendation of MRL of 2 mg/kg in head lettuce

Conclusion: The proposed Codex MRL is not acceptable because of acute intake concerns identified at EU level (see below)

No feeding study was available. The MRL proposals were derived from metabolism study in lactating goats. At EU level, MRLs are set for muscle. The residue concentration in muscle at the calculated dietary burden of 29 ppm (EU diet) is expected to be between 0.05 and 0.06 mg/kg

Conclusion: The proposed Codex MRL is not acceptable; considering the significant dietary burden, a feeding study would be required to derive a reliable MRL for animal products

Critical GAP: Brazil, 4 foliar applications at 0.133 kg a.i./ha, PHI 7 days

Number of trials: 6

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: See table olives is proposed

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: Extrapolation from table olives.

In the framework of an Art. 10 application, additional toxicological data were requested for certain degradation products formed under conditions representative for frying and raffination (metabolite 500M04 and 500M49). The application was withdrawn

JMPR assessed data on 500M04 and 500M49 (see comments on toxicological reference values)

Conclusion: The proposed Codex MRL is acceptable

Proposed PF for olive oil: 6.24

It is noted that in the EU MRLs are set only for unprocessed olives, but not for olive oil

Critical GAP: Spain, 2 applications of 0.1 kg a.i./ha, PHI 7 days

Number of trials: 5

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Brazil, 4 foliar applications of 0.15 kg a.i./ha, PHI 7 days

Number of trials: 4

Sufficiently supported by data: Yes

Specific comments/observations:

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Brazil, 4 foliar applications of 0.15 kg a.i./ha, PHI 3 days.

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: In 4 residue trials, residue concentration was measured in the pulp as well. At EU level, a peeling factor of 0.27 was proposed

Conclusion: The proposed Codex MRL is acceptable

0.5 pome fruit,

0.02^* kaki,

3 azaroles

Critical GAP: Germany, 4 foliar application of 0.1 kg a.i./ha, PHI 7 days

Number of trials: 33 (25 in apples + 8 in pears)

Sufficiently supported by data: Yes

Specific comments/observations: extrapolation to the entire pome fruits group (apples, pears, quinces, medlar and loquats/Japanese medlars) but also including azarole (0154070) and kaki (Japanese persimmon) (0131060)

Conclusion: The proposed Codex MRL is sufficiently supported by data, but since an acute intake concern was identified for apples, pears and kakis the proposed MRL is not acceptable

Critical GAP: Indonesia, 2 foliar applications at 0.1 kg a.i./ha and BBCH 65 (last application at mid‐flowering), PHI not defined.

Number of trials: 16 (results for brown rice)

Sufficiently supported by data: Yes

Specific comments/observations: Residue trials conducted in Asian countries, Italy and Spain.

Conclusion: The proposed Codex MRL is acceptable

0.06 for Jerusalem artichokes,

0.09 for swedes and turnips;

0.1 beetroots, parsley roots, salsifies;

0.3 for parsnips and horseradish; 0.5 for radishes, carrots, celeriacs

Critical GAP: in USA for 3 foliar applications at 0.234 kg a.i./ha and PHI 0

Number of trials: 5 trials in radishes (minor crop), 6 in carrots (major crop)

Sufficiently supported by data: No

Specific comments/observations: The number of trials is not sufficient to derive a MRL proposal for the subgroup of root vegetables; furthermore, following the agreed policy on also trials on sugar beet or beetroots would be required

Conclusion: The proposed Codex MRL is not acceptable because the residue trials are not sufficient

Critical GAP: Germany and Italy, 2 applications of 0.1 kg a.i./ha, PHI 14 days, RTI 8 days (DE), 7 days (IT)

Number of trials: 10

Sufficiently supported by data: Yes

Specific comments/observations: Trials were conducted in Germany, France and Italy. JMPR merged the NEU and SEU trials to derive the MRL proposal. The EU MRL was derived from residue trials reflecting the NEU use. The trial with the highest residue (0.91 mg/kg) that is driving the MRL calculation was not available in the EU data package. Most likely this result is not correctly reflecting the trial results (the total residue (sum of parent plus metabolite is 0.1 mg/kg, while the parent alone was reported as 0.91 mg/kg; the results at a shorter PHI of 7 days were lower than at PHI 14 days)

Conclusion: JMPR should be asked to verify the results for the residue trial leading to the highest result. Most likely the value of 0.91 mg/kg is a typo

0.15 peas

0.02^* lentils

Critical GAP: Spain, 2 applications of 0.1 kg a.i./ha, PHI 7 days

Number of trials: 16 trials in peas

Sufficiently supported by data: Yes

Specific comments/observations: The proposed Codex MRL covers also fresh lentils. At EU level, the residue trials in peas would not be acceptable to set an MRL for lentils

