Focussed assessment of certain existing maximum residues levels of concern for abamectin

Abstract

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for abamectin which might lead to consumers intake concerns on the basis of the lower toxicological reference values established during the peer review, the data currently available to EFSA and the outcome of the Member States’ consultation. To identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for abamectin considering the new toxicological reference values and an acute risk could not be excluded for 12 commodities. Fall‐back MRLs for nine commodities were proposed based on the data received under the present assessment. For apples, pears and escaroles, fall‐back MRLs could not be derived, and thus, a lowering of the MRLs for these crops to the limit of quantification (LOQ) is proposed.

Summary

Abamectin was approved on 1 May 2009 by means of Commission Directive 2008/107/EC in the framework of Directive 91/414/EEC for the use as insecticide and acaricide. On 3 April 2017, after the peer review by EFSA of additional uses, the use of abamectin was extended to nematicide. On 17 September 2014, EFSA finalised its reasoned opinion on the review of the existing maximum residue levels (MRLs) for the active substance abamectin in compliance with Article 12(1) of Regulation (EC) No 396/2005 and the proposed MRLs were implemented in Regulation EU 2015/2075. Subsequently, EFSA published other reasoned opinions on the active substance and some of the MRL proposals were also considered in more recent Regulations. On 20 August 2020, EFSA finalised the conclusion on the peer review of the active substance according to Article 13 of Regulation (EU) No 844/2012 in the framework of the renewal of the approval under Regulation (EC) No 1107/2009. In the conclusion, EFSA proposed to lower the existing acceptable daily intake (ADI) and the acute reference dose (ARfD) for abamectin. Considering the new ARfD value and the highest residue levels related to the uses evaluated under the Article 12 MRL review and subsequent reasoned opinions, EFSA identified a risk to consumers for several food products and the MRLs that are currently set under Regulation (EC) No 396/2005 need to be reconsidered. Although the new endpoints have not yet been formally endorsed by risk managers, the Standing Committee on Plants, Animals, Food and Feed (PAFF) – section Pesticide Legislation agreed on 3 December 2020, that the new ADI and ARfD proposed by EFSA in the conclusion on the peer review of the pesticide risk assessment should be considered to perform an updated exposure assessment of the active substance, considering a focused assessment of those MRLs that might be of concern to consumers in terms of acute risk.

As the basis for the focussed assessment, on 11 March 2021, EFSA initiated the collection of data for this active substance. In a first step, Member States (MSs) and the United Kingdom (UK) were invited to submit by 30 April 2021 fall‐back good agricultural practices (GAPs) that would lead to a safe scenario in relation to those uses that might lead to intake concerns. Furthermore, according to the EFSA conclusion, certain risks identified could only be addressed by restricting EU uses to greenhouses; and therefore, Member States were invited to submit only EU indoor uses and import tolerance fall‐back GAPs and to provide supporting residue data. On the basis of all the data submitted by Member States and the United Kingdom, and taking into account the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009 for the renewal of approval of abamectin and the data available to EFSA from previous MRL assessments, EFSA prepared in July 2021 a draft reasoned opinion, which was circulated to Member States and EURLs for consultation via a written procedure. Comments received by 23 August 2021 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

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 (EU) 2018/1514. An acute risk could not be excluded for 12 commodities, therefore for these commodities, EFSA asked MSs and UK to report fall‐back GAPs together with supporting residue data. The data collection was restricted to indoor uses and import tolerances.

The available residue data and those submitted by the MSs and UK in support of the fall‐back GAPs were sufficient to derive fall‐back (tentative) MRLs that are safe for consumers for all commodities of concern, except for apples, pears and escaroles. Therefore, EFSA recommends that the national authorisations for strawberries, tomatoes, sweet peppers, cucumbers, courgettes, Lamb's lettuces, lettuce, chervil and parsley are modified in order to comply with the derived fall‐back MRLs, whereas the national authorisations for apples, pears and escaroles are recommended to be withdrawn. Moreover, the MRL for sweet peppers requires further consideration by risk managers, as the tentative fall‐back MRL recommended needs to be confirmed by further trials. In addition, risk managers should consider that for pears the default MRL of 0.01 mg/kg may not be sufficiently protective for consumers; however, the combined LOQ of 0.006 mg/kg will be sufficiently protective. EFSA highlights that the MRL derived according to the fall‐back GAP for strawberries may not cover its use during the winter period; therefore, national authorisations of the fall‐back GAP for strawberries are recommended to be restricted to the summer use.

In addition, the proposed modification of the existing MRLs for peaches, spinaches and chards derived in a previous reasoned opinion but not yet implemented in Regulation is no longer recommended.

This conclusion was reached based on the calculations performed according to the internationally agreed methodology, demonstrating that the uses under consideration will not result in consumer intake exceeding the new ARfD. However, EFSA noted a narrow safety margin. Hence, if residues of abamectin occur in aubergines, bananas, Chinese cabbages, peaches, sweet peppers, chives, melons, sage, Florence fennels (boiled), strawberries, papayas and watermelons at the relevant existing MRL or derived fall‐back value, the dietary exposure of certain consumers may exceed the ARfD under certain conditions (i.e. consumption of a large portion of the product without washing/peeling/processing which would lead to a reduction of the residues in the product). Risk managers should decide whether the safety margin of the exposure assessment based on the highest residue is sufficient, considering that residues in individual units/lot consumed at or above the proposed MRL might occur.

Background

Abamectin was first evaluated in the framework of Directive 91/414/EEC1 with the Netherlands designated as rapporteur Member State (RMS) for the representative uses as a spray treatment on citrus, lettuces and tomatoes. The draft assessment report (DAR) prepared by the RMS was peer reviewed by EFSA (EFSA, 2008). Following the initial peer review, abamectin was approved on 1 May 2009 by means of Commission Directive 2008/107/EC2 for the use as insecticide and acaricide. The evaluation of the additional representative uses of abamectin as soil drip applications on tomatoes, aubergines, peppers, cucurbits (edible and non‐edible peel) and green beans, were peer reviewed by EFSA (EFSA, 2016). On 3 April 2017, the use was extended to nematicide. The EU maximum residue levels (MRLs) for abamectin are established in Annex II of Regulation (EC) No 396/20053. The existing MRLs were assessed by EFSA according to Article 12 of Regulation (EFSA, 2014) and amended by Commission Regulation (EU) No 2015/20754. After completion of the MRL review, EFSA has issued several reasoned opinions (EFSA, 2015, 2017, 2018b, 2020a,b) on the modification of MRLs for abamectin. Apart from the most recent ones (EFSA, 2020a,b), the proposals from these reasoned opinions have been considered in recent MRL regulations.5

