, THE 132nd 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: Friday, June 26, 2009

10;30-12;00

Place: Ministry ofHealth, Labour and Welfare Building

Temporary Meeting Room No.4

Address: 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo

Agenda:

1. Establishment of Maximum Residue Limits for Agricultural Chemicals

CAcequinocyl, Imidacloprid, Tefuryltrione, Novaluron, EPN, Oxaziclomefone,

Diclocymet, Fenoxanil, Ferimzone and Pretilachlor} in Food

2_ Revision of the Standards for Use of Food Additive (Sodium Chlorite)

3. Miscellaneous

The Ministry of Health, Labour and Welfare (MHLW) will revise the existing

standards, specifications for food as shown in the following pages. Please provide

comments on proposed agendas by Friday. July 10, 2009. After the given date,' all

comments should he directed to the enquiry point in accordance with the WTO/SPS

Agreement.

<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, 100-8916

Tel: 03-5253-1] 11

Fax: 03-3501-4868

Agenda 1

Mr. K. OGl (ogi-katsuhiro@mhlw.go.jp)

Mr. T. KUDOU(kudou·toshiaki@mhlw.go.jp)

Ms.A. NAKATA (nakata'ayumi@mhlw.go.jp)

Mr. H. WATANABE (watanabe'hidemi@mhlw.go.jp)

Tel. ex. 4273, 2486, 2487,4281

Agenda 2

Ms. M, ISOZAKI (;sozaki'makiko@mhlw.go.jp)

Mr. T. GOTOU (gotou·takashi@mhlw.go.jp)

Dr. M. YAMATE (yamate'masanobU@mhlw.go.jp)

Tel. ex. 4282,2453

Agenda 1. Establishment of Maximum Residue Limits for Agricultural

Chemicals in Food

Purpose and Background

The Ministry of Health, Labour and Welfare (MHLW) IS going to develop the

compositional specification for food.

Under the provisions of Article 11, Paragraph I of the Food Sanitation Law, the

MHLW is authorized to establish residue standards (maximum residue limits:

MRLs) for pesticides, feed additives, and veterinary drugs (hereafter referred to as

just "agricultural chemicals") that may remain in foods. Any food for which

standards are established pursuant to the provisions is not permitted to be

marketed in Japan unless such food complies with the established standards.

On May 29, 2006, the MHLW introduced the positive list system for agricultural

chemicals in food. * Basically, all foods distributed in the Japanese marketplace are

subject to regulation based on the system.

This time the MHLW has newly established MRLs (draft) for some food

commodities as well as has comprehensively reviewed the current MRLs. This

activity is targeted to ten pesticides: Acequinocyl, lmidacloprid, Tefuryltrione,

Novaluron, EPN, Oxaziclomefone, Diclocymet, Fenoxanil, Ferirnzone and

Pretilachlor. Details are given below.

Note: The positive h'st system was estabh'shed based on the 2003 amendment olthe

Food Sam'tation Law. The system aims to prohibit the distribution olany food in the

Japanese marketplace ifit contains agricultural chemicals at amounts exceeding a

certain level (0.01 ppm) specified under the Law.

-Outline of revision

Acequinocyl <acaricide}

This chemical is already permitted for use in Japan. An application has been filed

by the Korean Government with the MHLW for the establishment ofMRLs for the

chemical, based on the Guideline for Application for Establishment and Revision of

Maximum Residue Limits for Agricultural Chemicals Used outside Japan,

published on 5 February 2004. In response to the application, the MHLW has newly

established MRLs (draft) for some crops and comprehensively reviewed the existing

:MRLs. For draft MRLs, see Attachments 1-1.

The MHLW already explained in the previous FSG meeting about the setting of

MRLs for crops for which the use of this pesticide was newly permitted.

Imidacloprid I:i.nBecticide)

This chemical is already permitted for use in Japan. This time the Ministry of

Agriculture, Forestry and Fisheries (MAFF) will expand the scope of target crops for

which the use of the chemical is permitted. Also, an application has been filed by a

foreign business with the MHLW for the establishment of MRLs for this. chemical,

based on the Guideline for Application for Establishment and Revision of Maximum

Residue Limits for Agricultural Chemicals Used outside Japan, published on 5

February 2004. In response to the MAFF's action and the manufacture's application,

the MHLW has newly established MRLs (draft) for some crops and comprehensively

reviewed the existing MRLs. For draft MRLs, see Attachments 1-2.

Tefmyltrione (herbicide)

This chemical is not permitted for use in Japan. This time MAFF has decided to

approve the chemical based on the Agricultural Chemicals Regulation Law. In

response to the MAFF's action, the MHLW has newly established MRLs (draft) for

some crops. Currently, MRLs are not set for any crops. For draft MRLs, see

Attachments 1"3.

Novaluron Gnsecticide)

This chemical is already permitted for use in Japan. This time MAFF will expand

the scope of target crops for which the use of the chemical is permitted. Also, an

application has been filed by the Korean Government with the MHLW for the

establishment of MRLs for the chemical, based on the Guideline for Application for . Establishment and Revision of Maximum Residue Limits for Agricultural Chemicals

Used outside Japan, published on 5 February 2004. In response t<HJIte- MAFFs action

and the Korean application, the MHLW has newly established MRLs (draft) for some

crops and comprehensively reviewed the existing MRLs. For draft MRLs, see

Attachments 1-4.

