Outline

Principles of MRL setting

Changes in Pesticide residue control

New MRLs of Pesticides

 Outlines

Principles of MRL setting

Changes in Pesticide residue control

New MRLs of Pesticides

 Why we need pesticides?
Control pesticide and Enhance productivity
w/ pesticide w/o pesticides

100 100 100

59

44

11
Cereal Vegetable Fruit
(rice, wheat) (cucumber, cabbage) (apple, pear)
w/o Pesticide w/ Pesticide
Enhance convenience
Time (hr) to remove weeds/ 992m2 rice cultivation
60
논 50 50.6
잡
초 40
30
제
거 20 17.4
시 8.4
4.3
간 10 2.4 1.7 0.5
0
1945 1955 1965 1975 1985 1995 2005 2015
 Principles of MRL setting
 Basic principle
– Set MRLs which have no harm by consumption of
the pesticide residue during lifetime

 Basic policy
– Domestic foods
• Set MRL of registered pesticides under
Agrochemicals Controls Act
– Imported foods
• Set MRL of pesticides which are registered
abroad, submit data, and have no harm
evaluated by MFDS risk assessment
 Principle of MRL setting

Domestic Imported

Notice registration Notice MRL

Import tolerance

RDA MFDS
Registrant (Agrochemical Registrant
(Food Sanitation
control act) Act)
Submit data Residue date Notice MRL
Pesticide
registration MRL set and
re-evaluation
Advance notice/
Notice

Permitted to import and distribute the food with MRL

– Dietary Intake evaluation

• Risk cap :

TMDI ≤ 80% of ADI

(10% potable water, 10% environment)

TMDI : Theoretical Maximum Daily Intake
ADI : Acceptable Daily Intake

TMDI
 – Determine ADI(Acceptable Daily Intake)
• Based on Acute, Subacute, Chronic, Genetic,
Reproduction, Developmental toxicology data
 No Observed Adverse Effect Level(NOAEL)
• NOAEL X Uncertainty Factor = AD
※ Uncertainty Factor : most cases 100, between 10∼1000 depending on cases

ADI
Ex.) ADI of Insecticide Sulfoxaflor
NOAEL LOAEL
Animal 시험 영향
(mg/kg bw/day) (mg/kg bw/day)
13wk Toxicology Toxicity 1000 ppm ; 12.8 750 ppm ; 98
18 mo.
Mouse Toxicity 1000 ppm ; 10.4 750 ppm ; 79.6
Toxicology/Carcinog
Carcinogenicity 1000 ppm ; 10.4 750 ppm ; 79.6
enicity
13wk Toxicology Toxicity 100 ppm ; 6.36 750 ppm ; 47.6
2yr
Toxicity 100 ppm ; 5.13 750 ppm ; 39.0
Toxicology/Carcinog
Carcinogenicity 100 ppm ; 4.24 500 ppm ; 21.3
Rat enicity
Reproduction tox. 400 ppm ; 24.6
2 Generations 400 ppm ; 24.6
Pregnant and 100 ppm ; 6.07
Reproduction 400 ppm ; 24.6
Fetuses tox. 100 ppm ; 6.07
Pregnant and 150 ppm ; 11.5 1000 ppm ; 70.2
Reproduction
Fetuses tox. 150 ppm ; 11.5 1000 ppm ; 70.2
Rat Acute Neurotoxicity Neurotoxicity 25 75
Developmental Developmental
400 ppm ; 28.8 -
Neurotoxicity Neurotoxicity
13wk and 1 yr
Dog Toxicity 5 10
toxicology
Developmental Pregnant and 150 ppm ; 6.6
Rabbit 400 ppm ; 28.8
toxicology Fetuses tox. 750 ppm ; 31.9

 NOAEL of Dog, 1-yr toxicology = 5.0 mg/kg b.w./day,

apply x 100 uncertainty factor= ADI 0.05 mg/kg b.w./day

– MRL (Maximum Residue Level)

• Based on residue data of field trails with

GAP(Good Agricultural Practice)

