Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed
Date: 2001-07-26
Institutions: European Commission
Subjects: animal nutrition, consumer information, genetically modified organism, health policy, human nutrition, new product

30.10.2001

EN

Official Journal of the European Communities

C 304 E/221

Proposal for a Regulation of the European Parliament and of the Council on genetically modified
food and feed

(2001/C 304 E/15)

(Text with EEA relevance)

COM(2001) 425 final (cid:151) 2001/0173(COD)

(Submitted by the Commission on 30 July 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

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

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

Whereas:

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

the

(2) A high level of protection of human life and health
should be assured in the pursuit of Community policies.

(3) In order to protect human and animal health, food and
from
feed
consisting of,
genetically modified
called
(cid:145)genetically modified food and feed(cid:146)) should undergo a
safety assessment
through a Community procedure
before being placed on the market within the Community.

containing or produced

(hereunder

organisms

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

their

(5) An authorisation procedure involving Member States and
the Commission has been established for genetically
modified foods in Regulation (EC) No 258/97 on novel
food ingredients (1). This procedure
foods and novel
should be streamlined and made more transparent.

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

to ensure clarity,

In order

(7) Feed consisting of or containing genetically modified
organisms
(GMOs) have so far been authorised in
accordance with Directive 90/220/EEC on the deliberate
release into the environment of genetically modified
organisms (2); no authorisation procedure exists for feed
produced from GMOs; a single, efficient and transparent
Community authorisation procedure for feed consisting
of, containing or produced from GMOs should be estab-
lished.

(8) The new authorisation procedures for genetically modified
the new principles
food and feed should include
introduced in Directive 2001/18/EC on the deliberate
release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC (3).
They should further make use of the new framework for
risk assessment in matters of food safety set up by Regu-
lation (EC) No . . ./. . . laying down the general principles
and requirements of food law, establishing the European
Food Authority, and laying down procedures in matters of
food safety. Thus, genetically modified food and feed
the
on
authorised
should
Community market after a scientific evaluation of
the
highest possible standard,
to be undertaken under the
responsibility of
the European Food Authority, of any
risks which they present for human and animal health
for the environment. This
and, as the case may be,
scientific
risk
followed by a
management decision by the Community, under a regu-
latory procedure ensuring close cooperation between the
Commission and the Member States.

evaluation should be

placing

only

for

be

(1) OJ L 43, 14.2.1997, p. 1.
(2) OJ L 117, 8.5.1990, p. 15.
(3) OJ L 106, 17.4.2001, p. 1.

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

to human or animal health and the environment; these
feed materials containing, consisting of or produced from
GMOs should fall instead under the scope of this Regu-
lation.

(10) Under

foods and/or

this Regulation, authorisation may be granted
either to a GMO 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
feed
this Regulation,
authorised under
containing, consisting of or produced from that GMO
do not need an authorisation under this Regulation, but
are subject to the requirements laid down in the author-
isation granted in respect of the GMO. Furthermore, foods
covered by an authorisation granted under this Regulation
are exempted from the requirements of Regulation (EC)
No 258/97 concerning novel
food
ingredients, except where they fall under one or more
of the categories laid down in Article 1 (2) (a) of Regu-
lation (EC) No 258/97 in respect of a characteristic which
has not been considered for the purpose of the author-
isation granted under this Regulation.

foods and novel

(11) Council Directive 89/107/EEC of 21 December 1988
concerning food additives authorised for use in foodstuffs
intended for human consumption (1), as last amended by
Directive 94/34/EC of 30 June 1994 (2), provides for auth-
orisation of additives used in foodstuffs. In addition to this
authorisation
containing,
consisting of or produced from GMOs should fall also
under
the safety
assessment of the genetic modification, while the final
authorisation should be granted under
the procedure
laid down in Directive 89/107/EEC.

