Modification of the existing MRLs for pymetrozine in spinach and similar leaves 1

Transcription

1 REASONED OPINION Modification of th xisting MRLs for pymtrozin in spinach and similar lavs 1 Europan Food Safty Authority 2 Europan Food Safty Authority (EFSA), Parma, Italy SUMMARY According to Articl 6 of th Rgulation (EC) No 396/2005, Grmany, hrwith rfrrd to as th Evaluating Mmbr Stat (EMS), rcivd an application from Landwirtschaftskammr NRW to modify th MRLs for pymtrozin in spinach, purslan and bt lavs (chard). Grmany draftd an valuation rport according to Articl 8 of Rgulation (EC) No 396/2005 which was submittd to th Europan Commission and forwardd to EFSA on 7 Jun EFSA drivd th following conclusions basd on th submittd valuation rport as wll as th Draft Assssmnt Rport (DAR) prpard by th rapportur Mmbr Stat (RMS) Grmany undr Dirctiv 91/414/EEC. Th toxicological profil of pymtrozin was sufficintly addrssd in th pr rviw to conclud on an ADI valu of 0.03 mg/kg bw/day and an ARfD of 0.1 mg/kg bw. Th mtabolism of pymtrozin was invstigatd in four crop groups (crals, fruit and fruiting vgtabls, oilsds and root and tubr vgtabls) whr a similar mtabolic pathway was obsrvd. Th nforcmnt and risk assssmnt rsidu dfinitions ar stablishd for all plant commoditis as pymtrozin only. No additional mtabolism studis on lafy crops ar rquird. An adquat analytical mthod is availabl to nforc th proposd MRLs in spinach and similar (lavs). Th submittd suprvisd rsidu trials indicat that a MRL of 0.4 mg/kg for spinach, purslan and bt lavs (chard) would b rquird to support th proposd us on ths crops in Grmany. Th ffct of procssing on th natur of pymtrozin rsidus has not bn invstigatd. No studis as wll hav bn submittd by th applicant on th ffcts of procssing on th magnitud of pymtrozin rsidus in procssd spinach (or in purslan or bt lavs (chard)). Howvr, such 1 On rqust from th Europan Commission], Qustion No EFSA-Q , issud on 26 Octobr Corrspondnc: prapr.mrl@fsa.uropa.u Suggstd citation: Europan Food Safty Authority; Modification of th xisting MRLs for pymtrozin in spinach and similar lavs.. [24 pp.] doi: /j.fsa Availabl onlin: Europan Food Safty Authority,

2 studis ar not considrd ncssary taking into account th low contribution of ths crops to th total ditary intak. Th occurrnc of pymtrozin rsidus in rotational crops was also invstigatd. Similar mtabolic pathway of pymtrozin in rotational and in primary crops is obsrvd and nforcmnt and risk assssmnt rsidu dfinition in rotational crops is stablishd as pymtrozin only. Providd that pymtrozin is applid to spinach according to th proposd GAP, no significant pymtrozin rsidus ar xpctd to occur in rotational and/or succding crops. Crops undr considration ar normally not usd as livstock fd and thrfor th natur and magnitud of pymtrozin rsidus in th food of animal origin was not invstigatd. Th consumr xposur assssmnt was prformd with rvision 2 of th EFSA PRIMo. For th chronic xposur assssmnt th drivd STMR valu for spinach was usd as an input valu for spinach and similar (lavs). For th rmaining crops th MRLs stablishd in th Rgulation (EC) No 396/2005 wr takn as input valus. For th acut risk assssmnt th HR valu as drivd from th rsidu trials on spinach was usd as an input valu for spinach and similar (lavs). Th calculatd long-trm and short-trm xposur was thn compard with th ADI and ARfD, rspctivly, as drivd for pymtrozin. No long-trm consumr intak concrns wr idntifid for any of th Europan dits. Th total calculatd intak accountd for a maximum of 22 % of th ADI. Th individual contribution of spinach to th total ditary intak accounts for a maximum of 0.047% of th ADI (Frnch toddlr dit) and for lss than 0.005% of th ADI for chard and purslan. No shorttrm consumr intak concrns wr idntifid with rgard to th xposur of pymtrozin rsidus from th intak of spinach and similar lavs. Th highst acut xposur would b from th intak of spinach (4.7% of th ARfD), followd by purslan (3.7 % of th ARfD) and bt lavs (3.2 % of th ARfD). It is concludd that th intndd us of ispoyrazam on spinach and similar (lavs) will not rsult in consumr xposur concrns and th xcdanc of th toxicological rfrnc valus. Th following rcommndations hav bn drivd by EFSA: a Commodity Existing EC MRL (mg/kg) Proposd EC MRL (mg/kg) Justification for th proposal Enforcmnt rsidu dfinition: Pymtrozin Spinach 0.02* 0.4 Th MRL proposals ar Purslan 0.02* Bt lavs (chard) 0.02* 0.4 a according to Annx I of Rgulation (EC) No 396/2005 (*): Indicats that th MRL is st at th limit of analytical quantification. KEY WORDS sufficintly supportd by data and no risk for consumrs was idntifid for th intndd us. Notifir has to confirm that th GAP applis also to purslan. Pymtrozin, spinach and similar (lavs), purslan, bt lavs (chard), MRL application, Rgulation (EC) No 396/2005, consumr risk assssmnt 2

3 TABLE OF CONTENTS Summary... 1 Tabl of contnts... 3 Background... 4 Trms of rfrnc... 4 Th activ substanc and its us pattrn... 5 Assssmnt Mthods of analysis Mthods for nforcmnt of rsidus in food of plant origin Mthods for nforcmnt of rsidus in food of animal origin Mammalian toxicology Rsidus Natur and magnitud of rsidus in plant Primary crops Rotational crops Natur and magnitud of rsidus in livstock Consumr risk assssmnt Conclusions and rcommndations Rfrncs Appndix A Good Agricultural Practics (GAPs) Appndix B Psticid Rsidus Intak Modl (PRIMo) Appndix C Existing EC MRLs Abbrviations

