Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance)
Date: 2003-09-22
Institutions: Council of the European Union, European Parliament
Subjects: animal feedingstuffs, consumer information, genetically modified organism, health control, human nutrition, labelling, market approval, marketing standard

18.10.2003

EN

Official Journal of the European Union

L 268/1

I

(Acts whose publication is obligatory)

REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 22 September 2003

on genetically modified food and feed

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Articles 37, 95 and Article 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:

(1)

(2)

(3)

The free movement of safe and wholesome food and
feed is an essential aspect of the internal market and
contributes significantly to the health and well-being of
citizens, and to their social and economic interests.

A high level of protection of human life and health
should be ensured in the pursuit of Community policies.

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

(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 (OJ C 113 E, 13.5.2003, p. 31), Decision of the
European Parliament of 2 July 2003 (not yet published in the Offi-
cial Journal) and Council Decision of 22 July 2003.

(4)

(5)

(6)

(7)

Differences between national
regulations and
administrative provisions concerning the assessment and
authorisation of genetically modified food and feed may
hinder
free movement, creating conditions of
unequal and unfair competition.

laws,

their

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
1997 concerning novel foods and novel food ingredi-
ents (5). This procedure should be streamlined and made
more transparent.

Regulation (EC) No 258/97 also provides for a notifica-
tion procedure for novel foods which are substantially
equivalent to existing foods. Whilst substantial equiva-
lence 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, transpar-
ency and a harmonised framework for authorisation of
genetically modified food,
this notification procedure
should be abandoned in respect of genetically modified
foods.

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 Direc-
tive 90/220/EEC of 23 April 1990 (6) and Directive
2001/18/EC of
the
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 Commu-
nity authorisation procedure for
feed consisting of,
containing or produced from GMOs should be estab-
lished.

(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).

L 268/2

EN

Official Journal of the European Union

18.10.2003

(9)

the European Parliament and of

The new authorisation procedures for genetically modi-
fied 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
matters of food safety set up by Regulation (EC) No
the
178/2002 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 proce-
food safety (1). Thus, genetically
dures in matters of
modified food and feed should only be authorised for
placing on the Community market after a scientific
evaluation of the highest possible standard, to be under-
taken under the responsibility of the European Food
Safety Authority (Authority), of any risks which they
present for human and animal health and, as the case
may be, for the environment. This scientific evaluation
should be followed by a risk management decision by
the Community, under a regulatory procedure ensuring
close cooperation between the Commission and the
Member States.

this

food

procedure,

authorisation

additives
to
containing, consisting of or produced from GMOs
should fall also within the scope of this Regulation for
the safety assessment of the genetic modification, while
the final authorisation should be granted under the
procedure referred to in Directive 89/107/EEC.

(13)

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 foodstuffs and to source materials for their
production (3) which contain, consist of or are produced
from GMOs should also fall within the scope of this
Regulation for the safety assessment of the genetic modi-
fication.

(10)

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
should only be authorised when fulfilling
products
authorisation criteria for both food and feed.

(14)

(11) Under this Regulation, authorisation may be granted
either to a GMO to be used as a source material for
production 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 authorised 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 authorisation
granted under this Regulation will be exempted from the
requirements of Regulation (EC) No 258/97 concerning
novel foods and 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.

(12)

Council Directive 89/107/EEC of 21 December 1988 on
the approximation of
the Member States
concerning food additives authorised for use in food-
stuffs intended for human consumption (2) provides for
authorisation of additives used in foodstuffs. In addition

laws of

(1) OJ L 31, 1.2.2002, p. 1.
(2) 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).

Council Directive 82/471/EEC of 30 June 1982
concerning certain products used in animal nutrition (4)
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
Regulation.

(15)

Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs (5), provides for an
authorisation procedure for placing on the market addi-
tives used in feedingstuffs. In addition to this authorisa-
tion procedure, feed additives containing, consisting of
or produced from GMOs should also fall within the
scope of this Regulation.

(16)

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,

(3) 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).

(4) 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).

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

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

18.10.2003

EN

Official Journal of the European Union

L 268/3

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 fed with genetically modified feed or treated
with genetically modified medicinal products will be
subject neither to the authorisation requirements nor to
the labelling requirements referred to in this Regulation.

