Traceability of molluscan products — Specifications on the information to be recorded in farmed molluscan distribution chains

ISO 18538:2015 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.

Traçabilité des mollusques — Spécifications des informations à enregistrer dans les chaines de distribution de mollusques en ferme

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Status
Published
Publication Date
03-Aug-2015
Current Stage
9093 - International Standard confirmed
Start Date
04-Mar-2020
Completion Date
04-Mar-2020
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ISO 18538:2015 - Traceability of molluscan products -- Specifications on the information to be recorded in farmed molluscan distribution chains
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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 18538:2015(E)
ISO 2015
---------------------- Page: 1 ----------------------
ISO 18538:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

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ii © ISO 2015 – All rights reserved
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ISO 18538:2015(E)
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

© ISO 2015 – All rights reserved iii
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ISO 18538:2015(E)
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

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 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 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).

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 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
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ISO 18538:2015(E)
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.
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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.
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ISO 18538:2015(E)
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 molluscs from a microbiologically contaminated growing area to an acceptable

growing or holding area under the supervision of the agency having jurisdiction and holding them there

for the time necessary for the reduction of contamination to an acceptable level for human consumption

3.7
depuration

reduction of microorganisms to a level acceptable for direct consumption by the process of holding

live bivalve molluscs for a period of time under approved controlled conditions in natural or artificial

seawater suitable for the process which may be treated or untreated
3.8
heat shocking

process 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 facilitate rapid removal of meat from the shell for the purpose of

shucking (3.9)
3.9
shucking
process of removing the meat from the shell
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ISO 18538:2015(E)
4 Abbreviations
In this International Standard, the following abbreviations apply:
ACC Aquaculture Certification Council
CAC Codex Alimentarius Commission

EPC 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 chip

FAO The Food and Agriculture Organization of the United Nations

FBO Food Business Operator, generic term for someone in the supply chain who processes,

sends or receives relevant trade units or logistic units
GAqP Good Aquaculture Practices

GLN Global Location Number, a 13-digit globally unique number provided by GS1 used to

identify parties and physical locations
GMP Good Manufacturing Practice

GS1 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/UCC

GTIN Global Trade Item Number, an 8- to 14-digit globally unique number provided by GS1 used

to identify types of trade items (product types)
HACCP Hazard Analysis Critical Control Points
HS Harmonized Commodity Description and Coding System
LU Logistic Unit
OIE World Organization for Animal Health

RFID Radio-Frequency Identification, the use of an object (typically referred to as an RFID tag)

applied to or incorporated into a product for the purpose of identification and tracking

using radio waves
RFMO Regional Fisheries Management Organization

SGTIN Serialized Global Trade Item Number, a unique number provided by GS1 used to identify

instances of trade items (individual trade units) by extending the GTIN

SSCC Serial Shipping Container Code, an 18-digit globally unique number provided by GS1

used to identify logistics units
TU Trade Unit
UI Unique Identifier
ULUI Unique Logistic Unit Identifier
UTUI Unique Trade Unit Identifier
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ISO 18538:2015(E)
5 Principle

The 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 number, the combination of the globally unique scope

number and the locally unique TU number shall constitute a globally unique identifier for the TU.

NOTE 1 The UTUI term is introduced to indicate a TU identifier which is or can be made globally unique.

Trade units (TUs) can be grouped together to make logistic units (LUs) or LUs can be grouped together

to make higher level LUs. A fundamental principle of chain traceability is that logistic units shall be

identified by a unique code. This code shall be a national code which can be globally unique in itself

(similar to the GS1 SSCC code) or it could be unique in that particular scope only, which means that

there should be no other LUs in that part of the chain that may have the same number. If the scope (the

product type, the company, the chain, the sector, the country) is assigned a globally unique number, the

combination of the globally unique scope number and the locally unique LU number shall constitute a

globally unique identifier for the LU.

NOTE 2 The ULUI term is introduced to indicate a LU identifier which is or can be made globally unique.

