Modification of the existing maximum residue level for diflufenican in olives for oil production
2016; Wiley; Volume: 14; Issue: 10 Linguagem: Inglês
10.2903/j.efsa.2016.4585
ISSN1831-4732
Tópico(s)Pesticide Exposure and Toxicity
ResumoEFSA JournalVolume 14, Issue 10 e04585 Reasoned OpinionOpen Access Modification of the existing maximum residue level for diflufenican in olives for oil production European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 06 October 2016 https://doi.org/10.2903/j.efsa.2016.4585 Correspondence: pesticides.mrl@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2016-00334 Approved: 20 September 2016 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Spain, received an application from ADAMA Agriculture España, S.A. to modify the existing maximum residue level (MRL) for the active substance diflufenican in olives for oil production. To accommodate for the intended use of diflufenican, Spain proposed to raise the existing MRL value from 0.2 to 0.6 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive a MRL proposal of 0.6 mg/kg for the proposed use on olives for oil production. Adequate analytical enforcement methods are available to control the residues of diflufenican in olives. Based on the risk assessment results, EFSA concludes that the proposed use of diflufenican on olives for oil production will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Spain, received an application from ADAMA Agriculture España, S.A. (former Aragonesas Agro S.A., former Makhteshim Agan España S.A.) to modify the existing maximum residue level (MRL) for the active substance diflufenican in olives for oil production. To accommodate for the intended use of diflufenican, Spain proposed to raise the existing MRL from the value of 0.2 mg/kg to the proposed MRL of 0.6 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 4 May 2016. EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its final addendum) prepared under Council Directive 91/414/EEC, the Commission review report on diflufenican, the conclusion on the peer review of the pesticide risk assessment of the active substance diflufenican, the previous EFSA reasoned opinion on the review of the existing MRLs for diflufenican according to Article 12 of Regulation (EC) No 396/2005 as well as a previous EFSA reasoned opinion in which it was proposed to raise the MRL of diflufenican for olives for oil production from the limit of quantification (LOQ) of 0.05 mg/kg to the existing MRL of 0.2 mg/kg. The toxicological profile of diflufenican was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.2 mg/kg body weight (bw) per day. No acute reference dose (ARfD) was deemed necessary. The metabolism of diflufenican in primary crops was investigated in the fruit (olives) and cereal/grass (wheat) crop groups following foliar/soil applications. From these studies, the peer review established the residue definition for enforcement and risk assessment as diflufenican only. For the use in olives for oil production, EFSA concludes that the metabolism of diflufenican in primary crops has been sufficiently addressed and that the residue definitions for monitoring and risk assessment derived as 'diflufenican' are applicable. Furthermore, EFSA concludes that the submitted residue trials are sufficient to derive a MRL proposal of 0.6 mg/kg in olives for oil production. Adequate analytical enforcement methods are available to monitor the residues of diflufenican in olives at the validated LOQ of 0.01 mg/kg. Studies investigating the nature of diflufenican residues under standard hydrolysis conditions were not assessed during the peer review process but are not necessary since the total theoretical maximum daily intake (TMDI) for olives is below the trigger value of 10% of the ADI. Studies investigating the effect of processing on the magnitude of the diflufenican residues were provided and a processing factor of 1.6 was derived for olive oil (cold pressing), which is recommended to be included in the Annex VI of Regulation (EC) No 396/2005. As the proposed use of diflufenican is on a permanent crop and olives for oil production are normally not fed to livestock, the investigation of residues in rotational crops and the investigation of the residues in commodities of animal origin are not required in the framework of the current application. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). No risk for consumers was identified; the highest chronic intake was calculated to be less than 1% of the ADI (WHO cluster diet B) and the contribution of residues in olives for oil production to the total consumer exposure accounted for less than 1% of the ADI as well (WHO cluster diet B). As no acute reference dose (ARfD) was derived in the peer review process, an acute exposure scenario has not been assessed. EFSA concludes that the proposed use of diflufenican in olives will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers. EFSA proposes to amend the existing MRL as reported in the summary table below: Codea Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: Diflufenicanb 0402010 Olives for oil production 0.2 0.6 MRL proposal is supported by data reflecting the intended use on olives in Spain (SEU residue trials, ground harvest) No concern regarding human dietary exposure MRL: maximum residue level; SEU: southern Europe. a Commodity code number according to Annex I of Regulation (EC) No 396/2005. b Fat soluble. Background Regulation (EC) No 396/20051 (hereinafter referred to as 'the Regulation') establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at the European Union (EU) level. Article 6 of the Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC,2 repealed by Regulation (EC) No 1107/20093, shall submit to a Member State (MS), when appropriate, an application to modify a MRL in accordance with the provisions of Article 7 of the Regulation. Spain, hereafter referred to as the evaluating Member State (EMS), received an application from the company ADAMA Agriculture España S.A. (former Aragonesas Agro S.A., former Makhteshim Agan España S.A.)4 to modify the existing MRL for the active substance diflufenican in olives for oil production. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 4 May 2016. The application was included in the EFSA Register of Questions with the reference number EFSA-Q-2016-00334 and the following subject: Diflufenican – MRLs in olives for oil production. Spain proposed to raise the existing MRL of diflufenican in olives from the existing value of 0.2 to 0.6 mg/kg. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the EMS, provide a reasoned opinion on the risks to the consumer associated with the application. The evaluation report submitted by the EMS (Spain, 2016) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within 3 months (which may be extended to 6 months if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The active substance and its use pattern Diflufenican is the ISO common name for 2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide (IUPAC). The chemical structure of the active substance is reported in Appendix B. Diflufenican was evaluated in the framework of Directive 91/414/EEC with the United Kingdom designated as rapporteur Member State (RMS). It was included in Annex I of this Directive by Directive 2008/66/EC5 which entered into force on 1 January 2009 for use as a herbicide. In accordance with Commission Implementing Regulation (EU) No 540/20116, diflufenican is approved under Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC. The representative uses evaluated in the peer review were outdoor applications on winter wheat, winter barley and winter rye. The draft assessment report (DAR) has been peer reviewed by EFSA (EFSA, 2008). EFSA has completed the MRL review under Article 12 of Regulation (EU) No 396/2005 (EFSA, 2013). The EU MRLs for diflufenican are established in Annex II of Regulation (EC) No 396/2005. It is noted that in 2012 EFSA issued a reasoned opinion on the modification of MRLs for diflufenican in olives for oil production for a less critical GAP (EFSA, 2012). In Table 1, the relevant regulations implementing the EFSA recommendations can be found. Table 1. Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedurea Considered by Regulation Remarks Art 10 (EFSA, 2012) Reg. (EU) No 897/2012 Olives for oil production Art. 12 (EFSA, 2013) Reg. (EU) No 2015/603 MRL review MRL: maximum residue level. a Art. 10: Review of the existing MRLs according to Article 10 of Regulation (EC) No 396/2005. Art. 12: Review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005. Codex Alimentarius has not established maximum residue limits (codex maximum residue limits (CXLs)) for diflufenican. The details of the intended Good Agricultural Practices (GAPs) for diflufenican are given in Appendix A. Assessment EFSA has based its assessment on the evaluation report submitted by the EMS (Spain, 2016), the DAR (and its final addendum) prepared under Directive 91/414/EEC (United Kingdom, 2005, 2007), the Commission review report on diflufenican (European Commission, 2008), the conclusion on the peer review of the pesticide risk assessment of the active substance diflufenican (EFSA, 2008) as well as the conclusions from previous EFSA reasoned opinion on the review of the existing MRLs for diflufenican according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2013) and a previous EFSA reasoned opinion for a less critical GAP in olives for oil production in which it was proposed to raise the MRL for diflufenican from the limit of quantification (LOQ) of 0.05 mg/kg to the existing EU MRL of 0.2 mg/kg (EFSA, 2012). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20117 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2015; FAO, 2009; OECD, 2011). 