JFS-C Standard Document(Sector: CI, CII, CIII, CIV/K)

Requirements for Organizations
Version 3.1

Japan Food Safety Management Association
May 20, 2024

1． Introduction
1.1

JFS-C Standard Document

The JFS-C Standard Document (hereinafter referred to as “this Standard Document”) is a standard
document developed by the Japan Food Safety Management Association (JFSM) and is intended toassist organizations to establish, operate and improve its management systems for manufacturing
safe food products. In addition, this Standard Document can also be utilized to have the system of
the organization (*1) evaluated by external agencies including Certification Bodies. This Standard
Document is utilized by organizations that endeavor to realize a food safety management systemapplicable worldwide.
(*1) “Organization” refers to a business entity, group or individual to whom the requirements ofthis Standard Document apply.
1.2

Scope of application

This Standard Document applies to the following “Food Manufacturing Sectors (CI, CII, CIII, CIV)”and “Chemical Products (Including Biochemical Products) Manufacturing Sector (K)”. (See JFS
Standard Document sector list on page 5)*Pet food is included in the following food manufacturing sector (C).
Food manufacturing sector (C)CI:
Processing of perishable animal products
CII:
Processing of perishable plant products
CIII: Processing of perishable animal and plant products (mixed products)
CIV: Processing of ambient stable products
Manufacturing sector of chemical products (including biochemical products) (K)K:
Manufacture of chemical products (including biochemical products)(Production of chemical products (including biochemical products) and cultures used asfood ingredients or processing aids in food production.)
In addition, chemical products here means a chemical product (including a biochemical
product) related to food.

1.3

Structure of this Standard Document

This Standard Document consists of three elements, namely, Food Safety Management Systems(FSM), Hazard Analysis and Critical Control Point (HACCP), and Good Manufacturing Practice (GMP).
This Standard Document only specifies common requirements for the manufacturing sector, and does
not cover individual hygiene requirements for individual product. Organizations shall use information
appropriate for the organization (e.g. laws and regulations on food safety, standards specified by therelevant industry group, “General Principles of Food Hygiene Code of Practices” by the Codex
Alimentarius Commission (*2), specific code of conduct), in addition to the requirements stipulated inthis Standard Document.

1This Standard Document is consistent with the benchmark requirement version 2020.1 (*3 hereafter,
BR 2020.1) published by GFSI in June 2020. On the other hand, since BR 2020.1 adopts
ISO22000:2018 (*4) in its scope structure and numbering structure, this Standard Document has astructure consistent with both the scope structure and numbering structure.
In addition, this Standard Document uses a process approach that incorporates the plan-do-checkact (PDCA) cycle of ISO22000:2018 and a risk-based approach as a benchmark. This Standard
Document establishes and implements a food safety management system to ensure the provision ofsafe food and services while meeting each applicable requirement and adopts a process approach
for improving its effectiveness.
The process approach indicates that each process used for providing food and services is regarded
as a system and is managed as such. In the process approach, the purpose of each process is
clarified and managed in consideration of process interactions to aid the organization to achieve theintended results effectively and efficiently.
Risk (*5) in this Standard Document refers to all the factors that may hinder the achievement of theorganization's food safety objectives and targets. Risk-based thinking involves "focusing on what
factors may compromise the achievement of goals and objectives, identifying those factors, clarifying
their effects, and considering necessary measures." By establishing a hypothesis based on risk,
executing it, and performing verification based on the facts that are obtained, it becomes possible toaim to improve the accuracy of achieving the objectives and goals of the organization.
As shown in Figure 1, in this Standard Document the process approach adopts the concept of aplan-do-check-act (PDCA) cycle at two levels. The first level involves the FSM framework. The second
level is targeted at the Do process within the food safety management system. For this reason,communication between the two levels is extremely important.
(*2) Codex Alimentarius Commission"GENERAL PRINCIPLES OF FOOD HYGIENE," CXC 1-1969, Rev. 2022（*3）GFSI “The GFSI Benchmarking Requirements version 2020.1”（*4）The International Organization for Standardization“Food safety management systems – Requirements for any organization in the food chain”
ISO22000：2018(*5) Unlike the risk defined in ISO22000:2018 (ISO22000:2018 3.39), the term risk is usedin the JFS-C Standard Document as something limited more to food safety.

2

PLAN（FSM）
FSM 1

DO（FSM）

Top Management Responsibility
Top Management Commitment and Food
Safety Culture
Compliance with food safety laws
Food Safety Management System andGeneral Requirements
Food Safety Policy and Goals
Documentation procedures

FSM 7

Food Defense

FSM 8

Food Fraud Prevention

FSM 11

Procedures and Instructions

FSM 14.1

Traceability

FSM 15
FSM 16

Control and storage of documented
information
Specification Control of Purchased orProvided Items and Services

FSM 17

Product development
Allergen Management
Control of Measuring and Monitoring
Devices

FSM 12

Resource Management

FSM 19.2

FSM 13.1
FSM 13.2

Purchasing
Supplier Performance

FSM 22.1
FSM 23.2

FSM 13.3

Outsourcing

FSM 24

FSM 18.1

Product labeling (B-to-C products)

FSM 2
FSM 4
FSM 5
FSM 6
FSM 9.1
FSM 9.2
FSM 10

FSM 18.2
FSM 23.1
FSM 26

FSM 19.1

Analysis and Testing
Environmental Monitoring for Food
Manufacturing
Serious Incident Management
Product Release
Identification of nonconformities and control
of nonconforming products

CHECK（FSM）Performance evaluation

Product labeling(B-to-B products, work in progress, semifinished products)
Management of product specifications
Change management

FSM 3

Management Review

FSM 14.2
FSM 20
FSM 21

Traceability verification
Internal Audit
Complaint Handling
Verification of food incident management
procedure

FSM 22.2

ACT（FSM）Improvement
FSM 25
FSM 27

Corrective Action
Utilization of Kaizen suggestions frompersonnel

Figure 1 Conceptual diagram of two PDCA cycles in the JFS-C Standard Document Food Safety Management System3

At the beginning of this chapter, it was noted that this Standard Document consists of threeelements: Food Safety Management Systems (FSM), Hazard Analysis and Critical Control Point(HACCP), and Good Manufacturing Practice (GMP). Instead of working independently, each ofthese elements influences the other. Each element has an organic function within this relationshipthat spirals up while interlocking. Figure 2 shows a conceptual diagram of the three elements. An
understanding of this conceptual diagram will be effective for organizations that use this Standard
Document for building and operating a food safety management system.

