Evaluation of confirmatory data following the Article 12 MRL review for myclobutanil.

The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified.

Modification of the existing maximum residue levels for fluxapyroxad in kaki/Japanese persimmons and cultivated mushrooms.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Spain and Ireland to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in kaki/Japanese persimmons and in cultivated fungi, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kaki/Japanese persimmons and cultivated fungi. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad on the commodities under consideration at the validated 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 fluxapyroxad, according to the reported agricultural practices, is unlikely to present a risk to consumer health. The long-term consumer risk assessment is indicative, pending the submission of the confirmatory data requested under the MRL review.

Evaluation of confirmatory data following the Article 12 MRL review for quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop and modification of the existing maximum residue levels for quizalofop-P-tefuryl.

The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop-P-tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop-P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop-P variants: quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop-P-tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop-P-tefuryl, quizalofop acid, quizalofop-pentanoic acid and quizalofop-P-glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop-p-ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of quizalofop-P-tefuryl according to the reported agricultural practices is unlikely to present a risk to consumer health.

Updated reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl.

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl. Specifically, EFSA was asked to assess whether thiophanate-methyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrine-disrupting properties, EFSA was requested to carry out a follow-up assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanate-methyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed.

Modification of the temporary maximum residue levels for mepiquat in cultivated fungi and oyster mushrooms.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Finland to modify the temporary maximum residue level (MRL) to a permanent MRL for the active substance mepiquat in cultivated fungi (with a specific MRL for oyster mushrooms). The data submitted in support of the request (monitoring data from food business operators) are not sufficient to derive permanent MRL proposals. The assessment of these data, complemented by an analysis of the most recent monitoring data available from EU monitoring programmes, supports the conclusion that the existing t-MRL for cultivated fungi is still sufficient to account for the residue uptake in cultivated mushrooms other than oyster mushrooms. It was also noted that lower t-MRLs could be derived based on the assessment of the most recent monitoring data. A risk management decision is still needed on whether to maintain the existing t-MRL value. Regarding oyster mushrooms, EFSA derived different options for risk managers to eventually update the values of the temporary MRLs based on the most recent monitoring data from food business operators. Adequate analytical methods for enforcement are available to control the residues of mepiquat (expressed as mepiquat chloride) in the commodities under consideration at the 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 cross-contamination of untreated cultivated fungi (including oyster mushrooms) from cereal straw lawfully treated with mepiquat according to the current agricultural practices is unlikely to present a risk to consumer health.

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for aluminium phosphide and magnesium phosphide.

The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high-oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high-oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and 'others'), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and 'other' cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of AlP and Mg3P2 according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required.

Modification of the existing maximum residue levels for flonicamid in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted two requests to the competent national authority in Finland and Belgium, respectively, to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in potatoes and in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for potatoes, lettuces and salad plants, spinaches and similar leaves, beans (without pods), cardoons, celeries, Florence fennels and rhubarbs. Adequate analytical methods for enforcement are available to control the residues according to the residue definition as of the sum of flonicamid, TFNA and TFNG, expressed as flonicamid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue level for clopyralid in honey.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of clopyralid (including potential conjugates) in honey at the validated limit of quantification (LOQ) of 0.001 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of clopyralid residues in honey, resulting from the authorised use of clopyralid on oilseed rape notified in the present MRL assessment, is unlikely to present a risk to consumer health.

Targeted review of maximum residue levels (MRLs) for profenofos.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance profenofos in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. Existing EU MRLs are based on Codex Maximum Residue Limits still in place or reflect temporary MRLs set from monitoring data. EFSA performed an indicative chronic and acute dietary risk assessment for the list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Setting of an import tolerance for fenazaquin in hops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Greece to set an import tolerance for the active substance fenazaquin in hops imported from the United States of America. The data submitted in support of the request were found to be sufficient to derive an maximum residue limit (MRL) proposal for hops. An adequate analytical method for enforcement is available to control the residues of fenazaquin in the plant matrix under consideration at the 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 of fenazaquin and its toxicologically relevant plant metabolite TBPE resulting from the use of fenazaquin on imported hops from United States according to the reported agricultural practice is unlikely to present a risk to consumer health.