1 Method of analysis 1.1 Methods for enforcement of residues in food of plant origin Analytical methods for the determination of diflufenican residues in different crop groups, including matrices with high oil content were assessed in the framework of the peer review under Directive 91/414/EEC (EFSA, 2008) and in the Article 12 MRL review (EFSA, 2013). Sufficient validation and independent laboratory validation (ILV) data were submitted to conclude that an analytical method using gas chromatography with electron detector (GC-ECD) has been adequately validated to enforce diflufenican residues in high water (apple), high acid (orange), high oil (olives and sunflower) content commodities and in dry/protein and dry/starch matrices (wheat grain) at the LOQ of 0.01 mg/kg (EFSA, 2013). The multiresidue Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) method described in the European Standard EN 15662:2008 and using high-performance liquid chromatography with mass spectrometry (HPLC–MS/MS) is also applicable to analyse diflufenican residues in high water, high acid, high oil content commodities and in dry/protein and dry/starch matrices at the LOQ of 0.01 mg/kg (CEN, 2008; EFSA, 2013; Spain, 2016). As olives belong to the high oil content commodity group, EFSA concludes that sufficiently validated analytical methods are available for enforcing the proposed MRL for diflufenican in olives for oil production. 1.2 Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current application as olives are normally not fed to livestock. 2 Mammalian toxicology The toxicological profile of the active substance diflufenican was assessed in the framework of the peer review under Directive 91/414/EEC (EFSA, 2008). The data were sufficient to derive the toxicological reference values compiled in Table 2. Table 2. Overview of the toxicological reference values Source Year Value Study Safety factor Diflufenican ADI EFSA 2008 0.2 mg/kg bw per day 2-year-old rat and 13-week-old rat 100 ARfD EFSA 2008 Not necessary ADI: acceptable daily intake; ARfD: acute reference dose; bw: body weight. 3 Residues 3.1 Nature and magnitude of residues in plant 3.1.1 Primary crops 3.1.1.1 Nature of residues The metabolism of diflufenican in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC (EFSA, 2008; EFSA, 2013) in the fruit and cereals crop groups. A new metabolism study on apples was submitted in the framework of the current MRL application; however, data were disregarded due to incompleteness in the study. An overview of the available metabolism studies is presented in Table 3. Table 3. Summary of available metabolism studies in plants Crop groups Crops Applications Samplinga (day, DAT) Comments Fruit Olives Soil spray: 1 × 750 g/ha Ground harvest: 7, 21, 35 DAT Tree harvest: 7, 35 DAT Cereals/grass Wheat Soil spray (preemergence)/foliar spray: 1 × 190/400/940 g/ha Forage: at BBCH 41-65 Grain, straw: at BBCH 92 (maturity) Foliar spray: 1 × 380 g/ha BBCH 29 Forage: 6 DAT at BBCH 45 Grain, straw: 58 DAT (maturity) a DAT: Day(s) after treatment; BBCH: growth stages of mono- and dicotyledonous plants. Based on these metabolism studies, parent diflufenican was found to be the main component in olives and cereals straw. In cereal grain, residues levels were very low; and were not expected to be of concern for enforcement or risk assessment (EFSA, 2013). Consequently, the residue for both enforcement and risk assessment in fruit and cereals/grass crop groups is defined as diflufenican only. As information was lacking on other crop groups, the residue definitions were restricted to cereals and fruit crops (EFSA, 2013; EFSA, 2008). The current residue definition set in Regulation (EC) No 396/2005 is identical to the residue definition for enforcement derived after the MRL review and in the peer review process. For the use on olives for oil production, EFSA concludes that the metabolism of diflufenican is sufficiently addressed and the residue definitions as diflufenican only for enforcement and risk assessment are applicable. 3.1.1.2 Magnitude of residues In support of the MRL application, eight residue trials on olives performed in Spain in 2006 and 2007 were submitted. Residue trials in raw oil/virgin oil (processed commodities) were also submitted (Spain, 2016). In the residue trials, one single bare soil application according to the critical GAP (southern Europe (SEU), 1 × 240 g/ha), was performed. The olives were shaken off the tree and collected from the ground once the soil was dried after the herbicide application. Additional samples were taken between 3 and 35 days after the treatment. None of the olives were directly sprayed. After the herbicide application, ground harvest simulates the worst-case situation when, during the harvesting, some olives roll off the blanket/net which is usually placed under olive trees to facilitate the collection of olives fallen off the branches. By this direct contact with the bare soil, a cross-contamination may occur. However, direct harvest from the tree is common practice for harvesting olives for oil production. Residues of diflufenican at preharvest interval (PHI) of 21 days according to the GAP were detected in a