Dansk standard

DS/EN ISO 22000

1. udgave

2005-12-22

Ledelsessystemer for fødevare-

sikkerhed – Krav til virksomheder i fødevarekæden

Food safety management systems – Requirements for any organization in the food chain

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DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard

• standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller • standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard

DS-information • publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller • publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en

teknisk rapport, eller • europæisk præstandard DS-håndbog • samling af standarder, eventuelt suppleret med informativt materiale

DS-hæfte • publikation med informativt materiale

Til disse publikationstyper kan endvidere udgives

• tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis

• fuldtekstpublikation (publikationen er trykt i sin helhed) • godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) • elektronisk (publikationen leveres på et elektronisk medie)

DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD

• IDT: Når publikationen er identisk med en given publikation. • EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men

præsentationen er ændret. • NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en

given standard, men udarbejdet på baggrund af denne. • MOD: Når publikationen er modificeret i forhold til en given publikation.

DS/EN ISO 22000 København DS projekt: 52387 ICS: 67.020 Første del af denne publikations betegnelse er: DS/EN ISO, hvilket betyder, at det er en international standard, der har status både som europæisk og dansk standard. Denne publikations overensstemmelse er: IDT med: ISO 22000:2005. IDT med: EN ISO 22000:2005. DS-publikationen er på dansk og engelsk. I tilfælde af tvivl om den danske oversættelses korrekthed henvises til den engelske version. Denne publikation erstatter: DS 3027:2002 og DS 3027 E:2002. Der er tilføjet danske fodnoter markeret med DK og nummeret. Fodnoterne er vejledende og udgør ikke en del af standarden.

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EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN ISO 22000

September 2005

ICS 67.020

English Version

Food safety management systems - Requirements for anyorganization in the food chain (ISO 22000:2005)

Systèmes de management de la sécurité des denréesalimentaires - 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)

This European Standard was approved by CEN on 18 August 2005.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATIONC OM ITÉ EUR OP ÉEN DE NOR M ALIS AT IONEUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.

Ref. No. EN ISO 22000:2005: E

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EN ISO 22000:2005 (E)

2

Foreword This document (EN ISO 22000:2005) has been prepared by Technical Committee ISO/TC 34 "Agricultural food products" in collaboration with Technical Committee CEN/SS C01 "Food Products", the secretariat of which is held by CMC. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2006, and conflicting national standards shall be withdrawn at the latest by March 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice

The text of ISO 22000:2005 has been approved by CEN as EN ISO 22000:2005 without any modifications.

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Forord

Dette dokument (EN ISO 22000:2005) er udarbejdet af teknisk komité ISO/TC 34, Food productsDK1), i samarbejdemed teknisk komité CEN/SS C01, Food Products, hvis sekretariat varetages af CMC.

Denne europæiske standard skal inden marts 2006 have status som national standard, enten ved at der udgives enidentisk tekst, eller ved formel godkendelse, og modstridende nationale standarder skal være trukket tilbage senestmarts 2006.

I henhold til CEN/CENELEC’s interne regler er de nationale standardiseringsorganisationer i følgende lande forplig-tet til at implementere denne europæiske standard: Belgien, Cypern, Danmark, Estland, Finland, Frankrig, Græken-land, Holland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Malta, Norge, Polen, Portugal, Schweiz, Slovaki-et, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn og Østrig.

Godkendelse

Teksten i ISO 22000:2005 er godkendt af CEN som EN ISO 22000:2005 uden ændringer.

––––––––––DK1) I den engelske udgave af EN/ISO 22000:2005 er titlen på ISO/TC 34, Food products, ikke korrekt.

