Summary of contrast and revision of JFS-C Standard Documents (Ver. 3.0/Ver. 3.1)
JFS-C V.3.0: JFS-C Standard Document Ver. 3.0 and Supplemental Requirements
JFS-C V.3.1 Draft: JFS-C Standard Document Ver. 3.1
Red text: Main additions, corrections, etc.

JFS-C V.3.0

JFS-C V.3.1

IntroductionIntroduction

NumberItem

1.2

Scope ofapplication

Explanatory text etc.
NumberManufacturing sector of chemical products (including
biochemical products) (K)K: Manufacture of chemical products (including
biochemical products)(Manufacture of additives, vitamins, minerals, cultures,
1.2
flavors, enzymes, processing aids, etc.)

Item

Scope ofapplication

In addition, chemical products here means a chemical
product (including a biochemical product) related to
food.

1.3

Structure ofthis Standard
Document

Explanation regarding (*2) ~ (*5)
1.3

Explanatory text etc.
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 as foodingredients or processing aids in food production.)
In addition, chemical products here means a chemical
product (including a biochemical product) related tofood.

Structure ofthis Standard Explanation regarding (*2) ~ (*5)
Document（*2）Codex Alimentarius Commission“GENERAL PRINCIPLES OF FOOD HYGIENE” CXC 11969, Rev. 2020(*2) Codex Alimentarius Commission"GENERAL PRINCIPLES OF FOOD HYGIENE," CXC 11969, Rev. 2022.

Summary of Major Revisions
・Compatibility with JFS-B standard
Ver.3.0 standard

・Move the description (P4→P2)

・Correction of notation due torevision of cited standards

・Item number changes due to eachrevision

1.4

Exclusion(Reference) Category is as shown in the table below:
fromList of JFS Standard Document Sectors
Application of The following sectors apply to this JFS (Food Safety
Requirements Management) Standard Document.

("K" in thetable)

1.4

Manufacture of chemical products (including
biochemical products)(Manufacture of additives, vitamins, minerals,
cultures, flavors, enzymes, processing aids, etc.)(Reference) Category is as shown in the table below:
Sector list by GFSI
Exclusion
The following sectors apply to this JFS (Food Safety
fromManagement) Standard Document.
Application of※Of the sectors presented by GFSI, the sectors
Requirements
covered by this standard document are
enclosed in a box.

("K" in thetable)

Manufacture of chemical products (including
biochemical products)(Production of chemical products (including
biochemical products) and cultures used asfood ingredients or processing aids in foodproduction.)・Compatibility with JFS-B standard
Ver.3.0 standard

・Compatibility with JFS-B standard
Ver.3.0 standard

FSM
Number
FSM 1

FSM(Data) Item Requirement
NumberTop
Top management shall establish a clear organizational FSM 1
Management structure which unambiguously defines the job
Responsibility functions, responsibilities, directing and reporting
structure and information sharing of at least thepersonnel whose activities affect food safety.
Top management shall appoint personnel responsible
for the operation of the organization’s food safety
management system.

FSM 4Compliancewith foodsafety laws

FSM 7

Food Defense The organization shall document, implement, andFSM 7record assessment procedures to identify potential andovert threats to food defense and prioritize response to
those threats.
The organization shall document and implement a fooddefense plan that specifies the actions that theorganization implements to mitigate the identified fooddefense threat.
This plan shall cover GMP and shall be incorporated
into the food safety management system.

Food Defense The organization shall document, implement, and・Compatibility with JFS-B standard
record assessment procedures to identify potential and Ver.3.0 standard
overt threats to hazards of intentional food・Compatibility with GFSI GMaP
contamination by persons within or outside theorganization and prioritize response to those threats.
The organization shall document and implement a fooddefense plan that specifies the actions that theorganization implements to mitigate or exclude theidentified food defense threat.
This plan must include GMP and be incorporated into
the food safety management system.
The organization shall also establish access controls forareas where food defense vulnerabilities have been
identified.
The organization shall establish and implement
procedures for responding to possible intentional
contamination of product.

FSM 8

Food Fraud
Prevention

Food Fraud
Prevention

FSM 9.1

Documentatio The organization shall have documented procedures in FSM 9.1
n procedures place to formulate, implement and maintain the
documented information (including records) needed todemonstrate the effective operation of its food safety
management systems and process controls.

Documentatio The organization shall document, implement, and・Additional corrections to then procedures maintain documentation procedures to manage thenotation
documented information (including records) necessary ・Compatibility with GFSI GMaPfor effective operation of the food safety management
system and explicit control of the process.
In addition, the organization shall keep records
necessary to prove the implementation of food safety
management, determine an appropriate storage
period, and store them.

FSM 10Specification
Control ofPurchased orProvided
Items andServices

Specification
Control ofPurchased orProvided
Items andServices

When developing a food safety management system,
the organization shall develop, implement andmaintain detailed procedures to ensure that allprocesses and operations that have an effect on foodsafety are in compliance with the laws of both thecountry of manufacture and the intended country of
sale.

FSM 4

The organization shall document, implement, andFSM 8record assessment procedures to identify potential andovert tampering with records and labeling of products
and intentional dilution, and prioritize food fraud
mitigation measures.
The organization shall develop a documented plan thatspecifies the measures the organization implements tomitigate the identified threats of food fraud.
This plan shall cover the GMP and shall be incorporated
into the food safety management system.

