EN 15593:2008
(Main)Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
This European Standard specifies requirements for a hygiene management system for manufacturers and suppliers of food packaging including storage and transportation.
This European Standard enables an organization to:
- plan, design, implement, operate, maintain and update a hazard analysis and risk assessment system that ensures the production of food packaging materials conforming with the hygiene requirements;
- demonstrate conformity with agreed customers’ hygiene requirements;
- demonstrate the effectiveness of the system;
- help food manufacturers to provide adequate evidence to compliance with food and packaging safety regulations;
- ensure that it complies with its stated hygiene policy;
- demonstrate such compliance to other interested parties;
- seek registration or certification of its food packaging hygiene management system by an external organization.
This European Standard can be applied to all organizations wishing to implement an adequate and effective hygiene management system in the field of food packaging manufacturing including producers and suppliers of materials and services to the packaging manufacturers.
It is intended that this European Standard be applied in conjunction with a quality management system such as EN ISO 9001.
It may be appropriate to apply this European Standard to other articles and items coming into contact with food and to packaging of products other than food.
Verpackung - Hygienemanagement bei der Herstellung von Lebensmittelverpackungen - Anforderungen
Diese Europäische Norm legt die Anforderungen an ein Hygienemanagementsystem von Herstellern von Lebensmittelverpackungen und deren Zulieferern fest, einschließlich der Lagerhaltung und des Transportes.
Diese Europäische Norm befähigt ein Unternehmen:
ein System zur Gefährdungsanalyse und Risikobewertung zu entwickeln, zu gestalten, einzuführen, zu betreiben, zu pflegen und zu aktualisieren, welches die Herstellung von Lebensmittelverpackungsmaterial entsprechend den hygienischen Anforderungen sicherstellt;
die Übereinstimmung mit den mit dem Kunden vereinbarten Hygieneanforderungen nachzuweisen;
die Wirksamkeit des Systems nachzuweisen;
den Lebensmittelhersteller zu unterstützen, den geeigneten Nachweis hinsichtlich der Einhaltung der Bestimmungen über Lebensmittel- und Verpackungssicherheit zu erbringen;
sicherzustellen, dass es seine beschriebene Hygienepolitik einhält;
solch eine Übereinstimmung gegenüber anderen interessierten Parteien nachzuweisen;
die Zulassung oder Zertifizierung seines Hygienemanagementsystems für Lebensmittelverpackungen durch eine externe Organisation anzustreben.
Diese Europäische Norm kann von allen Unternehmen angewandt werden, die ein geeignetes and wirkungsvolles Hygienemanagementsystem für den Bereich der Herstellung von Lebensmittelverpackungen – einschließlich der Materialhersteller und -zulieferer und der Dienstleister – einführen wollen.
Es ist beabsichtigt, diese Europäische Norm in Verbindung mit einem Qualitätsmanagementsystem wie z. B. EN ISO 9001 anzuwenden.
Es kann angezeigt sein, diese Europäische Norm auf andere Gegenstände und Teile, die mit Lebensmitteln in Berührung kommen, und auf Verpackungen für Produkte, die keine Lebensmittel sind, anzuwenden.
Emballages - Management de l'hygiène dans la fabrication des emballages destinés aux denrées alimentaires - Exigences
La présente Norme européenne spécifie les exigences relatives à un système de management de l’hygiène
destiné aux fabricants et fournisseurs d’emballages pour produits alimentaires, y compris pour le stockage et
le transport.
La présente Norme européenne permet à une organisation de :
- planifier, concevoir, mettre en oeuvre, exploiter, maintenir et mettre à jour un système d’analyse des
dangers et d’évaluation des risques qui garantit que la production de matériaux d’emballage des produits
alimentaires est conforme aux exigences d’hygiène ;
- démontrer la conformité aux exigences d’hygiène convenues avec le client ;
- démontrer l’efficacité du système ;
- aider les producteurs de produits alimentaires à fournir les preuves appropriées qu’ils respectent les
réglementations de sécurité en matière d’aliment et d’emballage ;
- garantir qu’elle respecte la politique d’hygiène qu’elle déclare ;
- démontrer ce respect aux autres parties intéressées ;
- briguer une reconnaissance ou une certification de son système de management de l’hygiène de ses
emballages pour produits alimentaires par un organisme extérieur.
