Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Nisso Chemical Europe GmbH and Nufarm Europe GmbH submitted two separate requests to the competent national authorities in the Netherlands and Austria, respectively, to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid. The application assessed by Austria included requests to modify the MRLs for plums, soybeans, parsley, rosemary, basil and edible flowers, as well as honey. The request submitted to the Netherlands concerned modifications to the MRLs for soybeans and barley. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for soybeans, plums, parsley, rosemary, basil and edible flowers, and honey. For barley, a data gap was identified due to the lack of processing studies, which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control residues of acetamiprid in the plant matrices under consideration, at a validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acetamiprid according to the reported agricultural practices (with the exception of the Good Agricultural Practice (GAP) for barley, for which an MRL is not recommended in the present output) is unlikely to present a risk to consumer health.
Keywords: acetamiprid, consumer risk assessment, honey, MRL, pesticide, various crops
SUMMARY
In accordance with Article 6 of Regulation (EC) No 396/2005, Nisso Chemical Europe GmbH submitted an application to the Evalutaing Member State (EMS) the Netherlands to request modifications to the maximum residue levels (MRLs) for acetamiprid in soybeans and barley. Under the same Article, Nufarm Europe GmbH submitted a separate application to the competent national authority in Austria, acting as the EMS, to modify the existing MRLs for acetamiprid in plums, parsley, rosemary, basil, edible flowers, soyabeans and honey.
The application concerning MRLs in barley and soybeans, was submitted with its supporting IUCLID dossier on 2 December 2022. The appointed EMS, the Netherlands, assessed this dossier and declared its admissibility on 28 July 2023.
The second application for MRLs in various crops and honey, alongside the dossier containing the supporting data in IUCLID format, was submitted through the European Food Safety Authority (EFSA) Central Submission System on 25 April 2024. The appointed EMS, Austria, assessed the dossier and declared its admissibility on 9 September 2024.
Subsequently, following the implementation of the EFSA's confidentiality decision, the non‐confidential versions of the dossiers were published by EFSA and a public consultation launched on each dossier. The consultations aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted applications, in order to identify whether other relevant scientific data or studies are available. The two consultations run from 18 August 2023 and 8 September 2023, and for the second dossier from 4 October 2024 to 25 October 2024. No additional data were submitted in the framework of these consultations. EMS Austria received one comment and confirmed in response that Regulation PLAN/2024/1403v2 was considered in their evaluation.
At the end of the commenting period, each EMS proceeded drafting the evaluation report, in accordance with Article 8 of Regulation (EC) No 396/2005. Both evaluation reports were submitted to the European Commission and forwarded to EFSA on 20 December 2024 and on 11 February 2025 for the application on MRLs in various crops and honey and MRLs in barley and soyabeans, respectively.
To accommodate for the intended use of acetamiprid in Europe, the EMS Austria proposed to raise the existing MRL for plums to 0.08 mg/kg, for soyabeans to 0.08 mg/kg, for parsley, rosemary and basil and edible flowers to 4 mg/kg and for honey to 0.6 mg/kg. The EMS Netherlands proposed to raise the existing MRL for barley to 0.5 mg/kg, and for soyabeans to 0.03 mg/kg.
On 3 March 2025, the European Commission sent a mandate to EFSA to assess the application and the evaluation report on various crops and honey (from EMS Austria), as required by Article 10 of the MRL regulation. On 24 March 2025, under the same article, European Commission requested EFSA to assess the application and evaluation report on soyabeans and barley (from EMS the Netherlands).
EFSA assessed the applications and evaluation reports as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification for both applications and requested the EMSs to address them. The applicant provided the requested information for each application in an updated IUCLID dossier. The additional information was duly considered by the EMSs Austria and the Netherlands who submitted a revised evaluation report to EFSA on 17 September 2025 and 12 September 2025 respectively. These updated reports replaced the previously submitted evaluation reports. For efficiency, the assessment of both MRL applications was merged in a single reasoned opinion.
Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009 on the renewal of approval of acetamiprid, the EFSA statement on the toxicological properties and MRLs of acetamiprid and its metabolites (hereafter referred to as ‘EFSA 2024 Statement’), the data evaluated under previous MRL assessments, and the additional data provided by the EMSs in the framework of these applications, the following conclusions are derived.
The metabolism of acetamiprid following foliar application was investigated in crops belonging to the fruit, root, leafy and pulses/oilseeds crop groups, as well as following soil application in leafy crops. Studies investigating the effect of processing on the nature of acetamiprid (hydrolysis studies) demonstrated that the active substance is stable. In rotational crops, no major differences are expected compared to primary crops metabolism.
Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological relevance of metabolites and following the assessment of monitoring data of acetamiprid and its N‐desmethyl metabolite (IM‐2‐1), the residue definition for enforcement in plant products was confirmed as acetamiprid. The residue definition for risk assessment in plant commodities was reassessed in the framework on an ad‐hoc mandate of the European Commission in 2024 (the ‘EFSA 2024 Statement’), where EFSA proposed including the metabolite IM‐2‐1 in the residue definition for risk assessment in leafy and fruit crops, which had previously been limited to acetamiprid. The following residue definitions for risk assessment are therefore in place: ‘acetamiprid’ (pulses/oilseeds, roots, cereals/grass crops); ‘sum of acetamiprid and N‐desmethyl acetamiprid (IM‐2‐1), expressed as acetamiprid’ (fruit and leafy crops). The same residue definitions are applicable to rotational crops and processed products. EFSA concluded that for the crops assessed in this application, metabolism of acetamiprid in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.
A previously evaluated liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) analytical method was concluded to be sufficiently validated to quantify residues of acetamiprid in all analytical crop groups, in accordance with the enforcement residue definition. This method enables quantification of acetamiprid residues at or above 0.01 mg/kg limit of quantification (LOQ) in the crops assessed and in honey.
The available residue trials on plums are sufficient to support an MRL proposal of 0.08 mg/kg. The available trials on basil are sufficient to support an MRL proposal of 4 mg/kg for basil and, by extrapolation, for edible flowers, parsley and rosemary. For honey, the additional semi‐field tunnel trials submitted within the framework of the present application enabled the derivation of an MRL of 0.9 mg/kg. For soyabeans, the submitted residue trials are sufficient to support an MRL proposal of 0.08 mg/kg, based on the more critical results from the residue trials of the southern Europe (SEU) Good Agricultural Practice (GAP) evaluated by Austria, as compared to the northern Europe (NEU) GAP evaluated by the Netherlands.
Regarding the evaluation of the GAP on barley, the trials have been supported by a sufficient number of residue trials, but EFSA identified a data gap for processing studies, which are required under Regulation (EU) No 283/2013 when residue levels in edible commodity exceed 0.1 mg/kg. Therefore, EFSA did not propose an MRL in support of the intended use of acetamiprid on barley and excluded the new data on barley grain from exposure assessments. On this point, the EMS (Netherlands) and EFSA hold divergent views, as the EMS is of the opinion that processing studies are not required because median residue level in barley grain is below 0.1 mg/kg and the consumer exposure to residues is < 10% of the acceptable daily intake (ADI) or acute reference dose (ARfD). The EMS proposed an MRL of 0.5 mg/kg for barley grain. EFSA duly considered the arguments presented; however, it was decided that the claim of waiving is not fully justified. This is because, in three out of eight submitted barley trials, acetamiprid residue levels measured in grain exceeded 0.1 mg/kg, thus fulfilling the primary criterion for the need for processing studies. This criterion is based on the individual residue levels observed in the trials, not on the STMR. Further considerations on this matter are outlined in this opinion.
The occurrence of acetamiprid residues in rotational crops was investigated in the framework of the EU pesticides peer review. Based on the available information on the nature and magnitude of residues, it was concluded that significant residue levels are unlikely to occur in rotational crops, provided that the active substance is used according to the proposed GAP.
Although apples have not been included in present MRL applications, the applicant submitted processing studies on apples to populate the available data set of processing factors derived in the framework of the renewal of the approval. Old and new processing studies enabled the derivation of refined PF for apple juice, which was extrapolated to plums juice.
For honey, the current residue definition for both enforcement and risk assessment is ‘acetamiprid’. New semi‐field (tunnel) trials, along with previously assessed by EFSA GAP‐compliant residue data, support a new MRL proposal of 0.9 mg/kg. In addition, the applicant submitted the validation results for the new analytical method which is capable of monitoring acetamiprid residues in honey at or below LOQ of 0.01 mg/kg.
Soyabeans and their by‐products can be used as feed products and therefore a potential carry‐over of acetamiprid residues into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.004 mg/kg body weight (bw) for all relevant animal species.
The nature and magnitude of acetamiprid residues in livestock has been investigated during MRL review and the EU pesticides peer review of renewal of the approval. The MRL review proposed to set the following residue definitions: ‘Metabolite IM‐2‐1 (N‐desmethyl‐acetamiprid), expressed as acetamiprid’ for enforcement and ‘Sum of acetamiprid and metabolite IM‐2‐1 (N‐desmethyl‐acetamiprid)’, expressed as acetamiprid for risk assessment. The dietary burden calculated in the context of this MRL application was found not to be higher than that calculated with the values in the EFSA 2024 Statement for all livestock species and, therefore, the currently established MRLs are sufficient to accommodate the updated livestock dietary burdens.
The toxicological profile of acetamiprid and its N‐desmethyl metabolite (IM‐2‐1) was evaluated in the EFSA 2024 Statement. New toxicological reference values – an ADI and ARfD of 0.005 mg/kg bw (per day) – were proposed and subsequently endorsed by the European Commission in 2024. Metabolite IM‐2‐1, included in the risk assessment residue definition for fruits and leafy crops, was concluded to have a toxicity profile comparable to that of the parent compound.
The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure did not exceed the ARfD for the commodities assessed in the MRL application. The estimated maximum exposure accounted for 69%, 42% and 41% of the ARfD for parsley, basil and edible flowers and plums, respectively. A comprehensive long‐term exposure assessment was conducted as part of the EFSA Statement 2024, taking into account the current uses of acetamiprid at the EU level and the existing Codex MRLs (CXLs). EFSA updated the calculations using the median residue values for the assessed crops, derived from residue trials submitted in support of the two MRL applications.
The highest estimated long‐term dietary intake was 47% of the ADI (NL toddler diet). The combined contribution of residues in the assessed crops to the overall long‐term exposure was 2.6%, with parsley being the highest individual contributor at 0.75%.
EFSA concluded that the intended uses of acetamiprid on soyabeans, plums, parsley, rosemary, basil and edible flowers and residues in honey from authorised uses of acetamiprid on melliferous crops will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a risk to consumers' health. For barley, a data gap was identified due to the lack of processing studies, which precluded the derivation of an MRL proposal.
EFSA proposes to amend the existing MRLs as reported in the summary table below.
Full details of all end points and the consumer risk assessment can be found in Appendices B, C, D.
| Code a | Commodity | Existing EU MRL (mg/kg) | Proposed EU MRL (mg/kg) | Comment/justification |
|---|---|---|---|---|
| Enforcement residue definition: Acetamiprid | ||||
| 0140040 | Plums | 0.04 | 0.08 | The submitted data are sufficient to derive an MRL proposal for the NEU use. Risk for consumers unlikely. |
| 0401070 | Soyabeans | 0.01 | 0.08 | The submitted data are sufficient to derive an MRL proposal of 0.08 mg/kg based on the more critical SEU use. Risk for consumers unlikely. |
| 0256040 | Parsley | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use by extrapolation from residue data on basil. Risk for consumers unlikely. |
| 0256060 | Rosemary | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use by extrapolation form residue data on basil. Risk for consumers unlikely. |
| 0256080 | Basil and edible flowers | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use. Risk for consumers unlikely. |
| 1,040,000 | Honey and other apiculture products b | 1 [according to draft measure − 2025‐1931] c | 0.9 | The submitted data are sufficient to derive an MRL proposal for honey. Risk for consumers unlikely. |
| 0500010 | Barley | 0.05 | – | The intended use is supported by sufficient number of GAP‐compliant trials. However, due to the data gap identified for processing studies, no MRL is proposed. |
Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level; NEU, northern Europe; SEU, southern Europe.
Commodity code number according to Annex I of Regulation (EC) No 396/2005.
According to Regulation (EC) No 396/2005 (as amended by Commission Regulation (EU) 2018/62) MRLs are not applicable to other apiculture products until individual products have been identified and listed within this group.
Draft measure −2025‐1931. SANTE.g.3(2025)11601693. Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Pesticide Residues. 2–3 October 2025. (Section B. Point B01).
ASSESSMENT
The European Food Safety Authority (EFSA) received two applications from two different applicants to modify the existing maximum residue levels (MRLs) for acetamiprid. The first one received concerns a request to modify the MRLs in plums, parsley, rosemary, basil and edible flowers, soyabeans and honey. The second separate application regards a request to modify the MRLs in barley and soyabeans. The detailed description of the intended uses of acetamiprid in Europe, are reported in Appendix A.
Acetamiprid is the ISO common name for (1E)‐N‐[(6‐chloro‐3‐pyridyl)methyl]‐N′‐cyano‐N‐methylacetimidamide (IUPAC name). The chemical structures of the active substance and its main metabolites are reported in Appendix E.
Acetamiprid is an insecticide, which approval was evaluated for renewal in the framework of Regulation (EC) No 1107/2009 1 with the Netherlands designated as rapporteur Member State (RMS) for the representative uses as foliar treatments on pome fruits, tomatoes and potatoes. The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2016). The decision on the renewal of acetamiprid entered into force on 1 March 2018. 2 In 2024, the toxicological reference values and residue definitions as derived in the renewal of approval process were further revised by EFSA under the ad‐hoc mandate (EFSA, 2024a). Importantly, the toxicological reference values were lowered and new residue definition for risk assessment in fruits and leafy crops, which includes metabolite N‐desmethyl‐acetamiprid (IM‐2‐1), was derived. Those proposals were implemented in the EC Regulation 2025/158 3 and 2025/1212 4 in September 2024 (European Commission, 2024). It is to be noted that for new uses submitted after the modification of the risk assessment residue definition, the metabolite IM‐2‐1 must be analysed in the residue trial samples of fruits and leafy crops. However, since the applications in question were submitted before this decision became applicable, it was considered still acceptable to use conversion factors from the monitoring residue definition to the risk assessment residue definition to account for the presence of metabolite, as derived in the EFSA Statement of 2024.
The EU MRLs for acetamiprid are established in Annex II of Regulation (EC) No 396/2005. 5 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2011) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for acetamiprid including the EFSA, 2024 Statement (EFSA, 2024a), performed under Article 31 of Regulation (EC) No 178/2002. 6 The proposed MRL modifications from these opinions were implemented in the MRL legislation. In addition, certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation, 7 while others are pending the implementation but were considered in exposure assessments under current MRL application (EFSA, 2022b, EFSA, 2025b).
In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation' (EU) 2019/1381, 8 on 2 December 2022, Nisso Chemical Europe GmbH submitted an application to the EMS in the Netherlands to request modifications to the MRLs for acetamiprid in soybeans and barley. On the 25 Apil 2024, under the same article, the applicant Nufarm Europe GmbH submitted a separate application to the competent national authority in Austria, to modify the existing MRLs for acetamiprid in plums, parsley, rosemary, basil, edible flowers, soyabeans and honey (hereafter – application on various crops and honey). The appointed EMS, the Netherlands, assessed the dossier and declared its admissibility on 28 July 2023, while, the EMS, Austria, declared the admissibility of the second dossier on 9 September 2024.
