Animal Health Requirements for  raw milk and/or  milk products to be exported to Japan 
from FMD free countries  (draft)  
 
Animal Health Requirements for raw milk and/or milk products to be  exported to Japan from  FMD free 
countries are as follows.  
 
(Definitions)  
For the purpose of these Animal Health Requirements:  
 
“Raw milk”  
means the mammary secretion of cloven -hoofed animals as milked.  
 
“Milk product”  
means  the product obtained by any processing of raw milk, which is categorized in any of the 
following HS codes:  
0401  (Milk and cream , etc. ) 
0402  (Milk and cream , etc. ) 
0403  (Buttermilk , etc. ) 
0404  (Whey, etc.) 
0405  (Butter , etc. ) 
0406  (Cheese , etc. ) 
3502.20, 3502.90 (Milk albumins, etc.)  
1702 .11, 1702. 19 (Lactose , etc. ) 
2309 .10, 2309.90  (Feed and pet food, etc. ) 
 
“FMD free countries”  
means countries, regions and zones recognized by Ministry of Agriculture, Forestry and Fisheries  
of Japan  in terms of the export of raw milk and/or milk products to Japan .  
For the latest list of FMD free countries, refer to Annex.  
 
“The Japanese animal health authority”  
means Animal Health Division, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, 
Forestry and Fisheries of Japan . 
 
“UHT” 
means a process applying a minimum temperature of 132°C for at least one second (ultra -high 
temperature [ UHT]) in liquid form . 
 
“HTST ” 
means a process applying a minimum temperature of 72°C for at least 15 seconds (high 
temperature - short time pasteurisation [HTST]) in liquid form . 
 
(General conditions ) 
1. The exporting country must be free from  foot-and-mouth disease ( FMD ), and vaccination against 
FMD  must be prohibited in the exporting country . 
 
2. Importation of cloven -hoofed animals that have been vaccinated against FMD must be prohibited 
in the exporting country.   
 
3. The exporting country must have an appropriate quarantine system  for the import and export of 
raw milk and milk products  from the perspective of animal health .    
 
4. In the case of FMD outbreak in the exporting country, the competent authority of the export ing 
country must immediately suspend issuing  the health  certificate for  raw milk and/or  milk products 
to be exported to Japa n and notify the Japanese animal health authority  as such . On receipt of 
the information on FMD outbreak in the exporting country, the Japanese animal health authority 
can suspend the import from the said country.  
 
(Conditions of raw milk and/or milk products to be exported to Japan ) 
5.  Raw milk and/or milk products to be exported to Japan must be produced from raw milk obtained 
from clinically healthy animals , and 
it must b e prohibited to use raw milk obtained  from animals infected with animal  infectious    
diseases as an ingredient according to legislation of the exporting country . 
 
6-1. [In case of the raw milk and/or milk products not intended for animal* consumption]  
        (* ‘animal’ means cloven -hoofed animals)  
(1) Raw milk and/or milk products to be exported to Japan must be produced from raw milk 
collected only in the exporting country and/or FMD free countries, and must be produced, 
packaged and stored only in the exporting country and/or FMD free countries;  
or 
(2)  milk products to b e exported to Japan must satisfy all of the following items:  
(a) an ingredient derived from raw milk used in the production of milk products to be exported 
to Japan must originate from the exporting country and/or must be legally imported into 
the exporting country;  
and  
(b) an FMD virus inactivation treatment of milk p roducts to be exported to Japan (such as 
heat or acid treatment) must be carried out in any stage of production by any of the 
following methods:  
(i) UHT, or  
(ii) if the milk has a pH less than 7.0, HTST, or  
(iii) if the milk has a pH of 7.0 or greater, HTST applied twice.  
   (iv) a process maintaining a pH less than 6 for at least one hour.  
 (v) a method approved by the competent authority of the exporting country as an FMD 
inactivation  method equivalent to (i) – (iv) above.   
 
6-2．[In case of the raw milk and/or milk products intended for animal consumption]   
    (* ‘animal’ means cloven -hoofed animals)    
(1) Raw milk and/or milk products to be exported to Japan must be produced from raw milk 
collected only in the exporting country and/or FMD free countries, and must be produced, 
packaged and stored only in the exporting country and/or FMD free countries;  
or 
(2)  milk products to be exported to Japan must satisfy all of the following items:  
(a) an ingredient derived from raw milk used in the product ion of milk products to be exported 
to Japan must originate from the exporting country and/or must be legally imported into 
the exporting country;  
and  
(b) an FMD virus inactivation treatment of milk products to be exported to Japan  (such as 
heat or acid treatment) must be carried out in any stage of production by any of the 
following methods:  
(i) UHT, or  
(ii) if the milk has a pH less than 7.0, HTST, or  
(iii) if the milk has a pH of 7.0 or greater, HTST applied twice.  
    
7. Raw milk and/or milk products  to be exported to Japan must be produced, packaged and stored 
from raw milk collection to shipment of final products to Japan without contamination by 
pathogens of animal infectious diseases or commingl ing with raw milk and/or milk products  
which do not m eet Articles 5 , 6-1 and 6 -2 above . 
 
8. Packages and containers  such as carton boxes for raw milk and/or milk products  to be exported 
to Japan m ust be clean and hygienic.   
 