range from 0.01 to 0.22 mg/kg, in all cases above to the LOQ of 0.01 mg/kg. In several residue trials, the residues of diflufenican were found at a higher level at a longer PHI than the intended PHI of 21 days. EFSA derives an MRL proposal of 0.6 mg/kg from the data set that support the current application; the proposal represents the worst-case scenario in which cross-contamination may occur via contact of olives with treated ground. No data were submitted with regard to the tree harvest practice. The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposal are summarised in Table 4. Table 4. Overview of the available residues trials data Crop (GAPs) Region/indoora Residue levels observed in the supervised residue trialsb (mg/kg) Recommendations/commentsc MRL proposal (mg/kg) HRd (mg/kg) STMRe (mg/kg) Olives for oil production GAP (1 × 240 g/ha, 21 days, ground harvest) SEU 0.10, 2 × 0.12, 0.15, 0.18, 2 × 0.22, 0.25 MRLOECD: 0.51/0.60 0.60 0.25 0.17 GAPs: Good Agricultural Practices; MRL: maximum residue level; OECD: Organisation for Economic Co-operation and Development. a NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-EU trials. b Individual residue levels considered for MRL calculation are reported in ascending order (2 × < 0.01, 0.01, 6 × 0.02, 0.04, 0.08, 2 × 0.10, 0.15, 0.17). Underlined values: Samples taken at a PHI longer than the intended PHI. c Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values). d HR: Highest residue level according to the residue definition for monitoring/risk assessment (diflufenican parent compound). e STMR: Median residue level according to residue definition for monitoring/risk assessment (diflufenican parent compound). The stability of diflufenican residues in plant matrices under storage conditions prior to analysis was assessed during the previous MRL application for the use in olives for oil production. Residues of diflufenican were found to be stable at ≤ –18°C for 4 months in high oil content matrices (olives) (EFSA, 2012). Furthermore, a study was submitted under the current MRL application (Spain, 2016) demonstrating the stability of diflufenican residues in high acid content commodities (citrus fruit) and in high oil content commodities (olives) at least 12 months in deep-frozen conditions. As the trial samples were stored for a maximum period of 3 months under conditions for which integrity of the samples was demonstrated, it is concluded that the residue data are valid with regard to storage stability. According to the EMS, the analytical method used to analyse the residue trial samples has been sufficiently validated and was proven to be fit for purpose (Spain, 2016). In a previous EFSA reasoned opinion, EFSA proposed a MRL of 0.01* mg/kg (LOQ) reflecting tree harvest as well as a MRL of 0.2 mg/kg for ground harvest for the use of diflufenican in olives for oil production according to the GAP (SEU GAP: 1 × 60–360 g/ha; PHI 35 days) (EFSA, 2012). However, based on the current GAP and the supporting data set that represents a more critical use of diflufenican in olives for oil production, a MRL of 0.6 mg/kg is derived according to the ground harvest scenario for the use of diflufenican in olives for oil production. 3.1.1.3 Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of diflufenican residues under processing conditions representative of pasteurisation, boiling and sterilisation were not assessed previously and it was concluded that they are not necessary as the calculated theoretical maximum daily intake (TMDI) is below 10% of the acceptable daily intake (ADI) (European Commission, 1997d). Studies investigating the effect of processing on the magnitude of diflufenican residues were performed in support of the current MRL application. In four of the residue trials submitted, the oil extracted from the olives collected at different PHIs was analysed to detect the residues of diflufenican. In all the cases, the residues detected in the oil extracted after a process of 'cold pressure' were higher than in the raw commodities, resulting in a processing factor (PF) of 1.6 from olives to olive virgin oil. Table 5 summarises the processing factor resulting from the supervised residue trials submitted in the current MRL application. Table 5. Overview of the available processing studies Crop (RAC)/edible part or crop (RAC)/processed product Number of studiesa Processing factor (PF) Individual values Median PF Olives (raw commodity)/olive virgin oil 4 1, 1.43, 1.71, 2.30 1.6 a Studies with residues in the raw agricultural commodity (RAC) at or close to the LOQ should be disregarded (unless concentration). EFSA recommends the inclusion of the derived PFs for oil production in Annex VI of Regulation (EC) No 396/2005. 3.1.2 Rotational crops As the proposed use of diflufenican is on permanent crops, the investigation of residues in rotational crops is not required and is therefore not considered in this reasoned opinion. 