INTERSESSIONAL MEETING OF FAO IGG ON TEA, MILAN, ITAY, 15 - 16 OCTOBER 2015

REPORT OF THEWORKING GROUP ON MRL IN TEA (NOV 2014 TO SEPT 2015)

CHAIR: INDIA CO-CHAIR : UK

MEMBERS: CANDA, ARGENTINA

DR A K BAROOAH & MS KATIE DONNELLY

JOINT COORDINATORS, WG ON MRL

Background

The Working Group (WG) on MRLs in Tea was constituted in the Bali Meeting of the FAO-IGG on Tea in 2005 to assist data generation and submission as required for fixation of MRLs of pesticides in tea.

Pesticide residues in tea has been a major non-tariff trade barrier affecting tea trade globally.

A roadmap was prepared to work on 24 pesticides selected the on basis of global use pattern in 2005 in the 1st WG meeting at Kolkata.

The objective was to generate data for fixing Codex MRLs as well as to use the data for fixing national MRLs which may lead to harmonization.

Since then Codex MRLs in tea were fixed for 17 pesticides and the work of this initiative contributed to this process.

In 2008-2015, seven international MRLs for endosulfan (CAC and EPA), cypermethrin (CAC), bifenthrin (EPA) and indoxacarb (China, CAC and EU) have been regulated on the basis of data submitted by China and IGG.

Pesticide Agency Initial MRLs

(mg/kg)

Original proposed

MRLs(mg/kg)

Modified MRLs

(mg/kg)

Year of adoption

EndosulfanUS EPA 30 0.01 10 2008

CAC 300.01(EU

suggestion)10 2010

Cypermethrin CAC 200.01(EU

suggestion)15 2012

Bifenthrin US EPA 5 0.01 5 2009

IndoxacarbCAC not set not set 5 2014

EU 0.05 0.05 5 2015

China 3 5 5 2015

China & IGG Group initiative lead to change of MRLs in 2008-2015

The data also served as the basis for national & international MRLs.

Pesticides CODEX MRL (mg/kg) EU MRL (mg/kg)Paraquat 0.2 0.05*Methidathion 0.5 0.1*Clothianidin 0.7 0.7Fenpropathrin 2 2Chlorpyrifos 2 0.1*Indoxacarb 5 5Propargite 5 0.05*#Deltamethrin 5 5Endosulfan 10 30Etoxazole 15 15Cypermethrin 15 0.5Hexythiazox 15 4Thiamethoxam 20 20Permethrin 20 0.1*Bifenthrin 30 5Dicofol 40 20Flubendiamide 15 0.02*

[http://www.codexalimentarius.net/pestres/data/commodities/details.html?id=101 ]*Lower limit of analytical determination, # effective 3.10.2015

In 20th Session of the IGG on Tea (Colombo, 30 Jan - 1 Feb 2012)

The Group recommended that “harmonization of tea MRLs” be changed to "Achieve global cooperation obtaining MRLs in tea“.

Intergovernmental Action [Ref Doc:CCP 12/14 E, Feb 2012 ]

Canada 1 MRL [ Propiconazole ]

USA 8 MRLs [ Bifenthrin, Buprofezin, Clothianidin, Fenpropathrin, Fenpyroximate, Spiromesifen, Thiamethoxam & Tolfenpyrad]

Australia 6 MRLs [Temporary MRLs for Diquat, Fluazifop-butyl, Glufosinate ammonium, Paraquat, Imidacloprid & Azoxystrobin ]

Number of compounds under trial

Submission of data to JMPR

Capacity building for residue analysis

Cooperation in computation of dossiers

Feedback was sought from members to update the status

Identifying key issues to develop an action planon priority list

1. Priority list prepared & updated with 61 pesticides

Currently used compounds

Replacements for older chemicals

New pesticides with potential use in future

2. Data generation on residues in tea [China, India, Sri Lanka]

3. Data submission to Codex, national regulators

4. Scope of simultaneous submission for 10 other pesticides

In 21st Session of FAO-IGG on Tea at Bandung, held on 5-7 Nov 2014

Updates on the Priority List [Based on response from members]

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

1. Acetamiprid Yes4(Japan)4 (India) 8 (China)

40 (Jp), 50 (US)

2. Bifenthrin Yes6(Japan)2(India)

30 (Jp) , 30 (US) 30 (2011)

3. Buprofezin Submitted to EU 6(Japan) 30 (Jp), 20 (US)30 (codex, Green Tea)

4. Chlorfenapyr Yes 2(Japan)10 (China)

0.01 (US), 40 (Jp)