(Issue  of the health  certificate )  
9. The competent authority of the exporting country must be responsible for issuing the health 
certificate for raw milk and/or milk products to be exported to Japan, stating the following items 
in detail in English after confirming the raw milk and/or milk products comply with the se animal 
health requirements . 
(1) Statement that ‘all the requirements of ‘‘Animal Health Requirements for raw milk and/or 
milk products to be exported to Japan from FMD free countries’’ are satisfied.’  
(2) The n ame of the item, quantit y and the production date of the products, and the species of 
origin of raw milk as an ingredient  
(3) The e stablishment number of the facilit y where the final products to be exported to Japan 
are treated finally  
(4) Intended use (for animal consumption (including raw materials for animal feed ), human 
consumption, etc.)  
(5)  If Article 6-1(2) or 6-2(2) is applied, a relevant FMD virus inactivation treatment must be    
selected or described.  
(6)  The d ate, authority name and place of issue of the health certificate, and the name and 
title of the signer  
 
In addition, the health certificate must be in either the model format presented by the Japanese 
animal health authority or any other equivalent format . 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
Animal Health Requirements for milk products to be exported to Japan from countries 
other than FMD free countries  (draft)  
 
Animal Health Requirements for milk products to be exported to Japan from countries other than FMD 
free countries are as follows.  
 
(Definitions)  
For the purpose of these Animal Health Requirements:  
 
“Raw milk”  
means the mammary secretion of cloven -hoofed animals as milked.  
 
“Milk product”  
means the product obtained by any processing of raw milk, which is categorized in any of the 
following HS codes:  
0401 (Milk and cream, etc.)  
0402 (Milk and cream, etc.)  
0403 (Buttermilk, etc.)  
0404 (Whey, etc.)  
0405 (Butter, etc.)  
0406 (Cheese, etc.)  
3502.20, 3502.90 (Milk albumins, etc.)  
1702 .11, 1702.19 (Lactose, etc.)  
2309.10, 2309.90 (Feed and pet food, etc.)  
 
“FMD free countries”  
means  countries, regions and zones recognized by Ministry of Agriculture, Forestry and Fisheries 
of Japan  in terms of the export of milk products to Japan . 
For the latest list of FMD free countries, refer to Annex.  
 
“The Japanese animal health authority”  
means Animal Health Division, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, 
Forestry and Fisheries of Japan . 
 
“UHT” 
means a process applying a minimum temperature of 132°C for at least one second (ultra -high 
temperature [ UHT]) in liquid form . 
 
“HTST ” 
means a process applying a minimum temperature of 72°C for at least 15 seconds (high 
temperature - short time pasteurisation [HTST]) in liquid form . 
 
(Conditions of milk products to be exported to Japan ) 
1. Milk products to be exported to Japan mu st be produced from raw milk obtained from clinically 
healthy  animals , and 
it must be prohibited to use raw milk obtained from animals infected with animal  infectious 
diseases as an ingredient according to legislation of the exporting country.  
 
2.  Raw milk used in the production of milk products to be exported to Japan must originate from 
herds which were not infected or suspected of being infected with FMD at the time of milk 
collection.      
 
3.  An FMD virus inactivation treatment of milk products to be exported to Japan (such as heat or 
acid treatment) must be carried out in any stage of production by any of the following methods:  
(1) [In case the milk products  not intended for animal * consumption]  
(* ‘animal’ means cloven -hoofed animals)  
(a) UHT ; or 
(b) if the milk has a pH less than 7.0,  HTST ; or 
(c) if the milk has a pH of 7.0 or greater, HTST applied twice ; or 
(d) a process maintaining a pH less than 6 for at least one hour.  
 
(2) [In case milk products intended for animal consumption]   
  (* ‘animal ’ means cloven -hoofed animals)  
(a) HTST applied twice ; or  
(b) HTST combined with another physical treatment, maintaining a pH less than 6 for at least 
one hour or additional heating to at least 72°C combined with desiccation; or  
(c) UHT combined with another physical treatment referred to in (b) above . 
 
4. Milk products to be exported to Japan must be produced, packaged and stored from raw milk 
collection to shipment of final products to Japan without contamination by pathogens of animal 
infectious diseas es or commingling with milk products which do not meet Articles 1 to 3 above.  
 
5. Packages and containers such as carton boxes for milk products to be exported to Japan must 
be clean and hygienic.  
 
(Issue of the health  certificate )  
6. The competent authority o f the exporting country must be responsible for issuing the health 
certificate for milk products to be exported to Japan, stating the following items in detail in English 
after confirming the milk products comply with the se animal health requirements . 
(1)  Statement that ‘all the requirements of ‘‘Animal Health Requirements for milk products to 
be exported to Japan from countries other than FMD free countries’’ are satisfied.’  
(2) The n ame of the item, quantit y and the production date of the products, and the species of 
origin of raw milk as an ingredient  
(3) The e stablishment number of the facilit y where the final products to be exported to Japan 
are treated finally  
    (4) Intended use (for animal consumption (including raw materials for animal feed), human 
consum ption, etc.)  
(5) With regard to Article 3 above,  a relevant FMD virus inactivation treatment of milk products to 
be exported to Japan  must be selected or described.  
(6)  If a pathogen inactivation treatment was not carried out in the exporting country, the  name 
of the country where the treatment was implemented . 
(7) The d ate, authority name and place of issue of the health certificate, and the name and title 
of the signer.  
 
In addition, the health certificate must be in either the model format presented by the Japanese 
animal health authority or any other equivalent format.      
 
Finland, Sweden, Norway, Poland, Hungary, The Czech Republic, Germany, Denmark, 
Italy (excluding Sardinia island), San Marino, Liechtenstein, Swi tzerland , The 
Netherlands, Belgium, France, Austria, Spain, Portugal, Ireland, Iceland, United Kingdom 
(Great Britain and Northern Ireland only)  
Brazil  (State of Santa Catalina only) , Canada, U.S.A. (Mainl and, Hawaii and Guam  only), 
Mexic o, Belize, Guatemala, Honduras, El Salvador, Nicaragua, Costa Rica, Panama, 
The Dominican Republic, Chile  
Northern Mariana, New Zealand, Vanuat u, New Caledonia and Australia  
(39 areas)  Annex