Fig. 2 Conceptual diagram of the organic functions of the three elements (FSM, HACCP,
GMP)
The association also prepares guidelines on the requirements of the Standard Document andrecommends that organizations refer to them.

4

1.4

Exclusion from Application of Requirements

All the requirements in this Standard Document shall be applied in principle. However, in case anyof the requirements in this Standard Document is not able to apply for reasons arising from thebusiness scale, business form and so on of an organization, the organization shall provide a document
which indicates proof of non-applicability with explanations demonstrating the proper maintenance offood safety management system.
(Reference) Category is as shown in the table below:
Sector list by GFSI
The following sectors apply to this JFS (Food Safety Management) Standard Document.
※Of the sectors presented by GFSI, the sectors covered by this standard document are
enclosed in a box.
Code

Sector/Subsector

Code

Sector/Subsector

FI

Retail / Wholesale

FII

Food Broker / Agent

H

Provision of Food Safety Services

Farming of Animals for Meat/ Milk/AI
Eggs/ Honey
AII

Farming of Fish and Seafood
Farming of Plants (other than grainsBIand pulses)
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

Hygienic Design of Food Buildings andProcessing Equipment (for building

CI

Processing of perishable animal
products

JI
constructors
and equipment manufacturers)

CII

Processing of perishable plant
products

CIII

Processing of perishable animal andplant products (mixed products)

CIV

Processing of ambient stable productsHygienic Design of Food Buildings and
JII

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

K
D

Production of feedbiochemical products) and cultures used asfood ingredients or processing aids in foodproduction.)E

Catering

Reference: The GFSI Benchmarking Requirements version 2020 PART I

5

２．Specific Requirements (Standard Document)
2.1 Food safety management systems (FSM)
Number Clause Name

Requirements

FSM 1

Top
Management
Responsibility

Top management shall establish and operate a clear organizational
structure which unambiguously defines the job functions,
responsibilities, directing and reporting structure and information
sharing of at least the personnel whose activities affect food safety.
There shall also be evidence that employees are made aware of them.
Top management shall appoint personnel responsible for theoperation of the organization’s food safety management system.

FSM 2

Top
Management
Commitment
and Food
Safety Culture

Top management shall show evidence of its commitment to building,
implementing, maintaining and continually improving its food safety
management systems.
This commitment shall include elements of a food safety culture, andthis means, at a minimum, communicating with employees,
responding to Kaizen suggestions, training to improve food safety, andassessing the performance of food safety activities. In addition, these
efforts shall be incorporated and implemented in the food safety
management systems of the entire organization.

FSM 3

Management
Review

Top management shall conduct management reviews on a regularbasis and record them in an appropriate manner to review allelements of the overall food safety management system, including
HACCP plans for managing food safety hazards and risks.
In the event of changes that have an effect on food safety, top
management shall ensure that the food safety management systemremains relevant and effective.

FSM 4

Compliance
When developing a food safety management system, the organization
with food safety shall develop, implement and maintain detailed procedures to ensure
lawsthat all processes and operations that have an effect on food safety arein compliance with the laws of both the country of manufacture and theintended country of sale.
In addition, records of implementation shall also be maintained.

6

Number

Clause Name

Requirements

FSM 5

Food Safety
Management
System andGeneralRequirements

The organization shall document the elements of the Food Safety
Management Systems and shall establish, implement and maintainthem appropriate to the scope of the products covered by its businessactivities.
In addition, the Food Safety Management Systems shall be
continuously improved by properly adapting to changes in thesurrounding social environment.

FSM 6

Food Safety
Policy and
Goals

The organization shall have a clear, concise and documented foodsafety policy statement and objectives specifying the extent of theorganization’s commitment to meet the safety needs of its products.
Top management shall ensure the organization to establish
measurable objectives consistent with the organization’s food safety
policy, formulate plans to achieve the objectives, monitor the
progresses against the objectives, and to update the objectives asnecessary.

FSM 7

Food Defense

The organization shall document, implement, and record assessment
procedures to identify potential and overt threats to hazards ofintentional food contamination by persons within or outside theorganization and prioritize response to those threats.
The organization shall document and implement a food defense planthat specifies the actions that the organization implements to mitigate
or exclude the identified food defense threat.
This plan shall include GMP and shall be incorporated into the foodsafety management system.
The organization shall also establish access controls for areas where
food defense vulnerabilities have been identified.
The organization shall establish and implement procedures forresponding to possible intentional contamination of product.

FSM 8

Food Fraud
Prevention

The organization shall document, implement, and record assessment
procedures to identify potential and overt food fraud vulnerabilities
such as tampering with records and labeling of products andintentional dilution, and prioritize food fraud mitigation measures.
The organization shall develop a documented plan that specifies themeasures the organization implements to mitigate the identified
threats of food fraud.
This plan shall cover the GMP and shall be incorporated into the foodsafety management system.

7

Number

Clause Name

Requirements

FSM 9.1 Documentation The organization shall document, implement, and maintainprocedures
documentation procedures to manage the documented information(including records) necessary for effective operation of the food safety
management system and explicit control of the process.
In addition, the organization shall keep records necessary to prove theimplementation of food safety management, determine an appropriate
storage period, and store them.

