THE 185th CONFERENCE FOR PROMOTION OF FOOD IMPORT FACILITATION (FOOD SAFETY GROUP) Standards and Evaluation Division Department of Food Safety Pharmac

Transcription

1 THE 185th CONFERENCE FOR PROMOTION OF FOOD IMPORT FACILITATION (FOOD SAFETY GROUP) Standards and Evaluation Division Department of Food Safety Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Date: Wednesday, May 13, 2015 (10:30-12:00) Place: Ministry of Health, Labour and Welfare Temporary Meeting Room No , Kasumigaseki, Chiyoda-ku, Tokyo Agenda: Item 1. Establishment of Maximum Residue Limits for Agricultural Chemicals in Food Pesticide: Cymoxanil, Fenothiocarb, Mesotrione Veterinary drug: Ketoprofen Item 2. Designation of a Food Additive 1-Methylnaphthalene 1

2 The Ministry of Health, Labour and Welfare (MHLW) will revise the existing standards and specifications for food as shown in the Attachments. Please provide comments in writing by Wednesday, May 27, After the given date, comments on Item 1 should be directed to the enquiry point in accordance with the WTO/SPS Agreement. The revision of existing MRLs for Mesotrione, mentioned in Item 1, will not be notified to the WTO, because the existing regulation for them will not be strengthen by this amendment. We ask that for agenda, if you wish to request Japan to adopt the same limits as your country s maximum residue limits as Japanese MRLs, you are requested to submit data supporting your country s MRLs, such as risk assessment and residue data. <Contact> Standards and Evaluation Division, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare 1-2-2, Chiyoda-ku, Kasumigaseki, Tokyo, Tel: Fax: Pesticides/veterinary drugs Mr. R. Nakamura (nakamura-ryouta@mhlw.go.jp) Tel: (ex. 2487) Food additives Mr. T. Ikegami (ikegami-takahiro@mhlw.go.jp) Tel. ex

3 Item 1. Establishment of Maximum Residue Limits for Agricultural Chemicals in Food The government of Japan is going to amend existing residue standards for agricultural chemicals in foods. Summary The Food Sanitation Act authorizes the Minister of Health, Labour and Welfare to establish residue standards (maximum residue limits: MRLs) for pesticides, feed additives, and veterinary drugs (hereafter referred to as just 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* for agricultural chemicals in food. Basically, all foods distributed in the Japanese marketplace are subject to regulation of the system. The Ministry of Health, Labour and Welfare (MHLW) has comprehensively reviewed existing MRLs to modify those that were provisionally set at the introduction of the system. In addition, the MHLW has newly set MRLs (draft) for some commodities. This activity has been targeted at three pesticides (Cymoxanil, Fenothiocarb, Mesotrione) and one veterinary drug (Ketoprofen). Details are given below. Note: The positive list system was established based on the 2003 amendment of the Food Sanitation Law. The system aims to prohibit the distribution of any food in the Japanese marketplace if it contains agricultural chemicals at amounts exceeding a certain level (0.01 ppm) specified under the Law. Outline Cymoxanil (fungicide): Permitted for use in Japan. The MHLW has newly established MRLs for some commodities. This action has been 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 3

4 2004). In addition, the MHLW has modified some MRLs that were provisionally set at the introduction of the Positive List System. Fenothiocarb (acaricide): Permitted for use in Japan. The MHLW has modified some MRLs that were provisionally set at the introduction of the Positive List System. Mesotrione (herbicide): Permitted for use in Japan. The MHLW has newly established MRLs for some commodities. This action has been taken 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. Ketoprofen (anti-inflammatory agent): Permitted for use in Japan. The MHLW has modified MRLs for some commodities. This action has been based on MAFF s decision to revise the existing standards for the application of this substance based on the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. 4

