Common Position (EC) No 22/2003 of 17 March 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a regulation of the European Parliament and of the Council on genetically modified food and feed (Text with EEA relevance)
Date: 2003-03-17
Institutions: Council of the European Union
Subjects: animal nutrition, food inspection, food safety, foodstuff, genetically modified organism, labelling, marketing

13.5.2003

EN

Official Journal of the European Union

C 113 E/31

COMMON POSITION (EC) No 22/2003

adopted by the Council on 17 March 2003

with a view to adopting Regulation (EC) No . . ./2003 of the European Parliament and of the
Council of . . . on genetically modified food and feed

(2003/C 113 E/03)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Articles 37, 95 and 152 (4)
(b) 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 referred to in Article
251 of the Treaty (4),

Whereas:

an essential

(1) The free movement of safe and wholesome food and feed
and
is
contributes significantly to the health and wellbeing of
citizens, and to their social and economic interests.

internal market

aspect of

the

(2) A high level of protection of human life and health should

be ensured in the pursuit of Community policies.

(3)

In order to protect human and animal health, food and
feed consisting of, containing or produced from genetically
modified organisms (hereinafter referred to as ‘genetically
modified food and feed’)
safety
through a Community procedure before
assessment
being placed on the market within the Community.

should undergo a

(1) OJ C 304 E, 30.10.2001, p. 221.
(2) OJ C 221, 17.9.2002, p. 114.
(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 and Decision of the European Parliament of . . .
(not yet published in the Official Journal).

(4) Differences between national laws, regulations and admin-
istrative provisions concerning the assessment and author-
isation of genetically modified food and feed may hinder
their free movement, creating conditions of unequal and
unfair competition.

(5) An authorisation procedure involving Member States and
the Commission has been established for genetically
modified foods in Regulation (EC) No 258/97 of
the
European Parliament and of the Council of 27 January
food
1997
ingredients (5). This procedure should be streamlined and
made more transparent.

concerning

foods

novel

novel

and

for novel

foods which are

(6) Regulation (EC) No 258/97 also provides for a notification
procedure
substantially
equivalent to existing foods. Whilst substantial equivalence
is a key step in the procedure for assessment of the safety
of genetically modified foods, it is not a safety assessment
in itself. In order to ensure clarity, transparency and a
harmonised framework for authorisation of genetically
this notification procedure should be
modified food,
abandoned in respect of genetically modified foods.

(7)

23 April

1990 (6)
the European Parliament and of

Feed consisting of or containing genetically modified
organisms (GMOs) has so far been authorised, subject to
the authorisation procedure provided by Council Directive
and Directive
90/220/EEC of
the
2001/18/EC of
Council of 12 March 2001 on the deliberate release into
the environment of genetically modified organisms (7); no
authorisation procedure exists for feed produced from
GMOs; a single, efficient and transparent Community
authorisation procedure for feed consisting of, containing
or produced from GMOs should be established.

(8) The provisions of this Regulation should also apply to feed
intended for animals which are not destined for food
production.

(5) OJ L 43, 14.2.1997, p. 1.
(6) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive

2001/18/EC.

(7) 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).

C 113 E/32

EN

Official Journal of the European Union

13.5.2003

(9) The new authorisation procedures for genetically modified
food and feed should include
the new principles
introduced in Directive 2001/18/EC. They should also
make use of the new framework for risk assessment in
food safety set up by Regulation (EC)
matters of
No 178/2002 of
the
the European Parliament and of
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 (1). Thus, genetically
modified food and feed should only be authorised for
placing on the Community market after a scientific
evaluation of
to be
undertaken under
the European
Food Safety Authority (Authority), of any risks which
they present for human and animal health and, as the
case may be,
scientific
evaluation should be followed by a risk management
regulatory
decision
a
procedure
cooperation between the
Commission and the Member States.

the Community,
close

the highest possible

the responsibility of

environment. This

standard,

ensuring

under

the

for

by

(10) The making available of genetically modified micro-
organisms for activities regulated under Council Directive
90/219/EEC of 23 April 1990 on the contained use of
genetically modified micro-organisms (2),
including
culture collections, the making available of GMOs to be
used exclusively for activities where appropriate stringent
containment measures are used to limit their contact with
and to provide a high level of safety for the general popu-
lation and the environment, and the making available of
GMOs
to be used exclusively for deliberate releases
complying with the requirements referred to in part B of
Directive 2001/18/EC, are not considered as forms of
marketing under the latter Directive. Those operations
are therefore exempted from the need to obtain a
Community authorisation under Part C of Directive
2001/18/EC.
same
appropriate
exceptions in this Regulation. It is, however, appropriate
to maintain the need for an authorisation for genetically
modified food and feed, including food and feed produced
from GMOs or genetically modified micro-organisms in
contained use.

to apply

the

is

It

of food or feed and products for food and/or feed use
which contain, consist of or are produced from it, or to
foods or feed produced from a GMO. Thus, where a GMO
used in the production of food and/or feed has been auth-
orised under this Regulation, foods and/or feed containing,
consisting of or produced from that GMO will not need an
authorisation under this Regulation, but will be subject to
the requirements referred to in the authorisation granted
in respect of the GMO. Furthermore, foods covered by an
this Regulation will be
authorisation granted under
exempted from the requirements of Regulation (EC)
No 258/97 concerning novel
food
ingredients, except where they fall under one or more of
the categories referred to in Article 1(2)(a) of Regulation
(EC) No 258/97 in respect of a characteristic which has
not been considered for the purpose of the authorisation
granted under this Regulation.

foods and novel

laws of

approximation of

(13) Council Directive 89/107/EEC of 21 December 1988 on
the Member States
the
concerning food additives authorised for use in foodstuffs
intended for human consumption (3) provides for author-
isation of additives used in foodstuffs. In addition to this
authorisation
containing,
consisting of or produced from GMOs should fall also
within the scope of
the safety
assessment of the genetic modification, while the final
authorisation should be granted under
the procedure
referred to in Directive 89/107/EEC.

this Regulation for

procedure,

additives

food

(14) Flavourings falling within the scope of Council Directive
88/388/EEC of 22 June 1988 on the approximation of the
laws of the Member States relating to flavourings for use
in
their
production (4) which contain, consist of or are produced
from GMOs should also fall within the scope of this Regu-
lation for the safety assessment of the genetic modifi-
cation.

source materials

foodstuffs

and

for

to

(11) Experience has shown that authorisation should not be
granted for a single use, when a product is likely to be
used both for food and feed purposes;
therefore such
products should only be authorised when fulfilling auth-
orisation criteria for both food and feed.

(15) Council Directive

30

June

1982
82/471/EEC of
concerning certain products used in animal nutrition (5)
provides for an approval procedure for feed materials
produced using different technologies that may pose risk
to human or animal health and the environment. These
feed materials containing, consisting of or produced from
GMOs should fall instead within the scope of this Regu-
lation.

(12) Under this Regulation, authorisation may be granted either
to a GMO to be used as a source material for production

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 117, 8.5.1990, p. 1. Directive as last amended by Decision

2001/204/EC (OJ L 73, 15.3.2001, p. 32).

(3) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive
94/34/EC of the European Parliament and of the Council (OJ L
237, 10.9.1994, p. 1).

(4) OJ L 184, 15.7.1988, p. 61. Directive as amended by Commission

Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).

(5) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive

1999/20/EC (OJ L 80, 25.3.1999, p. 20).

13.5.2003

EN

Official Journal of the European Union

C 113 E/33

(16) Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs (1), provides for an
authorisation procedure
for placing on the market
additives used in feedingstuffs. In addition to this author-
isation procedure, feed additives containing, consisting of
or produced from GMOs should also fall within the scope
of this Regulation.

(17) This Regulation should cover food and feed produced
‘from’ a GMO but not food and feed ‘with’ a GMO. The
determining criterion is whether or not material derived
from the genetically modified source material is present in
the food or in the feed. Processing aids which are only
used during the food or feed production process are not
covered by the definition of food or feed and, therefore,
are not included in the scope of this Regulation. Nor are
food and feed which are manufactured with the help of a
genetically modified processing aid included in the scope
of this Regulation. Thus, products obtained from animals
treated with
fed with genetically modified feed or
genetically modified medicinal products will be subject
neither
to the
to the authorisation requirements nor
labelling requirements referred to in this Regulation.

(18) In accordance with Article 153 of

the
the Treaty,
Community is to contribute to the promotion of
the
right of consumers to information. In addition to other
types of information to the public provided for in this
Regulation,
the
consumer to make an informed choice and facilitates
fairness of transactions between seller and purchaser.

of products

labelling

enables

the

(19) Article 2 of Directive 2000/13/EC of

the

labelling,

the European
Parliament and of the Council of 20 March 2000 on the
approximation of the laws of the Member States relating
to
of
presentation
foodstuffs (2) provides that labelling must not mislead the
purchaser as to the characteristics of the foodstuff and
among other
to its nature,
identity, properties, composition, method of production
and manufacturing.

in particular, as

advertising

things,

and

(20) Additional requirements for the labelling of genetically
laid down in Regulation (EC)
in Council Regulation (EC) No 1139/98 of

modified foods
No 258/97,

are

labelling of

certain foodstuffs produced

26 May 1998 concerning the compulsory indication, on
the
from
genetically modified organisms, of particulars other than
those provided for in Directive 79/112/EEC (3) and in
Commission Regulation (EC) No 50/2000 of 10 January
2000 on the labelling of foodstuffs and food ingredients
containing additives and flavourings
that have been
genetically modified or have been produced from
genetically modified organisms (4).

(21) Harmonised labelling requirements should be laid down
for genetically modified feed to provide final users,
in
livestock farmers, with accurate information
particular
on the composition and properties of
thereby
enabling the user to make an informed choice.

feed,

(22) The labelling should include objective information to the
effect
that a food or feed consists of, contains or is
produced from GMOs. Clear labelling, irrespective of the
detectability of DNA or protein resulting from the genetic
modification in the final product, meets the demands
expressed in numerous surveys by a large majority of
consumers, facilitates informed choice and precludes the
potential misleading of consumers as regards methods of
manufacture or production.

(23) In addition, the labelling should give information about
any characteristic or property which renders a food or
from its conventional counterpart with
feed different
to composition, nutritional value or nutritional
respect
effects, intended use of the food or feed and health impli-
cations for certain sections of the population, as well as
any characteristic or property which gives rise to ethical or
religious concerns.

(24) Regulation (EC) No . . ./2003 of the European Parliament
and of the Council of . . . concerning the traceability and
labelling of genetically modified organisms and traceability
of
food and feed products produced from genetically
modified organisms (5) ensures that relevant information
concerning any genetic modification is available at each
stage of the placing on the market of GMOs and food and
feed produced therefrom and should thereby facilitate
accurate labelling.

(1) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regu-

lation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

(2) OJ L 109, 6.3.2000, p. 29. Directive as amended by Commission

Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

(3) OJ L 159, 3.6.1998, p. 4. Regulation as amended by Commission

Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).

(4) OJ L 6, 11.1.2000, p. 15.
(5) OJ L . . .