On 20 August 2020, EFSA finalised the conclusion on the peer review of the active substance according to Article 13 of Regulation (EU) No 844/20126 in the framework of the renewal of the approval under Regulation (EC) No 1107/20097 (EFSA, 2020c). In the conclusion, EFSA proposed to lower the existing acceptable daily intake (ADI) and the acute reference dose (ARfD) for abamectin. Considering the new ARfD value of 0.0012 mg/kg body weight (bw) and the highest residue levels related to the uses evaluated under the Article 12 MRL review and subsequent reasoned opinions, EFSA identified a risk to consumers for several food products, and therefore, the MRLs that are currently set under Regulation (EC) No 396/2005 need to be reconsidered. Although the new endpoints have not yet been formally endorsed by risk managers, the PAFF Standing Committee – section Pesticide Legislation agreed on 3 December 2020, that EFSA should consider the new ADI and ARfD proposed in the conclusion on the peer review of the pesticide risk assessment and perform an updated exposure assessment of the active substance, focusing on those MRLs that might be of concern to consumers in terms of acute risk. Also, the MRLs that were recommended in Reasoned Opinions subsequent to the Article 12 MRL review should be considered.

As the basis for the focussed assessment, on 11 March 2021, EFSA initiated the collection of data for this active substance. In a first step, Member States and the United Kingdom were invited to submit by 30 April 2021 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms. Member States and the United Kingdom8 were invited to provide specific fall‐back GAPs that would lead to a safe scenario in relation to those uses that might lead to intake concerns. Furthermore, according to the EFSA conclusion, certain risks identified could only be addressed by restricting EU uses to greenhouses, and therefore, Member States and the United Kingdom were invited to submit only EU indoor uses and import tolerance fall‐back GAPs and to provide supporting residue data. On the basis of all the data submitted by Member States, the United Kingdom and the EURLs, the previous EFSA reasoned opinions and taking into account the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009 for the renewal of approval of abamectin, EFSA prepared in July 2021 a draft reasoned opinion, which was circulated to Member States and EURLs for consultation via a written procedure. Comments received by 23 August 2021 were considered during the finalisation of this reasoned opinion.

The evaluation reports submitted by Member States and the EURLs during the collection of data are considered as main supporting documents to this reasoned opinion and, thus, made publicly available.

In addition, further supporting document to this reasoned opinion is the Member States consultation report (EFSA, 2021). Furthermore, the exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) and the updated PROFile as well as the GAP overview file listing all authorised uses submitted for the purpose of the focused assessment are key supporting documents and made publicly available as background documents to this reasoned opinion. A screenshot of the report sheet of the PRIMo is presented in Appendix C.

Terms of Reference

According to Article 43 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on those existing MRLs for abamectin which might lead to consumers intake concerns on the basis of the new toxicological reference values (TRVs) proposed in the framework of the renewal of the approval, the existing residue definitions for enforcement and risk assessment which were derived during the MRL review, the data currently available to EFSA and the outcome of the consultation of Member States. EFSA should deliver the reasoned opinion by 15 September 2021.

The active substance and its use pattern

Abamectin is the ISO common name for mixture of ≥ 80% avermectin B1a: (10E,14E,16E)‐(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)‐6′‐[(S)‐sec‐butyl]‐21,24‐dihydroxy‐5′,11,13,22‐tetramethyl‐2‐oxo‐(3,7,19‐trioxatetracyclo[15.6.1.1^4,8.0^20,24]pentacosa‐10,14,16,22‐tetraene)‐6‐spiro‐2′‐(5′,6′‐dihydro‐2′H‐pyran)‐12‐yl 2,6‐dideoxy‐4‐O‐(2,6‐dideoxy‐3‐O‐methyl‐α‐l‐arabino‐hexopyranosyl)‐3‐O‐methyl‐α‐l‐arabino‐hexopyranoside and ≤ 20% avermectin B1b: (10E,14E,16E)‐(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)‐21,24‐dihydroxy‐6′‐isopropyl‐5′,11,13,22‐tetramethyl‐2‐oxo‐(3,7,19‐trioxatetracyclo[15.6.1.1^4,8.0^20,24]pentacosa‐10,14,16,22‐tetraene)‐6‐spiro‐2′‐(5′,6′‐dihydro‐2′H‐pyran)‐12‐yl 2,6‐dideoxy‐4‐O‐(2,6‐dideoxy‐3‐O‐methyl‐α‐l‐arabino‐hexopyranosyl)‐3‐O‐methyl‐α‐l‐arabino‐hexopyranoside (IUPAC).

The chemical structure of the active substance and its main metabolites is reported in Appendix E.

The EU MRLs for active substance are established in Annexes II of Regulation (EC) No 396/2005. Codex maximum residue limits (CXLs) for abamectin were also established by the Codex Alimentarius Commission (CAC). Abamectin is also registered for use as a veterinary product in the EU. An overview of the MRL changes that occurred since the entry into force of the Regulation (EU) No 2015/2075 (implementing the proposals from the MRL review) is provided below (Table 1).

Table 1.

Overview of the MRL changes since the MRL review

Procedure	Legal implementation	Remarks
MRL review according to Article 12 of Regulation (EC) No 396/2005	Commission Regulation (EU) No 2015/2075	EFSA (2014)
MRL application	Commission Regulation (EU) 2016/1003	Pome fruits, cucurbits with edible peel, Chinese cabbages, lettuces and salad plants, lamb's Lettuces, lettuces, escaroles, rocket, rucola, baby leaf crops, spinaches and similar leaves, beans with pods, peas with pods, celery (EFSA, 2015).
MRL application	Commission Regulation (EU) 2018/685	Bananas (EFSA, 2017, 2018b, 2020a,b)
MRL application	Commission Regulation (EU) 2018/1514	Citrus fruits (EFSA, 2018b)
MRL application	Not yet legally implemented	Art.12 confirmatory data and modification of MRLs: almonds, hazelnuts/cobnuts, walnuts, pome fruits, currants, gooseberries, papayas, tomatoes, lamb's lettuces, lettuces, escaroles/broad‐leaved endives, cresses and other sprouts and shoots, roman rocket/rucola, baby leaf crops (including brassica species), spinaches and similar leaves, witloof/Belgian endives, celery leaves, beans (with pods), peas (with pods) (EFSA, 2020a)
MRL application	Not yet legally implemented	Almonds, brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, walnuts, peaches, avocados, lamb's lettuces/corn salads, lettuces, escaroles/broadleaved endives, cresses and other sprouts and shoots, land cresses, roman rocket/rucola, baby leaf crops (incl. brassica species) others (lettuces and salad plants), spinaches, purslanes, chards/beet leaves, others (spinaches and similar leaves), florence fennels, cotton seeds (EFSA, 2020b)

