Modification of the existing maximum residue levels for clopyralid in various commodities

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in various commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for wheat, oat and for animal commodities. An adequate analytical method for enforcement is available to control the residues of clopyralid in the plant commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. The analytical methods for animal commodities are validated at LOQ of 0.01 mg/kg, but demonstration of extraction efficiency is lacking. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of clopyralid according to the reported agricultural practices is unlikely to present a risk to consumer health provided that risk mitigation measures are in place to avoid clopyralid residues in rotational and/or succeeding crops.

Modification of the existing maximum residue level for clopyralid in honey

“…5 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has not yet been performed. After completion of the renewal of the first approval, EFSA has issued one reasoned opinion on the modification of MRLs for clopyralid (EFSA, 2021 ). The proposals from this reasoned opinion have been considered in recent MRL regulations.…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2023 ), the RAR (and its revision) (Finland, 2017 , 2018 ) prepared under Regulation (EC) 1107/2009, the Commission renewal report on clopyralid (European Commission, 2021b ), the conclusions on the peer review of the pesticide risk assessment of the active substance clopyralid (EFSA, 2005 , 2018c ), as well as the conclusions from previous EFSA opinions on clopyralid (EFSA, 2011 , 2018b , 2021 ).…”

“…A GLP metabolism study covering the group of cereals ( wheat ) was assessed in a previous MRL application (EFSA, 2021 ). Free clopyralid was the only identified residue in straw and grain, ranging between 20% and 28% TRR.…”

“…The results of a new study on oilseed rape showed similar results compared to the previously assessed study on wheat, with a significant part of the TRR corresponding to compounds less polar than clopyralid, not properly identified, but which are readily converted to free parent after basic hydrolysis. In both cases, an impact on the magnitude of residues in samples analysed in the residue trials and in monitoring is not expected, provided that the analytical methods used to generate the data also apply basic hydrolysis in order to convert all the relevant residues to clopyralid (EFSA, 2021 ).…”

“…8 8 ‘In accordance with Article 32b of the GFL Regulation, both potential applicants and laboratories/testing facilities commissioning or carrying out studies as of 27 March 2021 in view of an MRL application have the obligation to notify EFSA’ (For further details see EFSA Administrative guidance on Peer‐review of pesticide active substances and MRL applications; EFSA, 2021). …”