JFS-B Plus Standard Document(Sector：CⅠ,CⅡ,CⅢ,CⅣ/K)＜Manufacture of food products andManufacture of chemicals (including
biochemical products)＞〔Requirements for Organizations〕

Ver. 1.0
Japan Food Safety Management Association
May 29, 2024

1． Introduction
1.1

JFS-B Plus Standard Ver. 1.0

The JFS-B Plus Standard (hereinafter referred to as “this Standard”) is a standard document developedby the Japan Food Safety Management Association (JFSM) and is intended to assist organizations (*1) toimprove their systems for manufacturing safety food products. It can also be used to verify and evaluate
the organization's efforts by internal auditors and external evaluators.
JFS-B Plus is a standard that adds to the JFS-B standard the requirements for organizations in capacity
building programs developed by international industry associations for food-related businesses.
In addition, Codex Alimentarius Commission has published GPFH2020 (GENERAL PRINCIPLES OF
FOOD HYGIENE 2020)*2 , which includes HACCP; the contents of GPFH2020 are included in the HACCPand GMP requirements of the JFS-B Plus Standard..
(*1) “Organization” refers to a business entity, group or individual to whom the requirements of thisStandard Document apply.
In the food manufacturing sector, it is a business, organization, or individual that manufactures foodproducts.
In the chemical manufacturing sector of the scope of this Standard Preface 1.2, it is a business,organization or individual that manufactures chemicals.
(*2) Codex Alimentarius Commission "GENERAL PRINCIPLES OF FOOD HYGIENE," CXC 1-1969, Rev.
2020
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).
Chemical products herein refer to chemical products (including biochemical products) related to foodproducts, and include the production of additives, vitamins, minerals, cultures, flavorings, enzymes andprocessing aids.（Table 1: List of Sectors by GFSI）
Pet food is included in the following food manufacturing sector
Food Manufacturing Sectors（CI～CⅣ）
CI : Processing of perishable animal products
CII : Processing of perishable plant products
CIII : Processing of perishable animal and plant products (mixed products)
CIV : Processing of ambient stable products
Chemical Products (Including Biochemical Products) Manufacturing Sector（K）
K : Manufacture of chemicals (including biochemical products)1

(Production of chemical products (including biochemical products) and cultures used as food ingredientsor processing aids in food production)
In addition, chemical products here means a chemical product (including a biochemical product) related
to food.

2

Table 1: List of Sectors by GFSI

CodeSector/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
1.3

Structure of this Standard Document

This standard consist of Food Safety Management Systems：FSM, which are requirements for the
management of an organization's activities, HACCP, which is a method of controlling hazards, and Good
Manufacturing Practices (GMP).

3

Conceptual diagram of the organic functions of thethree elements (FSM, HACCP, 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 in this Standard
Document. JFSM has also prepares guidelines on the requirements of the Standard and recommends thatorganizations refer to them.

1.4

Exclusion from Application of Requirements

All the requirements in this Standard Document shall be applied in principle. However, in case any of therequirements in this Standard Document is not able to apply for reasons arising from the business 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 of food safety
management system.
1.5
Checklist
JFSM has provide a checklist that can be used to audit and record (describe points of non-compliance,
insufficiencies, and accomplishments, etc.) whether the organization is performing against therequirements.

4

2． Specific Requirements (Standard Document)
Ⅰ Food safety management systems (FSM)
Number
FSM 1

Clause Name

Requirements

Management

Management or senior management must share and operate anorsenior organizational structure that, at a minimum, clarifies the duties andmanagement

responsibilities of those who affect food safety. There shall also be

responsibility

evidence that employees are made aware of them. Management or
senior management must determine who is responsible for food safety
management.

FSM 2Commitment

Management or senior management shall show evidence of itsofcommitment to building, implementing, maintaining and continually

management

improving its food safety management systems.

orsenior This commitment shall include elements of a food safety culture, andmanagement
andthis means, at a minimum, communicating with employees, responding

food to Kaizen suggestions, training to improve food safety, and assessing

safety culture

the performance of food safety activities. In addition, these efforts shallbe incorporated and implemented in the food safety management
systems of the entire organization.