Subsequently, following the implementation of the EFSA's confidentiality decision, the non‐confidential versions of the dossiers were published by EFSA and a public consultation launched on each dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted applications, in order to identify whether other relevant scientific data or studies are available. The two consultations run from 18 August 2023 and 8 September 2023, and for the second dossier from 4 October 2024 to 25 October 2024. No additional data were submitted in the framework of these consultations. EMS Austria received one comment and confirmed in response that Regulation PLAN/2024/1403v2 was considered in their evaluation.
At the end of the commenting period, each EMS proceeded drafting the evaluation report, in accordance with Article 8 of Regulation (EC) No 396/2005. Both evaluation reports were submitted to the European Commission and forwarded to EFSA on 20 December 2024 and on 11 February 2025 for the application on MRLs in various crops and honey and MRLs in barley and soyabeans, respectively.
To accommodate for the intended use of acetamiprid in Europe, the EMS Austria proposed to raise the existing MRL for plums to 0.08 mg/kg, for soyabeans to 0.08 mg/kg, for parsley, rosemary and basil and edible flowers to 5 mg/kg, and for honey to 0.6 mg/kg. The EMS Netherlands proposed to raise the existing MRL for barley to 0.5 mg/kg, and for soyabeans to 0.03 mg/kg.
On 3 March 2025, the European Commission sent a mandate to EFSA to assess the application and the evaluation report on various crops and honey (from EMS Austria), as required by Article 10 of the MRL regulation. On 24 March 2025, under the same article, European Commission requested EFSA to assess the application and evaluation report on soyabeans and barley (from EMS the Netherlands).
EFSA assessed the applications and evaluation reports as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification for both applications and requested the EMSs to address them. The applicant provided the requested information for each application in an updated IUCLID dossier. The additional information was duly considered by the EMSs Austria and the Netherlands who submitted a revised evaluation report to EFSA on 17 September 2025 and 12 September 2025 respectively. These updated reports replaced the previously submitted evaluation reports. For efficiency, the assessment of both applications was merged in a single reasoned opinion.
EFSA based its assessment on the evaluation reports submitted by the EMSs (Austria, 2024; Netherlands, 2025), the conclusions from the peer review for renewal of approval of the active substance acetamiprid (EFSA, 2016), the recent outcomes of the EFSA 2024 Statement (EFSA, 2024a), the Commission review report on acetamiprid (European Commission, 2024), as well as the conclusions from previous EFSA MRL opinions on acetamiprid (EFSA, 2021, 2022a, 2022b, 2024b, 2025a), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2011), the focused MRL review according to Art. 43 of Regulation (EC) 396/2005 (EFSA, 2018b), and the latest EFSA's Scientific Support to 56th session of CCPR (EFSA, 2025b).
For this application, the data requirements established in Regulation (EU) No 283/2013 9 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 2010, 2018, 2020, 2021; OECD, 2007a, 2007b, 2007c, 2007d, 2007e, 2007f, 2007g, 2007h, 2008a, 2008b, 2009, 2014, 2016, 2021, 2023a, 2023b). 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 546/2011. 10
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 reports submitted by the EMS (Austria, 2024 and the Netherlands, 2025) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available as background documents to this reasoned opinion. 11
1. RESIDUES IN PLANTS
1.1. Nature of residues and methods of analysis in plants
1.1.1. Nature of residues in primary crops
In the framework of the Article 12 MRL review and the EU pesticides peer review for the renewal of the approval of the active substance acetamiprid, metabolism studies were conducted in primary crops representative of major crop groups: fruit crops (apple, aubergine), leafy crops (cabbage), root crops (carrot) and pulses/oilseeds (cotton) (EFSA, 2011, 2016).
Acetamiprid was identified as the major component of the total radioactive residue (TRR) in all crop parts except for cabbage head and cotton seed. It accounted for 79%–97% of the TRR in aubergine and apple fruits, 61%–99% in cabbage aerial parts and 27%–34% in mature carrot samples (roots and tops), while occurred for up to 0.3% in cabbage head and 5% in cotton seed. In these parts, the predominant residue was the metabolite 6‐chloronicotinic acid (IC‐0), reaching up to 46% TRR, along with its methyl ester (up to 13% TRR in cotton seed). Other metabolites such as IM‐0 (and its conjugate) and IM‐1‐4 were also found in significant amounts in carrot tops and immature carrot flesh.
The metabolite IM‐2‐1 (N‐desmethyl‐acetamiprid) was present at levels below 10% of the TRR in all crop parts, with values ranging from ≤ 4% in aubergine and apple fruits, ≤ 7% in cabbage, ≤ 6% in mature carrot samples and ≤ 8% in cotton seeds. An exception was observed in apple leaf samples, where IM‐2‐1 reached up to 16% TRR (3.64 mg eq./kg) at longer pre‐harvest intervals (PHI). Further assessment of the occurrence of the metabolite IM‐2‐1 in plant commodities was carried out within the framework of the EFSA Statement published in 2024. In this context, a data call was launched to collect results of pesticide residue analyses for acetamiprid and its metabolites in food of plant origin, as provided by national competent authorities. The objective was to better understand the metabolic pattern of acetamiprid across different crops and crop groups. Based on the monitoring data submitted to EFSA, it was concluded that IM‐2‐1 is a relevant residue component in certain commodities, particularly those belonging to the fruit and leafy crop groups (EFSA, 2024a).
1.1.2. Nature of residues in rotational crops
Some of the crops under consideration can be grown in a crop rotation.
Since acetamiprid shows low persistence in soil (highest field DT90 of 43 days), metabolism studies in rotational crops were conducted with its more persistent soil metabolite, IM‐1‐5, which has a DT50 ranging from 319 to 663 days (EFSA, 2016). The metabolism of IM‐1‐5 was investigated following bare soil applications at rates of 266 g/ha and 160 g/ha in rotational crops: wheat, turnip and spinach planted or sown on the same day as the treatment (0‐day plant back interval) (EFSA, 2016, 2022a).
In these studies, IM‐1‐5 was the predominant component of the TRR in mature plants at harvest, accounting for 77%–94% of the TRR. No other metabolites or unidentified residues were observed in significant proportions in any crop commodity. A limited metabolism of IM‐1‐5 was observed in rotational crops and no metabolic pathway was proposed for IM‐1‐5.
The metabolic behaviour of acetamiprid and its major soil metabolite (IM‐1‐5) in rotational crops is considered as sufficiently addressed.
1.1.3. Nature of residues in processed commodities
The effect of processing on the nature of acetamiprid was investigated in the framework of the art. 12 MRL review (EFSA, 2011) and the EU pesticides peer review (EFSA, 2016). Studies were performed under the standard processing conditions representative of pasteurisation (20 min, 90°C, pH 4), baking/brewing/boiling (60 min, 100°C, pH 5) and sterilisation (20 min, 120°C, pH 6).
The standard hydrolysis studies showed that acetamiprid is hydrolytically stable under all above‐mentioned standard processing conditions.
1.1.4. Analytical methods for enforcement purposes in plant commodities
Analytical methods for the determination of acetamiprid residues in plant commodities were assessed during the pesticides peer review (EFSA, 2016) and in subsequent MRLs assessments (EFSA, 2016, EFSA, 2018b). These analytical methods are sufficiently validated to monitor acetamiprid residues at the LOQ of 0.01 mg/kg in all plant commodity groups.
It is noted that the extraction efficiency of the analytical methods used for enforcement is not sufficiently demonstrated for all commodity groups, according to the requirements of the Extraction Efficiency Guidance, SANTE 2017/10632 (European Commission, 2023b) and the lack of these data introduces additional uncertainty of the present assessment.
1.1.5. Storage stability of residues in plants
The storage stability of acetamiprid residues in plants under frozen conditions was investigated in the framework of the EU pesticides peer review (EFSA, 2016) and subsequent MRL assessment (EFSA, 2018b). The stability of acetamiprid residues was demonstrated in high‐water, high‐acid, high‐oil, high‐protein and high‐starch content matrices, as well as in dry beans straw stored at ≤ −18°C for periods ranging between 8 and 15 months (see Appendix B.1.1.2).
In addition, a new study was submitted with the current application (Austria, 2024) investigating the stability of residues of metabolite IM‐2‐1 in frozen crop samples representative of four matrix types: high‐water content (tomatoes), high‐acid content (currants), high‐oil content (rapeseeds/canola seeds), high‐starch content (maize) and high‐protein content (dried broad beans). It should be noted that the submitted report provides interim results covering up to 12 months of storage, whereas the full study is designed to assess stability over a 24‐month period. As the interim data on tomato (high‐water content matrix) are relevant for supporting the four residue trials conducted on basil in Northern Europe in 2024 (see Section 1.2.1), where residues of metabolite IM‐2‐1 were analysed, EFSA has decided to take into consideration the interim results of this study. It is noted that while the interim study results allow for sound conclusions in the current framework, they are subject to uncertainty pending the submission of the final report. Therefore, the full study will be re‐evaluated once the complete data set becomes available.
In the storage stability study tomato samples were fortified with 0.1 mg IM‐2‐1/kg and stored frozen at −18°C for 12 months (Austria, 2024). The samples were analysed at the start (zero time) and again after 6 and 12 months. The results demonstrated that residues of IM‐2‐1 in frozen tomato samples remained stable for at least 12 months. However, this conclusion is based on interim data and is pending the submission of the full study report.
1.1.6. Proposed residue definitions
The existing enforcement residue definition for plant commodities was established by the EU pesticides peer review and is limited to parent acetamiprid (EFSA, 2016). This residue definition for enforcement is set in Regulation (EC) No 396/2005.
EFSA reassessed the residue definition for risk assessment in plant commodities under the ad‐hoc mandate received from the European Commission in 2024 (EFSA, 2024a), considering the monitoring data investigating the occurrence of metabolite IM‐2‐1 in various plant matrices. In the framework of this assessment, the toxicity of IM‐2‐1 was confirmed to be covered by the parent compound. Based on the results of the monitoring data, EFSA proposed to include IM‐2‐1 in the residue definition for leafy and fruit crops, while retaining ‘acetamiprid’ in the risk assessment residue definition for pulses/oilseeds, root crops and cereals. Therefore, the following residue definitions are in place:
- residue definition for risk assessment:
-
⚬pulses/oilseeds, roots, cereals: acetamiprid
-
⚬fruit and leafy crops: sum of acetamiprid and N‐desmethyl acetamiprid (IM‐2‐1), expressed as acetamiprid.
-
⚬
residue definition for enforcement: acetamiprid (all crop groups).
The same residue definitions are applicable to rotational crops and processed products.
1.2. Magnitude of residues in plants
1.2.1. Magnitude of residues in primary crops
Intended uses submitted in the application EFSA‐Q‐2024‐00271 (Austria, 2024 )
In support of the MRL application, the applicant submitted residue trials performed in plums, basil and soyabeans. The residue trials on basil were proposed for extrapolation to derive MRLs on basil and edible flowers, parsley and rosemary.
The samples of the submitted residue trials were stored under conditions for which the integrity of the samples had been demonstrated (Austria, 2024). The EMS confirmed that the analytical methods (using acetonitrile/water (50:50) with quick, easy, cheap, effective, rugged, and safe (QuEChERS) methodology) were sufficiently validated and fit for purpose (Austria, 2024).
It is to be noted that the new residue definitions for risk assessment in leafy and fruit crops were implemented into the EU legislation as proposed in the EFSA Statement of 2024 (EFSA, 2024a) (See Section 1.1.6). This change requires the metabolite IM‐2‐1 to be analysed in residue trials for new applications submitted after the update. However, since the current application was submitted before the change was officially implemented, it is acceptable to apply conversion factors. Therefore, in cases were data on metabolite IM‐2‐1 were not available, the conversion factors derived in the EFSA Statement were applied accordingly (EFSA, 2024a).
To address the extraction efficiency of the analytical methods used for the risk assessment, the applicant submitted an indirect cross‐validation study that investigated the relative extractability of four different solvents. The solvents were used for extracting incurred residues of acetamiprid and its metabolite IM‐1‐2 from various crop samples: dry lentils (dry matrices), currants (high‐acid content), spinach (high‐water content) and oilseed rape seeds (high‐oil content) (Austria, 2024). EFSA notes that the provided study cannot be considered a cross‐validation of the solvent system used in the metabolism studies on aubergine, apples and cabbage (high‐water matrices). In those metabolism studies, extraction was performed using a sequential combination of solvents. Specifically, fruits and leaves were surface‐washed with methanol, the homogenate was extracted with 75:25 methanol/water (v/v) and the extracts were subjected to liquid–liquid partitioning with n‐hexane and methylene chloride. In contrast, the cross‐validation study used only methanol/water (75:25) to represent the solvent system from the metabolism studies. In the fourth available metabolism study on cotton, the required TRR extractability did not reach 70% and therefore the results from this study cannot be used to prove extraction efficiency for high‐oil commodity group.
Nevertheless, as concluded by the applicant and the EMS, the indirect cross‐validation study provides the conclusions on the relative extractability of different solvent systems for acetamiprid and IM‐1‐2 residues across representative crops from various matrix groups. The four solvent systems evaluated were: (1) methanol/water (75:25), (2) 100% acetonitrile with QuEChERS methodology (3) acetonitrile/water (50:50) with QuEChERS methodology and (4) ethyl acetate. According to the study results, the third method achieved the highest average extraction efficiency for both compounds. The second method showed the lowest efficiency, while the first and fourth methods demonstrated moderate efficiencies.
EFSA concludes that the extraction efficiency of the analytical method No (3) – extraction with acetonitrile/water, used to analyse part of soyabeans residue trials samples (2023 trials) – has been demonstrated but it presents the additional uncertainties due to the use of indirect cross‐validation to prove the extraction efficiency. However, for spinach (representative of high water) it was observed that the same indirect cross‐validation study shows that the solvent system 1 has the best relative extricability slightly above the solvent system 3.
The detailed residue trials data are reported in the Appendix B.1.2.
Plums (NEU), SL formulation: 1 × 55 g a.s./ha, BBCH 69–89, PHI 14 days
In support of the intended NEU GAP for plums, the applicant submitted eight independent residue trials on plums conducted in Poland (2), France (1), Germany (1), Hungary (3) and United Kingdom (1) during the two growing seasons of 2021 and 2022.
In these trials, a single application was made to the treatment plots using a soluble concentrate at the nominal rate of 0.60 kg a.s./ha. In all cases, this resulted in an actual application rate higher than the GAP nominal rate of 0.55 kg a.s./ha, which is within the acceptable 25% deviation (European Commission, 2023a).
Subsequently, the samples from treated plums were collected at the intended PHI of 14 day (± 1 day). In four decline trials conducted in Poland (1), Hungary (2) and United Kingdom (1), the sampling was performed on the day of the application and at 3, 5, 9–11 and 13–15 days (corresponding to the intended PHI) after the application (Austria, 2024). These trials are considered sufficient to demonstrate the decline.
