Normativa UEJul. 11, 2013
UE: autoridad alimentaria revisa límites máximos de residuos para tolylfluanid
A decision not to include tolylfluanid in Annex I to Directive 91/414/EEC entered into force on 01 June 2010. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of Regulation (EC) No 396/2005. Considering that the use of tolylfluanid is no longer authorised within the European Union (authorisations for emergency situations in plant protection granted in application of Article 53 of Regulation (EC) No 1107/2009 are not considered in the context of this Reasoned Opinion) and that no import tolerances were notified by the designated rapporteur Member State (Finland), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRLs established by the Codex Alimentarius Commission.
On 30 January 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 05 April 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of tolylfluanid was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.1 mg/kg bw per d and 0.25 mg/kg bw, respectively.
Primary crop metabolism of tolylfluanid was investigated for two different crop groups (fruits/fruiting vegetables and leafy vegetables). Based on these studies, the relevant residue for enforcement can be defined as tolyfluanid only. Validated analytical methods for enforcement of the proposed residue definition (parent tolylfluanid) are available, except for dry commodities. For risk assessment, JMPR included the metabolite DMST and defined the residue as the sum of tolylfluanid and DMST, expressed as tolylfluanid. These residue definitions were also adopted by EFSA, except for grapes where it is also considered relevant to include 4-hydroxymethyl-DMST-glucoside and 2-hydroxymethyl-DMST-glucoside in the residue definition for risk assessment.
For all crops, except grapes, the existing CXLs for tolylfluanid are supported by data and their corresponding risk assessment values were available. For grapes however, it was not clear to EFSA whether the available data are supporting the critical GAP and data assessed by JMPR did not consider the presence of 4-hydroxymethyl-DMST-glucoside and 2-hydroxymethyl-DMST-glucoside in grapes. Therefore, EFSA is of the opinion that CXLs on grapes are not sufficiently supported by data and a tentative conversion factor for enforcement to risk assessment, in line with the proposed residue definition of grapes, was derived by EFSA based on a different dataset than the one considered by JMPR. It is also noted that these CXLs have initially been established on the basis of former EU authorisations which are no longer authorised but, assuming that existing CXLs may still accommodate tolylfluanid authorisations outside the EU, the decision to reject the existing CXLs on the basis of such criteria is considered to be a risk management decision.
In processed commodities, tolylfluanid residues are totally hydrolysed into DMST during pasteurisation, cooking, brewing and sterilisation. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be DMST only.
Metabolism of tolylfluanid was sufficiently investigated in lactating ruminants and poultry; findings can be extrapolated to pigs as well. EFSA considered that the residue definition proposed for both enforcement and risk assessment should be DMST only but it should be highlighted that significant residues are anyhow not expected and no validated analytical methods for enforcement of this residue in product of animal origin are available. No CXLs were therefore derived by JMPR for commodities of animal origin. In the absence of authorised uses on feed items within the EU and considering that the only CXL for feed item is not recommended for inclusion in the EU legislation (apples, see further), the setting of MRL in commodities of animal origin is not considered relevant by EFSA.
As tolylfluanid is no longer registered within the EU, only the CXLs were considered in the calculations of the consumer exposure. The highest chronic exposure was calculated for German children, representing 11.4 % of the ADI. For apples, pears, table grapes and lettuce, an exceedance of the ARfD was identified representing 159 %, 147 %, 146 % and 127 % of the ARfD, respectively. Excluding these CXLs from the calculation, the highest chronic exposure represented 7.3 % of the ADI (French population) and the highest acute exposure amounted to 58.6 % of the ARfD (tomatoes).
Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix C of the reasoned opinion (see summary table). None of the CXLs listed in the table are recommended for inclusion in Annex II to the Regulation because they require further consideration by risk managers (see summary table footnotes for details) regarding the fact that:
a possible risk to consumers was identified for certain commodities (footnotes a and c in the summary table);
a tentative conversion factor was used for risk assessment in grapes (footnotes c and d in the summary table);
several CXLs were initially based on EU GAPs which are no longer authorised (footnote b in summary table).