5.Chlorfluazuron Yes8 (Sri Lanka)2(Japan)

10 (Jp),Not submitted

6.Chlorpyrifos Yes2(Japan)6 (India)

10 (Jp), 2 (2005)

7.Chromafenozide Limited 2(Japan) 20 (Jp),

8.Clothianidin Yes 3(Japan)2 (India)

50 (Jp), 70 (US) 0.7 (2011)

9.Cypermethrin Yes2(Japan)4(India)

20 (Jp) 15 (2012)

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

10. Dimethoate Limited 1 (Jp)11. Emamectin Benzoate

In progress2(Japan)2(India)

0.5 (Jp)

12.Fenpropathrin Yes2(Japan)2 (India)

25 (Jp), 2 (US) 2 (2007)

13. Fenpyroximate Yes2(Japan)4 (India)

40 (Jp), 20 (US) 0.1 (Argentina)

14. Fipronil Yes8 (Sri Lanka)

0.002 (Jp)Not submitted

15.Flubendiamide Yes

2(Japan)2 (India)

50 (Jp) 50 (2011)

16. Flufenoxuron Yes 2(Japan) 15 (Jp)(8trials, 2014)

17.Imidacloprid Yes

2(Japan)8 (Sri Lanka)2 (India)

10 (Jp)(8trials, 2015)

18. Permethrin Limited 2(Japan) 20 (Jp)

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

19. Propargite Yes2(Japan)6 (India)

5 (Jp), 10 (US), 10 (India), 1 (Argentina)

5 (2004)

20. Spiromesifen Yes 2(Japan) 30 (Jp), 40 (US), 60 (Canada)

21. Thiacloprid Yes4 (Japan)2 (India)8(Registrant)

30 (Jp),

22.Thiamethoxam Yes 4 (Japan)4 (India)

20 (Jp), 20 (US) 20 (2011)

23. λ-Cyhalothrin Yes2(Japan)4 (India)

15 (Jp)

24. Indoxycarb Yes 8(China) 5 (2013)25. Dichorvos 0.1 (Jp)

26. NovaluronTo be generated

27. Abamectin

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

28. Acequinocyl In progress 4(Japan)0.5 (Argentina), 40 (Jp),

29. Chlofentezine 2(Japan) 20 (Jp)

30. Dicofol Yes 8(India)3(Jp), 5 (India)50(US)

50 (1997) Revoked,40 (2011)

31. Ethion Yes 12(India) 0.3(Jp), 5 (India)32. Etoxazole Yes 4(Japan) 15 (Jp), 15 (US) 33. Hexythiazox Yes Registration

for tea deleted (Jp)

35 (Jp),1 (Argentina)

15 (2012)Codex MRL [8 field trials conducted in India]

34. Milbemectin Limited 2(Japan) 0.7 (Jp)35. Permethrin Limited 2(Japan) 20 (Jp)

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

36. Polysulphide sulphur

Exempted

37. 2,4-D Limited 1 (India)38.Diuron In progress Not Regd in

Japan1 (Jp)

39. Glufosinate-ammonium

Limited Not registered in Japan

0.01 (India),0.3 (Jp)

40. Glyphosate Yes

2 (Japan) 0.5 (Argentina),1 (US) -- Leaf 7 (US) – Powder1 (Jp)

41. MCPA Yes 8 (Sri Lanka) Not submitted42. Metolachlor

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

43. Oxyfluorfen Limited 1 (India)

44. Paraquat Yes8 (Japan)2 (India)

0.3 (Jp) 0.2 (2006)

45. Azoxystrobin Yes 4 (Japan) 10 (Jp), 20 (US)

46. Bitertanol Yes 8 (Sri Lanka) 0.1 (Jp) Not submitted47. Chlorothalonil Limited 2 (Japan) 10 (Jp)

48. Copper hydroxide

Yes2 (India), Not Required in Japan

150 (India) as copper (ML), Exempted (Japan)

Joint Application with India

49. Copper Oxychloride

Yes

8 (Sri Lanka)4 (Japan)2 (India)

150 (India) as copper (ML),Exempted (US, Japan)

Joint Application with India

50. Copper oxide YesExempted (US, Japan)

51. Difenoconazol Limited 2 (Japan) 10 (Jp)

PesticidesData Availability

No of trials & Country

National MRLs[MRL (Country)]

Submission to Codex, MRL (date)

52 Hexaconazole Yes8 (Sri Lanka)3 (India)

0.05 (Jp) Not submitted

53. Propiconazole Yes8 (Sri Lanka)3 (India)

0.1 (Jp), 4 (Canada)

?