For all purchased or provided input items and services FSM 10(including raw materials and ingredients, utilities andservices (e.g. electricity, water, transportation,
maintenance)) that have an effect on the safety of 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 theconfirmation items (confirmation of inspection
certificate, condition, temperature, display, etc.) on
the items to be purchased or provided.
In addition, the organization shall define andimplement a review process that includes the handlingof changes in specifications and the frequency ofregular reviews.

(Data) Item Requirement
Summary of Major Revisions
Top
Top management shall establish and operate a clear
・Compatibility with GFSI GMaP
Management organizational structure which unambiguously defines
Responsibility the job functions, responsibilities, directing andreporting structure and information sharing of at least
the personnel whose activities affect food safety. There
shall also be evidence that employees are made awareof them.
Top management shall appoint personnel responsible
for the operation of the organization’s food safety
management system.
Compliancewith foodsafety laws

When developing a food safety management system,
the organization shall develop, implement andmaintain detailed procedures to ensure that allprocesses and operations that have an effect on foodsafety are in compliance with the laws of both thecountry of manufacture and the intended country ofsale.
In addition, records of implementation shall also be
maintained.

・Compatibility with GFSI GMaP

The organization shall document, implement, and・Additional corrections to therecord assessment procedures to identify potential and notation
overt food fraud vulnerabilities such as tampering withrecords and labeling of products and intentional
dilution, and prioritize food fraud mitigation measures.
The organization shall develop a documented plan thatspecifies the measures the organization implements tomitigate the identified threats of food fraud.
This plan shall cover the GMP and shall be incorporated
into the food safety management system.

For all purchased or provided input items and services ・Compatibility with GFSI Benchmark(including raw materials and ingredients (including
Requirements Part III JII Subsector
containers and packaging materials), equipment andtools, utilities, and services (e.g. electricity, water,transportation, maintenance)) that have an effect on
the safety of final product, the organization shallensure that documented specifications are prepared,
maintained, securely retained and readily accessible
when needed.
The organization shall evaluate the risks and set theconfirmation items (confirmation of inspection
certificate, condition, temperature, display, etc.) on theitems to be purchased or provided.
In addition, the organization shall define andimplement a review process that includes the handlingof changes in specifications and the frequency ofregular reviews.

FSM 11

ProceduresandInstructions

The organization shall establish, implement andFSM 11maintain effective procedures and instructions in allprocesses and activities that affect food safety.
In addition, these procedures and instructions shall be
understandable by personnel in different languages.

ProceduresandInstructions

The organization shall establish, implement and・Additional corrections to themaintain effective procedures and instructions in all
notationprocesses and activities that affect food safety.
In addition, these procedures and instructions shall be
understood by personnel who use different languages.

FSM 12

Resource
Top management shall determine and provide, in a
Management timely manner, the qualified resources (including
human resources, facilities and work environment,
equipment, systems for operating business sites(including communication technology andtransportation), means of measurement andtraceability, intellectual property management, etc.)that meet the standards required to implement,
maintain, and improve the food safety management
system.

FSM 12

Resource
Top management shall determine and provide, in a・Corrections to the notation
Management timely manner, the qualified resources (including
human resources, facilities and work environment,
equipment, systems for operating sites (including
communication technology and transportation), meansof measurement 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, and services that have an effecton food safety conform to stipulated specifications, aswell as legal and regulatory requirements related tofood safety.
In addition, these purchasing procedures shall also
apply to raw materials, packaging materials, andservices purchased from the organization's groupcompanies.

FSM 13.1

Purchasing

The organization shall control purchasing procedures・Compatibility with GFSI Benchmark
to ensure that all externally sourced raw materials,
Requirements Part III JII Subsector
packaging materials, services, and equipment andtools 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 theorganization's group companies.

FSM 13.2

Supplier
Performance

The organization shall establish, implement andFSM 13.2
maintain procedures for the evaluation, approval andcontinual monitoring of suppliers, which have an effecton food safety.
Supplier evaluation shall include measures for fooddefense and to prevent 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.
The organization shall maintain evaluation, approvaland monitoring records for suppliers.

Supplier
Performance

The organization shall document, implement, andmaintain procedures for the evaluation, approval, andcontinual monitoring of suppliers, which have an effecton food safety.
Supplier evaluation shall include measures for fooddefense and to prevent 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 followups with suppliers shall be maintained.

FSM 14

Traceability

The organization shall establish, implement andFSM 14.1
maintain appropriate tracing procedures covering allprocesses from supplier (at least one step before) torecipient (at least one step after) to ensure productidentification.
Documented procedures shall be verified at least oncea year by trace testing to ensure that they are working
effectively, and the verification results shall also berecorded.