0.2 ppm

0.6 ppm

MFDS Tolerance
With few data, we generally set MRL with 3 x Highest Residue

Field Trail GAP

Tested Suggested LOQ
Commodity Target Year HR
formulation PHI Number PHI Number MRL (mg/kg)
(ppm)
5 2 0.06
3 2 0.06
1 2 0.08
Aphis 0 2 0.09
Pepper 7% SC 2010 3 3 0.3 0.01
gossypii 5 3 0.07
3 3 0.10
1 3 0.11
0 3 0.14
5 2 0.09
3 2 0.12
1 2 0.16
Aphis 0 2 0.18
Cucumber 7% SC 2011 1 3 0.5 0.01
gossypii 5 3 0.11
3 3 0.13
1 3 0.18
0 3 0.20
– Exposure Evaluation
• ADI : 0.05 mg/kg b.w./day
• TMDI: 0.05 mg × 55 kg = 2.75 mg

Suggested MRL Food Intake TMDI

Commodity
(mg/kg) (kg/day) (mg/day)

Pepper 0.3 0.02427 0.007281

Cucumber 0.5 0.00975 0.004875

∑ TMDI (mg/day) 0.012156

TMDI/ADI (%) 0.44
EX.) Evaluation of Clethodim exposure
• ADI : 0.01 mg/kg b.w./day

• TMDI: 0.01 mg × 55 kg = 0.55 mg

Suggested
MRL Food Intake TMDI
Commodity MRL
(mg/kg) (kg/day) (mg/day)
(mg/kg)
Potato 0.2 0.23600 0.004720
Soybean 10.0 0.39820 0.398200
Strawberry 0.1 0.00377 0.000377
Garlic 0.2 0.00549 0.001098
Onion 0.2 0.01705 0.003410
Apple 2.0 0.02109 0.042180
Current ∑ TMDI (mg/day) / ADI (%) 0.407805 / 74.15
New ∑ TMDI (mg/day) / ADI (%) 0.449985 / 81.82

 TMDI/ADI >80% ,
2.0ppm for Apple cannot be established
• If data is enough,
we suggested MRL by using
OECD Calculator
※ OECD Calculator
- developed by OECD MRL working
Group
- USA, Codex and many countries use
this calculator for MRL setting

 Suggested MRL value

(Choose the highest value from

below)
– HR
– Mean + 4xSD

– 3xMean× CF (correction Factor)

* CF = 1 - 2/3 × Fraction censored
data in the dataset
 Outlines

Principles of MRL setting

Changes in Pesticide residue control

New MRLs of Pesticides

Current principle to set provisional MRL
MRLs have been established for individual crops or
Crop groups, and processed foods in Korea.

If registered pesticide which residue limit for an agricultural

product was not established, tentative limits shall be applied
by the following order.

First, the Codex standard

Second, the lowest of the MRL in similar

agricultural products

Third, lowest of the MRL, among MRLs of the

pesticide detected
 Positive List System

– If the pesticide is not registered and/or set MRL

by import tolerance, its MRL < 0.01 mg/kg

– Australia, EU, Japan and USA adapted this system already

* Japan and EU: 0.01 mg/kg (uniform level), USA : Not detection

- Reinforce Pesticide control in food from non-

registered pesticide
• Prevent excess use and misuse of pesticide

• Inhibit use of non-registered pesticides which are not

evaluated by scientific assessment.
 Change of pesticide control after PLS
Current (NLS) After PLS
MRLs of registered pesticide MRLs of registered pesticide
현행
→ Food code규제
is applied PLS
→ Food 도입후
code 규제
is applied