this Regulation for

the scope of

procedure,

additives

food

(12) Flavourings falling under the scope of Council Directive
88/388/EEC of 22 June 1988 relating to flavourings for
use in foodstuffs, which contain, consist of or are
produced from GMOs should fall also under the scope
of
the
genetic modification.

the safety assessment of

this Regulation for

(13) Council Directive

1982
82/471/EEC of
concerning certain products used in animal nutrition (3),
as last amended by Council Directive 1999/20/EC (4),
provides for an approval procedure for feed materials
produced using different technologies that may pose risk

June

30

(14) Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs (5), as last amended
by Council Directive 1999/20/EC (6), provides for an auth-
orisation procedure for placing on the market additives
used in feedingstuffs.
In addition to this authorisation
procedure,
feed additives containing, consisting of or
produced from GMOs should also fall under the scope
the
of
this Regulation for
genetic modification, while
authorisation
should be granted under the procedure laid down in
Directive 70/524/EEC.

the safety assessment of
final

the

(15) This Regulation covers food and feed produced (cid:145)from(cid:146) a
GMO but not food and feed (cid:145)with(cid:146) a GMO. The deter-
mining criterion is whether or not material derived
from the genetically modified starting material is present
in the food or in the feed. Processing aids as defined in
Council Directive 89/107/EEC, which are only used during
the food or feed production process, are not covered by
the definition of
therefore, are not
food or feed and,
included in the scope of this Regulation. Nor are food
and feed which are manufactured with the help of a
genetically modified processing aid. Thus, food produced
with a genetically modified enzyme that does not remain
in the final product and products obtained from animals
fed with genetically modified feed or
treated with
genetically modifed medicinal products will be subject
neither to the authorisation requirements, nor to the
labelling requirements laid down in this Regulation.

(16) In accordance with Article 153 of

the Treaty,

the
Community shall contribute to promote the right of
consumers to information. Additional to other types of
information to the public established in this Regulation,
labelling of products is a means that enables the consumer
to make an informed choice and facilitates fairness of
transactions between seller and purchaser.

the laws of

(17) Article 2 of Directive 2000/13/EC of 20 March 2000 on
the approximation of
the Member States
relating to the labelling, presentation and advertising of
foodstuffs (7) requires that the labelling must not mislead
the purchaser, as to the characteristics of the foodstuff and
among others,
identity,
properties,
composition, method of manufacture or
production.

in particular, as to its nature,

(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 237, 10.9.1994, p. 1.
(3) OJ L 213, 21.7.1982, p. 8.
(4) OJ L 80, 25.3.1999, p. 20.

(5) OJ L 270, 14.12.1970, p. 1.
(6) OJ L 80, 25.3.1999, p. 20.
(7) OJ L 109, 6.3.2000, p. 29.

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are

(18) Additional requirements for the labelling of genetically
modified foods
laid down in Regulation (EC)
No 258/97 on novel foods and novel foods ingredients,
in Regulation (EC) No 1139/98 (1)
concerning the
certain
compulsory indication, on the
foodstuffs produced from genetically modified organisms,
of particulars other than those provided for in Directive
79/112/EEC,
(EC)
No 49/2000 (2) and in Regulation (EC) No 50/2000 on
the labelling of foodstuffs and food ingredients containing
additives and flavourings (3).

labelling of

Regulation

amended

by

as

(19) 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
feed, which
enable the user to make an informed choice.

(20) The labelling should include objective information 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,
and precludes potential
facilitates
misleading of consumers as regards method of manu-
facture or production.

informed

choice

(21) Additionally, the labelling should inform about any char-
acteristic or property which renders a food or feed not
equivalent to its conventional counterpart in respect to
composition, nutritional value or nutritional
effects,
intended use of the food or feed and health implications
on certain sections of the population, as well as any char-
acteristic or property which gives rise to ethical or
religious concerns.

