슬라이드 1 - Aki̇b

슬라이드 1 - Aki̇b

Maximum Residue Limits(MRL) of Pesticide and Veterinary Drugs in Food 27th Nov. 2012 Food Standards Division Korea Food & Drug Administration * [email protected] Establishment of pesticide MRLs in Foods MRLs have been established for specific crops or crop groups, and processed foods in Korea. For example, a MRL for Tetraconazole was established for pome fruit (a crop group) and dried red pepper(a processed food). (297) Tetraconazole, ADI : 0.0073 mg/kg b.w./day Green & Red Pepper(Fresh) 1.0 Mandarin 2.0 Tomato

2.0 Red Pepper(Dried) 3.0 Watermelon 0.2 Sweet Pepper 1.0 Pepper Leave 1.0 Cucumber 1.0 Squash 0.2

Perilla Leaves 15 Korean Melon 1.0 Wild grape 3.0 Strawberry 1.0 Pome fruits 1.0 Pesticide residue DB : http://fse.foodnara.go.kr/residue Pesticide MRLs in Korea

Pesticide MRLs have been established for 431 pesticides and 213 commodities in Korea. Applicability of pesticide MRLs If a MRL is not established, Generally, the pesticide not resisted in Korea should not be detected in foods. Non-detection levels are determined from LOQ of the analytical method. If a pesticide, where residue limit for an agricultural product was not established, is detected in the product, the following tentative limits shall be applied. First, the Codex standard shall be applied. Second, the lowest of the MRL in question specified for similar agricultural products shall be applied. (See the similar products in Classification of Food Raw Material in Korea Food Code.) Third, lowest of the MRL, among MRLs of the pesticide detected, shall apply to the detected pesticide. Example of Classification of Fruits for pesticide MRL Type Group Pome fruits Citrus

fruits Stone fruits Commodity Apple, Pear, Chinese quince, Persimmon, Pomegranate, etc. Mandarin orange, Orange, Grapefruit, Lemon, Korean lemon, Lime, Kumguat, Trifoliate orange, Citron etc. Peach, Jujube, Apricot, Plum, Nectarine, Japanese apricot, Cherry, Korean-type cherry etc. Fruits Berries and other small fruits Tropical fruits Grape, Strawberry, Fig, Mulberry, Bilberry or Cranberry, Currant, Berry, Boxthorn, Schizandra, Wild grape, Rubus coreanus (Including wild berry, Raspberry) etc. Banana, Pineapple, Kiwifruit(Actinidia chinensis planch), Avocado, Papaya, Date palm, Mango, Guava, Coconut, Lychee, Passion fruit, Durian, etc.

Establishment of veterinary drug MRLs in Foods MRLs have been established for livestock or fishery product foods in Korea. For example, a MRL for Gentamicin was established for cattle, pig, chicken and fish (1) Gentamicin Cattle muscle 0.1 Pig muscle 0.1 Chicken muscle 0.1 Cattle liver 2.0 Pig liver 2.0

Chicken liver 0.1 Cattle fat 0.1 Pig fat 0.1 Chicken fat 0.1 Cattle kidney 5.0 Pig kidney 5.0

Chicken kidney 0.1 Milk 0.2 Flatfish 0.1 Trout 0.1 Carp 0.1 Veterinary drug residue DB : http://fse.foodnara.go.kr/residue/vd/index.jsp Veterinary drug in Korea

