Evaluation of confirmatory data following the Article 12 MRL review for chlorothalonil, including assessments for import tolerances for banana, papaya and peanuts

European Food Safety Authority (EFSA); Maria Anastassiadou; Giovanni Bernasconi; Alba Brancato; Luis Carrasco Cabrera; Lucien Ferreira; Luna Greco; Samira Jarrah; Aija Kazocina; Renata Leuschner; Jose Oriol Magrans; Ileana Miron; Stefanie Nave; Ragnor Pedersen; Hermine Reich; Alejandro Rojas; Angela Sacchi; Miguel Santos; Anne Theobald; Benedicte Vagenende; Alessia Verani

doi:10.2903/j.efsa.2020.6239

. 2020 Sep 28;18(9):e06239. doi: 10.2903/j.efsa.2020.6239

Evaluation of confirmatory data following the Article 12 MRL review for chlorothalonil, including assessments for import tolerances for banana, papaya and peanuts

European Food Safety Authority (EFSA)^✉, Maria Anastassiadou, Giovanni Bernasconi, Alba Brancato, Luis Carrasco Cabrera, Lucien Ferreira, Luna Greco, Samira Jarrah, Aija Kazocina, Renata Leuschner, Jose Oriol Magrans, Ileana Miron, Stefanie Nave, Ragnor Pedersen, Hermine Reich, Alejandro Rojas, Angela Sacchi, Miguel Santos, Anne Theobald, Benedicte Vagenende, Alessia Verani

PMCID: PMC7520804 PMID: 33005253

Abstract

The applicants Syngenta Crop Protection, UPL Europe Ltd. and Oxon Italia S.p.A. submitted requests to the competent national authority in the Netherlands to evaluate the confirmatory data for chlorothalonil that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available; in addition, Syngenta and UPL submitted requests for modifications of existing MRLs. Considering the recent decision on the non‐approval of chlorothalonil, the requests for amending existing MRLs to reflect intended EU uses for chlorothalonil and confirmatory data for EU uses became obsolete. EFSA focused therefore its assessment on the import tolerances and on general information on the analytical method required to enforce legal limits for chlorothalonil and its metabolite SDS‐3701 (R182281). Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS‐3701 in plant matrices at the validated LOQ of 0.01 mg/kg; data on the extraction efficiency for high oil content matrices as requested in the MRL review were not provided. This data gap is relevant for the import tolerance for peanuts. The data submitted in support of import tolerances were found to be sufficient to derive MRL proposals for chlorothalonil and SDS‐3701 for bagged bananas, papayas and peanuts. Studies investigating the effect of high temperature processing on the magnitude of SDS‐3701 in processed products are not available. Based on exposure calculations for chlorothalonil, EFSA concluded that the long‐term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumers. For papaya, an acute intake concern was noted for chlorothalonil, while for banana and peanuts, the expected short‐term intake of chlorothalonil residues was below the toxicological reference value. For the metabolite SDS‐3701, the toxicological profile is not fully elucidated, and therefore, toxicological reference values could not be derived. Hence, for this metabolite, the consumer risk assessment cannot be finalised.

Keywords: chlorothalonil, import tolerance, banana, papaya and peanuts, pesticide, MRL, consumer risk assessment

Summary

In 2012, when the European Food Safety Authority (EFSA) reviewed the existing Maximum Residue Levels (MRLs) for chlorothalonil according to Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data but for which no risk to consumers was identified. The following data gaps were noted which are considered relevant for the current assessment:

a)
for the finalisation of the risk assessment of SDS‐3701:
- 1
  A validated method for enforcement of metabolite SDS‐3701 in plant commodities, including processed fractions;
- 2
  A complete set of residue trials compliant with available guidance documents and allowing for the estimation of SDS‐3701 levels in all crops supported in the framework of this review;
- 3
  Storage stability studies demonstrating the stability of SDS‐3701 in plant commodities, including processed fractions;
- 4
  Further information on the magnitude of SDS‐3701 in processed commodities that have been subject to high temperatures;
- 5
  A study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs;
- 6
  Further characterisation of the total radioactive residue (TRR) in poultry commodities (if the dietary burden increases in the future).
b)
for the parent chlorothalonil:
- 7
  An analytical method, its ILV and a confirmatory method fully validated for the determination of parent chlorothalonil in hops;
- 8
  A storage stability study for parent chlorothalonil in high acid content commodities;
- 9
  Eight residue trials on apples and pears (with a minimum of four trials on apples) complying with the southern outdoor good agricultural practices (GAPs) for apples, quinces, medlars and loquats;
- 10
  Four residue trials on apricots and four residue trials on peaches complying with the southern outdoor GAP;
- 11
  Four residue trials on turnips complying with the southern outdoor GAP;
- 12
  Eight residue trials on head cabbage complying with the northern outdoor GAP;
- 13
  Eight residue trials on leek complying with the northern outdoor GAP;
- 14
  Four additional trials on fresh peas (without pods) complying with the southern outdoor GAP;
- 15
  Four residue trials on hops complying with the northern outdoor GAP.

