Review Of Maximum Residue Levels Research Articles

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

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 bifenthrin in view of the possible lowering of the MRLs. 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 maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. 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.

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for penconazole in various crops.

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for penconazole in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Moreover, in the application submitted to Germany, the applicant also included a request to raise the existing MRLs in pome fruits, raspberries and blackberries. To address the data gaps, detailed results on the metabolism substudy in tomato, a new storage stability on metabolites CGA127841, CGA132465 and CGA190503 and new residue trials were submitted. The data gap on metabolism was considered satisfactorily addressed. The data gap on complete sets of residue trials analysing simultaneously for monitoring and risk assessment residue definitions was considered addressed for raspberries, blackberries, pumpkins and watermelons; not addressed for pome fruits, stone fruits, grapes, gooseberries, tomatoes and aubergines. The new information provided justified an increase of the existing MRLs for pome fruits, plums, blackberries and raspberries and a revision of the risk assessment performed for penconazole. Adequate analytical methods for enforcement are available to control the residues of penconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of penconazole according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for metaldehyde in flowering brassica and leafy brassica.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Glanzit Pfeiffer Gmbh & Co. KG submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance metaldehyde in flowering brassica and leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both brassica crop groups. Adequate analytical methods for enforcement are available to control the residues of metaldehyde on the commodities under consideration at the validated limit of quantification (LOQ) of 0.05mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the intended uses of metaldehyde according to the reported agricultural practices is unlikely to present a risk to consumer health. The long-term consumer risk assessment shall be regarded as indicative only due to the data gaps identified for certain existing MRLs in the framework of the MRL review of metaldehyde according to Article 12 of Regulation (EC) No 396/2005.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005.

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Among the substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified six active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

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

The applicant Belchim Crop Protection submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for tebufenpyrad 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, new residue trials on peaches, apricots and raspberries (extrapolated to blackberries and dewberries) as well as a new analytical method for enforcement in animal commodities and its independent laboratory validation were submitted. The data gaps were considered satisfactorily addressed. The new information provided required a revision of the existing MRLs for peaches and apricots while the existing MRLs for blackberries and dewberries could be confirmed. An update of the consumer risk assessment for tebufenpyrad was performed in light of the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure and the acute exposure of the crops under consideration in the present assessment.

Review of the existing maximum residue levels for dithianon according to Article 12 of Regulation (EC) No 396/2005

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 dithianon. To assess the occurrence of dithianon residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK, including the supporting residues data. Given that a data gap as regards the magnitude of residues of the metabolites 1,4-naphthoquinone and phthalic acid was identified in the peer review for dithianon in light of confirmatory data, the toxicological profile of these metabolites was also assessed in the framework of the Article 12 MRL review. 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. In particular, it is highlighted that the toxicological reference values derived for the metabolite 1,4-naphthoquinone are provisional only, pending a conclusion on the mutagenicity potential. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

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

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for 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 storage stability study, new residues trials and a validated analytical enforcement method for the determination of the relevant residues in animal products were submitted. The data gaps were considered satisfactorily addressed for the plant commodities. The new information provided required a revision of the existing MRL for avocados. As regards the commodities of animal origin, the data gaps were only partially addressed and therefore further risk management considerations are required regarding the revision of the existing MRLs which were derived from Codex MRLs. The risk assessment performed for thiabendazole was also updated. No risk was identified.

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for deltamethrin in tomatoes and okra/lady’s fingers

The applicants Bayer SAS – Crop Science Division, Diachem S.p.A. and Isagro S.p.A., submitted two requests to the competent national authority in Austria to evaluate the confirmatory data identified for deltamethrin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The application from Bayer SAS – Crop Science Division also included a proposal for the modification of the MRL for deltamethrin in tomatoes in accordance with Article 6 of Regulation (EC) No 396/2005. A third application was submitted by the Federal Public Service (FPS) Health, Food chain safety and Environment on behalf of Belgium, to modify the existing maximum residue level for the active substance in okra/lady's fingers. The three applications were combined by EFSA under the current assessment. The data gaps based on monitoring analytical methods were addressed; the data gaps on storage stability studies, processing trials in potatoes, metabolism studies of deltamethrin isomers in livestock and livestock feeding studies were not addressed by providing the requested experimental data; data gap on residue trials analysing simultaneously for monitoring and risk assessment residue definitions was not addressed for most of the concerned crops and requires risk managers’ decisions in numerous cases. The new information provided requires a revision of certain existing MRLs. Adequate analytical methods for enforcement are available to control the residues of deltamethrin in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the results of the refined risk assessment following evaluation of the confirmatory data, EFSA concluded that the short‐term and long‐term intake of residues resulting from the proposed uses of deltamethrin according to the reported agricultural practices are unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties.

