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THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary - Internal Date: 8/2/2018 GAIN Report Number: JA8044 Japan Post: Tokyo Report of the 215th Food Safety Group Report Categories: Sanitary/Phytosanitary/Food Safety Approved By: Jess K. Paulson Prepared By: Tomohiro Kurai Report Highlights: On Tuesday, July 31, 2018, Japan’s Ministry of Health, Labor and Welfare (MHLW) announced revisions to Japan’s Maximum Residue Levels (MRLs) for the following agricultural chemicals and veterinary drugs: 1,3-Dichloropropene, Acynonapyr, Acibenzolar-S- methl, Chlorothalonil, Probenazole, and Morantel. Further, MHLW proposes to designate Tocopherol as an exempted substance for establishing its MRL. The Embassy comment period for these proposals is open until Tuesday, August 14, 2018. MHLW will notify these revisions and amendments to the World Trade Organization, which will provide another opportunity for interested parties to comment on these proposed changes.

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 THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY

                                       

Voluntary - Internal 

  Date:8/2/2018 GAIN Report Number: JA8044

 

Japan Post: Tokyo

Report of the 215th Food Safety GroupReport Categories:Sanitary/Phytosanitary/Food SafetyApproved By: Jess K. PaulsonPrepared By: Tomohiro Kurai Report Highlights:On Tuesday, July 31, 2018, Japan’s Ministry of Health, Labor and Welfare (MHLW) announced revisions to Japan’s Maximum Residue Levels (MRLs) for the following agricultural chemicals and veterinary drugs: 1,3-Dichloropropene, Acynonapyr, Acibenzolar-S-methl, Chlorothalonil, Probenazole, and Morantel.  Further, MHLW proposes to designate Tocopherol as an exempted substance for establishing its MRL.  The Embassy comment period for these proposals is open until Tuesday, August 14, 2018.  MHLW will notify these revisions and amendments to the World Trade Organization, which will provide another opportunity for interested parties to comment on these proposed changes. Keyword: JA8044

 

General Information:   

 <The manner of submitting comments>The Ministry of Health, Labour and Welfare (MHLW) will amend the existing standards and specifications for food as shown in this document. Please provide comments in writing by Tuesday, August 14, 2018. After the given date, comments should be directed to the enquiry point in accordance with the WTO/SPS Agreement.

With regard to agenda item 1, the SPS notification will be made for the setting or revision of the MRL for the agricultural and veterinary chemicals except for 1,3-Dichloropropene, Acynonapyr for which regulations will not be strengthened by this amendment.

If you wish to request Japan to adopt the same limits as your country’s MRLs, you are requested to submit data supporting your country’s MRLs, such as risk assessment and residue data.

<Contact person>Food Safety Standards and Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare1-2-2, Chiyoda-ku, Kasumigaseki, Tokyo, 100-8916

Pesticides/Veterinary drugs/Feed additives (Item 1 & 2) Mr. Tomoaki MIURA ([email protected])Tel : 03-3595-2423 (ex 4289) Fax: 03-3595-2432

Item 1. Establishment of the Maximum Residue Limits for Agricultural and Veterinary Chemicals in Foods

The Food Sanitation Act authorizes the Ministry of Health, Labour and Welfare (MHLW) to establish residue standards (maximum residue limits, “MRLs”) for pesticides, feed additives, and veterinary drugs (hereafter referred to as “agricultural and veterinary chemicals”) that may remain in foods. Any food for which standards are established pursuant to the provisions in Article 11, Paragraph 1 of the act is not permitted to be marketed in Japan unless it complies with the established standards.

On May 29, 2006, Japan introduced the Positive List System1 for agricultural and veterinary chemicals in food. All foods distributed in the Japanese marketplace are subject to regulation of the system.

The MHLW is going to modify or newly set MRLs in some commodities for the following substances:

Pesticides: 1,3-Dichloropropene, Acynonapyr,

Acibenzolar-S-methyl, Chlorothalonil, Probenazole

Veterinary drugs and Feed additives:Morantel

_____________1 The aim of the positive list system is to prohibit the distribution of any foods which contain agricultural chemicals at amounts exceeding a certain level (0.01 ppm) in the Japanese marketplace unless specific maximum residue limits (MRLs) have been set.

