EN ISO 22000:2005

SLOVENSKI SIST EN ISO 22000
STANDARD
november 2005
Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v prehranski

verigi (ISO 22000:2005)
Food safety management systems – Requirements for any organization in the

food chain (ISO 22000:2005)
Systèmes de management de la sécurité des denrées alimentaires – Exigences

pour tout organisme appartenant à la chaîne alimentaire (ISO 22000:2005)

Managementsysteme für die Lebensmittelsicherheit – Anforderungen an

Organisationen in der gesamten Lebensmittelkette (ISO 22000:2005)

Referenčna oznaka
ICS 67.020 SIST EN ISO 22000:2005 (sl, en)

Nadaljevanje na straneh II in od 1 do 61

2006-09. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
©
SIST EN ISO 22000 : 2005
NACIONALNI UVOD
Standard SIST EN ISO 22000 (sl,en), Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v
prehranski verigi (ISO 22000:2005), 2005, ima status slovenskega standarda in je enakovreden
evropskemu standardu EN ISO 22000 (en), Food safety management systems – Requirements for
any organization in the food chain (ISO 22000:2005), 2005-09-01.

NACIONALNI PREDGOVOR
Evropski standard EN ISO 22000:2005 je pripravil tehnični odbor ISO/TC 34 Živilski proizvodi v
sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/SS C01 Živilski
proizvodi.
Slovenski standard SIST EN ISO 22000:2005 je prevod evropskega standarda EN ISO 22000:2005.
Ob sporu zaradi besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard
v angleškem jeziku. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC KŽP Kmetijski
pridelki in živilski proizvodi.
ZVEZA S STANDARDOM
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistega, ki je že sprejet v nacionalno standardizacijo:

SIST EN ISO 9000 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar
OPOMBI
– Povsod, kjer se v besedilu standarda uporablja izraz »evropski standard« oziroma »mednarodni
standard«, v SIST EN ISO 22000:2005 to pomeni »slovenski standard«.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je enakovreden EN ISO 22000:2005 in je objavljen z dovoljenjem

CEN
Rue de Stassart 36
1050 Bruselj
Belgija
This national document is equivalent with EN ISO 22000:2005 and is published with the permission
of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
II
EVROPSKI STANDARD EN ISO 22000
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM september 2005

ICS: 67.020
Slovenska izdaja
Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v prehranski
verigi
Food safety management Systèmes de management de la Managementsysteme für die
systems – Requirements sécurité des denrées alimentaires Lebensmittelsicherheit –
for any organization in the – Exigences pour tout organisme Anforderungen an Organisationen
food chain appartenant à la chaîne in der gesamten Lebensmittelkette
(ISO 22000:2005) alimentaire (ISO 22000:2005) (ISO 22000:2005)

Ta evropski standard je CEN sprejel dne 2005-08-18.

Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerim je predpisano,
da mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami
najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri Centralnem
sekretariatu ali članih CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski, nemški). Izdaje v drugih
jezikih, ki jih članice CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Centralnem
sekretariatu CEN, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Cipra, Češke republike, Danske,
Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske,
Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Slovaške, Slovenije, Španije, Švedske,
Švice in Združenega kraljestva.

CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation

Centralni sekretariat: Rue de Stassart 36, B-1050 Bruselj

© 2005 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. št. EN ISO 22000:2005 E