54. Pyroclostrobin Yes8 (Sri Lanka)2 (Japan)

5 (Jp) Not submitted

55. TebuconazoleIn progress

4 (Sri Lanka)2 (Japan), 1 India

50 (Jp) Not submitted

56. Thiophanate-methyl

Limited 2 (Japan) 7 (Jp) Not submitted

57. Trifloxystrobin Limited 3 (Japan) 5 (Jp) Not submitted58. Carboxim To be done Not submitted

59. Tolfenpyrad Available8 (China)4 (Japan)

20 (Jp), 50 (US) 30 (Codex, Green Tea)

Scope of Global cooperation in obtaining MRLs in tea

Aetamiprid: 8 trials data available [Scope for submission by Japan, India & China] Hexaconazole: 11 trials data available

[Scope for submission by Sri Lanka & India]

Propiconazole: 11 trials data available[Scope for submission by Sri Lanka & India]

Chlorfluazuron: 10 trials data available[Scope for submission by Sri Lanka & Japan]

Fipronil : 8 trials data available [Scope for submission by Sri Lanka]

Imidacloprid: 12 trials data available[Scope for submission by India, Japan, & Sri Lanka,

for Evaluation 2015)]

Flufenoxuron: 8 trials data [Evaluation 2014]

MCPA: 8 trials data [Scope for submission by Sri Lanka]

Ethion: 12 trials data [Scope for submission by India]

Pyroclostrobin: 8 trial data [Scope for submission by Sri Lanka]

λ-Cyhalothrin: 6 trials data available. Needs 2 more.

Buprofezin: 6 trials data available. Needs 2 more. [The data submitted to EU did not meet the requirements for EU]

Fenpyroximate: 4 trials data available, Needs 4 more.

Scope of Global cooperation in obtaining MRLs in tea

(1) To assess status of field trials required for setting Codex MRLs & submission of the list for advance notification to FAO-IGG & National Codex Points.

(2) To update priority list based on new information on Risk assessment, or Replacements or Potential use in Tea.

(3) To assess status & development of required infrastructure & new methods to cope with changing situations & cost.

(4) Communication plan for quick information exchange and advance notification for simultaneous data submission by members & seeking manufacturers support and to negate adverse publicity.

(5) Data submission to include brew factor based risk assessment for all teas traded globally except Matcha Tea.

(6) To share available information on anthraquinone and risk assessment in tea and tea brew.

Action plan

Progress made since 21st Session at Bandung held on 5-7 Nov 2014

1. Codex Priority list updation for fixation of MRLs in Tea

Ethion (2017), Profenophos (2017), Propiconazole, Hexaconazole (2017), L-Cyhalothrin (2017), Fenazaquin (2017), Acetamiprid (2017), Quinalphos (2017), Imidacloprid (2017),Tebuconazole (2017), Spiromesifen (2016, 2017), Dimethoate (2017), Carbendazim (2017), 2,4-D (2017), Bifenthrin (2017)

[Request was made through Indian delegation to 47th Session CCPR, China in April 2015]

Cyclaniliprole (2017), Pyraclostrobin (2017) and Pyrifluquinazon (2017). [The above 3 compounds were requested by the manufacturers].

CCPR accepted this request

Multi-locational supervised field trials were carried out Oct-Dec (2014) & May to Aug (2015) in India to generate additional data on 17 pesticides Emamectin Benzoate, Flubendiamide, Imidacloprid, Acetamiprid, Propiconazole, Thiamethoxam, Dimethoate, Hexaconazole, Fenpyroximate, Mancozeb, Bifenthrin, Clothainidin, Fenpyroximate, Profenophos, Hexythiazox, Cypermethrin & L-Cyhalothrin in tea to close the data gap for fixation of national MRLs.

The data as required will also be submitted throughNational Codex Point for JMPR evaluation.

2. Data generation for fixation of MRL in tea

Supervised field trials as par Good Agricultural Practice (GAP) were carried out in China in 2014 on 12 pesticides, viz., tolfenpyrad, indoxacarb, propargite, pyraclostrobin, chlorfluazuron, propiconazole, thiacloprid, imidacloprid, thiamethoxam, acetamiprid, dimethoate and dinotefuran.

Data generation work in China

3. Data submission for MRL fixation

Data on 9 pesticides (Bifenthrin, Clothinidin, Fenpropathrin,

Fenpyroximate, Hexythiazox, Hexaconazole, Propiconazole,

Thiamethoxam and Mancozeb) were submitted to FSSAI

Food Safety Authority of India in June 2015

for revision/fixation of national MRLs in tea

using brew factor for risk assessment.