EPN Uneecticid&)

This chemical is already permitted for use in Japan. This time MAFF will expand

the scope of target crops for which the use of the chemical is permitted. In response

to the MAFF's action, the MHLW has newly established MRLs (draft) for some crops.

In addition, the MHLW has newly established an MRL (draft) for the "aquatic animals"

category. For draft MRLs, see Attachments 1-5.

Oxaziclomefone <herbicide), Diclocymet (fungicide), Fenoxanil (fungicide), Ferimzone

(fungicide), and Pretilachlor <herbicide}

These chemicals are already permitted for use in Japan. The MHLW has newly

established an MRL (draft) for the "aquatic animals" category and also reviewed the

existing MRLs. For draft MRLs, see Attachments 1-6, 1'7, 1'8, 1-9 and l-lD.

The existing MRLs for Acequinocyl, Imidacloprid, Oxaziclomefone, and Ferimzone

appear in either of the MRLs List (the Item 6, Section A "General Compositional

Standards for Food," Part I "Food" of the Specifications and Standards for Food,

Food Additives, Etc.) or Provisional MRLs List (Item 7, Section N, according to food

commodities. These MRLs have been modified as necessary. Finalized MRLs will be

placed on the MRLs List in Item 6, and the MRLs currently placed in Item 7 will be

deleted.

-

Attachment 1-1

Aceauinocvl (acaricidel

MRL Current Commodrty (draft) MRL

oom oom Rice (brown rice) 0.02 Wheat 0.02 Ba~ey 0.02 Rve 0.02 Com (maiZe) 0.02 Buckwheat 0.02 IOther cereal grains'

. ­ _ •... _-­

0.02 Soybeans, dry - O~~ B"an~ <in? 0.5 .oc.o~

~ 0.02

Broad beans 0.02

pea~,uts, dry 0.0"2 , I n"I~..~' 002

Potato 0.02 Taro 0.02 Sweet potato 0.02 Yam 0.2 0.02 Koniac 0.02 Other • 0.02 Sugar beet 0.02 SUQarcane 0.02 Japanese radish, roots (including radish) 0.02 Japanese radish, leaves (including radish) 0.02 Turnip, roots 0.02 Turnip, leaves 0.02 Horseradish 0.02 Watercress 0.02 Chinese cabbage 0.02 CabbaQe 0.02 Brussels sprouts 0.02 Kale 0.02 Komatsuna, Japanese mustard spinach 0.02 Kyona 0.02 QinQ-QenQ-ali 0.02 cauliflower 0.02 Broccoli 0.02 I~." ... 5 0.02 Burdock 0.02 Salsify - - 0.02 Artichoke 0.02 Chicory 0.02 Endive 0.02 §i!.ungiku 0.02 Lettuce (inclUding cos lettuce and leaf lettuce) 0.02 nth.., 6 0.02

------

AceQuinocyl (Continued)

Commodity

Onion Welsh (including leek) -Garlic Nira~___________0~spara~

Multiplying onion (including shallot). lather lili v"n"t"bl"o7

Carrot -----------------.P~rsni.P..._________0____ Pars~

-

~ Mitsuba nth", "mh"lIjf"",,,. • ~ato Pimiento (sweet pepper) ~Iant Oth"r ",. 9

Cucumber (including gherkin) Pumpkin (including squash) ~ntal pickling melon (vegetable) -¥¥ater melon Melons Makuwauri melon nth", ~,,~, '0 Spinach Bamboo shoots Okra trnnger Peas, immature (wnh pods) Kidney beans, immature (with pods) Green soybeans Button mushroom Shiitake mushroom

IOther "" 11

Inth", ' 12

Unshu orange, pulp C~rus natsudaidai, whole lemon . Orange (including navel orange) Grapefruit

~:r ,,~rus fru~s13

_--­

~-Japanese pear Pear Q'U1nce Loouat

MRL Current (draft) MRL ppm ppm

002 0.02--0:02 0.02

____________ 0.02 ________0_­

1---- f-----O:­. __ 02f---­

0.02

--1-~2 002 ------ ._--- ----__0­

-- ----f--­ ~~ Oo.~ 0002_.­ '---­0.02

1 00021---­

1 1 1.0 1 0.5 0.5 005 1 007 1 0.1 001

0.10.1 0.10.1

0.7 1 0.02 O~ 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02

10.7 0.2 0.2

2 2 1 1 2 2

-2 - 2 2 2 1 1 1 1 1 2 1 2

20.4 0.4 0.1

Aceouinocvl (Continued)

Commodny MRL

(draft) Dom

0.1Peach Nectarine 1

0.7 Apricot Japanese plum (including prune) Mume plum Cherry 2 Strawberry 2

0.5

Raspberry Blackberry Blueberrv

..

Cranberrv-Huckleberry Inlh'" ~o";o."

Grape Japanese persimmon

1

0.5

Banana Kiwifrun Papava Avocado .. Pineapple Guava Mango Passion frun .

2

0.02

Date 10th", fnlil" I. Sunflower seeds Sesame seeds Safflower seeds Cottonseeds Rapeseeds Oth.., nil " ....ti"1.

Ginkgo nut Chestnut Pecan 0.02 Almand 0.02 Walnut 0.02 Oth", nlll"17 0.02 Tea • 40

-5

10

Coffee beans Cacao beans HOD Oth.., oni".." t. Inlh'" h"rh",.