FSM 4

Compliance

When developing a food safety management system, the organization

withfood shall develop, implement and maintain detailed procedures to ensure
safety 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.
FSM 6

Food
PolicySafety Management or senior management shall have a clear, concise, written
and food safety policy.

Goals
FSM 7

Food Defense The organization

shall identify the risk of intentional foodcontamination by persons within or outside the organization, assess themagnitude of the risk, and prioritize and implement response measures
to reduce or eliminate the risk.
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.
5

Number
FSM8

Clause Name
Food

Requirements

Fraud The organization shall document, implement and maintain assessment

Prevention

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

FSM 9Documentand

The organization shall establish documented procedures to create,

record maintain, and record for control processes to ensure food safety andmanagement

evidence effective operations.
In addition, the organization shall keep records necessary to prove theimplementation of food safety management, determine an appropriate
storage period, and store them.

FSM 11

Procedures

Organizations must consider relevant safety requirements whenanddesigning products and manufacturing processes. The organization

Instructions

shall establish, implement and maintain effective procedures andinstructions in all processes and activities that affect food safety. These
work procedures and instructions must be visible to employees.

FSM 12

Resource

Management or senior management must ensure that the organization

Management

has the management resources (people, goods, and money) necessary
to implement the organization's food safety initiatives (hazard control(HACCP) and Good Manufacturing Practices (GMP) in this standard).

FSM 13.1

Purchasing

The organization must develop and implement purchasing procedures
to ensure that all externally procured raw materials, materials, andservices that affect food safety comply with the organization's
requirements.
When processes affecting food safety are subcontracted, control ofthese processes must be ensured by presenting the control methods tothe subcontractor, for example, by describing the control methods inspecifications and contracts.

6Number
FSM 13.2

Clause Name

Requirements

Supplier

The organization shall document, implement, and maintain

Performance

procedures for the evaluation, approval, and continual monitoring of
suppliers, which have an effect on food safety.
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 14

Traceability

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
and packaging throughout the manufacturing process●Record of purchasers and delivery destinations for all products
supplied●If the procedure has been updated, record it

FSM14.2

Traceability

The organization shall verify the documented procedures forverification

implementing and maintaining traceability through traceability test atleast once a year to ensure that they are functioning effectively. The
results of verification shall also be recorded.

7

Number
FSM 16

Clause Name

Requirements

AllergenThe organization shall document and implement allergen management

Management

plans.
The allergen management 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 that comeinto contact with food
●Procedures for identifying and displaying allergens that shall becontrolled in all processes from manufacturing to shipping
All final products containing or potentially containing allergens should
be identified in accordance with the laws and regulations of thecountry to which they are expected to be shipped, and appropriate
customer requirements.

FSM 17

Controlof The organization shall identify measuring and monitoring devices that

Measuringare parameters critical to ensure food safety.

and

In addition, the specified equipment and devices shall be calibrated

Monitoring
Devicesregularly. Calibration of these instruments and devices mustbe performed to equivalent standards, including national
and international standards, or to reasonably accepted
traceable methods.
The organization shall take appropriate action when equipment anddevices are found to be inaccurate, and these actions shall berecorded.

FSM 18

Product

Organizations must label or attach information to their products that willlabeling

enable a trading partner or consumer to safely handle, display, store,
store, prepare, or use the product.
It must also establish and implement procedures for labeling or
attaching the correct information.
8

Number
FSM 19Clause Name

Requirements

Analysis and The organization shall conduct appropriate inspections
Inspection

where and as they affect food safety.
Such inspections must be performed by a competentlaboratory or analytical laboratory.
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 21

Complaint

The organization shall document a system of management to respond

Handling

to complaints and utilize complaint data to identify, correct, and manage
omissions and deficiencies in food safety efforts.
Additionally, organization must record and maintain complaints,
investigation results, and corrective actions.