SIST EN ISO 22000 : 2005
VSEBINA Stran CONTENTS Page
Uvod.4 Introduction.4
1 Predmet standarda. 8 1 Scope .8
2 Zveza z drugimi standardi.9 2 Normative references.9
3 Izrazi in definicije . 9 3 Terms and definitions.9
4 Sistem vodenja varnosti živil . 13 4 Food safety management system.13
4.1 Splošne zahteve.13 4.1 General requirements .13
4.2 Zahteve glede dokumentacije.14 4.2 Documentation requirements.14
5 Odgovornost vodstva.15 5 Management responsibility .15
5.1 Zavezanost vodstva. 15 5.1 Management commitment.15
5.2 Politika varnosti živil . 15 5.2 Food safety policy .15
5.3 Planiranje sistema vodenja  5.3 Food safety management system
varnosti živil . 16 planning .16
5.4 Odgovornost in pooblastila.16 5.4 Responsibility and authority .16
5.5 Vodja tima za varnost živil. 16 5.5 Food safety team leader .16
5.6 Komunikacija.17 5.6 Communication .17
5.7 Pripravljenost in odziv v kriznih  5.7 Emergency preparedness and
situacijah. 18 response.18
5.8 Vodstveni pregled. 18 5.8 Management review.18
6 Vodenje virov.19 6 Resource management.19
6.1 Priskrba virov.19 6.1 Provision of resources.19
6.2 Človeški viri . 20 6.2 Human resources.20
6.3 Infrastruktura . 20 6.3 Infrastructure .20
6.4 Delovno okolje. 21 6.4 Work environment.21
7 Planiranje in realizacija varnih proizvodov . 21 7 Planning and realization of safe products.21
7.1 Splošno.21 7.1 General.21
7.2 Prerekvizitni programi (PRP). 21 7.2 Prerequisite programmes (PRPs).21
7.3 Predhodne stopnje, ki omogočajo analizo 7.3 Preliminary steps to enable hazard
tveganja . 22 analysis.22
7.4 Analiza tveganja . 25 7.4 Hazard analysis.25
7.5 Uvedba delujočih prerekvizitnih programov 7.5 Establishing the operational
(PRP) . 28 prerequisite programmes (PRPs).28
7.6 Uvedba načrta HACCP . 28 7.6 Establishing the HACCP plan .28
7.7 Posodabljanje predhodnih informacij  7.7 Updating of preliminary information
in dokumentov, ki opisujejo PRP and documents specifying the PRPs
in načrt HACCP . 30 and the HACCP plan .30
7.8 Planiranje overjanja.30 7.8 Verification planning.30
7.9 Sistem sledljivosti . 31 7.9 Traceability system .31
7.10 Obvladovanje neskladnosti . 31 7.10 Control of nonconformity.31
8 Validacija, overjanje in izboljševanje  8 Validation, verification and improvement
sistema vodenja varnosti živil. 34 of the food safety management system.34
8.1 Splošno.34 8.1 General.34
SIST EN ISO 22000 : 2005
8.2 Validacija kombinacij kontrolnih  8.2 Validation of control measure
ukrepov . 35 combinations .35
8.3 Obvladovanje monitoringa in merjenja. 35 8.3 Control of monitoring and measuring.35
8.4 Overjanje sistema vodenja  8.4 Food safety management system
varnosti živil . 36 verification .36
8.5 Izboljševanje. 38 8.5 Improvement .38
Dodatek A (informativni): Primerjava med ISO Annex A (informative): Cross references
22000:2005 in ISO 9001:2000. 40 between ISO 22000:2005 and
ISO 9001:2000.41
Dodatek B (informativni): Primerjava med Annex B (informative): Cross references
HACCP in ISO 22000:2005 . 52 between HACCP and ISO 22000:2005.53
Dodatek C (informativni): Seznam kodeksov s Annex C (informative): Codex references
primeri kontrolnih ukrepov, prerekvizitnimi providing examples of control measures,
programi in vodili za njihovo izbiro in including prerequisite programmes and
uporabo. 57 guidance for their selection and use.57
Literatura . 61 Bibliography.61

SIST EN ISO 22000 : 2005
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov Standardization) is a worldwide federation of
za standarde (članov ISO). Mednarodne national standards bodies (ISO member bodies).
standarde ponavadi pripravljajo tehnični odbori The work of preparing International Standards is
ISO. Vsak član, ki želi delovati na določenem normally carried out through ISO technical
področju, za katero je bil ustanovljen tehnični committees. Each member body interested in a
odbor, ima pravico biti zastopan v tem odboru. subject for which a technical committee has
Pri delu sodelujejo tudi vladne in nevladne been established has the right to be represented
mednarodne organizacije, povezane z ISO. V on that committee. International organizations,
vseh zadevah, ki so povezane s governmental and non-governmental, in liaison
standardizacijo na področju elektrotehnike, with ISO, also take part in the work. ISO
ISO tesno sodeluje z Mednarodno collaborates closely with the International
elektrotehniško komisijo (IEC). Electrotechnical Commission (IEC) on all matters

of electrotechnical standardization.
Osnutki mednarodnih standardov so International Standards are drafted in
pripravljeni v skladu s pravili, podanimi v accordance with the rules given in the ISO/IEC
drugem delu Direktiv ISO/IEC. Directives, Part 2.

Poglavitna naloga tehničnih odborov je The main task of technical committees is to
priprava mednarodnih standardov. Osnutki prepare International Standards. Draft
mednarodnih standardov, ki jih sprejmejo International Standards adopted by the technical
tehnični odbori, se pošljejo vsem članom v committees are circulated to the member bodies
glasovanje. Za objavo mednarodnega for voting. Publication as an International
standarda je treba pridobiti soglasje najmanj Standard requires approval by at least 75 % of
75 odstotkov članov, ki se udeležijo the member bodies casting a vote.
glasovanja.
Opozoriti je treba na možnost, da so nekateri Attention is drawn to the possibility that some of
elementi tega mednarodnega standarda lahko the elements of this document may be the subject
predmet patentnih pravic. ISO ne prevzema of patent rights. ISO shall not be held responsible
odgovornosti za identifikacijo katerihkoli ali vseh for identifying any or all such patent rights.
takih patentnih pravic.
ISO 22000 je pripravil tehnični odbor ISO/TC ISO 22000 was prepared by Technical
34 Živilski proizvodi. Committee ISO/TC 34, Food products.

