Modification of the existing maximum residue levels for copper compounds in other small fruits and berries.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Spiess-Urania Chemicals GmbH submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance copper compounds in the whole group of other small fruits and berries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the whole subgroup of other small fruits and berries. Adequate analytical methods for enforcement of mineral copper independently from its chemical form are available for matrices under consideration at the validated limit of quantification (LOQ) of 5 mg/kg. Based on indicative risk assessment results, EFSA concluded that the long-term intake of copper residues resulting from the intended and existing uses, natural background levels and monitoring levels might present a risk to consumer health. Although residues in other small fruits and berries are minor contributors to the overall consumer exposure, a risk management decision has to be taken on whether it is appropriate to increase the existing MRLs for these crops, given that a potential consumer intake concern could not be excluded.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Spiess‐Urania Chemicals GmbH submitted an application to the competent national authority in Austria (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance copper compounds in other small fruits and berries application.

The application, alongside the dossier containing the supporting data using the IUCLID format was submitted through the EFSA Central Submission System on 12 May 2021. The appointed EMS (Austria) assessed the dossier and declared its admissibility on 12 August 2021. Subsequently, following the implementation of the EFSA's confidentiality decision, the dossier was published by EFSA, and a public consultation was launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 13 October 2021 to 3 November 2021. No additional data nor comments were submitted in the framework of the consultation. At the end of the commenting period, the EMS proceeded with drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005. The report was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 28 February 2022. To accommodate for the intended uses of copper compounds, the EMS proposed to raise the existing MRLs for other small fruits and berries from the limit of quantification (LOQ) of 5–15 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps which were requested from the EMS. On 25 May 2022, the applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 30 May 2022, which replaced the previously submitted evaluation report.

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

Specific studies evaluating the metabolism and distribution of residues in plants following the use of copper compounds as a plant protection product are not available. According to the public scientific literature, in plants, copper ions are absorbed from the soil through the roots and then further transported to the rest of the plant. Upon foliar application, transportation and distribution of copper in plants are limited. As no metabolites are expected, the nature of residues in primary crops, rotational crops and processed commodities as well as the storage stability are considered addressed and specific studies are not required.

The relevant residue for monitoring and risk assessment was defined as total copper, including copper residues arising from all forms of copper. Analytical methods for enforcement of mineral copper independently from its chemical form are available for matrices under consideration (high acid content commodities) at the validated limit of quantification (LOQ) of 5 mg/kg.

The available data are considered sufficient to derive an MRL proposal of 15 mg/kg as well as risk assessment values for other small fruits and berries in support of the intended northern outdoor use of copper hydroxide.

Specific studies investigating the magnitude of copper residues in processed commodities from the group of other small fruits and berries were not submitted and are not required considering very low contribution of residues in these crops to the total theoretical maximum daily intake (TMDI).

Since the intended use of copper hydroxide is on permanent crops, investigations of residues in rotational crops are not required. However, copper being an essential nutrient for plant growth development, it is normally taken up from the soil where it occurs naturally or after applications of pesticide products and fertilisers. The uptake of copper is regulated by plants to provide the essential nutritional amount. Therefore, copper can be present in succeeding crops (annual and permanent) as an endogenous compound, following natural soil absorption as a micronutrient. Based on the literature data on the copper background levels in plant commodities and based on the copper levels measured in the untreated samples of the residue trials submitted in the present opinion, it could be concluded the MRL derived in the present opinion largely covers the potential uptake of copper from the soil in succeeding years of applications.

Residues of copper in commodities of animal origin were not assessed since other small fruits and berries are normally not fed to livestock.

The toxicological profile of copper was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were considered sufficient at the time to derive an acceptable daily intake (ADI) of 0.15 mg/kg body weight (bw) per day. An acute reference dose (ARfD) was not deemed necessary. It is noted that EFSA's Scientific Committee has recently prepared a scientific opinion under an European Commission mandate to harmonise previous divergent HBGVs for copper, where a replacement of this ADI is proposed and an updated exposure assessment from all sources of copper was performed (EFSA‐Q‐2020‐00399). The draft scientific opinion of the Scientific Committee is currently under public consultation. Should the proposed revised ADI be established as a result of the scientific opinion of the Scientific Committee, the risk assessment in this reasoned opinion shall be reconsidered.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). An indicative exposure to copper residues was calculated based on all critical GAPs authorised in the EU and the background levels (from survey or monitoring data) expected in all commodities of plant and animal origin in the EFSA review of the existing MRLs for copper under Article 12 of Regulation 396/2005 (MRL review). For the long‐term consumer exposure, an update of scenario 1 (considering all commodities of plant and animal origin) and scenario 2 (considering risk mitigation measures to reduce the exposure) performed in the MRL review was done considering the input values derived from the intended uses. In both scenarios, the maximum exposure exceeded the ADI (166% and 162% of the ADI for the Dutch toddler diet, respectively). It is noted that, in the MRL review, using revision 2 of PRIMo, an exceedance of the ADI was identified for scenario 1 but not for scenario 2. The significant increase in the calculated exposure derived in the current assessment compared with the risk assessment performed in the framework of the MRL review is related to the use of the new version of EFSA PRIMo (revision 3.1) which contains updated food consumption data. Nevertheless, the contribution of copper residues in other small fruits and berries to the actual long‐term consumer exposure is very low (1.08% of the ADI considering the contribution of the whole group of other small fruit and berries; individually, maximum of 0.46% of the ADI for currants).

EFSA concluded that the long‐term consumer intake concerns cannot be excluded for the intake of copper residues resulting from the intended uses, existing uses and background/monitoring levels. Although residues in other small fruits and berries from the new intended uses result in a very low contribution to the overall consumer exposure, a risk management decision needs to be taken on whether it is appropriate to increase the existing MRL for these commodities from 5 to 15 mg/kg, given that, based on the currently available information, potential consumer intake concerns cannot be excluded. It is noted that EFSA is also currently working on a mandate to review the ADI for copper and to perform exposure calculations from all sources of copper (EFSA‐Q‐2020‐00399). The draft opinion is currently under public consultation. Therefore, the conclusions reported in this reasoned opinion may need to be reconsidered following the outcome of the review of the ADI for copper and exposure assessment considering all sources of copper.

EFSA proposes to amend the existing MRLs as reported in the summary table below.

Full details of all end points and the consumer risk assessment can be found in Appendices Appendix B – List of end points, Appendix C – Pesticide Residue Intake Model (PRIMo)–D.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for copper compounds in other small fruits and berries. The detailed description of the intended uses of copper hydroxide which are the basis for the current MRL application is reported in Appendix A.

Copper hydroxide is the common name for copper (II) hydroxide (or copper (2+) hydroxide or cupric hydroxide) (IUPAC). The active substances are copper(I) and copper (II) ions.

