Modification of the existing maximum residue levels for sulfoxaflor in various crops

Abstract

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Dow AgroSciences submitted an application to the competent national authority in Ireland (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in cauliflowers, Brussels sprouts, kales, beans (without pods), peas (with pods), spinaches and similar leaves (except spinaches), herbs and edible flowers (except celery leaves), rye, oats and wheat (triticale) and in limes imported from Australia. 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 2017. The EMS proposed to establish an MRL for limes imported from Australia as 0.5 mg/kg and proposed to modify the existing MRLs as follows:

for cauliflowers from 0.04 mg/kg to 0.1 mg/kg, for Brussels sprouts from the limit of quantification (LOQ) of 0.01 mg/kg to 0.015 mg/kg, for kales from the LOQ of 0.01 mg/kg to 1 mg/kg; for the whole group spinaches and similar leaves (except spinaches) from the LOQ 0.01 mg/kg to 0.2 mg/kg, for the whole group of herbs and edible flowers (except celery leaves) from the LOQ of 0.02 mg/kg to 0.2 mg/kg; for beans (without pods) from the LOQ 0.01 mg/kg to 0.03 mg/kg, for peas (with pods) form the LOQ of 0.01 mg/kg to 0.15 mg/kg. Finally, the EMS proposed to raise the existing MRL for oat from 0.04 mg/kg to 0.06 mg/kg, for rye from 0.015 mg/kg to 0.03 mg/kg and for triticale from the LOQ 0.01 mg/kg to 0.03 mg/kg. EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps or points which needed further clarification, which were requested from the EMS. On 14 September 2018, the EMS submitted a revised evaluation report, 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 under 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 was investigated in primary crops belonging to the groups of fruit crops, root crops, leafy crops, cereals and pulses/oilseeds following foliar or soil application and in rotational crops (root/tuber crops, leafy crops and cereals) following application of sulfoxaflor to bare soil. Studies investigating the effect of processing of both sulfoxaflor and the plant metabolite X11719474 (hydrolysis studies) demonstrated that the substances are stable under standard hydrolysis conditions.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological significance of metabolite X11719474, the peer review derived the residue definitions for plant products as ‘sulfoxaflor (sum of isomers)’ for enforcement and ‘sum of sulfoxaflor and the metabolite X11719474, expressed as sulfoxaflor’ for risk assessment. These residue definitions are appropriate for primary crops including the crops under assessment and the processed products.

Sufficiently validated analytical methods are available to quantify residues according to the enforcement residue definition for the crops under consideration. The methods enable quantification of residues at or above 0.01 mg/kg (LOQ).

The available residue trials are sufficient to derive MRL proposals for all the crops assessed in this opinion.

Studies investigating the effect of processing on the magnitude of residues in cereals and citrus are available. Due to the limited data set, the processing factors (PF) derived for cereals and citrus are not recommended to be included in Annex VI of Regulation (EC) No 396/2005. For the remaining commodities, specific processing studies were not provided and are not required.

The occurrence of residues in rotational crops was investigated in the framework of the European Union (EU) pesticides peer review. Based on the available information, EFSA could not exclude that the use of sulfoxaflor according to the intended good agricultural practice (GAP) will result in significant residues of its metabolite X11719474 in rotational corps, particularly in feed items. When the new uses are authorised at national level, Member States should consider the need of setting specific risk mitigation measures to avoid the presence of the metabolite in rotational crops.

As several crops under consideration and their by‐products are used as feed item, a potential carry‐over into 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 animal species. However, considering that the Codex maximum residue levels (CXL) implemented in the MRL legislation were based on higher estimates compared to the dietary burdens obtained with the EU uses, EFSA concluded that a revision of the existing MRLs for commodities of animal origin is not necessary.

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 toxicological reference values of parent compound also apply to the metabolite X11719474 included in the residue definition for risk assessment.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA concluded that the use of sulfoxaflor according to the intended good agricultural practices will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to present 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 the request to assess the application on the modification of the existing maximum residue levels (MRLs) for sulfoxaflor in various crops, including limes imported from Australia. The detailed description of the intended European Union (EU) uses and the use on limes in Australia, which are the basis for the current MRL application on sulfoxaflor, is reported in Appendix A. In Australia, sulfoxaflor is authorised for the use on citrus fruits and a MRL of 0.7 mg/kg is established based on the residue definition for enforcement as ‘parent sulfoxaflor’.

Sulfoxaflor is the ISO common name for methyl(oxo){1‐[6‐(trifluoromethyl)‐3‐pyridyl]ethyl}‐λ6‐sulfanylidene]cyanamide (IUPAC). It is a mixture of two diastereomeric pairs of enantiomers in the range of 40:60 to 60:40% (w/w). The chemical structures of the active substance and its main metabolite are reported in Appendix E.

Sulfoxaflor was evaluated in the framework of Regulation (EC) No 1107/2009¹ with Ireland designated as rapporteur Member State (RMS). The representative uses assessed were foliar spraying treatments on fruiting vegetables, 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 (2014). Sulfoxaflor was approved² for the use as an insecticide on 18 August 2015. When granting national authorisations, Member States have to consider risk mitigation measures related to the risk for bees, bumble bees and other non‐target arthropods.

