The s ummary of the  amendment to the  Cabinet Order and Ordinance for 
Enforcement of the  Food Sanitation Act and other relevant ordinances  
 
 
 
The government of Japan is planning to amend the Cabinet Order and Ordinance 
for Enforcement of the Food Sanitation Act and other relevant ordinances in order  
to enforce the amendment to the Food Sanitation Act  (hereinafter referred to as 
“Act”)  promulgated in June 2018 . 
 
Background  
○ The amendment to the Act was established in June 2018 and its 
summary was previously  informed to  the WTO as G/SPS/N/JPN/55 2 in 
January 2018.    
○ In response to the establishment of the amendment to the Act, the 
government of Japan is planning to amend the Cabinet Order and 
Ordinance for Enforcement of the Food Sanitation Act and othe r relevant 
ordinances to introduce food hygiene control based on HACCP principles  
to food business operators , to ensur e safety  of imported foods and legaliz e 
administration related to food export, to improve sanitary regulations for 
utensils, containers and packaging, to revise the licensin g system for food 
business, and  to establish a notific ation system for food business and a 
reporting system for food recalls . 
○ Cabinet Order and Ordinance for Enforcement of the Food Sanitation 
Act and other relevant ordinances will be amended in the summer of 2019. 
Most of t hese amendments will come into effect  in the summer of 2020 *. 
*(d) and (e) will come into effect  in the summer of 2021.  
 
Outline of the amendments  
<Cabinet Order and Ordinance for Enforcement of the Food Sanitation Act 
(hereinafter referred to as “the Cabinet Order” and “the Ordinance” 
respectively), Ordinance for E nforcement of the Slaughterhouse  Act, and 
Ordinance for Enforcement of the Poultry Slaughtering Business Control and 
Poultry Meat Inspection Act (hereinafter referred to as “the Poultry 
Processing Act”) >  
 
 (a) Requirement of food hygiene control based on HACCP principles  
 
○ The standards for food hygiene control and its plan to be developed by 
food business operators are to be stipulated by Ordinance and Ordinances 
for Enforcement of the Slaughterhouse  Act and the Poultry Processing Act and to be equivalent with the contents of the Codex General 
Principles of Food Hygiene (CAC/RCP 1 -1969).  
 
○ Food business operators described  in item (ii) of paragraph (1) of Article 
51 of the Act (the one s for whom some fle xibility is applied in terms of 
HACCP implementation) are to be specified by the Cabinet Order as 
follows, also taking into consideration of the Codex General Principles of 
Food Hygiene:  
1. Among manufacturers or processors of food and food additives, the 
one with food handlers  not exceeding 50 people at a facility;  
2. Among manufacturers or processors of food and food additives, the 
one who retails food or food additives mainly in a shop adjacent to the 
facility where it manufactures or processes food or food additives;  
3. food business operator who cooks food;  
4. food business operator who stores, transports or sells packaged food 
or food additives only, or any other food business operator to be 
specified by the Ordinance as such who are able to conduct necessary 
hygiene control by following good hygiene practice stipulated in item 
(i) of paragraph (1) of Article 51 of the Act.  
 
〇 With regard to the hygiene control at slaughterhouses and poultry 
processing facilities, standard procedures for Prefectural governments to 
verify hygiene plans at facilities will be developed.  
 
 
 （b) Ensuring safety of imported foods and Legalizing administration 
related to food export  
○ Products newly added to those which are specified by the Ordinance  
according to paragraph  (2) of Article 10 of the Act (imported foods to 
which a health certificate must be attached) are milk and milk products, 
excluding butter oil, processed cheese, ice cream products, formulated 
milk powder, liquid infant formula, milk drink and products storabl e at 
room temperature (hereafter, “milk products”).  
 
○ For milk or milk products, the matters specified by the Ordinance 
according to paragraph (2) of Article 9 of the Act (matters to be described 
in an health certificate) are as follows;  
1. For meat, milk  or organs of livestock or poultr y, the types of livestock  
or poultry, and for meat products, milk or milk products , the names and 
the types of meat, milk or organs of ingredie nt 
2. The quantity and the weight  3. The address and name of the consignor (for a juridical person, its 
name and location)  
4. The address and name of the consignee (for a juridical person, its 
name and location)  
5. The following matters concerning the name, etc. of the agency which 
conducted the inspections  
(1)  For milk or milk produ cts, the name of the agency which issued 
an certificate, or the name and title of the official who signed the 
certificate  
(2)  For meat products, milk or milk products , the production facility 
where said products were manufactured  
6. The fact that producti on of milk or milk product was carried out in a 
sanitary manner based on equal or better criteria than those of Japan 
for sale for human consumption  
7. The date (day and month) when the production of meat products, milk 
or milk products was carried out  
 
 ○ Regarding an health certificate for milk and milk products, the detailed 
information requested to exporting countries is described in Annex 1.  
 
