RESUMEN
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.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in various crops. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration. The estimated long-term and short-term intake to residues of difenoconazole resulting from the existing and the intended uses did not exceed the toxicological reference values established for the active substance difenoconazole. The consumer exposure assessment has to be considered provisional as the impact of a potentially different isomer composition in the residues of difenoconazole on this risk assessment is currently unknown and has to be reconsidered when data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants is available and guidance on a risk assessment approach for residues containing isomers is implemented.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S. submitted a request to the competent national authority in France, to modify the existing maximum residue levels (MRLs) for the active substance fenpyrazamine in lamb's lettuces, lettuces, escaroles, dandelions, cresses, land cresses, rucola, red mustards, spinaches, purslanes and chards/beet leaves. The data submitted in support of the request were found to be sufficient to derive MRL proposals for lamb's lettuces/corn salads, lettuces, escaroles/broad-leaved endives (including dandelions), cresses, land cresses, roman rocket/rucola, red mustards, spinaches, purslanes and chards/beet leaves. Adequate analytical methods for enforcement are available to control the residues of fenpyrazamine in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues in the crops assessed at or above 0.01 mg/kg (limit of quantification (LOQ)). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of fenpyrazamine on lamb's lettuces/corn salads, lettuces, cresses, land cresses, roman rocket/rucola, red mustards, spinaches, purslanes and chards/beet leaves according to the reported agricultural practice is unlikely to present a risk to consumer health. According to the internationally agreed methodology for short-term exposure estimation (IESTI), the acute reference dose (ARfD) was not exceeded for the intended use of fenpyrazamine on escaroles (97.6%), and thus, there is a narrow safety margin.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV submitted an application to the competent national authority in Belgium (evaluating Member State (EMS)) to modify the existing maximum residue levels (MRLs) for the active substance prochloraz in sugar beet root and in liver and kidney of swine and ruminant. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sugar beet root. Residues in sugar beet tops from the new use were found to contribute significantly to the livestock exposure. As the dietary burden needs to be calculated including all feed items and since not all information is available at the moment, EFSA proposes to assess the magnitude of prochloraz residues in animal commodities under the currently ongoing review of prochloraz MRLs according to Article 12 of Regulation (EC) No 396/2005. Adequate analytical methods are available to control the residues of prochloraz residues in plant and animal matrices. The risk assessment performed by EFSA gave an indication that residues of prochloraz may lead to an exceedance of the acceptable daily intake (ADI). Thus, before the MRL for sugar beet is amended, it is necessary that a comprehensive, refined risk assessment is performed, taking into account all existing uses of prochloraz and the intended new use on sugar beet. Considering that the MRL review for prochloraz is currently ongoing, the results of the comprehensive risk assessment will be available in due time.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova Agro Italia Srl submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance abamectin in bananas. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of abamectin in the plant matrix under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of abamectin according to the reported agricultural practice is unlikely to present a risk to consumer health.
RESUMEN
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and the co-rapporteur Member State, the United Kingdom, for the pesticide active substance etoxazole and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of etoxazole as an acaricide on pome fruits, plums, peaches, nectarines, apricots, cherries (sweet), citrus, grapes, strawberries, tomatoes/eggplants, cucurbits inedible peel, cotton seeds and ornamental plants. MRLs were assessed in strawberries, cucurbits inedible peel, plums, tomatoes and aubergines/eggplants. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
RESUMEN
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Greece, for the pesticide active substance trifloxystrobin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of trifloxystrobin as a fungicide on apple, pear, quince, grapes and strawberry. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
RESUMEN
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 level (MRL) for the active substance tefluthrin in carrots. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for carrots. Adequate analytical methods for enforcement are available to control the residues of tefluthrin in carrots 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 tefluthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.
RESUMEN
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.
RESUMEN
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance paclobutrazol. To assess the occurrence of paclobutrazol 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 some MRL proposals derived by EFSA still require further consideration by risk managers.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS), the Netherlands and the United Kingdom, received an application from BASF SE to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in several crops in order to accommodate for proposed new uses in Europe and for the import of crops. According to EFSA, the data are sufficient to derive MRL proposals for all the crops assessed, except for citrus fruits other than oranges and grapefruits. Adequate analytical enforcement methods are available to control the residues of fluxapyroxad on the commodities under consideration, but additional validation data on herbal infusion and spices would be desirable. Based on the risk assessment results, EFSA concluded that the proposed uses on various crops of fluxapyroxad and the use authorised in Brazil on oranges and grapefruits for which import of crops has been requested, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.
