© ISO 2004 – All rights reserved

ISO TC 34 N 1130

Date: 2004-07-02

ISO/CD 22519

ISO TC 34

Secretariat: MSZT

Traceability in feed and food chain — General principles and guidance for
system design and development

Warning

This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

Document type: International Standard

Document subtype:
Document stage: (30) Committee
Document language: E

/conversion/tmp/activity_task_scratch/873616577.doc STD Version 2.1c

ISO/CD 22519

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II © ISO 2004 – All rights reserved

 ISO/CD 22519

Contents Page

Foreword................................................................................................................................................. iv
Introduction............................................................................................................................................. iv
1 Scope........................................................................................................................................... 1
2 Normative references................................................................................................................. 1
3 Terms and definitions................................................................................................................. 1
4 Principles applicable to a food chain traceability....................................................................2
5 Elements of a feed and food chain traceability system...........................................................3
6 Guidance for design and development of a food chain traceability system.........................3
6.1 Identifying the objective to be achieved...................................................................................3
6.2 Define the product(s) and/or ingredient(s) to be traced..........................................................4
6.3 Relevant steps in the food chain............................................................................................... 4
6.4 Establish procedures.................................................................................................................. 4
6.5 Develop a traceability plan......................................................................................................... 5
6.6 Training policy............................................................................................................................ 5
6.7 Internal organisation audit procedures.....................................................................................5
6.8 Documentation of the traceability system................................................................................5

© ISO 2004 – All rights reserved III

ISO/CD 22519

Foreword

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 for 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 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 are 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 responsible for identifying any or all such patent rights.

ISO 22519 was prepared by Technical Committee ISO/TC 34, Food Products, Working Group WG 9,
Traceability in feed and food chain.

IV © ISO 2004 – All rights reserved

 ISO/CD 22519

Introduction

An organization operating within a food chain could be interested in the design and implementation of a
traceability system. Traceability is a useful but not sufficient tool to achieve food safety or other defined
objectives in a management system.

This standard provides principles and guidance to establish a traceability system.

The design and implementation of a food chain traceability system are affected by the need to comply with
national laws, international standards and regulations in force.

The complexity of the chain traceability system may vary; the extension of the different components of the
product is established according to the specific features of the product itself and objectives to be achieved.

This standard is generic and therefore not related to specific needs.

Technical limits are inherent to the branches, the products and their origins (i.e. nature of the raw materials,
size of the batches, collection and transport procedures, product ranges, manufacturing and packaging
methods).

Economic limits are linked to the inherent conditions of the branches and of the products, and condition their
profitability. The choice of a traceability system results from balancing the different requirements with the
technical feasibility and the economic acceptability.

© ISO 2004 – All rights reserved V

COMMITTEE DRAFT ISO/CD 22519

Traceability in feed and food chain — General principles and

guidance for system design and development

1 Scope

The purpose of this standard is to:

- specify the definitions

- present the elements

- provide recommendations for the implementation of a traceability system.

This International standard specifies the principles and the requirements for design development and
implementation of a feed and food traceability system. It can be applied to the whole or part of the food chain.
It is a technical tool to comply with specific regulations and/or other defined objectives. It applies when it is
necessary to document the history, application or location of a product or of the relevant component(s). It is
intended to be flexible enough to allow food organisations to use it to achieve the specific identified objectives.

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 referenced
document (including any amendments) applies.

ISO 9000: 2000, Quality management systems - Fundamentals and vocabulary

ISO/DIS 22000:2004, Food safety management systems – Requirements for organizations throughout the
food chain

3 Terms and definitions

For the purposes of this document, the terms of ISO 9000: 2000, ISO/DIS 22000:2004 and the following terms
and definitions apply:

3.1
product
the product is a single unit of food or feed

NOTE Product may include packaging material

3.2
lot
the lot is defined by the organization as a set of units of a product having identical characteristics which have
been produced and/or manufactured and/or packaged under practically identical circumstances.

The lot is determined by parameters established beforehand by the organisation.

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COMMITTEE DRAFT ISO/CD 22519

3.3
location
location is the place of production, handling, storage and/or sale.

3.4
traceability
the ability to trace the history, application or location of that which is under consideration

NOTE 1 The term track and trace are also used with the same meaning

NOTE 2 When considering a product, traceability may relate to:

 the origin of the materials and their components

 the processing history, and/or - the distribution and location of the product after delivery.

NOTE 3 In the majority of cases a recorded identification is required in order to document or verify the traceability
within the food chain. Traceability generally applies to the product/process, or product/location pair and combines a flow of
materials and a flow of information.

NOTE 4 Terms such as "document traceability", "computer traceability", or "commercial traceability" should be
avoided.

3.5
food chain
organizations affecting relevant flows of materials, participating at any stage in the production, manufacture,
distribution, sale and/or supply of a food product

NOTE 1 The chain can be considered documented when it is possible to identify the involved organizations and flows.

