FSMS Vocabulary, Rev.05 Sep 2014

5
th
revision
2014-09-01

Food safety management systems-
Vocabulary

Food safety management systems- Vocabulary

MK 21999 Page 1

Key to the FSMS Vocabulary

A term in a definition or note which is defined elsewhere in this FSMS vocabulary is indicated by
boldface and text highlighted in yellow followed by its entry number (ISO standard, PAS, CAC,
reference documents, and their clause numbers source) are in parentheses.

Such a boldface term may be replaced in the definition by its complete definition.
For example:

correction (ISO 22000, 3.13)
action to eliminate a detected nonconformity (ISO 9000, 3.6.2)

nonconformity (ISO 9000, 3.6.2)
non-fulfilment of a requirement (ISO 9000, 3.1.2)

requirement (ISO 9000, 3.1.2)
need or expectation that is stated, generally implied or obligatory

If the term nonconformity and requirement are replaced by its definition, as follows

correction then becomes action to eliminate a detected non-fulfilment of a need or
expectation that is stated, generally implied or obligatory

A concept limited to a special meaning in a particular context is indicated by designating the subject
field in angle brackets, , before the definition.
For example:

protective security (PAS 96, 2.6)
<food defense> all the measures related to physical, electronic and personnel security (PAS 96, 2.4)
which any organization (ISO 22005, 3.10) takes to minimize the threat of malicious attack

Terms defined within a box, , served as alternative meaning to a previous definition.
For example:

hygiene (ISO/TS 22002-4, 3.10)
food packaging PRPs set of measures taken to ensure the food safety of a product that might
otherwise become hazardous or harmful

hygiene (ISO 14159, 3.11)
<safety of machinery> taking of all measures during product handling, preparation and
processing to ensure its suitability for use by humans or domestic animals

This 5
th
revision encompassed recently published terms and definition for the FSSC 22000
certification scheme; ISO 22004:2014 FSMS- Guidance on the application of ISO 22000; ISO/TS
22002-4:2013 PRPs for food packaging manufacturing, etc.

Mark B. Kwan
01 Sep 2014
Abu Dhabi, UAE


MK 21999 Page 2

A

action limit / action criterion (ISO 22004, 3.3)
<FSMS> measurable or observable criterion established for the monitoring of a control measure
applied as an oPRP (ISO 22000, 3.9)

Note 1 to entry: An action limit or criterion expresses whether or not the control measure is under control, and distinguishes
between what is acceptable (limit met or achieved means the control measure is operating as intended) and unacceptable
(limit not met nor achieved means the control measure is not operating as intended).

active ingredient (GlobalGAP, 03)
pesticide or pharmaceutical drug that is biologically active

Some pesticides and medications may contain more than one active ingredient/substance

adulteration (NCFPD)
<food fraud> a component of the finished (food) product is fraudulent

EXAMPLE: melamine added to milk

According to USDA, a (food) product is considered adulterated if:
it bears or contains any poisonous or deleterious substance which may render it injurious to health
it bears or contains any added poisonous or deleterious substance
any filthy, putrid, or decomposed, or otherwise unfit food [including if it achieved this during handling]
the product of a diseased animal or of an animal which has died other than by slaughter
its container [package] is composed, in whole or in part, of any poisonous or deleterious substance
any valuable constituent has been in whole or in part omitted or abstracted therefrom
damage or inferiority has been concealed in any manner
any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its
quality or strength, or make it appear better or of greater value than it is
it bears or contains a color additive which is unsafe within the meaning of this section

aspect (ISO PAS 99, 3.1)
<IMS> characteristic (ISO 20006, 3) of an activity, product (ISO 22005, 3.1) or service that has or can
have an impact (PAS 99, 3.4)

NOTE 1 See PAS 99, A.4.3.2 (identification and evaluation of aspects, impacts, and risk) for additional
explanation of this concept

NOTE 2 A significant aspect (PAS 99, 3.1) has or can have a significant impact (PAS 99, 3.4)

B

biocide (GlobalGAP, 16)
a chemical substance or a microorganism used to manage, mitigate, or remove any harmful
organisms via chemical or biological methods

There are two primary categories of biocides: (1) pesticides (e.g. fungicides, herbicides, insecticides, algicides,
moluscicides, miticides and rodenticides) and (2) antimicrobials (e.g. germicides, antibiotics, antibacterials, antivirals,
antifungals, antiprotozoas and antiparasites)

biosecurity (GlobalGAP, 19)
a set of preventative measures taken to protect from infectious diseases, quarantined pests, invasive
alien species, and living modified organisms

Mortality due to diseases and decreased production due to infections are major factors for economic loss but also a serious
food safety concern for the consumers

biosecurity plan (GlobalGAP, 18)
a written document addressing potential pathways for the introduction and spread of disease in a
zone or compartment, and describing the preventative measures which are being or will be applied
to mitigate the chemical and biological risks

The plan also describes procedures to ensure that the risks are regularly re-assessed and the measures adjusted
accordingly


MK 21999 Page 3

C

catering (ISO/TS 22002-2, 3.1)
catering PRPs preparation, storage and, where appropriate, delivery of food for consumption, at
the place of preparation or at a satellite unit

certificate of analysis [COA] (ISO/TS 22002-1, 3.14 / PAS 221, 3.1 / PAS 222, 2.1)
<PRPs> document (PAS 99, 3.3) provided by the supplier which indicates results of specific test or
analysis, including test methodology, performed on a defined lot (ISO 22005, 3.3) of the suppliers
product (ISO 22005, 3.1)

certificate of analysis [COA] (ISO/TS 22002-4, 3.1)
<food packaging PRPs> document that indicates results of specific tests or analysis, which may
include test methodology, performed on a defined amount of material or product

characteristic (ISO 22006, 3.3)
<IMS> distinctive trait that sets something apart

NOTE 1 to entry: A characteristic is an identifiable hereditary property, such as a specific component, a structural detail, a
colour or pattern, or resistance to pests. The synonym attribute is used especially when the trait is measurable

clean water (ISO/TS 22002-3, 3.1)
<farming PRPs> water that does not compromise food safety (ISO 22000, 3.1) in circumstances of its
use

NOTE 1 Adapted from CAC/RCP 53-2003, Code of hygienic practices for fresh fruits and vegetables

NOTE 2 In the context of ISO/TS 22002-3, the term refers to natural, artificial or purified water that does not
contain micro-organisms, harmful substances in quantities capable of directly or indirectly affecting the
safety of food

cleaning (ISO/TS 22002-1, 3.5 / ISO/TS 22002-2, 3.2 / ISO/TS 22002-4, 3.2 / PAS 221, 3.2)
<PRPs> removal of soil, food residue, dirt, grease or other objectionable matter [NOTE Adapted from
CAC/RCP 1, 2.3]

cleaning in place [CIP] (ISO/TS 22002-1, 3.10)
<food manufacturing PRPs> cleaning (PAS 220, 3.5) of equipment by impingement or circulation of
flowing chemical solutions, cleaning liquids, and water rinses into, on to and over surfaces in
equipment or systems (ISO 9000, 3.2.1) without dismantling and designed for the purpose [ISO 14159,
3.3]

cleaning in place [CIP] (PAS 221, 3.3)
<food retail PRPs> system that cleans solely by circulating and/or flowing chemical detergent
solutions and water rinses by mechanical means onto and over surfaces to be cleaned

NOTE an example of this would be the method used, in part, to clean and sanitize a frozen dessert machine, oven or
dishwasher

cleaning out of place [COP] (ISO/TS 22002-1, 3.11 / PAS 221, 3.4)
<PRPs> system (ISO 9000, 3.2.1) where equipment is disassembled and cleaned in a tank or in an
automatic washer by circulating a cleaning solution and maintaining a minimum temperature
throughout the cleaning (ISO/TS 22002-1, 3.5) cycle
[PAS 221 addition] or using combination of the above with hoses or pressure sprays

NOTE an example of this would be equipment such as band saws, meat slicers or mixers that are subjected to COP
manual cleaning without the use of CIP

competence (ISO/TS 22003, 3.3)
ability to apply knowledge and skills to achieve intended results


MK 21999 Page 4

competent person (ISO/TS 22002-3, 3.2)
<farming PRPs> a person, qualified by knowledge and practical experience, with the necessary
skills and ability to perform an assigned task

NOTE Education, training or experience is how a person achieves competency

compliance criteria (CC) (GlobalGAP, 35)
Information provided to further illustrate each control point and how to successfully address the
requirement(s) identified in the control point (GlobalGAP, 42)

compound feed (GlobalGAP, 38)
(which can be complete or complementary), may be produced using any ingredients (except
medicated feed/supplements) as raw materials

Compound Feeds in the context of GlobalGAP exclude the production of ingredients such as forage or grains (Simple
Feed Materials), pre-mixtures, additives or medicated feeds (Prepared Feed Supplements) etc.

consequence (USFDA)
<food defense> the result of a terrorist attack or other incident that reflects the level, duration and
nature of the loss resulting from the incident

[NOTE] For purposes of US National Infrastructure Protection Plan (NIPP), there are four main categories: health,
economic, psychological and governance

contaminant (ISO/TS 22002-1, 3.2 / ISO/TS 22002-2, 3.4 / ISO/TS 22002-3, 3.4 / ISO/TS 22002-4,
3.3 / PAS 221, 3.5 / PAS 222, 2.2 / EN 15593, 3.1)
<PRPs> any biological ([for EN 15593] including microbiological) or chemical agent, foreign matter or
other substances not intentionally added to (food or feed) which may compromise food safety (ISO
22000, 3.1) or suitability [CAC/RCP 1, 2.3]