FSM 22.1

SeriousThe organization shall document serious food incident management

Incident

procedure, implement it in the event of an incident, and maintain it inManagement

effect 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.
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 of The organization shall verify the effectiveness of its food incident
food incident management procedure by conducting tests at least annually on

FSM 23.1

management

products supplied by the organization to ensure that product recalls aremanualimplemented, and maintain records of the verifications.

product

The organization shall document and maintain specifications for raw

specifications

materials (including packaging materials), semi-finished products, workin progress, remanufactured products, reworked products, and finishedproducts.
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.

9Number
FSM 23.2

Clause Name

Requirements

Product

The

organization

shall

document

andReleaseprocedures for product release (shipping).

implement

appropriate

Product release procedures shall include steps to ensure that the final
product meets specifications
FSM 24Controlof The organization shall document and enforce rules for not using ornon-shipping raw materials (including containers and packaging materials),conforming

semi-finished products, work-in-process products, recycled products,

products

reworked products, and finished products that may pose a safety
hazard.
The organization shall also determine who will be responsible formanaging nonconforming products.

FSM 25

Corrective

The organization shall establish and implement documented corrective

Actionactions in the event of nonconformities affecting food safety.
(Corrective action is the process of correcting a nonconformity to acondition that is not a nonconformity, determining the cause of thenonconformity and eliminating the cause of the nonconformity.)10

Ⅱ Hazard Analysis and Critical Control Point (HACCP)
Clause Name

Requirements

HACCP

HACCP

team HACCP team shall be assembled with competent staff, and theStep 1

assemblyand scope of application of the HACCP system and applicable GMPs

identification of shall be identified. The scope shall be documented what products
the

scope

of and processes are covered by which HACCP plan.

application
HACCP

Product

Product specifications shall be documented.

Step 2

Description

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.

HACCP

Identification of Intended use of the product and target users (consumers) shall be

Step 3

Intended Use

HACCP

Construction of The flow diagram that covers all steps in the operation shall be

Step 4

Flow Diagram

constructed.

HACCP

On-siteThe flow diagram shall be verified whether it correctly reflects the

Step 5

Confirmation of existing process steps of the operation.

clearly described in a written document.

Flow Diagram
HACCP

HazardThe HACCP team shall list all the hazards that are reasonably

Step 6

Analysis

likely to occur in each process steps.

(Principle 1)

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.

HACCP

Critical Control Critical Control Points (CCPs) shall be determined.

Step 7

Points(Principle 2)
11Clause Name
HACCP

Requirements

Critical Limits

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

HACCP

Monitoring

Monitoring procedures shall be established for each CCP.

Step 9SystemStep 8(Principle 3)(Principle 4)
HACCPCorrective

A procedure of corrective actions (correction, and investigation andStep 10

Actions

removal of root cause) shall be established for deviations from a(Principle 5)

critical limit.

HACCP

Establish

HACCP plan shall be validated prior to implementation.

Step 11HACCP plan

Verification procedures shall be established to confirm whether the(Principle 6)

validation anddefined handling (HACCP Plans) is carried out as specified and toverification

judge whether it is necessary to modify the defined handling.

procedures

Verification shall be carried out considering the design ofequipment, change in processing method and technology
development in the manufacturing process.

HACCP

Documents and Necessary documents shall be prepared and maintained.

Step 12

Record(Principle 7)

These documents shall contain documents related to the standard
operating procedures (SOP) and the work instructions (WI)
necessary and applicable to the scope of conformity assessmentof the organization.

12

Ⅲ Good Manufacturing Practice (GMP)
NumberClause Name

Requirements

GMP 2

Site

The organization shall establish and maintain in accordance withManagement

appropriate standards for business premises. These standards shall
include the management of waste and unnecessary materials on thepremises.

GMP 3

The organization shall design, construct and maintain the factory

Design,construction,buildings and facilities (storage area, raw material and productlayouthandling area, preparation area, packaging and storage area, etc.) ofof

business site
and work andproductflow

the business site both outside and inside the plant to minimize foodsafety risks.
In addition, the equipment layout (including drainage system andlineslighting) 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 food safety to an
appropriate level of illuminance.
Additionally, the organization shall ensure that facilities and equipmentthat come into contact with food are constructed and made of materials
that allow for appropriate maintenance, cleaning, and disinfection.
GMP 4.1

Cross-The organization shall prevent physical, chemical (including allergens),

contamination

biological contamination, and cross-contamination (including allergen(including

cross-contact) of raw materials (including containers and packaging

allergencross-contact)and isolationmaterials), 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 these procedures
shall be documented and maintained effectively through periodic
review.