RESUMEN
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 imazalil. To assess the occurrence of imazalil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC and under 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). 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 and acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
RESUMEN
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Austria, and co-rapporteur Member State, the Czech Republic, for the pesticide active substance pethoxamid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of pethoxamid as a herbicide on maize and soya bean. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeScience Great Britain Ltd submitted a request to the competent national authority in Italy to set new maximum residue level (MRL) for the active substance bifenazate in soya beans. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for soya beans. Adequate analytical methods for enforcement are available to control the residues of bifenazate and its metabolite in the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of bifenazate according to the reported agricultural practice is unlikely to present a risk to consumer health.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance fluopyram in purslanes. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for purslanes. Adequate analytical methods for enforcement are available to control the residues of fluopyram in plant matrices/on the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of fluopyram according to the reported agricultural practice is unlikely to present a risk to consumer health.
RESUMEN
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance in kiwi fruits. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for the crop under consideration. Adequate analytical methods for enforcement are available to control the residues of acibenzolar-S-methyl in the plant matrix under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of acibenzolar-S-methyl according to the reported agricultural practice is unlikely to present a risk to consumer health.
RESUMEN
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 bromuconazole. To assess the occurrence of bromuconazole 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 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.
RESUMEN
ABCC2/Abcc2 (MRP2/Mrp2) is expressed at major physiological barriers, such as the canalicular membrane of liver cells, kidney proximal tubule epithelial cells, enterocytes of the small and large intestine, and syncytiotrophoblast of the placenta. ABCC2/Abcc2 always localizes in the apical membranes. Although ABCC2/Abcc2 transports a variety of amphiphilic anions that belong to different classes of molecules, such as endogenous compounds (e.g., bilirubin-glucuronides), drugs, toxic chemicals, nutraceuticals, and their conjugates, it displays a preference for phase II conjugates. Phenotypically, the most obvious consequence of mutations in ABCC2 that lead to Dubin-Johnson syndrome is conjugate hyperbilirubinemia. ABCC2/Abcc2 harbors multiple binding sites and displays complex transport kinetics.
Asunto(s)
Proteínas Asociadas a Resistencia a Múltiples Medicamentos/metabolismo , Animales , Transporte Biológico Activo , Clonación Molecular , Resistencia a Múltiples Medicamentos , Humanos , Cinética , Ratones , Ratones Noqueados , Proteína 2 Asociada a Resistencia a Múltiples Medicamentos , Proteínas Asociadas a Resistencia a Múltiples Medicamentos/biosíntesis , Proteínas Asociadas a Resistencia a Múltiples Medicamentos/química , Proteínas Asociadas a Resistencia a Múltiples Medicamentos/genética , Conformación Proteica , Xenobióticos/metabolismoAsunto(s)
Estradiol/metabolismo , Proteínas Asociadas a Resistencia a Múltiples Medicamentos/efectos de los fármacos , Proteínas Asociadas a Resistencia a Múltiples Medicamentos/metabolismo , Animales , Transporte Biológico Activo/efectos de los fármacos , Línea Celular , Glucurónidos/metabolismo , Humanos , Proteína 2 Asociada a Resistencia a Múltiples Medicamentos , Estimulación QuímicaRESUMEN
Calpain has long been implicated in the regulation of cell cycle, mostly based on studies with inhibitors that lack strict specificity toward the enzyme. Further, previous work has primarily focused on one particular point, the G(1) checkpoint, and made no attempt at dissecting the full cycle in terms of calpain action. To extend and complement these findings, we tested the effect of a specific inhibitor, PD 150606, on granulocyte-macrophage-colony stimulating factor (GM-CSF)-stimulated human TF-1 cells by flow cytometry following single- and double labelling by propidium iodide and bromodeoxyuridine. Using a new algorithm of analysis, we determined the time-dependence of the absolute number of cells leaving G(1), S and G(2)M phases following the application of the inhibitor. Our results point to the simultaneous involvement of calpain activity in promoting the cycle at the G(1) checkpoint and somewhere in the G(2)M compartment. Furthermore, the inhibitor significantly impedes the progress of cells through the S phase, indicating calpain activity in S phase checkpoint signalling. Overall, our analysis suggests that calpain regulates the cell cycle at more points than previously thought.