NOTE Measures for prevention of malicious contamination are outside the scope of this PAS (ISO/TS 22002-1,
ISO/TS 22002-4, PAS 221, & PAS 222). For further information and guidance on approaches to the protection of
food businesses from all forms of malicious attack see PAS 96

NOTE 2 In the context of ISO/TS 22002-3, the term foreign matter refers to physical contaminants

NOTE 3 This definition is similar to the definition of food safety hazard (ISO 22000, 3.3) given in ISO 22000:2005.
In fact, in the context of ISO 22000:2005, food safety hazards are identified during the hazard analysis, after
the establishment of PRPs. Consequently, the term contaminant is used in this Technical Specification (ISO/TS
22002-3)

contamination (ISO/TS 22002-1, 3.1 /ISO/TS 22002-3, 3.3 / ISO/TS 22002-4, 3.4 / PAS 221, 3.6 /
PAS 222, 2.3 / EN 15593, 3.2)
<PRPs> introduction or occurrence of a contaminant (ISO/TS 22002-1, 3.2) in food or food environment
[alternative for ISO/TS 22002-3, 3.3] in food, feed or in food and feed environment

[NOTE Adapted from CAC/RCP 1, 2.3]

NOTE [for ISO/TS 22002-4] In the context of this Technical Specification, contamination may also refer to the
impurities in the materials used in, or a decomposition or reaction product formed during, the production process,
which might compromise food safety
in the content of this PAS contamination may also refer to the introduction of non intentionally added
substances (NIAS) (see PAS 223, 3.13)

contingency planning (PAS 99, 3.2)
<IMS> consideration of the potentially serious incidents that could affect the operations of the
organization (ISO 22005, 3.10) and the formulation of a plan(s) to prevent or mitigate the effects and to
enable the organization to operate as normally as possible

control measure (ISO 22000, 3.7)
<FSMS> action or activity that can be used to prevent or eliminate a food safety hazard (ISO 22000,
3.3) or reduce it to an acceptable level [NOTE Adapted from CAC- Basic texts on food hygiene]


MK 21999 Page 5

Control Points (CP) (GlobalGAP, 42)
those measurable issues associated with the implementation of good agricultural practices
(GlobalGAP, 84) throughout the farming business

Within the GlobalGAP standards, control points are classified as major musts (GlobalGAP, 111), minor musts (GlobalGAP,
117), or recommendations (GlobalGAP, 161)

Control Points and Compliance Criteria (CPCC) (GlobalGAP, 43)
the comprehensive set of control points (GlobalGAP, 42) and compliance criteria (GlobalGAP, 35) that
make up the checklist against which producer/farm performance is measured both internally and
externally

correction (ISO 22000, 3.13)
<FSMS> action to eliminate a detected nonconformity (ISO 9000, 3.6.2)

NOTE 1 For the purposes of this International Standard (ISO 22000), a correction relates to the handling of
potentially unsafe products, and can therefore be made in conjunction with a corrective action (ISO 22000,
3.1.4)

NOTE 2 A correction may be, for example, reprocessing, further processing, and/or elimination of the adverse
consequences of the nonconformity (such as disposal for other use or specific labelling)

corrective action (ISO 22000, 3.14)
<FSMS> action to eliminate the cause of a detected nonconformity (ISO 9000, 3.6.2) or other
undesirable situation

NOTE 1 There can be more than one cause for a nonconformity (ISO 9000, 3.6.5)

NOTE 2 Corrective action includes cause analysis and is taken to prevent recurrence

counterfeiting (NCFPD)
<food fraud> Intellectual Property Rights infringement, which could include all aspects of the
fraudulent product and packaging being fully replicated

EXAMPLE: copies of popular foods not produced with same food safety assurances

critical control point [CCP] (ISO 22000, 3.10)
<FSMS> step at which control can be applied and is essential to prevent or eliminate a food safety
hazard (ISO 22000, 3.3) or reduce it to an acceptable level [NOTE Adapted from CAC- Basic texts on food
hygiene]

critical defect (GlobalGAP, 49)
a deviation at a critical control point (ISO 22000, 3.10) which results in a hazard occurring

critical limit (ISO 22000, 3.11)
<FSMS> criterion which separates acceptability from unacceptability

NOTE 1 Adapted from CAC- Basic texts on food hygiene

NOTE 2 Critical limits are established to determine whether a CCP (ISO 22000, 3.10) remains in control. If a
critical limit is exceeded or violated, the products (ISO 22005, 3.1) affected are deemed to be potentially unsafe

critical limits (GlobalGAP, 50)
a maximum and/or minimum value to which a biological, chemical or physical parameter must be
controlled at a critical control point (ISO 22000, 3.10) to prevent, eliminate or reduce to an
acceptable level the occurrence of a food-safety hazard

cross-contamination (ISO/TS 22002-2, 3.5)
catering PRPs contamination of cooked and pre-cooked foods by direct or indirect contact with
material at an earlier stage of the process

customer (GlobalGAP, 52)
a person or entity who purchases products or services from a supplier (GlobalGAP, 191)


MK 21999 Page 6

customer requirements (ISO 9000, 2.1)
<QMS> needs and expectation expressed in product specifications (ISO/TS 22002-1, 3.7)

D

data (ISO 22005, 3.11)
<FSMS> recorded information

declaration of compliance [DOC] (ISO/TS 22002-4, 3.5)
<food packaging PRPs> document (PAS 99, 3.3) that confirms conformance to specifications (ISO
9000, 3.7.3) or regulations

NOTE This is sometimes referred to as a certificate of compliance (CoC)

deviation (ISO 22004, 3.2)
failure to meet an expected outcome

disinfection (ISO/TS 22002-1, 3.9 / ISO/TS 22002-2, 3.6 / PAS 221, 3.7 / PAS 222, 2.7)
<PRPs> reduction, by means of chemical agents and/or physical methods, of the number of micro-
organisms in the environment, to a level that does not compromise food safety (ISO 22000, 3.1) or
suitability [NOTE adapted from CAC/RCP 1, 2.3]

document (ISO 9000, 3.7.2 / PAS 99, 3.3)
<IMS> information and its supporting medium

NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or
a combination thereof.

NOTE 2 A set of documents, for example specifications (ISO/TR 10013, 4.9) or records (ISO 9000, 3.7.6), is
frequently called documentation

NOTE 3 Some requirements [(SO 9000, 3.1.2) (e.g. the requirement to be readable) relate to all types of
documents, however there can be different requirements for specification (e.g. the requirement to be revision
controlled) and records (ISO 9000, 3.7.6) (e.g. the requirement to be retrievable)

E

Economically Motivated Adulteration [EMA] (NCFPD)
<food fraud> the fraudulent, intentional substitution or addition of a substance in a product for the
purpose of increasing the apparent value of the product or reducing the cost of its production. EMA
includes dilution of products with increased quantities of an already-present substance to the extent
that such dilution poses a known or possible health risk to consumers, as well as the addition or
substitution of substances in order to mask dilution

[NOTE] The corollary concept of economically motivated misbranding is when an act specifically meets the US Federal Food,
Drug, and Cosmetic (FD&C) Act definition of misbranding and not adulteration

electronic security (PAS 96, 2.1)
<food defense> procedures (ISO 9000, 3.4.5) used to protect electronic systems from sources of
threat, such as malware and hackers, intent on misusing them, corrupting them or putting them out
of use

end product (ISO 22000, 3.5)
<FSMS> product (ISO 22005, 3.1) that will undergo no further processing or transformation by the
organization (ISO 22005, 3.10)

NOTE A product (ISO 22005, 3.1) that undergoes further processing or transformation by another organization is an end
product in the context of the first organization and a raw material or an ingredient in the context of the second organization


MK 21999 Page 7

equipment (PAS 221, 3.8)
article that is used in the operation of food retail premises

NOTE 1 Equipment may include: freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator,
scale, sink, slicer, stove, table, thermometers, etc.