Targeted review of maximum residue levels (MRLs) for chlorfenapyr.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance chlorfenapyr in view of the possible lowering of the MRL set for tea. This current EU MRL is based on an import tolerance established in 2007. EFSA reviewed the toxicological data assessed by other scientific bodies, proposing toxicological reference values to be used for an indicative risk assessment, noting that the values are affected by additional, non-standard uncertainties. According to the indicative chronic and acute dietary risk assessment the existing MRL for tea does not pose an unacceptable risk for consumers. Further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Modification of the existing maximum residue levels and setting import tolerances for flupyradifurone and difluoroacetic acid (DFA) in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG, Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) and to set import tolerances for flupyradifurone and its metabolite difluoroacetic acid (DFA) in various plant commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in avocados, mangoes, papayas, asparagus, sesame seeds, sunflower seeds, sugar beet roots and chicory roots. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and DFA in plant matrices under consideration at the validated limits of quantification (LOQs) of 0.01 and 0.007 mg/kg, respectively. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of flupyradifurone and DFA residues resulting from the use of flupyradifurone according to the reported agricultural practices is unlikely to present a risk to consumer health.

Setting of an import tolerance for lambda-cyhalothrin in avocados.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to set an import tolerance for the active substance lambda-cyhalothrin in avocados. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for avocados. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required as to whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical methods for enforcement are available to control the residues of lambda-cyhalothrin in the commodity under consideration at the 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 lambda-cyhalothrin according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.

Review of the existing maximum residue levels for zoxamide according to Article 12 of Regulation (EC) No 396/2005 and setting of an import tolerance for onions, garlic and shallots.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance zoxamide. To assess the occurrence of zoxamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission and the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the Applicant Gowan Crop Protection Ltd, submitted a request to the competent national authority in Latvia to set an import tolerance for zoxamide in onions (extrapolated to garlic and shallots) based on the use authorised in USA. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of zoxamide according to the agricultural practices on onions, garlic and shallots is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for sulfoxaflor in various commodities.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRL) in okra/lady's fingers and various leaf vegetables, herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in plant matrices under consideration at the 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 sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue level for mandipropamid in radish leaves.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance mandipropamid in radish leaves (classified under the subgroup of kales), based on an intended indoor use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive an MRL proposal for this commodity. Adequate analytical methods for enforcement are available to control the residues of mandipropamid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that long-term intake of residues resulting from the use of mandipropamid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Guidance on the assessment of pesticide residues in rotational crops.

EFSA has prepared a guidance document on the assessment of studies on the nature and magnitude of pesticide residues in rotational crop studies as defined in Section 6.6 of the Annex to Regulation (EU) No 283/2013. This guidance document supports the practical implementation of the relevant OECD Test Guidelines (TGs) and OECD Guidance Documents in a harmonised way, respecting the EU regulatory framework for the pesticide assessments. The individual steps of the assessment are illustrated by examples, figures and flow charts. Sources of uncertainty in these assessments are identified and recommendations for further work are provided.

Targeted review of maximum residue levels (MRLs) for diazinon.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance diazinon in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex MRLs, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Modification of the existing maximum residue level for propamocarb in honey.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance propamocarb in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of propamocarb on the commodity under consideration at the 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 propamocarb according to the reported agricultural practice is unlikely to present a risk to consumer health.

Targeted review of maximum residue levels (MRLs) for dicofol.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance dicofol in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. All existing EU MRLs reflect previously authorised uses in the EU or are based on obsolete Codex Maximum Residue Limits. Furthermore, in view of the limitations of the toxicological dataset and related uncertainties, the existing toxicological reference values derived at the EU level cannot be confirmed for dicofol. EFSA therefore proposed lowering all existing EU MRLs for dicofol to the limit of quantification.