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: 3/1/2018

 GAIN Report Number: JA8013

 

Japan 

Post:Tokyo

Japan Proposes Revision of MRLs for 8 Agricultural ChemicalsReport Categories:Sanitary/Phytosanitary/Food Safety

Approved By: Jess K. Paulson

Prepared By: Tomohiro Kurai

 Report Highlights:On Tuesday, February 27, 2018, Japan’s Ministry of Health, Labor and Welfare (MHLW) announced revisions to Japan’s Maximum Residue Levels (MRLs) for the following agricultural chemicals, veterinary drugs and a feed additive: Acephate, Amisulbrom, Cyazofamid, Bicyclopyrone, Pyflubumide, Methamidophos, Dicyclanil and Semduramicin.  Further, MHLW proposes to designate Hydroxypropyl Distarch Phosphate as a substance having no potential to cause damage to human health (equivalent to GRAS in the United States).  Lastly, the announcement summarizes proposed revisions to sanitary regulations for utensils, containers and packaging.  The Embassy comment period for these proposals is open until Tuesday, March 13, 2018.  The proposed revisions that result in standards that are more strict will be notified to the WTO after the comment period, which will provide another opportunity for interested parties to

comment on these proposed changes. Keyword: JA8013

 

 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, March 13, 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 Amisulbrom, Cyazofamid, Bicyclopyrone, Pyflubumide and Dicyclanil 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 Mr. Ryota NAKAMURA (nakamura-ryouta@mhlw.go.jp) Tel : 03-3595-2423 (ex 4289)Fax: 03-3595-2432

Utensils, containers and packaging Ms. Niwa and Mr. Matsushita (kijunpa@mhlw.go.jp) Tel : 03-3595-2341 (ex 2921 or 2487)Fax: 03-3501-4868

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: Acephate,Amisulbrom, Cyazofamid,

Bicyclopyrone, Pyflubumide,

Methamidophos

Veterinary drugs: Dicyclanil

Veterinary drugs and Feed additives: Semduramicin

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

Acephate (pesticide: insecticide): 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.

Amisulbrom (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 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.

Cyazofamid (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 and in response to a request for setting import tolerances based on the Guideline for Application 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.

Bicyclopyrone (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 Application 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.

Pyflubumide (pesticide: miticide): 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. This action will not strengthen the current regulation for any commodities.

Methamidophos (pesticide: insecticide): 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.

Dicyclanil (veterinary drug: insecticide): 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. This action will not strengthen the current regulation for any commodities.

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

Acephate

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice)※1 ○ 1Corn (maize, including pop corn and sweet corn) ● 0.3 0.5 §Soybeans, dry ● 0.3 0.5 § 0.3Beans, dry ● 1 3.0 §Broad beans ● 2Peanuts, dry ● 0.2Other pulses ● 1Potato ● 0.5 1.0 §Yam ○ 0.5 0.5 §Sugar beet ○ 0.1 0.1 §Japanese radish, roots (including radish) ● 0.05 1.0 §Japanese radish, leaves (including radish) ● 0.05 10 §Turnip, roots (including rutabaga) ● 0.5 1.0 §Turnip, leaves (including rutabaga) ● 0.5 10 §Horseradish ● 5.0Watercress ● 5.0Chinese cabbage ● 0.2 5.0 §Cabbage※2 ● 0.2 5.0 § 2Brussels sprouts ● 5.0Kale ● 5.0Komatsuna(Japanese mustard spinach) ● 1 5.0 §Kyona ● 1 5.0 §Qing-geng-cai ● 1 5.0 §Cauliflower ● 2 5.0 §Broccoli ● 0.05 5.0 §Other cruciferous vegetables ● 1 5.0 §Burdock ○ 0.1 0.1 §Artichoke ○ 0.3 0.3 0.3Chicory ● 6Endive ● 6Shungiku ● 6Lettuce (including cos lettuce and leaf lettuce) ● 1 5.0 §Other composite vegetables※2 ● 0.05 0.2 § 0.2Onion ● 0.3 0.5 §Welsh (including leek) ● 0.1Garlic ● 0.2 2.0 §Nira ● 0.5Multiplying onion (including shallot) ● 0.1Other liliaceous vegetables ● 0.5Parsley ● 0.5Celery ● 10Mitsuba ● 0.02Other umbelliferous vegetables ● 0.5Tomato※2 ● 0.03 5.0 § 1Pimiento (sweet pepper) ● 0.05 5.0 §Egg plant ● 0.05 5.0 §Other solanaceous vegetables ● 5.0Cucumber (including gherkin) ● 0.1 5.0 §Pumpkin (including squash) ● 1Oriental pickling melon (vegetable) ● 1Water melon ● 0.5Melons ● 1

