1、October 2007DEUTSCHE NORM English price group 10No 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 65.120; 67.020!$IJj“13
2、83971www.din.deDDIN EN ISO 22005Traceability in the feed and food chain General principles and basic requirements for system design andimplementation (ISO 22005:2007)English version of DIN EN ISO 22005:2007-10Rckverfolgbarkeit in der Futter- und Lebensmittelkette Allgemeine Grundstze und grundlegend
3、e Anforderungen fr die Gestaltung undVerwirklichung von Systemen (ISO 22005:2007)Englische Fassung DIN EN ISO 22005:2007-10www.beuth.deDocument comprises 13 pages DIN EN ISO 22005:2007-10 2 National foreword This standard has been published in accordance with the result of the parallel voting proced
4、ure within the scope of the Agreement on technical cooperation between ISO and CEN (Vienna Agreement) to adopt, without alteration, International Standard ISO 22005:2007 as a European Standard. ISO 22005:2007 has been prepared by Technical Committee ISO/TC 34 “Agricultural food products” (Secretaria
5、t: AFNOR, France), Working Group 9 “Traceability system in the agriculture food chain General principles for design and development” (Secretariat: UNI, Italy). The responsible German body involved in its preparation was the Normenausschuss Lebensmittel und land-wirtschaftliche Produkte (Foodstuffs a
6、nd Agricultural Products Standards Committee), Technical Committees AA Lebensmittelsicherheit Management-Systeme and AK Rckverfolgbarkeit in der Lebensmittelkette. Irrespective of the international provisions (Codex Alimentarius), Directive 178/2002/EC, article 18, and the associated guideline and D
7、irective 1935/2004/EC, article 17, are to be observed within the European Union. As regards the system-aided traceability, suitable standards have been prepared by Technical Committee ISO/IEC JTC 1/SC 31, such as ISO/IEC 15417 or ISO/IEC 15420 on bar codes and ISO/IEC 18000-6 Part C on radio frequen
8、cy identification for item management. The DIN Standard corresponding to the International Standard referred to in the EN is as follows: ISO 22000 DIN EN ISO 22000 National Annex NA (informative) Bibliography DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 19011, G
9、uidelines for quality and/or environmental management systems auditing DIN EN ISO 22000, Food safety management systems Requirements for any organization in the food chain EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22005 July 2007 ICS 67.040 English Version Traceability in the feed and
10、 food chain - General principles and basic requirements for system design and implementation (ISO 22005:2007) Traabilit de la chane alimentaire - Principes gnraux et exigences fondamentales sappliquant la conception du systme et sa mise en uvre (ISO 22005:2007) Rckverfolgbarkeit in der Futter- und L
11、ebensmittelkette - Allgemeine Grundstze und grundlegende Anforderungen fr die Gestaltung und Verwirklichung von Systemen (ISO 22005:2007) This European Standard was approved by CEN on 6 July 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition
12、s 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 of
13、ficial 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 Austr
14、ia, 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 COMMIT
15、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22005:2007: EForeword This docume
16、nt (EN ISO 22005:2007) 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 pub
17、lication of an identical text or by endorsement, at the latest by January 2008, and conflicting national standards shall be withdrawn at the latest by January 2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impleme
18、nt 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 an
19、d United Kingdom. Endorsement notice The text of ISO 22005:2007 has been approved by CEN as EN ISO 22005:2007 without any modifications. 2 EN ISO 22005:2007 (E) Introduction A traceability system is a useful tool to assist an organization operating within a feed and food chain to achieve defined obj
20、ectives in a management system. The choice of a traceability system is influenced by regulations, product characteristics and customer expectations. The complexity of the traceability system can vary depending on the features of the product and the objectives to be achieved. The implementation by an
21、 organization of a traceability system depends on technical limits inherent to the organization and products (i.e. nature of the raw materials, size of the lots, collection and transport procedures, processing and packaging methods), and the cost benefits of applying such a system. A traceability sy
22、stem on its own is insufficient to achieve food safety. 3 EN ISO 22005:2007 (E) 1 Scope This International Standard gives the principles and specifies basic requirements for the design and implementation of a feed and food traceability system. It can be applied by an organization operating at any st
23、ep in the feed and food chain. It is intended to be flexible enough to allow feed organizations and food organizations to achieve identified objectives. The traceability system is a technical tool to assist an organization to conform with its defined objectives and is applicable when necessary to de
24、termine the history, or location of a product or its relevant components. 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 referenc
25、ed document (including any amendments) applies. ISO 22000:2005, Food safety management systems Requirements for any organization in the food chain 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 22000 and the following apply. 3.1 product result of a
26、process ISO 9000:2005, definition 3.4.2 NOTE Product may include packaging material. 3.2 process set of interrelated or interacting activities which transforms inputs into outputs NOTE 1 Inputs to a process are generally outputs of other processes. NOTE 2 Processes in an organization (3.10) are gene
27、rally planned and carried out under controlled conditions to add value. NOTE 3 A process where the conformity of other resulting product (3.1) cannot be readily or economically verified is frequently referred to as a “special process”. ISO 9000:2005, definition 3.4.1 4 EN ISO 22005:2007 (E) 3.3 lot
28、set of units of a product which have been produced and/or processed or packaged under similar circumstances NOTE 1 The lot is determined by parameters established beforehand by the organization. NOTE 2 A set of units may be reduced to a single unit of product. 3.4 lot identification process of assig
