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
Date: 2003-09-22
Institutions: Council of the European Union, European Parliament
Subjects: animal feedingstuffs, food inspection, genetically modified organism, human nutrition, labelling, marketing standard, traceability

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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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95(1) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Having regard to the opinion of
Regions (3),

the Committee of

the

Acting in accordance with the procedure laid down in Article
251 of the Treaty (4),

Whereas:

(1)

(2)

(3)

Directive 2001/18/EC of the European Parliament and of
the Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organ-
isms (5) requires Member States to take measures to
ensure traceability and labelling of authorised genetically
modified organisms (GMOs) at all stages of their placing
on the market.

laws,

regulations and
Differences between national
administrative provisions concerning traceability and
labelling of GMOs as products or in products as well as
traceability of food and feed produced from GMOs may
hinder
free movement, creating conditions of
unequal and unfair competition. A harmonised Commu-
nity framework for traceability and labelling of GMOs
should contribute to the effective functioning of
the
internal market. Directive 2001/18/EC should therefore
be amended accordingly.

their

Traceability requirements for GMOs should facilitate
both the withdrawal of products where unforeseen
adverse effects on human health, animal health or the
environment, including ecosystems, are established, and
the targeting of monitoring to examine potential effects
on, in particular, the environment. Traceability should
also facilitate the implementation of risk management
measures
precautionary
principle.

accordance with

the

in

(1) OJ C 304 E, 30.10.2001, p. 327 and OJ C 331 E, 31.12.2002, p.

308.

(2) OJ C 125, 27.5.2002, p. 69.
(3) OJ C 278, 14.11.2002, p. 31.
(4) Opinion of

the European Parliament of 3 July 2002 (not yet
published in the Official Journal), Council Common Position of 17
March 2003 (OJ C 113 E, 13.5.2003, p. 21), Decision of the
European Parliament of 2 July 2003 (not yet published in the Offi-
cial Journal) and Council Decision of 22 July 2003.

Traceability requirements for food and feed produced
from GMOs should be established to facilitate accurate
labelling of such products,
in accordance with the
requirements of Regulation (EC) No 1829/2003 of the
European Parliament
the Council of 22
and of
September 2003 on genetically modified food and
feed (6), so as to ensure that accurate information is
available to operators and consumers to enable them to
exercise their freedom of choice in an effective manner
as well as to enable control and verification of labelling
claims. Requirements for food and feed produced from
GMOs should be similar in order to avoid discontinuity
of information in cases of change in end use.

The transmission and holding of
information that
products contain or consist of GMOs, and the unique
codes for those GMOs, at each stage of their placing on
the market provide the basis for appropriate traceability
and labelling for GMOs. The codes may be used to
access specific information on GMOs from a register,
and to facilitate their identification, detection and moni-
toring in accordance with Directive 2001/18/EC.

The transmission and holding of information that food
and feed have been produced from GMOs also provide
the basis for the appropriate traceability of products
produced from GMOs.

The Community legislation concerning GMOs as or in
feed should also apply to feed intended for animals
which are not destined for food production.

Guidance on sampling and detection should be devel-
oped in order to facilitate a coordinated approach for
control and inspection and provide legal certainty for
registers
operators. Account
should be
containing information on genetic modifications
in
GMOs established by the Commission in accordance
with Article 31(2) of Directive 2001/18/EC and Article
29 of Regulation (EC) No 1829/2003.

taken of

(5)

(6)

(7)

(8)

(9)

Member States should lay down rules on penalties
applicable to infringements of
the provisions of this
Regulation.

(5) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council

Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).

(6) See page 1 of this Official Journal.

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(10)

(11)

(12)

(13)

(14)

Certain traces of GMOs in products may be adventitious
or technically unavoidable. Such presence of GMOs
should therefore not trigger labelling and traceability
requirements. It is therefore necessary to fix thresholds
for the adventitious or technically unavoidable presence
of material consisting, containing or produced from
GMOs both when the marketing of such GMOs is
authorised in the Community and when their adventi-
tious or technically unavoidable presence is tolerated by
virtue of Article 47 of Regulation (EC) No 1829/2003. It
is also appropriate to provide that, when the combined
level of adventitious or technically unavoidable presence
of the above material in a food or feed or in one of its
components is higher than the aforesaid labelling thresh-
olds, such presence should be indicated in accordance
with the provisions of
this Regulation and detailed
provisions to be adopted for its implementation.

It is necessary to ensure that consumers are fully and
reliably informed about GMOs and the products, foods
and feed produced therefrom, so as to allow them to
make an informed choice of product.

The measures necessary for the implementation of this
Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1).

