Agenda Item 11 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON PESTICIDE RESIDUES 48 th Session Chongqing, P.R. China, April 2016

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Agenda Item 11 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON PESTICIDE RESIDUES 48 th Sessin Chngqing, P.R. China, 25-30 April 2016 CRD21 GUIDANCE DOCUMENT ON RISK ASSESSMENT USING BREW FACTOR FOR FIXATION OF MRLS OF PESTICIDES IN TEA (Prepared by Indian and Chinese delegatins, Wrking Grups n MRL and Tea Brew f FAO-IGG n Tea with cmments frm USA, Japan and Sri Lanka) SUMMARY Tea is mstly cnsumed after brewing dry tea leaves in ht water. Risk assessment n the basis f slid dry tea leaf is a grss verestimatin and will eliminate a number f useful cmpunds as nly a prtin f the residues in dry tea leaves is actually transferred int tea brew (liqur). The main reasn fr ppsitin t fixing MRL in tea brew is that the brew is nt the cmmdity n sale. The FAO-Intergvernmental Grup (IGG) n Tea Wrking grups n MRL and Tea Brew, therefre, had a detailed discussin n the issue and as a way frward suggested the fllwing apprach t be adpted in sequence: Generatin f data n residues in dry tea leaves and tea brew. Determinatin f brew factr (Rati f residues in brew t residues in dry tea leaves). Carry ut risk assessment n brew factr. Multiply [HR r STMR x Dry tea leaf cnsumed] by BF (Brew Factr) t btain TMDIb Cmpare TMDIb with Risk assessment f Prpsed MRL (MRLp) n brew factr. Multiply [MRLp x Dry tea leaf cnsumed] with BF t btain TMDIb (MRLp) Cmpare TMDIb(MRLp) with Data submissin t regulatrs fr fixatin f MRL in tea. This apprach will ensure fd safety as well as prvide setting realistic MRLs in tea that wuld als nt cntradict with ne f the purpses f the Cdex MRLs as MRLs fr trade and it wuld als nt be unfair t grwers with critical GAP (Gd Agricultural Practices). Thus, this apprach will have mre acceptability than the prpsal t set MRLs in tea brew in general and will help fixing realistic MRLs withut jepardizing fd safety and smth trade. Nte: 1. Brew Factr (BF) = Residues in tea brew Residues in dry tea leaves. 2. Brew Factr is distinctly different frm Prcessing Factr. [Prcessing Factr = Residues in fresh tea shts Residues in dry tea leaves]. 3. MRLp btained frm OECD MRL Calculatr. 4. TMDI: Theretical Maximum Daily Intake. 5. TMDIb: Theretical Maximum Daily Intake with brew factr incrprated. 6. : Acceptable Daily Intake. 7. HR: Highest Residues frm supervised trials. 8. STMR: Supervised Trials Median Residues.

PR48/CRD21 2 FAO-IGG ON TEA: WORKING GROUP ON MRL IN TEA BREW GUIDANCE DOCUMENT ON RISK ASSESSMENT USING BREW FACTOR FOR FIXATION OF MRLS OF PESTICIDES IN TEA 1 BACKGROUND The Wrking grups n MRL and Tea Brew f FAO-Intergvernmental (IGG) n Tea has presented a plicy dcument entitled Assessment f MRLs fr Pesticides in Tea presented by China and India at the 44th CCPR Sessin at Shanghai, China n 23-28 April 2012 under Agenda item 12 (b) supprted by tw reference dcuments [Ref Dc: PR 44 CRD 10 (China) & PR 44 CRD 29 (India)]. The presentatin highlighted the fact that thugh the dry tea leaves is the traded cmmdity, it is the brew r liqur which is the frm actually cnsumed. Hence all standard setting bdies including JMPR, Cdex and natinal regulatry agencies shuld cnsider the residue in tea brew r bth in brew and tea leaves, when setting MRLs. The cncept f using the brew factr (Barah et al., 2011) and cmpilatins f available data n extent f pssible transfer f pesticide residues int tea liqur frm dry tea (Chen, 2011) has served as the basis f this lgic. The cnsideratin fr taking int accunt the pesticide residues in tea infusin in the establishment f MRLs in tea was evident in the 44th CCPR Cmmittee cnclusin which mentined that The Cmmittee supprted the current prcedure f JMPR in the establishment f MRLs fr pesticides in tea and encuraged cuntries t submit relevant data / infrmatin n brewing factrs and standard methds t JMPR fr cnsideratin in estimatin f MRLs fr pesticides in tea. The recgnitin f brew factr has a great significance as it will pave the way fr setting realistic MRLs in tea as risk assessment n dry tea alne wuld have eliminated a number f useful prducts. MRLs fixed in tea after assessing risk t cnsumers n brew factr will satisfactrily ensure fd safety and shuld be acceptable t all stakehlders. It will als give the scpe fr upward revisin f many stringent MRLs set earlier n risk assessment n dry tea leaves alne. 2. Develpments at FAO-IGG n Tea FAO, Intergvernmental Grup n tea (IGG) and its Wrking Grup n MRL and Tea Brew held an intersessinal meeting n 17-18 Sept 2012 at Washingtn DC since the last CCPR 44 sessin held in Shanghai n 23-28 April 2012 decided t prepare a detail methdlgy and a plicy dcument n hw t apprach the regulatrs fllwing dispensatin in the 44th sessin f CCPR f the prpsal t fix MRL in tea n risk assessment using brew factr. This dcument will act as a guidance dcument fr fixing MRLs in tea and will be circulated t all members t assist them apprach natinal and internatinal regulatrs including manufacturers. 