FSM 9.2 Control andstorage of
documented
information

The organization shall provide the documented information required todemonstrate its effective operation of the food safety management
system and control of processes. Documented information shall be
stored for the period required by the customer or legal and regulatory
requirements, or if there are no applicable requirements, for a period
exceeding the shelf life of the food. In addition, the documented
information shall be effectively controlled so that it is always available
when it is required.

FSM 10 Specification
Control ofPurchased orProvided Items
and Services

For all purchased or provided input items and services (including raw
materials and ingredients (including containers and packaging
materials), equipment and tools, utilities, and services (e.g. electricity,water, transportation, maintenance)) that have an effect on the safetyof final product, the organization shall ensure that documented
specifications are prepared, maintained, securely retained and readily
accessible when needed.
The organization shall evaluate the risks and set the confirmation
items (confirmation of inspection certificate, condition, temperature,display, etc.) on the items to be purchased or provided.
In addition, the organization shall define and implement a review
process that includes the handling of changes in specifications andthe frequency of regular reviews.

FSM 11 Procedures and The organization shall establish, implement and maintain effective
Instructions
procedures and instructions in all processes and activities that affectfood safety.
In addition, these procedures and instructions shall be understood bypersonnel who use different languages.

8Number

Clause Name

Requirements

FSM 12 Resource
Management

Top management shall determine and provide, in a timely manner, thequalified resources (including human resources, facilities and work
environment, equipment, systems for operating sites (including
communication technology and transportation), means ofmeasurement and traceability, intellectual property management, etc.)that meet the standards required to implement, maintain, and improve
the food safety management system.

FSM
13.1

Purchasing

The organization shall control purchasing procedures to ensure that all
externally sourced raw materials, packaging materials, services, andequipment and tools that have an effect on food safety conform tostipulated specifications, as well as legal and regulatory requirements
related to food safety.
In addition, these purchasing procedures shall also apply to raw
materials, packaging materials, services, and equipment and tools
purchased from the organization's group companies.

FSM
13.2

Supplier
Performance

The organization shall document, implement, and maintain proceduresfor the evaluation, approval, and continual monitoring of suppliers,
which have an effect on food safety.
Supplier evaluation shall include measures for food defense and toprevent food fraud.
When accepting raw materials, packaging materials, and services
from unapproved suppliers in an emergency (such a natural disaster),the organization shall confirm that the products meet the required
specifications by an evaluation, inspection, visit, etc. before use.
Results of survey, evaluations, approvals, and follow-ups with
suppliers shall be maintained.

FSM
13.3

Outsourcing

The organization shall ensure, when the organization chooses to
outsource any process that that may have an effect on food safety(including contract manufacturers, service providers for existingprocess, and other service providers), that it complies with thecustomer requirements and takes into account the JFS-C standard
requirements required for food safety risk management.
Control of such outsourced processes shall be identified, documented
and monitored as a part of the food safety management system.
Changes to the contract content shall be approved by both parties andcommunicated to the relevant personnel.

9Number

Clause Name

FSM
14.1

Traceability

Requirements
The organization shall establish, implement, and maintain appropriate
tracing procedures covering all processes from supplier (at least one
step before) to recipient (at least one step after) to ensure productidentification. These procedures must include procedures (e.g.,labeling) to continuously identify the product throughout the
manufacturing process and throughout distribution.
To ensure traceability, at least the following shall be recorded:●Record of all externally procured raw materials (including containers
and packaging materials), products, or services●Records to identify batches, semi-finished products, work-inprogress, recycled products, reworked products, finished products andpackaging throughout the manufacturing process●Records of all product suppliers and recipients●If the procedure has been updated, record it

Traceability
verification

The organization shall verify the documented procedures for implementing
and maintaining traceability through traceability test at least once a year toensure that they are functioning effectively. The results of verification shallalso be recorded.

FSM 15 Productdevelopment

The organization shall establish, implement and maintain productdesign and development procedures to ensure that new products or
products whose specifications and manufacturing processes havechanged are manufactured safely and in accordance with legal andregulatory requirements.
These development procedures shall clearly confirm that the products
and services provided conform to specifications, and after identifying
all the hazards of food safety, shall include a review to evaluate andapprove the adequacy of food safety assurance in the design anddevelopment.

FSM
14.2

10

Number

Clause Name

FSM 16 Allergen
Management

Requirements
The organization shall document and implement allergenmanagement plans and maintain them appropriately. The allergenmanagement plans shall include:●Control procedures to properly assess the risk of allergen crosscontact and, based on that assessment, reduce, or eliminate the riskof cross-contact.
●Procedures for handling raw materials (including containers andpackaging materials), semi-finished products, work in progress,
reworked products, and final products to prevent cross-contact withallergens during all processes from manufacturing to shipping.
●Cleaning procedures and verification procedures for areas thatcome into contact with food
●Procedures for identifying and displaying allergens that shall becontrolled in all processes from manufacturing to shipping
The plan shall also ensure that all products containing or potentiallycontaining allergens that are shipped and offered for sale are labeledin accordance with the laws and regulations of the country to which
they are expected to be shipped, and appropriate customer
requirements.

FSM 17 Control of
Measuring andMonitoring
Devices

FSM
18.1

The organization shall identify measuring and monitoring devices thatare parameters critical to ensure food safety.
In addition, the specified equipment and devices shall be calibrated
regularly.
This calibration shall be performed in accordance with national orinternational standards concerned, or by a reasonably accepted
traceable method.
The organization shall take appropriate action when equipment anddevices are found to be inaccurate, and these actions shall berecorded.

Product labeling The organization shall ensure that all product labels or attached(B-to-C
information to enable the safe handling, display, storage, preparation
products)
and use of the product in the food supply chain or by the consumer.
The finished product shall be labeled according to the applicable foodregulations in the intended country of sale.