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Brazil, single application in‐furrow at 0.133 kg a.i./ha, followed by 5 foliar applications of 0.13 kg a.i./ha with PHI 30 days

Number of trials: 4 + 8 overdosed trails (scaled down to match the GAP)

Sufficiently supported by data: Yes

Specific comments/observations: –

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Greece, foliar application, 2 × 0.1 kg a.i./ha, last application no later than BBCH 71; PHI not specified

Number of trials: 8

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Japan, 2 applications of 0.003 kg a.i./hL, PHI 7 days

Number of trials: 6 overdosed trials, scaled down to match the GAP

Sufficiently supported by data: No

Specific comments/observations: Tea is a major crop and according to EFSA's understanding 8 trials would be required

Conclusion: The proposed Codex MRL is not acceptable because the number of trials is insufficient. To discuss with MS if EFSA'S view is shared

Critical GAP: USA for 6 foliar applications at 0.22 kg a.i./ha and PHI 3 days

Number of trials: 19 trials, probably in potatoes, not specified in which crops the trials were performed

Sufficiently supported by data: Yes

Specific comments/observations: The proposed Codex MRL covers arrowroots, cassava, potatoes, sweet potatoes, yams

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: France, 1 application of 0.42 g a.i./m² tray area, PHI 21 days

Number of trials: 4

Sufficiently supported by data: Yes

Specific comments/observations:

Conclusion: The proposed Codex MRL is acceptable

EFSA (2007) (2‐y rat with an uncertainty factor of 100)

confirmed in European Commission (2007b)

During the previous peer review at EU level (EFSA, 2007), the ADI was based on the NOAEL of 37 mg/kg bw per day in the 2‐year rat study; the same basis than the JMPR in 2004. The differences are because different policy in rounding. During the EU assessment, no assessment was done on whether metabolites oxidised to metabolite 2,2‐difluoro‐benzo[1,3]dioxole‐4 carboxylic acid (CGA 192155) could be covered by the parent compound

In the framework of the renewal process in the EU, the RMS proposed 0.1 mg/kg bw per day for both the ADI and ARfD, whereas the proposal of the co‐RMS was 0.37 mg/kg bw per day for both reference values. (Discussion at Expert meeting foreseen in April 2019). The toxicological profile of metabolites including CGA 192155 will be also discussed during Expert meeting foreseen in April, 2019

EU Reg. 2016/1902: Fludioxonil

EFSA (2007, 2011d) (Peer‐review, Art.12 MRL Review): Fludioxonil

Fludioxonil and its benzopyrrole metabolites, determined as 2,2‐difluoro‐1,3‐benzodioxole‐4‐carboxylic acid and expressed as fludioxonil

The residue is fat soluble

EU Reg. 2016/1902: Sum of fludioxonil and its metabolites oxidised to metabolite 2,2‐difluoro‐benzo[1,3]dioxole‐4 carboxylic acid

The residue is fat soluble

EFSA (2007, 2011d):

Sum of fludioxonil and its metabolites oxidised to metabolite 2,2‐difluoro‐benzo[1,3]dioxole‐4 carboxylic acid (CGA 192155), expressed as fludioxonil

EFSA (2007, 2011d):

Sum of fludioxonil and its metabolites oxidised to metabolite 2,2‐difluoro‐benzo[1,3]dioxole‐4 carboxylic acid (CGA 192155), expressed as fludioxonil

For cereals (seed treatment), fruits and leafy vegetables, pulses and oilseeds, the conversion factor (CF) of 1 between residue definitions for enforcement and risk assessment was derived which reflects the fact that no significant concentrations of metabolites containing the 2,2‐difluoro‐benzo[1,3]dioxole‐4 carboxylic moiety are expected. For root vegetables after foliar application the conversion factor of 2.8 (derived from the metabolism study on spring onions) from enforcement to risk assessment residue definition is proposed (EFSA, 2007, 2011d)

For the commodities for which Codex MRLs were proposed by JMPR, the different residue definition is not expected to have a major impact as for root vegetables a CF derived from metabolism studies can be used in risk assessment to account for the presence metabolites measured as CGA 192155 (CF 2.8); for the other commodities similarly as in the MRL review a CF of 1 can be used, assuming that the metabolites is not present in significant concentrations.

