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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

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Internal

Date: 10/27/2017

GAIN Report Number: JA7133

Japan

Post:Tokyo

Japan Proposes Revision of 8 MRLs and Addition of a Food AdditiveReport Categories:Agricultural SituationSanitary/Phytosanitary/Food Safety

Approved By: Jess K. Paulson

Prepared By: Tomohiro Kurai

Report Highlights:On Thursday, October 26, 2017, Japan’s Ministry of Health, Labor and Welfare (MHLW) announced revisions to Japan’s Maximum Residue Levels (MRLs) for the following pesticides, veterinary drugs, and feed additives: Aminocyclopyrachlor, Etofenprox, Captan, Fenbuconazole, Propiconazole, Josamycin, Spectinomycin, and Prednisolone. MHLW also proposes to establish the maximum limit for Deoxynivalenol (DON) in foods. Furthermore, MHLW proposes to designate Propiconazole as a new food additive. The Embassy comment period for these proposals is open until Thursday, November 09, 2017. 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: JA7133

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 Thursday, November 9, 2017. 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, 2, 3, 4 and 5, the SPS notification will be made for the setting or revision of the MRL for the agricultural and veterinary chemicals except for Aminocyclopyrachlor and Prednisolone 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, 100-8916Tel: 03-5253-1111 Fax: 03-3501-4868, 03-3595-2432

Pesticides/Veterinary drugs/Feed additives Mr. Ryota NAKAMURA ([email protected]) Tel: 03-5253-1111 (ex 4289)

Food standards Mr. Tsuyoshi ARAI ([email protected]) Tel: 03-5253-1111 (ex 4280)

Food additives Mr. Katsuya TANAKA ([email protected]) Tel: 03-5253-1111 (ex 2453)

mailto:[email protected]




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: Aminocyclopyrachlor, Etofenprox, Captan,

Fenbuconazole, Propiconazole

Veterinary drugs: Josamycin, Spectinomycin, Prednisolone

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

Aminocyclopyrachlor (pesticide: herbicide): Not permitted for use in Japan. The MHLW is going to establish MRLs in some commodities in response to a request for setting import tolerances based on the Guideline for Establishment and Revision of Maximum Residue Limits for Agricultural Chemicals Used outside Japan (Shokuan No. 0205001, 5 February 2004). This action will not strengthen the current regulation for any commodities.

Etofenprox (pesticide: insecticide): 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 Ministry of Agriculture, Forestry and Fisheries (MAFF) with the intention to expand its use pattern.

Captan (pesticide: fungicide): 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 expand its use pattern. The MHLW is also going to modify MRLs in some commodities that were provisionally set at the introduction of the Positive List System.

Fenbuconazole (pesticide: fungicide): 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 expand its use pattern.

Propiconazole (pesticide: fungicide): Permitted for use in Japan. The MHLW is going to modify the existing MRLs for animal products in response to a request by the MAFF.

Josamycin (veterinary drug: antibiotic): Not permitted for use in Japan. The MHLW is going to withdraw MRLs in some commodities that were provisionally set at the introduction of the Positive List System.

Spectinomycin (veterinary drug: antibiotic): Not 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.

Prednisolone (veterinary drug: synthetic adrenocortical hormone): 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. This action will not strengthen the current regulation for any commodities.

Aminocyclopyrachlor

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cattle, muscle ○ 0.01 IT 0.01Pig, muscle ○ 0.01 0.01Other terrestrial mammals, muscle ○ 0.01 IT 0.01Cattle, fat ○ 0.03 IT 0.03Pig, fat ○ 0.03 0.03Other terrestrial mammals, fat ○ 0.03 IT 0.03Cattle, liver ○ 0.3 IT 0.3Pig, liver ○ 0.3 0.3Other terrestrial mammals, liver ○ 0.3 IT 0.3Cattle, kidney ○ 0.3 IT 0.3Pig, kidney ○ 0.3 0.3Other terrestrial mammals, kidney ○ 0.3 IT 0.3Cattle, edible offal ○ 0.3 IT 0.3Pig, edible offal ○ 0.3 0.3Other terrestrial mammals, edible offal ○ 0.3 IT 0.3Milk ○ 0.02 IT 0.02

Note: The residue definition is Aminocyclopyrachlor 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. IT：Import tolerance

Etofenprox

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ○ 0.5 0.5 § 0.01Wheat ○ 0.5 0.5 §Barley ○ 0.5 0.5 0.5 EURye ○ 0.5 0.5 0.5 EUCorn (maize, including pop corn and sweet corn) ○ 0.3 0.3 § 0.05Other cereal grains ○ 5 3 Request・§Soybeans, dry ○ 0.2 0.2 § 0.05Beans, dry ● 0.05 0.2 § 0.05Peas ○ 0.05 0.05 §Broad beans ○ 0.05 0.05 §Peanuts, dry ○ 0.05 0.05 §Other pulses ○ 0.05 0.05 § 0.05Potato ○ 0.05 0.05 §Taro ● 0.03 0.1 §Sweet potato ○ 0.03 0.03 §Yam ● 0.02 0.1 §Sugar beet ○ 0.3 0.3 §Sugarcane ○ 0.03 0.03 §Japanese radish, roots (including radish) ● 0.2 2 §Japanese radish, leaves (including radish) ● 5 10 §Turnip, roots (including rutabaga) ● 2Turnip, leaves (including rutabaga) ● 10Chinese cabbage ○ 5 5 §Cabbage ● 1 2 §Brussels sprouts ○ 2 2 2 EUBroccoli ○ 10 10 §Other cruciferous vegetables ○ 1 1 §Lettuce (including cos lettuce and leaf lettuce) ○ 2 2 §Other composite vegetables ○ 2 2 §Welsh (including leek) ○ 2 2 §Multiplying onion (including shallot) ● 2Mitsuba ○ 5 5 §Other umbelliferous vegetables ○ 2 2 §Tomato ○ 2 2 §Pimiento (sweet pepper) ○ 5 5 §Egg plant ○ 2 2 §Other solanaceous vegetables ○ 2 2Cucumber (including gherkin) ○ 1 1 §Pumpkin (including squash) ○ 1 1 §Water melon ● 0.03 2 §Melons ● 0.2 2 §Makuwauri melon ● 2Other cucurbitaceous vegetables ○ 1 1 §Okra ○ 3 3 §Ginger ○ 3 2 Request・§Peas, immature (with pods) ○ 2 2 §Kidney beans, immature (with pods) ○ 3 2 Request・§Green soybeans ○ 3 3 §Other vegetables ○ 10 10 §Unshu orange, pulp ● 0.2 2 §Citrus natsudaidai, whole ○ 3 3 §