Uvod Introduction
Varnost živil je povezana s prisotnostjo Food safety is related to the presence of food-
dejavnikov tveganja v živilih v času, ko borne hazards in food at the point of
uporabnik to živilo zaužije. Ker se dejavniki consumption (intake by the consumer). As the
tveganja lahko pojavijo na vsaki stopnji introduction of food safety hazards can occur at
prehranske verige, je slednjo treba v celoti any stage of the food chain, adequate control
ustrezno nadzirati. Varnost živil je torej throughout the food chain is essential. Thus, food
zagotovljena, če so povezana prizadevanja safety is ensured through the combined efforts of
vseh, ki sodelujejo v prehranski verigi. all the parties participating in the food chain.

V prehransko verigo so vključene Organizations within the food chain range from
najrazličnejše organizacije: proizvajalci krme in feed producers and primary producers through
primarni proizvajalci, predelovalci živil, food manufacturers, transport and storage
prevozniki in izvajalci pri skladiščenju, operators and subcontractors to retail and food
podizvajalci, trgovci, prodajalci (skupaj z service outlets (together with inter-related
drugimi vključenimi organizacijami, kot so organizations such as producers of equipment,
izdelovalci opreme, proizvajalci embalaže in packaging material, cleaning agents, additives and
pakirnih materialov, čistil, aditivov in sestavin). ingredients). Service poviders are also included.
Vključeni so tudi dobavitelji servisnih storitev.
SIST EN ISO 22000 : 2005
Ta mednarodni standard opredeljuje zahteve This International Standard specifies the
za sistem vodenja varnosti živil, ki s requirements for a food safety management
povezovanjem naslednjih splošno znanih system that combines the following generally
ključnih elementov zagotovi varnost živil v vsej recognized key elements to ensure food safety
prehranski verigi, prav do končne točke along the food chain, up to the point of final
potrošnje: consumption:
– vmesne povezave, – interactive communication;
– vodenje sistema, – system management;
– prerekvizitni programi, – prerequisite programmes;
– načela HACCP. – HACCP principles.
Povezovanje v vsej prehranski verigi je nujno za Communication along the food chain is essential to
zagotovitev, da so vsi pomembni dejavniki ensure that all relevant food safety hazards are
tveganja prepoznani in ustrezno nadzorovani identified and adequately controlled at each step
prav na vsaki stopnji prehranske verige, kar within the food chain. This implies communication
vključuje povezave navzgor in navzdol v verigi. between organizations both upstream and
Povezave med odjemalci in dobavitelji zaradi downstream in the food chain. Communication with
prepoznanih dejavnikov tveganja in kontrolnih customers and suppliers about identified hazards
ukrepov pripomorejo k jasni opredelitvi and control measures will assist in clarifying
uporabnikovih in dobaviteljevih zahtev (glede na customer and supplier requirements (e.g. with
možnost in potrebe po teh zahtevah in njihov regard to the feasibility and need for these
vpliv na končni proizvod). requirements and their impact on the end product).

Nujno je tudi prepoznavanje vloge in položaja Recognition of the organization's role and
organizacije v prehranski verigi, saj lahko position within the food chain is essential to
omogoči uspešne medsebojne povezave v ensure effective interactive communication
vsej verigi, da so končnemu uporabniku throughout the chain in order to deliver safe food
dobavljeni varni živilski proizvodi. Na sliki 1 je products to the final consumer. An example of
prikazan primer komunikacijskih povezav med the communication channels among interested
zainteresiranimi v prehranski verigi. parties of the food chain is shown in Figure 1.

