Scientific guidance on soil phototransformation products in groundwater – consideration, parameterisation and simulation in the exposure assessment of plant protection products

Abstract This Guidance Document gives recommendations how to consider transformation products from soil photolysis (‘phototransformation products’) when modelling the predicted environmental concentrations in groundwater. It describes possible parameterisations of the photolytic pathway (i.e. the photolytic half‐life and the corresponding reference irradiation) in a tiered approach using the FOCUS‐PELMO model. Following the recommendations of the EFSA guidance (2014), separate half‐lives can be derived for the surface processes (kfast) and the biodegradation in the soil matrix (kslow) from field dissipation studies by using biphasic models. From field dissipation studies evaluated with biphasic kinetics, the kfast value can be considered representative for the photolytic degradation on soil surface for non‐volatile substances. This value should be determined after a time‐step normalisation according to irradiance data for the location and period of the field trial, to a reference irradiance of 100 W m−2. In case irradiance values are not available in the study, these values can be derived from databases such as AGRI4CAST or NASA, freely available in the Internet

Modification of the existing maximum residue level for flonicamid in various crops

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Netherlands to modify the existing MRLs for the active substance flonicamid in strawberries, cane fruits, other small fruits and berries, lettuces and other salad plants, and pulses (dry beans, lentils, peas, lupins). The data submitted in support of the request were found to be sufficient to derive MRL proposals for strawberries, blackberries, raspberries, other small fruits and berries, radishes, lettuces and other salad plants, and pulses (dry beans, lentils, peas and lupins). Adequate analytical methods for enforcement are available to control the residues of flonicamid on in 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 use of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health

Modification of the existing maximum residue levels for flonicamid in various root crops

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, turnips. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities concerned. Adequate analytical methods for enforcement are available to control the residues of flonicamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte of the residue definition and in animal matrices at the validated LOQ of 0.01 mg/kg for each analyte of the residue definition. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Abstract 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

Setting of import tolerance for flutriafol in hops

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova A/S submitted a request to the competent national authority in Spain to set an import tolerance for the active substance flutriafol in hops. The data submitted in support of the request were found to be sufficient to derive an import tolerance proposal of 20 mg/kg for crops under consideration. Adequate analytical methods for enforcement are available to control the residues of flutriafol in plant matrices 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 flutriafol according to the reported agricultural practice is unlikely to present a risk to consumer health. However, as flutriafol belongs to the triazole chemical group, EFSA recommends that a separate risk assessment should be performed for triazole derivative metabolites (TDMs) as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their TDMs is available

Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water

Abstract This guidance document provides a tiered framework for risk assessors and facilitates risk managers in making decisions concerning the approval of active substances (AS) that are chemicals in plant protection products (PPPs) and biocidal products, and authorisation of the products. Based on the approaches presented in this document, a conclusion can be drawn on the impact of water treatment processes on residues of the AS or its metabolites in surface water and/or groundwater abstracted for the production of drinking water, i.e. the formation of transformation products (TPs). This guidance enables the identification of actual public health concerns from exposure to harmful compounds generated during the processing of water for the production of drinking water, and it focuses on water treatment methods commonly used in the European Union (EU). The tiered framework determines whether residues from PPP use or residues from biocidal product use can be present in water at water abstraction locations. Approaches, including experimental methods, are described that can be used to assess whether harmful TPs may form during water treatment and, if so, how to assess the impact of exposure to these water treatment TPs (tTPs) and other residues including environmental TPs (eTPs) on human and domesticated animal health through the consumption of TPs via drinking water. The types of studies or information that would be required are described while avoiding vertebrate testing as much as possible. The framework integrates the use of weight‐of‐evidence and, when possible alternative (new approach) methods to avoid as far as possible the need for additional testing

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

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 myclobutanil. To assess the occurrence of myclobutanil 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 import tolerances and/or 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

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

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 napropamide. To assess the occurrence of napropamide 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

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

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 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

Modification of the existing maximum residue levels for fluazinam in onions, shallots and garlic

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Makhteshim submitted a request to the competent national authority in the Netherlands to set maximum residue levels (MRL) for the active substance fluazinam in onions, shallots and garlic. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. An adequate analytical method for enforcement is available to control the residues of fluazinam in plant matrices. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of fluazinam according to the intended agricultural practices is unlikely to present a risk to consumer health