(17)

the Treaty,

In accordance with Article 153 of
the
Community is to contribute to promoting the right of
consumers to information. In addition to other types of
information to the public provided for in this Regula-
tion, the labelling of products enables the consumer to
make an informed choice and facilitates fairness of trans-
actions between seller and purchaser.

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

the European
Parliament and of the Council of 20 March 2000 on the
approximation of the laws of the Member States relating
to the labelling, presentation and advertising of food-
stuffs (1) provides that labelling must not mislead the
purchaser as to the characteristics of the foodstuff and
among other things, in particular, as to its nature, iden-
tity, properties, composition, method of production and
manufacturing.

(19) Additional requirements for the labelling of genetically
modified foods are laid down in Regulation (EC) No
258/97, in Council Regulation (EC) No 1139/98 of 26
May 1998 concerning the compulsory indication, on the
labelling of certain foodstuffs produced from genetically
modified organisms, of particulars other
than those
provided for in Directive 79/112/EEC (2) and in Commis-
sion 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 geneti-
cally modified organisms (3).

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

feed,

(21)

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 potential misleading of consumers as regards
methods of manufacture or production.

(1) OJ L 109, 6.5.2000, p. 29. Directive as amended by Commission

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

(2) 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).

(3) OJ L 6, 11.1.2000, p. 15.

(22)

(23)

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

Regulation (EC) No 1830/2003 of the European Parlia-
ment and of
the Council of 22 September 2003
concerning the traceability and labelling of genetically
modified organisms and traceability of food and feed
products produced from genetically modified organisms
and amending Directive 2001/18/EC (4) ensures that rele-
vant 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.

(24) Despite the fact that some operators avoid using geneti-
cally modified food and feed, such material may be
present in minute traces in conventional food and feed
as a result of 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 unavoidable presence of genetically modified
material in 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.

(25)

It is appropriate to provide that, when the combined
level of 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.

(26)

It is indispensable that operators strive to avoid any acci-
dental presence of genetically modified material not
authorised under Community legislation in food or feed.
However, in order to ensure the practicability and feasi-
bility of this Regulation, a specific threshold, with the
possibility of establishing lower levels in particular for

(4) See page 24 of this Official Journal.

L 268/4

EN

Official Journal of the European Union

18.10.2003

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 techni-
cally unavoidable and provided that all specific condi-
tions set in this Regulation are met. Directive 2001/18/
EC should be amended accordingly. The application of
this measure should be reviewed in the context of the
general review of the implementation of this Regulation.

(27)

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 autho-
rities that they have taken appropriate steps to avoid the
presence of the genetically modified food or feed.

(28) Operators should avoid the unintended presence of
GMOs in other products. The Commission should gather
information and develop on this basis guidelines on the
coexistence of genetically modified, conventional and
organic crops. Moreover, the Commission is invited to
bring forward, as soon as possible, any further necessary
proposal.

(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 1830/2003.

(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 review of such acts or omis-
sions.

(32)

It is recognised that, in some cases, scientific risk assess-
ment 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.

(33) Where the application concerns products containing or
consisting of a genetically modified organism, the appli-
cant should have the choice of either supplying an
authorisation for the deliberate release into the environ-
ment 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 environ-
mental 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 appro-
priate to give the Authority the possibility of asking one
of these competent authorities to carry out the environ-
mental risk assessment. It is also appropriate, in accor-
dance 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 envir-
onmental risk assessment.

(34)

risk assessment

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
national competent authority. Nonetheless, authorisa-
tions 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 vari-
eties and their official acceptance for
inclusion in
common catalogues; nor should they affect the provi-
sions 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.

(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 Direc-

tive 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 Direc-

tive 2001/64/EC.

(6) OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(7) OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regula-

tion (EC) No 806/2003.
(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 Commission

Directive 2003/45/EC (OJ L 138, 5.6.2003, p. 40).

18.10.2003

EN

Official Journal of the European Union

L 268/5

(35)

(36)

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

To facilitate controls on genetically modified food and
feed, applicants for authorisation should propose appro-
priate methods for sampling,
identification and detec-
tion, and deposit samples of the genetically modified
food and feed with the Authority; methods of sampling
and 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.

(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 the product, including, where
available, references to independent and peer-reviewed
studies, and to methods for sampling, identification and
detection. Non-confidential data should be made avail-
able to the public.

