Review of the existing maximum residue levels for cypermethrins according to Article 12 of Regulation (EC) No 396/2005
2023; Wiley; Volume: 21; Issue: 3 Linguagem: Inglês
10.2903/j.efsa.2023.7800
ISSN1831-4732
AutoresGiulia Bellisai, Giovanni Bernasconi, Marco Binaglia, Alba Brancato, Luis Carrasco Cabrera, Irene Castellan, Anna Federica Castoldi, Arianna Chiusolo, Federica Crivellente, Monica Del Aguila, Lucien Ferreira, Germán Giner Santonja, Luna Greco, Frédérique Istace, Samira Jarrah, Anna Lanzoni, Renata Leuschner, José Oriol Magrans, Iris Mangas, Ileana Miron, Stéfanie Nave, Martina Panzarea, Juan Manuel Parra Morte, Ragnor Pedersen, Hermine Reich, Tobin Robinson, Silvia Ruocco, Miguel Santos, Alessia Pia Scarlato, Andrea Terron, Anne Theobald, Alessia Verani,
Tópico(s)Pesticide Exposure and Toxicity
ResumoEFSA JournalVolume 21, Issue 3 e07800 Reasoned OpinionOpen Access Review of the existing maximum residue levels for cypermethrins according to Article 12 of Regulation (EC) No 396/2005 European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorGiulia Bellisai, Giulia BellisaiSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorMarco Binaglia, Marco BinagliaSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorIrene Castellan, Irene CastellanSearch for more papers by this authorAnna Federica Castoldi, Anna Federica CastoldiSearch for more papers by this authorArianna Chiusolo, Arianna ChiusoloSearch for more papers by this authorFederica Crivellente, Federica CrivellenteSearch for more papers by this authorMonica Del Aguila, Monica Del AguilaSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorGerman Giner Santonja, German Giner SantonjaSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorFrederique Istace, Frederique IstaceSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAnna Lanzoni, Anna LanzoniSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIris Mangas, Iris MangasSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorMartina Panzarea, Martina PanzareaSearch for more papers by this authorJuan Manuel Parra Morte, Juan Manuel Parra MorteSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorTobin Robinson, Tobin RobinsonSearch for more papers by this authorSilvia Ruocco, Silvia RuoccoSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlessia Pia Scarlato, Alessia Pia ScarlatoSearch for more papers by this authorAndrea Terron, Andrea TerronSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorGiulia Bellisai, Giulia BellisaiSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorMarco Binaglia, Marco BinagliaSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorIrene Castellan, Irene CastellanSearch for more papers by this authorAnna Federica Castoldi, Anna Federica CastoldiSearch for more papers by this authorArianna Chiusolo, Arianna ChiusoloSearch for more papers by this authorFederica Crivellente, Federica CrivellenteSearch for more papers by this authorMonica Del Aguila, Monica Del AguilaSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorGerman Giner Santonja, German Giner SantonjaSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorFrederique Istace, Frederique IstaceSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAnna Lanzoni, Anna LanzoniSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIris Mangas, Iris MangasSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorMartina Panzarea, Martina PanzareaSearch for more papers by this authorJuan Manuel Parra Morte, Juan Manuel Parra MorteSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorTobin Robinson, Tobin RobinsonSearch for more papers by this authorSilvia Ruocco, Silvia RuoccoSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlessia Pia Scarlato, Alessia Pia ScarlatoSearch for more papers by this authorAndrea Terron, Andrea TerronSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this author First published: 16 March 2023 https://doi.org/10.2903/j.efsa.2023.7800 Requestor: European Commission Question numbers: EFSA-Q-2008-487, EFSA-Q-2020-00074, EFSA-Q-2008-520, EFSA-Q-2010-00211 Declarations of interest: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu. Acknowledgement: EFSA wishes to thank the rapporteur Member States, Austria and Belgium for the preparatory work and Stathis Anagnos, Martin Gerhards, Javier Martinez Perez, Andrea Mioč, Marta Szot for the support provided to this scientific output. EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source. Approved: 21 December 2022 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat 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 group of pesticide active substances cypermethrins. To assess the occurrence of cypermethrin, alpha-cypermethrin, zeta-cypermethrin, beta-cypermethrin 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 (codex maximum residue limits; CXLs) for cypermethrin, alpha-cypermethrin and zeta-cypermethrin as well as the European authorisations and import tolerances reported by Member States and the UK (including the supporting residues data) for cypermethrin and zeta-cypermethrin. The toxicological profile of zeta-cypermethrin was also assessed. 