11

Number

Clause Name

Requirements

FSM
18.2

Product labeling The organization shall define and implement procedures to provide(B-to-B
information, such as on primary processed foods, commercial
products, work ingredients, or intermediates in the processing process, so thatin progress,
customers or consumers can be informed about product safety, evensemi-finished
if the information is not labeled on or attached to the product.
products)

FSM
19.1

Analysis andTesting

The organization shall establish, implement, and maintain procedures
to ensure the analysis of raw materials, semi-finished products,
finished products, manufacturing environments, etc. that affect foodsafety.
The analysis and testing shall be conducted by a competent analysis
institution or testing laboratory institution using appropriate sampling
and analytical / testing methods.
The testing that has a significant effect on food safety shall be
conducted in accordance with the applicable requirements of ISO/IEC
17025.
In addition, the organization shall establish and implement analysis
and testing procedures (methods, standards, etc.) to confirm that the
product meets product specifications within its shelf life.

FSM
19.2

Environmental
Monitoring

The organization shall establish, implement and maintain a microbial
environmental monitoring program to reduce the risk of foodcontamination.
This program shall consider microbial risks specific to the
manufacturing process and facility environment and include evaluation
methods tailored to the risks.

FSM 20 Internal Audit

The organization shall establish, implement and maintain documented
internal audit procedures for all applicable food safety management
systems (including HACCP plans, food defense plans, and food fraud
prevention plans).
The procedures shall include at least the following content.
a) Timing of internal audits. Schedules including frequency of at least
once a year.
b) Corrective action for nonconformity.
c) Rules that ensure the objectivity and fairness of internal audits.
The organization shall maintain a record of the performance of theinternal audit as evidence.
The organization shall specify the competence required for internal
auditors and provide training for internal auditors.

12Number

Clause Name

FSM 21 Complaint
Handling

Requirements
The organization shall document, implement, and maintain a system
of management to respond to complaints and utilize complaint data toidentify, correct, and manage omissions and deficiencies in foodsafety efforts.
Control procedures shall include analyzing complaints, evaluating themagnitude of the impact threatening food safety, and implementing
corrective action as necessary.
Additionally, organization must record and maintain complaints,
investigation results, and corrective actions.

FSM
22.1

Serious Incident The organization shall document serious food incident management
Management
procedure, implement it in the event of an incident, and maintain it ineffect at all times to ensure that they can respond in the event of aserious incident. This procedure shall also describe the methods for
product withdrawal and product recall and include tests to ensure that
product recalls are carried out reliably.
It shall also include systems and procedures for providing necessary
information to customers, consumers, and relevant authorities.
Incidents that occur shall be recorded and evaluated.

FSM
22.2

Verification offood incident
management
procedure

FSM
23.1

Management of The organization shall document and maintain specifications for raw
productmaterials (including packaging materials), semi-finished products,
specifications
work in progress, remanufactured products, reworked products, andfinished products.
The organization shall have a system for communicating changes to
product specifications both internally and externally.
The organization shall designate a person responsible for managing
product specifications.

FSM
23.2

Product
ReleaseThe organization shall verify the effectiveness of its food incident
management procedure by conducting tests at least annually on
products supplied by the organization to ensure that product recalls
are implemented, and maintain records of the verifications.

The organization shall document, implement and maintain appropriate
procedures for product release (shipping).
Product release procedures shall include steps to ensure that the final
product meets specifications.

13

Number

Clause Name

Requirements

FSM 24 Identification of The organization shall document, implement, and maintain effective
nonconformities procedures for raw materials (including containers and packaging
and control ofmaterials), semi-finished products, work in progress, recycled
nonconforming products, reworked products, and final products to identify
products
nonconformities affecting its food safety and to clearly identify, control,
dispose of, and rework nonconforming products resulting from suchnonconformities in order to prevent misuse and mis-shipment of
nonconforming products affecting food safety.
The organization shall also determine who will be responsible formanaging nonconforming products.

FSM 25 Corrective
ActionThe organization shall define, implement, and maintain the documentof procedures for the determination and implementation of corrective
actions in the event of any nonconformities arising relating to foodsafety.
In case of deviation or violation, the organization shall identify the root
cause, take measures to prevent recurrence, and review theeffectiveness for the series of corrective actions.

FSM 26 Change
management

The organization shall document, implement, and maintain proceduresto evaluate the impact to the necessary extent in advance whenchanges occur in all processes and operations (including equipment
and devices) that affect the safety of the final product.
The organization shall also determine who will be responsible forchange management.

FSM 27 Utilization of
Kaizensuggestions
from personnel

The organization shall establish and implement a system to properly
utilize food safety Kaizen suggestions from personnel.

142.2 Hazard Analysis and Critical Control Point (HACCP)

ClauseName

Requirements

HACCP
Step 1HACCP
HACCP team shall be assembled with competent staff, and the scope
teamof application of the HACCP system and applicable GMPs shall beassembly
identified. The scope shall be documented what products andandprocesses are covered by which HACCP plan.
identificationof the scopeof application

HACCP
Step 2

Product
Description

HACCP
Step 3

Identification Intended use of the product and target users (consumers) shall beof Intended clearly described in a written document.
Use

HACCP
Step 4

Construction The flow diagram that covers all steps in the operation shall beof Flow
constructed.
Diagram

HACCP
Step 5On-siteThe flow diagram shall be verified whether it correctly reflects theConfirmation existing process steps of the operation.
of Flow
Diagram

HACCP
Step 6(Principle 1)

HazardAnalysis

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 productgroup and per process line or process location.
This system should be systematic and comprehensive and take into
account legal and regulatory requirements related to food safety.

The HACCP team shall list all the hazards that are reasonably likely
to occur in each process steps.
Potential hazards in each process shall be identified, the criticalhazards shall be identified, and all measures to control them must be
considered.
Hazards shall include allergens, if necessary.

15

ClauseName

Requirements

HACCP
Step 7(Principle 2)

CriticalControl
Points

Critical Control Points (CCPs) shall be determined.

