Statement on the risk assessment of maximum residue levels (MRLs) for oxamyl in view of consumer protection

Abstract

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to perform a risk assessment of the existing maximum residues levels (MRLs) for oxamyl considering the new toxicological reference values. Additionally, if needed to ensure adequate consumer protection, lower limits of quantification (LOQs) than those currently established in the legislation should be proposed. EFSA performed various consumer exposure calculation scenarios, considering the risk assessment values as available for the existing uses of oxamyl and the lowering of LOQs for several plant and animal commodities as suggested by the European Union Reference Laboratories for Pesticide Residues (EURLs). Based on the results of the consumer exposure assessment calculated considering the risk assessment values for crops with authorised oxamyl uses and the existing EU MRLs at the LOQ for remaining commodities (scenario 1), chronic consumer intake concerns were identified for 34 diets. Acute exposure concerns were identified for a wide range of crops, including crops with currently authorised oxamyl uses: bananas, potatoes, melons, cucumbers, carrots, watermelons, tomatoes, courgettes, parsnips, salsifies and aubergines/eggplants. Under exposure calculation scenario 3, which considered lowering of all MRLs to the lowest analytically achievable limits of quantification, EFSA concludes that chronic consumer exposure concerns can still not be excluded. Similarly, acute consumer exposure concerns were identified for 16 commodities, including crops with known authorised uses: potatoes, melons, watermelons and tomatoes, even though for these crops a lower LOQ as proposed by the EURLs were considered. Further refinements of the calculated exposure at the current stage were not possible by EFSA, but EFSA identified a list of commodities for which a lower LOQ than routinely achievable is expected to significantly reduce the consumer exposure and for which a risk management decision is required.

Background

Oxamyl is a nematicide which was first assessed in 2005 for the inclusion in Annex I of the Council Directive 91/414/EEC1 (EFSA, 2005). Oxamyl is considered to be approved for use in the EU until 31 January 2023.2

On 1 October 2010, EFSA provided a reasoned opinion on the review of the existing maximum residue levels (MRLs) for the active substance oxamyl in compliance with Article 12(2) of Regulation (EC) No 396/20053 (MRL review) (EFSA, 2010). This risk assessment was performed using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) and the calculated exposures were compared with the toxicological reference values (TRVs) for oxamyl valid at that time, i.e., acceptable daily intake (ADI) of 0.001 mg/kg body weight (bw) per day and acute reference dose (ARfD) of 0.001 mg/kg bw. The MRLs resulting from this review were implemented by Regulation (EU) No 61/2014.4 The MRLs for potatoes, carrots, parsnips, salsify, Brussels sprouts and sugar beet roots were implemented at the limit of quantification (LOQ) of 0.01 mg/kg. For oranges, mandarins, bananas, tomatoes and cucurbits with edible peel (cucumbers, courgettes, gherkins) tentative MRLs of 0.01 mg/kg (at the LOQ) and for aubergines/eggplants at 0.02 mg/kg were implemented. For the uses of oxamyl on melons, watermelons and sweet peppers/bell peppers, consumer intake concerns could not be excluded and therefore these uses were withdrawn and the MRL was set at the default LOQ of 0.01 mg/kg.

On 6 July 2018, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for oxamyl.5 EFSA provided scientific support by assessing the proposed CXLs (EFSA, 2018b). The CXLs that were found to be safe for European consumers, namely for melons and watermelons, were implemented by Regulation (EU) No 2019/552.6 For tomatoes, the MRL at the LOQ of 0.01 mg/kg was confirmed by the same Regulation; the use of oxamyl on tomatoes was also evaluated by the JMPR.

On 18 May 2022, in the framework of the procedure on the renewal of the approval of oxamyl under Regulation (EC) No 1107/2009,7 EFSA in the conclusions on the peer review (EFSA, 2022) proposed to lower by a factor of 10 the TRVs for oxamyl (i.e. ADI of 0.0001 mg/kg bw day and ARfD of 0.0001 mg/kg bw) and identified several areas of critical concern, inter alia, that the preliminary consumer dietary risk assessment indicates a large exceedance of the ARfD for all the representative uses. During the EU pesticides peer review, the screening assessment for all MRLs confirmed after the MRL review was also performed, considering the new lowered TRVs for oxamyl. The screening indicated that the LOQs are not sufficiently protective for European consumers, as the calculated theoretical maximum daily intake (TMDI) exceeded the new lowered TRVs (1,240% of the ADI (NL toddler) and a large exceedance of the ARfD for several commodities (top 3: 1,538% potatoes, 1,517% melons, 1,385% pears)).

The EU pesticides peer review also concluded that for the uses assessed in the MRL review, the Article 12 confirmatory data gaps are addressed for a metabolism study with a radioactive marker representative for the use of oxamyl by drip irrigation in fruits and fruiting vegetables and for a study demonstrating storage stability of oxamyl residues in commodities with high acid content. The Article 12 confirmatory data gap for four additional residues trials on oranges and four additional residues trials on mandarins compliant with southern outdoor GAPs for these crops is considered as obsolete as the use on citrus is no longer supported (EFSA, 2022). In addition, the consumer dietary risk assessment could not be finalised since the residue definition for risk assessment was set on provisional basis as oxamyl alone, pending the assessment of relevance of metabolites IN‐D2708, IN‐A2213, IN‐QKT34 and IN‐N0079 in various crops.

All oxamyl EU MRLs are currently set at the LOQs of 0.01* mg/kg, 0.02* mg/kg (herbs and edible flowers) and 0.05* mg/kg (teas, hops, spices, honey), with the exception of melons and watermelons (0.01 mg/kg), and aubergines/eggplants (0.02 mg/kg). The MRLs for melons and watermelons reflect Codex MRLs implemented in EU legislation while the MRL on aubergines/eggplants reflect a plant protection use authorised in the EU. No import tolerances exist.

The decision on the renewal of approval of oxamyl is expected in 2023. However, considering the significantly lowered TRVs and the acute consumer risks identified in the EFSA conclusions on the peer review resulting from the existing MRLs, the Commission requests EFSA to carry out a risk assessment of the existing MRLs in view of the consumer protection level they provide and to investigate whether the LOQs of 0.01* mg/kg, 0.02* mg/kg (herbs and edible flowers) and 0.05* mg/kg (teas, hops, spices, honey) are protective enough, and, if need be, to propose lower achievable LOQs that ensure adequate consumer protection.