○ Foods specified by the Ordinance according to paragraph (1) of Article 
11 of the Act (imported foods requiring hygiene control by HACCP)  are 
meat and offal derived from livestock and poultry.  
 
○ Procedures to designate exporting countries, regions or establishments 
by the Minister of Health, Labour and Welfare a ccording to paragraph (1) 
of Article 11 of the Act are described in Annex 2.  
 
 
○ Foods specified by the Ordinance according to paragraph (2) of Article 
11 of the Act (foods requiring to demonstrate the status of hygiene control 
at the places of production  in terms of food hygiene) are oysters for eating 
raw and puffer fish.  
 
○ the matters specified by the Ordinance according to paragraph (2) of 
Article 11 of the Act (matters to be certified for foods requiring to 
demonstrate the status of hygiene control at the places of production in 
terms of food hygiene) are as follows;  
1. For puffer fish, the type (scientific name) ※ 
2. The quantity and the weight  
3. The address and name of the consignor (for a juridical person, its name and location)  
4. The address and  name of the consignee (for a juridical person, its 
name and location)  
5. The name, address and registration number of the facility where 
processing or, for oysters for eating raw, purification is performed  
6. The following matters on waters where the prod uct is harvested etc.  
 (1) For oysters for eating raw, the waters where they were harvested  
 (2) For puffer fish, the waters where it was caught ※ 
(3) The fact that the product was processed in a sanitary manner  
7. The date of the following matters, e.g. ha rvest  
(1) For oysters for eating raw, the harvest  
(2) For puffer fish, the fishing  
8. The fact that the product was processed in a sanitary manner b
ased on equal or better criteria than those of Japan in the facility 
authorized by the government of the exporting country for oysters f
or eating raw and , for puffer fish , the facility supervised by the gov
ernment  
   ※ For puffer fish, the waters and the types are limited to ones 
authorized for export.  
  
(c) Improvement of sanitary regulations for utensils, c ontainers and packaging 
considering international consistency  
○ The materia l specified by the Cabinet Order according to paragraph (3) 
of Article 18 of the Act (The material subject to the Positive List: 
specifications and standards) is synthetic resin.  
 
○ The following issues are established according to the guideline for 
safety assurance in the manufacture etc. of food utensils, containers and 
packaging 
(https://www.mhlw.go.jp/english/topics/foodsafety/containers/dl/guidelin
e-english.pdf).  
 The standards s pecified by the Ordinance according to item (i) of 
paragraph (1) of Article 52 of the Act (The standards of the 
prerequisite programs)  
 The standards specified by the Ordinance according to item (ii) of 
paragraph (1) of Article 52 of the Act (The standards  of Good 
Manufacturing Practice)  
 Matters for information provision specified by the Ordinance 
according to paragraph (1) and (2) of Article 53 of the Act (Obligation 
to provide information by the business operators who manufacture 
and sell utensils, contai ners, and packaging; and obligation to make effort to provide information by the business operators who 
manufacture and sell raw materials)  
Matters for explanation specified in paragraph (1) and (2) of Article 53 of 
the Act are as follows:  
1. Information c onfirms the following points: the products using the 
materials specified by the Cabinet Order according to paragraph 3 of 
Article 18 of the Act are those specified in item (i) or (ii) of paragraph 
(1) of Article 53 of the Act, or the raw materials using th e materials 
specified by the Cabinet Order  are appropriate as raw materials used 
for the products satisfy the item (i) or (ii) 
2. Information confirms the subjects of above information 1  
 
 The Positive List (specifications and standards) and the exceptions of 
regulations by the List (migration levels that are no concern relevant to 
human health) will be established separately.  
 
(d) Revision of licensing system and establishment of notification system for 
food business  
 
○ Reclassify the current 34 categories of food business requiring business 
license (such as catering, processing and manufacturing of specific food 
items etc.) into about 32 categories, for each of which facility criteria 
should be established by Prefectural  governors according to  the 
provisions of Article 54 of the Act.  
 
○ The facility criteria described in Article 54 of the Act will be stipulated 
by the Ordinance and they should be taken into consideration by 
Prefectural governors when establishing their ow n facility criteria. These 
facility criteria will be divided into general criteria covering all types of 
food business and business -specific criteria.  
 