Before the analysis, the fruits were destoned and the weights of whole fruits, stones and plum flesh were recorded separately. Residue levels in the whole fruit were calculated based on the recorded weights. Residue levels of acetamiprid were analysed in the plum flesh, in accordance with the residue definition for enforcement. No residue data according to the risk assessment residue definition, which includes metabolite IM‐2‐1 are available. Therefore, the conversion factor of 1.21 form enforcement to the risk assessment, as derived for fruit crops in the EFSA Statement (2024a), was applied. No residues above the LOQ (0.01 mg/kg) were measured in untreated samples.
Although SEU use of acetamiprid on plums is not intended, the applicant also submitted four residue trials on plums conducted in Southern Europe to provide additional data on the occurrence of the metabolite IM‐2‐1 in plums. However, as the GAP under assessment is a NEU EU GAP, this data was not considered for the CF derivation (Austria, 2024). In this view, the results reported here are for information only: residues of the metabolite IM‐2‐1 above the LOQ were not detected in the trials conducted under the use pattern of 1 × 0.55 kg a.i./ha, BBCH 69–89 and harvested at 14 DALA.
Basil and edible flowers, Parsley, Rosemary (SEU), SL formulation: 1 × 45 g a.s./ha, BBCH: n.r., PHI 14 days
In support of the intended SEU GAPs for basil and edible flowers, parsley and rosemary, the applicant submitted a total of 12 independent residue trials on basil conducted during the 2021 and 2024 growing seasons. Eight trials were carried out in 2021 across Greece (2), Italy (3) and Spain (3), while four additional trials were conducted in 2024 in Italy (2), Spain (1) and Greece (1).
In all trials, a single application was made to the treatment plots using a soluble concentrate. In 2021, the nominal application rate was 0.50 kg a.s./ha, while in 2024, the nominal rate was 0.45 kg a.s./ha falling within the 25% acceptable deviation (European Commission, 2023a).
Samples from treated basil were collected at the intended PHI of 14 days (or on day 13). In six trials conducted in 2021, basil leaves were analysed according to the residue definition for monitoring. In four additional trials conducted in 2024, basil tops were analysed in line with both the residue definition for enforcement and the residue definition for risk assessment.
In six decline trials – four from 2021 (Greece, Italy, Spain) and two from 2024 (Italy, Spain) – sampling was performed on the day of application (day 0), and at intervals of 3, 5–6, 9–11 and 13–14 days after application, corresponding to the intended PHI (Austria, 2024). Across all trials, a clear residue decline pattern was observed; however, it should be noted that samples were not analysed beyond the target PHI of the GAP.
Four trials conducted in 2024 where basil leaves were analysed also for metabolite IM‐2‐1 served to derive a conversion factor of 1.07 from monitoring to risk assessment residue definition, which was then applied to the remaining six trials analysed for acetamiprid only to account for the presence of the metabolite IM‐2‐1. The EMS confirmed that the analytical methods used to analyse both acetamiprid and IM‐2‐1 are sufficiently validated and fit for purpose (Austria, 2024).
Basil samples prior to analysis were stored frozen for 166 days (approximately 5.5 months). This period sufficiently covers the storage stability of parent acetamiprid. Regarding stability of IM‐2‐1, EFSA concludes that sample integrity was ensured since the data from the interim storage stability study (see Section 1.1.5), demonstrated stability of metabolite IM‐2‐ for at least 12 months. It should be noted that the conversion factor of 1.07, derived from the four residue trials in question, is lower than the factor of 1.21 reported in the EFSA Statement 2024 (EFSA, 2024a). Since the conversion factor (CF) was derived from residue trials supported by a storage stability study that is still pending finalisation, the derived conversion factor is considered tentative, applies only to the GAP under assessment and might be the subject of future revisions.
Soyabeans (SEU), SL formulation: 1 × 100 g a.s./ha, BBCH 71 (beginning of pod development), PHI n.a.
In support of the intended SEU GAP on soyabeans, the applicant submitted eight independent residue trials on soyabeans conducted in Italy (4), Greece, France and Spain (2) during the 2021 and 2022 growing seasons.
In these trials, a single application was made to the treatment plots using a soluble concentrate at the nominal application rate of 0.100 kg a.s./ha and actual application rates between 99.4 and 100.8 g a.s./ha. The a.s was consistently applied at BBCH stage 71 of the crop. Subsequently, seed samples from the treated soybeans were collected at commercial harvest, when the plants had reached BBCH stage 89 (28 to 83 days after last application (DALA)). Considering that the variability in the time needed to reach crop maturity shown in the submitted trials is evident, EFSA accepted the trials supporting the GAP with no defined PHI.
In four decline trials conducted in Italy (2), France (1) and Spain (1), in addition to the sampling of seeds, the sampling of whole plants was performed on the day of application (day 0) and at the following BBCH stages: 75, 79 and 85. Hay samples were taken at BBCH stage 85 (Austria, 2024). In all these trials a clear residue decline pattern is observed.
Seed samples were analysed, in accordance with the residue definition for enforcement and risk assessment (Austria, 2024). No residues above the LOQ (0.01 mg/kg) were measured in any of the untreated samples. In the treated seed samples, higher residue levels were observed in trials with shorter intervals after application: residues of acetamiprid of 0.05 mg/kg were observed 28 DALA and 0.02 mg/kg at 44 DALA, while at all later intervals after application residues in seed samples showed residue levels of 0.01 mg/kg. EFSA considers the residues measured at 28 DALA as the most critical point of reference. Considering that no PHI is defined for the GAP under assessment, instances of MRL exceedance may potentially occur if the crop is harvested earlier.
In one of the submitted residue trials on soybean, the samples were analysed also for metabolite IM‐2‐1. In this sample, the metabolite was present at higher levels (0.089 mg/kg) than parent acetamiprid (0.05 mg/kg). EFSA acknowledges that this metabolite is not included in the residue definition of risk assessment for oilseeds and applicants are not required to provide data on metabolite IM‐2‐1. However, the submitted data give an indication that the presence of metabolite IM‐2‐1 in soybean seed cannot be excluded, and this is confirmed by monitoring data on pulses/oilseeds where in 11 out of 914 samples the metabolite IM‐2‐1 was identified in beans with pods (7), peas with pods (2) and peas without pods (2) at levels 0.001 and 0.012 mg/kg (EFSA, 2024a). For the present assessment EFSA concludes that further data are not required, given a sufficient margin of safety for the residue intake from soybean. However, EFSA recommends that applicants keep monitoring the presence of metabolite IM‐2‐1 for future uses of acetamiprid in oilseeds/pulses.
Overall conclusions for the GAPs submitted under application EFSA‐Q‐2024‐00271
The number of GAP‐compliant residue trials is sufficient to support MRL proposals of 0.08 mg/kg for the intended uses of acetamiprid on plums and soyabeans. Additionally, the available residue trials on basil are adequate to derive an MRL of 4 mg/kg in basil, and, by extrapolation in edible flowers, rosemary and parsley.
Intended uses submitted in the application EFSA‐Q‐2023‐00537 (Netherlands, 2025 )
In support of the MRL application, the applicant submitted residue trials performed in barley and soyabeans. The samples were analysed for the parent compound acetamiprid in line with the residue definition for enforcement and risk assessment using QuECheRS, liquid chromatography–tandem mass spectrometry detector (LC–MS/MS) method. The EMS confirmed that the analytical methods were sufficiently validated and fit for purpose (Netherlands, 2025). The samples of the submitted residue trials were stored under conditions for which the integrity of the samples had been demonstrated (Netherlands, 2025). The detailed residue trials data are reported in the Appendix B.1.2.
Barley (NEU), SL formulation: 2 × 42 g a.s./ha, BBCH 40–85, interval 14 days, PHI 28 days
In support of the intended NEU GAP for barley, the applicant submitted eight independent residue trials conducted in Northern France (2), Poland (2), Belgium (1), the United Kingdom (1), the Czech Republic (1) and Germany (1) during the 2013 and 2014 growing seasons. In these trials, the test substance was applied as soluble granules (SG) in five cases, while three trials included a side‐by‐side comparison of SG and soluble concentrate (SL) formulations.
The two applications were made 13–15 days apart, at rates ranging from 0.044 to 0.053 kg a.s./ha (intended nominal rate: 0.042 kg a.s./ha). Samples of treated barley straw and grain were collected 24–30 days after the final application, corresponding to ±25% of the intended pre‐harvest interval (PHI) of 28 days. Four of the eight trials followed a decline design, with residues additionally measured in whole plants at 0, 3 and 6–8 DALA, and in ears and the remaining plant parts at 13–15 DALA. The decline in residues was demonstrated. No residues of acetamiprid above the LOQ of 0.01 mg/kg were detected in any untreated sample (Netherlands, 2025).
It is noted that in one of the trials, the first spray application resulted in a rate 25.2% higher than that specified in the intended GAP. Although this slightly exceeded the maximum tolerance level of ±25% (European Commission, 2020), the deviation was accepted by the EMS due to its marginal nature and because it occurred during the first application at BBCH 59. EFSA agrees with the EMS.
Soyabeans (NEU), SL formulation: 1 × 48 g a.s./ha, BBCH 55–80, PHI 30 days
In support of the intended NEU GAP for soyabean, the applicant submitted nine independent residue trials conducted in Northen France (5), Poland (2), Czech Republic (1) and Hungary (1) during the two growing seasons of 2020 and 2021. In five residue trials, the test substance was applied once as soluble granules (SG), and in four additional trials as a SL formulation in line with the GAP. In all trials the application rate ranged from 0.048 to 0.053 kg a.s./ha (intended nominal rate: 0.048 kg a.s./ha).
In all trials the residues of acetamiprid were measured at harvest in hay, pods (not specified whether pods with or without seeds) and in seeds separately. Except for one trial in Northern France, where measurements were taken only in pods and hay (without measurement taken for seeds). In all above trials, the samples were collected at 26–31 DALA (corresponding to ±25% of the intended PHI of 30 days).
Four of the above trials performed with SG formulation followed the decline design where residues were measured in pods at five sampling points: 0, 6–8, 13–14, 20–22, 29–31 DALA, while residues in seed and in hay were measured at 29–31 days DALA. Notably, in one decline trial conducted in Northern France in 2020, acetamiprid residues were not measured in soyabean seeds, and therefore the requirement of minimum 50% of the trials following a decline design is not met, since decline results are available for three out of eight trials considered for MRL setting. The EMS is of the opinion that this deviation can be accepted, since the decline of residues in soyabean pods is sufficiently addressed (Netherlands, 2025). EFSA, supports this conclusion. No residues of acetamiprid above the LOQ (0.01 mg/kg) were found in any of the untreated samples (Netherlands, 2025).
Overall, the samples from all residue trials submitted to support the GAP for soyabeans were stored under conditions that ensured sample integrity. A deviation was noted for one soyabean sample, where the time between sampling and freezing exceeded 24 h by 2 h and 35 min. This deviation was considered acceptable due to not long exceedance time (Netherlands, 2025).
Overall conclusions for the GAPs submitted under application EFSA‐Q‐2023‐00537
As described above, some of the residue trials were conducted using a SG formulation, which differs from the SL formulation specified in the intended GAPs. It is important to note that neither SANTE/2019/12752 (European Commission, 2020) nor OECD 509 (2021) explicitly state whether SG and SL formulations can be considered equivalent. To demonstrate the comparability of the residue trials bridging studies should be conducted for at least three major crop groups, with four comparative trials per crop. While ideally 50% of the trials should include SG–SL comparisons, only three out of eight barley trials meet this criterion and no side‐by‐side comparisons were conducted for soybean seeds (four comparison trials involved only pods and hay). Nevertheless, the bridging studies did not show higher residue levels with either formulation, and the values were considered similar. No statistical analysis was applicable due to the limited number of paired trials. EFSA agrees with the EMS that formulations diluted in water can be considered comparable when the PHI exceeds 7 days, noting that the longer PHIs further support the reliability of residue data extrapolation between formulations, despite the limited dataset. When bridging studies are conducted, trials with both formulations follow Case 5 12 of the EFSA's publication on Residues trials and MRL calculations (EFSA, 2015), using the highest residue level observed in either SG or SL plots.
Overall, EFSA concluded that the comparability of the SG and SL formulations is acceptable, based on the results of side‐by‐side bridging studies and the fact that both formulations are water‐diluted and PHIs of the GAPs for barley and soyabeans exceed 7 days.
The number of the GAP‐compliant trials is sufficient to derive an MRL proposal of 0.03 mg/kg for the intended NEU use of acetamiprid on soyabeans. However, considering that the intended SEU use evaluated in the application submitted to Austria is more critical, an MRL of 0.08 mg/kg based on the SEU use is recommended in this output. For barley, an MRL of 0.5 mg/kg could be calculated but no MRL is recommended, due to the data gap identified by EFSA on the need of processing studies (refer to Section: 1.2.3). It is to be noted that the Applicant submitted the results of the extraction efficiency study for the method used for analysis of the soyabean seed samples. However, since the proposed MRL for soyabeans is based on a more critical SEU use, EFSA did not review the extraction efficiency study submitted in support of the NEU use.
1.2.2. Magnitude of residues in rotational crops
Studies investigating the uptake of residues from soil resulting from the use of acetamiprid in primary crops (rotational crop field studies) in root crops (turnips), leafy crops (spinaches) and cereals (wheat) have been assessed in the framework of the renewal of the approval of acetamiprid (EFSA, 2016). In the framework of a previous application to modify the existing MRLs for acetamiprid in honey and various oilseed crops, an additional rotational crops study with radish, spinach and wheat was assessed (EFSA, 2022a). The available studies demonstrated that acetamiprid, IM‐1‐4 and IM‐1‐5 residues are not expected to be present in succeeding crops such as turnip, spinach and wheat, when planted in soil treated at 300 g a.s./ha (EFSA, 2016, 2022a).
Since the maximum annual application rate for the crops under consideration (i.e. maximum of 100 g a.s./ha considering GAP on soyabeans) is lower than the application rate tested in the available rotational crop studies (ca. 300 g/ha or ca. 200 g/ha), it is concluded that no residues are expected in rotational crops, provided that the active substance on primary crop is applied according to the proposed GAPs.
1.2.3. Magnitude of residues in processed commodities
Processing studies with several crops were assessed during the EU pesticides peer review (EFSA, 2016). Among these, studies on apples (juicing) and gherkins (cooking and pickling/canning) showed a reduction in acetamiprid residues in the processed products.
In case of the commodities under consideration the need for studies assessing the impact of processing on the magnitude of residues is triggered for plums and barley in accordance with the Regulation (EU) 283/2013.
Specifically, regarding the regulatory criteria, residues in soyabean seeds do not exceed the trigger value of 0.1 mg/kg in the portion of the commodity to be processed and their contribution to the ARfD and ADI is below 10% (Austria, 2024; Netherlands, 2025). Under the same Regulation, processing studies are not required for commodities used exclusively in their raw form, which includes herbs (Austria, 2024). In view of the above, specific processing studies for herbs and soyabean seeds are therefore not required.
Barley
No studies investigating the effect of processing on the magnitude of acetamiprid residues have been submitted. EFSA considers that processing studies for barley are required in the context of the current application (data gap) in line with the data requirements outlined in Regulation (EU) No 283/2013, which specify that processing studies are triggered when residue levels ‘in the commodity to be processed’ exceed 0.1 mg/kg (primary criterion) or if the contribution of the commodity under consideration to the theoretical maximum daily intake (TMDI) is ≥ 10% of the ADI or if the estimated daily intake is ≥ 10% of the ARfD for any European consumer group diet (secondary criterion).
