1、BRITISH STANDARDBS EN ISO 22005:2007Traceability in the feed and food chain General principles and basic requirements for system design and implementationThe European Standard EN ISO 22005:2007 has the status of a British StandardICS 67.040g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54
2、g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 22005:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2007 BSI 2007ISBN 978
3、0 580 59378 9National forewordThis British Standard is the UK implementation of EN ISO 22005:2007.The UK participation in its preparation was entrusted to Technical Committee AW/90, Quality systems for the food industry.A list of organizations represented on this committee can be obtained on request
4、 to its secretary.This publication does not purport to include 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 issued since publicationAmd. No. Date CommentsEUROP
5、EAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22005July 2007ICS 67.040English VersionTraceability in the feed and food chain - General principles andbasic requirements for system design and implementation (ISO22005:2007)Traabilit de la chane alimentaire - Principes gnraux etexigences fondamentale
6、s sappliquant la conception dusystme et sa mise en oeuvre (ISO 22005:2007)Rckverfolgbarkeit in der Futter- und Lebensmittelkette -Allgemeine Grundstze und grundlegende Anforderungenfr die Gestaltung und Verwirklichung von Systemen (ISO22005:2007)This European Standard was approved by CEN on 6 July 2
7、007.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
8、 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 into its own language and notified to the CEN Management Cent
9、re 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
10、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 2007 CEN All rights of exploitation in any form and by any mean
11、s reservedworldwide for CEN national Members.Ref. No. EN ISO 22005:2007: EForeword This document (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
12、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 January 2008, and conflicting national standards shall be withdrawn at the latest by January 2008. According to the CEN/CENELEC Internal Reg
13、ulations, 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, Net
14、herlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22005:2007 has been approved by CEN as EN ISO 22005:2007 without any modifications. EN ISO 22005:2007Reference numberISO 22005:2007(E)INTERNATIONAL STAND
15、ARD ISO22005First edition2007-07-15Traceability in the feed and food chain General principles and basic requirements for system design and implementation Traabilit de la chane alimentaire Principes gnraux et exigences fondamentales sappliquant la conception du systme et sa mise en oeuvre EN ISO 2200
16、5:2007ii iiiForeword 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 ISO technical committees. Each member body interested in a subject f
17、or which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on
18、 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 Standards adopted by the technical committees a
19、re circulated to the member bodies for voting. Publication as an International 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 patent rights. ISO shall not be held
20、responsible for identifying any or all such patent rights. ISO 22005 was prepared by Technical Committee ISO/TC 34, Food products. EN ISO 22005:2007iv Introduction A traceability system is a useful tool to assist an organization operating within a feed and food chain to achieve defined objectives in
21、 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 organizat
22、ion 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 system on it
23、s own is insufficient to achieve food safety. EN ISO 22005:20071Traceability in the feed and food chain General principles and basic requirements for system design and implementation 1 Scope This International Standard gives the principles and specifies basic requirements for the design and implemen
24、tation of a feed and food traceability system. It can be applied by an organization operating at any step 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
25、to assist an organization to conform with its defined objectives and is applicable when necessary to determine 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
26、 references, only the edition cited applies. For undated references, the latest edition of the referenced 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 d
27、ocument, the terms and definitions given in ISO 22000 and the following apply. 3.1 product result of a 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
28、a process are generally outputs of other processes. NOTE 2 Processes in an organization (3.10) are generally 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 frequent
29、ly referred to as a “special process”. ISO 9000:2005, definition 3.4.1 EN ISO 22005:20072 3.3 lot 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
30、A set of units may be reduced to a single unit of product. 3.4 lot identification process of assigning 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 f
31、eed or food through specified stage(s) of production, processing and distribution NOTE 1 Adapted from 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”
32、or “commercial traceability” should be avoided. 3.7 feed and food chain sequence of the stages and 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-pr
33、oducing animals and for animals intended for food production. 3.8 flow of materials movement of any 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
34、 responsibilities, authorities and relationships ISO 9000:2005, definition 3.3.1 NOTE 1 An organization may consist of one person. NOTE 2 An organization can be public or private. 3.11 data recorded information EN ISO 22005:200733.12 traceability system totality of data and operations that is capabl
35、e of maintaining desired information about a product and its components through all or part 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 a
36、nd food chain. Traceability systems contribute to the search for the cause of nonconformity 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. Traceabili
37、ty systems should be able to achieve the objectives (see 4.3) from a technical and economic 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 organizat
38、ion in the chain. On agreement amongst the organizations concerned, it may apply to more than 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 regul
39、ations or policy, and compliant with defined accuracy requirements. 4.3 Objectives In developing 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 o
40、f objectives are the following: a) to support food safety and/or quality objectives; b) to meet 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 foo
41、d chain; f) to facilitate the verification of specific information about the product; EN ISO 22005:20074 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 effecti
42、veness, productivity and profitability of the organization. 5 Design 5.1 General design 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 requirement
43、s, the technical feasibility and the economic acceptability. The traceability system should 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 f
44、ollowing shall be included: a) objectives; b) regulatory and policy requirements relevant 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.
45、5.2 Choice of objectives The organization shall identify the objectives of its traceability 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 T
46、he organization shall identify the relevant products and/or ingredients for which the objectives of its traceability system apply. EN ISO 22005:200755.5 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 identify
47、ing its suppliers and customers. 5.5.2 Flow of materials The organization shall determine 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 shal
48、l define the information to be obtained from its suppliers, to be collected concerning 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 organizatio
49、n in the feed and food chain. 5.6 Establishment of procedures Procedures generally 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, and information including media for record keeping; d) data management and recording protocols; e) information retrieval protocols. In the devel