3. The Cncept The main reasn fr ppsitin t fixing MRL in tea brew was that the brew r the tea liqur is nt the cmmdity n sale. The Wrking grup n MRL and Tea Brew, therefre, had a detailed discussin n the issue and as a way frward suggested the fllwing apprach t be adpted in sequence: Generatin f data n residues in dry tea leaves and tea brew. Determinatin f brew factr. Risk assessment n brew factr. Risk assessment f Prpsed MRL (MRLp) n brew factr. Data submissin t regulatrs fr MRL fixatin in tea. This apprach will ensure fd safety as well as prvide setting realistic MRLs in tea that wuld als nt cntradict with ne f the purpses f the Cdex MRLs as MRLs fr trade and it wuld als nt be unfair t grwers with critical GAP (Gd Agricultural Practices). Thus, this apprach will have mre acceptability than the prpsal t set MRLs in tea brew in general. Risk assessment n the basis f slid tea is a grss verestimatin f risk and will eliminate a number f useful cmpunds. The prpsed apprach has scpe fr fixing realistic MRLs withut jepardizing fd safety and smth trade. This is als what has reflected in the cnclusin f the 44th CCPR meeting in China in April 2012 and als the recmmendatins f the Cre Cmmittee in India in 2011 that rate f transfer frm dry tea leaves t brew shuld be adpted by Fd Safety & Standards Authrity f India during risk assessment while fixing MRLs fr the three cmpunds namely, bifenthrin, imidaclprid and dimethate in tea. Use f such factrs relating t transfer f residues int tea infusin has in fact been reprted by Eurpean Fd Safety Authrity [EFSA Scientific reprt (2009), 267, 1-24] citing a prvisinal prcessing factr f 0.44 fr the pesticide flufenxurn residues fr green tea infusin. This dcument is therefre prepared t assist regulatrs while fixing MRLs f pesticide in tea.

PR48/CRD21 3 4. Scpe This dcument is applicable in assisting regulatrs, scientists r ther cmpetent bdies while fixing MRLs f pesticide in dry tea leaves (traded cmmdity) using brew factrs fr risk assessment. 5. Definitins and terms used in this dcument 5.1 Black Tea: As defined in ISO 3720 r equivalent natinal standards. 5.2 Green Tea: As defined in ISO 5.3 Dry tea leaves: Refers t any dry tea leaves f fermented tea (black tea), semi-fermented tea (Olng tea), nn-fermented tea (green tea, white tea) and pst-fermented tea (Pu-er tea). 5.4 Tea shts: Fresh green tea shts cmprising mstly 2 leaves and a bud, plucked t prduce dry tea leaves. 5.5 Brew: Tea liqur prduced by adding ht biling water t dry tea leaves. 5.6 Brew Factr: Brew Factr (BF) = Residues in tea brew Residues in dry tea leaves. 5.7 Prcessing Factr: Prcessing factr (PF)= Residues in fresh tea shts Residues in dry tea leaves. 5.8 : Acceptable Daily Intake 5.9 TMDI: Theretical Maximum Daily Intake 5.10 STMR: Supervised Trial Median Residues 6. Prcedure fr determinatin f Brew Factr T determine the brew factr, the data n residues f a pesticide in bth dry tea leaves and the residues in the tea brew prepared frm the same dry tea leaves are required. The brew factr can be determined frm residue data as fllws: Brew Factr (BF) = Residues in tea brew Residues in dry tea leaves (Equatin.1) The residue in tea brew is the residues in tea liqur expressed in mg per kg f dry tea leaves (black r green tea) used fr preparing the brew. It is btained by dividing the amunt f residues in brew (mg) by the amunt f black r green tea used (kg) fr preparing the brew. The residues in dry tea leaves (black r green tea) are expressed in mg/kg. The Brew Factr thus, has n units as illustrated in Table 1 and Table 2 Table 1. Residues f pesticides in black tea and in tea brew and Brew Factr Pesticides Rate f RBT RTB Brew Factr Transfer int applicatin (mg/kg black tea (BF) brew In field used) (RTB RBT) (BF 100) (%) (kg ai/hm2) Deltamethrin 0.0056 0.34 0.003 0.0090 0.90 Bifenthrin 0.08 0.83 0.038 0.0458 4.58 Fenprpathrin 0.03 1.38 0.002 0.0019 0.19 Hexacnazle 0.05 1.90 0.022 0.0114 1.14 Prpicnazle 0.25 1.66 0.218 0.1315 13.15 Nte: 1. RBT: Residues in black tea. 2. RTB: Residues in tea brew. [Adapted frm Barah, et al, (2011)]. Table 2. Residues f pesticides in green tea and in tea brew and Brew Factr Pesticides Rate f RGT RTB Brew Factr Transfer int applicatin (mg/kg green tea (BF) brew In field used) (RTB RBT) (BF 100) (%) (kg ai/hm2) Dimethate 0.36 1.34 1.32 0.983 98.3 Tlfenpyrad 0.122 8.93 0.018 0.002 0.2 Indxacarb 0.05 1.85 0.115 0.062 6.2 Fenitrthin 0.203 1.27 0.96 0.756 75.6 Malathin 0.405 7.76 6.70 0.863 86.3 Chlrfenapyr 0.045 2.55 0.0038 0.0015 0.15 Nte: 1. RGT: Residues in green tea. 2. RTB: Residues in tea brew. [Adapted frm Chen ZM et al, (2012) ].