C 113 E/34

EN

Official Journal of the European Union

13.5.2003

(25) Despite

the

fact

that

some operators

avoid using
genetically modified food and feed, such material may be
present in minute traces in conventional food and feed as
a result of
its adventitious or technically unavoidable
presence during seed production, cultivation, harvest,
transport or processing. In such cases, this food or feed
should not be subject to the labelling requirements of this
Regulation. In order to achieve this objective, a threshold
should be established for the adventitious or technically
in
unavoidable presence of genetically modified material
foods or feed, both when the marketing of such material is
authorised in the Community and when this presence is
tolerated by virtue of this Regulation.

(26) It is appropriate to provide that, when the combined level
of the adventitious or technically unavoidable presence of
genetically modified materials in a food or feed or in one
of its components is higher than the set threshold, such
presence should be indicated in accordance with this
Regulation and that detailed provisions
should be
adopted for its implementation. The possibility of estab-
lishing lower thresholds, in particular for foods and feed
containing or consisting of GMOs or in order to take into
account advances in science and technology, should be
provided for.

(27) It is vital that operators strive to avoid any accidental
presence of genetically modified material not authorised
under Community legislation in food or feed. However,
in order to ensure the practicability and feasibility of
this Regulation, a specific threshold, with the possibility
of establishing lower levels in particular for GMOs sold
directly to the final consumer, should be established as a
transitional measure for minute traces in food or feed of
this genetically modified material, where the presence of
such material
is adventitious or technically unavoidable
and provided that all specific conditions set in this Regu-
lation are met. Directive 2001/18/EC should be amended
accordingly. The application of this measure should be
reviewed in the context of
the
implementation of this Regulation.

the general review of

(28) In order to establish that the presence of this material is
adventitious or technically unavoidable, operators must be
in a position to demonstrate to the competent authorities
that
they have taken appropriate steps to avoid the
presence of the genetically modified food or feed.

(29) The traceability and labelling of GMOs at all stages of
placing on the market, including the possibility of estab-
lishing thresholds, is ensured by Directive 2001/18/EC and
Regulation (EC) No . . ./2003.

(30) It is necessary to establish harmonised procedures for risk
assessment and authorisation that are efficient,
time-
limited and transparent, and criteria for evaluation of the
potential risks arising from genetically modified foods and
feed.

(31) In order to ensure a harmonised scientific assessment of
genetically modified foods and feed, such assessments
should be carried out by the Authority. However, as
specific acts or omissions on the part of the Authority
under this Regulation could produce direct legal effects
on applicants, it is appropriate to provide for the possi-
bility of an administrative
such acts or
omissions.

review of

(32) It

is

in some cases,

recognised that,

scientific risk
assessment alone cannot provide all the information on
which a risk management decision should be based, and
that other legitimate factors relevant to the matter under
consideration may be taken into account.

a

for

the

into

release

deliberate

genetically modified organism,

(33) Where the application concerns products containing or
consisting of
the
applicant should have the choice of either supplying an
the
authorisation
environment already obtained under Part C of Directive
2001/18/EC, without prejudice to the conditions set by
that authorisation, or of applying for the environmental
risk assessment to be carried out at the same time as the
safety assessment under this Regulation. In the latter case,
it is necessary for the evaluation of the environmental risk
to comply with the requirements referred to in Directive
2001/18/EC and for the national competent authorities
designated by Member States for this purpose to be
consulted by the Authority. In addition, it is appropriate
to give the Authority the possibility of asking one of these
competent authorities to carry out the environmental risk
assessment.
in accordance with
Article 12(4) of Directive 2001/18/EC, for the national
competent authorities designated under the said Directive
in all cases concerning GMOs and food and/or
feed
containing or consisting of a GMO to be consulted by
the Authority before it finalises the environmental risk
assessment.

is also appropriate,

It

13.5.2003

EN

Official Journal of the European Union

C 113 E/35

risk assessment

(34) In the case of GMOs to be used as seeds or other plant-
propagating materials falling within the scope of
this
Regulation, the Authority should be under an obligation
to delegate the environmental
to a
competent national authority. Nonetheless, authorisations
under this Regulation should be without prejudice to the
provisions of Directives 68/193/EEC (1), 2002/53/EC (2)
and 2002/55/EC (3), which provide in particular for the
rules and the criteria for the acceptance of varieties and
their official acceptance for inclusion in common cata-
logues; nor
the provisions of
Directives 66/401/EEC (4), 66/402/EEC (5), 68/193/EEC,
92/33/EEC (6), 92/34/EEC (7), 2002/54/EC (8), 2002/55/EC,
2002/56/EC (9) or 2002/57/EC (10) which regulate
in
particular the certification and the marketing of seeds
and other plant-propagating materials.

should they

affect

the conclusions of

(35) It is necessary to introduce, where appropriate and on the
basis of
the risk assessment, post-
market monitoring requirements for the use of genetically
modified foods for human consumption and for the use of
genetically modified feed for animal consumption. In the
case of GMOs, a monitoring plan concerning environ-
mental effects is compulsory under Directive 2001/18/EC.

(36) To facilitate controls on genetically modified food and
feed, applicants for authorisation should propose appro-
priate methods for sampling, identification and detection,
and deposit samples of the genetically modified food and
sampling and
feed with the Authority; methods of
detection should be validated, where appropriate, by the
Community reference laboratory.

(37) Technological progress and scientific developments should
be taken into account when implementing this Regulation.

(1) OJ L 93, 17.4.1968, p. 15. Directive as last amended by Directive

2002/11/EC (OJ L 53, 23.2.2002, p. 20).

(2) OJ L 193, 20.7.2002, p. 1.
(3) OJ L 193, 20.7.2002, p. 33.
(4) OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by

Directive 2001/64/EC (OJ L 234, 1.9.2001, p. 60).

(5) OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by

Directive 2001/64/EC.

(6) OJ L 157, 10.6.1992, p. 1. Directive as

last amended by
Commission Decision 2002/111/EC (OJ L 41, 13.2.2002, p. 43).
(7) OJ L 157, 10.6.1992, p. 10. Directive as last amended by
Commission Decision 2002/112/EC (OJ L 41, 13.2.2002, p. 44).

(8) OJ L 193, 20.7.2002, p. 12.
(9) OJ L 193, 20.7.2002, p. 60. Directive amended by Commission

Decision 2003/66/EC (OJ L 25, 30.1.2003, p. 42).

(10) OJ L 193, 20.7.2002, p. 74. Directive amended by Directive

2002/68/EC (OJ L 195, 24.7.2002, p. 32).

(38) Food and feed falling within the scope of this Regulation
which have been lawfully placed on the Community
market before the date of application of this Regulation
should continue to be allowed on the market, subject to
the transmission to the Commission by the operators of
information concerning the risk assessment, methods for
sampling,
identification and detection as appropriate,
including the transmission of samples of the food and
feed and their control samples within six months after
the date of application of this Regulation.

(39) A register of genetically modified food and feed authorised
under this Regulation should be established,
including
product specific information, studies which demonstrate
the safety of
including, where available,
references to independent and peer-reviewed studies, and
to methods for sampling,
identification and detection.
Non-confidential data should be made available to the
public.

the product,

(40) In order

it

to stimulate research and development

into
GMOs for food and/or feed use,
is appropriate to
protect the investment made by innovators in gathering
the information and data supporting an application under
this Regulation. This protection should however be limited
in time in order to avoid the unnecessary repetition of
studies and trials which would be against
the public
interest.

(41) 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 (11).

other

(42) Provision should be made for consultation of the European
Group on Ethics in Science and New Technologies estab-
lished by Commission Decision of 16 December 1997, or
any
the
Commission, with a view to obtaining advice on ethical
issues regarding the placing on the market of genetically
feed. Such consultations should be
modified food or
without prejudice to the competence of Member States
as regards ethical issues.

appropriate

established

body

by

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

C 113 E/36

EN

Official Journal of the European Union

13.5.2003

interests

consumer

(43) In order to provide a high level of protection of human
life and health, animal health and welfare, environment
and
in relation to genetically
modified food and feed, requirements arising from this
Regulation should apply in a non-discriminatory manner
to products originating in the Community and imported
from third countries, in accordance with the general prin-
ciples referred to in Regulation (EC) No 178/2002. The
content of
the inter-
this Regulation takes account of
national trade commitments of the European Communities
and of the requirements of the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity as
regards importer obligations and notification.

(44) Certain instruments of Community law should be repealed
and others amended as a result of this Regulation.

(45) The implementation of this Regulation should be reviewed
in the light of experience gained in the short term, and the
impact of the application of this Regulation on human and
consumer
animal
information and the functioning of the internal market
should be monitored by the Commission,

protection,

consumer

health,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVE AND DEFINITIONS

Article 1

Objective

The objective of this Regulation, in accordance with the general
principles laid down in Regulation (EC) No 178/2002, is to:

(a) provide the basis for ensuring a high level of protection of
animal health and welfare,
human life
in relation to
environment
genetically modified food and feed, whilst ensuring the
effective functioning of the internal market;

and health,
and consumer

interests

1. the definitions of ‘food’, ‘feed’, ‘risk’, ‘final consumer’, ‘food
business’ and ‘feed business’ given in Regulation (EC)
No 178/2002 shall apply;

2.

‘operator’ means the natural or legal person responsible for
ensuring that the requirements of this Regulation are met
within the food businesses or feed businesses under its
control;

3. the definitions of

release’ and
‘environmental risk assessment’ referred to in Directive
2001/18/EC shall apply;

‘organism’,

‘deliberate

4.

a
‘genetically modified organism’ or
genetically modified organism as defined in Article 2(2)
of Directive 2001/18/EC, excluding organisms obtained
through the techniques of genetic modification listed in
Annex I B to Directive 2001/18/EC;

‘GMO’ means

5.

‘genetically modified
consisting of or produced from GMOs;

food’ means

food

containing,

6.

‘genetically modified
consisting of or produced from GMOs;

feed’ means

feed

containing,

7.

‘genetically modified organism for food use’ means a GMO
that may be used as food or as a source material for the
production of food;

8.

‘genetically modified organism for feed use’ means a GMO
that may be used as feed or as a source material for the
production of feed;

9.

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

(b) lay down Community procedures for the authorisation and

10.

supervision of genetically modified food and feed;

‘control sample’ means the GMO or its genetic material
(positive sample) and the parental organism or its genetic
material that has been used for the purpose of the genetic
modification (negative sample);

(c)

lay down provisions
modified food and feed.

for

the

labelling of genetically

Article 2

Definitions

For the purposes of this Regulation:

11.

‘conventional counterpart’ means a similar food or feed
produced without the help of genetic modification and
for which there is a well-established history of safe use;

12.

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

13.5.2003

EN

Official Journal of the European Union

C 113 E/37

13.

‘placing on the market’ means the holding of food or feed
for the purpose of sale, including offering for sale, or any
other form of transfer, whether free of charge or not, and
the sale, distribution and other forms of transfer them-
selves. The following operations shall not be regarded as
placing on the market:

— making available genetically modified micro-organisms
for activities regulated under Directive 90/219/EEC,
including culture collections,

— making available GMOs, other than micro-organisms
referred to in the first indent, to be used exclusively
for activities where appropriate stringent containment
measures are used to limit their contact with, and to
provide a high level of safety for, the general popu-
lation and the environment; the measures should be
based on the same principles of containment as those
referred to in Directive 90/219/EEC,

it may be determined in accordance
2. Where necessary,
with the procedure referred to in Article 35(2) whether a
type of food falls within the scope of this Section.

