Focussed assessment of certain existing MRLs of concern for Spinosad

Abstract

In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for spinosad which might lead to consumers intake concerns on the basis of a new toxicological reference value established during the peer review and of the data currently available to EFSA. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for spinosad considering the new toxicological reference values and an acute risk could not be excluded for six commodities. Fall‐back MRLs for all six commodities were proposed on the basis of the data received under the present assessment.

Summary

Spinosad was firstly included in Annex I to Directive 91/414/EEC on 1 February 2007 by Commission Directive 2007/06/EC. After the first approval, EFSA published several reasoned opinions on the modifications of the existing maximum residue levels (MRLs), including the assessment of the all existing MRLs in compliance with Article 12(2) of Regulation (EC) No 396/2005 and the evaluation of confirmatory data addressing data gaps identified in the MRL review.

Spinosad was evaluated for renewal of approval in the framework of Commission Regulation (EC) No 1107/2009 and for the first time, a toxicological reference value for acute exposure of the substance was established. Potential exceedances of the threshold value considering the newly established acute reference dose (ARfD) were highlighted during the peer review.

EFSA therefore received on 23 June 2020, a mandate from the European Commission in accordance with Article 43 of Regulation (EC) No 396/2005 to perform a focussed review of the existing MRLs for spinosad taking into consideration the new toxicological reference value as proposed in the Conclusion and, in case of consumer intake concerns, to derive fall‐back MRLs that would not lead to unacceptable risk for consumers.

Subsequent to the request from the European Commission, EFSA performed a preliminary risk assessment of the existing EU MRLs for spinosad and for six plant commodities (sweet peppers, lettuces, escarole/broad leaved endives, spinaches, beet leaves (chards) and witloofs) an acute consumer intake concern could not be excluded when the new toxicological reference value was considered. Furthermore, a chronic intake concern was also identified. Therefore, EFSA asked Member States (MS) to provide fall‐back good agricultural practices (GAPs) with supporting residue data for those commodities for which the existing MRL leads to a potential acute intake concern.

To be noted that in the conclusion of the peer review, the residue definition for risk assessment was proposed to be extended by further components, pending the submission of additional data and its outcome. In accordance with the mandate, the focused assessment was carried out considering the residue definition for risk assessment as derived during the MRL review and the existing MRLs.

For this assessment, EFSA mainly relied on its previous reasoned opinions, its conclusion on the peer review and the evaluation reports provided by the MSs during the Member State consultation.

The residue data submitted by the MSs in support of the fall‐back GAPs were sufficient to derive fall‐back MRLs that are safe for consumers for all commodities of concern. Therefore, EFSA recommends that the national authorisations for sweet peppers, lettuce, escaroles, spinaches, beet leaves (chard) and witloofs are being modified in order to comply with the derived fall‐back MRLs.

Regarding all other MRLs that are currently in place for spinosad, acute intake calculations were below the ARfD. These MRLs are therefore not considered to be of concern for European consumers and further action is not required.

Nonetheless, EFSA underlines that these conclusions were reached while considering residues of only spinosyn A and D, and it may need to be reconsidered pending revision of the residue definition for risk assessment as proposed by the peer review in the framework of the renewal.

Background

Spinosad was first included in Annex I to Directive 91/414/EEC1 which entered into force on 1 February 2007 by Commission Directive 2007/06/EC2. In accordance with Commission Implementing Regulation (EU) No 540/20113, spinosad is approved under Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC. After the first approval, EFSA published several reasoned opinions on the modifications of the existing MRLs, including the assessment of the all existing MRLs in compliance with Article 12(2) of Regulation (EC) No 396/20054 and the evaluation of confirmatory data addressing data gaps identified in the MRL review (EFSA, 2012a,b, 2013, 2019a).

Spinosad was evaluated for renewal of approval in the framework of Commission Regulation (EC) No 1107/2009. On 03 May 2018, EFSA published its conclusion on the peer review of the pesticide risk assessment of the active substance spinosad (EFSA, 2018a). In the conclusion, the existing acceptable daily intake (ADI) was confirmed and an acute reference dose (ARfD) of 0.1 mg/kg body weight (bw) was proposed. Potential exceedances of the threshold value considering the newly established ARfD was highlighted during the peer review. The new endpoint has not yet been endorsed by risk managers given that the evaluation of the endocrine‐disrupting properties of spinosad is not yet completed.

On 19 June 2020, in accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to perform a focussed review of the existing maximum residue levels for spinosad taking into consideration the new toxicological reference value and to derive fall‐back MRLs, where appropriate, not leading to unacceptable risk for consumers. According to the mandate, the focused assessment was carried out considering the residue definition for risk assessment as derived during the MRL review and the existing MRLs legally implemented in the EU legislation.

To address the request from the European Commission, EFSA performed a preliminary risk assessment of the existing EU MRLs for spinosad and on 03 July 2020, EFSA asked Member States and UK5 to provide fall‐back GAP with supporting residue data for those commodities (sweet peppers, lettuces, escarole/broad leaved endives, spinaches, beet leaves (chards) and witloofs) for which, according to the preliminary risk assessment, the existing MRL leads to potential acute intake concerns.

All fall‐back data received by 04 September 2020 were compiled in a GAP overview file, evaluated and considered by EFSA during the drafting of the reasoned opinion. On the basis of the data received, EFSA prepared in October 2020 a draft reasoned opinion, which was circulated to Member States and UK for commenting via a written procedure. All comments received by 12 November 2020 were evaluated and considered by EFSA during the finalisation of the reasoned opinion.