Summary

1,3-Dichloropropene (pesticide: insecticide): Permitted for use in Japan. The MHLW is going to establish MRL for other umbelliferous vegetables in response to a request for setting MRL by the Ministry of Agriculture, Forestry and Fisheries (MAFF) with the intention to expand its use pattern. This action will not strengthen the current regulation for any commodities.

Acynonapyr (pesticide: miticide): Not permitted for use in Japan. The MHLW is going to establish MRLs in some commodities in response to a request for setting MRLs by the MAFF with the intention to newly register this substance as a pesticide. The MHLW is also going to establish MRL for fish in response to a request for setting MRL by the MAFF. This action will not strengthen the current regulation for any commodities.

Acibenzolar-S-methyl (pesticide: fungicide): Not permitted for use in Japan. The MHLW is going to establish MRLs in some commodities in response to a request for setting MRLs by the MAFF with the intention to newly register this substance as a pesticide.

Chlorothalonil (pesticide: fungicide): Permitted for use in Japan. The MHLW is going to modify MRLs in some commodities that were provisionally set at the introduction of the Positive List System.

Probenazole (pesticide: fungicide): Permitted for use in Japan. The MHLW is going to establish MRL for fish in response to a request for setting MRL by the MAFF. The MHLW is also going to modify MRLs in some commodities that were provisionally set at the introduction of the Positive List System.

Morantel (veterinary drug and feed additive: anthelmintic): Permitted for use in Japan. The MHLW is going to modify MRLs in some commodities that were provisionally set at the introduction of the Positive List System.

1,3-Dichloropropene

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Soybeans, dry ○ 0.01 0.01 §Peanuts, dry ○ 0.01 0.01 §Potato ○ 0.01 0.01 §Taro ○ 0.01 0.01 §Sweet potato ○ 0.01 0.01 §Yam ○ 0.01 0.01 §Konjac ○ 0.01 0.01 §Sugar beet ○ 0.01 0.01 §Japanese radish, roots (including radish) ○ 0.01 0.01 §Japanese radish, leaves (including radish) ○ 0.01 0.01 §Turnip, roots (including rutabaga) ○ 0.01 0.01 §Turnip, leaves (including rutabaga) ○ 0.01 0.01 §Chinese cabbage ○ 0.01 0.01 §Cabbage ○ 0.01 0.01 §Kale ○ 0.01 0.01 §Komatsuna(Japanese mustard spinach) ○ 0.01 0.01 §Kyona ○ 0.01 0.01 §Qing-geng-cai ○ 0.01 0.01 §Other cruciferous vegetables ○ 0.01 0.01 §Burdock ○ 0.01 0.01 §Lettuce (including cos lettuce and leaf lettuce) ○ 0.01 0.01 §Other composite vegetables ○ 0.01 0.01 §Onion ○ 0.01 0.01 §Welsh (including leek) ○ 0.01 0.01 §Garlic ○ 0.01 0.01 §Nira ○ 0.01 0.01 §Multiplying onion (including shallot) ○ 0.01 0.01 §Other liliaceous vegetables ○ 0.01 0.01 §Carrot ○ 0.01 0.01 §Parsley ○ 0.01 0.01 §Celery ○ 0.01 0.01 §Mitsuba ○ 0.01 0.01 §Other umbelliferous vegetables ○ 0.01 RequestTomato ○ 0.01 0.01 §Pimiento (sweet pepper) ○ 0.01 0.01 §Egg plant ○ 0.01 0.01 §Other solanaceous vegetables ○ 0.01 0.01 §Cucumber (including gherkin) ○ 0.01 0.01 §Pumpkin (including squash) ○ 0.01 0.01 §Oriental pickling melon (vegetable) ○ 0.01 0.01 §Water melon ○ 0.01 0.01 §Melons ○ 0.01 0.01 §Makuwauri melon ○ 0.01 0.01 §Other cucurbitaceous vegetables ○ 0.01 0.01 §Spinach ○ 0.01 0.01 §Okra ○ 0.01 0.01 §Ginger ○ 0.01 0.01 §Peas, immature (with pods) ○ 0.01 0.01 §Kidney beans, immature (with pods) ○ 0.01 0.01 §Green soybeans ○ 0.01 0.01 §

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other vegetables ○ 0.01 0.01 §Strawberry ○ 0.01 0.01 §Other herbs ○ 0.01 0.01 §Mineral waters ○ 0.02 0.02 0.02

The residue definition is the sum of E and Z isomers of 1,3-dichloropropene.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

○:Commodities for which MRLs are to be maintained, increased or newly set.§:Permitted for use in Japan.Request:Request for setting/revising MRL was made by the MAFF.