Terms of reference (as provided by the requestor)

EFSA is requested, according to Article 43 of Regulation (EC) No 396/2005:

• to perform a risk assessment of the existing MRLs considering the input values for risk assessment as derived during the MRL review and by the JMPR, the new toxicological reference values, the provisional residue definition for risk assessment (set as oxamyl only) and the newest version of PRIMo.

• if need be, to propose lower LOQs than those currently established in the legislation that ensure adequate consumer protection.

Assessment

EFSA based the assessment on the following documents:

• – the conclusion on the peer review of the pesticide risk assessment of the active substance oxamyl (EFSA, 2022);
• – the reasoned opinion on the review of the existing MRLs for oxamyl according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2010);
• – the scientific support for preparing an EU position in the 50th Session of the Codex Committee on Pesticide Residues (CCPR) (EFSA, 2018b);
• – the Joint FAO/WHO Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2018);
• – the Report of the 50th Session of the Codex Committee on Pesticide Residues (FAO/WHO, 2018);
• – information provided upon request to European Commission by the European Union Reference Laboratories for Pesticide Residues (EURLs).

The deadline for delivering a statement according to Article 43 of Regulation (EC) No 396/2005 on the safety of the proposed MRLs for consumers was agreed to be 2 months from receipt of this mandate. EFSA accepted the mandate and included it in the EFSA Register of Questions with the reference number EFSA‐Q‐2022‐00833 and committed to provide the statement by 23 January 2023.

The additional information provided by the EURLs and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents and, thus, are made publicly available as background documents to this statement.8 Screenshots of the report sheets of the PRIMo are presented in Appendix C.

1. Toxicological reference values

The toxicological assessment of oxamyl was initially performed by the EU pesticides peer review for the inclusion of the active substance in Annex I of the Council Directive 91/414/EEC (EFSA, 2005). The ADI of 0.001 mg/kg bw per day and an acute reference dose (ARfD) of 0.001 mg/kg bw were derived (EFSA, 2005). These values were confirmed in the EU review report (European Commission, 2011) and implemented by Commission Directive 2006/16/EC9 on the inclusion of oxamyl as active substance in Annex I of Directive 91/414/EEC.

In the framework of the renewal of the approval of oxamyl, the toxicological reference values (TRVs) were derived from the same key study as selected by EFSA in 200510 (i.e. the rat acute oral neurotoxicity study, with a no observed adverse effect level (NOAEL) of 0.1 mg/kg bw based on neurotoxicity findings) (EFSA, 2022). Compared with the TRVs agreed for the first approval (European Commission, 2011), these newly agreed TRVs have been decreased by 10‐fold, by adding an extra‐factor of 10 to the standard uncertainty factor (UF) of 100. Consequently, the ADI of 0.0001 mg/kg bw per day and an ARfD of 0.0001 mg/kg bw were derived by EFSA in the framework of the EU pesticides peer review for renewal of the approval of oxamyl (EFSA, 2022). These values have not been implemented yet.

The metabolites IN‐D2708, IN‐A2213, IN‐QKT34 (IN‐A2213 glucoside conjugate) and IN‐N0079 which were present in tomatoes and potatoes (representative uses assessed by the EU peer review on the renewal of the approval) are major rat metabolites, and therefore, the toxicological reference values of the parent compound are applicable to these compounds (EFSA, 2022).

As requested by the present mandate, the consumer exposure assessment for oxamyl will be performed considering the TRVs derived in the renewal of the approval process of oxamyl.

2. Residue definitions

The enforcement residue definition established for plant and animal commodities in Regulation (EC) No 396/2005 comprises the parent compound oxamyl alone. The same enforcement residue definition for plant commodities has been agreed by the EU pesticides peer review on the renewal of the approval of oxamyl (EFSA, 2022). The enforcement residue definition for commodities of animal origin could not be concluded by the EU pesticides peer review on the renewal of the approval pending the submission of residue trials on crops that could be fed to livestock to estimate the livestock dietary burden (EFSA, 2022).

The residue definition for the risk assessment was derived as parent oxamyl by the EU pesticides peer review for the inclusion of the active substance in Annex I of the Council Directive 91/414/EEC (EFSA, 2005). The EU pesticides peer review on the renewal of the approval on the basis of metabolism studies with fruit crops, root crops, leafy crops and pulses/oilseeds concluded that the residue definition for risk assessment in primary and rotational crops can be set as ‘oxamyl’ on provisional basis, pending the submission of residue trials on tomatoes and potatoes (representative uses considered for the renewal of the approval of oxamyl) analysing residues of metabolites IN‐D2708, IN‐A2213, IN‐QKT34 (IN‐A2213 glucoside conjugate) and IN‐N0079. In processed commodities, parent oxamyl is unstable and degrades to metabolite IN‐A2213. In animal commodities the risk assessment residue definition has not been concluded since, pending the residue data on potatoes and rotational crops, it is not known if the livestock dietary burden triggers the setting of residue definitions for products of animal origin (EFSA, 2022).

The data gaps set by the EU pesticides peer review on the renewal of the approval (EFSA, 2022) have not been addressed so far and the assessment of the impact of these data gaps on the outcome of the consumer exposure is not within the remit of the present assessment.

Noting the terms of reference of the mandate, the residue definition for risk assessment and enforcement in plant and animal commodities applicable for the present consumer risk assessment is ‘oxamyl’ alone, as set by the EU peer review for the approval of oxamyl (EFSA, 2005) and confirmed by the MRL review (EFSA, 2010).

3. Analytical methods for enforcement

The availability of the analytical enforcement methods for the determination of residues of oxamyl according to the existing enforcement residue definition (i.e., oxamyl alone), was investigated both in the MRL review and in the EU pesticides peer review on the renewal of the approval of the active substance (EFSA, 2010, 2022).

The MRL review concluded that suitable analytical methods are available for enforcement of parent oxamyl in commodities with high water content, high acid content and dry commodities at the validated LOQ of 0.01 mg/kg (EFSA, 2010). The availability of analytical enforcement method for the determination of residues in commodities of animal origin was not further investigated due to insignificant livestock exposure to oxamyl residues.