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DS/EN ISO 22000:2005

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ISO 22000:2005(E)

© ISO 2005 – All rights reserved iii

Contents Page

1 Scope .................................................................................................................................................... 1

2 Normative references .......................................................................................................................... 1

3 Terms and definitions .......................................................................................................................... 2

4 Food safety management system ...................................................................................................... 4

4.1 General requirements ......................................................................................................................... 4

4.2 Documentation requirements ............................................................................................................ 5

5 Management responsibility ................................................................................................................ 5

5.1 Management commitment .................................................................................................................. 5

5.2 Food safety policy ............................................................................................................................... 6

5.3 Food safety management system planning ...................................................................................... 6

5.4 Responsibility and authority .............................................................................................................. 6

5.5 Food safety team leader ..................................................................................................................... 6

5.6 Communication ................................................................................................................................... 7

5.7 Emergency preparedness and response .......................................................................................... 8

5.8 Management review ............................................................................................................................ 8

6 Resource management ....................................................................................................................... 8

6.1 Provision of resources ........................................................................................................................ 8

6.2 Human resources ................................................................................................................................ 9

6.3 Infrastructure ....................................................................................................................................... 9

6.4 Work environment ............................................................................................................................... 9

7 Planning and realization of safe products ......................................................................................... 9

7.1 General ................................................................................................................................................. 9

7.2 Prerequisite programmes (PRPs) .................................................................................................... 10

7.3 Preliminary steps to enable hazard analysis .................................................................................. 11

7.4 Hazard analysis ................................................................................................................................. 13

7.5 Establishing the operational prerequisite programmes (PRPs) ................................................... 14

7.6 Establishing the HACCP plan ........................................................................................................... 14

7.7 Updating of preliminary information and documents specifying the PRPsand the HACCP plan .................................................................................................................................. 15

7.8 Verification planning ......................................................................................................................... 16

7.9 Traceability system ........................................................................................................................... 16

7.10 Control of nonconformity ............................................................................................................... 16

8 Validation, verification and improvement of the food safety management system .................... 18

8.1 General ............................................................................................................................................... 18

8.2 Validation of control measure combinations .................................................................................. 19

8.3 Control of monitoring and measuring ............................................................................................. 19

8.4 Food safety management system verification ............................................................................... 19

8.5 Improvement ...................................................................................................................................... 20

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Indhold

Side

1 Emne og anvendelsesområde ............................................................................................................................... 1

2 Normative referencer .............................................................................................................................................. 1

3 Termer og definitioner............................................................................................................................................. 2

4 Ledelsessystem for fødevaresikkerhed ............................................................................................................... 44.1 Generelle krav.............................................................................................................................................. 44.2 Dokumentationskrav .................................................................................................................................. 5

5 Ledelsens ansvar ...................................................................................................................................................... 55.1 Ledelsens forpligtelse................................................................................................................................. 55.2 Fødevaresikkerhedspolitik......................................................................................................................... 65.3 Planlægning af ledelsessystemet for fødevaresikkerhed ..................................................................... 65.4 Ansvar og beføjelser................................................................................................................................... 65.5 Teamleder for fødevaresikkerhed............................................................................................................. 65.6 Kommunikation........................................................................................................................................... 75.7 Nødberedskab og afværgeforanstaltninger ........................................................................................... 85.8 Ledelsens evaluering.................................................................................................................................. 8

6 Styring af ressourcer ............................................................................................................................................... 86.1 Tilvejebringelse af ressourcer ................................................................................................................... 86.2 Menneskelige ressourcer........................................................................................................................... 96.3 Infrastruktur ................................................................................................................................................. 96.4 Arbejdsforhold ............................................................................................................................................ 9

7 Planlægning og frembringelse af sikre produkter ............................................................................................ 97.1 Generelt........................................................................................................................................................ 97.2 Basisprogrammer (PRP'er)........................................................................................................................ 107.3 Indledende trin til brug for risikofaktoranalyse....................................................................................... 117.4 Risikofaktoranalyse..................................................................................................................................... 137.5 Fastlæggelse af de operationelle basisprogrammer (OPRP'er)........................................................... 147.6 Fastlæggelse af HACCP-planen ................................................................................................................ 147.7 Opdatering af indledende informationer og dokumenter, der specificerer PRP'erne og