Article 4

Requirements

1.

Food referred to in Article 3(1) must not:

(a) present an unacceptable risk for human health or the

environment;

(b) mislead the consumer;

(c) differ from the food which it is intended to replace to such
an extent that its normal consumption would be nutri-
tionally disadvantageous for the consumer.

— making available GMOs to be used exclusively for
deliberate releases complying with the requirements
referred to in Part B of Directive 2001/18/EC;

2.
No person shall place on the market a GMO for food use
or food referred to in Article 3(1) unless it is covered by an
authorisation granted in accordance with this Section and the
relevant conditions of the authorisation are satisfied.

14.

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

15.

‘mass caterer’ means ‘mass caterer’ as referred to in Article
1 of Directive 2000/13/EC.

CHAPTER II

GENETICALLY MODIFIED FOOD

SECTION 1

AUTHORISATION AND SUPERVISION

Article 3

Scope

1.

This Section shall apply to:

(a) GMOs for food use;

(b) food containing or consisting of GMOs;

3.
No GMO for food use or food referred to in Article 3(1)
shall be authorised unless the applicant for such authorisation
has adequately and sufficiently demonstrated that it satisfies the
requirements of paragraph 1 of this Article.

4.

The authorisation referred to in paragraph 2 may cover:

(a) a GMO and foods containing or consisting of that GMO as
well as foods produced from or containing ingredients
produced from that GMO, or

(b) food produced from a GMO as well as foods produced

from or containing that food;

(c) an ingredient produced from a GMO as well as food

containing that ingredient.

An authorisation as referred to in paragraph 2 shall not
5.
be granted, refused, renewed, modified, suspended or revoked
except on the grounds and under the procedures set out in this
Regulation.

The applicant

6.
for an authorisation as referred to in
paragraph 2 and, after the authorisation is granted, the auth-
orisation-holder or his representative, shall be established in the
Community.

(c)

food produced from or containing ingredients produced
from GMOs.

7.
Authorisation under this Regulation shall be without
prejudice to Directive 2002/53/EC, Directive 2002/55/EC and
Directive 68/193/EEC.

C 113 E/38

EN

Official Journal of the European Union

13.5.2003

Article 5

Application for authorisation

1.
To obtain the authorisation referred to in Article 4(2), an
application shall be submitted in accordance with the following
provisions.

The application shall be sent to the competent national

2.
authority of a Member State.

(a) The competent national authority:

(f) either an analysis, supported by appropriate information
and data, showing that the characteristics of the food are
not different from those of its conventional counterpart,
having regard to the accepted limits of natural variations
for such characteristics and to the criteria specified in
Article 13(2)(a), or a proposal for labelling the food in
accordance with Article 13(2)(a) and (3);

(g) either a reasoned statement that the food does not give rise
to ethical or religious concerns, or a proposal for labelling
it in accordance with Article 13(2)(b);

(i) shall acknowledge receipt of the application in writing
to the applicant within 14 days of its receipt. The
acknowledgement shall state the date of receipt of
the application;

(ii) shall inform without delay the European Food Safety
Authority (hereinafter referred to as the Authority);
and

(iii) shall make the application and any supplementary
information supplied by the applicant available to the
Authority.

(b) The Authority

(i) shall inform without delay the other Member States and
the Commission of the application and shall make the
application
information
any
supplied by the applicant available to them;

supplementary

and

(ii) shall make the summary of the dossier referred to in

paragraph 3(1) available to the public.

3.

The application shall be accompanied by the following:

(a)

the name and the address of the applicant;

(h) where appropriate,

market
specific conditions for use and handling;

the food or foods produced from it,

the conditions for placing on the
including

(i) methods for detection, sampling (including references to
existing official or standardised sampling methods) and
identification of
the transformation event and, where
applicable, for the detection and identification of the trans-
formation event in the food and/or in foods produced from
it;

(j)

samples of
samples, and
the food and their control
information as to the place where the reference material
can be accessed;

(k) where appropriate, a proposal for post-market monitoring

regarding use of the food for human consumption;

(l) a summary of the dossier in a standardised form.

4.
In the case of an application relating to a GMO for food
use, references to ‘food’ in paragraph 3 shall be interpreted as
referring to food containing, consisting of or produced from
the GMO in respect of which an application is made.

In the case of GMOs or food containing or consisting of

5.
GMOs, the application shall also be accompanied by:

(b) the designation of the food, and its specification, including

the transformation event(s) used;

(c) where applicable, the information to be provided for the
purpose of complying with Annex II
to the Cartagena
Protocol on Biosafety to the Convention on Biological
Diversity (hereinafter referred to as the Cartagena Protocol);

(a) the complete technical dossier supplying the information
required by Annexes III and IV to Directive 2001/18/EC
and information and conclusions about the risk assessment
carried out in accordance with the principles set out in
Annex II to Directive 2001/18/EC or, where the placing
on the market of the GMO has been authorised under Part
C of Directive 2001/18/EC, a copy of the authorisation
decision;

(d) where applicable, a detailed description of the method of

production and manufacturing;

(e) a copy of the studies,

including, where available,

inde-
pendent, peer-reviewed studies, which have been carried
out and any other material which is available to demon-
strate that the food complies with the criteria referred to in
Article 4(1);

(b) a monitoring plan for environmental effects conforming
including a
with Annex VII
proposal
this
duration may be different from the proposed period for
the consent.

to Directive 2001/18/EC,

the monitoring plan;

for the duration of

In such case, Articles 13 to 24 of Directive 2001/18/EC shall
not apply.

13.5.2003

EN

Official Journal of the European Union

C 113 E/39

6. Where the application concerns a substance, the use and
placing on the market of which is subject, under other
provisions of Community law, to its inclusion on a list of
substances registered or authorised to the exclusion of others,
this must be stated in the application and the status of the
substance under the relevant legislation must be indicated.

The Commission, having first consulted the Authority,
in accordance with the procedure referred to
implementing rules for the application of
including rules concerning the preparation and

7.
shall establish,
in Article 35(2),
this Article,
the presentation of the application.

Before the date of application of this Regulation,
to assist
in the preparation and the presentation of

8.
Authority shall publish detailed guidance
applicant
application.

the
the
the

Article 6

Opinion of the Authority

1.
In giving its opinion, the Authority shall endeavour to
respect a time limit of six months as from the receipt of a valid
application. This time limit shall be extended whenever the
Authority
from the
applicant as provided for in paragraph 2.

supplementary

information

seeks

shall test and validate the method of detection and identi-
fication proposed by the applicant;

(e) shall,

in verifying the application of Article 13(2)(a),
examine the information and data submitted by the
applicant to show that the characteristics of the food are
not different from those of its conventional counterpart,
having regard to the accepted limits of natural variations
for such characteristics.

4.
In the case of GMOs or food containing or consisting of
GMOs, the environmental safety requirements referred to in
Directive 2001/18/EC shall apply to the evaluation to ensure
that all appropriate measures are taken to prevent the adverse
effects on human and animal health and the environment
which might arise from the deliberate release of GMOs.
During evaluation of requests for the placing on the market
of products consisting of or containing GMOs, the competent
national authority within the meaning of Directive 2001/18/EC
designated by each Member State for this purpose shall be
consulted by the Authority. The competent authorities shall
have three months after the date of receiving the request
within which to make their opinion known.

In the event of an opinion in favour of authorising the
5.
food, the opinion shall also include the following particulars:

The Authority or a competent national authority through
2.
the Authority may, where appropriate, ask the applicant to
supplement
the particulars accompanying the application
within a specific time limit.

(a) the name and address of the applicant;

(b) the designation of the food, and its specification;

3.

In order to prepare its opinion the Authority:

to the Cartagena Protocol;

(c) where applicable, the information required under Annex II

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 5, and
examine whether
the food complies with the criteria
referred to in Article 4(1);

(b) may ask the appropriate food assessment body of a
Member State to carry out a safety assessment of
the
food in accordance with Article 36 of Regulation (EC)
No 178/2002;

(c) may ask a competent authority designated in accordance
with Article 4 of Directive 2001/18/EC to carry out an
environmental risk assessment; however, if the application
concerns GMOs to be used as seeds or other plant-propa-
the Authority shall ask a competent
gating material,
national authority to carry out
the environmental risk
assessment;

(d) the proposal for the labelling of the food and/or foods

produced from it;

(e) where applicable, any conditions or

restrictions which
should be imposed on the placing on the market and/or
specific conditions or restrictions for use and handling,
including post-market monitoring requirements based on
in the case of
the outcome of the risk assessment and,
consisting of GMOs,
GMOs or
conditions for the protection of particular ecosystems/
environment and/or geographical areas;

food containing or

(f)

the method, validated by the Community reference
laboratory, for detection, including sampling, identification
of the transformation event and, where applicable, for the
detection and identification of the transformation event in
the food and/or in foods produced from it; an indication of
where appropriate reference material can be accessed;

(d) shall

forward to the Community reference laboratory
referred to in Article 32 the particulars referred to in
Article 5(3)(i) and (j). The Community reference laboratory

(g) where appropriate,
Article 5(5)(b).

the monitoring plan referred to in

C 113 E/40

EN

Official Journal of the European Union

13.5.2003

shall

The Authority

forward its opinion to the
6.
Commission, the Member States and the applicant, including
a report describing its assessment of the food and stating the
reasons for its opinion and the information on which this
including the opinions of the competent
opinion is based,
authorities when consulted in accordance with paragraph 4.

7.
The Authority, in conformity with Article 38(1) of Regu-
lation (EC) No 178/2002, shall make its opinion public, after
in
deletion of any information identified as confidential
accordance with Article 30 of
this Regulation. The public
may make comments to the Commission within 30 days
from such publication.

Article 7

Authorisation

the Commission shall submit

1. Within three months after receiving the opinion of the
Authority,
to the Committee
referred to in Article 35 a draft of the decision to be taken
in respect of the application, taking into account the opinion
of the Authority, any relevant provisions of Community law
and other legitimate factors relevant
to the matter under
consideration. Where the draft decision is not in accordance
with the opinion of
the Commission shall
the Authority,
provide an explanation for the differences.

2.
Any draft decision which envisages the granting of auth-
orisation shall include the particulars referred to in Article 6(5),
the name of the authorisation-holder and, where appropriate,
the unique identifier attributed to the GMO as referred to in
the Regulation (EC) No . . ./2003 (*).

A final decision on the application shall be adopted in

3.
accordance with the procedure referred to in Article 35(2).

4.
The Commission shall without delay inform the applicant
of the decision taken and publish details of the decision in the
Official Journal of the European Union.

