JFS-A Standard Document(Sector: CⅠ, CⅡ, CⅢ, CⅣ/K)<Manufacture of food products andManufacture of chemicals (including
biochemical products)>
Version 3.0[Guidelines]
Edition 1.0

Japan Food Safety Management Association

July 25 ,2022

Table of Contents
Introduction .............................................................................................................................................................................. 3
Ⅰ Food Safety Management Systems (FSM) .......................................................................................................10
FSM 1 Management or senior management responsibility .................................................................................10
FSM 2 Commitment of management or senior management ............................................................................12
FSM 6 Food Safety Policy and Goals.........................................................................................................................12
FSM 9 Document and record management.............................................................................................................13
FSM 12 Resource Management..................................................................................................................................14
FSM 13 Purchasing..........................................................................................................................................................14
FSM 14 Traceability .........................................................................................................................................................17
FSM17 Control of Measuring and Monitoring Devices .........................................................................................18
FSM 22 Serious Incident Management ....................................................................................................................20
FSM 23 Product Release ...............................................................................................................................................21
FSM24 Control of non-conforming products ............................................................................................................22
FSM25 Corrective Action................................................................................................................................................22
Ⅱ Hazard Analysis and Critical Control Point(HACCP) ......................................................................................24
HACCP Step 1 Formation of HACCP team .............................................................................................................24
HACCP Step 2 Product Information Description.....................................................................................................25
HACCP Step 3 Identification of Intended Use..........................................................................................................25
HACCP Step 4 Construction of Flow Diagram ........................................................................................................25
HACCP Step 5 On-site Confirmation of Flow Diagram.........................................................................................28
HACCP Step 6,7 (Principle 1 and 2) Establishment of methods for analyzing hazards and controlling
critical hazards......................................................................................................................................................................28
HACCP Step 8, 9 (Principle 3, 4) Establishment of control criteria and monitoring methods ......................30
HACCP Step 10 (Principle 5) Establishment of corrective actions (improvement measures) ..................31
HACCP Step11 (Principle 6) Setup of verification procedures ..........................................................................32
HACCP Step 12 (Principle 7) Record keeping ........................................................................................................33
Ⅲ Good Manufacturing Practice (GMP)....................................................................................................................34
GMP 2 Site Management...............................................................................................................................................34
1

GMP 3 Design, construction and layout of facilities and equipment, and work and product flow lines ..36
GMP 4 Control of critical hazards that cannot be controlled by the control measures in HACCP
procedures 6 and 7 (prevention of cross-contamination)........................................................................................38
GMP 5 Personnel Facilities............................................................................................................................................41
GMP 6 Sanitation, work clothes and health management of employees, etc. ..............................................42
GMP 7 Training..................................................................................................................................................................45
GMP 8 Housekeeping, cleaning, sterilization and disinfection............................................................................46
GMP 11 Air and water management ..........................................................................................................................48
GMP 12 Waste Management .......................................................................................................................................51
GMP 13 Pest control........................................................................................................................................................52
GMP 15 Transport ............................................................................................................................................................54
GMP 17 Stock Management........................................................................................................................................56
GMP 18 Devices and Tools.........................................................................................................................................56
GMP 19 Maintenance ....................................................................................................................................................59

Disclaimer：This translated document is machine translated by JFSM and is provided for information purposes only.
In the event of a difference of interpretation or a dispute, the original Japanese version of this document is binding.

2Introduction
This guideline provides ideas and specific examples of what organizations should implement withregard to the JFS-A Standard Ver. 3.0 For food business operators (organizations) to comply with JFSA standard.
Food safety management systems vary depending on many factors such as the type of industry,business category, business scale, and social background of the food business operator (organization).
It is envisioned that each organization will use these guidelines as a guide for establishing a food safety
management system suited to their own needs.
The overall JFS standard is shown in Figure 1. These guidelines are for the JFS-A for the food
manufacturing sector (CI - CIV) and for the "chemical products (including biochemical products)
manufacturing sector (K). (Table 1)
The JFS-A standard is intended for food business operators (organizations) aiming to improve the levelof food safety, mainly in general hygiene management, and to operate HACCP in a flexible manner.
In this guideline, illustrative examples in the form of figures and tables are included where necessary to
make it easier for food business operators (organizations) to understand.
[Two operational
mechanisms][A/B/C standard with continuity]

JFS-C Certification
Program(Utilizes
internationally accepted
GFSI-approved standards,
ISO and other certification
mechanisms)

International Trade
Standards used forinternational trade

stage

C

Standards

BA

including

JFS-A/B Conformity
Certification
Program(Establish asystem for small- andmedium-scale foodbusinesses to conduct
their own verification)

Sanitation
managementcentered standard
incorporating the
HACCP concept

Types of requirements
Figure 1: Overall view of the JFS Standards and Certification/Certification of Conformity Program3

Table 1: List of Sectors by GFSI
CodeSector/Subsector

Code

Sector/Subsector

AI

Farming of Animals for Meat/ Milk/
Eggs/ HoneyFI

Retail / Wholesale

AII

Farming of Fish and Seafood

FII

Food Broker / Agent

BI

Farming of Plants (other than grains
and pulses)

H

Provision of Food Safety Services

BII

Farming of Grains and Pulses

G

Provision of Storage and Distribution Services

BIII

Pre-process handling of plant products

I

Production of Food Packaging

C0

Animal primary conversion

CI

Processing of perishable animal
products

CII

Processing of perishable plant products

CIII

Processing of perishable animal andplant products (mixed products)

CIV

Processing of ambient stable productsD

Production of feedE

Catering

Hygienic Design of Food Buildings and
JI

Processing Equipment (for building constructors
and equipment manufacturers)
Hygienic Design of Food Buildings and

JII

Processing Equipment (for building andequipment users)
Manufacture of chemical products (including
biochemical products)

K(Manufacture of additives, vitamins, minerals,
cultures, flavors, enzymes, processing aids,
etc.)

Reference: The GFSI Benchmarking Requirements version 2020 PART I＊：Sectors presented by GFSI that are covered by this standard document are framed.
The JFS-A standard is intended for businesses that implement HACCP in addition to general hygiene
control.
This Standard Document applies to the following“Food Manufacturing Sectors(CI, CII, CIII,
CIV)“and“Chemical Products (Including Biochemical Products) Manufacturing Sector(K)“(Table 1)※Pet food is included in the following food manufacturing sector
Food Manufacturing Sectors(CⅠ～CⅣ)

CI : Processing of perishable animal products
CII : Processing of perishable plant products
4

CIII : Processing of perishable animal and plant products (mixed products)
CIV : Processing of ambient stable products

Chemical Products (Including Biochemical Products) Manufacturing Sector(K)K : Manufacture of chemicals (including biochemical products)(Production of chemical products (including biochemical products) and cultures used as food ingredientsor processing aids in food production)
Chemical products herein refer to chemical products (including biochemical products) related to foodproducts.

《Features of JFS-A Standard Ver. 3.0》.
JFS-A Standard is intended for relatively small food business operators (organizations) to establish afoundation for food safety management.
(Feature 1) Even small-scale food business operators can aim for international standard food safety
To ensure consistency with international food safety initiatives, the GFSI (Global Food Safety Initiative)
Global Market Program Fundamentals (a program to improve food safety initiatives for small- andmedium-scale operators) is referenced.
It also incorporates the seven principles and 12 procedures of hazard control (HACCP) proposed by the
Codex Alimentarius Commission and allows for their flexible application.
(Feature 2) Easy-to-understand and easy-to-apply HACCPJFS-A standard enables flexible application of HACCP so that even small-scale organizations can work
on HACCP. For example, it allows for commonly published information and data to be referred to in
identifying risk factors (HACCP procedures 6 and 7), and for monitoring to be recorded using a logbook(HACCP procedure 12).
(Feature 3) Food safety level can be improved step by step.
Food business operators (organizations) can work on food safety management in accordance withinternational food safety management systems. In order to further improve their efforts, they can step up
to the higher level JFS-B and JFS-C standards. For reference, a comparison of the requirements of JFSA, B, and C standards is shown in Table 2.
(Feature 4) Complying with Japan's Revised Food Sanitation Law
Japan's Law for Partial Revision of the Food Sanitation Law, etc. (Law No. 46, 2008) requires smallscale business operators to implement "sanitation management appropriate to the characteristics of foodhandled" (so-called "sanitation management incorporating the HACCP concept"), which is necessary to
prevent the occurrence of food sanitation hazards (Food Sanitation Law, Article 50-2, Paragraph 2).
The requirements of the JFS-A standard are structured so that they can respond to this "sanitation control
incorporating the concept of HACCP." By appropriately implementing food safety management based on
the JFS-A standard, it will be easier to explain their efforts to food sanitation inspectors at health centers.
《How to use the JFS-A Standard Ver. 3.0 Guidelines》○ This guideline is intended to provide guidelines for understanding the meaning and purpose of therequirements of the JFS-A standard and what exactly should be implemented.
○ Desirable food safety management practices differ among food business operators (organizations).
In order to assist all food business operators who intend to work on the JFS-A standard to establish
5

a food safety management system (FSMS) that meets the requirements of the standard, thisguideline includes basic concepts and various examples related to the requirements. The JFS-A
standard requires food business operators (organizations) to work on food safety management
through on-site creativity and ingenuity, and does not require capital investment to comply with the
JFS-A standard. We hope that each food business operator (organization) will make maximum useof these guidelines and incorporate information from the government and industry associations to
implement food safety management initiatives in line with the JFS-A standards.
These Guidelines are organized as follows.
● Requirementｓ● Concepts, specific examples● Items to be referred to in the legal provisions related to food safety*※Legal provisions are taken from the Food Sanitation Law Enforcement Regulations of Japan.

〇 Points to be noted in this guideline➢ The specific examples in this guideline are not requirements, but are presented only as examples.
➢
It is not necessary to establish an implementation system according to the sequence of
requirements in the standard. It is also possible to build from Good Manufacturing Practices(GMP) and Food Safety Management (FSM).
➢
The legal provisions in these Guidelines are based on Japanese laws and regulations.
《Elements and Composition of JFS Standards (Sectors: CI - CIV/K)》
JFS standards consist of Food Safety Management Systems：FSM, which are requirements for the
management of an organization's activities, HACCP, which is a method of controlling hazards, andGood Manufacturing Practices (GMP), which are requirements for general hygiene management, andare interrelated. (Figure 2)

Figure 2: Basic structure of the JFS standard6

On the other hand, the order of standards is not the order in which implementation systems are
established. In practice, it is possible to start from GMP or FSM, and each organization should takeappropriate measures. This guideline provides ideas and specific examples to serve as a reference whenutilizing the JFS-A standards. However, these are examples only, and other ideas and methods may be
selected if it can be explained technically and scientifically that the requirements of the JFS standards are
met. They can also be used together with research data and food safety theory from research institutes
and industry associations that have been published in the past, making use of technical information andknow-how possessed by individual industries.
The legal and regulatory requirements for food safety management systems vary by industry and region,
and while the JFS Standards and these Guidelines assume compliance with those legal and regulatory
requirements, they are not all encompassed in these Guidelines and should be reviewed by eachorganization on an individual basis. Therefore, it is necessary for each organization to individually confirm
the compliance.
We hope that these guidelines will help you understand JFS standards.

7

Table 2 Comparison of JFS-A/B/C

JFS-Astandard Version 3.0

JFS-Bstandard Version 3.0

JFS-Cstandard Version 3.0
supplementary requirements

No.

item（FSM 12 items）

No.

item（FSM 20 items）

No.

item（FSM 31 items）

FSM 1

Management or senior management
responsibility

FSM 1

Management or senior management
responsibility

FSM 1

Top Management Responsibility

FSM 2

Commitment of management or senior
management

FSM 2

Commitment of management or senior
management

FSM 2

Top Management Commitment
and Food Safety Culture

FSM 3

Management Review

FSM4

Compliance with food safety laws

FSM 4

Compliance with food safety laws

FSM 5

Food Safety Management System
and General Requirements

FSM 6

FSM 9

Food Safety Policy and Goals

Document and record management

FSM 6

Food Safety Policy and Goals

FSM 6

Food Safety Policy and Goals

FSM 7

Food Defense

FSM 7

Food Defense

FSM 8

Food Fraud Prevention

FSM 9.1

Documentation procedures

FSM 9.2

Control and storage of
documented information

FSM 10Specification Control of Purchased
or Provided Items and Services

FSM 9

Document and record management

FSM 11

Procedures and Instructions

FSM 11

Procedures and Instructions

FSM 12

Resource Management

FSM 12

Resource Management

FSM 12

Resource Management

FSM 13Purchasing

FSM 13.1

Purchasing

FSM 13.1

Purchasing

FSM 13.2

Supplier Performance

FSM 13.2

Supplier Performance

FSM 13.3

Outsourcing

FSM 14

Traceability

FSM 15

Product development

項目名をC規格に合せ
FSM 14

FSM 17

Traceability

Control of Measuring and Monitoring
Devices

FSM 14

Traceability

FSM 16

Allergen Management

FSM 16

Allergen Management

FSM 17

Control of Measuring and Monitoring
Devices

FSM 17

Control of Measuring andMonitoring Devices

FSM 18

Product labeling

FSM 18.1

Product labeling(B-to-C products)

FSM 18.2

Product labeling(B-to-B products,
work in progress,
semi-finished products)

FSM 19.1

Analysis and Testing

FSM 19.2

Environmental Monitoring

FSM 20Internal Audit

FSM 19Analysis and Inspection

FSM 21

Complaint Handling

FSM 21

Complaint Handling

FSM 22

Serious Incident Management

FSM 22

Serious Incident Management

FSM22

Serious Incident Management

FSM 23

Product Release

FSM 23

Product Release

FSM 23

Product Release

FSM 24

Identification of nonconformities andcontrol of nonconforming products

FSM 24

Identification of nonconformities andcontrol of nonconforming products

FSM 24

Identification of nonconformities
and control of nonconforming
products

FSM 25

Corrective Action

FSM 25

Corrective Action

FSM 25

Corrective Action

FSM 26

Utilization of Kaizen
suggestions from personne8

JFS-Astandard Ver.3.0

JFS-Cstandard Version 3.0
supplementary requirements

JFS-Bstandard Ver.3.0

No.

item（ＨＡＣＣＰ１０item）

No.

item（ＨＡＣＣＰ１２item）

No.

item（ＨＡＣＣＰ１２item）

HACCP step 1

Formation of HACCP team

HACCP step 1

Formation of HACCP team

HACCP step1

HACCP Team Assembly

HACCP step 2

Product Information Description

HACCP step 2

Product Information Description

HACCP step2

Product Description

HACCP step 3

Identification of Intended Use

HACCP step 3

Identification of Intended Use

HACCP step3

Identification of Intended Use

HACCP step4

Construction of Flow Diagram

HACCP step4

Construction of Flow Diagram

HACCP step4

Construction of Flow Diagram

HACCP step 5

On-siteDiagram

HACCP step 5

On-site Confirmation
Diagram

HACCP step5

On-site Confirmation
Diagram

HACCP step 6、７（principle1, 2）（Principle 1） Hazard Analysis（Principle 2） Critical Control Points

HACCP step 6（principle１）

Hazard Analysis

HACCP step6（principle1）

Hazard Analysis

HACCPstep 7（principle2）

Critical Control Points

HACCP step7（principle2）

Critical Control Points

HACCP step 8（principle3）

Establishment of Critical Limits

HACCP step8（principle3）

Establishment of Critical Limits

HACCP step 9（principle4）

Monitoring System

HACCP step9（principle4）

Monitoring System

HACCP、step 8、9（principle3, 4）

Confirmation

of

Flow

（Principle 3) Establishment of
Critical Limits（Principle 4) Monitoring System

of

Flow

HACCP step10（principle5）

Corrective Actions

HACCP step10（principle5）

Corrective Actions

HACCP step10（principle5）

Corrective Actions

HACCP step11（principle6）

Establish HACCP plan validation andverification procedures

HACCP step11（principle6）

Establish HACCP plan validationand verification procedures

HACCP step11（principle6）

Verification

HACCP step12（principle7）

Documents and Record

HACCP step12（principle7）

Documents and Record

HACCP step12（principle7）

Documents and Record

JFS-Astandard Ver.3.0
No.

item（ＧＭＰ１４item）

JFS-Bstandard Ver.3.0
No.

item（ＧＭＰ１４item）

of

Flow

JFS-Cstandard Version 3.0
supplementary requirements
No.

item（ＧＭＰ２２item）

GMP 1

Facility Environment

GMP 2

Site Management

GMP 2

Site Management

GMP 2

Site Management

GMP 3

Design, construction, layout ofbusiness site and work and productflow lines

GMP 3

Design, construction, layout ofbusiness site and work andproduct flow lines

GMP 3

Design, construction, layout ofbusiness site and work andproduct flow lines

GMP 4

Control of critical hazard factors thatcannot be controlled by criticalcontrol points (CCPs) （Preventionof cross-contamination）

GMP 4

Control of critical hazard factorsthat cannot be controlled by
critical control points (CCPs)（Prevention of crosscontamination）

GMP 4

Physical, chemical andbiological productcontamination risks andisolation

GMP 5

Personnel Facilities

GMP 5

Personnel Facilities

GMP 5

Personnel Facilities

GMP 6

Hygiene, workwear and Healthmanagement of personnel, etc.