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 chronic/acute risk to consumer was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. Summary Cypermethrin was included in Annex I to Directive 91/414/EEC on 1 March 2006 by Commission Directive 2005/53/EC and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. Alpha-cypermethrin was included in Annex I to Directive 91/414/EEC on 1 March 2005 by Commission Directive 2004/58/EC and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. The approval of the active substance has been withdrawn by Commission Implementing Regulation (EU) 2021/795. Zeta-cypermethrin was included in Annex I to Directive 91/414/EEC on 1 December 2009 by Commission Directive 2009/37/EC and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. The approval of the active substance has been withdrawn by Commission Implementing Regulation (EU) 2020/1643. Beta-cypermethrin was never included in Annex I to Directive 91/414/EEC. The decision of non-approval was taken according to Commission Implementing Regulation (EU) 2017/1526. As the active substances cypermethrin and alpha-cypermethrin were approved before the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(2) of the aforementioned regulation. As the active substance zeta-cypermethrin was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation. As the active substance beta-cypermethrin was not approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation. Considering that this group of active substances shares a common residue definition, EFSA initiated a combined review of all existing MRLs for all the active substances above. As the basis for the MRL review, on 15 April 2021, EFSA initiated the collection of data for the active substance cypermethrin; on 16 April 2021, for the active substance alpha-cypermethrin; and on 12 May 2021, for the active substances zeta-cypermethrin and beta-cypermethrin. In a first step, Member States and the UK were invited to submit by 21 May 2021 (cypermethrin), by 14 May 2021 (alpha-cypermethrin) and by 16 June 2021 (beta-cypermethrin and zeta-cypermethrin) their national good agricultural practices (GAPs) that are authorised nationally and/or the GAPs in non-EU countries for which import tolerances are authorised, in the format of specific GAP forms, allowing the designated rapporteur Member State, Belgium (for alpha-cypermethrin, beta-cypermethrin and cypermethrin) and Austria (for zeta-cypermethrin) to identify the critical GAPs in the format of specific GAP overview files. Subsequently, Member States and the UK were requested to provide residue data supporting the critical GAPs for the active substance cypermethrin, within a period of 1 month, by 16 September 2021. For alpha-cypermethrin and beta-cypermethrin, no import tolerances were reported during the GAPs collection; therefore, Member States and the UK were not required to provide any supporting data. For zeta-cypermethrin, import tolerances were reported only by the RMS, Austria; therefore, Member States and the UK were not required to provide any additional supporting data as already available at RMS level. On the basis of all the data submitted by Member States, the UK and the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked the RMS, Belgium, to complete the Pesticide Residues Overview Files (PROFile) for cypermethrin and to prepare a combined supporting evaluation report covering cypermethrin, alpha-cypermethrin and beta-cypermethrin. Since no uses were reported for alpha-cypermethrin and beta-cypermethrin, it was agreed with the RMS Belgium that a PROFile was not required for these active substances. The RMS, Austria, was asked to complete the PROFile and to prepare a supporting evaluation report for zeta-cypermethrin including the assessment on the toxicological profile of the substance, in order to be able to perform the consumer risk assessment in the framework of the Article 12 MRL review. The PROFile and the supporting evaluation report on residues for zeta-cypermethrin were submitted to EFSA on 5 November 2021. The evaluation report with toxicological data was submitted to EFSA on 7 July 2022 and it was circulated to Member States and the EURLs for consultation via a written procedure. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS was compiled in the completeness check report. On the basis of the feedback received by Member States and observations by EFSA on the toxicological assessment of zeta-cypermethrin, an expert meeting was held on 6 September 2022. A final consultation on the conclusions arising from the expert meeting took place with Member State experts via a written procedure on 21 September 2022. The conclusions of the expert meeting were compiled by EFSA in the format of an evaluation table. Based on the information provided by the RMS, Member States, the UK and the EURLs, and taking into account the conclusions derived by EFSA in the framework of Directive 91/414/EEC, Regulation (EC) No 1107/2009, Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in October 2022 a combined draft reasoned opinion, which was circulated to Member States and the EURLs for consultation via a written procedure. Comments received by 27 November 2022 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of all the various isomer combinations of cypermethrins was investigated in primary and rotational crops. According to the results of the metabolism studies and the hydrolysis studies, the residue definition for enforcement and risk assessment in raw and processed commodities can be proposed as 'cypermethrin including other mixtures of constituent isomers (sum of isomers)'. Nevertheless, the residue definition for risk assessment should be considered still provisional, pending the conclusions in the framework of the ongoing mandate on the toxicology of metabolites 3-PBA and 4-OH-PBA and the residue definitions for risk assessment for the active substances releasing these metabolites. A specific residue definition for rotational crops is not deemed necessary considering the limited persistence of cypermethrins and/or metabolites in the soil. An analytical method for the enforcement of the proposed residue definition in all four main plant matrix groups at the LOQ of 0.01 mg/kg and in straw at the LOQ of 0.1 mg/kg is available. However, linearity data for confirmatory ions are missing for the analytical methods in plants (data gap). According to the EURLs, the enforcement of cypermethrin (sum of isomers) at the LOQ of 0.01 mg/kg in all four main plant matrix groups and at the LOQ of 0.05 mg/kg in black pepper (difficult matrix) is achievable by using the QuEChERS method in routine analyses. For cypermethrin, available residue trials data were considered sufficient to derive tentative MRL proposals as well as risk assessment values for all commodities under evaluation, except on cherries, plums blackberries, raspberries, spring onions, sweet peppers, gherkins, okra, kohlrabies, grape leaves, lentils(fresh)celeries, cardoons, Florence fennels, rhubarbs, bamboo shoots, palm hearts, herbal infusions from leaves and herbs, hops, barley/oat for forage and wheat/rye for forage. While for zeta-cypermethrin, available residue trials data were considered sufficient to derive tentative MRL proposals as well as risk assessment values for all commodities under evaluation except on raspberries, soybeans, coffee beans and sugar beet. Considering the data gaps related to the toxicological profiles of the cypermethrins, and to the enforcement analytical method, all derived MRLs should be considered tentative only. Cypermethrin and zeta-cypermethrin are authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.004 mg/kg body weight (bw) per day. Behaviour of residues was therefore assessed in all commodities of animal origin. The metabolism of various isomer combinations of cypermethrins in livestock was investigated in lactating goats and laying hens at dose rate covering the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definition for enforcement and risk assessment in livestock commodities was proposed as 'cypermethrin including other mixtures of constituent isomers (sum of isomers)'. This residue definition should be confirmed in the framework of the ongoing mandate on the toxicology of metabolites 3-PBA and 4-OH-PBA and the residue definitions for risk assessment for the active substances releasing these metabolites. Analytical methods for the enforcement of the proposed residue definition at the LOQ of 0.03 mg/kg in tissues and at the LOQs of 0.01 and 0.005 mg/kg in eggs and milk, respectively, are available. However, an additional confirmatory data for the method for milk are needed (data gap). According to the EURLs, the LOQ of 0.01 mg/kg is achievable in liver, milk and egg and 0.02 mg/kg in fat by using multiresidue methods in routine analysis. An LOQ of 0.01 mg/kg is supposed to be achievable in muscle and kidney. Livestock feeding studies on animals were used to derive MRL and risk assessment values in milk, eggs, tissues of ruminants and poultry. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs. Considering the data gaps related to the toxicological profiles of the cypermethrins and that a confirmatory method in milk is missing, all derived MRLs should be considered tentative only. In the framework of this review, only the uses of cypermethrin and the import tolerances for zeta-cypermethrin reported by the RMSs were considered; however, the uses of cypermethrin, alpha-cypermethrin and zeta-cypermethrin were previously also assessed by the JMPR. The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs. In addition, MRLs in products of animal origin resulting from the use of cypermethrin and alpha-cypermethrin as a veterinary medicine are also established in the framework of Regulation (EU) No 37/2010. In order to facilitate consideration of these veterinary MRLs by risk managers, the consumer exposure was also assessed with consideration of these MRLs. Since different toxicological reference values are established for the different compounds, separate risk assessments were performed for each active substance. This allowed to identify, for each active substance, uses, CXLs and veterinary MRLs leading to a possible risk for consumers. Moreover, considering that consumers might be exposed to residue from the different compounds, a combined risk assessment was also performed considering the safe uses identified. Furthermore, since the MRLs proposed will be enforced as the sum of isomers, it is still possible that residues in food commodities result from any other cypermethrin isomer which is also used as an active substance. As alpha-cypermethrin is known to be more toxic than other cypermethrin isomers, EFSA performed a screening of the proposed MRLs considering the acute reference dose (ARfD) for alpha-cypermethrin and derived a threshold value that would not pose a risk for consumers in case residues would consist only of the more toxic alpha-cypermethrin. All the exposure calculations were performed by using revision 3.1 of the EFSA PRIMo. Regarding cypermethrin, a risk to consumers was identified for the most critical GAPs of cypermethrin on several crops. For some, no further refinements of the risk assessment were possible and these uses are recommended to be withdrawn, whereas for others, fall-back GAPs were identified. The second risk assessment, in which these considerations were applied, did not indicate exceedances of the toxicological reference values. For the remaining commodities, although major uncertainties remain due to the general data gaps identified in the previous sections, the indicative exposure calculation did not indicate exceedances of the toxicological reference values for cypermethrin. Additional calculations of the consumer exposure were performed, considering the CXLs based on the uses of cypermethrin. Based on these calculations, a potential risk to consumers was identified for the CXLs based on the use of cypermethrin on mangoes, papayas, litchis, tea, wheat, rye, barley, and oat. For the remaining CXLs, although major uncertainties remain due to the general data gaps identified, the indicative exposure calculation did not indicate exceedances of the toxicological reference values for cypermethrin. Regarding zeta-cypermethrin, a risk to consumers was identified for the most critical GAPs for import tolerances on sugar beet, raspberries, table grapes, peaches, cherries, plums, sweet peppers, wine grapes, rice, tomatoes and barley and no further refinements of the risk assessment were possible. For the remaining commodities, although major uncertainties remain due to the general data gaps identified in the previous sections, the indicative exposure calculation did not indicate exceedances of the toxicological reference values for zeta-cypermethrin. Additional calculations of the consumer exposure were performed, considering the CXLs based on the uses of zeta-cypermethrin. Based on these calculations, a potential risk to consumers was identified for the CXLs based on the use of zeta-cypermethrin on pome fruits, peaches, stone fruits, tomatoes, sweet peppers, rice, beans with and without pods, peas with and without pods and fresh lentils and no further refinements of the risk assessment were possible. For the remaining CXLs, although major uncertainties remain due to the general data gaps identified, the indicative exposure calculation did not indicate exceedances of the toxicological reference values for zeta-cypermethrin. Internationally recommended CXLs have also been established for alpha-cypermethrin. Additional calculations of the consumer exposure were performed, considering these CXLs. CXL for spices derived from monitoring data and CXLs for livestock were also considered in this scenario. Based on these calculations, a potential risk to consumers was identified for the CXLs based on the uses of alpha-cypermethrin on cauliflowers, kohlrabies, head cabbages, broccoli, kales, escaroles, witloof, lettuces, Chinese cabbages, spinaches, chards, table grapes, Brussels sprouts, cucumber, courgettes, red mustards, wine grapes, leeks, potatoes, melons, lamb's lettuce, roman rocket, and for the CXLs on bovine meat and fat, swine meat and fat, cattle milk and meat from other farmed animals and no further refinements of the risk assessment were possible. For the remaining CXLs, although major uncertainties remain due to the general data gaps identified, the indicative exposure calculation did not indicate exceedances of the