Copper compounds1 have been evaluated for renewal of the approval in the framework of Regulation (EC) No 1107/20092 with France designated as rapporteur Member State (RMS) for the representative uses as fungicide/bactericide on field applications on grapes and field and greenhouse applications on tomatoes and cucurbits. The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA (2018b). The peer review conclusions of EFSA published in 2018 (EFSA, 2018b) supersede the previous EFSA assessments (EFSA, 2008, 2013). The decision on the renewal of copper compounds entered into force on 1 January 2019.3 The use of plant protection products containing copper compounds is restricted to a maximum application rate of 28 kg/ha of copper over a period of 7 years (i.e. on average 4 kg/ha per year).4

The EU MRLs covering the uses of the different copper compounds are established in Annex III of Regulation (EC) No 396/20055; the MRLs are expressed on the basis of copper ions (all forms of copper present in the plant converted to Cu2+). The review of existing EU MRLs for copper compounds according to Article12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2018c). The MRL proposals have not yet been implemented in the EU MRL regulation.

In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/13816, the applicant Spiess‐Urania Chemicals GmbH submitted on 12 May 2021 an application to the competent national authority in Austria, alongside the dossier containing the supporting data using the IUCLID format.

It is noted that for the current application, no general presubmission advice (GPSA) from EFSA was sought by the applicant in accordance with Article 32a(1) of the General Food Law GFL Regulation,7 prior to submission of this dossier.

Furthermore, none of the studies submitted to support this MRL application were subject to the obligation of study notifications in accordance with Article 32b of the GFL Regulation,8 since they were all commissioned or carried out before 27 March 2021.

The EMS assessed the dossier and declared its admissibility on 12 August 2021. Subsequently, following the implementation of the EFSA's confidentiality decision, the dossier was published by EFSA, and a public consultation was launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 13 October 2021 to 3 November 2021. No additional data nor comments were submitted in the framework of the consultation. At the end of the commenting period, the EMS proceeded with drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005. The report was submitted to the European Commission and forwarded to the EFSA on 28 February 2022. To accommodate for the intended uses of copper compounds, the EMS proposed to raise the existing MRLs for other small fruits and berries from the limit of quantification (LOQ) of 5–15 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps which were requested from the EMS. On 25 May 2022, the applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 30 May 2022 (Austria, 2022), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Austria, 2022), the draft renewal assessment report (RAR) (and its addendum) (France, 2016, 2017) prepared under Regulation (EC) 1107/2009, the Commission review report on copper compounds (European Commission, 2018), the conclusion on the peer review of the pesticide risk assessment of the active substance copper compounds (EFSA, 2018b), as well as the conclusions from previous EFSA opinions on copper compounds, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2018c, 2020).

For this application, the data requirements established in Regulation (EU) No 283/20139 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 2010, 2017, 2020, 2021; OECD, 2007a,b, 2009a,b, 2011, 2016). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/201110.

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

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

Residues in plants

Nature of residues and methods of analysis in plants

Nature of residues in primary crops

Specific studies evaluating the metabolism and distribution of residues in plants following the use of copper as a plant protection product are not available. However, the public scientific literature reported in the framework of the first peer review provided enough information on the uptake, translocation and effects of copper in plants (EFSA, 2018b,c).

In plants, copper is absorbed from the soil through the roots. From the roots, copper is transported in the sap to the rest of the plant. Upon foliar application, transportation and distribution of copper in plants are limited.

For the intended use, the metabolic behaviour in primary crops is thus considered addressed.

Nature of residues in rotational crops

Copper is extremely stable in soil and since no degradation is expected, no DT50/DT90 values were derived during the EU pesticides peer review and the MRL review (EFSA, 2018b,c). However, for the same reason as mentioned in Section 1.1.1, specific studies to evaluate the nature of residues in succeeding crops are not necessary.

Copper hydroxide is proposed to be used on permanent crops that are not grown in rotation with other crops. Nevertheless, all soil‐grown crops may contain copper (EFSA, 2018c), which is absorbed from the soil and can be transported to the rest of the plant, residue uptake in succeeding crops is a relevant issue. This point is further discussed under Section 1.2.2.

Nature of residues in processed commodities

Studies investigating the effects of industrial processing or household preparation on the nature of copper residues are not available. However, such studies are not necessary as copper is known to be inherently stable (see also Section 1.1.1) (EFSA, 2018a,c).

Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of copper residues in plant matrices were provided and evaluated in the framework of the initial EU pesticides peer review (EFSA, 2008) and the MRL review (2018c). The available methods involve atomic absorption spectrometry (AAS) and were validated in commodities with high water content (limit of quantification (LOQ) of 2 mg/kg) and high acid content (LOQ of 5 mg/kg) (EFSA, 2018c).

It is noted that in the framework of the renewal of the approval of copper compounds under Regulation (EC) No 1107/2009, similar methods were reassessed and there are indications that a lower LOQ of 0.2 mg/kg could be achieved in these crops. Data gaps were identified for additional validation data for high oil content commodities, dry commodities and for an independent laboratory validation (ILV) for plants (EFSA, 2018b). The MRL review concluded that the ILV is not deemed necessary since AAS are recognised as standard methods of analysis for inorganic elements (EFSA, 2018c).

With regard to the crops under consideration (high acid content commodities), EFSA concludes that sufficiently validated analytical enforcement methods are available.

Storage stability of residues in plants

Since copper cannot degrade and since the analytical techniques measure total copper content, storage stability studies are not required (EFSA, 2018b,c).

Proposed residue definitions

The nature of copper residues in primary crops, rotational crops and processed commodities as well as its stability during storage are considered sufficiently addressed. The relevant residue for monitoring and risk assessment was defined as total copper, including copper residues arising from the different variants of copper (EFSA, 2018b). This definition is expected to include copper residues arising from all forms of copper as they would be converted to Cu2+ during the analytical phase (EFSA, 2018c).

The current residue definition for enforcement set in Regulation (EC) No 396/2005 is ‘Copper compounds (copper)’, therefore identifying the same marker compound for enforcement as the above‐mentioned residue definition, but with a slightly different wording.

EFSA concluded that these residue definitions are appropriate for the current assessment and no further information is required.

Magnitude of residues in plants

Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted six residue trials performed in currants. The samples were analysed for total copper as per residue definition for enforcement and risk assessment. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose. Since copper is a nutrient, naturally present in plants, copper residues were also found in untreated control samples (see Section 1.2.2).

The six residue trials were performed in 2020 in various Member States of northern Europe (Austria, Northern France, Germany, Hungary and Poland). All trials were conducted according to the GAP, with three foliar spray applications at an application rate of 1 kg a.s./ha. The interval between the applications was 5 days. No PHI is specified in the intended GAP as the timing of application is defined by the growth stage of the plant.

In three residue trials, the growth stage at last application was reported as BBCH 59 (before flowering) in perfect accordance with the intended GAP. In the three other trials however, the growth stage at the last application was reported as BBCH 61 (10% of flowers open). In both cases, no consumable parts of the crop were present at last application. Nevertheless, it was noted that residues in samples treated at BBCH 59 were < 0.8 (LOQ), 1.08, 1.36 mg/kg while residues of samples treated at BBCH 61 were 2.73, 3.23 and 6.22 mg/kg. A robust statistical correlation between crop stage at last application and the residue levels measured in currants is not possible based on six samples. However, upon EFSA's request, the applicant was invited to provide further clarifications on the trials performed with the last application at BBCH 61. The applicant clarified that while the growth stage at the last application was reported as BBCH 61, the crop development of the plant bushes of the same plot can be inhomogeneous. For example, in the trial leading to the highest value of the data set (6.22 mg/kg), individual samples were taken from at least six separate bushes, where the BBCH at last application varied between 55 and 61.

