IMPLEMENTING TRACEABILITY IN THE FOOD SUPPLY CHAIN
Executive Summary
The CIES “Implementing Traceability in the Food Chain” document aims to build awareness and provide
information to food businesses, enabling them to make the right business decisions regarding traceability.
It describes the potential impact of the implementation of a traceability system and provides some
recommendations. It is aimed at the senior management level of food companies, independent of their
position in the food chain. It seeks to guide food businesses by highlighting the components of such a
system, the pitfalls when designing and implementing such a system and above all how to ensure that
systems can be aligned along the food supply chain. The document focuses on food and not on product
safety in general.
Traceability systems cover all types of food and affect food businesses from farm suppliers to retailers.
Traceability systems are or will be obligatory for all businesses in the food chain in the European Union
(EU), the USA and Japan. In addition to this legislation, there are other existing requirements for
traceability, particularly in standards related to quality improvement and/or food safety. There is an
underlying need to define the specific information elements that each sector of the food business must
agree upon. This information should then be compiled and shared between the different sectors in order
to achieve chain traceability.
Traceability is multi-disciplinary in the sense that many departments of a company will be involved in its
development and its implementation. In addition to the quality (or food safety) department, at least
logistics and IT should be involved. A fundamental decision to take in the beginning of this process is to
define who has internal responsibility. In a traceability system, information can be used to trace back to
find the source and cause of a problem, to stop the problem or prevent it from happening again. Products
can also be found that have already been forwarded in case of a necessary withdrawal or recall in such a
system. Other added value to a food business needs to be considered.
Depending on the degree of implementation and the infrastructure selected by a company, product
traceability processes may require significant investment. The benefits and savings are not obvious at first
glance. The expenditure should be considered as a long-term strategic investment because it is linked to
consumer's perception, the image of the company and the trust that consumers display when buying a
product.
The application of EAN.UCC standards is a prerequisite for the alignment of traceability systems.
Companies that implement collaborative best practices and EAN*UCC standards should encourage their
partners to do the same thing. (See Annex 1)
CIES – The Food Business Forum - January 2005
4Introduction
In January 1999, a car demolition company in Walloon, Belgium, delivered oil from a transformer to a
municipal oil recycling plant. The oil contained approximately 1 gram of dioxins. The oil ended up in a
vegetable oil storage tank, an ingredient for feedstuff. Through the animal feed, the contaminated product
entered the human food chain. The problem could not be contained since a targeted recall was impossible.
There were few records on the feedstuff ingredients, the production date or the batch identity. It was
impossible to ascertain whether other feed factories were involved, which farmers had bought the
contaminated feedstuff, let alone which food products were contaminated and to which countries these
products had been transported. Consequently, it was impossible to launch a proper recall, due to a lack of
coherent and adequate information. As a result, millions of Euros were wasted on the withdrawal and recall
of products that on hindsight were perfectly safe, but that were considered to be a major public health risk
at the time. Ever since, the concept of the implementation of traceability in the food supply chain has
received a great deal of attention. It is about to become a legal obligation within the EU.
In the United States, the desire to protect the nation’s food supply and fear of food tampering led to the
enactment of the Bioterrorism Preparedness and Response Act in 2002. A record-keeping regulation has
been issued to help the US Food and Drug Administration (FDA) track foods implicated in future
emergencies, such as terrorism-related contamination. The obligations are similar to those in Europe.
What is the issue?
Many food businesses will be or are already confronted with the need to build a traceability system. This
document aims to build awareness on this issue and to provide information to food businesses, to enable
them to make the right business decisions. It will describe the impact that the implementation of a
traceability system may have and provide some recommendations. It is aimed at the senior management
level of food companies independent of their position in the food chain. It seeks to guide food businesses
in the implementation of traceability systems, by highlighting the nuts and bolts of such a system, the
pitfalls when designing and implementing such a system and above all how to ensure that systems can be
aligned along the food supply chain. It focuses on food and not on product safety in general.
Scope
Traceability systems cover all types of food and related products in the entire food chain and affect food
businesses from farm suppliers to retailers. Feedstuffs and other farm supplies needed to produce food, are
included, as well as food contact materials such as packaging. As requirements for traceability systems are
present in the US, Europe and Japan the implications of this document have a global reach.
Applicable legislation
Traceability systems are obligatory for all businesses in the food chain in the EU from 1st January 2005.
