1、BSI Standards PublicationBS ISO 18538:2015Traceability of molluscanproducts Specificationson the information to berecorded in farmed molluscandistribution chainsBS ISO 18538:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18538:2015.The UK participation in
2、 its preparation was entrusted to TechnicalCommittee AW/234, Fisheries and Aquaculture.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for it
3、s correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83934 4ICS 67.120.30Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and St
4、rategy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedBS ISO 18538:2015 ISO 2015Traceability of molluscan products Specifications on the information to be recorded in farmed molluscan distribution chainsTraabilit des mollusques Spcifications des informations enregis
5、trer dans les chaines de distribution de mollusques en fermeINTERNATIONAL STANDARDISO18538First edition2015-08-01Reference numberISO 18538:2015(E)BS ISO 18538:2015ISO 18538:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unles
6、s otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the ad
7、dress below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18538:2015ISO 18538:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative refe
8、rences 13 Terms and definitions . 14 Abbreviations. 35 Principle 46 Requirements 46.1 Identification of the units traded 46.2 Recording of information . 46.3 Controlled relaying and depuration . 66.4 Broodstock supplier and natural seed collectors/suppliers . 66.5 Hatcheries/nurseries 96.6 Molluscan
9、 farms 126.7 Processors 166.8 Transporters and store operators . 216.8.1 Live molluscs 216.8.2 Molluscs other than live 236.9 Traders and wholesalers . 266.10 Retailers and caterers 296.11 Bringing in supplies from outside the domain . 316.12 Molluscan feed producers 34Bibliography .38 ISO 2015 All
10、rights reserved iiiContents PageBS ISO 18538:2015ISO 18538:2015(E)ForewordISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC partici
11、pate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental
12、and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of information technology, ISO and IEC have established a joint technical committee, ISO/IEC JTC 1.The procedures used to develop this document and those intended for its further maintenance are described in
13、the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibil
14、ity that some of the elements of this document may be the subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO li
15、st of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well
16、 as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 234, Fisheries and aquaculture.iv ISO 2015 All rights reservedBS ISO 18538:2015ISO 1853
17、8:2015(E)IntroductionThere are increasing demands for detailed information on the nature and origin of food products. Traceability is becoming a legal and commercial necessity.The ISO definition of traceability concerns the ability to trace the history, application, and location of that which is und
18、er consideration and for products, this can include the origin of food materials and non-food parts; thereof, the processing history and the distribution and location of the product after delivery. Traceability includes not only the principal requirement to be able to physically trace products throu
19、gh the distribution chain from origin to destination and vice versa, but also to be able to provide information on what they are made of and what has happened to them. These further aspects of traceability are important in relation to food safety, quality, and labelling.The scheme specified in this
20、International Standard does not demand perfect traceability, i.e. that a particular retail product should be traceable back to a hatchery and or farm and batch of origin. Pragmatically, it is recognized that mixing of animals or materials is often commercially necessary at a number of stages in the
21、distribution chains, e.g. in grading at first sale prior to sale and in the processing of raw materials into products. As a result, there will be occasions where whole chain traceability of materials and products is neither possible nor commercially practical. These limitations are to be recognized
22、and taken into consideration when auditing against this International Standard and are not to preclude compliance so as to disadvantage, otherwise compliant operators. Where such mixing necessarily occurs, the food business shall generate a trade unit or units only from the point that identification
23、 of units is possible. The requirement for traceability is that the business records the IDs of created or received trade units that can be input into each subsequently created unit, thereafter and vice versa. The particular product or products are then traceable through the supply chain (as far as
24、is practical) to generate information on the maximum number of stages of the chain as possible.Given the variety of molluscan products and of their distribution chains that operate within and between different countries and varying legal requirements, the information specifications cannot itemise al
25、l the information that may possibly be required in every situation. This International Standard provides a generic basis for traceability. Flexibility is allowed for businesses to record further information in their own non-standardised files, but keyed to the same unit IDs.The information remains i
26、n the ownership of the food business that generated it, but is available when required by law for the purposes of traceability (in the event of a food safety problem) or by commercial agreement between businesses. The structure, names, and content of the information is standardised so that it can be
27、 readily communicated from business to business through the distribution chains ensuring common understanding of terms and meanings.Commercial arrangements for businesses to communicate information through the distribution chains are to be encouraged, particularly for the information desired by the
28、trade to be visible at the various transaction points in the chains, but that is not the subject of this International Standard.Though this International Standard is designed with electronic representation and communication of data in mind, the specifications can be met by paper systems. ISO 2015 Al