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Makuwauri melon ● 1Other cucurbitaceous vegetables ● 0.5Spinach ● 0.7 6 §Bamboo shoots ● 3.0Okra ● 3 5.0 §Ginger※2 ● 0.05 0.1 § 0.2Peas, immature (with pods) ● 0.1Kidney beans, immature (with pods) ○ 5 3.0 5Green soybeans ○ 0.5 0.5 §Button mushroom ● 1Shiitake mushroom ● 1Other mushrooms ● 1Other vegetables※2 ● 0.05 3.0 § 5Unshu orange, pulp ● 5.0Citrus natsudaidai, whole ● 5.0Lemon ● 5.0Orange (including navel orange) ● 5.0Grapefruit ● 5.0Lime ● 5.0Other citrus fruits ● 5.0Cranberry ○ 0.5 0.5 0.5Grape※3 ● 5.0 §Japanese persimmon ● 0.3 2.0 §Banana ● 1Other fruits※2 ● 0.05 1.0 § 0.2Cotton seeds ● 2.0Other oil seeds※1 ○ 0.2Other nuts ● 0.1Tea ● 0.2 10 §SANSHO (Japanese pepper)※4 ● 1Other spices ○ 0.7 § 0.2Other herbs ● 5Cattle, muscle ○ 0.05 0.05 0.05Pig, muscle ○ 0.05 0.05 0.05Other terrestrial mammals, muscle ○ 0.05 0.05 0.05Cattle, fat ● 0.05 0.1Pig, fat ● 0.05 0.1Other terrestrial mammals, fat ● 0.05 0.1Cattle, liver ○ 0.05 0.05 0.05Pig, liver ○ 0.05 0.05 0.05Other terrestrial mammals, liver ○ 0.05 0.05 0.05Cattle, kidney ○ 0.05 0.05 0.05Pig, kidney ○ 0.05 0.05 0.05Other terrestrial mammals, kidney ○ 0.05 0.05 0.05Cattle, edible offal ○ 0.05 0.05 0.05Pig, edible offal ○ 0.05 0.05 0.05Other terrestrial mammals, edible offal ○ 0.05 0.05 0.05Milk※1 ● 0.02 0.02Chicken, muscle ○ 0.01 0.01 0.01Other poultry, muscle ○ 0.01 0.01 0.01Chicken, fat ○ 0.1 0.1 0.1

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other poultry, fat ○ 0.1 0.1 0.1Chicken, liver ○ 0.01 0.01 0.01Other poultry, liver ○ 0.01 0.01 0.01Chicken, kidney ○ 0.01 0.01 0.01Other poultry, kidney ○ 0.01 0.01 0.01Chicken, edible offal ○ 0.01 0.01 0.01Other poultry, edible offal ○ 0.01 0.01 0.01Chicken eggs ○ 0.01 0.01 0.01Other poultry, eggs ○ 0.01 0.01 0.01Pepper,dried ○ 50 50

Other spices, dried (except SANSHO (Japanese pepper)) ※5 ● 0.2

The residue definition is acephate 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.* 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.

●：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 For rice (brown rice), other oil seeds and milk in which the Codex has set MRLs, the dietary exposure of acephate estimated by using the supervised trial median residue (STMR) of the supervised residue trials submitted to the JMPR and national food consumption data of rice, other oilseeds and milk would exceed an ADI of 0.0024 mg/kg/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided maintain the current MRLs(i.e. the uniform limit of 0.01 ppm) in these commodities.

※2 For cabbage, other composite vegetables, tomato, ginger, other vegetables, other fruits in which the Codex has set MRLs, the dietary exposure of acephate estimated by using the STMR of the supervised residue trials submitted to the JMPR and national food consumption data of these commodities would exceed an ADI of 0.0024 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set the MRLs for these commodities based on the residue data from the domestic supervised residue trials.

