Setting of import tolerances for sulfoxaflor in various crops

Abstract

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Dow AgroSciences Ltd submitted an application to the competent national authority in Greece (evaluating Member State, EMS) to set import tolerances for the active substance sulfoxaflor in various crops. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 7 April 2022. The EMS proposed to establish maximum residue levels (MRLs) for cane fruits, blueberries, avocados, mangoes, pineapples, asparagus, globe artichokes, sunflower seeds and coffee beans imported from the USA, Vietnam and Kenya at the levels of 1.5 mg/kg, 2.0 mg/kg, 0.15 mg/kg, 0.3 mg/kg, 0.09 mg/kg, 0.015 mg/kg, 0.9 mg/kg, 0.4 mg/kg, 0.3 mg/kg, respectively.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points in need of further clarification, which were requested from the EMS. On 15 February 2023, the EMS submitted the requested information and a revised evaluation report (Greece, 2022), which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, the data evaluated in previous MRL assessments and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of sulfoxaflor following foliar and soil applications was investigated in crops belonging to the groups of fruit crops, leafy crops, cereals and pulses/oilseeds. After foliar applications, parent sulfoxaflor was the most significant residue (16–71% of total radioactive residue (TRR)) with the metabolite X11719474 as a major metabolite in mature crops (7–30% TRR). After soil applications, sulfoxaflor was present in a much lower proportion (up to 18% TRR in fruit crops and below 1% TRR in leafy crops) or not even detected (pulses and cereals) and the metabolite X11719474 was the major residue (31–90% TRR). No significant shift was reported for the diastereomer ratios of sulfoxaflor and X11719474.

Studies investigating the effect of processing on the nature of sulfoxaflor (hydrolysis studies) demonstrated that the sulfoxaflor and metabolite X11719474 are stable. Investigations of residues in rotational crops are not required because the authorised uses of sulfoxaflor are on imported crops.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies and the toxicological relevance of metabolites, the residue definitions for plant products were proposed as ‘sulfoxaflor (sum of isomers)’ for enforcement and ‘sum of sulfoxaflor and metabolite X11719474, expressed as sulfoxaflor’ for risk assessment. These residue definitions are applicable to primary crops and processed products.

EFSA concluded that for the crops assessed in this application, the metabolism of sulfoxaflor in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectrometry detection (HPLC–MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. In the framework of this assessment, the EMS proposes the QuEChERS EN 15662 method (LC–MS/MS) to be used for enforcement purposes in difficult matrices (coffee, tea, tobacco and hops). The method has been sufficiently validated for the determination of sulfoxaflor and metabolite X11719474 in these matrices, at the LOQ 0.01 mg/kg for individual analytes and an independent laboratory validation (ILV) was provided for coffee, tea and hops.

The available residue trials are sufficient to derive MRL proposals of 1.5 mg/kg for cane fruits, of 2.0 mg/kg for blueberries, of 0.15 mg/kg for avocados, of 0.3 mg/kg for mangoes, of 0.09 mg/kg for pineapples, of 0.015 mg/kg for asparagus, of 0.9 mg/kg for globe artichokes, of 0.4 mg/kg for sunflower seeds and of 0.3 mg/kg for coffee beans.

Specific studies investigating the magnitude of sulfoxaflor residues in processed commodities are in principle not required because the individual contribution of the crops assessed in this application to the total theoretical maximum daily intake (TMDI) is well below 1% of the ADI.

Nevertheless, several processing studies were provided to investigate the effect of processing on the magnitude of sulfoxaflor residues in processed commodities of pineapples, sunflower seeds and coffee beans and in mangoes pulp. The number of processing studies was insufficient to derive robust processing factors, except for avocados, where the derived processing factor is recommended to be included in Annex VI of Regulation (EC) No 396/2005:

PF according to the residue definition for monitoring:

• –
  Avocado/pulp: 0.63.

PF according to the residue definition for risk assessment:

• –
  Avocado/pulp: 0.75.