The European Union (EU) MRLs for sulfoxaflor have been assessed in the framework of the peer review established in Annex II of Regulation (EC) No 396/2005³. After the finalisation of the peer review, EFSA has issued one reasoned opinion on the modification of MRLs for sulfoxaflor on grape leaves and globe artichokes; the proposed MRLs have been considered in the EU MRL legislation.⁴ In 2017, certain Codex maximum residue limits (CXLs) have been implemented in Regulation (EU) 2017/405⁵.

In accordance with Article 6 of Regulation (EC) No 396/2005, Dow AgroSciences submitted an application to the competent national authority in Ireland (EMS) to modify the existing MRLs 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 EFSA on 7 April 2017. The EMS proposed to raise the existing MRL for sulfoxaflor for cauliflowers from 0.04 mg/kg to 0.1 mg/kg, for Brussels sprouts from the limit of quantification (LOQ) of 0.01 mg/kg to 0.015 mg/kg, for kales from the LOQ of 0.01 mg/kg to 1 mg/kg; for the whole group spinaches and similar leaves (except spinaches) from the LOQ 0.01 mg/kg to 0.2 mg/kg, for the whole group of herbs and edible flowers (except celery leaves) from the LOQ of 0.02 mg/kg to 0.2 mg/kg; for beans (without pods) from the LOQ 0.01 mg/kg to 0.03 mg/kg, for peas (with pods) form the LOQ of 0.01 mg/kg to 0.15 mg/kg. Finally, the EMS proposed to raise the existing MRL for oat from 0.04 mg/kg to 0.06 mg/kg, for rye from 0.015 mg/kg to 0.03 mg/kg and for triticale from the LOQ 0.01 mg/kg to 0.03 mg/kg. EFSA identified data gaps or points which needed further clarification, which were requested from the EMS. On 14 September 2018, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report.

EFSA based its assessment on the revised evaluation report submitted by the EMS (Ireland, 2018), 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, 2014) as well as the conclusions from a previous EFSA opinion on sulfoxaflor (EFSA, 2017).

For this application, the data requirements established in Regulation (EU) No 544/2011⁶ and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017; OECD, 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 546/2011⁷.

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, are presented in Appendix B.

The revised evaluation report submitted by the EMS (Ireland, 2018) 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

3. Consumer risk assessment

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population (EFSA, 2007).

The estimated exposure was then compared with the acceptable daily intake (ADI) of 0.04 mg/kg body weight (bw) per day and the acute reference dose (ARfD) of 0.25 mg/kg bw derived for sulfoxaflor (European Commission, 2015). The EU pesticides peer review agreed to apply the toxicological reference values of the parent to the metabolite X11719474 (EFSA, 2014).

The most recent long‐term exposure assessment performed by EFSA (EFSA, 2017) was updated with the median residue values (STMR) derived from the residue trials submitted in support of this MRL application. The short‐term exposure was conducted only with regards to the crops under consideration, using the highest and median values in accordance with the internationally agreed methodology. The input values used for the dietary exposure calculation are summarised in Appendix D.

No long‐term intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The estimated long‐term dietary intake was in the range of 1.5–12% of the ADI (NL children diet). The contribution of the residues expected in the crops under consideration to the total exposure accounted individually for a maximum of 0.2% of ADI (rye). The short‐term exposure did not exceed the ARfD for any the crops considered in this application.

In the EU pesticides peer review, a theoretical factor of 2 was applied to the risk assessment in order to accommodate for the lack of information on the ratio of the enantiomers present in the individual diastereomers of sulfoxaflor and X11719474 (EFSA, 2014). Following this approach, the margin of safety of the exposure calculation is still sufficiently large to conclude that the assessed uses are unlikely to present a consumer health concern.

For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar leaves, herbs and edible flowers, beans without pods, peas with pods, oat, rye and triticale (wheat). EFSA concluded that the use of sulfoxaflor according to the intended good agricultural practices is unlikely to present a risk to consumers’ health.

The MRL recommendations are summarised in Appendix D.

Abbreviations

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

Appendix B – List of end points

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

Appendix E – Used compound codes

1.

Code/trivial namea	IUPAC name/SMILES notation/InChiKeyb	Structural formulac
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

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.

^aThe metabolite name in bold is the name used in the conclusion.

^bACD/Name 2015 ACD/Labs 2015 Release (File version N20E41, Build 75170, 19 December 2014).

^cACD/ChemSketch 2015 ACD/Labs 2015 Release (File version C10H41, Build 75059, 17 December 2014).

Notes

Suggested citation: EFSA (European Food Safety Authority) , Abdourahime H, Anastassiadou M, Brancato A, Brocca D, Carrasco Cabrera L, De Lentdecker C, Ferreira L, Greco L, Jarrah S, Kardassi D, Leuschner R, Lostia A, Lythgo C, Medina P, Miron I, Molnar T, Nave S, Pedersen R, Raczyk M, Reich H, Ruocco S, Sacchi A, Santos M, Stanek A, Sturma J, Tarazona J, Theobald A, Vagenende B, Verani A and Villamar‐Bouza L, 2019. Reasoned opinion on the modification of the existing maximum residue levels for sulfoxaflor in various crops. EFSA Journal 2019;17(1):5587, 31 pp. 10.2903/j.efsa.2019.5587 [PMC free article] [PubMed] [CrossRef]

Requestor: European Commission

Question number: EFSA‐Q‐2017‐00284

Approved: 20 December 2018

Notes

References