HACCP-planen............................................................................................................................................. 157.8 Verifikationsplanlægning........................................................................................................................... 167.9 Sporbarhedssystem ................................................................................................................................... 167.10 Styring af afvigelser.................................................................................................................................... 16

8 Validering, verifikation og forbedring af ledelsessystemet for fødevaresikkerhed ................................... 188.1 Generelt........................................................................................................................................................ 188.2 Validering af kombinationer af styrende foranstaltninger .................................................................... 198.3 Styring af overvågning og måling............................................................................................................ 198.4 Verifikation af ledelsessystemet for fødevaresikkerhed........................................................................ 198.5 Forbedring.................................................................................................................................................... 20

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DS/EN ISO 22000:2005

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ISO 22000:2005(E)

© ISO 2005 – All rights reserved

Annex A (informative) Cross references between ISO 22000:2005 and ISO 9001:2000 ....................... 22

Annex B (informative) Cross references between HACCP and ISO 22000:2005 ................................... 27

Annex C (informative) Codex references providing examples of control measures, including prerequisite programmes and guidance for their selection and use .................................................... 28

Bibliography ............................................................................................................................................... 32

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Anneks A (informativt) Krydshenvisninger mellem ISO 22000:2005 og ISO 9001:2000 ....................................... 22

Anneks B (informativt) Krydshenvisninger mellem HACCP og ISO 22000:2005..................................................... 27

Anneks C (informativt) Henvisninger til Codex-dokumenter, der giver eksempler på styrende foranstaltninger, herunder basisprogrammer og vejledning i deres udvælgelse og anvendelse....................................................................................................... 28

Bibliografi................................................................................................................................................................................. 32

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ISO 22000:2005(E)

© ISO 2005 – All rights reserved

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International Standards is normally carried out through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 22000 was prepared by Technical Committee ISO/TC 34, Food products.

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Forord

ISO (the International Organization for Standardization) er en verdensomspændende sammenslutning af nationalestandardiseringsorganer (ISO’s medlemslande). Internationale standarder udarbejdes normalt af ISO’s tekniske ko-mitéer. Hvert medlemsland, som er interesseret i et emne, inden for hvilket der er oprettet en teknisk komité, har rettil at være repræsenteret i den pågældende komité. Internationale organisationer, både statslige og ikke-statslige,der har en samarbejdsaftale med ISO, deltager ligeledes i arbejdet. ISO samarbejder tæt med IEC (the InternationalElectrotechnical Commission) i alle anliggender vedrørende elektroteknisk standardisering.

Internationale standarder udarbejdes i overensstemmelse med reglerne i ISO/IEC Directives, Part 2.

Tekniske komitéers primære opgave er at udarbejde internationale standarder. Forslag til internationale standarder,der er godkendt af de tekniske komitéer, sendes ud til medlemslandene til afstemning. Offentliggørelse som interna-tional standard kræver godkendelse af mindst 75 % af de medlemslande, som afgiver deres stemme.

Der gøres opmærksom på muligheden for, at dele af dette dokument kan være genstand for patentrettigheder. ISOkan ikke drages til ansvar for at identificere sådanne rettigheder.

ISO 22000 er udarbejdet af teknisk komité ISO/TC 34, Food products.

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ISO 22000:2005(E)

© ISO 2005 – All rights reserved

Introduction

Food safety is related to the presence of food-borne hazards in food at the point of consumption (intake by theconsumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequatecontrol throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of allthe parties participating in the food chain.

Organizations within the food chain range from feed producers and primary producers through foodmanufacturers, transport and storage operators and subcontractors to retail and food service outlets (togetherwith inter-related organizations such as producers of equipment, packaging material, cleaning agents, additivesand ingredients). Service providers are also included.

This International Standard specifies the requirements for a food safety management system that combines thefollowing generally recognized key elements to ensure food safety along the food chain, up to the point of finalconsumption:

— interactive communication;

— system management;

— prerequisite programmes;

— HACCP principles.