4 BACKGROUND Commission Rgulation (EC) No 396/ stablishs th ruls govrning th stting of psticid MRLs at Community lvl. Articl 6 of that rgulation lays down that a party rqusting an authorisation for th us of a plant protction product in accordanc with Council Dirctiv 91/414/EEC 4 shall submit to a Mmbr Stat, whn appropriat, an application to st or modify an MRL in accordanc with th provisions of Articl 7 of that rgulation. Grmany, hraftr rfrrd to as th valuating Mmbr Stat (EMS), rcivd an application from Landwirtschaftskammr NRW 5 to modify th xisting MRLs for th activ substanc pymtrozin in spinach and similar (lavs). This application was notifid to th Europan Commission and EFSA and subsquntly valuatd by th EMS in accordanc with Articl 8 of th Rgulation. Aftr compltion, th valuation rport of th EMS was submittd to th Europan Commission who forwardd th application, th valuation rport and th supporting dossir to EFSA on 7 Jun Th application was includd in th EFSA Rgistr of Qustions with th rfrnc EFSA-Q and th following subjct: Pymtrozin - Application to modify th xisting MRLs in spinach and similar (lavs). Th applicant proposs to stablish th MRL of 0.5 mg/kg for pymtrozin in spinach and similar (lavs). EFSA thn procdd with th assssmnt of th application as rquird by Articl 10 of th Rgulation. TERMS OF REFERENCE According to Articl 10 of Rgulation (EC) No 396/2005, EFSA shall, basd on th valuation rport providd by th valuating Mmbr Stat, provid a rasond opinion on th risks to th consumr associatd with th application. According to Articl 11 of that Rgulation, th rasond opinion shall b providd as soon as possibl and at th latst within 3 months from th dat of rcipt of th application. Whr EFSA rqusts supplmntary information, th tim limit laid down shall b suspndd until that information has bn providd. In this particular cas th calculatd dadlin for providing th rasond opinion is 7 Sptmbr Rgulation of Council and Parliamnt (EC) No 396/2005 of 23 Fbruary OJ L 70, , p Council Dirctiv 91/414/EEC of 15 July 1991, OJ L 230, , p Landwirtschaftskammr NRW, Sibngbirgsstraβ 200, 53229, Bonn, Grmany 4

5 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Pymtrozin is th ISO common nam for (E)-4,5-dihydro-6-mthyl-4-(3-pyridylmthylnamino)- 1,2,4-triazin-3(2H)-on (IUPAC). Th structur of th substanc is as follows: Molcular wight: Pymtrozin is a systmic inscticid with slctiv proprtis against Homoptra and acts by blocking th fding of th inscts. Pymtrozin is usd to control aphids and whitfly in vgtabls, potatos, ornamntals, cotton, citrus fruits, tc. Pymtrozin has bn pr rviwd undr Dirctiv 91/414/EEC and is includd in Annx I to this Dirctiv by th Commission Dirctiv 2001/87/EC 6. Th rprsntativ uss invstigatd for th pr rviw wr foliar applications on a wid rang of crops. Th activ substanc was not pr rviwd by EFSA and thrfor EFSA conclusion is not availabl. Th xisting EU MRLs for pymtrozin is stablishd in Annxs II and IIIB to Rgulation 396/2005/EC (Appndix C). Currntly th MRLs for pymtrozin in spinach and similar (lavs) ar st at th LOQ of 0.02 mg/kg. x Alimntarius has not stablishd CXLs for pymtrozin. Th GAP for which th authorisation now is rqustd in Grmany rfrs to an application of pymtrozin on spinach two tims at an application rat of 0.2 kg a.s./ha. Th intndd PHI intrval is 14 days. Th dtails of th GAP ar givn in Appndix A. 6 Commission Dirctiv (EC) 2001/87 of 12 Octobr 2001, OJ L 279, , p

6 ASSESSMENT EFSA bass its assssmnt on th valuation rport submittd by Grmany (2010), th Draft Assssmnt Rport (DAR) prpard undr Dirctiv 91/414/EEC (Grmany, 1998), th Addndum to th DAR (Grmany, 1999) and th EU Rviw Rport (2002). Th assssmnt is prformd in accordanc with th lgal provisions of th Uniform Principls for th Evaluation of th Authorization of Plant Protction Products st out in Annx VI to Dirctiv 91/414/EEC and th currntly valid EU guidanc documnts for consumr risk assssmnt (Europan Commission, 1996, 1997a, 1997b, 1997c, 1997d, 1997, 1997f, 1997g, 2008, 2010). 1. Mthods of analysis 1.1. Mthods for nforcmnt of rsidus in food of plant origin According to th Europan Standard EN 15637, pymtrozin rsidus in spinach and similar lavs can b dtrmind with HLPC-MS/MS mthod which is validatd LOQ of 0.01 mg/kg in matrics with high watr contnt (CEN, 2008a). In addition, multi-rsidu mthod QuEChERS (with LC- MS/MS principl) is also validatd at th LOQ of 0.01 mg/kg in matrics with high watr contnt (CEN, 2008b). EFSA concluds that thr ar adquat analytical mthods availabl for th nforcmnt of th proposd MRLs in spinach and similar (lavs) Mthods for nforcmnt of rsidus in food of animal origin Crops undr considration ar not usd as livstock fd and thrfor th availability of analytical nforcmnt mthods for th dtrmination of pymtrozin rsidus in commoditis of animal origin was not invstigatd undr th currnt application. 2. Mammalian toxicology Th toxicological proprtis of pymtrozin hav bn valuatd in th DAR prpard undr Dirctiv 91/414/EEC (Europan Commission, 2002) and th rlvant rfrnc valus hav bn drivd (Tabl 2-1). Tabl 2-1. Ovrviw of th toxicological rfrnc valus Pymtrozin Sourc Yar Valu (mg/kg bw/d) Study rlid upon Safty factor ADI COM d and 1 yr dog 100 ARfD COM rabbit dvlopmntal toxicity; rat, 28 d gavag study 100 6

7 3. Rsidus 3.1. Natur and magnitud of rsidus in plant Primary crops Natur of rsidus Th studis invstigating th mtabolism of pymtrozin in primary plants ar rportd in th DAR (Grmany, 1998) and in th Addndum to th DAR (Grmany, 1999): Crop group Crop Position of radiolabl Fruits and fruiting vgtabls Crals Oilsds Root and tubr vgtabls Tomatos Ric Cotton Potatos Typ of application Rat (kg a.s/ha) Application data No Sampling Rmarks 14 - C-triazin - C-pyridin foliar spray up to 7 days; 26 and 49 DAT 7 and 14 d intrval 14 d intrval 14 - C-triazin foliar spray , 7, 14 DAT 1-3 d intrval 14 - C-triazin foliar spray DAT; C-pyridin 0.25 DAT 14 - C-triazin 14 - C-pyridin granular , 41 DAT (25 % maturity) 69 d (50% maturity), 116 d (maturity) 14 - C-triazin foliar spray DAT, C-pyridin DAT (maturity) 14 -C-triazin 14 - C-pyridin foliar spray h; 29 DAT and 55 DAT (harvst) 1 wk intrval 42 d intrval Th availabl mtabolism studis indicat a similar mtabolic rout in all crops invstigatd. Whn applid to plants, pymtrozin is translocatd systmically to othr parts of th crop. During mtabolism, th clavag of amino group of pymtrozin occurs, lading to a wid rang of mtabolits, part of which is incorporatd in plant tissus or conjugatd with sugars. Parnt pymtrozin was idntifid as th main componnt of th TRR in plants and consquntly th risk assssmnt and nforcmnt dfinition was stablishd as pymtrozin only. Th mtabolism of pymtrozin in lafy vgtabls was not invstigatd, but as th mtabolic pathway in invstigatd four crop groups is similar, it is assumd to procd in a similar way also in lafy vgtabls undr considration. Consquntly EFSA concluds that th risk assssmnt and nforcmnt rsidu dfinition in spinach (and similar lavs) is also dfind as parnt pymtrozin which is in lin with th rsidu dfinition st in Rgulation No (EC) 396/ Magnitud of rsidus Spinach In support of th proposd us of pymtrozin in Grmany on spinach and similar lavs (purslan, bt lavs), in total 5 GAP compliant rsidu trials on spinach hav bn submittd. Th rsidu data xtrapolation from spinach to bt lavs (chard) and purslan is proposd. Trials wr carrid out 7