Systems for the development and assignment of unique
identifiers for GMOs should be established before the
measures relating to traceability and labelling can be
applied.

to the
The Commission should submit
European Parliament and the Council on the implemen-
tation of this Regulation and, more specifically, on the
effectiveness of the rules on traceability and labelling.

report

a

(15)

This Regulation respects the fundamental rights and
observes the principles recognised in particular by the
Charter of Fundamental Rights of the European Union,

HAVE ADOPTED THIS REGULATION:

Article 1

Objectives

with the objectives of facilitating accurate labelling, monitoring
the effects on the environment and, where appropriate, on
health, and the implementation of the appropriate risk manage-
ment measures including, if necessary, withdrawal of products.

Article 2

Scope

This Regulation shall apply, at all stages of the placing on

1.
the market, to:

(a) products consisting of, or containing, GMOs, placed on the

market in accordance with Community legislation;

(b) food produced from GMOs, placed on the market in accor-

dance with Community legislation;

(c) feed produced from GMOs, placed on the market in accor-

dance with Community legislation.

2.
This Regulation shall not apply to medicinal products for
human and veterinary use authorised under Regulation (EEC)
No 2309/93 (2).

Article 3

Definitions

For the purpose of this Regulation:

1.

2.

3.

4.

5.

‘Genetically modified organism’ or ‘GMO’ means geneti-
cally modified organism as defined in Article 2(2) of Direc-
tive 2001/18/EC, excluding organisms obtained through
the techniques of genetic modification listed in Annex IB
to Directive 2001/18/EC;

‘Produced from GMOs’ means derived, in whole or in part,
from GMOs, but not containing or consisting of GMOs;

‘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;

‘Unique identifier’ means a simple numeric or alphanu-
meric code which serves to identify a GMO on the basis of
the authorised transformation event from which it was
developed and providing the means to retrieve specific
information pertinent to that GMO;

‘Operator’ means a natural or legal person who places a
product on the market or who receives a product that has
been placed on the market in the Community, either from
a Member State or from a third country, at any stage of
the production and distribution chain, but does not include
the final consumer;

This Regulation provides a framework for the traceability of
products consisting of or containing genetically modified
organisms (GMOs), and food and feed produced from GMOs,

(1) OJ L 184, 17.7.1999, p. 23.

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down
Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal products (OJ L
214, 24.8.1993, p. 1). Regulation as last amended by Regulation
(EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

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‘Final consumer’ means the ultimate consumer who will
not use the product as part of any business operation or
activity;

‘Food’ means food as defined in Article 2 of Regulation
(EC) No 178/2002 (1);

In the case of products consisting of or containing
3.
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.

6.

7.

8.

9.

10.

11.

12.

‘Ingredient’ means ingredient as referred to in Article 6(4)
of Directive 2000/13/EC (2);

‘Feed’ means feed as defined in Article 3(4) of Regulation
(EC) No 178/2002;

‘Placing on the market’ means placing on the market as
defined in the specific Community legislation under which
the relevant product has been authorised; in other cases, it
is defined as in Article 2(4) of Directive 2001/18/EC;

‘The first stage of the placing on the market of a product’
means the initial transaction in the production and distri-
bution chains, where a product is made available to a third
party;

‘Pre-packaged product’ means any single item offered for
sale consisting of a product and the packaging into which
it was put before being offered for sale, whether such
packaging encloses
completely or only
the product
partially, provided that
the contents cannot be altered
without opening or changing the packaging.

Article 4

Traceability and labelling requirements

for products

consisting of or containing GMOs

A. TRACEABILITY

At the first stage of the placing on the market of a
1.
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 accor-

dance 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.

(1) Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles
food law, establishing the European Food
and requirements of
Safety Authority and laying down procedures in matters of food
safety (OJ L 31, 1.2.2002, p. 1).

(2) Directive 2000/13/EC of

the European Parliament and of

the
Council of 20 March 2000 on the approximation of the laws of the
Member States relating to the labelling, presentation and advertising
of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as amended by
Commission Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

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.

Paragraphs 1 to 4 shall be without prejudice to other

5.
specific requirements in Community legislation.

B. LABELLING

For products consisting of or containing GMOs, operators

6.
shall ensure that:

(a) for pre-packaged products consisting of, or containing
GMOs, the words ‘This product contains genetically modi-
fied organisms’ or ‘This product contains genetically modi-
fied [name of organism(s)]’ appear on a label;

(b) for non-pre-packaged products offered to the

final
consumer the words ‘This product contains genetically
modified organisms’ or ‘This product contains genetically
modified [name of organism(s)]’ shall appear on, or in
connection with, the display of the product.

This paragraph shall be without prejudice to other specific
requirements in Community legislation.