29、ning a unique code to a lot 3.5 location place of production, processing, distribution, storage and handling from primary production to consumption 3.6 traceability ability to follow the movement of a feed or food through specified stage(s) of production, processing and distribution NOTE 1 Adapted f
30、rom Reference 3. NOTE 2 Movement can relate to the origin of the materials, processing history or distribution of the feed or food. NOTE 3 Terms such as “document traceability”, “computer traceability” or “commercial traceability” should be avoided. 3.7 feed and food chain sequence of the stages and
31、 operations involved in the production, processing, distribution and handling of feed and food, from primary production to consumption NOTE Primary production includes the production of feed for food-producing animals and for animals intended for food production. 3.8 flow of materials movement of an
32、y materials at any point in the feed and food chain 3.9 materials feed and food, feed and food ingredients and packaging materials 3.10 organization group of people and facilities with an arrangement of responsibilities, authorities and relationships ISO 9000:2005, definition 3.3.1 NOTE 1 An organiz
33、ation may consist of one person. NOTE 2 An organization can be public or private. 3.11 data recorded information 5 EN ISO 22005:2007 (E) 3.12 traceability system totality of data and operations that is capable of maintaining desired information about a product and its components through all or part
34、of its production and utilization chain 4 Principles and objectives of traceability 4.1 General Traceability systems should be able to document the history of the product and/or locate a product in the feed and food chain. Traceability systems contribute to the search for the cause of nonconformity
35、and the ability to withdraw and/or recall products if necessary. Traceability systems can improve appropriate use and reliability of information, effectiveness and productivity of the organization. Traceability systems should be able to achieve the objectives (see 4.3) from a technical and economic
36、point of view. Movement can relate to the origin of the materials, processing history or distribution of the feed or food, and should address at least one step forward and one step backward for each organization in the chain. On agreement amongst the organizations concerned, it may apply to more tha
37、n one part of the chain. 4.2 Principles Traceability systems should be verifiable, applied consistently and equitably, results oriented, cost effective, practical to apply, compliant with any applicable regulations or policy, and compliant with defined accuracy requirements. 4.3 Objectives In develo
38、ping a feed and food chain traceability system, it is necessary to identify the specific objectives to be achieved. These objectives should take into consideration the principles identified in 4.2. Examples of objectives are the following: a) to support food safety and/or quality objectives; b) to m
39、eet customer specification(s); c) to determine the history or origin of the product; d) to facilitate the withdrawal and/or recall of products; e) to identify the responsible organizations in the feed and food chain; f) to facilitate the verification of specific information about the product; 6 EN I
40、SO 22005:2007 (E) g) to communicate information to relevant stakeholders and consumers; h) to fulfil any local, regional, national or international regulations or policies, as applicable; i) to improve the effectiveness, productivity and profitability of the organization. 5 Design 5.1 General design
41、 considerations A traceability system is a tool that should be designed within the context of a broader management system. The choice of a traceability system should result from balancing the different requirements, the technical feasibility and the economic acceptability. The traceability system sh
42、ould be verifiable. Each element of a traceability system shall be considered and justified on a case-by-case basis, taking into account the objectives to be achieved. In the design of a traceability system, the following shall be included: a) objectives; b) regulatory and policy requirements releva
43、nt to traceability; c) products and/or ingredients; d) position in the feed and food chain; e) flow of materials; f) information requirements; g) procedures; h) documentation; i) feed and food chain coordination. 5.2 Choice of objectives The organization shall identify the objectives of its traceabi
44、lity system (see 4.3). 5.3 Regulatory and policy requirements The organization shall identify the relevant regulatory and policy requirements to be met by its traceability system. 5.4 Products and/or ingredients The organization shall identify the relevant products and/or ingredients for which the o
45、bjectives of its traceability system apply. 7 EN ISO 22005:2007 (E) 5.5 Steps for the design 5.5.1 Position in the feed and food chain The organization shall determine its position in the food chain by at least identifying its suppliers and customers. 5.5.2 Flow of materials The organization shall d
46、etermine and document the flow of materials within its control in a manner which meets the objectives of the traceability system. 5.5.3 Information requirements To meet its traceability objectives, the organization shall define the information to be obtained from its suppliers, to be collected conce
47、rning the product and process history, and to be provided to its customers and/or suppliers. NOTE The information required for a traceability system is influenced by its objectives and by the position of the organization in the feed and food chain. 5.6 Establishment of procedures Procedures generall
48、y relate to documenting the flow of materials and related information, including document retention and verification. The organization shall establish procedures that include at least the following: a) product definition; b) lot definition and identification; c) documentation of flow of materials, a
49、nd information including media for record keeping; d) data management and recording protocols; e) information retrieval protocols. In the development and implementation of a traceability system, it is necessary to take into account the existing operation and management systems present in the organization. Procedures to manage traceability information shall include a means to link and record the flow of information concerning materials and products, if needed. Procedures shall be established to deal with nonconformity in
