Proposal for a Regulation of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
Date: 2001-07-26
Institutions: European Commission
Subjects: animal nutrition, environmental protection, genetically modified organism, health policy, human nutrition, labelling, marketing

30.10.2001

EN

Official Journal of the European Communities

C 304 E/327

Proposal for a Regulation of the European Parliament and of the Council concerning traceability
food and feed products
and labelling of genetically modified organisms and traceability of

produced from genetically modified organisms and amending Directive 2001/18/EC

(2001/C 304 E/22)

(Text with EEA relevance)

COM(2001) 182 final (cid:151) 2001/0180(COD)

(Submitted by the Commission on 20 August 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL
OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) Directive 2001/18/EC of the European Parliament and the
Council of 12 March 2001 on the deliberate release into
the environment of genetically modified organisms and
the Council (1), as
repealing Directive 90/220/EEC of
amended by Regulation (EC) No . . ./2002 [on genetically
modified food and feed], 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.

(2) Differences between national laws, regulations and admin-
istrative 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 their free
movement, creating conditions of unequal and unfair
competition. A harmonised Community framework for
traceability and labelling of GMOs should contribute to
the effective functioning of the internal market. Directive
2001/18/EC should be amended accordingly.

(3) Traceability requirements for GMOs should facilitate both
the withdrawal of products where unforeseen adverse
effects to human health, animal health or the environment
are established, and the targeting of monitoring to
examine
the
environment.

particular,

potential

effects

on,

in

such products,

(4) Traceability requirements for food and feed produced
from GMOs should be established to facilitate accurate
in accordance with the
labelling of
requirements of Regulation (EC) No . . ./2002 [on
genetically modified food and feed], so as to enable
operators and consumers to exercise their freedom of
choice in an effective manner as well as control and verifi-
cation 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.

(5) Transmission and retention 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 provides 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.

(6) Transmission and retention of information that food and
feed have been produced from GMOs also provides the
basis for appropriate traceability of products produced
from GMOs.

(7) Guidance on sampling and detection should be developed
in order to facilitate a coordinated approach for control
and inspection, and provide legal certainty for operators.

(8) Member States

should lay down rules on penalties
applicable to infringements of the provisions of this Regu-
lation.

(9) Certain traces of GMOs in products may be adventitious
technically unavoidable. Such presence of GMOs
labelling and traceability

trigger

or
should therefore not
requirements.

(10) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (2),
they should be adopted by use of
regulatory
procedure provided for in Article 5 of that Decision.

the

(1) OJ L 106, 17.4.2001, p. 1.

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

C 304 E/328

EN

Official Journal of the European Communities

30.10.2001

(11) Systems for the development and assignment of unique
codes
the
should be
measures relating to traceability and labelling can be
applied.

established before

for GMOs

(12) This Regulation respects

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

the fundamental

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation provides a framework for the traceability of
genetically modified organisms (GMOs), and food and feed
produced from GMOs, with the objective of
facilitating
accurate labelling, environmental monitoring and withdrawals
of products.

Article 2

Scope

2.

(cid:145)produced from GMOs(cid:146) means derived, in whole or in part,
from GMOs, but not containing or consisting of GMOs;

3.

(cid:145)traceability(cid:146) 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;

4.

5.

6.

(cid:145)unique code(cid:146) means a simple numeric or alphanumeric
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;

(cid:145)operator(cid:146) means a person who places a product on the
market and also a person who receives a product that has
been placed on the market in the Community, at any stage
of the production and distribution chain, but does not
include the ultimate consumer;

(cid:145)food(cid:146) means food as defined in [Article 2 of the Proposal
for a Regulation of the European Parliament and of the
Council
and
the
requirements of food law, establishing the European Food
Authority, and laying down procedures in matters of food];

principles

general

laying

down

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

1.
the market, to:

7.

(cid:145)food additive(cid:146) means food additive as defined in Article
1(2) of Council Directive 89/107/EEC (2);

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

market in accordance with Community legislation;

8.

(cid:145)flavouring(cid:146) means flavouring as defined in Article 1(2) of
Council Directive 88/388/EEC (3);

(b) foods and food ingredients,

including food additives and
flavourings, produced from GMOs, placed on the market
in accordance with Community legislation;

(c)

feed materials, compound feedingstuffs and feed additives,
produced from GMOs, placed on the market in accordance
with Community legislation.

9.

(cid:145)feed(cid:146) or (cid:145)feedingstuff(cid:146) means feed or feedingstuff as defined
in [Article 3(4) of the Proposal for a Regulation laying
down the general principles and requirements of
food
law,
establishing the European Food Authority, and
laying down procedures in matters of food];

10.

(cid:145)compound feedingstuffs(cid:146) means compound feedingstuffs as
defined in Article 2(b) of Council Directive 79/373/EEC (4);

2.
This Regulation shall not apply to medicinal products for
human and veterinary use authorised under the provisions of
Council Regulation (EEC) No 2309/93 (1).

11.

(cid:145)feed materials(cid:146) means feed materials as defined in Article
2(a) of Council Directive 96/25/EC (5);

Article 3

Definitions

12.

(cid:145)feed additives(cid:146) means additives as defined in Article 2(a) of
Council Directive 70/524/EEC (6);

For the purpose of this Regulation:

13.

(cid:145)placing on the market(cid:146) means making available to third
parties, whether in return for payment or free of charge;

1.