MRLs have been established for 156 veterinary drug and 60 foods in Korea. Applicability of veterinary drug MRLs If a MRL is not established, Generally, the veterinary drug not registed in Korea should not be detected in foods. Non-detection levels are determined from LOQ of the analytical method. If a veterinary drug, where residue limit for an livestock or fishery product was not established, is detected in the product, the following tentative limits shall be applied. First, the Codex standard shall be applied. Second, Application of the lowest residue limits in the area of the similar edible animals (only, horse, non-ruminant, shall follow the standard for ruminant) Third, antibiotics and synthetic antibiotic substances in livestock and fishery products (including milk and eggs), and honey (including royal jelly and propolis) shall be limited to 0.03 mg/kg. Example of Classification of livestock or fishery product for veterinary drug MRL Group Ruminant Nonruminant

livestock or fishery product Cattle, sheep, goat. Deer etc Horse, pig, rabbit etc Poultry Chicken, duck, goose, turkey, quail, pheasant etc Fishes Snakehead, flatfish, sea bass, catfish, loach, yellow tail, eel, trout, gray mullet, carp, horse mackerel, gizzard shard, pseudorasbora palta etc Crustacea shrimp, crab, lobster, crayfish, small crab, krill etc Positive List System (PLS) Status of imported foods Inspection of imported foods : 2007-2011 year

dollars> Classificati on 2007 2008 2009 2010 2011 Case 270,163 254,809 255,341 293,988 312,723

Weight 11,799 11,731 11,301 12,905 13,471 Amount 8,449 9,860 8,434 10,358 13,212

Reject 1,448 1,020 1,229 1,143 1,015 (Rate) (0.54%) (0.40%) (0.48%) (0.39%) (0.32%) Increasing Every years

Promoting New regulations in Korea Positive list system(PLS) will be adopted. Background Increasing food imports, accuracy of risk assessment has been challenged due to the fact that the imported f oods are applied with MRLs in codex or tentative resid ue limits in similar agriculture products, livestock produ cts and aquatic products. So, it is necessary to evaluate the safety of the pestici des, which compounds are not registered in Korea, to protect human health. Recently, the following works have being processed. The MRLs before 2000 were adopted from MRLs of foreign count ries, not based on scientific data. So, the MRLs should be re-eval uated for safety. The pesticide and veterinary drug MRLs, which are not regist ered in Korea, are planned to be deleted from Korea Food Co de. See Withdrawn MRLs List (next presentation) Exemption list will be considered and developed. The compounds that should not be detected in foods will be listed as the compound can be harmful to human health.

List of pesticide MRLs to be deleted List of veterinary drug MRLs to be deleted Exemption list No. No MRL required 1 Progesterone 2 Estradiol-17beta 3

Acetymethionine 4 Acetylsalicylic acid 5 Alanine 6 Aluminium hydroxide acetate 7 Calcium phosphate 8 Vaitamin A 9 Vaitamin B1

10 The compounds that should not be detecte in foods Veterinary drug list that shall be not detected (example) No. Forbidden Veterinary drugs in foods 1 Nitrofurans and its derivatives (Furazolidone, Furaltadone, Nitrofurazone, Nitrofurantoine, Nitrovin etc) 2 Chloramphenicol 3 Malachite green and its derivatives

4 Diethylstilbestrol, DES 5 Dimetridazole 6 Clenbuterol 7 Vancomycin 8 Chlorpromazine 9 Thiouracil 10 Colchicine

11 Pyrimethamine 12 Medroxyprogesterone acetate, MPA If a country or producing company which object to re-eval uate a compound, they are able to request the import tole rance. It is expected that more than of 150 import tolerances will be requested in 2012. As re-evaluating the MRLs of pesticide, the MRLs will be revised and established reasonably and harmoniously wit h the Codex MRLs. Group MRLs will be extended. The methods using GC-MS/MS and LC-MS/MS will be es tablished for detecting pesticide and veterinary drug resid Comments on the PLS will be collected from consume rs, producers and importers. It is planed to make an administration notice after gath ering the information for PLS, and collect the comment s for 2 years. Change of Pesticide regulation in K Current