GMP 6

Hygiene, workwear and Healthmanagement of personnel, etc.

GMP 6.1

Personal hygiene criteria for
personnel

GMP 6.2

Personnel workwear

GMP 6.3

Health management of
personnel

GMP 6.4

Application to nonbusinesspersonnel and visitors

GMP 7

Training

GMP 7

Training

GMP 7

Training

GMP 8Housekeeping, cleaning, sterilizationand disinfection

GMP 8Housekeeping, cleaning,sterilization and disinfection

GMP 8Housekeeping,cleaning,sterilization and disinfection

GMP 9

ReworkGMP 10Patrol and inspection of thesite

GMP 11

Air and water management

GMP 11

Air and water management

GMP11

Air and water management

GMP 12

Waste Management

GMP 12

Waste Management

GMP 12

Waste Management

GMP 13

Pest control

GMP 13

Pest control

GMP 13

Pest control

GMP 14

Acceptance of purchased items

GMP 15

Transport

GMP 16Storage

GMP 15

Transport

GMP 15

Transport

GMP 17

Stock Management

GMP 17

Stock Management

GMP 17

Stock Management

GMP 18Devices and Tools

GMP 18Devices and Tools

GMP 18Devices and Tools

GMP 19Maintenance

GMP 19Maintenance

GMP 19Maintenance9

［JFS-A Standard Documents Version 3.0 guideline］
JFS-A Standard (Sector：CI～CIV/K)< Manufacture of food products><Manufacture of chemicals (including biochemical products)>
Ⅰ Food Safety Management Systems (FSM)
FSM 1 Management or senior management responsibility●Requirementｓ
Management or senior management must share and operate an organizational structure
that, at a minimum, clarifies the duties and responsibilities of those who affect food safety.
Management or senior management must determine who is responsible for food safety
management.
●Concepts, specific examples
1. Role of management or senior management
1) Periodically verify and review the effectiveness of the company’s own efforts to ensure foodsafety and quality and to secure consumer confidence.
2) Clearly define an organizational chart that includes a communication system for instructions,
reporting, and consultation, and share it with employees.
2. Communication system for instructions, reporting, and consultation
1) In order to clarify the communication system for instructions, reporting, and consultation, it iseasier to manage by using meeting bodies and morning meetings to determine the activities
necessary for food safety. Instructions, reporting, and consultation are as follows.
(1) Instructions: The clarification of tasks and roles by a supervisor, manager, or other person.
(2) Reporting: The person who performed the work communicates the facts to a supervisor,
manager, or other person.
(3) Consultation: Confirmation of appropriateness should be obtained when it is not possible todetermine whether the work is appropriate, or when new activities are undertaken.
2) A communication system should be in place to ensure that safe food products can be shipped
even in the event of major changes in the manufacturing environment, such as a sudden
increase in order volume, accelerated shipping times, or personnel shortages. (Shipment
decisions are also related to procedures in FSM 23 (Product Release).
3. Food safety officer
1) Determine a food safety officer as the person responsible for food safety management.
2) The food safety manager′s knowledge of food safety policies, food safety knowledge, and fieldknowledge and experience in the organization will enable him or her to create an effective
system.
3) If there is a separate food safety manager or food safety officer, it is important to share
information and collaborate. They may also serve concurrently.

●Items to be referenced in legal provisions related to food safety10Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(i) Appointment of food sanitation supervisors, etc.
(a) Appointment of a person who conducts business prescribed in Article 51, paragraph (1) of the Act(including the cases where it is applied mutatis mutandis pursuant to Article 68 and Article 62,
paragraph (3) of the Act) Hereinafter referred to as a "business person" in this table) shall appoint a
person responsible for food sanitation. Article 68 A person engaged in a business prescribed in
Article 1, paragraph (1) of the Act (including cases where it is applied mutatis mutandis under Article
62, paragraph (3) of the Act) shall specify a person responsible for food sanitation. However, thisshall not apply to business persons prescribed in each item of Article 66-2, paragraph (4). In addition,a food sanitation supervisor prescribed in Article 48 of the Act may also serve as a person
responsible for food sanitation.
(d) A business person shall respect the opinions of the person responsible for food sanitation.
(e) A person responsible for food sanitation shall take necessary precautions to ensure compliancewith the measures prescribed in Article 66-2, paragraph (3) and endeavor to state necessary
opinions to a business person.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(i) c. Food sanitation supervisors shall comply with the following matters(1) Attend seminars held by prefectural governors, etc. or seminars approved by prefectural
governors, etc. on a regular basis, and endeavor to acquire new knowledge concerning foodsanitation (limited to business under Article 54 of the Act (including cases where it is applied mutatis
mutandis under Article 68, paragraph (3) of the Act)) (limited to businesses under Article 54 of the Act(including cases where it is applied mutatis mutandis under Article 68, paragraph (3) of the Act)) (i) To
make efforts to learn new knowledge concerning food sanitation (limited to businesses under Article
54 of the Act (including cases where it applies mutatis mutandis to Article 68, paragraph (3) of theAct))(ii) follow the instructions of a business person and take charge of sanitation control.
(e) A person responsible for food sanitation shall take necessary precautions to ensurecompliance with the measures prescribed in Article 66-2, paragraph (3), and shall endeavor tostate necessary opinions to the business person.
■Reference: "Food Hygiene Manager" and "Food Hygiene Manager

food sanitation manager

food sanitation supervisor

Laws and regulations
governing

Article 48 of the Food SanitationLaw

To be specified by prefectures,designated cities, etc. under Article
50, paragraph 2 of the Food
Sanitation Act.

Qualifications

national qualification

official certification

Report toprefectural governor

health care centre

TargetFor each licensed facility that
manufactures or processes the
subject food, additive, etc.

Per business license facility

Whether qualifications are
renewed or not

Basically none.
Regular attendance at practicaltraining courses is recommended.

Basically none.
Regular attendance at designatedtraining sessions is recommended.

11

FSM 2 Commitment of management or senior management●Requirementｓ
Management or senior management shall show evidence of its commitment to building,
implementing, maintaining and continually improving its food safety management systems.
The organizational structure for the implementation of the food safety management system must be
clearly defined and the duties must be made known to all employees. Evidence must also be
maintained that employees have been made aware of them.
●Concepts, specific examples
1. Management or senior management is responsible for the establishment, implementation,
maintenance, and continuous improvement of the food safety management system anddemonstrates its commitment to the establishment, implementation, maintenance, andcontinuous improvement of the system through the implementation of the following.
1) Develop a food safety policy.
2) All organizations involved in food safety and their respective roles are clearly defined and madeknown to all employees.
3) Communicate to employees in a timely manner the importance of compliance with laws andregulations, social norms, and rules set by the organization.
4) Establish business goals that support food safety.
5) Review the food safety management system in a timely manner.
6) Provide necessary resources in a timely manner.
7) Continuous improvement is required from verification of HACCP procedures 11 and FSM 14
and 22.
8) Other matters necessary for the establishment, implementation and maintenance of food safety
management systems
2. Evidence of employee awareness" includes documentation of communication through foodsafety-related employee communication opportunities and training, as well as wall postings.

FSM 6 Food Safety Policy and Goals●Requirementｓ
Management or senior management must have a clear, concise, written food safety policy.
●Concepts, specific examples
1. Management or senior management should create a food safety policy that meets safe andappropriate quality standards and that all employees understand and recognize. The policy should
be developed with the following in mind.
1) The organization provides safe and trusted food products to consumers based on the consumer.
2) Respond appropriately to changes in the social environment and comply with laws, ordinances,fair rules and social norms.
2. To ensure that all employees understand and recognize the food safety policy, for example;
1) Always teach it during employee training.
2) Posting the policy in a place where employees can see it on a regular basis.
3) Communicating the policy at morning meetings. etc.
3. Food safety policies should be developed with the involvement of management or senior
management, and food safety policies should be reviewed periodically for adequacy.

12

FSM 9 Document and record management●Requirementｓ
The organization shall establish and implement procedures to control processes to ensure foodsafety and to create, maintain, and preserve documents and records to evidence effective
operations.
●Concepts, specific examples
1. Record
1) Record keeping will enable the following actions to be taken.
(1) Clearly demonstrate appropriate food safety management systems to third parties(2) Able to analyze trends in activity over a period of time(3) Information can be shared within the organization
2) The records required will vary depending on the industry, type of business, size, and complexityof the organization's operations.
3) Some documents, mainly records, require long-term storage. Therefore, "appropriate storage
period" should be set in consideration of the shelf life of products and other factors.
Therefore, "appropriate storage period" should be set in consideration of the shelf life of products,
etc., and the documents should be managed so that they will not be disposed of by mistake
during that period.
4) Stablish "rules for amending records" so that corrections such as erroneous entries will not besuspected of being "falsification." For example, "Corrections should be made with double lines,
and the date of correction and the name of the person who made the correction should be written
on the corrected part, etc. It is desirable to establish a method that can be clearly understood by athird party.

●Items to be referenced in legal provisions related to food safety
Procedure Manual for Cleaning, Washing and Sanitizing
Food Sanitation Act Enforcement Regulations, Article 66-2, paragraph 3(ii) Taking into consideration the structure and materials of facilities and equipment, machineryand appliances, and the processes of manufacturing, processing, cooking, transporting, storing, or
selling food, a procedure manual (hereinafter referred to as a "procedure manual") to properly
implement measures necessary for public health in these processes(iv) Verify the effectiveness of the sanitation management plan and procedure manuals, andreview their contents as necessary.
Record Keeping
Article 66-2, paragraph (3) of the Ordinance for Enforcement of the Food Sanitation Act(iii) The status of implementation of sanitation management shall be recorded and preserved. The
period for keeping records shall be reasonably set based on the period until the food or additives
handled are used or consumed.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow meters, and for equipmentused for sterilization, disinfection, sanitization, or water purification, their functions shall be
periodically inspected, and the inspection results shall be recorded.
(iv) Control of water used, etc.
(e) When water suitable for drinking is used and sterilization or water purification equipment isinstalled, periodically check that the equipment is working properly and record the results.
13

(v) Rats and insect control
Rats and insects shall be exterminated at least twice a year, and records shall be kept for aperiod of one year.
(xiv) Others(a) To the extent necessary to prevent the occurrence of food sanitation hazards, efforts should bemade to prepare and preserve records concerning the source of purchase, state of manufacture orprocessing, shipping or sales destination, and other necessary matters concerning the food or
additives handled.
(b) When self-inspections have been conducted on manufactured or processed products, efforts
shall be made to preserve the records.
FSM 12 Resource Management●Requirementｓ
Management or senior management must ensure that the organization has the management
resources (people, goods, and money) necessary to implement the organization's food safety
initiatives (hazard control (HACCP) and Good Manufacturing Practices (GMP) in this standard).
●Concepts, specific examples
1. Management or management should make management resources (people, goods, and money)
available to ensure food safety.
2. Since management resources are limited, management should determine priorities and devise
ways to maximize effectiveness and ensure that food safety is implemented in a rational manner.
3. Management or senior management must constantly check to ensure that goals and plans are
not in line with reality and that front-line employees are well educated and trained to respond tochanges in the manufacturing environment.
4. Specific management resources are as follows(1) Human resources: employees (number and competence), etc.
(2) Goods: buildings, interiors, machinery, equipment, facilities, etc.
(3) Money: funds used for food safety activities
5. Example 1 of Rational Implementation: Training
External training, for example, can be difficult to conduct on a regular basis due to the high cost of
training a large number of workers, but if one person receives training and internal training is
conducted and deployed horizontally, it is possible to share the latest information throughout theorganization.
6. Example of Reasonable Practice 2: Interior
When a facility has deteriorated due to long-term use, it is effective to prioritize items in order of
their direct impact on food safety and to prepare the manufacturing environment over a period ofseveral years, rather than repairing everything at once.
FSM 13 Purchasing●Requirementｓ
The organization must establish and implement acceptance procedures to ensure that all externallyprocured raw materials, materials, and services that affect food safety comply with the organization's
requirements.
●Concepts, specific examples14

【 Purchasing】
1. This standard requirement requires that each organization establish and implement procedures toverify what it purchases from outside sources according to the magnitude of the risk it poses to foodsafety.
Procedures related to acceptance confirm that there are no discrepancies with the specifications
and contracts for the raw materials.
2. Confirmation method means to determine whether or not what is purchased from outside conforms
to the specifications established by the company, and specifically includes the following.
1) Inspection of a sample representative of the lot of what is to be purchased
2) Acceptance inspection of items to be purchased(e.g., temperature of acceptance, expiration/expiration dates, appearance, etc.)
3) Compliance with specifications in Certificate of Quality and Certificate of Analysis
3. The organization should periodically verify that the raw materials it purchases meet its standards
and that verification methods are implemented in accordance with its procedures
4. Where appropriate, an audit of the food safety management system of the manufacturer of what isbeing purchased or a review of the results of an audit by a third party is also an example ofverification.