8 ovr two sasons in 2006 and In on rsidu trial a comparably high rsidu valu of 0.21 mg/kg was idntifid, whil in othr trial sampls rsidus rangd from < mg/kg. No dtails on possibl outlir wr providd and thrfor this valu was includd in th MRL data bas. Th sampls prior to analysis wr stord dp frozn for lss than 3 months thrfor not xcding th dmonstratd storag stability priod of 6 to 12 months for pymtrozin in high watr contnt commoditis (Grmany, 1998). According to th RMS, th analytical mthod usd to analys rsidu trial sampls is considrd as sufficintly valid and fit for purpos. EFSA concluds that an MRL of 0.3 mg/kg would b rquird to support th proposd us of pymtrozin on spinach. An xtrapolation of rsidu data from spinach to bt lavs (chard) and purslan is supportd. 8

9 Tabl 3-1. Ovrviw of th availabl rsidus trials data Commodity Spinach Bt lavs (chard), purslan Rgion (a) Outdoor /Indoor Individual trial rsults (mg/kg) Enforcmnt (pymtrozin) NEU Outdoor <0.01; <0.01; 0.02; 0.02; 0.21 Risk assssmnt (pymtrozin) <0.01; <0.01; 0.02; 0.02; 0.21 STMR (mg/kg) (b) HR (mg/kg) (c) MRL proposal (mg/kg) Mdian CF (d) Commnts R br =0.23 R max =0.42 (a): NEU, SEU, EU or Import (country cod). In th cas of indoor uss thr is no ncssity to diffrntiat btwn NEU and SEU. (b): Mdian valu of th individual trial rsults according to th nforcmnt rsidu dfinition. (c): Highst valu of th individual trial rsults according to th nforcmnt rsidu dfinition. (d): Th mdian convrsion factor for nforcmnt to risk assssmnt is obtaind by calculating th mdian of th individual convrsion factors for ach rsidus trial. 9

10 Effct of industrial procssing and/or houshold prparation Th ffct of procssing on th natur of pymtrozin rsidus was not invstigatd in th pr rviw (Grmany, 1998). No studis invstigating th ffct of procssing on th magnitud of pymtrozin in spinach hav bn submittd undr th currnt application. Such studis, howvr, ar not considrd ncssary considring th low contribution of ths crops to th total ditary intak Rotational crops Prliminary considrations Spinach can b grown in a crop rotation. Th rat of dgradation of pymtrozin in soil was invstigatd in th framwork of th pr rviw of Dirctiv 91/414/EEC (Grmany, 1998). According to laboratory studis, th DT 90 valu of pymtrozin is within a rang of days; according to fild studis, th DT 90 valu is within a rang of days. Svral soil mtabolits wr idntifid having DT 90 valus of mor than 100 days. Consquntly th occurrnc of pymtrozin rsidus in rotational crops has to b invstigatd Natur of rsidus Th natur of pymtrozin rsidus in rotational crops was invstigatd undr th pr rviw of Dirctiv 91/414/EEC (Grmany, 1998, 1999). In th study I 14 C-triazin lablld pymtrozin was applid to a bar soil at an application rat of 0.46 kg a.s/ha and th following crops wr plantd as rotational crops: lttuc (36 DAT), wintr what (3 months aftr th soil tratmnt), maiz (10 months aftr th soil tratmnt) and sugar bt (9 months aftr th soil tratmnt). In th study II 14 C-pyridin lablld pymtrozin was applid to a bar soil at an application rat of 0.5 kg a.s./ha and 36 DAT lttuc was plantd, 91 DAT what and maiz and 307 DAT sugar bt wr sown. In study III 14 C-triazin and 14 C-pyridin pymtrozin was applid on a bar soil at an application rats of and kg a.s./ha and 30, 60, 95, 122 and 361 DAT what, radish and mustard wr plantd. In study I and II th TRR in dibl parts of matur crops wr blow th 0.01 mg quiv./kg. Th highst TRR was idntifid in what stalks (0.06 mg quiv./kg), what husks (0.023 mg quiv./kg) and matur corn stalks (0.027 mg quiv./kg). In study III th crop sampls from all planting intrvals had th TRR > 0.01 mg/kg. Th TRR (mg quiv./kg) from triazin and pyridin studis in all plant-back intrvals (PBI) in matur crops wr in th rang of (360 d) (30 d) mg/kg in what grain, (360d) (30d) mg/kg in what foddr, 0.011(120 d) (30d) mg/kg in mustard lavs and (120d) 0.06 (30d) mg/kg in radish roots. Mtabolism studis indicat xtnsiv mtabolism of pymtrozin via soil uptak in plants. Pymtrozin is partially transformd in th soil prior to absorption in th plants. Hydrolysis of th namin bridg is th major pathway. Th highst magnitud of parnt pymtrozin in crop sampls was mg/kg. Th only mtabolit bing idntifid >0.05 mg/kg was glucosid of GS in immatur what forag plantd 30 DAT. For th pr rviw it was concludd that th mtabolism of 7 GS 23199: 6-mthyl-1,2,4-triazin-3,5 (2H, 4H)-dion 10

11 pymtrozin in rotational crops procds in a similar pathway as in primary plants and consquntly th rsidu in rotational crops for th risk assssmnt and nforcmnt purposs is to b dfind as parnt pymtrozin Magnitud of rsidus No fild rotational crop studis ar availabl. According to th mtabolism studis rportd in sction , it can b concludd that no significant pymtrozin rsidus ar xpctd in rotational and/or succding crops providd that pymtrozin on spinach is applid according to th proposd GAP Natur and magnitud of rsidus in livstock Spinach and similar lavs ar not usd as livstock fd and thrfor th natur and magnitud of pymtrozin rsidus in livstock was not invstigatd undr th currnt application. 4. Consumr risk assssmnt Th consumr xposur assssmnt was prformd with rvision 2 of th EFSA PRIMo (Psticid Rsidu Intak Modl) (EFSA, 2007). For th chronic xposur assssmnt th drivd STMR valu for spinach was usd as an input valu for spinach, bt lavs (chard) and purslan. For th rmaining crops th MRLs stablishd in th Rgulation (EC) No 396/2005 wr takn as input valus. For th acut risk assssmnt th HR valu as drivd from th rsidu trials on spinach was usd as an input valu for spinach, purslan and bt lavs (chard). Th input valus for th consumr xposur calculation ar summarizd in th Tabl 4-1. Tabl 4-1. Input valus for th consumr xposur assssmnt Commodity Chronic xposur assssmnt Acut xposur assssmnt Input valu (mg/kg) Commnt Risk assssmnt rsidu dfinition for plant commoditis: pymtrozin Spinach, purslan, bt lavs (chard) Othr commoditis of plant and animal origin Input valu (mg/kg) Commnt 0.02 STMR 0.21 HR MRL S Appndix C Acut xposur assssmnt was prformd only with rgard to crops undr considration. Th summary of th consumr xposur calculation is providd in Appndix B to this rasond opinion. Th calculatd long-trm and short-trm xposur was thn compard with th ADI and ARfD, rspctivly, as drivd for pymtrozin. No long-trm consumr intak concrns wr idntifid for any of th Europan dits. Th total calculatd intak accountd for a maximum of 22 % of th ADI. Th individual contribution of spinach to th total ditary intak accounts for a maximum of 0.047% of th ADI (Frnch toddlr dit) and for lss than 0.005% of th ADI for chard and purslan. 11