Assessment

EFSA has based its assessment on the following documents:

• The PROFile prepared by EFSA covering all existing EU uses and import tolerances assessed by EFSA in the framework of the Article 12 and subsequent Article 10 reasoned opinions;

• The authorised GAPs submitted during the data call by Member States (Belgium; Bulgaria; Croatia; Czech Republic; France; Germany; Ireland; Italy; Lithuania; Netherlands; Poland; Portugal; Spain) and United Kingdom;

• The evaluation reports prepared by Member States (Netherlands, 2019, 2021; Belgium, 2021; France, 2021; Germany, 2021; Italy, 2021; Poland, 2021; Spain, 2021), United Kingdom (2021) and EURLs (EURLs, 2021);

• The conclusion on the peer review of the pesticide risk assessment of the active substance abamectin (EFSA, 2020c);

• The conclusions from the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2014);

• The reasoned opinions on abamectin published after the Art.12 review (EFSA, 2015, 2017, 2018b, 2020a,b).

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, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010a, 2010b, 2017; OECD, 2011, 2013).

More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

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 derived in the EFSA conclusion (EFSA, 2020c), EFSA performed a preliminary risk assessment (scenario 1) of the existing EU MRLs established in the Regulation (EU) 2018/1514. The calculations are based on the residue levels in the raw agricultural commodities reported in the MRL review (EFSA, 2014) and in the subsequent MRL assessments (EFSA, 2015, 2017, 2018a,b, 2020a,b), except for citrus fruits, where the relevant peeling factor was applied. 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 (EFSA, 2018a, 2019). The calculated exposure levels were compared with the toxicological reference values for abamectin derived by EFSA in the framework of the renewal for the approval of the active substance (EFSA, 2020c).

The highest chronic exposure was calculated for the Dutch toddler, representing 22% of the ADI. With regard to the acute exposure, an exceedance of the ARfD was identified for escarole/broadleaved endives (boiled), sweet peppers, Lamb's lettuces, cucumbers, lettuces, tomatoes, pears, courgettes, chervil, apples, parsley and strawberries representing 287%, 278%, 227%, 186%, 159%, 155%, 142%, 132%, 115%, 110%, 107% and 101% of the ARfD, respectively.

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 2 gives an overview of the results of the preliminary acute risk assessment together with these indicative threshold levels derived by inverse modelling. It is noted that, according to the results of this preliminary risk assessment, the default LOQ of 0.01 mg/kg will not be sufficiently protective for pears (see threshold reported in Table 2).

Table 2.

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 threshold levelb (mg/kg)	Acute intake (% ARfD)
Apples	0.03	0.0123	0.01	110
Pears	0.03	0.0123	0.008	142
Strawberries	0.15	0.074	0.073	101
Tomatoes	0.09	0.032	0.02	155
Sweet peppers/bell peppers	0.07	0.056	0.02	278
Cucumbers	0.04	0.034	0.016	186
Courgettes	0.04	0.034	0.025	132
Lamb's lettuces	2	0.97	0.427	227
Lettuces	0.09	0.05	0.031	159
Escaroles/broadleaved endives (boiled)	0.1	0.054	0.018	287
Chervil	2	1.07	0.93	115
Parsley	2	1.07	1	107

^aHighest residue.

^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.

Regarding all other MRLs that are currently in place for abamectin, 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.

In addition to the existing MRLs, regarding the proposed MRLs in peaches, spinaches and chards derived in a recent reasoned opinion (EFSA, 2020b) but not yet legally implemented, a potential concern considering the new ARfD value of 0.0012 mg/kg body weight could not be excluded (see Table 3). Therefore, these MRLs are no longer recommended.

Table 3.

MRLs derived in recent reasoned opinions not legally implemented leading to potential concern considering the ARfD value of 0.0012 mg/kg body weight

Commodities	Calculated MRL (mg/kg) (GAP source)	Acute intake (% ARfD)	Comments
Peaches	0.04 Import tolerance (EFSA, 2020b)	206%	MRL initially proposed leads to acute exposure concern considering the lower ARfD, and therefore, MRL no longer proposed. MRL of 0.02 mg/kg in force leads to no dietary exposure concern (79% ARfD).
Spinaches	0.1 Import tolerance (EFSA, 2020b)	175%	MRL initially proposed leads to acute exposure concern considering the lower ARfD, and therefore, MRL no longer proposed. Existing MRL 0.01* mg/kg; no use authorised.
Chards/beet leaves/boiled	0.1 or 0.15 Import tolerance (EFSA, 2020b)	241%	MRL initially proposed leads to acute exposure concern considering the lower ARfD, and therefore, MRL no longer proposed. Existing MRL 0.01* mg/kg; no use authorised.

2. Assessment of the available information following the data call

The results of the preliminary risk assessment indicated that for 12 commodities of plant origin (apples, pears, strawberries, tomatoes, sweet peppers, cucumbers, courgettes, Lamb's lettuces, lettuces, escaroles, chervil and parsley), the current MRLs might pose an acute risk to European consumers (see Table 1). For these commodities, EFSA asked MSs and UK to report fall‐back GAPs restricted to indoor uses or import tolerances and to submit supporting residue data.

In response to the data call, Member States and UK reported several potential fall‐back GAPs for indoor uses. EFSA prepared a GAP overview file summarising the GAPs collected during the data call and including a conclusion on whether the GAP could be considered to derive a fall‐back MRL. The authorised uses for which a risk for consumers have been identified and the less critical indoor GAPs and import tolerances further considered by EFSA to derive fall‐back MRLs are given in Appendix A.1, Appendix A.2 and Appendix A.3, respectively.

In order to derive fall‐back MRLs and risk assessment values, EFSA considered all GAPs and residue trials reported during the data call (Belgium, 2021; France, 2021; Germany, 2021; Italy, 2021; Netherlands, 2021; Poland, 2021; Spain, 2021; United Kingdom, 2021), as well as all GAPs and residue trials evaluated in its previous reasoned opinions (EFSA, 2020a,b) or accompanying evaluation reports (Netherlands, 2019), and the residue trials evaluated in the framework of the peer review (Austria, 2020; EFSA, 2020c).