15

Example of Supplier Data Entry Form
(Product Specification)

16

FSM 14 Traceability●Requirementｓ
The organization must establish procedures for implementing and maintaining tracing, covering allprocesses from the supplier (at least one step before) to the recipient (at least one step after) toensure product identification.
●Concepts, specific examples【Traceability in the FSM14】
1. Traceability records are important to confirm the manufacturing process of the subject productand to assure the safety of the food in the event of a serious product accident.
2. "Recipient" in this requirement basically refers to the purchaser one step further in the foodchain, and does not necessarily include the final consumer of the product. Recipient" may also
refer to wholesalers, retailers, etc., who handle the shipped product.
3. Shipped products are not always delivered to the purchaser, but may be delivered to awarehouse designated by the purchaser. Therefore, this requirement requires that the owner ofthe product and the "recipient" where the product is actually placed be known so that speedy
action can be taken when a problem occurs. Raw materials, containers and packaging
materials, services, and outsourced processes purchased from outside (hereinafter referred toas "raw materials, etc.") are also basically subject to traceability up to one step before.
4. Each organization is required to reliably identify the supplier (at least one step before) to therecipient (at least one step after). By linking these organizations, the entire supply chain can betraced.
【Recorded information required for traceability】
1. The maintenance and provision of record information necessary for traceability is as follows
1) Maintenance of traceability(1) Establish procedures related to traceability, depending on the product (including identifiable
labels for raw materials and products, as well as external procurement).
(2) Identify the status of raw materials at the main product stage (including primary processed
products).
(3) Establish lot units for products and raw materials as necessary.
(4) Establish and implement procedures for preparing and maintaining records of incoming andoutgoing shipments.
(5) Confirm that traceability is functioning, including work in process, recycled products, andreworked products.
(6) If necessary, product samples for each lot are stored.
2) Provide records related to traceability(1) Establish and implement procedures for the preparation of records and the retention ofrecords.
(2) When requested by the government, submit records related to traceability.

17

Examples of records required for process and tracing
accessioning
Product Information

manufacture

custody

shipping

Ingredient
Information

Daily Production
ReportProducttemperature records

Product Shipping
Information

Food Safety
Information

Inspection records

Inventory records

Destination
Information

Internal temperaturerecordDelivery Vehicle
Temperature
RecordProcess records

Receiving
Inspection Records
Environmental
Information

Delivery Vehicle
Temperature
RecordDelivery vehicle
hygiene records

Sampling
Information

pre-sampled
product record

GMP-Related
Records
Person in charge
information
Quality Control
Inspection andAcceptance

Delivery vehicle
hygiene records
Quality Control
Thermometer
Calibration Record―

FSM17 Control of Measuring and Monitoring Devices●Requirementｓ
The organization must manage to ensure that the devices and equipment it measures and monitors
to ensure food safety remain reliable at all times.
●Concepts, specific examples
1. It is necessary to check the accuracy of devices and equipment used in measurement andmonitoring activities to ensure food safety (calibration).
2. Creation of a list
Make a list of all devices and equipment used for all measurements and monitoring that need to
be checked for accuracy (fairness), clarify the frequency and methods of calibration andmaintenance, implement them to ensure that there are no omissions in the accuracy check, andrecord them. Records may be kept in a logbook.
Scales for weighing food additives, etc. (K sorbate, nitrite, etc.) for which use standards are set
under the Food Sanitation Law should also be added to the list. (For details on the standards foruse, check "Standards for Foods, Additives, etc. (Ministry of Health and Welfare Notification No.
370, December 28, 1959)", etc.)
The list should clearly state the allowable error range (e.g., ±2°C, ±5 seconds, etc.) for eachdevice.
3. Accuracy check (calibration) method
Timers should be checked to confirm that they match the time signal by using a telephone or othermeans.
For thermometers, refer to "Accuracy Check (Calibration) of Equipment" on page 50 of the "Guidefor Introduction to HACCP in Food Production" (available on the Ministry of Health, Labor andWelfare website).

18

From "A Guide for Introduction to HACCP in Food Production" (Ministry of Health, Labour andWelfare)4. Frequency of accuracy checks (calibration)
For precision instruments other than thermometers and timers (e.g., metal detection detectors),
the frequency should be set based on the schedule recommended by the instrument
manufacturer.
５．After accuracy verification (fairness) is completed, measuring/monitoring equipment, test
equipment, and inspection equipment should be managed to prevent damage and adjustment
errors.
６．If it becomes apparent that measuring, monitoring, testing, or inspection equipment is not
appropriate (i.e., has errors beyond acceptable limits), a record (including a logbook) should be
kept, posted at the site, and the equipment itself should be marked. Define procedures forevaluating potentially affected products and taking appropriate action.
19

●Items to be referenced in legal provisions related to food safety
Sanitation of facilities, etc.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of theFood Sanitation Act(iii) Sanitation control of facilities, etc.
(d) For instruments such as thermometers, pressure gauges, and flow meters, and forequipment used for sterilization, disinfection, sanitization, or water purification, their functions
shall be periodically inspected, and the inspection results shall be recorded.
FSM 22 Serious Incident Management●Requirementｓ
The organization must develop an incident response manual*, implement it in the event of anincident, and maintain it in effect at all times. This manual should also describe how to remove or
recall (recall) products, if necessary.
The products supplied by the organization must be tested at least once a year in accordance with
the Incident Response Manual.
※This manual is designed to ensure that when a food safety issue arises, appropriate actions andcontrols are taken to prevent the problem from escalating.
●Concepts, specific examples
1. A critical incident is a food accident that has the potential to affect food safety, but does notinclude accidents that do not affect food safety but may affect quality.
2. Since it is often not known at first whether an accident is serious or not, it is advisable to work on
the assumption of a worst-case scenario when an accident occurs.
3. In the event of a recall accident that has a serious impact on food safety, the incident should bereported to the audit company after the initial response is complete. In addition, once a voluntary
recall is initiated, it should be reported to the Ministry of Health, Labour and Welfare through thehealth center with jurisdiction.
4. An accident response manual documenting accident reporting, product removal, and productrecall shall be prepared as follows
1) In the event of a major accident, the response shall be based on relevant management
procedures such as nonconformity handling and complaint handling.
2) Appoint an authorized person in charge for critical incident management.
3) Establish and maintain an up-to-date emergency contact network for customers, consumers,
and relevant authorities.
4) Appoint a person responsible for providing information to customers, consumers, and relevant
authorities to ensure effective communication.
5) Clearly define internal communication mechanisms, such as notifications to employees.
6) Conduct mock drills and reviews at least once a year based on the accident response manual
to evaluate the company's ability to respond to serious accidents.
7) To establish the severity of the accident and whether or not there is a risk to customers, theaccident should be documented and evaluated. Accident records should include the following(1) The product involved and the location of manufacture(2) Quantity of product affected(3) The extent of the affected product (lot, batch, etc.)(4) Records of manufacturing
20(5) Quantity and location of shipments made
●Items to be referenced in legal provisions related to food safety
Emergency response
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(ix) Provision of information(b) A business person shall provide information on health hazards (limited to those diagnosed by aphysician and diagnosed as being caused or suspected to be caused by said food or additive;
hereinafter the same shall apply in this item) from consumers concerning the product. The
same shall apply hereinafter in this item). (ii) When obtaining information on the health hazardsof a product (limited to those that have been diagnosed by a physician and that are or aresuspected to be caused by said food or additive) and information on violations of the Law, abusiness person shall endeavor to provide said information to the prefectural governor, etc.
(c) When a business person obtains information about a product from a consumer or a person who
handles the product that is undeniably likely to lead to the occurrence of a strange taste or odor,
contamination with a foreign substance, or other health hazard, the business person shallendeavor to provide said information to the prefectural governor, etc.
Collection Mechanism
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(x) Recovery and disposal(a) In the event of food sanitation hazards or the threat of such hazards arising from a product, abusiness person shall, from the viewpoint of preventing health hazards to consumers, establish
a system for responsibility for recall, methods for alerting consumers, specific methods forrecall, and procedures for reporting to the prefectural governor, etc. having jurisdiction over thearea where said food or additive is handled, so that said food or additive can be quickly andappropriately recovered. The procedures for reporting to the prefectural governor, etc. withjurisdiction over the area where the facility handling the food or additive is located should beestablished.

FSM 23 Product Release●Requirementｓ
The organization must establish and implement appropriate procedures for product release(shipment).
●Concepts, specific examples
Product Release Procedures
1. the procedures for releasing a product include the following
1) Verify that the product to be shipped conforms to the product specifications.
2) Verify that not only the product specification but also the process control is appropriate.
2. The following items must be confirmed prior to release
1) Release procedures are up-to-date and available to personnel2) Specifications of raw materials, ingredients, additives, packaging materials, recycled products,
rework and finished products are clearly identified
3) The final shipping decision makers are clearly identified.
4) Procedures are in place to verify that products to be shipped conform to product specifications
and that process controls have been properly implemented.
21

FSM24 Control of non-conforming products●Requirementｓ
The organization must create and enforce rules for not using or shipping raw materials (including
containers and packaging materials), semi-finished products, work-in-process products, recycled
products, reworked products, and finished products that may pose a safety hazard.
●Concepts, specific examples
1. These requirements set up barriers at each stage on the way to the final product, and play therole of stopping nonconformity when it occurs.
2. Raw materials (including containers and packaging materials), semi-finished products, work-inprocess products, recycled products, reworked products, and finished products that pose asafety problem are treated as nonconformities. The organization determines the responsible
person and manages according to procedures to prevent unintended use or erroneous shipmentof nonconforming items.
1) It is effective to have well-defined manufacturing and inspection procedures in advance todetect nonconformities in each process.
2) In addition to detection through manufacturing and inspection procedures, nonconformities
may also be detected through customer complaints.
3) Nonconforming products found are to be clearly identified and segregated so that they cannot
be mistakenly used. In identifying the scope of nonconforming products, appropriate judgment
should be made to ensure that nonconforming products are not mixed in with compliant
products.
4) Non-conforming products are disposed of or corrected (reprocessed, reworked, etc.).
5) After that, if recurrence prevention is necessary, FSM25 is implemented.
3. It is important to recognize that process control is capable of detecting nonconformities, because
if we recognize that the discovery of nonconformities is a bad thing, it will be difficult to get reports
from the field.
●Items to be referenced in legal provisions related to food safety
Nonconformity Management
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of the Food
Sanitation Act(v) Establishment of improvement measures
At individual critical control points, improvement measures shall be established when monitoring
results reveal deviations from the control standards.

FSM25 Corrective Action●Requirementｓ
The organization shall establish and implement written corrective actions in the event of
nonconformities affecting food safety. (Corrective action is the process of correcting anonconformity to a condition that is not a nonconformity, determining the cause of thenonconformity and eliminating the cause of the nonconformity.)●Concepts, specific examples
221. The organization establishes and implements procedures to ensure that causes of detectednonconformities affecting food safety are eliminated as soon as possible and to prevent recurrence
2. corrective actions are developed and implemented by those who have the competence toanalyze the causes and develop countermeasures.
3. The flow of corrective actions shall be handled according to the following procedures.
1) Grasp the actual situation of nonconformity (including customer complaints).
2) Identify the causes of nonconformity.
3) Implement necessary measures to prevent recurrence of nonconformity.
4) Review the effectiveness of the corrective actions taken.
5) It is desirable to document the sequence of actions related to corrective actions.

23

Ⅱ Hazard Analysis and Critical Control Point(HACCP)
Hazard Analysis and Critical Control Point(Control of Hazardous Factors)
HACCP is a tool for establishing a preventive control system in a process that identifies specifichazards (hazards) and their control measures for food safety and does not rely on testing andinspection of the final product.
The success of HACCP requires management and engaged personnel to work together andexpertise in a wide range of areas, including primary production, microbiology, and manufacturing
and processing techniques.
A HACCP plan is a document or set of documents prepared in accordance with HACCP principles(Codex General Principles of Food Hygiene 2020: from the first edition of 2021 by the Japan Food
Sanitation Association) to ensure control of critical hazards in food operations. A HACCP systemrefers to the development of a HACCP plan and the implementation of procedures according to thatplan (from Codex General Principles of Food Hygiene 2020: Japan Food Sanitation Association,
first edition 2021).
HACCP Step 1 Formation of HACCP team
●Requirementｓ
A HACCP team shall be assembled with competent staff.
●Concepts, specific examples
1. The HACCP team should be composed of people with various professional skills to the extent
possible, such as those in charge of the manufacturing and processing departments, quality
assurance, quality control, and engineering departments including facilities, maintenance, andmaintenance of machinery and equipment used in manufacturing, to eliminate blind spots inhazard factor analysis and to facilitate communication. The HACCP team leader (food safety
manager) should be a food sanitation manager or food sanitation supervisor who has
knowledge of the product, specialized skills, and knowledge of the product characteristics andprocesses, and who has good communication skills and can organize opinions within thecompany.
When the food safety manager and the HACCP team leader are different personnel,
coordination must be ensured.
2. Depending on the size of the business, there are many cases in which various tasks are
performed concurrently, and for this reason, the manager himself may be the team leader, or
one person may be responsible for all food safety-related actions, etc. However, it is important
to try to ensure the cooperation of employees within the company to the extent possible.
3. If there is a lack of knowledge or expertise within the organization, it may be useful to receive
outside training or to engage the participation and advice of outside food sanitation experts. A
guide for industry associations by the Ministry of Health, Labor and Welfare can be used as areference.
4. The HACCP team is responsible for managing food safety initiatives within the organization.
5. The HACCP team will identify the scope of application of the HACCP system and appropriate
GMPs. Within the scope, the team identifies what products and processes are covered by the
HACCP plan.

24

HACCP Step 2 Product Information Description●Requirementｓ
Product specifications shall be documented.
The document shall describe all product information necessary to conduct hazard analysis.
Scope of the HACCP system shall be defined per product or product group and per process line orprocess location.
●Concepts, specific examples
1. In order to clarify the characteristics of the product, the specifications and characteristics shallbe described for the final product in necessary items as follows
1) Specifically, for the final product, describe the name and type of product, productcharacteristics, names of raw materials, names of additives and standards for use, form of
packaging, units and quantities, materials of containers and packaging, expiration date orbest before date and storage method, internal targets for controlling hazards in the product(including standards specified by the supplier, such as ingredient standards for bacteria
specified by the Food Sanitation Law). (including standards specified by the supplier, such as
ingredient standards for bacteria specified in the Food Sanitation Law).
2) In facilities that manufacture multiple products, it may be effective to group foods by similar
characteristics and processing steps for the purpose of creating a HACCP plan.
3) If the food contains allergens or there may be cross-contact of allergens within the facility, thisshould also be noted.
2. Identify the scope of the HACCP system and the appropriate GMP (PRP in Codex).
HACCP Step 3 Identification of Intended Use●Requirementｓ
Intended use of the product and target consumers shall be clearly described in a written
document.
●Concepts, specific examples
1. Describe the intended use (manner of use) and target consumers of the product in the
documentation as follows
1) Clarify the method of consumption or use and the intended consumers. Particular attention
should be paid to the contents in the case of vulnerable persons, young children, and theelderly.
2) If the intended use includes the need for cooking or precautions after opening the package,
the necessary information should be described.
2. For foods intended for susceptible populations, enhanced process controls, more frequentmonitoring, product testing to verify the effectiveness of controls, or other activities may benecessary to assure a high level of assurance that the food is safe.

