Voluntary Report - public distribution

**Date:** 6/15/2004

**GAIN Report Number:** JA4056

JA4056

**Japan**

**Food and Agricultural Import Regulations and Standards**

**Country Information on Maximum Residue Limits Regulations**

**2004**

**Approved by:**

![](media/image1.wmf)Kevin Latner

U. S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

This report contains country information on the maximum residue limits
of pesticides in crops and foods as of June 2004.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

Table of Contents

[**Government agency involved in MRL establishment and its
responsibilities
3**](#government-agency-involved-in-mrl-establishment-and-its-responsibilities)

[Laws and regulations guide the development and enforcement of MRLs for
pesticides
3](#laws-and-regulations-guiding-the-development-and-enforcement-of-mrls-for-pesticides)

[The process for the establishment of MRLs
3](#the-process-for-the-establishment-of-mrls)

[Update frequently of the printed copy or website listing of MRLs
4](#update-frequently-of-the-printed-copy-or-website-listing-of-mrls)

[Regulatory process for the establishment of import MRLs
4](#regulatory-process-for-the-establishment-of-import-mrls)

[Crop groups, individual crops used for the establishment of MRLs
4](#crop-groups-individual-crops-used-for-the-establishment-of-mrls)

[Surveillance/testing program for pesticide residues in imported foods,
number ofsamples tested, how priorities are identified, availability of
test results, sampling and testing procedures
6](#surveillancetesting-program-for-pesticide-residues-in-imported-foods-number-of-samples-tested-how-priorities-are-identified-availability-of-test-results-sampling-and-testing-procedures)

[Codex MRLs\' role 7](#codex-mrls-role)

[Actions to be taken when residues are found above the MRL
7](#actions-to-be-taken-when-residues-are-found-above-the-mrl)

[Default pesticide enforcement level
8](#default-pesticide-enforcement-level)

[The name, office telephone and email address of a pertinent government
official for contact purposes
8](#the-coordinates-of-relevant-offices-and-online-information)

**Note: This report was prepared by the Office of Agricultural Affairs
of the USDA/Foreign Agricultural Service at the U.S. Embassy/Tokyo for
exporters of U.S. agricultural products. While great care was taken in
preparation of this report, information provided may not be completely
accurate due to either changes in policies since its preparation, or
because clear and consistent information about these policies was not
available at the time of publication. U.S. Exporters are highly
recommended to verify the relevant import requirements with their
foreign customers, who normally have the most updated information on
local requirements, prior to exportation. FINAL IMPORT APPROVAL OF ANY
PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY'S RULES AND REGULATIONS AS
INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY.**

Adobe's Japanese language module may need to be installed to view pdf
documents from the Japanese government and organizations even if they
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# Government agency involved in MRL establishment and its responsibilities

The Ministry of Health, Labor and Welfare (MHLW) maintains a list of
maximum residue levels (MRLs) for pesticides. As of June 2004, there
were about 9,000 MRLs established for 240 pesticides on about 130
commodities. Each year, MHLW reviews a number of substances for the
purposes of establishing an MRL.

Currently, MHLW has a negative list system for pesticide and veterinary
drug residues. Crops containing pesticides without MRLs may be
distributed in Japan unless they pose a health hazard. To be regarded as
such, products without a MRL listed in the present list, residue levels
must be safe, usually meaning that the residue levels are below either
Codex or the exporting country standards - whichever is stricter. For a
full list of MRLs, please refer to (Specifications and Standards for
Foods, Food Additives, etc. Under The Food Sanitation Law) the JETRO
website:
[\<http://www.jetro.go.jp/se/e/standards_regulation/index.html\>]{.underline}.

# 

# Laws and regulations guiding the development and enforcement of MRLs for pesticides

There are three major laws pertaining to food safety and standards; the
Food Safety Law, Food Sanitation Law and Japan Agricultural Standards
Law. The Food Safety Basic Law sets the principles for developing a food
safety regime and the role of the Food Safety Commission, a food related
risk assessment body (for details, please see JA3029). The Food
Sanitation Law ensures the safety and sanitation of foods by MHLW, a
food risk management agency. The law prohibits the sale of foods
containing poisonous or harmful substances. It also prescribes the
standards for foods, additives, food apparatus and container packages,
and certain toys. The law is available in English on the Japan External
Trade Organization (JETRO) website
(http://www.jetro.go.jp/se/e/standards_regulation/index.html).

However, MHLW is in the process of changing the way it controls farm
chemicals. In the fall of 2003, the GOJ issued draft list of provisional
pesticide maximum residue limits (provisional MRLs). All products sold
in Japan, including imports, will have to comply with the current final
list or the provisional MRL in May 2006. Any residues not on the
provisional or final lists of chemicals will be illegal after May 2006.
MHLW will use the provisional MRLs until establishment of official MRLs
based on full risk assessment for individual farm chemicals.