NOTE 2 Equipment does not include apparatus used for handling or storing large quantities of packaged foods that
are received from a supplier in a cased or over-wrapped lot/batch, such as hand trucks, forklifts, dollies, racks and
skids

establishment (ISO/TS 22002-1, 3.3 / ISO/TS 22002-2, 3.7)
<PRPs> any building or area in which food is handled and the surroundings under the control of the
same management (ISO 9000, 3.2.6) [adapted from CAC/RCP 1, 2.3]

establishment (ISO/TS 22002-4, 3.6)
<food packaging PRPs> any building or area in which raw materials, intermediate products,
chemicals or food packaging are handled, and the surroundings under the control of the same
management

F

facility (FSSC 22000, 05)
a building or structure that provides a particular service or is used by a supplier

farm (GlobalGAP, 67)
geographically owned or rented land with sufficient infrastructure and management to enable the
production of the product

feed (ISO/TS 22002-3, 3.5)
<farming PRPs> any single or multiple materials, whether processed, semi-processed or raw, which
is intended to be fed directly to food-producing animals

feed (FSSC 22000, 06)
any substance or product, including feed additives, whether processed or unprocessed, intended
to be used for direct or indirect feeding of animals

feed additives (ISO/TS 22002-3, 3.6)
<farming PRPs> any intentionally added ingredient not normally consumed as feed by itself,
whether or not it has nutritional value, which affects the characteristics of feed or animal products

feed and food chain (ISO 22005, 3.7)
<FSMS> sequence of the stages and operations involved in the production, processing, distribution
and handling of feed and food, from primary production to consumption

NOTE Primary production includes the production of feed for food-producing animals and for animals intended for food
production

feed ingredient (ISO/TS 22002-3, 3.7)
<farming PRPs> a component part or constituent of any combination or mixture making up a feed,
whether or not it has a nutritional value in the animals diet, including feed additives

NOTE Ingredients are of plant or animal origin, whether terrestrial or aquatic, or other organic or inorganic substances

feed manufacturing/feed processing (FSSC 22000, 07)
the manufacture/processing of materials intended to be consumed by animals and contribute energy
and/or nutrients to their diet

feed safety (FSSC 22000, 08)
a concept that feed will not cause harm to animals or adversely affect animal health when utilized
according to its intended purpose


MK 21999 Page 8

first expired first out [FEFO] (ISO/TS 22002-1, 3.18 / PAS 221, 3.9)
<PRPs> stock rotation based on the principle of dispatching earliest expiration dates first

first in first out [FIFO] (ISO/TS 22002-1, 3.19 / PAS 221, 3.10)
<PRPs> stock rotation based on the principle of dispatching earliest received products (ISO 22005,
3.1) first

flow diagram (ISO 22000, 3.6)
<FSMS> schematic and systematic presentation of the sequence and interactions of step(s)

flow of materials (ISO 22005, 3.8)
<FSMS> movement of any materials (ISO 22005, 3.9) at any point in the feed and food chain (ISO
22005, 3.7)

food (FSSC 22000, 09)
any substance, whether processed, semi-processed or raw, which is intended for human
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 used only as drugs

food chain (ISO 22000, 3.2)
<FSMS> sequence of the stages and operations involved in the production, processing, distribution,
storage and handling of a food and its ingredients, from primary production to consumption

NOTE 1 This includes the production of feed for food-producing animals and for animals intended for food
production

NOTE 2 The food chain also includes the production of materials (ISO 22005, 3.9) intended to come into contact
with food or raw materials

food-contact side (EC 223, e)
<food packaging> the surface of a material or article that is directly in contact with the food

food defense (PAS 96, 2.2)
<food defense> security of food and drink and their supply chains from all forms of malicious attack
including ideologically motivated attack leading to contamination (ISO/TS 22002-1, 3.1) or supply failure

food defense (FSSC 22000, 10)
the process to ensure the security of food and feed and their supply chains from all forms of
malicious attack including ideologically motivated attack leading to contamination or supply failure

food defense (GlobalGAP, 71)
activities associated with protecting food supply (ISO 22000, 3.3) from intentional contamination
(food defense refers to intentional, sporadic, and plausible but unknown threat)

food defense (USFDA)
<food defense> the collective term used by the US Food and Drug Administration (FDA), US
Department of Agriculture (USDA), US Department of Homeland Security (DHS), etc. to
encompass activities associated with protecting the nation's food supply from deliberate or
intentional acts of contamination or tampering. This term encompasses other similar verbiage (i.e.,
bioterrorism (BT), counter-terrorism (CT), etc.)

food fraud (NCFPD)
the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food
ingredients, or food packaging; or false or misleading statements made about a product, for
economic gain

[NOTE] Food fraud is a broader term than either the economically motivated adulteration (EMA) defined by the US Food
and Drug Administration (USFDA) or the more specific general concept of food counterfeiting. Food fraud may not include
adulteration or misbranding, as defined in the US Food, Drug, and Cosmetic Act (FD&C Act), when it involves acts such
as tax-avoidance and smuggling. The economic motivation behind food fraud is distinctly different from those for food
safety, food defense, and food quality. The cause of an event might be food fraud, but if a public health threat becomes
involved, the effect is an adulterated product and a food safety incident. All of this is under the umbrella of food protection,
which encompasses food fraud, food quality, food safety, and food defense


MK 21999 Page 9

Three types of public health risks can result from food fraud:
Direct food fraud risk occurs when there is an immediate or imminent risk to the consumer, such as the inclusion of an
acutely toxic or lethal contaminant
Indirect food fraud risk occurs when the consumer is put at risk through long-term exposure, such as the build up in the
body of a chronically toxic contaminant through the ingestion of low doses. Indirect risk also includes the omission of
beneficial ingredients, such as preservatives or vitamins
Technical food fraud risk is non-material in nature. For example, food documentation fraud occurs when product
content or country-of-origin information is deliberately misrepresented

food grade (ISO/TS 22002-1, 3.8 / PAS 221, 3.11)
<PRPs> lubricants and heat transfer fluids formulated to be suitable for use in food processes where
there may be incidental contact between the lubricant and the food

food handler (ISO/TS 22002-2, 3.8)
catering PRPs any person who directly handles packaged or unpackaged food, food equipment
and utensils, or food contact surfaces and is therefore expected to comply with food hygiene
requirements

food handling (ISO/TS 22002-2, 3.9)
catering PRPs any operation in the preparation, processing, cooking, packaging (EN 15593, 3.7),
storage, transport, distribution and service of food

food ingredient (ISO/TS 22002-2, 3.11)
catering PRPs any substance, including food additives, used in the manufacturing or preparation
of food and which is present, whether maintaining its original aspect or modified, in the end product

food packaging (ISO/TS 22002-4, 3.7)
food packaging PRPs any product to be used for containment, protection, handling, delivery,
storage, transport and presentation of food

NOTE 1 to entry: Food packaging may have direct or indirect contact with the food
Direct food contact surfaces or materials are in contact (i.e. physically touching the food or in contact with the
headspace) or will be in contact with the food during normal use of the food packaging
Indirect food contact surfaces or materials are not in direct contact with the food during normal use of the food
packaging, but there is the possibility for substances to be transferred into the food
The classification of the food packaging as direct or indirect food contact should be part of the hazard analysis

food packaging hazard (ISO/TS 22002-4, 3.8)
food packaging PRPs biological, chemical or physical agent in food packaging, or condition of
use, with the potential to cause an effect in the food leading to adverse health effects

food packaging withdrawal (ISO/TS 22002-4, 3.9)
food packaging PRPs removal of non-conforming food packaging from any part of the food
supply chain because the food packaging does not meet specified food safety standards or
requirements

EXAMPLE: Any part of the food supply chain includes trade warehouses, distribution centres or customer operations and
warehouses

food protection (NCFPD)
<food fraud> an overall concept that includes prevention, intervention, and response for incidents in
food quality, food safety, food fraud, and food defense

food retail establishment (PAS 221, 3.12)
<food retail PRPs> any building or area under the control of the owner or designated person-in-
charge, including the contents, and the contiguous land or property (surrounds), in which food is
stored, prepared, packaged, served, vended, or otherwise provided as food for human consumption
[Adapted from Codex Alimentarius, 2.3 and US FDA Code, 1.2]

food retail premises (PAS 221, 3.13)
<food retail PRPs> physical building under direct full or partial control of the retailer


MK 21999 Page 10

food safety (ISO 22000, 3.1)
<FSMS> concept that food will not cause harm to the consumer when it is prepared and/or eaten
according to its intended use


NOTE 2 Food safety is related to the occurrence of food safety hazards (ISO 22000, 3.3) and does not include
other human health aspects related to, for example, malnutrition

food safety control system (CAC/GL 69-2008, 3.2)
the combination of control measures (ISO 22000, 3.7) that, when taken as a whole, ensure that food is
safe for its intended use

food safety hazard (ISO 22000, 3.3 / FSSC 22000, 11)
<FSMS> biological, chemical or physical agent in food, or condition of food, with the potential to
cause an adverse health effect [FSSC 22000 addition] to humans and/or animals


NOTE 2 The term hazard is not to be confused with the term risk which, in the context of food safety, means
a function of the probability of an adverse health effect (e.g. becoming diseased) and the severity of that
effect (death, hospitalization, absence from work, etc.) when exposed to a specified hazard. Risk is defined in
ISO/IEC Guide 51 as the combination of the probability of occurrence of harm and the severity of that harm

NOTE 3 Food safety hazards include allergens

NOTE 4 In the context of feed and feed ingredients, relevant food safety hazards are those that may be present in
and/or on feed and feed ingredients and that may subsequently be transferred to food through animal consumption
of feed and may thus have the potential to cause an adverse human health effect. In the context of operations other
than those directly handling feed and food (e.g. producers of packaging materials (PAS 223, 3.14), cleaning
agents, etc.), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food
because of the intended use of the provided products (ISO 22005, 3.1) and/or services and thus can have the
potential to cause an adverse human health effect

food safety management system [FSMS] (ISO/TS 22003, 3.2)
set of interrelated or interacting elements to establish policy and objectives and to achieve those
objectives, used to direct and control an organization (ISO 22005, 3.10) with regard to food safety (ISO
22000, 3.1)

NOTE 1 to entry: See ISO 9000:2005, 3.2.1, 3.2.2 and 3.2.3

NOTE 2 to entry: In this Technical Specification (ISO/TS 22003), food safety management system replaces the
term management system used in ISO/IEC 17021.