Najuspešnejši sistemi varnosti živil so The most effective food safety systems are
vzpostavljeni, delujejo in se posodabljajo v established, operated and updated within the
okviru strukturiranega sistema vodenja ter so framework of a structured management system
vključeni v najširše vodstvene aktivnosti v and incorporated into the overall management
organizaciji. To zagotavlja organizacijam in activities of the organization. This provides
zainteresiranim udeležencem največjo korist. maximum benefit for the organization and
Ta mednarodni standard je usklajen z ISO 9001 interested parties. This International Standard
prav zato, da se poveča vzajemno delovanje has been aligned with ISO 9001 in order to
obeh standardov. Navzkrižni prikaz zahtev enhance the compatibility of the two standards.
tega mednarodnega standarda in ISO 9001 je Cross-references between this International
naveden v dodatku A. Standard and ISO 9001 are provided in Annex A.
Ta mednarodni standard se lahko uporablja This International Standard can be applied inde-
neodvisno od drugih standardov vodenja. pendently of other management system standards.
Njegovo izvajanje lahko poteka vzporedno ali Its implementation can be aligned or integrated
pa tako, da je vključen v že obstoječe zahteve with existing related management system
za vodenje. Organizacije pa lahko uporabijo requirements, while organizations may utilize
obstoječe sisteme vodenja, da vzpostavijo existing management system(s) to establish a food
sistem vodenja varnosti živil, ki je skladen z safety management system that complies with the
zahtevami tega mednarodnega standarda. requirements of this International Standard.
Ta mednarodni standard povezuje načela This International Standard integrates the
sistema analize tveganja in kritičnih kontrolnih principles of the Hazard Analysis and Critical
točk (HACCP) in uporabo stopenj, ki jih je Control Point (HACCP) system and application
razvila komisija Codex Alimentarius steps developed by the Codex Alimentarius
SIST EN ISO 22000 : 2005
Commission. S pomočjo zahtev presoje Commission. By means of auditable requirements,
povezuje načrt HACCP s prerekvizitnimi it combines the HACCP plan with prerequisite
programi. Analiza tveganja je ključ do programmes (PRPs). Hazard analysis is the key to
uspešnega sistema vodenja varnosti živil, saj an effective food safety management system,
prav izvedba analize tveganja pomaga pri since conducting a hazard analysis assists in
organiziranju znanja, potrebnega za organizing the knowledge required to establish an
vzpostavitev uspešne kombinacije kontrolnih effective combination of control measures. This
ukrepov. Ta mednarodni standard zahteva, da International Standard requires that all hazards
so prepoznani in določeni vsi dejavniki tveganja, that may be reasonably expected to occur in the
katerih pojav se v prehranski verigi upravičeno food chain, including hazards that may be
pričakuje, vključno s tistimi, ko so lahko associated with the type of process and facilities
povezani z vrsto procesa ali prostori. Na ta način used, are identified and assessed. Thus it provides
zagotavlja orodje, s katerim se določiin the means to determine and document why certain
dokumentira, zakaj mora organizacija nekatere identified hazards need to be controlled by a
prepoznane dejavnike tveganja nadzorovati, particular organization and why others need not.
drugih pa ne.
Proizvajalci pesticidov, gnojil,
Pridelovalci
veterinarskih zdravil
Crop producers
Producers of pesticides, fertilizers,

and veterinary drugs
Proizvajalci krmil
Proizvajalci aditivov in drugih

Feed producers
dodatkov
Food chain for the production of

ingredients and additives
Primarni proizvajalci
Primary food producers
Izvajalci prevoznih in skladiščnih

storitev
Transport and storage operators
Predelava, proizvodnja
Food manufacturers
Proizvajalci opreme
Producers of equipment
Sekundarna predelava
Secondary food manufacturers
Proizvajalci sredstev za čiščenje
in razkuževanje
Producers of cleaning and
Veletrgovci
sanitizing agents
Wholesalers
Proizvajalci embalaže
Producers of packaging materials
Trgovine, gostinstvo, catering

Retailers, food service operators and
Dobavitelji servisnih storitev

caterers
Service providers
Potrošniki
Consumers
OPOMBA: Slika ne prikazuje medsebojnih komunikacij NOTE The figure does not show the type of interactive
vzdolž in križem prehranske verige, ki obide communications along and across the food chain that
neposredne dobavitelje in potrošnike. by-pass immediate suppliers and customers.
Slika 1: Primer komunikacije znotraj prehranske verige
Figure 1 – Example of communication within the food chain

Zakonski in regulativni organi
Statutory and regulatory authorities

SIST EN ISO 22000 : 2005
Med analizo tveganja organizacija določi During hazard analysis, the organization
strategijo, ki jo mora izvajati, da s kombinacijo determines the strategy to be used to ensure
prerekvizitnih programov, delujočih hazard control by combining the PRP(s),
prerekvizitnih programov in načrtom HACCP operational PRP(s) and the HACCP plan.
zagotovi nadzor nad dejavniki tveganja.

Povezave med načeli HACCP komisije Codex Cross-references between the Codex Alimentarius
Alimentarius in aplikacijskimi koraki (glej Commission HACCP principles and application
referenco 11) ter tem mednarodnim steps (see Reference [11]) and this International
standardom so opredeljene v dodatku B. Standard are provided in Annex B.

Za lažjo uporabo je ta mednarodni standard To facilitate the application of this International
pripravljen kot standard za presojo. Vendar pa Standard, it has been developed as an auditable
se posamezne organizacije svobodno odločajo standard. However, individual organizations are
o potrebnih metodah in pristopih za izpolnitev free to choose the necessary methods and
zahtev tega mednarodnega standarda. Napotki approaches to fulfil the requirements of this
za pomoč posameznim organizacijam pri International Standard. To assist individual
izvajanju tega mednarodnega standarda in za organizations with the implementation of this
njegovo uporabo so opredeljeni v ISO/TS International Standard, guidance on its use is
22004. provided in ISO/TS 22004.

Ta mednarodni standard se nanaša samo na This International Standard is intended to address
tiste vidike, ki zadevajo varnost živil. A enak aspects of food safety concerns only. The same
pristop, kot je določen s tem mednarodnim approach as provided by this International
standardom, se lahko uporabi pri oblikovanju Standard can be used to organize and respond to
in odzivanju na druge specifične vidike glede other food specific aspects (e.g. ethical issues and
živil (npr. etični vidik in zavedanje potrošnika). consumer awareness).