As sunflower seeds and/or their by‐products can be used as feed products, a potential residue carry‐over into the food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg dry matter (DM) for all relevant species/animal species. However, the contribution of sulfoxaflor residues in sunflower seeds to the total livestock exposure was insignificant, and therefore, a modification of the existing MRLs for commodities of animal origin was considered unnecessary.

The toxicological profile of sulfoxaflor was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.04 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.25 mg/kg bw. The metabolites included in the residue definition are of similar toxicity as the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure did not exceed the ARfD for any of the crops assessed in this application and ranged from 0.012% ARfD for coffee beans up to 3.9% ARfD for mangoes. The highest estimated long‐term dietary intake accounted for 37% of the ADI (NL toddler diet) with contributions ranging between the crops under assessment from 0.01% of the ADI for asparagus (IE adult diet) and avocados (GEMS/Food G11 diet), respectively, up to 0.61% ADI (FI adult diet) for coffee beans.

EFSA concluded that the existing and the authorised uses assessed under the present application will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

EFSA proposes to amend the existing MRLs as reported in the summary table below. Full details of all end points and the consumer risk assessment can be found in Appendices B–D.

Assessment

The European Food Safety Authority (EFSA) received an application to set an import tolerance for the active substance sulfoxaflor in various crops. The detailed description of the existing uses of sulfoxaflor authorised in Kenya, the United States of America and Vietnam in various crops, which is the basis for the current MRL application, is reported in Appendix A.

Sulfoxaflor is the ISO common name for methyl(oxo){1‐[6‐(trifluoromethyl)‐3‐pyridyl]ethyl}‐λ6‐sulfanylidene]cyanamide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Sulfoxaflor was evaluated in the framework of Regulation (EC) No 1107/2009 ¹ with Austria designated as rapporteur Member State (RMS) for the representative use(s) as a foliar treatment on fruiting vegetables, cucurbits, spring and winter cereals and cotton to control sap‐feeding insects. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (2014a)). Sulfoxaflor was approved ² for the use as insecticide on 18 August 2015. When granting national authorisations, Member States need to consider risk mitigation measures related to the risk for bees, bumble bees and other non‐target arthropods. Recently, approval restrictions ³ were agreed by risk managers that ‘only uses in permanent greenhouses may be authorised’ with a grace period of 19 May 2023 at the latest to allow withdrawal or amendment of authorisations for plant protection products containing sulfoxaflor that do not comply with the restricted conditions of approval.

EU MRLs for sulfoxaflor are established in Annex II of Regulation (EC) No 396/2005 ⁴ . A review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) is not required (EFSA, 2017c). Proposals for setting MRLs covering the representative uses according to good agricultural practices (GAP) in the EU were assessed during the approval of sulfoxaflor under Regulation (EC) No 1107/2009 and implemented in Regulation in accordance with Article 11(2) of the Regulation (EC) 1107/2009. EFSA has issued several reasoned opinions on the modification of MRLs for sulfoxaflor. The proposals from these reasoned opinions have been considered in recent MRL regulation. ⁵ Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation. The MRL proposals for sulfoxaflor in various crops as derived in the recent EFSA assessments (EFSA, 2019b, 2022a) have not been yet adopted in the EU MRL legislation but will nevertheless be considered in the present consumer risk assessment. The same refers to several CXL proposals which were evaluated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and are supported for the inclusion in the EU MRL legislation (EFSA, 2019c, 2022b; FAO, 2019, 2021, 2023).

In 2022, Codex Alimentarius Commission (CAC) adopted a number of Codex MRLs, some of them being higher than the existing EU MRLs (JMPR meeting 2021 (FAO, 2021)). As the EU did not express a reservation in the 53rd session of Codex Committee for Pesticide Residues (CCPR) (EFSA, 2022b; FAO, 2022, 2022), for the Codex MRL proposals and as no consumer exposure concerns were identified, the CXLs for asparagus, avocados, bush berries including blueberries, cane berries, coffee beans and mangoes are expected to be implemented in the EU legislation.