GMP 4.2

Controlof The organization must establish control measures for hazards thathazards

that require particularly enhanced controls, other than CCPs, document

requirethose procedures as necessary, and maintain them effectively throughenhancement

periodic review.

13

Number

Clause Name

Requirements

GMP 5

Personnel

The organization shall provide changing rooms and hand washing

Facilities

facilities.
Facilities for employees, including these, must be properly managed tominimize food safety risks, including allergens.
The organization shall separate toilets and areas where food and drinks
are stored and consumed such as cafeterias, and break rooms, fromareas where food is manufactured, packaged, and stored.

GMP 6

Hygiene,The organization must document and enforce appropriate hygiene

workwear and standards for employees in accordance with the laws and regulations
Healthof the country in which the employees are working.
management
The criteria shall include provisions of hand washing and toiletof personnel,
facilities, ways and frequency of hand washing, medical screening
etc.
procedure to identify conditions impacting food safety, proper
protective clothing, rules on the clothing and shoes, rules on accessing
production area, ways of food handling, and control measures forforeign materials, and management procedures and reporting systemin the event of an infected person that poses food safety risks.

These requirements must be made known to employees andapplied without exception to contractors and visitors.
The organization shall also determine who will be responsible formanaging personnel with health conditions.
GMP 7

Training

The organization must ensure that all employees, including new
employees, receive adequate education and training in food safety
principles (including HACCP) and practices appropriate to their jobs.
In addition, a system must be established to ensure that employees
receive appropriate guidance and supervision.
The organization shall keep records of the implementation of educationand training. Additionally, the system for retraining as necessary shallbe documented and implemented.
This education and training shall enable employees to recognize theirrole in food safety and the significance of their efforts.

This education and training should enable employees torecognize their role in food safety and the significance of theirefforts.
14

Number

Clause Name

Requirements

GMP 8Housekeeping, The organization shall document and implement a management
cleaning,

procedure of maintain an appropriate level of hygiene at all times bysterilization

conducting tidying and cleaning operations throughout all processes

andand phases, and disinfecting where necessary.

disinfection

This procedure should include procedures for verifying that sanitaryconditions are ensured.
Cleaning tools, cleaning agents and disinfectants shall be suitable for
their intended purpose, clearly identified and stored in areas separated
from food production areas.

GMP 11

Air and water The organization shall establish application-specific standards andmanagement

regular monitoring procedures for air, high-pressure gas, and water(including ice and steam) used in food production to minimize impacts
on food safety, and the records shall be kept.
If water not intended for use in food production and water that has beenused and is still acceptable in contact with food is applied to foodproduction, it shall be controlled to prevent it from being contaminatedwith water for food production.

GMP 12

Waste
Management

The organization shall establish adequate systems forsegregation, collection and disposal of waste.
Waste placement and containers must be controlled toprevent the attraction of pests and the development ofharmful organisms and microorganisms.
Containers for storing waste materials (including by-products notsuitable for food use) shall be clearly distinguished from othercontainers.

Waste flow lines must be set up so as not to cause crosscontamination of food.
GMP 13

Pest control

The organization shall monitor pests and implement controls (surveys
and countermeasures) to minimize the risk of insects, rodents, birds,
and other pests occurring or entering the premises and facilities.
If chemicals are used, handling procedures shall be established toensure that food is not affected.
Pest control shall be carried out by persons with the necessarycompetence.

15

Number

Clause Name

GMP 15

Transport

Requirements
The organization shall establish a system to ensure that containers andtransportation vehicles, including contracted vehicles, used for thetransportation of raw materials and ingredients (including packaging
materials), partially processed 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 from contamination, andtransported within its intended temperature range.

GMP 17Stock

The organization shall establish a system to use raw materials andManagement

ingredients (including packaging materials),partially processed

products, work in progress, recycled products, reworks, and finishedproducts in a 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 18Devicesand The organization shall suitably design and select equipment and tools

Tools

for the intended uses and shall use, maintain, and store so as tominimize food safety hazards.