The key to the operation of this traceability scheme is the labelling of each unit of goods traded, whether

of raw materials or finished products, with a unique ID. This shall be done by the food business that

creates each unit. Businesses that transform units such as processors who convert the units of raw

materials received into the products dispatched shall create new units and shall give them new IDs.

As indicated above, the simplest way of implementing UTUIs and ULUIs is to use the GS1 SGTIN/EPC

and SSCC codes. This practice is recommended, but is not mandatory. The central principle behind this

International Standard is that businesses which create TUs or LUs should assign unique numbers to them.

Each of the food businesses that create or physically trade in those units throughout the distribution

chains from catcher through to retailer or caterer shall generate and hold the information necessary for

traceability. The information is to be held on paper or electronically, keyed to the unit IDs.

6 Requirements
6.1 Identification of the units traded

Businesses that bring in supplies of farmed molluscan products from outside of the domain of the

specifications and trade them onwards shall identify each unit traded and record associated information

elements as indicated in Table 3 to Table 12.
6.2 Recording of information

To distinguish between the different categories of information, all information elements are classified

as either “shall”, “should”, or “may” with definition (see Table 1).
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ISO 18538:2015(E)
Table 1 — Classification of informative elements
Definition Explanation

“shall” This category contains recordings related to “shall” elements are data elements that are

identifiers and transformations that is necessary deemed necessary to record to ensure that

in order to trace the history, application, or traceability is possible. Data elements relating

location of an entity. This means the unique to product properties are not in this category

identity of trade and logistic units, as well as the even if these properties are essential for other

dependencies between the identifiers of inputs purposes like product documentation or food

and outputs in a process. safety.

“should” This category contains parameters that describe This includes parameters like “species”,

and provide supporting information on the units “production date”, etc. If certification according

being traced. Common parameters required by to this International Standard is to

law, commercial requirements, or good happen in the future, the “should” parameters

manufacturing practises are recorded, but only are to be considered.
where an established international format or
data list for the value exists.

“may” This category contains parameters that describe The “may” category is informative only and it is

and provide supporting information on the units included to enable use and uptake of the

being traced. It contains parameters that are not standard. If certification according to this

part of the “should” category, but that may still International Standard is to happen in the future,

be useful or relevant to record. It also contains the recording of “may” parameters are not to be

parameters that may be deemed important, but considered when evaluating adherence. The list

where no established international format or of “may” elements is not definitive or exclusive.

data list exists. It is by design extendible and the threshold for
including new elements in this category is low.

Businesses that physically trade in molluscan products shall generate and hold the required information

appropriate to the type of business for each of the units traded. The detailed information requirements

are tabulated in Table 2.
Table 2 — Information requirements to be recorded by the different businesses
Food business operator (FBO)
Data Create/
Table Receive Transform Dispatch
prefix produce
type
Brood stock suppliers/natural seed TU/LU TU/LU
3 MBR - -
collectors
Hatcheries/nurseries 4 MHA TU/LU Yes TU/LU TU/LU
Molluscan farms 5 MFF TU/LU Yes TU/LU TU/LU
Processors 6 MPR TU/LU Yes TU/LU TU/LU
Live molluscan transporters 7.1 MTR TU/LU Yes TU/LU TU/LU
Transporters and cold store TU/LU
operators for molluscs other than 7.2 MTS TU/LU No LU
live
Traders and wholesalers 8 MTW TU/LU No TU/LU TU/LU
Retailers and caterers 9 MRC TU/LU Yes TU/LU —
Bringing in materials from outside TU/LU TU/LU TU/LU
10 MOT —
the domain
Feed production 11 MFE TU/LU Yes TU/LU TU/LU

For the purpose of unique identification to establish an extendable framework for data element identification, each table

has been identified with a three letter alphanumeric code. This code plus three digits is used to give a unique number to each

data element.