In line with the terms of reference of the mandate, the existing residue definition for enforcement and risk assessment for abamectin (sum of avermectin B1a, delta‐8,9 isomer of avermectin B1a and avermectin B1b, expressed as avermectin B1a) as derived during the MRL review was considered in the assessment. According to a previous EFSA assessment, fully validated analytical methods are available for the enforcement of the proposed residue definition in all major matrices at the LOQ of 0.002 mg/kg per each analyte, resulting in a combined LOQ of 0.006 mg/kg (EFSA, 2020b).

The residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2020). All residue trial samples considered were stored in compliance with the conditions for which storage stability of residues was demonstrated. Decline of residues during storage of the trial samples is therefore not expected. Detailed results of the residue trials supporting the less critical GAPs and the derived risk assessment values are reported in Appendix B.1.1.

For apples and pears, only outdoor fall‐back GAPs were reported while according to the mandate only EU indoor uses and import tolerances could be considered as fall‐back GAPs; supporting data were not available for the less critical GAP reported for escaroles. Therefore, no fall‐back MRL could be derived for apples, pears and escaroles. For all other crops under assessment, the available data were sufficient to derive MRLs and risk assessment values, taking note of the following considerations:

• –Strawberries: Although MRL and risk assessment values can be derived from the indoor data, all trials were conducted within the period of March–October. Therefore, national authorisations of the fall‐back GAP for strawberries should consider restricting use in the winter period.
• –Sweet peppers: Although tentative MRL and risk assessment values can be derived from the indoor data, three additional trials compliant with the indoor GAP are still required.
• –Lamb's lettuces: MRL and risk assessment values can be derived from the import tolerance data. The indoor GAP trials on lettuces (uncertain if performed on open leaf variety), conducted with four applications instead of two, were considered on a tentative basis (Austria, 2020; Germany, 2021; Netherlands, 2021). Since this use is restricted to application in summer only (March–October) and considering the results from overdosed trials, the import tolerance GAP is clearly more critical, and therefore, no additional trials are required.

3. Consumer risk assessment

A second exposure calculation (scenario 2) was performed based on the same input values as in scenario 1, except for the commodities for which an acute concern was identified. For strawberries, tomatoes, sweet peppers, cucumbers, courgettes, Lamb's lettuces, lettuces, chervil and parsley risk assessment values were replaced by those resulting from the respective most critical fall‐back GAPs. Residues in apples, pears and escaroles were disregarded assuming that all the existing uses on these crops will be withdrawn. For peaches, spinaches and chards, the MRLs derived in a previous reasoned opinion and not yet implemented are no longer recommended. Therefore, for peaches, the risk assessment values derived in the MRL review were used (EFSA, 2014), and since no authorised use exists for spinaches and chards, these were not included in the calculation. An overview of the input values considered in this second calculation is given in Appendix D.

Chronic and acute exposure calculations were performed using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 2019). The exposures calculated were compared with the toxicological reference values for abamectin derived by EFSA in the framework of the renewal for the approval of the active substance (EFSA, 2020c).

According to the results of scenario 2, the highest chronic exposure declined to 16% of the ADI (GEMS/Food G10 diet) and the highest acute exposure was calculated for melons, followed by sweet peppers, representing 83% and 79% of the ARfD, respectively. Based on these refined calculations, EFSA concludes that no risk to consumers was identified.

EFSA notes that, although according to the internationally agreed methodology for acute risk assessment which is based on the highest residue found in the supervised field trials no acute consumer intake concerns were identified, for the uses on aubergines, bananas, Chinese cabbages, peaches, sweet peppers, chives, melons, sage, Florence fennels (boiled), strawberries, papayas and watermelons, the safety margin for acute exposure is narrow. If these crops contain residues at the existing or derived new MRLs, an exceedance of the ARfD cannot be excluded as the calculated acute exposure accounts for 102–188% of the ARfD.

Conclusions and recommendations

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 (EU) 2018/1514. An acute risk could not be excluded for 12 commodities; therefore, for these commodities, EFSA asked MSs and UK to report fall‐back GAPs together with supporting residue data. The data collection was restricted to indoor uses and import tolerances.

The available residue data and those submitted by the MSs and UK in support of the fall‐back GAPs were sufficient to derive fall‐back MRLs (tentative for sweet peppers) that are safe for consumers for all commodities of concern, except for apples, pears and escaroles. Therefore, EFSA recommends that the national authorisations for strawberries, tomatoes, sweet peppers, cucumbers, courgettes, Lamb's lettuces, lettuces, chervil and parsley are modified in order to comply with the derived fall‐back MRLs, whereas the national authorisations for apples, pears and escaroles are recommended to be withdrawn. In addition, risk managers should consider that for pears, the default MRL of 0.01 mg/kg may not be sufficiently protective for consumers; however, the combined LOQ of 0.006 mg/kg will be sufficiently protective. Moreover, the MRL for sweet peppers require further consideration by risk managers, as the tentative fall‐back MRL recommended needs to be confirmed by further trials. EFSA highlights that the MRL derived according to the fall‐back GAP for strawberries may not cover its use during the winter period; therefore, national authorisations of the fall‐back GAP for strawberries are recommended to be restricted to summer use.

Finally, the proposed modification of the existing MRLs for peaches, spinaches and chards derived in a previous reasoned opinion but not yet implemented in Regulation is no longer recommended.

This conclusion was reached based on the calculations performed according to the internationally agreed methodology, demonstrating that the uses under consideration will not result in consumer intake exceeding the ARfD. However, EFSA noted a narrow safety margin. Hence, if residues of abamectin occur in aubergines, bananas, Chinese cabbages, peaches, sweet peppers, chives, melons, sage, Florence fennels (boiled), strawberries, papayas and watermelons at the relevant existing or derived fall‐back MRL value, the dietary exposure of certain consumers may exceed the ARfD under certain conditions (i.e. consumption of a large portion of the product without washing/peeling/processing which would lead to a reduction of the residues in the product). Risk managers should decide whether the safety margin of the exposure assessment based on the highest residue is sufficient, considering that residues in individual units/lot consumed at or above the proposed MRL might occur.

A summary of the conclusions and recommendations is provided in Table 4.

Table 4.