The dietary risk assessment may need to be reviewed pending the conclusion of the ongoing renewal

Critical GAP: Australia post‐harvest dip/drench/flood spray application at a rate of 60 g a.i./hL

Number of trials: 8 (dip treatment) + 2 (flood spray); trials combined

Sufficiently supported by data: Yes

Specific comments/observations: JMPR agreed to use the STMR of 0.01 mg/kg derived from the combined residues in the flesh. However, as information is not available on the time of sampling (whether samples analysed after a realistic storage period, allowing for penetration of residues in edible part of the fruit, as fludioxonil is fat soluble) the STMR relevant for the whole fruit was used in the exposure calculation

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Canada: 3 × 244 g a.i./ha, RTI 7 days, PHI 1 days

Number of trials: 8 trials (JMPR, 2004); 2 new trials compliant with the Canadian GAP

Sufficiently supported by data: Yes

Specific comments/observations: JMPR concluded that the existing CXL derived in 2004 for the US GAP (4 × 250 g a.i./ha PHI: 0 day) covers the Canadian GAP

Conclusion: No change to the current Codex MRL is foreseen

onions: 0.5

garlic and shallots: 0.02

Critical GAP: US, 4 × 245 g a.i./ha, PHI 7 days

Number of trials: 16 (13 assessed by JMPR in 2004)

Sufficiently supported by data: Yes

Specific comments/observations: JMPR proposed to set a group tolerance which covers also garlic (0220010), and shallots (0220030). It should be verified whether the US GAP applies to the whole group of bulb onions

Conclusion: The proposed Codex MRL is acceptable, provided US GAP for the subgroup exists

Critical GAP: US, 4 × 250 g a.i./ha, PHI 7 days.

Number of trials: 6 (JMPR 2004) + 5 new trials

Sufficiently supported by data: Yes

Specific comments/observations: The previous MRL and STMR recommendations were maintained

Conclusion: No change necessary

Critical GAP: EU (DE), 3 × 250 g a.i./ha, RTI and PHI 7 days

Number of trials: 15

Sufficiently supported by data: Yes

Specific comments/observations: The RTI in the trials were 14 days, but was considered acceptable based on decline studies showing limited degradation. In the EU, a CF of 2.8 is proposed

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 4 × 245 g a.i./ha, RTI 7 days, PHI 0 days

Number of trials: 8 (±25% GAP)Sufficiently supported by data: Yes

Specific comments/observations: Pending on the setting of the ARfD an acute risk may occur (if ARfD is set at 0.1 mg/kg bw per day; no concern if set at 0.37 mg/kg)

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Canada, 3 × 244 g a.i./ha foliar; PHI 7 days

Number of trials: 7

Sufficiently supported by data: No

Specific comments/observations: In the EU food classification, chick peas are classified under peas (dry): 8 trials would be required for peas. However, considering that the EU MRL is higher than the proposed Codex MRL, the lack of 1 study may not be of relevance

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Ireland 3 × 250 g a.i./ha, 10 days interval between 1st and 2nd applications and 28 days interval between 2nd and 3rd application, PHI 7 days

Number of trials: 5

Sufficiently supported by data: Yes

Specific comments/observations: Same GAP assessed by EFSA(2011d). In the MRL review, the MRL was based on 9 GAP compliant residue trials on blueberries (0.15; 0.31; 0.31; 0.37) and currants (0.26; 0.6; 0.62; 0.63; 1.44) combined. The trials on currants are the same

Conclusion: The proposed Codex MRL is acceptable

Swine liver, kidney, edible offals: 0.05^*

Liver, kidney of other species: 0.2(ft)

Critical GAP: Australian animal burden – dairy cattle (max dietary burden 23 ppm/mean dietary burden 6.4 ppm); since the dietary burden calculation was not presented in Annex 6 of the JMPR report, the calculations cannot be checked

Sufficiently supported by data: Yes, a new feeding study was provided that covered the calculated dietary burden

Specific comments/observations: In the EU, a livestock feeding study was requested as confirmatory data (deadline 30 January 2016). Confirmatory data assessment currently ongoing

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: EU, laying hen (maximum dietary burden calculation 1.9 ppm/mean dietary burden 0.86 ppm)

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Green onion, Subgroup of (includes all commodities in this subgroup)

VA 2032

Spring onions: 5

Leek: 0.01^*

Chives: 20

Critical GAP: EU (Italy), 3 × 250 g a.i./ha, RTI 10 days and PHI 7 days

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: –

The MRL proposal would also cover leeks and chives which are classified in the subgroup of green onions

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 4 × 245 g a.i./ha; RTI 7 days, PHI 0 days

Number of trials: 4

Sufficiently supported by data: Yes

Specific comments/observations: –

Conclusion: The proposed Codex MRL is acceptable

0.3

Chinese cabbage: 10

land cress: 20,

Kale: 0.01^*

Broccoli (covering chinese broccoli): 0.7

Rucola: 20

Critical GAP: US, 4 × 240 g a.i./ha, PHI 7 days

Number of trials: 9 trials in mustard greens and water cress (assessed in 2004 JMPR) + 1 new trial in mustard greens