Tentative MRL proposals for chlorothalonil have been implemented in the MRL legislation by Commission Regulation (EU) No 1146/2014, including footnotes related to data gaps number 1–15 referred to above, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 29 October 2016. Considering the data gaps identified, MRL proposals for the metabolite SDS‐3701 could not be derived, and consequently, no specific MRLs for SDS‐3701 have been implemented in Regulation (EC) No 396/2005.

In accordance with the agreed procedure set out in the working document SANTE/10235/2016, the applicants Syngenta Crop Protection, UPL Europe Ltd. (formerly Arysta LifeScience SAS) and Oxon Italia S.p.A (members of Chlorothalonil Task Force) submitted applications to the competent national authority in the Netherlands (rapporteur Member State, RMS) providing confirmatory data identified during the MRL review for a wide range of crops. In addition, applications for modifications of some of the existing MRLs were submitted reflecting intended modifications of the EU use patterns by Syngenta Crop Protection and UPL Europe Ltd. (formerly Arysta LifeScience SAS).

The RMS assessed the new information in an evaluation report, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 26 April 2018.

When assessing the evaluation report, EFSA identified points which needed further clarifications. On 16 January 2020, the EMS submitted a revised evaluation report which addressed the points for clarification.

It is noted that on 29 April 2019, a decision on the non‐renewal of the approval of chlorothalonil under Regulation (EC) No 1107/2009 was taken, because of concerns – amongst other concerns – regarding the dietary consumer risk assessment. The toxicological profile of certain metabolites/degradation products (i.e. SDS‐3701 (R182281), R613636 and R417888) was not fully elucidated and, consequently, definitive residue definitions for risk assessment in plant and animal commodities could not be derived by EFSA in previous assessments. Hence, a comprehensive risks assessment cannot be performed.

Following the decision on the non‐renewal of the approval, the EU uses of plant protection products containing chlorothalonil had to been withdrawn by 20 November 2019 (period of grace according to Article 46 of Regulation (EC) No 1107/2009: 20 May 2020). Considering the new situation for EU authorisations, data gaps identified in the MRL review related to the EU uses became obsolete (i.e. data gaps 7 and 9 to 15 and eventually data gaps 2 and 4 to 6).

The submitted applications of Syngenta Crop Protection and UPL Europe Ltd. (formerly Arysta LifeScience SAS) for new EU uses of chlorothalonil also became obsolete.

In the current assessment, EFSA therefore focused on the import tolerance requests and the generic data gap on analytical method, storage stability and the data gap on the magnitude of SDS‐3701 in processed commodities that have been subject to high temperatures, which are also relevant for the import tolerance requests. In addition, EFSA re‐evaluated whether metabolism studies in pigs and data to characterise the TRR in poultry commodities are still required, considering the import tolerances for crops that are used as feed items. It should be highlighted that the current assessment was not an assessment of data gaps identified in the renewal process.

Based on the data available, the following conclusions were derived:

Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS‐3701 in plant matrices at or above the LOQ of 0.01 mg/kg; however, further data on the extraction efficiency for SDS‐3701 are still required for high oil content matrices. Hence, data gap number 1 was partially addressed; for peanuts, the enforcement method for the determination of SDS‐3701 is not fully compliant with the data requirements.

Studies investigating the storage stability of chlorothalonil and SDS‐3701 in high acid content commodities were assessed in the framework of the renewal of chlorothalonil. The data gaps number 3 and 8 were sufficiently addressed.

The following provisional residue definitions for enforcement and risk assessment were previously derived for plant commodities (MRL review):

Residue definition 1: chlorothalonil;

Residue definition 2: R182281 (SDS‐3701);

In Regulation (EC) No 396/2005, currently the residue definition for plant commodities is only parent chlorothalonil. Since no data on the residue levels expected for SDS‐3701 were available at the time of the MRL review, residue definition 2 has not been implemented in the EU MRL legislation.