5 Cymoxanil Reference MRL MRL MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Rice (brown rice) 0.05 Wheat 0.05 Barley 0.05 Rye 0.05 Corn (maize, including pop corn and sweet corn) 0.05 Buckwheat 0.05 Other cereal grains 0.05 Soybeans, dry Beans, dry Peas IT 0.5 EU Broad beans 0.05 Peanuts, dry 0.05 Other pulses 0.05 Potato 2 2 Taro 0.1 Sweet potato 0.1 Yam 0.1 Konjac 0.1 Other potatoes 0.1 Sugar beet 0.05 Sugarcane 0.05 Japanese radish, roots (including radish) 0.05 Japanese radish, leaves (including radish) 0.05 Turnip, roots (including rutabaga) 0.05 Turnip, leaves (including rutabaga) 0.05 Horseradish 0.05 Watercress IT 19 USA Chinese cabbage Cabbage 0.2 Brussels sprouts 0.05 Kale 0.05 Komatsuna(Japanese mustard spinach) 0.05 Kyona 0.05 Qing-geng-cai 0.05 Cauliflower 0.05 Broccoli 0.05 Other cruciferous vegetables 0.05 Burdock 0.05 Salsify 0.05 Artichoke IT 0.1 EU Chicory 0.05 Endive IT 19 USA Shungiku 0.05 Lettuce (including cos lettuce and leaf lettuce) 2 2 Other composite vegetables 0.05 Onion IT 0.05 USA Welsh (including leek) IT 1.1 USA Garlic IT 0.05 USA Nira IT 1.1 USA Asparagus 0.05 Multiplying onion (including shallot)

6 MRL MRL Reference MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Other liliaceous vegetables Carrot 0.05 Parsnip 0.05 Parsley IT 19 USA Celery IT 6.0 USA Mitsuba 0.05 Other umbelliferous vegetables 0.05 Tomato 2 2 Pimiento (sweet pepper) IT 0.2 USA Egg plant Other solanaceous vegetables IT 0.2 USA Cucumber (including gherkin) 2 2 Pumpkin (including squash) IT 0.1 EU Oriental pickling melon (vegetable) IT 0.05 USA Water melon Melons Makuwauri melon IT 0.1 EU Other cucurbitaceous vegetables IT 0.1 EU Spinach 0.05 Bamboo shoots 0.05 Okra 0.05 Ginger 0.05 Peas, immature (with pods) IT 0.5 EU Kidney beans, immature (with pods) 0.05 Green soybeans 0.05 Button mushroom 0.05 Shiitake mushroom 0.05 Other mushrooms 0.05 Other vegetables 0.5 Unshu orange, pulp 0.05 Citrus natsudaidai, whole 0.05 Lemon 0.05 Orange (including navel orange) 0.05 Grapefruit 0.05 Lime 0.05 Other citrus fruits 0.05 Apple 0.05 Japanese pear 0.05 Pear 0.05 Quince 0.05 Loquat 0.1 Peach 0.1 Nectarine 0.05 Apricot 0.2 Japanese plum (including prune) 0.2 Mume plum 0.2 Cherry 0.2 Strawberry 0.2 Raspberry IT 4.0 USA Blackberry IT 4.0 USA Blueberry 0.2 6

7 Reference MRL MRL MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Cranberry 0.2 Huckleberry 0.2 Other berries IT 4.0 USA Grape 1 1 Japanese persimmon 0.05 Banana 0.05 Kiwifruit 0.1 Papaya 0.05 Avocado 0.05 Pineapple 0.05 Guava 0.05 Mango 0.05 Passion fruit 0.05 Date 0.2 Other fruits 0.2 Sunflower seeds IT 0.1 EU Sesame seeds 0.05 Safflower seeds 0.05 Cotton seeds 0.05 Rapeseeds 0.05 Other oil seeds 0.05 Ginkgo nut 0.05 Chestnut 0.05 Pecan 0.05 Almond 0.05 Walnut 0.05 Other nuts 0.05 Tea 0.05 Coffee beans 0.05 Cacao beans 0.05 Hop 7 2 IT 7.0 USA Other spices IT 0.1 EU Other herbs IT 19 USA Milk 0.05 Note: The residue definition is cymoxanil 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 :Commodities for which MRLs were lowered :Commodities for which MRLs were maintained or increased :Permitted for use in Japan. IT:Import tolerance 7