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Lemon ○ 5 5 §Orange (including navel orange) ○ 5 5 §Grapefruit ○ 5 5 §Lime ○ 5 5 §Other citrus fruits ○ 5 5 §Apple ○ 2 2 § 0.6Japanese pear ○ 2 2 § 0.6Pear ○ 2 2 § 0.6Peach ● 0.1 2 §Nectarine ○ 0.6 0.6 0.6Grape ○ 4 4 4Japanese persimmon ○ 2 2 §Mango ○ 5 5 §Rapeseeds ○ 0.01 0.01 0.01Chestnut ● 0.05 2 §Tea ○ 10 10 §Other spices ○ 20 20 §Other herbs ○ 0.7 0.7 §Cattle, muscle ● 0.2 0.5Pig, muscle ● 0.2 0.5Other terrestrial mammals, muscle ● 0.2 0.5Cattle, fat ● 6 7 0.5Pig, fat ● 6 7 0.5Other terrestrial mammals, fat ● 6 7 0.5Cattle, liver ● 0.3 0.5 0.05Pig, liver ● 0.3 0.5 0.05Other terrestrial mammals, liver ● 0.3 0.5 0.05Cattle, kidney ● 0.4 0.5 0.05Pig, kidney ● 0.4 0.5 0.05Other terrestrial mammals, kidney ● 0.4 0.5 0.05Cattle, edible offal ● 0.4 0.5 0.05Pig, edible offal ● 0.4 0.5 0.05Other terrestrial mammals, edible offal ● 0.4 0.5 0.05Milk ● 0.4 0.5 0.02Chicken, muscle ○ 0.02 0.01 0.01Other poultry, muscle ○ 0.02 0.01 0.01Chicken, fat ○ 1 1 1.0 USAOther poultry, fat ○ 1 1 1.0 USAChicken, liver ○ 0.07 0.06 0.01Other poultry, liver ○ 0.07 0.06 0.01Chicken, kidney ○ 0.07 0.06 0.01Other poultry, kidney ○ 0.07 0.06 0.01Chicken, edible offal ○ 0.07 0.06 0.01Other poultry, edible offal ○ 0.07 0.06 0.01Chicken eggs ○ 0.4 0.4 0.01 0.40 USAOther poultry, eggs ○ 0.4 0.4 0.01 0.40 USAFish ○ 0.8 0.8Raisin ※ ● 8 8

Note: The residue definition is Etofenprox 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.* Diagonal line means deletion of a food category to which an MRL applies.


●：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 MAFF.

* Food categories “Raisin” will be deleted, and hereafter, MRLs in their raw commodities (i.e. Grape) will also apply to such processed commodities, taking into account their processing factors. For this substance, JMPR estimated processing factors of 2.1 for Raisin.

Captan

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

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

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Mitsuba ● 0.01 5 §Other umbelliferous vegetables ● 0.01 5 §Tomato ○ 5 5.0 § 5Pimiento (sweet pepper) ● 0.02 5 §Egg plant ○ 5 5.0 §Other solanaceous vegetables ● 0.05 5 §Cucumber (including gherkin) ● 3 5.0 § 3Pumpkin (including squash) ○ 5 5 §Oriental pickling melon (vegetable) ● 0.2 5 §Water melon ● 0.05 5 §Melons ● 0.02 5 §Makuwauri melon ● 0.01 5 §Other cucurbitaceous vegetables ● 0.01 5 §Spinach ○ 15 5 RequestBamboo shoots ● 0.01 5 §Okra ● 0.01 5 §Ginger ● 0.3 5 § 0.05Peas, immature (with pods) ● 0.01 5 §Kidney beans, immature (with pods) ● 0.01 5 §Green soybeans ● 0.01 5 §Button mushroom ● 5Shiitake mushroom ● 5Other mushrooms ● 5Other vegetables ● 0.01 5 §Unshu orange, pulp ● 5Citrus natsudaidai, whole ● 5Lemon ● 5Orange (including navel orange) ● 5Grapefruit ● 5Lime ● 5Other citrus fruits ● 5Apple ○ 15 5.0 §・Request 15Japanese pear ● 15 25 § 15Pear ● 15 25 § 15Quince ○ 15 5 § 15Loquat ● 5Peach ● 0.01 15 §Nectarine ○ 3 3 3Apricot ○ 5 5 §Japanese plum (including prune) ○ 10 5 § 10Mume plum ○ 5 5 §Cherry ○ 25 5 §・Request 25Strawberry ● 15 20 § 15Raspberry ○ 20 20 § 20Blackberry ● 0.01 20 §Blueberry ○ 20 20 § 20Cranberry ● 0.01 20 §Huckleberry ○ 20 20 § 20Other berries ● 0.01 20 §Grape ○ 25 5 §・Request 25Japanese persimmon ○ 5 5 §

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Banana ● 5Kiwifruit ● 5Papaya ○ 5 5 §Avocado ● 5Pineapple ● 0.7 5 §Guava ● 5Mango ○ 5 5 §Passion fruit ● 5Date ● 5Other fruits ● 5Sunflower seeds ● 5Sesame seeds ● 5Safflower seeds ● 5Cotton seeds ● 5Rapeseeds ● 5Other oil seeds ● 5Ginkgo nut ● 5Chestnut ● 5Pecan ● 5Almond ○ 0.3 0.3 0.3Walnut ● 5Other nuts ● 5Other spices(limited to roots and rhizome) ※

● 0.05 5 0.05Other herbs ● 0.05 5 0.05Cattle, muscle ● 0.05Pig, muscle ● 0.05Other terrestrial mammals, muscle ● 0.05Cattle, fat ● 0.05Pig, fat ● 0.05Other terrestrial mammals, fat ● 0.05Cattle, liver ● 0.05Pig, liver ● 0.05Other terrestrial mammals, liver ● 0.05Cattle, kidney ● 0.05Pig, kidney ● 0.05Other terrestrial mammals, kidney ● 0.05Cattle, edible offal ● 0.05Pig, edible offal ● 0.05Other terrestrial mammals, edible offal ● 0.05Milk ○ 0.01Chicken, muscle ● 0.02Other poultry, muscle ● 0.02Chicken, fat ● 0.02Other poultry, fat ● 0.02Chicken, liver ● 0.02Other poultry, liver ● 0.02Chicken, kidney ● 0.02Other poultry, kidney ● 0.02Chicken, edible offal ● 0.02Other poultry, edible offal ● 0.02Chicken eggs ● 0.02

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other poultry, eggs ● 0.02Raisin ○ 50 50

Note: The residue definition is Captan 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.



※："Other spices (limited to root or rhizome) refers to root or rhizome of asafetida, turmeric, zedoary, galangal and licorice.

Fenbuconazole

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Wheat ○ 0.1 0.1 § 0.1Barley ○ 0.2 0.2 0.2Rye ○ 0.1 0.1 0.1Soybeans, dry ○ 0.2 0.2 §Peanuts, dry ○ 0.1 0.1 0.1Sugar beet ○ 0.5 0.5 §Onion ○ 0.05 0.05 §Pimiento (sweet pepper) ○ 0.6 0.6Other solanaceous vegetables ○ 0.6 0.6Cucumber (including gherkin) ○ 0.2 0.2 0.2Pumpkin (including squash) ○ 0.05 0.05 0.05Melons ○ 0.2 0.2Makuwauri melon ○ 0.2 0.2Unshu orange, pulp ○ 1 1Citrus natsudaidai, whole ○ 1 1 0.5 1.0 USALemon ○ 1 1 1Orange (including navel orange) ○ 1 1 0.5 1.0 USAGrapefruit ○ 1 1 0.5 1.0 USALime ○ 1 1 1Other citrus fruits ○ 1 1 1Apple ○ 1 1 § 0.5Japanese pear ○ 0.7 0.7 § 0.5Pear ○ 0.7 0.7 § 0.5Quince ○ 0.5 0.1 0.5Loquat ○ 0.1 0.1Peach ○ 0.5 0.5 §Nectarine ○ 1 1 § 1.0 USAApricot ○ 0.5 0.5 § 0.5Japanese plum (including prune) ○ 1 1 § 0.3 1.0 USAMume plum ○ 2 2 § 0.5Cherry ○ 1 1 § 1Blueberry ○ 0.7 0.3 Request 0.5Cranberry ○ 1 0.5 1Huckleberry ○ 0.5 0.3 0.5Other berries ○ 0.3 0.3 0.3 USAGrape ○ 3 3 § 1Japanese persimmon ○ 0.7 0.7 §Banana ○ 0.05 0.05 0.05Other fruits ○ 0.01 0.01 0.01Sunflower seeds ○ 0.05 0.05 0.05Rapeseeds ○ 0.05 0.05 0.05Ginkgo nut ○ 0.01 0.01Chestnut ○ 0.01 0.01 0.01Pecan ● 0.01 0.05 0.01Almond ○ 0.05 0.05 0.01 0.05 USAWalnut ○ 0.01 0.01 0.01Other nuts ○ 0.01 0.01 0.01Tea ○ 10 10 §Other spices ○ 1 1 0.6Cattle, muscle ● 0.01 0.05 0.01Pig, muscle ○ 0.01 0.01 0.01