Key supporting documents to this reasoned opinion are the evaluation reports (Belgium, 2020; Czech Republic, 2020; France, 2020; Germany, 2020; Greece, 2020; Italy, 2020; Netherlands, 2020; Portugal, 2020; Spain, 2020; United Kingdom, 2020), the GAP overview file summarising the fall‐back GAPs collected during the data call, the Member States and UK evaluation reports on the data call (EFSA, 2020a) and on the draft reasoned opinion (EFSA, 2020b), and the chronic and acute exposure calculations performed using the EFSA Pesticide Residues Intake Model (PRIMo), revision 3.1 (EFSA, 2018b, 2019b) (Appendix C). Therefore, also these documents are made publicly available.

The active substance and its use pattern

Spinosad is the ISO common name of a mixture of spinosyn A and spinosyn D (in a ratio between 95:5 and 50:50). The IUPAC names are as follows:

• 2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)‐2-(6-deoxy‐2,3,4‐tri-O‐methyl‐α‐L‐mannopyranosyloxy)‐13-(4‐dimethylamino‐2,3,4,6‐tetradeoxy‐β‐D‐erythropyranosyloxy)‐9-ethyl‐2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b‐hexadecahydro‐14-methyl‐1H‐as-indaceno[3,2‐d]oxacyclododecine‐7,15-dione (spinosyn A);

• 2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)‐2-(6-deoxy‐2,3,4‐tri-O‐methyl‐α‐L‐mannopyranosyloxy)‐13-(4‐dimethylamino‐2,3,4,6‐tetradeoxy‐β‐D‐erythropyranosyloxy)‐9-ethyl‐2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b‐hexadecahydro‐4,14-dimethyl‐1H‐as-indaceno[3,2‐d]oxacyclododecine‐7,15-dione (spinosyn D).

Molecular weight: 732.0 (spinosyn A); 746.0 (spinosyn D)

The chemical structure of the active substance is reported in Appendix E.

Spinosad is an active substance belonging to the spinosyn class of insecticides. The compound acts by contact and ingestion causing paralysis of the insect by activation of the nicotinic acetylcholine receptor, but at a different site than nicotine or the neonicotinoids. Spinosad is used in a wide range of crops for the control of different pests. Spinosad is also approved to be used as a biocide (product‐type 18, insecticides, acaricides and products to control other arthropods) according to Commission Directive 2010/72/EU6. Furthermore, spinosad is included in Annex II of Regulation (EC) No 889/20087 as a pesticide that may be used in organic farming.

The EU MRLs for spinosad are established in Annex II of Regulation (EC) No 396/2005. Codex maximum residue limits (CXLs) for spinosad were also established by the Codex Alimentarius Commission (CAC). The MRLs derived in the framework of the MRL review and in the following MRL applications (EFSA, 2012a,b, 2013) were legally implemented by Commission Regulation (EU) No 2015/6038. The EU MRLs for spinosad were not modified since the entry into force of the above‐mentioned regulation.

Assessment

For this assessment, EFSA mainly relied on its previous reasoned opinions, its conclusion on the peer review and the additional information provided by the MSs and UK during the Member State consultation (EFSA, 2012a,b, 2013, 2018a, 2019a,b, 2020a; Belgium, 2020; Czech Republic, 2020; France, 2020; Germany, 2020; Greece, 2020; Italy, 2020; Netherlands, 2020; Portugal, 2020 Spain, 2020; United Kingdom, 2020).

The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/20119 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017; OECD, 2011).

The focused assessment was carried out considering the residue definition for risk assessment as derived during the MRL review and the existing MRLs legally implemented in the EU legislation.

1. Identifying potential MRLs of concern and data call

In order to identify the potential MRLs of concern when considering the new toxicological reference values, EFSA performed a preliminary risk assessment (scenario 1) of the existing EU MRLs established in the Regulation (EC) 2015/603. The calculations are based on the residue levels in the raw agricultural commodities reported in the most recent EFSA reasoned opinion (2019a), except for cucurbits with inedible peel, where the relevant peeling factor was applied, and for spinaches, escaroles and chards for which the processing factor for spinach cooked leaves was used. The processing factors used in the assessment were established in the framework of the peer review (2018a) and are summarised in Appendix B.1.2. An overview of the input values considered in the preliminary assessment is given in Appendix D.

Chronic and acute exposure calculations were performed using revision 3.1 of the EFSA PRIMo. The exposures calculated were compared with the toxicological reference values for spinosad, derived by EFSA in the framework of the renewal for the approval of the active substance (EFSA, 2018a).

The highest chronic exposure was calculated for the Dutch toddler, representing 113% of the ADI. Main contributors of the exposure were milk (33%), maize/corn (20%) and spinach (15%). With regard to the acute exposure, an exceedance of the ARfD was identified for witloofs (boiled), escarole/broad leaved endives (boiled), chards/beet leaves (boiled), lettuces, spinaches and sweet peppers, representing 506%, 321%, 212%, 199%, 181% and 102% of the ARfD, respectively. The MRLs for escarole and witloof were based on existing CXLs.

With regard to the commodities where an acute risk was identified, a data call was launched to identify potential fall‐back GAPs. EFSA calculated for each crop concerned the residue concentration that would lead to an intake calculation equivalent to 100% of the ARfD. Table 1 gives an overview of the results of the preliminary acute risk assessment together with these indicative threshold levels derived by inverse modelling.