La présente Norme européenne peut être appliquée à toutes les organisations souhaitant mettre en oeuvre un
système approprié et efficace de management de l’hygiène dans le domaine de la fabrication des emballages
alimentaires, y compris les producteurs et les fournisseurs de matériaux et de services aux fabricants
d’emballages.
Il est prévu que la présente Norme européenne soit applicable en conjonction avec un système de
management de la qualité tel que celui de l’EN ISO 9001.
Il peut être approprié d’appliquer la présente Norme européenne à d’autres articles et produits venant en
contact avec des produits alimentaires ainsi qu’à l’emballage de produits autres que les produits alimentaires.
Embalaža - Obvladovanje higiene v proizvodnji embalaže za živila - Zahteve
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2008
Embalaža - Obvladovanje higiene v proizvodnji embalaže za živila - Zahteve
Packaging - Management of hygiene in the production of packaging for foodstuffs -
Requirements
Verpackung - Hygienemanagement bei der Herstellung von Lebensmittelverpackungen -
Anforderungen
Emballages - Management de l'hygiene dans la fabrication des emballages destinés aux
denrées alimentaires - Exigences
Ta slovenski standard je istoveten z: EN 15593:2008
ICS:
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 15593
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 55.020; 67.020
English Version
Packaging - Management of hygiene in the production of
packaging for foodstuffs - Requirements
Emballages - Management de l'hygiène dans la fabrication Verpackung - Hygienemanagement bei der Herstellung von
des emballages destinés aux denrées alimentaires - Lebensmittelverpackungen - Anforderungen
Exigences
This European Standard was approved by CEN on 7 February 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15593:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Introduction .4
1 Scope.5
2 Normative references.5
3 Terms and definitions .5
4 Hygiene management system .7
4.1 Management responsibility.7
4.2 Control of documents .7
4.3 Specifications.7
4.4 Management of nonconformities and incidents.8
4.5 Traceability.8
4.6 Internal audits.8
4.7 Complaints management.8
4.8 Approval and monitoring of suppliers.8
4.9 Outsourcing.9
4.10 Monitoring and measurement of product .9
4.11 Human resources.9
5 Hazard analysis and risk assessment .9
5.1 General.9
5.2 Procedures.10
6 Sources of contamination.10
6.1 Physical contaminants (foreign bodies) .10
6.2 Chemical contaminants.10
6.3 Biological contaminants.11
6.4 Storage and distribution.11
6.5 Cleaning.11
6.6 Maintenance.12
6.7 Scrap and waste handling .12
7 Factory requirements.12
7.1 External areas.12
7.2 Buildings.12
7.3 Equipment.13
7.4 Facilities.13
8 Personnel.14
8.1 Access points and specific routes.14
8.2 Work clothes.14
8.3 Personal belongings.14
8.4 Toilets and lockers .14
8.5 Eating, drinking and use of tobacco and medicines.15
8.6 Injuries and diseases .15
8.7 Visitors.15
Bibliography .16
Foreword
This document (EN 15593:2008) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the
secretariat of which is held by AFNOR.
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 September 2008, and conflicting national standards shall be
withdrawn at the latest by September 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
All manufacturers of food packaging recognize the increasing need to demonstrate and provide adequate
evidence of their ability to identify and control hygiene hazards related to their products.
Packaging hygiene is a joint responsibility that is principally assured through the combined efforts of all the
parties participating in the chain.
Communication along the food packaging chain is essential to ensure that all relevant packaging hygiene
hazards are identified and adequately controlled.
