Modification of the existing maximum residue level for fosetyl in blackberry, celeriac and Florence fennel

Transcription

1 REASONED OPINION APPROVED: 20 November 2015 PUBLISHED: 11 December 2015 doi: /j.efsa Modification of the existing maximum residue level for fosetyl in blackberry, celeriac and Florence fennel Abstract European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Germany, received applications from Landwirtschaftliches Technologiezentrum Augustenberg and Landwirtschaftskammer NRW Pflanzenschutzdienst to modify existing MRLs for the active substance fosetyl-al in blackberry, celeriac and Florence fennel. Germany drafted evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA data are sufficient to derive MRL proposals of 100 mg/kg for fosetyl in blackberries and of 8 mg/kg in celeriac. No change is recommended for fennel, since the supported use results in a lower MRL proposal than the MRL of 2 mg/kg currently into force under Regulation (EU) 991/2014. Based on the risk assessment results, EFSA concludes that the proposed use of fosetyl on blackberries, celeriac and Florence fennel will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. European Food Safety Authority, 2015 Keywords: fosetyl, blackberry, celeriac, Florence fennel, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q and EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2015;13(12):4327

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residue level for fosetyl in blackberry, celeriac and Florence fennel. EFSA Journal 2015;13(12):4327, 20 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2015;13(12):4327

3 Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany, received applications from Landwirtschaftliches Technologiezentrum Augustenberg and from Landwirtschaftskammer NRW Pflanzenschutzdienst to modify existing MRLs for the active substance fosetyl-al in blackberry, celeriac and Florence fennel. Germany drafted evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 3 June 2015 (application on blackberry) and 2 September 2015 (application on celeriac and Florence fennel). EFSA bases its assessment on the evaluation reports submitted by the EMS Germany, the draft assessment report (DAR) (and its addendum) prepared under Directive 91/414/EEC, and the conclusions of the peer review of the pesticide risk assessment of the active substance fosetyl, as well as the conclusions from previous EFSA opinions on fosetyl. The toxicological profile of fosetyl-al 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 3 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary. The ADI for fosetyl is calculated from the ADI of fosetyl-al, by applying a molecular weight conversion factor. The metabolism of fosetyl in primary crops was investigated in the fruit crop group only and the residue definition for the risk assessment and enforcement was proposed by the peer review as the sum of fosetyl, phosphorous acid and their salts, expressed as fosetyl. No metabolism studies are available in root and leafy crops. However, the peer review concluded that, due to the elementary nature of fosetyl-al, and given similar results obtained on fruits and leafy parts of the plant, the metabolic pattern is expected to be similar in all crop groups. Thus, for the uses on the crops under consideration, EFSA concludes that the metabolism of fosetyl-al is sufficiently addressed. Adequate analytical enforcement methods are available. EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 100 mg/kg in blackberries, 8 mg/kg in celeriac and 1.5 mg/kg in Florence fennel. However, since the current MRL for Florence fennel under Regulation (EU) No 991/2014 is 2 mg/kg, EFSA would not recommend the decrease of the MRL to 1.5 mg/kg. Studies investigating the nature of fosetyl residues under standard hydrolysis conditions were assessed during the peer review and showed that fosetyl and phosphonic acid are hydrolytically stable. Specific studies to assess the magnitude of fosetyl residues during the processing of blackberry, celeriac or fennel have not been submitted and are not necessary. Celery and fennel can be grown in a crop rotation and therefore the possible occurrence of residues in succeeding crops was assessed. Although the total application rate supported on celeriac and fennel is high, given the specific use pattern it is unlikely that significant residues would occur in rotational crops planted after celeriac and fennel outdoors. Nevertheless, Member States granting authorization of fosetyl shall take appropriate risk mitigation measures to avoid the presence of fosetyl or phosphonic acid residues in rotational crops from the post transplantation use of the soil. Residues of fosetyl in commodities of animal origin were not assessed, since the crops under consideration are normally not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic exposure, EFSA used median residue values (STMR) derived from the residue trials conducted on blackberries and celeriac. For fennel the derived MRL proposal is lower than the existing MRL, which was therefore used as an input value. For the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EU) No 991/2014 were used as input values. The MRL proposals derived by the Article 12 MRL review are not yet legally implemented and were therefore not considered in the consumer exposure calculation. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 74% of the ADI (DE child diet). The contribution of residues in blackberries to the total consumer exposure accounted for a maximum of 0.07% of the ADI (IE adult diet) and for celery and fennel was below 0.01% of the ADI. 3 EFSA Journal 2015;13(12):4327

