Voluntary Report - public distribution

**Date:** 2/2/2004

**GAIN Report Number:** JA4005

JA0000

**Japan**

**Food and Agricultural Import Regulations and Standards**

**Product Testing and Import Bans**

**2004**

**Approved by:**

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

#### U. S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

Japan has three levels of regulatory schemes for imported foods:
monitoring, testing-by-order and comprehensive ban. Which scheme is
applied depends on the number of regulatory violations. In 2004, 76,000
samples will be taken to monitor antimicrobials, residue chemicals, food
additives, microorganisms, fungal toxins, and unapproved genetically
modified products.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

Japan's Ministry of Health, Labor and Welfare (MHLW) has three levels of
regulation schemes for imported foods, monitoring, testing-by-order and
comprehensive ban, each providing an increasing level of regulatory
oversight. These at-the-border programs test for antimicrobials, residue
chemicals, food additives, microorganisms, fungal toxins and unapproved
genetically modified products.

The comprehensive ban authority may be applied to foods where there is a
high risk of continued violations and may be invoked where
testing-by-order reveals a greater than 5% rate of violation. MHLW may
impose the comprehensive ban on countries, regions or companies.

Testing-by-order is imposed after a second violation on a particular
product from a single country. Testing-by-order requires importers to
pay for the cost of testing 100% of imports. Imports are held at the
port pending the results of the tests. Although MHLW reports the tests
should only take 3-4 days, importers report that in fact, testing can
delay entry 1-3 weeks.

MHLW normally monitors imports for antimicrobials, residue chemicals,
food additives, microorganisms, fungal toxins and unapproved genetically
modified products at between 3-5%. The annual monitoring plan was
announced for the fiscal year 2004 includes testing 76,000 samples for
antimicrobials, residue chemicals, food additives, microorganisms,
fungal toxins and unapproved genetically modified products.

The Ministry of Health, Labor and Welfare (MHLW) tests imported foods at
port quarantine stations. Table 1 shows the number of imported foods,
the number of test, and the number of violations for the past five
fiscal years (April - March).

Table 1: Food import notifications, tests and violations of imported
foods.

  -------- --------------- ---------- ---------- -------------- ------------ ------------ ------------
  Fiscal   No. of Import   Imported   Total No.  No. of Tests   No. of Tests              No. of
  Year     Notifications   Amount     of         per            at Testing                Violations
                           (1,000 MT) tests\*1   Notification   Labs                      
                                                 (%)                                      

                                                                Government   Designated   
                                                                             Labs\*2      

  1998     1,276,994       29,150     104,918    8.2            48,439       55,911       881
                                                                             (34,677)     

  1999     1,404,110       28,928     108,515    7.7            49,289       62,276       948
                                                                             (37,013)     

  2000     1,550,925       30,034     112,281    7.2            52,244       63,789       1,037
                                                                             (37,484)     

  2001     1,607,011       32,508     109,733    6.8            45,353       66,620       992
                                                                             (40,138)     

  2002     1,618,880       33,202     136,087    8.4            63,689       78,327       972
                                                                             (47,333)     
  -------- --------------- ---------- ---------- -------------- ------------ ------------ ------------

\*1: Total numbers do not match with the sums of numbers of tests
because of duplicated counts.

\*2: Numbers in parentheses represent those for testing-by-order (See
No. 2 below).

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 as described below. When MHLW finds violations or problems in a
certain imported food, it goes to testing-by-order. If MHLW finds the
problem persists, it may implement a comprehensive ban of imports.

\(1\) Monitoring test

Under the Food Sanitation Law, MHLW samples imported foods at the ports
of entry. 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. MHLW bears the cost of
testing and laboratory tests for monitoring.

Annual monitoring testing plan

Food Sanitation Law requires MHLW to establish a monitoring test plan
for each fiscal year. The monitoring plan for fiscal year 2004 (April
2004 to March 2005) is shown in Table 2.

Table 2 Categories of foods and testing items for imported food
monitoring

  ----------------- ----------------- ----------------- -----------------
  Food category     Test item         No. of tests      Total No. of
                                                        tests

  Livestock (beef,  Antimicrobials    4,600             10,000
  pork, poultry,                                        
  other meat                                            
  products)                                             

                    Residue chemicals 4,500             

                    Specifications    900               

  Processed         Antimicrobials    1,000             4,300
  livestock (cheese                                     
  and other                                             
  processed meat)                                       

                    Food additives    1,100             

                    Specifications    2,200             

  Seafood           Antimicrobials    2,300             3,600
  (shellfish and                                        
  fish)                                                 

                    Food additives    700               

                    Specifications    600               

  Processed seafood Antimicrobials    5,700             14,000
  (surimi and other                                     
  processed                                             
  seafood)                                              

                    Food additives    2,500             

                    Specifications    5,800             

  Ag. products      Chemical residues 17,800            24,200
  (grains, fruits                                       
  and vegetables)                                       

                    Fungal toxins     4,800             

                    Unapproved GMOs   1,600             

  Processed ag.     Chemical residues 3,700             8,100
  products (frozen                                      
  vegetables,                                           
  spice, noodles)                                       

                    Food additives    2,800             

                    Specifications    1,200             

                    Fungal toxins     300               

                    Unapproved GMOs   100               

  Other foods       Food additives    3,400             4,100
  (soup,                                                
  confectionary,                                        
  etc)                                                  

                    Specifications    700               

  Drinks (minearal  Food additives    1,200             1,900
  water, alcoholic                                      
  and non-alcoholic                                     
  beverages)                                            

                    Specifications    700               

  Food additives,   Specifications    1,300             1,300
  apparatus and                                         
  packaging, toys                                       

  Foods of special  Antimicrobials,   4,500             4,500
  emphasis          Chemical                            
                    residues, Food                      
                    additives,                          
                    Specifications,                     
                    Fungal toxins,                      
                    Unapproved GMOs                     

  Total                                                 76,000
  ----------------- ----------------- ----------------- -----------------

Antimicrobials: Antibiotics, residue antimicrobial substances

Specifications: Items listed under specifications and standards for
foods, including microorganisms

Foods of special emphasis: The number is set aside for testing foods
emerging as human health problems during the fiscal year

\(2\) Testing-by-order

When monitoring test results reveal a violation, monitoring is increased
to 50% of imported foods from the same manufacturer or processor. If the
second violation is found under the 50% monitoring program,
testing-by-order is triggered for the food product. When a human
health-related incident occurs or serious health hazard is strongly
suspected from an imported food (such as E. coli O157/H7 in ground
meat), one violation under the monitoring program triggers
testing-by-order.

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.

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.

\(3\) Comprehensive ban of food importation and sales

MHLW has discretion to prohibit the import and sales of certain foods
without testing at the port. 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.