Current MRL ppm

0.1 2 2 1 2._--= 2 2

'---0­2 2 2 2 2 2

0.5 2 2

0.1 2 2 2 2 2 2 2 2

0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02

50

-0.02 0.02 0.02

2 1

Aceouinocvl (Continued)

MRL Current Commodity (draft) MRL

ppm ppm Cattle, muscle

IOthAr' '0 ~".~I~

~,fat Other terrestrial mammals, fat

..

0.02 0.02

O.Q;1 0.02 0.02 0.02

Cattle, liver Other terrestrial mammals, liver

... 0.02 0.02

--.<lcO~ 0.02

Cattle, kidney Other temestrial mammals, kidney

.. _.~ 0.02

Cattle ed ible offal" Other terrestrial mammals edible offal

.- . ._-­ 0.02 ~---'"",,

0.02

The unifonn limit (0.01 ppm) is applied to commodities for which draft MRls are not given.

'The MRLs for acequinocyl are established for the sum of residues of acequinocyl and hydroxyl acequinocyl (3-dodecyl·2-hydroxy-1 ,4·naphlhoquinone), calculated as acequinocyl.

Attachment 1-2, Imidacroplid(insecticide1

MRL Commodity (draft)

oom Rice (brown rice) 1 Wheat 0.05 Barley 0.05 Rye 0.05 Corn (maize) 0.05 Buckwheat 0.05 Other cereal arains1 0.05 Soybeans, dry 2.5 Beans dnl 2.8 Peas 2.8 Broad beans 2.8 Peanuts, dry 0.7 Other leournes I oulses' 2.8 Pota1o 0.5 Taro 0.4 Sweet potato 0.4 Yam 0.4 Konjac 0.4 Other notatoes' 0.4 Sugar beet 0.4 Sugarcane 0.04 Japanese radish, roots (including radish) 0.4 Japanese radish, leaves (includina radish) 3.5 Turnip, roots 0.4 Turnip, leaves 2.8 Horseradish 0.4 Watercress 2.5 Chinese cabbage 0.5 Cabbage 0.5 Brussels sprouts 0.5 Kale 5 Komatsuna, Japanese mustard spinach 5 Kyona 5 Qing-geng-cai 5 Cauliflower 0.4 Broccoli . 5 Other cruciferous veoetables' 5 Burdock e.4 Salsify 0.4 Artichoke 1.8 Chicory 2.8 Endive 5 Shungiku 2.5 Lettuce (including cos lettuce and leaf lettuce) 2.5 IOther nA' b1A"· 5

Current MRL oom

0.2 0.05 0.05 0.05

0.1 0.05 0.05

1 4 1 1 1 1

0.5 0.1 0.1 0.1 0.1 0.1

0.05 0.05

0.1 5

0.1 5

0.1 5

0.5 0.5 0.5

5 5 5 5 5 5 5 - 0.1

0.1 5 5 5 5 5 5

Imidacroplid(Continued)

MRL Current Commodity (draft) MRL

ppm ppm Onion 0.07 O,! Weish (including leek) 0.7 1 Nira 1 5 Asparagus 0.7 5 Multiplying onion (including shallot) ...­ f-. 2 5 IOther .. 7 5 Carrot 0.4 ..~ Parsnip 0.4 0.1 Parsley .. 3 5_._­Celery 4.2 5 Mitsuba 5 5 Other umbelliferous veaetables' 4.2 5 Tomato 2 1 fpj;:;;;"ento (sweet pepper) 3 3 Egg plant 0.5 0.5 other solanaceous veaetables· 5 5 Cucumber (including gherkin) 1 1 fumpkin (including squash) 1 .----.1 Oriental pickling melon (vegetable) 1 1 Watermelon 0.5 05 Melons 0.35 0.2 Makuwauri melon 0.35 0.5 Other cuc"rhitacPnus venetable~I. 1 1 ~pinach 2.5 5 Bamboo shoots 0.1 Okra 0.7 5 Ginger 0.3 0.1 Peas, immature (with pods) 3.5 0.5 Kidney beans, immature (with pods) 2.8 2 Green soybeans 2.5 0.5 l3utton mushroom 0.5 Shiitake mushroom 0.5 Other mU~hrnnm~" 0.5 Other veaetables12 5 5 Unshu orange, pulp 0.3 1 Cnrus natsudaidai, whole 0.7 1 Lemon 0.7 1 Orange (including navel orange) 0.7 1 Grapefrun 0.7 1 Lime 0.7 1 Other cnrus fru~s 13 0.7 3 Apple 0.5 0.5 Japanese pear 0.7 1 Pear 0.7 1 Quincett;QUai

0.5 0.5

1 0.5

, Imidacroplid(Continuedl

Commodity MRL

(draft) ppm

0.5

Current MRL ppm

Peach 0.5 1 1

0.2 3 3 3 3 3 3 3 3 3 3 1

0.05 0.5

1 1 1 1 1 3 3 3

0.02 0.05

3 0.05

2 0.1 0.1

0.05 0.1 0.1 0.1 10

. 0.05

10 5 5

Nectarine 2.1 Apricot 2.1 Japanese plum (including prune) 2.1 Mume plum 0.3 Cherry 2.1 Strawberry 0.5 Raspberry 3.5 Blackberry 35 Blueberry 3.5 Cranberry 0.04 Huckleberry 3.5 Other berries,. 3.5 Grape 3

1 0.04

Japanese persimmon Banana Kiwifrutt 0.2 Papaya 0.7 Avocado 0.7 Pineapple

0.7Guava Mango 1

0.7Passion frutt Date

3.5Other frutts15

Sunflower seeds 0.04 Safflower seeds. 0.04 Cotton seeds 4.2 Rapeseeds 0.04 Other oil seeds,. 0.04 Ginkgo nut 0.05 Chestnut 0.05 Pecan 0.04 Almond 0.04 Walnut 0.04 other nuts17 0.04 Tea 10 Coffee beans 0.7 Cacao beans --,,:'1)5 Hop 7

5 5

Other spices,. OthAr herbs,.

