G/SPS/JPN/471/Add.4  
1/6 
 Animal Health Requirements for raw milk and/ or milk products to be exported to Japan  
from Listed countries 
 
Animal Health Requirements for raw milk and/or m ilk products to be export ed to Japan from Listed 
countries are as follows. 
 
(Definitions) For the purpose of these Animal Health Requirements: 
 
“Raw milk” 
means the mammary secretion of cl oven-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.) 2309.10, 2309.90 (Feed and pet food, etc.) 
 
*The following items are excluded from the above definition. Evaporated milk, evaporated skim milk, y oghurt, butter oil and processed cheese 
 
“Listed countries” 
means countries, regions and zones recognized by Ministry of Ag riculture, Forestry and Fisheries 
of Japan where exporting raw m ilk and un-heat-treated milk pr oducts to Japan is allowed.  
For the latest list of List ed countries, refer to Annex.
 
 
“The Japanese animal health authority” 
means Animal Health Division, Food Safety and Cons umer 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 temperatur e of 72°C for at least 15 seconds (high 
temperature - short time pasteur isation [HTST]) in liquid form. 
 
(General conditions) 
1. The exporting country must be free from f oot-and-mouth disease (FMD ), and vaccination against 
FMD must be prohibited in the exporting country. 
 
2. Importation of cloven-hoofed ani mals 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.   G/SPS/JPN/471/Add.4  
2/6 
  
4. In the case of FMD outbreak in the exporting  country, the competent aut hority of the exporting 
country must immediately suspend is suing the health certificate for  raw milk and/or milk products 
to be exported to Japan and notify the Japanese animal health authority as such. On receipt of 
the information on FMD outbreak in the export ing country, the Japanese animal health authority 
can suspend the import fr om 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 be prohibited to use ra w milk obtained from animals in fected 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 export ed to Japan must be produced from raw milk 
collected only in the exporting country and/ or Listed countries, and must be produced, 
packaged and stored only in the exporti ng country and/or Listed countries; 
or (2)  milk products to be exported to Japan must satisfy all of the following items: 
(a) an ingredient derived from raw milk us ed in the production of milk products to be 
exported to Japan must originate from th e exporting country and/or must be legally 
imported into the exporting country;  
and  
(b) an FMD virus inactivation treatment of m ilk products to be expor ted 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 aut hority of the exporti ng country as an FMD 
inactivation method equivalent to (i) – (iv) above.  
 6-2．[In case of the raw milk and/or milk pr oducts intended for animal consumption]   
    (* ‘animal’ means cloven-hoofed animals)   
(1) Raw milk and/or milk products to be export ed to Japan must be produced from raw milk 
collected only in the exporting country and/ or Listed countries, and must be produced, 
packaged and stored only in the exporti ng country and/or Listed countries; 
or (2)  milk products to be exported to Japan must satisfy all of the following items: 
(a) an ingredient derived from raw milk us ed in the production of milk products to be 
exported to Japan must originate from th e exporting country and/or must be legally 
imported into the exporting country;  
and  
(b) an FMD virus inactivation treatment of m ilk products to be expor ted 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 pr oducts to be exported to J apan must be produced, packaged and 
stored from raw milk collection to shipment of final products to Japan wi thout contamination by   G/SPS/JPN/471/Add.4  
3/6 
 pathogens of animal infectious diseases or co mmingling with raw milk  and/or milk products 
which do not meet 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 must be clean and hygienic.  
 
(Issue of the health certificate)   
9. The competent authority of t he 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 co mply with these animal 
health requirements. 
(1) Statement that ‘all the requirements of ‘‘An imal Health Requirements for raw milk and/or 
milk products to be exported to Japan from  Listed countries’’ are satisfied.’(*1) 
(2) The name of the item, quantit y and the production date of t he products, and the species of 
origin of raw milk as an ingredient 
(3) The establishment number of the facility where the final products to be exported to Japan 
are treated finally(*2,*3) 
(4) Intended use (for animal c onsumption (including raw mate rials for animal feed), human 
consumption, etc.) 
(5) If Article 6-1(2) or 6-2(2) is applied, a re levant FMD virus inactivation treatment must be    
selected or described. 
(6) The date, authority name and pl ace of issue of the health ce rtificate, and t he name and title 
of the signer 
 
In addition, the health certificate must be in ei ther the model format presented by the Japanese 
animal health authority or any other equivalent format. 
 
*1. Alternatively, it is also acceptable to state Article 1, 2, 3, 5, 6, 7 and 8 of ‘‘Animal Health 
Requirements for raw milk and/or milk products to be exported to Japan fr om Listed countries’’. 
*2. “The facility” means a facility that produces(including only repacki ng, blending, etc.) final products 
(cheese, skim milk powder etc. ) to be exported to Japan. 
*3.  Alternatively, it is also acceptabl e to state name and address of the facility. 
 