PR48/CRD21 4 6. Brew Factr and rate f transfer f residues frm dry tea t tea brew The transfer f pesticide residues frm dry tea t tea brew (as percentage f residues in dry tea) is calculated frm the brew factr (BF) using the fllwing frmula: Transfer f residues int tea brew (%) = BF 100 (Equatin 2) The rate f transfer f residues f 5 pesticides tea leaves in black and 8 in green dry tea leaves t tea brew is indicated in the last clumn f Table 1 and Table 2 abve as calculated frm the brew factr. A number f scientific published literatures are available n transfer rate f pesticide residues frm dry tea leaves t tea infusin and the brew factrs fr each pesticide can als be calculated frm the published data. Typical examples f brew factrs that can be calculated frm the published data are illustrated in Table 3. Table 3. Transfer rate f pesticide residue frm dry tea leaves t tea brew and Brew Factr pesticide Transfer rate Water slubility References # Brew Factr* (%) (mg/l) (using Equatin 6.2) Alphacypermethrin 1.4 0.01 ((25 ) Barah and Brthakur 0.014 (1994) Cypermethrin 1.4-2.1 0.01 ((25 ) Chen Zngma et al, 0.014-0.021 (1986) 0.006 Jaggi et al (2001) 0.0006 DDT <1 0.0012 (25 ) Chen Zngma et al, 0.01 (taking 1% (1980) transfer) Deltamethrin <1 0.14-0.46 0.002 (25 ) Chen Zngma et al (1983). Manikanadan at el (2009) 0.9 Barah et al. (2011) 0.009 Fenprpathrin 0.19 0.014 Barah et al (2011) 0.0019 0.01 (taking 1% transfer) 0.0014 t 0.0046 0.14-2.63 Manikanadan (2009) 0.0014 0.0263 Hexacnazle 0.14-1.85 17 Manikanadan et al 0.0014-0.0185 (2009). 1.14 Barah et al. (2011) 0.0114 8.84-8.88 Kumar et al (2004) 0.0884-0.0888 Fenvalerate 10-30 0.002 Sharma. et al (2008) 0.1-0.3 Endsulfan 1.67-2.05 0.3 Manikanadan et al (2009) 0.0167 1.8 Jaggi et al (2001) 0.018 7.72-8.74 Chen Zngma et al 0.072-0.0874 (1998) Dicfl 2.2 0.8 Chen Zngma et al 0.022 1.64 (1988) 0.0164 0.1 Barah et al. (1994) 0.001 Jaggi et al (2001) Ethin 2.36 2 Barah et al. (1994), 0.0236 2.25-2.5 Manikanadan et al (2009) 0.0225 0.025 0.8 Jaggi et al (2001) 0.008 Fenazaquin 2.80 0.007 Kumar et al (2004) 0.028 3-22 Kumar et al (2005) 0.03-0.22 Permethrin 3.9-4.67 0.07 Chen Zngma et al 0.0396-0.0467 (1981) Bifenthrin 4.2-4.6 0.1 Chen Zngma et al 0.042-0.046 (1986) 1 1.5-14 Tewary et al (2005) 0.015-0.14 4.58 Barah et al (2011) 0.0458 Isxathin <5 0.001 Nagayama et al (1989) 0.05 (taking 5% transfer) Prthiphs <5 0.001 Nagayama et al (1989) 0.05 (taking 5% transfer) BHC 5-8 10(20 ) Chen Zngma et 0.05 0.08 al(1980) Prpicnazle 13.2 100 (20 ) Barah et al (2011) 0.132

PR48/CRD21 5 Pyridaben 6.68 0.1(25 ) Chen Zngma et al 0.0668 (1997) Chlrpyrifs 9.12 1.4 Manikanadan et al (2009) 0.0912 11 Ozbey et al (2007) 0.11 3.14 Jaggi et al (2001) 0.0314 Pirimiphs-ethyl 13.0 2.3 Ozbey et al (2007) 0.13 Mncrtphs 19.78 1000 Jaggi et al (2001) 0.1978 Quinalphs 21.4-44.5 17.8 (23 ) Chen Zngma et al 0.214 0.445 (1986) 8.04 Jaggi et al (2001) 0.0804 9.2 Manikanadan et al (2009) 0.092 Triazphs 29.06 39 Wu et al (2007) 0.296 Parathin-methyl 25.8 55 Jaggi et al (2001) 0.258 Imidaclprid 29.2-42.0 610 Gupta and Shanker 0.292-0.42 (2008) 62.2-63.1 Hu et al (2013) 0.622-0.631 Phsphamidn 33.3 1000 Jaggi et al (2001) 0.333 Chlrfenvinphs-E 45 145 Nagayama et al (1989) 0.45 Malathin 48.8-86.3 145 (23 ) Chen Zngma et al 0.488-0.863 (1980) 62.0 Ozbey et al (2007) 0.62 12.14 Jaggi et al (2001) 0.121 Chlrfenvinphs-Z 52 145 Nagayama et al (1989) 0.52 Acetamiprid 36.8-50 4200 Gupta and Shankar 0.368-0.50 (2008) 78.3-80.6 Hu et al (2013) 0.783-0.806 