The EU pesticides peer review on the renewal of the approval concluded that oxamyl residues can be monitored in food and feed of plant origin by the quick, easy, cheap, effective and safe (QuEChERS) method using high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) with a LOQ of 0.01 mg/kg in the four major plant matrices and dried tobacco leaf. The lack of studies on matrix effects and the verification of the extraction efficiency were identified as data gaps (EFSA, 2022). In food of animal origin oxamyl residues can be determined either by a multi‐residue QuEChERS method or by a single residue method using HPLC–MS/MS determination with a validated LOQ of 0.01 mg/kg in all animal matrices. Also, for these methods matrix effects were not examined and the extraction efficiency has not been verified (EFSA, 2022).

Noting potential consumer intake concerns related to oxamyl residues at the LOQ, the European Commission requested the EURLs to investigate whether a lower LOQs could be achieved in plant and animal matrices. The EURLs provided information that a lower LOQs could be achieved for the following crops/commodities:

• – 0.002 mg/kg in oranges and tomatoes.
• – 0.001 mg/kg in commodities of high water and high acid content11: citrus fruits (except oranges), pome fruits, stone fruits, berries and small fruits, miscellaneous fruit (except table olives, avocados), root and tuber vegetables, bulb vegetables, fruiting vegetables (except tomatoes), brassica vegetables, leaf vegetables, fresh herbs and edible flowers, legume vegetables, stem vegetables, fungi, sugar plants.
• – 0.005 mg/kg in avocados, cereals, meat of mammals12 and bird's eggs.
• – 0.001 mg/kg in cow's milk.

The information provided by the EURLs will be further considered in the consumer exposure assessment.

4. Consumer risk assessment

As a basis for this risk assessment and in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016), EFSA performed a chronic and acute consumer risk assessment for the existing oxamyl MRLs as established in the Regulation (EU) 2019/552, considering the newest version of EFSA PRIMo rev. 3.1 (EFSA, 2018a, 2019).

The existing EU MRLs are set on the basis of the known authorised uses of oxamyl in the EU for bananas, potatoes, carrots, parsnips, salsifies, aubergines/eggplants, cucumbers, gherkins, courgettes, Brussels sprouts and sugar beet (roots), assessed during the MRL review (EFSA, 2010). For melons and watermelons, the existing EU MRL is set on the basis of CXL. The uses on tomatoes were assessed by the MRL review in 2010 (resulting in tentative MRL of 0.01* mg/kg as implemented by Regulation (EU) No 61/2014), the EU pesticides peer review in 2022 (provisional MRL proposal of 0.01* mg/kg) and by the JMPR in 2018 (CXL of 0.01* mg/kg confirmed by Regulation (EU) 2019/552) resulting in the same MRL proposal at the LOQ of 0.01 mg/kg. For the remaining commodities of plant origin, the existing EU MRLs for oxamyl are set at the LOQs of 0.01, 0.02 and 0.05 mg/kg (depending on the matrices). For commodities of animal origin, the existing EU MRLs are set at the LOQ of 0.01 mg/kg.

4.1. Scenario with available risk assessment values (scenario 1)

4.1.1. Input values

The consumer exposure was calculated for the existing oxamyl EU MRLs as established in the Regulation (EU) 2019/552. For those crops on which known oxamyl uses exist, the risk assessment values, namely the median residue values (STMR) for the chronic exposure and the highest residue values (HR) for the acute exposure, as derived by the MRL review (EFSA, 2010) or by the JMPR (FAO, 2018) were used to refine the exposure assessments. For melons and watermelons, the input values for residues in pulp were available. For the remaining commodities of plant and animal origin the existing EU MRLs (set at LOQ) were used as input values.

All input values considered in the risk assessment scenario 1 are reported in Appendix A.1.

4.1.2. Results

The chronic consumer exposure exceeded the ADI for a total of 34 diets, with the highest exposure being 1,219% of the ADI as calculated for NL toddler diet. The main contributing commodities (in % of the ADI) were cattle milk (from 30% in UK adult diet to 597% in NL toddler diet), coffee beans (278%, FI adult diet), apples (125%, DE child diet), sugar beet roots (84.4% NL child diet), wheat (72% GEMS/Food G06), maize/corn (70%, NL toddler diet), rye (55% rye, DK child diet) and was individually below 50% of the ADI for other commodities.

The contribution of residues (in % of the ADI) in the crops with known oxamyl authorised uses was the highest for sugar beet root (84.4% NL child diet), bananas (53.7% NL toddler diet), tomatoes (35.8% GEMS/Food G06 diet), potatoes (26.7% PT general diet) and was below 20% of the ADI for other crops (for details see Appendix B).

The contribution of MRLs set at the LOQ was 1,068% in the NL toddler diet.

When only crops with known authorised uses are considered (disregarding MRLs at the LOQ for remaining commodities of plant and animal origin), the chronic consumer intake concerns are identified for two diets with the maximum calculated exposure of 151% of the ADI for NL toddler diet and 134% of the ADI for NL child diet. When only crops with MRLs above the LOQ of 0.01 mg/kg are considered (i.e., watermelons, melons and aubergines/eggplants) the chronic exposure amounts to 11% of the ADI (GEMS/Food G08 diet).

Acute consumer intake concerns could not be excluded for 82 commodities (the crops with known authorised uses are reported in bold):

• – with acute exposure above 1,000% of the ARfD: pears, oranges, cattle milk, apples, pineapples.
• – with acute exposure between 500% and 1,000% of the ARfD: bananas (971%), peaches, mangoes, grapefruits, potatoes (769%), melons (758%), table grapes, cucumbers (656%), carrots 634%), kiwi fruits, watermelons (611%), sweet peppers/bell peppers, mandarins, leeks, tomatoes (581%), cauliflowers, beetroots, celeriacs/turnip rooted, granate apples/pomegranates, kohlrabies, swedes/rutabagas, avocados.
• – with acute exposure between 100% and 500% of the ARfD: kaki/Japanese persimmons, courgettes (465%), head cabbages, kales, sweet corn, papayas, plums, broccoli, escaroles/broad‐leaved, witloofs/Belgian endives, carobs/Sain John's bread, carambolas, lettuces, celeries, rhubarbs, parsnips (361%), turnips, apricots, lemons, Chinese cabbages‐pe‐tsai, yams, salsifies (310%), pumpkins, aubergines/eggplants (250%), quinces, radishes, goat milk, onions, spinaches, prickly pears/cactus fruits, guavas, limes, asparagus, beans, honey and other apiculture products, globe artichokes, poultry muscle/meat, cultivated fungi, strawberries, Florence fennels, cocoa beans, spring onions/green onions, chards/beet leaves, cherimoyas, wheat, coconuts, medlar, rice, chicken eggs, cherries (sweet), swine muscle/meat, litchis/lychees, figs, beans (with pods), blackberries.