Table 1.

Overview of the MRLs for which acute risk to European consumers could not be excluded and fall‐back GAPs were requested

Commodity	Existing EU MRL (mg/kg)	HRa	HR	RAC	Processed (boiled)c
			Threshold levelb (mg/kg)	Acute intake (% ARfD)	Acute intake (% ARfD)
Sweet peppers/bell peppers	2	1.72	1.68	102%	–
Lettuces	10	5.24	2.63	199%	–
Escaroles/broad‐leaved endives	10	5.7	1.78	229%	321%
Spinaches	15	8.02	4.43	181%	112%
Chards/beet leaves	15	8.02	3.78	125%	212%
Witloofs	10	5.7	1.12	226%	506%

RAC: Raw agricultural commodity.

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

^bValue is derived by inverse modelling where the residue concentration is calculated that would lead to an intake calculation equivalent to 100% of the ARfD.

^cFor these commodities, the results of the acute intake calculations refer to the consumption of processed (boiled) commodities.

Regarding all other MRLs that are currently in place for spinosad, acute intake calculations were below the ARfD. These MRLs are therefore not considered to be of concern for European consumers and further action is not required.

2. Assessment of GAPs submitted during the data call

The results of the preliminary risk assessment indicated that for six commodities of plant origin (sweet peppers, escaroles, spinaches, lettuce, beet leaves (chard) and witloofs) the current MRL might pose an acute risk to European consumers (see Table 1). For these commodities, EFSA asked MSs to report fall‐back GAPs with supporting residue data.

Member States and UK reported several potential fall‐back GAPs in various climatic zones (EFSA, 2020a). EFSA prepared a GAP overview file summarising the GAPs collected during the data call.

In order to derive fall‐back MRLs and risk assessment values, EFSA considered the less critical GAPs reported during the MSC, as well as all residue trials evaluated in its previous reasoned opinions (EFSA, 2012a,b, 2013, 2019a), the residue trials evaluated in the framework of the peer review and additional data submitted during the data call by MSs and UK (Belgium, 2020; Czech Republic, 2020; EFSA, 2020a; France, 2020; Germany, 2020; Greece, 2020; Italy, 2020; Netherlands, 2020; Portugal, 2020 Spain, 2020; United Kingdom, 2020). Detailed results of the residue trials supporting the less critical GAPs and the derived risk assessment values are reported in Appendix B.1.1.

As the HR values for escaroles, spinaches, lettuce, beet leaves (chard) derived from the respective indoor GAPs exceeded the indicative threshold residue levels reported in Table 1, EFSA concluded these indoor GAPs cannot be considered to derive a fall‐back MRL. The uses for which a risk for consumers have been identified and the less critical GAPs further considered by EFSA to derive fall‐back MRLs are given in Appendix A.1 and Appendix A.2, respectively.

A second exposure calculation (scenario 2) was performed based on the same input values as in the scenario 1, except for the commodities for which an acute concern was identified. An overview of the input values considered in this second calculation is given in Appendix D.

According to the results of scenario 2, considering the most critical fall‐back residue data and excluding the existing CXLs for escaroles and witloofs, the highest chronic exposure declined to 95% of the ADI (Dutch toddler) and the highest acute exposure was calculated for Florence fennels (boiled), followed by lettuces, representing 90% and 88% of the ARfD, respectively.

Based on these refined calculations, EFSA concludes that no risk to consumers was identified.

Conclusions and recommendations

The residue data submitted by the MSs and UK in support of the fall‐back GAPs were sufficient to derive fall‐back MRLs that are safe for consumers for all commodities of concern. Therefore, EFSA recommends that the national authorisations for sweet peppers, lettuce, escaroles, spinaches, beet leaves (chard) and witloofs are being modified in order to comply with the derived fall‐back MRLs.

Regarding all other MRLs that are currently in place for spinosad, acute intake calculations were below the ARfD. These MRLs are therefore not considered to be of concern for European consumers and further action is not required.

Nonetheless, EFSA underlines that these conclusions were reached while considering residues of only spinosyn A and D, and it may need to be reconsidered pending revision of the residue definition for risk assessment as proposed by the peer review in the framework of the renewal.

A summary of the conclusions and recommendations is provided in Table 2.

Table 2.

Summary table

Code numbera	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			MRL (mg/kg)	Comment
Enforcement residue definition: Spinosad (spinosad, sum of spinosyn A and spinosyn D)F
0231020	Sweet peppers/bell peppers	2	0.6	Fall‐back MRL is proposedb
0251020	Lettuces	10	4	Fall‐back MRL is proposedb
0251030	Escaroles/broad‐leaved endives	10	3	Fall‐back MRL is proposedb
0252010	Spinaches	15	4	Fall‐back MRL is proposedb
0252030	Chards/beet leaves	15	4	Fall‐back MRL is proposedb
0255000	Witloofs/Belgian endives	10	0.02*	Fall‐back MRL is proposedb
–	Other products of plant and animal origin	See Regulation 2015/603	–	Existing MRLs can be maintainedc

MRL: maximum residue level.

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

^FThe residue definition is fat soluble.

^aCommodity code number, as listed in Annex I of Regulation (EC) No 396/2005.