GMP 19Maintenance

The organization shall document and implement a system forsystematic maintenance of all equipment critical to product safety.
Maintenance 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, andsterilization procedures) for returning the food production facility to astate capable of producing food after maintenance activities.
Maintenance activities shall not represent food safety hazards.
All materials used for maintenance shall be suitable for the intended
purpose.

16

Annex●Definition
1．

Term

Definition

Access control

Control access by persons inside and outside the organization.
Examples include restricting and recording who enters and exits, andcontrolling locks.

2．

Allergen cross-contact

The unintentional incorporation of an allergenic food, or ingredient, intoanother 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)3．

Competence

Ability to apply knowledge and skills to achieve intended results.
Note to entry: Demonstrated competence is sometimes referred to as
qualification.
(Cited from the definition in ISO 9000:2015. Note 2 to entry is notincluded in the definition of “competence” in this document.)

4．

Control measure

Any action or activity that can be used to prevent, eliminate, or reducefood safety hazards

to acceptable levels.

(Cited from Codex Alimentarius Commission CAC/RCP 1-1969 Annex:
Hazard analysis and critical control point (HACCP) system andguideline for its application)
This is also defined as a control measure in the glossary of the “Guide
to Implementing HACCP in Food Manufacturing” (in Japanese)
published by the Ministry of Health, Labor and Welfare.
5．

Correction

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, or after
corrective action.
Note 2: Modifications include, for example, rework and rerating.

6．

Corrective action

The organization shall define, implement, and maintain the document ofprocedures 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.

17

7．

Term

Definition

CCP (Critical control

A step at which a control measure or control measures, essential topoint)

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)8．

Critical limit

A criterion, observable or measurable, relating to a control measure at a
CCP which separates acceptability from unacceptability of the food.
(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 other contaminants
that can contaminate food.

10．

Disinfection

Reduction by means of biological or chemical agents and/or physicalmethods in the number of viable microorganisms on surfaces, in wateror 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)

11．

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 opticalcomputer disc, photographic or master sample, or combination thereof.
(Cited from the definition of ISO 22000:2018 3.13)

12．

Employee, Personnel

All personnel in an organization who are involved in work related to foodsafety, including part-timers, contractors, and dispatched personnel.

13．

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)

18

14．

Term

Definition

Food

Substance (ingredient), whether processed, semi processed or raw,
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 not include cosmetics or
tobacco or substances (ingredients) used only as drugs.
(Cited from the definition of ISO 22000:2018 3.18)

15．

Food fraud

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 gainthat could impact consumer health.
(GFSI BENCHMARKING REQUIREMENTS VERSION 2020.1 / PARTIV GLOSSARY OF TERMS)

16．

Food fraud mitigation

食品偽装の脆弱性評価によって特定された、偽装行為をいつ、どこ The

plan

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

17．

18．

Food incident

A procedure for appropriate response and management in the event ofmanagement procedure

food safety problems to prevent it from escalating.

Food safety

A system to specify policies and objectives and to achieve thesemanagement systemobjectives so that food does not harm the consumer for when the food is
cooked and/or consumed in accordance with the intended use.
(Referenced to ISO 9000:2015 and ISO 22000:2018)19．

HACCP Plan

Documentation or set of documents, prepared in accordance with theprinciples of HACCP, to ensure control of significant hazards in the foodbusiness.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)20．

HACCP system

Develop a HACCP plan and implement procedures according to thatplan.
(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)

19

21．

Term

Definition

HazardA biological, chemical, or physical agent in food with the potential tocause an adverse health effect.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)22．

Intended use

Methods of use and consumption methods established at the time ofplanning and design for products, buildings and equipment.

23．

Management

Coordinated activities to direct and control an organization.
Note to entry: Management can include establishing policies andobjectives, and processes to achieve these objectives.