4 EFSA concludes that the intended use of fosetyl on blackberries, celeriac and fennel will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health. EFSA proposes to amend the existing MRLs as reported in the summary table below. Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/Justification Enforcement residue definition: Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) Blackberries 75 (b) 100 Indoor and NEU uses Celeriac/turnip rooted celeries Florence fennels 2* No change 2* 8 Drench applications at sowing/early postemergence (indoor) and then transplantation of the plants outdoor (NEU) several weeks after sowing. No change recommended for fennel since the proposed GAP results in a lower MRL proposal of 1.5 mg/kg. (a): Commodity code number according to Annex I of Regulation (EC) No 396/2005. (b): This MRL, unless modified by a Regulation, will be replaced after 31 December 2015 with an LOQ of 2 mg/kg. (*): Indicates that the MRL is set at the limit of analytical quantification (LOQ). 4 EFSA Journal 2015;13(12):4327

5 Table of contents Abstract... 1 Summary... 3 Background... 6 The active substance and its use pattern... 6 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Consumer risk assessment Conclusions and recommendations References Abbreviations Appendix A Good Agricultural Practice (GAPs) Appendix B Pesticide Residue Intake Model (PRIMo) Appendix C Used compound codes EFSA Journal 2015;13(12):4327

6 Background Regulation (EC) No 396/ establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at 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 1107/2009, 3 shall submit to a Member State, when appropriate, an application to modify a MRL in accordance with the provisions of Article 7 of the Regulation. Germany, hereafter referred to as the evaluating Member State (EMS), received applications from Landwirtschaftliches Technologiezentrum Augustenberg 4 and from Landwirtschaftskammer NRW Pflanzenschutzdienst 5 to modify existing MRLs for the active substance fosetyl in blackberry, celeriac and Florence fennel. Both applications were notified to the European Commission and the European Food Safety Authority (EFSA) and were subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation reports were submitted to the European Commission and to EFSA on 3 June 2015 (application on blackberry) and 2 September 2015 (application on celeriac and fennel). Both applications were included in the EFSA Register of Questions with the reference number EFSA-Q and EFSA-Q with the following subjects: Fosetyl - Application to modify the existing MRLs in blackberry Fosetyl - Modification of MRLs in celeriac and fennel. Germany proposed to raise the existing MRL of fosetyl in blackberry from the value of 75 mg/kg 6 to 100 mg/kg and from the LOQ of 2 mg/kg to 8 mg/kg in celeriac. For Florence fennel Germany proposed to lower the existing MRL from 2 (set at the LOQ) to 1.5 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. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within three months (which may be extended to six 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 Fosetyl is the ISO common name for ethyl hydrogen phosphonate (IUPAC). In formulated plant protection products the variant fosetyl aluminium (fosetyl-al: aluminium tris-o-ethylphosphonate) is used. The chemical structure of the active substance is reported in Appendix C. Fosetyl was evaluated in the framework of Directive 91/414/EEC with France designated as rapporteur Member State (RMS). It was included in Annex I of this Directive by Directive 2006/64/EC 7 which entered into force on 1 May 2007 for use as fungicide only. In accordance with Commission 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, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p 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, , p Landwirtschaftliches Technologiezentrum Augustenberg, Neßlerstraße 25, Karlsruhe, Germany 5 Landwirtschaftskammer NRW Pflanzenschutzdienst, Siebengebirgstrasse 200, Bonn, 53299, Germany 6 This MRL, unless modified by a Regulation will be replaced after 31 December 2015 with an LOQ of 2 mg/kg. 7 Commission Directive 2006/64/CE of 18 July 2006 amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac as active substances, OJ L 206, , p EFSA Journal 2015;13(12):4327