From the crops on which the authorised uses of oxamyl exist in Europe, no acute intake concerns were identified only for Brussels sprouts (84% of the ARfD) and gherkins (28% of the ARfD). For sugar beet root the acute exposure is not calculated as no consumption data are available.

The detailed results of the calculations are presented in Appendix B.

4.2. Scenario with lower limits of analytical quantification, except crops with known authorised uses (scenario 2)

4.2.1. Input values

Under this scenario, further attempts were made to refine the exposure calculated under scenario 1. For those crops/commodities for which the EURLs confirmed that lower LOQs could be achieved (see Section 3), the lower LOQ values were used in the exposure calculation. For the crops with known existing authorised uses, the input values were the same as in scenario 1, except for sugar beet root where the input value was a lower LOQ of 0.001 mg/kg considering the unlikely concentration of residues in sugar.

All input values considered in the risk assessment scenario 2 are reported in Appendix A.1.

4.2.2. Results

The chronic exposure calculated under scenario 2 indicated intake concerns for 22 diets, with the highest exposure of 315% of the ADI calculated for Finnish adult diet. The main contributing commodities (in % of the ADI) were coffee beans (278%, FI adult diet), cattle milk (60%, NL toddler diet), bananas (54%, NL toddler diet) and was individually below 50% of the ADI for other commodities.

The contribution of residues (in % of the ADI) in the crops on which there exist known oxamyl uses was the same as calculated in the scenario 1, except for sugar beet root where the exposure was reduced to 8.4% of the ADI (NL child diet).

The contribution of MRLs set at the LOQ accounted for 294% of the ADI in the Finnish adult diet.

When only crops with known authorised uses are considered (disregarding MRLs at the LOQ for remaining commodities of plant and animal origin), the chronic consumer intake concerns are identified for NL toddler diet with a maximum calculated exposure of 104% of the ADI.

Acute consumer intake concerns could not be excluded for 23 commodities (the crops with known authorised uses are reported in bold):

• – with acute exposure between 500% and 1,000% of the ARfD: bananas (971%), potatoes (769%), melons (758%), cucumbers (656%), carrots (634%), watermelons (611%), tomatoes (581%).
• – with acute exposure between 100% and 500% of the ARfD: courgettes (465%), carobs/Saint John's bread, parsnips (361%), salsifies (310%), oranges, avocados, aubergines/eggplants (250%), goat milk, beans, honey and other apiculture, cocoa beans, coconuts, pears, cattle milk, apples, pineapples.

From the crops with known authorised uses of oxamyl, no intake concerns are identified for Brussels sprouts and gherkins. For sugar beet root the acute exposure is not calculated as no consumption data are available.

The detailed results of the calculations are presented in Appendix B.

4.3. Scenario with lowering of all oxamyl MRLs to the existing LOQ or lower LOQ (scenario 3)

4.3.1. Input values

Under this scenario the lowering of all EU MRLs of oxamyl to the lowest analytically achievable LOQs and the impact on the consumer exposure was investigated. According to the information provided by the EURLs, for several commodities/commodity groups a lower LOQ could be potentially achieved, thus for these commodities the input values were as reported by the EURLs (see Section 3). For the commodities of plant and animal origin for which the EURLs did not provide any indication of lower analytically achievable LOQs, the input values were the MRLs at the LOQs (of 0.01 mg/kg, 0.02 mg/kg or 0.05 mg/kg, depending on the matrix) as established by Regulation (EU) 2019/552.

All input values considered in the risk assessment scenario 3 are reported in Appendix A.1.

4.3.2. Results

The chronic exposure calculated under scenario 3 indicated intake concerns for 15 diets, with the highest exposure of 297% of the ADI calculated for Finnish adult diet.

The highest contributing commodities (>10% of the ADI) were coffee beans (278%, FI adult diet), cattle milk (60%, NL toddler diet and 39% UK infant diet), soyabeans (37%, GEMS/Food G11 diet), wheat (36%, GEMS/Food G06 diet), maize/corn (35%, NL toddler diet), rye (27.5%, DK child diet), cocoa beans (26%, ES child diet), bovine muscle/meat (22%, SE general population diet), apples (12%, DE child diet) and swine muscle/meat (11%, DK child diet).

All calculated exposure is attributed to residues at the LOQ.

Acute consumer intake concerns (in % of the ARfD) could not be excluded for 16 commodities (the crops with known authorised uses are reported in bold): carobs (393%), oranges (265%), avocados (252%), goat milk (242%), beans (183%), honey (179%), cocoa beans (161%), potatoes (154%), melons (152%), sheep milk (151%), coconuts (144%), pears (138%), cattle milk (124%), watermelons (1225), tomatoes (116%), apples (108%) and pineapples (101%).

The detailed results of the calculations are presented in Appendix B.

Based on scenario 3, EFSA identified a list of commodities for which a lower LOQ is expected to significantly reduce the consumer exposure.

5. Uncertainties related to exposure calculations

The different consumer exposure calculations are affected by the following uncertainties:

• – the conclusions of the EU pesticides peer review on the renewal of the approval have not been taken into consideration in this assessment (scenarios 1, 2 and 3);
• – no information is available on national authorizations of oxamyl in EU on commodities other than those assessed by the MRL review in 2010 (scenarios 1 and 2);
• – the LOQ of 0.001 mg/kg applied for commodities of plant origin with high water and high acid content is provisional and further validation data would be needed to confirm this LOQ (scenarios 2 and 3);
• – none of the LOQs proposed by the EURLs have been validated according to the requirements for the post‐registration methods as currently applicable by EU Guidance document SANTE/2020/12830 (scenarios 2 and 3).

6. Conclusions and recommendations

Based on the results of the consumer exposure assessment calculated considering the risk assessment values for crops with authorised oxamyl uses and the existing EU MRLs at the LOQ for remaining commodities as reported in the Regulation (EU) 2019/552, chronic and acute consumer exposure concerns cannot be excluded.

When all oxamyl MRLs are lowered to the routinely achievable LOQ or to a lower LOQ as reported by the European Reference Laboratories, the chronic consumer exposure is lower, but intake concerns remain. Acute intake concerns can also not be excluded with those lower LOQs for a range of commodities, including several crops with known authorised uses of oxamyl: potatoes, melons, watermelons and tomatoes. Furthermore, the exposure assessment is affected by uncertainties related to insufficient validation data package for these lower LOQs in several plant and animal matrices.