food safety policy (ISO 22000, 3.4)
<FSMS> overall intentions and direction of an organization (ISO 22005, 3.10) related to food safety
(ISO 22000, 3.1) as formally expressed by top management (ISO 9000, 3.2.7)

food supply (PAS 96, 2.3)
<food defense> any and all elements of what is commonly called the food supply chain, net or web
with the inclusion of drink and supporting and allied services (see PAS 96, 4.3 the food supply web)

food terrorism (WHO, 2008)
an act or threat of deliberate contamination of food for human consumption with chemical, biological,
or radionuclear agents for the purpose of causing injury or death to civilian populations and/or
disruption of social, economic or political stability

form (ISO/TR 10013, 3.2)
<QMS> document (ISO 9000, 3.7.2) used to record (ISO 9000, 3.7.6) data (ISO 22005, 3.11) required by the
quality management system (ISO 9000, 3.2.3) (and, or other) management system (ISO 9000, 3.2.2)

NOTE A form (ISO/TR 10013, 3.2) becomes a record (ISO 9000, 3.7.6) when data (ISO 22005, 3.11) are entered

fumigant (GlobalGAP, 74)
volatile liquid or gas used to kill insects, nematodes, fungi, bacteria, seeds, roots, rhizomes, or entire
plants


MK 21999 Page 11

G

GlobalGAP Risk Assessment on Social Practice [GRASP] (GlobalGAP, 79)
a voluntary assessment on the implemented social practices on farm (GlobalGAP, 67). The outcome of
the assessment does not affect the GlobalGAP certification but serves as additional information to
supply chain partners who have been granted access to the results

good agricultural practices [GAP] (GlobalGAP, 84)
practices that address environmental, economic, and social sustainability for on-farm processes, and
result in safe and quality food and non-food agricultural products

good distribution practices [GDP] (WHO- GDP, Glossary)
that part of quality assurance that ensure that the quality of food and pharmaceutical products is
maintained through adequate control throughout the numerous activities which occur during the
distribution process

good hygiene practice [GHP] (APO- FSMS manual, Definition Box 9)
refers to all practices regarding the conditions and measures necessary to ensure the safety and
suitability of food at all stages of the food chain

good manufacturing practice [GMP] (EC 223, a)
those aspects of quality assurance which ensure that materials and articles are consistently
produced and controlled to ensure conformity with the rules applicable to them and with the quality
standards appropriate to their intended use by not endangering human health or causing an
unacceptable change in the composition of the food or causing a deterioration in the organoleptic
characteristics thereof

good trading practices [GTP] (WHO- GDP, Glossary)
that part of quality assurance that ensure that the quality of food and pharmaceutical products is
maintained through adequate control throughout the numerous activities which occur during the
trading process

good veterinary practice [GVP] (FVE)
a standard which ensures that services provided by the veterinary profession are consistently
produced and controlled to the quality standards

guidelines (ISO 9000, 2.7.2.d)
<QMS> documents (ISO 9000, 3.7.2) stating recommendations or suggestions

H

HACCP plan (CAC/RCP-01, Annex 2.10)
a document (ISO 9000, 3.7.2) prepared in accordance with the principles of HACCP (ISO/TS 22003, 3.1) to
ensure control of hazards which are significant for food safety (ISO 22000, 3.1) in the segment of the
food chain (ISO 22000, 3.2) under consideration

hand washing (ISO/TS 22002-2, 3.10)
catering PRPs removal of dirt from skin with the help of a skin compatible soap

hazard (EN 15593, 3.3)
food packaging biological, chemical or physical contaminant in the product, or a condition of the
product (EN 15593, 3.8) that may cause an adverse health effect or a nonconformity to the hygiene
(EN 15593, 3.4) requirements for that product

hazard (GlobalGAP, 89)
a biological, chemical, physical or any other property that may cause a situation unsafe for
workers, consumers, and/or the environment


MK 21999 Page 12

hazard analysis and critical control point [HACCP] (ISO/TS 22003, 3.1)
<FSMS> system (ISO 9000, 3.2.1) which identifies, evaluates and controls hazards which are
significant for food safety (ISO 22000, 3.1)

NOTE Adapted from CAC Food hygiene basic texts

hazard analysis critical control points [HACCP] (GlobalGAP, 88)
a food safety management methodology used in the analysis and control of biological, chemical,
and physical hazards from raw material production, procurement and handling, to manufacturing,
distribution and consumption of the finished product

hazard assessment (PAS 222, 2.11)
<animal feed PRPs> evaluation to determine, for each food safety hazard (ISO 22000, 3.3) identified,
whether its elimination or reduction to acceptable levels is essential to the production of a safe
product (ISO 22005, 3.1), and whether its control is needed to enable the defined acceptable levels to
be met

NOTE In hazard assessment (see Annex A of PAS 222), possible severity of adverse health effects and the likelihood of
occurrence of identified hazards are considered [Derived from ISO 22000, 7.4.3]

herbicide (GlobalGAP, 90)
a chemical that controls or destroys undesirable plants

hierarchy (ISO/TR 10013, 4.1)
<document> the structure of the documentation used in the quality management system (ISO 9000,
3.2.3) (or any) management system (ISO 9000, 3.2.2)

hygiene (ISO/TS 22002-4, 3.10)
food packaging PRPs set of measures taken to ensure the food safety of a product that might
otherwise become hazardous or harmful

hygiene (ISO 14159, 3.11)
<safety of machinery> taking of all measures during product handling, preparation and
processing to ensure its suitability for use by humans or domestic animals

I

impact (PAS 99, 3.4)
<IMS> effect on the organizations policy commitments and objectives, its interested parties (ISO
9000, 3.3.7), the organization (ISO 22005, 3.10) itself and/or on the environment

NOTE An effect can be positive or negative

incident (ISO/TS 22002-4, 3.11)
food packaging PRPs event that might potentially compromise the food safety of a material or
product

incidental product contact (ISO 21469, 3.6)
<safety of machinery> contact with product that is not intended but which is not preventable

infrastructure (ISO 9000, 3.3.3)
<organization> system (ISO 9000, 3.2.1) of facilities, equipment and services needed for the operation
of an organization (ISO 9000, 3.3.1)

ingredients (FSSC 22000, 17)
a component of food, feed or packaging that has undergone processing

intended use (ISO 21469, 3.5)
<safety of machinery> use of a lubricant in accordance with the instructions of the lubricant and
machinery manufacturers in consideration of the expected operating conditions including service life,
chemical, thermal and mechanical loads


MK 21999 Page 13

interested party (ISO 9000, 3.3.5 / PAS 99, 3.5)
<IMS> person or group concerned with or affected by the activities, products (ISO 22005, 3.1) and/or
services of an organization (ISO 22005, 3.10)

NOTE 1 This could include customers, owners, regulators, non governmental organizations (NGO), people in an
organization, suppliers, bankers, unions, partners or society

NOTE 2 A group can comprise an organization (ISO 9000, 3.3.1), a part thereof or more than one organization

intermediate material (PAS 223, 3.10)
<food packaging PRPs> physical output of part of the production process that still requires further
processing to create finished food packaging (EN 15593, 3.7)

NOTE For example, a plastic powder, granules or flakes (including masterbatch), ink, coating, adhesive, pre-polymer, any
semi-finished material and article such as a film, sheet or laminate requiring further processing/reformulation steps to become
a finished material or article. In short, this is any product that is not a basic chemical and not yet a finished material or article,
and includes part-processed, semi-converted and converted materials

intermediate product (ISO/TS 22002-4, 3.12)
<food packaging PRPs> product that is not yet food packaging and will undergo further processing
or transformation by the organization

L

label (ISO/TS 22002-1, 3.16 / PAS 221, 3.15 / PAS 223, 3.11)
<PRPs> printed matter that is part of the finished product package conveying specific information
about the contents of the package, the food ingredients and any storage and preparation
requirements (ISO 9000, 3.1.2)

[For ISO/TS 22002-1, and PAS 221] EXAMPLE: The term covers, but is not limited to:
a) The package itself, printed matter attached to the package, or a sticker used for over-labelling;

b) Multi-packs which have an inner label on the individual product (ISO 22005, 3.1) and an outer combined
label for the whole contents

[addition for PAS 221]
c) Point of sale display material/signage

NOTE [for PAS 223] This includes the package itself, printed matter that is, or is intended to be, attached to the
package or a sticker used for over-labelling

location (ISO 22005, 3.5)
<FSMS> place of production, processing, distribution, storage and handling from primary production
to consumption

lot (ISO/TS 22002-3, 3.8 / ISO 22005, 3.3)
<FSMS> set of units of a product (ISO 22005, 3.1) which have been produced and/or processed or
packaged under similar circumstances

NOTE 1 The lot is determined by parameters established beforehand by the organization (ISO 22005, 3.10)

NOTE 2 A set of units may be reduced to a single unit of product (ISO 22005, 3.1)

lot identification (ISO 22005, 3.4)
<FSMS> process (ISO 22005, 3.2) of assigning a unique code to a lot (ISO 22005, 3.3)

lubricant (ISO 21469, 3.1)
<safety of machinery> substance capable of reducing friction, adhesion, heat and wear when
introduced as a film between solid surfaces


MK 21999 Page 14

M

major must (GlobalGAP, 111)
one of three types of control points (GlobalGAP, 42) that the producer is required to comply with in
order to obtain GlobalGAP certification. Complying with 100% of the major musts is compulsory

management (ISO 9000, 3.2.6)
<QMS> coordinated activities to direct and control an organization (ISO 9000, 3.3.1)