7 Implementing Regulation (EU) No 540/ fosetyl is approved under Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC. The representative uses evaluated in the peer review were foliar spraying in citrus, cucumber and grapes. The draft assessment report (DAR) has been peer reviewed by EFSA (EFSA, 2005). The EU MRLs for fosetyl are established in Annex IIIA of Regulation (EC) No 396/2005. Since the entry into force of this Regulation, EFSA has issued reasoned opinions on the modification of MRLs for fosetyl in radishes, potato, kiwi and certain spices (EFSA, 2009, 2012a). On April 2014 EFSA was asked by the European Commission to perform the dietary exposure assessment of the temporary MRLs (t-mrls) which were proposed by the European Commission for certain crops (EFSA, 2014). These t-mrls were afterwards implemented in the EU legislation by Commission Regulation (EU) No 991/ The review of the existing fosetyl MRLs according to Article 12 of Regulation (EC) No 396/2005 (here after Article 12 MRL review) has been finalized (EFSA, 2012b), but the proposals of EFSA have not been legally implemented yet. The MRL changes that were reported in the EU legislation since the entry into force of the Regulation (EC) No 396/2005 are summarised in Table 1. Table 1: Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedure (a) Considered by Regulation Remarks Art. 10 (EFSA, 2009) (EC) No 459/2010 Radishes Art. 10 (EFSA, 2012a) (EU) No 737/2014 Potatoes, kiwi and certain spices Art. 12 (EFSA, 2012b) Not yet implemented Review of the existing MRLs Art. 43 (EFSA, 2014) (EU) No 991/2014 Setting of temporary MRLs (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) No 396/2005 Art. 12: Review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 Art. 43: EFSA scientific opinion according to Article 43 of Regulation (EC) No 396/2005 No CXLs are established for fosetyl. The details of the intended GAPs for fosetyl on blackberries, celeriac and fennel are given in Appendix A. Assessment EFSA bases its assessment on the evaluation reports submitted by the EMS (Germany, 2015a, 2015b), the DAR (and its addendum) prepared under Directive 91/414/EEC (France, 2003, 2005), the conclusions of the peer review of the pesticide risk assessment of the active substance fosetyl (EFSA, 2005) as well as the conclusions from previous EFSA opinions on fosetyl, including the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2012b, 2014). 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/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a g, 2000, 2010a, b, 2011; OECD, 2011). 8 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, , p Commission Regulation (EU) No 991/2014 amending Annex III to Regulation (EC) No 396/2005 f the European Parliament and of the Council as regards maximum residue levels for fosetyl in or on certain products. OJ L 279, , p 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, , p EFSA Journal 2015;13(12):4327

8 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin Analytical methods for the determination of fosetyl residues in plant commodities were assessed during the peer review under Directive 91/414/EEC (EFSA, 2005) and under the Article 12 MRL review (EFSA, 2012b). The enforcement residue definition established for fosetyl in the Regulation (EC) No 396/2005 is fosetyl-al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl). During the peer review, an analytical method using GC-FPD, confirmed by GC-NPD and its ILV were evaluated and validated for the determination of fosetyl-al and phosphonic acid at an LOQ of 0.5 mg fosetyl-al/kg and 0.5 mg phosphonic acid/kg in high water (banana) and high acid content commodities (orange, grape) and an LOQ of 2 mg fosetyl-al/kg and 20 mg phosphonic acid/kg in hops. The EFSA conclusion states that the method is not capable of distinguishing fosetyl-al or phosphorous from their respective salts (EFSA, 2005). In addition, after Annex I inclusion, the RMS evaluated an HPLC-MS/MS method, which was validated for the determination of fosetyl-al and phosphonic acid with an LOQ of 0.01 mg fosetyl-al/kg and 0.1 mg phosphonic acid/kg in high water (lettuce, cucumber), high oil (avocado), high acid (oranges, grapes) and dry/starch content commodities (wheat) (EFSA, 2012b). Hence it is concluded, that fosetyl can be enforced in food of plant origin with an LOQ of 0.01 mg/kg in high water, high oil, high acid and dry/starch content commodities. Phosphonic acid can be enforced in food of plant origin with an LOQ of 0.1 mg/kg in high water, high oil, high acid and dry/starch content commodities. EFSA notes that all methods reported for fosetyl-al are also applicable to analyse residues of fosetyl only (taking into account that there are three molecules of fosetyl for each fosetyl-al, the LOQ for fosetyl is ca. three times lower than the LOQ expressed for fosetyl-al). As the commodities under consideration belong to high water and high acid content commodity groups, EFSA concludes that sufficiently validated analytical methods are available to control residues of fosetyl and phosphonic acid in the crops under consideration Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin were not assessed in the current application, since crops under consideration are not fed to livestock. 2. Mammalian toxicology The toxicological profile of the active substance fosetyl-al was assessed in the framework of the peer review under Directive 91/414/EEC (EFSA, 2005). The data were sufficient to derive toxicological reference values compiled in Table 2. Table 2: Overview of the toxicological reference values Fosetyl-Al Source Year Value Study Safety factor ADI EFSA mg/kg bw per day 2 year rat and dog 100 ARfD EFSA 2005 Not necessary Fosetyl ADI mg/kg bw per day Calculated from the fosetyl-al ADI, using appropriate molecular weight conversion factor- ARfD - - Not necessary Phosphonic acid ADI EFSA mg/kg bw per day 117 week rat 100 ARfD EFSA Not necessary 8 EFSA Journal 2015;13(12):4327