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

ensures

specific

that

the

(23) Despite

the

fact

that

some operators

avoid using
genetically modified food and feed, such material may
be present
food and
in minute traces in conventional
feed as a result of adventitious or technically unavoidable
contamination during cultivation, harvest, transport and
processing; in such cases, this food or feed should not be

(1) OJ L 159, 3.6.1998, p. 4.
(2) OJ L 6, 11.1.2000, p. 13.
(3) OJ L 6, 11.1.2000, p. 15.

subject to the labelling requirements of this Regulation; in
order to achieve this objective, it is necessary to establish
thresholds for the adventitious or technically unavoidable
presence of genetically modified material in foods or feed.

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

(25) In order to ensure the practicability and feasibility of this
Regulation, a threshold of 1 %, with the possibility of
establishing lower
established for
minute traces in food or feed of genetically modified
material not authorised under Community legislation,
where the presence of such material
is adventitious or
technically unavoidable; Directive 2001/18/EC should be
amended accordingly.

should be

levels,

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

that are efficient,

(27) In order to ensure a harmonised scientific assessment of
genetically modified foods and feed, such assessments
should be carried out by the European Food Authority.

(28) It

recognised that

scientific risk assessment alone
is
cannot,
in some cases, 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.

in accordance with that part of

(29) Risks to the environment may be associated with foods
and feed which contain or consist of GMOs. Part C of
Directive 2001/18/EC provides that no product consisting
of or containing a GMO may be placed on the market
without inter alia a risk assessment having been carried
out
the Directive.
However, that requirement is waived in respect of any
product covered by sectoral Community legislation that
provides for a specific environmental risk assessment at
to the environmental risk assessment
least equivalent
to
carried out
that Directive. This Regulation should satisfy
the
conditions for the waiver to apply the requirements of
that Directive.
its
provisions in regard to risk management, labelling, moni-
information to the public and safeguard clause,
toring,
must be at
to those laid down in
Directive 2001/18/EC.

in accordance with Annexes II and III

is therefore also necessary that

least equivalent

It

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(30) It is necessary to introduce, where appropriate and based
on the conclusions of the risk assessment, post-market
monitoring requirements for the use of the genetically
modified foods for human consumption and for the use
of the genetically modified feed for animal consumption.
In the case of genetically modified organisms, a moni-
toring plan concerning environment effects is compulsory
in accordance with Directive 2001/18/EC.

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

(32) Technological progress and scientific developments should
be taken into account when implementing this Regu-
lation.

foods

and novel

(33) Existing authorisations and notifications for placing on
the market genetically modified foods under Regulation
(EC) No 258/97 on novel
food
ingredients and existing authorisations of genetically
modified food and feed,
granted under Directives
90/220/EEC and 2001/18/EC, Directive 82/471/EEC or
should continue to remain in
Directive 70/524/EEC,
the European Food Authority is
force, subject
to that
provided with
risk
assessment, methods for sampling and detection as appro-
priate, including samples of the food and feed and their
control samples within six months of the entry into force
of this Regulation.

information

concerning

the

(34) A register of genetically modified food and feed auth-
established,
orised under
including product
studies which
demonstrate the safety of the product, and sampling and
detection methods; non-confidential data should be made
available to the public.

this Regulation shall be
specific information,

(35) In order

is appropriate to protect

to stimulate research and development

into
genetically modified organisms for food and/or feed use,
the investment made by
it
innovators
information and data
the
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 should be against the public interest.

in gathering

on

the

conferred

Commission (1).

The
powers
Commission shall be assisted by the Committee referred
to in Article 57 (1) of Regulation (EC) No . . ./2001 laying
down the general principles and requirements of food law,
establishing the European Food Authority, and laying
down procedures in matters of food safety.

