Japan Japan Proposes Revision of MRLs for 8 Agricultural ...€¦ · MRL (draft) ppm MRL (current)...

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE

BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S.

GOVERNMENT POLICY

-

Date:

GAIN Report Number:

Post:

Report Categories:

Approved By:

Prepared By:

Report Highlights:

On Tuesday, February 27, 2018, Japan’s Ministry of Health, Labor and Welfare (MHLW)

announced revisions to Japan’s Maximum Residue Levels (MRLs) for the following agricultural

chemicals, veterinary drugs and a feed additive: Acephate, Amisulbrom, Cyazofamid,

Bicyclopyrone, Pyflubumide, Methamidophos, Dicyclanil and Semduramicin. Further, MHLW

proposes to designate Hydroxypropyl Distarch Phosphate as a substance having no potential to

cause damage to human health (equivalent to GRAS in the United States). Lastly, the

announcement summarizes proposed revisions to sanitary regulations for utensils, containers and

packaging. The Embassy comment period for these proposals is open until Tuesday, March 13,

2018. The proposed revisions that result in standards that are more strict will be notified to the

WTO after the comment period, which will provide another opportunity for interested parties to

comment on these proposed changes.

Keyword: JA8013

Tomohiro Kurai

Jess K. Paulson

Sanitary/Phytosanitary/Food Safety

Japan Proposes Revision of MRLs for 8 Agricultural

Chemicals

Tokyo

Japan

JA8013

3/1/2018

Internal Voluntary

General Information:

<The manner of submitting comments>

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

standards and specifications for food as shown in this document. Please provide

comments in writing by Tuesday, March 13, 2018. After the given date,

comments should be directed to the enquiry point in accordance with the

WTO/SPS Agreement.

With regard to agenda item 1, the SPS notification will be made for the setting or

revision of the MRL for the agricultural and veterinary chemicals except for

Amisulbrom, Cyazofamid, Bicyclopyrone, Pyflubumide and Dicyclanil for which

regulations will not be strengthened by this amendment.

If you wish to request Japan to adopt the same limits as your country’s MRLs,

you are requested to submit data supporting your country’s MRLs, such as risk

assessment and residue data.

<Contact person>

Food Safety Standards and Evaluation Division,

Pharmaceutical Safety and Environmental Health Bureau,

Ministry of Health, Labour and Welfare

1-2-2, Chiyoda-ku, Kasumigaseki, Tokyo, 100-8916

Pesticides/Veterinary drugs/Feed additives

Mr. Ryota NAKAMURA ([email protected])

Tel : 03-3595-2423 (ex 4289)

Fax: 03-3595-2432

Utensils, containers and packaging

Ms. Niwa and Mr. Matsushita ([email protected])

Tel : 03-3595-2341 (ex 2921 or 2487)

Fax: 03-3501-4868

mailto:[email protected]


Item 1. Establishment of the Maximum Residue Limits for Agricultural and

Veterinary Chemicals in Foods

The Food Sanitation Act authorizes the Ministry of Health, Labour and Welfare (MHLW)

to establish residue standards (maximum residue limits, “MRLs”) for pesticides, feed

additives, and veterinary drugs (hereafter referred to as “agricultural and veterinary

chemicals”) that may remain in foods. Any food for which standards are established

pursuant to the provisions in Article 11, Paragraph 1 of the act is not permitted to be

marketed in Japan unless it complies with the established standards.

On May 29, 2006, Japan introduced the Positive List System1 for agricultural and

veterinary chemicals in food. All foods distributed in the Japanese marketplace are

subject to regulation of the system.

The MHLW is going to modify or newly set MRLs in some commodities for the following

substances:

Pesticides: Acephate, Amisulbrom, Cyazofamid, Bicyclopyrone,

Pyflubumide, Methamidophos

Veterinary drugs: Dicyclanil

Veterinary drugs and Feed additives: Semduramicin

1 The aim of the positive list system is to prohibit the distribution of any foods which contain

agricultural chemicals at amounts exceeding a certain level (0.01 ppm) in the Japanese

marketplace unless specific maximum residue limits (MRLs) have been set.