(40)

In order to stimulate research and development into
GMOs for food and/or feed use,
it 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.

(42)

(43)

(44)

(45)

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

In order to provide a high level of protection of human
life and health, animal health and welfare, environment
and consumer interests in relation to genetically modi-
fied food and feed, requirements arising from this Regu-
lation should apply in a non-discriminatory manner to
products originating in the Community and imported
from third countries,
in accordance with the general
principles referred to in Regulation (EC) No 178/2002.
The content of this Regulation takes account of the
international
the European
Communities and of the requirements of the Cartagena
Protocol on Biosafety to the Convention on Biological
Diversity as regards importer obligations and notifica-
tion.

commitments of

trade

Certain instruments of Community law should be
repealed and others amended as a result of this Regula-
tion.

implementation of

The
this Regulation should be
reviewed in the light of experience gained in the short
term, and the impact of the application of this Regula-
tion on human and animal health, consumer protection,
consumer
the
internal market should be monitored by the Commis-
sion,

information and the functioning of

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVE AND DEFINITIONS

Article 1

Objective

(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 (1).

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

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
human life and health, animal health and welfare, environ-
ment and consumer interests in relation to genetically
modified food and feed, whilst ensuring the effective func-
tioning of the internal market;

L 268/6

EN

Official Journal of the European Union

18.10.2003

(b) lay down Community procedures for the authorisation and

11.

supervision of genetically modified food and feed;

(c) lay down provisions for the labelling of genetically modi-

fied food and feed.

Article 2

Definitions

For the purposes of this Regulation:

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

‘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);

12.

‘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;

13.

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

14.

15.

‘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.

‘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,
the contents cannot be altered without
provided that
opening or changing the packaging.

2. the definition of ‘traceability’, laid down in Regulation (EC)

No 1830/2003;

16.

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

3.

‘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;

4. the definitions of ‘organism’, ‘deliberate release’ and ‘envir-
onmental risk assessment’ referred to in Directive 2001/
18/EC shall apply;

5.

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

6.

‘genetically modified
food’ means
consisting of or produced from GMOs;

food

containing,

7.

feed’ means
‘genetically modified
consisting of or produced from GMOs;

feed

containing,

8.

‘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;

CHAPTER II

GENETICALLY MODIFIED FOOD

Se c ti on 1

A ut h ori sat i o n an d su p e rvi si on

Article 3

Scope

1.

This Section shall apply to:

(a) GMOs for food use;

(b) food containing or consisting of GMOs;

9.

‘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;

(c) food produced from or containing ingredients produced

from GMOs.

10.

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

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

18.10.2003

EN

Official Journal of the European Union

L 268/7

Article 4

Requirements

1.

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

(a) have adverse effects on human health, animal 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 nutrition-
ally disadvantageous for the consumer.

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.

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.

The application shall be sent to the national competent

2.
authority of a Member State.

(a) The national competent authority:

(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.

4.

The authorisation referred to in paragraph 2 may cover:

3.

The application shall be accompanied by the following:

(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.

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 para-
6.
graph 2 and, after the authorisation is granted, the authorisa-
tion-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 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.

(a) the name and the address of the applicant;

(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
to the Cartagena
purpose of complying with Annex II
Protocol on Biosafety to the Convention on Biological
Diversity (hereinafter referred to as the Cartagena Protocol);

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

production and manufacturing;

(e) a copy of the studies, including, where available, indepen-
dent, peer-reviewed studies, which have been carried out
and any other material which is available to demonstrate
that
the food complies with the criteria referred to in
Article 4(1);

(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);

(h) where appropriate,

market
specific conditions for use and handling;

the food or foods produced from it,

the conditions for placing on the
including

L 268/8

EN

Official Journal of the European Union

18.10.2003

(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 the food and their control samples, and infor-
mation 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.

In the case of an application relating to a GMO for food
4.
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:

(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;

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

to Directive 2001/18/EC,

In such 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 provi-
sions 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.

7.
The Commission, having first consulted the Authority,
shall establish, in accordance with the procedure referred to in
implementing rules for the application of this
Article 35(2),
Article,
including rules concerning the preparation and the
presentation of the application.