It should be noted that inhomogeneous development of bushes is also happening in real agricultural conditions as it is very unlikely that all bushes reach the same growth stage on the same day. Consequently, the single plants that have been treated at growth stages slightly exceeding BBCH 59 (e.g. BBCH 61) in those trials might also be present in real conditions. Therefore, EFSA agrees with the conclusion of the EMS that the six available residue trials can be considered as GAP compliant.

According to the current technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation on residue data on products from plant and animal origin – SANTE/2019/12752 (European Commission, 2020), six trials are sufficient to support the northern GAP on currants and the extrapolation of results in currants to the whole subgroup of other small fruits and berries (0154000) is possible.

Magnitude of residues in rotational crops

Copper is an essential nutrient for plant growth development and is normally taken up from soil where it occurs naturally or after succeeding applications. Considering information published in scientific literature, the peer review concluded that the uptake of copper is regulated by plants to provide the essential nutritional amount. Therefore, copper can be present in succeeding crops (annual and permanent) as an endogenous compound, following natural soil absorption as a micronutrient (EFSA, 2018b).

A comprehensive survey on the copper background levels in plant commodities was reported in the framework of the MRL review (full report available in Annex A of the EFSA reasoned opinion on the review of existing MRLs for copper compounds; EFSA, 2018c). According to this survey, the maximum natural background level of copper in the group of other small fruits and berries is 1.8 mg/kg (found in rose hips). The maximum for all berries (including cane fruits) is 2.2 mg/kg. In addition, copper levels in the untreated samples of the residue trials submitted in the present opinion range between < 0.8 mg/kg (LOQ) and 2.09 mg/kg. This information gives an indication of the background levels of copper that are expected in the commodities belonging to the group of other small fruits and berries. The assessment performed in Section 1.2.1 indicates that the MRL proposal derived in the present opinion (15 mg/kg) largely covers the potential uptake of copper from the soil, which is regulated by the plant depending on its nutritional needs.

Since the intended use of copper hydroxide is on permanent crops, investigations of residues in rotational crops are not required. Furthermore, the intended use of copper hydroxide on the group of other small fruits and berries is in line with the provisions of the Commission Implementing Regulation EU 2018/198111 (restricted annual application rate of average 4 kg copper/ha and maximum total application of 28 kg copper/ha over a period of 7 years) and is below the application rates assessed for the representative uses in the renewal of the approval of copper compounds (EFSA, 2018b).

Magnitude of residues in processed commodities

New studies investigating the effect on the magnitude of copper residues in processed crops under consideration were not submitted in the framework of this assessment and are not requested since the contribution of other small fruits and berries to the consumer intake is very low (see Section 3) and further refinements would not have major impact on reducing the total exposure to copper residues.

Proposed MRLs

The available data are considered sufficient to derive an MRL proposal of 15 mg/kg as well as risk assessment values for crops belonging to the group of other small fruits and berries in support of the intended northern outdoor use of copper hydroxide.

EFSA notes that a different MRL proposal (LOQ of 5 mg/kg) was recommended by the MRL review (EFSA, 2018c). In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

Residues in livestock

Not relevant as crops under consideration are not used for feed purposes.

Consumer risk assessment

In the framework of the MRL review (EFSA, 2018c), a comprehensive long‐term exposure assessment was performed using revision 2 of EFSA Pesticide Residues Intake Model (PRIMo), taking into account the exposure to copper from authorised (existing) uses as well as from any other sources (background concentrations, uptake from the soil, etc.). The commodities on which no uses were reported in the MRL review were therefore also included in the calculation.

Two scenarios of exposure calculation were performed in the MRL review:

scenario 1, including all commodities of plant and animal origin;

scenario 2, considering a proposal for risk mitigation measures to reduce the exposure based on the main contributors to the chronic exposures identified using the revision 2 of PRIMo.

In the context of an MRL assessment performed in 2020 for fresh herbs and edible flowers, EFSA has updated these exposure calculations using revision 3.1 of the EFSA PRIMo and new STMR values derived from fresh herbs and edible flowers (EFSA, 2020). For the current assessment, EFSA now updated the calculations performed in EFSA (2020), adding the new STMR derived for currants and extrapolated to the other commodities included in the group other small fruits and berries. Calculations were done assuming that the recommendations of the MRL review will be taken over in the EU legislation and are indicative considering the data gaps identified in the MRL review (EFSA, 2018c). The detailed input values used for each crop are available in Appendix D.1 of the present opinion.

The revision 3.1 of the EFSA PRIMo is still used in the current assessment. This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population (EFSA, 2018a, 2019).

The toxicological reference value for copper compounds used in the risk assessment (i.e. ADI value of 0.15 mg/kg bw day) was derived in the framework of the EU pesticides peer review (European Commission, 2018).12 The setting of the ARfD was considered not necessary.

The calculated long‐term dietary exposure to copper residues considering all commodities of plant and animal origin (scenario 1) and the new STMR for other small fruit and berries exceeded the ADI. In scenario 1, the maximum exposure accounted for 166% of the ADI for the Dutch toddler diet. It is noted that an exceedance of the ADI (108.9%; WHO Cluster diet B) was also identified in the MRL review for scenario 1 (EFSA, 2018c) using revision 2 of PRIMo. However, the food contributors identified in the MRL review to propose risk mitigation measures (wine grapes, tomatoes, potatoes and lettuce) are not significantly contributing to the exposure calculated for the Dutch toddler diet with PRIMo rev. 3.1. Therefore, scenario 2 (risk mitigation measures as defined in the MRL review) does not have a significant impact on the chronic exposure calculated for Dutch toddler. When assessing scenario 2 with PRIMo 3.1, the calculated exposure still accounts for 162% of the ADI for the Dutch toddler diet. EFSA notes that in the MRL review, the exposure calculated in scenario 2 with PRIMo 2 resulted in a chronic exposure below the ADI (93.4% of the ADI) (EFSA, 2018c).

The significant increase of the calculated exposure derived in the current assessment compared with the risk assessment performed in the framework of the MRL review is related to the use of the new version of EFSA PRIMo (revision 3.1) which contains updated food consumption data. Nevertheless, the contribution of copper residues from the whole group of other small fruits and berries to the actual long‐term consumer exposure is very low (1.08% of the ADI considering the contribution of the whole group of other small fruit and berries; individually, maximum of 0.46% of the ADI for currants).

The MRL review EFSA also assessed potential exposure via drinking water (EFSA, 2018c).