^bThe existing EU MRL was identified as a potential MRL of concern. Data supporting a fall‐back MRL were submitted by MSs and no risk to consumers is identified for this fall‐back MRL.

^cThe existing EU MRL was not identified as a potential MRL of concern.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

Bw

body weight

CAC

Codex Alimentarius Commission

CF

conversion factor for enforcement residue definition to risk assessment residue definition

CS

capsule suspension

CXL

codex maximum residue limit

d

Day

DAR

Draft Assessment Report (prepared under Council Directive 91/414/EEC)

DAT

days after treatment

DB

dietary burden

DM

dry matter

FAO

Food and Agriculture Organisation of the United Nations

GAP

good agricultural practice

HR

highest residue

ISO

International Organisation for Standardization

IUPAC

International Union of Pure and Applied Chemistry

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

NEU

northern European Union

OECD

Organisation for Economic Co‐operation and Development

PF

processing factor

PHI

pre‐harvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

STMR

short‐term median residue

Appendix A – Good Agricultural Practices (GAPs) and residue trials considered by EFSA

A.1. Authorised uses for which a risk for consumers could not be excluded

Crop and/or situation	MS or country	F G or Ia	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
			Typeb	Conc. a.s.	Method kind	Range ofgrowth stages & seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Sweet peppers	IT	I	SC	480 g/L	Foliar treatment	61–71	1–3		–	–	0.43 kg a.i./ha	3	EFSA (2012a)
Lettuces	IT	I	SC	480 g/L	Foliar treatment – spraying	45	1–5		–	–	0.22 kg a.i./ha	3	EFSA (2012a)
Lettuces	IT, BE, UK, EL, NL	I	SC	480 g/L	Foliar treatment – spraying	13–49	1–3	7	–	–	0.096 kg a.i./ha	3
Escaroles	IT, EL	F	SC	480 g/L	Foliar treatment – spraying	10–49	1–3	7	–	–	0.096 kg a.i./ha	3
Escaroles	IT, BE, EL, NL	I	SC	480 g/L	Foliar treatment – spraying	10–49	1–3	7	–	–	0.096 kg a.i./ha	3
Spinaches	IT	F	SC	480 g/L	Foliar treatment – spraying	45	1–5		–	–	0.22 kg a.i./ha	3	EFSA (2012a)
Spinaches	UK, BE, IT, EL	I	SC	480 g/L	Foliar treatment – spraying		1–3	7	–	–	0.096 kg a.i./ha	3
Chards	IT	F	SC	480 g/L	Foliar treatment – spraying	45	1–5		–	–	0.22 kg a.i./ha	3	EFSA (2012a)
Chards	UK, BE	I	SC	480 g/L	Foliar treatment – spraying		1–3	7	–	–	0.096 kg a.i./ha	3

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide.

^cGrowth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

^dPHI – minimum preharvest interval.

A.2. Authorised uses considered to derive fall‐back GAPs

Crop and/or situation	MS or country	F G or Ia	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
			Typeb	Conc. a.s.	Method kind	Range of growth stages & seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Sweet peppers	EL, PT	F	SC	480 g/L	Foliar treatment – spraying	14–89	1–3	7	–	–	0.12 kg a.i./ha	3
Sweet peppers	EL, IT, PT, ES	I	SC	480 g/L	Foliar treatment – spraying		1–3	7	–	–	0.12 kg a.i./ha	3
Lettuces	FR, BE, NL	F	SC	480 g/L	Foliar treatment – spraying	10–49	1–3	7	–	–	0.096 kg a.i./ha	3	Same GAP as in MRL Review (EFSA, 2012a)
Lettuces	PT, ES	F	SC	480 g/L	Foliar treatment – spraying	13–49	1–3	7	–	–	0.12 kg a.i./ha	3
Escaroles	BE, NL	F	SC	480 g/L	Foliar treatment – spraying		1–3	7	–	–	0.096 kg a.i./ha	3	Same GAP as in MRL Review for FR (EFSA, 2012a)
Spinaches	BE, NL, UK	F	SC	480 g/L	Foliar treatment – general (see also comment field)		1–3	7	–	–	0.096 kg a.i./ha	3
Spinaches	EL/IT	F	SC	480 g/L	Foliar treatment – spraying	10–50	1–3	7	–	–	0.096 kg a.i./ha	3
Chards	UK, NL	F	SC	480 g/L	Foliar treatment – general (see also comment field)		1–3	7	–	–	0.096 kg a.i./ha	3
Chards	IT	F	SC	480 g/L	Foliar treatment – spraying	10–50	1–3	7	–	–	0.096 kg a.i./ha	3
Witloofs	NL	I	SC	480 g/L	Foliar treatment – spraying		1		–	–	0.24 g a.i./m2	18	Application rate: 0.24 g/m2; 1–3 L water/m2, Directly after filling forcing container (same GAP as in MRL Review; EFSA, 2012a)

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^cGrowth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

^dPHI – minimum preharvest interval.