Fenitrthrin 69.7-75.6 19 Chen Zngma et al 0.697-0.756 (1991) 48 Nagayama et al (1989) 0.48 Methidathin 83 250 Nagayama et al (1989) 0.83 Dimethate 97.5-98.3 39800 Chen Zngma et al 0.975-0.983 (1991) 91 Ozbey et al (2007) 0.91 Cyhalthrin 1.73 0.004 Chen Zngma et al 0.0173 (1990) 0.11-1.15 Wu et al (2007) 0.0011-0.0115 Prpargite 23.6-40 0.215 Kumar et al (2005) 0.236-0.4 Thiamethxam 80.5-81.6 4100 Hu et al (2013) 0.805-0.816 Thiaclprid 49.7 184 Banerjee et al (2012) 0.497 Prfenfs 2.44-7.2 28 Pramanik et al(2005) 0.0244-0.072 *Nte: The Brew Factr shwn in the last clumn was calculated frm the transfer rate values published. 7. Prcedure fr assessment f risk frm pesticide residues in tea 7.1 Risk assessment n the residues in dry tea leaves In the current prcedure fr establishing MRLs in tea, the Theretical Maximum Daily Intake (TMDI) is cmputed frm the Highest Residues (HR) r Supervised Trial Median Residues (STMR) frm field trial data and the daily cnsumptin f dry tea leaves. TMDI = HR r STMR x Dry tea cnsumed daily (Equatin 3). The TMDI s cmputed is then cmpared with the Acceptable Daily Intake () per persn, fr a particular cmpund. Hwever, this cmparisn f TMDI (s btained) with is actually a grss verestimatin f ptential risk t cnsumers as the dry tea leaves are never cnsumed raw. In additin, the cnsequence f such verestimatin f risk will unduly eliminate a number f therwise useful pesticides that culd have been used fr effective management f pests and diseases in the tea plantatins.

PR48/CRD21 6 7.2 Risk assessment n the brew factr The use f brew factr gives much scpe fr assessing the actual intake f residues. The intake f pesticide residues can be calculated by multiplying the cncentratin f residues in dry tea by average daily per capita cnsumptin f tea. The actual intake f pesticide residues thrugh cnsumptin f tea liqur can be btained by multiplying the intake values btained abve by the brew factr as nly tea liqur is cnsumed. The dietary risk assessment thrugh cnsumptin f tea liqur can therefre be assessed by incrpratin f the brew factr in the intake calculatins as given belw; TMDIb = HR r STMR x Dry tea cnsumed daily x Brew Factr (Equatin 4). where, TMDIb is Theritical maximum Daily Intake n Brew factr Recent studies shwed that the actual intakes f residues thrugh tea cnsumptin can be determined by incrprating this new parameter termed brew factr in the cnventinal estimates f TMDI. The cmpund specific brew factr imprves risk assessment and will enable setting realistic maximum residue limits fr pesticides in tea. Illustratins n the use f brew factr fr assessing risk frm residues in teas are given belw: Illustratin-I Cmputatin f MRL fr Fenpyrximate in tea (Fr an Indian adult f 50kg weight) ( : 0.01 mg/kg bw) Pesticide Fenpyrxima te Highest Fd TMDI residue cnsumpti(mg/day s (HR) n (g) ) n HR TMDI (mg/day ) n prpse d MRL f 4 mg/kg (mg/k g/ day) per persn (mg/da y) % f per pers n n HR % f per persn n prpse d MRL 1.78 10 0.0178 0.04 0.01 0.5 3.56 8 4.0 1.78 10 0.0178 x 0.031* = 0.00055 2 0.0.04 x 0.031* = 0.00124 0.01 0.5 0.11 0.25 4.0 * [Brew Factr] # [ Obtained using OECD MRL Calculatr] #Prpse d MRL The MRL f 4 mg/kg fr fenpyrximate is prpsed fr dry tea leaves n TMDIb (calculated using brew factr) which is nly 0.26 percent f the per persn which is unlikely t be f any health cncern. Illustratin-II Cmputatin f MRL fr Indxacarb in tea (Fr a Chinese adult f 60 kg weight) ( : 0.01 mg/kg bw) Pesticide Indxacar b * [Brew Factr] Highest residue s (HR) Fd cnsumpti n (g) TMDI (mg/day) n HR TMDI (mg/day) n prpse d MRL f 3mg/kg (mg/k g /day) per persn (mg/day ) % f per pers n n HR % f per persn n prpse d MRL 1.85 13 0.02405 0.039 0.01 0.6 4.01 6.5 3 0.02405 0.039x x 0.062* 0.062*= 1.85 13 0.01 0.6 0.25 0.414 3 = 0.00248 0.00149 1 Prpse d MRL