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other terrestrial mammals, muscle ○ 0.01 0.01 0.01Cattle, fat ● 0.01 0.05Pig, fat ○ 0.01Other terrestrial mammals, fat ○ 0.01Cattle, liver ○ 0.1 0.05 0.1Pig, liver ○ 0.1 0.01 0.1Other terrestrial mammals, liver ○ 0.1 0.05 0.1Cattle, kidney ○ 0.1 0.05 0.1Pig, kidney ○ 0.1 0.01 0.1Other terrestrial mammals, kidney ○ 0.1 0.05 0.1Cattle, edible offal ○ 0.1 0.05 0.1Pig, edible offal ○ 0.1 0.01 0.1Other terrestrial mammals, edible offal ○ 0.1 0.05 0.1Milk ● 0.01 0.05 0.01Chicken, muscle ● 0.01 0.05 0.01Other poultry, muscle ● 0.01 0.05 0.01Chicken, fat ● 0.01 0.05Other poultry, fat ● 0.01 0.05Chicken, liver ● 0.01 0.05 0.01Other poultry, liver ● 0.01 0.05 0.01Chicken, kidney ● 0.01 0.05 0.01Other poultry, kidney ● 0.01 0.05 0.01Chicken, edible offal ● 0.01 0.05 0.01Other poultry, edible offal ● 0.01 0.05 0.01Chicken eggs ● 0.01 0.05 0.01Other poultry, eggs ● 0.01 0.05 0.01

Note: The residue definition is Fenbuconazole only.





Propiconazole

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ○ 0.1 0.1Wheat ○ 1 1 § 0.09Barley ○ 2 1 § 2Rye ○ 0.3 0.3 0.09 0.3 USACorn (maize, including pop corn and sweet corn) ● 0.2 1 § 0.05 0.2 USABuckwheat ○ 1 1Other cereal grains ○ 4 4 0.7 3.5 USASoybeans, dry ○ 2 2 0.07 2.0 USABeans, dry ○ 0.05 0.05Peas ○ 0.05 0.05Broad beans ○ 0.05 0.05Peanuts, dry ○ 0.2 0.2 0.2 USAOther pulses ○ 0.05 0.05Potato ● 0.05Sweet potato ● 0.05Sugar beet ○ 0.3 0.3 0.02 0.3 USASugarcane ● 0.02 0.05 0.02Japanese radish, roots (including radish) ● 0.04 0.05Turnip, roots (including rutabaga) ● 0.05Horseradish ● 0.05Chinese cabbage ○ 0.05 0.05Cabbage ● 0.05Brussels sprouts ● 0.05Kale ○ 0.05 0.05Qing-geng-cai ○ 0.05 0.05Cauliflower ● 0.05Broccoli ● 0.05Other cruciferous vegetables ○ 0.05 0.05Chicory ● 0.05Endive ○ 0.05 0.05Other composite vegetables ○ 5 5 5.0 USAOnion ○ 0.2 0.2 0.2 USAWelsh (including leek) ○ 0.1 0.1Garlic ○ 0.05 0.05Asparagus ○ 0.05 0.05Other liliaceous vegetables ○ 0.2 0.2 0.2 USACarrot ○ 0.3 0.3 0.25 USAParsley ○ 13 13 13 USACelery ○ 5 5 5.0 USAOther umbelliferous vegetables ○ 5 5 5.0 USATomato ○ 0.05 0.05Pimiento (sweet pepper) ● 0.1Egg plant ● 0.05Cucumber (including gherkin) ● 0.05Pumpkin (including squash) ● 0.05Water melon ● 0.05Melons ● 0.05Other cucurbitaceous vegetables ● 0.05Spinach ○ 0.05 0.05Peas, immature (with pods) ○ 0.05 0.05Kidney beans, immature (with pods) ○ 0.05 0.05

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Green soybeans ○ 0.07 0.07Button mushroom ○ 0.1 0.1Other vegetables ○ 5 5 5.0 USAUnshu orange, pulp ● 0.05Citrus natsudaidai, whole ○ 8 0.05 8 USALemon ○ 8 0.05 8 USAOrange (including navel orange) ○ 8 0.05 9 8 USAGrapefruit ○ 8 0.05 8 USALime ○ 8 0.05 8 USAOther citrus fruits ○ 8 0.05 9 8 USAApple ○ 0.05 0.05Japanese pear ● 0.05Pear ● 0.05Quince ● 0.05Peach ○ 4 1 5 4 USANectarine ○ 4 1 4 USAApricot ○ 4 1 4 USAJapanese plum (including prune) ● 0.6 1 0.6 0.6 USAMume plum ○ 1 1Cherry ○ 4 1 4 USAStrawberry ○ 1 1 1.3 USARaspberry ○ 0.05 0.05Blackberry ○ 0.05 0.05Blueberry ○ 1 1 1.3 USACranberry ○ 1 1 0.3 1.0 USAOther berries ○ 1 1 1.3 USAGrape ○ 0.5 0.5Banana ○ 0.1 0.1 0.1Kiwifruit ● 0.05Avocado ○ 0.05 0.05Pineapple ● 0.02 0.1 0.02Mango ● 0.05Passion fruit ● 0.05Date ● 0.05Sunflower seeds ○ 0.05 0.05Sesame seeds ○ 0.05 0.05Cotton seeds ● 0.05Rapeseeds ● 0.02 0.07 0.02Other oil seeds ○ 0.05 0.05Pecan ● 0.02 0.05 0.02Almond ○ 0.05 0.05Walnut ○ 0.05 0.05Other nuts ○ 0.05 0.05Tea ○ 0.1 0.1Coffee beans ● 0.02 0.1 0.02Hop ● 0.1Cattle, muscle ○ 0.05 0.01 Request 0.01Pig, muscle ○ 0.05 0.01 Request 0.01Other terrestrial mammals, muscle ○ 0.05 0.01 Request 0.01Cattle, fat ○ 0.05 0.01 Request 0.01Pig, fat ○ 0.05 0.01 Request 0.01

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other terrestrial mammals, fat ○ 0.05 0.01 Request 0.01Cattle, liver ○ 0.5 0.01 Request 0.5Pig, liver ○ 0.5 0.01 Request 0.5Other terrestrial mammals, liver ○ 0.5 0.01 Request 0.5Cattle, kidney ○ 0.5 0.01 Request 0.5Pig, kidney ○ 0.5 0.01 Request 0.5Other terrestrial mammals, kidney ○ 0.5 0.01 Request 0.5Cattle, edible offal ○ 0.5 0.01 Request 0.5Pig, edible offal ○ 0.5 0.01 Request 0.5Other terrestrial mammals, edible offal ○ 0.5 0.01 Request 0.5Milk ○ 0.01 0.01 Request 0.01Chicken, muscle ○ 0.04 0.01 Request 0.01Other poultry, muscle ○ 0.04 0.01 Request 0.01Chicken, fat ○ 0.04 0.01 Request 0.01Other poultry, fat ○ 0.04 0.01 Request 0.01Chicken, liver ○ 0.04 0.01 RequestOther poultry, liver ○ 0.04 0.01 RequestChicken, kidney ○ 0.04 0.01 RequestOther poultry, kidney ○ 0.04 0.01 RequestChicken, edible offal ○ 0.04 0.01 RequestOther poultry, edible offal ○ 0.04 0.01 RequestChicken eggs ○ 0.04 0.01 Request 0.01Other poultry, eggs ○ 0.04 0.01 Request 0.01

Note: The residue definition is Propiconazole only.