8 Fenothiocarb Reference MRL MRL MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Water melon 0.5 Melons 0.5 Makuwauri melon 0.5 Unshu orange, pulp Citrus natsudaidai, peels 20 Citrus natsudaidai, whole 0.5 Lemon 0.5 Orange (including navel orange) 0.5 Grapefruit 0.5 Lime 0.5 Other citrus fruits 0.5 Apple 0.5 Japanese pear 0.5 Pear 0.5 Quince 0.5 Loquat 0.5 Peach 0.5 Nectarine 0.5 Apricot 0.5 Japanese plum (including prune) 0.5 Mume plum 0.5 Cherry 0.5 Strawberry 0.5 Raspberry 0.5 Blackberry 0.5 Blueberry 0.5 Cranberry 0.5 Huckleberry 0.5 Other berries 0.5 Grape 0.5 Japanese persimmon 0.5 Banana 0.5 Kiwifruit 0.5 Papaya 0.5 Avocado 0.5 Pineapple 0.5 Guava 0.5 Mango 0.5 Passion fruit 0.5 Date 0.5 Other fruits 0.5 Sunflower seeds 0.5 Sesame seeds 0.5 Safflower seeds 0.5 Cotton seeds 0.5 Rapeseeds 0.5 Other oil seeds 0.5 Ginkgo nut 0.5 Chestnut 0.5 Pecan 0.5 Almond 0.5 8

9 MRL MRL Reference MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Walnut 0.5 Other nuts 0.5 Other spices Note: The residue definition is fenothiocarb 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 :Commodities for which MRLs were lowered :Commodities for which MRLs were maintained or increased :Permitted for use in Japan. 9

10 Mesotrione MRL MRL Reference MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Rice (brown rice) Corn (maize, including pop corn and sweet corn) Other cereal grains USA Soybeans, dry 0.03 IT 0.03 Canada Sugarcane USA Asparagus USA Okra USA Raspberry USA Blackberry USA Blueberry USA Cranberry USA Other berries USA Other oil seeds USA Other herbs USA Note: The residue definition is mesotrione only. * The uniform limit 0.01 ppm will be applied 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 were maintained or increased :Permitted for use in Japan. IT:Import tolerance 10

11 Ketoprofen MRL MRL Reference MRL Commodity (draft) (current) Registration Codex National ppm ppm ppm ppm Cattle, muscle AU Pig, muscle 0.01 Request Cattle, fat Pig, fat 0.01 Request Cattle, liver Pig, liver 0.03 Request Cattle, kidney AU Pig, kidney 0.05 Request Cattle, edible offal AU Pig, edible offal 0.05 Request Milk AU Note: The residue definition is ketoprofen only. * The uniform limit 0.01 ppm will be applied to commodities not listed above. :Commodities for which MRLs were lowered :Commodities for which MRLs were maintained or increased Request:The MRL was modified in response to MAFF request 11

12 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. 12

13 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. 13

14 Item 2. Designation of Food Additives The government of Japan will designate 1-Methylnaphthalene as an authorized food additive. Summary Under Article 10 of the Food Sanitation Act, food additives shall not be used or marketed without authorization by the Minister of Health, Labour and Welfare (hereinafter referred as the Minister ). In addition, when specifications or standards are established for food additives 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 marketed 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 the adequacy of the designation of 1-Methylnaphthalene [CAS: ]* as a food additive. The committee concluded that the Minister should designate 1-Methylnaphthalene as a food additive unlikely to harm human health, based on Article 10 of the act, and establish compositional specifications, based on Article 11 of the act. See Attachment 2-1. Note: 1-Methylnaphthalene is naturally occurring in some food products, such as olives oil, and paprika. In Europe and United States, this substance is used as a flavoring agent to reproduce natural flavors in various processed foods to improve the flavor quality of the foods. The processed foods include frozen dairy products, meat products, non-alcoholic beverages, and candies. <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 May 13, 2015, 52 of the 54 flavorings and 40 of the 45 non-flavoring additives were already approved. See Attachment

15 Attachment Methylnaphthalene 1- メチルナフタレン CH 3 Standards for use For flavoring purposes only. Compositional specifications Substance name 1-Methylnaphthalene Molecular formula C11H10 Molecular weight Chemical name [CAS number] 1-Methylnaphthalene [ ] Content 1-Methylnaphthalene contains not less than 96.0% of 1-methylnaphthalene (C11H10). Description 1-Methylnaphthalene is a colorless to pale yellow liquid having a characteristic odor. Identification Determine the infrared absorption spectrum of 1-Methylnaphthalene as directed in the Liquid Film Method under Infrared Spectrophotometry, and compare with the Reference Spectrum. Both spectra exhibit absorptions having about the same intensity at the same wavenumbers. Purity (1) Refractive index n 20 D : (2) Specific gravity : (3) Acid value Not more than 1.0 (Flavoring Substances Tests). Assay Proceed as directed in the Peak Area Percentage Method in the Gas Chromatographic Assay of Flavoring Agents under the Flavoring Substances Tests. Use operation conditions (1) except for the column temperature. Raise the column temperature from 150 C to 230 C at a rate of 5 C/minute, and maintain at 230 C for 24 minutes. 15