Imidacroplid(Continued)

Current Commodity

MRL (draft) MRL oom oom

Callie, muscle 0.020.1 Pig, muscle 0.1 0.02

0.1 0.02Other terrestrial mammals'o muscle Callie, fat 0.02 0.3 Pig, fat 0.02 0.3 Other terrestrial mammals, fat 0.02 0.3 Callie, liver 0.2 0.05 PiQ, liver 0.2 0.05 Other terrestrial mammals, liver 0.2 0.05 Callie, kidney 0.050.2 -Pia, kidney 0.2 0.05 Other terrestrial mammals, kidney 0.2 0.05

0.2 005Callie, edible offal" Pig, edible offal 0.2 005 Other terrestrial mammals, edible offal 0.2 0.05 Milk 0.1 0.02 Chicken, muscle 0.02 0.02 Other oouKrv animals", muscle 0.020.02 Chicken, fat 0.02 0.05 Other oouKrv animals, fat 002 0.05 Chicken, liver 0.1 0.02 Other pouttrv animals liver 0.1 0.02 Chicken, kidney 0.1 0.02 Other oouttrv animals, kidnev 0.1 0.02 Chicken, edible offal 0.020.1 Other pouKrv animals edible offal 0.020.1 Chicken, egg 0.02 0.02 Other pouKrv animals, eQa 0.02 0.02 Wheat flour (except whole Qrainl 0.02 0.03 Wheat bran 0.2 0.3 Pepper, dried 7

The unnorm limit (0.01 ppm) is applied to commodities for which draft MRLs are not given.

MRLs for imidacloprid are established for the sum of residues of imidacloprid and its metaboliles containing the &chloropyridinyl moiety, all calculated as imidadoprid on animal products, and for the sum of for the residue of imidadoprid alone on other foods.

Attachment 1-3 . , Tefury~rione (herbicide)

MRL Current Commodity (draft) MRL

ppm ppm Rice (brown rice) 0.02

The uniform limij (0.01 ppm) is applied to commodities (Of which draft MRls are not given.

-

Attachment 1-4 , Novaluron (insecticide)

Commodity MRL

(draft) nnm

Current MRL nnm

Potato 0.05 0.05 Taro 0.05 0.05 Sweet potato 0.05 0.05 Yam 0.05 0.05

Other potatoes4 0.05 0.05 Sugar beet 0.05 0.05 Cabbage 1 1

Other comoosite veoetables· 1 Tomato 2 2 Pimiento (sweet pepper) - 0.7 0.7 Egg plant 0.5 0.5

Other solanaceous veoetables' 0.7

Other cucurbitaceous veaetables '0 0.05 0.05 Ginger 0.05 0.05 Green soybeans 0.01 0,01

Other veaetables12 0.05 0.05 Apple 3 3 Japanese pear 3 3 Pear 3 3 Quince 3 3 Loauat 3 3 Strawberry . 2 2 Cotton seeds 1 1 Other soices,. 0.05 0.05 Other herbs,. 0.05 0.05 Cattle, muscle 0.7 0.7 PiQ, muscle 0.7 0.7

Other terrestrial mammals20 muscle 0.7 0.7 Cattle, fat 10 10 Pia, fat 10 10 Other terrestrial mammals, fat 10 10 Cattle, liver 0.7 0.7 Pig, liver 0.7 0.7 Other terrestrial mammals, liver 0.7 0.7 Cattle, kidney 0.7 0.7 Pig, kidney 0.7 0.7 Other terrestrial mammals, kidneY 0.7 0.7

Cattle edible offal21 lJ.7 0.7 Pia, edible offal 0.7 0.7 Other terrestrial mammals, edible offal 0.7 0.7 Milk 0.4 0.4 Chicken, muscle 0.01 0.01 Other pouttrv animals22

, muscle 0.01 0.01 Ch ieken, fat 0.01 0.01 Other pouttrv animals, fat' 0.01 0.01

Novaluron (Continued) ,

Commodity MRl

(draft) oom

Current MRl oom

Chicken, liver 0.01 0.01 Other pou~rv animals liver 0.01 . 0.01 Chicken, kidney 0.01 0.01 Other pouttrv animals, kidney 0.01 0.01 Chicken, edible offal 0.01 0.01 Other pou~rv animals, edible offal 0.01 0.01 Chicken, egg 0.01 0.01 Other pou~rv animals, elUI 0.01 0.01

The unifonn lim~ (0.01 ppm) is applied to commodities for which draft MRLs are not given.