HACCP
Step 8(Principle 3)

Critical
LimitsValidated critical limit(s) shall be stipulated for each CCP.

HACCP
Step 9(Principle 4)

Monitoring
SystemMonitoring procedures shall be established for each CCP.

HACCP
Step 10(Principle 5)

Corrective
Actions

A procedure of corrective actions (correction, and investigation andremoval of root cause) shall be established for deviations from a
critical limit.

HACCP
Step 11(Principle 6)

Establish
HACCP planvalidation
andverification
procedures

HACCP plan shall be validated prior to implementation.
Verification procedures shall be established to confirm whether thedefined handling (HACCP Plans) is carried out as specified and tojudge whether it is necessary to modify the defined handling.
Verification shall be carried out considering the design of equipment,change in processing method and technology development in the
manufacturing process.

HACCPStep 12(Principle 7)Documents
and Record

Necessary documents shall be prepared and maintained.
These documents shall contain documents related to the standard
operating procedures (SOP) and the work instructions (WI) necessary
and applicable to the scope of certification of the organization.

16

2.3 Good Manufacturing Practice (GMP)

NumberClause Name

Requirements

GMP 1

Facility Environment

The organization shall locate and maintain their business site
in a location where pollution can be prevented and products
can be safely received, stored, manufactured and delivered.

GMP 2

Factory premiseenvironment

The organization shall establish and maintain appropriate
standards for the area around and on the premises of thebusiness so that contamination can be prevented, and safe
products can be made accordingly.
These Standards shall include the management of waste andunnecessary materials on the premises.

GMP 3

Design, construction,layout of business site
and work and productflow lines

The organization shall design, construct and maintain thefactory buildings and facilities (storage area, raw material andproduct handling area, preparation area, packaging andstorage area, etc.) of the business site both outside and inside
the plant to minimize food safety risks.
In addition, the equipment layout (including drainage system
and lighting) and the flow lines of people, goods, and work
shall be designed to meet the intended purpose and minimize
food safety risks.
The organization shall set the lighting necessary for foodsafety to an appropriate level of illuminance.
Additionally, the organization shall ensure that facilities andequipment that come into contact with food are constructed
and made of materials that allow for appropriate maintenance,
cleaning, and disinfection.

GMP 4.1

Cross-contamination(including allergencross-contact) andisolation

The organization shall prevent physical, chemical (including
allergens), biological contamination, and cross-contamination(including allergen cross-contact) of raw materials (including
containers and packaging materials), semi-finished products,
work in progress, reworked products, and finished products.
The necessary control measures, including isolation, shall beestablished to cover all aspects of food safety, and theseprocedures shall be documented and maintained effectively
through periodic review.

17

Number

Clause Name

Requirements

GMP 4.2

Control of hazards
that require
enhancement

The organization must establish control measures for hazards
that require particularly enhanced controls, other than CCPs,
document those procedures as necessary, and maintain themeffectively through periodic review.

GMP 5

Personnel Facilities

The organization shall design, install, and manage personnel
facilities, including changing rooms, washbasins and toilets,
and applicable shared facilities to minimize food safety
hazards including allergens.
The organization shall separate toilets and areas where foodand drinks are stored and consumed such as cafeterias, andbreak rooms, from areas where food is manufactured,
packaged, and stored.

GMP 6.1

Personal hygiene
criteria for personnel

The organization shall establish, implement, and maintainappropriate hygiene standards that be assessed anddocumented product-specific hazards to minimize food safety
hazards, for its employees in accordance with the laws andregulations of the countries in which they work.
The criteria shall include provisions of hand washing and toilet
facilities, ways and frequency of hand washing, medical
screening procedure to identify conditions impacting foodsafety, proper protective clothing, rules on the clothing andshoes, rules on accessing production area, ways of foodhandling, and control measures for foreign materials, andmanagement procedures and reporting system in the event of
an infected person that poses food safety risks.
These hygiene criteria shall also be understood by personnel
who use different languages.

GMP 6.2

Personnel workwear

The organization shall evaluate product-specific risks andprovide appropriate work clothing to minimize food safety
risks.

18

Number

Clause Name

Requirements

GMP 6.3

Health managementof personnel

The organization shall develop, implement and maintain healthcare procedures that evaluate and document product-specificrisks to minimize food safety risks.
These shall include procedures for personnel suspected ofillness to promptly report illness or symptoms to their superiors
according to the laws and regulations of the country in which
personnel are working.
The organization shall also determine who will be responsible
for managing personnel with health conditions.

GMP 6.4

Application to
subcontractors andvisitors

The organization shall ensure that GMP 6.1, 6.2, and 6.3 are
well known to personnel who have an impact on food safety,
and apply them to subcontractors and visitors without
exception.

GMP 7

Training

The organization shall ensure that all personnel, including new
personnel, be trained in their appropriate language on foodsafety (including management, culture, HACCP, GMP), and bea system for each personnel to deepen their understanding,
implement, and maintain food safety in their respective work.
The organization shall keep records of the implementation of
education and training. Additionally, the system for retraining
as necessary shall be documented and implemented.
This education and training shall enable employees torecognize their role in food safety and the significance of theirefforts.
In addition, there shall be a system to improve comprehension
by repeating the training as necessary after evaluatingcompetence.

19

Number

Clause Name

Requirements

GMP 8Housekeeping,cleaning, sterilization,and disinfection

The organization shall identify product-specific risks based ona hazard analysis throughout all processes and stages andestablish, implement, and maintain documented organization,cleaning, sterilization, and disinfection procedures.
In these procedures, the organization shall include steps toverify that product-specific risks have been minimized.
Cleaning tools, cleaning agents and disinfectants shall besuitable for their intended purpose, clearly identified andstored in areas separated from areas where food is
manufactured, packaged, and stored.
Food safety information on potentially harmful chemicals shallbe obtained and confirmed.

GMP 9

ReworkThe organization shall control product rework in a traceable
manner with minimal food safety risk.
The food safety risks involved in rework shall be evaluatedand included in HACCP flow diagrams.
Records shall be maintained as evidence of control.

GMP 10Patrol and inspectionof the site

The organization shall establish a patrol plan and regularly
inspect the environment, facilities, and process design(people, goods, workflow lines) of the entire site.
Records shall be maintained as evidence of the inspection.
The patrol plan shall ensure that the workplace is maintainedin an appropriate state according to its activities and that foodsafety is ensured.

GMP 11

Air and water
management

The organization shall establish application-specific standards
and regular monitoring procedures for air, high-pressure gas,
and water (including ice and steam) used in food production tominimize impacts on food safety, and the records shall be
kept.
If water not intended for use in food production and water thathas been used and is still acceptable in contact with food isapplied to food production, it shall be controlled to prevent itfrom being contaminated with water for food production.

20

Number

Clause Name

Requirements

GMP 12

Waste Management

The organization shall establish adequate systems forsegregation, collection and disposal of waste (including
wastewater). The flow lines of waste shall be established so
as not to cause cross-contamination of food.
Locations and containers for placing waste shall be controlled
to prevent attraction of pests or growth of harmfulorganisms/micro-organisms. Containers for storing wastematerials (including by-products not suitable for food use) shallbe clearly distinguished from other containers.

GMP 13

Pest control

The organization shall establish, implement and maintainprocedures to control or remove food safety risks caused bypests (pests and vermin) on the premises and in the facilities.
These procedures shall be implemented using the following
cycle.
1. Understanding of the pest outbreak situation andformulation of monitoring plans.
2. Implementation of pest control and invasion prevention.
3. Pest monitoring and dissemination of results to personnel.
The organization shall establish procedures for eliminatingpests and vermin as necessary. If chemicals are used,handling procedures shall be established to ensure that food is
not affected.
Pest control shall be carried out by persons with the necessarycompetence.

GMP 14

Acceptance ofpurchased items

The organization shall establish, implement, and maintainacceptance procedures for all externally sourced raw
materials, packaging materials and services that influence
food safety. In addition, in order to ensure that the safety of the
final product is not compromised and that the materials are
suitable for the intended use, verification of raw materials,
containers and packaging materials shall be carried out.

21

Number

Clause Name

Requirements

GMP 15

Transport

The organization shall establish a system to ensure that
containers and transportation vehicles, including contracted
vehicles, used for the transportation of raw materials andingredients (including packaging materials), partiallyprocessed products, works in progress, recycled products,
reworks, and finished products (including packed fresh
products in final packaging) are suitable for the intended use,maintained in good repair and clean, protected fromcontamination, and transported within its intended temperature
range.

GMP 16Storage

The organization shall hold or store foods (raw materials,
semi-finished products, work in progress, reworked products,
and final products) at designated locations, and manage themunder appropriate conditions to minimize food safety risks.

GMP 17

Stock Management

The organization shall establish, implement and maintain asystem to use raw materials and ingredients (including
packaging materials), partially processed products, work inprogress, recycled products, reworks, and finished products ina designated order and within the defined expiry period, andshall store these materials under the proper conditions to
avoid contamination and deterioration.
Storage facilities and equipment shall be designed to allow
food to be stored under appropriate storage conditions.

GMP 18Equipment and Tools

The organization shall suitably design and select equipment
and tools for the intended uses and shall use, maintain, andstore so as to minimize food safety hazards.

22Number
GMP 19Clause Name
MaintenanceRequirements
The organization shall document and implement a system forsystematic maintenance of all facility and equipment critical toproduct safety. Maintenance activities shall be performed insuch a way that they do not pose a food safety risk.
This system shall include procedures (such as cleaning,
washing, and sterilization procedures) for returning the foodproduction facility to a state capable of producing food after
maintenance activities.
Maintenance activities shall not represent food safety hazards.
All materials used for maintenance shall be suitable for theintended purpose.

23Annex 1●List of documented information explicitly required by the standard（Refer to FSM 5）
ClauseContent of documented information
FSM 1
Records that top management has made employees aware of the definedorganizational structure (at least the duties, responsibilities,
instruction/reporting system, and information sharing for employees in chargeof activities that affect food safety).
FSM 3
Management review by top management
FSM 4
Records of implementation of food legal compliance procedures
FSM 5
Elements of the food safety management system that are deemed necessary
by the organization
FSM 6
Food Safety Policy and Goals
FSM 7●Assessment procedures for prioritizing responses to threats to fooddefense●Food Defense Plan
FSM 8

●Evaluation procedures for assigning predominance to food deception
reduction measures●Food Deception Prevention Plan

FSM 9.1●Information documentation procedure

FSM 10
FSM 13.2
FSM 13.3
FSM 14.1●Records required to prove the implementation of food safety management
Specifications of what is being purchased or supplied
Supplier evaluation/approval/monitoring records
Documents related to the management of outsourced processes●Documented procedures for implementing and maintaining product tracing●The following records are required to ensure traceability:
・Identification of all externally procured raw materials (including containers
and packaging materials), products, or services
・Records to identify batches, semi-finished products, work in progress,
refurbished products, reworked products, finished products and packaging
throughout the manufacturing process
・Record of purchasers and shipping destinations for all products supplied

FSM 14.2
FSM 16
FSM 17
FSM 21
FSM 22.1
FSM 22.2
FSM 23.1

FSM 23.2
FSM 24・If the procedure has been updated, record it
Trace test verification results
Allergen management plan
Records of actions taken if equipment or devices is found to be inaccurateManagement mechanism for handling complaints and utilizing complaint data
●Food incident management procedure●Record of incidents that have occurred
Product recall test verification results
Specifications of products (raw materials (including containers and packaging
materials), semi-finished products, work in progress, recycled products,
reworked products, and final products)
Product release (shipping) procedures
Procedures for identifying nonconformities that impact food safety and forclearly identifying, managing, disposing of, and reworking resulting
nonconforming products

24

FSM 25
FSM 26HACCP
Step 12(Principle 7)
GMP 4.1

GMP 4.2
GMP 6.1
GMP 6.3
GMP 6.4
GMP 7
GMP 8
GMP 9
GMP 10
GMP 11
GMP 19Procedures for determining and implementing corrective actions whennonconformities impacting food safety occur
Procedures to assess, to the extent necessary, the impact of changes that
may impact food safety in advance
Documents and records required for HACCP plan
（Step 12 requires documentation of all documents and records required for
the HACCP plan.）
Necessary control measures/methodological procedures, including isolation,
aimed at preventing contamination and cross-contamination (including crosscontact)
Procedures for control measures/methods for hazards that require enhanced
control (as appropriate)
Personal hygiene standards for employees, etc.
Health management procedures for employees, etc.
Documents related to GMP 6.1 and GMP 6.3 applied to contracted
businesses and visitors●Record of education/training implementation●System for re-education (if necessary)
Documented procedures for organizing, cleaning, and sanitizing/disinfecting
Records of product rework
Business site patrol/inspection results
Monitoring records of air, high pressure gas, and water (including ice andsteam) used in food production
Systems for systematically maintaining all equipment and devices importantto product safety25Annex 2●Definitions
Term

Definition

1.

Allergen cross-contact

The unintentional incorporation of an allergenic food, or ingredient,
into another food that is not intended to contain that allergenic food or
ingredient.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)2.

Intended use

3.

Outsourced processes

Methods of use and consumption methods established at the timeof planning and design for products, buildings and equipment.
Outsourcing refers to an organization commissioning its own
processes to be performed by an external party.
This commissioning includes not only the services provided by acontractor, but also the provision of the services by the contractor.
Services provided by contractors include provision of lunch forpersonnel, cleaning of work clothes, insect, vermin and sanitation
consultants, sanitation of facilities at business sites, maintenanceof facilities and equipment, etc.

4.

Control measure

Any action or activity that can be used to prevent, eliminate, or
reduce food safety hazards to acceptable levels.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
This is also defined as a control measure in the glossary of the“Guide to Implementing HACCP in Food Manufacturing” (inJapanese) published by the Ministry of Health, Labor and Welfare.

5.

Hazard6.

Critical limit

7.

RecordA biological, chemical, or physical agent in food with the potential
to cause an adverse health effect.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation
First Edition)
A criterion, observable or measurable, relating to a control
measure at a CCP which separates acceptability fromunacceptability of the food.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation
First Edition)
Document stating results achieved or providing evidence ofactivities performed.
Note 1 to entry: Records can be used, for example, to formalize
traceability and to provide evidence of verification, preventive
action and corrective action.
Note 2 to entry: Generally records need not be under revisioncontrol.
(Cited from the definition in ISO 9000:2015)

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8.

Term
Verification

Definition
The application of methods, procedures, tests, and otherevaluations, in addition to monitoring, to determine whether acontrol measure is or has been operating as intended.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation
First Edition)

9.

Cross-contamination

When people or objects (raw materials, packaging materials, semifinished products, finished products, carts, etc.) are moved between
different sanitary areas, they can bring in bacteria or othercontaminants that can contaminate food.

10.

Raw materials andingredients

Ingredients refer to those used as part of product including
packaging materials and water as well.

11.

Updating

12.

CCP

Immediate and/or planned activity to ensure application of themost recent information.
(Cited from the definition in ISO 22000:2018)
A step at which a control measure or control measures, essential
to control a significant hazard, is/are applied in a HACCP system.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation
First Edition)（Critical control point）

13.

Employee, Personnel

All personnel in an organization who are involved in work related tofood safety, including part-timers, contractors, and dispatchedpersonnel.

14.

Correction

15.

Serious incident

Action to eliminate a detected nonconformity.
(Cited from the definition of ISO 22000:2018 3.9)
Note 1: Corrections may occur prior to, in conjunction with, orafter corrective action.
Note 2: Modifications include, for example, rework and rerating.
Food incident that may have an effect on food safety. Does notinclude incidents that do not have an effect on food safety but
may have an effect on the quality.

16.

Disinfection

Reduction by means of biological or chemical agents and/or physicalmethods in the number of viable microorganisms on surfaces, inwater or in air to a level that does not compromise food safety and/or
suitability.
(Cited from Codex Alimentarius Commission CXC 1-1969 (Revised in
2022.) GENERAL PRINCIPLES OF FOOD HYGIENE)

17.

Food

Substance (ingredient), whether processed, semi processed orraw, which is intended for consumption, and includes drink,chewing gum and any substance which has been used in the
manufacture, preparation or treatment of “food” but does notinclude cosmetics or tobacco or substances (ingredients) used
only as drugs.
(Cited from the definition of ISO 22000:2018 3.18)

27

18.

Term
Food safety policy

Definition
Overall intentions and direction of an organization related to foodsafety as formally expressed by top management.
(Cited from the definition in ISO 22000:2018)19.

A culture of food safety

Shared values, beliefs and norms that affect mind-set and behavior
toward food safety in, across and throughout an organization.
(Cited from A Culture of Food Safety, a position paper from the
Global Food Safety Initiative (GFSI) 4/11/18 V1.0)

20.

Food safety management
system

A system to specify policies and objectives and to achieve theseobjectives so that food does not harm the consumer for when thefood is cooked and/or consumed in accordance with the intendeduse.
(Referenced to ISO 9000:2015 and ISO 22000:2018)21.

Food fraud

22.

Food fraud mitigation plan

23.

Food incident management
procedure

A collective term encompassing the deliberate and intentional
substitution, addition, tampering or misrepresentation of food, foodingredients, feed, food packaging or labelling, product information or
false or misleading statements made about a product for economic
gain that could impact consumer health.
(GFSI BENCHMARKING REQUIREMENTS VERSION 2020.1 /PART IV GLOSSARY OF TERMS)
The process of defining requirements regarding when, where, andhow to mitigate deceptive practices identified by the food mitigation
vulnerability assessment. The plan developed defines the measuresand checks necessary to effectively mitigate the identified hazards.
A procedure for appropriate response and management in the eventof food safety problems to prevent it from escalating.