It is noted that in the evaluation report of the EMS, an additional calculation of the chronic exposure performed by the applicant was reported. This calculation resulted in a non‐exceedance of the ADI (Austria, 2022). However, this calculation seems to be based on different input values for several crops, most of them not fully justified. For many crops where authorised GAPs were reported and assessed during the MRL review (e.g. pome fruits, grapes, lettuces and similar, spinach and similar), the STMR values derived in the MRL review were not considered. Instead, the medians of the background levels were considered without justification. Furthermore, for maize grain, sunflower seed and sugar beet, a dilution factor of 10 was applied based on the rational that these crops are mainly eaten as processed. While it is noted that a processing factor of 10 was supported for oil processing of rapeseed (EFSA, 2018c), the use of this dilution factor of 10 for maize, sunflower and sugar beet is not justified. For maize, processing to oil is not the only possible process and there is no evidence that the dilution factor of 10 would also apply to maize oil and to other maize products. Furthermore, for maize grain, a median background level of 2.4 mg/kg was considered while a median background level of 4.15 mg/kg was used in the MRL review (EFSA, 2018c). For sugar beet, EFSA agrees that a dilution might be expected through the sugar production, but the factor of 10 is not supported by any data. For sunflower oil, a dilution factor of 10 could indeed be extrapolated but EFSA already considered in the MRL review that this crop is not exclusively consumed as oil (in the contrary to rapeseed). Consequently, EFSA agrees with the EMS that the calculation performed by the applicant is not reliable. Therefore, the concerns identified by the EMS and EFSA regarding the chronic exposure of the Dutch toddler diet are still relevant.

In addition, it should be noted that EFSA has received a mandate to review the hazard assessment (ADI) and to update the exposure assessment for copper compounds considering all sources of copper (EFSA‐Q‐2020‐00399). The draft opinion is currently under public consultation.

EFSA concluded that the long‐term consumer intake concerns cannot be excluded for the intake of copper residues resulting from the intended uses, existing uses and background/monitoring levels. Although residues in the group of other small fruits and berries from the new intended use contribute to a very low extent to the overall consumer exposure, a risk management decision needs to be taken whether it is appropriate to increase the existing MRL for these commodities from 5 to 15 mg/kg, given that, based on the currently available information, potential consumer intake concerns cannot be excluded. The ongoing assessment performed by EFSA upon European Commission mandate (EFSA‐Q‐2020‐00399) may provide further new elements to assist risk managers in this decision process.

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

Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal of 15 mg/kg for copper for the whole group of other small fruits and berries in support of the intended use of copper hydroxide. The intended NEU use results in a more critical residue situation in these crops compared to the GAPs assessment in the MRL review, which proposed to set the MRL at the LOQ of 5 mg/kg.

Based on an indicative risk assessment, EFSA concluded that the long‐term consumer intake concerns cannot be excluded for the intake of copper residues resulting from all existing uses and considering the background copper levels present in food of plant and animal origin. Residues in the group of other small fruits and berries resulting from the new intended uses contribute to a very low extent to the overall consumer exposure. A risk management decision has to be taken on whether it is appropriate to increase the existing MRL in these crops to 15 mg/kg, given that, based on the currently available information, potential consumer intake concerns cannot be excluded and considering that EFSA is also currently working on a mandate to review the ADI for copper and to perform exposure calculations from all sources of copper (EFSA‐Q‐2020‐00399). Since the draft opinion is currently under public consultation, the conclusions reported in this reasoned opinion may need to be reconsidered following the outcome of the review of the ADI for copper and exposure assessment considering all sources of copper.

The MRL recommendations are summarised in Appendix B.4.

active substance

acceptable daily intake

applied radioactivity

acute reference dose

growth stages of mono‐ and dicotyledonous plants

body weight

Codex Alimentarius Commission

Chemical Abstract Service

Codex Committee on Pesticide Residues

European Committee for Standardisation (Comité Européen de Normalisation)

conversion factor for enforcement to risk assessment residue definition

critical GAP

Collaborative International Pesticide Analytical Council

(EU) Communication & Information Resource Centre Administrator

Communication and Information Resource Centre for Administrations, Businesses and Citizens

capsule suspension

coefficient of variation (relative standard deviation)

Codex maximum residue limit

days after last application

draft assessment report

days after treatment

dry matter

dustable powder

powder for dry seed treatment

period required for 90% dissipation (define method of estimation)

dry weight

emulsifiable concentrate

electron capture detector

estimated daily intake

evaluating Member State

residue expressed as a.s. equivalent

electrospray ionisation

EU Reference Laboratory (former Community Reference Laboratory (CRL))

Food and Agriculture Organization of the United Nations

flame ionisation detector

fluorescence detector

flame photometric detector

Good Agricultural Practice

gas chromatography

gas chromatography with electron capture detector

gas chromatography with flame ionisation detector

gas chromatography with flame photometric detector

gas chromatography with mass spectrometry

gas chromatography with tandem mass spectrometry

gas chromatography with nitrogen/phosphorous detector

Global Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP))

good laboratory practice

granule

growth stage

high performance liquid chromatography

high performance liquid chromatography with mass spectrometry

high performance liquid chromatography with tandem mass spectrometry

high performance liquid chromatography with ultra‐violet detector

highest residue

international estimated daily intake

international estimated short‐term intake

independent laboratory validation

International Programme of Chemical Safety

International Organisation for Standardisation

International Union of Pure and Applied Chemistry

Joint FAO/WHO Meeting on Pesticide Residues

organic carbon adsorption coefficient

liquid chromatography

lowest observed adverse effect level

limit of detection

limit of quantification

maximum residue level

mass spectrometry detector

Member States

tandem mass spectrometry detector

molecular weight

northern Europe

no observed adverse effect level

nitrogen/phosphorous detector

Organisation for Economic Co‐operation and Development

Standing Committee on Plants, Animals, Food and Feed

plant back interval

processing factor

pre‐harvest interval

partition coefficient between n‐octanol and water

(EFSA) Pesticide Residues Intake Model

(EFSA) Pesticide Residues Overview File

Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)

risk assessment

raw agricultural commodity

statistical calculation of the MRL by using a non‐parametric method

residue definition

statistical calculation of the MRL by using a parametric method

rapporteur Member State

relative potency factor

Directorate‐General for Health and Consumers

suspension concentrate

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

southern Europe

water‐soluble granule

soluble concentrate

water‐soluble powder

supervised trials median residue

total applied radioactivity

theoretical maximum daily intake

total radioactive residue

ultraviolet (detector)

water‐dispersible granule

World Health Organization

wettable powder

yield factor

mixed CS and SC formulation

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

Appendix B – List of end points

B.1 Residues in plants

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

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

B.1.1.2 Stability of residues in plants

B.1.2 Magnitude of residues in plants

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

B.1.2.2 Residues in rotational crops

B.1.2.3 Processing factors

No processing studies were submitted in the framework of the present MRL application.

B.2 Residues in livestock

Not relevant.

B.3 Consumer risk assessment

Acute exposure assessment not relevant since no ARfD has been considered necessary.