In accordance with Article 6 of Regulation (EC) No 396/2005, Dow AgroSciences Ltd submitted an application to the competent national authority in Greece (evaluating Member State, EMS) to set import tolerances for the active substance sulfoxaflor in various crops. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 7 April 2022. The EMS proposed to establish maximum residue levels (MRLs) for cane fruits, blueberries, avocados, mangoes, pineapples, asparagus, globe artichokes, sunflower seeds and coffee beans imported from Kenya, USA and Vietnam at the level of 1.5 mg/kg, 2.0 mg/kg, 0.15 mg/kg, 0.3 mg/kg, 0.09 mg/kg, 0.015 mg/kg, 0.9 mg/kg, 0.4 mg/kg, 0.3 mg/kg, respectively.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points that needed further clarification, which were requested from the EMS. On 15 February 2023, the EMS submitted the requested information and a revised evaluation report (Greece, 2022), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Greece, 2022), the DAR and its addendum (Ireland, 2012, 2014) prepared under Regulation (EC) 1107/2009, the Commission review report on sulfoxaflor (European Commission, 2015), the conclusion on the peer review of the pesticide risk assessment of the active substance sulfoxaflor (EFSA, 2014a), as well as the conclusions from previous EFSA opinions on sulfoxaflor (EFSA, 2017b, 2019b, 2022) and the EFSA reports based on JMPR assessments (EFSA, 2014b, 2015, 2017a, 2019c, 2022b).

For this application, the data requirements established in Regulation (EU) No 544/2011 ⁶ and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f–g, 2010, 2017, 2020, 2021; OECD, 2007, 2011, 2013). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 ⁷ .

A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously is presented in Appendix B.

The evaluation report submitted by the EMS (Greece, 2022) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1. Residues in plants

2. Residues in livestock

Sunflower seeds (meal) may be used for feed purposes. Hence, it was necessary to perform a dietary burden calculation for livestock to estimate whether the authorised use of sulfoxaflor on sunflower and residues in imported sunflower seeds would have an impact on the residues expected in food of animal origin. Therefore, the previous calculation was updated (EFSA, 2019a,b) with the risk assessment values as derived for sunflower seeds from the submitted residue trials.

The input values for the exposure calculations for livestock are presented in Appendix D.1. The results of the dietary burden calculation are presented in Section B.2 and demonstrated that the exposure of all animal species did not increase with the consideration of sunflower seeds of this assessment. Therefore, further consideration of residues in livestock were not considered necessary in the context of this application.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019a). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).

The toxicological reference values for sulfoxaflor used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2015). The metabolite included in the risk assessment residue definition was considered of similar toxicity to that of the parent compound (EFSA, 2014a).

The input values used in the exposure calculations are summarised in Appendix B.4.

4. Conclusion and recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for all crops under consideration: cane fruits, blueberries, avocados, mangoes, pineapples, asparagus, globe artichokes, sunflower seeds and coffee beans.

EFSA concluded that the proposed import tolerances for sulfoxaflor on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

The MRL recommendations are summarised in Appendix B.4.

Appendix A – Summary of intended GAP triggering the amendment of existing EU MRLs

Appendix B – List of end points

B.1. Residues in plants

B.1.1. Nature of residues and analytical methods for enforcement purposes in plant commodities

B.1.1.1. Metabolism studies, analytical methods and residue definitions in plants