Pesticide for which MRLs are set (registered compound) Food code is applied Pesticide for which no MRLs have been set (not registered compound) - Codex MRLs and MRLs for similar agricultural /livestock/ aquatic products is applied It is permitted to distribute the food in which pesticide residue level not exceed the MRLs. Actually, the compounds have not been inspected. Pesticide for which MRLs After PLS

adopted are set (registered compound) Food code is applied Pesticide for which no MRLs have been set (not registered compound) - It is not permitted to distribute the food in which pesticide residue level exceed 0.01 ppm. Compounds authorized by Korea Food and Drug Administration(KFDA) - Not harmful compound Exemption list - Harmful compound

Non-detection list Recently, KFDA has provided the Guidelines on MRLs for Pesticides and Veterinary Drugs in Food The purpose of guidelines is To clarify procedures of establishment of MRLs, and to improve scientific transparency and predictability in establishment of M RLs to related companies The English version of guidelines is available at http://www.kfda.go.kr/eng/index.do > KFDA NEWS > News & Notice * Guidelines for establishment of pesticide and veterinary drug MRLs in food Guidelines for Establishment of Pesticide and Veterinary Drug MRLs in Food Guidelines for Establishment of Pestic and Veterinary Drug MRLs in Food - Notice No. 2012-15 of the KFDA(April 23, 2012) Purpose

To clarify procedures of establishment of Attachment to Foods Import MRLs, and Report to improve scientific transparency and predictability in establishment companies. of

MRLs to related Details Scope of for the establishment of MRLs of Pesticides and Veterinary Drugs Procedures and Methods for the Establishment to Foods Import ofAttachment MRLs Report Expert Review Panel and its Operation Scope of Materials Submitted for

the Establishment of MRLs - such as stipulations in toxicity and residue data for the establishment of MRLs Methods for the Establishment of MRLs at Each Step Contents Article 1 Purpose Article 2 Definition Article 3 Scope of Application Article 4 Applications to Establish, Amend or Attachment to Foods Import Article to Establish, Amend or Exemption Exemption of MRLs Report5 Review Article of MRLs6 Expert Review Panel and its Operation

Article 7 Matters for Consideration in Submitting Article 8 Supplementary Data, etc. document Article 9 Announcement and Notification Article 10 Scope of Documents Submitted for the Establishment ofScope MRLs of Materials PesticidesSubmitted for the Article 11 Establishment of MRLs of Veterinary Drugs Scope of Application Domestically used or registered pesticides; Pesticides applied for use or registration domestically; Pesticides that have MRLs and is used in overseas,

albeit not used or registered domestically Domestically used or registered veterinary drugs; Veterinary drugs applied for use or registration domestically; Veterinary drugs that have MRLs and is in use in overseas, albeit not used or registered domestically; Pesticides or veterinary drugs that were used in the past, or have remained in the environment for too long Application for MRLs Expected to register pesticide and veterinary

drug in Korea Pesticide : submit to Rural Development Administration(RDA) Veterinary drug : submit to Animal, Plant and Fisheries Quarantine and Inspection Agency(QIA) Import tolerance for pesticide and veterinary drug Those that wish to establish, change or exempt the Requirements for establishment of MRLs In case of setting the MRLs for a compound, the following data and supports are requested by KFDA. Toxicity data (Pesticide, Veterinary drug) - Acute Oral Toxicity Studies(Oral toxicity, Dermal toxicity, Inhalation toxicity, Eye irritation, Dermal irritation, Dermal sensitization, Neurotoxicity) - Sub-Chronic Toxicity Studies (90 day oral toxicity, 21/28 day dermal toxicity, 90 day inhalation toxicity, 90 day neurotoxicity, 28 day delayed neurotoxicity)

- Chronic Toxicity Studies(Repeated dose chronic oral toxicity, Carcinogenicity) - Genetic toxicity studies - Development and reproductive toxicity studies - Teratogenicity studies - Metabolism and pharmacokinetics - Other toxicity data deemed necessary by the Commissioner in determining the establishment of maximum residue limit. Residue Data (Pesticide) - Basic information(Physicochemical characteristics, Applicable diseases and insect pests) - Supervised trials for crops results Field description, Pesticide spraying tools and methods, Sample collection methods, Sample analysis method and recovery test result, Residue trial data, Storage stability, Proposed MRL, Guidelines on safe use - Livestock, poultry, egg and milk residue data (directly, carry-over through feed ingestion) - Plant metabolism data - Other residue data deemed necessary by the Commissioner in determining the establishment of MRL