# The process for the establishment of MRLs

In establishing MRLs, MHLW obtains the data necessary for pesticides
registered for use in Japan through MAFF. For pesticides registered in
other countries, MHLW collects data by directly requesting information
from the pesticide manufacturers abroad. Data needed for evaluation
usually includes data on acute toxicity, subacute toxicity, chronic
toxicity, carcinogenicity, reproductive toxicity, teratogenicity,
mutagenicity, pharmacokinetic and general pharmacological parameters,
animal metabolism, and plant metabolism as well as residue data (for
commodities treated with target pesticides).

# Update frequently of the printed copy or website listing of MRLs

The JETRO information website
(http://www.jetro.go.jp/se/e/standards_regulation/index.html) contains
important MRL information and is updated once every year or two, as
necessary. There is also a useful website for the list of food
additives, residue chemical limits, and specifications of packaging and
containers (http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/e-lists).
MHLW has an English website that contains some food safety information
(http://www.mhlw.go.jp/english/topics/importedfoods/index.html). Those
websites are also updated on an as needed basis.

# Regulatory process for the establishment of import MRLs

MHLW establishes MRLs on each pesticide mainly based on scientific data
and information provided by its manufacturer. The information includes
its range and scope of use, such as registered crops and countries. MHLW
basically does not discriminate between import MRLs from MRLs registered
for domestic use.

After the implementation of the positive list system, for pesticides
mainly used abroad, a request for the establishment of MRLs may be made
using 'Guideline for Application for Establishment and Revision of
Maximum Residue Limits for Agricultural Chemicals used outside Japan'
(http://www.mhlw.go.jp/english/topics/foodsafety/dl/importguideline.pdf)
with necessary documentation.

# Crop groups, individual crops used for the establishment of MRLs

MRLs are established for each major crop and for crops groups for minor
crops. Below is a typical example of grouping of crops for MRL
establishment.

Soybeans (dry)

Beans (dry)

Peas

Broad beans

Peanuts (dry)

Other legumes/pulses

Potato

Taro

Sweet potato

Yam

Other potatoes

Horseradish

Chinese cabbage

Cabbage

Brussels sprouts

Kale

KOMATSUNA

KYONA

Cauliflower

Broccoli

Other cruciferous vegetables

Burdock

Salsify

Lettuce (Cos lettuce, Leaf lettuce)

Other composite vegetables

Onion

Welsh (including Leek)

Garlic

Other liliaceous vegetables

Carrot

Parsnip

Other umbelliferous vegetables

Tomato

Pimento (Sweet pepper)

Egg plant

Other solanceous vegetables

Cucumber (including Gherkin)

Pumpkin (including Squash)

Oriental pickling melon (vegetable)

Water melon

Melons

MAKUWAURI

Other cucurbitaceous vegetables

Ginger

Peas (with pods, immature)

Kidney beans (with pods, immature)

Soybeans

Other vegetables

Apple

Japanese pear

Pear

Quince

Loquat

Peach

Nectarine

Apricot

Japanese plum (including Prunes)

Cherry

Strawberry

Raspberry

Blackberry

Blueberry

Huckleberry

Other berries

Grape

Other fruits

Sunflower seeds

Rape seeds

Chestnut

Pecan

Almond

Walnut

Other nuts

Hop

Cattle, muscle

Cattle, fat

Cattle, edible offal

Pig, muscle

Pig, fat

Pig, edible offal

Sheep, muscle

Sheep, fat

Sheep, edible offal

Horse, muscle

Horse, fat

Horse, edible offal

Goat, muscle

Goat, fat

Goat, edible offal

Cattle, milk

Chicken, muscle

Chicken, fat

Chicken, edible offal

Chicken eggs

Rapeseed oil, refined

Peanut oil, refined

Grapes, dried

# Surveillance/testing program for pesticide residues in imported foods, number of samples tested, how priorities are identified, availability of test results, sampling and testing procedures

Quarantine offices (for imported crops) and local laboratories in
municipalities (for domestic crops) conduct monitoring tests for
pesticides for which MRLs are established. The purpose of the monitoring
tests is to check whether crops in the marketplace comply with
established MRLs. Any product found to contain a substance in excess of
an established MRL, may not be marketed in Japan.

At ports, MHLW normally monitors between 3-5% of imports for
antimicrobials, chemical residues, food additives, microorganisms,
fungal toxins and unapproved genetically modified products. The annual
monitoring plan announced for fiscal year 2004 includes testing 76,000
samples for antimicrobials, residue chemicals, food additives,
microorganisms, fungal toxins and unapproved genetically modified
products. Among them 30,600 samples are for testing chemical residues.