※The Guideline Value of the WHO Drinking Water Quality Guidelines (Guideline Value: In the WHO drinking water quality guideline set for the purpose of maintaining and improving the quality of drinking water by the regulators and water supply service providers of each country in WHO, drinking water. It is a numerical value that is the basis for evaluating water quality and indicates the concentration that does not cause serious risk to the health of the consumer when ingested over the lifetime.)

Acynonapyr

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Egg plant ○ 0.5 RequestWater melon ○ 0.03 RequestUnshu orange, pulp ○ 0.1 RequestCitrus natsudaidai, whole ○ 1 RequestLemon ○ 1 RequestOrange (including navel orange) ○ 1 RequestGrapefruit ○ 1 RequestLime ○ 1 RequestOther citrus fruits ○ 1 RequestApple ○ 3 RequestJapanese pear ○ 0.7 RequestPear ○ 0.7 RequestApricot ○ 2 RequestJapanese plum (including prune) ○ 0.2 RequestMume plum ○ 2 RequestCherry ○ 3 RequestStrawberry ○ 2 RequestTea ○ 20 RequestOther spices ○ 5 RequestFish ○ 0.7 Request

The residue definition for agricultural products is the sum of acynonapyr and metabolite C [3-endo -[2-Propoxy-4- (trifluoromethyl)phenoxy]-9-azabicyclo[3.3.1]nonane】, expressed as acynonapyr. For aquatic products, acynonapyr only.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

○:Commodities for which MRLs are to be maintained, increased or newly set. Request:Request for setting/revising MRL was made by the MAFF.

Acibenzolar-S-methyl

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ○ 0.1 0.1Wheat ○ 0.05 0.05 0.05 SwitzerlandBarley ● 0.05Rye ● 0.05Corn (maize, including pop corn and sweet corn) ● 0.05Buckwheat ● 0.05Other cereal grains ● 0.05Turnip, leaves (including rutabaga) ○ 1 1Watercress ○ 0.3 0.3 0.25 USAChinese cabbage ○ 1 1 Request 1Cabbage ○ 1 1 Request 0.7 1.0 USABrussels sprouts ○ 1 1 0.7 1.0 USAKale ○ 1 1 1Komatsuna(Japanese mustard spinach) ○ 1 1 1Kyona ○ 1 1 1Qing-geng-cai ○ 1 1 1Cauliflower ○ 1 1 0.7 1.0 USABroccoli ○ 1 1 0.7 1.0 USAOther cruciferous vegetables ○ 1 1 1Endive ○ 0.3 0.3 0.25 USAShungiku ○ 0.3 0.3 0.25 USALettuce (including cos lettuce and leaf lettuce) ○ 0.4 0.3 0.4Other composite vegetables ○ 0.3 0.3 0.25 USAOnion ○ 0.2 0.1 0.15Garlic ○ 0.2 0.15Parsley ○ 0.3 0.3 0.25 USACelery ○ 0.3 0.3 0.25 USAOther umbelliferous vegetables ○ 0.3 0.3 0.25 USATomato ○ 1 1 0.3 1.0 USAPimiento (sweet pepper) ○ 1 1 1.0 USAEgg plant ○ 1 1 1.0 USAOther solanaceous vegetables ○ 1 1 1.0 USACucumber (including gherkin) ○ 0.8 0.8Pumpkin (including squash) ○ 0.8 0.8Oriental pickling melon (vegetable) ○ 0.8 0.8Other cucurbitaceous vegetables ○ 0.8 0.8Spinach ○ 1 1 0.6 1.0 USAOther vegetables ○ 0.3 0.3 0.25 USACitrus natsudaidai, whole ○ 0.02 0.015Lemon ○ 0.02 0.015Orange (including navel orange) ○ 0.02 0.015Grapefruit ○ 0.02 0.015Lime ○ 0.02 0.015Other citrus fruits ○ 0.02 0.015Apple ○ 0.3 0.3Nectarine ○ 0.2 0.2Apricot ○ 0.2 0.2Mume plum ○ 0.2 0.2Strawberry ○ 0.2 0.2 0.15Blueberry ○ 0.2 0.2 0.15 USA