-

Attachment 1-5

EPN ~nseclicide\

Commodrty MRL

(draft) ppm

Current MRL ppm

Rice (brown rice) 0.02 0.1 Wheat 0.2 0.2 Sweet potato 0.05 Cabballe 0.1 0.1 Cauliflower 0.02 0.1 Broccoli 0.1 0.1 Welsh (includinll leek) 0.1 0.1 Tomato 0.1 Pimiento (sweet pepper) 0.1 Eaa plant 0.1 Cucumber (including gherkin) 0.1 Pumpkin iincludina sauash) 0.2 0.2 Watermelon 0.02 0.1 Melons 0.02 0.1 Ginaer 0.1 0.1 Aquatic animals 0.3

The unifonn limil (0.01 ppm) is applied 10 commodities for which draft MRLs are not given.

Attachment 1-6 , Oxaziclomefone (herbicide)

MRL Current Commodity (draft) MRL

ppm oom Rice (brown rice) 0.05 0.1 Wheat 0.02 Barlev 0.02 Rye 0.02 Com (maize) 0.02 Buckwheat 0.02 Other r",,,,,1 n",lno 1 0.02 Soybeans, dry 002 R""n~ rl.,} 0.02 Peas 0.02 Broad beans 0.02 Peanuts, dry 0.02 10th", ./ nul~,,~3 0.02 Potato 0.02 Taro 0.02 Sweet potato 0.02 Yam 0.02 Konjac 0.02 Inth." • 0.02 Sugar beet 0.02 Sugarcane 0.02 Japanese radish, roots fincludina radish) 0.02 Japanese radish, leaves (including radish) 0.02 Tumip, roots 0.02 TumiD, leaves 0.02 Horseradish 0.02 Watercress 0.02 Chinese cabbage 0.02 Cabbage 0.02 Brussels sprouts 0.02 Kale 0.02 Komalsuna. Japanese mustard spinach 0.02 Kyona 0.02 Qinll-Qenll-cai 0.02 Cauliflower 0.02 Broccoli 0.02 nth", .~

, 5 0.02 Burdock 0.02 Salsify - . 0.02 Artichoke 0.02 Chicory 0.02 Endive 0.02 Shunaiku 0.02 Lettuce (including cos lettuce and leaf lettuce) 0.02 nth", , • 0.02

Oxaziclomefone (Continuedt

MRL Current (draft) MRLCommodity oom oom

Onion 0.02 Welsh (including leek) 0.02 Ga~ic 0.02 Nira 0.02 Asparagus 0.02 Multiolyino onion (includino shallot) 0.02

0.02Other I·· y 7

Carrot 0.02 Parsnip 0.02 Parsley 0.02 Celerv 0.02 Mitsuba 0.02 ,

,,~ 0.02nih." Tomato 0.02 Pimiento (sweet pepper) 0.02 Eoo plant 0.02

9 0.02Other Cucumber (includino oher1<in) 0.02 Pumpkin (including squash) 0.02 Oriental pickling melon (veoetable) 0.02 Watermelon 0.02 Melons 0.02 Makuwauri melon 0.02

10 0.0210th", Spinach 0.02 Bamboo shoots 0.02 Okra 0.02 Ginoer 0.02 Peas, immature (with pods) 0.02 Kidney beans, immature (w~h Pods) 0.02 Green soYbeans 0.02 Button mushroom 0.02 Shiitake mushroom 0.02

11 0.02IOther I

12 0.02 Unshu orange, pulp 0.02 C~rus natsudaidai, whole 0.02 Lemon 0.02 Orange (including nayel orange) 0.02 Grapefru~ 0.02 Lime 0.02 nth." ,,~nl" fTII~,,13 0.02 ADDie 0.02 Japanese pear 0.02 Pear 0.02 Quince 0.02

0.02LOQuat

Oxaziclomefone (Continued)

MRL Current Commodity (draft) MRL

ppm ppm Peach 0.02 Nectarine 0.02 Apricot 0.02 Japanese plum (including prune) 0.02 Mume plum 0.02 Cherry 0.02 ~wberry 0.02 Raspberry 0.02 Blackberry 0.02 Blueberry 0.02 Cranberry 0.02 Huckleberry 0.02 nth", •• 0.02 Grape 0.02 Japanese persimmon 0.02 Banana 0.02 Kiwifruit 0.02 Papaya 0.02 Avocado 0.02 Pineapple 0.02 Guava 0.02 Mango 0.02 Passion fruit 0.02 Dale 0.02 IOthe, fruils'· 0.02 Sunflower seeds 0.02 Sesame seeds 0.02 Safflower seeds 0.02 Colton seeds 0.02 Rapeseeds 0.02 Oth", nil s""rls'· 0.02 Ginkgo nut 0.02 Chestnut 0.02 Pecan 0.02 Almond 0.02 Walnut 0.02 nih.... nuts17 0.02 Tea

, 0.02 Coffee beans 0.02 Cacao beans - - 0.02 Hop 0.02

0.02Oth", sni,....s1.

IOther herbs'· 0.02 IAQuatic animals 0.03

.

The uniform limit (0.01 ppm) is applied to commodities for which draft MRLs are not given.

Attachment 1-7 ,Diclocymet (funoicide)

Commodity MRL

(draft) oom

Current MRL oom

Rice (brown rice) 0.5 0.5 Aquatic animals 0.03

The uniform limij (0.01 ppm) is applied to commodities for which draft MRLs are not given.

-

Attachment 1-8 , Fenoxanil (funQicide)

MRL Current Commodity (draft) MRL

oom oom Rice (brown rice) 1 1 AQ ualic animals 0.2

The uniform limit (0.01 ppm) is applied to commodities for which draft MRLs are not given.