Appendix B – List of end points

B.1. Magnitude of residues in plants

B.1.1. Summary of residues data from the supervised residue trials

Crop	Region/Indoora	Residue levels observed in the supervised residue trials relevant to the supported GAPs (mg/kg)	Recommendations/comments (OECD calculations)	Fall‐back MRL proposals (mg/kg)	HR (mg/kg)b	STMR (mg/kg)c
Sweet peppers/bell peppers	SEU	3 × 0.04; 2 × 0.05; 0.09; 0.14; 0.15; 0.17; 0.18	Trials on peppers compliant with the fall‐back GAP (EFSA, 2018a; Greece, 2020; Italy, 2020; Portugal, 2020) MRLOECD = 0.33	0.4	0.18	0.07
	EU	0.04; 0.05; 0.06; 0.07; 0.09; 0.11d; 0.11; 0.22; 0.29; 0.35	Trials on peppers compliant with the fall‐back GAP (EFSA, 2018a; Greece, 2020; Italy, 2020; Portugal, 2020; Spain, 2020) MRLOECD = 0.57	0.6	0.35	0.10
Lettuces	NEU	2 × 0.05; 0.07; 0.08; 0.10; 0.14; 0.2; 1.44	Trials on open leaf variety lettuce compliant with the fall‐back GAP (Belgium, 2020) MRLOECD = 2.17	3	1.44	0.09
	SEU	Lettuce (open leaf): 2 × 0.14; 0.20; 0.23; 0.51; 0.69; 0.74; 1.38; 1.46; 2.00 Spinaches: 1.03; 2.31	Trials on lettuces and spinaches with application rates within 25% deviation of the fall‐back GAP. (Greece, 2020; Italy, 2020; Portugal, 2020; Spain, 2020). Extrapolation to lettuces is possible MRLOECD = 3.88	4	2.31	0.72
	EU	Lettuce (open leaf): 0.71; 0.73; 2.21; 2.28; 2.4; 2.96; 3.34; 3.78; 4.07 Head lettuce: 1.16; 1.55; 2.30 Spinach: 2.48; 3.49; 4.40; 5.13	Trials on lettuces and spinaches application rates within 25% deviation. (Greece, 2020; Italy, 2020; Netherlands, 2020). Extrapolation to lettuces is possible. An acute intake concern is identified MRLOECD = 8.06	–	5.13	2.44
Escaroles/broad‐leaved endives	NEU	2 × 0.05; 0.07; 0.08; 0.10; 0.14; 0.2; 1.44	Trials on open leaf variety lettuce compliant with the fall‐back GAP (Belgium, 2020). Extrapolation to escarole is possible MRLOECD = 2.17	3	1.44	0.09
	SEU	Lettuce (open leaf): 2 × 0.14; 0.20; 0.23; 0.51; 0.69; 0.74; 1.38; 1.46; 2.00 Spinaches: 1.03; 2.31	Trials on lettuces and spinaches with application rates within 25% deviation (Greece, 2020; Italy, 2020; Portugal, 2020; Spain, 2020). Extrapolation to escarole is possible. An acute intake concern is identified MRLOECD = 3.88	–	2.31	0.72
	EU	Lettuces: 0.71; 0.73; 2.21; 2.28; 2.4; 2.96; 3.34; 3.78; 4.07 Spinach: 2.48; 3.49; 4.40; 5.13	Trials on open leaf var. lettuces and spinaches with application rates within 25% deviation (Greece, 2020; Italy, 2020; Netherlands, 2020). Extrapolation to escarole is possible. An acute intake concern is identified MRLOECD = 8.76	–	5.13	2.96
Spinaches, Chards/beet leaves	NEU	2 × 0.05; 0.07; 0.08; 0.10; 0.14; 0.2; 1.44	Trials on open leaf variety lettuce compliant with the fall‐back GAP (Belgium, 2020). Extrapolation to spinaches and chards is possible MRLOECD = 2.17	3	1.44	0.09
	SEU	Lettuce (open leaf): 2 × 0.14; 0.20; 0.23; 0.51; 0.69; 0.74; 1.38; 1.46; 2.00 Spinaches: 1.03; 2.31	Trials on lettuces and spinaches compliant with the fall‐back GAP (Greece, 2020; Italy, 2020; Portugal, 2020; Spain, 2020). Extrapolation to spinaches and chards possible MRLOECD = 3.88	4	2.31	0.72
	EU	Lettuces: 0.71; 0.73; 2.21; 2.28; 2.4; 2.96; 3.34; 3.78; 4.07 Spinach: 2.48; 3.49; 4.40; 5.13	Trials on open leaf var. lettuces and spinaches with application rates within 25% deviation (Greece, 2020; Italy, 2020; Netherlands, 2020). Extrapolation to spinaches and chards is possible. An acute intake concern is identified MRLOECD = 8.76	–	5.13	2.96
Witloofs/Belgian endives	EU	4 × < 0.02	Trials on witloofs compliant with the fall‐back GAP (EFSA, 2012a; Netherlands, 2020) MRLOECD = 0.02	0.02*	0.02	0.02

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

^aNEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non‐EU trials.

^bHighest residue.

^cSupervised trials median residue.

^dTrial result selected at a later sampling interval because it was higher than the trial result observed at the sampling interval compliant with GAP.

B.1.2. Processing factors

Processed commodity	Number of valid studiesa	Processing Factor (PF)		Comment/Source
		Individual values	Median PF
Melon, peeling factor	13	0.37, 0.44, 0.49, 0.56, 0.57, 0.59, 0.69, 0.71, 0.74, 0.74, 0.87, 0.95, 1.00	0.69	Netherlands (2018) Residues in pulp < LOQ of 0.02 mg/kg
Spinach, boiled	2	1.1; 0.6	0.9	EFSA (2018a) Extrapolation to escarole and chards

PF: Processing factor (=Residue level in processed commodity expressed according to RD‐Mo/Residue level in raw commodity expressed according to RD‐Mo).