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cranberry ○ 0.2 0.2 0.15Other berries ○ 0.2 0.2 0.15Banana ○ 0.1 0.1 0.06 0.1 USAOther herbs ○ 1 1 1Cattle, muscle ○ 0.02 0.02Pig, muscle ○ 0.02 0.02Other terrestrial mammals, muscle ○ 0.02 0.02Cattle, fat ○ 0.02 0.02Pig, fat ○ 0.02 0.02Other terrestrial mammals, fat ○ 0.02 0.02Cattle, liver ○ 0.02 0.02Pig, liver ○ 0.02 0.02Other terrestrial mammals, liver ○ 0.02 0.02Cattle, kidney ○ 0.02 0.02Pig, kidney ○ 0.02 0.02Other terrestrial mammals, kidney ○ 0.02 0.02Cattle, edible offal ○ 0.02 0.02Pig, edible offal ○ 0.02 0.02Other terrestrial mammals, edible offal ○ 0.02 0.02Milk ○ 0.01 0.01Chicken, muscle ○ 0.02 0.02Other poultry, muscle ○ 0.02 0.02Chicken, fat ○ 0.02 0.02Other poultry, fat ○ 0.02 0.02Chicken, liver ○ 0.02 0.02Other poultry, liver ○ 0.02 0.02Chicken, kidney ○ 0.02 0.02Other poultry, kidney ○ 0.02 0.02Chicken, edible offal ○ 0.02 0.02Other poultry, edible offal ○ 0.02 0.02Chicken eggs ○ 0.02 0.02Other poultry, eggs ○ 0.02 0.02

The residue definition is sum of acibenzolar-S-methyl and metabolite B 【benzo[1,2,3]thiadiazole-7-carboxylic acid】(including metabolites that can be hydrolyzed to metabolite B), expressed as acibenzolar-S-methyl.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

●:Commodities for which MRLs are to be lowered or deleted.○:Commodities for which MRLs are to be maintained, increased or newly set. Request:Request for setting/revising MRL was made by the MAFF.

Chlorothalonil

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ● 0.03 0.1 §Wheat ○ 0.1 0.1 §Barley ● 0.02 0.1 §Rye ○ 0.1 0.1 §Corn (maize, including pop corn and sweet corn) ● 0.01Buckwheat ● 0.01Other cereal grains ○ 0.1 0.1 §Soybeans, dry ○ 1 0.2 § 1Beans, dry ○ 1 0.2 § 1Peas ○ 1 0.2 1Broad beans ○ 1 0.2 1Peanuts, dry ○ 0.1 0.05 § 0.1Other pulses ○ 1 0.2 1Potato ○ 0.3 0.2 § 0.3Taro ○ 0.3 0.2 0.3Sweet potato ○ 0.3 0.2 0.3Yam ○ 0.3 0.01 § 0.3Konjac ○ 0.3 0.2 0.3Other potatoes ○ 0.3 0.2 0.3Sugar beet ○ 0.3 0.2 § 0.3Japanese radish, roots (including radish) ○ 0.3 0.1 § 0.3Japanese radish, leaves (including radish) ○ 2 2 §Turnip, roots (including rutabaga) ○ 0.3 0.02 § 0.3Turnip, leaves (including rutabaga) ○ 0.05 0.05 §Horseradish ● 1 4 1Watercress ● 4Chinese cabbage ○ 2 2 §Cabbage ○ 2 2 §Brussels sprouts ○ 6 5 6Kale ● 4Komatsuna(Japanese mustard spinach) ● 4Kyona ● 0.03 4 §Qing-geng-cai ● 2Cauliflower ○ 5 1 § 5Broccoli ○ 5 5 § 5Other cruciferous vegetables ● 0.3 2 § 0.3Burdock ● 0.3 4 § 0.3Salsify ● 0.3 4 0.3Artichoke ● 4Chicory ● 4Endive ● 4Shungiku ● 6Lettuce (including cos lettuce and leaf lettuce) ● 0.7 1 §Other composite vegetables ● 1 2 § 0.3Onion ○ 2 0.5 § 1.5Welsh (including leek) ※1 ○ 10 5 § 10Garlic ● 0.05 10 §Nira ● 2Asparagus ○ 3 2 §Multiplying onion (including shallot) ● 3 5 §