8.
the
Before the date of application of this Regulation,
Authority shall publish detailed guidance to assist the applicant
in the preparation and the presentation of the application.

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. Such time limit shall be extended whenever the
Authority seeks supplementary information from the applicant
as provided for in paragraph 2.

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

3.

In order to prepare its opinion the Authority:

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 5 and
the food complies with the criteria
examine whether
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-
gating material, the Authority shall ask a national compe-
tent authority to carry out the environmental risk assess-
ment;

(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
shall test and validate the method of detection and identifi-
cation proposed by the applicant;

(e) shall,

in verifying the application of Article 13(2)(a),
examine the information and data submitted by the appli-
cant 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
the placing on the market of
evaluation of
products consisting of or containing GMOs,
the national
competent 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.

requests for

18.10.2003

EN

Official Journal of the European Union

L 268/9

In the event of an opinion in favour of authorising the

5.
food, the opinion shall also include the following particulars:

A final decision on the application shall be adopted in

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

(a) the name and address of the applicant;

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

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

to the Cartagena Protocol;

(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
the outcome of the risk assessment and,
in the case of
GMOs or food containing or consisting of GMOs, condi-
tions for the protection of particular ecosystems/environ-
ment and/or geographical areas;

(f) the method, validated by the Community reference labora-
tory, for detection, including sampling, identification of the
transformation event and, where applicable, for the detec-
tion 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;

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

the monitoring plan referred to in

6.
The Authority shall forward its opinion to the Commis-
sion, 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 opinion is
based,
the competent authorities
when consulted in accordance with paragraph 4.

including the opinions of

7.
The Authority, in conformity with Article 38(1) of Regu-
lation (EC) No 178/2002, shall make its opinion public, after
deletion of any information identified as confidential in accor-
dance 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 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 considera-
tion. Where the draft decision is not in accordance with the
opinion of the Authority, the Commission shall provide an
explanation for the differences.

Any draft decision which envisages

2.
the granting of
authorisation shall include the particulars referred to in Article
6(5), the name of the authorisation-holder and, where appro-
priate, the unique identifier attributed to the GMO as referred
to in the Regulation (EC) No 1830/2003.

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 proce-
dure referred to in this Regulation shall be valid throughout the
Community for 10 years and shall be 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 authorisation and shall include the
particulars referred to in paragraph 2.

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 food operator in respect of
the food concerned.

8.
References made in parts A and D of Directive 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

By way of derogation from Article 4(2), products falling
1.
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 Direc-
tive 90/220/EEC before the entry into force of Regulation
(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
concerned shall, within six months after the date of applica-
tion 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
products concerned shall, within six months after the date
of application of this Regulation, notify the Commission
that
in the
Community before the date of application of this Regula-
tion.

the products were placed on the market

L 268/10

EN

Official Journal of the European Union

18.10.2003

The notification referred to in paragraph 1 shall be
2.
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 labora-
tory shall test and validate the method of detection and identifi-
cation 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 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,
but in no case earlier than three years after the date of applica-
tion of this Regulation, operators responsible for placing them
on the market shall submit an application in accordance with
Article 11, which shall apply mutatis mutandis.

Within three years from the date of application of this Regula-
tion, operators responsible for placing on the market products
referred to in paragraph 1(b) shall submit an application in
accordance with Article 11, which shall apply mutatis mutandis.

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 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 infor-
mation 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).

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
authorisation-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 monitoring
reports referred to shall be made accessible to the public after
deletion of any information identified as confidential in accor-
dance with Article 30.

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.

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
forthwith
food.
the authorisation-holder shall
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.

In particular,

4.
The Commission shall make the information supplied by
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

1.
from a
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 accor-
dance with the procedure referred to in Article 7.

3.

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

Article 9

Supervision

Article 11

Renewal of authorisations

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

1.
Authorisations under this Regulation shall be renewable
for 10-year periods, on application to the Commission by the
authorisation-holder at the latest one year before the expiry
date of the authorisation.

18.10.2003

EN

Official Journal of the European Union

L 268/11

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 the safety in use of the
food and the risks of the food to the consumer 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 5(2), 6 and 7 shall apply mutatis mutandis.

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

5.
The Commission, having first consulted the Authority,
may establish, in accordance with the procedure referred to in
implementing rules for the application of this
Article 35(2),
including rules concerning the preparation and the
Article,
presentation of the application.