Exemption from notification  
 ○  Food businesses described in paragraph (1) of Article 57 of the Act as 
they are likely to impose low impact on public health and thus to be 
exempted from notification are to be specified  by the Cabinet Order as 
follows:  
1. business which sells or stores packaged food or food additives 
resistant to decomposition or deterioration resulting in impairment 
of its safety when stored at room temperature for a prolonged period 
of time (including vending machines);  
2. business which does not directly handle food, such as food importers and sellers of utensils/containers/packaging for food an d food 
additives;  
3. business which stores or transports food or food additives at the 
request of customers based on a contract (except cold -storage 
business);  
4. business manufacturing food utensils , containers  and packaging 
(limited to food utensils , containe rs and packaging using materials 
other than those specified by paragraph (3) of Article 18 of the Act).  
 
(e) Establishment of a reporting system for food recalls  
 
Exemption from reporting a recall  
○The conditions described in the chapeau of item (ii) of pa ragraph (1) of 
Article 58 of the Act as there is no concern of adverse health effects and 
thus to be exempted from reporting a recall are the cases where the food 
or food additive in question will already have passed its expiration date 
or best before date  by the time when the food business operator recognizes 
any violation of the Act or its possibility.  
 
Procedures for reporting of recalls for food business operators and Prefectural 
governors  
 ○ With regard to a recall, the items to be notified (by a food  business 
operator to a Prefectural governor or by a Prefectural governor to the 
Minister of Health, Labour and Welfare), according to  the provisions in 
paragraph (1) of Article 58 of the Act, are as follows:  
1. the name and address of the food business operator who conducts a 
recall (in the case of a juridical person, its name and the location of 
the office). If this food business operator is not a manufacturer of the 
food or food additives to be recalled, also t he name and address of the 
manufacturer (in the case of a juridical person, its name and the 
location of the office);  
2. the trade name, the generic name, the contents of labelling and any 
other information necessary to specify the food or food products to b e 
recalled;  
3. the reason why the food or food additives to be recalled is considered 
to fall under either item in paragraph (1) of Article 58 of the Act (the 
reason why the recall is necessary);   
4. the sales destinations, and sales date and quantity of each 
destination (identified at the point of the commencement of the 
recall);  
5. the date of commencement of the recall;  6. the methods of the recall;  
7. with or without of actual cases of adverse health effects resulting 
from the consumption of the food or food additive s to be recalled;  
8. (for Prefectural governors only)  the degree of risk of adverse health 
effects which could be caused by the recalled food or food additives.  
 
 1 
 Annex 1 
 
Contents which the MHLW requi res to exporting countries on a  health certificate  
for milk and milk products  (draft) 
 
 
 
1. Objectives of request for information  
 
According to Item 2, Article 10 of the amended Food Sanitation Act, Japan requires 
countries exporting milk or milk products to Japan to attach a health certificate 
to them. MHLW needs to confirm that exporting countries can demonstrate that milk 
or milk products exported to Japan me ets requirements under the Act, such as “milk 
and/or milk product has been produced from raw milk obtained from healthy animals” 
and “the fact that production was carried out in a sanitary manner based on equal 
or better criter ia than those of Japan”.  For this purpose, MHLW will request the 
exporting countries to provide information on its laws and regulations related to 
such food.  
 
 
2. Information requested  
MHLW will ask exporting countries to p rovide answers to the following questions 
(Yes or No, or description) with indicating t he relevant provision number of the 
relevant laws and regulations, and to attach copies of such laws and regulations.  
 
I. Laws and regulations regulating milk and milk products  
 
I-1. Outlines of regulations on milk and milk products  (the names of the relevant 
laws and regulations, provisions covering requirements to be certified, such as 
“milk and/or milk product has been produced from raw milk obtained from healthy 
animals” and “the fact that pro duction was carried out in a sanitary manner 
based on equal or better criteria than those of Japan” etc.) ※ 
 
* Particular information to be included in the relevant laws and regulations  
 Standards for milk processing plants and milk product manufacturing pl ants 
 Standards on hygiene control in such plants (if they are in align ment with the 
Codex relevant guidelines （CAC/RCP1 -1969、CAC/RCP57 -2004）, provide the information)  
 Specifications of milk and milk products (general and by each item), standards for 
manufacturing and storage, standards for use of food additives and standards for 
packages  
 2 
 I-2. The scope of milk and/or milk products in the relevant regulations in the 
exporting  country 
I-3. Whether or not milk and/or milk products imported from other co untries are 
used as ingredients for milk and/or milk products exported to Japan (if yes, the 
way to make sure that the ingredients are processed or manufactured in a sanitary 
manner) 
 
 
II. Official control systems for manufacturing and exporting milk and m ilk products  
 
II-1. The name of competent authorities (CAs) in charge of development and 
implementation of the regulations above, the organization chart and the number 
of officers involved  
 
II-2. Systems of supervision and inspection by CAs for processing plants 
(relationship between national and local governments, whether or not there is 
their competence of inspection and on -site investigation etc.)  
 
