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


European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4240 [37 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
10 September 2015
17 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 fluazinam. In order to assess the occurrence of fluazinam 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. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.


Fluazinam was included in Annex I to Directive 91/414/EEC on 1 March 2009 by Commission Directive 2008/108/EC, 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 maximum residue levels (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 Austria , 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 13 February 2015 and finalised on 13 April 2015. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 8 May 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 June‑July 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 31 July 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.
The metabolism of fluazinam has been investigated in three different crop groups as well as in rotational crops. Based on these studies, the residue definition for monitoring in raw commodities was proposed as fluazinam only. Validated analytical methods for enforcement of the proposed residue definition in high water content, acidic and dry commodities are available. An appropriate radiolabeled hydrolysis study was not reported but, based on the available data, the monitoring residue definition in processed commodities was tentatively proposed as the sum of fluazinam, AMPA-fluazinam and AMGT, expressed as fluazinam. There are indications that AMPA-fluazinam and AMPGT can be enforced in watery and acidic processed commodities. Finally, as AMPA-fluazinam and AMGT may contribute in a significant extent to the toxicological burden, a general risk assessment residue definition was proposed as the sum of fluazinam, AMPA-fluazinam and AMGT, expressed as fluazinam.
It noted that the ubiquitous metabolite trifluoroacetic acid (TFA) was observed in peanuts and rotational crops. However, as this compound is not specific to the use of fluazinam, a separate residue definition including TFA was not considered by EFSA. Furthermore, an overall risk assessment for this metabolite was previously carried by EFSA and, in spite of certain uncertainties highlighted for cane fruits and dry beans, this assessment is covering the use of fluazinam as a pesticide.
The available residue trials allowed EFSA assessing the magnitude of residues resulting from the authorised GAPs reported in this review. MRL proposals, risk assessment values and conversion factors were derived for all commodities under evaluation. Nevertheless, due to the several data gaps identified in this review, all the MRL proposals are tentative, except for potatoes, onions, shallots and tomatoes. In addition, studies investigating the magnitude of residues in processed commodities of wine grapes and tomatoes allowed EFSA to derive processing factors for enforcement and risk assessment in grapes dry pomace, must, red and white wine as well as in peeled and canned tomatoes, tomatoes sauce, paste and juice. Nevertheless, in the absence of an appropriate radiolabeled study investigating the nature of residues in processed commodities, these processing factors remain tentative.
Fluazinam is authorised for use on apples, potatoes and dry beans that might be fed to livestock. However, the calculated dietary burden for meat ruminants was only 0.15 mg/kg dry matter (DM) and may have been overestimated because of several conservative assumptions such as the default processing factor for apples dry pomace and the use of the limit of quantification (LOQ) in potatoes. Moreover, the metabolism of fluazinam was investigated in lactating goats and the available results demonstrated that the relevant compounds are expected to remain below 0.004 mg/kg in animal tissues and products. Consequently, EFSA concluded that MRLs for fluazinam in animal commodities were not required.
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. The highest chronic exposure represented 31.8% of the ADI (FR all population) and the highest acute exposure amounted to 35.7% of the acute reference dose (ARfD) (apples).

fluazinam, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyridine, fungicide, trifluoroacetic acid (TFA)
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