6.
The Authority shall publish detailed guidance to assist the
applicant in the preparation and the presentation of its applica-
tion.

S e c ti on 2

L ab e l l i n g

Article 12

Scope

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.

Article 13

Requirements

1. Without prejudice to the other requirements of Commu-
nity law concerning the labelling of foodstuffs, foods falling
within the scope of
to the
following specific labelling requirements:

this Section shall be subject

(a) where the food consists of more than one ingredient, the
words ‘genetically modified’ or ‘produced from genetically
modified (name of the ingredient)’ shall appear in the list of
ingredients provided for in Article 6 of Directive 2000/13/
EC in parentheses immediately following the ingredient
concerned;

(b) where the ingredient is designated by the name of a cate-
gory, 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 the list of
ingredients. Where there is no list of ingredients, they shall
appear clearly on the labelling;

This Section shall apply to foods which are to be deliv-
1.
ered 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.

(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, the information required under this para-
graph must be permanently and visibly displayed either on
the food display or immediately next to it, or on the packa-
ging material, in a font sufficiently large for it to be easily
identified and read.

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

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.

In addition to the labelling requirements referred to in
2.
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;

(ii) nutritional value or nutritional effects;

L 268/12

EN

Official Journal of the European Union

18.10.2003

(iii) intended use of the food;

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

population;

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

3.
In addition to the labelling requirements referred to in
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.

Article 14

Implementing measures

Article 16

Requirements

1.

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

(a) have adverse effects on human health, animal health or the

environment;

(b) mislead the user;

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

features of the animal products;

(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.

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).

2.
No person shall place on the market, use or process a
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.

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

3.
No product referred to in Article 15(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.

In order to take into account the specific situation of mass
caterers, such rules may provide for adaptation of the require-
ments of Article 13(1)(e).

CHAPTER III

GENETICALLY MODIFIED FEED

S e c ti on 1

A uthori sat ion an d sup e rvisi on

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.

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 para-
6.
graph 2 and, after the authorisation is granted, the authorisa-
tion-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

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

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

18.10.2003

EN

Official Journal of the European Union

L 268/13

The application shall be sent to the national competent

2.
authority of a Member State.

(a) The national competent authority:

(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 the Authority without delay; and

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

(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;

(j) samples of the feed and their control samples and informa-
tion as to the place where the reference material can be
accessed;

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

for the use of the feed for animal consumption;

(b) The Authority:

(i) shall inform without delay the other Member States and
the Commission of the application and shall make the
information
any
application
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;

(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;

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

(e) a copy of the studies including, where available, indepen-
dent, peer-reviewed studies, which have been carried out
and any other material which is available to demonstrate
that the feed complies with the criteria referred to in Article
16(1), and, in particular for feed falling within the scope of
Directive 82/471/EEC,
the information required 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 (1);

(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
the market, including specific conditions for use and hand-
ling;

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

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

In the case of an application relating to a GMO for feed
4.
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.

In the case of GMOs or feed containing or consisting of

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

(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
with Annex VII
including a
proposal for the duration of the monitoring plan; this dura-
tion may be different from the proposed period for the
consent.

to Directive 2001/18/EC,

In such 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 provi-
sions 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.

7.
The Commission, having first consulted the Authority,
shall establish, in accordance with the procedure referred to in
Article 35(2),
implementing rules for the application of this
Article,
including rules concerning the preparation and the
presentation of the application.

8.
the
Before the date of application of this Regulation,
Authority shall publish detailed guidance to assist the applicant
in the preparation and the presentation of the application.

L 268/14

EN

Official Journal of the European Union

18.10.2003

Article 18

In the event of an opinion in favour of authorising the

5.
feed, the opinion shall also include the following particulars:

Opinion of the Authority

(a) the name and address of the applicant;

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. Such time limit shall be extended whenever
the Authority seeks supplementary information from the appli-
cant as provided in paragraph 2.

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

3.