B.4 Recommended MRLs

Appendix C – Pesticide Residue Intake Model (PRIMo)

EFSA_Q_2021_00463_Copper hydroxide_PRIMo_rev.3.1_scenario 1.xlsm

EFSA_Q_2021_00463_Copper hydroxide_PRIMo_rev.3.1_scenario 2.xlsm

Appendix D – Input values for the exposure calculations

D.1 Consumer risk assessment

Code (a)	Commodity	Existing EU MRL/MRL proposed in the MRL review (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Copper compounds (Copper)
0154010	Blueberries	5/5*	Further risk management considerations required	The submitted data are sufficient to derive an MRL proposal of 15 mg/kg in support of the intended norther outdoor use of copper hydroxide. Long‐term consumer intake concerns cannot be excluded for the intake of copper residues resulting from the intended and existing uses of copper compounds and background/monitoring levels. Residues in the group of other small fruits and berries contribute to a very low extent to the overall consumer exposure (1.08% of the ADI). A risk management decision has to be taken whether it is appropriate to raise the existing MRL, given that based on the currently available information, a potential consumer intake concern cannot be excluded.
0154020	Cranberries	5/5*
0154030	Currants (black, red and white)	5/5*
0154040	Gooseberries (green, red and yellow)	5/5*
0154050	Rose hips	5/5*
0154060	Mulberries (black and white)	5/5*
0154070	Azaroles/Mediterranean medlars	5/5*
0154080	Elderberries	5/5*
0154990	Others	5/5*

MRL: maximum residue level; EU: European Union; ADI: acceptable daily intake.

Indicates that the MRL is set at the limit of analytical quantification (LOQ).

Commodity code number according to Annex I of Regulation (EC) No 396/2005.

Crop and/or situation	NEU, SEU, MS or country	F G or I (a)	Pests or group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) (d)	Remarks
				Type (b)	Conc. a.s. (g/L)	Method kind	Range of growth stages & season (c)	Number min–max	Interval between application (days) min–max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Small fruit crops (3RIBC, 3VACC, 3MULC, ROSSS, CSCAZ, SAMNI) (e)	NEU (AT, CZ, PL, HU, SK, DE)	F	Drepanopeziza ribis (Leaf spot) (DREPRI) Cronartium ribicola (Rust of gooseberry) (CRONRI)	SC	250 g Cu/L 384 g CuOH/L	Foliar treatment – broadcast spraying	After harvest until flowering (BBCH 91–59)	3	5–7	4	500–1,000	1	kg a.s./ha	n.a.	In case of treatments with low doses (with less effectiveness, e.g. in organic farming), the maximal number of applications could be increased as far as the acceptable annual active ingredient amount of the product is not exceeded.

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; SC: suspension concentrate, n.a.: not applicable.

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

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

Growth 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.

PHI: minimum preharvest interval.

Reference is made to the EPPO codes used for crop groups (https://gd.eppo.int/taxon/3CRGK).

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	–	–	–	–	–
	Copper is a monoatomic element and inherently stable. Therefore, it is not expected to metabolise or to form degradation products (EFSA, 2018b,c)

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	Since copper cannot degrade and since the analytical techniques measure total copper content, storage stability studies are not required (EFSA, 2018b,c).

Commodity	Region (a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (b) (mg/kg)	STMR (c) (mg/kg)
Blueberries Cranberries Currants (black, red and white) Gooseberries (green, red and yellow) Rose hips Mulberries (black and white) Azaroles/Mediterranean medlars Elderberries	NEU	< 0.8 (LOQ); 1.08; 1.36; 2.73; 3.23; 6.22	Six trials performed on currants, all deemed compliant with GAP (last application performed between BBCH 57 and BBCH 61). Extrapolation from currants to the whole subgroup of other small fruits and berries is possible.	15	6.22	2.05

MRL: maximum residue level; GAP: Good Agricultural Practice; BBCH: growth stages of mono‐ and dicotyledonous plants.

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

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

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

Appendix C – Code (a)	Commodity	Existing EU MRL/MRL proposed in the MRL review (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Copper compounds (Copper)
0154010	Blueberries	5/5*	Further risk management considerations required	The submitted data are sufficient to derive an MRL proposal of 15 mg/kg in support of the intended northern outdoor use of copper hydroxide. Long‐term consumer intake concerns cannot be excluded for the intake of copper residues resulting from the intended and existing uses of copper compounds and background/monitoring levels. Residues in the group of other small fruits and berries contribute to a very low extent to the overall consumer exposure (1.08% of the ADI). A risk management decision has to be taken whether it is appropriate to raise the existing MRL, given that based on the currently available information, a potential consumer intake concern cannot be excluded.
0154020	Cranberries	5/5*
0154030	Currants (black, red and white)	5/5*
0154040	Gooseberries (green, red and yellow)	5/5*
0154050	Rose hips	5/5*
0154060	Mulberries (black and white)	5/5*
0154070	Azaroles/Mediterranean medlars	5/5*
0154080	Elderberries	5/5*
0154990	Others	5/5*

MRL: maximum residue level; EU: European Union; ADI: acceptable daily intake.

Indicates that the MRL is set at the limit of analytical quantification (LOQ).

Commodity code number according to Annex I of Regulation (EC) No 396/2005.