24．

Management system

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

25．

Monitoring

Definitions related to CCP
A planned observation procedure or measurement of control
parameters performed to assess whether the CCP is under control.
(Cited from Codex Alimentarius Commission CAC/RCP 1-1969 Annex:
Hazard analysis and critical control point (HACCP) system andguideline 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 be required
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 toconfirm conformance.
(Cited from ISO 22000:2018)

20

26．

Term

Definition

Nonconformities

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

27．

Outsourced processes

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, maintenance offacilities and equipment, etc.

28．

Packaging materials

Materials used for packaging food products, such as papers, plastics,
wooden boxes, cardboards, PET bottles, and tin cans.

29．

Product

Output of an organization that can be produced without any transaction
taking place between the organization and the customer.
Note 1 to entry: Production of a product is achieved without any
transaction necessarily taking place between provider and customer,
but can often involve this service element upon its delivery to thecustomer.
Note 2 to entry: The dominant element of product is that it is generally
tangible.
Note 3 to entry: Hardware is tangible and its amount is a countablecharacteristic (e.g. tires). Processed materials are tangible and theiramount is a continuous characteristic (e.g. fuel and soft drinks).
Hardware and processed materials are often referred to as goods.
Software consists of information regardless of 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)

30．

31．

Raw materials andIngredients refer to those used as part of product including packaging

ingredientsmaterials and water as well.

Recall

Products that have been or are being sold to the end consumer and areconsidered unsafe are removed from the supply chain by the supplier.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)

21

32．

Term

Definition

RecordDocument stating results achieved or providing evidence of activities
performed.
Note 1 to entry: Records can be used, for example, to formalize
traceability and to provide evidence of verification, preventive action andcorrective action.
Note 2 to entry: Generally records need not be under revision control.
(Cited from the definition in ISO 9000:2015)

33．

Rework[When indicating an act].
Indicates the action to be taken when returning to the manufacturing
flow a product that complies with the requirements for products thathave deviated from the regular series of processes, including final
products, semi-finished products, work-in-process, and raw materials inall 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 for reasons
other than insanitary conditions or that has been successfullyreconditioned by reprocessing and that is suitable for use as food or afood component.
(Adapted from Codex Alimentarius Commission CXC 80-2020 (Adopted
in 2020) CODE OF PRACTICE ON FOOD ALLERGEN MANAGEMENTFOR FOOD BUSINESS OPERATORS)

34．

Sector, sub-sector

Scope of conformity assessment.

35．

Serious incident

Food incident that may have an effect on food safety. Does not include
incidents that do not have an effect on food safety but may have aneffect on the quality.

36．

Significant hazard

Hazard identified by a hazard analysis that, in the absence of controls,
are reasonably likely to occur to an unacceptable level and whose
control is essential for the intended use of the food.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)

22

37．

Term

Definition

Top management

Person or group of people who directs and controls an organization at
the highest level.
Note 1 to entry: Top management has the power to delegate authorityand provide resources within the organization.
Note 2 to entry: If the scope of the management system covers only partof an organization, then top management refers to those who direct andcontrol that part of the organization.
(Cited from the definition of ISO 22000:2018 3.41)

38．

Updating

Immediate and/or planned activity to ensure application of the mostrecent information.
(Cited from the definition in ISO 22000:2018)

39．

Validation of control

Obtain evidence that the control measures or combination of control

measuresmeasures, if properly implemented, will control the hazards to theidentified results.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)40．

Validation of the HACCP

Ensure that the food business operator is capable of controlling thePlanappropriate critical hazards by the following elements: identification of
hazards, CCP, CL, control measures, frequency and type of CCP
monitoring, remedial actions, frequency and type of verification, andtype of information to be recorded.
(Cited from Codex General Principles of Food Hygiene 2020:(Reference) Japan Food Hygiene Association 2021 Translation First
Edition)41．

Verification

The application of methods, procedures, tests, and other evaluations, inaddition to monitoring, to determine 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)42．

Withdrawal

Removal of products from the supply chain that are considered unsafe
before they are sold to the end consumer.
(Cited from the definition of GFSI Benchmarking Requirement ver.
2020.1)23

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

Supplementary provision
Revision history
Document Number

Revision Number

Revision Date

Details

SS_102_03_R00_en

R00

2024/05/29

First Edition24