Traceability

The organization shall establish, implement, and・Compatibility with JFS-B standard
maintain appropriate tracing procedures covering all
Ver.3.0 standard
processes from supplier (at least one step before) to・Compatibility with GFSI GMaP
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 andthroughout distribution.
To ensure traceability, at least the following shall berecorded:●Record of all externally procured raw materials(including containers and packaging materials),
products, or services●Records to identify batches, semi-finished products,
work-in-progress, recycled products, reworked
products, finished products and packaging throughout
the manufacturing process●Records of all product suppliers and recipients●If the procedure has been updated, record it

FSM 14.2

Traceability
verification

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

・Compatibility with JFS-B standard
Ver.3.0 standard
・Additional corrections to thenotation・Compatibility with GFSI GMaP・Compatibility with GFSI GMaP

FSM 16

AllergenThe organization shall develop and implement allergen FSM 16
Management management plans and maintain them appropriately.
The plans shall include a risk assessment of allergencrosscontamination and control measures to be
implemented to reduce or eliminate the risk of crosscontamination.
In addition, the plans shall ensure that products thatare shipped and sold are labeled according to theallergen labeling regulations in the country where they
are to be sold.

AllergenThe organization shall document and implement
・Compatibility with JFS-B standard
Management allergen management plans and maintain themVer.3.0 standard
appropriately. The allergen management plans shall・Compatibility with GFSI GMaP
include:●Control procedures to properly assess the risk ofallergen cross-contact and, based on that assessment,
reduce, or eliminate the risk of cross-contact.
●Procedures for handling raw materials (including
containers and packaging materials), semi-finishedproducts, work in progress, reworked products, andfinal products to prevent cross-contact with allergens
during all processes from manufacturing to shipping.
●Cleaning procedures and verification procedures forareas that come into contact with food
●Procedures for identifying and displaying allergens
that shall be controlled in all processes frommanufacturing to shipping
The plan shall also ensure that all products containing
or potentially containing allergens that are shipped andoffered for sale are labeled in 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
MeasuringandMonitoring
Devices

The organization shall identify measuring andmonitoring devices that are parameters critical toensure food safety.
In addition, the specified equipment and devices shallbe calibrated regularly.
The calibration shall be traceable by the relevant
national or international standards and methods.

FSM 17

Control of
MeasuringandMonitoring
Devices

The organization shall identify measuring and・Compatibility with JFS-B standard
monitoring devices that are parameters critical to
Ver.3.0 standard
ensure food safety.
・Compatibility with GFSI GMaP
In addition, the specified equipment and devices shallbe calibrated regularly.
This calibration shall be performed in accordance withnational or international standards concerned, or by areasonably accepted traceable method.
The organization shall take appropriate action whenequipment and devices are found to be inaccurate, andthese actions shall be recorded.

FSM 19.1

Analysis andTesting

The organization shall establish, implement, andmaintain 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 acompetent 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 applicablerequirements of ISO/IEC 17025.

FSM 19.1

Analysis andTesting

The organization shall establish, implement, andmaintain 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 acompetent 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 applicablerequirements of ISO/IEC 17025.
In addition, the organization shall establish andimplement analysis and testing procedures (methods,
standards, etc.) to confirm that the product meetsproduct specifications within its shelf life.

FSM 21

Complaint
Handling

The organization shall establish, implement, andmaintain complaint handling and complaint data
management procedures.
Control procedures shall include analyzing complaints,
evaluating the magnitude of the impact threatening
food safety, and implementing corrective action asnecessary.

FSM 21

Complaint
Handling

The organization shall document, implement, and・Compatibility with JFS-B standard
maintain a system of management to respond to
Ver.3.0 standard
complaints and utilize complaint data to identify,・Compatibility with GFSI GMaP
correct, and manage omissions and deficiencies in foodsafety efforts.
Control procedures shall include analyzing complaints,
evaluating the magnitude of the impact threatening
food safety, and implementing corrective action asnecessary.
Additionally, organization must record and maintaincomplaints, investigation results, and corrective
actions.

FSM 22

SeriousThe organization shall establish, implement andIncident
maintain an effective management procedure ofManagement serious incidents.
The incident management procedure shall coverplanning for product withdrawal and product recall as
required, and be regularly tested for all products it
supplies.
The effectiveness of the incident management
procedure shall be verified at least once a year, andthe results shall be recorded.

FSM 22.1

SeriousThe organization shall document serious food incident ・Compatibility with JFS-B standard
Incident
management procedure, implement it in the event of
Ver.3.0 standard
Management an incident, and maintain it in effect at all times to・Compatibility with GFSI GMaP
ensure that they can respond in the event of a serious
incident. This procedure shall also describe themethods for product withdrawal and product recall andinclude tests to ensure that product recalls are carriedout reliably.
It shall also include systems and procedures forproviding necessary information to customers,
consumers, and relevant authorities.
Incidents that occur shall be recorded and evaluated.

・Compatibility with GFSI GMaP

Verification of The organization shall verify the effectiveness of its
・Compatibility with GFSI GMaP
food incident food incident management procedure by conducting
management tests at least annually on products supplied by theprocedureorganization to ensure that product recalls are
implemented, and maintain records of the verifications.

FSM 23.1

Management The organization shall document and maintain・Compatibility with GFSI GMaPof productspecifications for raw materials (including packaging
specifications materials), semi-finished products, work in progress,
remanufactured products, reworked products, andfinished products.
The organization shall have a system forcommunicating changes to product specifications bothinternally and externally.
The organization shall designate a person responsible
for managing product specifications.