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other liliaceous vegetables ○ 10 2 § 10Carrot ● 0.7 1 § 0.3Parsnip ● 1Parsley ● 3Celery ○ 20 10 § 20Mitsuba ● 0.02 0.05 §Other umbelliferous vegetables ○ 0.5 0.5 § 0.3Tomato ○ 5 5 § 5Pimiento (sweet pepper) ○ 10 7 § 7Egg plant ○ 2 2 §Other solanaceous vegetables ○ 7 2 7Cucumber (including gherkin) ○ 5 5 § 3Pumpkin (including squash) ● 3 5 § 3Oriental pickling melon (vegetable) ● 2 5 §

Water melon ● 0.03 5 §Melons ● 0.02 2 §Makuwauri melon ● 5Other cucurbitaceous vegetables ● 3 5 §Spinach ● 4Bamboo shoots ● 2Okra ● 5 6 §Ginger ● 0.02 0.05 §Peas, immature (with pods) ● 2Kidney beans, immature (with pods) ● 5Green soybeans ● 2Button mushroom ● 1Shiitake mushroom ● 5Other mushrooms ● 5Other vegetables ※2 ○ 2 2 § 2Unshu orange, pulp ● 0.01Citrus natsudaidai, whole ● 0.01Lemon ● 0.01Orange (including navel orange) ● 0.01Grapefruit ● 0.01Lime ● 0.01Other citrus fruits ● 0.01Apple ○ 2 2 §Japanese pear ● 0.3 0.5 §Pear ○ 2 2 §Quince ● 0.7 1 §Loquat ● 1Peach ● 0.2 2 §Nectarine ● 5 25 § 1.5Apricot ● 2 25 1.5Japanese plum (including prune) ● 2 25 ※3Mume plum ● 2 5 1.5Cherry ○ 3 0.5 3Strawberry ● 5 8 5Raspberry ● 10Blackberry ● 10Blueberry ● 1Cranberry ○ 5 5 5

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Huckleberry ● 7Other berries ○ 20 10 20Grape ○ 3 0.5 § 3Japanese persimmon ○ 1 1 §Banana ○ 15 0.2 15Kiwifruit ○ 0.2 0.2 §Papaya ○ 20 15 § 20Avocado ● 0.01Pineapple ● 0.01Guava ● 0.01Mango ● 0.5Passion fruit ● 2 3 §Date ● 0.1Other fruits ● 2 5 §

Sunflower seeds ● 0.01Sesame seeds ● 0.01Safflower seeds ● 0.01Cotton seeds ● 0.01Rapeseeds ● 0.01Other oil seeds ● 0.01Ginkgo nut ● 0.01Chestnut ● 0.01Pecan ● 0.01Almond ● 0.05Walnut ● 0.01Other nuts ○ 0.3 0.1 0.3Tea ○ 10 10 §Coffee beans ● 0.2Cacao beans ● 0.05Hop ● 0.1Other spices ● 0.3 5 0.3Other herbs ○ 7 2 § 7Cattle, muscle ○ 0.02 0.02 0.02Pig, muscle ○ 0.02 0.02 0.02Other terrestrial mammals, muscle ○ 0.02 0.02 0.02Cattle, fat ● 0.07 0.1 0.07Pig, fat ○ 0.07 0.06 0.07Other terrestrial mammals, fat ● 0.07 0.1 0.07Cattle, liver ○ 0.2 0.03 0.2Pig, liver ○ 0.2 0.03 0.2Other terrestrial mammals, liver ○ 0.2 0.03 0.2Cattle, kidney ● 0.2 0.3 0.2Pig, kidney ● 0.2 0.3 0.2Other terrestrial mammals, kidney ● 0.2 0.3 0.2Cattle, edible offal ○ 0.2 0.03 0.2Pig, edible offal ○ 0.2 0.03 0.2Other terrestrial mammals, edible offal ○ 0.2 0.03 0.2Milk ○ 0.07 0.06 0.07Chicken, muscle ○ 0.01 0.01 0.01Other poultry, muscle ○ 0.01 0.01 0.01Chicken, fat ○ 0.01 0.01 0.01