II-3. Whether or not processing plants shall not be established without permits 
from the CAs  (if yes, whether or not the CAs concerned may cancel permits)  
 
II-4. The CAs and procedures to issue a health certificate (whether or not the 
exporting  country has already issued it for export to other countries)  
 
II-5. Existing formats of health certificates to ot her countries  and Japan (related 
to animal health)  
 
II-6. How to make sure to use raw milk obtained from healthy animals  (e.g. guidance 
to farmers, test of raw milk etc.)  
 
 
III. The status of introduction of HACCP based hygiene control  
 
III-1. Whether or n ot hygiene control based on HACCP is obliged in the exporting 
country (if yes, whether or not any guideline on HACCP -based hygiene control is 
developed by the gove rnment or industry associations.  If yes, please provide the 
guideline .) 
 
 
IV. The status of i mplementation of official observation by competent authorities 
and hygiene control by facilities (including the status of compliance with the 3 
 relevant l aws and regulations)  
 
IV-1. The number of processing plants in the exporting  country (the latest data), 
the number of supervision/inspection for them and the results (for the last three 
years) 
 
IV-2. Voluntary test program that owners of processing plants implement to ensure 
compliance with the relevant regulations  
 
IV-3. Sampling  and test program on microorganisms, residues of antibiotics, 
specifications (e.g. alcohol test) etc. for export of milk and/or milk products, 
and the test result for the latest one year  (if such program applies to all 
products, regardless domestically dis tributed or exported, test results of 
domestic ones can be included in the data)  
 
IV-4. Summaries of issues that have occurred in the past year  (non-compliances with 
the relevant regulations above, e.g. residue of veterinary drug)  
 
 1 
 Annex 2 
 
Designation of countries , regions  or establishments eligible to export 
meat and poultry meat  by the Minister of Health, Labour and Welfare 
based on the paragraph  1 of Article 11 of the amended Food Sanitation 
Act 
 
1. Backgrounds  
 
The amended Food Sanitation Act  requires implementation of hygiene 
control based on HACCP for imported food defined by the Ministerial 
Ordinance (meat and poultry meat) , and the food shall not be imported  
for sale , unless the Minister of Health, Labour and Welfare recognizes 
that they are manufactured or processed in a country  or region, or at 
an establishment which takes HACCP based control measures. This measure 
is along with requirement of food hygiene control based on HACCP 
principles for food business operators in Japan  according to Article 50 -
2.2 of the amended Act . 
 
 
2. Requirements for designation of a country or region, or  an 
establishment which takes HACCP based control measures  recognize d by 
the Minister of Health, Labour and Welfare  
 
 The government of designated export country shall certify  and inspect 
an establishment complying with requirements for export of meat and 
poultry meat to Japan  
 The government shall provide a list of establis hments which meet the 
requirements for export of such food to Japan  
 The Ministry of Health, Labour and Welfare  (MHLW) periodically  audits 
to review the system of the exporting country.  
 
* Before the enforcement of the amended Act,  the government of export 
country shall present MHLW copies of the laws and regulations , the 
relevant information , as well as information ensur ing that the control 
system described above  is established  based on guidelines which will 2 
 be notified by MHLW.  MHLW will discuss with expor ting country and 
conduct on -site investigation, in order to confirm that their control 
system such as the scheme to ensure  the establishment to perform 
hygiene control based on HACCP and the supervisory framework by the 
government is equivalent  or better to those in Japan.  
 
* In case that it is impossible for the government of exporting country 
to take the procedures mentioned above points described in 2 , the 
establishment which is willing to be designated may apply for the 
designation to MHLW, through the  government of the exporting country, 
in accordance with procedures set by MHLW.  
 
 
3. Timelines (related to enforcement of the amended Act)  
 
MHLW will discuss with the countries etc. which have already exported 
meat and/or poultry meat to Japan, so that it  can notify such 
countries etc. as a ministerial announcement by June 2021 (i.e. by the 
end of 1 year transitional period after the enforcement of the amended 
Act).