              G/SPS/JPN/471/Add.4  
4/6 
 Animal Health Requirements for milk products to be exported to Japan  
from countries other than Listed countries 
 
Animal Health Requirements for milk products to  be exported to Japan from  countries other than 
Listed countries are as follows. 
 
(Definitions) For the purpose of these Animal Health Requirements: 
 
“Raw milk” 
means the mammary secretion of cl oven-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.) 2309.10, 2309.90 (Feed and pet food, etc.) 
 
*The following items are excluded from the above definition. Evaporated milk, evaporated skim milk, y oghurt, butter oil and processed cheese 
 
“Listed countries” 
means countries, regions and zones recognized by Ministry of Ag riculture, Forestry and Fisheries 
of Japan where exporting raw milk and un-heat -treated milk products to Japan is allowed. 
For the latest list of List ed countries, refer to Annex.
 
 
“The Japanese animal health authority” 
means Animal Health Division, Food Safety and Cons umer 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 temperatur e of 72°C for at least 15 seconds (high 
temperature - short time pasteur isation [HTST]) in liquid form. 
 
(Conditions of milk products to be exported to Japan) 
1. Milk products to be exported to Japan must be produced from raw milk obtained from clinically 
healthy animals, and 
it must be prohibited to use ra w milk obtained from animals in fected with animal infectious 
diseases as an ingredient according to  legislation of the exporting country. 
 
2.  Raw milk used in the producti on of milk products to be exporte d to Japan must originate from 
herds which were not infected or  suspected of being infected wi th FMD at the time of milk 
collection.    G/SPS/JPN/471/Add.4  
5/6 
  
3.  An FMD virus inactivation tr eatment of milk products to be exported to Japan (s uch 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 in tended 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 treatm ent, maintaining a pH less than 6 for at least 
one hour or additional heating to at le ast 72°C combined with desiccation; or 
(c) UHT combined with another physical  treatment referred to in (b) above. 
 
4. Milk products to be export ed to Japan must be produced, pa ckaged and stored from raw milk 
collection to shipment of final products to J apan without contam ination by pathogens of animal 
infectious diseases or commingling with milk pr oducts which do not meet Articles 1 to 3 above. 
 
5. Packages and containers such as carton boxes fo r milk products to be ex ported to Japan must 
be clean and hygienic.  
 
(Issue of the health certificate)   
6. The competent authority of t he exporting country must be res ponsible for issuing the health 
certificate for milk products to  be exported to Japan, stating t he following items in detail in 
English after confirming the m ilk products comply with thes e animal health requirements. 
(1)  Statement that ‘all the requirements of ‘‘An imal Health Requirements for milk products to 
be exported to Japan from countries other t han Listed countries’’ are satisfied.’(*1) 
(2) The name of the item, quantit y and the production date of t he products, and the species of 
origin of raw milk as an ingredient 
(3) The establishment number of the facility where the final products to be exported to Japan 
are treated finally(*2,*3) 
(4) Intended use (for animal c onsumption (including raw mate rials for animal feed), human 
consumption, etc.) 
(5) With regard to Article 3 above, a relevant FM D virus inactivation treat ment 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 date, authority name and pl ace of issue of the health ce rtificate, and t he name and title 
of the signer. 
 
In addition, the health certificate must be in ei ther the model format presented by the Japanese 
animal health authority or any other equivalent format.  
 *1. *Alternatively, it is also acceptable to state Article 1, 2,  3, 4 and 5 of ‘‘Animal Health 
Requirements for milk products to be export ed to Japan from countri es other than Listed 
countries’’. 
*2. “The facility” means a fac ility that produces(inc luding only repacking, blending, etc.) final  
products (cheese, skim milk powder  etc.) to be exported to Japan. 
*3.  Alternatively, it is also acceptabl e to state name and address of the facility.   G/SPS/JPN/471/Add.4  
6/6 
  
Listed countries 
 
Australia, Austria, Belarus, Belgium, Belize,  Brazil (State of Santa Catalina only), 
Bulgaria, Canada, Chile, Costa Rica, Cr oatia, Cyprus, Czech Republic, Denmark, 
Dominican Republic,  El Salvador, Estonia, Finlan d, France, Germany, Greece, 
Guatemala, Honduras, Hungary, Iceland, Ireland, Italy(Including Sardinia island), Latvia,  
Liechtenstein, Lithuania, Lux embourg, Mexico, Netherl ands, New Caledonia, New 
Zealand, Nicaragua, Northern Mariana Isla nds, Norway, Panama, Poland, Portugal,  San 
Marino, Singapore, Slovakia,  Slovenia, Spain, Sweden, S witzerland, United Kingdom 
(Great Britain and No rthern Ireland only),  Ukraine, U.S.A. (Mainl and, Hawaii, Guam and 
Puerto Rico only) and Vanuatu  
 (52 areas) Annex