16 Infrared Reference Spectrum 1-Methylnaphthalene 16

17 Attachment 2-2 Progress of evaluation of food additives that have been proven safe and are widely used in the world 13 May, 2015 Food Safety Commission MHLW Substance name Request for evaluation Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 Closing date for comments 4 Date of designation as food additives Isobutanol 24 Mar 2004(fin.) 27 May Apr 2004(fin.) 19 Aug Dec Ethyl-3, (5 or 6)- dimethylpyrazine 21 Nov Mar 2004(fin.) 27 May Apr 2004(fin.) 26 Jul Dec ,3,5,6-Tetramethylpyrazine 3 Mar 2004(fin.) 27 May Apr 2004(fin.) 26 Jul Dec 2004 Calcium stearate 4 Mar May 2004(fin.) 29 Jul Jun 2004(fin.) 21 Oct Dec 2004 Propanol 21 Nov 2003 Nitrous oxide 20 Oct 2003 Isopropanol 15 Dec Mar May Jul 2004(fin.) 17 Dec Oct 2004(fin.) 24 Mar Apr Sep Oct 2004(fin.) 9 Sep Aug 2004(fin.) 14 Dec Feb Dec Dec 2004(fin.) 19 Feb Mar Dec Oct 2004(fin.) 4 Mar Apr 2005 Hydroxypropyl cellulse 16 Aug Dec 2004(fin.) 10 Mar Feb 2005(fin.) 14 Jun Aug 2005 Isoamylalcohol 2,3,5-Trimethylpyrazine Amylalcohol Natamycin 20 Oct 2003 Acetaldehyde 21 Nov Ethyl-3-methylpyrazine 5-Methylquinoxaline Butanol Ammonium alginate Potassium alginate Calcium alginate 5 Nov Jan 2005(fin.) 17 Mar Mar Mar Jan Nov Jan 2005(fin.) 3 Mar Apr Apr Feb Apr 2005(fin.) 14 Jun 2005(fin.) 14 Jun Jul 2005(fin.) 2 Dec Dec 2005(fin.) 6 May Mar 2005(fin.) 7 Sep Nov Jul Jun 2005(fin.) 12 Oct May Aug Sep Feb 2005(fin.) 28 Jul 2005(fin.) 27 Oct Nov 2005(fin.) 30 Mar Mar 2006(fin.) 14 Jun Dec Apr Sep Aug May Sep Dec

18 Substance name Request for evaluation Food Safety Commission Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 MHLW Closing date for comments 4 Date of designation as food additives 2-Methylbutanol 19 Dec 2005 Isobutyraldehyde 19 Dec 2005 Butyraldehyde 19 Dec 2005 Polysorbate 20, 60, 65, 80 8 Oct 2003 Calcium silicate 15 Aug 2005 Calcium ascorbate 3 Oct 2005 Nisin 20 Oct 2003 Acetylated distarch adipate Acetylated distarch phosphate Acetylated oxidized starch Starch sodium octenylsuccinate Hydroxypropyl starch Hydroxypropyl distarch phosphate Phosphated distarch phosphate Monostarch phosphate Distarch phosphate Oxidized starch Starch acetate 26 Nov 2004 Magnesium hydroxide 9 Mar Jul Aug 2006(fin.) 28 Jun Jul Aug Sep Oct 2006(fin.) 19 Dec Jan 2007(fin.) 29 Oct Apr Jul Mar 2007(fin.) 28 Feb Mar Apr May 2007(fin.) 23 Mar Apr May Jun 2007(fin.) 9 Apr Nov Jan Jul Aug 2007(fin.) 23 Mar May Aug Sep 2007(fin.) 22 Jun Jul Aug 2007(fin.) 12 Oct Dec Dec Jan 2007 (Fin.) 8 Dec Jan 2007 (Fin.) 22 May Aug May Aug Mar Mar 2007(fin.) 27 Aug Oct Jun Jul Aug 2007(fin.) 16 Dec Apr Jul Aug 2007(fin.) 16 Dec Apr Aug Aug 2007(fin.) 16 Dec Apr Jan Nov Sep Oct Feb 2008(fin.) 24 Sep 2008(fin.) 28 Nov 2007(fin.) 4 Jul 2008(fin.) 18 Jul Mar May Oct Nov Oct 2007(fin.) 7 Feb Jul