In order to prepare its opinion, the Authority:

(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
State to carry out a safety assessment of the feed in accor-
dance 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-
gating material, the Authority shall ask a national compe-
tent authority to carry out the environmental risk assess-
ment;

(d) 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;

(e) shall,

in verifying the application of Article 25(2)(c),
examine the information and data submitted by the appli-
cant 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
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
the placing on the market of
evaluation of
products consisting of or containing GMOs,
the national
competent 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.

requests for

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

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

to the Cartagena Protocol;

(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
the outcome of the risk assessment and,
in the case of
GMOs or feed containing or consisting of GMOs, condi-
tions for the protection of particular ecosystems/environ-
ment and/or geographical areas;

(f) the method, validated by the Community reference labora-
tory, for detection, including sampling, identification of the
transformation event and, where applicable, for the detec-
tion 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;

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

Article 17(5)(b).

6.
The Authority shall forward its opinion to the Commis-
sion, 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 opinion is based,
including the opinions of
the competent 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 accor-
dance with Article 30 of this Regulation. The public may make
comments to the Commission within 30 days from such
publication.

Article 19

Authorisation

the Commission shall submit

1. Within three months after receiving the opinion of the
Authority,
to the Committee
referred 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 considera-
tion. Where the draft decision is not in accordance with the
opinion of the Authority, the Commission shall provide an
explanation for the differences.

18.10.2003

EN

Official Journal of the European Union

L 268/15

Any draft decision which envisages

the granting of
2.
authorisation 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 1830/2003.

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.

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 proce-
dure referred to in this Regulation shall be valid throughout the
Community for 10 years and shall be 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 and shall include the
particulars referred to in paragraph 2.

The authorisation under this Section shall be without
6.
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.

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 labora-
tory shall test and validate the method of detection and identifi-
cation proposed by the applicant.

3. Within one year from the date of application of this
the information
Regulation and after verification that all
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 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,
but in no case earlier than three years after the date of applica-
tion of this Regulation, operators responsible for placing them
on the market shall submit an application in accordance with
Article 23, which shall apply mutatis mutandis.

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

Within three years from the date of application of this Regula-
tion, operators responsible for placing on the market products
referred to in paragraph 1(b) shall submit an application in
accordance with Article 23, which shall apply mutatis mutandis.

Article 20

Status of existing products

By way of derogation from Article 16(2), products falling
1.
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 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
contain, consist of or are produced from GMOs, operators
responsible for placing on the market
the products
concerned shall, within six months after the date of applica-
tion of this Regulation, notify the Commission of the date
on which they were first placed on the market in the
Community;

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.

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 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 infor-
mation or the application to the Commission.

(b) in the case of products which have been lawfully placed on
the market in the Community but which are not referred to
in point (a), operators responsible for placing on the market

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

L 268/16

EN

Official Journal of the European Union

18.10.2003

Article 21

Supervision

Article 23

Renewal of authorisations

After an authorisation has been issued in accordance with
1.
this Regulation,
the authorisation-holder and the 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 authori-
sation 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

2.
If the authorisation-holder proposes to modify the terms
of 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 the safety in use of the
forthwith
feed.
the authorisation-holder shall
inform the Commission of any prohibition or
restriction
imposed by the competent Authority of any third country in
which the feed is placed on the market.

In particular,

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

Article 22

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 15(1) still meets the conditions set by this
this opinion to the
forthwith transmit
Regulation.
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.

Authorisations under this Regulation shall be renewable
1.
for 10-year periods, on application to the Commission by the
authorisation-holder at the latest one year before the expiry
date 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 the safety in use of the feed
and the risks of the feed to animals, humans or the envir-
onment;

(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 authorisa-
tion-holder, no decision is taken on the renewal of an authori-
sation before its expiry date, the period of authorisation of the
product shall automatically be extended until a decision is
taken.

5.
The Commission, having first consulted the Authority,
may establish, in accordance with the procedure referred to in
Article 35(2),
implementing rules for the application of this
Article,
including rules concerning the preparation and the
presentation of the application.

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

6.
applicant
application.

Se c ti on 2

L ab e l l i n g

Article 24

Scope

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 accor-
dance with the procedure referred to in Article 19.

3.

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

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 per cent of the feed and of each
feed of which it is composed, provided that this presence is
adventitious or technically unavoidable.

18.10.2003

EN

Official Journal of the European Union

L 268/17

In order to establish that the presence of this material is
3.
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.

