Normativa UEAbr. 18, 2013
UE: autoridad alimentaria revisa límites máximos de residuo para prohexadione
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(2) 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). The requested information was submitted to EFSA on 21 April 2009 and, after having considered several comments made by EFSA, the RMS provided on 07 September 2012 a revised PROFile.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 13 November 2012 a draft reasoned opinion that was circulated to Member States’ experts for consultation. Comments received by 18 January 2013 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of prohexadione was evaluated in the framework of Regulation (EC) No 737/2007 an ADI was established at 0.2 mg/kg bw per d (expressed as prohexadione-calcium). An ARfD was not deemed necessary.
Primary crops metabolism of prohexadione was investigated following foliar application in apples, peanuts, barley and rice, hereby covering three different crop groups. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in all plant commodities can be defined as prohexadione and its salts expressed as prohexadione. A validated analytical method for enforcement of the residue definition is available with an LOQ of 0.01 mg/kg in high water content, high fat content, acidic and dry commodities. Although validation in hops would still be desirable, this method was considered adequate for hops as well.
Regarding the magnitude of residues, a sufficient number of supervised residue trials is available for all the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs and risk assessment values.
As the chronic exposure does not exceed 10 % of the ADI and residues of prohexadione exceeding 0.1 mg/kg are not expected in the treated crops, except for peanuts which are not generally subjected to processing involving high temperatures, there is no need to investigate the effect of industrial and/or household processing. One processing study investigating the residue level after the industrial processing of peanuts is available however the derived processing factors are not fully reliable. Specific processing factors for enforcement of processed commodities are therefore not proposed.
Occurrence of prohexadione residues in rotational crops was considered in the re-evaluation under Regulation (EC) No 737/2007 of prohexadione. It was concluded that significant residues in rotational crops are not expected. These conclusions also apply to the GAPs supported in the framework of this review.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants and pigs. Metabolism in lactating ruminants was sufficiently investigated. The relevant residue definition for enforcement and risk assessment was defined as prohexadione and its salts expressed as prohexadione. The metabolism study also indicated that detectable residue levels in livestock commodities are not expected. MRLs for the relevant commodities in ruminants and swine are therefore established at the LOQ level. A validated analytical method for enforcement of this residue definition is available, with an LOQ of 0.01 mg/kg in milk, meat, fat, liver, kidney and eggs. MRLs for poultry products are not required because poultry are not expected to be exposed to significant levels of prohexadione residues.
Chronic 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 0.5 % of the ADI (German and Dutch children). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
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 D of the reasoned opinion (see summary table). All MRL values listed in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation.
A minor deficiency was identified in the assessment but this deficiency is not expected to impact either on the validity of the MRL derived or on the national authorisations. The following data are therefore considered desirable but not essential:
· a validated analytical method for enforcement of the residue definition in hops.