Sufficiently supported by data: Yes

Specific comments/observations: JMPR proposed to extrapolate to the whole subgroup of leaves of Brassicaceae. This crop group covers several crops that are classified differently in the EU food classification (e.g. Chinese cabbage, cress, kale, Chinese broccoli and rucola). It is noted that the higher MRL derived compared to the existing MRL is due to change in the method of calculation (OECD calculator, 2015) This approach is acceptable, however it needs to be confirmed that a US GAP refers to the whole group of Brassica. Based on the preliminary acute exposure calculation if the ARfD will be set at 0.1 mg/kg, a concern is foreseen for kales, broccoli and Chinese cabbage. No concern is expected if the ARfD is set at 0.37 mg/kg bw per day.

Conclusion: The proposed Codex MRL is acceptable, provided the US GAP covers the whole group; an acute intake concern may be expected if the ARfD is lowered as proposed by the RMS

Critical GAP: Canada, 3 × 244 g a.i./ha foliar; PHI 7 days

Number of trials: 7 on dry peas

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

swine fat: 0.05^*

other species: 0.2(ft)

See edible offal (Mammalians);

In the EU a metabolism study was requested as confirmatory data

Conclusion: The proposed Codex MRL is acceptable

swine muscle: 0.01^*

other species: 0.04 (ft)

See edible offal (Mammalians)

In the EU, a metabolism study was requested as confirmatory data

Conclusion: The proposed Codex MRL is acceptable. The respective MRL for muscle would be 0.01 or 0.02 mg/kg

Critical GAP: Australian animal burden – dairy cattle (maximum dietary burden 23 ppm/mean dietary burden 6.4 ppm)

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, one drench treatment and one spray treatment at a rate of 60 g a.i./hL

Number of trials: 4

Sufficiently supported by data: To be discussed with MS.

Specific comments/observations: According to the JMPR crop classification, at least 5 trials are required for pineapples. However, for the post‐harvest use 4 trials may be considered sufficient. In an US import tolerance application, EFSA derived the MRL proposal currently implemented in the EU legislation. In addition, pending on the ARfD to be set an acute risk may occur

Conclusion: The proposed Codex MRL may not acceptable if MS agree that the number of trials is insufficient. Nonetheless, in Europe a higher MRL is in place for pineapples

Critical GAP: USA two post‐harvest dip applications at a rate of 36 g a.i./hL

Number of trials: 4

Sufficiently supported by data: Yes

Specific comments/observations: The current CXL for fludioxonil is 2 mg/kg. This change in CXL has no implications on the current EU MRL

Conclusion: The proposed Codex MRL is acceptable

See eggs

Conclusion: The proposed Codex MRL is acceptable

See eggs

Conclusion: The proposed Codex MRL is acceptable. For muscle the corresponding MRL would be 0.01^* mg/kg

See eggs

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Brazil, foliar, 2 × 250 g a.i./ha, RTI 7 days, PHI 30 days

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: –

Conclusion: The proposed Codex MRL is acceptable

Rat, 2‐year with an uncertainty factor of 100

(EFSA, 2012d, 2018i) confirmed in European Commission (2018a)

Not

necessary

The different ADI values derived by JMPR and at EU level are the result of different policy on rounding (same study, same NOAEL)

For the metabolite SYN500003, more acutely toxic than mandipropamid, JMPR concluded that it was unlikely to be genotoxic based on genotoxicity studies not available for the EU peer review. Nevertheless, both JMPR and EU review concluded that the ADI for mandipropamid is not applicable to the metabolite SYN500003, and no specific ADI or ARfD can be established

Mandipropamid

The residue is not fat soluble

EU Reg. 2015/845: Mandipropamid

The residue is not fat soluble

Art.12 (EFSA, 2018i): Fruits and leafy vegetables: mandipropamid (any ratio of constituent isomers)

Root crops: Sum of mandipropamid and SYN 500003 [tentative, pending on the submission of toxicological information on SYN 500003]

Peer‐review (EFSA, 2012d): Mandipropamid except for root/tuber crops where the definition is provisionally proposed as ‘mandipropamid and SYN 500003’, pending the submission of toxicological information on SYN 500003

Art.12 (EFSA, 2018i): not required

Peer‐review (EFSA, 2012d): Mandipropamid

The JMPR and EU residue definitions for enforcement and risk assessment for plant and animal commodities are comparable except for the risk assessment residue definition for root/tuber crops, where the EU residue definition is provisionally proposed as ‘mandipropamid and SYN 500003’, pending the submission of toxicological information on SYN 500003

The JMPR plant risk assessment residue definition, in contrast to the EU definition for root/tuber crops, does not include the plant metabolite SYN 500003