-

Attachment 1-9 , Ferimzone (funaicide)

Commodity MRL

(draft) ppm

Current MRL ppm

Rice (brown riceI 1 1 Aquatic animals 0.5

The un"onn limit (0.01 ppm) is applied to commodities (or which draft MRLs are not given.

MRLs for ferimzone are established for the sum of residues of (E}-ferimzone and (Z)­ferirnzone.

-

Attachment 1-10

Pretilachlor (herbicide)

Commodity MRL

(draft) ppm

Current MRL ppm

Rice (brown rice) 0.03 0.1 Aquatic animals 0.3

The uniform limit (0.01 ppm) is applied to commodities for which draft MRls are not given.

-

- -

Note:

1. "Other cereal grains· refers to all cereal grains, except rice (brown rice), wheat,' ,barley, rye, corn (maize), and buckwheat.

2. "Beans (dry)" includes butter beans, cowbeans (red beans), lentil, lima beans,

pegia, sultani, sultapya, and white beans.

3. "Other legumes/pulses· refers to all legumes/pulses, except soybeans (dry),

beans (dry), peas, broad beans, peanuts (dry), and spices.

4. "Other potatoes· refers to all potatoes, except potato, taro, sweet potato, yam,

and konjac.

5. "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.

6. "Other composite vegetables' refers to all composite vegetables, except burdock,

salsify, artichoke, chicory, endive, shungiku, lettuce (including cos lettuce and leaf

lettuce), and herbs.

7. "Other Iiliaceous vegetables· refers to all liIiaceous vegetables, except onion,

welsh (including leek), garlic, nira, asparagus, multiplying onion, and herbs.

8. "Other umbelliferous vegetables' refers to all umbelliferous vegetables, except

carrot, parsnip, parsley, celery, mitsuba, spices, and herbs.

9. "Other solanaceous vegetables' refers to all solanaceous vegetables, except

tomato, pimiento (sweet pepper), and egg plant.

10. "Other cucurbitaceous vegetables' refers to all cucurbitaceous vegetables,

except cucumber (including gherkin), pumpkin (including squash), oriental pickling

melon (vegetable), watermelon, melons, and makuwaun·melon.

11. ·Other mushrooms· refers to all mushrooms, except button mushroom, and

shiitake mushroom.

12. "Other vegetables' refers to all vegetables, except potatoes, sugar beet,

sugarcane,' cruciferous vegetables, cOmposite vegetables, liIiaceous 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.

13. "Other citrus fruits" refers to all citrus fruits, except unshu orange (pulp), citrus

natsudaidai (pulp), citrus natsudaidai (peel), citrusnatsudaidai (whole), lemon,

orange (including navel orange), grapefruit, lime, and spices.

14. "Other berries" refers to all berries, except strawberry, raspberry, blackberry,

blueberry, cranberry, and huckleberry.

15. "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.

16. "Other oil seeds" refers to all oil seeds, except sunflower seeds, sesame seeds,

safflower seeds, cotton seeds, rapeseeds and spices.

17. "Other nuts" refers to all nuts, except ginkgo nut, chestnut, pecan, almond and

walnut.

18. "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.

19. "Other herbs" refers to all herbs, except watercress, nira, parsley stems and

leaves, celery stems and leaves.

20. "Other terrestrial mammals" refers to all terrestrial mammals, except cattle and

pig.

21. "Edible offal" refers to all edible parts, except muscle, fat, liver, and kidney.

22. "Other poultry" refers to all poultry, except chicken.

Agenda 2. Revision of the Standards for Use of Food Additive

Purpose and background

The Minister of Health, Labour and Welfare is going to partially revise the standards

for use of Sodium Chlorite.

Under Article 10 of the Food Sanitation Law, food additives can be used or marketed

only when they are designated by the Minister of Health, Labour and Welfare. When

use standards or compositional specifications are established for food additives based

on Article 11 of the law, those additives are not permitted to be used or marketed

unless they meet these standards or specifications.

Sodium Chlorite was designated as a food additive in 1963. This additive is usually

used as a sterilizer or bleaching agent. The use standards were revised once in 2005.

This time an application was filed with the Minister of Health, Labour and Welfare,

asking for the partial revision of the use standards for Sodium Chlorite. The Minister

asked the Pharmaceutical Affairs and Food Sanitation Council to discuss the adequacy

of the revision of the standards. In response to the request from the Minister, the

Subcommittee on Food Additives of the Food Sanitation Committee conducted

discussions and concluded as follows.

Outline of conclusion

The Minister should partially revise tbe standards for use of Sodium Chlorite based on

Article 11 of the Food Sanitation Law (see Attachments 2-1).

Additional Information

Progress in the designation procedure of food additives that have been proven safe by

JECFA (Joint FAOIWHO Expert Committee on Food Additives) and that are widely

used in countries other than Japan <Attachment 2-2) _

Attachment 2-1

Partial Revision of Standatds for Use of FoodAdditive (Sodium Chlorite)

Current standards

Cherries.

0.50 glkg of dipping liquid

Citrus peels for confections.

Eggs (for shells).

Fuki (Japanese butterbur)

Grapes.

Peaches.

Seasnned hpmoko It (herring roes> (excluding salted products).

Vegetables for raw consumption.

Shall be decomposed or removed before the pre­paration of the final food.