5.
The
authorisation granted in accordance with the
procedure
referred to in this Regulation shall be valid
ten years and shall be
throughout
the Community for
renewable in accordance with Article 11. The authorised
food shall be entered in the Register referred to in Article
28. Each entry in the Register shall mention the date of auth-
referred to in
orisation and shall
paragraph 2.

include the particulars

6.
The authorisation under this Section shall be without
prejudice to other provisions of Community law governing
the use and placing on the market of substances which may
only be used if
they are included in a list of substances
registered or authorised to the exclusion of others.

The granting of authorisation shall not lessen the general
7.
civil and criminal liability of any food operator in respect of
the food concerned.

(*) Note for the Official Journal (GMO Traceability Regulation).

References made

in Parts A and D of Directive
8.
2001/18/EC to GMOs authorised under Part C of
that
Directive shall be considered as applying equally to GMOs
authorised under this Regulation.

Article 8

Status of existing products

1.
By way of derogation from Article 4(2), products falling
within the scope of this Section which have been lawfully
placed on the market in the Community before the date of
application of this Regulation may continue to be placed on
the market, used and processed provided that the following
conditions are met:

(a)

in the case of products placed on the market under
Directive 90/220/EEC before the entry into force of Regu-
lation (EC) No 258/97 or in accordance with the provisions
referred to in Regulation (EC) No 258/97, operators
responsible for placing on the market
the products
the date of
concerned shall, within six months after
application of this Regulation, notify the Commission of
the date on which they were first placed on the market
in the Community;

(b) in the case of products which have been lawfully placed on
the market in the Community but are not covered by point
(a), operators responsible for placing on the market the
the
products concerned shall, within six months after
date of
the
this Regulation, notify
Commission that the products were placed on the market
in the Community before the date of application of this
Regulation.

application of

2.
The notification referred to in paragraph 1 shall be
accompanied by the particulars mentioned in Article 5(3) and
(5), as appropriate, which the Commission shall forward to the
Authority and the Member States. The Authority shall forward
to the Community reference laboratory the particulars referred
to in Article 5(3)(i) and (j). The Community reference
laboratory shall test and validate the method of detection and
identification proposed by the applicant.

3. Within one year from the date of application of this
Regulation and after verification that all
the information
the products
required has been submitted and examined,
concerned shall be entered in the Register. Each entry in the
Register shall include the particulars referred to in Article 7(2)
as appropriate and, in the case of the products referred to in
paragraph 1(a), shall mention the date on which the products
concerned were first placed on the market.

4. Within nine years from the date on which the products
referred to in paragraph 1(a) were first placed on the market,
in no case earlier than three years after the date of
but
application of
for
this Regulation, operators
placing them on the market shall submit an application in
accordance with Article 11, which shall
apply mutatis
mutandis.

responsible

13.5.2003

EN

Official Journal of the European Union

C 113 E/41

Within three years from the date of application of this Regu-
responsible for placing on the market
lation, operators
products
submit an
application in accordance with Article 11, which shall apply
mutatis mutandis.

referred to in paragraph 1(b)

shall

5.
Products referred to in paragraph 1 and food containing
them or produced from them shall be subject to the provisions
of this Regulation, in particular Articles 9, 10 and 34, which
shall apply mutatis mutandis.

6. Where the notification and accompanying particulars
referred to in paragraphs 1 and 2 are not supplied within
the period specified or are found to be incorrect, or where
an application is not submitted as required by paragraph 4
within the period specified,
the Commission, acting in
accordance with the procedure referred to in Article 35(2),
shall adopt a measure requiring the product concerned and
to be withdrawn from the
any products derived from it
market. Such a measure may provide for a limited period of
time within which existing stocks of the product may be used
up.

7.
In the case of authorisations not issued to a specific
holder, the operator who imports, produces or manufactures
the products referred to in this Article shall submit
the
information or the application to Commission.

8.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure referred to in
Article 35(2).

Article 9

Supervision

1.
After an authorisation has been issued in accordance with
this Regulation, the authorisation-holder and parties concerned
shall comply with any conditions or restrictions which have
been imposed in the authorisation and shall in particular make
sure that products not covered by the authorisation are not
placed on the market as food or feed. Where post-market
monitoring as referred to in Article 5(3)(k) and/or monitoring
as referred to in Article 5(5)(b) has been imposed on the auth-
orisation-holder, the authorisation-holder shall ensure that it is
carried out and shall submit reports to the Commission in
accordance with the terms of the authorisation. The moni-
toring reports referred to shall be made accessible to the
public after deletion of any information identified as confi-
dential in accordance with Article 30.

The Commission shall make the information supplied by
4.
the applicant available to the Authority and the Member States
without delay.

Article 10

Modification, suspension and revocation of authorisations

It shall

On its own initiative or following a request

from a
1.
Member State or from the Commission, the Authority shall
issue an opinion on whether an authorisation for a product
referred to in Article 3(1) still meets the conditions set by this
Regulation.
this opinion to the
forthwith transmit
Commission, the authorisation-holder and the Member States.
The Authority, in conformity with Article 38(1) of Regulation
(EC) No 178/2002, shall make its opinion public, after deletion
of any information identified as confidential in accordance with
Article 30 of this Regulation. The public may make comments
to the Commission within 30 days from such publication.

2.
the
The Commission shall examine the opinion of
Authority as soon as possible. Any appropriate measures
shall be taken in accordance with Article 34. If appropriate,
the authorisation shall be modified, suspended or revoked in
accordance with the procedure referred to in Article 7.

3.

Articles 5(2), 6 and 7 shall apply mutatis mutandis.

Article 11

Renewal of authorisations

1.
Authorisations under this Regulation shall be renewable
for ten-year periods, on application to the Commission by the
authorisation-holder at the latest one year before the expiry
date of the authorisation.

2.

The application shall be accompanied by the following:

(a) a copy of the authorisation for placing the food on the

market;

(b) a report on the results of the monitoring, if so specified in

the authorisation;

(c) any other new information which has become available
with regard to the evaluation of safety in the use of the
food and the risks of the food to the consumer or the
environment;

2.
If the authorisation-holder proposes to modify the terms
of the authorisation, the authorisation-holder shall submit an
application in accordance with Article 5(2). Articles 5, 6 and 7
shall apply mutatis mutandis.

(d) where appropriate, a proposal for amending or comple-
menting the conditions of the original authorisation, inter
alia the conditions concerning future monitoring.

shall

The authorisation-holder

forthwith inform the
3.
information
Commission of any new scientific or technical
which might influence the evaluation of the safety in use of
the food. In particular, the authorisation-holder shall forthwith
inform the Commission of any prohibition or
restriction
imposed by the competent authority of any third country in
which the food is placed on the market.

3.

Articles 5(2), 6 and 7 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the author-
isation-holder, no decision is taken on the renewal of an auth-
orisation before its expiry date, the period of authorisation of
the product shall automatically be extended until a decision is
taken.

C 113 E/42

EN

Official Journal of the European Union

13.5.2003

The Commission, having first consulted the Authority,
in accordance with the procedure referred to
implementing rules for the application of
including rules concerning the preparation and

5.
may establish,
in Article 35(2),
this Article,
the presentation of the application.

modified [name of the ingredient]’ shall appear in the list of
in Article 6 of Directive
ingredients provided for
2000/13/EC in parentheses
immediately following the
ingredient concerned;

The Authority shall publish detailed guidance to assist the
its
in the preparation and the presentation of

6.
applicant
application.

SECTION 2

LABELLING

Article 12

Scope

1.
This Section shall apply to foods which are to be
delivered as such to the final consumer or mass caterers in
the Community and which:

(a) contain or consist of GMOs, or

(b) are produced from or contain ingredients produced from

GMOs.

This Section shall not apply to foods containing material
2.
which contains, consists of or is produced from GMOs in a
the food ingredients
proportion no higher
than 0,9 % of
considered individually or
single
ingredient, provided that
this presence is adventitious or
technically unavoidable.

food consisting of

a

3.
In order to establish that the presence of this material is
adventitious or technically unavoidable, operators must be in a
position to supply evidence to satisfy the competent authorities
that they have taken appropriate steps to avoid the presence of
such material.

(b) where the ingredient

is designated by the name of a
category, the words ‘contains genetically modified [name
of organism]’ or ‘contains [name of ingredient] produced
from genetically modified [name of organism]’ shall appear
in the list of ingredients;

(c) where there is no list of ingredients, the words ‘genetically
modified’ or ‘produced from genetically modified [name of
organism]’ shall appear clearly on the labelling;

(d) the indications referred to in (a) and (b) may appear in a
footnote to the list of ingredients. In this case they shall be
printed in a font of at least the same size as that of the list
of ingredients. Where there is no list of ingredients, they
shall appear clearly on the labelling;

(e) where the food is offered for sale to the final consumer as
non-pre-packaged food, or as pre-packaged food in small
containers of which the largest surface has an area of less
than 10 cm2,
this
paragraph must be permanently and visibly displayed
either on the food display or immediately next to it, or
on the packaging material, in a font sufficiently large for it
to be easily identified and read.

information required under

the

2.
In addition to the labelling requirements referred to in
paragraph 1, the labelling shall also mention any characteristic
or property, as specified in the authorisation, in the following
cases:

(a) where a food is different from its conventional counterpart
as regards the following characteristics or properties:

(i) composition;

Appropriate lower

thresholds may be established in
4.
accordance with the procedure referred to in Article 35(2) in
particular in respect of foods containing or consisting of GMOs
or in order to take into account advances in science and tech-
nology.

(ii) nutritional value or nutritional effects;

(iii) intended use of the food;

Article 13

Requirements

1. Without prejudice
of
Community law concerning the labelling of foodstuffs, foods
falling within the scope of this Section shall be subject to the
following specific labelling requirements:

to the other

requirements

(a) where the food consists of more than one ingredient, the
words ‘genetically modified’ or ‘produced from genetically

(iv) implications for the health of certain sections of the

population,

(b) where a food may give rise to ethical or religious concerns.

In addition to the labelling requirements referred to in
3.
paragraph 1 and as specified in the authorisation, the labelling
of foods falling within the scope of this Section which do not
have a conventional counterpart shall contain appropriate
information about the nature and the characteristics of the
foods concerned.

13.5.2003

EN

Official Journal of the European Union

C 113 E/43

Article 14

Implementing measures

1.
Detailed rules for implementing this Section, amongst
other things regarding the measures necessary for operators
to comply with the labelling requirements, may be adopted
in accordance with the procedure referred to in Article 35(2).

Specific rules concerning the information to be given by
2.
mass caterers providing food to the final consumer may be
adopted in accordance with the procedure referred to in
Article 35(2).

In order to take into account the specific situation of mass
caterers,
the
requirements of Article 13(1)(e).

such rules may provide for adaptation of

CHAPTER III

GENETICALLY MODIFIED FEED

SECTION 1

AUTHORISATION AND SUPERVISION

Article 15

Scope

1.

This Section shall apply to:

(a) GMOs for feed use;

(b) feed containing or consisting of GMOs;

(c)

feed produced from GMOs.

it may be determined in accordance
2. Where necessary,
with the procedure referred to in Article 35(2) whether a
type of feed falls within the scope of this Section.

Article 16

Requirements

No person shall place on the market, use or process a
2.
product referred to in Article 15(1) unless it is covered by an
authorisation granted in accordance with this Section and the
relevant conditions of the authorisation are satisfied.