FSM 23.2

Product
ReleaseFSM 23

Product
ReleaseFSM 24

Identification The organization shall establish, implement andFSM 24ofmaintain effective procedures to identify
nonconformiti nonconformities that have an effect on food safety andes andto clearly identify, control, discard and reworkcontrol ofnonconforming products resulting fromnonconformin nonconformities in order to prevent misuse and misg products
shipment.

FSM 25

Corrective
Action

FSM 26HACCP
HACCP
Step 1HACCP
Step 3

Utilization of
Kaizensuggestions
frompersonnel

The organization shall establish and implement
appropriate procedures for product release.

FSM 22.2

The organization shall establish procedures for the
FSM 25determination and implementation of corrective actionsin the event of any nonconformities arising relating tofood safety.
In case of deviation or violation, the organization shallidentify the root cause, take measures to prevent
recurrence, and review the effectiveness for the seriesof corrective actions.

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

HACCP Team A HACCP team shall be assembled with competent
Assembly
staff.

Identification Intended use of the product and target consumers
of Intended
shall be clearly described in a written document.
Use

HACCP
HazardStep 6
Analysis(Principle 1)

The HACCP team shall list all of the hazards that arereasonably likely to occur in each process steps,
conduct an analysis, and identify any necessary
measures to control them.
Hazards shall include allergens where required.

HACCP
Establishment Critical limit(s) shall be stipulated for each CCP.
Step 8of Critical(Principle 3) Limits
HACCP
Verification
Step 11(Principle 6)

GMP
GMP 2

Factory
premiseenvironment

The organization shall document, implement andmaintain appropriate procedures for product release(shipping).
Product release procedures shall include steps toensure that the final product meets specifications.

・Compatibility with JFS-B standard
Ver.3.0 standard
・Compatibility with GFSI GMaP

Identification The organization shall document, implement, and・Additional corrections to theofmaintain effective procedures for raw materials
notation
nonconformiti (including containers and packaging materials), semi- ・Compatibility with GFSI GMaPes andfinished products, work in progress, recycled products,
control ofreworked products, and final products to identify
nonconformin nonconformities affecting its food safety and to clearlyg products
identify, control, dispose of, and rework
nonconforming products resulting from suchnonconformities in order to prevent misuse and misshipment of nonconforming products affecting foodsafety.
The organization shall also determine who will be
responsible for managing nonconforming products.
Corrective
The organization shall define, implement, and maintain ・Compatibility with JFS-B standard
Actionthe document of procedures for the determination and Ver.3.0 standard
implementation of corrective actions in the event of
any nonconformities arising relating to food safety.
In case of deviation or violation, the organization shallidentify the root cause, take measures to prevent
recurrence, and review the effectiveness for the seriesof corrective actions.

FSM 26

ChangeThe organization shall document, implement, and・Addition of new requirements
management maintain procedures to evaluate the impact to the・Compatibility with GFSI Benchmark
necessary extent in advance when changes occur in all Requirements Part III JII Subsector
processes and operations (including equipment anddevices) that affect the safety of the final product.
The organization shall also determine who will be
responsible for change management.

FSM 27

Utilization of
Kaizensuggestions
frompersonnel

HACCP
HACCP
Step 1HACCP
Step 3The organization shall establish and implement asystem to properly utilize food safety Kaizen
suggestions from personnel.

・Change item number

HACCP team HACCP team shall be assembled with competent staff, ・Added “Identification of HACCP
assembly and and the scope of application of the HACCP system and system application scope” (quoted
identification applicable GMPs shall be identified. The scope shall be from CODEX GPFH2020)of the scope documented what products and processes are coveredof application by which HACCP plan.

Identification Intended use of the product and target usersof Intended(consumers) shall be clearly described in a writtenUsedocument.

HACCP
HazardStep 6
Analysis(Principle 1)・Corrections to the notation

The HACCP team shall list all the hazards that are・Compatibility with JFS-B standard
reasonably likely to occur in each process steps.
Ver.3.0 standard
Potential hazards in each process shall be identified,the critical hazards shall be identified, and all measures
to control them must be considered.
Hazards shall include allergens, if necessary.

HACCP
Critical Limits Validated critical limit(s) shall be stipulated for each
Step 8CCP.
(Principle 3)・Compatibility with JFS-B standard
Ver.3.0 standard

Verification procedures shall be established to confirm HACCP
Establish
HACCP plan shall be validated prior to implementation. ・Compatibility with JFS-B standard
whether the defined handling (HACCP Plans) is carried Step 11
HACCP plan Verification procedures shall be established to confirm Ver.3.0 standard
out as specified and to judge whether it is necessary to (Principle 6) validation and whether the defined handling (HACCP Plans) is carried
modify the defined handling.
verificationout as specified and to judge whether it is necessary to
Verification shall be carried out considering the design
procedures
modify the defined handling.
of equipment, change in processing method andVerification shall be carried out considering the design
technology development in the manufacturing process.
of equipment, change in processing method andtechnology development in the manufacturing process.

The organization shall establish and maintainappropriate standards for the grounds of theirworkplaces to prevent pollution and produce safe
products.

GMP
GMP 2

Factory
premiseenvironment

The organization shall establish and maintainappropriate standards for the area around and on thepremises of the business so that contamination can beprevented, and safe products can be madeaccordingly.
These Standards shall include the management ofwaste and unnecessary materials on the premises.