(37) Provision should be made

for

consultation of

the
European Group on Ethics in Science and New Tech-
nologies established by Decision of 16 December 1997
with a view to obtaining advice on ethical
issues
regarding the placing on the market of genetically
modified food or feed. Such consultations should be
without prejudice to the competence of Member States
as regards ethical issues.

trade

(38) The content of this Regulation takes account of the inter-
national
European
commitments
Communities and of the requirements of the Cartagena
Protocol on Biosafety to the Convention on Biological
Diversity as regards importer obligations and notification.

the

of

(39) This Regulation respects

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

the fundamental

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVE AND DEFINITIONS

Article 1

Objective

The objective of this Regulation is:

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

(b) to lay down Community procedures for the authorisation
and supervision of genetically modified food and feed;

(36) The measures necessary for the implementation of this
Regulation are
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing

to be

(c)

to lay down provisions for the labelling of genetically
modified food and feed.

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

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Article 2

Definitions

For the purposes of this Regulation:

1. the definitions of (cid:145)food(cid:146), (cid:145)feed(cid:146), (cid:145)placing on the market(cid:146) and
(cid:145)traceability(cid:146),
laid down in Regulation (EC) No . . ./2001
laying down the general principles and requirements of food
law, establishing the European Food Authority, and laying
down procedures in matters of food safety shall apply;

2. the definitions of (cid:145)organism(cid:146), (cid:145)genetically modified organism(cid:146)
((cid:145)GMO(cid:146)),
risk
assessment(cid:146) laid down in Directive 2001/18/EC shall apply;

(cid:145)environmental

(cid:145)deliberate

release(cid:146)

and

3.

(cid:145)genetically modified food or feed(cid:146) means food or feed
containing, consisting of or produced from genetically
modified organisms;

4.

5.

6.

(cid:145)genetically modified organism for
food use(cid:146) means a
genetically modified organism which is not exempted from
the application of Directive 2001/18/EC and that may be
used as food or as a source material for the production of food;

(cid:145)genetically modified organism for
feed use(cid:146) means a
genetically modified organism which is not exempted from
the application of Directive 2001/18/EC and that may be
used as feed or as a source material for the production of feed;

(cid:145)produced from genetically modified organisms(cid:146) means
from genetically modified
derived,
organisms, but not containing or consisting of genetically
modified organisms;

in whole or in part,

7.

(cid:145)control sample(cid:146) means the genetically modified organism or
its genetic material
the parental
organism or its genetic material that has been used for
the purpose of the genetic modification (negative sample).

(positive sample) or

CHAPTER II

GENETICALLY MODIFIED FOOD

S e c t i o n 1

Authorisation and Monitoring

Article 3

Scope

1.

This Section shall apply to:

(a) genetically modified organisms for food use,

(b) food containing or consisting of genetically modified

organisms,

(c)

food produced from or containing ingredients produced
from genetically modified organisms.

2. Where necessary,
it may be determined in accordance
with the procedure laid down in Article 36 (2) whether a
type of food falls within the scope of this Section.

Article 4

Requirements

1.

Food falling within the scope of this Section must not:

(cid:151) present a risk for human health or the environment,

(cid:151) mislead the consumer,

(cid:151) differ from the food which it is intended to replace to such
an extent that its normal consumption would be nutri-
tionally disadvantageous for the consumer.

2.
No person shall place on the market a genetically
modified organism for food use or food falling within the
scope of this Section unless it is covered by an authorisation
granted in accordance with this Section and the relevant
conditions of the authorisation are adhered to.

3.
No genetically modified organism for food use or food
falling within the scope of this Section shall be authorised
unless the applicant
for such authorisation has adequately
and sufficiently demonstrated that it satisfies the requirements
of paragraph 1.

4.

The authorisation referred to in paragraph 2 may cover:

(cid:151) a genetically modified organism and foods containing or
consisting of that genetically modified organism as well
as
ingredients
from or
produced from that genetically modified organism, or

foods produced

containing

(cid:151) a food produced from or containing an ingredient produced
from a genetically modified organism as well as foods
produced from or containing that food.

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.

