1、May 2008DEUTSCHE NORM English price group 11No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 55.020; 67.020!$Ne“1439366
2、www.din.deDDIN EN 15593Packaging Management of hygiene in the production of packaging for foodstuffs RequirementsEnglish version of DIN EN 15593:2008-05Verpackung Hygienemanagement bei der Herstellung von Lebensmittelverpackungen AnforderungenEnglische Fassung DIN EN 15593:2008-05www.beuth.deDocumen
3、t comprises 18 pagesDIN EN 15593:2008-05 2 National foreword This standard has been prepared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France), Working Group WG 1 “Management of Hygiene in the production of packaging for foodstuffs” (Secretariat: DIN, Germany). The responsib
4、le German body involved in its preparation was the Normenausschuss Verpackungswesen (Packaging Standards Committee), Technical Committee NA 115-01-07 AA Hygienemanagement im Bereich der Packmittelerzeugung. EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 15593March 2008ICS 55.020; 67.020English Ve
5、rsionPackaging - Management of hygiene in the production ofpackaging for foodstuffs - RequirementsEmballages - Management de lhygine dans la fabricationdes emballages destins aux denres alimentaires -ExigencesVerpackung - Hygienemanagement bei der Herstellung vonLebensmittelverpackungen - Anforderun
6、genThis 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical re
7、ferences concerning such nationalstandards 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 translationunder the responsibility of a CEN member
8、into its own language and notified to the CEN Management Centre has the same status as theofficial 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
9、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 20
10、08 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15593:2008: EEN 15593:2008 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Hygiene management system 7 4.1 Management re
11、sponsibility 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 Outsourcing9 4.10 Monitoring and measurement of product .9 4.11 Human
12、resources.9 5 Hazard analysis and risk assessment .9 5.1 General9 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
13、 and waste handling 12 7 Factory requirements 12 7.1 External areas 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 medi
14、cines15 8.6 Injuries and diseases 15 8.7 Visitors15 Bibliography 16 DIN EN 15593:2008-05 EN 15593:2008 (E) 3 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 st
15、atus 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 t
16、he 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, Belg
17、ium, 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. DIN EN 15593:2008-
18、05 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 hazards related to their products. Packaging hygiene is a joint responsibility that is principally assur
19、ed 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 analysi
20、s 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 managemen
21、t 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
22、 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
23、 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 22
24、000. 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. DIN EN 15593:2008-05 EN 15593:2008 (E) 5 1 Scope This European Stan
25、dard 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 th
26、at 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 s
27、afety 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 organizatio
28、ns 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 man
29、agement 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 do
30、cument. 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
31、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 chemic
32、al agent or foreign matter or other substances not intentionally added which may compromise product safety or suitability DIN EN 15593:2008-05 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
33、a condition of the product that 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 potentia
34、lly compromise the safety and 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 produc
35、t 3.8 product physical final 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
36、of products identified as potentially 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 explic
37、it or detailed description of 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 DIN EN 15593:2008-05 EN 15593:2008 (E) 7 4 Hygiene management system 4.1 Management responsibility 4.1.1
38、Top management shall define its hygiene policy which shall state its commitment to develop and 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 a
39、t planned intervals and at least once a year and shall ensure the availability of resources in 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 applica
40、tion of this document. 4.1.3 Top management shall appoint a competent person responsible for 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.
41、 The scope shall specify the products or product categories, processes and production sites that 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 reca
42、lls. 4.1.6 The organization shall periodically review customer feedback, audit results and follow-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
43、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 requirements of this document shall also apply to contractors and temporary personnel. 4.2 Con
44、trol of documents 4.2.1 The organization shall have a procedure to control documents and records. 4.2.2 Documents shall be properly approved, reviewed and updated with changes and current version status identified. They shall be made available at the point of use. 4.2.3 Records shall be maintained t
45、o provide evidence of the effective operation of the hygiene management system and retained for a period covering the normal and foreseeable shelf life of the packaged food. 4.3 Specifications 4.3.1 The organization shall establish and regularly review specifications for incoming materials and for p
46、roducts. 4.3.2 Where appropriate, the specifications shall be agreed between the organization and the interested parties. DIN EN 15593:2008-05 EN 15593:2008 (E) 8 4.4 Management of nonconformities and incidents 4.4.1 The organization shall have procedures for dealing with nonconformities and inciden
47、ts and shall take action to eliminate them. Action shall be taken to eliminate the causes of nonconformities and incidents to prevent a recurrence. 4.4.2 The organization shall have written guidance to its personnel on events that could constitute an incident. 4.4.3 The nature of nonconformities and
48、 incidents and any subsequent actions taken shall be recorded. The effectiveness of the corrective action implemented shall be verified. 4.4.4 Where a nonconforming product is detected after delivery, or its use has started, the organization shall take appropriate action for all products concerned.
49、The customer shall be informed about the nature of the nonconformity. 4.5 Traceability 4.5.1 The organization shall have procedures in place which ensure that the traceability of materials and products can be provided. 4.5.2 The effectiveness of the traceability system shall be demonstrated by an audit or by existing recall records or by a simulation of a recall. 4.6 Internal audits 4.6.1 The organization shall conduct internal audits at planned intervals to assess that the hygiene management system is effectively implemented and maintained. 4.6.2 The r