9 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of fosetyl in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC (EFSA, 2005) in the fruit crop group. An overview of the available metabolism studies is presented in Table. Table 3: Summary of available metabolism studies in plants Crop group Crops Application Orange Paintbrush on leaves: 4 x n.r. n.r. Tangerine Paintbrush on leaves: 3 x n.r. n.r. Sampling (a) (day, DAT) Comments Fruit Apple Foliar: 2x 200 mg fosetyl/tree 7 and 14 DAT 2 a) Dipping: 2x 2.4 g/l a) 0, 7 14, 28, 56 and 120 DAT Pineapple b) Spray: 2x 2.4 g/l b) 115 and 122 DAT Tomato Foliar: 2x 4400 g/ha 2 hrs, 14, 28 and 156 DAT Grape Droplet deposition: 3024 µg/plant 5.5 hrs, 1, 2, 5, 7 or 14 DAT leaves only (a): DATx, days after treatment x. n.r.: not reported The studies indicate that the initial step of the metabolism proceeds through the hydrolytic cleavage of the ethyl ester bond with phosphonic acid and ethanol as the major plant metabolites. Ethanol, when not lost by volatilisation, is further incorporated into natural products such as D-glucose, starch, lignin, cellulose or fatty acids (EFSA, 2005). Phosphonic acid is considered to be toxicologically relevant and its level is generally expected to be higher than that of the parent compound. The residue definition for the risk assessment and enforcement was proposed by the peer review as the sum of fosetyl, phosphorous acid 11 and their salts, expressed as fosetyl (EFSA, 2005). No metabolism studies are available for root and leafy crops. However, the peer review concluded that, due to the elementary nature of fosetyl-al, and given similar results obtained on fruits and leafy parts of the plant, the metabolic pattern is expected to be similar in all crop groups (EFSA, 2005). Thus, for the uses on the crops under consideration, EFSA concludes that the metabolism of fosetyl-al is sufficiently addressed. In the framework of the Article 12 MRL review, the experts agreed that the residue definition for both risk assessment and monitoring should be set as phosphonic acid only and that risk managers should consider if a separate residue definition for fosetyl should be established to enforce residues that are specific to the use of fosetyl-al (EFSA, 2012b). Phosphonic acid residues in plants result not only from the use of fosetyl-al, but also from the use of pesticides containing potassium phosphonate, phosphorus containing fertilizers and some organic products used for foliar fertilization. For the intended uses on blackberries, celeriac and fennel, EFSA concludes that the metabolism of fosetyl is sufficiently addressed and the residue definitions for enforcement and risk assessment agreed during the peer review are applicable. Magnitude of residues In both MRL applications the residues in the crops were calculated according to the current residue definition as well as according to residue definitions proposed by the Article 12 MRL review as phosphonic acid and fosetyl, separately. 11 IUPAC name: phosphonic acid 9 EFSA Journal 2015;13(12):4327