Thus, it was not possible for EFSA at the current stage to identify a safe consumer exposure scenario. However, EFSA identified a list of commodities for which a lower LOQ than routinely achievable is expected to significantly reduce the consumer exposure and for which risk management decision is required.

The recommendations of EFSA are compiled in the table below (Table 1).

Table 1.

Summary table

Code (a)	Commodity (b)	Existing MRL (mg/kg)/ Source	Exisiting CXL	Outcome of the risk assessment
				MRL (mg/kg)	Comment
Enforcement residue definition (EU): Oxamyl Enforcement residue definition (JMPR): Oxamyl
0110010	Grapefruits	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0110020	Oranges	0.01* (ft 1) (EFSA, 2010)	Not established	Further consideration needed	Chronic and acute (265% ARfD) consumer intake concerns cannot be excluded. An LOQ of 0.002 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the acute intake concern. According to the EU pesticides peer review, the use on citrus fruits is no more authorised in EU (EFSA, 2022). Contribution of residues to the chronic exposure 8% ADI.
0110030	Lemons	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0110040	Limes
0110050	Mandarins	0.01* (ft 1) (EFSA, 2010)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. According to the EU pesticides peer review, the use on citrus fruits is no more authorised in EU. Contribution of residues to the chronic exposure <1% ADI.
0120010	Almonds	0.01* (Reg. 2019/552)	Not considered (d)	0.01*	Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0120020	Brazil nuts
0120030	Cashew nuts
0120040	Chestnuts
0120050	Coconuts			Further consideration needed	Chronic and acute (144%) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 5% ADI. An LOQ lower than 0.01 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
0120060	Hazelnuts/cobnuts			0.01*	Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0120070	Macadamia
0120080	Pecans
0120090	Pine nut kernels
0120100	Pistachios
0120110	Walnuts
0130010	Apples	0.01* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (108% ARfD) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 12% ADI. An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
0130020	Pears			Further consideration needed	Chronic and acute (138% ARfD) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 4% ADI. An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
0130030	Quinces			0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0130040	Medlars
0130050	Loquats/Japanese medlars
0140010	Apricots	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0140020	Cherries (sweet)
0140030	Peaches
0140040	Plums
0151010	Table grapes	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.5% ADI.
0151020	Wine grapes				Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 2.5% ADI.
0152000	Strawberries	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0153000	Cane fruits
0153010	Blackberries
0153020	Dewberries
0153030	Raspberries (red and yellow)
0153990	Other cane fruits
0154000	Other small fruits & berries
0154010	Blueberries
0154020	Cranberries
0154030	Currants (red, black and white)
0154040	Gooseberries (green, red and yellow)
0154050	Rose hips
0154060	Mulberries (black and white)
0154070	Azarole/Mediterranean medlar
0154080	Elderberries
0161010	Dates	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0161020	Figs
0161030	Table olives			0.01*	Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0161040	Kumquats			0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0161050	Carambolas
0161060	Kaki/Japanese persimmons
0161070	Jambuls/jambolans
0162010	Kiwi fruits (green, red, yellow)
0162020	Litchis/lychees
0162030	Passionfruits/maracujas
0162040	Prickly pears/cactus fruits
0162050	Star apples/cainitos
0162060	American persimmon/Virginia kaki
0163010	Avocados	0.01* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (252% ARfD) consumer intake concerns cannot be excluded. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the acute intake concern. Contribution of residues to the chronic exposure <1% ADI
0163020	Bananas	0.01* (ft 2) (EFSA, 2010)	Not established	0.001*	Lower LOQ provisional pending further validation. Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 5.4% ADI. A narrow safety margin regarding acute exposure is noted (97% ARfD). According to the EU pesticides peer review, the Article 12 confirmatory data gap has been addressed (EFSA, 2022).
0163030	Mangoes	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0163040	Papayas
0163050	Granate apples/pomegranates
0163060	Cherimoyas
0163070	Guavas
0163080	Pineapples			Further consideration needed	Chronic and acute (101% ARfD) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
0163090	Breadfruits			0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI
0163100	Durians
0163110	Soursops/guanabanas
0211000	Potatoes	0.01* (EFSA, 2010)	0.01* (FAO, 2018) (c)	Further consideration needed	Chronic and acute (154% ARfD) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 5.3% ADI. An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
0212010	Cassava roots/manioc	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0212020	Sweet potatoes				Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 3.5% ADI.
0212030	Yams				Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0212040	Arrowroots
0213010	Beetroots	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0213020	Carrots	0.01* (EFSA, 2010)	0.01* (FAO, 2018)(c)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.4% ADI.
0213030	Celeriacs/turnip rooted celeries	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0213040	Horse radishes
0213050	Jerusalem artichokes
0213060	Parsnips	0.01* (EFSA, 2010)	0.01* (FAO, 2018)(c)
0213070	Parsley roots/Hamburg roots parsley	0.01* (Reg. 2019/552)	Not considered (d)
0213080	Radishes
0213090	Salsifies	0.01* (EFSA, 2010)	Not established
0213100	Swedes/rutabagas	0.01* (Reg. 2019/552)	Not considered (d)
0213110	Turnips
0220010	Garlic	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0220020	Onions
0220030	Shallots
0220040	Spring onions/green onions and Welsh onions
0231010	Tomatoes	0.01* (FAO, 2018)	0.01* (FAO, 2018)(c)	Further consideration needed	Chronic and acute (116% ARfD) consumer intake concerns cannot be excluded. An LOQ of 0.002 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the acute intake concern. Contribution of residues to the chronic exposure 7% ADI.
0231020	Sweet peppers/bell peppers	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0231030	Aubergines/egg plants	0.02 (ft 2) (EFSA, 2010)	0.01* (FAO, 2018)(c)
0231040	Okra/lady's fingers	0.01* (Reg. 2019/552)	Not considered (d)
0232010	Cucumbers	0.01* (ft 2) (EFSA, 2010)	0.02 (FAO, 2018)(c)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.6% ADI. According to the EU pesticides peer review, the Article 12 confirmatory data gap has been addressed (EFSA, 2022).
0232020	Gherkins		0.02 (FAO, 2018)(c)		Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI. According to the EU pesticides peer review, the Article 12 confirmatory data gap has been addressed (EFSA, 2022).
0232030	Courgettes		0.04 (FAO, 2018)(c)
0233010	Melons	0.01 (FAO, 2018)	0.01 (FAO, 2018)(c)	Further consideration needed	Chronic and acute (152% ARfD) consumer intake concerns cannot be excluded. An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection considering the acute intake concern. Contribution of residues to the chronic exposure <1% ADI.
0233020	Pumpkins	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0233030	Watermelons	0.01 (FAO, 2018)	0.01 (FAO, 2018)(c)	Further consideration needed	Chronic and acute (122% ARfD) consumer intake concerns cannot be excluded. An LOQ lower than 0.001 mg/kg would be necessary to ensure sufficient consumer protection considering the acute intake concern. Contribution of residues to the chronic exposure 1% ADI.
0234000	Sweet corn	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0241010	Broccoli
0241020	Cauliflowers
0242010	Brussels sprouts	0.01* (EFSA, 2010)	0.01* (FAO, 2018)(c)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0242020	Head cabbages	0.01* (Reg. 2019/552)	Not considered (d)		Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.4% ADI.
0243010	Chinese cabbages/pe‐tsai	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0243020	Kales
0244000	Kohlrabies
0251010	Lamb's lettuce/corn salads	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0251020	Lettuces
0251030	Escaroles/broad‐leaved endives
0251040	Cress and other sprouts and shoots
0251050	Land cress
0251060	Roman rocket/rucola
0251070	Red mustards
0251080	Baby leaf crops (including brassica species)
0252010	Spinaches
0252020	Purslanes
0252030	Chards/beet leaves
0252990	Other spinach and similar
0253000	Grape leaves and similar species
0254000	Watercress
0255000	Witloofs/Belgian endives
0256010	Chervil
0256020	Chives
0256030	Celery leaves
0256040	Parsley
0256050	Sage
0256060	Rosemary
0256070	Thyme
0256080	Basil and edible flowers
0256090	Laurel/bay leaves
0256100	Tarragon
0260010	Beans (with pods)
0260020	Beans (without pods)
0260030	Peas (with pods)
0260040	Peas (without pods)
0260050	Lentils (fresh)
0270010	Asparagus
0270020	Cardoons
0270030	Celeries
0270040	Florence fennels
0270050	Globe artichokes
0270060	Leeks
0270070	Rhubarbs
0270080	Bamboo shoots
0270090	Palm hearts
0280000	Fungi
0280010	Cultivated fungi
0280020	Wild fungi
0280990	Mosses and lichens
0290000	Algae and prokaryotes organisms