Summary table

Code numbera	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			MRL (mg/kg)	Comment
Enforcement residue definition: Abamectin (sum of avermectin B1a, avermectin B1b and delta‐8,9 isomer of avermectin B1a, expressed as avermectin B1a)F – code 1000000 except 1040000: avermectin B1a
130010	Apples	0.03	–	A fall‐back MRL could not be proposedb
130020	Pears	0.03	–	A fall‐back MRL could not be proposedb
152000	Strawberries	0.15	0.08	Fall‐back MRL is proposedc
231010	Tomatoes	0.09	0.015	Fall‐back MRL is proposedc
0231020	Sweet peppers/bell peppers	0.07	0.03	Fall‐back tentative MRL is proposedd
232010	Cucumbers	0.04	0.02	Fall‐back MRL is proposedc
232030	Courgettes	0.04	0.02	Fall‐back MRL is proposedc
251010	Lamb's lettuces/corn salads	2	0.08	Fall‐back MRL is proposedc
0251020	Lettuces	0.09	0.03	Fall‐back MRL is proposedc
0251030	Escaroles/broadleaved endives	0.1	–	A fall‐back MRL could not be proposedb
0256010	Chervil	2	0.15 or 0.03	Fall‐back MRL is proposedc The submitted data on open leaf lettuces and spinaches are sufficient to derive an import tolerance (US GAP) of 0.15 mg/kg by extrapolation. The MRL in the country of origin (US) is 0.03 mg/kg.
256040	Parsley	2	0.15 or 0.03
–	Other products of plant and animal origin	See Regulation 2018/1514	–	Existing MRLs can be maintainede

MRL: maximum residue level.

^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. No uses are currently authorised that could be considered to derive a fall‐back MRL or the available fall‐back GAP is not supported by data. EFSA proposes to lower the MRL to the appropriate LOQ and to withdraw the relevant authorisations within the EU.

^cThe 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.

^dThe existing EU MRL was identified as a potential MRL of concern. Tentative MRL is derived from a fall‐back GAP submitted by MSs, which is not fully supported by data, and no risk to consumers is identified for this fall‐back MRL.

^eThe existing EU MRL was not identified as a potential MRL of concern. The modification of existing MRLs derived in a previous reasoned opinion not yet implemented for peaches, spinaches and chards is no longer recommended.

Abbreviations

a.i.

active ingredient

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

CAS

Chemical Abstract Service

CF

conversion factor for enforcement residue definition to risk assessment residue definition

CIRCA

(EU) Communication & Information Resource Centre Administrator

CS

capsule suspension

CV

coefficient of variation (relative standard deviation)

CXL

codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DB

dietary burden

DM

dry matter

DS

powder for dry seed treatment

EDI

estimated daily intake

EMS

evaluating Member State

EURLs

European Union Reference Laboratories for Pesticide Residues (former CRLs)

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GC

gas chromatography

GS

growth stage

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ISO

International Organisation for Standardization

IUPAC

International Union of Pure and Applied Chemistry

LOQ

limit of quantification

Mo

monitoring

MRL

maximum residue level

MS

Member States

MW

molecular weight

NEDI

national estimated daily intake

NESTI

national estimated short‐term intake

NTMDI

national theoretical maximum daily intake

OECD

Organisation for Economic Co‐operation and Development

PAFF

Standing Committee on Plants, Animals, Food and Feed

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

PROFile

(EFSA) Pesticide Residues Overview File

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

TAR

total applied radioactivity

TMDI

theoretical maximum daily intake

UV

ultraviolet (detector)

WHO

World Health Organization

Appendix A – Summary of authorised uses considered for the updated review of MRLs

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	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s.	Method kind	Range of growth stages and seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Apples	NL, SE	F	Spider mites, thrips and leaf miners	EC	18 g/L	Foliar treatment – spraying	60–70	1–2	7	–	–	20.3 g a.i./ha	28	EFSA (2014)
Pears	BE, NL, SE	F	Spider mites, thrips and leaf miners	EC	18 g/L	Foliar treatment – spraying	60–70	1–2	7	–	–	20.3 g a.i./ha	28	EFSA (2014)
Strawberries	BE, NL, IE, EL	I	Spider mites, thrips and leaf miners	EC	18 g/L	Foliar treatment – spraying	12–89	1–3	7	–	–	21.6 g a.i./ha	3	EFSA (2014)
Tomatoes	UK	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–6		–	–	32.4 g a.i./ha	3	EFSA (2014)
Sweet peppers	FR, SK	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–5	7	–	–	21.6 g a.i./ha	3	EFSA (2014)
Cucumbers	NLe	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–4	7	–	–	27 g a.i./ha	3	EFSA (2015)
Courgettes	NLe	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–4	7	–	–	27 g a.i./ha	3	EFSA (2015)
Lamb's lettuces	FR	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–3		–	–	9 g a.i./ha	14	EFSA (2014)
Lettuces	DE	I	Spider mites	SC	18 g/L	Foliar treatment – spraying		1–4		–	–	9 g a.i./ha	14	NO WINTER APPLICATIONS. EFSA (2014)
Escaroles	FR	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		1–3		–	–	9 g a.i./ha	7	NO WINTER APPLICATIONS. EFSA, 2014
Chervil	UK	I	Spider mites	SC	18 g/L	Foliar treatment – spraying		1–4		–	–	27 g a.i./ha	14	EFSA (2014)
Parsley	UK	I	Spider mites	SC	18 g/L	Foliar treatment – spraying		1–4		–	–	27 g a.i./ha	14	EFSA (2014)

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.

^eNL is reported here as the EMS of the MRL application assessed by EFSA (EFSA, 2015).

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

Crop and/or situation	MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s.	Method kind	Range of growth stages and seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Strawberries	DE	I	Spider mites, thrips and leaf miners	EC	18 g/L	Foliar treatment – spraying	12–89	2	10	–	–	23 g a.i./ha	3
Tomatoes	HR, PT, FR, ES, IT	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		3	7	–	–	18 g a.i./ha	3
Sweet peppers	PT	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		3	7	–	–	18 g a.i./ha	3
Cucumbers	IT, LT	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		2	7	–	–	21.6 g a.i./ha	3
Courgettes	LT	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		2	7	–	–	21.6 g a.i./ha	3	BG GAP similarly critical
Lamb's lettuces	NL	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		2	7	–	–	9 g a.i./ha	14	Authorised from March to October only
Lettuces	NL	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		4	7	–	–	9 g a.i./ha	14	Authorised from March to October only
Escaroles	BE	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		2	14	–	–	9 g a.i./ha	14
Chervil	IE, UK, NL	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		4	7	–	–	9 g a.i./ha	14
Parsley	IE, UK, NL	I	Spider mites	EC	18 g/L	Foliar treatment – spraying		4	7	–	–	9 g a.i./ha	14

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.