10 a. Blackberries In support of the MRL application the applicant submitted four indoor and four outdoor residue trials on blackberries. All trials were GAP compliant and performed in Germany in 2010, 2011 and Control samples from three trials contained phosphonic acid residues, but in significantly lower levels than in the samples collected from the treated plots. These trials were therefore not disregarded from the MRL calculations. Blackberries are a minor crop and therefore four trials are sufficient to derive an MRL proposal according to EU guidelines (European Commission, 2011). Higher residue levels where observed in northern outdoor trials and therefore an MRL proposal of 100 mg/kg was derived from this dataset, covering the indoor uses of fosetyl-al on blackberries. b. Celeriac The applicant submitted five residue trials conducted in Germany in 2011 and 2012, where the active substance was applied first at sowing and 7 to 10 days later, at BBCH stage 03 to 10. Plants were initially grown under greenhouse conditions and then transplanted outdoor about two months after sowing. In one trial the sample of the whole crop (leaves + tuber) was analysed and no residue data in tuber was provided. However, since residue levels were below the LOQ, this trial was not disregarded from the MRL calculation. In all samples fosetyl-al residues were below the LOQ of 0.01 mg/kg and phosphonic acid in the range of <0.20 to 2.9 mg/kg. The number of residue trials is sufficient to support the intended use and to derive a MRL proposal of 8 mg/kg. c. Fennel The applicant submitted four GAP compliant residue trials conducted in Germany in 2011 and 2012, where the active substance was applied first at sowing and 7 to 11 days later, at BBCH 03 to 11. Plants were initially grown under greenhouse conditions and then transplanted outdoor, more than one month after sowing. In all trial samples residues of fosetyl (or fosetyl-al) were below the LOQ of 0.01 mg/kg. The number of trials is sufficient to support the intended use and to derive a MRL proposal of 1.5 mg/kg. EFSA notes, that the existing MRL for fosetyl in fennel is set at the LOQ of 2 mg/kg, being higher than the derived MRL proposal. Unless consumer intake concerns are identified for the existing MRL, the lowering of an MRL is not recommended under Article 10 of Regulation (EC) No 396/2005. The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarised in Table 1. In addition, EFSA derived MRL proposals and risk assessment values for fosetyl and phosphonic acid separately, considering these residue definitions were proposed under the Article 12 MRL review. The stability of fosetyl residues in plant matrices under storage conditions prior to analysis was assessed during the peer review under Directive 91/414/EEC (EFSA, 2005). Residues of fosetyl degrades to phosphonic acid during the storage, however, the sum of phosphonic acid and fosetyl was found to be stable at -18 C for up to 12 months in high water (cucumber, lettuce), high starch (potatoes) and high acid (grapes) content matrices. Additional studies where high acid and high water content matrices were stored frozen for a period of 25 months were assessed during the Article 12 MRL review and confirmed the findings of the peer review (EFSA, 2012b). As the trial samples were stored for a maximum period of 8 to 11 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 methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for purpose (Germany, 2015a, 2015b). EFSA concludes that the data are sufficient to derive the following MRL proposals: 100 mg/kg blackberries, covering indoor and outdoor NEU uses 9 mg/kg celeriac, indoor/neu uses 1.5 mg/kg Florence fennel, indoor/neu uses. However, since the current MRL for fennel under Regulation (EU) No 991/2014 is 2 mg/kg, EFSA would not recommend the decrease of the MRL to 1.5 mg/kg EFSA Journal 2015;13(12):4327

11 Table 1: Overview of the available residues trials data Crop (Trial GAPs) Blackberries (2x g/ha; PHI 21 d) Blackberries (2x g/ha; PHI 14 d) Celeriac (2x 9300 g/ha) Fennel (2 x 9300 g/ha) Region/ Residue levels in the supervised residue trials (b) Indoor Sum: sum fosetyl, phosphorous acid expressed as fosetyl (mg/kg) (a) 1) phos.: phosphonic acid expressed as phosphonic acid (mg/kg) 2) fosetyl: fosetyl-al, expressed as fosetyl (mg/kg) NEU Sum: 5.21; 8.4; 8.63; ) phos.: 3.8; 6.12; 5.37; ) fosetyl: <0.10; 0.24; 1.42; 0.24 Indoor Sum: 3.51; 7.4; 26.0; 28.0 Indoor/ outdoor Indoor/ outdoor 1) phos.: 1.85; 4.93; 17.16; ) fosetyl: 2.49; 0.76; 2.80; 7.50 Sum: 3x <0.21; <0.28; 3.9 1) phos.: 3x <0.15; <0.20; 2.9 2) fosetyl: 5x <0.01 Sum: <0.21; 0.26; 0.37; 0.80 Recommendations/comments (c) Underlined values: trials with phosphonic acid residues in control samples (1.3 and 1.4 mg/kg) MRL OECD =102/100 Underlined value: trials with phosphonic acid residues in control sample (5.7 mg/kg) MRL OECD =66/70 MRL proposal derived from NEU dataset Drench applications at sowing/post-emergence (indoor) and transplantation of the crop outdoor MRL OECD =7.5/8.0 Drench applications at sowing/post-emergence (indoor) and transplantation of the crop outdoor MRL proposal (mg/kg) 1) 80 2) HR (d) (mg/kg) ) ) 5.75 (70) ) 7 2) 0.01* 1) phos.: <0.15; 0.19; 0.27; ) 1.5 2) fosetyl: 4x <0.01 MRL OECD =1.5/1.5 2) 0.01* (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; (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 risk assessment. (e): STMR: Median residue level according to residue definition for risk assessment ) ) ) 2.9 2) ) 0.6 2) 0.01 STMR (e) (mg/kg) ) ) ) 7.5 2) ) 0.2 2) ) ) EFSA Journal 2015;13(12):4327