・Compatibility with JFS-B standard
Ver.3.0 standard
・Additional corrections to thenotation・Compatibility with GFSI GMaP

GMP 3

Design,The organization shall design, construct and maintain GMP 3
construction, the factory buildings and facilities (storage area, raw
layout ofmaterial and product handling area, preparation area,business site packaging and storage area, etc.) of the business site
and work and both outside and inside the plant to minimize foodproduct flow safety risks.
lines
In addition, the equipment layout and the flow lines ofpeople, goods, and work shall be designed to meet theintended purpose and minimize food safety risks.

Design,The organization shall design, construct and maintain ・Compatibility with GFSI GMaP
construction, the factory buildings and facilities (storage area, raw
layout ofmaterial and product handling area, preparation area,business site packaging and storage area, etc.) of the business site
and work and both outside and inside the plant to minimize foodproduct flow safety risks.
lines
In addition, the equipment layout (including drainage
system and lighting) and the flow lines of people,
goods, and work shall be designed to meet theintended purpose and minimize food safety risks.
The organization shall set the lighting necessary forfood safety to an appropriate level of illuminance.
Additionally, the organization shall ensure that facilities
and equipment that come into contact with food are
constructed and made of materials that allow for
appropriate maintenance, cleaning, and disinfection.

GMP 4

Physical,chemical andbiologicalproduct
contaminaton risks andisolation

Crosscontamination (including
allergencrosscontact) andisolation

The organization shall clarify that all hazard factors
GMP 4.1(physical, chemical (including allergens), andbiological) for each process have been identified basedon consistency checks between the process flow
created by the HACCP team and the site. The
frequency of occurrence and the magnitude of theconsequences of the identified hazards shall be
evaluated and appropriate control measures shall be
set for each.
Procedures shall be established and documented tocontrol identified hazards other than critical control
points (CCPs) that are difficult to manage effectively
with a general hygiene control program to prevent
contamination of raw materials (including packaging
materials), semi-finished products, workin-process,rework and finished products, and crosscontamination.
The organization shall regularly review theseprocedures and keep them in effect.

The organization shall prevent physical, chemical(including allergens), biological contamination, andcross-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 be established to cover all aspects of food safety,
and these procedures shall be documented andmaintained effectively through periodic review.

・The existing GMP 4 was divided into
GMP 4.1 and GMP 4.2 and thestructure was reviewed (with theaim of clarifying the requirements of
GMP 4).
・Additional corrections to thenotation

GMP 4.2

Control of
The organization must establish control measures forhazards that hazards that require particularly enhanced controls,
requireother than CCPs, document those procedures asenhancement necessary, and maintain them effectively throughperiodic review.

・The existing GMP 4 was divided into
GMP 4.1 and GMP 4.2 and thestructure was reviewed (with theaim of clarifying the requirements of
GMP 4).
・Compatibility with JFS-B standard
Ver.3.0 standard
・Additional corrections to thenotation

GMP 5

Personnel
Facilities

The organization shall design, install, and manage
・Compatibility with JFS-B standard
personnel facilities, including changing rooms,
Ver.3.0 standard
washbasins and toilets, and applicable shared facilities ・Additional corrections to theto minimize food safety hazards including allergens.
notation
The organization shall separate toilets and areas where ・Compatibility with GFSI GMaP
food and drinks are stored and consumed such as
cafeterias, and break rooms, from areas where food is
manufactured, packaged, and stored.

Personal
hygienecriteria for
personnel

The organization shall establish, implement, and・Compatibility with JFS-B standard
maintain appropriate hygiene standards that be
Ver.3.0 standard
assessed and documented product-specific hazards to ・Compatibility with GFSI GMaP
minimize food safety hazards, for its employees inaccordance with the laws and regulations of thecountries in which they work.
The criteria shall include provisions of hand washingand toilet facilities, ways and frequency of handwashing, medical screening procedure to identify
conditions impacting food safety, proper protective
clothing, rules on the clothing and shoes, rules onaccessing production area, ways of food handling, andcontrol measures for foreign materials, andmanagement procedures and reporting system in theevent of an infected person that poses food safety
risks.
These hygiene criteria shall also be understood bypersonnel who use different languages.

GMP 5

Personnel
Facilities

Personnel facilities, including washbasins and toilets,
and applicable shared facilities shall be provided,
designed, and utilized to minimize food safety risks.

GMP 6.1

Personal
hygienecriteria for
personnel

The organization shall develop, implement and
GMP 6.1
maintain hygiene criteria that evaluate and document
product-specific risks to minimize food safety risks.
The criteria shall include provisions of hand washingand toilet facilities, ways and frequency of handwashing, medical screening procedure to identify
conditions impacting food safety, proper protective
clothing, rules on the clothing and shoes, rules onaccessing production area, ways of food handling, andcontrol measures for foreign materials.
These hygiene criteria shall also be understandable bypersonnel in different languages.

GMP 6.3

HealthThe organization shall develop, implement and
GMP 6.3
management maintain health care procedures that evaluate andof personnel document product-specific risks to minimize foodsafety risks.
These shall include procedures for personnel suspectedof illness to promptly report illness or symptoms totheir superiors according to the laws and regulations of
the country in which personnel are working.

