Review of the existing maximum residue levels for fluazifop-P according to Article 12 of Regulation (EC) No 396/2005


European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4228 [76 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
4 September 2015
16 September 2015
European Food Safety Authority (EFSA), Parma, Italy
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According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluazifop-P. In order to assess the occurrence of fluazifop-P 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 import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, 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 is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.


Fluazifop-P was included in Annex I to Directive 91/414/EEC on 1 January 2012 by Commission Implementing Regulation (EU) No 788/2011, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked France, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 21 January 2015 and finalised on 17 March 2015. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 24 April 2015.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS and Member States, EFSA prepared in July 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 4 August 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The primary crop metabolism of fluazifop-P has been investigated for soil treatment in fruit crops (grapes) and for foliar treatment in root crops (carrots, sugar beet), leafy crops (celery, lettuce) and pulses and oilseeds (soya bean, cotton). Rotational crop metabolism was also investigated in three different crop groups (root crops, leafy crops and cereals). Although compound X was found to be much more predominant in rotational crops, toxicological studies have demonstrated that this compound is not more toxic than the parent compound and based on the available rotational crop field trials, significant residue levels of this compound are not expected in rotational crops. Furthermore, considering that conjugates and esters of fluazifop did not hydrolyse beyond the stable fluazifop moiety under extreme hydrolytic conditions, the metabolic pattern in processed commodities is not expected to differ from the metabolic pattern observed in raw commodities. Hence a general residue definition for monitoring and risk assessment was derived for all plant commodities as the sum of all constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop. A validated analytical method for enforcement of the proposed residue definition is available for all plant commodities, although further validation in complex matrices such as spices, hops and herbal infusions is still required.

Regarding the magnitude of residues, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for spring onions, leek, cotton seeds, alfalfa and clover forage where the available data were insufficient to derive MRLs. Furthermore, considering the data gaps identified for residue trials and analytical methods for enforcement, MRL proposals are tentative for strawberries, spring onions, fresh beans without pods, herbal infusions, hops and spices. Provided that the active substance is applied in compliance with the reported GAPs, measurable levels of relevant residues are also not expected to occur in rotational crops. The available processing trials allowed deriving robust processing factors for cooked and canned peas.

Fluazifop-P is authorised for use on crops that might be fed to livestock and the livestock dietary burden calculated for all types of livestock was found to exceed the trigger value of 0.1 mg/kg DM. Metabolism of fluazifop-P was investigated in lactating goats and laying hens. As metabolic pathways were generally found to be similar, the results of the goat metabolism study can be extrapolated to pigs and the residue for monitoring and risk assessment in commodities of animal origin was defined as the sum of all the constituent isomers of fluazifop, its esters and its conjugates, expressed as fluazifop. Available livestock feeding studies also allowed EFSA to derive MRL and risk assessment values for ruminant, poultry and swine products. An analytical method for enforcement of the proposed residue definition and MRLs was reported but further validation of the method is still required. Also considering that the outcome of the livestock dietary burden calculation, for ruminants and pigs in particular, may still be significantly impacted by the missing residue trials on alfalfa and clover, all MRL proposals derived for commodities of animal origin should be considered tentative.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. For tomatoes, head cabbage, fresh beans without pods, carrots and peppers, an exceedance of the ARfD was identified representing 205 %, 173 %, 134 %, 108 % and 100 % of the ARfD, respectively. Considering a fall-back MRL for carrots and disregarding the uses on tomatoes, head cabbage, fresh beans without pods and peppers, the highest chronic exposure represented 42% of the ADI (WHO Cluster diet E) and the highest acute exposure amounted to 94 % of the ARfD (celeriac).

fluazifop-P, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, aryloxyphenoxypropionate, herbicide
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