The residue definition for enforcement proposed in the Peer Review and the MRL Review are equivalent to the residue definition set in Regulation (EC) No 396/2005, although they specifically detail that it covers any ratio of constituent isomers

The different risk assessment residue definition for root crops (due to the inclusion of SYN 500003), is a relevant issue in the risk assessment only with regard to the Codex MRL proposal for potatoes

The RMS informed EFSA that for renewal of the active, the notifier plans to fully address the toxicological properties of metabolite SYN500003

Critical GAP: Canada, 4 × 150 g/ha, RTI not reported, PHI 1 days

Number of trials: 10

Sufficiently supported by data: Yes

Specific comments/observations: Trials on snap beans. The available plant metabolism studies conducted on leafy crops and fruit crops are sufficient to address the metabolic behaviour for the specific use on beans (with pods).

Conclusion: The proposed Codex MRL is acceptable

0.02^*

(0.06 proposed EU MRL; EFSA, 2018i)

Critical GAP: Cameroon, 6 × 90 g/ha, retreatment interval not reported, PHI 14 days

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: Residue trials on cacao beans assessed previously in an EU import tolerance application (EFSA, 2018i). The available plant metabolism studies conducted on leafy crops and fruit crops are sufficient to address the metabolic behaviour for the specific use on cocoa

Conclusion: The proposed Codex MRL is acceptable

The dietary burden was calculated, including cabbage head, grape pomace, potato by‐products

Since a feeding study is not available, the Codex MRL proposals were derived from the available lactating goat metabolism study

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

The dietary burden was calculated, including the cabbage head and potato by‐products. No animal feeding studies on poultry are available and Codex MRL proposals were derived for poultry from the poultry metabolism study. The highest dose level covers the max DB

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

See comments on edible offal (mammalian)

Conclusion: The proposed Codex MRL is acceptable

See comments on edible offal (mammalian)

Conclusion: The proposed Codex MRL is acceptable

See comments on edible offal (mammalian)

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Canada and USA, seed treatment at 1 × 100 g/t seed potato followed by foliar treatment at 3 × 146 g/ha, retreatment interval not reported, PHI 14 days

Number of trials: 18

Sufficiently supported by data: Yes

Specific comments/observations: The metabolite SYN500003 was identified in potato tubers at levels up to 0.013 mg/kg with an estimated median reside of 0.005 mg/kg for SYN500003. No ADI or ARfD established for the metabolite SYN500003. The JMPR applied the threshold of toxicological concern (TTC) approach for the metabolite SYN500003 (the chronic exposure based on the median residue accounted for 0.027 μg/kg bw; an acute exposure was not calculated by JMPR; in the EU, this approach was not accepted to address the EU data requirements

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable/compatible with the EU policy on setting MRLs. Toxicological reference vales (ADI or ARfD) are not available for the metabolite SYN500003 which was identified in potato tubers at levels above 0.01 mg/kg

The RMS proposed to accept the proposed Codex MRLs, considering that individual residue levels of the metabolite are expected to be low (in all trials provided levels were below 0.01 mg/kg with the exception of 2, for which residues in potatoes were 0.01 mg/kg and 0.013 mg/kg). The use of TTC concept is according to the RMS acceptable. NL supported this view

See comments on eggs

Conclusion: The proposed Codex MRL is acceptable

See comments on eggs

Conclusion: The proposed Codex MRL is acceptable

See comments on eggs

Sufficiently supported by data: Yes

Conclusion: The proposed Codex MRL is acceptable

EFSA (2013b) (2‐yr, rat, uncertainty factor 100)

confirmed in European Commission (2013a)

EFSA (2013b) (acute

neurotoxicity, rat, uncertainty factor 100) confirmed in European Commission (2013a)

The agreed EU ADI is 0.012 mg/kg bw per day based on the NOAEL of the 2‐year study applying an uncertainty factor of 100. The EU ARfD is 0.5 mg/kg bw based on the acute neurotoxicity NOAEL with an uncertainty factor of 100

The slightly different ADI values are probably the result of a different policy on rounding

Sum of fluopyram and 2‐(trifluoromethyl) benzamide, expressed as fluopyram

The residue is not fat soluble

Sum fluopyram and fluopyram‐benzamide (M25), expressed

as fluopyram

The residue is not fat soluble

Sum of fluopyram, fluopyram‐benzamide (M25), expressed

as fluopyram

The residue definitions for enforcement (plant and animal commodities) derived by JMPR and applicable in the EU are identical. Thus, the Codex MRLs are compatible with the EU legal framework

As regards the residue definition for risk assessment for plants, the EU residue definition is wider