NOTE 2 For the purpose of this standard the traceability system can be applied to only part of the food chain

3.6
flow of materials
movement of any food, food ingredients and/or packaging at any point in the food chain

3.7
organisation
individual(s) and/or facilities with relevant responsibility or authority for food management

3.8
data
recorded information

4 Principles applicable to a food chain traceability

Traceability systems can be able to recreate the history of a product and to trace the destination of a product
in the food chain, and can achieve the following issues; the contribution to facilitate the search for the cause of
unconformity and the withdrawal and/or recall of products where unconformity for the food is appeared, the
greater reliability of information or the contribution to higher business efficiency.

The application of traceability is subjected to technical and economic limits which are inherent to the
components of the food chain.

The choice of a traceability system results from balancing the different requirements, the technical feasibility
and the economic acceptability.

© ISO 2004 – All rights reserved 2

4.1 Traceability should be:

 verifiable;

 applied consistently and equitably;

 objective and result oriented;

 cost effective;

 practical to apply.

4.2 Product traceability is a tool that shall be coordinated within the context of a broader management system

4.3 The scope of the application and specifications regarding each element of traceability should be
considered and justified on a case by case basis according to the objectives to be achieved taking into
account of the food safety.

5 Elements of a feed and food chain traceability system

To set up a feed and food chain traceability system it is necessary to consider the following elements. These
elements are explained in clause 6:

 Identified objective(s) (see clause 6.1)

 Defined products and/or the relevant ingredient(s) (see clause 6.2)

 Defined relevant steps of the food chain (see clause 6.3):

 Organisations and responsibilities;

 Flow of materials and information.

 Procedures (see clause 6.4)

 Documentation:

 Traceability plan (see clause 6.5)

 Training policy (see clause 6.6)

 Audit procedures (see clause 6.7)

 System information (see clause 6.8)

6 Guidance for design and development of a feed and food chain traceability
system

6.1 Identifying the objective to be achieved

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 clause 4 including the
technical and economic feasibility of achieving those objectives. Possible examples include to:

a) support food safety or quality objectives;

© ISO 2004 – All rights reserved 3

b) know the history or origin of the product;

c) facilitate the withdrawal and/or recall of products;

d) identify the responsible parties in the food chain;

e) verify specific information about the product; and/or to

f) communicate information to relevant stakeholders.

6.2 Define the product(s) and/or ingredient(s) to be traced

The objective(s) to be achieved in the traceability system, and mechanisms for achieving those objectives, will
be dependent upon the product and/or ingredient(s) involved. Those objectives may dictate different tools to
trace product information and to communicate that information.

6.3 Relevant steps in the food chain

The relevant steps in a traceability system along the food chain depend on the objective(s) to be achieved.
These steps may include the identification of organizations, which undertake production, manufacture, and/or
transportation, storage and distribution of the product, and responsibilities of relevant parties. The steps define
the field of application of a feed and food chain traceability system. Links in the feed and food chain are
established as each operator identifies his immediate prior source and immediate subsequent recipient.

When claims are made about “food chain traceability” for commercial purposes, the steps involved should be
identified to the relevant stakeholders.

6.4 Establish procedures

Procedures generally relate to documenting the flow of products, materials and information including
document retention and verification. Procedures should be established to

a) define the product;

b) define the lot

c) identify the lot

d) document the flow of materials including the media for documentation;

e) manage the data;

f) retrieve the information for communication; and

g) verify the accuracy of the data.

Each organisation in the food chain shares the relevant procedural steps. In the development and
implementation of a traceability system, it is necessary to take into account the suitability of any system
already present in an organisation.

Procedures to manage identification include a means to identify uniquely materials and products, to link the
flow of that information to the materials and to record it.

Procedures should be established for the product that does not conform to specific objectives established
through the traceability system. These management procedures should include adequate marking and follow
up steps intended to prevent recurring incidents of non-conformance.

4 © ISO 2004 – All rights reserved

6.5 Develop a traceability plan

Each organisation should establish a traceability plan. The plan entails each of the elements identified
including procedures for periodic assessment.

Tasks and responsibilities shall be defined and communicated to the appropriate organizations at each step
within the traceability system.

6.6 Training policy

Each organisation should develop and implement a training policy.

Personnel of the involved organisations, who can affect the traceability system, shall be adequately trained,
informed and involved and should demonstrate competence to correctly implement the traceability system.

6.7 Internal organisation audit procedures

A periodic internal audit in each organisation should be conducted in order to assess the effectiveness of the
system to meet the established objectives. This includes periodic monitoring activities for each relevant
element of the system.

The traceability system should be assessed whenever changes are made to the objectives or/and in the
product or process. Examples of input data for this review may include:

 obtained results (tests, previous audit);

 new or amended regulations;

 corrective actions.

6.8 Documentation of the traceability system

Within each organization, appropriate documentation for a traceability system may include:

 a description of the relevant steps in the chain, the responsibilities, management of data, applicable
procedures and auditing modalities (this should be shared with relevant organizations);

 written or recorded information documenting the activities and manufacturing process flows and results of
verification and audits;

 documentation addressing action taken to manage non-conformity related to the established traceability
system; and,

 document retention times.

© ISO 2004 – All rights reserved 5