NOTE In English, the term management sometimes refers to people, i.e. a person or group of people with authority and
responsibility for the conduct and control of an organization. When management is used in this sense, it should always be
used with some form of qualifier to avoid confusion with the concept management defined above. For example,
management shall is deprecated whereas top management (ISO 9000, 3.2.7) shall is acceptable

management system (PAS 99, 3.6 / ISO 9000, 3.2.2 / ISO 19011, 3.20)
<IMS> system(s) (ISO 9000, 3.2.1) to establish policy and objectives and to achieve those objectives

NOTE [PAS 99] A management system comprises the elements of policy, planning, implementation and operation,
performance assessment, improvement and management review

mass balance (GlobalGAP, 114)
or quantity check; may be undertaken in any traceability (GlobalGAP, 197) test or recall (GlobalGAP, 159)
scenario to account for all materials. This is defined as a reconciliation of the amount of incoming
raw material against the amount used in the resulting finished products, taking into account process
waste and rework

materials (ISO 22005, 3.9)
<FSMS> feed and food, feed and food ingredients and packaging materials (PAS 223, 3.14)

materials (ISO/TS 22002-1, 3.4 / PAS 221, 3.13)
<PRPs> general term used to indicate raw materials, packaging materials (PAS 223, 3.14),
ingredients, process aids, cleaning materials and lubricants

material specification [product specification] (ISO/TS 22002-1, 3.7 / PAS 221, 3.12)
<PRPs> detailed documented description or enumeration of parameters, including permissible
variations and tolerances, which are required to achieve a define level of acceptability or quality

medicated feed (ISO/TS 22002-3, 3.9)
<farming PRPs> any feed which contains veterinary drugs (ISO/TS 22002-3, 3.15)

migration (ISO/TS 22002-4, 3.13)
<food packaging PRPs> transfer of substances from an external source (e.g. packaging material,
environment) to food

NOTE Transfer of substances can take place by migration through the substrate, by set-off to the reverse side and
subsequent migration into food, or by gas phase transfer

minor must (GlobalGAP, 117)
One of three types of control points (GlobalGAP, 42) that the producer is required to comply with in
order to obtain GlobalGAP certification. Producers shall comply with 95% of all of the applicable
minor musts

misbranded (NCFPD)
<food fraud> to brand falsely or in a misleading way, specifically, to label in violation of statutory
requirements

According to USDA, a (food) product is considered misbranded if:
it is offered for sale under the name of another food
it is an imitation of another food (unless is bears the word imitation on the label)
its container [package] is so made, formed, or filled as to be misleading
it purports to be, or is represented as, a food for which a definition and standard identity have been prescribed by
regulations
it falls below such standards


MK 21999 Page 15

a food for which a standard or standards of fill of a container have been prescribed by regulations, and it falls below the
standard

monitoring (ISO 22000, 3.12)
<FSMS> conducting a planned sequence of observations or measurements to assess whether
control measures (ISO 22000, 3.7) are operating as intended

N

nonconformity (ISO 9000, 3.6.2 / ISO 19011, 3.19)
<IMS> non-fulfilment of a requirement (ISO 9000, 3.1.2)

non-food-contact side (EC 223, d)
<food packaging> the surface of the material or article that is not directly in contact with food

non-intentionally added substance [NIAS] (PAS 223, 3.13)
<food packaging PRPs> impurity in the materials (ISO 22005, 3.9) used in, or a decomposition or
reaction product formed during, the production process

O

operational PRP [operational prerequisite programme] (ISO 22000, 3.9)
<FSMS> PRP (ISO 22000, 3.8) identified by the hazard analysis as essential in order to control the
likelihood of introducing food safety hazards (ISO 22000, 3.3) to and/or the contamination (ISO/TS
22002-1, 3.1) or proliferation of food safety hazards (ISO 22000, 3.3) in the product(s) (ISO 22005, 3.1) or
in the processing environment

organization (ISO/TS 22002-3, 3.10 / ISO 22005, 3.10 / ISO 9000, 3.3.1)
<IMS> group of people and facilities with an arrangement of responsibilities, authorities and
relationships [ISO/TS 22002-3 addition] (e.g. company, corporation, firm, enterprise, institution, charity,
sole trader, association, or parts or combination thereof)

NOTE 1 An organization may consist of one person

NOTE 2 An organization can be public or private

NOTE 3 (for ISO 9000, 3.3.1) The definition is valid for the purposes of quality management system (ISO 9000,
3.2.3) (and, or other) management system standards. The term organization is defined directly in ISO/IEC Guide
2

NOTE [ISO/TS 22002-3 addition] In the context of ISO/TS 22002-3, the term refers to a farmer, a group of farmers,
farming company and/or an association, an authority or a processing company establishing PRPs for farmers. An
organization can be public or private

organization (ISO 22006, 3.13)
<crop production> farm operation or farm cooperative implementing a quality management
system

organization in the food chain (FSSC 22000, 21)
the food or feed chain partner that is responsible for ensuring that products meet and, if applicable,
continue to meet, the requirements on which the certification is based

outsourcing (ISO/TS 22002-4, 3.14)
food packaging PRPs any activity subcontracted by an organization to an external organization

over-run (NCFPD)
<food fraud> legitimate product that is made in excess of production agreements

EXAMPLE: under-reporting of production


MK 21999 Page 16

P

packaging (ISO/TS 22002-3, 3.11)
<farming PRPs> any product to be used for containment, protection, handling, delivery, storage,
transport and presentation of agricultural products or foods

packaging (ISO/TS 22002-4. 3.15)
food packaging PRPs any kind of product or material used to hold and protect food packaging
during shipping, transport, and storage

packing materials (PAS 223, 3.14)
<food packaging PRPs> materials used to hold and protect food packaging (EN 15593, 3.7) during
shipping, transport and storage

personnel security (PAS 96, 2.4)
<food defense> procedures (ISO 9000, 3.4.5) used to confirm an individuals identity, qualifications,
experience and right to work, and to monitor conduct as an employee or contractor

NOTE Not to be confused with personal security

pest (ISO/TS 22002-3, 3.12)
<farming PRPs> unwanted species of plants or animals that may have a detrimental effect for
humans, their activities or the products they use or produce, or for animals or for the environment

NOTE In the context of ISO/TS 22002-3, the term refers to small animals, birds and insects that destroy crops, spoil
food, or spread disease at fields/premises on farm

plant protection product (ISO/TS 22002-3, 3.13)
<farming PRPs> any substance or micro-organism, including a virus, or a mixture or solution
composed of two or more of them, put up in the form in which it is supplied to the user, intended to
protect plants or plant products against all harmful organisms or prevent the action of such
organisms; or influence the life processes of plants other than as a nutrient; or preserve plant
products; or destroy undesired plants or parts of plants or check or prevent the undesired growth of
plants

NOTE In the context of ISO/TS 22002-3, the term refers to herbicides, algaecides, rodenticides, talpicides, leporicides,
molluscicides, nematocides, insecticides, acaricides, fungicides, bactericides, viricides, disinfectants, repellents, attractants,
fumigants, plant activators, plant growth regulators, elicitators of self-defence mechanisms, etc. intended to be used in
growing, harvesting and post-harvest activities

Plant Protection Product (PPP) (GlobalGAP, 139)
any substance or mixture of substances intended for controlling insects, weeds, fungi, and other
forms of plant or animal life considered to be pests to agricultural plants

portioning (ISO/TS 22002-2, 3.13)
catering PRPs division of food into single or multiple portions

post harvest chemicals (GlobalGAP, 142)
includes plant protection products (GlobalGAP, 139) applied after harvest (e.g., including wax,
detergents, and lubricants where applicable)

potable water (ISO 22002-3, 3.14)
<farming PRPs> water of sufficiently high quality that can be consumed or used with low risk of
immediate or long term harm

NOTE Quality standards of drinking water are described in the WHO Guidelines for Drinking Water Quality

prevention (USFDA)
<food defense> actions taken to avoid an incident or to intervene to stop an incident from occurring


MK 21999 Page 17

preventive measure (GlobalGAP, 145)
physical, chemical, or biological factors that may be used to manage, mitigate, or eliminate an
identified hazard

procedure (ISO 9000, 3.4.5 / PAS 99, 3.7)
<IMS> specified way to carry out an activity or a process (PAS 99, 3.8)

NOTE Procedures can be documented or not

procedure (GlobalGAP, 147)
step-by-step instruction to achieve a desired result

process (ISO 22005, 3.2 / ISO 9000, 3.4.1 / PAS 99, 3.8)
<IMS> set of interrelated or interacting activities which transforms inputs into outputs

NOTE 1 Inputs to a process are generally outputs of other processes

NOTE 2 Processes in an organization (ISO 22005, 3.10) are generally planned and carried out under controlled
conditions to add value

NOTE 3 A process where the conformity of other resulting product (ISO 22005, 3.1) cannot be readily or
economically verified is frequently referred to as a special process [ISO 9000, 3.4.1]