This European Standard is based on the principles of hazard analysis and risk assessment.
This European Standard provides for the definition of the appropriate level of controls and measures for each
stage in the manufacturing process.
The most effective food packaging hygiene systems are designed, operated and updated within the
framework of a structured management system and incorporated into the overall management activities of the
organization. This provides maximum benefit for the organization and interested parties.
This European Standard has taken due consideration of the provisions of the EN ISO 9000 series in order to
enhance the compatibility of the two standards.
This European Standard may be applied independently from other management system standards. Its
implementation can be aligned or integrated with existing related management system requirements while
organizations may utilize existing management system(s) to establish a food packaging hygiene management
system that complies with the requirements of this European Standard.
This European Standard is a document describing both management system and hygiene practices for
packaging manufacturers considering themselves as an organization within the food chain as described in EN
ISO 22000.
This European Standard does not purport to address the compulsory conformity of packaging to food contact
regulations.
It is expected that the user of this European Standard has knowledge of applicable food contact regulations.
1 Scope
This European Standard specifies requirements for a hygiene management system for manufacturers and
suppliers of food packaging including storage and transportation.
This European Standard enables an organization to:
plan, design, implement, operate, maintain and update a hazard analysis and risk assessment system
that ensures the production of food packaging materials conforming with the hygiene requirements;
demonstrate conformity with agreed customers’ hygiene requirements;
demonstrate the effectiveness of the system;
help food manufacturers to provide adequate evidence to compliance with food and packaging safety
regulations;
ensure that it complies with its stated hygiene policy;
demonstrate such compliance to other interested parties;
seek registration or certification of its food packaging hygiene management system by an external
organization.
This European Standard can be applied to all organizations wishing to implement an adequate and effective
hygiene management system in the field of food packaging manufacturing including producers and suppliers
of materials and services to the packaging manufacturers.
It is intended that this European Standard be applied in conjunction with a quality management system such
as EN ISO 9001.
It may be appropriate to apply this European Standard to other articles and items coming into contact with
food and to packaging of products other than food.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced docu-
ment (including any amendments) applies.
EN ISO 9000:2005, Quality management systems – Fundamentals and vocabulary (ISO 9000:2005)
EN ISO 22000:2005, Food safety management systems – Requirements for any organization in the food
chain (ISO 22000:2005)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 9000:2005, EN ISO 22000:2005
and the following apply.
3.1
contaminant
any biological (including microbiological) or chemical agent or foreign matter or other substances not
intentionally added which may compromise product safety or suitability
...
SLOVENSKI STANDARD
01-september-2008
Embalaža - Obvladovanje higiene v proizvodnji embalaže za živila - Zahteve
Packaging - Management of hygiene in the production of packaging for foodstuffs -
Requirements
Verpackung - Hygienemanagement bei der Herstellung von Lebensmittelverpackungen -
Anforderungen
Emballages - Management de l'hygiene dans la fabrication des emballages destinés aux
denrées alimentaires - Exigences
Ta slovenski standard je istoveten z: EN 15593:2008
ICS:
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 15593
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 55.020; 67.020
English Version
Packaging - Management of hygiene in the production of
packaging for foodstuffs - Requirements
Emballages - Management de l'hygiène dans la fabrication Verpackung - Hygienemanagement bei der Herstellung von
des emballages destinés aux denrées alimentaires - Lebensmittelverpackungen - Anforderungen
Exigences
This European Standard was approved by CEN on 7 February 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15593:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Introduction .4
1 Scope.5
2 Normative references.5
3 Terms and definitions .5
4 Hygiene management system .7
4.1 Management responsibility.7
4.2 Control of documents .7
4.3 Specifications.7
4.4 Management of nonconformities and incidents.8
4.5 Traceability.8
4.6 Internal audits.8
4.7 Complaints management.8
4.8 Approval and monitoring of suppliers.8
4.9 Outsourcing.9
4.10 Monitoring and measurement of product .9
4.11 Human resources.9
5 Hazard analysis and risk assessment .9
5.1 General.9
5.2 Procedures.10
6 Sources of contamination.10
6.1 Physical contaminants (foreign bodies) .10
6.2 Chemical contaminants.10
6.3 Biological contaminants.11
6.4 Storage and distribution.11
6.5 Cleaning.11
6.6 Maintenance.12
6.7 Scrap and waste handling .12
7 Factory requirements.12
7.1 External areas.12
7.2 Buildings.12
7.3 Equipment.13
7.4 Facilities.13
8 Personnel.14
8.1 Access points and specific routes.14
8.2 Work clothes.14
8.3 Personal belongings.14
8.4 Toilets and lockers .14
8.5 Eating, drinking and use of tobacco and medicines.15
8.6 Injuries and diseases .15
8.7 Visitors.15
Bibliography .16
Foreword
This document (EN 15593:2008) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the
secretariat of which is held by AFNOR.