Commodity	Proposed MRL (a) (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment
Risk assessment residue definition: Total copper
Grapefruits	15	EFSA (2018c)	1.22	STMR‐RAC × PeF	Acute exposure not calculated since setting of the ARfD was considered not necessary.
Oranges	15	EFSA (2018c)	1.22	STMR‐RAC × PeF
Lemons	15	EFSA (2018c)	1.18	STMR‐RAC × PeF
Limes	15	EFSA (2018c)	1.18	STMR‐RAC × PeF
Mandarins	15	EFSA (2018c)	1.18	STMR‐RAC × PeF
Other citrus fruit	15	EFSA (2018c)	1.22	STMR‐RAC × PeF
Almonds	40	EFSA (2018c)	11.7	STMR‐RAC
Brazil nuts	40	EFSA (2018c)	11.7	STMR‐RAC
Cashew nuts	40	EFSA (2018c)	13.3	Median background levels
Chestnuts	40	EFSA (2018c)	11.7	STMR‐RAC
Coconuts	5	EFSA (2018c)	4.50	Median background levels
Hazelnuts/cobnuts	40	EFSA (2018c)	11.7	STMR‐RAC
Macadamia	40	EFSA (2018c)	11.7	STMR‐RAC
Pecans	40	EFSA (2018c)	11.7	STMR‐RAC
Pine nut kernels	40	EFSA (2018c)	16.0	Mean monitoring data
Pistachios	40	EFSA (2018c)	11.7	STMR‐RAC
Walnuts	40	EFSA (2018c)	11.7	STMR‐RAC
Apples	6	EFSA (2018c)	1.41	STMR‐RAC
Pears	6	EFSA (2018c)	1.41	STMR‐RAC
Quinces	6	EFSA (2018c)	1.41	STMR‐RAC
Medlar	6	EFSA (2018c)	1.41	STMR‐RAC
Loquats/Japanese medlars	6	EFSA (2018c)	1.41	STMR‐RAC
Apricots	3	EFSA (2018c)	1.5	STMR‐RAC
Cherries (sweet)	10	EFSA (2018c)	2.69	STMR‐RAC
Peaches	8	EFSA (2018c)	2.35	STMR‐RAC
Plums	4	EFSA (2018c)	1.15	STMR‐RAC
Table grapes	100	EFSA (2018c)	8.70	STMR‐RAC
Wine grapes	100	EFSA (2018c) (Scenario 1)	2.55	STMR‐RAC × 0.75 (yield factor for juice) × PF (juice) (b)
	2	EFSA (2018c) (Scenario 2)	0.35	Median background levels × 0.75 (yield factor for juice) × PF (juice) (b)
Strawberries	15	EFSA (2018c)	2.29	STMR‐RAC
Blackberries	5	EFSA (2018c)	0.99	STMR‐RAC
Dewberries	5	EFSA (2018c)	0.99	STMR‐RAC
Raspberries (red and yellow)	5	EFSA (2018c)	0.99	STMR‐RAC
Other cane fruit	5	EFSA (2018c)	0.99	STMR‐RAC
Blueberries	15	Intended	2.05	STMR‐RAC
Cranberries	15	Intended	2.05	STMR‐RAC
Currants (red, black and white)	15	Intended	2.05	STMR‐RAC
Gooseberries (green, red and yellow)	15	Intended	2.05	STMR‐RAC
Rose hips	15	Intended	2.05	STMR‐RAC
Mulberries (black and white)	15	Intended	2.05	STMR‐RAC
Azaroles/Mediterranean medlar	15	Intended	2.05	STMR‐RAC
Elderberries	15	Intended	2.05	STMR‐RAC
Dates	2	EFSA (2018c)	0.86	Median background levels
Figs	30	EFSA (2018c)	7.85	Mean monitoring data
Table olives	20	EFSA (2018c)	6.23	STMR‐RAC
Kumquats	2	EFSA (2018c)	0.86	Median background levels
Carambolas	2	EFSA (2018c)	0.86	Median background levels
Kaki/Japanese persimmons	2	EFSA (2018c)	0.86	Median background levels
Jambuls/jambolans	10	EFSA (2018c)	2.69	STMR‐RAC
Kiwi fruits (green, red, yellow)	30	EFSA (2018c)	6.94	STMR‐RAC × PeF
Litchis/lychees	2	EFSA (2018c)	1.48	Median background levels
Passion fruits/maracujas	4	EFSA (2018c)	3.55	Mean monitoring data
Prickly pears/cactus fruits	2	EFSA (2018c)	1.48	Median background levels
Star apples/cainitos	2	EFSA (2018c)	1.48	Median background levels
American persimmon/Virginia kaki	2	EFSA (2018c)	1.48	Median background levels
Avocados	6	EFSA (2018c)	0.96	Median background levels
Bananas	6	EFSA (2018c)	0.96	Median background levels
Mangoes	6	EFSA (2018c)	0.96	Median background levels
Papayas	6	EFSA (2018c)	0.96	Median background levels
Granate apples/ pomegranates	6	EFSA (2018c)	0.96	Median background levels
Cherimoyas	6	EFSA (2018c)	0.96	Median background levels
Guavas	6	EFSA (2018c)	0.96	Median background levels
Pineapples	6	EFSA (2018c)	0.96	Median background levels
Breadfruits	6	EFSA (2018c)	0.96	Median background levels
Durians	6	EFSA (2018c)	0.96	Median background levels
Soursops/guanabanas	6	EFSA (2018c)	0.96	Median background levels
Other miscellaneous fruit (inedible peel, large)	6	EFSA (2018c)	0.96	STMR‐RAC
Potatoes	7	EFSA (2018c) (Scenario 1)	2.00	STMR‐RAC
	4	EFSA (2018c) (Scenario 2)	1.30	STMR‐RAC
Cassava roots/manioc	4	EFSA (2018c)	1.30	STMR‐RAC
Sweet potatoes	4	EFSA (2018c)	1.30	STMR‐RAC
Yams	4	EFSA (2018c)	1.30	STMR‐RAC
Arrowroots	4	EFSA (2018c)	1.30	STMR‐RAC
Other tropical root and tuber vegetables	4	EFSA (2018c)	1.30	STMR‐RAC
Beetroots	3	EFSA (2018c)	0.74	STMR‐RAC
Carrots	3	EFSA (2018c)	0.74	STMR‐RAC
Celeriacs/turnip‐rooted celeries	3	EFSA (2018c)	0.74	STMR‐RAC
Horseradishes	3	EFSA (2018c)	0.74	STMR‐RAC
Jerusalem artichokes	3	EFSA (2018c)	0.74	STMR‐RAC
Parsnips	3	EFSA (2018c)	0.74	STMR‐RAC
Parsley roots/Hamburg roots parsley	3	EFSA (2018c)	0.74	STMR‐RAC
Radishes	3	EFSA (2018c)	0.74	STMR‐RAC
Salsifies	3	EFSA (2018c)	0.74	STMR‐RAC
Swedes/rutabagas	3	EFSA (2018c)	0.74	STMR‐RAC
Turnips	3	EFSA (2018c)	0.74	STMR‐RAC
Other root and tuber vegetables	3	EFSA (2018c)	0.74	STMR‐RAC
Garlic	4	EFSA (2018c)	1.93	Mean monitoring data
Onions	2	EFSA (2018c)	0.60	STMR‐RAC
Shallots	2	EFSA (2018c)	0.60	STMR‐RAC
Spring onions/green onions and Welsh onions	70	EFSA (2018c)	14.6	STMR‐RAC
Tomatoes	10	EFSA (2018c) (Scenario 1)	2.5	STMR‐RAC
	2	EFSA (2018c) (Scenario 2)	0.75	Median background levels
Sweet peppers/bell peppers	20	EFSA (2018c)	3.45	STMR‐RAC
Aubergines/egg plants	10	EFSA (2018c)	2.5	STMR‐RAC
Okra/lady's fingers	2	EFSA (2018c)	0.94	Median background levels
Cucumbers	5	EFSA (2018c)	2.0	STMR‐RAC
Gherkins	5	EFSA (2018c)	2.0	STMR‐RAC
Courgettes	5	EFSA (2018c)	2.0	STMR‐RAC
Other cucurbits – edible peel	5	EFSA (2018c)	2.0	STMR‐RAC
Melons	10	EFSA (2018c)	4.20	STMR‐RAC × PeF
Pumpkins	10	EFSA (2018c)	4.20	STMR‐RAC × PeF
Watermelons	10	EFSA (2018c)	4.20	STMR‐RAC × PeF
Other cucurbits – inedible peel	10	EFSA (2018c)	4.20	STMR‐RAC × PeF
Sweet corn	2	EFSA (2018c)	0.48	Median background levels
Broccoli	5	EFSA (2018c)	1.25	STMR‐RAC
Cauliflowers	5	EFSA (2018c)	1.25	STMR‐RAC
Other flowering brassica	5	EFSA (2018c)	1.25	STMR‐RAC