NOTE [for PAS 99, 3.8] Processes may be classified in a number of different ways. A distinction is sometimes
made between operational processes which are directly concerned with the planned outputs of the organization
(ISO 22005, 3.10), and management processes which provide the framework that enables the operational
processes to take place

process approach (ISO 9000, 2.4)
<QMS> the systematic identification and management (ISO 9000, 3.2.6) of the processed employed
within an organization (ISO 9000, 3.3.1) and particularly the interactions between such processes (ISO
9000, 3.4.1)

processed product (GlobalGAP, 148)
when the structure of the product (ISO 22005, 3.1) is altered in appearance or form

processing (ISO 21469, 3.4)
<safety of machinery> unit operations such as weighing, measuring, filling and refilling, stamping,
printing, packing, container filling, container sealing/closure, cooling, storage and transportation of
products

product (ISO 22005, 3.1 / ISO 22006, 3.15 / ISO 9000, 3.4.2)
<IMS> [end] result of a [farm] process[es]

NOTE Product may include packaging material (PAS 223, 3.14)

product (ISO 21469, 3.2)
<safety of machinery> any substance intended to be applied or taken into humans or domestic
animals, e.g. by ingestion, injection, topical application, insertion

product (EN 15593, 3.8)
food packaging physical final output of any kind of production process that takes place in the
packaging (EN 15593, 3.7) industry

NOTE This includes products that undergo further production steps to fulfil the specification defined by the filler/packer

product contact (ISO/TS 22002-1, 3.6 / PAS 221, 3.14 / PAS 222, 2.15)
<PRPs> all surfaces that are in contact with the (exposed) product (ISO 22005, 3.1) or the primary
package during normal operation

product recall (ISO/TS 22002-1, 3.17)
<food manufacturing PRPs> removal of a non-conforming product (ISO 22005, 3.1) from the market,
trade and warehouses, distribution centers and/or customer warehouses because it does not meet
specified standards


MK 21999 Page 18

product security (PAS 96, 2.5)
<food defense> techniques used to make food products resistant to contamination (ISO/TS 22002-1,
3.1) or misuse including tamper-evident closures and lot (ISO 22005, 3.3) marking

protective security (PAS 96, 2.6)
<food defense> all the measures related to physical, electronic and personnel security (PAS 96, 2.4)
which any organization (ISO 22005, 3.10) takes to minimize the threat of malicious attack

PRP [prerequisite programme] (ISO 22000, 3.8)
<FSMS> basic conditions and activities that are necessary to maintain a hygienic environment
throughout the food chain (ISO 22000, 3.2) suitable for the production, handling and provision of safe
end products (ISO 22000, 3.5) and safe food for human consumption

NOTE The PRPs needed depend on the segment of the food chain (ISO 22000, 3.2) in which the organization (ISO 22005,
3.10) operates and the type of organization (see Annex C). Examples of equivalent terms are: Good Agricultural Practice
(GAP) (GlobalGAP, 84), Good Veterinarian Practice (GVP) (FVE code of GVP, 4 Definitions), Good Manufacturing
Practice (GMP), Good Hygienic Practice (GHP) (APO- FSMS manual, Definition Box 9), Good Production Practice (GPP),
Good Distribution Practice (GDP) (WHO- GDP, Glossary) and Good Trading Practice (GTP) (WHO- GDP, Glossary)

Q

quality assurance system (EC 223, b)
the total sum of the organised and documented arrangements made with the purpose of ensuring
that materials and articles are of the quality required to ensure conformity with the rules applicable to
them and the quality standards necessary for their intended use

quality control system (EC 223, c)
the systematic application of measures established within the quality assurance system that ensure
compliance of starting materials and intermediate and finished materials and articles with the
specification determined in the quality assurance system (EC 223, b)

R

raw material (FSSC 22000, 23)
a component of food, feed or packaging that has not undergone processing

ready-to-eat food [RTE] (PAS 221, 3.15)
<food retail PRPs> food that is in a form that is edible without additional preparation to achieve food
safety based on law or recognized industry practices

NOTE this can include raw or partially cooked animal food as allowed by law when the consumer is adviced of the hazards
associated with that food as consuming raw, molluscan shellfish

recall (GlobalGAP, 159)
the process by which a product (ISO 22005, 3.1) is removed from the supply chain and returned to the
grower/handler. In some cases, consumers are advised to take action, such as returning or
destroying produce items

recall procedure (EN 15592, 3.9)
food packaging procedure to ensure the efficient return of products identified as potentially
having a nonconformity that could present a hazard

recommendation (GlobalGAP, 161)
one of three types of control points (GlobalGAP, 42) within the GlobalGAP standards

All recommendation control points must be inspected during the self-assessments and external announced inspections but
there is no requirement for successfully meeting recommendations


MK 21999 Page 19

record (ISO 9000, 3.7.6)
<QMS> document (ISO 9000, 3.7.2) stating results achieved or providing evidence of activities
performed

NOTE 1 Records can be used, for example, to document traceability (ISO 9000, 3.5.4) and to provide evidence of
verification (ISO 9000, 3.8.4), preventive action (ISO 9000, 3.6.4) and corrective action (ISO 9000, 3.6.5)

NOTE 2 Generally records need not be under revision control

record (GlobalGAP, 162)
a document containing objective evidence illustrating activities being performed and/or results
achieved

recovery (USFDA)
<food defense>The return-to-service activities that industry and government must undertake to
assure consumers the products will be safe and secure following an event. The development,
coordination and execution of service-and site-restoration plans for impacted communities and the
reconstitution of government operations and services through individual, private sector, non-
governmental and public assistance programs

relevant food safety hazards (ISO 22000, 3.3 NOTE 4)
<FSMS> hazards that can be directly or indirectly transferred to food because of the intended use of
the provided products (ISO 22005, 3.1) and/or services and thus can have the potential to cause an
adverse human health effect

requirement (ISO 9000, 3.1.2)
<QMS> need or expectation that is stated, generally implied or obligatory

NOTE 1 Generally implied means that it is custom or common practice for the organization (ISO 9000, 3.3.1), its
customers (ISO 9000, 3.3.5) and other interested parties (ISO 90000, 3.3.7), that the need or expectation under
consideration is implied

NOTE 2 A qualifier can be used to denote a specific type of requirement (ISO 9000, 3.1.2), e.g. product
requirement, quality management requirement, customer requirement

NOTE 3 A specified requirement is one that is stated, for example in a document (ISO 9000, 3.7.2)

NOTE 4 Requirements can be generated by different interested parties (ISO 9000, 3.3.7)

NOTE 5 This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004

requirement (ISO/IEC Directive Part 2:2004, 3.12.1)
expression in the content of a document conveying criteria to be fulfilled if compliance with
the document is to be claimed and from which no deviation is permitted

resolved (GlobalGAP, 167)
positive closure of a non-compliance

response (USFDA)
<food defense> activities that address the short-term, direct effects of an incident (e.g., save and
limit loss of life and property, meet basic human needs, execution of emergency plans, apply
intelligence to lessen consequences, immunizations, law enforcement operations)

retail premises (PAS 221, 3.16)
<food retail PRPs> building under direct food full or partial control of the retailer, in which food is
stored, prepared, packaged, served, vended, sold, or otherwise provided for consumption

rework (ISO/TS 22002-4, 3.16)
<food packaging PRPs> reuse of internal scrap of certain production into material with the same
composition

rework (FSSC 22000, 24)
the re-utilisation of feed, ingredients or raw materials


MK 21999 Page 20

risk (ISO 22000, 3.3 NOTE 2)
<FSMS> a function of the probability of an adverse health effect (e.g. becoming diseased) and the
severity of that effect (death, hospitalization, absence from work, etc.) when exposed to a specified
hazard

risk (ISO/TS 22002-4, 3.17)
<food packaging PRPs> probability of the occurrence of a hazard and the severity of its outcome

risk (PAS 99, 3.9)
<IMS> likelihood of an event occurring that will have an impact (PAS 99, 3.4) on objectives

NOTE 1 Risk is normally determined in terms of combination of the likelihood of an event and its consequences

NOTE 2 An event may be the occurrence of an aspect (PAS 99, 3.1) with the associated impact (PAS 99, 3.4)
as its consequence

NOTE 3 (PAS 99, A.3) Risks are possible occurrences that could impact (PAS 99, 3.4) upon objectives

risk (GlobalGAP, 172)
the likelihood of a hazard occurring in the future. For food safety, risks are categorized as
biological, chemical, or physical

risk assessment (GlobalGAP, 171)
an estimate of the probability, frequency and severity of the occurrence of a hazard or other non-
conformity with regard to food safety, worker safety, and pesticide safety (also called a risk
analysis)

S

safety (ISO/TS 22002-4, 3.18)
food packaging PRPs condition of product (EN 15593, 3.8) being free from unacceptable hazards

sanitation (ISO/TS 22002-1, 3.13 / PAS 221, 3.19)
<PRPs> all actions dealing with cleaning (ISO/TS 22002-1, 3.5) or maintaining hygienic conditions in an
establishment (ISO/TS 22002-1, 3.3), ranging from cleaning and/or sanitizing (ISO/TS 22002-1, 3.21) of
specific equipment to periodic cleaning activities throughout the establishment (ISO/TS 22002-1, 3.3)
[including building, structural, and grounds cleaning activities]

sanitizing (ISO/TS 22002-1, 3.12)
<food manufacturing PRPs> process (ISO 22005, 3.2) of cleaning (ISO/TS 22002-1, 3.5), followed by
disinfection (ISO/TS 22002-1, 3.9)

sanitizing (PAS 221, 3.18)
<food retail PRPs> the process (ISO 22005, 3.2) of cleaning (ISO/TS 22002-1, 3.5), followed by the
application of cumulative heat or chemicals on cleaned food contact surfaces that, when evaluated
for efficiency, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction of
representative disease micro-organisms of public health significance

satellite/satellite kitchen (ISO/TS 22002-2, 3.15)
catering PRPs kitchen where food from a central kitchen is portioned, reheated if needed, and
made ready for service

set-off (ISO/TS 22002-4, 3.19)
food packaging PRPs transfer of substances from one surface of a material or from the surface
of a contiguous surface, to the food contact surface through direct contact between the surfaces
caused by the stacking or reeling of the material(s)

significant hazard (ISO 22004, 3.1)
<FSMS> biological, chemical or physical hazard, identified through the hazard analysis process,
which needs to be controlled at critical control point(s) [CCP(s)], or by operational PRP(s) and/or by
combinations thereof