HACCP Step 4 Construction of Flow Diagram●Requirementｓ
The flow diagram that covers all steps in the operation shall be constructed.
25

●Concepts, specific examples
１. A flow diagram should be prepared for a series of manufacturing or processing processes fromthe receipt of raw materials to the shipment of the final product, showing the operations of eachprocess along the flow. The same flow diagram may be used for a group of products
manufactured using similar processing steps.
2. The flow diagram is used as the basis for conducting a hazard analysis to evaluate the likelihoodthat a hazardous factor will occur, increase, decrease, or be introduced.
3. The flow diagram should be accurate and detailed enough to perform a Hazard Analysis.
【Construction of Flow Diagram】
4. A flow diagram shall be prepared according to the following procedures
1) Briefly enumerate all processes and operations from receipt of raw materials to shipment of
final products.
2) Enclose the enumerated raw materials and processes in a frame, connect the frames witharrows, and number them in process order.
For raw materials, also include food additives, packaging containers, water used, gases (ifused), etc. These should be listed in the same column with a framework and an arrowconnecting them to the process in which they are used.
3) In the processing of raw materials, clearly indicate any wastes generated or raw materials
used in the processing that will be separately used in the product.
4) In the process, if there is a pass/fail judgment, reprocessing, reuse, or redo process, clearlystate it so that it can be controlled.
5) Outsourcing processes are also to be specified.
5. Drawings of the facility showing the outline of each process and the planar and threedimensional layout of the facility will help identify process points and possible crosscontamination areas and assist in the analysis of hazard factors.

26

Flow Diagram Example

reworkmain raw material

Other raw materials

food additive

Use of water

Packaging Materials

1accessioning

2accessioning

3accessioning

4accessioning

5accessioning

6storage

7storage

8storage

9storage

10 storage

11measure

12measure

13measure

14measure

15mixture
16mold17heating
18cooling
19sorting

20disposal

21Bulk Packing
22transport

Outsourcing
Packaging Materials
23accessioning

24accessioning

26packing25storage

27Metal Foreign Body Inspection

28disposal

29storage
30shipping

27

HACCP Step 5 On-site Confirmation of Flow Diagram●Requirementｓ
The flow diagram shall be verified whether it correctly reflects the existing process steps of theoperation.
●Concepts, specific examples
1. A person with sufficient knowledge of the process should check on site as follows to ensure thatthe process is clearly defined in the flow diagram so that the hazard analysis in HACCP
procedure 6 can be sufficiently performed. It is recommended to check the flow diagram on siteagainst the layout diagram of the site.
1) On site, check in order from the upstream process to confirm that the appropriate process isshown, including temporary storage and management of semi-finished products.
2) If there is any inconsistency between the flow diagram and the processes or activities on site,
confirm with the person in charge the correct management method and revise the document.
3) Confirmation is made by observing the work at various times during the work period andchecking if the flow diagram and the work are consistent.

HACCP Step 6,7 (Principle 1 and 2) Establishment of methods for analyzing hazards andcontrolling critical hazards●Requirementｓ
In the process from the purchase of raw materials to shipment, the company must analyze itself or
identify, by appropriate means, important hazard factors that may cause health hazards anddetermine how to control them (where and what to implement). Microorganisms, chemicals(including allergens), and hard foreign matter must be considered as hazard factors.
●Concepts, specific examples
1. Biological, chemical and physical factors in food that may cause adverse health effects arereferred to as "hazardous factors.
2. Organizations need to identify what kind of hazard factors specific to raw materials,
manufacturing processes, and products exist in their factories.
This requirement provides two methods for identifying these hazards: (1) analyze the significant
hazard factors by oneself, and (2) utilize information such as "industry-specific guides preparedby food business associations" that have been publicly announced.
Method 1) is based on the premise that the organization identifies and analyzes potential hazard
factors in raw materials and each manufacturing process on its own, and then identifies criticalhazard factors from the perspective of frequency and severity of occurrence of possible hazard
factors. This method may require the organization to inspect and take data in-house.
Method (2) does not assume that the organization itself analyzes the hazard factors. The
organization identifies hazard factors in an appropriate manner by utilizing publicly available
information on hazard factors.
Publicly available information on hazard factors includes the following.
◆Industry-specific guides prepared by food and other business associations (Japan, Ministry of
Health, Labour and Welfare)
URL: http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000179028.html)◆HACCP Related Information Database (Japan, Food Industry Center)
28

Use "Food and Hazard Analysis" and "Hazard Control Technology Data" in the HACCPrelated Information Search.
In "Food and Hazard Analysis", it is possible to search by food type.
(URL: http://www.haccp.shokusan.or.jp/information/search/ )◆Food Safety Commission, Cabinet Office, Government of Japan Home Page (Japan)
Hazard information, fact sheets, and risk profiles from the Food Safety Commission,
Japan's risk assessment agency, are available for viewing.(URL: https://www.fsc.or.jp/ )◆ "Fish and Fishery Products Hazards and Controls Guidance" (U.S. Food and Drug
Administration: USFDA)
This is a very useful guidance for those who handle food products using fish and fisheryproducts. It provides concise information on how to control hazards for each type of product. It
can be downloaded free of charge from the following URL. However, the entire document is in
English. Translated versions can be purchased from the website of the Japan Fisheries
Association. “Fish and Fishery Products Hazards and Controls Guidance”(U.S. Food and Drug
Administration：USFDA)
This guidance is very helpful when dealing with food products that use fish and shellfish. It provides
a concise organization of how to control hazards for each type of product. It can be
downloaded free of charge from the following URL. However, the entire document is in English.
A translated version can be purchased from the website of the Japan Fisheries Association.
(URL:
https://www.fda.gov/downloads/food/guidanceregulation/ucm251970.pdf)◆New Zealand Ministry of Primary Industries (MPI) Hazard Database
Hazards and their control methods are summarized in an easy-to-understand format.
(URL: https://www.foodsafety.govt.nz/registers-lists/hazards/)◆“Hazard analysis approaches for certain small retail establishments in view of the application of
their food safety management systems” (European Food Safety Authority: EFSA)This is a guideline for hazard analysis provided by EFSA for small and medium-sized businesses.
It can be downloaded free of charge from the following URL. However, the entire document is in
English.(URL: https://www.efsa.europa.eu/en/efsajournal/pub/4697 )3. When referring to published hazard factor information (manuals, etc.), check whether the raw
materials, manufacturing processes, etc. indicated therein are applicable to the company's target
products. If there is nothing that can be applied as it is, refer to data from similar cases as muchas possible, and if necessary, modify the data to suit your company's raw materials, processes,
etc., and use it.
4. Based on the flow diagram (process diagram) at each plant, consider where and how to control
the identified hazardous factors.
In general, there are three methods of control: (1) do not allow them to be introduced, (2) do notincrease them, and (3) sterilize (eliminate) them. While (1) is handled by general hygiene control,
part of (2) and (3) may be subject to critical control points (CCPs) in the process. Appropriate
control methods, such as temperature control and handling methods, should be determined.
In determining control methods, the "industry-specific guidelines prepared by food businessassociations" can be used as a reference.
5. Depending on the product, industry, business type, and process, there may be cases where
critical hazard factors are not identified and hazard factors can be controlled only by general
hygiene management. Even if general hygiene management (GMP) is implemented without fail,important hazard factors that may occur are controlled as critical control points.
6. The method of control should be documented as a "sanitation management plan. A model of asanitation management plan is provided in the "Industry-Specific Guideline Prepared by FoodBusiness Associations" for reference.

29

Critical Control Point (CCP): In a HACCP system, a process to which one or more control
measures are applied that are essential to control a critical hazard factor (from Codex General
Principles of Food Hygiene 2020: Japan Food Sanitation Association, first edition 2021).
●Items to be referenced in legal provisions related to food safety
Analyze hazards and determine critical control points
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of the Food
Sanitation Act(i) Analysis of Hazard Factors
A list of factors that may cause food sanitation hazards (hereinafter referred to as "risk factors" inthis table) shall be prepared for each process of manufacturing, processing, cooking, transporting,storing, or selling food or additives. (hereinafter in this table referred to as "control measures") for
each process of manufacturing, processing, cooking, transporting, storing, or selling food or
additives, and to establish measures to control these hazard factors (hereinafter in this tablereferred to as "control measures"). (2) The supplier shall establish the measures to control thesehazard factors (hereinafter referred to as "control measures" in this table).
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of the Food
Sanitation Act(ii) Determination of critical control points
Processes for which it is indispensable to take control measures to prevent, eliminate, or reduce toan acceptable level the occurrence of the hazard factors identified in the preceding item(hereinafter referred to as "critical control points" in this table).
(i) Processes for which it is essential to take control measures to prevent, eliminate, or reduce to an
acceptable level (hereinafter referred to as "critical control points" in this table), with respect to thehazardous factors identified in the preceding item.
HACCP Step 8, 9 (Principle 3, 4) Establishment of control criteria and monitoring methods●Requirementｓ
Validated criteria (referred to as control criteria or tolerance limits) to determine whether criticalhazard factors are being controlled must be established and implemented. The company shallestablish and implement a method for monitoring whether the control is being carried out inaccordance with these criteria.
●Concepts, specific examples
1. ①Determine criteria for checking whether critical hazard factors are controlled within
acceptable limits at critical control points, and ②Determine a method for monitoring whether
control is being achieved based on these criteria.
2. The criteria used to confirm that critical hazard factors are controlled within acceptable limits
are generally referred to as "critical limits" (CL). The Codex HACCP implementation
guidelines also require that this criterion be established. Tolerance limits are sometimes
referred to as control criteria (CL), which means the same thing.
3. Monitoring is conducted continuously or at a considerable frequency, visually or by using
measuring instruments, to see if control is achieved based on control standards or
permissible limits (CL). Examples of monitoring methods can be found in the "IndustrySpecific Guides Prepared by Food Industry Associations" for reference. The control criterionor tolerance limit (CL) is the most appropriate parameter to ensure that significant hazards areprevented, eliminated, controlled, or reduced to an acceptable level, and is a value that has
been substantiated (validated) with scientific evidence.
30

4. Monitoring should be conducted continuously or at a reasonable frequency, but records may
be kept in a logbook when abnormalities occur, rather than on a case-by-case basis. In either
case, the records should be available for later review.
Control Criteria or Acceptable Limits (CL) :Observable or measurable criteria that relate to control measures for Critical Control Points(CCPs) and that separate acceptable from unacceptable food (from Codex General
Principles of Food Hygiene 2020: Japan Food Sanitation Association, first edition 2021).
●Items to be referenced in legal provisions related to food safety
Establishment of management standards
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(iii) Establishment of control standards
For each critical control point, standards for preventing, eliminating, or reducing the occurrenceof hazardous factors to an acceptable level (hereinafter referred to as "control standards" in thistable) shall be established.
Establishment of Monitoring Methods
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(iv) Establishment of monitoring methods
Methods shall be established for monitoring the status of implementation of control of criticalcontrol points on a continuous basis or at a reasonable frequency (hereinafter referred to as"monitoring" in this table). (iii) Methods for monitoring the status of implementation(hereinafter referred to as "monitoring" in this table) of the management of critical control
points shall be established.
HACCP Step 10 (Principle 5) Establishment of corrective actions (improvement measures)●Requirementｓ
When there is a deviation from the control criteria (or tolerance limits), what action is to betaken (corrective action (correction, pursuit of the cause of the occurrence, and removal of
the cause, also known as remedial action)) must be determined. (Corrective action(correction, investigation of the cause of the occurrence, and removal of the cause, also
called improvement measures)) must be determined.
●Concepts, specific examples
1. In the event of a deviation from the control criteria or permissible limits (CL), theprocedures for restoring the control status of the process, restarting the production line thatwas stopped when the deviation occurred, and isolating the product affected by thedeviation and determining and implementing a disposal method are to be specified.
Furthermore, it is necessary to investigate the cause of the deviation and take measures
to prevent its recurrence. These are called "corrective actions" (improvement measures).
２．In the Codex HACCP implementation guidelines, the term "corrective action" or "remedialaction" is used. Corrective action and corrective action have the same meaning.
●Items to be referenced in legal provisions related to food safety
Establishment of remedial measures31Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(v) Establishment of improvement measures
Improvement measures shall be established for each critical control point in the event that a
violation of control standards is found as a result of monitoring.

HACCP Step11 (Principle 6) Setup of verification procedures●Requirementｓ
In addition to the "monitoring methods" specified in steps 8 and 9, a procedure must be
established and implemented to verify that critical risk factors are being controlled.
Whenever there is a change in the manufacturing process, raw materials, raw material ratio,or personnel, it must be verified that the method of controlling critical risk factors is properly
set up, and if necessary, the method of control must be modified.４●Concepts, specific examples
1. Verification procedures need to be determined to ensure that critical hazard factors areproperly controlled based on predetermined methods.
2. Verification methods include monitoring by a person responsible for verification other thanthe person who recorded the data, checking improvement measures and verification
records (see HACCP Procedure 12), observation of monitoring implementation, calibrationof measuring equipment (instruments) used for monitoring, and inspection of intermediate
and final products.
The verification methods include: monitoring by a person responsible for verification otherthan the recorder, confirmation of improvement measures and verification records (seeHACCP Procedure 12), observation of monitoring implementation, calibration of
measuring devices (instruments) used for monitoring, and inspection of intermediate andfinal products.
3. Once a control method has been established, it is necessary to confirm that the method
for controlling critical risk factors has been properly established when there is a change inthe manufacturing process, raw materials, manufacturing equipment, or employees at the
manufacturing process site. This should be done when any of the following events occur(1) Change in raw materials(2) Changes in manufacturing processes or systems (including computers and theirsoftware)(3) Changes in packaging and materials(4) Changes in the delivery system of the final product(5) Changes in the intended specifications of the final product or the intended consumers(6) When verification results indicate a deficiency or potential deficiency in the HACCP plan
(7) A new hazard factor is identified in the same food or in the same food group(8) New information regarding product safety is obtained.
4. Also, if any checks or corrections are made, record them (see HACCP Procedure 12).

●Items to be referred to in legal provisions related to food safety
Setting up a verification method
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(vi) Establishment of verification methods
32Procedures shall be established to periodically verify the effectiveness of the contents of themeasures prescribed in the preceding items.

HACCP Step 12 (Principle 7) Record keeping●Requirementｓ
Records (including a logbook) of the implementation of control of critical hazards,
implementation of corrective actions (remedial actions), and implementation and correctionof verifications must be taken and retained for a certain period of time.
● Concepts, specific examples
1. Required documents and records
1) Documents and records required by the 12 procedures of HACCP
HACCP team member list and role assignment, product description, flow diagram, hazard
factor analysis, Information that scientifically supports the determination of control
measures (critical control points: CCPs), control criteria (CLs), and control standards(CLs) for the critical hazards to be controlled; validation of control measures, HACCP
plan revision records, etc.
2) Records of activities in accordance with the HACCP plan
Monitoring records, corrective action records, verification records, personnel training
records, etc.
3) Records of HACCP plan implementation
2. Three types of records need to be kept: "Implementation of Control of Hazard Factors,""Implementation of Corrective Actions (Improvement Measures)," and "Implementation
and Correction of Verification. This is to ensure that what was implemented and when, thedate and time the deviation occurred, and the nature of the event can be identified later. 3.
3. It is sufficient to record "implementation of corrective actions (improvement measures)"and "implementation and correction of verification" in a daily logbook. When describing
them in a logbook, at least make sure to record what, when, and how they were
implemented.
For "implementation of control of risk factors," the "industry-specific guidelines preparedby food business associations" for each industry and business category provide a record
format, which can be used as a reference.
●Items to be referred to in legal provisions related to food safety
Creation of records
Appended Table 18 (Re: Article 66-2, paragraph (2)) of the Ordinance for Enforcement of theFood Sanitation Act(vii) Preparation of records
Depending on the size and type of business, a document concerning the details of themeasures stipulated in the preceding items and a record of the implementation of suchmeasures shall be prepared.