In three out of eight submitted barley trials acetamiprid residue levels measured in grain exceed 0.1 mg/kg i.e.: 0.11, 0.21, 0.27 mg/kg, thus fulfilling the primary criterion for the need of processing studies.
In this case, the EMS disagrees with EFSA's interpretation that the regulation explicitly requires the use of individual residue levels measured in the residue trials submitted in support of the GAP under assessment. Instead, the EMS interprets the requirement – ‘the level of residue in the plant or plant product to be processed (normally ≥ 0.1 mg/kg)’ – as referring to the median residue level in the bulked plant product, since barley grain is considered as bulked commodity. According to the EMS, the calculated supervised trials median residue (STMR) value of 0.05 mg/kg, as calculated for the intended use, is a more representative value for determining the need for processing studies.
The EMS emphasises that residues in barley grain from the intended use contributes to less than 1% to the ADI and a maximum of 6% (unprocessed) and 7% (processed) to the ARfD, when using the STMR as an input value. These values indicate a high margin of safety, and the EMS argues that the provision of processing studies would not alter the exposure estimates or the outcome of the consumer risk assessment. Therefore, no unacceptable risk to consumers is expected.
Finally, the EMS questions the proportionality of EFSA's request. While acknowledging that this is not a scientific argument, the EMS believes that requiring a processing study in this case is not justified, as it would not impact the risk assessment and does not correspond to the low level of risk identified.
With regard to the points raised above, EFSA does not accept the justification provided by the Applicant and the EMS to waive the requirement for processing data. This is based on the following considerations:
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proposal to use the STMR value as the basis for deciding whether processing studies are necessary. In EFSA's view, this approach is not aligned with the criteria set out in Regulation (EU) No. 283/2013, which refers specifically to the residue levels measured in the submitted field trials – the actual material that could be subjected to processing. EFSA also notes that residues above 0.1 mg/kg are determined in 3 out of 8 trials, which is nearly 40% considering the small dataset. Moreover, the STMR is not appropriate for determining the need for processing studies, as MRLs and processing factors (PFs) are derived from individual residue data.
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Although residues in barley grain (when using the STMR calculated for the intended use) contributes to less than 10% to both the ADI and the ARfD this alone does not qualify for waiving the processing data gap, since, the primary criterion – residue levels measured in barley grain exceed the regulatory trigger value of 0.1 mg/kg – is fulfilled.
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Given that barley grain undergoes various processing methods – such as brewing, milling and cooking – that can either dilute or concentrate residues, EFSA believes it is essential to assess the magnitude of residues in processed products.
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EFSA refers to OECD Guidance Document 508, which allows waivers for processing studies only under specific conditions. These conditions are not met in the case of barley, as its processing falls under Categories V (preparation of alcoholic beverages) and XI (distribution on milling), for which no waivers are foreseen.
Plums
No studies investigating the effect of processing on the magnitude of acetamiprid residues have been submitted.
EFSA notes that the estimated acute exposure to residues in plums exceeds the 10% ARfD. Therefore, processing studies are required under Regulation (EU) No. 283/2013. However, in line with OECD Guidance Document 508, data from apple processing studies may be extrapolated to plums in the absence of specific processing studies on plums (OECD, 2008b).
Processing studies with apples have been evaluated in the EU pesticides peer review and processing factors have been derived (EFSA, 2016). Under the present MRL application, the applicant provided additional new processing studies on apples (Austria, 2024).
Accordingly, the Applicant and EMS proposed to merge the available data on processing of apples, evaluated in a previous EFSA assessment, with new data submitted in this application (Austria, 2024; EFSA, 2016). As a result, the combination of old and new processing studies enabled the derivation of refined PFs for apples (apple/juice and apple/wet pomace).
In the framework of the study submitted with this application, apples were processed into juice, wet pomaces, dry pomaces, puree and dried apples. Samples of raw agricultural commodity (RAC) were taken from two field trials conducted in Northen France and Belgium in 2014, where fruits received one foliar spray application at 250 g a.s./ha. Samples were collected 14 days (±1 day) after the treatment. Residue levels of acetamiprid were analysed in the RAC (whole fruit) and in the processed commodities. According to the assessment of the EMS, the methods used to analyse residue trial samples based on LC–MS/MS, were sufficiently validated and able to quantify residues of acetamiprid at the LOQ of 0.01 mg/kg in both high‐water and dried processed commodities (Austria, 2024).
The new processing study on apples submitted within the MRL application, consistent with previously evaluated data, demonstrate that processing apples into juice and wet pomace leads to a reduction in residue levels. Based on the new study alone, a reduction of residues is observed for puree. While residue concentrations are observed in apples dry pomaces and dried apples (Austria, 2024). As in the submitted and previously evaluated processing studies samples were not analysed for the metabolite IM‐2‐1 the conversion factor of 1.21 for risk assessment as derived in EFSA Statement was applied (EFSA, 2024a). An overview of the processing studies and derived processing factors is presented in Appendix B.1.2.4.
1.2.4. Proposed MRLs
The available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation except for barley grain where a data gap for studies investigating the impact of processing on the magnitude of residues was identified by EFSA (see Appendix B.1.2.1).
In Section 4 EFSA assessed whether residues in these crops resulted from the intended uses are likely to pose a consumer health risk.
2. RESIDUES IN LIVESTOCK AND FISH
Soyabean seeds may be used for feed purposes (OECD, 2007e). Hence, it was necessary to update the previous dietary burden calculation for livestock calculated in EFSA MRL assessment published in 2022, and further revised in the EFSA 2024 Statement (EFSA, 2024a). Since in the EFSA Statement 2024 a risk for consumers was identified for existing EU MRLs in bovine tissues and some plant commodities (already previously considered in the DB calculated in 2022), EFSA proposed fall‐back MRLs in relevant plant commodities and recalculated the dietary burden for all livestock (EFSA, 2024a). This previous assessment was now updated to estimate whether the intended outdoor use of acetamiprid on soyabeans would have an impact on the residues expected in food of animal origin. Regarding barley, the data from previously reported and supported uses were considered in the livestock dietary burden calculation. The estimates were also updated with the STMR input values (for bean, lupin and pea seeds) derived for the CXLs assessed by EFSA in Scientific support for preparing an EU position for the 2025 CCPR meeting (EFSA, 2025b). It is noted that these CXLs are still pending the implementation into the EU MRL legislation, however, since no reservations were raised by the EU in the mentioned output, the related input values were considered.
The input values for the exposure calculations for livestock are presented in Appendix D.1. To estimate the animal dietary burden, EFSA used STMR for soyabean seeds as derived from the SEU residue trials. The results of the dietary burden calculation are presented in Section B.2 and confirmed that the dietary exposure of cattle, sheep, swine and poultry exceeded the trigger value of 0.004 mg/kg bw per day, indicating that the nature and magnitude of acetamiprid residues in livestock shall be investigated further.
However, it is to be noted that the updated dietary burdens did not increase as compared to the calculations performed in the EFSA 2024 Statement and no change was observed for all livestock (EFSA, 2024a).
As acetamiprid is not fat soluble (EFSA, 2016) investigation of the nature and magnitude of residues in fish in principle are not required according to SANCO/11187/2013 (European Commission, 2013).
2.1. Nature of residues and methods of analysis in livestock
Metabolism studies in livestock (goat and poultry) have been assessed previously in the framework of the EU pesticides peer review of the renewal of the approval (EFSA, 2016). Metabolism in lactating ruminants and poultry has been sufficiently investigated, and the findings are considered applicable to pigs as well. The following residue definitions were derived: ‘Metabolite IM‐2‐1 (N‐desmethyl‐acetamiprid), expressed as acetamiprid’ for enforcement purposes and ‘Sum of acetamiprid and metabolite IM‐2‐1 (N‐desmethyl‐acetamiprid), expressed as acetamiprid’ for risk assessment.
The QuEChERS multiresidue method followed by high performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) has been assessed by EFSA and was considered sufficiently validated for monitoring acetamiprid and IM‐2‐1 in products of animal origin, with an LOQ of 0.01 mg/kg in all animal matrices and for each compound (EFSA, 2016).
2.2. Magnitude of residues in livestock
Feeding studies with lactating cows were submitted evaluated in the framework of Directive 91/414/EEC (Greece, 2001) and by EFSA in the framework of the Article 12 MRL review (EFSA, 2011). In these study, three groups of lactating cows (three animals per group) were administered acetamiprid orally for 28 days at doses of 0.21, 0.63 and 2.13 mg/kg body weight per day. Samples collected from the cows were analysed for the presence of the parent compound acetamiprid and its metabolite IM‐2‐1. The samples were stored for less than 1 month under adequate conditions, and therefore, no specific storage stability studies were required, as no degradation of residues during storage is expected. The study results show that IM‐2‐1 was the main residue detected in all tissues and milk. No livestock feeding study on poultry was evaluated. However, based on the metabolism study, residues exceeding the LOQ are not expected in any poultry tissues or eggs (EFSA, 2011).
Since the maximum dietary burden (DB), compared to previous calculations, did not increase by more than 10% for any animal group, further assessment of the magnitude of residues in livestock is not needed. The MRLs for livestock tissues can remain at the previously established levels, with no increase required.
3. RESIDUES IN HONEY
3.1. Nature of residues in honey
Honey is produced by bees from sugary secretions of plants (floral nectar mainly) through regurgitation, enzymatic conversion and water evaporation and followed by storage in the bee hives for a certain time period.
In the absence of specific metabolism studies with honey bees, studies investigating the nature of residues in primary crops and rotational crops and studies investigating the degradation during pasteurisation should be considered to determine the nature of residues in honey (European Commission, 2018). It is likely that the nature of residues in pollen and nectar collected from primary and rotational crops, as well as in honey (resulting from the residues in floral nectar), is the same as in primary and rotational crops.
Considering that sufficient data investigating the metabolic profile in primary and rotational crops and the degradation of the active substance under standard hydrolysis conditions are available, no further information is required for the current application according to the guidelines.
3.1.1. Analytical methods for enforcement in honey
An analytical method for the determination of acetamiprid in honey was assessed in a previous MRL application evaluated by EFSA (2021). This method, based on HPLC–MS/MS, was fully validated for the enforcement of acetamiprid in honey, with a LOQ of 0.05 mg/kg. It is noted that the method is also suitable for the enforcement of two metabolites not included in the residue definition (IM‐1‐4 and IM‐1‐5).
Additionally, within the framework of the EU pesticides peer review (EFSA, 2016) and the focused MRL review under Article 43 of Regulation (EC) No 396/2005 (EFSA, 2018b), it was concluded that acetamiprid could be monitored in honey using the multiresidue method QuEChERS by HPLC–MS/MS, with an LOQ of 0.01 mg/kg, which is confirmed by the data submitted within the present application (Austria, 2024).
Information on the extraction efficiency of analytical methods for the enforcement of residues in honey is not required, according to the guidance document on extraction efficiency (European Commission, 2023b).
3.1.2. Storage stability of residues in honey
The storage stability of acetamiprid residues in honey samples stored under frozen conditions was investigated in a previous MRL applications assessed (EFSA, 2021, 2022a, 2025a). In the first study, acetamiprid and two metabolites (IM‐1‐4 and IM‐1‐5) were individually shown to be stable in honey for at least 4 months when stored at ≤ −18°C (EFSA, 2021). The second study demonstrated the stability for acetamiprid residues for a period of 11 months when stored at ≤ −18°C, and has been re‐submitted in the framework of the present application (Austria, 2024; EFSA, 2022a). The third study investigated the stability of acetamiprid and its metabolite IM‐2‐1 (EFSA, 2025a). The findings showed that both compounds remained individually stable in honey for a minimum duration of 3.8 months when stored at −20°C (EFSA, 2025b).
3.1.3. Proposed residue definitions
In the absence of specific metabolism studies on honey, the studies investigating the nature of residues in primary and rotational crops and studies investigating the degradation of the active substance during pasteurisation are considered to derive the residue definitions for honey.
The existing residue definition for risk assessment and enforcement for honey as ‘acetamiprid’ was discussed in an EFSA reasoned opinion on the modification of MRLs for honey in 2025 (EFSA, 2025a) with regard to the proposal by the EFSA 2024 Statement to include metabolite IM‐2‐1 in the risk assessment residue definition for fruits and leafy crops. It was concluded that the risk assessment residue definition shall be maintained as parent acetamiprid, however, as the residue definition for risk assessment is not common for all primary crop's groups, it was still recommended to measure the levels of IM‐2‐1 metabolite in the planned tunnel trials as a precautionary measure (EFSA, 2025a). It should be noted that in four previously assessed semi‐field trials on melliferous crops, the metabolite IM‐2‐1 was also analysed and remained below the LOQ in all honey samples (EFSA, 2025a).
3.2. Magnitude of residues in honey
Studies investigating the magnitude of residues in honey have been assessed in previous MRL applications (EFSA, 2021, 2022a, 2025a). All semi‐field tunnel trials were conducted on Phacelia tanacetifolia. The authorised uses on melliferous crops which have been considered as most critical in terms of residues in honey, were the uses on medlars, cherries and citrus fruits (See Appendix A2)
In the honey trials use patterns involving two applications of acetamiprid on P. tanacetifolia at either 2 × 80 (EFSA, 2022a) or 2 × 100 g a.s./ha were investigated (EFSA, 2021, 2025a). The first treatment was performed before or at early flowering of P. tanacetifolia (BBCH 55–61), and the second during full flowering (BBCH 63–67). Based on residue data from EFSA evaluations in 2021 and 2022, an MRL of 0.3 mg/kg was proposed and is currently considered in the MRL Regulation. Considering the combined dataset from 2021, 2022 and 2024 EFSA assessments, MRL proposal of 1.0 mg/kg was derived in 2025 by EFSA (EFSA, 2025a).
As part of the present MRL application, the applicant submitted results from two residue studies in honey. One of these studies had already been assessed by EFSA in its 2022 evaluation, while the second study had not been previously reviewed (Austria, 2024).
The applicant submitted four new semi‐field tunnel trials carried out in different sites in Germany on Phacelia t. Trials consisted of control and treatment tunnels, in the latter ones two applications of acetamiprid were performed at a rate of 80 g a.s./ha per treatment (actual rate between 79.4 and 80.8). The first application was made prior to flowering (BBCH 57–61), followed by a second application during flowering (BBCH 63–65). Honey bee colonies were placed in the tunnels in the evening before or in the morning of the second application. Honey samples were collected once mature, between 3 and 7 days after the second treatment. Sample weights from the treatment tunnels ranged from 10.2 to 107 g, and their water content was between 19.5% and 20%, which is found acceptable. From two of the locations it was possible to collect two replicate samples and derive a mean, while in the two other sites only one sample was collected as not enough freshly produced honey was available. No acetamiprid residues were detected in control samples and in the test samples residues ranged from 0.03 to 0.28 mg/kg. The residues of the metabolite IM‐2‐1 were not measured in the honey samples (Austria, 2024).