Summary

Acephate (pesticide: insecticide): Permitted for use in Japan. The MHLW is going

to modify MRLs in some commodities that were provisionally set at the

introduction of the Positive List System.

Amisulbrom (pesticide: fungicide): Permitted for use in Japan. The MHLW is

going to establish MRLs in some commodities in response to a request for

setting MRLs by the Ministry of Agriculture, Forestry and Fisheries (MAFF)

with the intention to expand its use pattern. This action will not strengthen the

current regulation for any commodities.

Cyazofamid (pesticide: fungicide): Permitted for use in Japan. The MHLW is going

to establish MRLs in some commodities in response to a request for setting

MRLs by the MAFF with the intention to expand its use pattern and in

response to a request for setting import tolerances based on the Guideline for

Application for Establishment and Revision of Maximum Residue Limits for

Agricultural Chemicals Used outside Japan (Shokuan No. 0205001, 5 February

2004). This action will not strengthen the current regulation for any

commodities.

Bicyclopyrone (pesticide: herbicide): Not permitted for use in Japan. The MHLW

is going to establish MRLs in some commodities in response to a request for

setting import tolerances based on the Guideline for Application for

Establishment and Revision of Maximum Residue Limits for Agricultural

Chemicals Used outside Japan (Shokuan No. 0205001, 5 February 2004). This

action will not strengthen the current regulation for any commodities.

Pyflubumide (pesticide: miticide): Permitted for use in Japan. The MHLW is going

to establish MRLs in some commodities in response to a request for setting

MRLs by the MAFF with the intention to expand its use pattern. This action

will not strengthen the current regulation for any commodities.

Methamidophos (pesticide: insecticide): Not permitted for use in Japan. The

MHLW is going to modify MRLs in some commodities that were provisionally

set at the introduction of the Positive List System.

Dicyclanil (veterinary drug: insecticide): Not permitted for use in Japan. The

MHLW is going to modify MRLs in some commodities that were provisionally

set at the introduction of the Positive List System. This action will not

strengthen the current regulation for any commodities.

Semduramicin (veterinary drug and feed additive: antibiotic/coccidiostat):

Permitted for use in Japan as a feed additive. The MHLW is going to modify

MRLs in some commodities that were provisionally set at the introduction of

the Positive List System.

Acephate

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

Other spices, dried (except SANSHO

(Japanese pepper)) ※5

●

0.2

The residue definition is acephate only.

* The uniform limit 0.01 ppm will be applied to commodities for which draft MRLs are not given in this table and

to commodities not listed above.

* Shaded figures indicate provisional MRLs.

* Diagonal line means deletion of a food category to which an MRL applies.

* In the Commodity column, for the food categories to which the word other is added, refer to the Notes given

in the last two pages of the Attachment.

●：Commodities for which MRLs are to be lowered or deleted.

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

§：Permitted for use in Japan.

※1 For rice (brown rice), other oil seeds and milk in which the Codex has set MRLs, the dietary exposure of

acephate estimated by using the supervised trial median residue (STMR) of the supervised residue trials

submitted to the JMPR and national food consumption data of rice, other oilseeds and milk would exceed an

ADI of 0.0024 mg/kg/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has

decided maintain the current MRLs(i.e. the uniform limit of 0.01 ppm) in these commodities.

※2 For cabbage, other composite vegetables, tomato, ginger, other vegetables, other fruits in which the

Codex has set MRLs, the dietary exposure of acephate estimated by using the STMR of the supervised

residue trials submitted to the JMPR and national food consumption data of these commodities would exceed

an ADI of 0.0024 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the

MHLW has decided to set the MRLs for these commodities based on the residue data from the domestic

supervised residue trials.

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

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

“Other spices”.

※5 Food categories “Other spices, dried (except SANSHO (Japanese pepper))” will be deleted, hereafter,

MRLs in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed

commodities, taking into account their processing factors.

Amisulbrom

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

The residue definition is amisulbrom only.