12 No short-trm consumr intak concrns wr idntifid with rgard to th xposur of pymtrozin rsidus from th intak of spinach and similar lavs. Th highst acut xposur would b from th intak of spinach (4.7% of th ARfD), followd by purslan (3.7 % of th ARfD) and bt lavs (3.2 % of th ARfD). It is concludd that th intndd us of pymtrozin on spinach and similar (lavs) will not rsult in consumr xposur concrns and th xcdanc of th toxicological rfrnc valus. 12

13 CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS Th toxicological profil of pymtrozin was sufficintly addrssd in th pr rviw to conclud on an ADI valu of 0.03 mg/kg bw/day and an ARfD of 0.1 mg/kg bw. Th mtabolism of pymtrozin was invstigatd in four crop groups (crals, fruit and fruiting vgtabls, oilsds and root and tubr vgtabls) whr a similar mtabolic pathway was obsrvd. Th nforcmnt and risk assssmnt rsidu dfinitions ar stablishd for all plant commoditis as pymtrozin only. No additional mtabolism studis on lafy crops ar rquird. An adquat analytical mthod is availabl to nforc th proposd MRLs in spinach and similar (lavs). Th submittd suprvisd rsidu trials indicat that a MRL of 0.4 mg/kg for spinach, purslan and bt lavs (chard) would b rquird to support th proposd us on ths crops in Grmany. Th ffct of procssing on th natur of pymtrozin rsidus has not bn invstigatd. No studis as wll hav bn submittd by th applicant on th ffcts of procssing on th magnitud of pymtrozin rsidus in procssd spinach (or in purslan or bt lavs (chard)). Howvr, such studis ar not considrd ncssary taking into account th low contribution of ths crops to th total ditary intak. Th occurrnc of pymtrozin rsidus in rotational crops was also invstigatd. Similar mtabolic pathway of pymtrozin in rotational and in primary crops is obsrvd and nforcmnt and risk assssmnt rsidu dfinition in rotational crops is stablishd as pymtrozin only. Providd that pymtrozin is applid to spinach according to th proposd GAP, no significant pymtrozin rsidus ar xpctd to occur in rotational and/or succding crops. Crops undr considration ar normally not usd as livstock fd and thrfor th natur and magnitud of pymtrozin rsidus in th food of animal origin was not invstigatd. Th consumr xposur assssmnt was prformd with rvision 2 of th EFSA PRIMo. For th chronic xposur assssmnt th drivd STMR valu for spinach was usd as an input valu for spinach and similar (lavs). For th rmaining crops th MRLs stablishd in th Rgulation (EC) No 396/2005 wr takn as input valus. For th acut risk assssmnt th HR valu as drivd from th rsidu trials on spinach was usd as an input valu for spinach and similar (lavs). Th calculatd long-trm and short-trm xposur was thn compard with th ADI and ARfD, rspctivly, as drivd for pymtrozin. No long-trm consumr intak concrns wr idntifid for any of th Europan dits. Th total calculatd intak accountd for a maximum of 22 % of th ADI. Th individual contribution of spinach to th total ditary intak accounts for a maximum of 0.047% of th ADI (Frnch toddlr dit) and for lss than 0.005% of th ADI for chard and purslan. No shorttrm consumr intak concrns wr idntifid with rgard to th xposur of pymtrozin rsidus from th intak of spinach and similar lavs. Th highst acut xposur would b from th intak of spinach (4.7% of th ARfD), followd by purslan (3.7 % of th ARfD) and bt lavs (3.2 % of th ARfD). It is concludd that th intndd us of ispoyrazam on spinach and similar (lavs) will not rsult in consumr xposur concrns and th xcdanc of th toxicological rfrnc valus. 13

14 RECOMMENDATIONS a Commodity Existing EC MRL (mg/kg) Proposd EC MRL (mg/kg) Justification for th proposal Enforcmnt rsidu dfinition: Pymtrozin Spinach 0.02* 0.4 Th MRL proposals ar Purslan 0.02* Bt lavs (chard) 0.02* 0.4 a according to Annx I of Rgulation (EC) No 396/2005 (*): Indicats that th MRL is st at th limit of analytical quantification. REFERENCES sufficintly supportd by data and no risk for consumrs was idntifid for th intndd us. Notifir has to confirm that th GAP applis also to purslan. CEN (Europan Committ for Standardization), 2008a. Foods of plant origin Dtrmination of psticid rsidus using LC-MS/MS following mthanol xtraction and clan-up using diatomacous arth. EN 15637, Novmbr CEN (Europan Committ for Standardization), 2008b. Foods of plant origin Dtrmination of psticid rsidus using GC-MS and /or LC-MS/MS following actonitril xtraction/partitioning and clan-up by disprsiv SPE- QuEChERS mthod. EN 15662, Novmbr Grmany, Evaluation rport on th modification of MRLs for pymtrozin in spinach and similar lavs prpard by th valuating Mmbr Stat Grmany undr Articl 8 of Rgulation (EC) No 396/2005, 7 April Grmany, Draft Assssmnt Rport (DAR) on th activ substanc pymtrozin, prpard by th rapportur Mmbr Stat Grmany in th framwork of Dirctiv 91/414/EEC, April Grmany, Addndum to th Draft Assssmnt Rport (DAR) on th activ substanc pymtrozin, prpard by th rapportur Mmbr Stat Grmany in th framwork of Dirctiv 91/414/EEC, April Europan Commission, Rviw rport for th activ substanc pymatrozin finalisd in th Standing Committ on Plant Halth at its mting on 29 Jun 2001 in viw of th inclusion of pymtrozin in Annx I of Dirctiv 91/414/EEC, 7455/VI/98- Final, 2 July Europan Commission, 1997a. Appndix A Mtabolism and distribution in plants. 7028/VI/95-rv. 3, 22 July Europan Commission, 1997b. Appndix B Gnral rcommndations for th dsign, prparation and ralization of rsidu trials. Annx 2 Classification of (minor) crops not listd in th Appndix of Council Dirctiv 90/642/EEC. 7029/VI/95-rv. 6, 17 August Europan Commission, 1997c. Appndix C Tsting of plant protction products in rotational crops. 7524/VI/95-rv. 2, 22 July Europan Commission, Appndix D Guidlins on comparability, xtrapolation, group tolrancs and data rquirmnts for stting MRLs. 7525/VI/96-rv.8, 1 Fbruary Europan Commission, 1997d. Appndix E Procssing studis. 7035/VI/95 Rv 5, 22 July Europan Commission, Appndix F Mtabolism and distribution in domstic animals. 7030/VI/95-rv 3, 22 July