The current EU residue definitions may need to be revised, taking into account the considerations of the renewal process.

To address data gap number 2, residue data were provided for bananas, papayas and peanuts. EFSA concluded that the available residue trials in bagged bananas are sufficient to derive MRL proposals of 0.02* mg/kg for chlorothalonil and 0.01* mg/kg for SDS‐3701 for the reported Latin American GAPs. It is noted that EFSA received authorised labels for banana in Latin American countries; however, the conditions of use did not match with the GAP assessed in this reasoned Opinion.

The available trials are sufficient to derive MRL proposals of 15 mg/kg for chlorothalonil and 0.02 mg/kg for SDS‐3701 on papaya in support of the authorised Brazilian GAP.

The available trials are sufficient to derive MRL proposals of 0.01* mg/kg for chlorothalonil and SDS‐3701 on peanuts in support of the authorised US GAP.

Processing studies to investigate the impact of high temperature treatment on the magnitude of residues parent chlorothalonil and the possible formation of the degradation products identified in standard hydrolysis studies (i.e. R182281 and R613636) are not available.

The dietary burden calculation was updated in the current assessment. The only remaining use relevant for feed is the use in peanuts. Overall, the expected intake of chlorothalonil by livestock was below the trigger value for all animal species. Hence, the existing MRLs for animal products are no longer required and risk managers may consider lowering them to the LOQ.

Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumer health for parent chlorothalonil. For papaya, an acute intake concern was identified (433% of the acute reference dose (ARfD)). For banana and peanuts, no acute consumer risk for chlorothalonil was derived.

Since toxicological reference values for SDS‐3701 are not available, the consumer risk assessment for this metabolite could not be finalised.

The summary table below provides an overview of the assessment of confirmatory data and the recommended MRL modifications to Regulation (EU) No 396/2005.

