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1、BRITISH STANDARD BS EN 15593:2008 Packaging Management of hygiene in the production of packaging for foodstuffs Requirements ICS 55.020; 67.020 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/200
2、8 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 15593:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008 ISBN 978 0 580 56568 7 National foreword This British Standard is the U
3、K implementation of EN 15593:2008. The UK participation in its preparation was entrusted by Technical Committee PKW/0, Packaging, to Panel PKW/0/-/2, Hygiene. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to inclu
4、de all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Copyright British Standards Institution Provided by IHS unde
5、r license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15593 March 2008 ICS 55.020; 67.020 English Version Packaging - Mana
6、gement of hygiene in the production of packaging for foodstuffs - Requirements Emballages - Management de lhygine dans la fabrication des emballages destins aux denres alimentaires - Exigences Verpackung - Hygienemanagement bei der Herstellung von Lebensmittelverpackungen - Anforderungen This Europe
7、an 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 con
8、cerning 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
9、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, Lith
10、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 200
11、8 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15593:2008: E Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:01:18 MDT
12、No reproduction or networking permitted without license from IHS -,-,- EN 15593:2008 (E) 2 Contents Page Foreword3 Introduction.4 1 Scope 5 2 Normative references5 3 Terms and definitions .5 4 Hygiene management system7 4.1 Management responsibility 7 4.2 Control of documents .7 4.3 Specifications.7
13、 4.4 Management of nonconformities and incidents.8 4.5 Traceability.8 4.6 Internal audits 8 4.7 Complaints management8 4.8 Approval and monitoring of suppliers.8 4.9 Outsourcing9 4.10 Monitoring and measurement of product .9 4.11 Human resources.9 5 Hazard analysis and risk assessment.9 5.1 General9
14、 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 Cleaning11 6.6 Maintenance.12 6.7 Scrap and waste handling 12 7 Factory requirements12 7.1 External areas
15、12 7.2 Buildings.12 7.3 Equipment 13 7.4 Facilities13 8 Personnel14 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 medicines15 8.6 Injuries and diseases 15 8.7 Visitors15 Bibliography16 B
16、S EN 15593:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EN 15593:2008 (E) 3 Foreword This document (E
17、N 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 confli
18、cting 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
19、 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, L
20、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 15593:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not fo
21、r Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EN 15593:2008 (E) 4 Introduction All manufacturers of food packaging recognize the increasing need to demonstrate and provide adequate evidence of their ability to identify and control hygiene haz
22、ards 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 iden
23、tified 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 packag
24、ing 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 c
25、onsideration 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 req
26、uirements 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 ma
27、nufacturers 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 app
28、licable food contact regulations. BS EN 15593:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EN 15593:2
29、008 (E) 5 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 an
30、alysis 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
31、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 Standa
32、rd 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 appli
33、ed 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 indispen
34、sable 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 IS
35、O 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
36、(including microbiological) or chemical agent or foreign matter or other substances not intentionally added which may compromise product safety or suitability BS EN 15593:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/591077
37、0001 Not for Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EN 15593:2008 (E) 6 3.2 contamination introduction or occurrence of a contaminant 3.3 hazard biological, chemical or physical contaminant in the product, or a condition of the product t
38、hat may cause an adverse health effect or a nonconformity to the hygiene requirements for that product 3.4 hygiene set of measures taken to ensure the safety and suitability of a product that might otherwise become hazardous or harmful 3.5 incident event that may potentially compromise the safety an
39、d suitability of a material or product 3.6 outsourced activity any activity subcontracted by an organization to an external organization 3.7 packaging any kind of product or material used by the packaging industry to wrap, pack, protect, handle or transport its own product 3.8 product physical final
40、 output of any kind of production process that takes place in the packaging industry. NOTE This includes products that undergo further production steps to fulfil the specification defined by the filler/packer. 3.9 recall procedure procedure to ensure the efficient return of products identified as po
41、tentially having a nonconformity that could present a hazard 3.10 risk function of the probability of the possible occurrence of a hazard and the severity of its outcome 3.11 safety condition of a product being free from unacceptable risk of harm 3.12 specification explicit or detailed description o
42、f a material, product or service including hygiene aspects 3.13 top management person or group of people who directs and controls an organization at the highest level BS EN 15593:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing C
43、o/5910770001 Not for Resale, 08/14/2008 21:01:18 MDTNo reproduction or networking permitted without license from IHS -,-,- EN 15593:2008 (E) 7 4 Hygiene management system 4.1 Management responsibility 4.1.1 Top management shall define its hygiene policy which shall state its commitment to develop an
44、d implement a hygiene management system to ensure that it meets its obligations to produce safe products and shall communicate this effectively through the organization. It shall conduct management reviews at planned intervals and at least once a year and shall ensure the availability of resources i
45、n accordance with the requirements of this document. 4.1.2 The organization shall apply hazard analysis and risk assessment to every stage from procurement to delivery of the product to determine the application of this document. 4.1.3 Top management shall appoint a competent person responsible for
46、implementing and maintaining the hygiene management system. 4.1.4 A manual defining the scope of the system including the documented procedures or references to them shall be established by the organization. The scope shall specify the products or product categories, processes and production sites t
47、hat are addressed by the hygiene management system. 4.1.5 The organization shall establish documents needed to ensure the effective planning, operation and control of processes related to hygiene and to recalls. 4.1.6 The organization shall periodically review customer feedback, audit results and fo
48、llow-up actions. 4.1.7 Top management shall ensure that responsibilities and authorities are defined. Duties of personnel that relate to this document shall be provided in job descriptions or other suitable documents. 4.1.8 Top management shall ensure that appropriate communication processes are in place within the organization. 4.1.9 The organization shall have a plan for cleaning and maintenance. 4.1.10 The requir