HealthThe organization shall develop, implement and・Compatibility with GFSI GMaP
management maintain health care procedures that evaluate andof personnel document product-specific risks to minimize foodsafety risks.
These shall include procedures for personnel suspectedof illness to promptly report illness or symptoms totheir 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 healthconditions.

GMP 6.4

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

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

GMP 7

Training

GMP 8Housekeeping The organization shall identify product-specific risks
GMP 8, cleaning,based on a hazard analysis and establish, implement
sterilizationand maintain documented organization, cleaning,andsterilization and disinfection procedures.
disinfection
In addition, the organization shall also verify thatprocedures that can minimize product-specific risks areworking effectively.
Cleaning tools, cleaning agents and disinfectants shallbe suitable for their intended use and stored
appropriately.
Food safety information on potentially harmful
chemicals shall be obtained and confirmed.

Housekeeping The organization shall identify product-specific risks
・Compatibility with JFS-B standard, cleaning,based on a hazard analysis throughout all processes
Ver.3.0 standard
sterilizationand stages and establish, implement, and maintain・Compatibility with GFSI GMaPanddocumented organization, cleaning, sterilization, anddisinfection
disinfection procedures.
In these procedures, the organization shall include
steps to verify that product-specific risks have beenminimized.
Cleaning tools, cleaning agents and disinfectants shallbe suitable for their intended purpose, clearly identified
and stored in areas separated from areas where food is
manufactured, packaged, and stored.
Food safety information on potentially harmful
chemicals shall be obtained and confirmed.

GMP 11

Air and water The organization shall define the required quality
GMP 11
management criteria according to the application, and regularly
monitor and record the air, highpressure gas, andwater (including ice and steam) used in foodproduction in order to minimize the effect on foodsafety.
If water not intended for use in food production andwater that has been used and is still acceptable incontact with food is applied to food production, it shallbe controlled to prevent it from being contaminatedwith water for food production.

Air and water The organization shall establish application-specific・Compatibility with GFSI GMaP
management standards and regular monitoring procedures for air,high-pressure gas, and water (including ice and steam)used in food production to minimize impacts on foodsafety, and the records shall be kept.
If water not intended for use in food production andwater that has been used and is still acceptable incontact with food is applied to food production, it shallbe controlled to prevent it from being contaminatedwith water for food production.

GMP 12Waste
The organization shall establish adequate systems for GMP 12
Management segregation, collection and disposal of waste (including
waste water). The flow lines of waste shall beestablished so as not to cause cross-contamination offood.
Locations and containers for placing waste shall becontrolled to prevent attraction of pests or growth ofharmful organisms/micro-organisms.

Waste
The organization shall establish adequate systems for ・Compatibility with GFSI GMaP
Management segregation, collection and disposal of waste (including
wastewater). The flow lines of waste shall beestablished so as not to cause cross-contamination offood.
Locations and containers for placing waste shall becontrolled to prevent attraction of pests or growth ofharmful organisms/micro-organisms. Containers forstoring waste materials (including by-products notsuitable for food use) shall be clearly distinguishedfrom other containers.

GMP 13

Pest control

The organization shall establish, implement andmaintain procedures to control or remove food safety
risks caused by pests (pests and vermin) on thepremises and in the facilities.
These procedures shall be implemented using thefollowing 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 topersonnel.
The organization shall establish procedures foreliminating pests and vermin as necessary.

Pest control

The organization shall establish, implement andmaintain procedures to control or remove food safety
risks caused by pests (pests and vermin) on thepremises and in the facilities.
These procedures shall be implemented using thefollowing 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 topersonnel.
The organization shall establish procedures foreliminating pests and vermin as necessary. If
chemicals are used, handling procedures shall beestablished to ensure that food is not affected.
Pest control shall be carried out by persons with thenecessary competence.

GMP 15

Transport

The organization shall establish a system to ensure
GMP 15that containers and vehicles, including contracted
vehicles, used for the transportation of raw materials
and ingredients (including packaging materials),partially processed products, works in progress,
reworks, and finished products (including packed fresh
products in final packaging) are suitable for theintended use, maintained in good repair and clean.

Transport

The organization shall establish a system to ensure・Compatibility with JFS-B standard
that containers and transportation vehicles, including
Ver.3.0 standard
contracted vehicles, used for the transportation of raw
materials and ingredients (including packaging
materials), partially processed products, works inprogress, recycled products, reworks, and finishedproducts (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 6.4

All personnel shall be trained in their appropriate
GMP 7language on food safety (including management,
culture, HACCP, GMP), and there shall be a system foreach personnel to deepen their understanding,
implement, and maintain food safety in their respectivework.
In addition, there shall be a system to improve
comprehension by repeating the training as necessary
after evaluating competence.

GMP 13Training

・Additional corrections to thenotation

The organization shall ensure that all personnel,
・Compatibility with JFS-B standard
including new personnel, be trained in theirVer.3.0 standard
appropriate language on food safety (including
・Additional corrections to the
management, culture, HACCP, GMP), and be a system notationfor each personnel to deepen their understanding,・Compatibility with GFSI GMaP
implement, and maintain food safety in their respectivework.
The organization shall keep records of theimplementation 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 significanceof their efforts.
In addition, there shall be a system to improve
comprehension by repeating the training as necessary
after evaluating competence.