0300010	Beans	0.01* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (183% ARfD) consumer intake concerns cannot be excluded. An LOQ lower than 0.01 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern. Contribution of residues to the chronic exposure 7.7% ADI.
0300020	Lentils			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <3% ADI.
0300030	Peas
0300040	Lupins/lupini beans
0401010	Linseeds	0.01* (Reg. 2019/552)	Not considered (d)	0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 1.5% ADI.
0401020	Peanuts/groundnuts			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 2.7% ADI.
0401030	Poppy seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0401040	Sesame seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0401050	Sunflower seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 6.7% ADI.
0401060	Rapeseeds/canola seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 9.5% ADI.
0401070	Soyabeans			Further consideration needed	Chronic consumer intake concerns cannot be excluded. Considering the high contribution of residues in soybean (37% ADI) to the total exposure, a lowering of the existing LOQ would be required to ensure consumer protection
0401080	Mustard seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
0401090	Cotton seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 3% ADI.
0401100	Pumpkin seeds			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0401110	Safflower seeds
0401120	Borage seeds
0401130	Gold of pleasure seeds
0401140	Hemp seeds
0401150	Castor beans
0402010	Olives for oil production	0.01* (Reg. 2019/552)	Not considered (d)	0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 8% ADI.
0402020	Oil palm kernels				Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 6% ADI.
0402030	Oil palm fruits				Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 7.8% ADI.
0402040	Kapok				Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 2.9% ADI.
0500010	Barley	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 4.4% ADI. An LOQ of 0.005 mg/kg is sufficiently validated.
0500020	Buckwheat and other pseudo‐cereals				Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 1.4% ADI. An LOQ of 0.005 mg/kg is sufficiently validated
0500030	Maize/corn			Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 35% ADI. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in maize/corn to the total exposure.
0500040	Common millet/proso millet			0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI. An LOQ of 0.005 mg/kg is sufficiently validated
0500050	Oat			0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 2.9% ADI. An LOQ of 0.005 mg/kg is sufficiently validated.
0500060	Rice			0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 7.8% ADI. An LOQ of 0.005 mg/kg is sufficiently validated.
0500070	Rye			Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 27.5% ADI. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in rye to the total exposure.
0500080	Sorghum			0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI. An LOQ of 0.005 mg/kg is sufficiently validated.
0500090	Wheat			Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 36% ADI. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in wheat to the total exposure.
0610000	Tea (dried leaves of Camellia sinensis)	0.05* (Reg. 2019/552)	Not considered (d)	0.05*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 7% ADI.
0620000	Coffee beans	0.05* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 278.5% ADI. An LOQ lower than 0.05 mg/kg would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in coffee beans to the chronic exposure.
0631010	Chamomille	0.05* (Reg. 2019/552)	Not considered (d)	0.05*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0631020	Hibiscus/roselle
0631030	Rose
0631040	Jasmine
0631050	Lime/linden
0632000	Herbal infusions (dried leaves)
0632010	Strawberry leaves
0632020	Rooibos
0632030	Mate/maté
0633010	Valerian root
0633020	Ginseng root
0640000	Cocoa beans	0.05* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (161% ARfD) consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 26% ADI. An LOQ lower than 0.05 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern and the high contribution of residues in cocoa beans to the chronic exposure.
0650000	Carobs/Saint John's bread	0.05* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (393% ARfD) consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI. An LOQ lower than 0.05 mg/kg would be necessary to ensure sufficient consumer protection, considering acute exposure concerns.
0700000	HOPS (dried)	0.05* (Reg. 2019/552)	Not considered (d)	0.05*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
0800000	SPICES	0.05* (Reg. 2019/552)	Not considered (d)	0.05*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI, except for vanilla pods (1%) and capers (2.9%).
0900010	Sugar beet roots	0.01* (EFSA, 2010)	0.01* (FAO, 2018) (c)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 8.4% ADI.
0900020	Sugar canes	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.9% ADI.
0900030	Chicory roots	0.01* (Reg. 2019/552)	Not considered (d)	0.001*	Lower LOQ provisional pending further validation. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
1011010	Swine: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 11% ADI. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in swine muscle/meat to the total exposure.
1011020	Swine: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually below 3% ADI.
1011030	Swine: Liver
1011040	Swine: Kidney
1011050	Swine: Edible offals (other than liver and kidney)
1012010	Bovine: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure 22% ADI. An LOQ of 0.005 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the high contribution of residues in bovine muscle/meat to the total exposure.
1012020	Bovine: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <2% ADI.
1012030	Bovine: Liver
1012040	Bovine: Kidney
1012050	Bovine: Edible offals (other than liver and kidney)
1013010	Sheep: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <3% ADI.
1013020	Sheep: Fat tissue			0.01*
1013030	Sheep: Liver
1013040	Sheep: Kidney
1013050	Sheep: Edible offals (other than liver and kidney)
1014010	Goat: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Lower LOQ sufficiently validated. Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
1014020	Goat: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI (for several matrices no consumption data available).
1014030	Goat: Liver
1014040	Goat: Kidney
1014050	Goat: Edible offals (other than liver and kidney)
1015010	Equine: Muscle/meat			0.005*	Lower LOQ sufficiently validated. Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure <1% ADI.
1015020	Equine: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI (for several matrices no consumption data available).
1015030	Equine: Liver
1015040	Equine: Kidney
1015050	Equine: Edible offals (other than liver and kidney)
1016010	Poultry: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Lower LOQ sufficiently validated. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 7% ADI.
1016020	Poultry: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI.
1016030	Poultry: Liver
1016040	Poultry: Kidney
1016050	Poultry: Edible offals (other than liver and kidney)
1017010	Other farmed animals: Muscle/meat	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Lower LOQ sufficiently validated. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 1.3% ADI.
1017020	Other farmed animals: Fat tissue			0.01*	Chronic consumer intake concerns cannot be excluded. Contribution of residues to the chronic exposure individually <1% ADI (for several matrices no consumption data available).
1017030	Other farmed animals: Liver
1017040	Other farmed animals: Kidney
1017050	Other farmed animals: Edible offals (other than liver and kidney)
1020010	Milk: Cattle	0.01* (Reg. 2019/552) 0.01	Not considered (d)	Further consideration needed	Chronic and acute (124%) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 59.7% ADI An LOQ of 0.001 mg/kg is sufficiently validated, but a lower LOQ would be necessary to ensure sufficient consumer protection, considering the acute intake concern and the high contribution of residues in cattle milk to the chronic exposure.
1020020	Milk: Sheep			Further consideration needed	Chronic and acute (151%) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 2.4% ADI. A lowering of the existing LOQ of 0.01 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
1020030	Milk: Goat			Further consideration needed	Chronic and acute (242%) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 3.6% ADI. A lowering of the existing LOQ of 0.01 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.
1020040	Milk: Horse			0.01*	Chronic exposure concerns cannot be excluded. No consumption data available to estimate contribution of residues to the total chronic exposure.
1030010	Eggs: Chicken	0.01* (Reg. 2019/552)	Not considered (d)	0.005*	Lower LOQ sufficiently validated. Chronic exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 6.7% ADI.
1030020	Eggs: Duck				Lower LOQ sufficiently validated. Chronic exposure concerns cannot be excluded. No consumption data available to estimate contribution of residues to the total chronic exposure.
1030030	Eggs: Goose
1030040	Eggs: Quail
1040000	Honey and other apiculture products	0.05* (Reg. 2019/552)	Not considered (d)	Further consideration needed	Chronic and acute (179%) exposure concerns cannot be excluded. Contribution of residues to the chronic exposure 5% ADI. A lowering of the existing LOQ of 0.05 mg/kg would be necessary to ensure sufficient consumer protection, considering the acute intake concern.