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other poultry, fat ○ 0.01 0.01 0.01Chicken, liver ○ 0.07 0.01 0.07Other poultry, liver ○ 0.07 0.01 0.07Chicken, kidney ○ 0.07 0.01 0.07Other poultry, kidney ○ 0.07 0.01 0.07Chicken, edible offal ○ 0.07 0.01 0.07Other poultry, edible offal ○ 0.07 0.01 0.07Chicken eggs ○ 0.04 0.01Other poultry, eggs ○ 0.04 0.01

The residue definition for agricultural products is chlorothalonil only. For animal products, metabolite I 【 2,5,6-trichloro-4-hydroxyisophthalonitrile】 only.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.

* Shaded figures indicate provisional MRLs.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

●:Commodities for which MRLs are to be lowered or deleted.○:Commodities for which MRLs are to be maintained,increased or newly set.§:Permitted for use in Japan.

※1 Though the Codex has set MRL in "leek" of 40 mg/kg, the dietary exposure of chlorothalonil estimated by using the supervised trial midian residue (STMR) submitted to the JMPR and national food consumption data would exceed the ADI of 0.018 mg/kg b.w. set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set MRL in "welsh (including leek)" following the Codex MRL in "onion, welsh" of 10 mg/kg.※2 Though the Codex has set MRL in "Chard" of 50 mg/kg, the dietary exposure of chlorothalonil estimated by using the supervised trial midian residue (STMR) submitted to the JMPR and national food consumption data would exceed the ADI of 0.018 mg/kg b.w. set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set MRL in "other vegetables" following the Codex MRL in "ginseng" of 2 mg/kg.※3 The MAFF is in the process of parmittion for use for "Japanese plum (including prune)" in Japan

Probenazole

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ● 0.05 0.5 §Wheat ● 0.03Barley ● 0.03Rye ● 0.03Corn (maize, including pop corn and sweet corn) ● 0.03Buckwheat ● 0.03Other cereal grains ● 0.03Soybeans, dry ● 0.03Beans, dry ● 0.03Peas ● 0.03Broad beans ● 0.03Peanuts, dry ● 0.03Other pulses ● 0.03Potato ● 0.03Taro ● 0.03Sweet potato ● 0.03Yam ● 0.03Konjac ● 0.03Other potatoes ● 0.03Sugar beet ● 0.03Sugarcane ● 0.03Japanese radish, roots (including radish) ● 0.1Japanese radish, leaves (including radish) ● 0.1Turnip, roots (including rutabaga) ● 0.1Turnip, leaves (including rutabaga) ● 0.1Horseradish ● 0.1Watercress ● 0.1Chinese cabbage ● 0.05 0.1 §Cabbage ● 0.05 0.1 §Brussels sprouts ● 0.1Kale ● 0.1Komatsuna(Japanese mustard spinach) ● 0.1Kyona ● 0.1Qing-geng-cai ● 0.1Cauliflower ● 0.05 0.1 §Broccoli ● 0.05 0.1 §Other cruciferous vegetables ● 0.05 0.1 §Burdock ● 0.1Salsify ● 0.1Artichoke ● 0.1Chicory ● 0.1Endive ● 0.1Shungiku ● 0.1Lettuce (including cos lettuce and leaf lettuce) ● 0.05 0.1 §Other composite vegetables ● 0.1Onion ● 0.1Welsh (including leek) ● 0.05 0.1 §Garlic ● 0.1Nira ● 0.1Asparagus ● 0.1

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Multiplying onion (including shallot) ● 0.05 0.1 §Other liliaceous vegetables ● 0.1Carrot ● 0.1Parsnip ● 0.1Parsley ● 0.1Celery ● 0.1Mitsuba ● 0.1Other umbelliferous vegetables ● 0.1Tomato ● 0.1Pimiento (sweet pepper) ● 0.05 0.1 §Egg plant ● 0.1Other solanaceous vegetables ● 0.03 0.1 §