Ta mednarodni standard dovoljuje organizaciji This International Standard allows an organization
(kot je majhna in/ali manj razvita organizacija), (such as a small and/or less developed
da izvaja kombinacijo kontrolnih ukrepov, ki je organization) to implement an externally developed
bila razvita zunaj organizacije. combination of control measures.

Cilj tega mednarodnega standarda je na The aim of this International Standard is to
globalni ravni uskladiti zahteve sistemov harmonize on a global level the requirements for
vodenja za zagotavljanje varnih živil za food safety management for businesses within the
podjetja znotraj prehranske verige. Posebej je food chain. It is particularly intended for application
namenjen temu, da ga uporabljajo by organizations that seek a more focused,
organizacije, ki želijo bolj osredotočen, coherent and integrated food safety management
povezan in integriran sistem vodenja varnosti system than is normally required by law. It requires
živil, kot to splošno zahteva zakonodaja. an organization to meet any applicable food safety
Zahteva, da se organizacija spozna z vsemi related statutory and regulatory requirements
zakonskimi in regulativnimi zahtevami glede through its food safety management system.
varnosti živil skozi lasten sistem vodenja za
zagotavljanje varnih živil.
SIST EN ISO 22000 : 2005
Sistemi vodenja varnosti živil – Food safety management systems –
Zahteve za vsako organizacijo v Requirements for any organization in
prehranski verigi the food chain

1 Predmet standarda 1 Scope
Ta mednarodni standard navaja zahteve za This International Standard specifies
sistem vodenja varnosti živil, ko organizacija v requirements for a food safety management
prehranski verigi dokazuje, da je sposobna system where an organization in the food chain
nadzorovati dejavnike tveganja in s tem needs to demonstrate its ability to control food
zagotoviti varnost živila v času njegovega safety hazards in order to ensure that food is
zaužitja. safe at the time of human consumption.

Primeren je za vse organizacije ne glede na It is applicable to all organizations, regardless of
velikost, ki so kakorkoli vključene v prehransko size, which are involved in any aspect of the food
verigo in želijo izvajati sisteme, ki stalno chain and want to implement systems that
zagotavljajo varnost izdelkov. Pomen katerekoli consistently provide safe products. The means of
zahteve tega mednarodnega standarda je lahko meeting any requirements of this International
izpopolnjen z uporabo notranjih ali zunanjih Standard can be accomplished through the use
virov. of internal and/or external resources.

Ta mednarodni standard določa zahteve, ki This International Standard specifies require-
organizaciji omogočajo: ments to enable an organization
a) načrtovati, izvajati, voditi, vzdrževati in a) to plan, implement, operate, maintain and
posodabljati sistem vodenja varnosti živil, s update a food safety management system
katerim zagotovi izdelke, ki so glede na aimed at providing products that, according
namen uporabe varni za uživanje; to their intended use, are safe for the
consumer,
b) prikazati skladnost z ustreznimi zakonskimi b) to demonstrate compliance with applicable
in regulativnimi zahtevami za varnost živil; statutory and regulatory food safety
requirements,
c) vrednotiti in oceniti zahteve kupcev in c) to evaluate and assess customer
prikazati skladnost z medsebojno requirements and demonstrate conformity
usklajenimi zahtevami kupcev glede with those mutually agreed customer
varnosti živil, da bi se povečalo njihovo requirements that relate to food safety, in
zadovoljstvo; order to enhance customer satisfaction,
d) uspešno povezati vidike varnosti živil svojih d) to effectively communicate food safety
dobaviteljev, odjemalcev in vključenih issues to their suppliers, customers and
zainteresiranih strank v prehranski verigi; relevant interested parties in the food chain,