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

Cyazofamid

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

Rice (brown rice) ○ 0.05 0.05 § Wheat ○ 0.05 0.05 § Soybeans, dry ○ 0.3 0.3 § Beans, dry ○ 0.1 0.1 § Potato ○ 0.05 0.05 § 0.01 Konjac ○ 0.3 0.3 § Japanese radish, roots (including radish) ○ 0.3 0.3 § Japanese radish, leaves (including radish) ○ 25 25 § 10 Turnip, roots (including rutabaga) ○ 0.3 0.3 § Turnip, leaves (including rutabaga) ○ 20 20 § 15 Watercress ○ 10 10 Chinese cabbage ○ 15 2 § 15 Cabbage ○ 2 0.7 § 1.5 Brussels sprouts ○ 2 1.5 Kale ○ 15 15 § 15 Komatsuna(Japanese mustard spinach) ○ 15 15 § 15 Kyona ○ 15 10 § 15 Qing-geng-cai ○ 15 3 § 15 Cauliflower ○ 2 Request 1.5 Broccoli ○ 2 1 § 1.5 Other cruciferous vegetables ○ 20 20 § 15 Chicory ○ 10 10 Endive ○ 10 10 Shungiku ○ 10 10 Lettuce (including cos lettuce and leaf lettuce) ○ 10 10 § 10 Other composite vegetables ○ 10 10 Onion ○ 2 0.05 §・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 ○ 0.09 0.09 0.09 USA

Mitsuba ○ 10 10 § Tomato ○ 2 2 § 0.2 Pimiento (sweet pepper) ○ 1 1 § 0.4 Egg plant ○ 0.5 0.5 § 0.2 Other solanaceous vegetables ○ 10 2 § 10 Cucumber (including gherkin) ○ 0.7 0.7 § 0.09 Pumpkin (including squash) ○ 0.7 0.7 § 0.09 Oriental pickling melon (vegetable) ○ 0.1 0.1 0.09 Water melon ○ 0.05 0.05 § Melons ○ 0.05 0.05 § Makuwauri melon ○ 0.1 0.1 Other cucurbitaceous vegetables ○ 10 0.1 § 10 Spinach ○ 25 25 § 10 Ginger ○ 3 3 § Kidney beans, immature (with pods) ○ 0.4 0.4 Green soybeans ○ 5 5 § Other vegetables ○ 10 10 § 10 Unshu orange, pulp ○ 0.7 0.7 § Citrus natsudaidai, whole ○ 2 2 §

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

Lemon ○ 5 5 § Orange (including navel orange) ○ 5 5 § Grapefruit ○ 5 5 § Lime ○ 5 5 § Other citrus fruits ○ 5 5 § Japanese pear ○ 0.5 Request Peach ○ 0.3 0.3 § Nectarine ○ 1 1 § Japanese plum (including prune) ○ 0.2 Request Strawberry ○ 0.7 0.7 § Grape ○ 10 10 § 1.5 Papaya ○ 0.5 0.5 0.5 Taiwan

Other fruits ○ 1 1 § Hop ○ 15 10 § 15 Other spices ○ 10 10 § Other herbs ○ 15 15 § 15

The residue definition is cyazofamid only.








IT：Import tolerance

Bicyclopyrone

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

Wheat ○ 0.04 IT 0.04 USA

Barley ○ 0.07 IT 0.07 USA

Corn (maize, including pop corn and sweet corn) ○ 0.03 0.03 0.03 USA

The residue definition is sum of bicyclopyrone, metabolite B 【2-2-(methoxy-ethoxymethyl)-6-trifluoromethyl-

nicotinic acid】(including metabolites that can be hydrolyzed to metabolite B) and metabolite K 【2-(2-hydoroxy-

ethoxymethyl)-6-trifluoromethyl-nicotinic acid】(including metabolites that can be hydrolyzed to metabolite K),

expressed as bicyclopyrone.