PR48/CRD21 7 The MRL f 3 mg/kg fr Indxacarb is prpsed fr dry tea leaves n TMDIb (calculated using brew factr) which is nly 0.414 percent f the per persn which is unlikely t be f any health cncern. 7.3 Tea Brew preparatin methd Tea brew needs t be prepared using the dry tea leaves crrespnding t the GAP PHI which is (7 days fr tea) and fllwing the standard f Internatinal Organizatin fr Standardizatin (ISO) fr rganleptic testing f teas fr preparatin f infusin (ISO 3130:1980). This invlves extracting black/green/white tea leaves with biling ht water (1:50=black tea : ht water rati) fr 5-6 min, partitining the residues int an rganic slvent (n-hexane) and estimating the residues after cncentratin t suitable vlumes. 8. Brew factr vs Prcessing factr Brew factr has been defined earlier and dentes prprtin f residues that can be transferred frm dry tea leaves t tea brew, the frm which is finally cnsumed. On the ther hand the Prcessing factr refers t the prprtin f residues in raw agricultural cmmdity (here freshly plucked tea shts) t residues in dry tea leaves which has been btained after prcessing the fresh tea shts in factries. Since MRL is fixed n the dry tea leaves which is the traded cmmdity and nly the tea brew (ht water extract) is cnsumed, the use f the term Brew Factr will be mre relevant in case f tea than the term Prcessing Factr which may be applicable fr ther dry cmmdities directly cnsumed unlike tea. This explanatin is expected t remve any cnfusin fr thse regulatrs r ther users f this dcument wh are nt familiar with tea. 9. Determinatin f Natinal Estimated Daily Intake (NEDI) using brew factr Determinatin f any natinal estimates f daily intakes using the Brew factr fr assessing actual risk frm residues in tea can be made by suitable replacement f the fllwing parameters in the Illustratins- I & II as applicable fr a particular member cuntry / regin: (a) Daily Tea cnsumptin (g/persn/day) (b) Average adult bdy weight (kg) 10. Determinatin f Internatinal Estimated Daily Intakes (IEDI) r internatinal estimated shrt term intake (IESTI) using brew factr Determinatin f the lng-term dietary intakes are calculated by multiplying the STMRs, r recmmended MRLs by the average daily per capita cnsumptin estimated fr each cmmdity n the basis f the GEMS/Fd diets and summing the intakes fr each fd. Intrducing the brew factr as an additinal multiplicatin factr will refine these estimates as well by realistic prprtining f the cntributin f residues frm tea. The estimated amunt will then be cmpared with the acute reference dse (ARfD). The highest residue frm the supervised residue trials at maximum GAP was generally seen as the better ptin than the MRL fr shrt-term dietary intake calculatins. Intrducing the brew factr is illustrated belw: IESTI = [LP x HR x Brew factr] BW where, LP is large prtin f tea cnsumed (kg fd/day) used fr IESTI calculatin [97.5% f the daily cnsumptin f dry tea leaves] HR: Highest residues in the maximum PHI BW: Average bdy weight f adult. 11. Advantage f assessing intakes with brew factrs: The advantages f the brew factr assessment f risk frm residues whether ne is required t use the HR r the prpsed MRL depending n the bjective are indicated in Table 4 and Table 5.