(d) as specified in the authorisation, any characteristic or prop-
erty 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 25

Requirements

1. Without prejudice to the other requirements of Commu-
nity law concerning the labelling of feed, feed referred to in
Article 15(1) shall be subject to the specific labelling require-
ments laid down below.

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 the list of feed;

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

‘produced
organism)’
following the specific name of the feed.

from genetically modified (name of
shall

in parentheses

appear

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 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 from its conventional counter-
part:

(i) composition;

(ii) nutritional properties;

(iii) intended use;

(iv) implications for the health of certain species or cate-

gories of animals;

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.

The Authority shall consider whether the application for

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

Article 28

Community register

1.
The Commission shall establish and maintain a Commu-
nity register of genetically modified food and feed, hereinafter
referred to as ‘the Register’.

2.

The Register shall be made available to the public.

Article 29

Public access

1.
The application for authorisation, supplementary infor-
mation 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.

L 268/18

EN

Official Journal of the European Union

18.10.2003

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 access to European
Parliament, Council and Commission documents (1) when hand-
ling applications
to documents held by the
Authority.

for access

The use of the detection methods and the reproduction of
5.
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.

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
determine, after consultation with the applicant, which infor-
mation should be kept confidential and shall inform the appli-
cant of its decision.

Information relating to the following shall not be

3.
considered confidential:

(a) name and composition of the GMO, food or feed referred
to in Articles 3(1) and 15(1) and, where appropriate, indi-
cation of the substrate and the micro-organism;

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

of the authorisation-holder;

(c) physico-chemical

and biological

characteristics of

the

GMO, food or feed referred to in Articles 3(1) and 15(1);

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

(e) 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) methods for detection, including sampling and identifica-
tion 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);

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.

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

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 10 years from the date of authorisation, unless
the other applicant has agreed with the authorisation-holder
that such data and information may be used.

On the expiry of this 10-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

Community reference laboratory

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

(g) information on waste treatment and emergency response.

National reference laboratories may be established in accor-
dance with the procedure referred to in Article 35(2).

Notwithstanding paragraph 2,

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

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

Applicants for authorisation of genetically modified food and
feed shall contribute to supporting the costs of the tasks of the
Community reference laboratory and the European Network of
GMO laboratories mentioned in the Annex.

18.10.2003

EN

Official Journal of the European Union

L 268/19

The contributions from applicants shall not exceed the costs
incurred in carrying out the validation of detection methods.

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).

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
take a decision within two months
requiring, if appropriate, the Authority to withdraw its decision
or to remedy its failure to act.

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.

The Commission shall make these opinions available to

2.
the public.

Article 34

Emergency measures

Where it is evident that products authorised by or in accor-
dance with this Regulation are likely to constitute a serious risk
to human health, animal health or the environment, or where,
in the light of an opinion of 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 proce-
dures provided for in Articles 53 and 54 of Regulation (EC) No
178/2002.

Article 35

Committee procedure

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

Article 37

Repeals

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

— Regulation (EC) No 1139/98,

— Regulation (EC) No 49/2000,

— 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),

— Article 9.

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

replaced by the following:

‘4.
By way of derogation from paragraph 2, the proce-
dure 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
the competent bodies referred to in Article 4(3), are substan-
tially equivalent to existing foods or food ingredients as
regards their composition, nutritional value, metabolism,
intended use and the level of undesirable substances
contained therein.’

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

Article 39

3.

The Committee shall adopt its rules of procedure.

Amendment to Directive 82/471/EEC

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.

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

This Directive does not apply to products which act
‘3.
as direct or indirect protein sources that fall within the
scope of Regulation (EC) No 1829/2003 of the European
Parliament and of the Council of 22 September 2003 on
genetically modified food and feed (*).

(*) OJ L 268, 18.10.2003, p. 1.’

L 268/20

EN

Official Journal of the European Union

18.10.2003

Article 40

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.

Amendments to Directive 2002/53/EC

(*) OJ L 31, 1.2.2002, p. 1.’

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

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

‘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 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically
modified food and feed (*), the variety shall be accepted only
if it has been approved in accordance with that Regulation.

(*) OJ L 268, 18.10.2003, p. 1.’

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, establishing
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

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:

‘3.