19 Substance name Request for evaluation Food Safety Commission Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 MHLW Closing date for comments 4 Date of designation as food additives Magnesium Monohydrogen Phosphate 28 Mar 2005 Polyvinylpyrrolidone 20 Jun 2005 Magnesium silicate(synthetic) 15 Aug 2005 Sodium aluminium silicate 15 Aug 2005 Calcium aluminium silicate 15 Aug 2005 Calcium saccharin 22 May May Jun Jul Aug Sep Nov Oct Nov Dec 2011(fin) 13 Sep Oct Nov Dec Jan Dec Jan Feb Mar Apr 2013(fin.) 28 Feb Mar Apr Sep Nov 2009(fin.) 28 Feb May May Jun Jul Aug 2013 (under consideration) 28 Feb May Jul May Jun Jul Aug 2013 (under consideration) 27 Aug Sep Oct Apr May Jun 2011(fin) 22 Mar Mar 2012(fin.) 22 Jul Nov Jul Jun Oct Jan 2014(fin) 18 Jun Jan Dec 2009(fin) 6 Jun Oct Aug Nov 2011 (fin) 12 May Dec

20 Substance name Request for evaluation Food Safety Commission Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 MHLW Closing date for comments 4 Date of designation as food additives Ammonium L-glutamate 22 May Jan 2008(fin.) 13 Mar Apr 2008 (fin.) 10 Oct Oct 2010 Sodium stearoyl-2-lactylate 6 Feb 2007 Potassium lactate 6 Feb Mar Apr 2008(fin.) 17 Jun Sep Aug Sep Oct 2012(fin.) 10 Jul Jul 2008(fin.) 1 Dec May Jan Dec Mar May 2013 Calcium sorbate 19 Mar Mar Jun Nov Nov 2008(fin) 25 Apr May Aug 2008(fin.) Valeraldehyde 19 Mar Feb 2008(fin.) 27 Mar Jul 2008(fin.) 1 Dec Jun 2009 Isovaleraldehyde 19 Mar Feb 2008(fin.) 27 Mar Jul 2008(fin.) 1 Dec Jun ,3-Dimethylpyrazine 7 Feb Apr May 2008(fin.) 31 Jul Sep 2008(fin.) 3 Feb Jun ,5-Dimethylpyrazine 7 Feb Apr May 2008(fin.) 31 Jul Sep 2008(fin.) 3 Feb Jun ,6-Dimethylpyrazine 7 Feb Apr May 2008(fin.) 31 Jul Sep 2008(fin.) 3 Feb Jun Ethylpyrazine 22 May Sep 2008(fin.) 27 Nov Oct 2008(fin.) 25 Apr May Methylpyrazine 22 May Sep 2008(fin.) 27 Nov Oct 2008(fin.) 25 Apr May Pentanol 14 Oct Nov 2008(fin.) 22 Jan Apr 2009(fin.) 20 Sep May Methylbutyraldehyde 14 Oct Nov 2008(fin.) 22 Jan Dec 2008(fin.) 29 May May 2010 Propionaldehyde 20 Nov Feb 2009(fin.) 2 Apr Apr 2009(fin.) 20 Sep May Methylquinoline 20 Nov Mar 2009(fin) 21 May Apr 2009(fin.) 20 Sep May Ethyl-5-methylpyrazine 12 Mar Jun Sep 2009(fin.) 8 Oct Dec 2009(fin) 6 Jun Oct ,6,7,8-Tetrahydroquinoxaline 12 Mar Jun 2009(fin) 27 Aug Sep 2009(fin.) 2 Feb May Methyl-2-butanol 12 Mar May 2009(fin.) 23 Jul Sep 2009(fin.) 2 Feb May 2010 Isopentylamine 12 Aug Sep 2009(fin.) 12 Nov Dec 2009(fin) 6 Jun Oct 2010 Butylamine 10 Sep Oct Nov 2009(fin) 4 Mar Mar 2010(fin) 30 Aug Nov 2010 Phenetylamine 5 Nov Nov 2009(fin) 18 Mar Mar 2010(fin) 30 Aug Nov 2010 Trimethylamine 26 Nov Dec 2009(fin) 29 Jul Nov 2011 (fin) 19 Mar Dec Penten-3-ol 2 Feb Feb 2010(fin) 28 Apr Feb 2011(fin) 24 May Jul Methyl-2-butenol 2 Feb Feb 2010(fin) 28 Apr Feb 2011(fin) 24 May Jul 2011 Piperidine 15 Mar Mar 2010(fin) 20 May Jun 2010(fin) 23 Oct Dec 2010 Pyrrolidine 5 Apr Apr 2010(fin) 3 Jun Jun 2010(fin) 23 Oct Dec ,6-Dimethylpyridine 13 May Jun 2010(fin) 15 Jul Sep 2010(fin) 3 Jan Mar Ethylpyridine 14 Jun Jun Aug Nov 2012(fin.) 18 Feb Jan May Aug Ethyl-2-methylpyridine 14 Jun Jun 2010(fin) 26 Aug Sep 2010(fin) 3 Jan Mar