PR48/CRD21 8 The brew factr will als help in bth shrt and lng term risk assessment t imprve the estimate f intake f pesticide residues in tea as a reductin factr which was fund t be cmpund specific. The illustratin shwed that the actual intakes f the residues f these seven pesticides were up t 526 fld lwer than the intakes predicted cnventinally. Table 6 illustrates the internatinal estimated daily intakes f these terminal residues in tea fr a 60 kg adult using the per capita tea cnsumptin figures fr five reginal diets used earlier (WHO, 2003). The 13 GEMS/Fd Cnsumptin Cluster Diets prpsed later [Ref: http://www.wh.int/fdsafety/ chem/cuntries.pdf] as well as the current 17 Cluster diets prpsed in 2012 can als be suitably cnsidered fr brew factr risk assessment fr MRL fixatin in tea. [Ref: http://www.wh.int/fdsafety/chem/gems/en/index1.html]. Table 7 illustrates estimated highest daily intakes f these terminal residues in green tea fr a 60 kg adult in China. The brew factr apprach f risk assessment has a greater significance as with the actual risk assessment fr assuring fd safety, there will als be ample scpe fr fixatin r revisin f MRLs in tea t realistic levels acceptable t all stakehlders. Table 4. Daily intake f pesticide residues in tea assessed with r withut brew factr fr an average Indian adult (Bdy weight: 50 kg) Residues Black tea in a Per capita black tea cnsump- tin (g) Brew Factr (BF) Intake (µg/persn) Withut BF [Cl 1 x Cl 2] With BF Intake as % f per persn (Withut BF) (With BF) [Cl 3 x [(Cl 4 Cl 4] ) x 100] 1 2 3 4 5 6 7 Bifenthrin (: 0.01 mg/kg bdy weight r 500 µg/persn) 0.83 10 0.0458 8.3 0.38014 1.66 0.076 5 (MRL) b 10 0.0458 50 2.29 10 0.458 Fenprpathrin (: 0.03 mg/kg bdy weight r 1500 µg/persn) 1.38 10 0.0019 13.8 0.02622 0.92 0.002 2 (MRL) b 10 0.0019 20 0.038 1.33 0.003 Deltamethrin (: 0.01 mg/kg bdy weight r 500 µg/persn) 0.34 10 0.009 3.4 0.0306 0.68 0.006 5 (MRL) b 10 0.009 50 0.45 10 0.09 Cypermethrin (: 0.005 mg/kg bdy weight r 250 µg/persn) 0.39 10 0.0051 d 3.9 0.01989 1.56 0.008 2 (MRLP) c 10 0.0051 d 20 0.102 8 0.041 [(Cl 5 ) x 100] L-cyhalthrin (: 0.02 mg/kg bdy weight r 1000 µg/persn) 0.18 10 0.0111 d 1.8 0.01998 0.18 0.002 1 (MRL) b 10 0.0111 d 10 0.111 1 0.011 Hexacnazle (: 0.005 mg/kg bdy weight r 250 µg/persn) 1.90 10 0.0114 19 0.2166 7.6 0.087 3 (MRLP) c 10 0.0114 30 0.342 12 0.137 Prpicnazle (: 0.04 mg/kg bdy weight r 2000 µg/persn) 1.66 10 0.1315 16.6 2.1829 0.83 0.109 2 (MRLP) c 10 0.1315 20 2.63 1 0.132 a Per capita tea cnsumptin: 10g in a ttal Indian diet f 1.5 kg/day b MRL: EU MRL; c MRLp: MRL prpsed fr this illustratin. d Calculated cnsidering the residues in tea brew at LOD (0.002 mg/kg). Surce f values: The Pesticide Manual (2006).

PR48/CRD21 9 Table 5. Daily intake f pesticide residues in green tea assessed with r withut brew factr fr an average Chinese adult (Bdy weight: 60 kg) Residues green tea in a Per capita green tea cnsumptin (g) Brew Factr (BF) Intake (µg/persn) Withut BF [Cl 1 x Cl 2] With BF Intake as % f per persn (Withut BF) (With BF) [Cl 3 x Cl 4] [(Cl 4 ) x 100] 1 2 3 4 5 6 7 Dimethate (: 0.002 mg/kg bdy weight r 120 µg/persn) 1.34 13 0.983 17.42 17.12386 14.51 14.26 0.05(MRL) b 13 0.983 0.65 0.63895 0.54 0.53 Imidaclprid (: 0.06 mg/kg bdy weight r 360 µg/persn) 1.07 13 0.28 13.91 3.8948 3.86 1.08 0.05 (MRL) b 13 0.28 0.65 0.182 0.18 0.05 Acetamiprid (: 0.07 mg/kg bdy weight r 4200 µg/persn) 5.46 13 0.85 70.98 60.333 1.69 1.43 0.1(MRL) b 13 0.85 1.3 1.105 0.03 0.03 Tlfenpyrad (: 0.0056 mg/kg bdy weight r 336 µg/persn) 