A.3. Import tolerance uses considered to derive fall‐back GAPs

Crop and/or situation	MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s.	Method kind	Range of growth stages and seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Strawberries	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Tomatoes	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Sweet peppers	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Cucumbers	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Courgettes	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Lamb's lettuces	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Chervil	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)
Parsley	US	F		SC	84	Foliar treatment – spraying		3	7	–	–	21 g a.i./ha	7	EFSA (2020b)

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 pre‐harvest 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 – Primary crops

Commodity	Region/Indoora	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)
Residue definition for enforcement and risk assessment: sum of avermectin B1a, avermectin B1b and delta‐8,9‐Z‐isomer of avermectin B1a, expressed as avermectin B1a
Strawberries	EU	< 0.006; 2 × 0.014; 0.019; 0.02; 0.021; 2 × 0.041	Trials on strawberries within 25% deviation of dose rate (Italy, 2021; Spain, 2021). Trials conducted only during summer and therefore not covering more critical winter period (November–February). MRLOECD = 0.072	0.08	0.041	0.02
Tomatoes	EU	6 × < 0.006; 2 × 0.01	Trials on tomato within 25% deviation of application rate (France, 2021; Italy, 2021; Netherlands, 2021; Poland, 2021; Spain, 2021). MRLOECD = 0.014	0.015	0.01	0.006
	Import (US)	6 × < 0.004; 0.005; 0.006; 2 × < 0.01	Trials on tomato compliant with GAP (Netherlands, 2019) MRLOECD = 0.015	0.015d	0.01	0.004
Sweet peppers/bell peppers	EU	4 × < 0.006; 0.016	Trials on peppers within 25% deviation of application rate (Germany, 2021; Italy, 2021; Poland, 2021). MRLOECD = 0.03	0.03 (tentative)e	0.016	0.006
	Import (US)	5 × < 0.004; 0.006; 0.008 2 × < 0.01; 0.01; 0.013	Trials on peppers compliant with GAP (Netherlands, 2019). MRLOECD = 0.02	0.02d	0.013	0.006
Cucumbers, courgettes	EU	10 × < 0.006; 0.006; 0.008; 0.011	Trials on cucumbers within 25% deviation with GAP (Germany, 2021; Italy, 2021; Poland, 2021; Spain, 2021). Extrapolation to courgettes possible. MRLOECD = 0.01	0.02	0.011	0.006
	Import (US)	6 × < 0.004; 4 × < 0.012	Trials in cucumbers compliant with GAP (Netherlands, 2019). Extrapolation to courgettes possible. MRLOECD = 0.012	0.015f	0.012	0.006
Lamb's lettuces/corn salads	EU	2 × 0.007; 2 × 0.008; 0.011; 0.016; 0.022	Trials on lettuces (uncertain if performed on open leaf variety) conducted with 4 applications instead of 2 considered on a tentative basis (Germany, 2021; Netherlands, 2008, 2021). Since this use is restricted to application in summer only (March–October) and considering the results from overdosed trials, import tolerance GAP is clearly more critical and no additional trials are required. MRLOECD = 0.034	0.04	0.022	0.008
	Import (US)	0.007; 0.0075; 0.01; 0.0145; 0.018; 0.019; 0.02; 2 × 0.022; 0.025; 0.032; 0.054	Trials on open leaf lettuces compliant with GAP (Netherlands, 2019). Extrapolation to Lamb's lettuces possible. MRLOECD = 0.072	0.08g	0.054	0.02
Lettuces	EU	< 0.006; 2 × 0.006; 2 × 0.007; 3 × 0.008; 0.01; 0.011; 0.013; 2 × 0.016; 0.022	Trials on lettuces compliant with the GAP (France, 2021; Germany, 2021; Netherlands, 2008, 2021). Use restricted to applications in summer only. MRLOECD = 0.028	0.03	0.022	0.008
Escaroles/broad‐leaved endives	EU	–	Fall‐back GAP not supported by data.	–	–	–
Chervil, parsley	EU	–	Fall‐back GAP not supported by data.	–	–	–
	Import (US)	Lettuces (open leaf): 0.007, 0.0075, 0.01, 0.0145, 0.018, 0.019, 0.02, 2 × 0.022, 0.025, 0.032, 0.054 spinaches: 2 × < 0.004, 0.017, 0.022, 0.023, 0.026, 0.031, 0.047, 0.048, 0.052, 0.093	Trials on open leaf lettuces and spinaches compliant with GAP (Netherlands, 2019). Extrapolation to herbs possible. MRLOECD = 0.11	0.15h	0.093	0.022

GAP: Good Agricultural Practice; _OECD: Organisation for Economic Co‐operation and Development; MRL: maximum residue level.

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

^aEU: indoor EU trials, Country code: if non‐EU trials.

^bHighest residue.

^cSupervised trials median residue.

^dMRL 0.07 mg/kg in country of origin based on US e‐CFR tolerance database.

^eMRL proposal is tentative because additional trials are required.

^fMRL 0.01* mg/kg in country of origin based on US e‐CFR tolerance database.

^gMRL 0.1 mg/kg in country of origin based on US e‐CFR tolerance database.

^hMRL 0.03 mg/kg in country of origin based on US e‐CFR tolerance database.

B.2. Consumer risk assessment

Consumer exposure assessment through drinking water resulting from groundwater metabolite(s) according to SANCO/221/2000 rev.10 Final (25/2/2003).

B.3. Proposed MRLs

Code numbera	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			MRL (mg/kg)	Comment
Enforcement residue definition: Abamectin (sum of avermectin B1a, avermectin B1b and delta‐8,9 isomer of avermectin B1a, expressed as avermectin B1a)F – code 1000000 except 1040000: avermectin B1a
130010	Apples	0.03	–	A fall‐back MRL could not be proposedb
130020	Pears	0.03	–	A fall‐back MRL could not be proposedb
152000	Strawberries	0.15	0.08	Fall‐back MRL is proposedc
231010	Tomatoes	0.09	0.015	Fall‐back MRL is proposedc
0231020	Sweet peppers/bell peppers	0.07	0.03	Fall‐back tentative MRL is proposedd
232010	Cucumbers	0.04	0.02	Fall‐back MRL is proposedc
232030	Courgettes	0.04	0.02	Fall‐back MRL is proposedc
251010	Lamb's lettuces/corn salads	2	0.08	Fall‐back MRL is proposedc
0251020	Lettuces	0.09	0.03	Fall‐back MRL is proposedc
0251030	Escaroles/broadleaved endives	0.1	–	A fall‐back MRL could not be proposedb
0256010	Chervil	2	0.15 or 0.03	Fall‐back MRL is proposedc The submitted data on open leaf lettuces and spinaches are sufficient to derive an import tolerance (US GAP) of 0.15 mg/kg by extrapolation. The MRL in the country of origin (US) is 0.03 mg/kg.
256040	Parsley	2	0.15 or 0.03
–	Other products of plant and animal origin	See Regulation 2018/1514	–	Existing MRLs can be maintainede

MRL: maximum residue level.