^aStudies with residues in the RAC at or close to the LOQ were disregarded (unless concentration may occur).

B.2. Consumer risk assessment

ADI	0.024 mg/kg bw per day (EFSA, 2018a)
Highest IEDI, according to EFSA PRIMo vers.3.1	Scenario 1: without risk mitigation measures 113% ADI (NL toddler) Scenario 2: with risk mitigation measures 95% ADI (NL toddler)
Assumptions made for the calculations	Scenario 1: without risk mitigation measures The calculation is based on the median residue levels in the raw agricultural commodities, except for cucurbits with inedible peel, where a peeling factor of 0.69 was applied. Scenario 2: with risk mitigation measures The same calculation as in scenario 1, except for peppers, lettuce, escaroles, chards, spinaches and witloofs where the median residue levels are replaced by those resulting from the respective most fall‐back GAPs. The indoor GAPs on lettuces, escaroles, chards and spinaches submitted during the data collection were disregarded as the highest residue levels supporting the GAPs were higher than the respective values derived by inverse modelling not resulting in intake concern.
ARfD	0.1 mg/kg bw (EFSA, 2018a)
Highest IESTI, according to EFSA PRIMo	Scenario 1: without risk mitigation measures 506% ARfD (Witloofs/boiled) 321% ARfD (Escaroles/broad‐leaved endives/boiled) 212% ARfD (Chards/beet leaves/boiled) 199% ARfD (Lettuces) 181% ARfD (Spinaches) 102% ARfD (Sweet peppers/bell peppers) Scenario 2: with risk mitigation measures 90% ARfD (Florence fennels, boiled) 88% ARfD (lettuce)
Assumptions made for the calculations	Scenario 1: The calculation is based on the highest residue levels in the raw agricultural commodities, except for melons, where the relevant peeling factor, and spinach, escarole and chards for which the processing factor for the boiled processed commodities was applied, and for bulk commodities where the median residue levels were considered. Scenario 2: with risk mitigation measures The same calculation as in scenario 1, except for peppers, lettuce, escaroles, chards, spinaches and witloofs where the highest residue levels are replaced by those resulting from the respective most critical fall‐back GAPs. The indoor GAPs on lettuces, escaroles, chards and spinaches submitted during the data collection were disregarded as the highest residue levels supporting the GAPs were higher than the respective values derived by inverse modelling not resulting in intake concern.

ADI: acceptable daily intake; bw: body weight; IEDI: international estimated daily intake; PRIMo: (EFSA) Pesticide Residues Intake Model; WHO: World Health Organization; ARfD: acute reference dose; IESTI: international estimated short‐term intake.

B.3. Proposed MRLs

Code numbera	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			MRL (mg/kg)	Comment
Enforcement residue definition: Spinosad (spinosad, sum of spinosyn A and spinosyn D)F
0231020	Sweet peppers/bell peppers	2	0.6	Fall‐back MRL is proposedb
0251020	Lettuces	10	4	Fall‐back MRL is proposedb
0251030	Escaroles/broad‐leaved endives	10	3	Fall‐back MRL is proposedb
0252010	Spinaches	15	4	Fall‐back MRL is proposedb
0252030	Chards/beet leaves	15	4	Fall‐back MRL is proposedb
0255000	Witloofs/Belgian endives	10	0.02*	Fall‐back MRL is proposedb
–	Other products of plant and animal origin	See Regulation 2015/603	See Regulation 2015/603	Existing MRLs can be maintainedc

MRL: maximum residue level.

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

^FThe residue definition is fat soluble.

^aCommodity code number, as listed in Annex I of Regulation (EC) No 396/2005.

^bThe existing EU MRL was identified as a potential MRL of concern. Data supporting a fall‐back MRL were submitted by MSs and no risk to consumers is identified for this fall‐back MRL.

^cThe existing EU MRL was not identified as a potential MRL of concern.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

• PRIMo(scenario 1)

• PRIMo(scenario 2)

Appendix D – Input values for the exposure calculations

1.