33

Ⅲ Good Manufacturing Practice (GMP)
GMP 2 Site Management●Requirementｓ
The organization shall establish and maintain in accordance with appropriate standards forbusiness premises.
●Concepts, specific examples
1.Concept of GMP2
1) In GMP2, it is important to take measures to prevent "influences from the vicinity andpremises of the business site from affecting the food safety risk to the products" and tomaintain them.
For this purpose, the following measures are required.
(1) Identify what exists in the vicinity and on the premises of the business site.
(2) Confirm whether or not they pose a food safety risk to the company's products(3) Examine the measures to be taken and maintained so that the system can be finallyestablished to "prevent food safety risks to products.
(4) Periodically check for changes in the environment while implementing maintenancemeasures.
2. Confirmation of site boundaries
1) Ensure that the boundaries of the site are clear and in a condition that can be reliably
accounted for.
2) Even if the site is located in an industrial park or other such area, make sure that the site ofyour organization is clear.
3) It is recommended that as much as possible, drawings or other means be used to show theconfirmed settings in order to maintain clarity.
3. Confirmation of the surrounding environment1) Check the area surrounding the facility for any concerns that may affect food safety.
The following may be considered as examples.
(1) Insect and bird damage
Rivers, drainage ditches, etc.
Mountains, forests, parks, agricultural land, livestock farms, etc.
Garbage dumps, waste disposal sites, etc.
(2) Foreign matter
Garbage dumps, waste disposal sites, etc.
(3) Others (impact on buildings, odor, chemicals, etc.)
Regional effects such as salt damage, strong winds, freezing, etc.
Agricultural lands where pesticides are sprayed ・Livestock industry (feedlots, etc.)
Exhaust and smoke emissions from other factories, etc.
4. Check the business premises
1) Check for food safety concerns within the facility as well.
The following may be considered as examples.
(1) Insect and bird damage
・Green space, etc.
・Puddling areas
・Drainage, septic tanks, rainwater tanks, etc.
・Unnecessary objects and waste storage areas, etc.
(2) Foreign matter
34

・Waste dumps, treatment areas, etc.
5. Response to each impact
1) For each of the items identified as having an impact, measures to reduce the impact to a
manageable level should be considered, verified, and periodically addressed.
Possible measures include the following(1) Insect and bird damage
・ Insect and bird damage - Removal or modification of the target, isolation, etc.
・Periodic checks of plantings and water ponding areas, and measures to deal with them.
(If the site is subject to the Green Space Law, compliance is necessary, but appropriate
consideration should be given to placement and management.)
・Building treatments (e.g., positive/negative pressure, entrances/exits, broken parts or gapsthat may be points of entry, light sources, odor leaks, etc.).
・Periodic monitoring by the insect control contractor or your own organization (perimeter,building interior, etc.)(2) Foreign material related
・Removal or modification of objects, isolation, etc.
・Countermeasures against foreign objects flying into the building or adhering to workers(3) Others
・Arrangements with related parties in the surrounding environment.
・Periodic maintenance of buildings and facilities to prevent deterioration
・Periodic verification of manufacturing areas and products[Example] Building Surroundings(facilities on the site as well as outside facilities and environment (outside the dotted line)).

35

GMP 3 Design, construction and layout of facilities and equipment, and work and product flow lines●Requirementｓ
The organization shall design, construct and maintain the factory buildings and facilities (storage
area, raw material and product handling area, preparation area, packaging and storage area,etc.) of the business site both outside and inside the plant to minimize food safety risks.
In addition, the equipment layout and the flow lines of people, goods, and work shall be designed
to meet the intended purpose and minimize food safety risks.
●Concepts, specific examples【Regarding the location, design, and layout of the facility】
1. When designing a manufacturing or processing facility, the most important thing is to fully
understand the impact on manufacturing and processing. In ascertaining the impact, reference
should be made to the following1) Layout drawings of the manufacturing/processing area2) Flow diagrams showing the manufacturing/processing process
3) Equipment, personnel, raw material and product transport methods, process capacity, etc.
4) Work classification appropriate to the manufacturing/processing process【Lines of movement of "goods," "people," etc.】
1. It is effective to describe manufacturing flow lines, personnel flow lines, etc. on the layout
diagram of the manufacturing/processing area, and consider the impact on food safety fromthis flow of movement (flow lines).
2. Lines of flow include the following, of which "goods" and "people" are the most important. Asmuch as possible, "objects" and "people" should be managed to avoid cross-contamination.
1) Objects: Routes from receipt of raw materials to shipment of final products2) Personnel: Routes for personnel entering and leaving the workplace, routes for movement
between workplaces, and routes for outside workers entering and leaving the workplace.
3) Waste: Routes for transporting leftover and unwanted materials from the workplace to the
outdoors
4) Drainage: routes for drainage of work area
5) Utilities: Routes for utilities such as steam, compressed air, carbon dioxide, nitrogen and othergases, air conditioning and ventilation, lighting, and water used directly or indirectly in
manufacturing and processing【Lighting】
1. The specifications shall be such that maintenance and cleaning are easy and that deterioration
is minimized.
2. When installing ducts for electrical wiring, etc., they should be constructed so that dust anddead insects do not accumulate on the top, and they should be installed in locations where
they can be easily cleaned.
3. If fluorescent lamps or light bulbs are damaged, protective covers (dust-proof type) should beinstalled or shatterproof tubes should be used to prevent shards and other physical hazards
from affecting products and production/processing lines.
4. For windows used for daylighting, select plastic windows made of materials that are resistant todeterioration and shattering, and glass windows made of glass that are resistant tocondensation, and apply shatterproof plastic film.
5. Illumination and color tones should be such that they do not cause misidentification of theworkplace.
1) Brightness that allows food handlers to work safely and hygienically must be provided.

362) If the illuminance of the area where work such as appearance inspection is performed isinsufficient, it is necessary to take measures such as installing supplementary lighting such as
electric stands.
3) When conducting color tone inspections, etc., the color tone of lamps should be considered inaddition to illuminance.
【Illuminance of the work environment】
1. The illuminance of the work environment is specified in Article 604 of the Industrial Safety and
Health Regulations and JIS. The work classification and standards in Article 604 are as follows:
precision work: 300 lux or more, ordinary work: 150 lux or more, and rough work: 70 lux ormore; the JIS illuminance standard is 500 lux for ordinary visual work in general manufacturing
plants, etc.
【Drainage system】
1. Drainage routes should be designed and managed to minimize the possibility of contaminationof products, etc.
2. Floors and drainage basins should be sloped to prevent puddles and be easy to clean.
【Specifications and general information in the production area】
1. The specifications of the facility should be designed to ensure that there is no crosscontamination or adverse effects on food products.
2. The specifications shall be easy to maintain, clean, and wash, and shall be resistant todeterioration.
3. Consider durability, such as the ability to handle heavy objects used in the work, wear, etc.
4. The material shall be capable of withstanding cleaning, washing, sterilization, and disinfection.
5. Design wastewater and wastewater systems so that they do not interfere with food safety.

Insects

Mold and

and

insectrodents

infestation

come in

Dark.
Hard toinspect

Hard towashequipment

Designed for hygienic operations andproduct/ingredient workers as well as theenvironment.

37

●Items to be referenced in legal provisions related to food safety
Facility specifications: General
Illuminance of the work environment
The illuminance of the work environment is specified in the Industrial Safety and HealthRegulations No. 604 and JIS.

Facility Management: Sanitation
Appended Table 17 (Re: Article 66-2, paragraph (1)) (Ordinance of the Ministry of Health, Labourand Welfare No. 68; addition)(ii) Sanitation management of facilities(a) The facility and its surroundings shall be cleaned regularly and kept clean to prevent theoccurrence of food sanitation hazards while the facility is in operation.
(b) Do not place unnecessary articles, etc. in places where food or additives are produced,
processed, prepared, stored, or sold.
(c) Maintain the interior walls, ceilings, and floors of the facility in a clean condition.
(d) Lighting, lighting, and ventilation inside the facility shall be adequate, and the temperature andhumidity shall be controlled appropriately as needed.
(f) Drainage ditches shall be cleaned to prevent the inflow of solids and ensure proper drainage,
and shall be repaired promptly in the event that they are damaged.

GMP 4 Control of critical hazards that cannot be controlled by the control measures in HACCP
procedures 6 and 7 (prevention of cross-contamination)●Requirementｓ
Based on the results of the Hazard Analysis in HACCP Procedures 6 and 7 (Principles 1 and 2),
the organization shall determine which of the identified hazards are not controlled by the control
measures in HACCP Procedures 6 and 7 and which are not effectively controlled outside of thisitem (GMP 4). The organization shall, based on the results of the HACCP Procedure 6 and 7(Principles 1 and 2) Hazard Analysis, control significant hazards identified that are not controlled by
the control measures in HACCP Procedures 6 and 7 and are difficult to effectively control outsideof this item (GMP 4). Procedures must be established to prevent contamination and crosscontamination of raw materials (including containers and packaging materials), semi-finishedproducts, work in process, rework, and finished products. The organization must periodicallyreview these procedures and maintain them in effect.
●Concepts, specific examples

38

1. Control by GMP 4
GMP 4 includes the management of hazard factors controlled by the GHP (GMP) that require
more attention of Codex HACCP, as well as the management of significant hazard factors thatcannot be controlled by the HACCP plan.
1) Management of Hazard Factors Controlled by GHP (GMP), which requires more attention in
Codex GPFH2020 and GMP4
Hazard factors identified by the Hazard Factor Analysis in HACCP Procedures 6 and 7(Principles 1 and 2), which, if managed incorrectly by GMP, could cause significant food safety
hazards, are listed as "Hazard Factors Requiring Greater Attention" in the GHP (GMP) Controls
and GMP4. Hazard factors identified by the Hazard Factor Analysis in HACCP Procedure 6
and 7 (Principles 1 and 2) that could cause significant food safety hazards if there is an error in
GMP controls are considered to be controlled under "GHP (GMP) requiring more attention" andare controlled under GMP4.
2) Significant Hazardous Factors Hazardous factors controlled by GMP4
(1) Critical Hazard Factors are "Hazard Factors identified by the Hazard Factor Analysis in
HACCP Procedure 6 that, in the absence of controls, are reasonably likely to occur to an
unacceptable level and whose control is essential for the intended use of the food" ( Codex
General Principles of Food Hygiene 2020: from the first edition of 2021 by the Japan Food
Sanitation Association).
(2) For critical hazard factors, control measures for critical control points (CCPs) are establishedand controlled by the HACCP plan.
However, there are hazardous factors that are judged to be important hazardous factors but
cannot be controlled by CCP control measures because continuous monitoring cannot be
implemented or quantified CLs cannot be set. Control of these hazardous factors by GMP
control measures corresponds to GMP4. Control procedures (monitoring methods, remedial
measures, verification, etc.) are required.
(3) The critical hazard factors controlled by GMP4 are almost the same concept as the OPRP in
ISO 22000; 2018.
2. Points to note for control by GMP4
1) Hazard factors controlled by GMP4 differ depending on the type of product, manufacturing
process, hazard factor analysis, frequency and severity, etc. These should be considered andidentified. The matrix of HACCP procedure 6, etc. can be used as a reference.
2) The procedures for control by GMP4 may involve not only the requirements of GMP, but also
the control by the requirements of FSM. Examples of relevant requirements, which are notuniform depending on the industry and products of the organization, are shown below.
FSM 13 Purchasing Management
GMP 3 Design, construction, and layout of facilities and equipment, and work and product flowlines
GMP 6 Hygiene, work clothes and health management of employees, etc.
GMP 8 Tidiness, cleanliness, hygiene, sterilization and disinfection
GMP 11 Air and water management
GMP 13 Pest control
GMP 18 Equipment and instruments
GMP 19 Maintenance
3. Examples of Hazard Factors Controlled by GMP4
1) Allergen control
Line cleaning after manufacturing products containing allergens can be a control measure thatshould be controlled under GMP 4. If allergens cannot be removed by washing, the next productthat does not contain allergens may contain allergens.
2) Control of Listeria monocytogenes :.
If RTE foods (ready-to-eat foods that do not require heating before consumption) after heatsterilization are contaminated with Listeria monocytogenes from the line, utensils, or39environment, they can multiply even at temperatures below 10°C, and food poisoning can occur
if stored for a long time. Therefore, lines and utensils that come into direct contact with RTE
foods should be monitored carefully. In addition, it is necessary to set up lines so that RTE foods
and contact lines are kept at lower temperatures (preferably 4°C or lower).
4. Measures to prevent cross-contamination
1) Cross-check the detailed process flow diagram prepared by the HACCP team with the
manufacturing site to enumerate the points where the work flow lines of on-site employeesintersect with the flow lines of raw materials (including containers and packaging materials),semi-finished products, work-in-process products, recycled products, reworked products, andfinished products.
2) For each of the listed locations, hazard factors are extracted, the frequency of occurrence andseverity of results are evaluated (comprehensive evaluation), and control measures, including
appropriate isolation, are established for each.
The Hazard Factor Analysis Sheet used in HACCP Procedure 6 and 7 (Principle 1 and 2) canbe utilized for setting up the measures, and the following list of identified hazard factors can also
be used effectively. The evaluation of the frequency of occurrence and severity ofconsequences can refer to HACCP Procedure 6 and 7 (Principle 1 and 2).
3) Control procedures should be validated, implemented, monitored, verified, and periodicallyreviewed as necessary. When evaluating control measures, it is necessary to consider what isalready in place in operating procedures, GMP work rules, etc. and what new measures areneeded.

Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Facility sanitation(a) Regularly clean the facility and its surroundings, and maintain cleanliness to prevent theoccurrence of food sanitation hazards while the facility is in operation.
(b) Do not place unnecessary articles, etc. in places where food or additives are produced,
processed, prepared, stored, or sold.
(iii) Hygiene control of equipment, etc.
(a) Machinery and equipment shall be used appropriately for their intended purposes in order tomaintain hygiene.
(b) Machinery, equipment, and parts thereof shall be cleaned and sanitized and stored hygienicallyin designated locations to prevent metal fragments, foreign substances, or chemical substances,
etc. from mixing with food or additives. In the event of malfunction or damage, they shall be
repaired promptly and maintained for proper use.
(c) When detergent is used for cleaning machinery, equipment, and their parts, the detergent shallbe used in an appropriate manner.
(e) Equipment, cleaning materials, and protective gear that may come in contact with food or
additives shall be disinfected with hot water, steam, or disinfectants each time they arecontaminated or work is completed, and then dried.
(f) Detergents, disinfectants, and other chemical substances must be handled with care and, if
necessary, the names of the contents must be indicated on the containers and packaging toprevent contamination of food or additives.