15 Europan Commission, Appndix G Livstock fding studis. 7031/VI/95 rv.4, 22 July Europan Commission, 1997f. Appndix H Storag stability of rsidus sampls. 7032/VI/95-rv.5, 22 July 1997 Europan Commission, 1997g. Appndix I Calculation of maximum rsidu lvls and safty intrvals.7039/vi/95, 22 July 1997 EFSA (Europan Food Safty Authority), Psticid Rsidu Intak Modl (PRIMo). Sptmbr EC (Europan Commission), Classs to b usd for th stting of EU psticid Maximum Rsidu Lvls (MRLs). SANCO 10634/2010 Rv. 0, finalizd in th Standing Committ on th Food Chain and Animal Halth at its mting of March Mir U. Ed., Growth Stags of mono- and dicotyldonous plants. BBCH Monograph, 2 nd Ed. Fdral Biological Rsarch Cntr of Agricultur and Forst, Braunschwig (Grmany). 15

16 APPENDIX A GOOD AGRICULTURAL PRACTICES (GAPS) Crop and/or situation (a) Spinach, stm chard Mmbr Stat or country F or G (b) Pst or group of psts controll d (c) Formulation rat pr tratmnt Typ (d-f) Conc. of a.s. (i) Grmany F Aphids WG 500 g/kg mthod, kind, if othr than spray (f-h) Application Application rat pr tratmnt PHI (days) (k) Growth stag and sason (j) spraying BBCH 9-19 At bginning of infstation and/or whn first symptoms/harmful organisms bcom visibl Rmarks: (a)in cas of group of crops th x classification should b usd (b) Outdoor or fild us (F), glasshous application (G) or indoor application (I) (c).g. biting and sucking inscts, soil born inscts, foliar fungi (d).g. wttabl powdr (WP), mulsifiabl concntration (EC), granul (GR) () Us CIPAC/FAO s whr appropriat (f) All abbrviations usd must b xplaind (g) Mthod,.g. high volum spraying, low volum spraying, sprading, dusting, drnch (h) Kind,.g. ovrall, broadcast, arial spraying, row, individual plant, btwn th plants Numbr (max) Intrval btwn applications kg a.s./ha, whr appropriat watr L/ha (i) g/kg or g/l (j) Growth stag at last tratmnt (Mir U. Ed., 2001) (k) PHI = Pr-harvst intrval (l) Rmarks may includ: Extnt of us/conomic importanc/rstrictions (.g. fding, grazing)/minimal intrvals btwn applications kg a.s./hl, whr appropriat

17 APPENDIX B PESTICIDE RESIDUES INTAKE MODEL (PRIMO) Pymtrozin Status of th activ substanc: Includd no. LOQ (mg/kg bw): proposd LOQ: Toxicological nd points ADI (mg/kg bw/day): 0.03 ARfD (mg/kg bw): 0.1 Sourc of ADI: EC Sourc of ARfD: EC Yar of valuation: 2002 Yar of valuation: 2002 Chronic risk assssmnt - rfind calculations TMDI (rang) in % of ADI minimum - maximum 4 22 No of dits xcding ADI: --- Highst calculatd TMDI valus in % of ADI MS Dit Highst contributor to MS dit (in % of ADI) Commodity / group of commoditis 2nd contributor to MS dit (in % of ADI) Commodity / group of commoditis 3rd contributor to MS dit (in % of ADI) Commodity / group of commoditis 22.1 WHO Clustr dit B 5.1 Tomatos 2.4 Lttuc 2.2 Bans (with pods) 20.8 NL child 3.4 Bans (with pods) 3.1 Orangs 1.4 Pas (without pods) 18.7 FR toddlr 7.4 Bans (with pods) 2.0 Orangs 1.3 Milk and cram, 17.3 DE child 3.8 Orangs 1.6 Tomatos 1.1 Cucurbits - dibl pl 14.6 IE adult 1.2 Blackbrris 1.1 Bans (with pods) 1.0 Orangs 14.1 FR infant 5.6 Bans (with pods) 1.1 Cucurbits - dibl pl 1.1 Cucurbits - dibl pl 12.4 ES child 2.8 Lttuc 2.2 Orangs 1.6 Tomatos 12.3 WHO rgional Europan dit 2.5 Lttuc 1.8 Tomatos 1.3 Bans (with pods) 12.1 UK Toddlr 2.0 Orangs 1.5 SUGAR PLANTS 1.5 SUGAR PLANTS 11.3 DK child 2.7 Cucurbits - dibl pl 2.7 Cucurbits - dibl pl 0.9 Lttuc 10.9 WHO clustr dit E 1.9 Bans (with pods) 0.9 Tomatos 0.8 Bans (without pods) 10.8 ES adult 3.6 Lttuc 1.6 Bans (with pods) 1.3 Tomatos 10.3 SE gnral population 90th prcntil 1.3 Tomatos 1.1 Cucurbits - dibl pl 0.7 Orangs 9.8 IT adult 2.5 Lttuc 1.9 Tomatos 1.1 Othr lttuc and othr salad 9.6 NL gnral 1.7 Bans (with pods) 1.5 Orangs 0.8 Lttuc 9.5 IT kids/toddlr 2.4 Tomatos 1.9 Lttuc 0.7 Othr lttuc and othr salad 8.8 UK Infant 1.9 Pas (without pods) 1.3 Orangs 1.3 Milk and cram, 8.4 WHO clustr dit D 1.7 Tomatos 0.8 Cucurbits - dibl pl 0.6 Cucurbits - indibl pl 8.3 WHO Clustr dit F 2.0 Lttuc 1.1 Tomatos 0.9 Orangs 7.1 FR all population 1.3 Othr lttuc and othr salad plants 0.9 Bans (with pods) 0.7 Tomatos 6.7 UK vgtarian 1.0 Tomatos 0.9 Lttuc 0.9 Orangs 6.0 PT Gnral population 1.5 Tomatos 0.9 Bans (without pods) 0.6 Ppprs 5.2 UK Adult 0.8 Lttuc 0.7 Tomatos 0.6 Orangs 4.8 FI adult 1.0 Orangs 0.7 Tomatos 0.5 Lttuc 4.7 LT adult 1.0 Tomatos 0.7 Cucurbits - dibl pl 0.7 Cucumbrs 4.0 DK adult 0.7 Tomatos 0.5 Cucurbits - dibl pl 0.4 Cucumbrs 3.5 PL gnral population 1.5 Tomatos 0.3 Ppprs 0.2 Potatos ptmrls at LOQ (in % of ADI) Conclusion: Th stimatd Thortical Maximum Daily Intaks (TMDI), basd on ptmrls wr blow th ADI. A long-trm intak of rsidus of Pymtrozin is unlikly to prsnt a public halth concrn. 17