IT：Import tolerance

Pyflubumide

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

The residue definition is sum of pyflubumide and metabolite B (3’-isobutyl-1,3,5-trimethyl-4’-[2,2,2-trifluoro-1-

methoxy-1-(trifluoromethyl)ethyl]pyrazole-4-carboxanilide), expressed as pyflubumide.








Methamidophos

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

Rice (brown rice)※1 ● 0.01 0.6 Wheat ● 0.01 Barley ● 0.01 Rye ● 0.01 Corn (maize, including pop corn and sweet corn) ○ 0.2 0.1 § Buckwheat ● 0.01 Other cereal grains ● 0.01 Soybeans, dry ○ 0.1 0.05 § 0.1 Beans, dry ○ 2 2 § Peas ● 0.01 Broad beans ● 0.2 Peanuts, dry ● 0.1 Other pulses ● 0.3 Potato ● 0.1 0.25 § 0.05 Taro ● 0.01 Sweet potato ● 0.01 Yam ● 0.1 0.3 Konjac ● 0.01 Other potatoes ● 0.01 Sugar beet ● 0.02 0.05 § 0.02 Japanese radish, roots (including radish) ● 0.03 0.5 § Japanese radish, leaves (including radish) ● 0.03 1 § Turnip, roots (including rutabaga) ● 0.3 0.5 § Turnip, leaves (including rutabaga) ● 0.5 5 § Horseradish ● 3 Watercress ● 0.5 Chinese cabbage ● 0.2 2 § Cabbage※2 ● 0.1 1.0 § Brussels sprouts ● 1.0 Kale ● 0.7 Komatsuna(Japanese mustard spinach) ● 0.5 0.7 § Kyona ● 0.5 2 § Qing-geng-cai ○ 0.5 0.5 § Cauliflower ● 0.5 1.0 § Broccoli ● 0.02 1.0 § Other cruciferous vegetables ● 0.5 3 § Burdock ● 0.02 0.05 § Salsify ● 0.01 Artichoke ○ 0.2 0.2 0.2 Chicory ● 0.5 Endive ● 0.5 Shungiku ● 0.5 Lettuce (including cos lettuce and leaf lettuce) ● 0.1 1.0 § Other composite vegetables※2 ● 0.1 0.5 § 0.1 Onion ● 0.2 0.3 § Welsh (including leek) ● 0.05 Garlic ● 0.1 1 § Nira ● 0.3 Asparagus ● 0.01 Multiplying onion (including shallot) ● 0.05 Other liliaceous vegetables ● 0.3

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

Carrot ● 0.01 Parsnip ● 0.01 Parsley ● 0.3 Celery ● 5 Mitsuba ● 0.02 Other umbelliferous vegetables ● 0.5 Tomato※2 ● 0.02 2.0 § Pimiento (sweet pepper) ● 0.03 2.0 § Egg plant ● 0.02 1.0 § Other solanaceous vegetables ● 2.0 Cucumber (including gherkin) ● 0.02 1.0 § 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 ● 0.2 0.5 § Bamboo shoots ● 2 Okra ○ 0.5 0.5 § Ginger※2 ○ 0.1 0.05 § 0.1 Peas, immature (with pods) ● 0.5 Kidney beans, immature (with pods) ○ 1 0.5 1 Green soybeans ● 0.3 0.5 § Button mushroom ● 0.1 Shiitake mushroom ● 0.1 Other mushrooms ● 0.1 Other vegetables※2 ● 0.03 30 § 1 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

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

Other spices, dried (except SANSHO

(Japanese pepper)) ※5

●

0.1

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




* Diagonal line means deletion of a food category to which an MRL applies.





§：Permitted for use in Japan (as acephate).

※1 For rice (brown rice) and milk in which the Codex has set MRLs, the dietary exposure of methamidophos

estimated by using the supervised trial median residue (STMR) of the supervised residue trials submitted to

the JMPR and national food consumption data of rice, other oilseeds and milk would exceed an ADI of

0.00056 mg/kg bw/day which was set by the Food Safety Commission of Japan. Therefore, the MHLW has

decided to maintain the current MRLs(i.e. the uniform limit of 0.01 ppm) in these commodities.