Codea	Commodity	Existing MRL Chlorothalonilb	Proposed MRL Chlorothalonil	Proposed MRL SDS‐3701	Conclusion/recommendation
Existing enforcement residue definition for plants and animals: Chlorothalonil Additional residue definitions for enforcement for plants: R182281 (SDS‐3701) (proposed in the MRL review, not yet implemented)
0130000	Pome fruit	2 (ft1)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP. Uses in third countries have not been reported Codex MRL (CXL) is not in place for pome fruits Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL for chlorothalonil to the LOQ should be considered
0140010 0140030	Apricots Peaches	1 (ft 1)	0.01*	0.01*	The existing MRL is based on the previously authorised SEU GAP Uses in third countries have not been reported CXL: 1.5 mg/kg (set by Codex Alimentarius Commission (CAC) in 2016, EU reservation because a separate residue definition for SDS‐3701 is considered necessary)c; Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0151000	Table and wine grapes	3 (ft 2)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAPs Uses in third countries have not been reported CXLs for grapes (3 mg/kg chlorothalonil), strawberries (5 mg/kg chlorothalonil) and gooseberries (20 mg/kg chlorothalonil) were already in place when the MRL review was performed. Data on SDS‐3701 demonstrated that significant residues of the metabolite cannot be excluded for grapes (HR: 0.15 mg/kg); in strawberries and gooseberries, residues of SDS‐3701 were not analysedc Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0152000	Strawberries	4 (ft 2)	0.01*	0.01*
0154040	Gooseberries	15 (ft 2)	0.01*	0.01*
0163020	Bananas	0.15 (ft 3)	0.02* Further risk management considerations required	0.01*	Label information for Latin American countries was provided for Mexico and Brazil, which did not match with the use pattern of the residue trials submitted in support of the application. Based on the submitted trials in bagged bananas, a tentative MRL proposal was derived. For unbagged bananas, the number of trials was insufficient. Further risk management considerations are required whether setting of an MRL at the level of the highest LOQ of the available residue trials in bagged bananas is appropriate Chlorothalonil MRLs in Latin American countries: 15 mg/kg in Costa Rica, 3 mg/kg in Brazil, 0.2 mg/kg pulp in Argentina and 0.01 mg/kg in Chile CXL: 15 mg/kg (set by CAC in 2013, EU reservation because of concerns on metabolite SDS‐3701)c
0163040	Papaya	15 (ft 3)	0.01*	0.01*	Residue data on chlorothalonil and SDS‐3701 were provided reflecting the authorised GAP in Brazil (calculated MRL for chlorothalonil: 15 mg/kg, SDS‐3701: 0.02 mg/kg) For chlorothalonil, an acute consumer health risk could not be excluded. The tolerance established in the US and Brazil is 15 mg/kg CXL: 20 mg/kg chlorothalonil (set by CAC in 2011, no EU reservation was noted)c The lowering of the existing MRL to the LOQ should be considered
0211000	Potatoes	0.01 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAPs Uses in third countries have not been reported Codex MRL is not in place for potatoes Following the non‐approval of chlorothalonil in the EU, the MRL at the LOQ of 0.01 mg/kg is appropriate
0213020	Carrots	0.3 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAP Uses in third countries have not been reported Codex MRL is not in place for carrots Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0213030	Celeriac	1 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported Codex MRLs are not in place for celeriac Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0213040	Horseradishes	0.3 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAP Uses in third countries have not been reported CXL: 1 mg/kg for chlorothalonil, set by CAC 2016; EU reservation because of their concern on metabolite SDS‐3701 Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0213060 0213070 0213090	Parsnips Parsley roots Salsify	0.3 (ft 3)	0.01*	0.01*	The existing MRLs reflect the previously authorised NEU/SEU GAP Uses in third countries have not been reported CXL: 0.3 mg/kg for chlorothalonil (set by CAC 2016. EU reservation because a separate residue definition for SDS‐3701 is considered necessary)c Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0213110	Turnips	0.3 (ft 1)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP. Uses in third countries have not been reported CXL of 0.3 mg/kg for chlorothalonil (set by CAC 2016. EU reservation because a separate residue definition for SDS‐3701 is considered necessary)c Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0220010 0220020 0220030	Garlic Onions Shallots	0.01* (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAPs Uses in third countries have not been reported No Codex MRL for garlic; for onions, bulb and shallots CXL of 1.5 mg/kg (set by CAC 2016. EU reservation because a separate residue definition for SDS‐3701 is considered necessary)c Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0220040	Spring onions	10 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAP Uses in third countries have not been reported CXL of 10 mg/kg chlorothalonil (set by CAC 2016. EU reservation because a separate residue definition for SDS‐3701 is considered necessary)c Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0231010	Tomatoes	6 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised EU indoor GAP Uses in third countries have not been reported CXL: 5 mg/kg for chlorothalonil (set by CAC 2016. EU reservation not explicitly mentioned in CCPR report.) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0231030	Aubergines	6 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised EU indoor GAP Uses in third countries have not been reported Codex MRL is not in place for aubergines Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0232000	Cucurbits‐edible peel	5 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised EU indoor GAP Uses in third countries have not been reported CXL: 3 mg/kg for chlorothalonil in cucumber, gherkins and courgettes (set by CAC 2011. EU reservation for cucumber (insufficient data set), gherkins, and summer squash (extrapolation practice of JMPR was not agreed by EU)) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0233000	Cucurbits (inedible peel)	1 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised EU indoor/SEU GAP Uses in third countries have not been reported CXL: 2 mg/kg for chlorothalonil for melons (set by CAC 2011; EU reservation because extrapolation practice of JMPR was not agreed by EU) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0241020	Cauliflower	2 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAP Uses in third countries have not been reported CXL: 5 mg/kg for chlorothalonil (set by CAC in 2011; no EU reservation was noted) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0242010	Brussels sprouts	3 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported CXL: 6 mg/kg for chlorothalonil (set by CAC in 2011; EU reservation because a lower MRL of 0.5 mg/kg was suggested when using the OECD calculator) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0242020	Head cabbage	0.6 (ft 1)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP Uses in third countries have not been reported Codex MRL is not in place for head cabbage Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0256030 0256040	Celery leaves Parsley	5 (ft 3)	0.01*	0.01*	The existing MRLs reflect the previously authorised NEU GAPs Uses in third countries have not been reported Codex MRLs are not in place for celery leaves and parsley Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0260010	Beans (with pods)	5 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported Codex MRL is not in place for beans with pods Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0260020	Beans (without pods)	3 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported Codex MRL is not in place for beans without pods Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0260030	Peas (with pods)	5 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported Codex MRL is not in place for peas with pods Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0260040	Peas (without pods)	1 (ft 1)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP Uses in third countries have not been reported Codex MRL is not in place for peas without pods Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0260050	Lentils	0.6 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRL is not in place for lentils Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0270010	Asparagus	0.01* (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU/SEU GAPs Uses in third countries have not been reported CXL: 0.01* mg/kg for chlorothalonil (set by CAC in 2016); no EU reservation
0270030	Celeries	10 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP Uses in third countries have not been reported CXL: 20 mg/kg for chlorothalonil (set by CAC in 2011; no EU reservation) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0270060	Leeks	8 (ft 1)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP Uses in third countries have not been reported CXL: 40 mg/kg (EFSA, 2011) (EU reservation in CCPR: The EU requested JMPR to perform a short‐term dietary risk assessment for leeks) Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0280010	Cultivated fungi	0.5 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised EU indoor GAP Uses in third countries have not been reported Codex MRL is not in place for cultivated fungi Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0300010	Beans	3 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRL is not in place for beans Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0300020	Lentils	0.2 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRL is not in place for lentils Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0300030	Peas	1 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised SEU GAP. Uses in third countries have not been reported Codex MRL is not in place for peas Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0300040	Lupins	0.2 (ft 3)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRL is not in place for lupins Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0401020	Peanuts	0.1 (ft 3)	0.01*	0.01*	In response to the confirmatory data request, the applicant submitted 13 trials for chlorothalonil and SDS‐3701, representative for the US GAP. Residues were below the LOQ of 0.01 mg/kg for both residue definitions A US tolerance for peanuts of 0.3 mg/kg is established Existing CXL: 0.1 mg/kg chlorothalonil (EFSA, 2011) Analytical method for SDS‐3701: data gap on extraction efficiency not addressed
0500010 0500050	Barley Oats	0.4 (ft 3)	0.01*	0.01*	The existing MRLs reflect the previously authorised SEU GAP Uses in third countries have not been reported Codex MRLs are not in place for barley and oats Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0500070 0500090	Rye Wheat	0.1 (ft 3)	0.01*	0.01*	The existing MRLs reflect the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRLs are not in place for rye and wheat Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered
0700000	Hops (dried)	60 (ft 4)	0.01*	0.01*	The existing MRL reflects the previously authorised NEU GAP. Uses in third countries have not been reported Codex MRL is not in place for hops Following the non‐approval of chlorothalonil in the EU, the lowering of the existing MRL to the LOQ should be considered