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 6 active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in various crops and in sweet peppers/bell peppers, respectively. Moreover, in the application submitted to the United Kingdom, the applicant also included a request to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. In the framework of the assessment process, these applications were re‐allocated to the Netherlands. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for sweet peppers/bell peppers, kales, escaroles, herbs and edible flowers, beans with pods, oat and chicory roots. Since the data gaps identified in the MRL review were not addressed, risk managers might consider lowering the tentative MRLs in passion fruits/maracujas and leafy brassica other than kales to the limit of quantification (LOQ), and the implementation of the Codex MRL (CXL) in the EU legislation for cucumbers and gherkins. The new intended use on witloof/Belgian endives was not adequately supported by residue data and therefore an MRL proposal cannot be derived. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodities under consideration. Based on the results of the risk assessment performed, considering the exposure to residues of trifloxystrobin and its metabolites CGA 321113 (apart for passion fruits), EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of trifloxystrobin under consideration is unlikely to present a risk to consumer health, except for escaroles. For the intended indoor use on escaroles, a risk from short‐term intake cannot be excluded, hence a modification of the existing EU MRL is not proposed for this commodity. The consumer risk assessment shall be regarded as indicative and affected by uncertainties.

Review of the existing maximum residue levels for novaluron according to Article 12 of Regulation (EC) No 396/2005.

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. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed.

Modification of the existing maximum residue levels for fosetyl/phosphonic acid in apricots, cherries and plums resulting from the use of potassium phosphonates.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LAINCO S.A. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs), currently expressed as fosetyl in the MRL Regulation, resulting from the use of the active substance potassium phosphonates on apricots, cherries and plums. The data submitted in support of the request were found to be sufficient to derive MRL proposals and address the data gap for residue trials compliant with the Southern EU uses identified in the joint MRL review for cherries and plums, but insufficient for apricots. Adequate analytical methods for enforcement are available to control the residues on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the uses of potassium phosphonates according to the intended agricultural practices is unlikely to present a risk to consumer health.

Setting of an import tolerance for glyphosate in soyabeans

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Germany to set an import tolerance for the active substance glyphosate in genetically modified (GM) soyabeans imported from the USA. The genetic modification confers tolerance to the herbicide glyphosate. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for soyabeans. When the MRL is calculated according to the existing residue definition for enforcement in soyabeans (glyphosate only), there is no indication that the existing MRL of 20 mg/kg needs to be modified. However, an MRL of 50 mg/kg was also calculated in line with the residue definition for enforcement which has been proposed during the MRL review for glyphosate‐tolerant (CP4‐EPSPS) soybeans (sum of glyphosate, AMPA and N‐acetyl‐glyphosate, expressed as glyphosate). A risk management decision needs to be taken on the possible implementation of the residue definition for enforcement derived by the MRL review and therefore on the need to change the existing MRL for soyabeans. Adequate analytical methods for enforcement are available to control the residues of glyphosate, AMPA and N‐acetyl‐glyphosate in the commodity under consideration, at the validated limit of quantification (LOQ) of 0.05 mg/kg (for each compound). However, confirmatory methods for N‐acetyl‐glyphosate (in high water and high fat content matrices and dry commodities) and for AMPA (in all matrices) are still missing. EFSA concluded that the short‐term and long‐term intake of residues resulting from the existing uses of glyphosate and the import tolerance on soyabeans is unlikely to present a risk to consumer health. The chronic exposure calculation, however, is affected by uncertainties related to the data gaps identified during the MRL review and is based on the assumption that MRLs for the existing uses of glyphosate will be amended as recommended in the recent MRL review.

Reasoned opinion on the joint review of maximum residue levels (MRLs) for fosetyl, disodium phosphonate and potassium phosphonates according to Articles 12 and 43 of Regulation (EC) No 396/2005.

EFSA received from the European Commission a mandate to provide its reasoned opinion on the joint review of maximum residue levels (MRLs) for fosetyl and phosphonates in or on food and feed according to Article 43 of Regulation (EC) No 396/2005. 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 substances potassium and disodium phosphonates. As fosetyl, potassium phosphonates and disodium phosphonates degrade to phosphonic acid, it was considered appropriate to jointly review the residues of these three active substances. To assess the occurrence of fosetyl, potassium phosphonates and disodium phosphonate 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 as well as the European authorisations reported by Member States (including the supporting residues data) and the monitoring data from official control. 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.

Modification of the existing maximum residue levels for emamectin in various crops

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France S.A.S. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for emamectin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots, cherries, spinaches and similar leaves and herbal infusions from leaves and herbs, whereas a change of the existing MRL is not necessary for pome fruits. Adequate analytical methods for enforcement are available to control the residues of emamectin B1a on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of emamectin benzoate according to the intended agricultural practices are unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review.