※2 For other vegetables in which the Codex has set MRLs, the dietary exposure (estimate of short term intake

(ESTI)) of methamidophos estimated by using the highest residues (HR) of the supervised residue trials

submitted to the JMPR and national food consumption data of these commodities would exceed an ARfD of

0.003 mg/kg which was set by the Food Safety Commission of Japan. Therefore, the MHLW has decided to

set the MRLs for these commodities based on the residue data from the domestic supervised residue trials.

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

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

“Other spices”.

※5 Food categories “Other spices, dried (except SANSHO (Japanese pepper))” will be deleted, hereafter,

MRLs in their raw commodities (i.e. other solanaceous vegetables) will also apply to such processed

commodities, taking into account their processing factors.

Dicyclanil

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

The residue definition is dicyclanil only.








Semduramicin

Commodity

MRL

(draft)

ppm

MRL

(current)

ppm

Registration

Reference MRL

Codex

ppm

National

ppm

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

The residue definition is semduramicin only.

* Not the uniform limit of 0.01 ppm but the regulation that foods shall not contain any antibiotics or chemically

synthesized substances will be applied to the commodities for which current MRLs are to be deleted, since this

substance is considered to be an antibiotic or chemically synthesized antibacterial substance.







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.

“Other vegetables” refers to all vegetables, except potatoes, sugar beet,

sugarcane, cruciferous vegetables, composite vegetables, liliaceous vegetables,

umbelliferous vegetables, solanaceous vegetables, cucurbitaceous vegetables,

spinach, bamboo shoots, okra, ginger, peas (with pods, immature), kidney beans

(with pods, immature), green soybeans, mushrooms, spices, and herbs.

“Other citrus fruits” refers to all citrus fruits, except unshu orange (pulp), citrus

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

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

“Other berries” refers to all berries, except strawberry, raspberry, blackberry,

blueberry, cranberry, and huckleberry.

“Other fruits” refers to all fruits, except citrus fruits, apple, Japanese pear, pear,

quince, loquat, peach, nectarine, apricot, Japanese plum (including prune),

mume plum, cherry, berries, grape, Japanese persimmon, banana, kiwifruit,

papaya, avocado, pineapple, guava, mango, passion fruit, date and spices.

“Other oil seeds” refers to all oil seeds, except sunflower seeds, sesame seeds,

safflower seeds, cotton seeds, rapeseeds and spices.

“Other nuts” refers to all nuts, except ginkgo nut, chestnut, pecan, almond and

walnut.

“Other spices” refers to all spices, except horseradish, wasabi (Japanese

horseradish) rhizomes, garlic, peppers chili, paprika, ginger, lemon peels, orange

peels (including navel orange), yuzu (Chinese citron) peels and sesame seeds.

“Other herbs” refers to all herbs, except watercress, nira, parsley stems and

leaves, celery stems and leaves.

“Edible offal “refers to all edible parts, except muscle, fat, liver, and kidney

“Other terrestrial mammals” refers to all terrestrial mammals, except cattle and

pig.

“Other poultry animals” refers to all poultry, except chicken.

“Other fish” refers to all fish, except salmoniformes, anguilliformes, and

perciformes.

“Other aquatic animals” refers to all aquatic animal, except fish, shelled molluscs

and crustaceans.

Item 2. Designation of Substances Having No Potential to Cause Damage to

Human Health (exempt substance)

The MHLW is going to designate the following agricultural chemicals as substances

having no potential to cause damage to human health, which is also referred to as

“exempt substance,” based on the provision of Paragraph 3, Article 11 of the Food

Sanitation Law:

Pesticides: Hydroxypropyl Distarch Phosphate

This substance is not permitted for use as pesticide in Japan. The MHLW requested the

Food Safety Commission of Japan (FSC) to conduct a risk assessment for this substance

in response to a request for setting MRLs by the MAFF with the intention to newly

register this substance as a pesticide. The FSC concluded that hydroxypropyl distarch

phosphate is not considered to have no potential to cause damage to human health from

its residue in foods. Based on the assessment, the MHLW has decided to designate

hydroxypropyl distarch phosphate as an exempt substance.