toxicological reference values for alpha-cypermethrin. The calculated acute and chronic exposures resulting with the inclusion of the veterinary MRL for milk and bovine fat (only veterinary MRLs higher than the demonstrated safe pesticides MRL proposals) would exceed both the ARfD (cattle milk, 199% of the ARfD) and the ADI (Dutch toddler, 130% of the ADI). Considering the safe uses and CXLs identified in the previous scenarios and comparing the calculated exposure with the TRVs derived for alpha-cypermethrin in a combined risk assessment, a long-term risk cannot be excluded for the Dutch toddler diet (with cattle milk, maize corn and wheat being the major contributors). Therefore, an additional calculation was performed, excluding the residues in wheat as derived from the import tolerance GAP for zeta-cypermethrin and considering as fall-back GAP, the northern outdoor use authorised for cypermethrin. This refined calculation did not indicate exceedances of the toxicological reference values for alpha-cypermethrin. EFSA concluded that based on the calculations performed according to the internationally agreed methodology, the uses under consideration will not result in consumer intake exceeding the ARfD. However, EFSA noted a narrow safety margin. Hence, if residues of cypermethrins occur in citrus fruits, table grapes, carambolas, potatoes, carrots, beetroots, celeriacs, swedes, parsnips (boiled), turnips (boiled), aubergines, watermelons, sweet corn, broccoli (boiled), head cabbages, red mustard, chervil, parsley, asparagus, globe artichokes, buckwheat, maize, sorghum, millet (boiled), sugar beets (sugar), sugar canes (sugar), equine and sheep meat, and cattle milk at the derived MRL value, the dietary exposure of certain consumers may exceed the ARfD under certain conditions (i.e. consumption of a large portion of the product without washing/peeling/processing which would lead to a reduction of the residues in the product). Risk managers should decide whether the safety margin of the exposure assessment based on the highest residue is sufficient, considering that in reality, residues in individual units/lot consumed may occur at or above the proposed MRL. Based on the screening of the proposed MRLs considering the ARfD for alpha-cypermethrin, EFSA identified 34 commodities for which a potential acute intake concern could not be excluded if the residues in these commodities would consist only of the more toxic alpha-cypermethrin. It should be stressed that these results do not contradict the risk assessment performed in the previous scenarios but are only intended to provide supporting information for the laboratories enforcing the proposed MRLs. In view of the very low toxicological reference values derived for alpha-cypermethrin and in order to further support risk managers, EFSA also screened the LOQ of 0.01 mg/kg to verify whether this default value would be sufficiently protective to European consumers. According to the results of this screening, exceedance of the ARfD was identified for potatoes, melons, pears and oranges. For these commodities, a lower LOQ of 0.005 mg/kg would provide sufficient protection. Background Regulation (EC) No 396/20051 (hereinafter referred to as 'the Regulation') establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(2) and 12(1) of that Regulation stipulates that the European Food Safety Authority (EFSA) shall provide, respectively, by 1 September 2009 or within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs. Cypermethrin was included in Annex I to Directive 91/414/EEC on 1 March 2006 by Commission Directive 2005/53/EC,3 and has been deemed to be approved under Regulation (EC) No 1107/2009,4 in accordance with Commission Implementing Regulation (EU) No 540/2011,5 as amended by Commission Implementing Regulation (EU) No 541/2011.6 Alpha-cypermethrin was included in Annex I to Directive 91/414/EEC on 1 March 2005 by Commission Directive 2004/58/EC7 and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. The approval of the active substance has been withdrawn by Commission Implementing Regulation (EU) 2021/795.8 Zeta-cypermethrin was included in Annex I to Directive 91/414/EEC on 1 December 2009 by Commission Directive 2009/37/EC9 and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. The approval of the active substance has been withdrawn by Commission Implementing Regulation (EU) 2020/1643.10 Beta-cypermethrin was never included in Annex I to Directive 91/414/EEC. The decision of non-approval was taken according to Commission Implementing Regulation (EU) 2017/1526.11 Therefore, in accordance with Regulation 396/2005 and considering that this group of active substances shares a common residue definition, EFSA initiated a combined review of all existing MRLs for all the active substances above. By way of background information, cypermethrin was evaluated by Belgium, designated as rapporteur Mem
Referência(s)