This means a business must be able to identify all its suppliers of food, food products and feed and all
businesses it has supplied food or feed to. The information needs to be systematically stored, in order to be
made available to inspection authorities on demand. (See Annex 2)
In the United States a similar requirement regarding the establishment of records to identify the immediate
previous sources and immediate subsequent recipients of food, including its packaging, was laid down in
the Bioterrorism Act (section 306) and will come into effect in three stages. The US industry will need to
comply with the record-keeping requirements by either December 2005, June 2006 or December 2006
depending on the company size, i.e., the larger, the earlier. (See Annex 3) In the US, food safety is seen as
part of food security.
CIES – The Food Business Forum - January 2005
5In Japan traceability is obligatory for beef as from December 2004. It can be expected that this will be
expanded to other agricultural products.
In the EU, traceability is related to labelling in specific cases only. For some sectors in Europe, the
requirement for traceability ran ahead of the general requirement, i.e. for the labelling of beef and some
beef products, fish, and for the labelling of (non) GMO’s. (See Annex 4) However, in the case of food
contact materials (mainly packaging) the requirement has to be implemented in 27 October 2006 (See
Annex 6).
The requirement for a traceability system is in essence quite simple, but implementing an effective system
that is also beneficial to the business may be difficult to put into place for some businesses to a greater or
lesser extent. There are no legal requirements for in-company traceability (from door to door), to set up a
complete food chain traceability system, nor to give any information to the consumer. The choice on how
to set up an in-company traceability system remains with each individual company.
For some, traceability appears to be a magic word, the ultimate solution to all food safety problems and a
means to create consumer confidence. In reality, it is an important tool, which assists in the management
of food safety and security issues. There are many other reasons why operators should implement
traceability systems.
Requirements for Traceability
In addition to the legislation described above, other requirements for traceability exist, particularly in
standards related to quality improvement and/or food safety. The use of such standards may help to
reduce the chances of a food safety crisis and subsequent product withdrawal or recall. Despite best efforts
at prevention however, there will always be some degree of risk of product contamination or tampering at
any point in the supply chain.
ISO 9001:2000
Traceability is mentioned in ISO 9001:2000 as one of the aspects that should be considered in a quality
management system. Many businesses are therefore interested to have traceability systems, whether it’s a
legal requirement or not.
CIES – The Food Business Forum - January 2005
6Definitions
There are many definitions and different terms for traceability. In Codex Alimentarius the term
Traceability/Product Tracing is used, many others speak of tracking and tracing and in the United States
this is simply called record-keeping. But the effects they have are all the same.
In this document the following definitions apply to traceability:
- Traceability is the ability to trace the history, application or location of an entity by means of recorded
identifications.
This definition is based on the definition in the ISO 9001:2000 standard: “Traceability: ability to trace the history,
application or location of that which is under consideration.”
- Chain Traceability is the ability to trace the history, application or location of an entity by means of
recorded identifications throughout the entire food chain.
To facilitate this, in practice the requirement for traceability is to keep records of suppliers and customers, sometimes called
“one step up, one step down”. If all food businesses keep these records and the information therein can be communicated and
exchanged, chain traceability is achieved.
- Traceback or Tracing is the ability to identify the origin of a particular unit and/or batch of product
located within the supply chain by reference to records held upstream.
- Traceforward or Tracking is the ability to follow the path of a specified unit of a product and/or batch
through the supply chain as it moves between organisations towards the final point-of-sale or point-ofservice.
- Internal Traceability is the ability to follow the path of a specified unit of a product and/or batch
within one company or company unit.
Another confusing area of terminology is the definition of “lot” and “batch”. Lot is defined in EU
legislation as:
- Lot is a batch of sales units of a foodstuff produced, manufactured or packaged under practically the
same conditions (Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the
lot to which a foodstuff belongs).
- Withdrawal is a procedure to withdraw food from the market where the food has left the immediate
control of that initial food business.
- Recall is procedure to withdraw food from the market where the food has left the immediate control of
that initial food business and where the product may have reached the consumer.
In this document lot and batch are considered to have the same meaning.
CIES – The Food Business Forum - January 2005
7Food Safety Standards
Food retailers often require certification from manufacturers of private-label food products, for the safe
production of food. Food safety standards are applied to other food products as well.
