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.
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
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 quizalofop-Pethyl, quizalofop-P-tefuryl and propaquizafop. To assess the occurrence of quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC 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 all MRL proposals derived by EFSA still require further consideration by risk managers.
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State France and co‐rapporteur Member State Estonia for the pesticide active substance fosetyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fosetyl as a fungicide on grapes, citrus and pome fruits. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
In accordance with Article 6 of Regulation (
EC
) No 396/2005, the applicants Bayer CropScience
AG
and Bayer
SAS
submitted two requests to the competent national authority in the Netherlands to set import tolerances and to modify existing
EU
maximum residue levels (
MRL
s) for the active substance flupyradifurone and its metabolite difluoroacetic acid (
DFA
) in various crops. The application also included the request to evaluate the confirmatory data related to residues that were identified in the framework of the peer review of flupyradifurone under Regulation (
EC
) No 1107/2009 as not available. The data submitted in support of intended and authorised uses were found to be sufficient to derive
MRL
proposals for flupyradifurone and
DFA
in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate
MRL
. Furthermore,
EFSA
recommended risk management discussion to examine different options to deal with
DFA
residues in crops that can be grown in crop rotation. The calculated livestock dietary burdens indicated that existing
EU MRL
s for flupyradifurone and
DFA
in animal commodities need to be modified. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and the
DFA
in plant and animal matrices. The submitted data are considered sufficient to address the data gaps related to residues which were identified in the framework of the
EU
pesticides peer review, and thus, the footnotes set for
DFA
and flupyradifurone
MRL
s in the Commission Regulation (
EU
) 2016/1902 can be deleted. Based on the consumer exposure assessment, acute consumer exposure concerns could not be excluded for tomatoes, melons, celery and processed escaroles. Hence, the raising of the existing
MRL
s for flupyradifurone in these crops is not recommended. For these four crops,
MRL
proposals for
DFA
were derived, which reflect the uptake of residues via soil resulting from previous use of flupyradifurone. For the remaining commodities of plant and animal origin,
EFSA
concludes that the intended
EU
uses and authorised
US
and Canadian uses of flupyradifurone and resulting residues of
DFA
will not result in chronic or acute consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.