18 Acut risk assssmnt /childrn - rfind calculations Acut risk assssmnt / adults / gnral population - rfind calculations Procssd commoditis Unprocssd commoditis Th acut risk assssmnt is basd on th ARfD. For ach commodity th calculation is basd on th highst rportd MS consumption pr kg bw and th corrsponding unit wight from th MS with th critical consumption. If no data on th unit wight was availabl from that MS an avrag Europan unit wight was usd for th IESTI calculation. In th IESTI 1 calculation, th variability factors wr 10, 7 or 5 (according to JMPR manual 2002), for lttuc a variability factor of 5 was usd. In th IESTI 2 calculations, th variability factors of 10 and 7 wr rplacd by 5. For lttuc th calculation was prformd with a variabilty factor of 3. Thrshold MRL is th calculatd rsidu lvl which would lads to an xposur quivalnt to 100 % of th ARfD. No of commoditis for which ARfD/ADI is xcdd (IESTI 1): No of commoditis for which No of commoditis for which ARfD/ADI No of commoditis for which ARfD/ADI is xcdd --- ARfD/ADI is xcdd (IESTI 2): --- is xcdd (IESTI 1): --- (IESTI 2): --- IESTI 1 *) **) IESTI 2 *) **) IESTI 1 *) **) IESTI 2 *) **) Highst % of ARfD/ADI Commoditis ptmrl/ thrshold MRL (mg/kg) Highst % of ARfD/ADI Commoditis ptmrl/ thrshold MRL (mg/kg) Highst % of ARfD/ADI Commoditis ptmrl/ thrshold MRL (mg/kg) Highst % of ARfD/ADI Commoditis ptmrl/ thrshold MRL (mg/kg) 4.7 Spinach 0.21 / Spinach 0.21 / Purslan 0.21 / Purslan 0.21 / Bt lavs (chard) 0.21 / Bt lavs 0.21 / Spinach 0.21 / Spinach 0.21 / Purslan 0.21 / Purslan 0.21 / Bt lavs (chard) 0.21 / Bt lavs (chard) 0.21 / - No of critical MRLs (IESTI 1) --- No of critical MRLs (IESTI 2) --- No of commoditis for which ARfD/ADI is xcdd: Highst % of ARfD/ADI Procssd commoditis No of commoditis for which ARfD/ADI --- is xcdd: --- ***) ***) ptmrl/ ptmrl/ thrshold MRL Highst % of Procssd thrshold MRL (mg/kg) ARfD/ADI commoditis (mg/kg) *) Th rsults of th IESTI calculations ar rportd for at last 5 commoditis. If th ARfD is xcdd for mor than 5 commoditis, all IESTI valus > 90% of ARfD ar rportd. **) ptmrl: provisional tmporary MRL ***) ptmrl: provisional tmporary MRL for unprocssd commodity Conclusion: For Pymtrozin IESTI 1 and IESTI 2 wr calculatd for food commoditis for which ptmrls wr submittd and for which consumption data ar availabl. No xcdanc of th ARfD/ADI was idntifid for any unprocssd commodity. For procssd commoditis, no xcdanc of th ARfD/ADI was idntifid. 18

19 APPENDIX C EXISTING EC MRLS Psticids - Wb Vrsion - EU MRLs (Fil cratd on 20/10/ :50) Groups and xampls of th MRLs apply (a) Pymtrozin FRUIT FRESH OR FROZEN; NUTS (i) Citrus fruit 0, Grapfruit (Shaddocks, 0,3 pomlos, swtis, tanglo (xcpt minola), ugli and othr hybrids) Orangs (Brgamot, 0,3 bittr orang, chinotto and othr hybrids) Lmons (Citron, lmon) 0, Lims 0, Mandarins (Clmntin, 0,3 tangrin, minola and othr hybrids) Othrs 0, (ii) Tr nuts (shlld or 0,02* unshlld) Almonds 0,02* Brazil nuts 0,02* Cashw nuts 0,02* Chstnuts 0,02* Coconuts 0,02* Hazlnuts (Filbrt) 0,02* Macadamia 0,02* Pcans 0,02* Pin nuts 0,02* Pistachios 0,02* Walnuts 0,02* Othrs 0,02* (iii) Pom fruit 0,02* Appls (Crab appl) 0,02* Pars (Orintal par) 0,02* Quincs 0,02* Mdlar 0,02* Loquat 0,02* Groups and xampls of th MRLs apply (a) Pymtrozin Othrs 0,02* (iv) Ston fruit Apricots 0, Chrris (swt chrris, 0,02* sour chrris ) Pachs (Nctarins and 0,05 similar hybrids) Plums (Damson, 0,02* grngag, mirabll, slo) Othrs 0,02* (v) Brris & small fruit (a) Tabl and win graps 0,02* Tabl graps 0,02* Win graps 0,02* (b) Strawbrris 0, (c) Can fruit Blackbrris Dwbrris 0,02* (Loganbrris, boysnbrris, and cloudbrris) Raspbrris 3 (Winbrris, arctic brambl/raspbrry, (Rubus arcticus), nctar raspbrris (Rubus arcticus x idaus)) Othrs 0,02* (d) Othr small fruit & brris Blubrris (Bilbrris ) 0,02* Cranbrris (Cowbrris 0,02* (rd bilbrris)) Currants (rd, black and 0,5 whit) Goosbrris (Including 0,5 hybrids with othr ribs spcis) Ros hips 0,02* Mulbrris (arbutus 0,02* brry) Azarol (mditranan 0,02* mdlar) (Kiwibrry (Actinidia arguta)) Eldrbrris (Black chokbrry (applbrry), mountain ash, buckthorn (sa sallowthorn), hawthorn, srvic brris, and othr 0,02* Groups and xampls of th MRLs apply (a) Pymtrozin trbrris) Othrs 0,02* (vi) Miscllanous fruit 0,02* (a) Edibl pl 0,02* Dats 0,02* Figs 0,02* Tabl olivs 0,02* Kumquats (Marumi 0,02* kumquats, nagami kumquats, limquats (Citrus aurantifolia x Fortunlla spp.)) Carambola (Bilimbi) 0,02* Prsimmon 0,02* Jambolan (java plum) 0,02* (Java appl (watr appl), pomrac, ros appl, Brazilan chrry Surinam chrry (grumichama Eugnia uniflora), ) Othrs 0,02* (b) Indibl pl, small 0,02* Kiwi 0,02* Lych (Litchi) (Pulasan, 0,02* rambutan (hairy litchi), mangostn) Passion fruit 0,02* Prickly par (cactus fruit) 0,02* Star appl 0,02* Amrican prsimmon 0,02* (Virginia kaki) (Black sapot, whit sapot, grn sapot, canistl (yllow sapot), and mammy sapot) Othrs 0,02* (c) Indibl pl, larg 0,02* Avocados 0,02* Bananas (Dwarf banana, 0,02* plantain, appl banana) Mangos 0,02* Papaya 0,02* Pomgranat 0,02* Chrimoya (Custard 0,02* appl, sugar appl (swtsop), llama and othr mdium sizd Annonaca) Guava (Rd pitaya or dragon fruit (Hylocrus 0,02* Groups and xampls of th MRLs apply (a) Pymtrozin undatus)) Pinappls 0,02* Brad fruit (Jackfruit) 0,02* Durian 0,02* Soursop (guanabana) 0,02* Othrs 0,02* VEGETABLES FRESH OR FROZEN (i) Root and tubr 0,02* vgtabls (a) Potatos 0,02* (b) Tropical root and tubr 0,02* vgtabls Cassava (Dashn, 0,02* ddo (Japans taro), tannia) Swt potatos 0,02* Yams (Potato ban (yam 0,02* ban), Mxican yam ban) Arrowroot 0,02* Othrs 0,02* (c) Othr root and tubr 0,02* vgtabls xcpt sugar bt Btroot 0,02* Carrots 0,02* Clriac 0,02* Horsradish (Anglica 0,02* roots, lovag roots, gntiana roots, ) Jrusalm artichoks 0,02* Parsnips 0,02* Parsly root 0,02* Radishs (Black radish, 0,02* Japans radish, small radish and similar varitis, tigr nut (Cyprus sculntus)) Salsify (Scorzonra, 0,02* Spanish salsify (Spanish oystrplant)) Swds 0,02* Turnips 0,02* Othrs 0,02* (ii) Bulb vgtabls 0,02* Garlic 0,02* Onions (Silvrskin 0,02* onions) Shallots 0,02* Spring onions (Wlsh 0,02* 19