The CIES Global Food Safety Initiative has issued a Guidance Document as a benchmarking tool for food
safety standards, and in effect provides requirements for food safety standards. The document can be
found at www.ciesnet.com. The Guidance Document contains the following paragraph concerning
traceability:
“6.1.17 Traceability
The standard shall require that the supplier develop and maintain appropriate procedures and systems to ensure:
• Identification in any case through a code marking on container and product, to identify the source of any out-sourced
product, ingredient or service;
• Record of purchaser and delivery destination for all product supplied.”
To date, five food safety standards have been benchmarked against the Guidance Document and were
found to be in compliance with it:
• The BRC Global Food Standard
• The Dutch HACCP Code
• The EFSIS Standard
• The International Food Standard (IFS)
• The SQF 2000 Code
All five therefore contain requirements for traceability. (Specific requirements are given in Annex 5). They may
differ in detail, but substantively the requirements are the same.
In addition to these standards, there is the need to define the specific information elements that each
sector of the food business must agree upon. This information may then be compiled and shared in order
to achieve chain traceability. Trace Fish, a consortium, initiated and financed by the EU is an example of a
body that was able to bring together different elements of information into a CEN standard. Based on the
Trace Fish standard, a generic version of the standard for use in all fresh produce in the food industry was
launched.
Many customers already ask for traceability systems to be in place through the requirement of certification
based on the ISO 9001 series or food safety standards. Besides the legal necessity to implement traceability
systems, there often is a commercial need to do so.
The implementation of traceability systems will be increasingly a part of the usual commercial negotiations
and product specifications. This will decide in how far implemented systems will be compatible.
Functions of a traceability system
Traceability is multi-disciplinary, as many departments of a company will be involved in its development
and its implementation. Besides the quality (or food safety) department, at least logistics and IT should be
involved. Marketing and Auditing departments could also benefit from a traceability system. A
fundamental decision to take in the beginning of this process is to define who has internal responsibility.
CIES – The Food Business Forum - January 2005
8A traceability system may serve many purposes. Essentially, it functions as a tool for communication,
making information available along the food supply chain. This information can be used for a wide variety
of purposes.
In food safety, the information can be used to trace back to find what the source and the cause of a
problem is, to stop the problem or prevent it from happening again. The system may also be used to find
products that have already been forwarded in case of a necessary withdrawal or recall.
Implementing a traceability system
When implementing a traceability system, the added value of such a system needs to be considered.
Traceability systems can serve many purposes and may lead to the following benefits. Here are a few
examples:
• Ensure a fast product withdrawal or recall, thus protecting the consumer.
• Minimise the impact of such a product recall, by limiting the scope of product implicated and
providing traceability tools. The financial impact of recalling an entire commodity or brand versus a
specific grouping of product (e.g., a lot) can be enormous.
• Enabling companies to demonstrate that their product is not implicated in a given product recall,
by ensuring proper segregation and clear identification of product.
• Address concerns of food-terrorism or tampering of the food supply chain.
• Strengthen consumer confidence, through the industry’s ability to promptly identify and recall
potentially unsafe product.
• Providing internal logistical and quality related information, improving efficiency.
• Create a feedback loop to improve product quality, condition and delivery.
• Providing transparency in distribution routes and improving supply chain efficiencies and trading
partner collaboration.
• Providing reliable information
o business to business
o to consumers
o to government inspectors
o to financial or technical auditors
• Establishing the responsibility and liability for a certain problem
• Facilitate protection of company and/or brand name
As the implementation of a traceability system requires upfront investments, companies are advised to take
all benefits into consideration when implementing a traceability system. These benefits should be analysed
as well as the risks that are managed with the system. This will also include a cost/benefit analysis.
Depending on the degree of implementation and the infrastructure selected by a company, product
traceability processes may require significant investment. The benefits and savings are not immediately
obvious. The expenditure involved should be considered as a long-term strategic investment because it is
linked to consumer's perception, the image of the company and the trust that consumers display when
buying a product.
It is of great importance to
1. decide on the exact product specification
2. decide on batch (or lot) sizes.
Batch sizes can be based on production or run time, on volume, or on the expiry date.
CIES – The Food Business Forum - January 2005
9Generally, being able to trace to the detail (product or a small batch level) will increase the costs in the
traceability system. Deciding on big batches will probably make the system less costly, but will increase the
risks because if a problem arises, more products will be involved than would have otherwise been
necessary. Based on the cost/benefit analysis the ideal balance should be sought between present and
future costs. This analysis should then be taken into account in the design of the system.
It is difficult to recommend a suitable traceability model for retailers and food producers by looking at the
most cost efficient process and the reliability of the links throughout the chain. Situations vary from case to
case. In case of a recall, a retailer may not necessarily take the smallest possible batch off the shelves.
Retailers will often withdraw all similar products, whether they belong to the affected lot or not. This is
more efficient for the retailer, as mistakes can be avoided in-store and consumers are provided with the
reassurance that everything is under control.
Many companies now have effective internal traceability systems in place. The next step is to achieve chain
traceability. The main requirements for handling withdrawals and recalls across the supply chain are having
reliable data, the possibility to exchange the data and properly mapped business processes. A good internal
traceability system is a prerequisite to a chain traceability system. The investments in an internal traceability
system will not be wasted in moving towards chain traceability. All good chain traceability software should
be able to integrate seamlessly to any internal system.
As a best practice on investments: some insurance companies are offering recall insurance and free
traceability software, for the same price as only the insurance.
The application of EAN.UCC standards is a prerequisite for the alignment of traceability systems.
Companies that implement collaborative best practices and EAN*UCC standards need to encourage their
partners to do the same thing. A further reference is contained in the ECR Blue Book “Using Traceability
in the Supply Chain to meet Consumer Safety Expectations”, March 2004, which describes the
implementation process in detail. More information may be found at www.ecrnet.org.
Bar-coding is often used as a means to transfer information. Radio frequency identification (RFID) is a
growing technology that utilises radio frequencies to identify products (trade items), pallets (logistic units)
and/or returnable assets throughout the supply chain. Recent EAN.UCC standardisation developments in
the field of RFID are internationally known as the Electronic Product Code (EPC) Network.
References
CIES – The Food Business Forum - January 2005
10
ECR Blue Book Using Traceability in the Supply Chain to meet Consumer Safety Expectations, March 2004 ANNEX 1 - Application of EAN.UCC standards in traceability systems
From an information management point of view, implementing a traceability system within a supply chain requires
all parties involved to systematically associate the physical flow of materials, intermediate and finished products with
the flow of information about them.
This is best attained by deploying a common business language – the EAN•UCC standards. Their global reach and
universal acceptance by consumers, businesses and governments make them uniquely positioned to provide the
appropriate response to traceability system requirements.
Because of its ability to provide globally unique identification of trade items, logistic units, parties and locations, the
EAN.UCC System is particularly well suited to be used for traceability purposes. The EAN.UCC standards provide a global
business language that is used to enable accurate and fast communication between different internal traceability systems
used by suppliers, manufacturers and retailers around the world.
EAN International has defined key traceability principles and produced an implementation grid, which links them to
enabling technologies and relevant EAN.UCC System tools.
TRACEABILITY
PRINCIPLES
ENABLING
TECHNOLOGIES
EAN•UCC SYSTEM
TOOLS
UNIQUE
IDENTIFICATION
AUTOMATED
IDENTIFICATION
GTIN, SSCC, GLN,
APPLICATION
IDENTIFIERS
DATA CAPTURE AND
RECORDING
AUTOMATED DATA
CAPTURE
EAN/UPC,
UCC/EAN-128
LINKS
MANAGEMENT
ELECTRONIC DATA
PROCESSING
SOFTWARE
APPLICATIONS
1
DATA
COMMUNICATION
ELECTRONIC DATA
INTERCHANGE
EANCOM®
/
XML
Unique Identification
Any product that needs to be traced or tracked must be uniquely identified. The EAN•UCC globally unique
identifiers are the keys that enable access to all available data about the product’s history, application or location.
• Identification of Locations
Unique identification of locations is ensured through the allocation of an EAN•UCC Global Location Number -
GLN, to each location and functional entity.
• Identification of Trade Items
CIES – The Food Business Forum - January 2005
11
1
Hardware and software manufacturers and vendors are not affiliated with EAN International. Unique product identification is ensured through the allocation of an EAN•UCC Global Trade Item Number -
GTIN, to each product (consumer unit). For traceability purposes, the GTIN has to be combined with a Serial
Number or Batch Number in order to identify the particular item.
Identification of Lots/Batches.
Traceability of Lots/Batches is ensured through the allocation of an EAN•UCC Global Trade Item Number -
GTIN and Lot/Batch Number to each product (e.g. consumer unit).
• Identification of Series
Traceability of Series is ensured through the allocation of an EAN•UCC Global Trade Item Number - GTIN and
Serial Number to each product (consumer unit).
• Identification across Product Hierarchies
A GTIN needs to be allocated to each of the three levels of the Product Hierarchy, namely: consumer unit, traded
unit and pallet – the latter only to be included if it is priced, ordered or invoiced at any point in the supply chain, in
other words, if the pallet is also considered to be a traded unit.
• Identification of Logistic Units (pallets)
Identification and traceability of pallets is ensured through the allocation of an EAN•UCC Serial Shipping Container
Code - SSCC. Any pallet, independently of its type (mixed or uniform), needs to carry an SSCC allocated at source. A
new SSCC must be allocated every time a new pallet (logistic unit) is created.
Data Capture and Recording
Products, Standard Trade Item Groupings and Pallets identified with applicable EAN•UCC standards [GTIN, SSCC,
Application Identifier (AI)] must be bar coded in relevant EAN•UCC bar code symbols.
( 0 1 ) 9 7 6 1 2 3 4 5 0 0 0 2 8 5 ( 1 0 ) 4 5 1 2 XA
4 5 1 2 3 4 5 6 7 8 9 0 6 >
Example of an EAN/UPC Bar Code Example of an UCC/EAN-128 Bar Code
Traceability Links Management
In a majority of supply chains, products are tracked and traced by their production batch, which has undergone the
same transformation (production process) and by their transport/storage path (distribution process). The figure
below shows the use of EAN•UCC standards for identifying locations (GLN), logistic units (SSCC), manufacturing
batches (AI 10) and consumer units (GTIN) in a production environment.
CIES – The Food Business Forum - January 2005
12G TIN1
lot1
S SCC6
S SCC7
S S CC1 S SCC5
G TIN1
lot2
S SCC3
S SCC4
S S CC2
G TIN2
G TIN2
G TIN2
G TIN2
G TIN2
G TIN2
R eception P roduction Packa ging Prep aratio n for
s hipping
L og istic
u n its of
finis he d
p rodu cts
Group in g
u n its
T rade item
lot
P roduction
line
L og istic u n its
of raw mater ials
De s tination
loc a t ion
Sto ra ge
G LN1
Intermediary
g roup ing
(op tion al)
S SCC6
S SCC7
S SCC5
Original
locations
Prod u ction
G TIN 1
G LN2
G LN3
G LN5
G LN6
G LN4
U P S TREAM
S U P P LIERS
S U P P LIER S DESTINATIONS
Traceability data management in production
Identification management in a production environment is characterised by:
a) Several supplier locations (GLN 1-3), which send pallets of materials (SSCC 1-4).
b) At reception, materials are stored and/or ordered for the production process.
c) At the production site (GLN 4), consumer units (GTIN 1) are produced in separate batches (each identified
with a distinct Batch Number).
d) In the packaging step, consumer units (GTIN 1 and its Batch Number) are packed into standard grouping units
(GTIN 2).
e) In the next two steps - storage and preparation for shipping, pallets are created (SSCC 5-7) and dispatched to
customer destinations (GLN 5-6).
Application of EAN.UCC standards for traceability in a production environment:
1. Reception: the SSCC of an incoming pallet is recorded and linked to the GLN of the supplier. Each time the
pallet is moved, its SSCC is recorded and linked to the GLN of its new location (e.g. to storage or production).
2. Production: Under ideal conditions the SSCC of the pallet and/or GTIN + Batch Number of materials used in
the production process are recorded and linked to the GTIN of the product made and its production batch. At
the end of the production process, standard trade item groupings are made from individual products. A new
GTIN is assigned and linked to the production Batch Number.
CIES – The Food Business Forum - January 2005
133. Packaging, storage and expedition: The GTIN of a standard trade item grouping is linked to the SSCC of the
pallet onto which it is packed. The SSCC of an outbound pallet is linked via scanning to the GLN of its
destination. The GLN of its destination must not necessarily be displayed on the label.
Traceability data management in distribution
SSCC1
SSCC3
SSCC4
SSCC2
Reception Storage Shipping
Logistic
units stored
for shipping
Logistic unit
stored
Logistic units
received
Destination
location
Storage
GLN1
Original
locations
GLN2
GLN3
GLN5
GLN6
SUPPLIERS
DISTRIBUTION
PLATFORM
DESTINATIONS
SSCC1
SSCC3
SSCC4
SSCC2
SSCC1
SSCC6
SSCC5
SSCC1
SSCC6
SSCC5
Picking, creation of
mixed
logistics units
Uniform
logistic units
and cross docking
SSCC7 SSCC7
Recording links between
newly created logictic units
and their componenets
GLN4
The figure above shows the use of EAN•UCC standards for identifying locations (GLN) and logistic units (SSCC) in
a distribution environment, which is characterised by:
a) Several supplier locations (identified with GLN 1-3), which send pallets of finished products (identified with
SSCC 1-4).
b) At distribution centre (GLN 4) reception, pallets are stored and sent to the order picking process.
c) In the order-picking step, orders are fulfilled either by shipping uniform pallets, cross docking or creation of
mixed pallets. They are either carried forward unchanged (uniform pallet identified with SSCC 1) or newly
created (mixed pallets identified with SSCC 5-7) with products originating from different pallets (SSCC 2-4).
d) In the last two steps - storage and preparation for shipping, both uniform (SSCC 1) and mixed pallets (SSCC
5-7) are dispatched to customer/point-of-sale destinations (identified with GLN 5-6).
Application of EAN.UCC standards for traceability in a distribution environment:
1. Reception: The SSCC of an incoming pallet is recorded and linked to the GLN of the supplier. Each time the
pallet is moved, its SSCC is recorded and linked to the GLN of its new location (e.g. to storage, order-picking or
distribution).
2. Order-picking and distribution:
a) The SSCC of an unmodified pallet picked for distribution from the storage area or cross-docked without any
storage is recorded and linked to the GLN of its destination.
b) A newly created pallet contains standard trade item groupings originating from different pallets. In this case, a
new SSCC is assigned to it and linked to the SSCC numbers of all other pallets used in its creation and/or, if
applicable, the GTIN and Batch Number of each standard trade item grouping that was used. This can create
the need for an enormous effort and can be solved through the application of a “time window”, to be defined by
CIES – The Food Business Forum - January 2005
14each company when a product is packed. Newly created pallets during this time window can be linked to pallets
used up within the same time frame. The SSCC is recorded and linked to the GLN of its destination.
The ability to retrieve traceability data in a fast and accurate manner along of a supply chain is critical. This requires
the management of successive links between what is received, produced, packed, stored and shipped across the
entire supply chain.
If one of the partners, in the supply chain, fails to manage these links, this will result in a break in the information
chain and in the subsequent loss of traceability. It is impossible to attain full product traceability without correctly
identifying products in all their configurations at each different point in the supply chain.
Data Communication
The use of EDI is recommended for the fast, accurate, and cost effective communication of traceability data.
Applicable EAN•UCC standards are EANCOM® and EAN•UCC XML messages. Traceability requires associating
the physical flow of products with the flow of information about them. To ensure the continuity of the information
flow, each supply chain participant must communicate pre-defined traceability data keys to the next one, enabling the
latter to apply traceability principles.
EAN.UCC System application: an example of a product withdrawal
1. Consumer - The consumer signals an anomaly in the sales transaction.
2. Distributor - The distributor relays the complaint to its supplier, i.e. the product’s manufacturer, specifying
the item reference (Global Trade Item Number - GTIN), and if possible, the Batch Number.
3. Manufacturing Plant - The manufacturer identifies the raw material associated with the anomaly and
identifies the corresponding upstream supplier (Global Location Number – GLN).
4. Upstream Supplier:
The upstream supplier analyses the cause of the anomaly and identifies the production batches
associated with it;
It identifies all units shipped from these production batches (Serial Shipping Container Code - SSCC);
Informs receiving customers about the nature of the problem and the Batch Number of the raw
material in question;
5. Manufacturing Plant:
The manufacturer decides to withdraw the finished products related to the problem.
Through its traceability system, the manufacturer searches its records for batches of finished products
for which the raw material in question has been used;
Identifies the SSCC of cartons and pallets containing batches of finished products to be withdrawn
(which may be in the process of being delivered, in external storage and/or already delivered to
customers);
Quarantines the cartons and pallets still present in its stocks;
Identifies customers (GLN) and provides them with information related to products to be quarantined
and returned (SSCC, GTIN, Batch Numbers).
6. Retail Distribution Centre:
The retail distribution centre identifies the cartons and pallets (SSCC) to be quarantined and returned
from the stock picking and shipment areas, and those already delivered at the retail points of sale;
Removes and returns affected products still within its premises (SSCC);
Provides retail stores with the SSCC, GTIN and Batch Number of the items to be removed.
7. Point of Sale:
Retail store quarantines suspect products (GTIN and Batch Number).
CIES – The Food Business Forum - January 2005
15ANNEX 2 - REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 28 January 2002 laying down the general principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures in matters of food safety
[EXCERPT]
Article 3, 15.
‘Traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be,
or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;
Article 14 Food safety requirements
1. Food shall not be placed on the market if it is unsafe.
2. Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.
3. In determining whether any food is unsafe, regard shall be had:
(a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and
distribution, and
(b) to the information provided to the consumer, including information on the label, or other information generally
available to the consumer concerning the avoidance of specific adverse health effects from a particular food or
category of foods.
6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it
shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed
assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.
Article 17 Responsibilities
1. Food and feed business operators at all stages of production, processing and distribution within the businesses
under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their
activities and shall verify that such requirements are met.
Article 18 Traceability
1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be,
incorporated into a food or feed shall be established at all stages of production, processing and distribution.
2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a
food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food
or feed.
To this end, such operators shall have in place systems and procedures which allow for this information to be made
available to the competent authorities on demand.
3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to
which their products have been supplied. This information shall be made available to the competent authorities on
demand.
4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be
adequately labelled or identified to facilitate its traceability, through relevant documentation or information in
accordance with the relevant requirements of more specific provisions.
5. Provisions for the purpose of applying the requirements of this Article in respect of specific sectors may be
adopted in accordance with the procedure laid down in Article 58(2).
Article 19 Responsibilities for food: food business operators
CIES – The Food Business Forum - January 2005
161. If a food business operator considers or has reason to believe that a food which it has imported, produced,
processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately
initiate procedures to withdraw the food in question from the market where the food has left the immediate control
of that initial food business operator and inform the competent authorities thereof. Where the product may have
reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its
withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not
sufficient to achieve a high level of health protection.
2. A food business operator responsible for retail or distribution activities which do not affect the packaging,
labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to
withdraw from the market products not in compliance with the food-safety requirements and shall participate in
contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in
the action taken by producers, processors, manufacturers and/or the competent authorities.
3. A food business operator shall immediately inform the competent authorities if it considers or has reason to
believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the
competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage
any person from cooperating, in accordance with national law and legal practice, with the competent authorities,
where this may prevent, reduce or eliminate a risk arising from a food.
3. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce
risks posed by a food which they supply or have supplied.
CIES – The Food Business Forum - January 2005
17ANNEX 3 - Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 306 (USA)
Regulations Concerning Recordkeeping.--The Secretary, in consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for not longer than two years, of records by persons
(excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import
food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate
previous sources and the immediate subsequent recipients of food, including its packaging, in order to address
credible threats of serious adverse health consequences or death
to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under
this section.
``(c) Protection of Sensitive Information.--The Secretary shall take appropriate measures to ensure that there are
in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information
that is obtained by the Secretary pursuant to this section.
Proposed requirements to establish and maintain records to trace the transportation of all food (Sec. Sec. 1.351 and
1.352) would require that you keep records that trace the transportation process of all food you transport. The
information that we propose as necessary to trace the transportation process includes: (1) The name, address, and
phone number of the person who had the food immediately before you (the transporter's immediate previous
source), and the date you received it from that person; (2) the name, address, and phone number of the person who
had the food immediately after you (the transporter's immediate subsequent recipient), and the date you delivered it
to that person; (3) the type of food transported; (4) the lot number or other identifier of the food if available; (5) the
quantity; and (6) identification of each and every mode of transportation used (e.g., company truck, private carrier,
rail, air, etc.) from the time you first received the food until the time you delivered it.
This proposal has been implemented in December 2004 with the regulation “Establishment and Maintenance of Records Under the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002”. An extensive fact sheet can be found on:
www.cfsan.fda.gov/~dms/fsbtac23.html
CIES – The Food Business Forum - January 2005
18ANNEX 4 - REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the
traceability of food and feed products produced from genetically modified organisms and amending Directive
2001/18/EC
[EXCERPT]
Article 3 Definitions
3. ‘Traceability’ means the ability to trace GMOs and products produced from GMOs at all stages of their placing on
the market through the production and distribution chains.
Article 4 A. TRACEABILITY
1. At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk
quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving
the product:
(a) that it contains or consists of GMOs;
(b) the unique identifier(s) assigned to those GMOs in accordance with Article 8.
2. At all subsequent stages of the placing on the market of products referred to in paragraph 1, operators shall ensure
that the information received in accordance with paragraph 1 is transmitted in writing to the operators receiving the
products.
3. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or
feed or for processing, the information referred to in paragraph 1(b) may be replaced by a declaration of use by the
operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the
mixture.
4. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the
holding of information specified in paragraphs (1), (2) and (3) and the identification, for a period of five years from
each transaction, of the operator by whom and the operator to whom the products referred to in paragraph 1 have
been made available.
Article 5 Traceability requirements for products for food and feed produced from GMOs
1. When placing products produced from GMOs on the market, operators shall ensure that the following
information is transmitted in writing to the operator receiving the product:
(a) an indication of each of the food ingredients which is produced from GMOs;
(b) an indication of each of the feed materials or additives which is produced from GMOs;
(c) in the case of products for which no list of ingredients exists, an indication that the product is produced from
GMOs.
2. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the
holding of the information specified in paragraph 1 and the identification, for a period of five years from each
transaction, of the operator by whom and to whom the products referred to in paragraph 1 have been made
available.
CIES – The Food Business Forum - January 2005
19ANNEX 5 - Description of five food safety standards benchmarked against CIES Global Food Safety Initiative
Guidance Document
The BRC Global; Food Standard:
2.13 Traceability
The Company shall have a system with the ability to trace materials from raw material source to finished product.
2.13.1 Where rework or any reworking operation is performed, traceability shall be maintained.
2.13.2 The system shall be regularly tested to ensure traceability can be determined from raw material source to
finished product.
EFSIS
23.1 The Company shall have a system with the ability to trace materials (including packaging) from raw material
source to finished product and from finished product back to raw material source.
23.1.1 Where rework or any reworking operation is performed, traceability shall be maintained.
23.1.2 The system shall be regularly tested to ensure traceability can be determined from raw material source to
finished product and from finished product back to raw material source.
23.1.3 The level of traceability shall be such as to enable the recall procedure to operate effectively and complaints to
be traced to a defined production run.
International Food Standard (This is a so-called KO criterion. Non-compliance automatically leads to an inability
to be certified)
4.19 Traceability
The Organisation shall adequately identify all raw materials and be able to trace work in progress and finished
product at all stages during manufacture, storage, despatch and, where appropriate, distribution to the customer.
Foundation level:
4.19.1 The organisation shall demonstrate the ability to trace each product backward to processing plant and raw
material organisations, and forwards to delivery point.
4.19.2 Where rework or any reworking operation is performed, traceability shall be maintained.
Higher level:
4.19.3 The organisation shall maintain records of the product during the relevant stages of production.
4.19.4 From all relevant raw materials samples shall be available and kept stored till the end of the expiry date of the
end product.
4.19.5 Samples from the produced charges shall be stored appropriate and kept until the expiry date of the end
product.
Criteria for Assessment of an Operational HACCP System (Dutch HACCP)
2.1 Product Characteristics. The traceability of the raw materials up to and including the final supply shall be
described.
The documentation and data shall be systematically arranged, easily retrievable and shall consist of at least: (…)
- registration of the use of raw material up to and including the point of (final) supply, in order to ensure
traceability of products.
SQF 2000 Code
4.6.2 Product Trace
Finished product shall be traceable to the customer. The product trace system shall be documented in a procedure
with responsibilities defined. It shall provide for the identification of raw materials and other inputs that may have an
impact on finished product quality and safety. Raw materials and other inputs shall be traceable through the process
to the finished product. Records of product dispatch and destination shall be maintained.
CIES – The Food Business Forum - January 2005
20 CIES – The Food Business Forum - January 2005
21
ANNEX 6 - REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing
Directives 80/590/EEC and 89/109/EEC
[EXCERPT]
Article 17
Traceability
1. The traceability of materials and articles shall be ensured at all stages in order to facilitate control, the recall of
defective products, consumer information and the attribution of responsibility.
2. With due regard to technological feasibility, business operators shall have in place systems and procedures to allow
identification of the businesses from which and to which materials or articles and, where appropriate, substances or
products covered by this Regulation and its implementing measures used in their manufacture are supplied. That
information shall be made available to the competent authorities on demand.
3. The materials and articles which are placed on the market in the Community shall be identifiable by an appropriate
system which allows their traceability by means of labelling or relevant documentation or information.
