ISO 18538:2015

INTERNATIONAL ISO
STANDARD 18538
First edition
2015-08-01
Traceability of molluscan products —
Specifications on the information
to be recorded in farmed molluscan
distribution chains
Traçabilité des mollusques — Spécifications des informations à
enregistrer dans les chaines de distribution de mollusques en ferme
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 3
5 Principle . 4
6 Requirements . 4
6.1 Identification of the units traded . 4
6.2 Recording of information . 4
6.3 Controlled relaying and depuration . 6
6.4 Broodstock supplier and natural seed collectors/suppliers . 6
6.5 Hatcheries/nurseries . 9
6.6 Molluscan farms .12
6.7 Processors .16
6.8 Transporters and store operators .21
6.8.1 Live molluscs .21
6.8.2 Molluscs other than live .23
6.9 Traders and wholesalers .26
6.10 Retailers and caterers .29
6.11 Bringing in supplies from outside the domain .31
6.12 Molluscan feed producers .34
Bibliography .38
Foreword
ISO (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 participate in the development of International Standards through technical
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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 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 possibility 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 list of patent declarations received (see www.iso.org/patents).
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constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 234, Fisheries and aquaculture.
iv © ISO 2015 – All rights reserved

Introduction
There 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 under 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 through 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 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 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 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 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 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 all 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 in 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 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 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.
INTERNATIONAL STANDARD ISO 18538:2015(E)
Traceability of molluscan products — Specifications on
the information to be recorded in farmed molluscan
distribution chains
1 Scope
This International Standard specifies the information to be recorded in farmed molluscs supply chains
(excluding cephalopods) 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 distribution 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 suppliers/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 molluscan distribution chain can be made up of some or all of the above components, but not
necessarily in the sequence listed.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, 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 times
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
traceability
ability to trace the history, application, or location of that which is under consideration
Note 1 to entry: When considering product, 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, modified]
3.2
unique logistic unit identifier
ULUI
any composition established for transport and/or storage that needs to be identified and managed
through the supply chain
3.3
unique trade unit identifier
UTUI
smallest unit which is guaranteed to retain its integrity as it moves from one link of the chain to the next
Note 1 to entry: It is the smallest unit that is kept whole and undivided with no change in content or
label/identification.
3.4
molluscan
invertebrate animal belonging to the phylum Mollusca
Note 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,
oysters, scallops, cockles, clams (bivalves), and abalone (gastropod).
3.5
molluscan products
products prepared out of molluscs or parts thereof
3.6
relaying
removal of bivalve
...