(cid:145)genetically modified organism(cid:146) means genetically modified
organism as
in Article 2(2) of Directive
2001/18/EC;

defined

(1) OJ L 214, 24.8.1993, p. 1.

(2) OJ L 40, 11.2.1989, p. 27.
(3) OJ L 184, 15.7.1988, p. 61.
(4) OJ L 86, 6.4.1979, p. 30.
(5) OJ L 125, 23.5.1996, p. 35.
(6) OJ L 270, 14.12.1970, p. 1.

30.10.2001

EN

Official Journal of the European Communities

C 304 E/329

14.

(cid:145)the first stage of the placing on the market of a product(cid:146)
means
transaction in the production and
distribution chains, where a product is made available to
a third party;

the initial

15.

(cid:145)pre-packaged(cid:146) means any single item for sale to the
ultimate user, consisting of a product and the packaging
into which it was put before being offered for sale, whether
such packaging encloses the product completely or only
partially, but in such a way that the contents cannot be
altered without opening or changing the packaging.

Article 4

Traceability and labelling requirements for GMOs

1. When placing pre-packaged products consisting of, or
containing GMOs on the market, operators shall ensure that
the words
genetically modified
(cid:145)This product
organisms(cid:146) appear on a label.

contains

At the first stage of

the placing on the market of a
2.
product consisting of or containing GMOs,
including bulk
quantities, operators shall ensure that the following information
is transmitted to the operator receiving the product:

(a) that it contains or consists of GMOs;

(b) the relevant unique code(s) assigned to those GMOs in

accordance with Article 8.

the information referred to in point

However,
(b) may be
replaced by a declaration by the operator that the product
for processing,
food or
shall only be used as
together with the unique codes
the
that
product may contain.

feed, or
for

the GMOs

At all subsequent stages of the placing on the market of
3.
products referred to in paragraph 2, operators shall ensure that
the information received in accordance with paragraph 2 is
transmitted to the operators receiving the products.

4. Without prejudice to Article 6, operators shall have in
place systems and procedures to allow the identification, for a
period of five years from each transaction, of the person from
whom and to whom the products referred to in paragraph 2
have been made available.

Paragraphs 1 to 4 are without prejudice to other specific

5.
requirements in Community legislation.

(a) an indication of each of the food ingredients,

including
additives and flavouring(s), 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 procedures to allow the identification, for a
period of five years from each transaction, as to the person
from whom and to whom the products
referred to in
paragraph 1 have been made available.

Paragraphs 1 and 2 are without prejudice to other

3.
specific requirements in Community legislation.

Article 6

Exemptions

such

systems,

identification

In cases where Community legislation provides

for
1.
specific
batch
numbering for pre-packaged products, operators shall not be
obliged to retain the information specified in Articles 4(2), 4(3)
and 5(1), provided that this information and the lot or batch
number is clearly marked on the package and that information
about batch or lot numbers is retained for the period of time
referred to in Articles 4(4) and 5(2).

lot

or

as

2.
By way of derogation from Articles 4(3), 4(4) and 5(2),
operators delivering food to the ultimate consumer shall not be
obliged to retain documentation detailing to whom products
were sold.

Products

3.
feed or
intended for direct use as
processing which consist of or contain GMOs in respect of
which the conditions set out
in Article 12a of Directive
2001/18/EC (1) are met shall be exempt from the requirements
of Article 4.

food,

4.
Food and feed produced from GMOs in respect of which
the conditions set out in Articles 5 and 18 of Regulation (EC)
No . . ./2002 [on genetically modified food and feed] are met
shall be exempt from the requirements of Article 5.

Article 5

Article 7

Traceability requirements for products produced from
GMOs

1. When placing products produced from GMOs on the
market, operators shall ensure that the following information
is transmitted to operators receiving the product:

Amendment of Directive 2001/18/EC

Article 4(6) of Directive 2001/18/EC is deleted.

(1) [as amended by Regulation (EC) No . . ./2002 on genetically

modified food and feed].

C 304 E/330

EN

Official Journal of the European Communities

30.10.2001

Article 8

Unique codes

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Articles 7 and 8 thereof.

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

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

(a) prior to the application of Articles 1 to 7 and taking into
account international developments, establish the system
for development and assignment of unique codes to GMOs;

(b) adapt the system provided for in point (a), as appropriate,
taking into account further developments in international
fora.

Article 9

Inspection and control measures

1. Member States shall ensure that inspections and other
control measures, as appropriate, are carried out to ensure
compliance with this Regulation.

Prior

to the

application of Articles 1 to 7,

2.
the
Commission shall develop technical guidance on sampling
and testing to facilitate a coordinated approach for
the
implementation of paragraph 1.

Article 10

Committee

Article 11

Penalties

Member States shall lay down the rules on penalties applicable
to infringements of the provisions of this Regulation and shall
they are imple-
take all measures necessary to ensure that
effective,
mented. The penalties provided for must be
shall notify
proportionate and dissuasive. Member States
those provisions to the Commission, by [180 days following
the date of publication of this Regulation in the Official Journal
the European Communities] at the latest and shall notify it
of
without delay of any subsequent amendment affecting them.

Article 12

Entry into force

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

2.
Articles 1 to 7 and Article 9(1) shall apply with effect
from the ninetieth day following the date of publication in the
the measure
Official
Journal of
referred to in Article 8(a).

the European Communities of

The Commission shall be assisted by the committee

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

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