※3 Pesticide registration for grape are planned to be deleted in Japan.

※4 According to the present food classification system in Japan, “SANSHO (Japanese pepper)” are included “Other spices”.

※5 Food categories “Other spices, dried (except SANSHO (Japanese pepper))” will be deleted, hereafter, MRLs in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed commodities, taking into account their processing factors.

Amisulbrom

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ○ 0.05 0.05 §Soybeans, dry ○ 0.3 0.3 §Beans, dry ○ 0.2 0.2 §Potato ○ 0.05 0.05 §Konjac ○ 0.05 RequestSugar beet ○ 1 1 §Japanese radish, roots (including radish) ○ 0.3 0.3 §Japanese radish, leaves (including radish) ○ 25 25 §Turnip, roots (including rutabaga) ○ 0.5 0.5 §Turnip, leaves (including rutabaga) ○ 30 30 §Chinese cabbage ○ 10 10 §Cabbage ○ 3 3 §Kale ○ 20 20 §Komatsuna(Japanese mustard spinach) ○ 15 15 §Kyona ○ 20 20 §Qing-geng-cai ○ 20 20 §Cauliflower ○ 2 2 §Broccoli ○ 2 2 §Other cruciferous vegetables ○ 20 20 §Lettuce (including cos lettuce and leaf lettuce) ○ 20 20 §Onion ○ 0.05 0.05 §Welsh (including leek) ○ 3 3 §Other liliaceous vegetables ○ 0.05 0.05 §Tomato ○ 2 2 §Pimiento (sweet pepper) ○ 3 3 §Egg plant ○ 1 1 §Other solanaceous vegetables ○ 5 5 §Cucumber (including gherkin) ○ 0.7 0.7 §Pumpkin (including squash) ○ 2 2 §Water melon ○ 0.05 0.05 §Melons ○ 0.05 0.05 §Spinach ○ 30 30 §Ginger ○ 2 0.7 §・RequestGreen soybeans ○ 10 10 §Unshu orange, pulp ○ 0.1 0.1 §Citrus natsudaidai, whole ○ 2 2 §Lemon ○ 2 2 §Orange (including navel orange) ○ 2 2 §Grapefruit ○ 2 2 §Lime ○ 2 2 §Other citrus fruits ○ 2 2 §Strawberry ○ 0.05 0.05 §Grape ○ 5 5 §Other fruits ○ 1 1 §Other spices ○ 15 15 §Other herbs ○ 20 20 §

The residue definition is amisulbrom 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.§：Permitted for use in Japan.

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

Cyazofamid

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice) ○ 0.05 0.05 §Wheat ○ 0.05 0.05 §Soybeans, dry ○ 0.3 0.3 §Beans, dry ○ 0.1 0.1 §Potato ○ 0.05 0.05 § 0.01Konjac ○ 0.3 0.3 §Japanese radish, roots (including radish) ○ 0.3 0.3 §Japanese radish, leaves (including radish) ○ 25 25 § 10Turnip, roots (including rutabaga) ○ 0.3 0.3 §Turnip, leaves (including rutabaga) ○ 20 20 § 15Watercress ○ 10 10Chinese cabbage ○ 15 2 § 15Cabbage ○ 2 0.7 § 1.5Brussels sprouts ○ 2 1.5Kale ○ 15 15 § 15Komatsuna(Japanese mustard spinach) ○ 15 15 § 15Kyona ○ 15 10 § 15Qing-geng-cai ○ 15 3 § 15Cauliflower ○ 2 Request 1.5Broccoli ○ 2 1 § 1.5Other cruciferous vegetables ○ 20 20 § 15Chicory ○ 10 10Endive ○ 10 10Shungiku ○ 10 10Lettuce (including cos lettuce and leaf lettuce) ○ 10 10 § 10Other composite vegetables ○ 10 10Onion ○ 2 0.05 §・IT 2.0 USAWelsh (including leek) ○ 2 2 §Garlic ○ 2 IT 2.0 USAMultiplying onion (including shallot) ○ 5 5 §Other liliaceous vegetables ○ 3 3 §Carrot ○ 0.09 0.09 0.09 USAMitsuba ○ 10 10 §Tomato ○ 2 2 § 0.2Pimiento (sweet pepper) ○ 1 1 § 0.4Egg plant ○ 0.5 0.5 § 0.2Other solanaceous vegetables ○ 10 2 § 10Cucumber (including gherkin) ○ 0.7 0.7 § 0.09Pumpkin (including squash) ○ 0.7 0.7 § 0.09Oriental pickling melon (vegetable) ○ 0.1 0.1 0.09Water melon ○ 0.05 0.05 §Melons ○ 0.05 0.05 §Makuwauri melon ○ 0.1 0.1Other cucurbitaceous vegetables ○ 10 0.1 § 10Spinach ○ 25 25 § 10Ginger ○ 3 3 §Kidney beans, immature (with pods) ○ 0.4 0.4Green soybeans ○ 5 5 §Other vegetables ○ 10 10 § 10Unshu orange, pulp ○ 0.7 0.7 §Citrus natsudaidai, whole ○ 2 2 §