Compound ThiamethoxamCrop TeaRegion / Country IndiaGAP 7 days

   Residues (mg/kg)

0.030  0.030  0.570  0.040  1.790  2.110  1.860           

Total number of data (n) 7Percentage of censored data 0%

Number of non-censored data 7Lowest residue 0.030Highest residue 2.110Median residue 0.570

Mean 0.919Standard deviation (SD) 0.961

Correction factor for censoring (CF) 1.000

Proposed MRL estimate 

- Highest residue2.110

- Mean + 4 SD 4.761- CF x 3 Mean 2.756

Unrounded MRL 4.761Rounded MRL 5

High uncertainty of MRL estimate.  [Small dataset]  

Proposed MRL in Tea is calculated using the OECD MRL calculator

Risk assessment carried out using the brew factor

Pesticide

Highest

residues

(HR)(mg/kg)

Food consum-ption

(g)

TMDI(mg/day)

based on HR

TMDI(mg/day)

based on

proposed MRL

of2

mg/kg

ADI(mg/kg/

day)

*ADI(mg/person/ day)

%of ADI per

personbased on HR

%of ADI per

personbased

on proposed MRL

Proposed MRL

(mg/kg)

Fenpyro-

ximate

1.78 10 0.0178 0.04 0.01 0.5 3.56 8.0 4.0

1.78 10 0.0178 x

0.031* =

0.000552

0.04x

0.031* =

0.00124

0.01 0.5 0.11 0.25 4.0

Computation of MRL for fenpyroximate in tea(*For an Indian adult of 50kg weight) (ADI : 0.01 mg/kg bw)

* [Brew Factor; Ref: Barooah et. al.,2011]

The proposed MRL of 4 mg.kg for fenpyroximate in tea should not be of health concern as it amounts to 0.25 % of the toxicological ref point (ADI).

MRL fixation in tea in China

Pesticides ClassificationChina MRL

mg/kgEU MRL

mg/kgJapan MRL

mg/kg

Acephate Insecticide 0.1 0.05* 10Bifenthrin Insecticide 5 5 30Buprofezin Insecticide 10 0.05* 30Carbendazim Fungicide 5 0.1* 10Carbofuran Insecticide 0.05 0.05* 0.2Cartap Insecticide 20 0.1* 30L-cyhalothrin,cyhalothrin Insecticide 15 1 15Cyfluthrin, beta-cyfluthrin Insecticide 1 0.1* 20Cypermethrin,beta-cypermethrin Insecticide 20 0.5 20DDT Insecticide 0.2 0.2* 0.2Demeton Insecticide 0.05 - -Deltamethrin Insecticide 10 5 10Diafenthiuron Insecticide 5 0.01* 20Dicofol Insecticide 0.2 20 3Difenoconazole Fungicide 10 0.05* 15Diflubenzuron Insecticide 20 0.1 20Endosulfan Insecticide 10 30 30Ethoprophos Insecticide 0.05 0.02* -Fenazaquin Insecticide 15 10 -Fenpropathrin Insecticide 5 2 25Fenitrothion Insecticide 0.5 0.05* 0.2

Fenvalerate/S-fenvalerate

Insecticide 0.1 0.1* 1.0

Flucythrinate Insecticide 20 0.05* 20Glufosinate-ammonium Herbicide 0.5 0.1* 0.3Glyphosate Herbicide 1 2 1Hexachlorocyclohexane HCH) Insecticide 0.2 0.02* 0.2Hexythiazox Insecticide 15 4 35Imidaclothiz Insecticide 3 0.01* -Indoxacarb Insecticide 5 5 -Isazofos Insecticide 0.01 0.01* -Isocarbophos Insecticide 0.05 0.01* -Methomyl Insecticide 0.2 0.1* 20Omethoate Insecticide 0.05 0.05* 1Permethrin Insecticide 20 0.1 20Phosfolan Insecticide 0.03 - -Phoxim Insecticide 0.2 0.1 0.1Pyridaben Insecticide 5 0.05* 10Terbufos Insecticide 0.01 0.01* -

* Indicates lower limit of analytical determination

The Food Safety & Standard Authority of India (FSSAI) initiated harmonization of its standards with that of Codex through e-working groups in May 2013. The work is in progress.

A submission has been made in Australia in Jan 2014 requesting adoption of the EU/Codex MRLs for thiacloprid, spiromesifen, clothianidin, etoxazole, hexythiazox, thiamethoxam & chlorfenapyr.

Harmonization of National Standards with Codex & other International Standards

India

Australia

4. Communication on change of status of standards

Kenya

Adopted Codex MRLs in tea for 14 pesticides in Aug 2015

Introduced a Draft Standard KS 2128: 2015 in August 2015.