MRL: maximum residue level; CXL: codex maximum residue limit; JMPR: Joint FAO/WHO Meeting on Pesticide Residues; LOQ: limit of quantification; ADI: acceptable daily intake; ARfD: acute reference dose.

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

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

^(b)Crops on which authorised uses were reported by the MRL review (EFSA, 2010) or an MRL was implemented on the basis of the CXL, are reported in bold.

^(c)Based on EU GAP.

^(d)Not considered relevant for the present assessment.

(ft 1): The European Food Safety Authority identified some information on storage stability, crop metabolism and residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 25 January 2016, or, if that information is not submitted by that date, the lack of it.

(ft 2): The European Food Safety Authority identified some information on crop metabolism as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 25 January 2016, or, if that information is not submitted by that date, the lack of it.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

bw

body weight

CAC

Codex Alimentarius Commission

CCPR

Codex Committee on Pesticide Residues

CXL

codex maximum residue limit

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

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

JMPR

Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues)

LOAEL

lowest observed adverse effect level

LOQ

limit of quantification

MRL

maximum residue level

NEDI

national estimated daily intake

NESTI

national estimated short‐term intake

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

PAFF

Standing Committee on Plants, Animals, Food and Feed

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RD

residue definition

SANCO

Directorate‐General for Health and Consumers

SCPAFF

Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH)

STMR

supervised trials median residue

WHO

World Health Organization

Appendix A – Input values for the exposure calculations

A.1 Input values consumer risk assessment – Scenario 1

Commodity	Existing/ Proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: oxamyl
Bananas	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Potatoes	0.01*	EFSA (2010)	0.005	STMR (EFSA, 2010)	0.005	HR (EFSA, 2010)
Carrots	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Parsnips	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Salsifies	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Tomatoes	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Aubergines/ eggplants	0.02	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Cucumbers, gherkins, courgettes	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Melons, watermelones	0.01	FAO (2018)	0.005	STMR (pulp) (FAO, 2018)	0.005	HR (pulp) (FAO, 2018)
Brussels sprouts	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Sugar beet root	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Other commodities of plant and animal origin	0.01* or 0.02* or 0.05*	EU MRL (Regulation (EU) 2019/552)	0.01 or 0.02 or 0.05	EU MRL (Regulation (EU) 2019/552)	0.01 or 0.02 or 0.05	EU MRL (Regulation (EU) 2019/552)

MRL: maximum residue level; STMR: supervised trials median residue in raw agricultural commodity; HR: highest residue in raw agricultural commodity