Codea	Commodity	Existing MRL SDS‐3701	Proposed MRL SDS‐3701	Conclusion/recommendation
Residue definitions for enforcement for animal commodities: SDS‐3701 (R182281)
1011010	Swine muscle	0.02 (ft 5)	0.01*	Considering the withdrawal of EU uses in feed, the dietary burden was re‐calculated. The requested confirmatory data (a study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs) is no longer relevant, since the dietary burden was below the trigger value The lowering of the existing MRL to the LOQ should be considered Codex MRLs of 0.02 mg/kg in place for swine meat; lacking data on the toxicological profile of SDS‐3701, the consumer risk assessment for this CXL cannot be performed. In addition, the commodity description of the EU and Codex are not compatible (meat vs. muscle)
1011020	Swine fat	0.07 (ft 5)	0.01*	Considering the withdrawal of EU uses in feed, the dietary burden was re‐calculated. The requested confirmatory data (a study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs) is no longer relevant, since the dietary burden was below the trigger value The lowering of the existing MRL to the LOQ should be considered Codex MRLs of 0.07 mg/kg in place for swine fat; lacking data on the toxicological profile of SDS‐3701, the consumer risk assessment for this CXL cannot be performed
1011030 1011040 1011050	Swine liver Swine kidney Swine edible offal	0.2 (ft 5)	0.01*	Considering the withdrawal of EU uses in feed, the dietary burden was re‐calculated. The requested confirmatory data (a study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs) is no longer relevant, since the dietary burden was below the trigger value The lowering of the existing MRL to the LOQ should be considered Codex MRLs of 0.2 mg/kg in place for liver and kidney; lacking data on the toxicological profile of SDS‐3701, the consumer risk assessment for this CXL cannot be performed
1016000 1030000	(f) Poultry (iii) Bird eggs	0.01* (ft 5)	0.01*	Considering the withdrawal of EU uses in feed, the dietary burden was re‐calculated. The requested confirmatory data (a study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs) is no longer relevant, since the dietary burden was below the trigger value The existing MRL should be maintained at the LOQ Codex MRLs of 0.01* mg/kg in place for bird eggs

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*: Indicates that the MRL is proposed at the limit of quantification.