 MRLs of non-registered
잔류허용기준이 정해진 것  MRLs
잔류허용기준이 of non-registered
정해진 것
pesticide
(사용·등록된 성분) (수입식품 잔류허용기준 포함)
pesticide
→ 기준 규격에 따라 기준 적용 → 기준 규격에 따라 기준 적용
→ Codex MRLs or MRLs for - It is not permitted to
similar
 잔류허용기준이agricultural
정해지지 /livestock/
않은 것 distribute the정해지지
 잔류허용기준이 food with
않은 것
aquatic
(사용·등록이 products
안된are성분) applied - pesticide residue level
일정량(0.01ppm)을 넘는 잔류
It is permitted
- Codex 기준 및 유사 to distribute
농산물 물질을 함유하는 식품 유통금지
exceeding 0.01 ppm.
기준적용 → 유통가능
the food with pesticide - 전세계 사용되는 대부분의 농약에
대해 검사 실시
residue level not exceeding  Compounds authorized by
the MRLs. MFDS
- Not harmful compound
※ Actually, the compounds → “Exemption list”
have not been inspected. - Harmful compound
→ “Non-detection list”
PLS Enforcement
- First step : Tree Nuts and oilseeds & Tropical Fruit
(Adv. Notice 2014.7)
(Expected : 2015. 3 Notice, 2016.12 enforcement)
Large Small
Commodity
classification classification
Peanut and Tree Chestnut, Walnut, Gingko nut, Pine nut, Peanut,
Almond, Pecan, Cashews, Hazelnut, Macadamia,
Nuts Pistachio, Acorn etc.
Tree Nuts and Sesame, Cotton Seeds, Sunflower, Canola Seeds,
Oilseeds Palm, Olive, Safflower etc.
Oilseeds
Seeds for
beverages and Coffee beans, Cacao beans, Cola nuts, Guarana
sweets
Banana, Pineapple, Kiwifruit, Avocado, Papaya,
Tropical
Fruit Mango, Guava, Coconut, Lychee, Passion Fruit,
Fruit Durian, Mangosteen etc.

- Second step : All agricultural commodities

(Expected :2016.6 Adv. Notice, 2018.1 enforcement)
Scheduled to be deleted and remained MRL
of Pesticides for Tree nuts and Tropical fruits
< 0.01 ppm
Ex. Peanut
Scheduled to be deleted MRL Remained MRL

Acephate, Bentazone, BHC, Captan, Carbaryl∶NAC,

Carbophenothion, Carboxin
Chlorfenvinphos, Chlorobenzilate, Chlorpropham,
Chlorpyrifos, Cyfluthrin, Cyhalothrin, Cypermethrin,
Daminozide, Diazinon, Dichlofluanid, Diphenamid,
Disulfoton, Ethiofencarb, Fenamiphos,
FenbutatinOxide, Fenoxaprop-ethyl, Fensulfothion,
Fentin, Fenvalerate, Fluazifop-butyl, Iprodione,
Malathion, Maleichydrazide, Metalaxyl, Methomyl,
Methoprene, Methoxychlor, Norflurazon, Omethoate,
Oxamyl, Parathion, Parathion-Methyl, Pendimethalin,
Permethrin(Permetrin), Phorate, Pirimiphos-ethyl,
Pirimiphos-methyl, Propargite, Propiconazole,
Pyrethrins, Sethoxydim, Thiobencarb, Trifluralin
Alachlor, Aluminium Phosphide (Hydrogen
phosphide), Benomyl, Bitertanol, Carbendazim,
Carbofuran, Carbosulfan, Chlorothalonil,
Difenoconazole, Dithiocarbamates, Ethalfluralin,
Ethoprophos(Ethoprop), Fenitrothion∶MEP,
Fluxapyroxad, Hexaconazole, Mancoseb,
Metolachlor, Napropamide, Tebuconazole,
Tefluthrin, Terbufos, Thiophanate-methyl, Thiram

50 23

(See Appendix 1 in booklet)

Scheduled to be deleted MRLs after PLS
Scheduled to be
Commodity Current MRL Remained MRL
deleted MRL
Peanut 73 50 23
Chest nut 51 31 18
Cotton Seeds 72 69 3
Almond 50 44 6
Canola Seeds 40 23 17
Pine nut 23 21 2
Sesame 62 27 35
Coffee 29 23 6
Cacao Beans 20 20 -
Pecan 51 46 5
Pistachio 24 22 2
Sunflower Seeds 38 34 4
Walnut 30 27 3
Scheduled to be deleted MRLs after PLS
Scheduled to be
Commodity Current MRL Remained MRL
deleted MRL

Banana 44 39 5

Mango 31 28 3

Avocado 33 31 2

Kiwi 56 29 27

Pineapple 42 37 5

Papaya 27 26 1
 Import history
Importing Tree nuts and tropical fruit to
Korea
- ~80 countries including USA, China