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Fruit crops	Tomato	Foliar, 4 × (200) + (200) + (125) + (75) g/ha	Immature plant (14 DAT1; 14 DAT2), fruit (1, 7, 14 DALA), vines (14 DALA)	Radiolabelled active substance: [14C‐pyridine]‐sulfoxaflor at 1:1 diastereomer mixture. Ratio of isomers in the individual diastereomer unknown (EFSA, 2014a)
			Soil, 2 × 225 g/ha	Immature plant (14 DAT1), fruit (14, 21, 28 DALA), vines (28 DALA)
	Leafy crops	Lettuces	Foliar, 3 × 200 g/ha	Immature plant (14 DAT1), mature plant (7 DALA)
			Soil, 2 × 225 g/ha	Immature plant (14 DAT1), mature plant (14 DALA)
	Cereals/grass	Rice	Foliar, 3 × (225) + (225) + (150)g/ha	Immature plant (14 DAT1), grain, straw hulls (at maturity)
			Soil, 1 × 400 g/ha, BBCH 13–14	Immature plant (14, 28 DAT), grain, straw, hulls (at maturity)
	Pulses/oilseeds	Snap Pea	Foliar, 3 × 200 g/ha	Immature plant (14 DAT1, 14 DAT2), pods, vines (at maturity)
			Soil, 1 × 450 g/ha	Immature plant (14 DAT1), pods, vines (at maturity)
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Radish	Bare soil, 1 × 600 g/ha	30, 120, 365	Radiolabelled active substance: [14C‐pyridine]‐sulfoxaflor at 1:1 diastereomer mixture. Ratio of isomers in the individual diastereomer unknown (EFSA, 2014a)
	Leafy crops	Lettuces	Bare soil, 1 × 600 g/ha	30, 120, 365
	Cereal (small grain)	Wheat	Bare soil, 1 × 600 g/ha	30, 120, 365
Processed commodities (hydrolysis study)	Conditions		Stable?		Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)		Yes		Radiolabelled active substance: [14C‐pyridine]‐sulfoxaflor and [14C‐pyridine]‐X11719474 (EFSA, 2014a)
	Baking, brewing and boiling (60 min, 100°C, pH 5)		Yes
	Sterilisation (20 min, 120°C, pH 6)		Yes

Open in a separate window

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Peaches	−20	22	Months	Sulfloxaflor, X11719474	EFSA (2014a)
		Globe artichokes	−20	735	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 735 days (24.5 months) (Greece, 2022)
		Asparagus	−20	304	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 304 days (Greece, 2022)
	High oil content	Soyabeans	−20	22	Months	Sulfloxaflor, X11719474	EFSA (2014a)
		Sunflower seeds	−20	736	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 736 days (24.5 months) (Greece, 2022)
	Dry/high starch	Wheat grain	−20	22	Months	Sulfloxaflor, X11719474	EFSA (2014a)
	High acid content	Oranges	−20	22	Months	Sulfloxaflor, X11719474	EFSA (2014a)
		Raspberry	−20	549	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 549 days (ca. 20 months) (Greece, 2022)
		Blackberry
		Blueberries	−20	756	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 756 days (25 months) (Greece, 2022)
	Other	Sunflower seeds, meal	−20	685	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 685 days (Greece, 2022)
		Sunflower seeds, refined oil	–20	696	Days	Sulfoxaflor, X11719474, X117121061	The study was terminated after 696 days (Greece, 2022)