Request：Request for setting/revising MRL was made by MAFF.* The residue definition in US is sum of Propiconazole, its metabolites and degradates.

Josamycin

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Pig, muscle ● ※ 0.04Pig, fat ● ※ 0.04Pig, liver ● ※ 0.04Pig, kidney ● ※ 0.04Pig, edible offal ● ※ 0.3Chicken, muscle ● ※ 0.04Chicken, fat ● ※ 0.04Chicken, liver ● ※ 0.04Chicken, kidney ● ※ 0.04Chicken, edible offal ● ※ 0.3Perciformes (such as bonito, horse mackerel, mackerel, sea bass, sea bream and tuna) ● ※ 0.05

* Not the uniform limit of 0.01 ppm but the regulation that foods shall not contain any antibiotics or chemically synthesized substances will be applied to the commodities for which current MRLs are to be deleted, since this substance is considered to be an antibiotic or chemically synthesized antibacterial substance.

* 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.

Spectinomycin

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cattle, muscle ○ 0.5 0.5 0.5Pig, muscle ○ 0.5 0.5 0.5Sheep, muscle ** ● 0.5 0.5Other terrestrial mammals, muscle ● 0.5 0.7 0.5Cattle, fat ○ 2 2.0 2Pig, fat ○ 2 2.0 2Sheep, fat ** ● 2.0 2Other terrestrial mammals, fat ○ 2 0.5 2Cattle, liver ○ 2 2.0 2Pig, liver ○ 2 2.0 2Sheep, liver ** ● 2.0 2Other terrestrial mammals, liver ○ 2 1 2Cattle, kidney ○ 5 5.0 5Pig, kidney ○ 5 5.0 5Sheep, kidney ** ● 5.0 5Other terrestrial mammals, kidney ○ 5 1 5Cattle, edible offal ○ 5 1Pig, edible offal ○ 5 1Other terrestrial mammals, edible offal ○ 5 1Milk ○ 0.2 0.2 0.2Chicken, muscle ○ 0.5 0.5 0.5Other poultry, muscle ○ 0.5 0.5Chicken, fat ○ 2 2.0 2Other poultry, fat ○ 2 0.3Chicken, liver ○ 2 2.0 2Other poultry, liver ○ 2 0.7Chicken, kidney ○ 5 5.0 5Other poultry, kidney ○ 5 2Chicken, edible offal ○ 5 0.4Other poultry, edible offal ○ 5 0.6Chicken eggs ○ 2 2.0 2Other poultry, eggs ○ 2 2Salmoniformes (such as salmon and trout) ● ※ 0.3Anguilliformes (such as eel) ● ※ 0.3Perciformes (such as bonito, horse mackerel, mackerel, sea bass, sea bream and tuna) ● ※ 0.3Other fish ● ※ 0.3Shelled molluscs ● ※ 0.3Crustaceans ● ※ 0.3Other aquatic animals ● ※ 0.3

Note: The residue definition is Spectinomycin only.

* Shaded figures indicate provisional MRLs.* Diagonal line means deletion of a food category to which an MRL applies.* 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.

** Food categories “Sheep, muscle”, “Sheep, fat”, “Sheep, liver” and “Sheep, kidney” will be abolished and integrated into “Other terrestrial mammals, muscle”,“Other terrestrial mammals, fat”, “Other terrestrial mammals, liver” and “Other terrestrial mammals, kidney”, followed by the current food category system for MRLs for agricultural and veterinary chemicals in Japan.

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

* The empty column means not the uniform limit (0.01 ppm) but no detection, since spectinomycin belongs to the family of medicines considered antibiotics or an antibacterial substance produced by chemical synthesis.

Prednisolone

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Cattle, muscle ○ 0.004 0.004 §Pig, muscle ○ 0.001 0.0007 §Other terrestrial mammals, muscle ○ 0.001 0.0007 §Cattle, fat ○ 0.004 0.004 §Pig, fat ○ 0.001 0.0007 §Other terrestrial mammals, fat ○ 0.001 0.0007 §Cattle, liver ○ 0.01 0.01 §Pig, liver ○ 0.001 0.0007 §Other terrestrial mammals, liver ○ 0.001 0.0007 §Cattle, kidney ○ 0.01 0.01 §Pig, kidney ○ 0.001 0.0007 §Other terrestrial mammals, kidney ○ 0.001 0.0007 §Cattle, edible offal ○ 0.01 0.01 §Pig, edible offal ○ 0.001 0.0007 §Other terrestrial mammals, edible offal ○ 0.001 0.0007 §Milk ○ 0.006 0.0007 § 0.006 EUChicken, muscle ● 0.0007Other poultry, muscle ● 0.0007Chicken, fat ● 0.0007Other poultry, fat ● 0.0007Chicken, liver ● 0.0007Other poultry, liver ● 0.0007Chicken, kidney ● 0.0007Other poultry, kidney ● 0.0007Chicken, edible offal ● 0.0007Other poultry, edible offal ● 0.0007Chicken eggs ● 0.0007Other poultry, eggs ● 0.0007Salmoniformes (such as salmon and trout) ● 0.0007Anguilliformes (such as eel) ● 0.0007Perciformes (such as bonito, horse mackerel, mackerel, sea bass, sea bream and tuna) ● 0.0007Other fish ● 0.0007Shelled molluscs ● 0.0007Crustaceans ● 0.0007Other aquatic animals ● 0.0007Honey (including royal-jelly) ● 0.0007

Note: The residue definition is Prednisolone 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.


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. The removal of Azadirachtin from the list of substances having no potential to cause damage to human health (exempt substance list).

Azadirachtin is obtained by extraction of neem (Azadirachtin indica) seeds or seed oil, which is considered to have an insecticidal effect. Azadirachtin has never been used as pesticide in Japan.

Azadirachtin is currently designated by Minister of Health, Labour and Welfare as the substance having no potential to cause damage to human health, which is also referred to as “exempt substance,” according to the Paragraph 3, Article 11, Food sanitation Act. Those substances are exempted from the Japan’s positive list system.

The Food Safety Commission of Japan conducted its risk assessment in response to the request from the Ministry of Health, Labour and Welfare (MHLW) on August, 2013, and concluded that azadirachtin is not considered to have no potential to cause damage to human health from its residue in foods. The reasons are there is insufficient data on its toxicology, residue in foods and dietary exposure and the European Food Safety Authority has set its Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD).