No product referred to in Article 15(1) shall be auth-
3.
orised unless
such authorisation has
for
adequately and sufficiently demonstrated that it satisfies the
requirements of paragraph 1 of this Article.

applicant

the

4.

The authorisation referred to in paragraph 2 may cover:

(a) a GMO and feed containing or consisting of that GMO as

well as feed produced from that GMO, or

(b) feed produced from a GMO as well as feeds produced from

or containing that feed.

5.
An authorisation as referred to in paragraph 2 shall not
be granted, refused, renewed, modified, suspended or revoked
except on the grounds and under the procedures set out in this
Regulation.

The applicant

for an authorisation as referred to in
6.
paragraph 2 and, after the authorisation is granted, the auth-
orisation-holder or his representative, shall be established in the
Community.

7.
Authorisation under this Regulation shall be without
prejudice to Directive 2002/53/EC, Directive 2002/55/EC and
Directive 68/193/EEC.

Article 17

Application for authorisation

1.
To obtain the authorisation referred to in Article 16(2),
an application shall be submitted in accordance with the
following provisions.

The application shall be sent to the national competent

2.
authority of a Member State.

1.

Feed referred to in Article 15(1) must not:

(a) The national competent authority:

(a) present an unacceptable risk for animal health, human

health or the environment;

(b) mislead the user;

(i) shall acknowledge receipt of the application in writing
to the applicant within 14 days of its receipt. The
acknowledgement shall state the date of receipt of
the application;

(c) harm or mislead the consumer by impairing the distinctive

features of the animal products;

(ii) shall inform the Authority without delay; and

(d) differ from feed which it is intended to replace to such an
extent that its normal consumption would be nutritionally
disadvantageous for animals or humans.

(iii) shall make the application and any supplementary
information supplied by the applicant available to the
Authority.

C 113 E/44

EN

Official Journal of the European Union

13.5.2003

(b) The Authority:

(i) shall inform without delay the other Member States and
the Commission of the application and shall make the
application
information
any
supplied by the applicant available to them;

supplementary

and

(i) methods for detection, sampling (including references to
existing official or standardised sampling methods) and
identification of
the transformation event and, where
applicable, for the detection and identification of the trans-
formation event in the feed and/or in the feed produced
from it;

(ii) shall make the summary of the dossier referred to in

paragraph 3(1) available to the public.

(j)

samples of
samples and
the feed and their control
information as to the place where the reference material
can be accessed;

3.

The application shall be accompanied by the following:

(a)

the name and the address of the applicant;

(b) the designation of the feed and its specification, including

the transformation event(s) used;

(c) where applicable, the information to be provided for the
to the Cartagena

purpose of complying with Annex II
Protocol;

(k) where appropriate, a proposal for post-market monitoring

for the use of the feed for animal consumption;

(l) a summary of the dossier in a standardised form.

4.
In the case of an application relating to a GMO for feed
use, references to ‘feed’ in paragraph 3 shall be interpreted as
referring to feed containing, consisting of or produced from the
GMO in respect of which an application is made.

(d) where applicable, a detailed description of the method of
production and manufacturing and intended uses of the
feed;

In the case of GMOs or feed containing or consisting of

5.
GMOs, the application shall also be accompanied by:

(e) a copy of

the studies including, where available,

inde-
pendent, peer-reviewed studies, which have been carried
out and any other material which is available to demon-
strate that the feed complies with the criteria referred to in
Article 16(1), and, in particular for feed falling within the
scope of Council Directive 82/471/EEC of 30 June 1982
concerning certain products used in animal nutrition (1),
the
under Council Directive
83/228/EEC of 18 April 1983 on the fixing of guidelines
for the assessment of certain products used in animal
nutrition (2);

information

required

(f) either an analysis, supported by appropriate information
and data, showing that the characteristics of the feed are
not different from those of its conventional counterpart,
having regard to the accepted limits of natural variations
for such characteristics and to the criteria specified in
Article 25(2)(c), or a proposal for labelling the feed in
accordance with Article 25(2)(c) and (3);

(g) either a reasoned statement that the feed does not give rise
to ethical or religious concerns, or a proposal for labelling
it in accordance with Article 25(2)(d);

(h) where appropriate, the conditions for placing the feed on
including specific conditions for use and

the market,
handling;

(1) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive

1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(2) OJ L 126, 13.5.1983, p. 23.

(a) the complete technical dossier supplying the information
required by Annexes III and IV to Directive 2001/18/EC
and information and conclusions about the risk assessment
carried out in accordance with the principles set out in
Annex II to Directive 2001/18/EC or, where the placing
on the market of the GMOs has been authorised under Part
C of Directive 2001/18/EC, a copy of the authorisation
decision;

(b) a monitoring plan for environmental effects conforming
including a
with Annex VII
proposal
this
duration may be different from the proposed period for
the consent.

to Directive 2001/18/EC,

the monitoring plan;

for the duration of

In such a case, Articles 13 to 24 of Directive 2001/18/EC shall
not apply.

6. Where the application concerns a substance, the use and
placing on the market of which is
subject under other
provisions of Community law to its inclusion on a list of
substances registered or authorised to the exclusion of others,
this must be stated in the application and the status of the
substance under the relevant legislation must be indicated.

The Commission, having first consulted the Authority,
in accordance with the procedure referred to
implementing rules for the application of
including rules concerning the preparation and

7.
shall establish,
in Article 35(2),
this Article,
the presentation of the application.

13.5.2003

EN

Official Journal of the European Union

C 113 E/45

Before the date of application of this Regulation,
to assist
in the preparation and the presentation of

8.
Authority shall publish detailed guidance
applicant
application.

the
the
the

Article 18

Opinion of the Authority

1.
In giving its opinion, the Authority shall endeavour to
comply with a time limit of six months as from the receipt of a
valid application. This time limit shall be extended whenever
supplementary information from the
the Authority seeks
applicant as provided in paragraph 2.

2.
The Authority or a competent national authority through
the Authority may, where appropriate, request the applicant to
supplement
the particulars accompanying the application
within a specific time limit.

that all appropriate measures are taken to prevent adverse
effects on human and animal health and the environment
which might arise from the deliberate release of GMOs.
During evaluation of requests for the placing on the market
of products consisting of or containing GMOs, the competent
of Directive
national
2001/18/EC, designated by each Member State for
this
purpose, shall be consulted by the Authority. The competent
authorities shall have three months after the date of receiving
the request within which to make their opinion known.

authority within

the meaning

5.
In the event of an opinion in favour of authorising the
feed, the opinion shall also include the following particulars:

(a) the name and address of the applicant;

(b) the designation of the feed, and its specification;

3.

In order to prepare its opinion, the Authority:

to the Cartagena Protocol;

(c) where applicable, the information required under Annex II

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 17, and
examine whether the feed complies with the criteria laid
down in Article 16(1);

(b) may ask the appropriate feed assessment body of a Member
the feed in
(EC)

State to carry out a safety assessment of
accordance with Article
No 178/2002;

Regulation

36

of

(d) the proposal for the labelling of the feed;

(e) where applicable, any conditions or

restrictions which
should be imposed on the placing on the market and/or
specific conditions or restrictions for use and handling,
including post-market monitoring requirements based on
in the case of
the outcome of the risk assessment and,
GMOs or
consisting of GMOs,
conditions for the protection of particular ecosystems/
environment and/or geographical areas;

feed containing or

(c) may ask a competent authority designated in accordance
with Article 4 of Directive 2001/18/EC to carry out an
environmental risk assessment; however, if the application
concerns GMOs to be used as seeds or other plant-propa-
the Authority shall ask a competent
gating material,
national authority to carry out
the environmental risk
assessment;

(f)

the method, validated by the Community reference
laboratory, for detection, including sampling, identification
of the transformation event and, where applicable, for the
detection and identification of the transformation event in
the feed and/or in feed produced from it; an indication of
where appropriate reference material can be accessed;

(d) shall forward to the Community reference laboratory the
referred to in Article 17(3)(i) and (j). The
particulars
Community reference laboratory shall
test and validate
the method of detection and identification proposed by
the applicant;

(e) shall,

in verifying the application of Article 25(2)(c),
examine the information and data submitted by the
applicant to show that the characteristics of the feed are
not different from those of its conventional counterpart,
having regard to the accepted limits of natural variations
for such characteristics.

4.
In the case of GMOs or feed containing or consisting of
GMOs, the environmental safety requirements referred to in
Directive 2001/18/EC shall apply to the evaluation to ensure

(g) where appropriate, the monitoring plan as referred to in

Article 17(5)(b).

shall

The Authority

6.
forward its opinion to the
Commission, the Member States and the applicant, including
a report describing its assessment of the feed and stating the
reasons for its opinion and the information on which this
including the opinions of the competent
opinion is based,
authorities when consulted in accordance with paragraph 4.

The Authority, in conformity with Article 38(1) of Regu-
7.
lation (EC) No 178/2002, shall make its opinion public, after
deletion of any information identified as confidential
in
accordance with Article 30 of
this Regulation. The public
may make comments to the Commission within 30 days
from such publication.

C 113 E/46

EN

Official Journal of the European Union

13.5.2003

Article 19

Authorisation

the market, used and processed provided that the following
conditions are met:

the Commission shall submit

1. Within three months after receiving the opinion of the
to the Committee
Authority,
referred to in Article 35 a draft of the decision to be taken
in respect of the application, taking into account the opinion
of the Authority, any relevant provisions of Community law
to the matter under
and other legitimate factors relevant
consideration. Where the draft decision is not in accordance
with the opinion of
the Commission shall
the Authority,
provide an explanation for the differences.

Any draft decision which envisages the granting of auth-
2.
orisation shall
include the particulars referred to in Article
18(5), the name of the authorisation-holder and, where appro-
priate, the unique identifier attributed to the GMO as referred
to in Regulation (EC) No . . ./2003 (*).

A final decision on the application shall be adopted in

3.
accordance with the procedure referred to in Article 35(2).

4.
The Commission shall without delay inform the applicant
of the decision taken and publish details of the decision in the
Official Journal of the European Union.

authorisation granted in accordance with the
5.
The
referred to in this Regulation shall be valid
procedure
throughout
ten years and shall be
the Community for
renewable in accordance with Article 23. The authorised feed
shall be entered in the Register referred to in Article 28. Each
entry in the Register shall mention the date of authorisation
include the particulars referred to in paragraph 2.
and shall

6.
The authorisation under this Section shall be without
prejudice to other provisions of Community law governing
the use and placing on the market of substances which may
only be used if
they are included in a list of substances
registered or authorised to the exclusion of others.

7.
The granting of authorisation shall not lessen the general
civil and criminal liability of any feed operator in respect of the
feed concerned.

References made

in Parts A and D of Directive
8.
that
2001/18/EC to GMOs authorised under Part C of
Directive shall be considered as applying equally to GMOs
authorised under this Regulation.

Article 20

Status of existing products

1.
By way of derogation from Article 16(2), products falling
within the scope of this Section which have been lawfully
placed on the market in the Community before the date of
application of this Regulation may continue to be placed on

(*) Note for the Official Journal (GMO Traceability Regulation).

