The s ummary of the  amendment to the  Food Sanitation Act  
 
 
The government of Japan is planning to amend the Food Sanitation Act.  
 
Background  
Approximately 15 years have passed  since the last revision of the Food 
Sanitation Act, and in the meantime, dietary pattern and the environment 
surrounding  food in Japan has been  changing, such as increasing demand for 
precooked food and eating -out due to the increase of double -income hous eholds and 
elderly single households , and interest in health foods , as well as  the progress of 
globalization of foods because of increase of imported foods.  
   
Also,  to control the occurrence and expansion of interregional  food poisoning 
cases  and to suppress the number of food poisoning  incidents which is now slowing 
its pace of decline, further hygiene control by food business operators (FBOs) and 
appropriate  response by national and local governments  are urgent issues.  
 
In addition, bearing in mind the Tokyo Olympic Games and the Paralympic 
Games in 2020 and aiming for further promotion of food export , food hygiene 
control  consistent with the international standards is also required.  
 
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, 
FBOs and experts.  
 
Outline  of the amendment  
 (a) Strengthening measures  taken by national and local governments for 
interregional food poisoning cases  
In order to prevent occurrence  and expansion  of interregional food poisoning 
cases , national and local governments  shall mutually cooperate .  As a framework  
of such cooperation , the Minister of Health, Labo ur and Welfare  may establish a 
council for wide area cooperation whi ch is composed of  relevant parties of  the 
national  and local  government s etc.  
 
When urgent response is required, the Minister of Health, Labo ur and Welfare 
may utilize the council to address  interr egional  food poisoning cases.  
 
  (b) Requirement  of food hygiene control based on  HACCP  principles   
In order to increase the level of food hygiene  control by food business operators 
(FBOs) in Japan  and to be aligned with the international standards , FBO s* 
including  operators of  slaughterhouse s and poultry  processing plants  shall  develop 
and comply with a plan on food hygiene control , adapted to their own situations 
(e.g. manufacturing method s and ra w materials ) covering both good hygiene  
practices such as maintenance and cleaning  of the facilities  and control measures  
critically important to prevent or eliminate specific hazards.  For certain category 
of FBOs , some flexibility  will be applied taking into account  the nature and size of 
the operation .  
 
* Industries considered having  a low impact on public health  will be excluded from 
the scope  (e.g. business  that only sells packaged foods that can be stored at room 
temperature )  
 
The current "comprehensive hygiene control  manufacturing process approval 
system" (Food Sanitation Act Article 13) (i.e. ministerial certification  of individual 
FBOs  who conduct  hygiene control based on HACCP principles ) is rescinded . 
However, the mechanis m will be maintained  allow ing FBOs to manufacture food 
in methods different from the manufacturing and processing standards pro vided in 
the Food Sanitation Act  when  the Minister of Health, Labo ur and Welfare 
individually confirms that they take appropriate  measures to prevent the 
occurrence of  food hygiene hazards.  
 
(c) Establishment of an adverse event reporting system for foods containing the 
designated substances*  
 
* The substances and/or ingredients with a probability that the uncontrolled use of 
those may cause serious adverse health consequences will be designated by the 
Minister of Health, Labour and Welfare.  
 
To prevent serious adverse events, FBOs that sell foo ds containing the designated 
substances shall report health -related adverse events associated with the use of 
their products to the Ministry of Health, Labour and Welfare through local 
governments.   
 
In addition, relevant stakeholders shall cooperate with the Minister of Health, 
Labour and Welfare for a survey on an adverse event and provide related 
information.  
 
 (d) Improvement of sanitary regulations for utensils, containers and packaging for 
food an d food additives considering  international consistency  
 
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 materi als, such as synthetic resins , for which 
specifications are not established, except case s 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 manuf acturing practices.  
 
Manufacturers and sellers of utensils, containers and packaging shall provide the 
business entities where the products are sold with information that the product s 
conform to the relevant specification s. 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.  
 
 (e) Revision of  licensing system and establishment of notification system for food 
businesses  
 
Prefectural  governments shall take into consideration the  criteria to be specified 
by the Ordinance of the Ministry of Health, Labo ur and Welfare  when establishing 
their own food business licens ing requirement s in the prefectural ordinance , which 
now greatly differ fr om prefecture to prefecture .  
 
(Note) The category of food b usiness es requiring licens e which are specified by 
the Cabinet Order will also be revie wed in light of the current situation .  
 
Those who intend to operate food business shall notify their local government  
prior to doing so. F ood related businesses with  little impact on public health  will be 
exempt .  
 
 (f) Establishment of a reporting system for food recall s  
 
When a food is in violation of  the Food S anitation Act  and is recalled , the 
manufacturers or sellers shall notify the prefectural governor of initiation  progress 
of the recall, unless any food safety hazard etc is not expected to occur . The 
governor who received the information shall report it to the Minister of Health, 
Labo ur and Welfare.  
 
 
  (g) Ensuring  safety of imported foods  and Legalizing  administration related to 
food export  
 
Foods requiring measures  to control processes particularly important to prevent 
occurrence  of adverse health effects *, food hygiene control based on HACCP  
principles , in exporting countries  shall not be import ed, unless they are  
manufactured at a facility where  the competent authorities o f the exporting 
country confirm  that such measures  are taken .  
*Food s such as meat and  poultry meat , etc. are assumed.  
 
In addition, when importing food of which risk may increase depending on hygiene 
practices*, health certificate issued by the exporting country which describes the 
status of hygiene control shall be attached.  
* Milk, milk  products, oysters to be eaten raw and puffer fish are assumed.  
 
Export food -related measures such as issuance of health certificates and other 
necessary measures by local governments are stipulated.  
 
 (h) Other  
Necessary provisions , such as provisions on administrative measures,  penalties 
and transitional measures  are developed .  
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