8.93 13 0.002 116.09 0.23218 34.55 0.07 20(MRLP) c 13 0.002 260 0.52 77.38 0.15 Indxacarb (: 0.01 mg/kg bdy weight r 600 µg/persn) 1.85 13 0.062 24.05 1.4911 4.01 0.25 3(MRLP) c 13 0.062 39 2.418 6.5 0.40 Fenitrthin (: 0.006 mg/kg bdy weight r 360 µg/persn) 1.27 13 0.756 16.51 12.48156 4.59 3.47 0.05(MRL) b 13 0.756 0.65 0.4914 0.18 0.14 Malathin (: 0.03 mg/kg bdy weight r 1800 µg/persn) 7.76 13 0.863 100.88 87.05944 5.60 4.84 0.5(MRL) b 13 0.863 6.5 5.6095 0.36 0.31 Chlrfenapyr (: 0.003 mg/kg bdy weight r 180 µg/persn) 2.55 13 0.0015 33.15 0.049725 18.42 0.03 20(MRLP) c 13 0.0015 260 0.39 144.44 0.22 [(Cl 5 ) x 100] a Per capita tea cnsumptin: 13g in a ttal Chinese diet f 1.5 kg/day b MRL: EU MRL; c MRLp: MRL prpsed fr this illustratin Surce f values: The Pesticide Manual (2006). Table 6. Internatinal estimates f intake f pesticide residues in tea by a 60 kg adult assessed using brew factr Pesticides Residues in Black tea a Per capita black tea cnsumptin (g) Brew Factr (BF) Intake (µg) (µg/persn) Intake as % f [Cl 2 x Cl 3 x Cl 4] 1 2 3 4 5 6 7 Middle Eastern Bifenthrin 0.83 2.3 0.0458 0.0874322 600 0.0157 Fenprpathrin 1.38 2.3 0.0019 0.0060306 1800 0.0003 Deltamethrin 0.34 2.3 0.009 0.007038 600 0.0012 Cypermethrin 0.39 2.3 0.0051 0.0045747 300 0.0015 L-cyhalthrin 0.18 2.3 0.0111 0.0045954 1200 0.0004 Hexacnazle 1.90 2.3 0.0114 0.049818 300 0.0167 Prpicnazle 1.66 2.3 0.1315 0.502067 2400 0.0209 Far Eastern Bifenthrin 0.83 1.2 0.0458 0.0456168 600 0.0076 Fenprpathrin 1.38 1.2 0.0019 0.0031464 1800 0.0002

PR48/CRD21 10 Deltamethrin 0.34 1.2 0.009 0.003672 600 0.0006 Cypermethrin 0.39 1.2 0.0051 0.0023868 300 0.0008 L-cyhalthrin 0.18 1.2 0.0111 0.0023976 1200 0.0002 Hexacnazle 1.90 1.2 0.0114 0.025992 300 0.0087 Prpicnazle 1.66 1.2 0.1315 0.261948 2400 0.0109 African Bifenthrin 0.83 0.5 0.0458 0.019007 600 0.0032 Fenprpathrin 1.38 0.5 0.0019 0.001311 1800 0.0001 Deltamethrin 0.34 0.5 0.009 0.00153 600 0.0003 Cypermethrin 0.39 0.5 0.0051 0.0009945 300 0.0003 L-cyhalthrin 0.18 0.5 0.0111 0.000999 1200 0.0001 Hexacnazle 1.90 0.5 0.0114 0.01083 300 0.0036 Prpicnazle 1.66 0.5 0.1315 0.109145 2400 0.0045 Latin American Bifenthrin 0.83 0.5 0.0458 0.019007 600 0.0032 Fenprpathrin 1.38 0.5 0.0019 0.001311 1800 0.0001 Deltamethrin 0.34 0.5 0.009 0.00153 600 0.0003 Cypermethrin 0.39 0.5 0.0051 0.0009945 300 0.0003 L-cyhalthrin 0.18 0.5 0.0111 0.000999 1200 0.0001 Hexacnazle 1.90 0.5 0.0114 0.01083 300 0.0036 Prpicnazle 1.66 0.5 0.1315 0.109145 2400 0.0045 Eurpean Bifenthrin 0.83 2.3 0.0458 0.0874322 600 0.0146 Fenprpathrin 1.38 2.3 0.0019 0.0060306 1800 0.0003 Deltamethrin 0.34 2.3 0.009 0.007038 600 0.0012 Cypermethrin 0.39 2.3 0.0051 0.0045747 300 0.0015 L-cyhalthrin 0.18 2.3 0.0111 0.0045954 1200 0.0004 Hexacnazle 1.90 2.3 0.0114 0.049818 300 0.0167 Prpicnazle 1.66 2.3 0.1315 0.502067 2400 0.0209 a Surce f tea cnsumptin figures: WHO (2003) GEMS/Fd Reginal Diets Surce f values: The Pesticide Manual (2006). Table 7. Internatinal estimates highest intake f pesticide residues in green tea by a 60 kg adult assessed using the brew factr in China Pesticides Residues in green tea b Per capita green tea cnsumptin (g) Brew Factr (BF) Intake (µg) (µg/persn) Intake as % f [Cl 2 x Cl 3 x Cl 4] 1 2 3 4 5 6 7 Dimethate 1.34 13 0.983 1.4489 120 14.27 Tlfenpyrad 8.93 13 0.002 0.0196 336 0.07 Indxacarb 1.85 13 0.062 0.1262 600 0.25 Fenitrthin 1.27 13 0.756 1.0561 360 3.47 Malathin 7.76 13 0.863 7.3666 1800 4.84 Chlrfenapyr 2.55 13 0.0015 0.0042 180 0.03 Surce f values: The Pesticide Manual (2006).