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The applicant

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

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

production and manufacturing;

Authorisation under this Regulation is without prejudice

7.
to Directive 70/457/EEC and Directive 70/458/EEC.

Article 5

Adventitious or

technically unavoidable presence of

genetically modified material

The presence in food of material which contains, consists of or
is produced from genetically modified organisms
in a
proportion no higher than 1 % or lower thresholds established
in accordance with the procedure laid down in Article 36 (2),
shall not be considered to be in breach of Article 4 (2),
provided that
technically
the genetically modified material has
unavoidable and that
to a scientific risk assessment made by the
been subject
the European Food
relevant
Authority, which concludes
this material does not
present a risk for human health or the environment.

this presence is adventitious or

Scientific Committee(s) or

that

the presence of

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

this material

(e) a copy of the studies which have been carried out and any
other material which is available to demonstrate that the
food complies with the criteria laid down in Article 4 (1);

(f) either an analysis, supported by appropriate information
and data, demonstrating that the food is not different to
a conventional food, having regard to the criteria specified
in Article 14 (2) (a), or a proposal for labelling the food in
accordance with Article 14 (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 14 (2) (b);

(h) where appropriate,

the conditions
the food or foods produced from it,

for placing on the
including

market
specific conditions for use and handling;

(i) a method for detection,

including sampling and identifi-
cation of the transformation event and, where applicable,
for the detection and identification of the transformation
event in the food and/or in foods produced from it;

(j)

samples of the food and their control samples;

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

for the use of the food for human consumption;

Article 6

Application for authorisation

(l) a summary of the dossier.

1.
To obtain the authorisation referred to in Article 4 (2), an
application shall be submitted to the European Food Authority,
hereinafter referred to as (cid:145)the Authority(cid:146).

shall

The Authority

2.
the
application, in writing, to the applicant within 15 days of its
receipt. The acknowledgement shall state the date of receipt of
the application.

acknowledge

receipt

of

The application shall be accompanied by the following

3.
particulars and documents:

(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 appropriate,

the information for the purpose of
complying with Annex II of the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity;

4.
In the case of an application relating to a GMO for food
use, references to (cid:145)food(cid:146) 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 genetically modified organisms or foods
5.
containing or consisting of genetically modified organisms,
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 genetically modified organism has
been authorised under part C of Directive 2001/18/EC, a
copy of the authorisation decision;

(b) a monitoring plan for environmental effects according to
Annex VII to Directive 2001/18/EC, including a proposal
for the time-period of
this time-
period may be different from the proposed period for the
consent.

the monitoring plan;

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

7.
The Commission, having first consulted the Authority,
may establish, in accordance with the procedure laid down in
Article 36 (2), implementing rules for the application of this
Article.

The Authority shall publish detailed guidance concerning

8.
the preparation and the presentation of the application.

Article 7

Opinion of the Authority

1.
Save in exceptionally complex cases, the Authority shall
give an opinion within 6 months of the receipt of a valid
application.

request

to supplement

The Authority may, where appropriate,

the
2.
applicant
the particulars accompanying the
application within a specific time limit. Where the Authority
requests supplementary information, the time limit laid down
in paragraph 1 shall be suspended until such time that this
information has been provided. Likewise, this time limit shall
be suspended for the time allowed to the applicant to prepare
oral or written explanations.

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 6, and
examine whether the food complies with the criteria laid
down in Article 4 (1);

(b) shall make

supplementary
information supplied by the applicant available to the
Member States and to the Commission;

application and any

the

(c) shall make the summary of

the dossier mentioned in

Article 6 (3) (l) available to the public;

(d) may ask the appropriate food assessment body of a
Member State to carry out a safety assessment of the food;

(e) may ask a competent authority designated in accordance
with Article 4 of Directive 2001/18/EC to carry out an
environmental risk assessment;

(f)

shall
forward to the Community reference laboratory
referred to in Article 33 the particulars referred to in

Article 6 (3)
validate
proposed by the applicant;

(h) and (i) and shall ask it

to test and
the method of detection and identification

(g) shall,

(a),
in verifying the application of Article 14 (2)
examine the information and data submitted by the
applicant showing that the characteristics of the food are
not different
conventional
in comparison with the
counterpart, having regard to the accepted limits of
natural variations for such characteristics.