(a) Where products derived 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 1829/2003 of the European Parlia-
ment and of the Council of 22 September 2003 on
genetically modified food and feed (*),
the vine
variety concerned shall be accepted only if it has
been authorised pursuant to the said Regulation.

the European Parliament and of

(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/
the
2002 of
Council of 28 January 2002 laying down the
general principles and requirements of food law,
establishing the European Food Safety Authority,
food
and laying down procedures in matters of
it has been
safety (**) shall be accepted only if
authorised pursuant to the relevant legislation.

Amendments to Directive 2002/55/EC

(*) OJ L 268, 18.10.2003, p. 1.
(**) OJ L 31, 1.2.2002, p. 1.’

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 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically
modified food and feed (*), the variety shall be accepted only
if it has been approved in accordance with that Regulation.

Article 43

Amendments to Directive 2001/18/EC

Directive 2001/18/EC is hereby amended with effect from the
date of entry into force of this Regulation, as follows:

1. The following Article shall be inserted:

(*) OJ L 268, 18.10.2003, p. 1.’

‘Article 12a

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, establishing

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

1.
Placing on the market of traces of a GMO or combina-
tion of GMOs in products intended for direct use as food or
feed or for processing shall be exempted from Articles 13 to

18.10.2003

EN

Official Journal of the European Union

L 268/21

21 provided that they meet the conditions referred to in
Article 47 of Regulation (EC) No 1829/2003 of
the
European Parliament and of the Council of 22 September
2003 on genetically modified food and feed (*).

This Article shall be applicable for a period of three
2.
years after the date of application of Regulation (EC) No
1829/2003.

(*) OJ L 268, 18.10.2003, p. 1.’

2. The following Article shall be inserted:

‘Article 26a

mented. The penalties provided for must be effective, propor-
tionate and dissuasive. The Member States shall notify those
provisions to the Commission six months after the date of
entry into force of this Regulation at the latest and shall notify
it without delay of any subsequent amendment affecting them.

Article 46

Measures to avoid the unintended presence of GMOs

Transitional measures

for

requests,

labelling

and

notifications

1. Member States may take appropriate measures to
avoid the unintended presence of GMOs in other products.

The Commission shall gather and coordinate informa-
2.
tion based on studies at Community and national
level,
observe the developments regarding coexistence in the
Member States and, on the basis of the information and
observations, develop guidelines on the coexistence of
genetically modified, conventional and organic crops.’

Article 44

Information to be provided in accordance with the
Cartagena Protocol

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.

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 the
laws, regulations and guidelines in accordance with Article
11(5) of that Protocol.

Article 45

Penalties

The Member States shall lay down the rules on penalties applic-
able to infringements of the provisions of this Regulation and
shall take all measures necessary to ensure that they are imple-

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
this Regulation where the initial assessment report 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 accordance
with Article 6(3) or (4) of Regulation (EC) No 258/97. Other
requests submitted under Article 4 of Regulation (EC) No 258/
97 before the date of application of this Regulation shall be
processed under the provisions of Regulation (EC) No 258/97,
notwithstanding Article 38 of this 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 accor-
dance with the legislation applicable to them before the date of
application of this Regulation.

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.

4.
Requests submitted for products referred to in Article
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.

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

L 268/22

EN

Official Journal of the European Union

18.10.2003

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
favourable
Scientific
opinion from the Community
Committee(s) or the Authority before the date of applica-
tion of this Regulation;

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

(d) detection methods are publicly available.

In order to establish that the presence of this material is
2.
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.

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

Detailed rules for implementing this Article shall be
4.
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 48

Review

the Commission shall

No later than 7 November 2005 and in the light of
1.
experience gained,
forward to the
European Parliament and to the Council a report on the imple-
mentation of this Regulation 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 Regula-
tion and its impact on human and animal health, consumer
protection, consumer information and the functioning of the
internal market and, if necessary, will bring forward proposals
at the earliest possible date.

Article 49

Entry into force

This Regulation shall enter
into force on the 20th 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, 22 September 2003.

For the European Parliament

The President

P. COX

For the Council

The President

R. BUTTIGLIONE

18.10.2003

EN

Official Journal of the European Union

L 268/23

ANNEX

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

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

2. For 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 laboratories’.

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

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

positive and negative control samples,

— testing and validation of the method for detection, including sampling and identification of the transformation
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.