The MHLW has decided to remove the substance from the exempt substance list on the basis of the risk assessment by the Food Safety Commission, which means that the residue of azadirachtin in foods is going to be regulated under the positive list system. The distribution of any foods which contain agricultural chemicals at amounts exceeding a level of 0.01 ppm in the Japanese marketplace is prohibited unless specific maximum residue limits have been set.

Item 3. Establishment of the Maximum Limit for Deoxynivalenol (DON) in Foods.

Background From the viewpoint of public health, the Minister of Health, Labour and Welfare is authorized to establish specifications and standards for food or additives to be served for the purpose of marketing by hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council. (Food Sanitation Act Article 11 Paragraph 1)

Based on the conclusion of discussion conducted by the Committee on Standards for Food* on September 22, 2017, the Ministry of Health, Labour and Welfare of Japan (MHLW) has decided to establish a maximum limit (ML) for Deoxynivalenol (DON) in wheat at 1.0 mg/kg.

* The Committee of the Standards for Food is one of the advisory bodies of the Food Sanitation Council that is established under the Pharmaceutical Affairs and Food Sanitation Council.

Outline of revision Deoxynivalenol (DON) is a trichothecene mycotoxin produced in cereals (especially wheat, maize and barely) by mainly G. zeae, F. graminearum andF. culmorum. It is known to cause acute toxicity characterized by emesis and disorders of the lymphoid tissue and digestive tract and chronic toxicity characterized by symptoms including weight loss.

In May 2002 the MHLW established a provisional standard limit of 1.1 mg/kg for wheat because a high concentration of DON (2.2 mg/kg) was detected in wheat distributed in the Japanese market. In July 2015 theCodex Alimentarius Commission set maximum levels for DON in wheat, maize, and barley. （CODEX STAN 193-1995）Wheat is a secondary staple food in Japan and most of wheat consumed in Japan is imported. In light of past food poisoning cases associated with DON, Japan will establish the ML for DON in wheat to prevent a public

health risk. The ML has been derived applying the Codex ALARA principle1, based on the actual situation of contamination of imported wheat and exposure assessment for Japanese consumers.

Provisional standard Maximum Limit (draft)1.1 mg/kg for wheat 1.0 mg/kg for wheat

Concept of setting MLs

・ Codex Alimentarius Commission separately set the maximum levels for DON in cereals (wheat, maize, and barley) in three categories: cereal grains for further processing, flour, and cereal-based foods for infants and young children. In Japan, however, it is difficult to process wheat to reduce possible contamination by DON. In addition, it is not easy to separately regulate wheat-based foods for infants and children.

・ Exposure assessment conducted by the Ministry of Agriculture, Forestryand Fisheries of Japan has found that if a maximum limit (ML) of 1.0 mg/kg is applied to wheat, the 95th percentile of the orally ingested DON by pre-school children would be the same level as the tolerable daily intake (TDI) for DON set by the Food Safety Commission of Japan, a risk assessment body, in the Cabinet Office. This means the application of the ML of 1.0 mg/kg will ensure food safety.

・ Codex Alimentarius Commission sets maximum levels as low as reasonablyachievable based on actual contamination studies, considering so that the violation rate can be 2–3%. According to the study carried out by the MHLW, an ML of 1.0 mg/kg will result in a violation rate of about 2%.

1 The ALARA principle: The principle that MLs should be set “As Low As Reasonably Achievable.” The principle is used for Codex Committee on Contaminants in Foods to set standards.

Item 4. Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act

Background Any food or food additive for which compositional specifications or standards are established based on Article 11, Paragraph 1 of the Food Sanitation Act of Japan and stipulated in the Ministry of Health, Labour and Welfare Notification (Ministry of Health and Welfare Notification No. 370, 1959) shall not be used or marketed unless it meets the standards or specifications.

Non-alcoholic beverages are classified into four categories: 1) mineral waters (non-alcoholic beverages consisting only of water), 2) frozen fruit beverages, 3) fruit juices for ingredients, and 4) beverages other than those listed in 1) through 3). Compositional specifications and standards are established for individual categories.

In December 2014 Japan revised the existing specifications and standards for consistency with Japan’s water quality standards and international standards. This time the Japan will revise the specifications and standards for the items that were not covered by the revision of December 2014 based on the assessment report from the risk assessment body, the Food Safety Commission of Japan, a risk assessment body, in the Cabinet Office.

Outline of revision (1) Compositional specifications for mineral waters (non-sterilized or non-

filter sterilized)（mg/L）

Substance name Maximum level (current)

Maximum level (draft)Selenium 0.01 0.01

Arsenic 0.05 0.01

Fluoride 2 2Boron 30 as boric acid 5Manganese 2 0.4Antimony Not specified 0.005 Zinc 5 Not specified Nitrate

nitrogen

and Nitrite 10 10

Nitrite nitrogen Not specified 0.04 Note: Underlined parts are modified standards.

(2) Compositional specifications for mineral waters (sterilized or filter sterilized)（mg/L）

Substance name

Maximum level (current)

Maximum level (draft)Selenium 0.01 0.01

Arsenic 0.05 0.01 Fluoride 2 2Boron 30 as boric acid 5Manganese 2 0.4Antimony Not specified 0.005 Zinc 5 Not specified Nitrate

nitrogen

and Nitrite 10 10

Nitrite nitrogen Not specified 0.04 Note: Underlined parts are modified standards.

(3) Beverages other than mineral waters, frozen fruit beverages, and fruit juices for ingredients

（mg/L）Substance name Maximum

level (current)

Maximum level (draft)Iron 0.3 Not specified

Calcium, Magnesium (hardness) 300 as sum Not specified Note: Underlined parts are modified standards.

Item 5. Designation of Food Additive

The government of Japan will designate Propiconazole as a

food additive. Summary The Food Sanitation Act, in Article 10, prohibits the use and sale of food additives the Minister of Health, Labour and Welfare (hereinafter referred as “the Minister”) does not designate. In addition, when specifications or standards for food additives are established based on Article 11 of the act and stipulated in the Ministry of Health, Labour and Welfare Notification (Ministry of Health and Welfare Notification No. 370, 1959), those additives shall not be used or sold unless they meet the standards or specifications.

In response to a request from the Minister, the Committee on Food Additives of the Food Sanitation Council that is established under the Pharmaceutical Affairs and Food Sanitation Council has discussed whether it is adequate to designate Propiconazole [CAS: 60207-90-1]※ as a food additive.

The committee has concluded that based on Article 10 of the act, the Minister should designate Propiconazole as a food additive unlikely to harm human health and establish specifications and standards for this additive based on Article 11 of the act. See Attachments 5-1.

Note: Propiconazole is a triazole fungicide. It has a fungicidal effect by inhibiting membrane ergosterol biosynthesis in filamentous fungi. It is applied overseas, such as in Europe and the United States, to crops, including citrus fruits, as a fungicide in the pre-harvest period or as an antimolding agent in the post-harvest period. In Japan, this substance is registered in 1990 as a fungicide in the pre-harvest period and used for commodities including wheats and barley. Propiconazole, however, has not been designated as a food additive.

<Additional Information>Progress in the designation procedure of food additives (54 flavorings and 45 non-flavoring additives) that have been proven safe by JECFA (Joint FAO/WHO Expert Committee on Food Additives) and that are widely used in countries other than Japan.

As of October 26, 2017, all flavorings and 41 non-flavoring additives were already approved. See Attachment 5-2.