4.
In the case of genetically modified organisms or food
containing or consisting of genetically modified organisms
falling within the scope of this Section, the evaluation shall
respect the environmental safety requirements laid down in
Directive 2001/18/EC to ensure that all appropriate measures
are taken to prevent the adverse effects on human health and
the environment which might arise from the deliberate release
of genetically modified organisms. During evaluation of
requests for the placing on the market of products containing
or consisting of genetically modified organisms, the necessary
consultations shall be held by the Authority with the bodies set
up by the Community and/or the Member States in accordance
with Directive 2001/18/EC.

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

(a) the name and address of the applicant;

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

(c) where appropriate, the information required under Annex
II of the Cartagena Protocol on Biosafety to the Convention
on Biological Diversity;

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

produced from it;

(e) where appropriate, any conditions or restrictions which
the food
including post-market
the

should be imposed on the supply or use of
and/or
monitoring requirements based on the outcome of
risk assessment;

foods produced from it,

(f) a method for detection,

including sampling and identifi-
cation of the transformation event and, where applicable,
for the detection and identification of the transformation
event in the food and/or in foods produced from it;

(g) where appropriate,
Article 6 (5) (b).

the monitoring plan referred to in

shall

The Authority

6.
its opinion to the
Commission, the Member States and the applicant, including
a report describing its assessment of the food and stating the
reasons for its opinion.

forward

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The Authority shall make its opinion public, after deletion
7.
of any information identified as confidential,
in accordance
with Article 31. The public may make comments to the
Commission within 30 days from this publication.

8.
Before the entry into application of this Regulation, the
Commission shall publish a recommendation on the nature of
the risk assessment to be undertaken by the Authority for the
purpose of preparing its opinion.

Article 9

Status of existing products

1.
By derogation to Article 4 (2), a product falling within
the scope of this Section which has been placed on the market
under Directive 90/220/EEC before the entry into force of
Regulation (EC) No 258/97 or
in accordance with the
provisions laid down in Regulation (EC) No 258/97 may
continue to be placed on the market, used and processed
provided that the following conditions are met:

Article 8

Authorisation by the Community

1.
Save in exceptionally complex cases, within three months
of receipt of the opinion of the Authority, the Commission
shall prepare a draft of the decision to be taken in respect of
the application, taking into account Community law and other
legitimate factors relevant to the matter under consideration.
Where the draft decision is not in accordance with the opinion
of the Authority, the Commission shall provide an explanation
of the reasons for the differences.

2.
In the event of a draft decision which envisages the
granting of authorisation, the draft decision shall include the
particulars mentioned in Article 7 (5), the name of the auth-
orisation-holder and, where appropriate,
the unique code
attributed to the genetically modified organism as referred to
in the Regulation (EC) No . . ./. . . of the European Parliament
the Council concerning traceability and labelling of
and of
genetically modified organisms and traceability of
food and
feed products produced from genetically modified organisms.

A final decision on the application shall be adopted in

3.
accordance with the procedure laid down in Article 36 (2).

The Commission shall without delay inform the applicant
4.
of the decision taken. The decision shall be published in the
Official Journal of the European Communities.

authorisation granted in accordance with the
The
5.
laid down in this Regulation shall be valid
procedure
throughout
ten years and shall be
the Community for
renewable in accordance with Article 12. The authorised
food shall be entered in the Register referred to in Article
30. Each entry in the Register shall mention the date of auth-
orisation and shall
referred to in
paragraph 2.

include the particulars

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 subject to their inclusion in a list of substances
registered or authorised to the exclusion of others.

