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The applicant Proplan Plant Protection Company submitted a request to the competent national authority in Austria (originally the United Kingdom) to evaluate the confirmatory data that were identified for paclobutrazol in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, two new metabolism studies performed on apples were submitted. In addition, two studies on the magnitude of residues in apples and pears providing data for triazole derivative metabolites were also submitted. The data gaps were considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs for pome fruits, apricots and peaches. An update of the risk assessment was performed for paclobutrazol and for the triazole derivative metabolites in light of the new data submitted and did not indicate any consumer intake concerns. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a reasoned opinion on the toxicological properties and the existing maximum residue levels (MRLs) set for propoxur. EFSA was requested to assess the toxicological properties of propoxur and derive toxicological reference values, based on the toxicological assessment performed by Health Canada. EFSA was also requested to review the information provided by Member States and the UK on the metabolism of propoxur in plants and animals and on the current MRLs, as well as the limit of quantification (LOQ) that can be achieved with analytical methods used in MRL enforcement. Based on the information available to EFSA, toxicological reference values could not be derived for propoxur. No evidence was provided by Member States and UK that the existing EU MRLs need to be maintained as import tolerances. Information to support the current MRLs or alternative MRLs have not been provided by Member States and the UK. Codex MRLs are not in place. EFSA therefore recommended lowering of all existing EU MRLs for propoxur to the LOQ. According to the EU Reference Laboratories, sufficiently validated analytical methods are available to analyse for propoxur residues in all plant and animal commodities. Lacking toxicological reference values derived at EU level, a conclusion cannot be derived whether the setting of MRLs at the LOQs is sufficiently protective for the European consumers. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Limited submitted a request to the competent national authority in the UK to set import tolerances for the active substance chlorantraniliprole in strawberries and the whole category pulses (beans, lentils, peas and lupins/lupini beans). The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for the whole category pulses. The available data are not sufficient to derive an import tolerance for strawberries and no modification of the current EU MRL is required. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the 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]

The applicant Syngenta submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified for azoxystrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available, and to consider new good agricultural practices (GAPs) for lettuces and other salad plants. To address the data gaps, new residue trials performed on open leaf varieties of lettuce supporting adjusted indoor, northern and southern GAPs, an assessment of the genotoxicity of the livestock metabolites L1, L4 and L9 and an assessment of the human dietary exposure to the livestock metabolites L1, L4 and L9 were submitted. The data gaps were considered partially addressed. The new information provided may require a revision (lowering) of the existing MRLs for lettuce and other salad plants and further risk management consideration for MRLs in animal commodities. [ABSTRACT FROM AUTHOR]

The applicant AgroFresh Holding France S.A.S. submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified 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 metabolism study representative for apples was submitted. In addition, residue trials in apples and bananas were provided. For apples, residues were below the limit of quantification (LOQ), and for bananas, EFSA concluded that there is sufficient evidence to assume that quantifiable residues of 1-methylcyclopropene (1-MCP) are unlikely to occur, if bananas are treated according to the Good Agricultural Practice (GAP) reported. The new information provided did not require a revision of the existing MRLs for apples and bananas. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance chlormequat in barley and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley grain, sheep muscle and sheep kidney. Adequate analytical methods for enforcement are available to control the residues of chlormequat and its salts in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of chlormequat according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance chlormequat in barley and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley grain, sheep muscle and sheep kidney. Adequate analytical methods for enforcement are available to control the residues of chlormequat and its salts in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of chlormequat according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 53 of Regulation (EC) 1107/2009, the United Kingdom granted two 120‐day emergency authorisations for the use of plant protection products containing the active substance cyantraniliprole in Chinese cabbages, raspberries and blackberries. The applicants (Agriculture & Horticulture Development Board (AHDB)) and FMC Agro Ltd) requested the setting of temporary maximum residue levels (MRLs) for cyantraniliprole in Chinese cabbages, raspberries and blackberries. The United Kingdom, as evaluating Member State (EMS), summarised the data provided by the applicants in two evaluation reports which were submitted to the European Commission and forwarded to EFSA. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Sufficient residue trials were submitted to calculate MRL proposals for the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of parent cyantraniliprole in crops under assessment according to the reported emergency agricultural practice is unlikely to present a risk to consumer health. Due to data gaps related to the toxicological profile of degradation products generated during processing, the risk assessment for processed products could not be finalised. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant H.L Hutchinson Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in sweet corn. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sweet corn. An analytical method for MRL enforcement and its independent laboratory validation, using liquid chromatography with tandem mass spectrometry (LC‐MS/MS) was sufficiently validated at a 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 pyraclostrobin according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]