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

Existing EU MRL and corresponding footnote on confirmatory data.

Risk management decision is required as regards the CXL, considering also the lack of information on the genotoxicity of metabolites/degradation products that may be formed during processing.

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The European Food Safety Authority identified some information on residue trials as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. Moreover, the European Food Safety Authority highlights that the metabolite 2,5,6‐trichloro‐4 hydroxyphtalonitrile (SDS‐3701) has not been taken into account, given that a validated method for enforcement, a complete set of residues trials, storage stability studies and data on processing of SDS‐3701, are unavailable for all plant commodities. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 1, 2, 3, 4, 9, 10, 11, 12, 13, 14).

^{ft 2}

The European Food Safety Authority identified some information on storage stability as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it.

Moreover, the European Food Safety Authority highlights that the metabolite 2,5,6‐trichloro‐4 hydroxyphtalonitrile (SDS‐3701) has not been taken into account, given that a validated method for enforcement, a complete set of residues trials, storage stability studies and data on processing of SDS‐3701, are unavailable for all plant commodities. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 1, 2, 3, 4, 8).

^{ft 3}

The European Food Safety Authority highlights that the metabolite 2,5,6‐trichloro‐4 hydroxyphtalonitrile (SDS‐3701) has not been taken into account, given that a validated method for enforcement, a complete set of residues trials, storage stability studies and data on processing of SDS‐3701, are unavailable for all plant commodities. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 1, 2, 3, 4).

^{ft 4}

The European Food Safety Authority identified some information on analytical methods and residue trials as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. Moreover, the European Food Safety Authority highlights that the metabolite 2,5,6‐trichloro‐4 hydroxyphtalonitrile (SDS‐3701) has not been taken into account, given that a validated method for enforcement, a complete set of residues trials, storage stability studies and data on processing of SDS‐3701, are unavailable for all plant commodities. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 7, 15).

^{ft 5}

The European Food Safety Authority identified some information on pigs metabolism and in TRR in poultry commodities as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 29 October 2016, or, if that information is not submitted by that date, the lack of it. (Footnote related to data gap No 5, 6).

Assessment

The review of existing MRLs for the active substance chlorothalonil according to Article 12 of Regulation (EC) No 396/20051 (MRL review) has been performed in 2012 (EFSA, 2012). European Food Safety Authority (EFSA) identified some information as unavailable (data gaps) and derived tentative MRLs for those uses not fully supported by data but for which no risk to consumers was identified. The following data gaps were identified by EFSA:

Data gaps for the finalisation of the risk assessment of SDS‐3701:

1
A validated method for enforcement of metabolite SDS‐3701 in plant commodities, including processed fractions;
2
A complete set of residue trials compliant with available guidance documents and allowing for the estimation of SDS‐3701 levels in all crops supported in the framework of this review;
3
Storage stability studies demonstrating the stability of SDS‐3701 in plant commodities, including processed fractions;
4
Further information on the magnitude of SDS‐3701 in processed commodities that have been subject to high temperatures;
5
A study investigating metabolism of chlorothalonil and metabolite SDS‐3701 in pigs;
6
Further characterisation of the TRR in poultry commodities (if the dietary burden increases in the future).

Data gaps for the parent chlorothalonil:

7
An analytical method, its ILV and a confirmatory method fully validated for the determination of parent chlorothalonil in hops;
8
A storage stability study for parent chlorothalonil in high acid content commodities;
9
Eight residue trials on apples and pears (with a minimum of 4 trials on apples) complying with the southern outdoor good agricultural practices (GAPs) for apples, quinces, medlars and loquats;
10
Four residue trials on apricots and four residue trials on peaches complying with the southern outdoor GAP;
11
Four residue trials on turnips complying with the southern outdoor GAP;
12
Eight residue trials on head cabbage complying with the northern outdoor GAP;
13
Eight residue trials on leek complying with the northern outdoor GAP;
14
Four additional trials on fresh peas (without pods) complying with the southern outdoor GAP;
15
Four residue trials on hops complying with the northern outdoor GAP.

Following the MRL review, the MRL modifications proposed for chlorothalonil have been implemented in the MRL legislation by Commission Regulation (EU) No 1146/20142, including footnotes implementing the data gaps identified by EFSA in points 1–15 (above) as confirmatory data requirements. Lacking data for SDS‐3701, MRLs for the second residue definition could not be established.