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 §Japanese pear ○ 0.5 RequestPeach ○ 0.3 0.3 §Nectarine ○ 1 1 §Japanese plum (including prune) ○ 0.2 RequestStrawberry ○ 0.7 0.7 §Grape ○ 10 10 § 1.5Papaya ○ 0.5 0.5 0.5 TaiwanOther fruits ○ 1 1 §Hop ○ 15 10 § 15Other spices ○ 10 10 §Other herbs ○ 15 15 § 15

The residue definition is cyazofamid 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.§：Permitted for use in Japan.

Request：Request for setting/revising MRL was made by MAFF. IT：Import tolerance

Bicyclopyrone

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Wheat ○ 0.04 IT 0.04 USABarley ○ 0.07 IT 0.07 USACorn (maize, including pop corn and sweet corn) ○ 0.03 0.03 0.03 USA

The residue definition is sum of bicyclopyrone, metabolite B 【2-2-(methoxy-ethoxymethyl)-6-trifluoromethyl- nicotinic acid】(including metabolites that can be hydrolyzed to metabolite B) and metabolite K 【2-(2-hydoroxy- ethoxymethyl)-6-trifluoromethyl-nicotinic acid】(including metabolites that can be hydrolyzed to metabolite K), expressed as bicyclopyrone.

* 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.

○：Commodities for which MRLs are to be maintained, increased or newly set.IT：Import tolerance

Pyflubumide

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Beans, dry ○ 0.3 0.3 §Pimiento (sweet pepper) ○ 1 1 §Egg plant ○ 0.7 0.7 §Cucumber (including gherkin) ○ 0.5 0.5 §Water melon ○ 0.2 0.2 §Melons ○ 0.2 0.2 §Kidney beans, immature (with pods) ○ 2 2 §Unshu orange, pulp ○ 0.2 0.2 §Citrus natsudaidai, whole ○ 2 2 §Lemon ○ 2 2 §Orange (including navel orange) ○ 2 2 §Grapefruit ○ 2 2 §Lime ○ 2 2 §Other citrus fruits ○ 2 2 §Apple ○ 1 1 §Japanese pear ○ 0.7 0.7 §Pear ○ 0.7 0.7 §Peach ○ 0.2 0.2 §Nectarine ○ 0.7 0.7 §Apricot ○ 3 3 §Japanese plum (including prune) ○ 0.3 0.3 §Mume plum ○ 3 3 §Cherry ○ 3 3 §Strawberry ○ 1 1 §Grape ○ 2 2 §Japanese persimmon ○ 0.5 0.5 §Other fruits ○ 1 1 §Tea ○ 50 50 §Other spices ○ 5 5 §Other herbs ○ 0.2 Request

The residue definition is sum of pyflubumide and metabolite B (3’-isobutyl-1,3,5-trimethyl-4’-[2,2,2-trifluoro-1- methoxy-1-(trifluoromethyl)ethyl]pyrazole-4-carboxanilide), expressed as pyflubumide.

* 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 MAFF.

Methamidophos

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Rice (brown rice)※1 ● 0.01 0.6Wheat ● 0.01Barley ● 0.01Rye ● 0.01Corn (maize, including pop corn and sweet corn)

○ 0.2 0.1 §Buckwheat ● 0.01Other cereal grains ● 0.01Soybeans, dry ○ 0.1 0.05 § 0.1Beans, dry ○ 2 2 §Peas ● 0.01Broad beans ● 0.2Peanuts, dry ● 0.1Other pulses ● 0.3Potato ● 0.1 0.25 § 0.05Taro ● 0.01Sweet potato ● 0.01Yam ● 0.1 0.3Konjac ● 0.01Other potatoes ● 0.01Sugar beet ● 0.02 0.05 § 0.02Japanese radish, roots (including radish) ● 0.03 0.5 §Japanese radish, leaves (including radish) ● 0.03 1 §Turnip, roots (including rutabaga) ● 0.3 0.5 §Turnip, leaves (including rutabaga) ● 0.5 5 §Horseradish ● 3Watercress ● 0.5Chinese cabbage ● 0.2 2 §Cabbage※2 ● 0.1 1.0 §Brussels sprouts ● 1.0Kale ● 0.7Komatsuna(Japanese mustard spinach) ● 0.5 0.7 §Kyona ● 0.5 2 §Qing-geng-cai ○ 0.5 0.5 §Cauliflower ● 0.5 1.0 §Broccoli ● 0.02 1.0 §Other cruciferous vegetables ● 0.5 3 §Burdock ● 0.02 0.05 §Salsify ● 0.01Artichoke ○ 0.2 0.2 0.2Chicory ● 0.5Endive ● 0.5Shungiku ● 0.5Lettuce (including cos lettuce and leaf lettuce) ● 0.1 1.0 §Other composite vegetables※2 ● 0.1 0.5 § 0.1Onion ● 0.2 0.3 §Welsh (including leek) ● 0.05Garlic ● 0.1 1 §Nira ● 0.3Asparagus ● 0.01Multiplying onion (including shallot) ● 0.05Other liliaceous vegetables ● 0.3

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Carrot ● 0.01Parsnip ● 0.01Parsley ● 0.3Celery ● 5Mitsuba ● 0.02Other umbelliferous vegetables ● 0.5Tomato※2 ● 0.02 2.0 §Pimiento (sweet pepper) ● 0.03 2.0 §Egg plant ● 0.02 1.0 §Other solanaceous vegetables ● 2.0Cucumber (including gherkin) ● 0.02 1.0 §Pumpkin (including squash) ● 0.1Oriental pickling melon (vegetable) ● 0.1Water melon ● 0.1Melons ● 0.5Makuwauri melon ● 0.2Other cucurbitaceous vegetables ● 0.5Spinach ● 0.2 0.5 §Bamboo shoots ● 2Okra ○ 0.5 0.5 §Ginger※2 ○ 0.1 0.05 § 0.1Peas, immature (with pods) ● 0.5Kidney beans, immature (with pods) ○ 1 0.5 1Green soybeans ● 0.3 0.5 §Button mushroom ● 0.1Shiitake mushroom ● 0.1Other mushrooms ● 0.1Other vegetables※2 ● 0.03 30 § 1Unshu orange, pulp ● 1Citrus natsudaidai, whole ● 1Lemon ● 1Orange (including navel orange) ● 1Grapefruit ● 1Lime ● 1Other citrus fruits ● 1Apple ● 0.05Japanese pear ● 0.05Pear ● 0.05Quince ● 0.05Loquat ● 0.05Peach ● 1.0Nectarine ● 0.01Apricot ● 0.1Japanese plum (including prune) ● 0.3Mume plum ● 0.01Cherry ● 0.01Strawberry ● 0.01Raspberry ● 0.01Blackberry ● 0.01Blueberry ● 0.01Cranberry ● 0.3