* excluding dried kazunoko and frozen kazunoko

Revised

The scope of the use will be extended and the additive will be also allowed to be used in

salted kazunoko. The food category "seasoned kazunokd' will be changed to "processed

kszunoko." Dried kazunokoand frozen kszunokoare excluded from the application.

Progress of evaluation of food additives that have been proven safe and are widely used in the world Attachment 2-2 Jun 2009

Food Safety Commission MHLWRequest forSubstance name

Evaluation byevaluation Discuseion by Closing date Date of designationNotification of result:! .L 3expert committee1

for • ae food additives .. Isobutanol 24 Mar 2004(fin.) 27 May 2004 23 Apr 2004(fin.) 19 Aug 2004 24 Dec 2004

2"ethyl-3, (5 or 6)- dimethylpyrazine 21 Nov 2003 3 Mar 2004(fin.) 27 May 2004 8 Apr 2004(fin.) 26 Jut 2004 24 Dec 2004 2,3,5,6-tetramethylpyrazine 3 Mar 2004(fin.) 27 May 2004 8 Apr 2004(fin.) 26 Jut 2004 24 Dec 2004 Calcium stearate 4 Mar 2004 20 May 2004(fin.) 29 Jut 2004 24 Jun 2004(fin.) 21 Oct 2004 24 Dec 2004

'.','i," , - 24 Mar 2004

Propanol 21 Nov 2003 20 May 2004 9 Sep 2004 26 Aug 2004(fin.) 14 Dec 2004 24 Feb 2005 28 Jul 2005(fin.) 17 Dec 2003 20 Oct 2003 Nitrous oxide 17 Dec 2004(fin.) 9 Dec 2004 19 Feb 2005 22 Mar 20055 Oct 2004(fin.) ... .. 24 Mar 2004 . 9 Apr 200415 Dec 2003 Isopropanol 9 Dec 2004 28 Oct 2004(fin.) 4 Mar 2005 28 Apr 20058 Sep 2004

, 5 Oct 2004(fin.) gv,jrox~rnnvl cAllulse 16 Aug 2004 22 Dec 2004(fin.) 24 Feb 2005(fin.) 10 Mar 2005 14 Jun 2005 19 Aug 2005 Isoamylalcohol

5 Nov 2004 14 Jan 2005(fin.) 24 Feb 2005(fin.) 17 Mar 2005 14 Jun 2005 19 Aug 20052,3,5-trimethylpyrazine

Amylalcohol 9 Jan 2004

Natamycin 24 Mar 2005(fin.) 7 Sep 2005 20 Oct 2003 16 Nov 2004 6 May 2005 28 Nov 2005 26 Jan 2005(fin.)...;­ 3 Mar 2004 9 Apr 2004

Acetaldehyde 21 Jut 2005 23 Jut 2005(fin.) 16 May 2006 23 Feb 2005 13 Anr 2005(fin.)

2"Ethvl-3"methvlnvrazine

21 Nov 2003 27 Apr 2004 12 Oct 2005

18 Aug 2005 28 Jut 2005(fin.) 16 May 200614 Jut 2005(fin.) 19 Dec 2005 5"Methvlouinoxaline

7 Mar 2005 27 Oct 2005 14 Jun 2005 22 Sep 2005 26 Apr 2006 12 Sep 2006 Butanol I

24 Nov 2005(fin.)22 Jut 2005(fin.)

Ammonium allrinate 2 Dec 2005 23 Mar 2006(fin.) 5 Sep 2006 26 Dec 2006 30 Mar 200628 Mar 2005 Potassium alldnate 14 Dec 2005(1in.)

Calcium ahzinate ,. ,····h·.·"'<'

8 Dec 2006 14 Jut 2006 22 May 2007 3 Aug 200712 Oct 200619 Dec 2005 2-Methylbutanol 16 Jan 2007 (Fin.)11 Aug 2008(fin.)

,~,-,... " . ,~, ..,.-~,' ~

Substance name

,;,.,'.

Request ror evaluation

Food Safety Commission

Evaluation by Notification of ..eult'expert committee l

28 JUh2006

Discuss;.on by, MHLW

Closing date rtlr •

Date or designation as rood additives

Isobutyraldehyde

I

19 Dec 2005 14 Jul2006 11 Aug 2006 13 Sep 2006

7 Dec 2006 8 Dec 2006 16 Jan 2007 (Fin.) 22 May 2007 3 Aug 2007

13 Oct 2006(fin.l

Butyraldehyde 19 Dec 2005 19 Dec 2006 26 Jan 2oo7(fin.) 22 Mar 2007 20 Mar 2007(fin.) 27 Aug 2007 26 Oct 2007

29 Oot 2003

Polysorbate 20, 60, 65, 80 8 Oct 2003 27 Apr 2004 28 Jul 2004 7 Jun 2007 4 Jul 2007

9 Aug 2007(fin.) 16 Dec 2007 30 Apr 2008

23 Mar 2007(fin.) 28 Feb 2007

Calcium silicate 15 Aug 2005 23 Mar 2007 17 Apr 2007 26 Jul 2007 9 Aug 2007(fin.) 16 Dec 2007 30 Apr 2006

29 Mav 2007(fin.) 23 Mar 2007

Calcium ascorbate 300t2005 17 Apr 2007 29 May 2007 23 Aug 2007 9 Aug 2007(fin.) 16 Dec 2007 30 Apr 2008