Any parties having an interest in maintaining the tentative MRLs were requested to address the confirmatory data requirement by 29 October 2016.

In accordance with the specific provisions, the applicants Syngenta Crop Protection, UPL Europe Ltd. (Arysta LifeScience SAS) and Oxon Italia S.p.A (members of Chlorothalonil Task Force) submitted applications to the competent national authority in the Netherlands (designated rapporteur Member State, RMS) to evaluate the confirmatory data identified during the MRL review. In support of the applications, the applicants provided residue trials and referred to data that were assessed in the framework of the renewal of the approval of chlorothalonil (EFSA, 2018a). In addition, applications for modifications of some of the existing MRLs were submitted reflecting intended modifications of the EU use patterns.

The applicant Syngenta Crop Protection provided the following information:

Information to support import tolerances for chlorothalonil in peanuts, bananas and papaya (for papaya and peanuts, the GAPs assessed in the framework of the MRL review were no longer supported. Instead, alternative GAPs were reported);
Data to justify the modification of the existing MRLs for chlorothalonil on peaches (incl. nectarines), apricots, grapes, carrot, parsley, salsify, parsnips, horseradish, radish, spring onions/welsh onions, cauliflower, Brussels sprouts, head cabbage, beans without pods, peas without pods and leek;
Data to support the setting MRLs for SDS‐3701 (R182281) in spring onions/welsh onions, cucurbits‐edible peel, cauliflower, Brussels sprouts, head cabbage, fresh legumes (beans and peas with pods, beans and peas without pods), asparagus, pulses (beans without pods, chickpeas), barley, oats, wheat, rye, triticale.

OXON Italia S.p.A. submitted information to address the confirmatory data requirements for metabolite SDS‐3701: residue trials were submitted for melon, cucumber/courgette, peas and sugar beet for GAPs which were less critical compared to the authorised EU GAPs assessed during the Article 12 review (EFSA, 2012).

UPL Europe Ltd. (formerly Arysta LifeScience SAS) submitted residue data on wheat, barley, tomatoes and dry peas (pulses) to address the confirmatory data requirements for the metabolite SDS‐3701; the data on wheat, barley and tomatoes were already assessed during the renewal process (EFSA, 2018a).

The RMS assessed the relevant information in an evaluation report, which was submitted to the European Commission and forwarded to EFSA on April 2018 (Netherlands, 2018).

EFSA proceeded with the assessment of the application and confirmatory data as requested by the European Commission in accordance with Article 9 of the Regulation. During the detailed assessment, EFSA identified points which needed further clarifications. In response to the clock‐stop letter, on 16 January 2020, the RMS submitted a revised evaluation report which addressed the points for clarification.

In the framework of the process on the renewal of the approval of chlorothalonil, a number of data gaps relevant for the consumer risk assessment were identified (data to elucidate the toxicological profile of the metabolite SDS‐3701 (R182281), R613636 and R417888 were missing, and consequently, definitive residue definitions for risk assessment in plant and animal commodities could not be derived) (EFSA, 2018a).

On 29 April 2019, a decision on the non‐renewal of the approval of chlorothalonil under Regulation (EC) No 1107/2009 was taken.3 Following the decision on the non‐renewal of the approval, the EU uses of plant protection products containing chlorothalonil had to be withdrawn by 20 November 2019 (period of grace according to Article 46 of Regulation (EC) No 1107/2009: 20 May 2020). Considering the new situation for EU authorisations, the data gaps related to the EU uses (i.e. data gaps 7 and 9 to 15 and partially data gaps 2 and 4 to 6) became obsolete.

EFSA therefore focused in this assessment on the import tolerance for banana, papaya and peanuts and the generic data gap on analytical method, storage stability and the data gap on the magnitude of SDS‐3701 in processed commodities that have been subject to high temperatures, which are also relevant for the import tolerance requests. For certain crops for which confirmatory data were requested, Codex MRLs are in place. EFSA also provided information to risk managers on the existing Codex MRLs. It should be highlighted that the purpose of the current assessment was not the assessment of data gaps identified in the renewal process that lead to the non‐renewal of the approval. However, to provide a comprehensive view and allow risk managers to take an informed decision, EFSA noted the relevance of the data gaps for the uses assessed, where relevant.

EFSA based its assessment on the evaluation report and additional information provided in response to the clock‐stop letter submitted by the RMS (Netherlands, 2018), the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 and additional assessments of chlorothalonil performed after the MRL review (EFSA, 2015, 2018a).