MK 21999 Page 21

NOTE 1 to entry: Lack of control will lead to a potentially unsafe product. Identified hazards, not assessed as
significant, need not be controlled at CCP(s) and/or by operational PRP(s)

NOTE 2 to entry: Operational prerequisite programme is abbreviated as OPRP

simulation (NCFPD)
<food fraud> illegitimate product designed to look like but not exactly copy of the legitimate product

EXAMPLE: Knock-offs of popular foods not produced with same food safety assurances

single-use articles (PAS 221, 3.21)
<food retail PRPs> utensils and bulk food containers designed and constructed to be used once
and discarded

NOTE includes disposable gloves and plastic/aluminium wrap/containers

site (PAS 222, 2.20)
<animal feed PRPs> area in which animal food is handled, together with any immediate surrounding
area under which prerequisite programmes [PRPs] (ISO 22000, 3.8) apply

specification (ISO/TS 22002-4, 3.20)
food packaging PRPs detailed description of the properties and requirements of a material, in
particular in relation to its technical and specific suitability

specifications (ISO 9000, 3.7.3 / ISO/TR 10013, 4.9)
<QMS> documents (ISO 9000, 3.7.2) stating requirements (ISO 9000, 3.1.2)

NOTE A specification can be related to activities (e.g. procedure document, process specification and test specification), or
products (ISO 9000, 3.4.2) (e.g. product specification (ISO/TS 22002-1, 3.7), performance specification and drawing)

standard operating procedures (SOP) (GlobalGAP, 184)
a written document detailing an operation, analysis, or action whose mechanisms are prescribed
thoroughly and which is commonly accepted as the method for performing certain routine or
repetitive tasks

sterilization (ISO 14159, 3.33)
<safety of machinery> process that inactivates all micro-organisms and relevant microbial spores

supplier (ISO 22006, 3.18)
<crop production> provider of inputs used in crop production

EXAMPLE: Crop producers, those supplying seed and plant material, fertilizer, equipment, chemicals, and others providing
inputs or services (including consultants and advisors) to farm operations

supplier (GlobalGAP, 191)
a person or an organization which provides products or services to customers (GlobalGAP, 52)

system (ISO 9000, 3.2.1)
<QMS> set of interrelated or interacting elements

T

tampering (NCFPD)
<food fraud> legitimate product and packaging used in a fraudulent way

EXAMPLE: changed expiry information, product up-labeling, etc.

theft (NCFPD)
<food fraud> legitimate product stolen and passed off as legitimately procured

EXAMPLE: stolen products are co-mingled with legitimate products


MK 21999 Page 22

threat (USFDA)
<food defense> an indicator of possible violence, harm or danger that includes both intent and
capabilities

Threat Assessment Critical Control Point (TACCP) (PAS 96, 2.7)
<food defense> systematic management (ISO 9000, 3.2.6) of risks (PAS 99, 3.9) through the process of
assessment of threats, identification of vulnerabilities, and implementation of controls to raw
materials, packaging (EN 15593, 3.7), finished products, processes, premises, distribution networks and
business systems by a knowledgeable and trusted team with the authority to implement changes to
procedures (ISO 9000, 3.4.5)

top management (ISO 22006, 3.19 / ISO 9000, 3.2.7 / EN 15593, 3.13)
<IMS> [single] person or group of people who directs and controls an organization (ISO 9000, 3.3.1)
[farm operation or farm cooperative operation (ISO 22006)] at the highest level

traceability (ISO 22005, 3.16)
<FSMS> ability to follow the movement of a feed or food through specified stage(s) of production,
processing and distribution

NOTE 1 Adapted from ISO 10012 Measurement management systems

NOTE 2 Movement can relate to the origin of the materials, processing history or distribution of the feed or food

NOTE 3 Terms such as document traceability, computer traceability or commercial traceability should
be avoided

traceability (GlobalGAP, 197)
the ability to retrace the history, use or location of a product (e.g. the origin of materials and parts,
the history of processes applied to the product, and/or the distribution and placement of the
product after delivery) by the means of recorded identification markers

traceability system (ISO 22005, 3.12)
<FSMS> totality of data (ISO 22005, 3.11) and operations that is capable of maintaining desired
information about a product (ISO 22005, 3.1) and its components through all or part of its production
and utilization chain

traceability system (ISO 22004, 5.12)
The following terms are associated with a traceability system:
External traceability: traceability between organizations (one step back, one step forward)
providing the ability to identify the immediate previous supplier of goods/units and the
immediate next customer;

NOTE External traceability requirements do not include the final consumer

Internal traceability: traceability inside the organization, i.e. the ability to follow the
movement within a single organization;

NOTE Transport or transfer steps are covered by internal traceability of the organization that has the ownership of the
goods/units (e.g. products, materials, reagents)

Mock withdrawal/recall (a programme used to verify the functionality of the withdrawal/recall
procedure using the traceability system). The verification may be extended to a mock trace
test of other parts of the traceability system.

U

updating (ISO 22000, 3.17)
<FSMS> immediate and/or planned activity to ensure application of the most recent information


MK 21999 Page 23

V

validation (ISO 22000, 3.15)
<FSMS> obtaining evidence that the control measures (ISO 22000, 3.7) managed by the HACCP plan
(CAC/RCP-01, Annex 2.10) and by the operational PRPs (ISO 22000, 3.9) are capable of being effective

NOTE This definition is based on CAC- Basic texts on food hygiene and is more suitable for the field of food safety (ISO
22000, 3.1) than the definition given in ISO 9000

vector (ISO/TS 22002-2, 3.16)
<epidemiology> organism which does not cause disease itself but which transmits infection by
conveying pathogens from one host to another

vehicle (FSSC 22000, 27)
any device used for the conveyance of raw material, ingredients, food, feed or packaging that is
capable of being moved upon roadways, railways or airways. Vehicles may be motorized or non
motorized

verification (ISO 22000, 3.16 / ISO 9000, 3.8.4)
<IMS> confirmation, through the provision of objective evidence, that specified requirements (ISO
9000, 3.1.2) have been fulfilled

verification (GlobalGAP, 198)
confirmation by examination of evidence that a product, process or service fulfills specified
requirements

veterinary drug (ISO/TS 22002-3, 3.15)
<farming PRPs> any substance applied or administered to any food-producing animal, such as
meat or milk-producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions or behaviour

NOTE This definition of veterinary drugs includes parasiticides intended to be applied or administered to food producing
animals

visitor (ISO/TS 22002-2, 3.17)
catering PRPs person who is not a permanent staff member of the establishment, including
external visitors and service support staff

NOTE 1 to entry: Examples of external visitors are auditors, enforcement officers, suppliers, and contractors. Service
support staff includes any other person who is not working in that particular area, e.g. maintenance, management staff, and
cleaners

vulnerability (USFDA)
<food defense> A weakness in the design, implementation or operation of an asset or system that
can be exploited by an adversary or disrupted by a natural hazard

W

waste (ISO/TS 22002-4, 3.21)
<food packaging PRPs> any substance or object that the organization discards or intends or is
required to discard

withdrawal (GlobalGAP, 204)
the process by which a product is removed from the supply chain prior to it reaching the end
consumer

withholding/withdrawal period (ISO/TS 22002-3, 3.16)
<farming PRPs> time during which a crop, an animal or its products cannot be used for human
consumption following the last application of a plant protection product (ISO/TS 22002-3, 3.13) to the


MK 21999 Page 24

crop (including pastures), or the last application or administration of a veterinary drug (ISO/TS 22002-3,
3.15) to the animal, that ensures that the foodstuff does not contain any residues in quantities in
excess of established maximum residue limits

work environment (ISO 22006, 3.20 / ISO 9000, 3.3.4)
<IMS> set of conditions under which work is performed

NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition
schemes, ergonomics and atmospheric composition)

work instructions (ISO/TR 10013, 3.1)
<QMS> detailed descriptions of how to perform and record (ISO 9000, 3.7.6) tasks

NOTE 1 Work instructions may be documented or not

NOTE 2 Work Instructions may be, for example, detailed written descriptions, flowcharts, templates, models,
technical notes incorporated into drawings, specifications (ISO 9000, 3.7.3), equipment instruction manuals,
pictures, videos, checklists, or combinations thereof. Work instructions should describe any materials (ISO 22005,
3.9), equipment and documentation to be used. When relevant, work instructions include acceptance criteria

wrapping (ISO/TS 22002-3, 3.17)
<farming PRPs> the action of placing a foodstuff in a wrapper or container in direct contact with the
foodstuff concerned; or the wrapper or container itself