Codex MRLs have been adopted for 14 compounds

Kenya

Sl No. Pesticides KenyaMRL (mg/kg)

Codex MRL(mg/kg)

1. Paraquat 0.2 0.22. Methidathion 0.5 0.53. Clothianidin 0.7 0.74. Fenpropathrin 2 25. Chlorpyrifos 2 26. Deltamethrin 5 57. Propargite 5 58. Endosulfan 10 109. Etoxazole 15 1510. Hexythiazox 15 1511. Cypermethrins (including

alpha- & zeta- cypermethrin) 15 15

12. Permethrin 20 2013. Thiamethoxam 20 2014. Bifenthrin 30 30

List of pesticides and maximum residue limits for tea (Green tea/Black tea)

Kenya Draft Standard KS 2128: 2015

Action taken on Propargite [EU notification to WTO (Notification G/SPS/N/EU/72 : MRL 5mg/kg to 0.05 mg/kg]

(1) Argentina, India & ETC sent communications to EU on the essentiality of propargite use in tea.

(2) Manufacturer submitted dossier to EU on 2 June, 2014

(3) Additional data on xenotoxicity submitted in 2015 for review by EU.

(4) India carried out a study on Propargite metabolites in tea in colla- boration with M/S Chemtura (USA) in Aug-Sep 2014.

Propargite, TBPC, HOMe-TBPC, HOMe-TBPC-diol, Carboxy-TBPC-diol & HOMe-TBPC glucoside

Residues in tea shoot, black tea and brew:

(5) EU decision on fresh submission of data is expected by end 2016.

5. Update information on Anthraquinone in Tea

Anthraquinone is a bird repellent.

Not used in tea as a pesticide.

Emerging as a major problem in tea [BfR opinion No. 005/2013, 12 Feb/2013 ]

BfR removes anthraquinone from its list of recommendations for food packaging following EFSA opinion in 2012

Source of contamination in tea :

Packaging material ???During Tea Manufacturing process ??? In Tea plants ???Through various Inputs ??? Ambient sources ???

In the last meeting it was decided to share information on anthraquinone as it was detected in many tea samples from a number of countries.

A LC-MS/MS based test method for determination of anthraquinone in tea was developed at TLabs TRA, India in March 2015 with an LOQ of 0.02 mg/kg.

The method was validated with a EU PT sample provided by EU-TIA (erstwhile ETC) Chair Dr Thomas Hann.

The study on the sources is in progress.

Simultaneous work on literature search showed ubiquitous presence of anthraquinone in the environment.

Anthraquinone in Tea

[Tea Research Association, India and UK Tea & Infusion, Associtation Collaboration studyinitiated in Oct 2014]

Representative MRM chromatograms for Anthraquinone & Anthraquinone-d8(at 20 ng/mL concentrations, m/z 208, 216), GC-MS/MS

The WG on Tea Brew

Chair: China, Co-chair(s), India, USA

Status of work undertaken

Policy document entitled “Guidance Document on Risk Assessment Using Brew Factor For Fixation of MRLs of Pesticides In Tea” drafted jointly by India and China with comments from USA and Japan.

GUIDANCE DOCUMENT ON RISK ASSESSMENT USING BREW FACTOR FOR FIXATION OF MRLS

OF PESTICIDES IN TEA

[Prepared By Indian and Chinese delegations, Working Groups on MRL and Tea Brew of FAO-IGG on Tea with

comments from USA , Japan and Sri Lanka]

Title page

•The policy document entitled “Guidance Document on Risk Assessment Using Brew Factor For Fixation of MRLs of Pesticides in Tea” will be discussed and finalized for submission to the CCPR and JMPR for reference.

In continuation.

(1) To assess status of field trials required for setting Codex MRLs & submission of the list for advance notification to FAO-IGG & National Codex Points.

(2) To update priority list based on new information on Risk assessment, or Replacements or Potential use in Tea

(3) To share information on consuming countries on MRL restrictions.

(4) To assess status & development of required infrastructure & new methods to cope with changing situations & cost.

(5) Communication plan for quick information exchange and advance notification for simultaneous data submission by members & seeking manufacturers support and to negate adverse publicity.

(6) Data submission to include brew factor based risk assessment for all teas traded globally except Matcha Tea.

(7) To share available information on anthraquinone, nicotine and other contaminants and to explore a global study for data.

Future Action Plan

(8) Explore a potential representation in CODEX for tea to give agreed position a voice

(9) Share information on development of pest resistance

Thank you