(a)

in the case of products which have been authorised under
Directives 90/220/EEC or 2001/18/EC,
including use as
feed, under Directive 82/471/EEC, which are produced
from GMOs, or under Directive 70/524/EEC, which
are produced from GMOs,
consist of or
contain,
the
responsible for placing on the market
operators
the
products concerned shall, within six months after
date of
the
this Regulation, notify
Commission of the date on which they were first placed
on the market in the Community;

application of

(b) in the case of products which have been lawfully placed on
the market in the Community but which are not referred to
(a), operators responsible for placing on the
in point
market in the Community the products concerned shall,
within six months after the date of application of this
Regulation, notify the Commission that the products were
placed on the market in the Community before the date of
application of this Regulation.

2.
The notification referred to in paragraph 1 shall be
accompanied by the particulars mentioned in Article 17(3)
and (5), as appropriate, which the Commission shall forward
to the Authority and the Member States. The Authority shall
forward to the Community reference laboratory the particulars
referred to in Article 17(3)(i) and (j). The Community reference
laboratory shall test and validate the method of detection and
identification proposed by the applicant.

3. Within one year from the date of application of this
the information
Regulation and after verification that all
required has been submitted and examined,
the products
concerned shall be entered in the Register. Each entry in the
Register shall include the particulars referred to in Article 19(2)
as appropriate and, in the case of the products referred to in
paragraph 1(a), shall mention the date on which the products
concerned were first placed on the market.

4. Within nine years from the date on which the products
referred to in paragraph 1(a) were first placed on the market,
in no case earlier than three years after the date of
but
application of
for
this Regulation, operators
placing them on the market shall submit an application in
apply mutatis
accordance with Article 23, which shall
mutandis.

responsible

Within three years from the date of application of this Regu-
responsible for placing on the market
lation, operators
products
submit an
application in accordance with Article 23, which shall apply
mutatis mutandis.

referred to in paragraph 1(b)

shall

5.
Products referred to in paragraph 1 and feed containing
them or produced from them shall be subject to the provisions
of this Regulation, in particular Articles 21, 22 and 34, which
shall apply mutatis mutandis.

13.5.2003

EN

Official Journal of the European Union

C 113 E/47

6. Where the notification and accompanying particulars
referred to in paragraphs 1 and 2 are not supplied within
the period specified or are found to be incorrect, or where
an application is not submitted as required by paragraph 4
the Commission, acting in
within the period specified,
accordance with the procedure laid down in Article 35(2),
shall adopt a measure requiring the product concerned and
any products derived from it
to be withdrawn from the
market. Such a measure may provide for a limited period of
time within which existing stocks of the product may be used
up.

7.
In the case of authorisations not issued to a specific
holder, the operator who imports, produces or manufactures
the products referred to in this Article shall submit
the
information or the application to the Commission.

8.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure referred to in
Article 35(2).

Article 21

Supervision

After an authorisation has been issued in accordance with
1.
the authorisation-holder and the parties
this Regulation,
concerned shall comply with any conditions or restrictions
which have been imposed in the authorisation and shall
in
particular make sure that products not covered by the author-
isation are not placed on the market as food or feed. Where
post-market monitoring as referred to in Article 17(3)(k) and/or
monitoring as referred to in Article 17(5)(b) has been imposed
on the authorisation-holder,
shall
ensure that it is carried out and shall submit reports to the
Commission in accordance with the terms of the authorisation.
The monitoring reports referred to shall be made accessible to
the public after deletion of any information identified as confi-
dential in accordance with Article 30.

the authorisation-holder

If the authorisation-holder wishes to modify the terms of
2.
the authorisation,
the authorisation-holder shall submit an
application in accordance with Article 17(2). Articles 17, 18
and 19 shall apply mutatis mutandis.

shall

The authorisation-holder

forthwith inform the
3.
Commission of any new scientific or technical
information
which might influence the evaluation of safety in the use of
the feed. In particular, the authorisation-holder shall forthwith
restriction
inform the Commission of any prohibition or
imposed by the competent Authority of any third country in
which the feed is placed on the market.

The Commission shall make the information supplied by
4.
the applicant available to the Authority and the Member States
without delay.

Article 22

It shall

issue an opinion on whether an authorisation for a product
referred to in Article 15(1) still meets the conditions set by this
Regulation.
this opinion to the
forthwith transmit
Commission, the authorisation-holder and the Member States.
The Authority, in conformity with Article 38(1) of Regulation
(EC) No 178/2002, shall make its opinion public, after deletion
of any information identified as confidential in accordance with
Article 30 of this Regulation. The public may make comments
to the Commission within 30 days from such publication.

2.
the
The Commission shall examine the opinion of
Authority as soon as possible. Any appropriate measures
shall be taken in accordance with Article 34. If appropriate,
the authorisation shall be modified, suspended or revoked in
accordance with the procedure referred to in Article 19.

3.

Articles 17(2), 18 and 19 shall apply mutatis mutandis.

Article 23

Renewal of authorisations

Authorisations under this Regulation shall be renewable
1.
for ten-year periods, on application to the Commission by the
authorisation-holder at the latest one year before the expiry of
the authorisation.

The application shall be accompanied by the following

2.
particulars and documents:

(a) a copy of the authorisation for placing the feed on the

market;

(b) a report on the results of the monitoring, if so specified in

the authorisation;

(c) any other new information which has become available
with regard to the evaluation of safety in the use of the
feed and the risks of the feed to animals, humans or the
environment;

(d) where appropriate, a proposal for amending or comple-
menting the conditions of the original authorisation, inter
alia the conditions concerning future monitoring.

3.

Articles 17(2), 18 and 19 shall apply mutatis mutandis.

4. Where, for reasons beyond the control of the author-
isation-holder, no decision is taken on the renewal of an auth-
orisation before its expiry, the period of authorisation of the
product shall automatically be extended until a decision is
taken.

The Commission, having first consulted the Authority,
in accordance with the procedure referred to
implementing rules for the application of
including rules concerning the preparation and

5.
may establish,
in Article 35(2),
this Article,
the presentation of the application.

Modification, suspension and revocation of authorisations

On its own initiative or following a request

1.
from a
Member State or from the Commission, the Authority shall

The Authority shall publish detailed guidance to assist the
its
in the preparation and the presentation of

6.
applicant
application.

C 113 E/48

EN

Official Journal of the European Union

13.5.2003

SECTION 2

LABELLING

Article 24

Scope

This Section shall apply to feed referred to in Article

1.
15(1).

2.
This Section shall not apply to feed containing material
which contains, consists of or is produced from GMOs in a
proportion no higher than 0,9 % of the feed and of each feed
of which it
this presence is
adventitious or technically unavoidable.

is composed, provided that

3.
In order to establish that the presence of this material is
adventitious or technically unavoidable, operators must be in a
position to supply evidence to satisfy the competent authorities
that they have taken appropriate steps to avoid the presence of
such materials.

Appropriate lower

4.
thresholds may be established in
accordance with the procedure referred to in Article 35(2) in
particular in respect of feed containing or consisting of GMOs
or in order to take into account advances in science and tech-
nology.

Article 25

Requirements

of
1. Without prejudice
Community law concerning the
feed
referred to in Article 15(1) shall be subject to the specific
labelling requirements laid down below.

to the other

requirements

labelling of

feed,

2.
No person shall place a feed referred to in Article 15(1)
on the market unless the particulars specified below are shown,
in a clearly visible, legible and indelible manner, on an accom-
panying document or, where appropriate, on the packaging, on
the container or on a label attached thereto.

Each feed of which a particular feed is composed shall be
subject to the following rules:

(a)

for the feeds referred to in Article 15(1) (a) and (b), the
words ‘genetically modified [name of the organism]’ shall
appear in parentheses immediately following the specific
name of the feed;

Alternatively, these words may appear in a footnote to the
list of feed. It shall be printed in a font of at least the same
size as that of the list of feed.

(b) for the feed referred to in Article 15(1)(c),

‘produced from genetically modified [name of
organism]’
following the specific name of the feed;

in parentheses

appear

shall

the words
the
immediately

Alternatively, these words may appear in a footnote to the
list of feed. It shall be printed in a font of at least the same
size as that of the list of feed.

(c) as specified in the authorisation, any characteristic of the
feed referred to in Article 15(1) such as those indicated
hereunder, which is different
conventional
counterpart:

from its

(i) composition;

(ii) nutritional properties;

(iii) intended use;

(iv) implications

for

the health of certain species or

categories of animals.

(d) as specified in the authorisation, any characteristic or
property where a feed may give rise to ethical or
religious concerns.

3.
In addition to the requirements referred to in paragraph
2(a) and (b) and as specified in the authorisation, the labelling
or accompanying documents of feed falling within the scope of
this Section which does not have a conventional counterpart
shall contain appropriate information about the nature and the
characteristics of the feed concerned.

Article 26

Implementing measures

Detailed rules for implementing this Section, amongst other
things regarding the measures necessary for operators to
comply with the labelling requirements, may be adopted in
accordance with the procedure referred to in Article 35(2).

CHAPTER IV

COMMON PROVISIONS

Article 27

Products likely to be used as both food and feed

1. Where a product is likely to be used as both food and
feed, a single application under Articles 5 and 17 shall be
submitted and shall give rise to a single opinion from the
Authority and a single Community decision.

13.5.2003

EN

Official Journal of the European Union

C 113 E/49

The Authority shall consider whether the application for

2.
authorisation should be submitted both as food and feed.

(b) the general description of the GMO and the name and

address of the authorisation-holder;

Article 28

Community Register

(c)

the physico-chemical and biological characteristics of the
GMO, food or feed referred to in Articles 3(1) and 15(1);

The Commission shall

1.
establish and maintain a
Community Register of Genetically Modified Food and Feed,
hereinafter referred to as ‘the Register’.

(d) the effects of the GMO, food or feed referred to in Articles
3(1) and 15(1) on human and animal health and on the
environment;

2.

The Register shall be made available to the public.

Article 29

Public access

for

The

application

authorisation,

1.
supplementary
information from the applicant, opinions from the competent
authorities designated in accordance with Article 4 of Directive
2001/18/EC, monitoring reports and information from the
authorisation holder, excluding confidential information, shall
be made accessible to the public.

The Authority shall apply the principles of Regulation
2.
(EC) No 1049/2001 of the European Parliament and of the
Council of 30 May 2001 regarding public
to
European Parliament, Council and Commission documents (1)
when handling applications for access to documents held by
the Authority.

access

3. Member States shall handle applications for access to
documents received under this regulation in accordance with
Article 5 of Regulation (EC) No 1049/2001.

Article 30

Confidentiality

1.
The applicant may indicate which information submitted
under this Regulation it wishes to be treated as confidential on
the ground that
its disclosure might significantly harm its
competitive position. Verifiable justification must be given in
such cases.

2. Without prejudice to paragraph 3, the Commission shall
applicant, which
consultation with the
determine,
information should be kept confidential and shall inform the
applicant of its decision.

after

Information relating to the following shall not be

3.
considered confidential:

(a) the name and composition of

food or feed
referred to in Articles 3(1) and 15(1) and, where appro-
priate, an indication of
the substrate and the micro-
organism;

the GMO,

(1) OJ L 145, 31.5.2001, p. 43.

