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Traceability requirements under the EU Food Law
Experience has shown that the functioning of the
internal market in food or feed can be jeopardised
where it is impossible to trace food and feed.
Recent food scares (BSE and dioxin crisis) have
demonstrated that the identification of the origin
of feed and food is of prime importance for the
protection of consumers. It is therefore necessary
to establish a comprehensive system of traceability
within food and feed businesses so that targeted and
accurate withdrawals can be undertaken or
information given to consumers or control officials,
thereby avoiding the potential for unnecessary wider
disruption in the event of food safety problems.
It is necessary to ensure that a food or feed
business including an importer can identify at least
the business from which the food, feed, animal or
substance that may be incorporated into a food or
feed has been supplied, to ensure that on
investigation, traceability can be assured at all
stages. In particular, traceability helps facilitate
the withdrawal of food and enables consumers to be
provided with targeted and accurate information
concerning implicated products. Traceability does
not itself make food safe. It is a risk management
tool to be used in order to assist in containing a
food safety problem.
For these reasons, the European Parliament and the
Council adopted on 28 January 2002 Regulation (EC)
No 178/2002 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. One of its objectives is to
establish common definitions and to lay down
overarching guiding principles and legitimate
objectives for food law in order to ensure a high
level of health protection and the effective
functioning of the internal market. Chapter II of
the Regulation seeks to harmonise at Community level
general food law principles (Articles 5 to 10) and
requirements (Article 14 to 21), already existing in
Member States’ legal history, placing them in the
European context and providing the basic framework
of definitions, principles and requirements for
future European food law.
According to Article 3 Point 15 of the Regulation,
‘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.
Traceability has different objectives such as food
safety, fair trading between operators and
reliability of the information provided to
consumers. The Regulation introduces the
traceability requirement with in particular the
objective to ensure food safety and to assist in
enabling unsafe food/feed to be removed from the
market.
Traceability is meant to ensure that targeted and
accurate withdrawals or recalls can be undertaken,
appropriate information can be given to consumers
and food business operators, risk assessment can be
performed by control authorities and unnecessary
wider disruption of trade can be avoided.
Article 18 of Regulation 178/2002
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).
Implications
Although traceability is not a new notion in the
food chain, it is the first time that the obligation
for all food business operators to identify the
suppliers and direct recipients of their food/feed
is stipulated explicitly in a horizontal community
legal text.
Consequently, Article 18 creates a new general
obligation for food business operators.
Article 18 is worded in terms of its goal and
intended result, rather than in terms of prescribing
how that result is to be achieved.
Without prejudice to specific requirements, this
more general approach leaves industry with greater
flexibility in the implementation of the requirement
and is thus likely to reduce compliance costs.
However, it requires both food businesses and the
control authorities to take an active role in
ensuring effective implementation. This may present
some difficulties, although the elaboration of
industry codes of practices could alleviate the
problem.
Article 18 requires food business operators:
• to be able to identify from whom and to whom a
product has been supplied;
• to have systems and procedures in place that allow
for this information to be made available to the
competent Authorities upon their request.
The requirement relies on the
“one-step-back/one-step-forward” approach which
implies for food business operators that:
• They shall have in place a system enabling them to
identify the immediate supplier(s) and immediate
customer(s) of their products.
• A link “supplier-product” shall be established
(which products supplied from which suppliers).
• A link “customer-product” shall be established
(which products supplied to which customers).
Nevertheless, food business operators do not have to
identify the immediate customers when they are final
consumers.
Scope of the traceability requirement
1. Covered products
The wording of this Article and in particular the
part “any substance intended to be, or expected to
be, incorporated into a food or feed” should not be
interpreted in the sense that veterinary medicinal
products, plant protection products, fertilisers may
fall into the scope of the requirement. It should be
noted that some of these products are covered by
specific Regulations or Directives that may even
impose more stringent requirements on traceability.
The covered substances are those intended or
expected to be “incorporated”, as a part of a food
or feed during its manufacture, preparation or
treatment. This would cover for example all types of
food and feed ingredients, included grain when
incorporated in a feed or food. But it excludes
grain when used as seed for cultivation.
Similarly, packaging material does not make part of
food as defined under Article 2 and does not fall
into the scope of Article 18 despite the possible
unvoluntary migration of its constituents into the
food. The traceability of those food packaging
materials has been covered by specific rules,
adopted on 27 October 2004 .
Furthermore, the new food hygiene Regulation (EC) N°
852/2004 and the forthcoming feed hygiene Regulation
should ensure, from the 1st of January 2006, a link
between food/feed and veterinary medicinal and plant
protection products, covering this gap as farmers
will have to keep and retain records on these
products.
2. Covered operators
Article 18 of the Regulation applies to food
business operators at all stages of the food chain,
from primary production (food producing animals,
harvests), food/feed processing to distribution.
This includes charities. However, Member States
should take into consideration the particular
situation of charities and donation activities in
the context of enforcement and sanctions.
Article 3 Points 2 and 5 defines a food business
operator as “any undertaking…carrying out any of the
activities related to any stage of production,
processing and distribution of food/feed”.
Transporters and storage operators, as undertakings
involved in the distribution of food/feed, are
covered by this definition and are required to
comply with Article 18.
Where transportation is integrated within a food
business, the business as a whole must comply with
the provision of Article 18. For the transport unit,
maintaining records of products supplied to
customers may be sufficient as other units within
the business would maintain records of products
received from suppliers.
The manufacturers of veterinary medicinal products,
agricultural production inputs (such as seeds) are
not subject to the requirements of Article 18.
3. Applicability to third country exporters
The traceability provisions of the Regulation do not
have an extra-territorial effect outside the EU.
This requirement covers all stages of production,
processing and distribution in the EU, namely from
the importer up to the retail level.
Article 11 of the Regulation should not be construed
as extending the traceability requirement to food
business operators in third countries. It requires
that food/feed imported into the Community complies
with the relevant requirements of EU food law.
Exporters in trading partner countries are not
legally required to fulfil the traceability
requirement imposed within the EU (except in
circumstances where there are special bilateral
agreements for certain sensitive sectors or where
there are specific Community legal requirements, for
example in the veterinary sector).
The objective of Article 18 is sufficiently
fulfilled because the requirement extends to the
importer. Since the EU importer shall be able to
identify from whom the product was exported in the
third country, the requirement of Article 18 and its
objective is deemed to be satisfied.
It is common practice among some EU food business
operators to request trading partners to meet the
traceability requirements and even beyond the “one
step back-one step forward” principle. However, it
should be noted that such requests are part of the
food business’s contractual arrangements and not of
requirements established by the Regulation.
Implementation of traceability requirement
1. Identification of suppliers and customers by food
business operators
A food business operator should be able to identify
any “person” from whom it received its food/raw
materials. This person can be an individual (for
example a hunter or a mushroom collector) or a legal
person. Recital 29 stipulates that a food business
must identify at least the business from which the
food/feed or substance that may be incorporated into
a food/feed has been supplied.
It should be clarified that the term “supply” should
not be interpreted as the mere physical delivery of
the food/feed or food producing animal (e.g. truck
driver who is an employer for a certain operator).
Identifying the name of the person physically
delivering is not the objective pursued by this rule
and it would not be sufficient to guarantee the
traceability along the food chain.
A food business operator must identify only the
other businesses (legal entity) to whom it provides
its products (excluding final consumers). In case of
trade between retailers, such as a distributor and a
restaurant, the traceability requirement is also
applicable.
2. Internal traceability
It is in the logic of Article 18 that a certain
level of internal traceability would be put in place
by food business operators. Article 18 has to be
read in conjunction with Recital 28 which refers to
a “comprehensive system of traceability within food
and feed businesses so that targeted and accurate
withdrawals can be undertaken…, thereby avoiding the
potential for unnecessary disruption in the event of
food safety problems”.
An internal traceability system will benefit the
operator by contributing to more targeted and
accurate withdrawals. Food business operators would
save costs in terms of time of a withdrawal and in
avoiding unnecessary wider disruption.
Without prejudice to more detailed rules, the
Regulation does not compel operators to establish a
link (so called internal traceability) between
incoming and outgoing products. Nor is there any
requirement for records to be kept identifying how
batches are split and combined within a business to
create particular products or new batches.
In summary, food business operators should be
encouraged to develop systems of internal
traceability designed in relation to the nature of
their activities (food processing, storage,
distribution etc). The decision on the level of
detail of the internal traceability should be left
upon the business operator, commensurate with the
nature and size of the food business.
3. Traceability systems laid down by specific
legislations
Apart from specific legislations establishing food
safety traceability rules for certain
sectors/products in line with the “spirit” of
Article 18, there is a set of specific regulations
laying down marketing and quality standards for
certain products. These regulations that often have
fair trade purposes contain provisions about the
identification of the products, the transmission of
the documents accompanying the transactions, the
keeping of records, etc.
Any other system of identification of products
existing within the framework of specific provisions
may be used to satisfy the requirement established
by Article 18, insofar as it allows the
identification of the suppliers and of the direct
recipients of the products at all stages of
production, processing and distribution.
However, the traceability requirements of the
Regulation are general requirements and are
therefore always applicable. The determination
whether sectoral traceability provisions already
meet Article 18 requirements would need a detailed
analysis of those provisions.
4. Types of information to be kept
Article 18 does not specify what types of
information should be kept by the food and feed
business operators. All relevant information for
traceability purpose should be kept depending on
each traceability system features.
However, to fulfil the objective of Article 18, the
registration of the following information is
considered necessary. This information can be
classified in 2 categories according to its level of
priority:
- The first category of information includes any
information which shall be made available to the
competent Authorities in all cases:
• Name, address of supplier, nature of products
which were supplied from him.
• Name, address of customer, nature of products that
were delivered to that customer.
• Date of transaction/delivery.
The registration of date of transaction/delivery
flows directly from the registration of the two
other items. When a same type of products is
provided several times to a food business operator,
the sole registration of name of supplier and nature
of products would not ensure the traceability
requirement.
- The second category of information includes
additional information which is highly recommended
to be kept:
• Volume or quantity
• Batch number, if any.
• More detailed description of the product
(pre-packed or bulk product, variety of
fruit/vegetable, raw or processed product).
The information to be registered has to be chosen in
light of the food business activity (nature and size
of business) and the characteristics of the
traceability system.
Food crises in the past have shown that tracing the
commercial flow of a product (by invoices at the
level of a company) was not sufficient to follow the
physical flow of the products.
Therefore, it is essential that traceability system
of each food/feed business operator is designed to
follow the physical flow of the products: the use of
delivery notes (or registration of the address of
producing units) would ensure more efficient
traceability.
5. Time of reaction for traceability data
availability
Article 18 requires food and feed operators to have
in place systems and procedures to ensure the
traceability of their products. Although the Article
does not provide any details about these systems,
the use of terms “systems” and “procedures” implies
a structured mechanism able to deliver the needed
information upon request from the competent
Authorities.
The most crucial point in having a good traceability
system in place that would satisfy the objective
pursued as described in Recital 28, is the time
needed to deliver fast and accurate information. A
delay in the delivery of this relevant information
would undermine a prompt reaction in case of crisis.
The minimal information which belongs to the first
category defined above shall be immediately
available to the competent authorities.
The information belonging to the second category
shall be available as soon as reasonably
practicable, within deadlines appropriate to
circumstances.
6. Time of records keeping
Article 18 does not foresee a minimum period of time
for keeping records. On a broad basis, it is
considered that commercial documents are usually
registered for a period of 5 years for taxation
controls. This 5 year period, where applied from
date of manufacturing or delivery to traceability
records , would be likely to meet the objective of
Article 18.
However, this common rule would need to be adapted
in some cases:
• For products without a specified shelf life, the
general rule of 5 years applies;
• For products with a shelf life above 5 years,
records should be kept for the period of the
shelf-life plus 6 months;
• For highly perishable products, which have a “use
by” date less than 3 months or without a specified
date , destined directly to final consumer, records
should be kept for the period of 6 months after date
of manufacturing or delivery.
Finally, it should be taken into account that, apart
from the traceability provisions of Article 18 of
the Regulation, many food businesses are subject to
more specific requirements in terms of record
keeping (type of information to be kept and time).
Competent authorities should ensure that they comply
with these rules.
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