The evaluation of confirmatory data was performed in accordance with the procedure set out in the Commission Staff Working Document SANTE/10235/2016 (European Commission, 2020). For this application, the data requirements established in Regulation (EU) No 544/20114 and the relevant guidance documents at the date of implementation of the confirmatory data requirements by Regulation (EU) No 1146/2014 are applicable.

An updated list of end points, including the end points of relevant studies assessed previously and the confirmatory data evaluated in this application, is presented in Appendix B.

The evaluation report submitted by the RMS (Netherlands, 2018) is considered as a supporting document to this reasoned opinion and, thus, is made publicly available as a background document to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

Not relevant for the current assessment.

1.1.2. Nature of residues in rotational crops

No confirmatory data were requested in the MRL review.

1.1.3. Nature of residues in processed commodities

No confirmatory data were requested in the MRL review.

In the framework of the renewal process, potentially genotoxic degradation products were identified (SDS‐3701 (R182281) and SDS‐47525 (R613636)) which are formed under processing conditions employing temperatures representative for baking/brewing/boiling and sterilisation. The genotoxic potential for both degradation products has not been adequately addressed (EFSA, 2018a).

For import tolerance applications in commodities that are likely to undergo processing (pasteurisation, baking/brewing/boiling and sterilisation at slightly acidic pH), the data gap on the degradation products R613636 and SDS‐3701 should be addressed by providing the relevant toxicological studies or by providing evidence that these degradation products are not formed.

Lacking this information, a final conclusion on the residue definition for processed products cannot be derived.

1.1.4. Methods of analysis in plants

Chlorothalonil: no data gap/no confirmatory data requirement.

Metabolite SDS‐3701: Studies for addressing the data gap number (1)5 were assessed in the framework of the renewal of the approval of chlorothalonil (EFSA, 2018a). It was concluded that the analytical enforcement method (LC‐MS/MS) was sufficiently validated for the determination of SDS‐3701 residues in all crop groups at an LOQ of 0.01 mg/kg, except in dry and high oil content commodities where a data gap regarding extraction efficiency was noted. Details on the analytical method are presented in Appendix B.1.1.1. In the framework of the current assessment, information on the extraction efficiency for dry and high oil content commodities has not been submitted.

For the import tolerance requests for banana and papaya sufficiently validated analytical methods are available for both residue definitions (chlorothalonil and SDS‐3701). For peanuts, belonging to the matrix class of high oil content, validated analytical methods are available to determine residues of chlorothalonil; as regards the method for the determination of SDS‐3701, further data on the extraction efficiency are still required.

1.1.5. Storage stability of residues in plants

Chlorothalonil: the studies addressing data gap number (8)6 were assessed in the framework of the renewal of the approval of chlorothalonil (EFSA, 2018a). Chlorothalonil was demonstrated to be stable in high acid content matrices for at least 24 months when stored at ≤ −18°C. EFSA concludes that the data gap is sufficiently addressed.

Metabolite SDS‐3701: studies addressing data gap number (3)7 were assessed in the framework of the renewal of the approval of chlorothalonil (EFSA, 2018a). Metabolite SDS‐3701 was considered stable for 24 months in commodities with high oil, high starch and high acid content when stored ≤ −18°C. The stability of SDS‐3701 in high water content commodities varies depending on the crop and ranged from less than 3 months in onions to 24 months in tomatoes. The results of these studies are considered sufficiently representative also for processed commodities with similar matrix characteristics.

EFSA concluded that the data gap identified in the framework of the MRL review has been addressed.

1.1.6. Proposed residue definitions

In the framework of MRL review (EFSA, 2012), the following residue definitions were derived for unprocessed plant commodities:

Residue definitions 1 and 2 for enforcement and risk assessment:

Residue definition 1: chlorothalonil;
Residue definition 2: R182281 (SDS‐3701).

In Regulation (EC) No 396/2005 currently the residue definition for plant commodities is only parent chlorothalonil. Since no data on the residue levels expected for SDS‐3701 were available at the time of the MRL review, residue definition 2 has not been implemented in the EU MRL legislation.

It is noted that in the framework of the renewal of chlorothalonil (EFSA, 2018a), additional considerations on the setting of residue definitions were made, leading to proposals of the following provisional residue definitions:

Residue definition for monitoring/enforcement

Residue definition for risk assessment

Primary crop