According to the evaluation by the EMS the analytical method used is sufficiently validated for the quantification of residues of acetamiprid and is fit for purpose. The study samples were analysed using QueChERS followed by LC‐MS/MS, which had been validated as part of the submitted honey study. This method allows for the quantification of acetamiprid residues at LOQ of 0.01 mg/kg. As the method is intended for monitoring, an independent laboratory validation (ILV) was submitted and assessed by the EMS, who confirmed its validity. It should be noted that the ILV included validation data for the IM‐2‐1 metabolite, which was not analysed in the trials (Austria, 2024). Information on extraction efficiency of the analytical method is not available and is not required according to the guidance document on extraction efficiency (European Commission, 2023b). The residue trial samples were stored for no more than 134 days at ≤ −18°C prior to analysis, which are the conditions for which integrity of the samples has been demonstrated.
The four newly reported residue trials are merged with 10 available trials assessed in previous EFSA opinions, leading to the combined dataset of 14 GAP‐compliant trials. The combined dataset is sufficient to derive a new MRL proposal of 0.9 mg/kg for honey based on the critical GAPs currently authorised on melliferous crops (see also Appendix A2). It should be noted that the applicant of the present application reported a different cGAP for the honey study (2 × 70 g a.s./ha) on citrus fruits. However, since the previously identified cGAP (2 × 100 g a.s./ha) on cherries and medlars is more critical and all performed trials are considered to be compliant with it, the alternative cGAP on citrus fruits is included in Appendix A.2 for information only.
3.2.1. Proposed MRLs
The available data are considered sufficient to derive an MRL proposal of 0.9 mg/kg as well as risk assessment values for honey (see Appendix B.3.2.1). In Section 4, EFSA assessed whether residues in honey resulting from the treatment of melliferous crops according to authorised EU uses are likely to pose a consumer health risk.
It should be noted that currently, MRLs set for honey are not applicable to other apicultural products, although these commodities are falling within the same commodity category (104000) according to Annex I of Regulation (EC) No 396/2005 as amended by Commission Regulation (EU) 2018/62. 13
4. CONSUMER RISK ASSESSMENT
EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 2019). This exposure assessment model contains food consumption data for different sub‐groups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).
The toxicological reference values for acetamiprid used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EFSA 2024 Statement (EFSA, 2024a). These TRVs of 0.005 mg/kg bw per day (ADI) and 0.005 mg/kg bw (ARfD) were endorsed by the European Commission (European Commission, 2024). The N‐desmethyl metabolite of acetamiprid (IM‐2‐1) included in the risk assessment residue definition for fruits and leafy crops was concluded to be of similar toxicity than the parent compound (EFSA, 2024a).
Short‐term (acute) dietary risk assessment
The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on the commodities assessed in this application. The calculations were based on the HR derived from supervised field trials and the complete list of input values can be found in Appendix D.2.
The short‐term exposure did not exceed the ARfD for the commodities assessed in this application.
Long‐term (chronic) dietary risk assessment
For the long‐term exposure assessment, EFSA updated the chronic exposure calculations originally performed in the EFSA 2024 Statement, considering the scenario corresponding to the risk mitigation measure referred to as ‘scenario 3’ in EFSA (2024a). The conclusions from this EFSA opinion have been implemented into EU MRL legislation in Regulations (EU) 2025/158 14 and (EU) 2025/1212. 15
The calculation is based on the median residue levels (STMR) derived for raw agricultural commodities. EFSA revised the calculations using the relevant STMR values derived from residue trials submitted in support of the MRL applications under assessment for soyabeans, plums and honey. For basil and edible flowers, rosemary and parsley a more critical STMR value was included as derived in the previous EFSA assessment (EFSA, 2018b, 2024a).
Following the publication of the EFSA Statement (2024a), EFSA issued scientific support for preparing the EU position for the 55th Session of the CCPR (EFSA, 2024b). This included an evaluation of a Codex MRL (CXL) proposal for soyabeans, as well as a separate MRL assessment for honey (EFSA, 2025a). The commodities assessed in these outputs are covered by the current evaluation, and therefore the new STMR values derived in this assessment have been used as input values, as previously mentioned. In addition, median values associated with CXLs for pistachios, spice seeds (FAO and WHO, 2020, 2021) and beans, lentils, peas and lupins (EFSA, 2025b; FAO and WHO, 2025), which have been adopted by Codex and supported by the EU, but not yet implemented in EU legislation, were also taken into account.
The applied assumptions are in line with the EFSA Statement (2024a). To account for the separate residue definitions for risk assessment in fruit and leafy crops, the median values were multiplied by a conversion factor of 1.21 for fruit and 1.44 for leafy crops in cases where residue data on IM‐2‐1 were not available. Therefore, a conversion factor of 1.21 was applied to STMR for plums (residues found in flesh) derived in the current assessment. For basil, rosemary and parsley a tentative CF of 1.07 for the GAPs under assessment was applied as derived based on the four residue trials on basil conducted in 2024 and analysing for metabolite IM‐1‐2 (Austria, 2024). Since this conversion factor is based on residue data where sample integrity during storage is supported by interim results from the storage stability study, it may be subject to revision once the full study report becomes available (see Section 1.1.5).
Furthermore, a conversion factor of 1 for risk assessment was applied to stem vegetables as derived in the EFSA 2024 Statement based on the monitoring data. Furthermore, no conversion factors for risk assessment were considered necessary for pomegranates and asparagus, due to a no‐residue situations. For citrus fruits, a peeling factor was used. In addition, a specific processing factor of 0.13 was considered for orange juice, 0.35 for pickled gherkins and 0.61 for apple juice and plum juice.
The input values used in the exposure calculations are summarised in Appendix D.2.
The estimated long‐term dietary intake was in the range of 2%–47% of the ADI (max observed for NL toddlers diet). The contribution of residues expected in the commodities assessed in the two applications to the overall long‐term exposure is very low with the highest contribution observed for parsley (0.75% ADI) as reported in Appendix B.4.
EFSA concluded that the long‐term intake of residues of acetamiprid resulting from the existing uses and the intended uses on plums, basil and edible flowers, parsley, rosemary and soyabeans and the potential residues in honey from the authorised uses on melliferous crops are unlikely to present a risk to consumer health.
For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.
5. CONCLUSION AND RECOMMENDATIONS
The data submitted in support of the submitted MRL applications were found to be sufficient to derive an MRL proposal for soyabeans, plums, rosemary, basil and edible flowers, parsley and honey. EFSA also reviewed the EMS's proposal to set an MRL of 0.5 mg/kg for barley grain; however, it found the available data insufficient to support this proposal. Further considerations on the matter are outlined in this opinion.
EFSA concluded that the proposed uses of acetamiprid on the above‐mentioned commodities will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.
The MRL recommendations are summarised in Appendix B.4.
ABBREVIATIONS
- ADI
acceptable daily intake
- ARfD
acute reference dose
- a.s.
active substance
- BBCH
growth stages of mono‐ and dicotyledonous plants
- bw
body weight
- CCPR
Codex Committee on Pesticide Residues
- CF
conversion factor for enforcement to risk assessment residue definition
- cGAP
critical GAP
- CXL
Codex maximum residue limit
- DALA
days after last application
- DAT
days after treatment
- DB
dietary burden
- DT90
period required for 90% dissipation (define method of estimation)
- EMS
evaluating Member State
- EURL
EU Reference Laboratory (former Community Reference Laboratory (CRL))
- FAO
Food and Agriculture Organization of the United Nations
- GAP
Good Agricultural Practice
- GC–MS/MS
gas chromatography with tandem mass spectrometry
- HPLC–MS/MS
high performance liquid chromatography with tandem mass spectrometry
- HR
highest residue
- IEDI
international estimated daily intake
- IESTI
international estimated short‐term intake
- ILV
independent laboratory validation
- ISO
International Organisation for Standardisation
- IUPAC
International Union of Pure and Applied Chemistry
- JMPR
Joint FAO/WHO Meeting on Pesticide Residues
- LC
liquid chromatography
- LOQ
limit of quantification
- MRL
maximum residue level
- MS
Member States
- MS/MS
tandem mass spectrometry detector
- MW
molecular weight
- NEU
northern Europe
- OECD
Organisation for Economic Co‐operation and Development
- PBI
plant back interval
- PF
processing factor
- PHI
pre‐harvest interval
- PRIMo
(EFSA) Pesticide Residues Intake Model
- QuEChERS
quick, easy, cheap, effective, rugged, and safe (analytical method)
- RA
risk assessment
- RAC
raw agricultural commodity
- RAR
renewal assessment report
- RD
residue definition
- RMS
rapporteur Member State
- SANCO
Directorate‐General for Health and Consumers
- SEU
southern Europe
- SG
water‐soluble granule
- SL
soluble concentrate
- STMR
supervised trials median residue
- TMDI
theoretical maximum daily intake
- TRR
total radioactive residue
- WHO
World Health Organization
REQUESTOR
European Commission
QUESTION NUMBERS
EFSA‐Q‐2023‐00537; EFSA‐Q‐2024‐00271
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APPENDIX A. Summary of GAPs
A.1. SUMMARY OF THE INTENDED GAPS TRIGGERING THE AMENDMENT OF EXISTING EU MRLS
| 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/kg) | Method kind | Range of growth stages & season c | Number min–max | Intervalbetween application (days) min–max | g a.s./hL min–max | Water (L/ha) min–max | Rate min–max | Unit | ||||||
| GAPs submitted in the application EFSA‐Q‐2024‐00271 (Austria, 2024 ) | |||||||||||||||
| Plums | NEU | F | Cydia funebrana | SL | 200 g/L | Foliar spray | 69–89 | 1 | – | 4.6–27.5 | 200–1200 | 55 | g a.i./ha | 14 | |
| Basil and edible flowers | SEU | F |
Trialeurodes vaporariorum Bemisia tabaci Aphis sp. |
SL | 200 g/L | Foliar spray | n.r. | 1 | – | 4.5–45 | 100–1000 | 45 | g a.i./ha | 14 | |
| Parsley | SEU | F |
Trialeurodes vaporariorum Bemisia tabaci Aphis sp. |
SL | 200 g/L | Foliar spray | n.r. | 1 | – | 4.5–45 | 100–1000 | 45 | g a.i./ha | 14 | |
| Rosemary | SEU | F |
Trialeurodes vaporariorum Bemisia tabaci Aphis sp. |
SL | 200 g/L | Foliar spray | n.r. | 1 | – | 4.5–45 | 100–1000 | 45 | g a.i./ha | 14 | |
| Soyabeans | SEU | F | Halyomorpha halys | SL | 200 g/L | Foliar spray | 71–71 | 1 | – | 20–33 | 300–500 | 100 | g a.i./ha | n.a. | |
| GAPs submitted in the application EFSA‐Q‐2023‐00537 (Netherlands, 2025) | |||||||||||||||
| Barley | NEU | F | Oulema | SL |
120 g/kg |
Foliar spray | 40–85 | 2 | 14 | 10.5–21 | 200–400 | 42 | g a.i./ha | 28 | |
| Soyabeans | NEU | F | Vanessa cardui, Helicoverpa armigera | SL | 120 g/kg | Foliar spray | 55–80 | 1 | – | 12–24 | 200–400 | 48 | g a.i./ha | 30 | |
Abbreviations: a.s.: active substance; GAP: Good Agricultural Practice; MRL: maximum residue level; MS: Member State; NEU: northern European Union; SEU: southern European Union; SL: Soluble concentrate.
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 pre‐harvest interval.
A.2. CRITICAL GAP TRIGGERING THE ASSESSMENT OF AN MRL IN HONEY
The GAP outlined below has been identified by the applicant as the worst‐case authorised EU GAP of acetamiprid on primary crops for the residue carry‐over to honey. On the basis of this GAP the worst‐case treatment pattern (application rate and timing) was selected to design tunnel trials with a Phacelia tanacetifolia (melliferious surrogate crop) to investigate magnitude of residues in honey.
| 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 | ||||||
| Medlars | SEU (PT/EL) | F | Popillia japonica | SL | 50 g/L | Foliar treatment – broadcast spraying | BBCH 51–85 | 1–2 | 14 | – | – | 100 | g a.s./ha | 14 | cGAP considered in the present applicaton as reported in EFSA (2025a) |
| Cherries | SEU (EL) | F | Aphids (M. persicae, A. pomi, A. spiraecola), Ceratitis capitata, Rhagoletis cerasi, Drosophila suzukii, Fruit tree tortrix (Cacoecia rosana) | SL | 50 g/L | Foliar treatment – general | BBCH 51–85 | 1–2 | 30 | – | – | 100 | g a.s./ha | 14 | cGAP considered in the present applicaton as reported in EFSA (2025a) |
| Citrus Fruits | SEU | F |
Aphis gossypii (APHIGO); Aphis spiraecola (APHISI) Toxoptera aurantii (TOXOAU) |
SL | 200 | Foliar spraying | 31–81 | 2 | 30 | 5–12 | 600–1400 | 70 | g a.s./ha | 14 | cGAP selected by the Applicant in the present assessment (Austria, 2024). Considered for information only as the submitted honey trials (new and old) are compliant with the more critical GAPs on cherries and medlars. |
Abbreviations: a.s., active substance; GAP, Good Agricultural Practice; MRL, maximum residue level; MS, Member State; NEU, northern European Union; SEU, southern European Union; SL, soluble concentrate.
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 pre‐harvest interval.
