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.
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.Electronic supplementary materialThe online version of this article (doi:10.1007/s00204-017-1962-5) contains supplementary material, which is available to authorized users.
The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide risk assessment for the triazole derivative metabolites are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data in relation to mammalian toxicology, metabolism and residue data. The conclusions were reached on the basis of the evaluation of various uses for a number of triazole fungicides. Recommendations are proposed. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
In January 2018, the guidance document on the use of EFSA PRIMo revision 3 was published in the EFSA Journal. Following feedback from users, the risk assessment tool has been updated, including editorial modifications and corrections of input values used for the calculation of the exposure assessments. This technical report summarises the modifications introduced in EFSA PRIMo revision 3.1.
Reasoned opinion on the joint review of maximum residue levels (MRLs) for fosetyl, disodium phosphonate and potassium phosphonates according to Articles 12 and 43 of Regulation (EC) No 396/2005
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