・Compatibility with JFS-B standard
Ver.3.0 standard
・Compatibility with GFSI GMaP

GMP 17Stock
The organization shall establish, implement andManagement maintain a system to use raw materials andingredients (including packaging materials), partiallyprocessed products, work in progress, reworks, andfinished products in a designated order and within thedefined expiry period, and shall store these materials
under the proper conditions to avoid contaminationand deterioration.

GMP 17Stock
The organization shall establish, implement and・Compatibility with JFS-B standard
Management maintain a system to use raw materials andVer.3.0 standard
ingredients (including packaging materials), partially・Compatibility with GFSI GMaP
processed products, work in progress, recycled
products, reworks, and finished products in adesignated order and within the defined expiry period,and shall store these materials under the properconditions to avoid contamination and deterioration.
Storage facilities and equipment shall be designed toallow food to be stored under appropriate storage
conditions.

GMP 18Devices andTools

Devices and tools shall be suitably designed andselected for the intended uses and shall be used,maintained and stored so as to minimize food safety
risks.

GMP 18Equipment
and Tools

The organization shall suitably design and select・Compatibility with JFS-B standard
equipment and tools for the intended uses and shallVer.3.0 standard
use, maintain, and store so as to minimize food safety ・Correction of notation
hazards.

GMP 19MaintenanceA system of planned maintenance covering all items of GMP 19
equipment which are critical to product safety shall beestablished.
Maintenance activities shall not represent food safety
risks.

Maintenance

The organization shall document and implement a・Compatibility with JFS-B standard
system for systematic maintenance of all facility andVer.3.0 standard
equipment critical to product safety. Maintenance・Compatibility with GFSI GMaP
activities shall be performed in such 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 thefood production 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 forthe intended purpose.

Annex 1
●List ofdocumentedinformation explicitly
requiredby thestandard(see FSM
5)・Addition of list of documented
information explicitly required by thestandard (see FSM 5)

Annex

Annex 2

Definitionof terms

Definitionof terms
1

AllergenThe unintentional incorporation of an allergenic food,・Compatibility with JFS-B standard
cross-contact or ingredient, into another food that is not intended to Ver.3.0 standard (Some notation
contain that allergenic food or ingredient.
corrections)(Cited from Codex General Principles of Food Hygiene
2020: (Reference) Japan Food Hygiene Association
2021 Translation First Edition)

5

HazardA biological, chemical, or physical agent in food withthe 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)

5

hazardA biological, chemical or physical material in, orcondition of, food with the potential to cause an
adverse health effect.
(Cited from the definition in the Codex General
Principles of food hygiene)

・Compatibility with JFS-B standard
Ver.3.0 standard (Some notation
corrections)6

critical limit

Criterion which separates acceptability from6
unacceptability.
(Cited from Codex Alimentarius Commission CAC/RCP
1-1969 Annex: Hazard analysis and critical control
point (HACCP) system and guideline for its application)

Critical limit

A criterion, observable or measurable, relating to a・Compatibility with JFS-B standard
control measure at a CCP which separates acceptability Ver.3.0 standard (Some notationfrom unacceptability of the food.
corrections)(Cited from Codex General Principles of Food Hygiene
2020: (Reference) Japan Food Hygiene Association
2021 Translation First Edition)8

verification

Confirmation, through the provision of objective
evidence, that specified requirements have been
fulfilled.
Note 1 to entry: The objective evidence needed for a
verification can be the result of an inspection or ofother forms of determination such as performing
alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out forverification are sometimes called a qualification
process.
Note 3 to entry: The word “verified” is used todesignate the corresponding status.
(Cited from the definition in ISO 9000:2015)8

Verification

The application of methods, procedures, tests, andother evaluations, in addition to monitoring, todetermine whether a control 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

CrossWhen people or objects (raw materials, packaging
・Postscript
contaminatio materials, semi-finished products, finished products,
ncarts, etc.) are moved between different sanitaryareas, they can bring in bacteria or other contaminants
that can contaminate food.

・Compatibility with JFS-B standard
Ver.3.0 standard (Some notation
corrections)

11

CCP（critical
control
point）

Controls can be applied and are essential steps to12
prevent or eliminate food safety hazards, or bring foodsafety 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)

CCP（Critical
control
point）

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)

13

correction

Action to eliminate a detected nonconformity.
Note 1 to entry: A correction can be made in advanceof, in conjunction with or after a corrective action.
Note 2: As terms with the same notation but different
meanings in this Standard Document: Modification,
which is the act of revising documents, records, anditems to be stated, and Rework, which is the act ofremedying a product in process.
(Refer to the definition in ISO 9000:2015)

Correction

Action to eliminate a detected nonconformity.
・Compatibility with JFS-B standard(Cited from the definition of ISO 22000:2018 3.9)
Ver.3.0 standard
Note 1: Corrections may occur prior to, in conjunction
with, or after corrective action.
Note 2: Modifications include, for example, rework andrerating.