Modification of the existing MRLs for potassium phosphonates in lemons, limes and mandarins and in herbal infusions from leaves and herbs.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Lainco S.A., Exclusivas Sarabia S.A., Biovert S.L., Sipcam Inagra S.A. and Tilco‐Alginure GmbH submitted respectively two requests to the competent national authorities in Greece and Germany, to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in certain citrus fruits and in herbal infusions from leaves and herbs. The data submitted in support of both requests were found to be sufficient to derive MRL proposals for lemons, limes, mandarins, strawberries leaves and the remaining plants included in the group of herbal infusions from leaves and herbs. Adequate analytical methods for enforcement are available to control potassium phosphonates residues in the commodities under consideration. Based on the risk assessment results using the currently set acceptable daily intake (ADI) of 2.25 mg/kg body weight (bw) per day for phosphonic acid, EFSA concluded that the long‐term intake of residues resulting from the uses of potassium phosphonates according to the reported good agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative; a more realistic intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and potassium phosphonates.

Setting of import tolerance for cyflufenamid in hops

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in Greece to set an import tolerance for the active substance cyflufenamid 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; however, further risk management considerations are required to decide on the appropriate MRL values considering that the MRL in the country of origin is lower than the MRL proposal derived from the residue trials. Adequate analytical methods for enforcement are available to control the residues of cyflufenamid in the crop under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the consumer risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of cyflufenamid according to the reported agricultural practice in the country of origin is unlikely to present a risk to consumer health. This conclusion shall be regarded as indicative considering that some MRL proposals derived by EFSA during the MRL review require further confirmatory data.

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

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for propiconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. Following the decision on the non‐renewal of the approval of propiconazole and the decision to lower the maximum residue levels (MRLs) for propiconazole to the limit of quantification (LOQ) for all commodities, the data gaps identified in the MRL review are no longer relevant. EFSA summarised some new studies on the toxicological profile of propiconazole metabolites CGA91305, SYN547889 and NOA436613, which were assessed by the rapporteur Member State. Overall, the available information is not sufficient to characterise the toxicological profile of metabolites convertible to 2,4‐dichlorobenzoic acid as data gaps still exist for SYN547889, NOA436613, CGA118244, CGA118245, CGA91304 and CGA91305.

Modification of the existing maximum residue levels and setting of import tolerances for metiram in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Italia Srl submitted a request to the competent national authority in Italy to set import tolerances for the active substance metiram in passion fruits/maracujas, bananas, pineapples and to modify the existing maximum residue level (MRL) in celeriacs on the basis of intended northern Europe (NEU) use. The data submitted in support of the request were found sufficient to derive MRL proposals for pineapples and passion fruits/maracujas; according to the data provided, the existing EU MRL in bananas did not require modification and the data were not sufficient to derive an MRL proposal for celeriacs. A consumer exposure calculation, which considered only metiram uses, indicated no long‐term consumer intake concerns, but is affected by several uncertainties related to the lack of residue data reflecting the existing uses of metiram. A second exposure scenario in which the lack of information was overcome by conservative assumptions indicated potential chronic exposure concerns for a number of diets. The contribution of residues in the crops under consideration to the long‐term consumer exposure is low. The consumer exposure to ethylenethiourea (ETU) residues from the existing and intended metiram uses indicated no consumer intake concerns. However, the risk assessment is affected by a number of uncertainties that could not be addressed with the currently available data. EFSA therefore proposed that a comprehensive consumer exposure to ETU residues is performed in the framework of Article 12 MRL review, considering the existing uses of dithiocarbamates that are known to degrade to ETU in processed products. Considering the inconclusive results and overall uncertainties in the risk assessment, EFSA is of the opinion that further risk management discussions are required whether a modification of existing dithiocarbamate MRLs is justified prior to the finalisation of the MRL review on metiram and other dithiocarbamates.

Evaluation of confirmatory data following the Article 12 MRL review and setting of an import tolerance for flutriafol in cucurbits (inedible peel).

The applicant Cheminova A/S submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data for the active substance flutriafol that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. The applicant provided residue trials on rice representative for an adjusted Good Agricultural Practice (GAP), metabolism studies in goats and storage stability data in tissues of animal origin addressing the data gaps identified in the MRL review. For the nature of residues in processed commodities, relevant to confirm the MRLs on pome fruits and wine grapes, the applicant referred to the information provided in a previous MRL application and already assessed by EFSA. The data gaps on the authorised uses on beetroots, melons and watermelons assessed in the MRL review were not addressed. At the same time, the applicant submitted a request to the United Kingdom to modify the existing maximum residue level (MRL) for flutriafol in cucurbits with inedible peel according to Article 6 of Regulation (EC) No 396/2005. The data submitted were found to be sufficient to derive an MRL proposal for these crops. EFSA concluded that the proposed use of flutriafol on the crops under assessment will not result in a consumer exposure exceeding the toxicological reference values for flutriafol and therefore is unlikely to pose a risk to consumers’ health. Regarding the triazole derivative metabolites (TDMs), the conclusions reached in a previously issued assessment for another triazole fungicide are still valid. An update of the indicative consumer risk assessment for each individual metabolite is not necessary since the residues expected in the concerned commodities are covered.