Cucumber (including gherkin) ● 0.05 0.1 §Pumpkin (including squash) ● 0.1Oriental pickling melon (vegetable) ● 0.1Water melon ● 0.03Melons ● 0.03Makuwauri melon ● 0.03Other cucurbitaceous vegetables ● 0.1Spinach ● 0.1Bamboo shoots ● 0.1Okra ● 0.1Ginger ● 0.1Peas, immature (with pods) ● 0.1Kidney beans, immature (with pods) ● 0.1Green soybeans ● 0.1Button mushroom ● 0.1Shiitake mushroom ● 0.1Other mushrooms ● 0.1Other vegetables ● 0.1Unshu orange, pulp ● 0.03Citrus natsudaidai, whole ● 0.03Lemon ● 0.03Orange (including navel orange) ● 0.03Grapefruit ● 0.03Lime ● 0.03Other citrus fruits ● 0.03Apple ● 0.03Japanese pear ● 0.03Pear ● 0.03Quince ● 0.03Loquat ● 0.03Peach ● 0.03Nectarine ● 0.03Apricot ● 0.03Japanese plum (including prune) ● 0.03Mume plum ● 0.03Cherry ● 0.03Strawberry ● 0.03Raspberry ● 0.03Blackberry ● 0.03Blueberry ● 0.03

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cranberry ● 0.03Huckleberry ● 0.03Other berries ● 0.03Grape ● 0.03Japanese persimmon ● 0.03Banana ● 0.03Kiwifruit ● 0.03Papaya ● 0.03Avocado ● 0.03Pineapple ● 0.03Guava ● 0.03Mango ● 0.03

Passion fruit ● 0.03Date ● 0.03Other fruits ● 0.03Sunflower seeds ● 0.03Sesame seeds ● 0.03Safflower seeds ● 0.03Cotton seeds ● 0.03Rapeseeds ● 0.03Other oil seeds ● 0.03Ginkgo nut ● 0.03Chestnut ● 0.03Pecan ● 0.03Almond ● 0.03Walnut ● 0.03Other nuts ● 0.03Tea ● 0.03Coffee beans ● 0.03Cacao beans ● 0.03Hop ● 0.03Other spices ● 0.1Other herbs ● 0.05 0.1 §Fish ○ 0.07 Request

The residue definition is probenazole only.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.* Shaded figures indicate provisional MRLs.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

●:Commodities for which MRLs are to be lowered or deleted.○:Commodities for which MRLs are to be maintained, increased or newly set.§:Permitted for use in Japan.

Request:Request for setting/revising MRL was made by the MAFF.

Morantel

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cattle, muscle ● 0.1 0.3 0.1 EUPig, muscle ● 0.1 0.3 §Other terrestrial mammals, muscle ● 0.1 0.3 0.1 EUCattle, fat ● 0.1 0.3 0.1 EUPig, fat ● 0.1 0.3 §Other terrestrial mammals, fat ● 0.1 0.3 0.1 EUCattle, liver ● 0.8 1 0.8 EUPig, liver ● 2 5 §Other terrestrial mammals, liver ● 0.8 1 0.8 EUCattle, kidney ● 0.2 2 0.2 EUPig, kidney ● 0.5 5 §Other terrestrial mammals, kidney ● 0.2 2 0.2 EUCattle, edible offal ● 0.8 2Pig, edible offal ● 2 5 §Other terrestrial mammals, edible offal ● 0.8 2Milk ○ 0.1 0.1Chicken, muscle ● 0.03Chicken, fat ● 0.03Chicken, liver ● 0.03Chicken, kidney ● 0.03Chicken, edible offal ● 0.03

The residue definition will be changed to the sum of residues which may be hydrolized to MAPA【N -methyl-1,3-propanediamine 】 and epressed as morantel equivalnets. The current residue definition is morantel only.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and to commodities not listed above.* Shaded figures indicate provisional MRLs.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given in the last two pages of the Attachment.

●:Commodities for which MRLs are to be lowered or deleted.○:Commodities for which MRLs are to be maintained, increased or newly set. (* It should

be noted that the residue definition will be changed.)§:Permitted for use in Japan.

Notes:

“Other cereal grains” refers to all cereal grains, except rice (brown rice), wheat, barley, rye, corn (maize), and buckwheat.

“Beans, dry” including butter beans, cowbeans (red beans), lentil, lima beans, pegia, sultani, sultapya

“Other legumes/pulses” refers to all legumes/pulses, except soybeans (dry), beans (dry), peas, broad beans, peanuts (dry), and spices.