20 Groups and xampls of th MRLs apply (a) Pymtrozin onion and similar varitis) Othrs 0,02* (iii) Fruiting vgtabls (a) Solanaca Tomatos (Chrry 0,5 tomatos, tr tomato, Physalis, gojibrry, wolfbrry (Lycium barbarum and L. chinns)) Ppprs (Chilli ppprs) Aubrgins (gg plants) 0,5 (Ppino) Okra, lady's fingrs Othrs 0,02* (b) Cucurbits - dibl pl 0, Cucumbrs 0, Ghrkins 0, Courgtts (Summr 0,5 squash, marrow (patisson)) Othrs 0, (c) Cucurbits-indibl pl 0, Mlons (Kiwano ) 0, Pumpkins (Wintr 0,2 squash) Watrmlons 0, Othrs 0, (d) Swt corn 0,02* () Othr fruiting 0,02* vgtabls (iv) Brassica vgtabls (a) Flowring brassica 0,02* Broccoli (Calabrs, 0,02* Chins broccoli, broccoli raab ) Cauliflowr 0,02* Othrs 0,02* (b) Had brassica Brussls sprouts 0,02* Had cabbag (Pointd 0,05 had cabbag, rd cabbag, savoy cabbag, whit cabbag) Othrs 0,02* (c) Lafy brassica 0, Chins cabbag (Indian (Chins) mustard, pak choi, Chins flat cabbag (tai goo choi), choi sum, pking 0,2 Groups and xampls of th MRLs apply (a) Pymtrozin cabbag (p-tsai), ) Kal (Borcol (curly 0,2 kal), collards, Portugus Kal, Portugus cabbag, cow cabbag) Othrs 0, (d) Kohlrabi 0,02* (v) Laf vgtabls & frsh hrbs (a) Lttuc and othr salad 2 plants including Brassicaca Lamb s lttuc (Italian 2 cornsalad) Lttuc (Had lttuc, 2 lollo rosso (cutting lttuc), icbrg lttuc, romain (cos) lttuc) Scarol (broad-laf 2 ndiv) (Wild chicory, rdlavd chicory, radicchio, curld lav ndiv, sugar loaf) Crss Land crss Rockt, Rucola (Wild 2 rockt) Rd mustard Lavs and sprouts of 2 Brassica spp (Mizuna, lavs of pas and radish and othr babylaf brassica crops (crops harvstd up to 8 tru laf stag)) Othrs (b) Spinach & similar 0,02* (lavs) Spinach (Nw Zaland 0,02* spinach, amaranthus spinach) Purslan (Wintr 0,02* purslan (minr s lttuc), gardn purslan, common purslan, sorrl, glassworth, Agrtti (Salsola soda)) Bt lavs (chard) 0,02* (Lavs of btroot) Othrs 0,02* (c) Vin lavs (grap lavs) 0,02* Groups and xampls of th MRLs apply (a) Pymtrozin (d) Watr crss 0,02* () Witloof 0,02* (f) Hrbs Chrvil Chivs Clry lavs (Fnnl 2 lavs, Coriandr lavs, dill lavs, Caraway lavs, lovag, anglica, swt cisly and othr Apiaca lavs) Parsly Sag (Wintr savory, 1 summr savory, ) Rosmary Thym (Marjoram, 1 organo) Basil (Balm lavs, mint, 1 ppprmint) Bay lavs (laurl) Tarragon (Hyssop) Othrs (Edibl flowrs ) (vi) Lgum vgtabls (frsh) Bans (with pods) 2 (Grn ban (frnch bans, snap bans), scarlt runnr ban, slicing ban, yardlong bans) Bans (without pods) 1 (Broad bans, Flagolts, jack ban, lima ban, cowpa) Pas (with pods) 1 (Mangtout (sugar pas, snow pas)) Pas (without pods) 1 (Gardn pa, grn pa, chickpa) Lntils Othrs (vii) Stm vgtabls (frsh) 0,02* Asparagus 0,02* Cardoons 0,02* Clry 0,02* Fnnl 0,02* Glob artichoks 0,02* Lk 0,02* Rhubarb 0,02* Groups and xampls of th MRLs apply (a) Pymtrozin Bamboo shoots 0,02* Palm harts 0,02* Othrs 0,02* (viii) Fungi 0,02* Cultivatd (Common 0,02* mushroom, Oystr mushroom, Shi-tak) Wild (Chantrll, 0,02* Truffl, Morl, Cp) Othrs 0,02* (ix) Sa wds PULSES, DRY 0,02* Bans (Broad bans, 0,02* navy bans, flagolts, jack bans, lima bans, fild bans, cowpas) Lntils 0,02* Pas (Chickpas, fild 0,02* pas, chickling vtch) Lupins 0,02* Othrs 0,02* OILSEEDS AND OILFRUITS (i) Oilsds Linsd 0,02* Panuts 0,02* Poppy sd 0,02* Ssam sd 0,02* Sunflowr sd 0,02* Rap sd (Bird 0,02* rapsd, turnip rap) Soya ban 0,02* Mustard sd 0,02* Cotton sd 0, Pumpkin sds (Othr 0,02* sds of cucurbitaca) Safflowr 0,02* Borag 0,02* Gold of plasur 0,02* Hmpsd 0,02* Castor ban 0,02* Othrs 0,02* (ii) Oilfruits 0,02* Olivs for oil production 0,02* Palm nuts (palmoil 0,02* krnls) Palmfruit 0,02* 20