Open in a separate window

B.1.2. Magnitude of residues in plants

B.1.2.1. Summary of residues data from the supervised residue trials

Commodity	Region (a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (b) (mg/kg)	STMR (c) (mg/kg)	CF (d)
Cane fruits	USA	Raspberries Mo: 0.236; 0.405; 0.443 0.536 RA: 0.245; 0.414; 0.457; 0.551 Blackberries Mo: 0.277; 0.490; 0.744 RA: 0.290; 0.505; 0.756 Combined data set Mo: 0.236; 0.277; 0.405; 0.443; 0.490; 0.536; 0.744 RA: 0.245; 0.290; 0.414; 0.457; 0.505; 0.551; 0.756 CFs: 1.04; 1.05; 1.02; 1.03; 1.03; 1.02; 1.01	Residue trials on raspberries and blackberries compliant with the authorised GAP. Underlined trials were performed in Canada, the remaining trials in the USA. The residue data on raspberries and blackberries were combined; an extrapolation to the whole group of cane fruits is acceptable (European Commission, 2020a).	1.5	Mo: 0.74 RA: 0.756	Mo: 0.44 RA: 0.46	1.03
Blueberry	USA	Mo: 0.155; 0.170; 0.268; 0.298; 0.310; 0.387; 0.392; 0.418; 0.425; 1.27 RA: 0.164; 0.179; 0.277; 0.307; 0.319; 0.396; 0.408; 0.427; 0.442; 1.28 CFs: 1.06; 1.05; 1.03; 1.03; 1.03; 1.02; 1.04; 1.02; 1.04; 1.01	GAP compliant trials on blueberries. 0.025–0.25% adjuvant used in all trials. Underlined trials were performed in Canada, the remaining trials in the USA (Greece, 2022).	2.0	Mo: 1.27 RA: 1.28	Mo: 0.35 RA: 0.36	1.03
Avocados	USA	Mo: 0.0126 (e) ; 0.0186; 0.0490; 0.0501; 0.0659 (f) , RA: 0.0220 (e) ; 0.0279; 0.0583; 0.0594; 0.0752 (f) RA pulp: < 0.019; 0.0211; 0.436; 0.0204; 0.0341 (g); CFs: 1.75; 1.5; 1.19; 1.19; 1.14	Residue trials on avocado compliant with maximum annual application rate of 298 g a.s./ha according to GAP of 3 × 100 g a.s./ha; interval 7 days, PHI: 7 days. Each trial was performed using an adjuvant however the amount is not quantified. (f) Higher residue at PHI of 14 days (Greece, 2022).	0.15	Mo: 0.07 RA: 0.075 RApulp: 0.04	Mo: 0.05 RA: 0.06 RApulp: 0.02	1.19
Mangoes	Kenya	Mo: 0.027; 0.037; 0.039; 0.054; 0.103; 0.114 RA: 0.036; 0.046; 0.048; 0.063; 0.112; 0.123 CFs: 1.33; 1.24; 1.23; 1.17; 1.09; 1.08	GAP compliant trials on mangoes with restrictions on number of annual and consecutive applications according to GAP of 2 × 100 (90.9–100.9) g a.s./ha; interval 14 days, PHI: 3 days considering that an additional application at an early stage will not affect the final residue (Greece, 2022); Trials performed in Uganda (1); Ghana (2), Senegal (1) and in Kenya (2). Underlined values refer to the Kent variety; the remaining two values to the apple variety [for information: For the Kent variety, the pit was 9% of the total fruit weight; for the apple variety 7%.] (Greece, 2022). The data on pulp available from two trials but not sufficient to derive RA values for the pulp (Table B.1.2.3).	0.30	Mo: 0.11 RA: 0.12	Mo: 0.05 RA: 0.06	1.2