It is noted that metabolite M25 was observed at important proportions in the metabolism study in beans. At EU level, a conversion factor was derived for fruit crops (1.1), peas without pods (1.5), peas/beans with pods, oilseeds, stem vegetables (1.2)

The lack of conversion factors introduces an uncertainty in the exposure calculations and the consumer risk assessment should be considered as tentative and may underestimate the actual exposure for plant products for which JMPR derived MRL proposals that are higher than the existing EU MRLs

Rotational crop studies in cereals, leafy vegetables and roots were assessed in the peer review (EFSA, 2013b). Fluopyram and the metabolites resulting from the cleavage of the parent (fluopyram‐benzamide (M25) and fluopyram‐PCA (M43)) major components of the residues in rotational crops. 7‐hydroxy metabolites observed in higher proportions than in primary crops.

Residues in rotational crops cannot be excluded. (Default MRL proposals have been made for root/tuber and leafy crops (0.1 mg/kg), cereals, oilseeds and perennial crops (0.01*))

JMPR proposed to withdraw the existing CXL for cherry tomato and to replace it with the new MRL for Subgroup of Tomatoes

At EU level, the MRL established for tomatoes is also applicable to cherry tomatoes

Critical GAP: Thailand 2 × 0.024 kg/hL (up to BBCH 59)

Number of trials: 8 trials in rice grain; 1 processing study (JMPR, 2017)

Sufficiently supported by data: No

Specific comments/observations: The Codex MRL proposal of 4 mg/kg derived by JMPR in 2017 referred to cereal grain (GC 0649). The MRL proposal for husked rice of 1.5 mg/kg (MRL relevant for rice, according to Annex I of Reg (EU) 2018/62) was derived by applying the processing factor of 0.29 (JMPR, 2017). Since only one processing study is available, the proposed MRL is not sufficiently supported.

Conclusion: The proposed Codex MRL is not acceptable because the number of processing studies is insufficient

Critical GAP: Thailand 2 × 0.024 kg/hL (up to BBCH 59)

Number of trials: 8 trials in rice grain; 1 processing study (JMPR, 2017)

Sufficiently supported by data: Yes

Specific comments/observations: The Codex MRL proposal of 4 mg/kg by JMPR in 2017 referred to cereal grain (GC 0649). The MRL proposal for polished rice of 0.5 mg/kg was derived by applying the processing factor of 0.11 JMPR (2017)

Conclusion: The proposed Codex MRL is acceptable, noting that in the EU the relevant commodity is husked rice

Critical GAP: USA, 2 × 0.25 kg a.i./ha, PHI 0 days

Number of trials: 11

Sufficiently supported by data: Yes

Specific comments/observations: revised from 2017 to accommodate comments by EU and Canada. MRL extrapolated from tomato to the whole group of tomato (no change, in the EU classification tomatoes cover the whole subgroup)

Conclusion: The proposed Codex MRL is acceptable

EFSA (2014e);

European Commission (2015b)

(Rat, 2‐year study, UF 100)

EFSA (2014e);

European Commission (2015b)

(Rat, acute

Neurotoxicity, UF 100)

Sulfoxaflor

The residue is not fat soluble

EU Reg. 2018/832: Sulfoxaflor (sum of isomers)

The residue is not fat soluble

Plant and animal commodities: The residue definitions for enforcement set by JMPR and at EU level are substantially identical. Since the routine analytical method could not separate the two diastereomeric pairs of enantiomers in sulfoxaflor, the residue definitions apply to the sum of all isomers

At EU level, the residue definition for risk assessment in plant and animal commodities is more comprehensive and includes the metabolite X11719474. X11719474 is a plant and soil metabolite, which has shown to be preferentially taken up by the roots of the plants and to be present (> LOQ) in the leafy parts of the crops in rotation crops, particularly in feed items. However, its inclusion in the residue definition for risk assessment of plant and animal products is provisional. It was agreed that if the metabolite X11719474 is shown to be significantly less toxic than sulfoxaflor, then the residue definitions for risk assessment will be restricted to parent sulfoxaflor only

For several crops, including crops previously assessed by JMPR (JMPR evaluation 2011) and recently assessed by EFSA (2019f), results for X11719474 were reported separately. At the uses and PHIs assessed, concentrations of this metabolite were at or close to the LOQ of 0.01 mg/kg, except in cereal straw (up to 0.034 mg/kg). Considering the low concentrations and its toxicological profile, the differences between the two risk assessment residue definitions is of low practical implication

Both assessments concluded residues in products of animal origin are not fat soluble

0.6

(edible offal, liver, kidney from farmed terrestrial animals, except poultry)

New maximum dietary burden of sulfoxaflor was calculated from the Australian diet for beef cattle. The Codex MRL proposal is based on estimates from previously assessed feeding studies