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

A.2 Input values consumer risk assessment – Scenario 2

Commodity	Existing/ Proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: oxamyl
Bananas	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Potatoes	0.01*	EFSA (2010)	0.005	STMR (EFSA, 2010)	0.005	HR (EFSA, 2010)
Carrots	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Parsnips	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Salsifies	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Tomatoes	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Aubergines/ eggplants	0.02	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Cucumbers, gherkins, courgettes	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Melons, watermelones	0.01	FAO (2018)	0.005	STMR (pulp) (FAO, 2018)	0.005	HR (pulp) (FAO, 2018)
Brussels sprouts	0.01*	EFSA (2010)	0.01	STMR (EFSA, 2010)	0.01	HR (EFSA, 2010)
Citrus fruits (except oranges), pome fruits, stone fruits, berries and small fruits, miscellaneous fruit (except table olives and avocados	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Oranges	0.01*	LOQ	0.002	Lowest analytical validation level (EURLs)	0.002	Lowest analytical validation level (EURLs)
Avocados	0.01*	LOQ	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Root and tuber vegetables (except potatoes, carrots, parsnips, salsifies)	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Bulb vegetables	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Fruiting vegetables (except tomatoes, aubergines/eggplants, cucumbers, gherkins, courgettes, melons and watermelons)	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Brassica vegetables (except Brussesl sprouts) Leaf vegetables, herbs and edible flowers Legume vegetables Stem vegetables, Fungi	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Cereals	0.01*	LOQ	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Sugar plants	0.01*	EU MRL (Regulation (EU) 2019/552)	0.001(a)	Lowest analytical validation level (EURLs)	0.001(a)	Lowest analytical validation level (EURLs)
Meat of swine, bovine, sheep, goat, equine, poultry, other farmed terrestrial animals	0.01*	LOQ	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Bird's Eggs	0.01*	LOQ	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Cattle milk	0.01*	LOQ	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Tree nuts, table olives; Pulses; Oilseeds; Oilfruits	0.01*	EU MRL (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Tea, coffee, herbal infusions; Hops; Spices	0.05*	EU MRL (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)
Fat, liver, kidney, edible offal of swine, bovine, sheep, goat, equine, poultry, other farmed terrestrial animals	0.01*	EU MRL (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Milk of sheep, goat, horse	0.01*	EU MRL (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Honey and other apiculture products	0.05*	EU MRL (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)

MRL: maximum residue level; STMR: supervised trials median residue in raw agricultural commodity; HR: highest residue in raw agricultural commodity; EURLs: European Union Reference Laboratories for Pesticide Residues; LOQ: limit of quantification.

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

^(a)No concentration of residues is expected in sugar and therefore in sugar beet root the input value is the lowest valdiation level of 0.001 mg/kg as reported by EURLs for high water content matrices.

A.3 Input values consumer risk assessment – Scenario 3

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: oxamyl
Citrus fruits (except oranges), pome fruits, stone fruits, berries and small fruits, miscellaneous fruit (except table olives and avocados	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Oranges	0.002	Lowest analytical validation level (EURLs)	0.002	Lowest analytical validation level (EURLs)
Avocados	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Root and tuber vegetables, Bulb vegetables, Fruiting vegetables (except tomatoes), Brassica vegetables, Leaf vegetables, Herbs and edible flowers Legume vegetables Stem vegetables, Fungi, Sugar plants	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Tomatoes	0.002	Lowest analytical validation level (EURLs)	0.002	Lowest analytical validation level (EURLs)
Cereals	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Meat of swine, bovine, sheep, goat, equine, poultry, other farmed terrestrial animals	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Bird's Eggs	0.005	Lowest analytical validation level (EURLs)	0.005	Lowest analytical validation level (EURLs)
Cattle milk	0.001	Lowest analytical validation level (EURLs)	0.001	Lowest analytical validation level (EURLs)
Tree nuts, table olives; Pulses; Oilseeds; Oilfruits	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Tea, coffee, herbal infusions; Hops; Spices	0.05	LOQ (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)
Fat, liver, kidney, edible offal of swine, bovine, sheep, goat, equine, poultry, other farmed terrestrial animals	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Milk of sheep, goat, horse	0.01	LOQ (Regulation (EU) 2019/552)	0.01	LOQ (Regulation (EU) 2019/552)
Honey and other apiculture products	0.05	LOQ (Regulation (EU) 2019/552)	0.05	LOQ (Regulation (EU) 2019/552)

EURLs: European Union Reference Laboratories for Pesticide Residues; LOQ: limit of quantification.

Appendix B – Consumer risk assessment

Appendix C – Pesticide Residue Intake Model (PRIMo)

PRIMo (scenario 1)

PRIMo (scenario 2)

PRIMo (scenario 3)

Appendix D – Used compound codes

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Oxamyl	methyl (EZ)‐2‐(dimethylamino)‐N‐[(methylcarbamoyl)oxy]‐2‐oxothioacetimidate KZAUOCCYDRDERY‐UHFFFAOYSA‐N O=C(C(=N\OC(=O)NC)/SC)N(C)C
IN‐D2708	(dimethylamino)(oxo)acetic acid CN(C)C(=O)C(=O)O YKFGLGXRUVEMNF‐UHFFFAOYSA‐N
IN‐A2213	methyl (1Z)‐2‐(dimethylamino)‐N‐hydroxy‐2‐oxoethanimidothioate CN(C)C(=O)C(=N\O)\SC KIDWGGCIROEJJW‐XQRVVYSFSA‐N
IN‐QKT34 (IN‐A2213 glucoside)	1‐O‐{(Z)‐[2‐(dimethylamino)‐1‐(methylsulfanyl)‐2‐oxoethylidene]amino}hexopyranose CN(C)C(=O)C(=N\OC1OC(CO)C(O)C(O)C1O)\SC BVJZJNMSARVECQ‐XFXZXTDPSA‐N
IN‐N0079	[(cyanocarbonyl)azanediyl]dimethane CN(C)C(=O)C#N DNRRZLQWEDPRRM‐UHFFFAOYSA‐N

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

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

^(b)ACD/Name 2021.1.3 ACD/Labs 2021.1.3 (File Version N15E41, Build 123,232, 7 July 2021).

^(c)ACD/ChemSketch 2021.1.3 ACD/Labs 2021.1.3 (File Version C25H41, Build 123,835, 28 August 2021).

Suggested citation: EFSA (European Food Safety Authority) , 2023. Statement on the risk assessment of maximum residue levels (MRLs) for oxamyl in view of consumer protection. EFSA Journal 2023;21(3):7823, 53 pp. 10.2903/j.efsa.2023.7823