Brussels sprouts	2	EFSA (2018c)	0.41	Median background levels
Head cabbages	2	EFSA (2018c)	0.26	Mean monitoring data
Other head brassica	2	EFSA (2018c)	0.41	STMR‐RAC
Chinese cabbages/pe‐tsai	3	EFSA (2018c)	0.56	Median background levels
Kales	3	EFSA (2018c)	0.56	Median background levels
Other leafy brassica	3	EFSA (2018c)	0.56	Median background levels
Kohlrabies	3	EFSA (2018c)	0.56	Median background levels
Lamb's lettuce/corn salads	150	EFSA (2018c)	34.6	STMR‐RAC
Lettuces	150	EFSA (2018c) (Scenario 1)	34.6	STMR‐RAC
	4	EFSA (2018c) (Scenario 2)	0.83	Median background levels
Escaroles/broad‐leaved endives	150	EFSA (2018c)	34.6	STMR‐RAC
Cress and other sprouts and shoots	150	EFSA (2018c)	34.6	STMR‐RAC
Land cress	150	EFSA (2018c)	34.6	STMR‐RAC
Roman rocket/rucola	150	EFSA (2018c)	34.6	STMR‐RAC
Red mustards	150	EFSA (2018c)	34.6	STMR‐RAC
Baby leaf crops (including brassica species)	150	EFSA (2018c)	34.6	STMR‐RAC
Other lettuce and other salad plants	150	EFSA (2018c)	34.6	STMR‐RAC
Spinaches	150	EFSA (2018c)	34.6	STMR‐RAC
Purslanes	150	EFSA (2018c)	34.6	STMR‐RAC
Chards/beet leaves	150	EFSA (2018c)	34.6	STMR‐RAC
Other spinach and similar	150	EFSA (2018c)	34.6	STMR‐RAC
Grape leaves and similar species	5	EFSA (2018c)	4.15	Median background levels
Watercress	150	EFSA (2018c)	11.7	STMR‐RAC
Witloofs/Belgian endives	2	EFSA (2018c)	0.51	Median background levels
Chervil	150	EFSA (2020)	38	STMR‐RAC
Chives	150	EFSA (2020)	38	STMR‐RAC
Celery leaves	150	EFSA (2020)	38	STMR‐RAC
Parsley	150	EFSA (2020)	38	STMR‐RAC
Sage	150	EFSA (2020)	38	STMR‐RAC
Rosemary	150	EFSA (2020)	38	STMR‐RAC
Thyme	150	EFSA (2020)	38	STMR‐RAC
Basil and edible flowers	150	EFSA (2020)	38	STMR‐RAC
Laurel/bay leaves	150	EFSA (2020)	38	STMR‐RAC
Tarragon	150	EFSA (2020)	38	STMR‐RAC
Other herbs	150	EFSA (2020)	38	STMR‐RAC
Beans (with pods)	10	EFSA (2018c)	3.25	STMR‐RAC
Beans (without pods)	4	EFSA (2018c)	3.18	Median background levels
Peas (with pods)	10	EFSA (2018c)	3.25	STMR‐RAC
Peas (without pods)	7	EFSA (2018c)	2.39	STMR‐RAC
Lentils (fresh)	4	EFSA (2018c)	3.18	Median background levels
Asparagus	7	EFSA (2018c)	0.65	Median background levels
Cardoons	7	EFSA (2018c)	0.65	Median background levels
Celeries	7	EFSA (2018c)	0.65	Median background levels
Florence fennels	7	EFSA (2018c)	0.65	Median background levels
Globe artichokes	30	EFSA (2018c)	7.44	STMR‐RAC
Leeks	70	EFSA (2018c)	14.6	STMR‐RAC
Rhubarbs	7	EFSA (2018c)	0.65	Median background levels
Bamboo shoots	7	EFSA (2018c)	0.65	Median background levels
Palm hearts	7	EFSA (2018c)	0.65	Median background levels
Cultivated fungi	6	EFSA (2018c)	2.86	Median background levels
Wild fungi	6	EFSA (2018c)	2.86	Median background levels
Algae and prokaryotes organisms	3	EFSA (2018c)	0.44	Median background levels
Beans	15	EFSA (2018c)	7.21	Mean monitoring data
Lentils	15	EFSA (2018c)	9.19	Mean monitoring data
Peas	15	EFSA (2018c)	7.30	Median background levels
Lupins/lupini beans	15	EFSA (2018c)	7.30	Median background levels
Other pulses	15	EFSA (2018c)	9.19	STMR‐RAC
Linseeds	30	EFSA (2018c)	12.02	Median background levels
Peanuts/groundnuts	30	EFSA (2018c)	12.02	Median background levels
Poppy seeds	30	EFSA (2018c)	12.02	Median background levels
Sesame seeds	30	EFSA (2018c)	12.02	Median background levels
Sunflower seeds	30	EFSA (2018c)	18.41	Mean monitoring data
Rapeseeds/ canola seeds	30	EFSA (2018c)	1.20	Median background levels × PF (oil)
Soybeans	30	EFSA (2018c)	12.02	Median background levels
Mustard seeds	30	EFSA (2018c)	12.02	Median background levels
Cotton seeds	30	EFSA (2018c)	12.02	Median background levels
Pumpkin seeds	30	EFSA (2018c)	12.02	Median background levels
Safflower seeds	30	EFSA (2018c)	12.02	Median background levels
Borage seeds	30	EFSA (2018c)	12.02	Median background levels
Gold of pleasure seeds	30	EFSA (2018c)	12.02	Median background levels
Hemp seeds	30	EFSA (2018c)	12.02	Median background levels
Castor beans	30	EFSA (2018c)	12.02	Median background levels
Other oilseeds	30	EFSA (2018c)	18.4	Mean monitoring data
Olives for oil production	20	EFSA (2018c)	0.62	STMR‐RAC × PF (oil)
Oil palm kernels	30	EFSA (2018c)	30	EU MRL
Oil palm fruits	30	EFSA (2018c)	30	EU MRL
Kapok	30	EFSA (2018c)	30	EU MRL
Barley	10	EFSA (2018c)	4.15	Median background levels
Buckwheat and other pseudo‐cereals	15	EFSA (2018c)	8.42	Median background levels
Maize/corn	10	EFSA (2018c)	4.15	Median background levels
Common millet/proso millet	10	EFSA (2018c)	4.15	Median background levels
Oat	10	EFSA (2018c)	4.15	Median background levels
Rice	10	EFSA (2018c)	4.15	Median background levels
Rye	10	EFSA (2018c)	4.15	Median background levels
Sorghum	10	EFSA (2018c)	4.15	Median background levels
Wheat	10	EFSA (2018c)	4.15	Median background levels
Tea (dried leaves of Camellia sinensis)	30	EFSA (2018c)	25	Median background levels
Coffee beans	20	EFSA (2018c)	16.3	Median background levels
Herbal infusions (dried flowers)	5	EFSA (2018c)	0.3	Median background levels
Chamomile	5	EFSA (2018c)	0.3	Median background levels
Hibiscus/roselle	5	EFSA (2018c)	0.3	Median background levels
Rose	5	EFSA (2018c)	0.3	Median background levels
Jasmine	5	EFSA (2018c)	0.3	Median background levels
Lime/linden	5	EFSA (2018c)	0.3	Median background levels
Other herbal infusions (dried flowers)	5	EFSA (2018c)	0.3	Median background levels
Herbal infusions (dried leaves)	5	EFSA (2018c)	0.3	Median background levels
Strawberry leaves	5	EFSA (2018c)	0.3	Median background levels
Rooibos	5	EFSA (2018c)	0.3	Median background levels
Mate/maté	5	EFSA (2018c)	0.3	Median background levels
Other herbal infusions (dried leaves)	5	EFSA (2018c)	0.3	Median background levels
Herbal infusions (dried roots)	5	EFSA (2018c)	0.95	Median background levels