21 Substance name Request for evaluation Food Safety Commission Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 MHLW Closing date for comments 4 Date of designation as food additives 2-(3-Phenylpropyl)pyridine 9 Jul Jul 2010(fin) 7 Oct Dec 2010(fin) 1 Apr Jun ,3-Diethyl-5-methylpyrazine 9 Jul Jul 2010(fin) 7 Oct Dec 2010(fin) 1 Apr Jun methyl-6,7-Dihydro-5H - cyclopentapyrazine 12 Aug Aug 2010(fin) 27 Jan Dec 2010(fin) 1 Apr Jun 2011 Pyrazine 12 Aug Aug 2010(fin) 4 Jan Feb 2011(fin) 24 May Jul Methyl-2-butenal 9 Sep Sep 2010(fin) 27 Jan Feb 2011(fin) 24 May Jul 2011 trans -2-Pentenal 29 Oct Nov Dec Dec Mar 2012(fin) 22 Jul Nov Sep 2011(fin) Isoquinolin 29 Oct Nov 2010(fin) 3 Feb May 2011(fin) 8 Aug Dec Ethyl-6-methylpyrazine 6 Dec Dec 2010(fin) 31 Mar Nov 2011 (fin) 19 Mar Dec 2012 trans -2-Methyl-2-butenal 4 Jan Jan 2011(fin) 21 Apr Nov 2011 (fin) 19 Mar Dec 2012 Pyrrole 4 Jan Jan 2011(fin) 31 Mar May 2011(fin) 8 Aug Dec 2011 (3-Amino-3- carboxypropyl)dimethylsulfonium 17 Feb Feb 2011(fin) 12 May Nov 2011 (fin) 19 Mar Dec 2012 chloride Ammonium isovalerate 3 Mar Apr May Nov 2012(fin.) 18 Feb Feb Nov Dec 2014 β-apo-8 -carotenal 19 Apr 2011 Carmine 19 Apr 2011 Canthaxanthin 19 Apr Mar Jul May Jun Jul Aug 2013(fin.) 26 Jul Aug May 2012 (under consideration) 27 Mar Jul Aug Sep Oct Nov Dec Jun 2014(fin) 25 Nov Nov Jun Oct Sep Nov Feb

22 Substance name Request for evaluation Food Safety Commission Evaluation by Discussion by expert committee 1 Notification of result 2 subcommittee 3 MHLW Closing date for comments 4 Date of designation as food additives Sodium aluminium phosphate,acidic 19 Apr 2011 Calcium acetate 19 Apr 2011 Calcium oxide 19 Apr 2011 Potassium sulfate 19 Apr May May Jun Jul Aug 2013 (under consideration) 24 Apr Nov Dec Jan 2013(fin) 24 Apr Nov Dec Jan 2013(fin) 24 Apr Sep Oct 2012(fin.) 15 Apr Mar Jun Dec Apr Mar Jun Oct Jan Dec Mar May 2013 Triethyl citrate 19 Apr 2011 Isopropanol 2,3-Diethylpyrazine 12 Feb May Dec Jan Feb Sep Oct 2014(fin.) 19 Apr Nov Dec 2011(fin) 29 Mar May May Mar May 2014(fin) 17 Feb Dec Mar May Oct Dec Aug Jun Oct Nov Methylnaphthalene 5 Nov Dec Jan Feb 2015(fin.) 24 Apr 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 22