FSMS Vocabulary, Rev.05 Sep 2014

th

5 revision 2014-09-01

Food safety management systemsVocabulary

Food safety management systems- Vocabulary

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) 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, For example:

, served as alternative meaning to a previous definition.

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) taking of all measures during product handling, preparation and processing to ensure its suitability for use by humans or domestic animals th

This 5 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

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Food safety management systems- Vocabulary

A

action limit / action criterion (ISO 22004, 3.3) 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) 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) 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

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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) 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 supplier’s product (ISO 22005, 3.1) certificate of analysis [COA] (ISO/TS 22002-4, 3.1) 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) 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) 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) 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) 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) 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) 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

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competent person (ISO/TS 22002-3, 3.2) 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) 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) 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) 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) 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) 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]

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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) 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) 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) 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) 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) 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

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

D

data (ISO 22005, 3.11) recorded information declaration of compliance [DOC] (ISO/TS 22002-4, 3.5) 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) reduction, by means of chemical agents and/or physical methods, of the number of microorganisms 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) 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) 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) 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) 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

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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) 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) 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) 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) 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) 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) a component part or constituent of any combination or mixture making up a feed, whether or not it has a nutritional value in the animal’s 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

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first expired first out [FEFO] (ISO/TS 22002-1, 3.18 / PAS 221, 3.9) 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) stock rotation based on the principle of dispatching earliest received products (ISO 22005, 3.1) first flow diagram (ISO 22000, 3.6) schematic and systematic presentation of the sequence and interactions of step(s) flow of materials (ISO 22005, 3.8) 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) 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) the surface of a material or article that is directly in contact with the food food defense (PAS 96, 2.2) 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) 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

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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) 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) 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) any building or area under the control of the owner or designated person-incharge, 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) physical building under direct full or partial control of the retailer

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food safety (ISO 22000, 3.1) concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use NOTE 1 Adapted from CAC- Basic texts on food hygiene 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) 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 1 Adapted from CAC- Basic texts on food hygiene 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) 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) 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) 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

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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) 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

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hazard analysis and critical control point [HACCP] (ISO/TS 22003, 3.1) 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) 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) 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) 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) effect on the organization‟s 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) contact with product that is not intended but which is not preventable infrastructure (ISO 9000, 3.3.3) 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) 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

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interested party (ISO 9000, 3.3.5 / PAS 99, 3.5) 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) 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) 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) 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) place of production, processing, distribution, storage and handling from primary production to consumption lot (ISO/TS 22002-3, 3.8 / ISO 22005, 3.3) 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) process (ISO 22005, 3.2) of assigning a unique code to a lot (ISO 22005, 3.3) lubricant (ISO 21469, 3.1) substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid surfaces

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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) 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) 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) 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) 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) 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) any feed which contains veterinary drugs (ISO/TS 22002-3, 3.15) migration (ISO/TS 22002-4, 3.13) 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) 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

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

“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) 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) non-fulfilment of a requirement (ISO 9000, 3.1.2) non-food-contact side (EC 223, d) the surface of the material or article that is not directly in contact with food non-intentionally added substance [NIAS] (PAS 223, 3.13) 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) 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) 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) 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) legitimate product that is made in excess of production agreements EXAMPLE: under-reporting of production

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P

packaging (ISO/TS 22002-3, 3.11) 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) materials used to hold and protect food packaging (EN 15593, 3.7) during shipping, transport and storage personnel security (PAS 96, 2.4) procedures (ISO 9000, 3.4.5) used to confirm an individual’s 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) 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) 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) 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) actions taken to avoid an incident or to intervene to stop an incident from occurring

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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) 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) 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) 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) 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) [end] result of a [farm] process[es] NOTE Product may include packaging material (PAS 223, 3.14)

product (ISO 21469, 3.2) 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) 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) 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

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product security (PAS 96, 2.5) 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) 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) 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 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

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record (ISO 9000, 3.7.6) 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) 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, nongovernmental and public assistance programs relevant food safety hazards (ISO 22000, 3.3 NOTE 4) 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) 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) 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) 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) 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

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risk (ISO 22000, 3.3 NOTE 2) 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) probability of the occurrence of a hazard and the severity of its outcome risk (PAS 99, 3.9) 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 nonconformity 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) 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) 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) 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) 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

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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) 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) 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) 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) 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) process that inactivates all micro-organisms and relevant microbial spores supplier (ISO 22006, 3.18) 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) set of interrelated or interacting elements

T

tampering (NCFPD) legitimate product and packaging used in a fraudulent way EXAMPLE: changed expiry information, product up-labeling, etc.

theft (NCFPD) legitimate product stolen and passed off as legitimately procured EXAMPLE: stolen products are co-mingled with legitimate products MK 21999