Communication along the food chain is essential to ensure that all relevant food safety hazards are identifiedand adequately controlled at each step within the food chain. This implies communication betweenorganizations both upstream and downstream in the food chain. Communication with customers and suppliersabout identified hazards and control measures will assist in clarifying customer and supplier requirements (e.g.with regard to the feasibility and need for these requirements and their impact on the end product).

Recognition of the organization's role and position within the food chain is essential to ensure effectiveinteractive communication throughout the chain in order to deliver safe food products to the final consumer. Anexample of the communication channels among interested parties of the food chain is shown in Figure 1.

The most effective food safety systems are established, operated and updated within the framework of astructured management system and incorporated into the overall management activities of the organization.This provides maximum benefit for the organization and interested parties. This International Standard hasbeen aligned with ISO 9001 in order to enhance the compatibility of the two standards. Cross-referencesbetween this International Standard and ISO 9001 are provided in Annex A.

This International Standard can be applied independently of other management system standards. Itsimplementation can be aligned or integrated with existing related management system requirements, whileorganizations may utilize existing management system(s) to establish a food safety management system thatcomplies with the requirements of this International Standard.

This International Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP)system and application steps developed by the Codex Alimentarius Commission. By means of auditablerequirements, it combines the HACCP plan with prerequisite programmes (PRPs). Hazard analysis is the key toan effective food safety management system, since conducting a hazard analysis assists in organizing theknowledge required to establish an effective combination of control measures. This International Standardrequires that all hazards that may be reasonably expected to occur in the food chain, including hazards that maybe associated with the type of process and facilities used, are identified and assessed. Thus it provides themeans to determine and document why certain identified hazards need to be controlled by a particularorganization and why others need not.

During hazard analysis, the organization determines the strategy to be used to ensure hazard control bycombining the PRP(s), operational PRP(s) and the HACCP plan.

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Indledning

Fødevaresikkerhed vedrører forekomsten af fødevarebårne risikofaktorer på det tidspunkt, hvor forbrugeren indta-ger fødevaren. Da risikofaktorer kan blive introduceret på et hvilket som helst trin i fødevarekæden, er tilstrækkeligstyring gennem hele fødevarekæden af afgørende betydning. Fødevaresikkerhed sikres derfor ved en kombineretindsats fra alle parter i fødevarekæden.

Virksomheder i fødevarekæden spænder fra foderstofproducenter og primærproducenter over fødevareproducen-ter, transport- og lagervirksomheder og leverandører til detailhandlere og forhandlere af tilberedt mad samt hertil re-laterede virksomheder som fx producenter af udstyr, emballagemateriale, rengøringsmidler, tilsætningsstoffer ogingredienser. Serviceudbydere er også omfattet.

Denne internationale standard fastlægger krav til et ledelsessystem for fødevaresikkerhed, der kombinerer følgendealmindeligt anerkendte centrale elementer for at sikre fødevaresikkerhed gennem hele fødevarekæden indtil den en-delige forbruger:

– interaktiv kommunikation

– systemledelse

– basisprogrammer

– HACCP-principperne.

Kommunikation gennem hele fødevarekæden er af afgørende betydning for at sikre, at alle relevante risikofaktoreridentificeres og styres i tilstrækkeligt omfang på hvert trin i kæden. Dette indebærer kommunikation mellem virk-somheder både opad og nedad i fødevarekæden. Kommunikation med kunder og leverandører om identificerede ri-sikofaktorer og styrende foranstaltninger vil hjælpe med til at tydeliggøre krav fra kunder og krav til leverandører (fxom det er muligt at opfylde disse krav, og om der er behov for dem samt kravenes indflydelse på slutproduktet).

Det er vigtigt at erkende virksomhedens rolle og placering i fødevarekæden for at sikre en effektiv interaktiv kommu-nikation gennem hele kæden, således at der leveres sikre fødevarer til den endelige forbruger. Et eksempel på kom-munikationsveje mellem interessenter i fødevarekæden er vist i figur 1.