e) zagotavljati, da usklajuje določeno politiko e) to ensure that the organization conforms to
zagotavljanja varnih živil; its stated food safety policy,
f) prikazati tako usklajenost pomembnim f) to demonstrate such conformity to relevant
zainteresiranim strankam in interested parties, and
g) pridobiti certifikacijo ali registracijo svojega g) to seek certification or registration of its
sistema vodenja varnosti živil pri zunanji food safety management system by an
organizaciji ali izvesti samoocenjevanje ali external organization, or make a self-
samodeklariranje skladnosti s tem assessment or self-declaration of
mednarodnim standardom. conformity to this International Standard.
Vse zahteve tega mednarodnega standarda so All requirements of this International Standard
splošne in so namenjene vsem organizacijam v are generic and are intended to be applicable to
prehranski verigi ne glede na velikost in all organizations in the food chain regardless of
SIST EN ISO 22000 : 2005
kompleksnost. To vključuje vse organizacije, ki size and complexity. This includes organizations
so neposredno ali posredno vključene v enega directly or indirectly involved in one or more steps
ali več členov prehranske verige. Med of the food chain. Organizations that are directly
organizacijami, ki so neposredno vključene, so involved include, but are not limited to, feed
proizvajalci krme, kmetje, proizvajalci sestavin, producers, harvesters, farmers, producers of
proizvajalci živil, trgovci, izvajalci strežbe hrane, ingredients, food manufacturers, retailers, food
oskrbe z živili, izvajalci čiščenja in sanitacije, services, catering services, organizations
prevoza, skladiščenja in distribucije. Med providing cleaning and sanitation services,
drugimi organizacijami, ki so posredno transportation, storage and distribution services.
vključene, so dobavitelji opreme, čistilnih in Other organizations that are indirectly involved
sanitacijskih sredstev, embalaže in drugih include, but are not limited to, suppliers of
materialov, ki vstopajo v stik z živili. equipment, cleaning and sanitizing agents,
packaging material, and other food contact
materials.
Ta mednarodni standard omogoča majhnim This International Standard allows an
in/ali manj razvitim organizacijam (npr. malim organization, such as a small and/or less
kmetijam, distributerjem, trgovcem ali strežbi), developed organization (e.g. a small farm, a
da izvajajo kombinacijo kontrolnih ukrepov, ki je small packer-distributor, a small retail or food
bila razvita z zunanjo pomočjo. service outlet), to implement an externally
developed combination of control measures.

OPOMBA: Napotki za uporabo tega mednarodnega NOTE Guidance on the application of this

standarda so podani v ISO/TS 22004. International Standard is given in ISO/TS
22004.
2 Zveza z drugimi standardi 2 Normative references
V nadaljevanju navedeni dokumenti so za The following referenced documents are
uporabo tega dokumenta nujni. Pri datiranem indispensable for the application of this
sklicevanju se uporablja samo navedena izdaja; document. For dated references, only the
pri nedatiranem sklicevanju se uporablja zadnja edition cited applies. For undated references,
izdaja dokumenta (vključno z morebitnimi the latest edition of the referenced document
spremembami). (including any amendments) applies.

ISO 9000:2000, Sistemi vodenja kakovosti – ISO 9000:2000, Quality management systems -
Osnove in slovar Fundamentals and vocabulary

3 Izrazi in definicije 3 Terms and definitions

V tem mednarodnem standardu se uporabljajo For the purposes of this document, the terms
izrazi in definicije, ki so podani v standardu and definitions given in ISO 9000 and the
ISO 9000, in tisti, ki so navedeni v nadaljevanju. following apply.

Za lažjo uporabo tega mednarodnega For the convenience of the users of this
standarda so nekaterim definicijam iz ISO 9000 International Standard, some of the definitions
dodane opombe, ki so uporabne le v in ISO 9000 are quoted with added notes that
posameznem primeru. are applicable only to this special application.

OPOMBA: Izrazi niso definirani, če so obdržali NOTE Terms are not defined where they retain

običajno definicijo iz slovarja. Poudarjeni their normal dictionary definition. Where
tisk definicije pomeni navzkrižno referenco bold type is used in a definition, this
za drug izraz, uporabljen v tem členu, indicates a cross-reference to another term
številka reference za izraz pa je navedena v defined in this clause, and the number
oklepaju. reference for the term is given in
parentheses.
3.1 varnost živil 3.1 food safety
(pojem) zagotovilo, da živilo, ki je pripravljeno concept that food will not cause harm to the
in/ali zaužito glede na nameravano uporabo, ne consumer when it is prepared and/or eaten
SIST EN ISO 22000 : 2005
ogroža zdravja potrošnika according to its intended use
OPOMBA 1: Povzeto iz reference (11). NOTE 1 Adapted from Reference [11].

OPOMBA 2: Varnost živil se navezuje na pojav
NOTE 2 Food safety is related to the occurrence of
dejavnikov tveganja (3.3) in ne vključuje
food safety hazards (3.3) and does not
drugih povezanih zdravstvenih vidikov, na
include other human health aspects related
primer podhranjenosti.
to, for example, malnutrition.

3.2 prehranska veriga  3.2 food chain
zaporedje stopenj in postopkov proizvodnje, sequence of the stages and operations involved
predelave, distribucije, skladiščenja in in the production, processing, distribution, storage
rokovanja z živili in njihovimi sestavinami od and handling of a food and its ingredients, from
primarne proizvodnje do porabe primary production to consumption

OPOMBA 1: To vključuje proizvodnjo krme za živali, NOTE 1 This includes the production of feed for

namenjene za proizvodnjo živil. food-producing animals and for animals
intended for food production.
OPOMBA 2: Prehranska veriga vključuje proizvodnjo NOTE 2 The food chain also includes the production
materialov, ki prihajajo v stik z živili ali s of materials intended to come into contact
surovinami. with food or raw materials.

