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Aiming at accelerating the implementation of cumulative risk assessment to pesticide residues, this report describes a two‐step prioritisation analysis, on individual pesticides and on target organ systems, that allows to identify (i) low‐priority substances expected to have a marginal contribution to cumulative risk, and (ii) high priority organ systems to be addressed in future cumulative risk assessments. The analysis encompassed 350 substances and 36 raw primary commodities of plant origin surveyed in the monitoring cycle 2019–2021, carried out in 30 population groups, covering 3 age classes, and 17 EU countries. Probabilistic exposure calculations, for chronic and acute effects, were executed on the occurrence and consumption data by a two‐dimensional procedure, modelling variability and uncertainty. In the first step, the prioritisation method adopted allowed to reduce the number of substances by about 80%. These substances were in turn grouped based on their capacity to cause toxicological effects on common organ systems and, as second step, probabilistic combined exposure calculations were carried out for 16 target organ systems. This step allowed to identify the organ systems that need further assessment, reducing their initial number by about 70%. The organ systems would need to be prioritised as follows: reproductive and developmental toxicity, liver, kidney, male reproductive system, and haematopoietic system and haematology. The sources of uncertainty stemming from the modelling procedure and from methodological assumptions were discussed and their impact qualitatively assessed. Overall, it was concluded that the risk estimates for the different organ systems were more likely to be overestimated than underestimated. [ABSTRACT FROM AUTHOR]

Abstract: 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 2,5‐dichlorobenzoic acid methylester. To assess the occurrence of 2,5‐dichlorobenzoic acid methylester residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States. No risk to consumers is expected from the authorised uses. However, due to the lack of data, it was not possible to identify a relevant marker compound and to derive MRLs. Hence, if risk managers would have interest to enforce potential misuses, further data may need to be generated. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DuPont de Nemours (Deutschland) GmbH submitted a request to the competent national authority in France to set an import tolerance for the active substance chlorantraniliprole in hops. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for hops in support of the authorised use in the USA. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole in hops at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the existing uses and the authorised use of chlorantraniliprole 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. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belchim Crop Protection NV/SA submitted a request to the competent national authority in Hungary to modify the existing maximum residue levels (MRLs) for the active substance valifenalate in various crops. The data submitted in support of the request were found to be sufficient to derive MRL proposals for lettuces, tomatoes, aubergines, onions, shallots and garlic. Adequate analytical methods for enforcement are available to control the residues of valifenalate on 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 long‐term intake of residues resulting from the use of valifenalate according to the reported agricultural practices is unlikely to present a risk to consumer health. The short‐term intake was not carried out since no acute reference dose (ARfD) is established for valifenalate. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

Abstract: According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past 3 years’ guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2017 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2017. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants ADAMA Agriculture Espana S.A., Sapec Agro SAU and LSA (Landesanstalt für Landwirtschaft, Forsten und Gartenbau) submitted requests to the competent national authorities in Spain and Germany, to modify the existing maximum residue levels (MRLs) for the active substance tebuconazole in olives, rice, herbs and herbal infusions (dried). The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of tebuconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.02 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 tebuconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 fenbutatin oxide. Although this active substance is no longer authorised within the EU due to the lack of toxicological data on di-hydroxy fenbutatin oxide, a compound observed in the metabolism studies but also present as an impurity in the technical active substance, MRLs established by the Codex Alimentarius Commission (CXLs) are still in place. Lacking a full toxicological characterisation of this compound, it was not possible for EFSA to perform an assessment of these CXLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses. [ABSTRACT FROM AUTHOR]

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 quizalofop-Pethyl, quizalofop-P-tefuryl and propaquizafop. To assess the occurrence of quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (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 all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium, Federal Public Service of Health, Food Chain Safety and Environment, submitted a request to modify the existing maximum residue level (MRL) for the active substance cymoxanil in beans without pods. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beans without pods. Adequate analytical methods for enforcement are available to control the residues of cymoxanil in beans without pods 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 cymoxanil according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 fenpyrazamine. To assess the occurrence of fenpyrazamine residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (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 unacceptable risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. In 2015, EFSA issued a thoroughly revised guidance defining the appropriate SSD codes to describe the samples and the analytical results for the reporting of the 2014 pesticide residues monitoring data. In May 2016, a new guidance was published for the coding of specific SSD data elements for the reporting of the 2015 pesticide monitoring data. In the current document, new coding provisions are delivered for specific data elements to code the data generated in 2016. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2016. In addition, new explanatory examples on the appropriate coding for specific food samples are provided. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State, Italy, received an application from Syngenta to modify the existing maximum residue level (MRL) for the active substance penconazole in grapes. The data submitted in support of the request are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on grapes. Adequate analytical enforcement methods are available to control the residues of penconazole in grapes. Based on the risk assessment results, EFSA concludes that the intended use of penconazole on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, these results should be considered provisional due to the fact that the risk assessment for triazole derivate metabolites is still pending. [ABSTRACT FROM AUTHOR]