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Canada, 2 × 36 g/ha, interval 7 days PHI 14 days (restriction max 72 g/ha per season)

Number of trials: 14

Sufficiently supported by data: Yes

Specific comments/observations: All trials overdosed (50 g/ha) with residues < LOQ (12) and at LOQ (2) proportionally scaled to derive STMR of 0.007 mg/kg, scaling factor 0.7. However, it is not a good practice to scale down overdosed trials with residues below the LOQ

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Canada, 2 × 36 g/ha, interval 7 days, PHI 14 days (restriction max 72 g/ha per season)

Number of trials: 15

Sufficiently supported by data: Yes

No MRLs are set for feed items at EU level

0.1

(farmed terrestrial animals, except poultry)

See comments on mammalian edible offal

Conclusion: The proposed Codex MRL is acceptable

0.3

(farmed terrestrial animals, except poultry)

See comments on mammalian edible offal

The Codex MRL proposal refers to meat; for muscle the same MRL proposal would be derived

Conclusion: The proposed Codex MRL is acceptable

New maximum dietary burden of sulfoxaflor was calculated from the Australian diet for dairy cattle. The Codex MRL proposal is based on estimates from previously assessed feeding studies. It was derived according to the residue definition set by JMPR, which includes parent compound only

Conclusion: The proposed Codex MRL is acceptable

New maximum dietary burden of sulfoxaflor was calculated from the Australian diet for broilers. The Codex MRL proposal was derived from a previously assessed feeding studies (JMPR 2011). The Codex MRL proposal refers to meat; for muscle the same MRL proposal would be derived

Conclusion: The proposed Codex MRL is acceptable

0.3

(edible offal, liver, kidney)

See comments on poultry meat

Conclusion: The proposed Codex MRL is acceptable

See comments on poultry meat

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Indonesia, 4 × 100 g/ha, interval 7 days, PHI 10 days (restriction 400 g/ha season)

Number of trials: 8

Sufficiently supported by data: Yes

Specific comments/observations: Trials conducted in Philippines and Australia. The Codex MRL proposal was derived from residues of sulfoxaflor in paddy rice

Conclusion: The proposed Codex MRL is not acceptable because it refers to paddy rice, which is not the commodity to which the EU MRL applies

Critical GAP: not reported in the Summary report

Number of trials: 3

Sufficiently supported by data: Yes

Specific comments/observations: median PF of 0.14

Critical GAP: not reported in the Summary report

Number of trials: 8 residue trials in paddy rice, 3 processing studies

Sufficiently supported by data: Yes

Specific comments/observations: The MRL proposal was derived by applying the median PF of 0.2 on the MRL proposal derived for rice

Conclusion: The proposed Codex MRL is acceptable; it refers to the commodity which is included in the EU MRL legislation

Critical GAP: Indonesia, 4 × 100 g/ha, interval 7 days, PHI 10 days (restriction 400 g/ha season)

Number of trials: 8

Sufficiently supported by data: Yes

No MRLs are set in the EU for feed items

Critical GAP: Canada, 2 × 36 g/ha, interval 7 days, PHI 14 days (restriction max 72 g/ha per season)

Number of trials: 9

Sufficiently supported by data: Yes

Specific comments/observations: All trials overdosed (50 g/ha) proportionally scaled, scaling factor 0.7

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: Critical GAP: Canada, 2 × 36 g/ha, interval 7 days, PHI 14 days

Number of trials: 9

Sufficiently supported by data: Yes

Specific comments/observations: All trials overdosed (50 g/ha) proportionally scaled, scaling factor 0.7

No MRLs are set in the EU for feed items

Critical GAP: Canadian, 2 × 36 g/ha, interval 7 days, PHI 7 days (restriction max 72 g/ha per season)

Number of trials: 9

Sufficiently supported by data: Yes

Specific comments/observations: All trials overdosed (50 g/ha) with residues < LOQ (9)

Conclusion: The proposed Codex MRL is acceptable

Critical GAP: USA, 4 × 101 g/ha, interval 7 days, PHI 7 days (restriction max 298 g/ha per season)

Number of trials: 10 trials conducted on almonds (5) and pecans (5) with 3 × 100 g/ha

Sufficiently supported by data: Yes

Specific comments/observations: Residues < LOQ except in one trial (0.02 mg/kg). The previously derived MRL proposal of 0.015 mg/kg (step 4) should be withdrawn

Conclusion: The proposed Codex MRL is acceptable

Information on the concentrations of the metabolite X11719474, currently included in the EU residue definitions for risk assessment, in the products of plant and animal origin under assessment are not available. It is expected that this deviation does not have a practical implication for the consumer risk assessment

Typos (summary report) STMR for maize fodder (dry) 0.16 mg/kg instead of 0.6 mg/kg

