54 research outputs found
Specific effects on the thyroid relevant for performing a dietary cumulative risk assessment of pesticide residues: 2024 update
Abstract EFSA updated its previous work on the establishment of specific effects that are considered relevant for grouping pesticide residues targeting the thyroid and for performing the retrospective assessment of dietary cumulative risk (CRA). The two specific effects already selected in 2019 leading to the two cumulative assessment groups (CAGs) âhypothyroidismâ and âCâcell hypertrophy, hyperplasia and neoplasiaâ were reconfirmed. Compared to 2019, the list of indicators that can be used to identify these specific effects was refined to only include histopathological changes. In a second phase of the work, data will be extracted on indicators of the specific effects from the dossiers on active substances (a.s.) used as plant protection products. The criteria for including a.s. into CAGs were also updated, together with the hazard characterisation methodology and the lines of evidence for assessing CAGâmembership probabilities. The tasks related to the data extraction and the establishment of the CAGs on hypothyroidism and on Câcell hypertrophy, hyperplasia and neoplasia are beyond the scope of this report. This part of the CRA process has been outsourced and will be the subject of a separate report
Peer review of the pesticide risk assessment for the active substance thiabendazole in light of confirmatory data submitted
Abstract The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance thiabendazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of thiabendazole as a fungicide on seed potato, apple and pear and citrus. Assessments not finalised together with the missing information identified as being required by the mandate are listed. Concerns are identified
Targeted review of maximum residue levels (MRLs) for azocyclotin and cyhexatin
Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the nonâapproved active substances azocyclotin and cyhexatin in view of the possible lowering of these MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities under assessment, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation
Updated reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanateâmethyl
Abstract In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanateâmethyl. Specifically, EFSA was asked to assess whether thiophanateâmethyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrineâdisrupting properties, EFSA was requested to carry out a followâup assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanateâmethyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed
Targeted review of maximum residue levels (MRLs) for fenpropathrin
Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the nonâapproved active substance fenpropathrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions
Targeted review of maximum residue levels (MRLs) for fenarimol
Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the nonâapproved active substance fenarimol in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed a chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation
Targeted review of maximum residue levels (MRLs) for endosulfan
Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the nonâapproved active substance endosulfan in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For all commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation
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