^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. No uses are currently authorised that could be considered to derive a fall‐back MRL or the available fall‐back GAP is not supported by data. EFSA proposes to lower the MRL to the appropriate LOQ and to withdraw the relevant authorisations within the EU.

^cThe 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.

^dThe existing EU MRL was identified as a potential MRL of concern. Tentative MRL is derived from a fall‐back GAP submitted by MSs, which is not fully supported by data, and no risk to consumers is identified for this fall‐back MRL.

^eThe existing EU MRL was not identified as a potential MRL of concern. The modification of existing MRLs derived in a previous reasoned opinion not yet implemented for peaches, spinaches and chards is no longer recommended.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

• PRIMo(Scenario1)

• PRIMo(Scenario2)

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: Abamectin (sum of avermectin B1a, avermectin B1b and delta‐8,9 isomer of avermectin B1a, expressed as avermectin B1a)
Citrus fruits	0.002	STMR × PF (0.17) (EFSA, 2018b)	0.005	HR × PF (0.17) (EFSA, 2018b)
Tree nuts	0.010	STMR (EFSA, 2020b)	0.01	HR (EFSA, 2020b)
Apples, pears	0.008	STMR (EFSA, 2014)/No fall‐back available	0.012/‐	HR (EFSA, 2014)/No fall‐back available
Quinces, medlars, loquats	0.008	STMR (EFSA, 2014)	0.012	HR (EFSA, 2014)
Apricots	0.009	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Peaches	0.009	STMR (EFSA, 2014)	0.026/0.01	HR (EFSA, 2020b)/HR (EFSA, 2014)
Plums	0.006*	STMR (EFSA, 2014)	0.006*	HR (EFSA, 2014)
Table grapes	0.006*	STMR (EFSA, 2014)	0.006*	HR (EFSA, 2014)
Wine grapes	0.006*	STMR (EFSA, 2014)	0.006*	HR (EFSA, 2014)
Strawberries	0.030/0.02	STMR (EFSA, 2014)/fall‐back	0.074/0.041	HR (EFSA, 2014)/fall‐back
Blackberries	0.023	STMR (EFSA, 2014)	0.033	HR (EFSA, 2014)
Raspberries	0.023	STMR (EFSA, 2014)	0.033	HR (EFSA, 2014)
Avocados	0.006	STMR (EFSA, 2020b)	0.009	HR (EFSA, 2020b)
Bananas	0.006*	STMR‐Pulp (EFSA, 2017, 2018b, 2020a,b)	0.006*	HR‐Pulp (EFSA, 2017, 2018b, 2020a,b)
Potatoes	0.002	STMR(CXL) (EFSA, 2014)	0.005	HR (CXL)(EFSA, 2014)
Radishes	0.004	STMR (EFSA, 2014)	0.004	HR (EFSA, 2014)
Garlic, Onions, Shallots	0.01	STMR (EFSA, 2014)	0.01	HR (EFSA, 2014)
Spring onions	0.006*	STMR (EFSA, 2014)	0.006*	HR (EFSA, 2014)
Tomatoes	0.031/0.006*	STMR (EFSA, 2014)/fall‐back	0.032/0.01	HR (EFSA, 2014)/fall‐back
Sweet peppers/bell peppers	0.012/0.006*	STMR (EFSA, 2014)/fall‐back (tentative)	0.056/0.016	HR (EFSA, 2014)/fall‐back (tentative)
Aubergines (egg plants)	0.031	STMR (EFSA, 2014)	0.032	HR (EFSA, 2014)
Cucumbers, courgettes	0.007/0.006*	STMR (EFSA, 2015)/fall‐back	0.034/0.012	HR (EFSA, 2015)/fall‐back
Gherkins	0.007	STMR (EFSA, 2015)	0.034	HR (EFSA, 2015)
Cucurbits, inedible peel	0.006*	STMR (EFSA, 2014)	0.007	HR (EFSA, 2014)
Chinese cabbages	0.009	STMR (EFSA, 2015)	0.024	HR (EFSA, 2015)
Lamb's lettuces	0.06/0.02	STMR (EFSA, 2014)/fall‐back	0.97/0.054	HR (EFSA, 2014)/fall‐back
Lettuces	0.01/0.008	STMR (EFSA, 2014)/fall‐back	0.05/0.022	HR (EFSA, 2014)/fall‐back
Escarole (broad‐leaf endive)	0.02/–	STMR (EFSA, 2020b)/No fall‐back available	0.054/–	HR (EFSA, 2020b)/No fall‐back available
Rocket, Rucola	0.02	STMR (EFSA, 2020b)	0.054	HR (EFSA, 2020b)
Cresses & other sprouts/shoots	0.02	STMR (EFSA, 2020b)	0.054	HR (EFSA, 2020b)
Baby leaf crops (including brassica species)	1.03	STMR (EFSA, 2020a,b)	1.30	HR (EFSA, 2020b)
Spinaches, chards	0.026/–	STMR (EFSA, 2020b)/no use authorised	0.093/–	HR (EFSA, 2020b)/no use authorised
Purslane	0.026	STMR (EFSA, 2020b)	0.093	HR (EFSA, 2020b)
Chervil, parsley	0.127/0.022	STMR (EFSA, 2014)/fall‐back	1.067/0.093	HR (EFSA, 2014)/fall‐back
Herbs, except celery leaves, chervil and parsley	0.127	STMR (EFSA, 2014)	1.067	HR (EFSA, 2014)
Celery leaves	0.009	STMR (EFSA, 2020a,b)	0.013	HR (EFSA, 2020a,b)
Beans (with pods)	0.011	STMR (EFSA, 2020a,b)	0.053	HR (EFSA, 2020a,b)
Peas (with pods)	0.02	STMR (EFSA, 2020a,b)	0.053	HR (EFSA, 2020a,b)
Celeries	0.015	STMR (EFSA, 2015)	0.022	HR (EFSA, 2015)
Florence fennel	0.008	STMR (EFSA, 2020b)	0.18	HR (EFSA, 2020b)
Leeks	0.006	STMR (EFSA, 2014)	0.007	HR (EFSA, 2014)
Cotton seeds	0.010	STMR (CXL) (EFSA, 2014)	0.13	HR (EFSA, 2020b)
Hops (dried)	0.016	STMR (CXL) (EFSA, 2014)	0.086	HR (CXL) (EFSA, 2014)
Risk assessment residue definition for animal products: Sum of avermectin B1a and B1b, expressed as avermectin B1a(a)
Bovine, Meat	0.013(b)	LOQ × CF (EFSA, 2014)	0.013(b)	LOQ × CF (EFSA, 2014)
Bovine, Fat	0.013	MRL × CF (EFSA, 2014)	0.013	MRL × CF (EFSA, 2014)
Bovine, Liver	0.025	MRL × CF (EFSA, 2014)	0.025	MRL × CF (EFSA, 2014)
Bovine, Kidney	0.01*	LOQ (EFSA, 2014)	0.01*	LOQ (EFSA, 2014)
Bovine, Edible offal	0.025	MRL × CF (EFSA, 2014)	0.025	MRL × CF (EFSA, 2014)
Sheep, Meat	0.033(b)	MRL × CF (EFSA, 2014)	0.033(b)	MRL × CF (EFSA, 2014)
Sheep, Fat	0.063	MRL × CF (EFSA, 2014)	0.063	MRL × CF (EFSA, 2014)
Sheep, Liver	0.031	MRL × CF (EFSA, 2014)	0.031	MRL × CF (EFSA, 2014)
Sheep, Kidney	0.025	MRL × CF (EFSA, 2014)	0.025	MRL × CF (EFSA, 2014)
Sheep, Edible offal	0.063	MRL × CF (EFSA, 2014)	0.063	MRL × CF (EFSA, 2014)