40

GMP 5 Personnel Facilities●Requirementｓ
Organizations must ensure that facilities for employees are designed and operated to minimize
food safety risks, including allergens.
●Concepts, specific examples【Facilities for Employees】
1. Facilities for employees include shoe boxes and shoe lockers for changing from commuting
shoes to on-premises footwear, changing rooms, toilets, hand washing facilities, cafeterias, rest
rooms, and smoking areas. These must be kept clean at all times to prevent the introduction ofcontaminants or foreign substances into the manufacturing or processing site.
【Changing rooms】
1. A sufficient number of lockers, etc. should be provided. Lockers and changing rooms should belocated so that clean work clothes worn in the production area are not cross-contaminated withpersonal clothing or used work clothes.
2. Changing rooms should be located in areas where work clothes are not contaminated before
food handlers move to the work area.
【Hand washing facilities】
1. Facilities for washing and drying hands in a hygienic manner are required.
1) It is important that there be a sufficient number of such facilities in appropriate locations forfood handlers, and that there be facilities for washing, drying, and sanitizing, and hot water
facilities, if necessary.
2) Maintain an adequate supply of water (or hot water if necessary for proper hand washing),
and provide liquid soap, nail brushes, paper towels, disinfectants, etc. appropriate for handwashing, which are clean and always available for use.
3) To prevent re-contamination of washed hands after hand washing, faucets should bedesigned so that they can be opened and closed without touching them with the hands.
4) Hand washing and disinfection procedures should be posted in an easily understood manner.
5) Hand washing facilities should not be used for washing food or mechanical equipment.
【Toilets】
1.It is important that toilets be of hygienic construction.
1) There should be a sufficient number of toilets for the number of employees.
2) They should be sufficiently separated from areas where food is handled.
2.Hand washing and disinfection facilities and means to dry hands should be provided.
3. Always keep the area clean and perform periodic cleaning and disinfection.
【Cafeteria, Break Rooms, and Smoking Areas】
1. Places where food and beverages are stored and consumed, such as company cafeterias andbreak rooms, should be set up to minimize the possibility of cross-contamination with the
production area. 2.
2. Cafeterias should be kept clean and controlled so that waste materials are not left unattended toprevent them from becoming a source of pests.
3. Smoking areas should be located and controlled to minimize the potential for crosscontamination with work clothes and manufacturing areas.

41

●Items to be referenced in legal provisions related to food safety
Facilities for food handlers, hand washing and lavatories
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Sanitation of facilities(g) Latrines shall be kept clean at all times, and shall be cleaned and disinfected regularly.
(iii) Hygiene control of facilities, etc.
(h) Hand washing facilities shall be equipped with soap, paper towels, etc., and disinfectants, andshall be maintained in a state whereby hands can be washed and dried appropriately.
(iii) Hand washing facilities shall be equipped with soap, paper towels, etc. and disinfectants, andshall be maintained in a condition that enables hand washing and drying to be performed
properly. (2) Hand washing and drying facilities shall be maintained in such a way that they canbe used appropriately and that a sufficient supply of water can be provided. In addition, handwashing facilities shall be equipped with appropriate soap, etc. for hand washing, and shall beclean and ready for use at all times.

GMP 6 Sanitation, work clothes and health management of employees, etc.
●Requirementｓ
The organization must document and enforce appropriate hygiene standards for employees inaccordance with the laws and regulations of the country in which the employees are working.
This must include hand washing methods and frequency, health check methods, work clothing
and footwear rules, entry and exit from the manufacturing facility, food handling methods, andforeign material contamination control.
These requirements must be made known to employees and applied without exception tocontractors and visitors.
●Concepts, specific examples
1. Concepts in GMP6
1) In GMP6, the organization needs to take appropriate sanitation standards to prevent
contamination factors.
(1) Provide appropriate guidance and control to prevent contamination from occurring due toemployee behavior.
(2) Establish a manufacturing environment that prevents contamination and foreign matter fromentering the product.
(3) External visitors are also to be handled in such a way that they do not affect food safety.
2) The important point in this section is to "ensure that workers are properly trained and instructed
so that there are no problems with on-site operations.
To this end, "documentation" is required to ensure that the information is accurately
communicated to each worker.
2. Management of employees' health conditions
1) Managers shall explain the health conditions and food safety risks to employees when they join
the company, etc., and seek their understanding of their pre-existing medical conditions to theextent necessary, what to do in case of illness, and what to do in case of food poisoning, etc.,
so that they can maintain appropriate knowledge and awareness of food safety.
2) Managers are to ascertain employees' pre-existing medical conditions as necessary for foodsafety.
3) The health condition of employees shall be checked before work. If any physical abnormality isobserved, the employee must report it to the person in charge of the work site, etc. If an
42employee reports an abnormality in his/her physical condition, he/she should not be allowed towork handling products unless it is clear that the abnormality does not affect food safety (e.g.,
minor tooth decay, etc.).
4) In the event of a suspected infectious disease or food poisoning, report it to management, thefood safety manager, etc. If necessary, disinfect the facility, equipment, etc., check with theparties (including outside visitors) who came in contact with the product, and take action on
products manufactured or shipped prior to the suspected infection or food poisoning.
5) Conduct periodic stool samples to confirm that there are no abnormalities.
6) For external visitors, especially those entering manufacturing areas (equipment, inspectors,
consultants, etc.), confirm their length of stay, health status, and contact information so that
confirmation can be obtained in the event of an abnormality. Visitors (including maintenanceworkers), especially those visiting food production, processing or handling areas, should be
instructed and supervised, where appropriate, and, like employees, should wear protective
clothing that will not contaminate food and comply with other employee hygiene requirements.
Instruct visitors to report any type of illness/injury that could cause cross-contamination
problems through the business's sanitation policy prior to the visit.
3. Management of personal hygiene of employees
1) Establish and document basic hygienic behaviors in the series of work from start to finish, andprovide explanations at the time of employment, etc., to properly align and maintain employees'
personal hygiene levels. Examples of employee hygiene behaviors include the following It isnecessary to set them appropriately by selecting and choosing the appropriate ones andconsidering unique items according to the organization's situation.
(1) Hand washing and disinfection at specified times(2) No unhygienic behavior with items (hands, gloves, utensils, etc.) that may come in contact
with products(3) Refrain from sneezing or coughing at the work site, and make efforts to avoid splashing,especially in areas related to the product.
(4) Wear masks properly as specified, covering the nose and mouth.
(5) To prevent the introduction of foreign substances into the manufacturing area, wear thedesignated work clothes properly to prevent hair and body hair from mixing in. In addition, airshowers, adhesive rollers, and other measures should be taken at designated times.
(6) When wearing work clothes or work shoes, do not carelessly go outside the production area
or take any actions that may result in contamination.
(7) Do not wear ornaments or other items to prevent foreign matter from falling out.
(8) Keep fingernails appropriately short and clean. Do not wear nail polish.
(9) Do not wear makeup that could fall off and affect the product (e.g., lame powder, etc.).
(10) No use of perfume(11) No food or drink is allowed to be stored or consumed in the work area. Observe operation indesignated areas.
(12) When work clothes are stored in common in lockers where personal clothes and belongings
are owned, handle them in such a way that they will not be contaminated.
(13) Do not bring unnecessary items to the work site. If there is a need for regular medication,etc., consult with the manager and take measures to ensure that contamination of products isprevented.
(14) Wash hair and bathe regularly to maintain proper hygiene.
2) Appropriate consideration shall be given to the shape of work clothes and shoes to prevent hairand body hair from falling out and mixing with products.
3) Rules for washing and replacing work clothes and footwear are to be established andimplemented so that employees can wear clean work clothes and footwear in good condition
according to their work needs, to prevent contamination and foreign matter from entering the
products.
4) When gloves are used, the material is selected according to the purpose, the usage and storage
methods are specified, and the gloves are handled in a clean and good condition. If disposable
gloves are used, check the material and strength of the gloves according to the work to be43

performed, determine the appropriate replacement frequency, and strive to prevent damage.
Control external visitors as necessary in relation to the above. 4.
4. Maintenance of hygienic environment
1) Appropriate consideration shall be given to the shape of work clothes and shoes to prevent hairand body hair from falling out and mixing with products.
2) Rules for washing and changing work clothes and footwear are to be established so that
employees can wear clean and good condition work clothes and footwear according to thenecessity of the work, and they are to be operated reliably to prevent contamination andcontamination by foreign substances.
3) When gloves are used, the material is selected according to the purpose, the usage andstorage methods are specified, and the gloves are handled in a clean and good condition.
4) When disposable gloves are used, check the material and strength according to the work,
determine the appropriate replacement frequency, and strive to prevent damage. Rules forwashing hands before wearing gloves should be established and implemented.
5) In relation to the above, control external visitors as necessary.
●Items to be referenced in legal provisions related to food safety
Food handlers and health conditions
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(vii) Hygiene Control for Persons Handling Food or Additives(a) Health examinations of persons who handle food or additives (hereinafter referred to as "foodhandlers") (a) Medical examinations of persons who handle food or additives (hereinafterreferred to as "food handlers") shall be conducted for the purpose of ascertaining the healthconditions necessary to prevent food sanitation hazards from occurring.
(b) When a prefectural governor, etc. has given instructions that a person handling food, etc.
should undergo a stool examination, the person handling food, etc. shall be instructed toundergo a stool examination.
(c) When a food handler is showing any of the following symptoms, efforts should be made to
grasp the details of the symptoms and to determine whether the symptoms require medical
examination by a physician and suspension of work to handle food or additives(1) Jaundice(2) Diarrhea(3) Abdominal pain
(4) Fever(5) Pyogenic skin disease, etc.
(6) Secretions from the ears, eyes, or nose (limited to those that may infect infect infectious
diseases, etc.)(7) Nausea and vomiting(d) When a person who has a skin injury is engaged, the area shall be covered with a waterresistant covering. Foods or additives that may be contaminated by vomit should be discarded.
In the event of vomiting in the facility, the area should be disinfected immediately with adisinfectant.
(e) When food handlers are engaged in work to handle food or additives, they should wear work
clothes specially designed for the purpose, and hats and masks as necessary. In addition, theyshall use special footwear in the work area and shall not leave the designated area while
wearing the footwear used in the work area.
(f) Personnel handling food shall not bring into the facility where food is handled any ornaments orother items that may interfere with hand washing or cause foreign matter to be mixed in.
(g) When using gloves, food handlers shall, in principle, use gloves made of water-resistantmaterials for the parts that come into direct contact with raw materials.
(h) Personnel who handle food, etc. must cut fingernails short, wash hands, and keep fingers cleanso as not to cause food sanitation hazards.
44

(h) Food handlers shall wash and sanitize their fingers thoroughly when they finish urinating or
handling fresh raw materials or raw materials before heating. In cases where disposable gloves
are used to handle fresh raw materials or raw materials before heating, the gloves shall bechanged after the work.
(3) In handling food or additives, food handlers shall not do the following while handling food or
additives from the viewpoint of preventing the occurrence of food sanitation hazards(1) Unnecessarily contaminate fingers, utensils or containers/packaging(2) Spitting phlegm, dandruff or spit
(3) Mixing or causing the possibility of mixing comb or cough droplets with food or additives.
(vi) Persons handling food, etc. shall not change clothes, smoke, or eat or drink outside of thedesignated areas.
(w) When persons other than food handlers enter the facility, have them change into clean,exclusive work clothes and follow the hygiene control regulations for food handlers as indicatedin this section.

GMP 7 Training●Requirementｓ
The organization must ensure that all employees receive adequate education and training in foodsafety principles (including HACCP) and practices appropriate to their jobs.
In addition, a system must be established to ensure that employees receive appropriate guidanceand supervision.
This education and training should enable employees to recognize their role in food safety and thesignificance of their efforts.
●Concepts, specific examples
1. Food safety managers
1) The person in charge of food safety shall enhance his/her own knowledge, techniques andskills, and shall set up education programs (content, timing, method, frequency (including
refresher courses), etc.) for food handlers, and conduct education and training accordingly, andrecord the results.
2. Food Hygiene Manager
Refer to the explanation in FSM2.
3. Education and training
1) Education and training are to be conducted and recorded for all employees, including new
employees, according to their roles in handling food products, in order to provide them with theknowledge and skills necessary for food safety.
2) Ensure that current rules and procedures can be reviewed at any time, incorporating theopinions of on-site food handlers.
3) Records created from education and training can be used for individual evaluation.
4) Re-training (hygiene training) is conducted for employees as necessary, and records are kept.
5) Conduct HACCP training.
●Items to be referenced in legal provisions related to food safety
Education and Training
Article 66-5 Standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
under Article 50-3, paragraph (1), item (i) of the Act concerning matters listed in the same
paragraph shall be as follows
45

(v) Education and training shall be provided for those who manage the manufacture of utensils orcontainers and packaging and for workers, and information and efforts necessary for preventing
food sanitation hazards shall be shared among persons concerned.
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(i) Appointment of a person responsible for food sanitation, etc.
(a) Appointment of a person who conducts business prescribed in Article 50-2, paragraph (1) of the
Act (including the cases where it is applied mutatis mutandis pursuant to Article 62, paragraph (3)of the Act) Hereinafter referred to as a "business person" in this table) shall appoint a person
responsible for food sanitation. Article 63 A person engaged in a business prescribed in Article 562, paragraph (1) of the Food Sanitation Act (including cases where it is applied mutatis mutandis
under Article 62, paragraph (3) of the Act) shall designate a person responsible for food sanitation.
However, this shall not apply to business operators prescribed in each item of Article 66-2,
paragraph (4). In addition, a food sanitation supervisor prescribed in Article 48 of the Act may also
serve as a person responsible for food sanitation.
(b) A person responsible for food sanitation shall be a person who falls under any of the following(1) A person who satisfies the qualification requirements for a food sanitation inspector prescribedin Article 30 of the Act or a food sanitation supervisor prescribed in Article 48 of the Act(2) Cooks, confectionery sanitarians, nutritionists, ship's cooks, sanitation supervisors prescribed in
Article 7 of the Slaughterhouse Act (Act No. 114 of 1953), occupational health supervisorsprescribed in Article 10 of the same Act, or poultry slaughtering sanitation supervisors prescribed in
Article 12 of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act (Act No. 70
of 1990)(iii) A person who has attended a training session conducted by a prefectural governor, etc. or a
training session deemed appropriate by a prefectural governor, etc.
(c) Food sanitation supervisors shall comply with the following matters(1) Attend seminars held by prefectural governors, etc. or seminars that are recognized by
prefectural governors, etc. on a regular basis and endeavor to acquire new knowledge concerning
food sanitation (limited to those concerning business under Article 51 of the Act (including cases
where it is applied mutatis mutandis under Article 62, paragraph (3) of the Act)). (limited tobusinesses under Article 51 of the Act (including cases where it is applied mutatis mutandis under
Article 62, paragraph (3) of the Act)) (2) To follow the instructions of the business person.
(d) A business person shall follow the instructions of a person responsible for food sanitation.
(d) A business person shall respect the opinions of the person responsible for food sanitation.
(e) A person responsible for food sanitation shall take necessary precautions to ensure compliancewith the measures prescribed in Article 66-2, paragraph (3), and shall endeavor to state necessary
opinions to the business person.
(xiii) Education and training(a) Provide education necessary for sanitation management to persons who handle food, etc.
(b) Education and training shall be provided for those who handle chemical substances so thatthey can safely handle the chemical substances used.
(c) Periodically verify the effectiveness of education and training in (a) and (b) above, and review
the content of education and training as necessary.

GMP 8 Housekeeping, cleaning, sterilization and disinfection●Requirementｓ
The organization must maintain an appropriate level of hygiene at all times by conducting tidying
and cleaning operations throughout all processes and phases, and disinfecting where necessary.
46

And cleaning tools, cleaning agents and disinfectants must be used for their intended purpose andproperly stored.
●Concepts, specific examples【Method Plan】
1. Cleaning removes food residues and contaminants that may be sources of contamination,
including allergens. Cleaning methods and materials required depend on the nature of the foodoperation, the type of food, and the surfaces to be cleaned. Disinfection may be necessary after
cleaning, especially for surfaces that come in contact with food.
2. Attention should be paid to sanitation during cleaning and maintenance operations so that foodsafety and appropriateness are not compromised. Food preparation and storage areas should
use cleaning agent materials appropriate for food contact surfaces.
3. Chemicals used for cleaning and disinfection should be handled with care and used according to
the manufacturer's instructions. For example, they should be used at the appropriate dilution andcontact time and, if necessary, stored away from food in clearly identified containers to avoid
food contamination.
4. Organizing, cleaning, and sanitation procedures are to be effective and documented
procedures.
5．Train food handlers in standardized methods. It is also effective to show actual cleaning
procedures and to post pictures or illustrations of the procedures. Trained personnel should
perform cleaning, washing, and sanitizing.
6. Monitor whether the cleaning and disinfection program is being implemented according to therules and regulations by visual inspection and other means, and verify whether it is effective byusing sanitary inspections such as product inspection and wipe-down inspections. Monitoring
methods will depend on the nature of the procedure, but may include pH, water temperature,
conductivity, detergent concentration, disinfectant concentration, and other parameters important
to ensure that the cleaning and disinfection program is being implemented as planned and toverify its effectiveness.
7. Training is provided based on the results of basic training and sanitation inspections.
8．Care should be taken to ensure that cleaning procedures do not lead to food contamination. For
example, sprays from high-pressure washing can spread contamination from dirty areas such as
floors and drains to large areas, and can contaminate food contact surfaces or bare food.
9. In some operations and/or food processing areas where water increases the potential for
microbial contamination, such as when the food handled is low moisture and the product ismanufactured under dry conditions, controlling the amount of water used in cleaning (e.g.,
removing and collecting residues and dry cleaning) can reduce the risk of microbiologicalcontamination.
10. The following items are to be implemented for the handling of detergents and chemicals used
for cleaning, sterilization, and disinfection.
1) Appoint a person responsible for the management
2) Inventory control of chemicals and other materials (incoming and outgoing shipments, amountused, number of items in stock, user and first-in first-out)
3) Locking and key management of drug storage4) Training of food handlers on the handling of chemicals, etc. (including proper dilution, contact
time, etc.)
5) Prevention of mixing of detergents and chemicals with food (e.g., labeling of containers withnames of contents, etc.)
11. To ensure that cleaning and washing of the facility is carried out systematically, plans andprocedures are to be prepared as follows
1) Plan for cleaning and washing facilities
The frequency of the work, the date of implementation, the person who performs the work, andthe method of recording the work should be described.
472) Written procedures for cleaning and washing facilities
Ensure to describe the person responsible for the work, subject, method, frequency, monitoring
and verification procedures, designation of work tools, post-work inspection procedures, andinspection procedures prior to the start of production, etc.
【Cleaning Tools, Cleaning Equipment, etc.】
1. If foreign matter or microorganisms adhere to equipment, facilities, or utensils used for cleaning,
washing, sterilization, or disinfection, it may lead to contamination of products with foreign
matter or microorganisms. Use separate cleaning machinery, equipment, and utensils
designed for different sanitation zones (areas), such as for food-contact surfaces and noncontact surfaces, to suit the purpose.
Contaminated cleaning equipment and utensils can also spread contamination.
2. Inspection and maintenance
1) Check operation and deterioration before and after use, and immediately repair or replace any
defective items.
2) Since dirt remains on the back and bottom of equipment, facilities, and utensils, disassemble
them to check for contamination. Cleaning equipment should be kept clean, maintained, andreplaced regularly to avoid contact surfaces and sources of cross-contamination of food.
3. storage location
1) Cleaning equipment should be stored in an appropriate location to prevent contamination.
2) Cleaning utensils should be hung and stored to dry so that they do not stick to the floor or othersurfaces.
3) Storage areas should be designated and kept clean so that food handlers can use them
immediately. Posting a notice to this effect is another way to keep the area clean.
4. Identification
1) It is necessary to devise ways to ensure that cleaning and washing utensils used incontaminated areas are not misused in clean areas. It is important to color-code themaccording to their use, such as "red" for floors and "blue" for cooking utensils, and to separate
their storage locations.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(iii) Sanitation of equipment, etc.
(c) When detergents are used to clean machinery, equipment, and their parts, they must be usedin an appropriate manner.
(f) Detergents, disinfectants, and other chemical substances shall be handled with due care, and if
necessary, the names of the contents shall be indicated on the containers and packaging toprevent contamination of food or additives.
(g) Equipment and materials for cleaning facilities and equipment are to be used appropriately for
their intended purpose, cleaned and dried each time they are used, and stored in a designatedplace.

GMP 11 Air and water management●Requirementｓ
The organization shall define the required quality criteria according to the application, and regularly
monitor and record the air, high-pressure gas, and water (including ice and steam) used in foodproduction in order to minimize the effect on food safety.

48

Water not intended for use in food production, and water that has been used but is acceptable forcontact with food, must be controlled so that it is not mixed with water used exclusively for
production.

●Concepts, specific examples
1. When manufacturing food products, it is possible to use different types of water for different
purposes, and in such cases, standards should be established according to the intended use.
2. Water quality is to be checked by water quality tests, etc., and if necessary, filtered, sterilized,
etc., to ensure water quality before use
3. If necessary, comply with microbiological and water quality standards for drinking waterrecognized by local, national, or international authorities.
4. In Japan, in principle, water used for food production or water suitable for drinking should be
used, and water for food production means water that complies with applicable laws andregulations.
5. In Japan, should be referred to in the legal and regulatory requirements.
1) Water quality standards based on the Water Supply Law (51 items): Ministerial Ordinance on
Water Quality Standards (Ordinance of the Ministry of Health, Labour and Welfare No. 101,
May 30, 2003)
2) Water for food production: Standards for foods, additives, etc. (26 items) (Ministry of Health andWelfare Notification No. 370, 1959)
3) Water suitable for drinking: Regulated by the Food Sanitation Law Enforcement Regulations
following the revision of the Food Sanitation Law (enacted on June 1, 2020). (Reference:
Appended Table 17 of the Food Sanitation Law Enforcement Regulations, July 14, 2020)
6. In order to reduce the cost of water, there are cases where water other than water for foodproduction is used in the manufacturing process (e.g., for primary washing of food, heating andcooling), and these waters must be controlled to prevent contamination of water for foodproduction. Specific examples include the following.
1) Well water that is only pumped up2) Water that has not been disinfected with hypochlorous acid or chlorine
7. In the food industry, water that has been used but is acceptable for contact with food may bereused in food production for the effective use of water resources. Specific examples include thefollowing.
1) Water used for heating and sterilizing equipment
2) Water used for heating and cooling prepackaged foods
3) Secondary washing water for cut vegetables (water used in the final stage of the washingprocess)4) Reused steam drain water
8. In addition to water, ice and steam used in food production must also be addressed to minimize
their impact on food safety, including the following1) Ice and steam should be made and handled in a manner that prevents contamination. In
particular, ice machine cleaning agents and can-cleaning agents (chemical agents) used inboilers that generate steam should be approved for food use and should not be mixed with ice
and steam.
2) A filtration device (filter) should be installed near the end of the ice maker's water supply andsteam piping.
3) Make sure that ice/steam in direct contact with food products does not have any adverse
effects (odor, coloration, etc.) on food products.
4) Description of air and gas
9. Compressed air, carbon dioxide, nitrogen, and other gases
1) Equipment for gases used in manufacturing and filling should be of specifications that do notpresent a risk of food contamination, and should be properly maintained.
492) Gases that come in contact with foodstuffs shall be those approved for general use in foodadditives.
3) Ensure that air and gases that come into contact with food are free of dust, oil, and water.
4) Gases should be filtered as close to the point of use as possible.
10. air conditioning and ventilation
1) To prevent dust, debris, insects, etc. from entering and contaminating the air, the following
points should be taken into consideration when devising air conditioning and ventilation
systems.
(1) The air conditioning and ventilation system should be designed to be easy to clean, wash,
and replace filters.
(2) Consideration should be given to the air balance between intake and exhaust air in the facility.
(3) Avoid inflow of outside air through windows, doors, and crevices.
(4) Soot and vapor should be easily excluded (to prevent condensation and mold formation,etc.).
(5) If necessary, maintain differential pressure to prevent air from flowing into the clean area.
2) Periodically check the outside air intakes for damage, clogging of filters due to suction of dust,
insects, etc., and deterioration due to rust and corrosion.
3) It is convenient to have inspection ports for both intake and exhaust for inspection, cleaning andwashing, and filter replacement.
4) When aiming to step up to the JFS-C standard, it is desirable to monitor and control thecleanliness of the air in areas where products that are prone to the development and survival of
microorganisms are manufactured, in accordance with procedures.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(iv) Control of water used, etc.
(a) Water used in the manufacture, processing, or cooking of food or additives shall be watersupplied by waterworks provided under Article 3, paragraph (2) of the Waterworks Act (Act No. 177
of 1957), dedicated waterworks provided under paragraph (6) of the said Article, or simplified
exclusive waterworks provided under paragraph (7) of the said Article, or other water suitable fordrinking (hereinafter referred to as "water suitable for drinking"). (hereinafter referred to as "water fit
for drinking"). (2) The water shall be water that is suitable for drinking (hereinafter referred to as"water suitable for drinking"). However, this shall not apply to use in cooling or other processes that
do not affect the safety of food or additives.
(b) In the case of using water fit for drinking, water quality tests shall be conducted at least once a
year, and a written report shall be kept for one year (or for the period of one year or more if the foodor additive to be handled is to be used or consumed for one year or more). However, if there is apossibility that the water source, etc. has been contaminated due to an unforeseen disaster, awater quality test shall be conducted each time.
(c) If, as a result of the inspection in (b), it becomes clear that the conditions in (a) are not met,
immediately discontinue use.
(d) When water storage tanks are used, the water storage tanks must be cleaned regularly andkept clean.
(e) When water suitable for drinking is used and a sterilization or water purification device isinstalled, periodically check that the device is working properly and record the results.
(f) Ice that comes in direct contact with food shall be made from water that meets the conditions in(a) above, which is supplied by a properly controlled water supply system. Ice should be handled
and stored in a hygienic manner.
(g) When used water is to be reused, necessary treatment is to be performed so as not to affectthe safety of the food or additives.
50

GMP 12 Waste Management●Requirementｓ
The organization shall establish adequate systems for segregation, collection and disposal of waste.

Waste placement and containers must be controlled to prevent the attraction of pests and thedevelopment of harmful organisms and microorganisms.
Waste flow lines must be set up so as not to cause cross-contamination of food.

●Concepts, specific examples
1. Waste and other materials generated as a result of food production and processing (including
by-products not suitable for food use) can become a breeding ground for microorganisms, pests,
insects, and other harmful organisms and lead to contamination of the production andprocessing environment if not properly managed.
2. Contact between wastes and raw materials, materials, and manufacturing/processing
equipment should be avoided.
3. A person in charge of consistent management (identification, accumulation, segregation,
storage, removal, and disposal) of wastes, etc., should be designated, and a written procedure
for such management work should be prepared. It is important to periodically check the status ofwaste management, such as whether the work has been carried out according to the procedure
manual.
4. Confirm that wastes are promptly disposed of according to the following procedures.
Waste, etc. generated in manufacturing/processing lines → Containers of waste, etc. →Temporary storage location → Indoor/outdoor storage location of waste, etc. → Pickup by
designated contractor → Issuance and storage of manifest slip (in accordance with laws andregulations)
5. Control and store wastes in such a way that they do not affect products, raw materials, andmaterials and equipment that come in contact with products.
6. In order to prevent cross-contamination of wastes with products, in principle, wastes should not
be stored in areas where food is handled or stored (except for temporary storage during
manufacturing - even then, be aware of cross-contamination with products). Containers for
wastes should be stored in a manner that prevents cross-contamination.
7. Ensure that waste containers are clearly distinguishable from other containers.

●Items to be referenced in legal provisions related to food safety
generalRegulations for Enforcement of the Food Sanitation Act
Article 66-5 The standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act with regard to the matters listed in thesame paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections of facilities and disposal ofwaste in order to maintain a clean working environment.
Appended Table 17 (Re: Article 66-2, paragraph (1)) of the Ordinance for Enforcement of the Food
Sanitation Act(vi) Handling of waste and wastewater(a) Procedures shall be established for the storage of waste and its disposal.
51

(b) Containers for waste shall be clearly distinguishable from other containers, and shall be kept
clean to prevent leakage of contaminated liquids or odors.
(c) Waste shall not be stored in areas where food or additives are handled or stored (including
adjacent areas), unless it is deemed possible to prevent the occurrence of food sanitation
hazards. (d) Waste shall not be stored in areas where food or additives are handled or stored(including adjacent areas) unless it is deemed possible to prevent food sanitation hazards.
(d) Waste should be stored in a location that can be properly controlled so as not to adversely
affect the surrounding environment.
(e) Waste and wastewater shall be treated appropriately.

GMP 13 Pest control●Requirementｓ
The organization must implement controls (surveys and countermeasures) to minimize the risk of
insects, rodents, birds, and other pests occurring or entering the premises and facilities.
If chemicals are used, handling procedures must be established to ensure that they do not affectfood products.
●Concepts, specific examples【Pest control measures】
1. Pest control measures shall be taken as follows
1) Analysis and inspection plan for pests such as rodents and insects
Target pests are identified based on past occurrences in the facility, biological evidence, andcharacteristics of products handled, and inspection plans are formulated.
2) Pest control and invasion prevention measures
Remove internal sources of pests and implement measures to prevent external invasions andincursions.
3) Monitoring and extermination of pests such as rodents and insects
Monitoring will periodically confirm that sanitation and pest control measures within the facility are
secured and that there is no evidence of pest infestation. If extermination is necessary based on
the results of monitoring, countermeasures that do not affect food or interfere with facility
operations should be formulated and implemented by competent personnel. Identify the cause of
the infestation, take corrective action to prevent the problem from reoccurring, and document
monitoring and eradication.
2. When pest control is outsourced to a specialized contractor, the above information should also
be confirmed with the specialized contractor and measures should be promoted. Even whenmonitoring and eradication are outsourced, the organization reviews monitoring reports and, if
necessary, ensures that its designated pest control operators take remedial action (e.g.,
eradication of small pests, elimination of hiding places or entry routes).
3. Plantings that produce flowers or fruits that attract pests such as rodents and insects should be
avoided, and the smell of wastes and sewage should be prevented from spreading. Mowing andpruning of plants should be done regularly to avoid sources of pests.
4. Areas prone to puddling can be a source of chironomids and other pests. For example, in
unpaved parking lots, it is possible to prevent outbreaks by frequently adding gravel to theparking lot.
52