12 Effect of industrial processing and/or household preparation The effect of processing on the nature of fosetyl was investigated in the framework of the peer review (EFSA, 2005). Standard hydrolysis studies representative for pasteurisation, boiling and sterilisation conditions were submitted. From these studies it was concluded that both fosetyl and phosphonic acid are hydrolytically stable and the relevant residue for enforcement and risk assessment in processed commodities is the same as in primary crops (EFSA, 2005). Specific studies to assess the magnitude of fosetyl residues during the processing of blackberry, celeriac or fennel have not been submitted. However, given the low contribution of residues in the crops under consideration to the total consumer exposure, such studies are not necessary Rotational crops Celery and fennel can be grown in rotation with other plants and therefore the possible occurrence of residues in succeeding crops resulting from the use on primary crops has to be assessed. According to the soil degradation studies evaluated in the framework of the peer review, fosetyl-al is expected to degrade rapidly in soil to its metabolite phosphonic acid. Phosphonic acid has a DT 90 value in excess of 1 year and therefore has the potential to accumulate (France, 2003). Rotational crop field studies were performed with radishes, lettuce and barley, which were planted/sown one month after a soil treatment with phosphonic acid at a rate of 4.9 mg/kg soil (representative of a concentration resulting from an application of 15 kg/ha of fosetyl-al). The levels of phosphonic acid in the crops were higher than under natural conditions, but only slightly above the LOQ of 0.5 mg/kg in plant products. Nevertheless, the peer review proposed a pre-planting interval of 30 days for rotational crops (EFSA, 2005). The application rate for the soil drench treatment of fosetyl-al on celery and fennel is higher (1.2 N) than the application rate investigated in the peer review. However, both crops are treated at an early growth stage indoors and re-planted outdoors in an untreated soil and thus it is unlikely that significant residues would occur in rotational crops planted after celeriac and fennel outdoors. Nevertheless, the Member States granting authorization of fosetyl shall take appropriate risk mitigation measures to avoid the presence of fosetyl or phosphonic acid residues in rotational crops from the post transplantation use of the soil Nature and magnitude of residues in livestock As crops under consideration and their by-products are not normally fed to livestock, the nature and magnitude of fosetyl residues in livestock was 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 Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 12 (EFSA, 2007). To calculate the chronic exposure, EFSA used median residue values (STMR) derived from the residue trials conducted on blackberries and celeriac as reported in Table 1. For fennel the derived MRL proposal is lower than the existing MRL, which was therefore used as an input value. For the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EU) No 991/2014 were used as input values. The MRL proposals derived by the Article 12 MRL review are not yet legally implemented and were therefore not considered in the consumer exposure calculation. An acute consumer exposure assessment was not performed, since the setting of an ARfD was concluded to be unnecessary for fosetyl. 12 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 1 regional and 4 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 is used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007) EFSA Journal 2015;13(12):4327