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Food safety management systems- Vocabulary

threat (USFDA) an indicator of possible violence, harm or danger that includes both intent and capabilities Threat Assessment Critical Control Point (TACCP) (PAS 96, 2.7) 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) [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) 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) 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) immediate and/or planned activity to ensure application of the most recent information

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V

validation (ISO 22000, 3.15) 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) 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) 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) 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) 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) 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) 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

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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) 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) 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) 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) 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

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Alphabetical Index A

food safety policy 10 food supply 10 food terrorism 10 form 10 fumigant 10

Action limit / action criterion 2 active ingredient 2 adulteration 2 aspect 2

G B GlobalGAP Risk Assessment on Social Practice [GRASP] 11 good agriculture practice [GAP] 11 good distribution practice [GDP] 11 good hygiene practice [GHP] 11 good manufacturing practice [GMP] 11 good trading practice [GTP] 11 good veterinary practice [GVP] 11 guidelines 11

biocide 2 biosecurity 2 biosecurity plan 2 C catering 3 certificate of analysis [COA] 3 characteristic 3 clean water 3 cleaning 3 cleaning in place [CIP] 3 cleaning out of place [COP] 3 competence 3 competent person 4 compliance criteria [CC] 4 compound feed 4 consequence 4 contaminant 4 contamination 4 contingency planning 4 control measure 4 control points [CP] 5 control point and compliance criteria [CPCC] 5 correction 5 corrective action 5 counterfeiting 5 critical control point [CCP] 5 critical defect 5 critical limit 5 cross-contamination 5 customer 5 customer requirement 6

R

HACCP plan 11 hand washing 11 hazard 11 hazard analysis and critical control point [HACCP] 12 hazard assessment 12 herbicide 12 hierarchy 12 hygiene 12 I impact 12 incident 12 incidental product contact infrastructure 12 ingredient 12 intended use 12 interested party 13 intermediate material 13 Intermediate product 13

12

L

D

label 13 location 13 lot 13 lot identification 13 lubricant 13 M

E economically motivated adulteration [EMA] 6 electronic security 6 end product 6 equipment 7 establishment 7 F

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Q quality assurance system 18 quality control system 18

H

data 6 declaration of compliance [DOC] 6 deviation 6 disinfection 6 document 6

facility 7 farm 7 feed 7 feed additives 7 feed and food chain 7 feed ingredient 7 feed manufacturing/feed processing 7 feed safety 7 first expired first out [FEFO] 8 first in first out [FIFO] 8 flow diagram 8 flow of materials 8 food 8 food chain 8 food-contact side 8 food defense 8 food fraud 8 food grade 9 food handler 9 food handling 9 food ingredient 9 food packaging 9 food packaging hazard 9 food packaging withdrawal 9 food protection 9 food retail establishment 9 food retail premises 9 food safety 10 food safety control system 10 food safety hazard 10 food safety management system [FSMS]

primary production 17 procedure 17 process 17 process approach 17 processed product 17 processing 17 product 17 product contact 17 product recall 17 product security 18 protective security 18 PRP [prerequisite programme] 18

major must 14 management 14 management system 14 mass balance 14 materials 14 material specification [product specification] 14 medicated feed 14 migration 14 minor must 14 misbranded 14 monitoring 15

raw material 18 ready-to-eat [RTE] 18 recall 18 recall procedure 18 recommendation 18 record 19 recovery 19 relevant food safety hazard 19 requirement 19 resolved 19 response 19 retail premises 19 rework 19 risk 20 risk assessment 20 S safety 20 sanitation 20 sanitizing 20 satellite/satellite kitchen 20 set-off 20 significant hazard 20 simulation 21 single-use articles 21 site 21 specification 21 standard operating procedures [SOP] 21 sterilization 21 supplier 21 system 21 T tampering 21 theft 21 threat 22 Threat Assessment Critical Control Point [TACCP] 22 top management 22 traceability 22 traceability system 23 U

N updating 22 nonconformity 15 non-food contact side 15 non-intentionally added substance [NIAS] 15 O operational PRPs [operational prerequisite programmes] 15 organization 15 organization in the food chain 15 outsourced activity 15 outsourcing 15 over-run 15 P

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packaging 16 packaging materials 16 personnel security 16 pest 16 plant protection product 16 portioning 16 post harvest chemicals 16 potable water 16 prevention 16 preventive measure 17

V validation 23 vector 23 vehicle 23 verification 23 veterinary drug 23 visitor 23 vulnerability 23 W waste 23 withdrawal 23 withholding/withdrawal period 23 work environment 24 work instructions 24 wrapping 24 Z zoning 24

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Bibliography [1]

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

[2]

CAC Food Hygiene Basic texts, 5 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

th

manufacturing]

[23]

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

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[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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