C. EXEMPTIONS

7.
Paragraphs 1 to 6 shall not apply to traces of GMOs in
products in a proportion no higher than the thresholds estab-
lished in accordance with Article 21(2) or (3) of Directive
specific Community legislation,
2001/18/EC and in other
provided that these traces of GMOs are adventitious or techni-
cally unavoidable.

8.
Paragraphs 1 to 6 shall not apply to traces of GMOs in
products intended for direct use as food, feed or for processing
in a proportion no higher than the thresholds established for
those GMOs in accordance with Articles 12, 24 or 47 of Regu-
lation (EC) No 1829/2003, provided that these traces of GMOs
are adventitious or technically unavoidable.

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Article 5

2. the following paragraph is added to Article 21:

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 identifica-
tion, 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.

‘3.
For products intended for direct processing, paragraph
1 shall not apply to traces of authorised GMOs in a propor-
tion no higher than 0,9 % or lower thresholds established
under the provisions of Article 30(2), provided that these
traces are adventitious or technically unavoidable.’

Article 8

Unique identifiers

In accordance with the procedure referred to in Article 10(2),
the Commission shall:

(a) prior to the application of Articles 1 to 7 establish a system
for development and assignment of unique identifiers to
GMOs;

(b) adapt the system provided for in point (a), as appropriate.

Paragraphs 1 and 2 shall be without prejudice to other

3.
specific requirements in Community legislation.

In so doing, account shall be taken of developments in interna-
tional fora.

4.
Paragraphs 1, 2 and 3 shall not apply to traces of GMOs
in products for food and feed produced from GMOs in a
proportion no higher than the thresholds established for those
GMOs in accordance with Articles 12, 24 or 47 of Regulation
(EC) No 1829/2003, provided that these traces of GMOs are
adventitious or technically unavoidable.

Article 9

Inspection and control measures

Article 6

Exemptions

1.
for
In cases where Community legislation provides
specific identification systems, such as lot numbering for pre-
packaged products, operators shall not be obliged to hold the
information specified in Articles 4(1), 4(2), 4(3) and 5(1),
provided that this information and the lot number is clearly
marked on the package and that
lot
numbers is held for the periods of time referred to in Articles
4(4) and 5(2).

information about

2.
Paragraph 1 shall not apply to the first stage of placing
on the market of a product or to primary manufacture or re-
packaging of a product.

Article 7

Amendment of Directive 2001/18/EC

Directive 2001/18/EC is amended as follows:

1. Article 4(6) is deleted;

1. Member States shall ensure that inspections and other
control measures including sample checks and testing (qualita-
tive and quantitative), as appropriate, are carried out to ensure
Inspection and control
compliance with this Regulation.
measures may also include inspection and control regarding
the holding of a product.

Prior to the application of Articles 1 to 7, the Commis-
2.
sion, in accordance with the procedure referred to in Article
10(3),
shall develop and publish technical guidance on
sampling and testing to facilitate a coordinated approach for
the implementation of paragraph 1 of this Article. In devel-
oping the above technical guidance, the Commission shall take
account of the work of national competent authorities, the
committee referred to in Article 58(1) of Regulation (EC) No
178/2002 and the Community Reference Laboratory estab-
lished under Regulation (EC) No 1829/2003.

3.
In order to help the Member States meet the requirements
set out in paragraphs 1 and 2, the Commission shall ensure
that a central register is put in place at Community level, which
shall contain all available sequencing information and reference
material for GMOs authorised to be put into circulation in the
Community. The competent authorities in the Member States
shall have access to the register. The register shall also contain,
where available, relevant information concerning GMOs which
are not authorised in the European Union.

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Article 10

Committee

Member States shall notify those provisions to the Commission,
not later than 18 April 2004 and shall notify it without delay
of any subsequent amendment affecting them.

The Commission shall be assisted by the committee set

1.
up by Article 30 of Directive 2001/18/EC.

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3. Where reference is made to this paragraph, Articles 3 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

4.

The Committee shall adopt its rules of procedure.

Article 12

Review clause

No later than 18 October 2005, the Commission shall forward
to the European Parliament and to the Council a report on the
implementation of this Regulation, in particular with regard to
Article 4(3) and, where appropriate, bring forward a proposal.

Article 13

Entry into force

Article 11

Penalties

1.
This Regulation shall enter into force on the 20th day
following that of its publication in the Official Journal of the
European Union.

Member States shall lay down the rules on penalties applicable
to infringements of this Regulation and shall take all measures
necessary to ensure that they are implemented. The penalties
provided for must be effective, proportionate and dissuasive.

2.
Articles 1 to 7 and Article 9(1) shall apply with effect
from the 90th day following the date of publication in the Offi-
cial Journal of the European Union of the measure referred to in
Article 8(a).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 September 2003.

For the European Parliament

The President

P. COX

For the Council

The President

R. BUTTIGLIONE