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition:
Citrus fruits	0.01	STMR × eelF (EFSA, 2019a)	0.01	HR × PeelF (EFSA, 2019a)
Tree nuts	0.03	STMR (CXL) (EFSA, 2019a)	0.05	HR (CXL) (EFSA, 2019a)
Pome fruits	0.05	STMR (EFSA, 2019a)	0.15	HR (EFSA, 2019a)
Apricots, Peaches	0.21	STMR (EFSA, 2019a)	0.39	HR (EFSA, 2019a)
Cherries, Plums	0.03	STMR (CXL) (EFSA, 2019a)	0.11	HR (CXL)( EFSA, 2019a)
Table, wine grapes	0.08	STMR (CXL) (EFSA, 2019a)	0.39	HR (CXL) (EFSA, 2019a)
Strawberries	0.12	STMR (EFSA, 2019a)	0.24	HR (EFSA, 2019a)
Blackberries	0.35	STMR (EFSA, 2019a)	0.58	HR (EFSA, 2019a)
Dewberries	0.14	STMR (CXL)( EFSA, 2019a)	0.42	HR(CXL)( EFSA, 2019a)
Raspberries	0.35	STMR (EFSA, 2019a)	0.58	HR (EFSA, 2019a)
Other small fruits & berries	0.34	STMR (EFSA, 2019a)	0.66	HR (EFSA, 2019a)
Table olives	0.02	STMR (EFSA, 2019a)	0.02	HR (EFSA, 2019a)
Kiwi fruits	0.02	STMR (EFSA, 2019a)	0.05	HR (EFSA, 2019a)
Passion fruit	0.23	STMR (CXL) (EFSA, 2019a)	0.33	HR (CXL) (EFSA, 2019a)
Bananas	0.62	STMR (EFSA, 2019a)	0.85	HR (EFSA, 2019a)
Papayas	0.21	STMR (EFSA, 2019a)	0.23	HR (EFSA, 2019a)
Potatoes	0.02	STMR (EFSA, 2019a)	0.02	HR (EFSA, 2019a)
Radishes	0.08	STMR (EFSA, 2019a)	0.10	HR (EFSA, 2019a)
Garlic, Onions, Shallots	0.05	STMR (EFSA, 2019a)	0.05	HR (EFSA, 2019a)
Spring onions	0.20	STMR (CXL)( EFSA, 2019a)	1.50	HR (CXL)( EFSA, 2019a)
Tomatoes, Aubergines	0.25	STMR (EFSA, 2019a)	0.57	HR (EFSA, 2019a)
Peppers	0.33	STMR (EFSA, 2019a)	1.72	HR (EFSA, 2019a)
	0.1	STMR (Fall‐back)	0.35	HR (Fall‐back)
Cucurbits, edible peel	0.08	STMR (EFSA, 2019a)	0.17	HR (EFSA, 2019a)
Cucurbits, inedible peel	0.1	STMR (EFSA, 2019a) × PeelF (EFSA, 2018a)	0.44	HR (EFSA, 2019a) × PeelF(EFSA, 2018a)
Sweet corn	0.01	STMR (EFSA, 2019a)	0.01	HR (EFSA, 2019a)
Flowering brassica	0.11	STMR (EFSA, 2019a)	0.79	HR (EFSA, 2019a)
Head brassica	0.27	STMR (EFSA, 2019a)	1.1	HR (CXL)( EFSA, 2019a)
Chinese cabbage	0.27	STMR (EFSA, 2019a)	1.1	HR (CXL)( EFSA, 2019a)
Kale	0.54	STMR (EFSA, 2019a)	1.1	HR (CXL)( EFSA, 2019a)
Kohlrabies	0.27	STMR (EFSA, 2019a)	1.1	HR (CXL)( EFSA, 2019a)
Lamb's lettuces	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Lettuces	4.29	STMR (EFSA, 2019a)	5.24	HR (EFSA, 2019a)
	0.72	STMR (Fall‐back)	2.31	HR (Fall‐back)
Scarole (broad‐leaf endive)	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
	0.09	STMR (Fall‐back)	1.44	HR (Fall‐back)
Cresses, Land cresses	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Rocket, rucola	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Red mustard	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Baby leaf crops	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Spinaches, Beet leaves (chard)	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
	0.72	STMR (Fall‐back)	2.31	HR (Fall‐back)
Purslanes	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Vine leaves	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
Water cress	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)(EFSA, 2019a)
Witloof	1.90	STMR (EFSA, 2019a)	5.70	HR (CXL)( EFSA, 2019a)
	0.02*	STMR (Fall‐back)	0.02*	HR (Fall‐back)
Chervil	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Chives	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Celery leaves	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Parsley	10.0	STMR (EFSA, 2019a)	43.0	HR (EFSA, 2019a)
Sage, Rosemary	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Thyme, Basil	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Bay leaves (laurel)	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Tarragon	4.90	STMR (EFSA, 2019a)	8.02	HR (EFSA, 2019a)
Beans (with pods)	0.07	STMR (EFSA, 2019a)	0.12	HR (EFSA, 2019a)
Legume vegetables, except beans with pods	0.04	STMR (EFSA, 2019a)	0.21	HR (CXL)(EFSA, 2019a)
Celeries	0.65	STMR (EFSA, 2019a)	1.98	HR (EFSA, 2019a)
Fennel	0.65	STMR (EFSA, 2019a)	1.98	HR (EFSA, 2019a)
Globe artichokes	0.04	STMR (EFSA, 2019a)	0.07	HR (EFSA, 2019a)
Leeks	0.07	STMR (EFSA, 2019a)	0.17	HR (EFSA, 2019a)
Soya beans	0.01	STMR (EFSA, 2019a)	0.01	STMR(CXL)(EFSA, 2019a)
Cotton seeds	0.01	STMR (EFSA, 2019a)	0.01	STMR (EFSA, 2019a)
Olives for oil production	0.02	STMR (EFSA, 2019a)	0.02	STMR (EFSA, 2019a)
Cereals	0.70	STMR (EFSA, 2019a)	0.95	HR (EFSA, 2019a)
Swine meat	0.21	STMR (EFSA, 2019a)	0.33	HR (EFSA, 2019a)
Swine fat	0.89	STMR (EFSA, 2019a)	1.36	HR (EFSA, 2019a)
Swine liver	0.34	STMR (EFSA, 2019a)	0.61	HR (EFSA, 2019a)
Swine kidney	0.19	STMR (EFSA, 2019a)	0.28	HR (EFSA, 2019a)
Swine edible offal	0.89	STMR (EFSA, 2019a)	1.36	HR (EFSA, 2019a)
Bovine meat	0.08	STMR (CXL)(EFSA, 2019a)	0.3	MRL (CXL)(EFSA, 2019a)
Bovine fat	0.08	STMR (CXL)(EFSA, 2019a)	3	MRL (CXL)(EFSA, 2019a)
Bovine liver	0.66	STMR (CXL)(EFSA, 2019a)	2	MRL (CXL)(EFSA, 2019a)
Bovine kidney	0.31	STMR (CXL)(EFSA, 2019a)	1	MRL (CXL)(EFSA, 2019a)
Bovine edible offal	0.66	MRL (CXL)(EFSA, 2019a)	3	MRL (CXL)(EFSA, 2019a)
Sheep, goat meat	0.28	STMR (EFSA, 2019a)	0.57	HR (EFSA, 2019a)
Sheep, goat fat	1.18	STMR (EFSA, 2019a)	2.31	HR (EFSA, 2019a)
Sheep, goat liver	0.50	STMR (EFSA, 2019a)	1.05	HR (EFSA, 2019a)
Sheep, goat kidney	0.30	STMR (EFSA, 2019a)	0.46	HR (EFSA, 2019a)
Sheep, goat edible offal	1.18	STMR (EFSA, 2019a)	2.31	HR (EFSA, 2019a)
Horse meat	0.28	STMR (EFSA, 2019a)	0.57	HR (EFSA, 2019a)
Horse fat	1.18	STMR (EFSA, 2019a)	2.31	HR (EFSA, 2019a)
Horse liver	0.50	STMR (EFSA, 2019a)	1.05	HR (EFSA, 2019a)
Horse kidney	0.30	STMR (EFSA, 2019a)	0.46	HR (EFSA, 2019a)
Horse edible offal	1.18	STMR (EFSA, 2019a)	2.31	HR (EFSA, 2019a)
Poultry meat	0.03	STMR (EFSA, 2019a)	0.08	HR (EFSA, 2019a)
Poultry fat	0.03	STMR (EFSA, 2019a)	0.31	HR (EFSA, 2019a)
Poultry liver	0.15	STMR (STMRMo × CF (4)) (EFSA, 2019a)	0.23	HR (HRMo × CF (4)) (EFSA, 2019a)
Poultry edible offal	0.03	STMR (fat) (EFSA, 2019a)	0.31	HR (fat) (EFSA, 2019a)
Milks	0.13	STMR (EFSA, 2019a)	0.13	STMR (EFSA, 2019a)
Birds’ eggs	0.06	STMR (STMRMo × CF (1.5)) (EFSA, 2019a)	0.07	HR (HRMo × CF (1.5)) (EFSA, 2019a)