“Other potatoes” refers to all potatoes, except potato, taro, sweet potato, yam, and konjac.

“Other cruciferous vegetables” refers to all cruciferous vegetables, except Japanese radish roots and leaves (including radish), turnip roots and leaves, horseradish, watercress, Chinese cabbage, cabbage, brussels sprouts, kale, komatsuna (Japanese mustard spinach), kyona, qing-geng-cai, cauliflower, broccoli, and herbs.

“Other composite vegetables” refers to all composite vegetables, except burdock, salsify, artichoke, chicory, endive, shungiku, lettuce (including cos lettuce and leaf lettuce), and herbs.

“Other liliaceous vegetables” refers to all liliaceous vegetables, except onion, welsh (including leek), garlic, nira, asparagus, multiplying onion, and herbs.

“Other umbelliferous vegetables” refers to all umbelliferous vegetables, except carrot, parsnip, parsley, celery, mitsuba, spices, and herbs.

“Other solanaceous vegetables” refers to all solanaceous vegetables, except tomato, pimiento (sweet pepper), and egg plant.

“Other cucurbitaceous vegetables” refers to all cucurbitaceous vegetables, except cucumber (including gherkin), pumpkin (including squash), oriental pickling melon (vegetable), watermelon, melons, and makuwauri melon.

“Other mushrooms” refers to all mushrooms, except button mushroom, and shiitakemushroom.

“Other vegetables” refers to all vegetables, except potatoes, sugar beet, sugarcane, cruciferous vegetables, composite vegetables, liliaceous vegetables, umbelliferous vegetables, solanaceous vegetables, cucurbitaceous vegetables, spinach, bamboo shoots, okra, ginger, peas (with pods, immature), kidney beans (with pods, immature), green soybeans, mushrooms, spices, and herbs.

“Other citrus fruits” refers to all citrus fruits, except unshu orange (pulp), citrus natsudaidai (pulp), citrus natsudaidai (peel), citrus natsudaidai (whole), lemon, orange (including navel orange), grapefruit, lime, and spices.

“Other berries” refers to all berries, except strawberry, raspberry, blackberry, blueberry, cranberry, and huckleberry.

“Other fruits” refers to all fruits, except citrus fruits, apple, Japanese pear, pear, quince, loquat, peach, nectarine, apricot, Japanese plum (including prune), mume plum, cherry, berries, grape, Japanese persimmon, banana, kiwifruit, papaya, avocado, pineapple, guava, mango, passion fruit, date and spices.

“Other oil seeds” refers to all oil seeds, except sunflower seeds, sesame seeds, safflower seeds, cotton seeds, rapeseeds and spices.

“Other nuts” refers to all nuts, except ginkgo nut, chestnut, pecan, almond and walnut.

“Other spices” refers to all spices, except horseradish, wasabi (Japanese horseradish) rhizomes, garlic, peppers chili, paprika, ginger, lemon peels, orange peels (including navel orange), yuzu (Chinese citron) peels and sesame seeds.

“Other herbs” refers to all herbs, except watercress, nira, parsley stems and leaves, celery stems and leaves.

“Edible offal “refers to all edible parts, except muscle, fat, liver, and kidney

“Other terrestrial mammals” refers to all terrestrial mammals, except cattle and pig.

“Other poultry animals” refers to all poultry, except chicken.

“Other fish” refers to all fish, except salmoniformes, anguilliformes, and perciformes.

“Other aquatic animals” refers to all aquatic animal, except fish, shelled molluscs

and crustaceans.

Item 2. Designation of Substances Having No Potential to Cause Damage to Human Health (Exempt Substance)

The MHLW is going to designate the following agricultural and veterinary chemicals as substances having no potential to cause damage to human health, which is also referred to as “exempt substance,” based on the provision of Paragraph 3, Article 11 of the Food Sanitation Act:

Veterinary drug and Feed additive:Tocopherol

Summary

Tocopherol (veterinary drug and feed additive: vitamin): Permitted for use in Japan. The MHLW requested the Food Safety Commission of Japan (FSC) to conduct a risk assessment for this substance. The FSC concluded that tocopherol is not considered to have no potential to cause damage to human health from its residue in foods. Based on the assessment, the MHLW has decided to designate tocopherol as an exempt substance.