29、l rights reserved vBS ISO 18538:2015BS ISO 18538:2015Traceability of molluscan products Specifications on the information to be recorded in farmed molluscan distribution chains1 ScopeThis International Standard specifies the information to be recorded in farmed molluscs supply chains (excluding ceph
30、alopods) in order to establish the traceability of products originating from farm-raised molluscs. It specifies how molluscan products traded are to be identified and the information to be generated and held on those products by each of the food businesses that physically trade them through the dist
31、ribution chains. It is specific to the distribution for human consumption of molluscs and their products from farm through to retailers or caterers.The types of businesses identified in this International Standard for farmed molluscan distribution chains are the following: farming;a) broodstock supp
32、liers/natural seed collectors;b) hatcheries and nurseries;c) molluscan farm;d) harvesting; depuration and shucking etc.; processors; transporters and store operators; traders and wholesalers; retailers and caterers; logistics including materials brought from other domains; feed production.Any given
33、molluscan distribution chain can be made up of some or all of the above components, but not necessarily in the sequence listed.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referenc
34、es, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times3 Terms and definitionsFor the purposes of this docume
35、nt, the following terms and definitions apply.INTERNATIONAL STANDARD ISO 18538:2015(E) ISO 2015 All rights reserved 1BS ISO 18538:2015ISO 18538:2015(E)3.1traceabilityability to trace the history, application, or location of that which is under considerationNote 1 to entry: When considering product,
36、traceability can relate to: the origin of materials and parts, the processing history, and the distribution and location of the product after delivery.SOURCE: ISO 9000:2005, 3.5.4, modified3.2unique logistic unit identifierULUIany composition established for transport and/or storage that needs to be
37、 identified and managed through the supply chain3.3unique trade unit identifierUTUIsmallest unit which is guaranteed to retain its integrity as it moves from one link of the chain to the nextNote 1 to entry: It is the smallest unit that is kept whole and undivided with no change in content or label/
38、identification.3.4molluscaninvertebrate animal belonging to the phylum MolluscaNote 1 to entry: A molluscan has a soft unsegmented body and is covered by a calcium carbonate shell of one to eight parts or sections. In some species, the shell is lacking or reduced. Major cultured molluscs are mussels
39、, oysters, scallops, cockles, clams (bivalves), and abalone (gastropod).3.5molluscan productsproducts prepared out of molluscs or parts thereof3.6relayingremoval of bivalve molluscs from a microbiologically contaminated growing area to an acceptable growing or holding area under the supervision of t
40、he agency having jurisdiction and holding them there for the time necessary for the reduction of contamination to an acceptable level for human consumption3.7depurationreduction of microorganisms to a level acceptable for direct consumption by the process of holding live bivalve molluscs for a perio
41、d of time under approved controlled conditions in natural or artificial seawater suitable for the process which may be treated or untreated3.8heat shockingprocess of subjecting bivalve molluscs in the shell to any form of heat treatment such as steam, hot water, or dry heat for a short period to fac
42、ilitate rapid removal of meat from the shell for the purpose of shucking (3.9)3.9shuckingprocess of removing the meat from the shell2 ISO 2015 All rights reservedBS ISO 18538:2015ISO 18538:2015(E)4 AbbreviationsIn this International Standard, the following abbreviations apply:ACC Aquaculture Certifi
43、cation CouncilCAC Codex Alimentarius CommissionEPC Electronic Product Code, a unique number provided by GS1 used to identify instances of trade items (individual trade units) particularly suited for representation in an RFID chipFAO The Food and Agriculture Organization of the United NationsFBO Food
44、 Business Operator, generic term for someone in the supply chain who processes, sends or receives relevant trade units or logistic unitsGAqP Good Aquaculture PracticesGLN Global Location Number, a 13-digit globally unique number provided by GS1 used to identify parties and physical locationsGMP Good
45、 Manufacturing PracticeGS1 Global non-profit organization dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors; previously EAN/UCCGTIN Global Trade Item Number, an 8- to 14-digit
46、globally unique number provided by GS1 used to identify types of trade items (product types)HACCP Hazard Analysis Critical Control PointsHS Harmonized Commodity Description and Coding SystemLU Logistic UnitOIE World Organization for Animal HealthRFID Radio-Frequency Identification, the use of an obj
47、ect (typically referred to as an RFID tag) applied to or incorporated into a product for the purpose of identification and tracking using radio wavesRFMO Regional Fisheries Management OrganizationSGTIN Serialized Global Trade Item Number, a unique number provided by GS1 used to identify instances of
48、 trade items (individual trade units) by extending the GTINSSCC Serial Shipping Container Code, an 18-digit globally unique number provided by GS1 used to identify logistics unitsTU Trade UnitUI Unique IdentifierULUI Unique Logistic Unit IdentifierUTUI Unique Trade Unit Identifier ISO 2015 All right
49、s reserved 3BS ISO 18538:2015ISO 18538:2015(E)5 PrincipleThe fundamental principle of chain traceability is that trade units (TU) shall be identified by unique codes (UI). This code may be globally unique in itself (for instance, the GS1 SGTIN or EPC numbers) or it could be unique in that particular scope only which means that it should be no other TUs in that part of the chain that can have the same number. If the scope (the product type, the company, the chain, the sector, the country, or similar) is assigned a globally unique num
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