Pineapples	USA	Mo: 0.011; 0.0117 (f) ; 0.020; 0.0202 (h) ; 0.0220 (h) ; 0.0270 (h) ; 0.030; 0.034; 0.035 (h) ; 0.0417; 0.0513; 0.057 RA: 0.020; 0.0211 (f) ; 0.029; 0.0296 (h) ; 0.0314 (h) ; 0.0363 (h) ; 0.039; 0.043; 0.044 (h) ; 0.0511; 0.0607; 0.066 CFs: 1.82; 1.80; 1.45; 1.47; 1.43; 1.34; 1.3; 1.26; 1.26; 1.23; 1.18; 1.16	GAP compliant trials on pineapples with restrictions on number of annual and consecutive applications according to GAP of 2 × 100 (98–103.5) g a.s./ha; interval 14 days, PHI: 7 days; Trials No 1, 3, 7 and 8 were performed in the USA with 0.1% adjuvant and trials 9, 10, 11 and 12 with 0.125% adjuvant, respectively. The remaining trials were performed in Costa Rica with 0.1% adjuvant added (Greece, 2022).	0.09	Mo: 0.057 RA: 0.066	Mo: 0.029 RA: 0.038	1.32
Asparagus	USA	Mo: 5 × < 0.01; 0.01063 RA: 5 × < 0.019; 0.0196 CFs: 5 × 1; 1.84	GAP compliant trials on asparagus with restrictions on number of annual and consecutive applications according to GAP of 3 × 100 (99.8–105.4) g a.s./ha; interval 6–8 days, PHI: 126–302 days; The trials were performed in the USA with 0.25% adjuvant added to three trials. Three trials with residues below the LOQ had added adjuvant of 0.04%, 0.07% and 0.3% adjuvant added (Greece, 2022).	0.20	Mo: 0.01 RA: 0.02	Mo: 0.01 RA: 0.02	1
Globe artichokes	USA	Mo: 0.217; 0.226; 0.260; 0.41 RA: 0.226; 0.235; 0.269; 0.416 CFs: 1.04; 1.04; 1.03; 1.01	GAP compliant trials on globe artichokes with restrictions on number of annual and consecutive applications according to GAP of 3 × 100 (98.2–104) g a.s./ha; interval 7–9 days, PHI: 3 days. The trials were performed in the USA with adjuvants ranging from 0.06% to 0.63%, except the 4th trial which was done in Canada with 0.25% adjuvant (Greece, 2022).	0.90	Mo: 0.41 RA: 0.42	Mo: 0.24 RA: 0.25	1.04
Sunflower seeds	USA	Mo: < 0.01; 0.014; 0.0185; 0.024; 0.047; 0.076 (f) ; 0.091; 0.149; 0.190 RA: < 0.019; 0.023; 0.0275; 0.033; 0.056; 0.085 (f) ; 0.100; 0.158; 0.199 CFs: 1; 1.64; 1.49; 1.38; 1.19; 1.12; 1.10; 1.06; 1.05	GAP compliant trials on sunflower seeds with restrictions on number of annual applications according to GAP of 2 × 100 (98.6–107.5) g a.s./ha; interval 7 days, PHI: 14–15 days; (f) residue at PHI of 21 day. The trials were performed in the USA with adjuvants ranging from 0.06% to 1% (Greece, 2022).	0.40	Mo: 0.19 RA: 0.199	Mo: 0.047 RA: 0.056	1.12
Coffee beans	Vietnam	Mo: < 0.01; 2 × 0.01;0.01 (f) ; 0.03 (f) ; 0.04 (f) ; 0.05; 0.06; 0.09 (f) ; 0.15 RA: < 0.019; 2 × 0.019; 0.019 (f) ; 0.039 (f) ; 0.049 (f) ; 0.059; 0.069; 0.099 (f) ; 0.16 CFs: 1; 3 × 1.9; 1.3; 1.23; 1.18; 1.15; 1.1; 1.07	GAP compliant trials on coffee beans (peeled and sun dried) according to GAP of 1 × 75 g a.s./ha; PHI: 3 days. (f) residue of 5th and 6th trial at PHI of 15 days, of 7th trial at PHI of 7 days and of 10th trial at PHI of 21 days (Greece, 2022).	0.30	Mo: 0.15 RA: 0.16	Mo: 0.035 RA: 0.044	1.2