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 triflumuron. To assess the occurrence of triflumuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (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 all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past four years' guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2018 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2018. This EFSA Guidance will not be applicable for the 2019 data collection provided to EFSA in 2020. In 2020, all data on annual monitoring will be transmitted in SSD2 format only. [ABSTRACT FROM AUTHOR]

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 sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wheat has been considered unnecessary. Adequate analytical methods for enforcement are available to control the residues of aminopyralid and its conjugates in plant matrices and on the commodities under assessment 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 aminopyralid according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of chromafenozide are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition and a limit of quantification (LOQ) for enforcement against potential illegal uses. [ABSTRACT FROM AUTHOR]

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 pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (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. Some information required by the regulatory framework was missing and a possible risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only and no MRL proposals were derived by EFSA. Further consideration by risk managers are needed and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement are available to control the residues of captan in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte in the crops assessed. Based on the exposure calculation, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of captan according to the reported agricultural practice will not result in a consumer exposure exceeding the existing toxicological reference values. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue trials is sufficient to derive a tentative maximum residue level (MRL) for hops according to the residue definitions derived for fruits and fruiting vegetables, EFSA did not recommend this MRL for being implemented in the MRL legislation because due to the lack of a reliable residue definition for risk assessment. Adequate analytical methods for enforcement are available to control the residues of captan in hops. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. 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 the 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 consumer risk assessment is affected by non‐standard uncertainties related to the pending hazard characterisation for the metabolite SYN 500003, which is expected to occur in root crops. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical methods for enforcement are available to control the residues of haloxyfop‐P in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg. EFSA reiterates the recommendation from the Article 12 MRL review that an independent laboratory validation (ILV) should be provided. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of haloxyfop‐P according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (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. An MRL application for modification of MRLs in products of animal origin was also considered in this review. 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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of pyraclostrobin according to the reported agricultural practices is unlikely to present a risk to consumer health. Taking into account the proposed new MRL, a long‐term intake concern for consumers was not identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived for mandarins is not fully compliant with the EU guidance on extrapolation and the proposal requires further risk management consideration. Adequate analytical methods for enforcement are available to control the residues of teflubenzuron on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of teflubenzuron according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities and a new validated analytical method for enforcement of the residue in ruminant matrices were submitted. The data gaps were considered satisfactorily addressed. The new information provided may require a revision of the existing MRLs for barley, oat, rye and wheat and for products of animal origin. The risk assessment performed for picolinafen was updated. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for mandarins, grapefruits, lemons, limes, passion fruits/maracujas, pineapples, flowering brassica, head cabbages, lamb's lettuce, cresses and other sprouts, land cresses, rucola, red mustards, baby leaf crops, globe artichokes and leeks. For oranges, American persimmons, spinaches and similar leaves and sugar canes, data gaps were identified which precluded the derivation of MRL proposals. The data submitted did not provide evidence that the existing MRLs for crops belonging to the group of lettuces and maize have to be modified to accommodate for the intended uses. For escaroles, no MRL was proposed as the intended use was found to lead to residues for which a potential consumer health risk cannot be excluded. EFSA concluded that the short‐term intake of residues resulting from the uses of pyraclostrobin according to the reported agricultural practices assessed is unlikely to present a risk to consumer health, except for escaroles, where the expected intake was found to exceed the toxicological reference value. Taking into account the existing and the proposed new MRLs, a long‐term intake concern for consumers was not identified. [ABSTRACT FROM AUTHOR]

The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed. The new information provided does not require a revision of risk assessment performed for cyazofamid. [ABSTRACT FROM AUTHOR]

The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in coffee beans were submitted. The data gap for coffee beans was considered satisfactorily addressed. The new residue trials in table grapes give an indication that the existing MRL for table grapes should be raised. However, since a potential acute consumer health risk for table grapes could not be excluded, EFSA recommend the lowering of the existing MRL. [ABSTRACT FROM AUTHOR]

The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs and of the risk assessment performed for kresoxim‐methyl. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be still valid. Adequate analytical methods for enforcement are available to control the residues of mepiquat chloride in the plant and animal 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 use of mepiquat chloride according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]