13 The input values used for the dietary exposure calculation are summarised in Table 2. Table 2: 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: Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) Blackberries 16.7 STMR indoor use (Table 4) Acute exposure was not calculated as the Celeriac 0.21 STMR (Table 4) ARfD not established for fosetyl. Fennel 2 MRL Other plant and animal commodities MRL Regulation (EU) 991/2014 The estimated exposure was then compared with the toxicological reference value derived for fosetyl (see Table 2). The results of the intake calculation are presented in Appendix B of this reasoned opinion. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 74% of the ADI (DE child diet). The contribution of residues in blackberries to the total consumer exposure accounted for a maximum of 0.07% of the ADI (IE adult diet) and for celery and fennel was below 0.01% of the ADI. EFSA concludes that the intended use of fosetyl on blackberries, celeriac and Florence fennel 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 MRLs summarised in the table below: Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/Justification Enforcement residue definition: Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) Blackberries 75 (b) 100 Indoor and NEU outdoor uses Celeriac/turnip rooted celeries Florence fennels 2* 2* 8 No change Drench applications at sowing/early postemergence (indoor) and then transplantation of the plants outdoor (NEU) several weeks after sowing. No change recommended for fennel since the proposed GAP results in a lower MRL proposal of 1.5 mg/kg. (a): Commodity code number according to Annex I of Regulation (EC) No 396/2005 (b): This MRL, unless modified by a Regulation, will be replaced after 31 December 2015 with an LOQ of 2 mg/kg. (*): Indicates that the MRL is set at the limit of analytical quantification (LOQ) 13 EFSA Journal 2015;13(12):4327

14 References European Commission, 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, 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- 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 March European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance fosetyl. The EFSA Journal 2005, 54, 1 79, doi: /j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. The EFSA Journal 2007, 32r, doi: /j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing MRL(s) for fosetyl-al in radishes. EFSA Journal 2009;7(9):1313, 22 pp., doi: /j.efsa EFSA (European Food Safety Authority), 2012a. Reasoned opinion on the modification of the existing MRLs for fosetyl in potato, kiwi and certain spices. EFSA Journal 2012;10(12):3019, 43 pp., doi: /j.efsa EFSA (European Food Safety Authority), 2012b. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for fosetyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2012;10(11):2961, 65 pp., doi: /j.efsa EFSA (European Food Safety Authority), Statement on the dietary risk assessment for proposed temporary maximum residue levels (t-mrls) for fosetyl-al in certain crops. EFSA Journal 2014;12(5):3695, 22 pp., doi: /j.efsa FAO (Food and Agriculture Organization of the United Nations), 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 EFSA Journal 2015;13(12):4327

15 France, Draft assessment report on the active substance fosetyl prepared by the rapporteur Member State France in the framework of Council Directive 91/414/EEC, December Available online: France, Addendum to the draft assessment report on the active substance fosetyl prepared by the rapporteur Member State France in the framework of Council Directive 91/414/EEC, September Available online: Germany, 2015a. Evaluation report on the modification of MRL for fosetyl in blackberry prepared by the evaluating Member State Germany under Article 8 of Regulation (EC) No 396/2005, 27 July 2015, 22 pp. Germany, 2015b. Evaluation report on the modification of MRL for fosetyl in celeriac and fennel prepared by the evaluating Member State Germany under Article 8 of Regulation (EC) No 396/2005, 29 September 2015, 23 pp. OECD (Organisation for Economic Co-operation and Development), OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March In: Pesticide Publications/Publications on Pesticide Residues. Available online: EFSA Journal 2015;13(12):4327

16 Abbreviations a.s. ADI Al AR ARfD BBCH bw CXL DAR DE DAT DT90 EMS FPD GAP GC GCPF HPLC HR ILV ISO IUPAC LOQ MRL MS MS/MS MW NEU NPD OECD PHI PRIMo RD RMS SEU STMR active substance acceptable daily intake aluminium applied radioactivity acute reference dose growth stages of mono- and dicotyledonous plants body weight Codex maximum residue limit (Codex MRL) draft assessment report Germany days after treatment period required for 90% dissipation evaluating Member State flame photometric detector good agricultural practice gas chromatography Global Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP)) high performance liquid chromatography highest residue independent laboratory validation International Organization for Standardization International Union of Pure and Applied Chemistry limit of quantification maximum residue level mass spectrometry detector tandem mass spectrometry detector molecular weight northern Europe nitrogen/phosphorous detector Organisation for Economic Co-operation and Development pre-harvest interval (EFSA) Pesticide Residues Intake Model residue definition rapporteur Member State southern Europe supervised trials median residue 16 EFSA Journal 2015;13(12):4327