Open in a separate window

MRL: maximum residue level; GAP: good agricultural practice; Mo: monitoring; RA: risk assessment.

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

^(a)NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials or Country code: if non‐EU trials.

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

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

^(d)Conversion factor (derived was the median value) to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

^(e)The 2nd application was 127 g a.s./ha and slightly above 25% deviation which is not considered as concern since the other two were 96 and 91 g a.s./ha, altogether not exceeding the annual limit of 300 g a.s./ha (Greece, 2022).

^(f)Higher residue at longer PHI.

^(g)The residue values for pulp refer to a PHI of 7 days because for avocados pulp, no information was available at the PHI of 14 days where higher residues were reported for whole fruits. A consideration of this value has no impact on the HR and STMR values.

^(h)Shorter PHI of 6 days.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

Processed commodity	Number of valid studies (a)	Processing Factor (PF)		CFP (b)	Comment/Source
		Individual values	Median PF
Avocados, pitted fruit with peel	5	Mo: 1.19; 1.16; 1.16; 1.09; 1.13 RA: 1.16; 1.14; 1.14; 1.05; 1.09	1.16	1	Greece (2022)
Avocados, pitted fruit with peel	5	Mo: 1.19; 1.16; 1.16; 1.09; 1.13 RA: 1.16; 1.14; 1.14; 1.05; 1.09	1.16	1	Greece (2022)
Avocado, pulp	5	Mo: 0.22; 0.40 (c) ; 0.63; 0.70; < 0.79 (d) RA: 0.34; 0.48 (c) ; 0.76; 0.75; < 0.83 (d)	0.63	1.2	Greece (2022)
Mango, pulp	2	Mo: < 0.09 (d) ; 1.03 RA: < 0.15 (d) ; 1.03	1	1	Tentative (e) (Greece, 2022)
Pineapple, peeled fruit	1	Mo: 0.155 RA: 0.204	0.155	1.3	Tentative (e) (Greece, 2022)
Pineapple, juice	1	Mo: 0.088 RA: 0.139	0.088	1.58	Tentative (e) (Greece, 2022)
Pineapple, wet bran	1	Mo: 0.101 RA: 0.152	0.10	1.5	Tentative (e) (Greece, 2022)
Sunflower, meal	1	Mo: < 0.71 RA: < 0.83	< 0.71	–	Tentative (e) (Greece, 2022) Residues in RAC: Mo: 0.014 mg/kg and RA: 0.023 mg/kg; in sunflower meal and refined oil: Mo: < 0.01 mg/kg; RA: < 0.019 mg/kg.
Sunflower, refined oil	1	Mo: < 0.71 RA: < 0.83	< 0.71	–
Coffee, roasted beans	2	Mo: 0.45; 0.49 RA: 0.45; 0.51	0.47	1.1	Tentative (e) (Greece, 2022)
Coffee, instant coffee	2	Mo: 2.8; 2.9 RA: 2.8; 2.8	2.9	1.0	Tentative (e) (Greece, 2022)

Open in a separate window

^(a)PF: processing factor; Mo: monitoring; RA: risk assessment. Studies with residues in the raw agricultural commodities (RAC) at or close to the LOQ were disregarded (unless concentration may occur).

^(b)Conversion factor for risk assessment in the processed commodity; median of the individual conversion factors for each processing residues trial.

^(c)The processing factor (PF) is based on residues in whole fruit and pulp at a PHI of 7 days by noting that higher residues were reported at a PHI of 14 days (see Table B.1.2.1) however for a PHI of 14 days, residue data for pulp were not reported.

^(d)Residues in pulp below the LOQ of 0.01 mg/kg for monitoring and below the LOQ of 0.019 mg/kg for risk assessment.

^(e)A tentative PF is derived based on a limited data set noting that for the current assessment, the data requirement according to Commission Regulation (EU) No 544/2011 apply (a balance study and at least 3 follow‐up processing studies are required). According to the new data requirements (Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, OJ L93, 3.4.2013 p. 1) however two processing studies with less than 50% divergence would be considered as sufficient.

B.3. Consumer risk assessment

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

Appendix E – Used compound codes

1.

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Sulfoxaflor	[methyl(oxo){1‐[6‐(trifluoromethyl)‐3‐pyridyl]ethyl}‐λ6‐sulfanylidene]cyanamide FC(F)(F)c1ccc(cn1)C(C)S(C)(=O) = NC#N ZVQOOHYFBIDMTQ‐UHFFFAOYSA‐N
X11719474	N N‐[methyl(oxo){1‐[6‐(trifluoromethyl)pyridin‐3‐yl]ethyl}‐λ6‐sulfanylidene]urea FC(F)(F)c1ccc(cn1)C(C)S(C)(=O) = NC(N) = O YLQFVPNHUKREEW‐UHFFFAOYSA‐N
X11721061	(1RS)‐1‐[6‐(trifluoromethyl)‐3‐pyridinyl]ethanol FC(F)(F)c1ccc(cn1)C(C)O JGVSFNXTWYOUFV‐UHFFFAOYSA‐N

Open in a separate window

IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^(a)The metabolite name in bold is the name used in the conclusion.

^(b)ACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 June 2020).

^(c)ACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 March 2021).

Notes

Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M and Verani A, 2023. Reasoned Opinion on the setting of import tolerances for sulfoxaflor in various crops. EFSA Journal 2023;21(6):8062, 44 pp. 10.2903/j.efsa.2023.8062 [CrossRef] [Google Scholar]

Requestor European Commission

Question number EFSA‐Q‐2022‐00436

Declarations of interest If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact ue.aporue.asfe@tnemeganamtseretni.

Acknowledgements EFSA wishes to thank Stathis Anagnos, Javier Martinez Perez, Andrea Mioč, Marta Szot, for the support provided to this scientific output.

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

Adopted: 23 May 2023

Notes

References