3.3 dejavnik tveganja 3.3 food safety hazard
biološki, kemični ali fizikalni dejavnik v živilu ali biological, chemical or physical agent in food,
stanje živila, ki lahko ogroža zdravje or condition of food, with the potential to cause
an adverse health effect
OPOMBA 1: Povzeto iz reference (11). NOTE 1 Adapted from Reference [11].

OPOMBA 2: Izraz “tveganje” se ne sme zamenjati z NOTE 2 The term "hazard" is not to be confused with
izrazom “tveganost”, ki v kontekstu varnosti the term "risk" which, in the context of food
živil pomeni funkcijo verjetnosti pojava, ki safety, means a function of the probability of
ogroža zdravje ljudi (npr. pojav an adverse health effect (e.g. becoming
bolezni/obolenja), in resnosti tega vpliva diseased) and the severity of that effect
(smrt, zdravljenje, odsotnost z dela …) ob (death, hospitalization, absence from work,
izpostavljenosti določenemu tveganju. etc.) when exposed to a specified hazard.
Tveganost (ang. risk) je v ISO/IEC Guide Risk is defined in ISO/IEC Guide 51 as the
51 opredeljena kot kombinacija verjetnosti combination of the probability of occurrence of
pojava nevarnosti in resnosti te nevarnosti. harm and the severity of that harm.

OPOMBA 3: Dejavniki tveganja vključujejo alergene. NOTE 3 Food safety hazards include allergens.

OPOMBA 4: Pri krmi in sestavinah krme so pomembni NOTE 4 In the context of feed and feed ingredients,
dejavniki tveganja tisti, ki so lahko prisotni v relevant food safety hazards are those that
krmi in/ali na njej in so lahko nato naknadno may be present in and/or on feed and feed
vneseni v živila pri hranjenju živali s krmo in ingredients and that may subsequently be
tako lahko ogrožajo zdravje ljudi. Razen transferred to food through animal
tistih postopkov, ki so neposredno povezani consumption of feed and may thus have the
z ravnanjem s krmo ali z živili (proizvajalci potential to cause an adverse human health
embalažnih materialov, čistil …), so effect. In the context of operations other than
pomembni dejavniki tveganja tudi tisti, ki so those directly handling feed and food (e.g.
lahko posredno ali neposredno preneseni v producers of packaging materials, cleaning
živila pri nameravani uporabi dobavljenih agents, etc.), relevant food safety hazards are
proizvodov in/ali servisiranju in tako lahko those hazards that can be directly or indirectly
ogrozijo zdravje ljudi. transferred to food because of the intended
use of the provided products and/or services

and thus can have the potential to cause an
adverse human health effect.
3.4 politika varnosti živil 3.4 food safety policy
splošni cilji in usmeritve organizacije, vezani na overall intentions and direction of an
varnost živil, ki jih formalno izrazi najvišje organization related to food safety (3.1) as
vodstvo formally expressed by top management

3.5 končni proizvod 3.5 end product
proizvod, ki ne gre več v nadaljnjo predelavo in product that will undergo no further processing
spremembo v organizaciji or transformation by the organization
SIST EN ISO 22000 : 2005
OPOMBA: Proizvod, ki gre skozi nadaljnjo predelavo NOTE A product that undergoes further processing

ali preoblikovanje v drugi organizaciji, je or transformation by another organization is
končni proizvod v prvi organizaciji in an end product in the context of the first
surovina ali sestavina v drugi organizaciji. organization and a raw material or an
ingredient in the context of the second

organization.
3.6 diagram poteka 3.6 flow diagram
shematičen in sistematičen prikaz zaporedja in schematic and systematic presentation of the
medsebojnega vpliva stopenj sequence and interactions of steps

3.7 kontrolni ukrep 3.7 control measure
(varnost živil) postopek ali aktivnost, ki se lahko (food safety) action or activity that can be used
izvede za preprečitev ali izločitev dejavnika to prevent or eliminate a food safety hazard
tveganja ali njegovo zmanjšanje na sprejemljivo (3.3) or reduce it to an acceptable level
raven
OPOMBA: Povzeto iz reference (11). NOTE Adapted from Reference [11].

3.8 prerekvizitni programi (PRP) 3.8 PRP prerequisite programme
(varnost živil) osnovni pogoji in aktivnosti, ki so (food safety) basic conditions and activities that
potrebni za vzdrževanje higienskega okolja v are necessary to maintain a hygienic
celotni prehranski verigi (3.2), primernega za environment throughout the food chain (3.2)
proizvodnjo, ravnanje in zagotavljanje varnih suitable for the production, handling and
končnih proizvodov (3.5) in varne hrane za provision of safe end products (3.5) and safe
prehrano ljudi food for human consumption

OPOMBA: Potrebni prerekvizitni programi so odvisni od NOTE The PRPs needed depend on the segment

področja prehranske verige, v kateri of the food chain in which the organization
organizacija deluje, in od vrste organizacije operates and the type of organization (see
(glej dodatek C). Primeri enakovrednih Annex C). Examples of equivalent terms
izrazov so: dobra kmetijska praksa (DKP), are: Good Agricultural Practice (GAP),
dobra veterinarska praksa (DVP), dobra Good Veterinarian Practice (GVP), Good
proizvodna praksa (DPP), dobra higienska Manufacturing Practice (GMP), Good
praksa (DHP), dobra trgovinska praksa Hygienic Practice (GHP), Good Production
(DTP). Practice (GPP), Good Distribution Practice
(GDP) and Good Trading Practice (GTP).