- 2011~14 history of Import (See Appendix 2)

Ex. Import history of tropical fruit from China (11∼14)

Group Commodity Weight (tons) Dollar($1,000) Case (number)

Lychee 4,960 5,878 221

Mango 3 5 1
Tropical Fruit
Kiwi 127 157 10

Pineapple 5 7 1
Import of Tree nuts from China (2011∼14)
Group Commodity Weigh(tons) Dollar($1,000) Case (number)

Hazelnut 17 109 3

Onothera Biennis seed 19 49 10

Acorn 45,616 50,554 1,184

Perilla Seeds 91,560 153,782 2,562

Peanut 2,810 4,557 133

Macadamia 15 264 3

Chest nut 19,198 41,642 821

Tree nuts and Almond <1 2 1

oilseeds Ginkgo nut 223 285 10

Pine nut 135 931 12

Sesame Seeds 117,639 268,099 1,294

Coffee beans 4,499 17,625 42

Sunflower seeds 5,436 9,053 499

Walnut 119 901 14

Pumpkin Seeds 4,926 22,530 438

Safflower seed 173 118 13

 2011~14 Detected Pesticide Residues
Current provisional MRLs are applied, However,
0.01 ppm after PLS
Test
Group Commodity Result MRL Reference
compound
Domestic MRL
Almond 2,4-D 0.03 0.2 (scheduled to be deleted)

Domestic MRL
Peanut Chlorpyrifos 0.02 0.5 (scheduled to be deleted)

Domestic MRL
Sesame Fenvalerate 0.03 0.5 (scheduled to be deleted)

Sunflower 0.05
Imazalil 0.02
Tree seed (cotton seed)
nuts Coffee Bifenthrin 0.02
0.05
(chest nut)
0.05
Coffee Chlorpyrifos 0.03
(Codex)
0.05
Coffee Imazalil 0.04
(Cotton Seed)
0.05
Coffee Prochloraz 0.04
(Other Agri. Product)

(See Appendix 3)
Currently provisional MRLs are applied, However,
0.01 ppm after PLS
Test
Group Commodity Result MRL Reference
compound
0.1
Banana Bifenthrin 0.02
(Codex)
0.2
Banana Carbendazim 0.1
(Codex)
2
Banana Chlorpyrifos 0.02
(Codex)
2
Banana Chlorpyrifos 0.02
(Codex)
Domestic MRL
Banana Imazalil 0.07 2 (scheduled to be deleted)
Domestic MRL
Tropical Mango Chlorpyrifos 0.05 0.5 (scheduled to be deleted)
Fruit 0.5
Mango Endosulfan 0.1
(Codex)
0.2
Mango Fenthion 0.1
(Kiwi)
0.02
Mango Iprodione 0.2 Banana MRL, 2014
(Banana)
Domestic MRL
Mango Malathion 0.02 0.5 (scheduled to be deleted)
0.2
Mango Phenthoate 0.03
(Pear)
0.05
Mango Prochloraz 0.1
(Banana)
 Please note below
 Change the test items for the first close inspection
- Adjust based on items for non-complying pesticides
 Expending test items for random sample inspection
- 282 (‘14)  expected 286 (‘15)  expected 400 (‘17)
 Expending test items for single-residue analysis
monitoring
- reduce periodic time of inspection (15yr 5yr) with 3 steps of
analysis (1”: at custom, 2”: after custom (paper and sensory test),
3: research project)

Check before Importing food to Korea

1) History of detection
2) Scheduled deletion of Pesticide MRL
2) Registered in Korea
 if not, please submit application for IT
Current MRLs in Korea
Current MRLs of Pesticides

Codex Korea USA EU Japan

농약 186 441 393 539 824

한국 기준수 변화

2001 2003 2004 … 2010 2011 2012 2013 2014 2015

240 318 347 … 418 424 431 432 440 441

 Import tolerance
 Import tolerance?
– A system to assess the safety of foods with residual
pesticide for which domestic MRLs are not set and used
in accordance with the regulations of foreign countries.
If there is no safety concern, MRLs for the relevant foods
are established.