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
| Primary crops (available studies) | Crop groups | Crops | Applications | Sampling | Comment/source |
|---|---|---|---|---|---|
| Fruit crops | Aubergine | Foliar (dotting on leave and fruit surface): 1 × 9.5 g/100 L | 7, 14 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |
| Apple | Foliar (dotting on leave): 1 × 208 g/ha) | 0, 7, 14, 28, 62, 90 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | ||
| Foliar (dotting on fruit): 1 × 104 g/ha | 0, 7, 14, 28, 62 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |||
| Root crops | Carrot | Foliar: 2× 100 g/ha | 14 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |
| Leafy crops | Cabbage | Foliar: 1 × 301.5 g/ha (study 1) | 0, 7, 14, 21, 28 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |
| Foliar: 1 × 298.5 g/ha (study 2) | 0, 7, 14, 28, 63 DAT | Radiolabelled active substance: cyano‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |||
| Soil treatment: 1 × 5940 g/ha | 7, 14, 28 DAT | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) | |||
| Pulses/oilseeds | Cotton | Foliar: 4 × 1230 g/ha | 14, 28 DALA | Radiolabelled active substance: pyridine‐2,6‐14C]‐acetamiprid (EFSA, 2011, 2016) |
| Rotational crops (available studies) | Crop groups | Crops | Application | PBI (DAT) | Comment/Source |
|---|---|---|---|---|---|
| Root/tuber crops | Turnip | Bare soil, 1 × 266 g a.s./ha | 0 | Radiolabelled active substance: pyridyl‐14C‐IM‐1‐5 (study conducted with acetamiprid most persistent soil metabolite (IM‐1‐5 DT50 319–663 days) (EFSA, 2016). | |
| Leafy crops | Spinaches | Bare soil, 1 × 266 g a.s./ha | 0 | ||
| Cereal (small grain) | Wheat | Bare soil, 1 × 266 g a.s./ha | 0 | ||
| Root/tuber crops | Turnip | Bare soil, 1 × 160 g a.s./ha | 0 | Radiolabelled active substance: pyridyl‐14C‐IM‐1‐5 (study conducted with acetamiprid most persistent soil metabolite (IM‐1‐5 DT50 319–663 days) (EFSA, 2022a) | |
| Leafy crops | Spinaches | Bare soil, 1 × 160 g a.s./ha | 0 | ||
| Cereal (small grain) | Wheat | Bare soil, 1 × 160 g a.s./ha | 0 |

B.1.1.2. Stability of residues in plants
| Plant products (available studies) | Category | Commodity | T (°C) | Stability period | Compounds covered | Comment/ source | |
|---|---|---|---|---|---|---|---|
| Value | Unit | ||||||
| High‐water content | Cabbage | −18 | 12 | Months | Acetamiprid | EFSA (2016) | |
| Cucumber | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Apple | −18 | ≤ 13 | Months | Acetamiprid | EFSA (2016) | ||
| Tomato | −18 | ≤ 13 | Months | Acetamiprid | EFSA (2016) | ||
| Tomato | −18 | ≥ 12 | Months | IM‐2‐1 | Austria, 2024 | ||
| Lettuce | −18 | 15 | Months | Acetamiprid | EFSA (2016) | ||
| High‐oil content | Cotton seed | −18 | 12 | Months | Acetamiprid | EFSA (2016) | |
| High‐protein content | Fodder peas | −18 | 12 | Months | Acetamiprid | EFSA (2016) | |
| Dry/High starch | Potato tuber | −18 | 8 | Months | Acetamiprid | EFSA (2016) | |
| High‐acid content | Orange | −18 | 12 | Months | Acetamiprid | EFSA (2016) | |
| Others | Dry bean straw | −18 | 12 | Months | Acetamiprid | EFSA (2018b) | |
| Processed products | Apple, juice | −18 | 12 | Months | Acetamiprid | EFSA (2016) | |
| Appel, wet pomace | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Cotton oil | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Orange oil | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Cotton, gin trash | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Cotton, hulls | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Cotton, meal | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Orange, juice | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
| Orange, dried pulp | −18 | 12 | Months | Acetamiprid | EFSA (2016) | ||
B.1.2. Magnitude of residues in plants
B.1.2.1. Summary of residues data from the supervised residue trials
| 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) | CF d |
|---|---|---|---|---|---|---|---|
|
Enforcement residue definition: Acetamiprid Risk Assessment residue definition (all crop groups, except fruits and leafy crops): Acetamiprid Residue definition for Risk Assessment in fruits and leafy crops: Sum of acetamiprid and its metabolite IM 2–1, expressed as acetamiprid | |||||||
| GAPs submitted in the application EFSA‐Q‐2024‐00271 (Austria, 2024 ) | |||||||
| Plums | NEU |
Mo: Whole fruit e : 4 × < 0.010; 0.027; 0.037; 0.038; 0.039 Plum flesh: 4 × < 0.01; 0.03; 3 × 0.04 RA: no data available |
Eight independent and GAP‐compliant residue trials on plums | 0.08 | Whole fruit e : 0.039 (plum flesh: 0.04) | Whole fruit e : 0.019 (plum flesh: 0.02) | 1.21 (EFSA, 2024a) |
| Soyabean seeds | SEU | Mo = RA: 6 × < 0.010; 0.020; 0.050 | Eight independent and GAP‐compliant residue trials on soyabeans | 0.08 | 0.05 | 0.01 | n.a. |
|
Basil and edible flowers Parsley Rosmary |
SEU |
Mo: 0.06; 0.11; 0.15; 0.16; 0.16; 0.32; 0.36; 0.59; 0.62; 0.70; 1.27; 2.70 RA: 0.06; 0.12 f ; 0.16 f ; 0.17 f ; 0.17; 0.34 f ; 0.39; 0.63; 0.66; 0.75; 1.36; 2.89 |
Twelve independent and GAP‐compliant residue trials on basil. Extrapolation of residue data to edible flowers, rosemary and parsley possible (European Commission, 2023a). In four residue trials (underlined) the samples were analysed according to the RA residue definition. To derive risk assessment data for remaining trials, a CF of 1.07 calculated from the four trials was applied. The validity of these four basil trials relies on the interim storage stability data (Austria, 2024), pending the final report (see Section 1.1.5); For the purpose of the chronic risk assessment a more critical STMR value of 0.83 mg/kg (× CF of 1.07) is used, as it was derived in the previous EFSA opinion (EFSA, 2018b). |
4 | 2.89 | 0.36 | 1.07 g (Austria, 2024) |
| GAPs submitted in the application EFSA‐ Q‐2023‐00537 (Netherlands, 2025) | |||||||
| Barley grain | NEU | Mo = RA: < 0.01; 0.02 h ; 0.03 h ; 0.04 h ; 0.06; 0.11; 0.21; 0.27 |
Residue trials on barley compliant with GAP. Three trials were performed in parallel with both SG and SL formulation (formulation of the GAP). The results for SL formulation are underlined. The MRL of 0.5 mg/kg can be calculated, but the intended use is not supported due to a data gap identified by EFSA regarding the magnitude of residues in processed commodities (see Section 1.2.3) |
Not derived | 0.27 | 0.05 | |
| Barley straw | NEU | Mo: 0.04, 0.13, 0.20, 0.32 h ; 0.35, 0.39 h , 0.40 h , 0.95 | Residue trials on barley compliant with GAP. The intended use is not supported due to a data gap identified by EFSA regarding the magnitude of residues in processed commodities (see Section 1.2.3) | Not derived | Not derived | 1.44 (EFSA Statement 2024) | |
| Soyabean seeds | NEU | Mo = RA: 4 × < 0.01; 3 × < 0.01; 0.02 |
Residue trials on soyabean compliant with the GAP. Four trials were conducted with the SG formulation and four with the SL (formulation of the GAP). The results for SL formulation are underlined. |
0.03 | 0.02 | 0.01 | |
Abbreviations: GAP, Good Agricultural Practice; Mo, monitoring; MRL, maximum residue level; n.a., not applicable; RA, risk assessment.
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.
Tentative median conversion factor from monitoring to risk assessment in primary fruit commodities, derived from monitoring data (EFSA Statement, 2024). Samples from all residue trials have been analysed for parent acetamiprid only. No data on the magnitude of metabolite IM‐2‐1 are available.
Residue levels in whole fruit were calculated using the following formula: [residues in flesh × flesh/whole fruit ratio (%)]/ 100 assuming no residues in stone.
Before summing up, the residue levels of metabolite IM‐2‐1 were converted to parent acetamiprid equivalents based on molecular weight (MW) conversion factor (CF): 1.07. Considering the molecular mass of 222.67 for acetamiprid and of 208.67 for metabolite IM‐2‐1 (EFSA, 2024a).
A tentative conversion factor has been derived from four residue trials on basil conducted in 2024 and the results of an interim storage stability study. This factor is considered applicable only to the GAP currently under assessment. It should be noted that the factor may be revised once the full storage stability study report becomes available (see Section 1.1.5). The current factor is lower than the one reported in the EFSA Statement of 2024 (1.21), but is based on the actual field data on residues in basil.
Trials performed with both SG and SL (formulation of the GAP under assessment) formulations. As both formulations are regarded to be equivalent, the higher residue level between the two results have been selected. The remaining trials (not underlined) have been performed only with SG formulation.
B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors
| Processed commodity | Number of valid studies a | Processing factor (PF) | CFP b | Comment/source | |
|---|---|---|---|---|---|
| Individual values | Median PF | ||||
| Apples, juice | 4 | 0.46 d ; 0.49 d ; 0.73 c ; 0.87 c | 0.61 | 1.21 |
Extrapolation of the derived PF to plums is acceptable (OECD, 2008b) |
| Apples, wet pomaces | 4 | 1.23 c ; 1.39 c ; 0.89 d ; 1.27 d | 1.25 | 1.21 | EFSA (2016), Austria (2024) |
| Apples, dry pomaces | 2 | 3.78; 3.67 | 3.73 | 1.21 | Austria (2024) |
| Apples, puree | 2 | 0.62 d ; 0.57 d , 0.73 e | 0.6 | 1.21 |
Austria (2024) Netherlands (2016) Extrapolation of the derived PF to plums is acceptable (OECD, 2008b) |
| Apples, dry | 2 | 3.11; 3.19 | 3.15 | 1.21 | Austria (2024) |
Abbreviation: PF, processing factor.
Studies with residues in the RAC at or close to the LOQ were disregarded (unless concentration may occur).
Tentative median conversion factor from monitoring to risk assessment in processed fruit commodities, derived from monitoring data (EFSA, 2024a). Samples from all residue trials have been analysed for parent acetamiprid only. No data on the magnitude of metabolite IM‐2‐1 are available.
Source: EFSA (2016).
Source: Austria (2024).
Source: Netherlands (2016).
B.2. RESIDUES IN LIVESTOCK
Dietary burden calculation according to OECD (2013).
| Relevant groups | Dietary burden expressed in | Most critical diet a | Most critical commodity b | Trigger exceeded (yes/No) | Previous assessment (EFSA statement 2024a and EFSA, 2022a) | ||||
|---|---|---|---|---|---|---|---|---|---|
| mg/kg bw per day | mg/kg DM | 0.004 | Max burden | ||||||
| Median | Maximum | Median | Maximum | mg/kg bw | mg/kg bw | ||||
| Cattle (all diets) | 0.026 | 0.046 | 0.68 | 1.32 | Dairy cattle | Citrus | Dried pulp | Yes | 0.046 (EFSA, 2024a) |
| Cattle (dairy only) | 0.026 | 0.046 | 0.68 | 1.21 | Dairy cattle | Citrus | Dried pulp | Yes | 0.046 (EFSA, 2024a) |
| Sheep (all diets) | 0.009 | 0.046 | 0.22 | 1.09 | Lamb | Wheat | Straw | Yes | 0.046 (EFSA, 2024a) |
| Sheep (ewe only) | 0.007 | 0.036 | 0.22 | 1.09 | Ram/Ewe | Wheat | Straw | Yes | 0.036 (EFSA, 2024a) |
| Swine (all diets) | 0.010 | 0.013 | 0.44 | 0.57 | Swine (breeding) | Citrus | Dried pulp | Yes | 0.013 (EFSA, 2024a) |
| Poultry (all diets) | 0.005 | 0.020 | 0.07 | 0.29 | Poultry layer | Wheat | Straw | Yes | 0.020 (EFSA, 2024a) |
| Poultry (layer only) | 0.005 | 0.020 | 0.07 | 0.29 | Poultry layer | Wheat | Straw | Yes | 0.020 (EFSA, 2024a) |
Abbreviations: bw, body weight; DM, dry matter.
When several diets are relevant (e.g. cattle, sheep and poultry ‘all diets’), the most critical diet is identified from the maximum dietary burdens expressed as ‘mg/kg bw per day’.
The most critical commodity is the major contributor identified from the maximum dietary burden expressed as ‘mg/kg bw per day’.
B.2.1. Nature of residues and methods of analysis in livestock
B.2.1.1. Metabolism studies, methods of analysis and residue definitions in livestock
| Livestock (available studies) | Animal | Dose (mg/kg DM) | Duration (days) | Comment/source |
|---|---|---|---|---|
| Laying hen | 10 | 14 | Poultry, pyridine‐2,6‐14C acetamiprid, 1 or 10 mg/kg feed, respectively (EFSA, 2016) | |
| Lactating ruminants | 10 | 7 | Goat pyridine‐2,6‐14C acetamiprid, 1 or 10 mg/kg feed, respectively (EFSA, 2016) | |
| Pig | – | |||
| Fish | – |

B.2.1.2. Stability of residues in livestock
Samples of the livestock feeding studies were stored for less than 1 month under freezer conditions. Storage stability studies are therefore not required (EFSA, 2011, 2016).
B.2.2. Magnitude of residues in livestock
No assessment is required (See section: 2.2).
B.3. RESIDUES IN HONEY
B.3.1. Nature of residues and analytical methods for enforcement purposes in honey
B.3.1.1. Metabolism studies, analytical methods and residue definitions in honey

B.3.1.2. Storage stability of residues in honey
| Products of animal origin (available studies) | Category | Commodity | T (°C) | Stability period | Compounds covered | Comment/source | |
|---|---|---|---|---|---|---|---|
| Value | Unit | ||||||
| Bee products | Honey | −18 | 4 | Months | Acetamiprid | EFSA (2021) | |
| −18 | 11 | Months | Acetamiprid | EFSA (2022a), Austria (2024) | |||
| −20 | 3.8 | Months | Acetamiprid | EFSA (2025a) | |||
| −20 | 3.8 | Months | IM‐2‐1 | EFSA (2025a) | |||
| −18 | 4 | Months | IM‐1‐5 | EFSA (2021) | |||
| −18 | 4 | Months | IM‐1‐4 | EFSA (2021) | |||
B.3.2. Magnitude of residues in honey
B.3.2.1. Summary of residues data from the supervised residue trials
| 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) | CF d |
|---|---|---|---|---|---|---|---|
|
Residue definition for Enforcement: Acetamiprid Residue definition for Risk Assessment: Acetamiprid | |||||||
| Honey | n.r. | 2 × 80 g a. s./ha ( Austria, 2024 ): 0.03; 0.09; 0.24; 0.28 |
Residue levels determined in honey from 4 new semi‐field tunnel trials performed on Phacelia tanacetifolia supporting the critical GAP on melliferous crops identified in the present application (2 × 70 g a.s./ha) (Austria, 2024). The application rate in the assessed studies differed within acceptable 25% deviation from the critical GAP identified by EFSA in 2025 (2 × 100 g/ha); therefore, the residue data can be combined with the previously assessed dataset. |
0.7 | 0.28 | 0.17 | – |
| Honey | n.r. | 2 × 100 g a. s./ha (EFSA, 2025a ): < 0.05; < 0.05; 0.03; 0.05; 0.09; 0.16; 0.03; 0.37; 0.48; 0.55 |
Residue levels in honey were determined from 10 valid semi‐field tunnel trials on Phacelia tanacetifolia, assessed in EFSA outputs 2021 e , 2022a and 2025a f , supporting the critical GAP for melliferous crops identified in EFSA (2025b) output (2 × 100 g a.s./ha). Studies assessed in 2022 differed by 20% the application rate of this cGAP, which is acceptable (European Commission, 2023a) |
1 [according to draft measure −2025‐1931] g | 0.55 | 0.07 | n.r. |
| Honey | n.r. | 2 × < 0.05; 2 × 0.03; 0.03; 0.05; 0.09; 0.09; 0.16; 0.24; 0.28; 0.37; 0.48; 0.55 | A combined dataset, including residue data assessed by EFSA in 2021, 2022a and 2025, along with new trials (underlined) assessed in the present application (Austria, 2024), considered for deriving a new MRL proposal. | 0.9 | 0.55 | 0.09 | |
Note: The MRL proposal and the input values used for risk assessment are underlined in bold.
Abbreviations: GAP, Good Agricultural Practice; Mo, monitoring; MRL, maximum residue level; n.r., not relevant; RA, risk assessment.
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.
Supervised trials median residue.
Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.; n/a: not applicable.
Metabolites: I‐M‐1‐4 and I‐M‐1‐5 were analysed in the submitted honey residue trials but were not detected above the LOQ.
Metabolite: IM‐2‐1 was analysed in the submitted honey residue trials but was not detected above the LOQ.
Draft measure −2025‐1931. SANTE.g.3(2025)11601693. Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Pesticide Residues. 2–3 October 2025. (Section B. Point B01).
