Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Abstract The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower‐tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user‐friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower‐tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher‐ and lower‐tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite‐dosed studies. The formation fraction can be derived from parent‐dosed degradation studies, provided that the parent and metabolite are fitted with the best‐fit model, which is the double first‐order in parallel model in the case of aged sorption

Modification of the existing maximum residue level for fosetyl/phosphonic acid for potatoes and wheat

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Luxembourg Industries (Pamol) Ltd and De Sangosse SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for fosetyl/phosphonic acid related to the use of potassium phosphonates on potatoes, wheat and some animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessments and for animal commodities. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for high water‐ and dry matrices and at LOQ of 0.1 mg/kg in high acid matrices and in animal matrices and eggs at the validated LOQ of 0.05 mg/kg and in milk at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumers

Review of the existing maximum residue levels for clethodim 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 clethodim. To assess the occurrence of clethodim residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL could not be proposed because an overall consumer risk assessment could not be finalised. Risk managers should be made aware that the genotoxic potential of the clethodim metabolite 3‐chloroallyl alcohol, the aglycon of 3‐chlorolallyl alcohol glucoside (M14A/M15A) could not be concluded and no toxicological reference values could be derived for this metabolite. Until a conclusion on the toxicological properties of the metabolite is reached, a decision on the residue definition for risk assessment cannot be made which is a prerequisite to perform a reliable dietary risk assessment

Modification of the existing maximum residue level for fludioxonil in Florence fennels

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belgium Federal Public Service for Health, Food chain safety and Environment (Belgium FPS Health) submitted a request to modify the existing maximum residue level (MRL) for the active substance fludioxonil in Florence fennels. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 1.5 mg/kg for Florence fennels. Adequate analytical methods for enforcement are available to control the residues of fludioxonil on the commodity 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 fludioxonil according to the reported agricultural practice is unlikely to present a risk to consumer health

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

Abstract The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone 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 livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified

Modification of the existing maximum residue levels and setting of import tolerances for oxathiapiprolin in various commodities

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Du Pont de Nemours GmbH submitted two requests to the competent national authority in Ireland to modify the existing EU maximum residue levels (MRLs) and to set import tolerances for oxathiapiprolin in various plant commodities in order to accommodate the intended EU uses and the authorised uses of this active substance in China, Canada and the United States. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration, except for Brussels sprouts and peas (without pods), for which residue data were either not submitted or were insufficient to support the use. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that, taking into account the existing and the intended uses, the long‐term intake of residues of oxathiapiprolin is unlikely to present a risk to consumer health

Review of the existing maximum residue levels for pinoxaden 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 pinoxaden. To assess the occurrence of pinoxaden residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, 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). 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 bupirimate 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 bupirimate. To assess the occurrence of bupirimate 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. 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

Setting of import tolerance for cyflufenamid in hops

Abstract 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

Modification of the existing maximum residue level for apricots and setting of import tolerances for cyantraniliprole in various crops

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants FMC International and Syngenta Crop Protection submitted two requests to the competent national authority in France, respectively, to set import tolerances for the active substance cyantraniliprole in various crops and to modify the existing maximum residue levels (MRLs) in apricots. The data submitted in support of the requests were found sufficient to derive MRL proposals for apricots, potatoes, tropical root and tuber vegetables, cucurbits (inedible peel), lettuces and salad plants, Chinese cabbage and other leafy brassica (except kale), spinaches and similar leaves (except spinach), parsley and minor oilseeds. Based on the risk assessment results, EFSA concluded that the dietary intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health for the parent compound. A definitive conclusion on the risk for consumers cannot be derived for the degradation products IN‐N5M09 and IN‐F6L99 which are formed during cooking/boiling. For both compounds, the concerns on genotoxicity have been ruled out, but the general toxicity has not been addressed. The indicative exposure calculated by the EMS and EFSA for these compounds is affected by non‐standard uncertainties but can support risk managers to take an informed decision on the requested modification of the existing MRLs for the crops under assessment