 Background
– Positive List System (PLS)* enforcement
• Ensure the food safety from non-registered pesticides
• Supply safe foods in Korea

* Domestic agricultural products exported to foreign

countries shall meet the MRLs of the importing countries.
 Application of Import Tolerance
Application
– Relevant Reference
• Food Sanitation Act 7-3(Requesting the establishment
of MRLs for pesticides)
• Enforcement Rule of the Food Sanitation Act Article 5.
2(Establishment of MRLs for pesticide and veterinarian
drugs), Article 5. 3 (Revising MRL)
• Food Code [Appendix 8] Guideline for Pesticides and/or
Veterinary Drugs in Foods

• MFDS on-line application system

(http://minwon.mfds.go.kr)
Search with “ Pesticide”, then click “Apply”

1
2

3
 Caution for application
1. Application via on-line
MFDS has an on-line system for civil affairs
(http://minwon.mfds.go.kr)

2. Processing Time
- Establishment of MRL : 12 months
- Change or Exemption of MRL : 7 months
Fees are not
3. Processing Fee
refundable!!
Toxicity data
- Establishment of MRL : 30,000,000 KRW per
commodity
- Change or Exemption of MRL : 10,000,000
KRW per commodity
2) Residual data
- Establishment, Change or Exemption of
MRL : 5, 000,000 KRW per commodity
5. Requirement Data
1) New compound
- Toxicity data and Residual data (2 copies)
2) Registered compound
(add new commodities) :
- Residual data only (2 copies)

3)Miscellaneous data (but, it will be helpful!)

- Usage and registration status in other
countries
- MRL establishment status in Codex and other
countries
- Impurity information regarding the product
6. Number of Field Trials
- Minimum of 6 trials
- 3 trials /commodity when Group MRL in Codex
- 3 trials /commodity for Minor Crop
- In the case of herbicide (which shows no residue),
MFDS accept the data with higher treatment
amount than GAP

7. Standard
- For new compound,
Parent compound 5g and 1g/metabolite
- MFDS might ask more standard for analysis
method develop and other reasons.
9. Supplemental request
- If information is not written in accordance with to the regulation
- If the submitted documents are not sufficient
- If the credibility of the submitted documents are not secured
- If it is acknowledged by the Commissioner of the MFDS that
supplemental materials are necessary
- Possible to request for supplemental materials for maximum of 6
months depending on the matter

10. Rejection
- If submitted documents are not in accordance with the
regulation
- If there is a concern for public health
- If is not possible to review due to insufficient materials
- If supplemental materials are not submitted in time
Data requirements
– Toxicity data
• Acute oral toxicity, Sub-chronic toxicity ,
Chronic toxicity, Genetic toxicity,
Teratogenicity, Metabolism and
pharmacokinetics etc.

– Residue data
• Physicochemical characteristics,
Applicable diseases and insect pests,
Supervised trials for crops etc.
 Import tolerance application
500
No. of import tolerance