24.

Scope

25.

Control

GFSI defined certification scope. A code with a specificclassification is assigned to each food, feed, and food-related
service industry, and a detailed business category for eachclassification is indicated.
The state wherein correct procedures are being followed andcriteria are being met.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)

28

26.

Term
Product

Definition
Output of an organization that can be produced without any
transaction taking place between the organization and thecustomer.
Note 1 to entry: Production of a product is achieved without any
transaction necessarily taking place between provider andcustomer, but can often involve this service element upon its
delivery to the customer.
Note 2 to entry: The dominant element of product is that it isgenerally tangible.
Note 3 to entry: Hardware is tangible and its amount is acountable characteristic (e.g. tires). Processed materials are
tangible and their amount is a continuous characteristic (e.g. fueland soft drinks). Hardware and processed materials are often
referred to as goods. Software consists of information regardlessof delivery medium (e.g. computer program, mobile phone app,
instruction manual dictionary content, musical composition
copyright, driver’s license).
(Cited from the definition in ISO 9000:2015)

27.
28.

Sector, Sub-sector
Corrective action

29.

Product withdrawal

Scope of certification.
Any action taken when a deviation occurs in order to re-establish
control, segregate and determine the disposition of the affected
product, if any, and prevent or minimize reoccurrence of thedeviation.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)Removal of products from the supply chain that are consideredunsafe before they are sold to the end consumer.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)

29

30.

Term
ReworkDefinition[When indicating an act].
Indicates the action to be taken when returning to the
manufacturing flow a product that complies with the requirementsfor products that have deviated from the regular series ofprocesses, including final products, semi-finished products, workin-process, and raw materials in all processes.
Rework includes the action of returning a product from a series ofprocesses to an upstream process for reworking, and the action of
returning a product to a process again without processing.
[When indicating an item].
Indicates clean, unadulterated food that has been removed fromprocessing at any point up to and including final packaging forreasons other than insanitary conditions or that has beensuccessfully reconditioned by reprocessing and that is suitable foruse as food or a food component.
(Adapted from Codex Alimentarius Commission CXC 80-2020(Adopted in 2020) CODE OF PRACTICE ON FOOD ALLERGENMANAGEMENT FOR FOOD BUSINESS OPERATORS)
Person or group of people who directs and controls anorganization at the highest level.
Note 1 to entry: Top management has the power to delegate
authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system covers
only part of an organization, then top management refers to those
who direct and control that part of the organization.
(Cited from the definition of ISO 22000:2018 3.41)

31.

Top management

32.

HACCP plan

Documentation or set of documents, prepared in accordance with theprinciples of HACCP, to ensure control of significant hazards in thefood business.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)33.

Food chain

A series of steps from primary production to consumption thatinvolve the production, processing, distribution, storage andhandling of food and its ingredients.
Note 1: Production also includes the production of feed and foodfor animals.
Note 2: The food chain also includes the production of ingredients
intended to come into contact with food or ingredients.
Note 3: The food chain also includes service providers.
(Cited from the definition of ISO 22000:2018)34.

Flow diagram

A systematic representation of the sequence of steps used in the
production or manufacture of food.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation
First Edition)

30

35.

Term
Document

36.

Nonconformities

37.

Management

38.

Management system

39.

Monitoring40.

Packaging materials

41.

Competence

Definition
Information and the medium on which it is contained.
Example: Record, specification, procedure document, drawing,
report, Standard Document
Note to entry: The medium can be paper, magnetic, electronic or
optical computer disc, photographic or master sample, or
combination thereof.
(Cited from the definition of ISO 22000:2018 3.13)
Non-fulfilment of a requirement.
(Cited from the definition of ISO 22000:2018 3.28)
Coordinated activities to direct and control an organization.
Note to entry: Management can include establishing policies andobjectives, and processes to achieve these objectives.
Set of interrelated or interacting elements of an organization toestablish policies and objectives, and processes to achieve theseobjectives.
(Cited from the definition of ISO 22000:2018 3.25)
Definitions related to CCP
A planned observation procedure or measurement of control
parameters performed to assess whether the CCP is undercontrol.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969
Annex: Hazard analysis and critical control point (HACCP) system
and guideline for its application)
Definitions other than CCP
Determination of the status of a system, process or activity
Note 1: Inspection, supervision or careful observation may berequired to determine the situation.
Note 2: Monitoring in food safety involves a series of planned
observations or measurements to assess whether a process is
operating as intended.
Note 3: ISO 22000:2018 makes a distinction between validation,
monitoring and verification.
- Validation is applicable prior to the activity and provides
information on the ability to produce the intended result.
- Monitoring is applicable during the activity and provides
information on the activity within a specified period of time.
- Verification is applicable after the activity and provides
information to confirm conformance.
(Cited from ISO 22000:2018)Materials used for packaging food products, such as papers,
plastics, wooden boxes, cardboards, PET bottles, and tin cans.
Ability to apply knowledge and skills to achieve intended results.
Note to entry: Demonstrated competence is sometimes referred toas qualification.
(Cited from the definition in ISO 9000:2015. Note 2 to entry is notincluded in the definition of “competence” in this document.)

31

42.

Term
Product recall

43.

Review

Definition
Products that have been or are being sold to the end consumer
and are considered unsafe are removed from the supply chain by
the supplier.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)
Determination of the suitability, adequacy or effectiveness of an
object to achieve established objectives
EXAMPLE: Management review, design and development review,
review of customer requirements, review of corrective action andpeer review.
Note to entry: Review can also include the determination ofefficiency.
(Cited from the definition in ISO 9000:2015)

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

32