B.4. CONSUMER RISK ASSESSMENT

B.5. RECOMMENDED MRLS
| Code a | Commodity | Existing EU MRL (mg/kg) | Proposed EU MRL (mg/kg) | Comment/justification |
|---|---|---|---|---|
| Enforcement residue definition: Acetamiprid | ||||
| 0140040 | Plums | 0.04 | 0.08 | The submitted data are sufficient to derive an MRL proposal for the NEU use. Risk for consumers unlikely. |
| 0401070 | Soyabeans | 0.01 | 0.08 | The submitted data are sufficient to derive an MRL proposal of 0.08 mg/kg based on the more critical SEU use. Risk for consumers unlikely. |
| 0256040 | Parsley | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use by extrapolation from residue data on basil. Risk for consumers unlikely. |
| 0256060 | Rosemary | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use by extrapolation form residue data on basil. Risk for consumers unlikely. |
| 0256080 | Basil and edible flowers | 3 | 4 | The submitted data are sufficient to derive an MRL proposal for the intended SEU use. Risk for consumers unlikely. |
| 1,040,000 | Honey and other apiculture products b | 1 [according to draft measure −2025‐1931] c | 0.9 | The submitted data are sufficient to derive an MRL proposal for honey. Risk for consumers unlikely. |
| 0500010 | Barley | 0.05 | – | The intended use is supported by sufficient number of GAP‐compliant trials. However, due to the data gap identified for processing studies, no MRL is proposed. |
Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level; NEU, northern Europe; SEU, southern Europe.
Commodity code number according to Annex I of Regulation (EC) No 396/2005.
According to Regulation (EC) No 396/2005 (as amended by Commission Regulation (EU) 2018/62) MRLs are not applicable to other apiculture products until individual products have been identified and listed within this group.
Draft measure −2025‐1931. SANTE.g.3(2025)11601693. Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Pesticide Residues. 2–3 October 2025. (Section B. Point B01).
APPENDIX C. Pesticide Residue Intake Model (PRIMo)


APPENDIX D. Input values for the exposure calculations
D.1. LIVESTOCK DIETARY BURDEN CALCULATIONS
| Feed commodity | Median dietary burden | Maximum dietary burden | ||
|---|---|---|---|---|
| Input value a (mg/kg) | Comment | Input value a (mg/kg) | Comment | |
| Risk assessment residue definition: acetamiprid, except for fruit and leafy crops: sum of acetamiprid and N‐desmethyl acetamiprid (IM‐2‐1), expressed as acetamiprid | ||||
| Alfalfa forage (green) | 0.13 | STMRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) | 0.59 | HRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) |
| Alfalfa hay (fodder) | 0.32 | STMRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (2.5) b | 1.48 | HRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (2.5) b |
| Alfalfa meal | 0.32 | STMRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (2.5) b | 1.48 | HRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (2.5) b |
| Alfalfa silage | 0.14 | STMRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (1.1) b | 0.65 | HRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) × PF (1.1) b |
| Barley straw; Oat straw | 0.25 | STMRMo (EFSA, 2018b) × CF (1.44) (EFSA, 2024a) | 0.46 | HRMo (EFSA, 2018b) × CF (1.44) (EFSA, 2024a) |
| Cabbage, heads leaves | 0.01 | STMRMo (EFSA, 2024a) × CF (1.44) (EFSA, 2024a) | 0.03 | HRMo (EFSA, 2024a) × CF (1.44) (EFSA, 2024a) |
| Triticale straw; What straw | 0.39 | STMRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) | 2.3 | HRMo (EFSA, 2011) × CF (1.44) (EFSA, 2024a) |
| Potato culls | 0.01 | STMR (EFSA, 2011) | 0.01 | HR (EFSA, 2011) |
| Barley grain; Oat grain | 0.01 | STMR (EFSA, 2018b) | 0.01 | STMR (EFSA, 2018b) |
| Bean, seed (dry) Cowpea, seed Lupin, seed Pea (Field pea), seed (dry) | 0.03 | STMR (FAO and WHO, 2025) c | 0.03 | STMR (FAO and WHO, 2025) c |
| Cotton undelinted seed | 0.09 | STMR (EFSA, 2011) | 0.09 | STMR (EFSA, (EFSA, 2011) |
| Soybean seed | 0.01 | STMR (intended use) Table B.1.2.1 | 0.01 | STMR (intended use) Table B.1.2.1 |
| Triticale grain; Wheat grain | 0.01 | STMR (EFSA, 2016) | 0.01 | STMR (EFSA, 2016) |
| Apple pomace, wet | 0.03 | STMRMo × CF (1.21) (EFSA, 2024a) × PF (1.25) d | 0.03 | STMRMo × CF (1.21) (EFSA, 2024a) × PF (1.25) d |
| Brewer's grain, dried; Wheat, distiller's grain (dry) | 0.03 | STMR × PF (3.3) b (EFSA, 2016) | 0.03 | STMR × PF (3.3) b (EFSA, 2016) |
| Canola (Rape seed) meal | 0.06 | STMR × PF (2) b (EFSA, 2016) | 0.06 | STMR × PF (2) b (EFSA, 2016) |
| Citrus dried pulp | 2.3 | STMRMo (EFSA, 2011) × CF (1.21) (EFSA, 2024a) × PF (10) b | 2.3 | STMRMo (EFSA, 2011) × CF (1.21) (EFSA, 2024a) × PF (10) b |
| Coconut meal | 0.02 | STMRMo (EFSA, 2011) × CF (1.21) (EFSA, 2024a) × PF (1.5) b | 0.02 | STMRMo (EFSA, 2011) × CF (1.21) (EFSA, 2024a) × PF (1.5) b |
| Cotton meal | 0.04 | STMR × PF (0.4) (EFSA, 2011) | 0.04 | STMR × PF (0.4) (EFSA, 2011) |
| Lupin seed meal | 0.03 | STMR × PF (1.1) b (FAO and WHO, 2025) c | 0.03 | STMR × PF (1.1) b (FAO and WHO, 2025) c |
| Potato process waste | 0.01 | STMR e (EFSA, 2011) | 0.01 | STMR e (EFSA, 2011) |
| Potato dried pulp | 0.01 | STMR e (EFSA, 2011) | 0.01 | STMR e (EFSA, 2011) |
| Rape meal | 0.06 | STMR × PF (2) b (EFSA, 2016) | 0.06 | STMR × PF (2) b (EFSA, 2016) |
| Soybean meal | 0.01 | STMR × PF (1.3) b (intended use) Table B.1.2.1 | 0.01 | STMR × PF (1.3) b (intended use) Table B.1.2.1 |
| Soybean hulls | 0.13 | STMR × PF (13) b (intended use) Table B.1.2.1 | 0.13 | STMR × PF (13) b (intended use) Table B.1.2.1 |
| Wheat gluten meal | 0.02 | STMR × PF (1.8) b (EFSA, 2016) | 0.02 | STMR × PF (1.8) b (EFSA, 2016) |
| Wheat milled by‐pdts | 0.07 | STMR × PF (7) b (EFSA, 2016) | 0.07 | STMR × PF (7) b (EFSA, 2016) |
| Flaxseed/Linseed, meal | 0.02 | STMR × PF (2) b (EFSA, 2022a) | 0.02 | STMR × PF (2) b (EFSA, 2022a) |
Abbreviations: CF, from the reside definition for monitoring to the residue definition for risk assessment as derived in EFSA Statement for fruit and leafy crops, 1.21 and 1.44, respectively (EFSA, 2024a); HR, highest residue; PF, processing factor; STMR, supervised trials median residue.
Figures in the table are rounded to two digits, but the calculations are normally performed with the actually calculated values (which may contain more digits). To reproduce dietary burden calculations, the unrounded values need to be used.
In the absence of processing factors supported by data, default processing factors (in bracket) were respectively included in the calculation to consider the potential concentration of residues in these commodities.
Codex MRLs for beans, lentils, peas and lupins (FAO and WHO, 2025; EFSA, 2025b) were adopted by the Codex and supported by the EU, but not yet considered for implementation in the EU legislation.
More robust processing factor for apples pomace was derived in the current opinion (Austria, 2024).
For potatoes process waste and dried pulp, no default processing factor was applied because residues in the raw commodities were below the LOQ. Concentration of residues in these commodities is therefore not expected.
D.2. CONSUMER RISK ASSESSMENT
| Commodity | Existing/proposed MRL (mg/kg) | Source | Chronic risk assessment | Acute risk assessment | ||
|---|---|---|---|---|---|---|
| Input value a (mg/kg) | Comment | Input value a (mg/kg) | Comment b | |||
| Risk assessment residue definition 1: Acetamiprid (applicable to Pulses/oilseeds, Root crops, Cereals/Grass and Honey) | ||||||
| Honey | 0.9 c | MRL proposal | 0.09 | STMR‐RAC (Table B.1.2.1) | 0.55 | HR‐RAC (Table B.1.2.1) |
| Potatoes | 0.01 | EFSA (2018b) | 0.01 | LOQ | 0.01 | LOQ |
| Garlic | 0.02 | FAO and WHO (2011) | 0.01 | STMR‐RAC | 0.01 | HR‐RAC |
| Onions | 0.02 | EFSA (2018b) | 0.01 | STMR‐RAC | 0.02 | HR‐RAC |
| Beans (with pods) | 0.6 | EFSA (2018b) | 0.06 | STMR‐RAC | 0.32 | HR‐RAC |
| Beans (without pods) | 0.3 | FAO and WHO (2011) | 0.03 | STMR‐RAC | 0.18 | HR‐RAC |
| Peas (with pods) | 0.6 | EFSA (2018b) | 0.06 | STMR‐RAC | 0.32 | HR‐RAC |
| Peas (without pods) | 0.3 | FAO and WHO (2011) | 0.03 | STMR‐RAC | 0.18 | HR‐RAC |
| Beans | 0.4 | FAO and WHO (2025) d | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Lentils | 0.24 | FAO and WHO (2025) d | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Peas | 0.24 | FAO and WHO (2025) d | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Lupins/lupin beans | 0.2 | FAO and WHO (2025) d | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Other pulses | 0.15 | EFSA (2018b) | 0.02 | STMR‐RAC | ||
| Linseeds | 0.06 | EFSA (2022a) | 0.01 | STMR‐RAC | 0.01 | STMR‐RAC |
| Poppy seeds | 0.3 | EFSA (2021) | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Rapeseeds/canola seeds | 0.4 | EFSA (2018b) | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Soyabeans | 0.08 | MRL proposal | 0.01 | STMR‐RAC (Table B.1.2.1) | 0.05 | STMR‐RAC (Table B.1.2.1) |
| Mustard seeds | 0.15 | EFSA (2021) | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
| Cotton seeds | 0.7 | FAO and WHO (2011) | 0.09 | STMR‐RAC | 0.09 | STMR‐RAC |
| Gold of pleasure seeds | 0.06 | EFSA (2022a) | 0.01 | STMR‐RAC | 0.01 | STMR‐RAC |
| Barley | 0.05 | EFSA (2018b) | 0.01 | STMR‐RAC | 0.03 | STMR‐RAC |
| Oat | 0.05 | EFSA (2018b) | 0.01 | STMR‐RAC | 0.01 | STMR‐RAC |
| Wheat | 0.1 | EFSA (2018b) | 0.01 | STMR‐RAC | 0.01 | STMR‐RAC |
| Anise/aniseed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Black caraway/black cumin | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Celery seed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Coriander seed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Cumin seed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Dill seed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Fennel seed | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Fenugreek | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Nutmeg | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | 2.00 | HR‐RAC |
| Other spices (seeds) | 2 | FAO and WHO (2020) d | 0.57 | STMR‐RAC | ||
| Cardamom | 0.1 | FAO and WHO (2015) | 0.10 | MRL | 0.10 | MRL |
| Peppercorn (black, green and white) | 0.1 | FAO and WHO (2015) | 0.1‐ | MRL | 0.10 | MRL |
|
Risk assessment residue definition 2: Sum of acetamiprid and N‐desmethyl‐acetamiprid (IM‐2‐1), expressed as acetamiprid (applicable to Fruits, Leafy crops and to commodities of animal origin) The CF of 1.44 is applied to input values for fruit crops The CF of 1.21 is applied to input values for leafy crops unless a specific CF is derived on the basis of field residue data | ||||||
| Grapefruits | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | 0.03 | HR‐RAC*CF*PeF |
| Oranges | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | 0.03 | HR‐RAC*CF*PeF |
| Lemons | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | 0.03 | HR‐RAC*CF*PeF |
| Limes | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | 0.03 | HR‐RAC*CF*PeF |
| Mandarins | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | 0.03 | HR‐RAC*CF*PeF |
| Other citrus fruit | 0.9 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF*PeF | ||
| Almonds | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Brazil nuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Cashew nuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Chestnuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Coconuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Hazelnuts/cobnuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Macadamia | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Pecans | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Pine nut kernels | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Pistachios | 1 | FAO and WHO (2021) d ; EFSA (2024a) (CF) | 0.40 | STMR‐RAC*CF | 0.62 | HR‐RAC*CF |
| Walnuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Other tree nuts | 0.07 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | ||
| Apples | 0.07 | EFSA (2024a) | 0.03 | STMR‐RAC*CF | 0.04 | HR‐RAC*CF |
| Pears | 0.07 | EFSA (2024a) | 0.03 | STMR‐RAC*CF | 0.04 | HR‐RAC*CF |
| Quinces | 0.15 | EFSA (2024a) | 0.04 | STMR‐RAC*CF | 0.09 | HR‐RAC*CF |
| Medlar | 0.3 | EFSA (2024a) | 0.08 | STMR‐RAC*CF | 0.24 | HR‐RAC*CF |
| Loquats/Japanese medlars | 0.8 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.28 | STMR‐RAC*CF | 0.77 | HR‐RAC*CF |
| Other pome fruit | 0.8 | EFSA (2018b, 2024a) (CF) | 0.28 | STMR‐RAC*CF | ||
| Apricots | 0.08 | EFSA (2024a) | 0.03 | STMR‐RAC*CF | 0.05 | HR‐RAC*CF |
| Cherries (sweet) | 0.8 | EFSA (2024a) | 0.26 | STMR‐RAC*CF | 0.40 | HR‐RAC*CF |
| Peaches | 0.08 | EFSA (2024a) | 0.03 | STMR‐RAC*CF | 0.05 | HR‐RAC*CF |
| Plums | 0.08 | MRL proposal | 0.02 | STMR‐RAC*CF (Table B.1.2.1) | 0.04 | HR‐RAC*CF (Table B.1.2.1) |
| Table grapes | 0.08 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.05 | HR‐RAC*CF |
| Wine grapes | 0.08 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.05 | HR‐RAC*CF |
| Strawberries | 0.5 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.12 | STMR‐RAC*CF | 0.30 | HR‐RAC*CF |
| Blackberries | 0.6 | EFSA (2024a) | 0.21 | STMR‐RAC*CF | 0.35 | HR‐RAC*CF |
| Dewberries | 2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.77 | STMR‐RAC*CF | 1.21 | HR‐RAC*CF |
| Raspberries (red and yellow) | 0.6 | EFSA (2024a) | 0.21 | STMR‐RAC*CF | 0.35 | HR‐RAC*CF |
| Other cane fruit | 2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.77 | STMR‐RAC*CF | ||
| Blueberries | 0.7 | EFSA (2024a) | 0.25 | STMR‐RAC*CF | 0.41 | HR‐RAC*CF |
| Cranberries | 0.7 | EFSA (2024a) | 0.25 | STMR‐RAC*CF | 0.41 | HR‐RAC*CF |
| Gooseberries (green, red and yellow) | 0.7 | EFSA (2024a) | 0.25 | STMR‐RAC*CF | 0.41 | HR‐RAC*CF |