425
400
application

300

200
152
100 100
(예상) (예상)
100
64
6 14
0
2010 2011 2012 2013 2014 2015 2016

Year
 MRLs by Import tolerance
90 MRLs ( 16 Pesticide, 39 Commodities, 45 MRL w/ advanced notices)
Pesticide Commodities Notice No.
Glufosinate Cotton Seeds 2010-58(2010.7.23)
Acetochlor Wheat, Sorghum, Corn 2012-131(2012.12.27)
Azoxystrobin Lemon, Orange, Grapefruit 2012-1(2012.1.20)
Fenpropathrin Cherry 2012-1(2012.1.20)
Fludioxonil Lemon, Orange, Grapefruit 2012-1(2012.1.20)
Tree nuts, Soybean, Cotton Seeds, Banana, Peach, Apricot,
Oxyfluorfen 2012-131(2012.12.27)
Avocado, Cabbage, Corn, Plum, Cherry, Coffee bean, Kiwi
Soybean, Lemon, Mango, Cotton Seeds, Wheat, Banana, Pear,
Barley, Peach, Apple, Sugar cane, Rice, Sorghum, Almond,
Saflufenacil 2012-131(2012.12.27)
Orange, Corn, canola Seeds, Plum, Grape Fruits, Cherry,
Coffee beans, Grape, Pecan, Sunflower Seeds
Acetochlor Soybean 2013-204(2013.8.5)
Myclobutanil Cherry, Apricot, Peach 2013-233(2013.11.12)
Pyrimethanil Lemon, Orange, Grapefruit, Cherry 2013-233(2013.11.12)
Ametoctradin Hop 2014-106(2014.3.25)
Azoxystrobin Soybean(Change domestic MRL), Corn 2014-146(2014.8.28)
Potato, Soybean, Peanut, wheat, Barley, Sugar beets,
Fluxapyroxad 2014-106(2014.3.25)
Sorghum, Corn, Pea, canola Seeds, Cherry, Sunflower Seeds
Sulfuryl fluoride Almond, Pistachio, Pecan, Walnut 2014-117(2014.5.26)
Pyraclostrobin Cherry 2014-117(2014.5.26)
Orange, Lemon, Grape Fruits, Blueberry, Cranberry, Corn,
Methoxyfenozide 2014-146(2014.8.28)
Kidney bean
Saflufenacil Pea, Kidney bean 2014-146(2014.8.28)
2,4-D Orange, Lemon, Grape Fruits 2014-174(2014.10.21)
Dicamba Corn, Wheat 2014-174(2014.10.21)
Exemption list
 Outline

Principles of MRL setting

Changes in Pesticide residue control

New MRLs of Pesticides

 Procedure of MRL setting
Risk assessment
Registrant MFDS (National Institute of Food and
Drug Safety Evaluation)

Export Review

Peer Review

Food Sanitation
Deliberation Committee
Re-consideration
Information provided
Advanced Notice/ WTO
by SNS, meeting
Judging
Restrictions
Notice
 New MRLs
After notice,
- Enforcement date will be in 2 months.

 Please note new MRL by Import Tolerance, minor

crop, and

 Notice no. 2015-4, 2015.02.03

- 174 New MRLs ( 77 pesticides, 69 Commodities)
New MRLs (Notice no. 2015-4, 2015.02.03)

Current Commodities applied

Code New MRL New/
Pesticide Commodity MRL IT by same provisional
NO (mg/kg) Tighten
(mg/kg) MRL
Sunflower Seeds, Pumpkin
3.0 seeds, Perilla seeds, Olive,
Sesame
2 Glufosinate (Cotton 0.05 New Cotton seeds, Canola
Seeds seeds, Palm, Safflower
Seed)
seeds etc

Green soy 0.05

2 Glufosinate 0.05 New
beans (Pepper)

0.05
2 Glufosinate Squash 0.05 New
(Pepper)

0.2 Barley, Wheat, Buckwheat,

조 , Sorghum, Corn, Oat,
3 Glyphosate Rice (Lowest 0.05 New Rye, Adlay, Quinoa,
MRL) Triticale etc.

New MRL becomes

provisional MRL for these
commodities.
(See Appendix 4)
New MRLs (Notice no. 2015-4, 2015.02.03)

Current MRL NewMRL New/ Commodities applied by

NO Pesticide Comm. IT
(mg/kg) (mg/kg) Tighten same provisional MRL
Difenocona
26 Squach 0.05 0.5 0.05
-zole
Difenocona Jujube 2.0
26 7.0 2.0
-zole (Dried) (Jujube)

Difenocona Radish 0.05

26 0.2 New
-zole (Root) (Deodeok, Onion)

Difenocona Radish 5.0

26 5.0 New
-zole (leaf) (Chwinamul)

Difenocona 1.0
26 Orange 0.5 New o
-zole (Tangerine)

Difenocona 1.0
26 Lemon 0.6 New o
-zole (Tangerine)
Yuzu, Lime, Kumquat,
Difenocona Grape 1.0
26 0.4 New o Trifoliate, Citron ( Except
-zole Fruits (Tangerine) Orange, Lemon )
Green
0.1
40 Metolachlor soy 0.05 New Cherry Tomato, Okra etc.
(Paprika)
beans
Residue database
www.foodnara.go.kr/residue/main.do
Thank you