Since 2007, the EFSA PRIMo (Pesticide Residue Intake Model), an Excel‐based calculation spreadsheet, is the standard tool used at EU level to perform the dietary risk assessment for pesticide ...residues in the framework of setting and reviewing of maximum residue levels for pesticides under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. The model was now updated with regard to food consumption data derived from some recent dietary food surveys. In addition, new functionalities were included in the calculation spread sheet to make the tool more user‐friendly and to allow automatic integration of the EFSA PRIMo in the workflows where dietary risk assessments are performed.
This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1605/full
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.
In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member ...State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for aubergines/eggplants. Adequate analytical methods for enforcement are available to control the residues of methoxyfenozide in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, the EFSA concluded that the short‐term and long‐term intake of residues resulting from the indoor use of methoxyfenozide according to the reported agricultural practice is unlikely to present a risk to consumer health.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants De Sangosse SAS and Tilco‐Alginure submitted two requests, respectively, to the competent national authorities in France ...and Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various plant commodities. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under assessment. For the derived MRL on baby leaf crops, further risk manager consideration is required to decide between two MRL options. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the residue definition ‘phosphonic acid and its salts expressed as phosphonic acid’ in the commodities under consideration. Based on the risk assessment results and assuming that the existing MRLs will be amended as proposed by EFSA in previous outputs, EFSA concluded that the long‐term intake of residues resulting from the existing uses of fosetyl and phosphonates (previously assessed in a joint MRL review) and new proposed uses of potassium phosphonates is unlikely to present a risk to consumer health. Considering the toxicological profile of the active substance, a short‐term dietary risk assessment was not required. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 require further consideration by risk managers.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Finland to modify the temporary maximum residue level ...(MRL) to a permanent MRL for the active substance mepiquat in cultivated fungi (with a specific MRL for oyster mushrooms). The data submitted in support of the request (monitoring data from food business operators) are not sufficient to derive permanent MRL proposals. The assessment of these data, complemented by an analysis of the most recent monitoring data available from EU monitoring programmes, supports the conclusion that the existing t‐MRL for cultivated fungi is still sufficient to account for the residue uptake in cultivated mushrooms other than oyster mushrooms. It was also noted that lower t‐MRLs could be derived based on the assessment of the most recent monitoring data. A risk management decision is still needed on whether to maintain the existing t‐MRL value. Regarding oyster mushrooms, EFSA derived different options for risk managers to eventually update the values of the temporary MRLs based on the most recent monitoring data from food business operators. Adequate analytical methods for enforcement are available to control the residues of mepiquat (expressed as mepiquat chloride) 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 short‐term and long‐term intake of residues resulting from the cross‐contamination of untreated cultivated fungi (including oyster mushrooms) from cereal straw lawfully treated with mepiquat according to the current agricultural practices is unlikely to present a risk to consumer health.
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 ...gamma‐cyhalothrin. To assess the occurrence of gamma‐cyhalothrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data) in the framework of this review. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no risk to consumers was identified, some information required by the regulatory framework was missing. The residue definition for monitoring (lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R, S and S, R isomers)) covers both lambda‐ and gamma‐cyhalothrin. Appropriate enantioselective techniques, which are not commonly used in routine analysis, are required to differentiate gamma‐cyhalothrin residues from lambda‐cyhalothrin. According to the available data, it is expected that the MRLs currently set in Regulation (EC) No 396/2005 will cover the uses of gamma‐cyhalothrin assessed in the present review. Therefore, risk managers can consider maintaining the existing EU MRLs.
The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the ...MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Spain and Ireland to modify the existing maximum ...residue levels (MRLs) for the active substance fluxapyroxad in kaki/Japanese persimmons and in cultivated fungi, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kaki/Japanese persimmons and cultivated fungi. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad on the commodities under consideration 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 fluxapyroxad, according to the reported agricultural practices, is unlikely to present a risk to consumer health. The long‐term consumer risk assessment is indicative, pending the submission of the confirmatory data requested under the MRL review.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Greece to set an import tolerance ...for the active substance fenazaquin in hops imported from the United States of America. The data submitted in support of the request were found to be sufficient to derive an maximum residue limit (MRL) proposal for hops. An adequate analytical method for enforcement is available to control the residues of fenazaquin in the plant matrix under consideration 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 of fenazaquin and its toxicologically relevant plant metabolite TBPE resulting from the use of fenazaquin on imported hops from United States according to the reported agricultural practice is unlikely to present a risk to consumer health.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to set an import tolerance for ...the active substance lambda‐cyhalothrin in avocados. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for avocados. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required as to whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical methods for enforcement are available to control the residues of lambda‐cyhalothrin in 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 short‐term and long‐term intake of residues resulting from the use of lambda‐cyhalothrin according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.
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