De mest effektive systemer til styring af fødevaresikkerhed er dem, der bliver etableret, anvendt og opdateret indenfor rammerne af et struktureret ledelsessystem og bliver indarbejdet i virksomhedens samlede ledelsesaktiviteter.Dette giver både virksomhed og interessenter de største fordele. Denne internationale standard er bragt på linje medISO 9001 for at øge de to standarders forenelighed. Krydsreferencer mellem denne internationale standard og ISO9001 er vist i anneks A.

Denne internationale standard kan anvendes uafhængigt af andre standarder for ledelsessystemer. Implementerin-gen kan samordnes eller integreres med eksisterende, lignende krav til ledelsessystemer, og virksomheder kan sam-tidigt anvende eksisterende ledelsessystemer til at etablere et ledelsessystem for fødevaresikkerhed, der opfylderkravene i denne internationale standard.

Denne internationale standard integrerer principperne i HACCP-systemet (Hazard Analysis and Critical Control Point) og den fremgangsmåde, der er udarbejdet af Codex Alimentarius Kommissionen. Ved hjælp af auditerbarekrav kombinerer den HACCP-planen og basisprogrammer (PRP'er). Risikofaktoranalyse er nøglen til et effektivt le-delsessystem for fødevaresikkerhed, da en risikofaktoranalyse hjælper med at organisere den viden, som er nød-vendig for at fastlægge en effektiv kombination af styrende foranstaltninger. Denne internationale standard kræver,at alle risikofaktorer, som med rimelighed kan forventes at forekomme i fødevarekæden, herunder risikofaktorer derkan være forbundet med anvendte procestyper og faciliteter, bliver identificeret og vurderet. Den er således et red-skab til at afgøre og dokumentere, hvorfor nogle identificerede risikofaktorer kræver styring af en bestemt virksom-hed, og hvorfor andre risikofaktorer ikke kræver det.

I forbindelse med risikofaktoranalysen beslutter virksomheden, hvilken strategi der skal følges for at sikre styring afrisikofaktorer ved at kombinere basisprogrammer (PRP’er), operationelle basisprogrammer (OPRP’er) og HACCP-planen.

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ISO 22000:2005(E)

© ISO 2005 – All rights reserved

Cross-references between the Codex Alimentarius Commission HACCP principles and application steps (seeReference [11]) and this International Standard are provided in Annex B.

To facilitate the application of this International Standard, it has been developed as an auditable standard.However, individual organizations are free to choose the necessary methods and approaches to fulfil therequirements of this International Standard. To assist individual organizations with the implementation of thisInternational Standard, guidance on its use is provided in ISO/TS 22004.

This International Standard is intended to address aspects of food safety concerns only. The same approach asprovided by this International Standard can be used to organize and respond to other food specific aspects (e.g.ethical issues and consumer awareness).

This International Standard allows an organization (such as a small and/or less developed organization) toimplement an externally developed combination of control measures.

The aim of this International Standard is to harmonize on a global level the requirements for food safetymanagement for businesses within the food chain. It is particularly intended for application by organizations thatseek a more focused, coherent and integrated food safety management system than is normally required bylaw. It requires an organization to meet any applicable food safety related statutory and regulatory requirementsthrough its food safety management system.

NOTE The figure does not show the type of interactive communications along and across the food chain that by-passimmediate suppliers and customers.

Figure 1 — Example of communication within the food chain

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NOTE – Figuren viser ikke den type interaktiv kommunikation på langs og tværs af fødevarekæden, der går uden om de nærme-ste leverandører og kunder.

Figur 1 – Eksempel på kommunikation i fødevarekæden

Krydshenvisninger mellem Codex Alimentarius Kommissionens HACCP-principper og fremgangsmåde (se referen-ce [11]) og denne internationale standard fremgår af anneks B.

