Suchergebnisse

Glyphosate is the most widely used herbicide worldwide. It is a broad spectrum herbicide and its agricultural uses increased considerably after the development of glyphosate-resistant genetically modified (GM) varieties. Since glyphosate was introduced in 1974, all regulatory assessments have established that glyphosate has low hazard potential to mammals, however, the International Agency for Research on Cancer (IARC) concluded in March 2015 that it is probably carcinogenic. The IARC conclusion was not confirmed by the EU assessment or the recent joint WHO/FAO evaluation, both using additional evidence. Glyphosate is not the first topic of disagreement between IARC and regulatory evaluations, but has received greater attention. This review presents the scientific basis of the glyphosate health assessment conducted within the European Union (EU) renewal process, and explains the differences in the carcinogenicity assessment with IARC. Use of different data sets, particularly on long-term toxicity/carcinogenicity in rodents, could partially explain the divergent views; but methodological differences in the evaluation of the available evidence have been identified. The EU assessment did not identify a carcinogenicity hazard, revised the toxicological profile proposing new toxicological reference values, and conducted a risk assessment for some representatives uses. Two complementary exposure assessments, human-biomonitoring and food-residues-monitoring, suggests that actual exposure levels are below these reference values and do not represent a public concern.

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. In 2015, EFSA issued a thoroughly revised guidance defining the appropriate SSD codes to describe the samples and the analytical results for the reporting of the 2014 pesticide residues monitoring data. In May 2016, a new guidance was published for the coding of specific SSD data elements for the reporting of the 2015 pesticide monitoring data. In the current document, new coding provisions are delivered for specific data elements to code the data generated in 2016. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2016. In addition, new explanatory examples on the appropriate coding for specific food samples are provided.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in various crops and in sweet peppers/bell peppers, respectively. Moreover, in the application submitted to the United Kingdom, the applicant also included a request to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. In the framework of the assessment process, these applications were re‐allocated to the Netherlands. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for sweet peppers/bell peppers, kales, escaroles, herbs and edible flowers, beans with pods, oat and chicory roots. Since the data gaps identified in the MRL review were not addressed, risk managers might consider lowering the tentative MRLs in passion fruits/maracujas and leafy brassica other than kales to the limit of quantification (LOQ), and the implementation of the Codex MRL (CXL) in the EU legislation for cucumbers and gherkins. The new intended use on witloof/Belgian endives was not adequately supported by residue data and therefore an MRL proposal cannot be derived. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodities under consideration. Based on the results of the risk assessment performed, considering the exposure to residues of trifloxystrobin and its metabolites CGA 321113 (apart for passion fruits), EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of trifloxystrobin under consideration is unlikely to present a risk to consumer health, except for escaroles. For the intended indoor use on escaroles, a risk from short‐term intake cannot be excluded, hence a modification of the existing EU MRL is not ...

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. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd submitted a request to the competent national authority in Denmark to modify the existing maximum residue levels (MRL) for the active substance tau‐fluvalinate in tomatoes and watermelons. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for tomatoes. For watermelons, a change of the MRL recently set in the EU legislation is not required. Adequate analytical methods for enforcement are available to control the residues of tau‐fluvalinate 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 intended uses of tau‐fluvalinate according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative.

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 propineb. Although this active substance is no longer authorised within the EU, due to insufficient information in order to conclude on the consumer risk assessment for the active substance, the toxicity of the metabolite propane‐1,2‐diamine (PDA) the impact on non‐target organisms and the risk to honeybees, MRLs based on the use of propineb were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and are still in place. Additionally, propineb has potential endocrine‐disrupting properties related to the hazards of its major metabolite 4‐methylimidazolidine‐2‐thione (PTU). Lacking a full toxicological characterisation for the compound PDA, exposure data for metabolites propineb‐DIDT in plants and PDA in processed commodities and considering that propineb‐MRLs correlated to CXLs were based on EU uses that were withdrawn following the non‐renewal and are no longer in place, it was not possible for EFSA to perform an assessment of these MRLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance lambda‐cyhalothrin in seed and fruit spices. The data submitted in support of the request were found to be sufficient to derive MRL proposals in seed spices and in fruit spices. 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 whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical enforcement methods are available to control the residues of lambda‐cyhalothrin 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 lambda‐cyhalothrin on spices 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.

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 substances Beta‐cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified