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

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1 THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary - Internal Date: 3/1/2018 GAIN Report Number: JA8013 Japan Post: Tokyo Japan Proposes Revision of s for 8 Agricultural Chemicals Report 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 (s) 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, 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

2 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, 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 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 s, you are requested to submit data supporting your country s s, 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 Welfare 1-2-2, Chiyoda-ku, Kasumigaseki, Tokyo, Pesticides/Veterinary drugs/feed additives Mr. Ryota NAKAMURA (nakamura-ryouta@mhlw.go.jp) Tel : (ex 4289) Fax: Utensils, containers and packaging Ms. Niwa and Mr. Matsushita (kijunpa@mhlw.go.jp) Tel : (ex 2921 or 2487) Fax:

3 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, s ) 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 System 1 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 s 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 ) in the Japanese marketplace unless specific maximum residue limits (s) have been set.

4 Summary Acephate (pesticide: insecticide): Permitted for use in Japan. The MHLW is going to modify s 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 s in some commodities in response to a request for setting s 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 s in some commodities in response to a request for setting s 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 , 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 s 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 , 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 s in some commodities in response to a request for setting s 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 s in some commodities that were provisionally set at the introduction of the Positive List System.

5 Dicyclanil (veterinary drug: insecticide): Not permitted for use in Japan. The MHLW is going to modify s 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 s in some commodities that were provisionally set at the introduction of the Positive List System.

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

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

8 Other poultry, fat Chicken, liver Other poultry, liver Chicken, kidney Other poultry, kidney Chicken, edible offal Other poultry, edible offal Chicken eggs Other poultry, eggs Pepper,dried Other spices, dried (except SANSHO (Japanese pepper)) The residue definition is acephate only. Reference * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. * Shaded figures indicate provisional s. * Diagonal line means deletion of a food category to which an applies. * In the 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 s are to be lowered or deleted. :Commodities for which s 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 has set s, 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 mg/kg/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided maintain the current s(i.e. the uniform limit of 0.01 ) in these commodities. 2 For cabbage, other composite vegetables, tomato, ginger, other vegetables, other fruits in which the has set s, 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 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set the s 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, s in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed commodities, taking into account their processing factors.

9 Amisulbrom Rice (brown rice) Soybeans, dry Beans, dry Potato Konjac 0.05 Request Sugar beet 1 1 Japanese radish, roots (including radish) Japanese radish, leaves (including radish) Turnip, roots (including rutabaga) Turnip, leaves (including rutabaga) Chinese cabbage Cabbage 3 3 Kale Komatsuna(Japanese mustard spinach) Kyona Qing-geng-cai Cauliflower 2 2 Broccoli 2 2 Other cruciferous vegetables Lettuce (including cos lettuce and leaf lettuce) Onion Welsh (including leek) 3 3 Other liliaceous vegetables Tomato 2 2 Pimiento (sweet pepper) 3 3 Egg plant 1 1 Other solanaceous vegetables 5 5 Cucumber (including gherkin) Pumpkin (including squash) 2 2 Water melon Melons Spinach Ginger Request Green soybeans Unshu orange, pulp 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 Grape 5 5 Other fruits 1 1 Other spices Other herbs Reference The residue definition is amisulbrom only. * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above.

10 * In the 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 s are to be maintained, increased or newly set. :Permitted for use in Japan. Request:Request for setting/revising was made by MAFF.

11 Cyazofamid Reference Rice (brown rice) Wheat Soybeans, dry Beans, dry Potato Konjac Japanese radish, roots (including radish) Japanese radish, leaves (including radish) Turnip, roots (including rutabaga) Turnip, leaves (including rutabaga) Watercress Chinese cabbage Cabbage Brussels sprouts Kale Komatsuna(Japanese mustard spinach) Kyona Qing-geng-cai Cauliflower 2 Request 1.5 Broccoli Other cruciferous vegetables Chicory Endive Shungiku Lettuce (including cos lettuce and leaf lettuce) Other composite vegetables Onion IT 2.0 USA Welsh (including leek) 2 2 Garlic 2 IT 2.0 USA Multiplying onion (including shallot) 5 5 Other liliaceous vegetables 3 3 Carrot USA Mitsuba Tomato Pimiento (sweet pepper) Egg plant Other solanaceous vegetables Cucumber (including gherkin) Pumpkin (including squash) Oriental pickling melon (vegetable) Water melon Melons Makuwauri melon Other cucurbitaceous vegetables Spinach Ginger 3 3 Kidney beans, immature (with pods) Green soybeans 5 5 Other vegetables Unshu orange, pulp Citrus natsudaidai, whole 2 2

12 Reference Lemon 5 5 Orange (including navel orange) 5 5 Grapefruit 5 5 Lime 5 5 Other citrus fruits 5 5 Japanese pear 0.5 Request Peach Nectarine 1 1 Japanese plum (including prune) 0.2 Request Strawberry Grape Papaya Taiwan Other fruits 1 1 Hop Other spices Other herbs The residue definition is cyazofamid only. * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. * In the 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 s are to be maintained, increased or newly set. :Permitted for use in Japan. Request:Request for setting/revising was made by MAFF. IT:Import tolerance

13 Bicyclopyrone Reference Wheat 0.04 IT 0.04 USA Barley 0.07 IT 0.07 USA Corn (maize, including pop corn and sweet corn) USA The residue definition is sum of bicyclopyrone, metabolite B 2-2-(methoxy-ethoxymethyl)-6-trifluoromethylnicotinic acid (including metabolites that can be hydrolyzed to metabolite B) and metabolite K 2-(2-hydoroxyethoxymethyl)-6-trifluoromethyl-nicotinic acid (including metabolites that can be hydrolyzed to metabolite K), expressed as bicyclopyrone. * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. :Commodities for which s are to be maintained, increased or newly set. IT:Import tolerance

14 Pyflubumide Beans, dry Pimiento (sweet pepper) 1 1 Egg plant Cucumber (including gherkin) Water melon Melons Kidney beans, immature (with pods) 2 2 Unshu orange, pulp 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 Pear Peach Nectarine Apricot 3 3 Japanese plum (including prune) Mume plum 3 3 Cherry 3 3 Strawberry 1 1 Grape 2 2 Japanese persimmon Other fruits 1 1 Tea Other spices 5 5 Other herbs 0.2 Request Reference 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 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. * In the 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 s are to be maintained, increased or newly set. :Permitted for use in Japan. Request:Request for setting/revising was made by MAFF.

15 Methamidophos Rice (brown rice) Wheat 0.01 Barley 0.01 Rye 0.01 Corn (maize, including pop corn and sweet corn) Buckwheat 0.01 Other cereal grains 0.01 Soybeans, dry Beans, dry 2 2 Peas 0.01 Broad beans 0.2 Peanuts, dry 0.1 Other pulses 0.3 Potato Taro 0.01 Sweet potato 0.01 Yam Konjac 0.01 Other potatoes 0.01 Sugar beet Japanese radish, roots (including radish) Japanese radish, leaves (including radish) Turnip, roots (including rutabaga) Turnip, leaves (including rutabaga) Horseradish 3 Watercress 0.5 Chinese cabbage Cabbage Brussels sprouts 1.0 Kale 0.7 Komatsuna(Japanese mustard spinach) Kyona Qing-geng-cai Cauliflower Broccoli Other cruciferous vegetables Burdock Salsify 0.01 Artichoke Chicory 0.5 Endive 0.5 Shungiku 0.5 Lettuce (including cos lettuce and leaf lettuce) Other composite vegetables Onion Welsh (including leek) 0.05 Garlic Nira 0.3 Asparagus 0.01 Multiplying onion (including shallot) 0.05 Other liliaceous vegetables 0.3 Reference

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

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

18 Other poultry, liver Chicken, kidney Other poultry, kidney Chicken, edible offal Other poultry, edible offal Chicken eggs Other poultry, eggs Other spices, dried (except SANSHO (Japanese pepper)) The residue definition is methamidophos, including methamidophos derived from acephate. Reference * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. * Shaded figures indicate provisional s. * Diagonal line means deletion of a food category to which an applies. * In the 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 s are to be lowered or deleted. :Commodities for which s 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 has set s, 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 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to maintain the current s(i.e. the uniform limit of 0.01 ) in these commodities. 2 For other vegetables in which the has set s, 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 of mg/kg which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to set the s 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, s in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed commodities, taking into account their processing factors.

19 Dicyclanil Other terrestrial mammals, muscle Other terrestrial mammals, fat Other terrestrial mammals, liver Other terrestrial mammals, kidney Other terrestrial mammals, edible offal The residue definition is dicyclanil only. Reference * The uniform limit 0.01 will be applied to commodities for which draft s are not given in this table and to commodities not listed above. * Shaded figures indicate provisional s. * In the 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 s are to be lowered or deleted. :Commodities for which s are to be maintained, increased or newly set.

20 Semduramicin Chicken, muscle Other poultry, muscle 0.09 Chicken, fat Other poultry, fat 0.5 Chicken, liver Other poultry, liver 0.5 Chicken, kidney Other poultry, kidney 0.5 Chicken, edible offal Other poultry, edible offal 0.5 Reference The residue definition is semduramicin only. * Not the uniform limit of 0.01 but the regulation that foods shall not contain any antibiotics or chemically synthesized substances will be applied to the commodities for which current s are to be deleted, since this substance is considered to be an antibiotic or chemically synthesized antibacterial substance. * Shaded figures indicate provisional s. * In the 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 s are to be lowered or deleted. :Commodities for which s are to be maintained, increased or newly set. :Permitted for use in Japan.

21 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 shiitake mushroom.

22 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.

23 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 s 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.

24 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.

25 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 the request to our division by March, 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) kijunpa@mhlw.go.jp Contact persons: Ms. Hiroko NIWA and Mr. Shunsuke MATSUSHITA (Tel: (ext or 2487))

26 * 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