Item 3. Improvement of sanitary regulations for utensils, containers and

packaging considering international consistency

【WTO-TBT Notification(G/TBT/N/JPN/582)】

The summary of the amendment to the Food Sanitation Act

(Improvement of sanitary regulations for utensils, containers and packaging

considering international consistency)

The government of Japan is planning to amend the Food Sanitation Act and

introduce a positive list system that allows only substances whose safety is evaluated

to be used for utensils, containers and packaging for food and food additives.

Background

In Japan, the safety of food utensils, containers and packaging has been secured

mainly by regulating the use of only substances whose specifications and

standards are established based on the Food Sanitation Act (=Negative list

system).

In light of recent developments and the diversification of products, as well as

global trends, Japan has decided that the management system of utensils,

containers and packaging should be founded on the policy that basically prohibits

all substances except those approved for use based on risk assessment (= Positive

list system), in order to ensure the further safety of utensils, containers and

packaging.

Based on these circumstances, in order to ensure food safety, the government of

Japan is planning to amend the Food Sanitation Act and other relevant laws

taking into consideration the opinions of concerned parties such as consumers, food

business operators (FBOs), and experts.

Outline of the amendment

In order to ensure the safety of utensils, containers and packaging, and to ensure

international consistency of regulations, FBOs associated with these products

shall not sell those made of raw materials, such as synthetic resins, for which

specifications are not established, except cases that the Minister of Health, Labour

and Welfare specifies as having no risk to human health. In addition, the

manufacturers shall comply with the codes of good manufacturing practices.

Manufacturers and sellers of utensils, containers and packaging shall provide

the business entities where the products are sold with information that the

products conform to the relevant specifications. Also manufacturers and sellers of

the raw materials shall endeavor to provide the manufacturers of utensils,

containers and packaging with the relevant information if requested.

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

for food

Ministry of Health, Labour and Welfare (MHLW) is planning to establish the

Positive List System that basically allows substances whose safety is evaluated to be

used for synthetic resin utensils, containers and packaging for food. After the

establishment, only substances registered on the Positive List will be permitted to use

for synthetic resin utensils, containers and packaging for food. Therefore, MHLW is

planning to investigate whether substances which are added or mixed to synthetic resin

utensils, containers and packaging distributed in the current domestic market

(hereinafter referred to as “the existing substances”) are appropriate for registration

on the Positive List after confirming the result of safety evaluation, the information

on toxicity etc.

MHLW recognizes the substances which are voluntarily managed by Japan Hygienic

Olefin And Styrene Plastics Association, Japan Hygienic PVC Association and Japan

Hygienic Association of Vinylidene Chloride in Japan (hereinafter referred to as “the

three associations”)*. However, MHLW does not recognize the other substances which

are used for synthetic resin utensils, containers and packaging distributed in the

domestic market as use for food. For smooth implementation of the Positive List

System, information of unrecognized substances which are used in Japan and overseas

should be collected and should be judged the appropriateness for registration on the

Positive List.

From above reason, if there is a substance which is the existing substance but not

voluntarily managed by the three associations, and is need to be registered on the

Positive List, please email the request to our division by March, 2018.

For each substance which needs registration, MHLW will request submission of the

result of safety evaluation, information on toxicity etc. by a public organization in due

course. Please note that the substance without these data is difficult to be registered

on the Positive List.

Contact address: Food Safety Standards and Evaluation Division, Pharmaceutical

Safety and Environmental Health Bureau, Ministry of Health, Labour and

Welfare (MHLW)

E-mail : [email protected]

Contact persons: Ms. Hiroko NIWA and Mr. Shunsuke MATSUSHITA (Tel: +81-

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


* For the substance list of the three associations, please check the following

references of Guideline for safety assurance in the manufacture etc. of food

utensils, containers and packaging, which are published on website of MHLW.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000170730.xlsx








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