PR48/CRD21 11 CONCLUSION Tea plant (Camellia sinensis) is the mst ppular beverage glbally and a cmmn man s drink. With the increasing awareness n the health benefits f tea, it is nly natural that mre and mre peple will turn t tea. Tea is prduced in mre than 45 cuntries and invlves intensive cultivatin practices. Tender tea shts are plucked and prcessed in factries t dry tea leaves (black r green) and is traded. Hwever, unlike ther agricultural and hrticultural crps, tea is never cnsumed directly. Cnsumers mstly drink the infusin f tea leaves in ht water. Hence fr assessing fd safety frm the pint f view f residues f crp prtectin prducts in tea, it is necessary t cnsider the residues in bth marketed but nt eaten frms as well as in brew the frm in which tea is cnsumed. A number f studies have indicated that nly a prtin f the residues detected in the dry tea leaves in fact are transferred int the liqur which led t the prpsal f brew factr risk assessment fr fixatin f MRLs f pesticides in tea. Fllwing dispensatin f this prpsal in the 44 th Sessin f CCPR held at Shanghai n April 23-28, 2012 and in pursuance f the decisin taken at the intersessinal meeting f the FAO-IGG n Tea held in Washingtn DC in Sept 17-18, 2012, this dcument is prepared as a guidance fr assessing risk frm pesticide residues in tea using brew factr fr fixatin f MRL in tea. The dcument aims at prviding the basis and prcedures with simple illustratin t assist regulatrs, reviewers and ther stakehlders invlved in MRL fixatin. Reference Banerjee D and Banerjee H (2012). Thiaclprid residues and its safety evaluatin in Darjeeling tea. Bull Envirn Cntam Txicl., 89(3):598-601. Barah A K, Brthakur Mnrama, Kalita J N, Hussain,T, Chwdury Kasturi and Nath R (2011). Pesticide Residues in Tea and their Intake assessment Using Brew Factr. Jurnal f Tea Science, 31 (4): 289-294. Barah A K and Brthakur M C (1994). Residues f alphamethrin in tea and its ptential daily intake. Pesticide Science Jurnal, 6(2): 161-166. Barah A K, Kalita J N, Cllier P D, and Barbra B C (1994). Residues f pesticides in made tea and ht water brew. In Prceedings f the 32nd Tcklai Cnference (pp196-211). Jrhat: TRA. Chen Z M (2012). Cmpilatin f available wrk. CRD 10 (44th CCPR 2012). Chen Z M and Wan H B. (1988). Factrs affecting residues f pesticides in tea. Pesticide Science, 23: 109-118. Chen Z M, and Liu G (2003). The fate f pesticides n tea plant and the predictin f pesticide residues in fresh leaves f tea plant. Internatinal Jurnal f Tea Science, 2(4): 109-118. Chen Z M, Wan H B and Xia W L (1992). Predictin n degradative rates f pesticides n tea plant, made tea and tea infusin. Bichem& Biphy Cmmunicatin, 189(1): 689-693 Chen ZM, Wan HB and Wang YH,(1986). Degradative dynamics f quinzphs in tea, Sinica, 13(3): 205-210. Chen ZM, Chen XF, Wang YH, Zhu YC, Xue YZ, Wan HB,Xia Q and Xia HL (1986). Applicatin f bifenthrin in tea pest management and residue research. Tea Science Research Jurnal, 32-42. Gupta M and Shanker A (2008). Persistence f Imidaclprid in tea and its transfer frm made tea t infusin. Fd Chemistry, 111: 805-810. Chen Z M, Han HQ, Yue R Z (1983). Degradatin f pyrethrid decis (NRDC 161) n tea-shts. Acta Entmlgica Sinica, 26:146-153. Chen Z Mand Yue R Z (1983).The degradative dynamics f pesticides in tea plant and the selective parameters f the safety pesticide design. Agricultural Sciences in China, 1: 62-79. Chen Z M, Han H Q andhe W K (1981). Degradatin pyrethrid permethrin (Nrdc 143) n tea-shts. Acta Entmlgica Sinica, 24: 9-16. Chen Z M and Liu G M (1997). Investigatin n the degradative dnamics f pridaben residues in tea. Pesticides, 36: 27-28. Chen Z M, Wan H Band Xia H L (1990). The fate f pesticides in plantatin crps and the design f parameters fr selecting suitable pesticides. Academic cnference prceedings: Recent develpments in the field f pesticides and their applicatin t pest cntrl. 328-337.

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