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Huckleberry ● 0.01Other berries ● 0.01Grape※3 ● 3 §Japanese persimmon ● 0.3 1 §Banana ● 0.1Kiwifruit ● 0.01Avocado ● 0.01Pineapple ● 0.01Guava ● 0.01Mango ● 0.01Passion fruit ● 0.01Date ● 0.01Other fruits※2 ○ 0.1 0.1 § 0.1Sunflower seeds ● 0.01Sesame seeds ● 0.01Safflower seeds ● 0.01Cotton seeds ○ 0.2 0.1 0.2Rapeseeds ● 0.1Other oil seeds※1 ○ 0.1 0.01 0.1Ginkgo nut ● 0.01Chestnut ● 0.01Pecan ● 0.01Almond ● 0.01Walnut ● 0.01Other nuts ● 0.05Tea ● 0.05 5 §Hop ● 5.0SANSHO (Japanese pepper)※4 ● 0.2 §Other spices ○ 0.1 § 0.1Other herbs ● 0.8Cattle, muscle ○ 0.01 0.01 0.01Pig, muscle ○ 0.01 0.01 0.01Other terrestrial mammals, muscle ○ 0.01 0.01 0.01Cattle, fat ● 0.01 0.05Pig, fat ● 0.01 0.05Other terrestrial mammals, fat ● 0.01 0.05Cattle, liver ○ 0.01 0.01 0.01Pig, liver ○ 0.01 0.01 0.01Other terrestrial mammals, liver ○ 0.01 0.01 0.01Cattle, kidney ○ 0.01 0.01 0.01Pig, kidney ○ 0.01 0.01 0.01Other terrestrial mammals, kidney ○ 0.01 0.01 0.01Cattle, edible offal ○ 0.01 0.01 0.01Pig, edible offal ○ 0.01 0.01 0.01Other terrestrial mammals, edible offal ○ 0.01 0.01 0.01Milk※1 ● 0.02 0.02Chicken, muscle ○ 0.01 0.01 0.01Other poultry, muscle ○ 0.01 0.01 0.01Chicken, fat ● 0.01 0.05Other poultry, fat ● 0.01 0.05Chicken, liver ○ 0.01 0.01 0.01

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other poultry, liver ○ 0.01 0.01 0.01Chicken, kidney ○ 0.01 0.01 0.01Other poultry, kidney ○ 0.01 0.01 0.01Chicken, edible offal ○ 0.01 0.01 0.01Other poultry, edible offal ○ 0.01 0.01 0.01Chicken eggs ○ 0.01 0.01 0.01Other poultry, eggs ○ 0.01 0.01 0.01

Other spices, dried (except SANSHO (Japanese pepper)) ※5 ● 0.1

The residue definition is methamidophos, including methamidophos derived from acephate.

* 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.* 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.

●：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 (as acephate).

※1 For rice (brown rice) and milk in which the Codex has set MRLs, the dietary exposure of methamidophos estimated by using the supervised trial median residue (STMR) of the supervised residue trials submitted to the JMPR and national food consumption data of rice, other oilseeds and milk would exceed an ADI of 0.00056 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to maintain the current MRLs(i.e. the uniform limit of 0.01 ppm) in these commodities.

※2 For other vegetables in which the Codex has set MRLs, the dietary exposure (estimate of short term intake (ESTI)) of methamidophos estimated by using the highest residues (HR) of the supervised residue trials submitted to the JMPR and national food consumption data of these commodities would exceed an ARfD of0.003 mg/kg which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set the MRLs for these commodities based on the residue data from the domestic supervised residue trials.

※3 Pesticide registration for grape are planned to be deleted in Japan.

※4 According to the present food classification system in Japan, “SANSHO(Japanese pepper)” are included “Other spices”.

※5 Food categories “Other spices, dried (except SANSHO (Japanese pepper))” will be deleted, hereafter, MRLs in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed commodities, taking into account their processing factors.

Dicyclanil

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Other terrestrial mammals, muscle ○ 0.2 0.15 0.15Other terrestrial mammals, fat ○ 0.2 0.2 0.2Other terrestrial mammals, liver ○ 0.1 0.125 0.125Other terrestrial mammals, kidney ○ 0.1 0.125 0.125Other terrestrial mammals, edible offal ○ 0.1 0.1

The residue definition is dicyclanil 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.

Semduramicin

CommodityMRL

(draft) ppm

MRL(current)

ppmRegistration

Reference MRL

Codex ppm

National ppm

Chicken, muscle ● 0.05 0.09 §Other poultry, muscle ● ※ 0.09Chicken, fat ● 0.4 0.5 §Other poultry, fat ● ※ 0.5Chicken, liver ○ 0.6 0.5 §Other poultry, liver ● ※ 0.5Chicken, kidney ○ 0.2 0.2 §Other poultry, kidney ● ※ 0.5Chicken, edible offal ○ 0.6 0.03 §Other poultry, edible offal ● ※ 0.5

The residue definition is semduramicin only.