21 Groups and xampls of th MRLs apply (a) Pymtrozin Kapok 0,02* Othrs 0,02* CEREALS 0,02* Barly 0,02* Buckwhat 0,02* (Amaranthus, quinoa) Maiz 0,02* Millt (Foxtail millt, 0,02* tff) Oats 0,02* Ric 0,02* Ry 0,02* Sorghum 0,02* What (Splt, tritical ) 0,02* Othrs 0,02* TEA, COFFEE, HERBAL 0,1* INFUSIONS AND COCOA (i) Ta (drid lavs and stalks, frmntd or othrwis of Camllia sinnsis) 0, (ii) Coff bans 0,1* (iii) Hrbal infusions (drid) 0,1* (a) Flowrs 0,1* Camomill flowrs 0,1* Hybiscus flowrs 0,1* Ros ptals 0,1* Jasmin flowrs 0,1* (Eldrflowrs (Sambucus nigra) ) Lim (lindn) 0,1* Othrs 0,1* (b) Lavs 0,1* Strawbrry lavs 0,1* Rooibos lavs (Ginkgo 0,1* lavs) Maté 0,1* Othrs 0,1* (c) Roots 0,1* Valrian root 0,1* Ginsng root 0,1* Othrs 0,1* (d) Othr hrbal infusions 0,1* (iv) Cocoa (frmntd 0,1* bans) (v) Carob (st johns brad) 0,1* HOPS (drid), including 15 Groups and xampls of th MRLs apply (a) Pymtrozin hop pllts and unconcntratd powdr SPICES 0,1* (i) Sds 0,1* Anis 0,1* Black caraway 0,1* Clry sd (Lovag 0,1* sd) Coriandr sd 0,1* Cumin sd 0,1* Dill sd 0,1* Fnnl sd 0,1* Fnugrk 0,1* Nutmg 0,1* Othrs 0,1* (ii) Fruits and brris 0,1* Allspic 0,1* Anis pppr (Japan 0,1* pppr) Caraway 0,1* Cardamom 0,1* Junipr brris 0,1* Pppr, black and whit 0,1* (Long pppr, pink pppr) Vanilla pods 0,1* Tamarind 0,1* Othrs 0,1* (iii) Bark 0,1* Cinnamon (Cassia ) 0,1* Othrs 0,1* (iv) Roots or rhizom 0,1* Liquoric 0,1* Gingr 0,1* Turmric (Curcuma) 0,1* Horsradish 0,1* Othrs 0,1* (v) Buds 0,1* Clovs 0,1* Caprs 0,1* Othrs 0,1* (vi) Flowr stigma 0,1* Saffron 0,1* Othrs 0,1* (vii) Aril 0,1* Mac 0,1* Othrs 0,1* Groups and xampls of th MRLs apply (a) Pymtrozin SUGAR PLANTS 0,02* Sugar bt (root) 0,02* Sugar can 0,02* Chicory roots 0,02* Othrs 0,02* PRODUCTS OF ANIMAL ORIGIN- TERRESTRIAL ANIMALS (i) Mat, prparations of 0,01* mat, offals, blood, animal fats frsh chilld or frozn, saltd, in brin, drid or smokd or procssd as flours or mals othr procssd products such as sausags and food prparations basd on ths (a) Swin 0,01* Mat 0,01* Fat fr of lan mat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (b) Bovin 0,01* Mat 0,01* Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (c) Shp 0,01* Mat 0,01* Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (d) Goat 0,01* Mat 0,01* Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* () Horss, asss, muls or 0,01* hinnis Mat 0,01* Groups and xampls of th MRLs apply (a) Pymtrozin Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (f) Poultry -chickn, gs, 0,01* duck, turky and Guina fowl-, ostrich, pigon Mat 0,01* Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (g) Othr farm animals 0,01* (Rabbit, Kangaroo) Mat 0,01* Fat 0,01* Livr 0,01* Kidny 0,01* Edibl offal 0,01* Othrs 0,01* (ii) Milk and cram, not 0,01* concntratd, nor containing addd sugar or swtning mattr, buttr and othr fats drivd from milk, chs and curd Cattl 0,01* Shp 0,01* Goat 0,01* Hors 0,01* Othrs 0,01* (iii) Birds' ggs, frsh 0,01* prsrvd or cookd Shlld ggs and gg yolks frsh, drid, cookd by staming or boiling in watr, mouldd, frozn or othrwis prsrvd whthr or not containing addd sugar or swtning mattr Chickn 0,01* Duck 0,01* Goos 0,01* Quail 0,01* Othrs 0,01* 21

22 Groups and xampls of th MRLs apply (a) (iv) Hony (Royal jlly, polln) (v) Amphibians and rptils (Frog lgs, crocodils) (vi) Snails (vii) Othr trrstrial animal products Pymtrozin 22

23 ABBREVIATIONS a.s. activ substanc ADI accptabl daily intak ARfD acut rfrnc dos BBCH growth stags of mono- and dicotyldonous plants (Mir, 2001) bw body wight CAC x Alimntarius Commission CF CXL d DAR DAT DM DP DT 90lab DT 90f dw EC EDI EFSA EMS EU F FAO G GAP GS ha hl HPLC HR ILV ISO convrsion factor for nforcmnt rsidu dfinition to risk assssmnt rsidu dfinition x maximum rsidu limit day Draft Assssmnt Rport (prpard undr Council Dirctiv 91/414/EEC) days aftr tratmnt dry mattr dustabl powdr priod rquird for 90 prcnt dissipation (laboratory studis) priod rquird for 90 prcnt dissipation (fild studis) dry wight mulsifiabl concntrat stimatd daily intak Europan Food Safty Authority valuating Mmbr Stat Europan Union Fild us (outdoor) Food and Agricultur Organisation of th Unitd Nations Glasshous us (indoor) good agricultural practic growth stag hctar hctolitr high prformanc liquid chromatography highst rsidu indpndnt laboratory validation Intrnational Organization for Standardization 23

24 IUPAC JMPR K oc L LC LC-MS LC-MS-MS LOAEL LOD LOQ MRL MS NEU NOAEL PF PHI PRIMo R br R max RMS SEU STMR TMDI TRR WHO Intrnational Union of Pur and Applid Chmistry Joint FAO/WHO Mting on Psticid Rsidus organic carbon adsorption cofficint litr liquid chromatography liquid chromatography-mass spctromtry liquid chromatography with tandm mass spctromtry lowst obsrvd advrs ffct lvl limit of dtction limit of quantification maximum rsidu limit Mmbr Stats northrn Europan Union no obsrvd advrs ffct lvl procssing factor pr harvst intrval Psticid Rsidus Intak Modl statistical calculation of th MRL by using a non-paramtric mthod statistical calculation of th MRL by using a paramtric mthod rapportur Mmbr Stat Southrn Europan Union suprvisd trials mdian rsidu thortical maximum daily intak total radioactiv rsidu World Halth Organisation 24