For at lette anvendelsen af denne internationale standard er den udarbejdet som en auditerbar standard. Hver virk-somhed kan imidlertid frit vælge de metoder og fremgangsmåder, der er nødvendige for at opfylde kravene i denneinternationale standard. Virksomheder kan finde hjælp i ISO/TS 22004, der indeholder en vejledning om implemen-tering og anvendelse af denne internationale standard.

Denne internationale standard har udelukkende til formål at behandle forhold af betydning for fødevaresikkerhed.Fremgangsmåden, som denne internationale standard bygger på, kan anvendes til at organisere og reagere på an-dre fødevarespecifikke aspekter (fx etiske spørgsmål og forbrugerbevidsthed).

Denne internationale standard giver en virksomhed (fx en lille og/eller mindre udviklet virksomhed) mulighed for atimplementere en kombination af styrende foranstaltninger, der er udviklet uden for virksomheden.

Formålet med denne internationale standard er på globalt plan at harmonisere kravene til styring af fødevaresikker-hed for virksomheder i fødevarekæden. Den er specielt beregnet til at blive anvendt af virksomheder, der søger etmere fokuseret, sammenhængende og integreret ledelsessystem for fødevaresikkerhed, end loven normalt kræver.Den stiller krav om, at en virksomhed opfylder alle gældende lov- og myndighedskrav til fødevaresikkerhed gennemsit ledelsessystem.

vii (da)

DS/EN ISO 22000:2005

Planteavlere

Foderstofproducenter

Primærproducenter

Fødevareproducenter

Sekundære fødevareproducenter

Grossister

Detailhandlere, cateringvirksomhederog lignende

Forbrugere

Myn

digh

eder

Producenter af pesticider, gødning og veterinærmedicinske præparater

Fødevarekæden for fremstilling af ingredienser og tilsætningsstoffer

Transport- og lagervirksomheder

Maskin- og udstyrsproducenter

Producenter af rengørings- ogdesinfektionsmidler

Emballageproducenter

Serviceudbydere

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INTERNATIONAL STANDARD ISO 22000:2005(E)

1

Food safety management systems — Requirements for any organization in the food chain

1 Scope

This International Standard specifies requirements for a food safety management system where anorganization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensurethat food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain andwant to implement systems that consistently provide safe products. The means of meeting any requirements ofthis International Standard can be accomplished through the use of internal and/or external resources.

This International Standard specifies requirements to enable an organization

a) to plan, implement, operate, maintain and update a food safety management system aimed at providingproducts that, according to their intended use, are safe for the consumer,

b) to demonstrate compliance with applicable statutory and regulatory food safety requirements,

c) to evaluate and assess customer requirements and demonstrate conformity with those mutually agreedcustomer requirements that relate to food safety, in order to enhance customer satisfaction,

d) to effectively communicate food safety issues to their suppliers, customers and relevant interested parties inthe food chain,

e) to ensure that the organization conforms to its stated food safety policy,

f) to demonstrate such conformity to relevant interested parties, and

g) to seek certification or registration of its food safety management system by an external organization, ormake a self-assessment or self-declaration of conformity to this International Standard.

All requirements of this International Standard are generic and are intended to be applicable to all organizationsin the food chain regardless of size and complexity. This includes organizations directly or indirectly involved inone or more steps of the food chain. Organizations that are directly involved include, but are not limited to, feedproducers, harvesters, farmers, producers of ingredients, food manufacturers, retailers, food services, cateringservices, organizations providing cleaning and sanitation services, transportation, storage and distributionservices. Other organizations that are indirectly involved include, but are not limited to, suppliers of equipment,cleaning and sanitizing agents, packaging material, and other food contact materials.

This International Standard allows an organization, such as a small and/or less developed organization (e.g. asmall farm, a small packer-distributor, a small retail or food service outlet), to implement an externally developedcombination of control measures.

NOTE Guidance on the application of this International Standard is given in ISO/TS 22004.

2 Normative references

The following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

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