14・Compatibility with JFS-B standard
Ver.3.0 standard (Some notation
corrections)

16

15

food

Disinfection

Reduction by means of biological or chemical agents
and/or physical methods in the number of viablemicroorganisms on surfaces, in water or in air to alevel that does not compromise food safety and/or
suitability.
(Cited from Codex Alimentarius Commission CXC 11969 (Revised in 2022.) GENERAL PRINCIPLES OF
FOOD HYGIENE)

・Postscript

Food

Substance (ingredient), whether processed, semi
processed or raw, which is intended for consumption,and includes drink, chewing gum and any substancewhich has been used in the manufacture, preparation
or treatment of “food” but does not include cosmetics
or tobacco or substances (ingredients) used only as
drugs.
(Cited from the definition of ISO 22000:2018 3.18)

・Compatibility with JFS-B standard
Ver.3.0 standard

21

Food fraud

A collective term encompassing the deliberate and・Postscript
intentional substitution, addition, tampering or
misrepresentation of food, food ingredients, feed, foodpackaging or labelling, product information or false or
misleading statements made about a product foreconomic gain that could impact consumer health.
(GFSI BENCHMARKING REQUIREMENTS VERSION
2020.1 / PART IV GLOSSARY OF TERMS)

22

Food fraud
mitigation
plan

The process of defining requirements regarding when, ・Postscript
where, and how to mitigate deceptive practices
identified by the food mitigation vulnerability
assessment. The plan developed defines the measuresand checks necessary to effectively mitigate theidentified hazards.

23

Food incident A procedure for appropriate response andmanagement management in the event of food safety problems toprocedure
prevent it from escalating.

・Postscript

27

Sector, Subsector

Scope of certification.

・Compatibility with JFS-B standard
Ver.3.0 standard

All substances that are processed, semi-processed or 17
unprocessed with the intention of human consumption.
Note to entry: Food includes all substances used for
manufacturing, preparation and processing ofbeverages, chewing gums and foods. However, it does
not include substances used solely for cosmetics,
cigarettes and drugs.

22

corrective
actionAction to eliminate the cause of a nonconformity and28
to prevent recurrence.
Note to entry: There can be more than one cause for anonconformity.
(Cited from the definition in ISO 9000:2015)

Corrective
actionAny action taken when a deviation occurs in order to・Compatibility with JFS-B standard
re-establish control, segregate and determine theVer.3.0 standard (Some notation
disposition of the affected product, if any, and prevent corrections)or minimize reoccurrence of the deviation.
(Cited from Codex General Principles of Food Hygiene
2020: (Reference) Japan Food Hygiene Association
2021 Translation First Edition)

24

reworkIndicates the action to be taken when returning to the 30
manufacturing flow a product that complies with therequirements for products that have deviated from theregular series of processes, including final products,
semi-finished products, workin-process, and raw
materials in all processes.
Rework includes the action of returning a product froma series of processes to an upstream process forreworking, and the action of returning a product to aprocess again without processing.

Rework[When indicating an act].
・Postscript
Indicates the action to be taken when returning to the ・Additional corrections to the
manufacturing flow a product that complies with thenotationrequirements for products that have deviated from theregular series of processes, including final products,
semi-finished products, work-in-process, and raw
materials in all processes.
Rework includes the action of returning a product froma series of processes to an upstream process forreworking, and the action of returning a product to aprocess again without processing.
[When indicating an item].
Indicates clean, unadulterated food that has been
removed from processing at any point up to andincluding final packaging for reasons other than
insanitary conditions or that has been successfullyreconditioned 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 ALLERGEN MANAGEMENT FOR FOOD BUSINESSOPERATORS)

25

top
Person or group of people who directs and controls an 31
management organization at the highest level.
Note 1 to entry: Top management has the power todelegate authority and provide resources within theorganization.
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 in ISO 9000:2015. Note 3 toentry is not included in the definition of “topmanagement” in this document.)
32

Top
Person or group of people who directs and controls an ・Compatibility with JFS-B standard
management organization at the highest level.
Ver.3.0 standard
Note 1 to entry: Top management has the power todelegate authority and provide resources within theorganization.
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)

HACCP plan

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

・Compatibility with JFS-B standard
Ver.3.0 standard (Some notation
corrections)27

flow diagram Diagrams constructed to show all the process steps for 34
specified product.

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)

・Compatibility with JFS-B standard
Ver.3.0 standard (Some notation
corrections)28

document

35

Document

・Compatibility with JFS-B standard
Ver.3.0 standard

29

nonconformiti Non-fulfilment of a requirement.
es(Cited from the definition in ISO 9000:2015)36

Nonconformit Non-fulfilment of a requirement.
ies(Cited from the definition of ISO 22000:2018 3.28)

・Compatibility with JFS-B standard
Ver.3.0 standard

31

management Set of interrelated or interacting elements of ansystemorganization to establish policies and objectives, andprocesses to achieve these objectives.
(Cited from the definition in ISO 9000:2015)

38

Management Set of interrelated or interacting elements of ansystemorganization to establish policies and objectives, andprocesses to achieve these objectives.
(Cited from the definition of ISO 22000:2018 3.25)

・Compatibility with JFS-B standard
Ver.3.0 standard

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 ormaster sample, or combination thereof.
(Cited from the definition in ISO 9000:2015. Notes 2
and 3 to entry are not included in the definition of“document” in this document.)

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 ormaster sample, or combination thereof.
(Cited from the definition of ISO 22000:2018 3.13)