Attachment 5-1

Propiconazoleプロピコナゾール

Standards for use (draft)

Propiconazole is permitted for use on apricot, cherry, citrus fruits (excluding unshū oranges), nectarine, peach, and Japanese plum. It shall not remain more than 0.008 g/kg in citrus fruits (excluding unshū oranges), 0.004 g/kg in apricot, cherry, nectarine, and peach, and 0.0006 g/kg in Japanese plum.

Compositional specifications (draft)

Substance name

Propiconazole Structural

formula

Cl Cl

NN

O O N

Molecular formula

C15H17Cl2N3O2 Molecular weight 342.22Chemical name [CAS number](2RS, 4RS; 2RS, 4SR)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]- 1H-1,2,4-triazole［60207-90-1］Content Propiconazole contains not less than

95.0% of propiconazole (C15H17Cl2N3O2).

Description Propiconazole is a colorless to dark yellow-red viscous liquid. It is odorless.Identification Determine the infrared absorption spectrum of Propiconazole, as

ℎ ( )ℎ ()

ℎ

directed in the Liquid Film Paste Method under Infrared Spectrophotometry, and compare it with the Reference Spectrum. Both spectra exhibit absorptions having about the same intensity at the same wavenumbers. Use optical plates made from sodium chloride.

Specific Gravity d : 1.288–1.290.Purity

Lead Not more than 2 g/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 4.0 mL, Flame Method). After the sample is charred, ignite it at 450°C in an electric furnace.

AssayTest Solution and Standard Solution Weigh accurately about 50

mg each of Propiconazole and propiconazole for assay, add 20 mL of the internal standard solution to each, add acetone to dissolve the mixture, and then make each of the solutions up to exactly 100 mL with acetone.

Internal Standard Solution Dissolve 75 mg of fludioxonil for assay in acetone to make exactly 50 mL.

Procedure Analyze 1- L portions of the test solution and the standard solution by gas chromatography using the operating conditions given below. Determine the peak area ratios of propiconazole to fludioxonil for the test solution and the standard solution, and express as Q T and Q S , respectively. Calculate the amount of propiconazole by the formula:

Content (%) ( )= × × 100

Operating ConditionsDetector: Hydrogen flame-ionization detector.Column: A fused silica tube (0.25 mm internal diameter and 30 m

length) coated with a 0.25- m thick layer of dimethylpolysiloxan for gas chromatography.

Column temperature: Inject at 200ºC, then raise the temperature at a rate of 5ºC/minute to 280ºC.

Detector temperature: A constant temperature of about 300ºC. Injection port temperature: A constant temperature of about 250ºC. Carrier gas: Helium.Flow rate: Adjust the retention time of propiconazole to 10–15 minutes. Injection method: Split.

Split ratio: 1:10.

Reagents and Test Solutions (TS)

Propiconazole for assay C15H17Cl2N3O2 ［ 60207-90-1 ］ A colorless to yellow semi-gelatinous substance or a transparent viscous liquid.

Content Not less than 97.0% of propiconazole (C15H17Cl2N3O2).Identification Measure the absorption spectrum of propiconazole

for assay as directed in the Liquid Film Method under Infrared Spectrophotometry. It exhibits absorptions at about 2960 cm-1, 2870 cm-1, 1587 cm-1, 1506 cm-1, and 1466 cm-1, 1273 cm-1, 1138 cm-1, and 1028 cm-1. Use optical plates made from sodium chloride.

Specific gravity d : 1.288–1.290.Assay Weigh accurately about 40 mg of propiconazole for assay and about 4 mg

of 1,4-BTMSB-d4, and dissolve them together in 4 mL of deuterated acetone. Transfer the resulting solution to an NMR tube of 5 mm in external diameter, stopper tightly, and measure 1HNMR spectra using an NMR spectrometer at a proton resonance frequency of 400 MHz or more. Assuming the signal of 1,4-BTMSB-d4 .00 ppm, determine the signal area intensity (A) (corresponding to 1 hydrogen) at around 7.05–7.13 ppm. Assuming the signal area intensity of 1,4-BTMSB-d4 as 18.00, when the conversion value of A and the purity of 1,4-BTMSB-d4 are designated as I and P(%), respectively, determine the content of propiconazole by the following formula. Confirm that the signal from propiconazole around 05–7.13 ppm is not overlapped with that from a contaminant.Content (%) of propiconazole (C H Cl N O )( ) , × ×= × 1.511

( )Operating conditions Digital resolution: Not more than 0.25.Spectral width: Not less than 20 ppm including between −5 ppm and 15 ppm.Spinning: Off. Flip angle: 90º.13C decoupling: Present.Acquisition time: Not less than 4 seconds. Relaxation delay time: 60 seconds.Number of accumulation: Not less than 8. Dummy scans: 2 or more.Temperature at measurement: 20–30°C.

Deuterated acetone CD3COCD3 [666-52-4] Use a product exclusively produced for NMR spectrum measurement.

Reference spectrum

Propiconazole

35

Progress of evaluation of food additives that have been proven safe and are widely used in the world

Attachment 5-2

26 Oct, 2017

Substance name Request for evaluation

Food Safety Commission MHLWEvaluation by

expert committee1

Notification of result2

Discussion by subcommitt

Closing date for comments4

Date of designation as food additivesIsobutanol

21 Nov 2003

24 Mar 2004(fin.)

27 May 2004 23 Apr 2004(fin.)

19 Aug 2004 24 Dec 20042-Ethyl-3, (5 or 6)- 3 Mar 2004(fin.) 27 May 2004 8 Apr

2004(fin.)26 Jul 2004 24 Dec 2004

2,3,5,6-Tetramethylpyrazine 3 Mar 2004(fin.) 27 May 2004 8 Apr 2004(fin.)