Valerian root	5	EFSA (2018c)	0.95	Median background levels
Ginseng root	5	EFSA (2018c)	0.95	Median background levels
Other herbal infusions (dried roots)	5	EFSA (2018c)	0.95	Median background levels
Cocoa beans	5	EFSA (2018c)	1.5	Median background levels
Carobs/Staint John's bread	6	EFSA (2018c)	5.71	Median background levels
HOPS (dried)	1,500	EFSA (2018c)	337.5	STMR‐RAC
Spices (seeds)	15	EFSA (2018c)	9.75	Median background levels
Anise/aniseed	15	EFSA (2018c)	9.75	Median background levels
Black caraway/black cumin	15	EFSA (2018c)	9.75	Median background levels
Celery seed	15	EFSA (2018c)	9.75	Median background levels
Coriander seed	15	EFSA (2018c)	9.75	Median background levels
Cumin seed	15	EFSA (2018c)	9.75	Median background levels
Dill seed	15	EFSA (2018c)	9.75	Median background levels
Fennel seed	15	EFSA (2018c)	9.75	Median background levels
Fenugreek	15	EFSA (2018c)	9.75	Median background levels
Nutmeg	15	EFSA (2018c)	9.75	Median background levels
Other spices (seeds)	15	EFSA (2018c)	9.75	Median background levels
Spices (fruits)	15	EFSA (2018c)	11.3	Median background levels
Allspice/pimento	15	EFSA (2018c)	11.3	Median background levels
Sichuan pepper	15	EFSA (2018c)	11.3	Median background levels
Caraway	15	EFSA (2018c)	11.3	Median background levels
Cardamom	15	EFSA (2018c)	11.3	Median background levels
Juniper berry	15	EFSA (2018c)	11.3	Median background levels
Peppercorn (black, green and white)	15	EFSA (2018c)	11.3	Median background levels
Vanilla pods	15	EFSA (2018c)	11.3	Median background levels
Tamarind	15	EFSA (2018c)	11.3	Median background levels
Other spices (fruits)	15	EFSA (2018c)	11.3	Median background levels
Spices (bark)	5	EFSA (2018c)	3.39	Median background levels
Cinnamon	5	EFSA (2018c)	3.39	Median background levels
Other spices (bark)	5	EFSA (2018c)	3.39	Median background levels
Spices (roots or rhizome)	5	EFSA (2018c)	2.13	Median background levels
Liquorice	5	EFSA (2018c)	2.13	Median background levels
Ginger	5	EFSA (2018c)	2.13	Median background levels
Turmeric/curcuma	5	EFSA (2018c)	2.13	Median background levels
Horseradish, root spices	5	EFSA (2018c)	2.13	Median background levels
Other spices (roots)	5	EFSA (2018c)	2.13	Median background levels
Spices (buds)	5	EFSA (2018c)	3.61	Median background levels
Cloves	5	EFSA (2018c)	3.61	Median background levels
Capers	5	EFSA (2018c)	3.61	Median background levels
Other spices (buds)	5	EFSA (2018c)	3.61	Median background levels
Spices (flower stigma)	5	EFSA (2018c)	3.28	Median background levels
Saffron	5	EFSA (2018c)	3.28	Median background levels
Other spices (flower stigma)	5	EFSA (2018c)	3.28	Median background levels
Spices (aril)	30	EFSA (2018c)	24.7	Median background levels
Mace	30	EFSA (2018c)	24.7	Median background levels
Other spices (aril)	30	EFSA (2018c)	24.7	Median background levels
Sugar beet roots	2	EFSA (2018c)	1.25	Median background levels
Sugar canes	2	EFSA (2018c)	0.69	Median background levels
Chicory roots	2	EFSA (2018c)	1.09	Median background levels
Other sugar plants	2	EFSA (2018c)	1.25	Median background levels
Swine: Muscle/meat	7	EFSA (2018c)	0.88	Median background levels
Swine: Fat tissue	2	EFSA (2018c)	0.41	Median background levels
Swine: Liver	90	EFSA (2018c)	11.6	Median background levels
Swine: Kidney	10	EFSA (2018c)	7.28	Median background levels
Bovine: Muscle/meat	3	EFSA (2018c)	0.9	Median background levels
Bovine: Fat tissue	0.6	EFSA (2018c)	0.39	Median background levels
Bovine: Liver	400	EFSA (2018c)	86.7	Mean monitoring data
Bovine: Kidney	10	EFSA (2018c)	4.61	Median background levels
Sheep: Muscle/meat	3	EFSA (2018c)	1.25	Median background levels
Sheep: Fat tissue	0.6	EFSA (2018c)	0.3	Median background levels
Sheep: Liver	150	EFSA (2018c)	90	Median background levels
Sheep: Kidney	6	EFSA (2018c)	3.85	Median background levels
Goat: Muscle/meat	3	EFSA (2018c)	1.25	Median background levels
Goat: Fat tissue	0.6	EFSA (2018c)	0.3	Median background levels
Goat: Liver	150	EFSA (2018c)	90	Median background levels
Goat: Kidney	6	EFSA (2018c)	3.85	Median background levels
Equine: Muscle/meat	3	EFSA (2018c)	0.9	Median background levels
Equine: Fat tissue	0.6	EFSA (2018c)	0.39	Median background levels
Equine: Liver	400	EFSA (2018c)	64.3	Median background levels
Equine: Kidney	10	EFSA (2018c)	4.61	Median background levels
Poultry: Muscle/meat	7	EFSA (2018c)	3.47	Mean monitoring data
Poultry: Fat tissue	1	EFSA (2018c)	0.00	Median background levels
Poultry: Liver	80	EFSA (2018c)	6.90	Median background levels
Milk: Cattle	1	EFSA (2018c)	0.24	Mean monitoring data
Milk: Sheep	1	EFSA (2018c)	0.24	Mean monitoring data
Milk: Goat	1	EFSA (2018c)	0.24	Mean monitoring data
Milk: Horse	1	EFSA (2018c)	0.24	Mean monitoring data
Eggs: Chicken	1	EFSA (2018c)	0.58	Mean monitoring data
Eggs: Duck	1	EFSA (2018c)	0.58	Mean monitoring data
Eggs: Goose	1	EFSA (2018c)	0.58	Mean monitoring data
Eggs: Quail	1	EFSA (2018c)	0.58	Mean monitoring data
Wild terrestrial vertebrate animals	3	EFSA (2018c) MRL review	1.72	Mean monitoring data

STMR‐RAC: supervised trials median residue in raw agricultural commodity; PeF: Peeling factor.

‘Proposed MRLs’ come from the MRLs derived during the MRL review (EFSA, 2018c), not implemented in the EU legislation.

The MRL review applied the median PF derived for grape juice (0.39) and the yield factor for juice (0.75) to refine the input value for wine grapes. It was noted that wine grapes consumption referred to grape juice (for children) and to wine (for adults). However, the PF for juice was retain (not the PF for wines (0.04) was not considered) to perform a more conservative assessment (EFSA, 2018c).