Its sampling is based on Codex recommendations: 299 samples for each
food group, enabling it to find violations of below 1% at 95% level of
confidence. MHLW may increase the sampling ratio based on past violation
and the significance of the violations. In the case of monitoring for
imports, MHLW bears the cost of monitoring and laboratory tests.

There are 31 quarantine stations around Japan and six of them have
testing facilities. Besides those quarantine stations, there are two
imported food testing and inspection centers that have the capability to
test. MHLW has designated about 40 testing laboratories to do monitoring
tests on behalf of MHLW.

For imported foods, MHLW has three levels of testing and regulating
schemes. When MHLW finds two or more violations or problems with a
certain imported food, it imposes testing-by-order. If MHLW finds the
problem persists, it may implement a comprehensive ban of imports from
the origin or the persistent problem.

MHLW has been conducting surveys of residues, including pesticides
without MRLs, to obtain basic data for the establishment of MRLs. The
monitoring test results typically show that less than 0.1% of the
samples tested were above the established MRLs. The monitoring test
plans and results are made available to the public on the MHLW Japanese
website.

Details of testing programs for imports are summarized in the Gain
Report JA4005.

# Codex MRLs\' role

Under the negative list system currently applied in Japan, there are
cases where no MRL is established for a specific pesticide on a specific
crop. In those cases, MHLW makes a determination whether the residue
level potentially influences human health. To make the determination,
MHLW at first refers to Codex MRLs. If there are no Codex MRLs, MHLW
refers to the MRLs in producing/exporting country. MHLW will make a
decision whether it needs to take an action based on such information.

In preparation for the introduction of the positive list system in 2006,
MHLW is in the process of establishing provisional MRLs. To establish
provisional MRLs, MHLW's basic position is to adopt Codex standards
whenever possible. (Details see Gain Report JA4051)

# Actions to be taken when residues are found above the MRL

Crops not meeting the standards and specifications of the Food
Sanitation Law, including MRLs, were discarded, re-exported,
reconditioned, or otherwise disposed of.

The first step is when monitoring test results reveal a violation,
monitoring of the same product from the same country of origin is
increased to 50%. If a second violation is found under the 50%
monitoring program, testing-by-order is triggered for the food product.
Depending on the ability to trace back the product, the testing-by-order
may apply to an exporting country, a region or a specific producer or
manufacturer. When a human health-related incident occurs or serious
health hazard is strongly suspected from an imported food, one violation
under the monitoring program triggers testing-by-order. If MHLW finds
the problem persists, it may implement a comprehensive ban of imports.

Testing-by-order is a mandatory testing program under which each
shipment has to be held until the test result shows negative. Tests
under testing-by-order are performed at one of the designated domestic
laboratories at the expense of the importer.

MHLW lifts the order of testing when it is confirmed that no violated
foods are to be exported due to appropriate measures that prevent the
same incident from occurring again in the exporting country, region,
manufacturer or processor.

The comprehensive ban may be considered by MHLW if "there are a
considerable number of violations (over 5% violation ratio for the most
recent 60 samples under testing-by-order for imported foods) or human
health hazard occurrence or situations that have a potential of
adulterating foods (e.g., radioactivity contamination by a nuclear plant
accident). The ban will only be imposed after an investigation of
production or manufacturing finds a potential hazard and the relevant
expert committee, the Pharmaceutical and Food Sanitation Committee
affirms the ban.

# Default pesticide enforcement level

Under the current negative list system, there is no default pesticide
enforcement level. MHLW is considering 0.01 ppm for the default
tolerance after the introduction of the positive list system in 2006
(Details see Gain Report JA4051)

# The coordinates of relevant offices and online information

The United States Department of Agriculture, Foreign Agricultural
Service provides U.S. exporter assistance and may be able to assist in
identifying relevant local contacts for additional information:

Office of Agricultural Affairs

U.S. Embassy, Tokyo

Tel: 81-3-3224-5102

Fax: 81-3-3589-0793

Email: agtokyo@usda.gov

Information on food safety regulations in Japan including those on
pesticide residues:

The JETRO information website:
(http://www.jetro.go.jp/se/e/standards_regulation/index.html)

The San Ei Gen website:
(http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/e-lists).

MHLW\' English website that contains some food safety information:
(http://www.mhlw.go.jp/english/topics/importedfoods/index.html)

MHLW responsible division:

Standards and Evaluation Division

Department of Food Safety

Ministry of Health, Labor and Welfare

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

Japan

Fax: 81-3-3501-4868

Importer association contact point:

Japan Fresh Produce Import and Safety Association (Nisseikyo)

Suehiro Bldg.

1-12-16 Kanda Izumi-cho, Chiyoda-ku, Tokyo 101-0024 Japan.

Tel: 81-3-5833-5141

Fax: 81-3-5833-5140