| Rose hips | 2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.77 | STMR‐RAC*CF | 1.21 | HR‐RAC*CF |
| Mulberries (black and white) | 2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.77 | STMR‐RAC*CF | 1.21 | HR‐RAC*CF |
| Elderberries | 0.5 | EFSA (2024a) | 0.21 | STMR‐RAC*CF | 0.34 | HR‐RAC*CF |
| Figs | 0.03 | EFSA (2018b, 2024a) (CF) | 0.01 | STMR‐RAC*CF | 0.01 | HR‐RAC*CF |
| Table olives | 0.9 | EFSA (2024a) | 0.29 | STMR‐RAC*CF | 0.58 | HR‐RAC*CF |
| Granate apples/pomegranates | 0.01* | EFSA (2024a) | 0.01 | STMR‐RAC(LOQ) g | 0.01 | HR‐RAC(LOQ) g |
| Tomatoes | 0.06 | EFSA (2024a) | 0.01 | STMR‐RAC*CF | 0.05 | HR‐RAC*CF |
| Sweet peppers/bell peppers | 0.09 | EFSA (2024a) | 0.04 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Aubergines/egg plants | 0.2 | EFSA (2024a) | 0.08 | STMR‐RAC*CF | 0.11 | HR‐RAC*CF |
| Okra/lady's fingers | 0.2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.05 | STMR‐RAC*CF | 0.17 | HR‐RAC*CF |
| Other solanacea | 0.2 | EFSA (2018b, 2024a) (CF) | 0.05 | STMR‐RAC*CF | ||
| Cucumbers | 0.05 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.04 | HR‐RAC*CF |
| Gherkins | 0.6 | EFSA (2018b, 2024a) (CF) | 0.17 | STMR‐RAC*CF | 0.45 | HR‐RAC*CF |
| Courgettes | 0.05 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.04 | HR‐RAC*CF |
| Other cucurbits ‐ edible peel | 0.3 | EFSA (2018b, 2024a) (CF) | 0.06 | STMR‐RAC*CF | ||
| Melons | 0.08 | EFSA (2024a) | 0.01 | STMR‐RAC*CF | 0.01 | HR‐RAC*CF |
| Pumpkins | 0.08 | EFSA (2024a) | 0.01 | STMR‐RAC*CF | 0.01 | HR‐RAC*CF |
| Watermelons | 0.08 | EFSA (2024a) | 0.01 | STMR‐RAC*CF | 0.01 | HR‐RAC*CF |
| Other cucurbits ‐ inedible peel | 0.2 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.06 | STMR‐RAC*CF | ||
| Sweet corn | 0.01 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.01 | LOQ*CF | 0.01 | LOQ*CF |
| Broccoli | 0.06 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Cauliflowers | 0.06 | EFSA (2024a) | 0.02 | STMR‐RAC*CF | 0.06 | HR‐RAC*CF |
| Other flowering brassica | 0.4 | FAO and WHO (2011), EFSA (2024a) (CF) | 0.04 | STMR‐RAC*CF | ||
| Brussels sprouts | 0.05 | EFSA (2018b, 2024a) (CF) | 0.03 | STMR‐RAC*CF | 0.04 | HR‐RAC*CF |
| Head cabbages | 0.03 | EFSA (2024a) | 0.01 | STMR‐RAC*CF | 0.03 | HR‐RAC*CF |
| Lamb's lettuce/corn salads | 1.5 | EFSA (2024a) | 0.71 | STMR‐RAC*CF | 1.08 | HR‐RAC*CF |
| Cress and other sprouts and shoots | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Land cress | 3 | EFSA (2018b, 2024a) (CF) | 1.17 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Roman rocket/rucola | 1.5 | EFSA (2024a) | 0.71 | STMR‐RAC*CF | 1.08 | HR‐RAC*CF |
| Red mustards | 0.9 | EFSA (2024a) | 0.22 | STMR‐RAC*CF | 0.71 | HR‐RAC*CF |
| Baby leaf crops (including brassica species) | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Purslanes | 0.6 | EFSA (2018b, 2024a) (CF) | 0.29 | STMR‐RAC*CF | 0.45 | HR‐RAC*CF |
| Other spinach and similar | 0.6 | EFSA (2018b, 2024a) (CF) | 0.29 | STMR‐RAC*CF | ||
| Chervil | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Chives | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Celery leaves | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Parsley | 4 | MRL proposal | 0.89 e | STMR‐RAC*CF (1.07) f (EFSA, 2018b ) | 2.89 | HR‐RAC*CF (1.07) f (Table B.1.2.1 |
| Sage | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Rosemary | 4 | MRL proposal | 0.89 e | STMR‐RAC*CF (1.07) f (EFSA, 2018b ) | 2.89 | HR‐RAC*CF (1.07) f (Table B.1.2.1 |
| Thyme | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Basil and edible flowers | 4 | MRL proposal | 0.89 e | STMR‐RAC*CF (1.07) f (EFSA, 2018b ; EFSA, 2024a ) | 2.89 | HR‐RAC*CF (1.07) f (Table B.1.2.1) |
| Laurel/bay leaves | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Tarragon | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | 2.74 | HR‐RAC*CF |
| Other herbs | 3 | EFSA (2018b, 2024a) (CF) | 1.20 | STMR‐RAC*CF | ||
| Asparagus | 0.01* | EFSA (2024a) | 0.01 | STMR‐RAC(LOQ)g,h | 0.01 | HR‐RAC(LOQ) g,h |
| Globe artichokes | 0.7 | EFSA (2018b, 2024a) (CF) | 0.11 | STMR‐RAC h | 0.25 | HR‐RAC h |
| Olives for oil production | 3 | EFSA (2018b, 2024a) (CF) | 0.97 | STMR‐RAC*CF | 0.97 | STMR‐RAC*CF |
| Swine: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Swine: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Swine: Liver | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Swine: Kidney | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Swine: Edible offal (other than liver and kidney) | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Bovine: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Bovine: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Bovine: Liver | 0.03 | EFSA (2024a) | 0.02 | STMR‐RAC | 0.03 | HR‐RAC |
| Bovine: Kidney | 1 |
FAO and WHO (2015) |
0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Bovine: Edible offals (other than liver and kidney) | 0.05 | EFSA (2024a) | 0.02 | STMR‐RAC | 0.04 | HR‐RAC |
| Sheep: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Sheep: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Sheep: Liver | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Sheep: Kidney | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Sheep: Edible offal (other than liver and kidney) | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Goat: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Goat: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Goat: Liver | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Goat: Kidney | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Goat: Edible offal (other than liver and kidney) | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Equine: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Equine: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Equine: Liver | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Equine: Kidney | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Equine: Edible offal (other than liver and kidney) | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Poultry: Muscle/meat | 0.02* | FAO and WHO (2015) | 0.02 | LOQ | 0.02 | LOQ |
| Poultry: Fat tissue | 0.02* | FAO and WHO (2015) | 0.02 | LOQ | 0.02 | LOQ |
| Poultry: Liver | 0.1* | FAO and WHO (2015) | 0.10 | LOQ | 0.10 | LOQ |
| Other farmed animals: Muscle/meat | 0.5 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.27 | HR‐RAC |
| Other farmed animals: Fat tissue | 0.3 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.16 | HR‐RAC |
| Other farmed animals: Liver | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Other farmed animals: Kidney | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Other farmed animals: Edible offal (other than liver and kidney) | 1 | FAO and WHO (2015) | 0.11 | STMR‐RAC | 0.89 | HR‐RAC |
| Milks | 0.2 | FAO and WHO (2015) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
| Eggs | 0.02* | EFSA (2018b) | 0.02 | LOQ | 0.02 | LOQ |
Abbreviations: HR‐RAC, highest residue in raw agricultural commodity; PeF, Peeling factor; STMR‐RAC, supervised trials median residue in raw agricultural commodity.
Figures in the table are rounded to three or two digits, but the calculations are normally performed with the actually calculated values (which may contain more digits). To reproduce dietary burden calculations, the unrounded values need to be used.
Input values for the commodities which are not under consideration for the acute risk assessment are reported in grey.
It is noted that an MRL option of 1 mg/kg for honey was proposed in EFSA's 2025 Reasoned Opinion on the modification of existing MRLs for acetamiprid in honey. A risk management decision on this opinion is still pending. In the present assessment, a more robust MRL of 0.9 mg/kg is proposed, taking into account data evaluated by EFSA (2021, 2022a, 2025a, 2025b).
Codex MRLs for seed spices (FAO and WHO, 2020), pistachios (FAO and WHO, 2021; EFSA, 2022b) and beans, lentils, peas and lupins (FAO and WHO, 2025; EFSA, 2025b) were adopted by the Codex and supported by the EU, but not yet considered for implementation in the EU legislation.
For parsley, rosemary, basil and edible flowers a more critical STMR value of 0.83 mg/kg was derived in the previous EFSA opinion (EFSA, 2018b) and therefore it was kept in the current assessment.
A median conversion factor from monitoring to risk assessment was derived for the GAP under assessment. It should be noted that the four residue trials on basil conducted in 2024 enabled the calculation of a conversion factor of 1.07, which is lower than the factor reported in the EFSA Statement 2024. Since this conversion factor is based on interim results from the storage stability study, it may be subject to revision once the full storage stability study report becomes available (see Section 1.1.5).
For pomegranate and asparagus, no conversion factor is applied because residues are expected to remain below the LOQ according to the GAP assessed in the EFSA 2024 Statement (EFSA, 2024a).
For stem vegetables, a conversion factor of 1 was applied in line with the assessment performed in the EFSA 2024 Statement (EFSA, 2024a).
APPENDIX E. Used compound codes
| Code/trivial name a | IUPAC name/SMILES notation/InChiKey b | Structural formula c |
|---|---|---|
| Acetamiprid |
(1E)‐N‐[(6‐chloro‐3‐pyridyl)methyl]‐N′‐cyano‐N‐methylacetimidamide Clc1ccc(CN(C)C(\C) = N\C#N)cn1 WCXDHFDTOYPNIE‐RIYZIHGNSA‐N |
|
| N‐desmethyl‐acetamiprid (IM‐2‐1) |
(1E)‐N‐[(6‐chloropyridin‐3‐yl)methyl]‐N′‐cyanoethanimidamide Clc1ccc(CNC(\C) = N\C#N)cn1 AYEAUPRZTZWBBF‐UHFFFAOYSA‐N |
|
| IM‐1‐4 |
1‐(6‐chloropyridin‐3‐yl)‐N‐methylmethanamine Clc1ccc(CNC)cn1 XALCOJXGWJXWBL‐UHFFFAOYSA‐N |
|
| IM‐1‐5 |
N‐[(6‐chloropyridin‐3‐yl)methyl]‐N‐methylethanimidamide Clc1ccc(CN(C)C(C) = N)cn1 JHZWQGRBAHJYIZ‐UHFFFAOYSA‐N |
|
| 6‐chloronicotinic acid (IC‐0) |
6‐chloropyridine‐3‐carboxylic acid OC(=O)c1cnc(Cl)cc1 UAWMVMPAYRWUFX‐UHFFFAOYSA‐N |
|
| IC‐0‐methyl ester |
methyl 6‐chloropyridine‐3‐carboxylate Clc1ccc(cn1)C(=O)OC RMEDXVIWDFLGES‐UHFFFAOYSA‐N |
|
| IM‐0 |
(6‐chloropyridin‐3‐yl)methanol OCc1cnc(Cl)cc1 GOXYBEXWMJZLJB‐UHFFFAOYSA‐N |
|
| IM‐0 (gly conjugate) |
(2R,3R,4S,5S,6R)‐2‐[(6‐chloropyridin‐3‐yl)methoxy]‐6‐(hydroxymethyl)oxane‐3,4,5‐triol Clc1ccc(CO[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cn1 ZRRXFGLNJBNGQI‐DVYMNCLGSA‐N |
|
| IS‐2‐1 (N‐cyanoacetamidine derivative) |
(1E)‐N′‐cyanoethanimidamide N/C(C) = N/C#N KKZFHAKALPLYLL‐UHFFFAOYSA‐N |
|
Abbreviations: InChiKey, International Chemical Identifier Key; IUPAC, International Union of Pure and Applied Chemistry; SMILES, simplified molecular‐input line‐entry system.
The metabolite name in bold is the name used in the conclusion.
ACD/Name 2023.2.4 ACD/Labs 2023.2.4 (File Version N25E41, Build 137185, 31 January 2024).
ACD/ChemSketch 2023.2.4 ACD/Labs 2024.2.4 (File Version C45H41, Build 137017, 18 January 2024).
EFSA (European Food Safety Authority) , Bellisai, G. , Bernasconi, G. , Cabrera, L. C. , Castellan, I. , del Aguila, M. , Ferreira, L. , Greco, L. , Leuschner, R. , Mioč, A. , Nave, S. , Reich, H. , Ruocco, S. , Scarlato, A. P. , Szot, M. , Theobald, A. , Tiramani, M. , Verani, A. , & Zioga, E. (2025). Modification of the existing maximum residue levels for acetamiprid in various crops and honey. EFSA Journal, 23(12), e9774. 10.2903/j.efsa.2025.9774
Approved: 14 November 2025
Correspondence: Ask a Question
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts.
Notes
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1–50.
Commission Implementing Regulation (EU) 2018/113 of 24 January 2018 renewing the approval of the active substance acetamiprid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 20, 25.1.2018, p. 7–10.
Commission Regulation (EU) 2025/158 of 29 January 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products. C/2025/493. OJ L, 2025/158, 30.1.2025, ELI: https://data.europa.eu/eli/reg/2025/158/oj.
Commission Regulation (EU) 2025/1212 of 24 June 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products. C/2025/3919. OJ L, 2025/1212, 31.7.2025, ELI: https://data.europa.eu/eli/reg/2025/1212/oj.
Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1–16.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, pp. 1–24.
For an overview of all MRL Regulations on this active substance, please consult: https://ec.europa.eu/food/plant/pesticides/eu‐pesticides‐database/active‐substances/?event=search.as.
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, PE/41/2019/REV/1. OJ L 231, 6.9.2019, p. 1–28.
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93, 3.4.2013, p. 1–84.
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.6.2011, p. 127–175.
Background documents to this reasoned opinion are published on OpenEFSA portal and are available at the following link: https://open.efsa.europa.eu/EFSA‐Q‐2023‐00537; https://open.efsa.europa.euEFSA‐Q‐2024‐00271.
Case 5 has to be understood as different experimental conditions within a same trial (within the same experimental site) such as: several different formulations/PPPs (EFSA, 2015).
Commission Regulation (EU) 2018/62 of 17 January 2018 replacing Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council. C/2018/0138. OJ L 18, 23.1.2018, p. 1–73.
Commission Regulation (EU) 2025/158 of 29 January 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products. C/2025/493. OJ L, 2025/158, 30.1.2025. ELI: http://data.europa.eu/eli/reg/2025/158/oj.
Commission Regulation (EU) 2025/1212 of 24 June 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products. C/2025/3919. OJ L, 2025/1212, 31.7.2025, ELI: http://data.europa.eu/eli/reg/2025/1212/oj.
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