3.9 delujoči PRP,
3.9 operational PRP
delujoči prerekvizitni programi operational prerequisite programme
PRP (3.8), določeni z analizo tveganja kot PRP (3.8) identified by the hazard analysis as
bistveni za nadzorovanje verjetnosti vnosa essential in order to control the likelihood of
dejavnikov tveganja in s tem onesnaževanja ali introducing food safety hazards (3.3) to and/or
razširjanja dejavnikov tveganja (3.3) v the contamination or proliferation of food safety
proizvodu(-ih) ali v okolju predelave hazards in the product(s) or in the processing
environment
3.10 KKT, kritična kontrolna točka 3.10 CCP critical control point
(varnost živil) stopnja, na kateri je lahko step at which control can be
uporabljen nadzor, ki je bistven za preprečitev ali applied and is essential to prevent or eliminate
izločitev dejavnika tveganja (3.3) ali za a food safety hazard (3.3) or reduce it to an
zmanjšanje le-tega na sprejemljivo raven acceptable level

OPOMBA: Povzeto iz reference (11). NOTE Adapted from Reference [11].

3.11 kritična meja 3.11 critical limit
kriterij, ki ločuje sprejemljivo od nesprejemljivega criterion which separates acceptability from
unacceptability
SIST EN ISO 22000 : 2005
OPOMBA 1: Prirejeno iz reference (11). NOTE 1 Adapted from Reference [11].

OPOMBA 2: Kritične meje so vpeljane, da opredelijo, ali NOTE 2 Critical limits are established to determine
KKT (3.10) ostajajo nadzorovane. Če je whether a CCP (3.10) remains in control. If
kritična meja presežena ali prekršena, so a critical limit is exceeded or violated, the
proizvodi obravnavani, kot da potencialno products affected are deemed to be
niso varni. potentially unsafe.

3.12 monitoring 3.12 monitoring
izvajanje načrtovanih zaporedij opazovanj ali conducting a planned sequence of observations
merjenj, da se oceni, ali kontrolni ukrepi (3.7) or measurements to assess whether control
delujejo tako, kot je načrtovano measures (3.7) are operating as intended

3.13 korekcija 3.13 correction
ukrep za odpravo ugotovljene neskladnosti action to eliminate a detected nonconformity

[ISO 9000:2000, definicija 3.6.6] [ISO 9000:2000, definition 3.6.6]

OPOMBA 1: V tem mednarodnem standardu se NOTE 1 For the purposes of this International

korekcija navezuje na ravnanje s proizvodi, Standard, a correction relates to the
ki potencialno niso varni, in zato lahko pride handling of potentially unsafe products, and
do povezave s korektivnim ukrepom (3.14). can therefore be made in conjunction with a
corrective action (3.14).
OPOMBA 2: Korekcija je lahko npr. ponovna predelava, NOTE 2 A correction may be, for example,

nadaljnja predelava in/ali izločitev škodljivih reprocessing, further processing, and/or
posledic neskladnosti (kot je elimination of the adverse consequences of
razporeditev/odreditev za drugo uporabo ali the nonconformity (such as disposal for
posebno označevanje). other use or specific labelling).

3.14 korektivni ukrep 3.14 corrective action
ukrep za odpravo vzrokov ugotovljene action to eliminate the cause of a detected
neskladnosti ali drugega neželenega stanja nonconformity or other undesirable situation

[ISO 9000:2000, definicija 3.6.5] [ISO 9000:2000, definition 3.6.5]

OPOMBA 1: Vzrokov za ugotovljeno neskladnost je NOTE 1 There can be more than one cause for a

lahko več. nonconformity.
OPOMBA 2: Korektivni ukrep vključuje analizo vzroka in NOTE 2 Corrective action includes cause analysis

se izvede zato, da se prepreči ponavljanje. and is taken to prevent recurrence.

3.15 validacija 3.15 validation
(varnost živil) pridobitev dokazov, da so obtaining evidence that the
kontrolni ukrepi (3.7), ki izhajajo iz načrta control measures (3.7) managed by the
HACCP in delujočih PRP (3.9), uspešni HACCP and by the operational PRPs (3.9) are
capable of being effective
OPOMBA: Ta definicija je povzeta iz reference (11) in je NOTE This definition is based on Reference [11]

bolj uporabna za področje varnosti živil (3.1) and is more suitable for the field of
...