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 September 2008, and conflicting national standards shall be
withdrawn at the latest by September 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
All manufacturers of food packaging recognize the increasing need to demonstrate and provide adequate
evidence of their ability to identify and control hygiene hazards related to their products.
Packaging hygiene is a joint responsibility that is principally assured through the combined efforts of all the
parties participating in the chain.
Communication along the food packaging chain is essential to ensure that all relevant packaging hygiene
hazards are identified and adequately controlled.
This European Standard is based on the principles of hazard analysis and risk assessment.
This European Standard provides for the definition of the appropriate level of controls and measures for each
stage in the manufacturing process.
The most effective food packaging hygiene systems are designed, operated and updated within the
framework of a structured management system and incorporated into the overall management activities of the
organization. This provides maximum benefit for the organization and interested parties.
This European Standard has taken due consideration of the provisions of the EN ISO 9000 series in order to
enhance the compatibility of the two standards.
This European Standard may be applied independently from other management system standards. Its
implementation can be aligned or integrated with existing related management system requirements while
organizations may utilize existing management system(s) to establish a food packaging hygiene management
system that complies with the requirements of this European Standard.
This European Standard is a document describing both management system and hygiene practices for
packaging manufacturers considering themselves as an organization within the food chain as described in EN
ISO 22000.
This European Standard does not purport to address the compulsory conformity of packaging to food contact
regulations.
It is expected that the user of this European Standard has knowledge of applicable food contact regulations.
1 Scope
This European Standard specifies requirements for a hygiene management system for manufacturers and
suppliers of food packaging including storage and transportation.
This European Standard enables an organization to:
plan, design, implement, operate, maintain and update a hazard analysis and risk assessment system
that ensures the production of food packaging materials conforming with the hygiene requirements;
demonstrate conformity with agreed customers’ hygiene requirements;
demonstrate the effectiveness of the system;
help food manufacturers to provide adequate evidence to compliance with food and packaging safety
regulations;
ensure that it complies with its stated hygiene policy;
demonstrate such compliance to other interested parties;
seek registration or certification of its food packaging hygiene management system by an external
organization.
This European Standard can be applied to all organizations wishing to implement an adequate and effective
hygiene management system in the field of food packaging manufacturing including producers and suppliers
of materials and services to the packaging manufacturers.
It is intended that this European Standard be applied in conjunction with a quality management system such
as EN ISO 9001.
It may be appropriate to apply this European Standard to other articles and items coming into contact with
food and to packaging of products other than food.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced docu-
ment (including any amendments) applies.
EN ISO 9000:2005, Quality management systems – Fundamentals and vocabulary (ISO 9000:2005)
EN ISO 22000:2005, Food safety management systems – Requirements for any organization in the food
chain (ISO 22000:2005)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 9000:2005, EN ISO 22000:2005
and the following apply.
3.1
contaminant
any biological (including microbiological) or chemical agent or foreign matter or other substances not
intentionally added which may compromise product safety or suitability
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.