Parent compound: No recent toxicological assessment available for the a.s. used as a pesticide

The ADI established by the JMPR is based on a NOAEL of 2.8 mg/kg bw per day for decreases in body weight gain and vacuolation of the white matter of the brain in an 18‐month mouse study and a NOAEL of 2.9 mg/kg bw per day for reduced body weight and body weight gain and increased liver weight associated with hepatocellular enlargement in a 2‐year rat study. This was supported by a NOAEL of 2.6 mg/kg bw per day for reversible vacuolar myelopathy, vacuolation and/or myelin sheath swelling of the brain and spinal cord in males in a 1‐year neurotoxicity study in rats. An uncertainty factor (UF) of 100 was applied

The ARfD is based on the NOAEL of 3 mg/kg bw for depression of grooming and reactivity and decreased spontaneous motor activity observed in a pharmacological study in mice and applying an UF of 100

In the framework of the EU biocides assessment, an ADI of 0.028 mg/kg bw per day was derived, based on the same NOAELs from the same studies as the ones used by the JMPR; no ARfD was allocated under Reg. 98/8/EC, however it seems that the biocide assessment may not have had access to the study that was used by the JMPR to establish the ARfD

According to JMPR, the metabolite 4‐bromo‐2‐(p‐chlorophenyl)‐5‐(trifluoromethyl)‐pyrrole‐3‐carbonitrile (tralopyril) which was observed in plant metabolism studies, is more toxic than parent chlorfenapyr and an additional uncertainty factor of 10 was applied with regards to chlorfenapyr toxicological reference values (JMPR, 2013)

Details on the studies on genotoxicity are not reported in the JMPR report (it states only that in vitro and in vivo studies were provided); EFSA could not find evidence on these genotoxicity studies in JMPR Evaluations and therefore a conclusion cannot be derived whether all genotoxicity endpoint have been covered

…..

Six metabolites identified in residue studies were considered toxicologically not relevant at currently estimated dietary exposures using TTC approach (exposure was estimated individually for the 6 metabolites and compared to the TTC threshold of 1.5 μg/kg bw for Cramer Class 3). Toxicological data on these substances are not available to justify the use of the TTC threshold for Cramer Class 3. The calculated exposure for these metabolites ranged from < 0.001 μg/kg bw (CL 152832), to 0.003 μg/kg bw (CL322250, CL151835 and CL325157, respectively), 0.015 μg/kg bw (CL152837) and 0.018 μg/kg bw (CL 325195)

Chlorfenapyr

The residue is fat soluble

Reg. 396/2005: Chlorfenapyr

The residue is not labelled as fat soluble

Plant metabolism studies were assessed by the 2012 JMPR. Metabolism studies in oranges, tomatoes, head lettuce, potatoes and cotton are available

JMPR recommended that if in future further uses of chlorfenapyr result in an increase in exposure to the metabolites for which no toxicological studies (except genotoxicity data) are available, the residue definition should be reconsidered

EU assessment: RMS informed EFSA that in the peer review a residue definition for plants was agreed (residue definition was finally proposed as chlorfenapyr + AC 303268 (= tralopyril) expressed as AC 303268); for animal products the proposed residue definition was finally proposed as chlorfenapyr + CL 303268 (= tralopyril), expressed as CL 303268 (Evaluation table; ECCO, 99)

The proposed Codex MRL is based on the MRL proposal for peppers, applying the default dehydration factor of 10

No MRLs are set in the EU for processed products

The MRL proposal was derived from a feeding study assessed previously by JMPR (2012), taking into account the updated dietary burden calculation. Since the samples taken in the feeding study were not analysed for tralopyril, JMPR derived conversion factors on the basis of metabolism studies

Conclusion: It is recommended to discuss with MS whether the proposed Codex MRL is acceptable with the EU policy on setting MRLs, considering the approach to derive input values for risk assessment using conversion factors derived from metabolism studies

Critical GAP: BR, 24 g a.i./hL, 1,000 L/ha, PHI 14 days, number of application was not specified (GAP originally reported in 2012 JMPR)

Number of trials: 5 trials with 3 × 240 g a.i./ha, PHI 14 days

Sufficiently supported by data: If it is confirmed by JMPR/BR that the residue trials reflect an approved GAP, the supporting residue trials are sufficient. See also general comments below

0.01*

Kumquats: 0.01*

Critical GAP: BR, 3 × 15 g a.i./hL, PHI 14 days. Water amount per ha are not specified

Number of trials: 8 trials with 3 × 15 g/hL, PHI 14 days

Sufficiently supported by data: Yes

Specific comments/observations: See general comments below

Conclusion: The proposed Codex MRL is acceptable