5. Yellow or green fluorescent lights or plastic curtains, which are considered to be less visible toinsects, should be installed in outdoor lighting, entrances, corridors, etc.
6. The eaves of the facility and areas around the air supply facilities should be designed to prevent
birds and other insects from nesting in them. Mesh and filters should be inspected regularly. 7.
7. Drainage ditches around the plant should be designed to prevent rodents and insects fromentering through the openings of the facility. Measures such as netting or water sealing at theends of drains are effective. 8.
8. Windows that are not opened and closed should have their gaps filled and be removed asnecessary. Ensure that entrances and exits for employees and goods are closed except whennecessary. 8. wire mesh screens should be installed on windows, doors, etc. that open andclose to reduce the risk of entry of small pests.
9. Use screens on swinging door windows to prevent dust and insects from entering the building
due to wind pressure when opening and closing the doors.
10. Make sure that lighting around window and shutter openings does not leak to the outside.
Attaching light-blocking film or insect repellent sheets to windows is also an effective method.
Roll-up doors should be closed tightly against the floor.
11. Insect traps at work area entrances should be located inside the building where light cannot beseen from the outside.
【Measures for facilities that are easy to clean】
1. Insufficient cleaning leads to the internal generation of pests. The gap between walls and floors
should have an easy-to-clean structure, such as an arched joint.
2. Openings and pits caused by damage to floors and walls are likely to become entryways forpests and internal emergence sites, so damaged areas should be repaired as soon as possible.
3. Equipment and objects should be kept away from the walls of the facility and arranged for easyinspection and cleaning.
【Drug Control】
1. It is important to have established procedures for chemical administration, spraying, and initiationof production and processing after spraying
2. Ensure that the use of chemicals is restricted to well-trained personnel.
3. The amount of chemicals entering and leaving the warehouse should be controlled and stored ina locked area isolated from the manufacturing/processing area.
4. It is necessary to record the type of chemical used, the amount used, the concentration used(dilution factor), the date and time of application, and the location of application.
5. It is acceptable to outsource the entire pest control to a specialized contractor because more
efficient measures can be expected and chemical management can be omitted.
6. It is important to inspect regularly for pest infestation and internal development of pests, such as
once a week or once a month, depending on the season and other factors.
7. To prevent pests from mixing with products, poisonous bait should not be used in the production
area.
●Items to be referenced in legal provisions related to food safety
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(ii) Sanitary management of facilities
53(e) As a rule, windows and entrances shall not be left open. When they are left open, measures
shall be taken to prevent the entry of dust, rats, insects, etc.
(v) Measures against rats and insects(a) The facility and its surroundings shall be maintained in a condition that allows for proper
maintenance and management, and breeding grounds for rats and insects shall be eliminated.
(b) Extermination of rats and insects shall be carried out at least twice a year, and the records ofthe extermination shall be kept for one year. However, if the objective can be achieved byconducting periodic, uniform surveys of the locations of rats and insects, their habitats androutes of entry, and the state of damage, and taking necessary measures based on the resultsof said surveys, then the method and frequency may be implemented in accordance with theconditions of the facility in question.
(c) When using pesticides or insecticides, care must be taken in handling them so as not to
contaminate food or additives.
(d) To prevent contamination by rats and insects, raw materials, products and packaging materials
shall be stored in containers and kept away from floors and walls. Once opened, the productshall be stored in a container with a lid or other measures to prevent contamination.

GMP 15 Transport●Requirementｓ
The organization shall establish a system to ensure that containers and vehicles used to transport
raw materials (including packaging materials), semi-finished products, work-in-process, recycled
products, reworked products, and finished products (including perishable products in their final
packaging and packaging), including outsourced vehicles, are fit for their intended use and aremaintained, kept clean and protected from contamination, and transported within their intended
temperature range.
●Concepts, specific examples
1. Concepts in GMP15
1) In GMP15, organizations need to ensure that raw and packaging materials are free of defects
prior to use to prevent food safety risks to the product.
It is also required to ensure that the product (including intermediate stages) can proceed to thecustomer or the next process without any abnormality.
2. When receiving raw and packaging materials
1) With respect to materials used in the manufacture of products, they must be in a condition freeof abnormalities prior to use.
When purchasing or using items that are already packaged as ready-to-use products, thespecifications of each raw or packaging material should be checked, and only if no problems
arise when delivered under general transportation conditions, such as "refrigerated", "frozen", or"room temperature" temperature control, rather than in a specialized vehicle, should it beallowed.
2) If abnormal temperature, damage, contamination, etc. are found upon receipt, the productshould not be used, but should be checked and returned as necessary.
3) When semi-finished products or work-in-progress are received from related parties and used as
raw materials, if the counterparty uses a special vehicle, confirm the transportation conditions,establish items to be checked upon receipt, and take action such as returning the product if any
abnormality is found.
Examples of items to be checked: appearance (presence of damage, sealed condition, etc.),
temperature zone during transportation, pallets used, etc.
54

3. When transporting semi-finished products, work-in-process, reworked products, reworked
products and finished products
1) When delivering products to the destination, check the product specifications and consider thenecessary conditions that allow delivery without abnormalities.
(e.g., temperature and humidity settings, stacking and loading methods, pallet-related items
used, delivery containers, and other special conditions)2) Confirm that the delivery vehicle can handle the set conditions without any problems and thatthe environment is such that the product can be delivered without damage or contamination.
(1) Can the temperature and humidity be set to the required temperature and humidity? Can thetemperature and humidity be maintained at the maximum loading capacity? If not, can the
maximum loading capacity be changed?
(2) Is the temperature and humidity recorded at the required frequency? (2) Is the temperatureand humidity recorded as often as necessary, and is it possible to confirm that there are noabnormalities in the 55hermos-hygrometer as needed?
(3) If containers and pallets are not manufactured by the company, check the frequency ofcleaning, disinfecting, and replacement.
(4) Is the interior of the vehicle kept in an appropriate state of cleanliness?
(5) Confirm whether mixed loads with non-products are allowed, and if so, the loading capacity
and the items that can be loaded.
(6)Confirm that no outsiders other than the person in charge of delivery are involved.
4. If necessary, the organization will also conduct checks to maintain the delivery environment. If
any abnormality is found, it is necessary to seek appropriate improvement.
●Items to be referenced in legal provisions related to food safety
transport
Regulations for Enforcement of the Food Sanitation Act Appended Table 17 (Re: Article 66-2,
paragraph (1))(xi) Transportation(a) Vehicles, containers, etc. used for transporting food or additives shall be cleaned anddisinfected as necessary to prevent contamination of the food, additives, or their containers
and packaging.
(b) Vehicles, containers, etc. shall be maintained in a clean condition, and shall be kept in an
appropriate condition by repairing, etc.
€ When food or additives and cargo other than food or additives are mixed, food or additives shallbe placed in appropriate containers or otherwise classified, as necessary, to prevent
contamination from cargo other than food or additives.
(d) Foods or additives in transit shall be managed so as not to be contaminated by dust andexhaust gases, etc.
€ When vehicles, containers, etc. used for transporting food or additives of different items andcargo other than food or additives are used, they are to be cleaned by effective methods anddisinfected as necessary.
(f) In the case of food or additives in bulk, vehicles, containers, etc. exclusively for food or additives
shall be used as necessary, and it shall be clearly indicated that they are exclusively for food or
additives.
(g) Care shall be taken to control temperature and humidity during transportation.
(h) Delivery times shall be set based on the temperature and humidity during transportation, andshall be properly controlled so as not to exceed the prescribed delivery time.
(h) In the case of delivering and serving cooked food, the time until it is served for eating anddrinking shall be taken into account and properly controlled.

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GMP 17 Stock Management●Requirementｓ
The organization shall establish a system to use raw materials and ingredients (including
packaging materials), partially processed products, work in progress, reworks, and finishedproducts in a designated order and within the defined expiry period, and shall store these materials
under the proper conditions to avoid contamination and deterioration.

●Concepts, specific examples【Storage period】
1. Raw materials (including containers and packaging materials), semi-finished products, work-inprocess, recycled products, reworked products, and finished products should be stored for an
appropriate period of time and used within the specified period, utilizing first-in, first-out, etc.
2. During storage, the traceability of raw materials (including containers and packaging materials),semi-finished products, work-in-process, recycled products, reworked products, and finishedproducts (see FSM 14) should be managed so that they can be linked to the records.
【Storage location】
1. Raw materials (including containers and packaging materials), semi-finished products, work-inprocess products, recycled products, reworked products, and finished products shall be stored instorage facilities that are not contaminated and do not deteriorate due to temperature, humidity,
or other factors.

GMP 18 Devices and Tools●Requirementｓ
The organization shall design and select equipment and instruments to be suitable for theirintended use, and shall use, maintain, and store them in a manner that minimizes food safety risks.
●Concepts, specific examples
1. Concept in GMP181) GMP18 requires organizations to prevent food safety risks derived from equipment andinstruments.
Examples of risks include the following(1) Biological: Contamination due to residual food residues, etc.
(2) Chemical: Mold and allergen residues due to inadequate cleaning and drying, chemical
damage due to detergent residues, etc.
(3) Physical: Foreign matter contamination due to breakage, deterioration, or loss.
It is necessary to consider how to sufficiently prevent these risks before enabling production
activities.
2. When selecting equipment and instruments
1) Cleaning and drying(1) As much as possible, it is desirable to be able to "wash the entire unit in a washing room, etc."
and "reliably dry the unit in a drying room, etc.". For equipment that needs to be fixed to thefloor, consider specifications that can be accommodated without difficulty, such as
disassembly of cleaning parts.
(2) Assuming actual operation, the necessary capacity and quantity should be provided to allow
sufficient time for cleaning and drying.
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(3) Confirm that periodic cleaning and confirmation of water and residue in pipes, ducts, etc. are
possible.
2) Specifications(1) Check that areas that come in contact with foodstuffs are food-compliant, and take action toensure that this can be verified.
(2) For parts that come in contact with food, confirm that they can be easily cleaned, inspected,
and replaced, and consider the degree of deterioration that should be addressed and thefrequency of such action to be realistically feasible.
(3) Avoid items (screws, labels, etc.) that may fall off the top of the food as much as possible, andmonitor as necessary.
(4) Check carefully before initial use to ensure that there are no paint chips, facets, or othercontaminants.
(5) If the product is made of metal, it should be made of a material that is resistant to rust andcorrosion.
3. After installation of equipment
1) Establish procedures for cleaning, drying, and, if necessary, disinfection.
(1) Cleaning method: cleaning tools to be used, water temperature during cleaning, whether or
not detergent is used, etc.
(2) Drying method: temperature setting of drying room, temperature setting for drying with warm
air, time required for drying, etc.
(3) Others: Whether alcohol spray is used or not, etc.
2) It is desirable to verify whether any of the intended hazardous factors will remain if theprocedures are implemented as discussed. As an example, after actual washing and drying
according to the procedures, the residual allergens may be confirmed by means of a bacterial
test or ELISA test of wiped specimens.
3) If workers need to be informed and educated about the established procedures, it is desirable
to have a procedure manual or visual explanation materials. In addition, it is recommended thatrecords be kept to ensure that the procedures are followed, such as records of checks on areas
prone to insufficient cleaning and records of the completion of drying, if necessary.
4) Monitoring should be conducted at an appropriate frequency for damage, deterioration, andother areas where food safety risks may be a concern. When monitoring is conducted, it isdesirable to keep records.
5) Inform workers to report any abnormalities such as breakage, parts falling off, or abnormal
noise.

57

■Activities to maintain sanitation of food handling equipment, facilities, and utensils●Items to be referenced in legal provisions related to food safety
Sanitation of equipment and instruments
Regulations for Enforcement of the Food Sanitation Act
Article 66-5 The standards specified by Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act concerning matters listed in the same
paragraph shall be as follows(i) Allocation of necessary personnel, establishment of work contents, and maintenance of facilities
and equipment, etc., so that the containers and packaging are manufactured appropriately(ii) Maintaining the cleanliness and health of personnel engaged in the manufacture of containers
and packaging (hereinafter referred to as "workers" in this Article and the following Article). (iii) The
facility or work area shall be designed to maintain the cleanliness and health of the equipment,
containers, and packaging (hereinafter referred to as "equipment, containers, and packaging"), andto ensure that the workers understand the work procedures and matters necessary for hygiene
management, and that they perform their work in accordance with those procedures and matters.
(iii) The facility or work area shall be designed to prevent contamination by dust, dirt, or othercontaminants as necessary, based on the usage of the equipment or containers and packaging,and shall be maintained in a clean condition.

58

Sanitation of equipment and instruments
Appended Table 17 (Re: Article 66-2, paragraph (1))(iii) Hygiene control of facilities, etc.
(a) To maintain hygiene, machinery and equipment shall be used appropriately for their intended
purposes.
(b) Machinery, equipment, and parts thereof shall be cleaned and sanitized to prevent metalfragments, foreign substances, or chemical substances from mixing with food or additives, andshall be stored hygienically in designated locations. In the event of malfunction or damage, it shallbe repaired promptly and maintained for proper use. e. Equipment, cleaning equipment, and parts
shall be stored in a hygienic location.
(e) Items that may come in contact with food or additives, such as utensils, cleaning equipment,
and protective gear, shall be disinfected with hot water, steam, or disinfectants and dried each timethey are contaminated or work is completed.
(li) Cleaning facilities are to be kept clean.
GMP 19 Maintenance●Requirementｓ
The organization must establish a system for the planned maintenance of all equipment andinstruments critical to the safety of the product.
Maintenance activities must be performed in such a way that they do not pose a food safety risk.
●Concepts, specific examples
1. maintenance and management of equipment and instruments
1) Procedures shall be developed and implemented for the maintenance of all equipment andinstruments that are important for product safety. The procedures shall include the following
concepts(1) After-the-fact maintenance: A management method in which maintenance is performed after
a failure has occurred and the equipment has stopped or its functions have deteriorated.
(2) Preventive maintenance: Management methods that focus on prevention, such as equipment
inspection and periodic parts replacement.
(3) Improved maintenance: Management method that focuses on improvement andreinforcement to prevent recurrence of breakdowns.
2) Procedures for maintenance and management of equipment and instruments include thefollowing items(1) Planning of maintenance and inspection(2) Persons in charge of maintenance and inspection(3) Identification of equipment and instruments requiring maintenance and inspection(4) Frequency of maintenance and inspection(5) Procedures for performing maintenance and inspections (including chemicals to be used)(6) Methods for checking and recording the status of maintenance and inspections(7) Procedures for returning to a state in which food production can be performed after
maintenance (including cleaning, etc.)●Items to be referenced in legal provisions related to food safety
Maintenance of equipment and instruments

59

Article 66-5 The standards specified by an Ordinance of the Ministry of Health, Labour and Welfare
set forth in Article 50-3, paragraph (1), item (i) of the Act with regard to the matters listed in thesame paragraph shall be as follows(iv) Proper implementation of cleaning and maintenance inspections of facilities and disposal ofwaste materials in order to maintain a clean working environment.
The end60

Disclaimer：This translated document is machine translated by JFSM and is provided for information purposes only.
In the event of a difference of interpretation or a dispute, the original Japanese version of this document is binding.

JFS-A Standard Document (Sector：CI,CII,CIII,CIV/K) Version 3.0 〔Guidelines〕 Edition 1.0
July 25, 2022 Issued
Editing and publishing Japan Food Safety Management AssociationThe
copyright of this guideline belongs
to the Food Safety Management
本ガイドラインの著作権は一般財団法人
食品安全マネジメント協会または正当なAssociationof Japan or legitimate third parties. If you wish to use any of
第三者に帰属します。本ガイドラインのコンテンツのご利用を希望する際には事前に以
thecontents of these guidelines, please contact us in advance at
下までご連絡ください。
SHINTOMICYO BLDG.,
3-10-9Irifune, Chuo-ku, Tokyo
104-0042〒104-0042
東京都中央区入船三丁目
10 番
9 号 新富町ビル 8 階Japan
Food Safety食品安全マネジメント協会(JFSM)Management Association(JFSM)
一般財団法人Tel: 03-6268-9691 Email: info@jfsm.or.jp

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