(e)

the effects of the GMO, food or feed referred to in Articles
3(1) and 15(1) on the characteristics of animal products
and its nutritional properties;

(f)

the methods for detection, including sampling and identi-
fication of the transformation event and, where applicable,
for the detection and identification of the transformation
event in the food or feed referred to in Articles 3(1) and
15(1);

(g)

information on waste treatment and emergency response.

Notwithstanding paragraph 2,

the Authority shall on
4.
request supply the Commission and Member States with all
information in its possession.

5.
The use of the detection methods and the reproduction of
the reference materials, provided under Article 5(3) and 17(3)
for the purpose of applying this Regulation to the GMOs, food
or feed to which an application refers, shall not be restricted by
the exercise of intellectual property rights or otherwise.

6.
The Commission, the Authority and the Member States
shall take the necessary measures to ensure appropriate confi-
dentiality of the information received by them under this Regu-
lation except for information which must be made public if
circumstances so require in order to protect human health,
animal health or the environment.

If

7.
an applicant withdraws or has withdrawn an
application, the Authority, the Commission and the Member
the confidentiality of commercial and
States shall
including research and development
industrial
information, as well as information as to the confidentiality
of which the Commission and the applicant disagree.

respect
information,

Article 31

Data protection

The scientific data and other information in the application
dossier required under Article 5(3) and (5) and Article 17(3)
and (5) may not be used for the benefit of another applicant
for a period of ten years from the date of authorisation, unless
the other applicant has agreed with the authorisation-holder
that such data and information may be used.

C 113 E/50

EN

Official Journal of the European Union

13.5.2003

On the expiry of this ten-year period, the findings of all or part
of the evaluation conducted on the basis of the scientific data
and information contained in the application dossier may be
used by the Authority for the benefit of another applicant if
the applicant can demonstrate that the food or feed for which
it is seeking authorisation is essentially similar to a food or feed
already authorised under this Regulation.

Article 32

Article 58 of Regulation (EC) No 178/2002, hereinafter
referred to as the ‘Committee’.

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.

Community reference laboratory

3.

The Committee shall adopt its rules of procedure.

The Community reference laboratory and its duties and tasks
shall be those referred to in the Annex.

National
accordance with the procedure referred to in Article 35(2).

laboratories may

established

reference

be

in

Applicants for authorisation of genetically modified food and
feed shall contribute to the cost of the tasks of the Community
reference laboratory and the European Network of GMO labo-
ratories mentioned in the Annex.

Detailed rules for implementing this Article, the Annex and any
changes to it may be adopted in accordance with the procedure
referred to in Article 35(2).

Article 33

Consultation with the European Group on Ethics in
Science and New Technologies

1.
The Commission, on its own initiative or at the request
of a Member State, may consult the European Group on Ethics
in Science and New Technologies or any other appropriate
body it might establish, with a view to obtaining its opinion
on ethical issues.

Article 36

Administrative review

Any decision taken under, or failure to exercise, the powers
vested in the Authority by this Regulation may be reviewed by
the Commission on its own initiative or in response to a
request
from a Member State or from any person directly
and individually concerned.

To this effect a request shall be submitted to the Commission
within two months from the day on which the party concerned
became aware of the act or omission in question.

The Commission shall
requiring,
if appropriate,
decision or to remedy its failure to act.

take a decision within two months
the Authority to withdraw its

Article 37

Repeals

The following Regulations shall be repealed with effect from
the date of application of this Regulation:

— Regulation (EC) No 1139/98;

The Commission shall make these opinions available to

2.
the public.

— Regulation (EC) No 49/2000;

Article 34

Emergency measures

risk

is evident

to human health,

that products authorised by or

Where it
in
accordance with this Regulation are likely to constitute a
the
serious
environment, or where,
the
Authority issued under Article 10 or Article 22, the need to
suspend or modify urgently an authorisation arises, measures
shall be taken under the procedures provided for in Articles 53
and 54 of Regulation (EC) No 178/2002.

animal health or
in the light of an opinion of

Article 35

Committee procedure

— Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

Regulation (EC) No 258/97 is hereby amended with effect from
the date of application of this Regulation as follows:

1. The following provisions shall be deleted:

— Article 1(2)(a) and (b);

— Article 3(2), second subparagraph, and (3);

— Article 8(1)(d);

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health, set up by

— Article 9.

13.5.2003

EN

Official Journal of the European Union

C 113 E/51

2. In Article 3, the first sentence of paragraph 4 shall be

replaced by the following:

the
By way of derogation from paragraph 2,
‘(4)
procedure referred to in Article 5 shall apply to foods or
food ingredients referred to in Article 1(2)(d) and (e) which,
on the basis of the scientific evidence available and generally
recognised or on the basis of an opinion delivered by one of
referred to in Article 4(3), are
the competent bodies
substantially equivalent to existing foods or food ingredients
as regards their composition, nutritional value, metabolism,
intended use and the level of undesirable substances
contained therein (. . .).’

Article 39

Amendment to Directive 82/471/EEC

The following paragraph shall be added to Article 1 of
Directive 82/471/EEC with effect from the date of application
of this Regulation:

‘3.
This Directive does not apply to products which act
as direct or indirect protein sources that fall within the
scope of Regulation (EC) No . . ./2003 of the European
Parliament and of
. . . on genetically
the Council of
modified food and feed (*).

___________
(*) OJ L . . .’

Article 40

Amendments to Directive 2002/53/EC

Directive 2002/53/EC is hereby amended with effect from the
date of application of this Regulation as follows:

and of the Council of 28 January 2002 laying down the
general principles and requirements of
food law, estab-
lishing the European Food Safety Authority, and laying
down procedures in matters of food safety (*) is accepted
only if it has been authorised under the relevant legislation.

___________
(*) OJ L 31, 1.2.2002, p. 1.’

Article 41

Amendments to Directive 2002/55/EC

Directive 2002/55/EC is hereby amended with effect from the
date of application of this Regulation as follows:

1. Article 4(3) shall be replaced by the following:

‘3.
Further, when material derived from a plant variety is
intended to be used in food falling within the scope of
Article 3, or in feed falling within the scope of Article 15
of Regulation (EC) No . . ./2003 of the European Parliament
and of the Council of . . . on genetically modified food and
feed (*), the variety shall be accepted only if it has been
approved in accordance with that Regulation.

___________
(*) OJ L . . .’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to
be used in food or feed as defined in Articles 2 and 3 of
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, estab-
lishing the European Food Safety Authority, and laying
down procedures in matters of food safety (*) is accepted
only if it has been authorised under the relevant legislation.

1. Article 4(5) shall be replaced by the following:

___________
(*) OJ L 31, 1.2.2002, p. 1.’

‘5.
Further, when material derived from a plant variety is
intended to be used in food falling within the scope of
Article 3, or in feed falling within the scope of Article 15
of Regulation (EC) No . . ./2003 of the European Parliament
and of the Council of . . . on genetically modified food and
feed (*), the variety shall be accepted only if it has been
approved in accordance with that Regulation.

Article 42

Amendment to Directive 68/193/EEC

Article 5ba(3) of Directive 68/193/EEC shall be replaced by the
following wording with effect from the date of application of
this Regulation:

___________
(*) OJ L . . .’

2. Article 7(5) shall be replaced by the following:

‘5. Member States shall ensure that a variety intended to
be used in food or feed as defined in Articles 2 and 3 of
Regulation (EC) No 178/2002 of the European Parliament

‘3(a) Where

derived

products

from vine-propagating
material are intended to be used as or
in food
falling within the scope of Article 3 or as or in a
feed falling within the scope of Article 15 of Regu-
lation (EC) No . . ./2003 of the European Parliament
and of the Council of . . . on genetically modified food
and feed (*),
the vine variety concerned shall be
accepted only if it has been authorised pursuant to
the said Regulation.

C 113 E/52

EN

Official Journal of the European Union

13.5.2003

(b) Member States shall ensure that a vine variety, from
the propagating material of which products were
derived intended for use in food and feed pursuant
to Articles 2 and 3 of 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
establishing the
European Food Safety Authority, and laying down
procedures in matters of
food safety (**) shall be
accepted only if it has been authorised pursuant to
the relevant legislation.

food law,

The Commission shall provide a copy of the information, in
writing, to the national focal point of each Party that informs
the Secretariat in advance that it does not have access to the
Biosafety Clearing-House.

2.
The Commission shall also process requests for additional
information made by any Party in accordance with Article
11(3) of the Cartagena Protocol and shall provide copies of
in accordance with
the laws,
Article 11(5) of that Protocol.

regulations and guidelines

___________
(*) OJ L . . .
(**) OJ L 31, 1.2.2002, p. 1.’

Article 43

Amendment to Directive 2001/18/EC

The following Article shall be inserted in Directive 2001/18/EC
with effect from the date of entry into force of this Regulation:

‘Article 12a

Transitional measures for adventitious or technically
unavoidable
genetically modified
of
organisms having benefited from a favourable risk
evaluation

presence

1.
The placing on the market of traces of a GMO or
combination of GMOs in products intended for direct use
as food or feed or for processing shall be exempted from
Articles 13 to 21 provided that they meet the conditions
referred to in Article 47 of Regulation (EC) No . . ./2003 of
the European Parliament and of the Council of
. . . on
genetically modified food and feed (*).

This Article shall be applicable for a period of three
the date of application of Regulation (EC)

2.
years after
No . . ./2003.

___________
(*) OJ L . . .’

Article 44

Information to be provided in accordance with the
Cartagena Protocol

Article 45

Penalties

lay down the rules on penalties
The Member States shall
applicable to infringements of the provisions 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. The Member States shall notify
those provisions to the Commission at the latest six months
after the date of entry into force of this Regulation and shall
notify it without delay of any subsequent amendment affecting
them.

Article 46

Transitional measures for requests,

labelling and notifi-

cations

1.
Requests submitted under Article 4 of Regulation (EC)
No 258/97 before the date of application of this Regulation
shall be transformed into applications under Chapter II, Section
1 of
report
this Regulation where the initial assessment
provided for under Article 6(3) of Regulation (EC) No 258/97
has not yet been forwarded to the Commission, as well as in all
cases where an additional assessment report
is required in
(4) of Regulation (EC)
accordance with Article 6(3) or
No 258/97. Other requests submitted under Article 4 of Regu-
lation (EC) No 258/97 before the date of application of this
Regulation shall be processed under the provisions of Regu-
this
lation (EC) No 258/97, notwithstanding Article 38 of
Regulation.

The labelling requirements referred to in this Regulation
2.
shall not apply to products,
the manufacturing process of
which has commenced before the date of application of this
Regulation, provided that
these products are labelled in
accordance with the legislation applicable to them before the
date of application of this Regulation.

1.
Any authorisation, renewal, modification, suspension or
revocation of authorisation of a GMO, food or feed referred to
in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by
the Commission to the Parties to the Cartagena Protocol
through the Biosafety Clearing-House in accordance with
Article 11(1) or Article 12(1) of the Cartagena Protocol, as
the case may be.