Processing study(Pesticide) Miscellaneous(Pesticide) - Usage and registration status in other countries - MRL establishment status in Codex and other countries - Impurity information regarding the product Of materials to be submitted under paragraphs 1 and/or 2, should there be items that are meaningless to conduct tests on, and can be explained as such, theoretically and/or technically, then some of the materials can be omitted. Residue data (Veterinary drug)

Physicochemical characteristics Pharmacodynamics Animals used in the tests (species, gender, age, weight, etc.) Test conditions (breeding management, diet, drug administration method, and etc.) Milk production and spawning ratio (when applicable) Sampling method Sample analysis method and recovery test result Residue trial data Storage stability Proposed MRL Withdrawal period - Animal metabolism data - Other residue data deemed necessary by the Commissioner in determining the establishment of MRL Of materials to be submitted under paragraphs 1 and/

or 2, should there be items that are meaningless to conduct tests on, and can be explained as such, theoretically and/or technically, then some of the materials can be omitted. Application Form in Korea Food Code Import tolerance Status of the import tolerance apply Year Compound Company 2011 Azoxystrobi n Syngenta Orange, lemon, grapefruit

2011 Fludioxonil Syngenta Orange, lemon, grapefruit 2011 Fenpropathr in Smitomo Cherry 2011 Oxyfluorfen Dow agro

Apple and 17 others 2011 Saflufenacil BASF 2011 Imazlil Janssen Orange and 4 others 2011 Pyrimethani l Janssen Orange and 7 others

2011 Myclobutani l Dow agro 2012 2,4-D Ametoctradi CCQC Food Orange and 28 others Apricot, cherry, peach Orange, lemon, grapefruit Cabbage and 16 Year

Compound Company 2012 Fluxapyroxad BASF Apple and 22 others 2012 Sulfuryl fluoride Dow agro Almond and 4 others 2012 Azoxystrobin

2012 Methoxyfenozid e Dow agro Almond and 35 others 2012 Chlorantranilipr ole Dupont Potato and 32 others 2012 Boscalid BASF

Potato 2012 Pyraclostrobin BASF Cherry 2012 Saflufenacil BASF Pea and 6 others 2012 Dicamba BASF Soybean and 8 others

2012 Tilipirosin Intervet Cattle, pig 2012 Zilpaterol-HCl Intervet Cattle Syngent a Food Rice and 12 others Import Tolerance

Total weight (ton) 3000000 2500000 2000000 1500000 1000000 500000 0 Status of imported agricultural commodities in 2011 FAQ: Import Tolerance 1) Do you have any form for the application? A: In, Korea Food Code [Appendix 8] Guidelines for Establishment of Pesticide and Veterinary Drug MRLs in Food. The application should be filled in Korean. 2) To whom should the application filed? A: The application should be submitted to our division (Food standard division), Korea Food & Drug Administration. 3) Anyone who has not legal entity in Korea, could apply the petition directly? A: Anyone can apply the import tolerance directly, But should be available to contact with us (phone, e-mail, etc.).

4) English is acceptable? A: Yes, English report is acceptable including the data. But, summary report should be written in Korean. FAQ: Import Tolerance 5) The necessary information/data might be different between pesticides, which the Korean domestic registration is existed (already reviewed the toxicity data) or not. May we understand that only the residue data would be sufficient for the application of the import MRLs? A : When the pesticide already resisted for the other commodities, the residue data is sufficient for the application of the import MRLs 6) How long it will take for the review and establishment of import MRLs after the application? A : It will be take 365 days for a new compound, and 210 days for the additional establishment or alleviation of MRL. Thank you

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