26 Jul 2004 24 Dec 2004Calcium stearate 4 Mar 2004 20 May

2004(fin.)29 Jul 2004 24 Jun

2004(fin.)21 Oct 2004 24 Dec 2004

Propanol 21 Nov 2003

24 Mar 200420 May 200428 Jul 2004(fin.)

9 Sep 2004 26 Aug 2004(fin.)

14 Dec 2004 24 Feb 2005

Nitrous oxide 20 Oct 2003

17 Dec 20035 Oct 2004(fin.) 9 Dec 2004 17 Dec

2004(fin.)19 Feb 2005 22 Mar 2005

Isopropanol 15 Dec 2003

24 Mar 20049 Apr 20048 Sep 20045 Oct 2004(fin.)

9 Dec 2004 28 Oct 2004(fin.)

4 Mar 2005 28 Apr 2005

Hydroxypropyl cellulse 16 Aug 2004

22 Dec 2004(fin.)

10 Mar 2005 24 Feb 2005(fin.)

14 Jun 2005 19 Aug 2005Isoamylalcohol

5 Nov 2004 14 Jan 2005(fin.)

17 Mar 2005 24 Feb 2005(fin.)

14 Jun 2005 19 Aug 20052,3,5-TrimethylpyrazineAmylalcohol

Natamycin 20 Oct 2003

9 Jan 200416 Nov 200426 Jan

6 May 2005 24 Mar 2005(fin.)

7 Sep 2005 28 Nov 2005

Acetaldehyde 21 Nov 2003

3 Mar 20049 Apr 200427 Apr 200423 Feb 200513 Apr

21 Jul 2005 23 Jun 2005(fin.)

12 Oct 2005 16 May 2006

2-Ethyl-3-methylpyrazine

7 Mar 200514 Jun 2005(fin.)

18 Aug 2005 28 Jul 2005(fin.)

19 Dec 2005 16 May 20065-Methylquinoxaline

Butanol 14 Jun 200522 Jul 2005(fin.) 22 Sep 2005 27 Oct 2005

24 Nov 2005(fin.)

26 Apr 2006 12 Sep 2006

Ammonium alginate28 Mar 2005

2 Dec 200514 Dec 2005(fin.)

30 Mar 2006 23 Mar 2006(fin.)

5 Sep 2006 26 Dec 2006Potassium alginateCalcium alginate



expert committee1




Date of designation as food additives

2-Methylbutanol 19 Dec 2005

14 Jul 200611 Aug 2006(fin.)

12 Oct 2006 8 Dec 200616 Jan 2007 (Fin.)

22 May 2007 3 Aug 2007

Isobutyraldehyde 19 Dec 2005

28 Jun 200614 Jul 200611 Aug 200613 Sep 200613 Oct 2006(fin.)

7 Dec 2006 8 Dec 200616 Jan 2007 (Fin.)

22 May 2007 3 Aug 2007

Butyraldehyde 19 Dec 2005

19 Dec 200626 Jan 2007(fin.)

22 Mar 2007 20 Mar 2007(fin.)

27 Aug 2007 26 Oct 2007

Polysorbate 20, 60, 65, 80 8 Oct 200329 Oct 200327 Apr 200428 Jul 200423 Mar

7 Jun 2007 4 Jul 20079 Aug 2007(fin.)

16 Dec 2007 30 Apr 2008

Calcium silicate 15 Aug 2005

28 Feb 200723 Mar 200717 Apr 200729 May

26 Jul 2007 9 Aug 2007(fin.)

16 Dec 2007 30 Apr 2008

Calcium ascorbate 3 Oct 200523 Mar 200717 Apr 200729 May 200722 Jun

23 Aug 2007 9 Aug 2007(fin.)

16 Dec 2007 30 Apr 2008

Nisin 20 Oct 2003

9 Apr 200416 Nov 200426 Jan 200530 Jul 200727 Aug

31 Jan 200826 Sep 200724 Oct 200728 Feb 2008(fin.)24 Sep

18 Jul 2008 2 Mar 2009



expert committee1




Date of designation as food additivesAcetylated distarch adipate

26 Nov 2004

23 Mar 200517 May 200527 Aug 200728 Sep 2007(fin.)

29 Nov 2007 28 Nov 2007(fin.)4 Jul 2008(fin.)

29 May 2008 1 Oct 2008

Acetylated distarch phosphateAcetylated oxidized starchStarch sodium octenylsuccinateHydroxypropyl starchHydroxypropyl distarch phosphatePhosphated distarch phosphateMonostarch phosphateDistarch phosphateOxidized starchStarch acetate

Magnesium hydroxide 9 Mar 200622 Jun 200730 Jul 200727 Aug

1 Nov 2007 24 Oct 2007(fin.)

7 Feb 2008 4 Jul 2008

Magnesium Monohydrogen Phosphate

28 Mar 2005

31 May 200628 Jun 200614 Jul 200611 Aug 200613 Sep 200628 Nov 200625 Oct 201129 Nov 201116 Dec 2011(fin)

22 Mar 2012 6 Mar 2012(fin.)

22 Jul 2012 2 Nov 2012

Polyvinylpyrrolidone 20 Jun 2005

13 Sep 200613 Oct 200628 Nov 200619 Dec 200626 Jan 200718 Dec 201222 Jan 201322 Feb 201327 Mar 201325 Apr 2013(fin.)

30 Jul 201321 Jun 201330 Oct 2013

29 Jan 2014(fin)― 18 Jun 2014



expert committee1





Magnesium silicate(synthetic) 15 Aug 2005

28 Feb 200723 Mar 200717 Apr 200728 Sep 200917 Nov 2009(fin.)

21 Jan 2010 25 Dec 2009(fin)

6 Jun 2010 20 Oct 2010

Sodium aluminium silicate 15 Aug 2005

28 Feb 200730 May 2012

16 May 201328 Jun 201330 Jul 201320 Aug 2013

(under consideration)

Calcium aluminium silicate 15 Aug 2005

28 Feb 200730 May 201227 Jul 2012

16 May 201328 Jun 201330 Jul 201320 Aug 2013

(under

Calcium saccharin 22 May 2006

27 Aug 200728 Sep 200726 Oct 200726 Apr 201131 May 201128 Jun 2011(fin)

25 Aug 2011 2 Nov 2011 (fin)

12 May 2012 28 Dec 2012

Ammonium L-glutamate 22 May 2006

15 Jan 2008(fin.)

13 Mar 2008 11 Apr 2008 (fin.)

10 Oct 2008 20 Oct 2010

Sodium stearoyl-2-lactylate 6 Feb 2007 24 Mar 200815 Apr 2008(fin.)

10 Jul 2008 4 Jul 2008(fin.) 1 Dec 2008 28 May 2010

Potassium lactate 6 Feb 2007

17 Jun 200829 Sep 200821 Aug 201226 Sep 201225 Oct 2012(fin.)

21 Jan 2013 6 Dec 2012 11 Mar 2013 15 May 2013



expert committee1





Calcium sorbate 19 Mar 2007

26 Mar 200817 Jun 200829 Aug 2008(fin.)

20 Nov 2008 25 Nov 2008(fin)

25 Apr 2009 28 May 2010

Valeraldehyde 19 Mar 2007

1 Feb 2008(fin.)

27 Mar 2008 4 Jul 2008(fin.) 1 Dec 2008 4 Jun 2009Isovaleraldehyde 19 Mar

20071 Feb 2008(fin.)

27 Mar 2008 4 Jul 2008(fin.) 1 Dec 2008 4 Jun 20092,3-Dimethylpyrazine 7 Feb 2008 15 Apr 2008

26 May 31 Jul 2008 24 Sep 2008(fin.)

3 Feb 2009 4 Jun 2009

2,5-Dimethylpyrazine 7 Feb 2008 15 Apr 200826 May 31 Jul 2008 24 Sep

2008(fin.)3 Feb 2009 4 Jun 2009

2,6-Dimethylpyrazine 7 Feb 2008 15 Apr 200826 May 31 Jul 2008 24 Sep

2008(fin.)3 Feb 2009 4 Jun 2009

2-Ethylpyrazine 22 May 2008

29 Sep 2008(fin.)

27 Nov 2008 22 Oct 2008(fin.)

25 Apr 2009 28 May 20102-Methylpyrazine 22 May

200829 Sep 2008(fin.)

27 Nov 2008 22 Oct 2008(fin.)

25 Apr 2009 28 May 20102-Pentanol 14 Oct

200811 Nov 2008(fin.)

22 Jan 2009 28 Apr 2009(fin.)

20 Sep 2009 28 May 20102-Methylbutyraldehyde 14 Oct

200811 Nov 2008(fin.)

22 Jan 2009 22 Dec 2008(fin.)

29 May 2009 28 May 2010Propionaldehyde 20 Nov

20082 Feb 2009(fin.) 2 Apr 2009 28 Apr

2009(fin.)20 Sep 2009 28 May 2010

6-Methylquinoline 20 Nov 2008

23 Mar 2009(fin)

21 May 2009 28 Apr 2009(fin.)

20 Sep 2009 28 May 20102-Ethyl-5-methylpyrazine 12 Mar

200929 Jun 200928 Sep 8 Oct 2009 25 Dec

2009(fin)6 Jun 2010 20 Oct 2010

5,6,7,8-Tetrahydroquinoxaline 12 Mar 2009

29 Jun 2009(fin) 27 Aug 2009 3 Sep 2009(fin.)

2 Feb 2010 28 May 20103-Methyl-2-butanol 12 Mar

200918 May 2009(fin.)

23 Jul 2009 3 Sep 2009(fin.)

2 Feb 2010 28 May 2010Isopentylamine 12 Aug

20097 Sep 2009(fin.) 12 Nov 2009 25 Dec

2009(fin)6 Jun 2010 20 Oct 2010

Butylamine 10 Sep 2009

20 Oct 200917 Nov 4 Mar 2010 5 Mar

2010(fin)30 Aug 2010 10 Nov 2010

Phenetylamine 5 Nov 2009 17 Nov 2009(fin)