* 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.○：Commodities for which MRLs are to be maintained, increased or newly set.§：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 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 Law:

Pesticides: Hydroxypropyl Distarch Phosphate

This substance is not permitted for use as pesticide in Japan. The MHLW requested the Food Safety Commission of Japan (FSC) to conduct a risk assessment for this substance in response to a request for setting MRLs by the MAFF with the intention to newly register this substance as a pesticide. The FSC concluded that hydroxypropyl distarch phosphate 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 hydroxypropyl distarch phosphate as an exempt substance.

Item 3. Improvement of sanitary regulations for utensils, containers and packaging considering international consistency

【WTO-TBT Notification(G/TBT/N/JPN/582)】 The summary of the amendment to the Food

Sanitation Act(Improvement of sanitary regulations for utensils, containers and packaging

considering international consistency)

The government of Japan is planning to amend the Food Sanitation Act and introduce a positive list system that allows only substances whose safety is evaluated to be used for utensils, containers and packaging for food and food additives.

Background

In Japan, the safety of food utensils, containers and packaging has been secured mainly by regulating the use of only substances whose specifications and standards are established based on the Food Sanitation Act (=Negative list system).

In light of recent developments and the diversification of products, as well as global trends, Japan has decided that the management system of utensils, containers and packaging should be founded on the policy that basically prohibits all substances except those approved for use based on risk assessment (= Positive list system), in order to ensure the further safety of utensils, containers and packaging.

Based on these circumstances, in order to ensure food safety, the government of Japan is planning to amend the Food Sanitation Act and other relevant laws taking into consideration the opinions of concerned parties such as consumers, food business operators (FBOs), and experts.

Outline of the amendment

In order to ensure the safety of utensils, containers and packaging, and to ensure international consistency of regulations, FBOs associated with these products shall not sell those made of raw materials, such as synthetic resins, for which specifications are not established, except cases that the Minister of Health, Labour and Welfare specifies as having no risk to human health. In addition, the manufacturers shall comply with the codes of good manufacturing practices.

Manufacturers and sellers of utensils, containers and packaging shall provide the business entities where the products are sold with information that the products conform to the relevant specifications. Also

manufacturers and sellers of the raw materials shall endeavor to provide the manufacturers of utensils, containers and packaging with the relevant information if requested.

Investigation of substances used for synthetic resin utensils, containers and packaging for food

Ministry of Health, Labour and Welfare (MHLW) is planning to establish the Positive List System that basically allows substances whose safety is evaluated to be used for synthetic resin utensils, containers and packaging for food. After the establishment, only substances registered on the Positive List will be permitted to use for synthetic resin utensils, containers and packaging for food. Therefore, MHLW is planning to investigate whether substances which are added or mixed to synthetic resin utensils, containers and packaging distributed in the current domestic market (hereinafter referred to as “the existing substances”) are appropriate for registration on the Positive List after confirming the result of safety evaluation, the information on toxicity etc.

MHLW recognizes the substances which are voluntarily managed by Japan Hygienic Olefin And Styrene Plastics Association, Japan Hygienic PVC Association and Japan Hygienic Association of Vinylidene Chloride in Japan (hereinafter referred to as “the three associations”)*. However, MHLW does not recognize the other substances which are used for synthetic resin utensils, containers and packaging distributed in the domestic market as use for food. For smooth implementation of the Positive List System, information of unrecognized substances which are used in Japan and overseas should be collected and should be judged the appropriateness for registration on the Positive List.

From above reason, if there is a substance which is the existing substance but not voluntarily managed by the three associations, and is need to be registered on the Positive List, please email the request to our division by March, 2018.

For each substance which needs registration, MHLW will request submission of the result of safety evaluation, information on toxicity etc. by a public organization in due course. Please note that the substance without these data is difficult to be registered on the Positive List.

Contact address: Food Safety Standards and Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW)

E-mail : kijunpa@mhlw.go.jpContact persons: Ms. Hiroko NIWA and Mr. Shunsuke MATSUSHITA (Tel:

+81-3-5253-1111 (ext. 2921 or 2487))

* For the substance list of the three associations, please check the following references of Guideline for safety assurance in the manufacture etc. of food utensils, containers and packaging, which are published on website of MHLW.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000170730.xls x http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000170731.xls x http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000170732.xls x