The information specifications separately tabulate the information to be recorded by each of these

types of business. Some businesses may carry out the functions of more than one of the types listed,

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ISO 18538:2015(E)

for example, distribution businesses can act as wholesalers and as transporters in which case those

businesses shall record the relevant information requirements for each of the functions carried out.

NOTE 1 This International Standard is limited in scope to the distribution for human consumption of molluscs

and their products. The molluscs information specifications are substantially the same from processing onward.

Pragmatically, it is recognized that some supplies of molluscan products and supplies of ingredients,

etc. will come from outside of the domain and may lack the required IDs and information records.

To accommodate this, a business that brings in molluscs and materials from outside of the domain is

required to generate and hold the key information necessary for the traceability of the units brought in

and if they are to be traded on to label those units with the required IDs.

NOTE 2 These specifications are designed with electronic representation and communication of data in mind, but

this is not a requirement when using the International Standard. The specifications can also be met by paper systems.

Note that the specification is for data to be generated, recorded, and stored at the respective link. For

all links, except “Breeders”, relevant data shall be generated in a previous link in the supply chain and

passed along with the trade unit/logistic unit.

NOTE 3 In these tabulations, there is no repetition of the information originally recorded to describe the units

created and their history, although businesses receiving those units later in the distribution chain will often need

some of that information. The information is keyed to the unit IDs and can be supplied by commercial agreement

between the businesses without having to re-input the data.
6.3 Controlled relaying and depuration

Bivalve molluscs concentrate contaminants from the water column in which they grow. These

contaminants may then cause illness to humans when the bivalves are eaten. Depuration is effective in

removing many faecal contaminants from shellfish. Depuration means the reduction of microorganisms

sand and other contaminants to a level acceptable for direct consumption by the process of holding live

bivalve molluscs for a period of time under approved controlled conditions in natural or artificial sea water

suitable for the process which may be treated or untreated. Relay systems (natural or in containers) and

land-based depuration establishments are efficient methods of achieving microbiologically safe bivalve

molluscs that are harvested from approved areas. Each registered facility that depurates or relays

molluscs should follow their quality management program and appropriate documentation should be

maintained for the process. The details of traceability of depuration process are shown in Table 5.

6.4 Broodstock supplier and natural seed collectors/suppliers

For the purposes of this International Standard, broodstock suppliers are considered to be

establishments/self help groups/farmer groups/fisherman that produce/collect broodstocks that are

supplied to hatcheries for further maturation and production of spat. They may carry out basic operations

like collection and maintenance of broodstock under good management practices in a sustainable way.

Prior to dispatch, broodstock suppliers can carry out their own operations or get it done through

approved agencies/laboratories for absence of OIE-listed diseases, quality, grading, etc.

The trade units created by broodstock suppliers can range from a few hundred to several thousand

passed into the hands of the next food business, i.e. hatcheries.

For the purposes of this International Standard, natural seed collectors/suppliers are considered to be

establishments that produce/collect seeds from natural sources that are supplied to farms for further

maturation. They may carry out basic operations like collection and maintenance of natural seed in a

responsible way to ensure sustainability.
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ISO 18538:2015(E)

Table 3 — Detailed information for broodstock suppliers and natural seed collectors/suppliers

Categorization
Data element Description Examples
Shall Should May
BROODSTOCK SUPPLIERS AND NATURAL SEED COLLECTORS/SUPPLIERS
MBR101 Food Unique national identification Name, reg. no., and x
business number for the unit plus country prefix
ID country prefix or name and
address of the group/business
that operates maintenance of
broodstock (either indegenous
or exploited)
MBR102 Broodstock Unique national identification Women self-help group, x
supplier number for the Padanna, Kasargod,
establish group/unit/organization plus Kerala (bivalve spat
ment ID country prefix or name and suppliers)
address of the broodstock
supplier
MBR103 Broodstock Any quality certification Norms suggested by x
supplier available National Competent
GAqP Authority and aligned to
certificate codex GAqP
ion
MBR104 Natural Unique national identifica
...

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