18 Mar 2010 5 Mar 2010(fin)

30 Aug 2010 10 Nov 2010Trimethylamine 26 Nov

200915 Dec 2009(fin)

29 Jul 2010 2 Nov 2011 (fin)

19 Mar 2012 28 Dec 20121-Penten-3-ol 2 Feb 2010 23 Feb

2010(fin)28 Apr 2010 9 Feb 2011(fin) 24 May 2011 19 Jul 2011

3-Methyl-2-butenol 2 Feb 2010 23 Feb 2010(fin)

28 Apr 2010 9 Feb 2011(fin) 24 May 2011 19 Jul 2011Piperidine 15 Mar

201030 Mar 2010(fin)

20 May 2010 23 Jun 2010(fin)

23 Oct 2010 13 Dec 2010Pyrrolidine 5 Apr 2010 20 Apr

2010(fin)3 Jun 2010 23 Jun

2010(fin)23 Oct 2010 13 Dec 2010

2,6-Dimethylpyridine 13 May 2010

2 Jun 2010(fin) 15 Jul 2010 9 Sep 2010(fin) 3 Jan 2011 15 Mar 2011

3-Ethylpyridine 14 Jun 201029 Jun 201023 Aug 201115 Nov 2012(fin.)

18 Feb 2013 18 Jan 2013 18 May 2013 6 Aug 2013



expert committee1




Date of designation as food additives5-Ethyl-2-methylpyridine 14 Jun 2010 29 Jun

2010(fin)26 Aug 2010 9 Sep 2010(fin) 3 Jan 2011 15 Mar 2011

2-(3-Phenylpropyl)pyridine 9 Jul 2010 27 Jul 2010(fin) 7 Oct 2010 22 Dec 2010(fin)

1 Apr 2011 28 Jun 20112,3-Diethyl-5-methylpyrazine 9 Jul 2010 27 Jul 2010(fin) 7 Oct 2010 22 Dec

2010(fin)1 Apr 2011 28 Jun 2011

5-methyl-6,7-Dihydro-5H - cyclopentapyrazine 12 Aug

201031 Aug 2010(fin)

27 Jan 2011 22 Dec 2010(fin)

1 Apr 2011 28 Jun 2011

Pyrazine 12 Aug 2010

31 Aug 2010(fin)

4 Jan 2011 9 Feb 2011(fin) 24 May 2011 19 Jul 20113-Methyl-2-butenal 9 Sep 2010 27 Sep

2010(fin)27 Jan 2011 9 Feb 2011(fin) 24 May 2011 19 Jul 2011

trans -2-Pentenal 29 Oct 2010

12 Nov 201021 Dec 201027 Sep 2011(fin)

1 Dec 2011 6 Mar 2012(fin)

22 Jul 2012 2 Nov 2012

Isoquinolin 29 Oct 2010

12 Nov 2010(fin)

3 Feb 2011 11 May 2011(fin)

8 Aug 2011 27 Dec 20112-Ethyl-6-methylpyrazine 6 Dec 2010 21 Dec

2010(fin)31 Mar 2011 2 Nov 2011

(fin)19 Mar 2012 28 Dec 2012

trans -2-Methyl-2-butenal 4 Jan 2011 18 Jan 2011(fin)

21 Apr 2011 2 Nov 2011 (fin)

19 Mar 2012 28 Dec 2012Pyrrole 4 Jan 2011 18 Jan

2011(fin)31 Mar 2011 11 May

2011(fin)8 Aug 2011 27 Dec 2011

(3-Amino-3-carboxypropyl)dimethylsulfonium chloride

17 Feb 2011

22 Feb 2011(fin)

12 May 2011 2 Nov 2011 (fin)

19 Mar 2012 28 Dec 2012

Ammonium isovalerate

3 Mar 201126 Apr 201131 May 201115 Nov 2012(fin.)

18 Feb 201316 Feb 2015 21 May 2015 29 Jul 2015

28 Nov 2014

- 9 Dec 2014

β-apo-8’-carotenal 19 Apr 2011

27 Mar 201227 Jul 201216 May 201328 Jun 201330 Jul 201320 Aug 2013(fin.)

25 Nov 2013 27 Nov 2013 － 18 Jun 2014

Carmine 19 Apr 2011

26 Jul 201123 Aug 201130 May 2012




expert committee1





Canthaxanthin 19 Apr 2011

27 Mar 201227 Jul 201220 Aug 201324 Sep 201317 Oct 201320 Nov 201325 Dec 201330 Jun 2014(fin)

14 Oct 2014 5 Sep 2014 18 Nov 2014 20 Feb 2015

Sodium aluminium phosphate,acidic

19 Apr 2011

30 May 201216 May 201328 Jun 201330 Jul 201320 Aug 2013


Calcium acetate 19 Apr 2011

24 Apr 201215 Nov 201218 Dec 201222 Jan 2013(fin)

15 Apr 2013 13 Mar 2013 22 Jun 2013 4 Dec 2013

Calcium oxide 19 Apr 2011

24 Apr 201215 Nov 201218 Dec 201222 Jan 2013(fin）

15 Apr 2013 13 Mar 2013 22 Jun 2013 22 Oct 2013

Potassium sulfate 19 Apr 2011

24 Apr 201226 Sep 201225 Oct 2012(fin.)

21 Jan 2013 6 Dec 2012 11 Mar 2013 15 May 2013

Triethyl citrate 19 Apr 2011

30 May 201218 Dec 201222 Jan 201322 Feb 201329 Sep 201429 Oct 2014(fin.)

17 Feb 2015 25 Dec 2014 3 Mar 2015 19 May 2015



expert committee1





Isopropanol 19 Apr 2011

29 Nov 201116 Dec 2011(fin)

29 Mar 2012 31 May 2013 8 Oct 2013 4 Dec 201316 May 2013

― 27 May 20132,3-Diethylpyrazine 12 Feb

201413 Mar 2014

22 May 2014（fin）

26 Aug 2014 20 Jun 2014 23 Oct 2014 17 Nov 2014

1-Methylnaphthalene 5 Nov 201412 Dec 201414 Jan 2015

5 Feb 2015(fin.)19 May 2015 24 Apr 2015 12 Jun 2015 18 Sep 2015

flavouring agents 1. Date when discussion was conducted by the expert committee.2. Date when the evaluation result was filed with the MHLW.3. Date when discussion was conducted by the Subcommittee on Food Additives under the Pharmaceutical Affairs and Food

Sanitation Council.4. Closing date for comment on WTO notification

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