22 Jun 2007(fin.)

Nisin 20 Oct 2003

9 Apr 2004 \6 Nov 2004 26 Jan 2005 30 Jul 2007 27 Au~ 2007(fin.)

31 Jan 2008

26 Sep 2007 24 Oct 2007 28 Feb 2008(fin.) 24 Sep 2008(fin.)

18 Jul 2008 2 Mar 2009

Acetvlat"d distarch adin.te Acetvlat.erl dist.rch nhtlsnhate Acetvlated oxidiz-d starch Starch sodium nctenvlsuccinate Hvdrnxvnronvl starch Hvdroxvnronvl distarch nhosj,hatA Phosnhated distarch nho.nh.l:e ~onostarchnho.nhate

26 Nov 2004

23 Mar 2005 t7 May 2005 27 Aug 2007 28 Sep 2007(fin.)

29 Nov 2007 28 Nov 2007(fin.) 4 Jul 2008(fin.) 29 May 2008 1 Oct 2008

Distarch nho.nhate Oxidized starch Starch

22 Jun 2007 ~gnesium hydroxide 9 Mar 2006 30 Jul 2007 I Nov 2007 24 Oct 2007(fin.) 7 Feb 2008 4 Jul 2008

27 Au" 2007(fin.)

•Food Safety Commission MHLWRequest forSubstance name

Evaluation byevaluation Discussion by Closing date Date of designationNotification of result2

3expert committee1 I 'no • as food additives

31 May 2006 2B Jun 2006 14 Jul 2006 11 Aug 2006Dimagnesium phosphate 2B Mar 2005 13 Sop 2006 13 Oct 2006 28 Nov 2006

under consideration) 13 Sep 2006 13 Oct 2006 28 Nov 2006

20 Jun 2005Polyvinylpyrrolidone 19 Dec 2006 26 Jan 2007

under consideration) 28 Feb 2007 . 23 Mar 2007

15 Aug 2005Magnesium silicate(synthetic) 17 Apr 2007 (under consideration)

28 Feb 2007 Sodium alminum silicate 15 Aug 2005

(under consideration) 28 Feb 2007 15 Aug 2005Calcium aluminum silicate

(under consideration) 27 Aug 2007 28 Sep 2007

22 May 2006Calcium saccharin 26 Oct 2007 under consideration)

22 Mav 2006 15 Jan 2008(fin.) 13 Mar 2008 11 ADr 200B (fin.) 10 Oct 2008 24 Mar 2008

Ammnnium L-"lutam.tp

4 Jul 200B(fin.)6 Feb 2007 10 Jul 200B . 1 Dec 2008Sodium stearoyl-2-lactylate 15 ADr 2008Ifin.) 17 Jun 2008

Potassium lactate 29 Sep 2008 I(under consideration)

26 Mar 200B Calcium sorbate I

6 Feb 2007

20 Nov 2008 25 Nov 200B(fin) 25 Apr 2009 29 Au£ 200S(fin.)

4 Jul 200B(fin.)

19 Mar 2007 17 Jun 2008

4 Jun 2009 f Feb 2008(fin.) 27 Mar 2008 1 Dec 2008 Isnv·1o••1.1ohvdp

19"Mar2007"V·' 4 Jun 2009

15 Apr 2008 27 Mar 2008 4 Jul 200B(fin.)1 Feb 2008(fin.) 1 Dec 2008 19 Msr 2007

24 Sop 2008(fin.) 31 Jul 20087 Feb 2008 2,3-Dimethylpyrazine 4 Jun 2009 15 Apr 2008

3 Feb 2009 26 Mav 2008(fin.l

24 Sop 2008(fin.l 31 Jul 20087 Feb 200B2,5-Dimethylpyrazine 4 Jun 2009 3 Feb 2009 26 Mav 2008Ifin.)

Food Safety Commission Substance name

2,6-DiJnethylpyrazine

2-Ethylpyrazine 2-Methvlnvrazine 2-Pentanol 2-Mp.thvlbutvral~ 0 ",,~,

Prooionaldehyde 6-Methylquinoline 2-Ethvl-6­6.6.7.8-Tetrahydroq H-Mp.thvl·2-but~nnl

Request for evaluation

7 Feb 2008

22 May 2008 22 Mav 2008 14 Oct 2008 14 Oct 2008 20 Nov 2008 20 Nov 2008 12 Mar 2009 12 Mar 2009 12 Mar 2009

Eval...tion by expert committee!

16 Apr 2008 26 Mav 2008(fin.)

29 Sep 2008(fin.) 29 Sep 2008(fin.) 11 Nov 2008(fin.) 11 Nov 2008(fin.) 2 Feb 2009(fin.) 23 Mar 2009(fin)

18 May 2009(fin.)

Noti1ication of r88ultll

31 Jul2oo8

27 Nov 2008 27 Nov 2008 22 Jan 2009 22 Jan 2009 2 Apr 2009

21 Mav 2009

Discussion by ,oi+... ­ _3

24 Sep 2008(fin.)I

22 Oct 2008(fin.) 22 Oct 2008(fin.)

28 Apr 2009 22 Dec 2008(fin.)

28 Apr 2009 28 Apr 2009

MHLW

Cloaing date I for ,--- ­ __ L_'

3 Feb 2009 25 Apr 2009 25 Apr 2009

29 Mav 2009

Date of designation as food additives

4 Jun 2009

·N~tJiT:.;::f>::';;:.:\~):>::{~:~;,~t5Lt:~j;{~~,~,t~I 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 WTD notification

I

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