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

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

^aVeterinary use of abamectin is derived for avermectin B1a. A conversion factor (CF) of 1.25 was used to take into account the consumers’ exposure to avermectin B1b.

^bConsumption figures in the EFSA PRIMo are expressed as meat. Since the active substance is fat‐soluble, residue values were calculated considering an 80% muscle and 20% fat content for mammalian meat (FAO, 2016).

Appendix E – Used compound codes

1.

Code/trivial name(a)	Chemical name/SMILES notation/InChiKey(b)	Structural formulac
avermectin B1a	(10E,14E,16E)‐(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)‐6′‐[(S)‐sec‐butyl]‐21,24‐dihydroxy‐5′,11,13,22‐tetramethyl‐2‐oxo‐(3,7,19‐trioxatetracyclo[15.6.1.14,8.020,24]pentacosa‐10,14,16,22‐tetraene)‐6‐spiro‐2′‐(5′,6′‐dihydro‐2′H‐pyran)‐12‐yl 2,6‐dideoxy‐4‐O‐(2,6‐dideoxy‐3‐O‐methyl‐α‐L‐arabino‐hexopyranosyl)‐3‐O‐methyl‐α‐L‐arabino‐hexopyranoside CO[C@H]1C[C@@H](O[C@@H]c[C@@H]1O)O[C@@H]1[C@@H](OC)C[C@@H](O[C@H]1C)O[C@@H]1Cc=CC[C@@H]2C[C@H](OC(=O)[C@@H]3C=Cc[C@@H](O)[C@H]4OCC(=CC=C[C@@H]1C)[C@@]34O)C[C@@]1(O2)C=C[C@H]c[C@H](O1)[C@@H]cCC RRZXIRBKKLTSOM‐XPNPUAGNSA‐N
avermectin B1b	(10E,14E,16E)‐(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)‐21,24‐dihydroxy‐6′‐isopropyl‐5′,11,13,22‐tetramethyl‐2‐oxo‐(3,7,19‐trioxatetracyclo[15.6.1.14,8.020,24]pentacosa‐10,14,16,22‐tetraene)‐6‐spiro‐2′‐(5′,6′‐dihydro‐2′H‐pyran)‐12‐yl 2,6‐dideoxy‐4‐O‐(2,6‐dideoxy‐3‐O‐methyl‐α‐L‐arabino‐hexopyranosyl)‐3‐O‐methyl‐α‐L‐arabino‐hexopyranoside CO[C@H]1C[C@@H](O[C@@H]c[C@@H]1O)O[C@@H]1[C@@H](OC)C[C@@H](O[C@H]1C)O[C@@H]1Cc=CC[C@@H]2C[C@H](OC(=O)[C@@H]3C=Cc[C@@H](O)[C@H]4OCC(=CC=C[C@@H]1C)[C@@]34O)C[C@@]1(O2)C=C[C@H]c[C@H](O1)CcC ZFUKERYTFURFGA‐PVVXTEPVSA‐N
[8,9‐Z]‐isomer of avermectin B1a (NOA427011)	[2′S,2a(3)E,4E,5′S,6S,6′R,7S,8Z,11R,15S,17aR,20R,20aR,20bS]‐6′‐[(2S)‐butan‐2‐yl]‐20,20b‐dihydroxy‐5′,6,8,19‐tetramethyl‐17‐oxo‐5′,6,6′,10,11,14,15,17,17a,20,20a,20b‐dodecahydro‐2H,7H‐spiro[11,15‐methanofuro[4,3,2‐pq][2,6]benzodioxacyclooctadecine‐13,2′‐pyran]‐7‐yl 2,6‐dideoxy‐4‐O‐(2,6‐dideoxy‐3‐O‐methyl‐α‐L‐arabino‐hexopyranosyl)‐3‐O‐methyl‐α‐L‐arabino‐hexopyranoside CO[C@H]1C[C@@H](O[C@@H]c[C@@H]1O)O[C@@H]1[C@@H](OC)C[C@@H](O[C@H]1C)O[C@@H]1Cc=CC[C@@H]2C[C@H](OC(=O)[C@@H]3C=Cc[C@@H](O)[C@H]4OCC(=CC=C[C@@H]1C)[C@@]34O)C[C@@]1(O2)C=C[C@H]c[C@H](O1)[C@@H]cCC RRZXIRBKKLTSOM‐RVQYPMJNSA‐N

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 2019.1.1 ACD/Labs 2019 Release (File version N05E41, Build 110555, 18 July 2019).

^cACD/ChemSketch 2019.1.1 ACD/Labs 2019 Release (File version C05H41, Build 110712, 24 July 2019).

Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Giner G, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Vagenende B and Verani A, 2021. Reasoned opinion on the focussed assessment of certain existing maximum residues levels of concern for abamectin. EFSA Journal 2021;19(10):6842, 33 pp. 10.2903/j.efsa.2021.6842