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level; PeelF: peeling factor; CF: conversion factor.

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

Crops in bold indicate the commodities of relevance in the assessment.

Appendix E – Used compound code(s)

1.

Code/trivial namea	Chemical name/SMILES notationb	Structural formulab
Spinosad	Spinosad is a mixture of 50–95% spinosyn A and 50–5% spinosyn D
spinosyn A	(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)‐2‐(6‐deoxy‐2,3,4‐tri‐O‐methyl‐α‐L‐mannopyranosyloxy)‐13‐(4‐dimethylamino‐2,3,4,6‐tetradeoxy‐β‐D‐erythropyranosyloxy)‐9‐ethyl‐2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b‐hexadecahydro‐14‐methyl‐1H‐as‐indaceno[3,2‐d]oxacyclododecine‐7,15‐dione CN(C)[C@H]1CC[C@@H](O[C@@H]1C)O[C@H]6CCC[C@H](CC)OC(=O)C[C@@H]5C(=C[C@@H]3[C@H]5C=C[C@@H]2C[C@H](C[C@H]23)O[C@@H]4O[C@@H](C)[C@H](OC)[C@@H](OC)[C@H]4OC)C(=O)[C@@H]6C SRJQTHAZUNRMPR‐UYQKXTDMSA‐N
spinosyn D	(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)‐2‐(6‐deoxy‐2,3,4‐tri‐O‐methyl‐α‐L‐mannopyranosyloxy)‐13‐(4‐dimethylamino‐2,3,4,6‐tetradeoxy‐β‐D‐erythropyranosyloxy)‐9‐ethyl‐2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b‐hexadecahydro‐4,14‐dimethyl‐1H‐as‐indaceno[3,2‐d]oxacyclododecine‐7,15‐dione CN(C)[C@H]1CC[C@@H](O[C@@H]1C)O[C@H]6CCC[C@H](CC)OC(=O)C[C@@H]5C(=C[C@@H]3[C@H]5C=C(C)[C@@H]2C[C@H](C[C@H]23)O[C@@H]4O[C@@H](C)[C@H](OC)[C@@H](OC)[C@H]4OC)C(=O)[C@@H]6C RDECBWLKMPEKPM‐PSCJHHPTSA‐N

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

^bACD/Name 2019.1.1 ACD/Labs 2019 Release (File version N05E41, Build 110555, 18 July 2019). ACD/ChemSketch 2019.1.1 ACD/Labs 2019 Release (File version C05H41, Build 110712, 24 July 2019).

Suggested citation: EFSA (European Food Safety Authority) , Anastassiadou M, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Rojas A, Sacchi A, Santos M, Scarlato AP, Theobald A, Vagenende B and Verani A, 2021. Reasoned Opinion on the focussed assessment of certain existing MRLs of concern for Spinosad. EFSA Journal 2021;19(2):6404, 27 pp. 10.2903/j.efsa.2021.6404