Z

zoning (ISO/TS 22002-1, 3.15)
<food manufacturing PRPs> demarcation of an area within an establishment (ISO/TS 22002-1, 3.3)
where specific operating, hygiene (ISO 14159, 3.11) or other practices may be applied to minimize the
potential for microbiological cross-contamination (ISO/TS 22002-2, 3.5)

Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow patterns


MK 21999 Page 25

Alphabetical Index

A food safety policy 10 primary production 17
food supply 10 procedure 17
Action limit / action criterion 2 food terrorism 10 process 17
active ingredient 2 form 10 process approach 17
adulteration 2 fumigant 10 processed product 17
aspect 2 processing 17
G product 17
B product contact 17
GlobalGAP Risk Assessment on Social product recall 17
biocide 2 Practice [GRASP] 11 product security 18
biosecurity 2 good agriculture practice [GAP] 11 protective security 18
biosecurity plan 2 good distribution practice [GDP] 11 PRP [prerequisite programme] 18
good hygiene practice [GHP] 11
C good manufacturing practice [GMP] 11 Q
good trading practice [GTP] 11
catering 3 good veterinary practice [GVP] 11 quality assurance system 18
certificate of analysis [COA] 3 guidelines 11 quality control system 18
characteristic 3
clean water 3 H R
cleaning 3
cleaning in place [CIP] 3 HACCP plan 11 raw material 18
cleaning out of place [COP] 3 hand washing 11 ready-to-eat [RTE] 18
competence 3 hazard 11 recall 18
competent person 4 hazard analysis and critical control point recall procedure 18
compliance criteria [CC] 4 [HACCP] 12 recommendation 18
compound feed 4 hazard assessment 12 record 19
consequence 4 herbicide 12 recovery 19
contaminant 4 hierarchy 12 relevant food safety hazard 19
contamination 4 hygiene 12 requirement 19
contingency planning 4 resolved 19
control measure 4 I response 19
control points [CP] 5 retail premises 19
control point and compliance criteria impact 12 rework 19
[CPCC] 5 incident 12 risk 20
correction 5 incidental product contact 12 risk assessment 20
corrective action 5 infrastructure 12
counterfeiting 5 ingredient 12 S
critical control point [CCP] 5 intended use 12
critical defect 5 interested party 13 safety 20
critical limit 5 intermediate material 13 sanitation 20
cross-contamination 5 Intermediate product 13 sanitizing 20
customer 5 satellite/satellite kitchen 20
customer requirement 6 L set-off 20
significant hazard 20
D label 13 simulation 21
location 13 single-use articles 21
data 6 lot 13 site 21
declaration of compliance [DOC] 6 lot identification 13 specification 21
deviation 6 lubricant 13 standard operating procedures [SOP] 21
disinfection 6 sterilization 21
document 6 M supplier 21
system 21
E major must 14
management 14 T
economically motivated adulteration [EMA] 6 management system 14
electronic security 6 mass balance 14 tampering 21
end product 6 materials 14 theft 21
equipment 7 material specification [product threat 22
establishment 7 specification] 14 Threat Assessment Critical Control Point
medicated feed 14 [TACCP] 22
F migration 14 top management 22
minor must 14 traceability 22
facility 7 misbranded 14 traceability system 23
farm 7 monitoring 15
feed 7 U
feed additives 7 N
feed and food chain 7 updating 22
feed ingredient 7 nonconformity 15
feed manufacturing/feed processing 7 non-food contact side 15 V
feed safety 7 non-intentionally added substance [NIAS] 15
first expired first out [FEFO] 8 validation 23
first in first out [FIFO] 8 O vector 23
flow diagram 8 vehicle 23
flow of materials 8 operational PRPs [operational prerequisite verification 23
food 8 programmes] 15 veterinary drug 23
food chain 8 organization 15 visitor 23
food-contact side 8 organization in the food chain 15 vulnerability 23
food defense 8 outsourced activity 15
food fraud 8 outsourcing 15 W
food grade 9 over-run 15
food handler 9 waste 23
food handling 9 P withdrawal 23
food ingredient 9 withholding/withdrawal period 23
food packaging 9 packaging 16 work environment 24
food packaging hazard 9 packaging materials 16 work instructions 24
food packaging withdrawal 9 personnel security 16 wrapping 24
food protection 9 pest 16
food retail establishment 9 plant protection product 16 Z
food retail premises 9 portioning 16
food safety 10 post harvest chemicals 16 zoning 24
food safety control system 10 potable water 16
food safety hazard 10 prevention 16
food safety management system [FSMS] 10 preventive measure 17


MK 21999 Page 26

Bibliography

[1] Asian Productivity Organization (APO)- Food safety management system manual, Jun
2009

[2] CAC Food Hygiene Basic texts, 5
th
ed., 2013

[3] CAC/GL 19-1995, Rev. 2013 Principles and guidelines for the exchange of information in
food control emergency situations

[4] CAC/GL 69-2008 Guidelines for the validation of food safety control measure

[5] CAC/RCP 1-1969, Rev.4-2003 Recommended international code of practice, General
principles of food hygiene with annex, Guidelines for the application of the HACCP system

[6] Commission Regulation (EC) No 2023/2006 of 22 Dec 2006 on good manufacturing
practice for materials and articles intended to come into contact with food

[7] EN 15593:2008 Packaging- Management of hygiene in the production of packaging for
foodstuffs- Requirements

[8] Federations of Veterinarians of Europe- Code of good veterinary practice, 2002

[9] Foundation for Food Safety Certification- FSSC 22000 Certification scheme for food
safety system in compliance with ISO 22000:2005 and technical specifications for sector
PRPs- terms and definition, ver. 3.1, Apr 2014

[10] GlobalGAP Glossary, English Version 1.0, valid from Apr 2013

[11] International Life Science Institute (ILSI)- Food safety objective [FSO]: An integral part
of food chain management, 2005 [as cited within the ISO FSMS series]

[12] ISO/IEC 17021:2011 Conformity assessment Requirements for bodies providing audit and
certification of management systems

[13] ISO 7218:2007 Microbiology of food and animal feeding stuffs- General requirements and
guidance for microbiological examinations

[14] ISO 7218:2007/Amd.1:2003 Microbiology of food and animal feeding stuffs- General
requirements and guidance for microbiological examinations, Amendment 1

[15] ISO 9000:2005 Quality management systems- Fundamentals and vocabulary

[16] ISO/TR 10013:2001 Guidelines for quality management system documentation

[17] ISO 14159:2002 Safety of machinery- Hygiene requirements for the design of machinery

[18] ISO 19011:2011 Guidelines for auditing management systems

[19] ISO 21067:2007 Packaging- Vocabulary

[20] ISO 21469:2006 Safety of machinery- Lubricants with incidental product contact- Hygiene
requirements

[21] ISO 22000:2005 Food safety management systems- Requirements for any organization in
the food chain

[22] ISO/TS 22002-1:2009 Prerequisite programmes [PRPs] on food safety- Part 1: Food
manufacturing [formerly known as PAS 220:2008 Prerequisite programmes [PRPs] on food safety for food
manufacturing]

[23] ISO/TS 22002-2:2013 Prerequisite programmes [PRPs] on food safety- Part 2: Catering


MK 21999 Page 27

[24] ISO/TS 22002-3:2011 Prerequisite programmes [PRPs] on food safety- Part 3: Farming

[25] ISO/TS 22002-4:2013 Prerequisite programmes [PRPs] on food safety- Part 4: Food
packaging manufacturing [based on PAS 223:2011 and EN 15593:2008]

[26] ISO/TS 22002-5 (Draft) Prerequisite programmes [PRPs] on food safety- Part 5: Transport
and Storage

[27] ISO/TS 22003:2013 Food safety management systems- Requirements for bodies providing
audit and certification of food safety management systems

[28] ISO/TS 22003 with ISO/IEC 17021 Food safety management systems- Requirements for
bodies providing audit and certification of food safety management systems, 2014

[29] ISO 22004:2014 Food safety management systems- Guidance on the application of ISO
22000

[30] ISO 22005:2007 Traceability in the feed and food chain- General principles and basic
requirements for system design and implementation

[31] ISO 22006:2009 Guidelines on the application of ISO 9001:2008 in crop production

[32] PAS 96:2010 Defending food and drink- Guidance for the deterrence, detection, and defeat
of ideologically motivated and other forms of malicious attack on food and drink and their
supply arrangements

[33] PAS 99:2006 Specification of common management system requirements as a framework
for integration

[34] PAS 221:2013 Prerequisite programmes [PRPs] for food safety in food retail - specification

[35] PAS 222:2011 Prerequisite programmes [PRPs] for food safety in the manufacture of food
and feed for animals

[36] PAS 223:2011 Prerequisite programmes [PRPs] and design requirements for food safety in
the manufacturing and provision of food packaging

[37] US Food and Drug Administration (FDA)- Food Code [1-2 Definitions, subpart 1-201
Applicability and Terms Defined, 1-201.10 Statement of application and listing of terms],
2009

[38] US Food and Drug Administration (FDA)- Food defense acronyms, abbreviations, and
definitions, 12 Apr 2013

[39] US National Center for Food Protection and Defense (NCFPD)- Defining the public health
threat of food fraud, John Spink & Douglas C Moyer, 30 Apr 2011

[40] WHO- Good distribution practices [GDP], 2005

[41] WHO- Terrorist Threats to Food: Guidelines for Establishing and Strengthening Prevention
and Response Systems, May 2008

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