3.2 Nature and magnitude of residues in livestock Olives and their byproducts are normally not fed to livestock; therefore, the nature and magnitude of diflufenican residues in livestock are not assessed in the framework of this application (European Commission, 1996). 4 Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population8 (EFSA, 2007). In the framework of the review of the existing MRLs for diflufenican according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long-term exposure assessment was performed taking into account the existing uses at the EU level (EFSA, 2013). EFSA updated this risk assessment with the median residue levels (STMR) derived from the residue trials conducted on the crop under consideration in this MRL application (Table 4). The food commodities, for which no uses were reported in the framework of the Article 12 review, were excluded from the exposure calculation, assuming that there is no use of diflufenican on these crops. An acute consumer exposure assessment was not performed, since the setting of an acute reference dose (ARfD) was concluded to be unnecessary for diflufenican. The input values used for the dietary exposure calculation are summarised in Table 6. Table 6. Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Acute exposure assessment Input (mg/kg) Comment Input (mg/kg) Comment Risk assessment residue definition: Diflufenican Olives for oil production 0.17 STMR (Table 4) Acute risk assessment undertaken only with regard to the crop under consideration Other plant and animal commodities STMR/MRL See table 4-1 (EFSA, 2013) STMR: supervised trials median residue; MRL: maximum residue level. The estimated exposure was then compared with the toxicological reference value derived for diflufenican (Table 2). The results of the intake calculation using the PRIMo is a key supporting document and is made publicly available as a background document to this reasoned opinion. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was calculated to be less than 1% of the ADI (WHO cluster diet B). The contribution of residues in olives for oil production to the total consumer exposure accounted for less than 1% of the ADI (WHO cluster diet B). An acute consumer risk was not identified in relation to the MRL proposal for olives for oil production as no ARfD was derived in the peer review process for further comparison in an acute exposure scenario. EFSA concludes that the intended use of diflufenican on olives for oil production will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health. Conclusions and recommendations The information submitted was sufficient to propose the MRL summarised in the table below: Codea Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: Diflufenicanb 0402010 Olives for oil production 0.2 0.6 MRL proposal is supported by data reflecting the intended use in olives in Spain (SEU residue trials, ground harvest). No concern regarding human dietary exposure MRL: maximum residue level; SEU: southern Europe. a Commodity code number according to Annex I of Regulation (EC) No 396/2005. b Fat soluble. Notes 1 Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1–16. 2 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1–32. 3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1–50. 4 ADAMA Agriculture España, S.A., Calle Mendes Álvaro, 20-5a, 28045, Madrid, Spain. 5 Commission Directive 2008/66/EC of 30 June 2008 amending Council Directive 91/414/EEC to include bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as active substances, OJ L 171, 1.7.2008, p. 9–15. 6 Commission Implementing Regulation (EU) No 540/2011 of 23 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p. 1–186. 7 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.6.2011, p. 127–175. 8 The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from MS surveys plus one regional and four cluster diets from the WHO GEMS Food database; for the acute exposure assessment, the most critical large portion consumption data from 19 national diets collected from MS surveys are used. The complete list of diets incorporated in the EFSA PRIMo is given in its reference section (EFSA, 2007). References CEN (European Committee for Standardization), 2008. Foods of plant origin – Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN 15662.2008. November 2008. EFSA (European Food Safety Authority), 2007. Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. EFSA Journal 2007; 5(3): 32r, 1141 pp. doi:10.2903/j.efsa.2007.32r EFSA (European Food Safety Authority), 2008. Conclusion on the peer review of the pesticide risk assessment of the active substance diflufenican. EFSA Journal 2008; 6(2): 122r, 84 pp. doi: 10.2903/j.efsa.2008.122r EFSA (European Food Safety Authority), 2012. Reasoned opinion on the modification of the existing MRLs for diflufenican in olives for oil production. EFSA Journal 2012; 10(3): 2649, 23 pp. doi:10.2903/j.efsa.2012.2649 EFSA (European Food Safety Authority), 2013. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for diflufenican according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013; 11(6): 3281, 42 pp. doi:10.2903/j.efsa.2013.3281 European Commission, 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5 European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. European Commission, 2000. Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99. European Commission, 2008. Review report for the active substance diflufenican. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 14 March 2008 in view of the inclusion of diflufenican in Annex I of Council Directive 91/414/EEC. SANCO/3782/08 – rev. 1, 14 March 2008, 8 pp. rev.4. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010-rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010. European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. European Commission, 2015. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. FAO (Food and Agriculture Organization of the United Nations), 2009. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp. OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide Publications/Publications on Pesticide Residues. Available online: http://www.oecd.org Spain, 2016. Evaluation report on the modification of MRL for diflufenican in olives for oil production prepared by the evaluating Member State Spain under Article 8 of Regulation (EC) No 396/2005, 1 April 2016, 54 pp. United Kingdom, 2005. Draft assessment report on the active substance diflufenican prepared by the rapporteur Member State United Kingdom in the framework of Council Directive 91/414/EEC, July 2005. United Kingdom, 2007. Final addendum to the draft assessment report on the active substance diflufenican prepared by the rapporteur Member State United Kingdom in the framework of Council Directive 91/414/EEC, compiled by EFSA, August 2007. Abbreviations a.s. active substance ADI acceptable daily intake ARfD acute reference dose BBCH growth stages of mono- and dicotyledonous plants bw body weight CAC Codex Alimentarius Commission CAS Chemical Abstract Service CEN European Committee for Standardisation (Comité Européen de Normalisation) CXL Codex maximum residue limit DAR draft assessment report DAT days after treatment DT90 period required for 90% dissipation (define method of estimation) EMS evaluating Member State FAO Food and Agriculture Organization of the United Nations GAPs Good Agricultural Practices GC-ECD gas chromatography with electron detector HPLC–MS high-performance liquid chromatography with mass spectrometry HR highest residue ILV independent laboratory validation ISO International Organisation for Standardisation IUPAC International Union of Pure and Applied Chemistry LOQ limit of quantification MRL maximum residue level MS Member States MS/MS tandem mass spectrometry detector NEU northern Europe OECD Organisation for Economic Co-operation and Development PF processing factor PHI preharvest interval PRIMo (EFSA) Pesticide Residues Intake Model QuEChERS Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method) RAC raw agricultural commodity RMS rapporteur Member State SANCO Directorate-General for Health and Consumers SC suspension concentrate SEU southern Europe STMR supervised trials median residue TMDI theoretical maximum daily intake WHO World Health Organization Appendix A – Good Agricultural Practice Crop NEU, SEU, MS or country F G or Ia Pests or group of pests controlled Preparation Application Application rate per treatment PHI (days)d Remarks Typeb Conc. a.s. (g/L) Method kind Range of growth stages & seasonc Number min-max Interval between application g/hL min–max Water L/ha min–max g/ha min–max Olives for oil production ES (SEU) F Weeds SC 40 Strip soil application (trees row). Tractor mounted sprayer Pre- and post-emergence weeds 1 – 45–120 200–400 180–240 21 Spray application onto the bare soil. When dry, trees will be beaten to loosen the olives The rate is referred to treated surface. If the surface to be treated in bands representing an x% of the total surface, the rate of product to be applied should be reduce in the same proportion, maintaining the amount of active substance in treated hectare 2/3 of the surface treated resulting in an equivalent dose for environmental risk assessment of 0.16 kg a.s./ha NEU: northern European Union; SEU: southern European Union; MS; Member State; SC: suspension concentrate; a.s.: active substance. a Outdoor or field use (F), greenhouse application (G) or indoor application (I). b CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide. c Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including, where relevant, information on season at time of application. d PHI: minimum preharvest interval. Appendix B – Used compound codes Code/trivial name Chemical name Structural formula Diflufenican 2′,4′-Difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide (IUPAC) IUPAC: International Union of Pure and Applied Chemistry. Volume14, Issue10October 2016e04585 ReferencesRelatedInformation
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