3.
Notifications concerning products, including their use as
feed, submitted under Article 13 of Directive 2001/18/EC
before the date of application of this Regulation shall be trans-
formed into applications under Chapter III, Section 1 of this
Regulation where the assessment report provided for in Article
14 of Directive 2001/18/EC has not yet been sent to the
Commission.

13.5.2003

EN

Official Journal of the European Union

C 113 E/53

Requests submitted for products referred to in Article
4.
15(1)(c) of
this Regulation under Article 7 of Directive
82/471/EEC before the date of application of this Regulation
shall be transformed into applications under Chapter
III,
Section 1 of this Regulation.

Requests submitted for products referred to in Article
5.
15(1) of
this Regulation under Article 4 of Directive
70/524/EEC before the date of application of this Regulation
III,
shall be supplemented by applications under Chapter
Section 1 of this Regulation.

The thresholds referred to in paragraph 1 may be
3.
lowered in accordance with the procedure referred to in
Article 35(2),
in particular for GMOs sold directly to the
final consumer.

4.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure referred to in
Article 35(2).

This Article shall remain applicable for a period of three

5.
years after the date of application of this Regulation.

Article 47

Transitional measures
technically
unavoidable presence of genetically modified material
which has benefited from a favourable risk evaluation

for adventitious or

The presence in food or feed of material which contains,
1.
consists of or is produced from GMOs in a proportion no
higher than 0,5 % shall not be considered to be in breach of
Article 4(2) or Article 16(2), provided that:

(a) this presence is adventitious or technically unavoidable;

(b) the genetically modified material has benefited from a
Scientific
the date of

opinion from the Community
the Authority before

favourable
Committee(s) or
application of this Regulation;

Article 48

Review

1.
No later than . . . (*) and in the light of experience gained,
the Commission shall forward to the European Parliament and
to the Council a report on the implementation of this Regu-
lation and in particular of Article 47, accompanied, where
appropriate, by any suitable proposal. The report and any
proposal shall be made accessible to the public.

2. Without prejudice to the powers of national authorities,
the Commission shall monitor the application of this Regu-
lation and its impact on human and animal health, consumer
protection, consumer information and the functioning of the
internal market and, if necessary, will put forward proposals at
the earliest possible date.

(c) the application for its authorisation has not been rejected
in accordance with the relevant Community legislation, and

(d) detection methods are publicly available.

2.
In order to establish that the presence of this material is
adventitious or technically unavoidable, operators must be in a
position to demonstrate to the competent authorities that they
have taken appropriate steps to avoid the presence of such
materials.

Article 49

Entry into force

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

It shall apply from six months after the date of publication of
this Regulation.

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

Done at Brussels, . . .

For the European Parliament

The President

For the Council

The President

(*) Two years from the date of entry into force of this Regulation.

C 113 E/54

EN

Official Journal of the European Union

13.5.2003

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

ANNEX

1. The Community reference laboratory referred to in Article 32 is the Commission's Joint Research Centre.

2. For the purposes of the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a
consortium of national reference laboratories, which will be referred to as the ‘European Network of GMO labora-
tories’.

3. The Community reference laboratory shall be responsible, in particular, for:

— the reception, preparation, storage, maintenance and distribution to national reference laboratories of the

appropriate positive and negative control samples;

— the testing and validation of the method for detection,

including sampling and identification of the trans-
formation event and, where applicable, for the detection and identification of the transformation event in the
food or feed;

— evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for

the purpose of testing and validation of the method for sampling and detection;

— submitting full evaluation reports to the Authority.

4. The Community reference laboratory shall play a role in dispute settlements between Member States concerning the

results of the tasks outlined in this Annex.

13.5.2003

EN

Official Journal of the European Union

C 113 E/55

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

On 25 July 2001 the Council adopted a proposal for a Regulation of the European Parliament and of
the Council on genetically modified food and feed, based on Articles 37, 95, and 152(4)(b) of the EC
Treaty.

The European Parliament delivered its opinion at first reading on 3 July 2002; the Committee of the
Regions and the Economic and Social Committee delivered their opinions on 16 and 30 May 2002
respectively.

On 8 October 2002 the Commission adopted an amended proposal for a Regulation of the European
Parliament and of the Council in accordance with Article 250(2) of the EC Treaty.

The Council adopted its common position on 17 March 2003, in accordance with the procedure laid
down in Article 251 of the EC Treaty.

II. OBJECTIVE

In accordance with the White Paper on food safety, the aim of this proposal is to:

(a) guarantee a high level of protection for human life and health, animal health, the environment and
consumers' interests as regards genetically modified food and feed, while ensuring that the internal
market functions properly;

(b) establish clear and transparent Community procedures to assess, authorise and monitor genetically

modified food and feed;

(c) establish as complete a system as possible for the labelling of genetically modified food and feed.

III. ANALYSIS OF THE COMMON POSITION

A. General comments

The common position is substantially in accordance with the positions taken by the Commission
and the Parliament, insofar as it

— confirms all the objectives and essential elements of the Commission's proposal which were also

supported by the European Parliament;

— takes the greatest possible account of the opinion of the European Parliament by taking on, in

letter or in spirit, a great number of its amendments.

On its own initiative, the Council also felt it appropriate to introduce a range of amendments to its
common position, either to clarify the scope of certain provisions, or to make the wording of the
Regulation more explicit and thus ensure legal certainty, or to increase its consistency with other
Community acts.

B. Specific comments

1. Main provisions of the common position

(a) Authorisation procedure established for genetically modified food and feed (Articles 5, 6, 7,

17, 18 and 19)

The Council has followed entirely the solutions proposed on this subject by the Commission
and supported by the Parliament.

C 113 E/56

EN

Official Journal of the European Union

13.5.2003

The new authorisation procedures for genetically modified food will reproduce the new
principles introduced in Directive 2001/18/EC and will make use of the new framework
for the food safety risk assessment set by Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002.

The placing on the market of genetically modified food and feed will therefore only be
authorised after an independent and rigorous assessment of the risks which they might
carry for human and animal health and, where appropriate,
the environment. This
the European Food
assessment, which will be carried out under the responsibility of
Safety Authority, will be followed by a risk management decision taken by the Community,
within the framework of a regulatory procedure which will ensure close cooperation between
the Commission and the Member States.

However,
Council:

two significant amendments have been introduced to this procedure by the

— the request for authorisation must be addressed to the Authority not directly, but through

the intermediary of a Member State,

— regarding environmental risk assessment, when the request relates to GMOs to be used as
seed or other plant propagating material, the Authority will ask a competent national
authority to carry out the assessment itself.

(b) Transitional measures in respect of the adventitious or technically unavoidable presence of
genetically modified material which has benefited from a favourable risk evaluation (Article
47)

To ensure that the Regulation is applicable and feasible, the Council felt it appropriate to
consider that below a certain threshold the presence of such traces in a food or feedingstuff
should not be considered as a violation of the obligation to hold a marketing authorisation, if
strict conditions were otherwise met.

The Council has therefore set a threshold which it has fixed at 0,5 %, subject to compliance
with the following strict conditions:

— the GMOs concerned must have received a favourable opinion from a Community

scientific authority before the date of application of the Regulation,

— this tolerance will apply only during the three years following the entry into force of this

Regulation,

— the threshold may if necessary be lowered in accordance with the committee procedure.

The Council also noted that,
Regulation,
measures was giving rise to any difficulties.

the Commission undertook to monitor whether

in the context of the review clause in Article 48 of the
the

the application of

It should be noted that the Council here chose a much stricter and more consistent approach
than that initially proposed by the Commission (since the threshold has been significantly
lowered, and the measures provided for are now only temporary), and that it has therefore
come considerably closer to the position expressed by the European Parliament.

13.5.2003

EN

Official Journal of the European Union

C 113 E/57

(c) Labelling threshold concerning the adventitious presence of GMOs (Articles 12 and 24)

The Council took into account the fact that, despite operators' wishes to the contrary, GMO
material might nonetheless be present in the form of traces in the food or feed which they
produced, as a result of its adventitious or technically unavoidable presence during the
production of seed, cultivation,
like the
Commission, that in such cases the food or feed should not be subject to the obligation
to indicate the presence of GMOs on the labelling, if that presence was below a certain
threshold.

transport or processing.

therefore judged,

It

The Council set the proportion of adventitious or technically unavoidable presence of GMOs
at a maximum of 0,9 % for each ingredient.

However, it will also be possible to set lower thresholds under the committee procedure,
particularly as regards food and feed containing GMOs or consisting of such organisms or to
take account of progress in science and technology.

It should be noted that the threshold was fixed following a careful examination of all points
raised by this issue, and that the Council considers that it represents a good balance enabling
the objectives pursued to be attained, while ensuring the applicability of the future Regu-
lation.

(d) Status of existing products (Articles 8 and 20)

The common position extends the scope of the rules applicable to existing products, not
limiting these only to GMO products which have already been authorised on the basis of
existing legislation but also including GMO products put legally onto the Community market
before the Regulation was applied.

Thus the Council
modified food and feed on the Community market.

intends to establish improved monitoring of all existing genetically

2. Council's position on the European Parliament's amendments

(a) The following amendments have been either accepted or taken into account in the common

position:

— Authorisation procedure

37, 39, 81, 84, 87, 93 and 165 (see Article 5(2), Articles 6(3)(c) and 6(4), Article 17(2),
Articles 18(3)(c) and 18(4), and recitals 33 and 34).

— Transparency and public information

30, 38, 45, 47, 52, 55, 56, 57, 77, 82, 90, 92, 98, 101, 102, and 103 (see Article 5(3)(j),
Articles 6(5)(f) and 6(6), Article 17(3)(j), Articles 18(5)(f) and 18(6), and more particularly
Article 29 which lists the documents and information to be made accessible to the
public).

C 113 E/58

EN

Official Journal of the European Union

13.5.2003

— Community reference laboratory

41, 44, 86 and 89 (see Articles 6(3)(d) and 5(f), 18(3)(d) and 5(f)).

— Labelling

70, 71, 110, 112, 123, 145, 146, 147, 162, 163, 164 (see Articles 12, 13, 24, 25 and
46(2)).

— Precautionary principle

1 and 13 (see Article 1 which refers to the general principles laid down in Regulation
(EC) No 178/2002).

— Concept of risk

23 (see Articles 4(1)(a) and 16(1)(a) which introduce the concept of an unacceptable risk
for health).

— Emergency measures

117 and 118 (see Article 34).

(b) Various editorial amendments

Many of the editorial
improvements which have been made to the text of the common
position on points of detail are consistent with the spirit of many of the amendments
proposed by the European Parliament.

(c) However, the Council has aligned itself with the Commission's position by not taking into

account the following amendments:

8, 14, 22, 25, 26, 29, 33, 35, 43, 46, 48, 49, 50, 51, 53, 54, 58, 59, 60, 61, 72, 73, 74, 76,
79, 83, 88, 91, 95, 96, 97, 99, 100, 104, 105, 109, 111, 113, 116, 120, 122, 142, 156,
159, 161, 167.