17 WG WHO water-dispersible granule World Health Organization 17 EFSA Journal 2015;13(12):4327

18 Appendix A Good Agricultural Practice (GAPs) Crop and/or situation (a) Blackberries Celeriac Fennel MS or NEU/SEU or Country DE (NEU) DE (EU) DE (EU) F G or I (b) F Pest or group of pests controlled (c) Downy mildew (Peronospora sparsa) Formulation type (d-f) conc. a.s. (i) Method kind (f-h) Application Growth stage & season (j) WG Spray BBCH Number min-max (k) Interval minmax days Application rate per treatment g/hl min-max Water L/ha min-max g/ha max G 14 G Pythium spp. Douse (drench) G Pythium spp. Douse (drench) Young plantation, directly after sowing days days 30 L/ha L/ha PHI (days) (l) 21 Remarks (m) Drench applications at sowing/early post-emergence 9300 (indoor) before transplantation of the crop (outdoor) Remarks: (a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the usage situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), water soluble granule (WG) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) all abbreviations must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants. type of equipment used must be indicated (i) g/kg or µg/l (j) Growth stage at last treatment (Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2nd ed., Federal Biological Research Centre of Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant, information on season at time of application (k) The minimum and maximum number of application possible under practical conditions of use must be provided (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions 18 EFSA Journal 2015;13(12):4327

19 Appendix B Pesticide Residue Intake Model (PRIMo) Fosetyl Status of the active substance: Included Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 2,8 ARfD (mg/kg bw): n.n. Source of ADI: EFSA Source of ARfD: EFSA Year of evaluation: 2005 Year of evaluation: 2005 The ADI of fosetyl recalculated from the ADI of fosetyl-al, by applying the molecular weight converion factor of 0,9. Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum No of diets exceeding ADI: --- Prepare workbook for refined calculations Undo refined calculations Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities 74 DE child 32 Apples 10 Oranges 5 Table grapes 53 NL child 17 Apples 8 Oranges 6 Potatoes 49 WHO Cluster diet B 11 Tomatoes 6 Wine grapes 3 Potatoes 38 IE adult 4 Wine grapes 3 Oranges 2 Potatoes 35 FR toddler 7 Apples 5 Potatoes 5 Oranges 30 PT General population 9 Wine grapes 6 Potatoes 3 Tomatoes 27 WHO cluster diet E 6 Wine grapes 4 Potatoes 2 Apples 26 FR all population 14 Wine grapes 2 Tomatoes 1 Apples 25 FR infant 7 Apples 4 Potatoes 2 Oranges 25 UK Toddler 5 Oranges 5 Apples 4 Potatoes 24 WHO regional European diet 4 Potatoes 4 Tomatoes 2 Apples 24 DK child 6 Apples 4 Cucumbers 3 Potatoes 24 SE general population 90th percentile 4 Potatoes 3 Apples 3 Tomatoes 23 ES child 6 Oranges 4 Tomatoes 3 Apples 23 WHO cluster diet D 4 Potatoes 4 Tomatoes 2 Apples 23 NL general 4 Oranges 3 Apples 3 Potatoes 20 ES adult 3 Oranges 3 Tomatoes 2 Apples 20 WHO Cluster diet F 4 Potatoes 2 Tomatoes 2 Oranges 19 UK Infant 4 Apples 3 Potatoes 3 Oranges 19 IT kids/toddler 5 Tomatoes 2 Apples 1 Oranges 18 PL general population 5 Apples 4 Potatoes 3 Tomatoes 17 IT adult 4 Tomatoes 2 Apples 1 Lettuce 16 UK vegetarian 3 Wine grapes 2 Oranges 2 Tomatoes 15 DK adult 5 Wine grapes 2 Apples 2 Potatoes 14 LT adult 5 Apples 3 Potatoes 2 Tomatoes 14 UK Adult 4 Wine grapes 2 Tomatoes 2 Oranges 11 FI adult 3 Oranges 2 Tomatoes 1 Potatoes ptmrls at LOQ (in % of ADI) Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Fosetyl is unlikely to present a public health concern EFSA Journal 2015;13(12):4327

20 Appendix C Used compound codes Code/Trivial name Chemical name Structural formula Fosetyl Ethyl hydrogen phosphonate MW: 110 Fosetyl-Al Aluminium tris (ethyl phosphonate) MW: EFSA Journal 2015;13(12):4327