(a) within six months of the entry into force of this Regu-
lation, the person responsible for placing on the market
the concerned product shall notify the Authority of the
date at which it was first placed on the market in the
Community. This notification shall be accompanied by
the particulars mentioned in Article 6 (3) and (5), as appro-
to the
priate, which the Authority
Commission and the Member States. The Authority shall
forward to the Community reference laboratory referred to
in Article 33 the particulars referred to in Article 6 (3) (i)
and (j) and shall ask it to test and validate the method of
detection and identification proposed by the applicant;

forward

shall

shall,

verification that

(b) within one year of the entry into force of this Regulation,
the
after
the Authority
information required has been submitted, notify the
Commission that it has received the information required
under this Article. The product concerned shall be entered
in the Register. Each entry in the Register shall mention the
date at which the concerned product was first placed on
the market and shall include the particulars referred to in
Article 8 (2) as appropriate.

all

2. Within nine years from the date at which the concerned
product was first placed on the market, the person responsible
for placing it on the market shall submit an application in
accordance with Article 12, which shall apply in a like manner.

3.
Products referred to in paragraph 1 and foods containing
them or produced from them shall be subject to the provisions
of this Regulation, in particular Articles 10, 11 and 35, which
shall apply in a like manner.

4. Where the notification and accompanying particulars
referred to in paragraph 1(a) are not supplied within the
period specified or are found to be incorrect, or where an
application is not submitted as required by paragraph 2
within the period specifed,
acting in
accordance with the procedure laid down in Article 36 (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.

the Commission,

The granting of authorisation shall not diminish the
liability of any food operator in

7.
general civil and criminal
respect of the food concerned.

5.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure laid down in
Article 36 (2).

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Article 10

Supervision

1.
After an authorisation has been issued in accordance with
this Regulation, the authorisation-holder shall comply with any
conditions or restrictions which have been imposed in the
authorisation. Where post-market monitoring as referred to
in Article 6 (3) (k) and Article 6 (5) (b) has been imposed
on the authorisation-holder, he shall ensure that it is carried
out and shall submit reports to the Authority in accordance
with the authorisation.

2.
If the authorisation-holder proposes to modify the terms
of the authorisation, he shall submit an application to the
Authority.

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

Article 11

Modification, suspension and revocation of authorisations

1. Where, on its own initiative or following a request from a
Member State or from the Commission, the Authority is of the
opinion that an authorisation granted in accordance with this
Regulation should be modified, suspended or revoked, it shall
forthwith transmit this opinion to the Commission.

2.
The Commission shall examine the opinion of
Authority as soon as possible and prepare a draft of
decision to be taken.

the
the

In the event of a draft decision which envisages the modi-
3.
fication of the authorisation, the draft decision shall
include
any amendment needed to the particulars mentioned in Article
8 (2).

A final decision on the modification, the suspension or
the authorisation shall be adopted in

4.
the revocation of
accordance with the procedure laid down in Article 36 (2).

The Commission shall without delay inform the author-
the decision taken. The decision shall be
the European Communities.

5.
isation-holder of
published in the Official Journal of
The Register shall be amended as appropriate.

Article 12

Renewal of authorisations

1. Without prejudice to the right of a third party to submit
an application for authorisation for a food essentially similar to
a food for which an authorisation has already been granted,
authorisations under this Regulation shall be renewable for
ten-years periods, on application to the Authority by the auth-
orisation-holder at the latest one year before the expiry date of
the authorisation.

The Authority shall acknowledge receipt of the application, in
writing,
its
receipt. The acknowledgement shall state the date of receipt
of the application.

to the authorisation-holder within 15 days of

The application shall be accompanied by the following

2.
particulars and documents:

(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.

Article 7 and Article 8 shall apply in a like manner.

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

extended until

shall

5.
The implementing rules for the application of this Article
shall be established by the Commission after consulting the
Authority,
in accordance with the procedure laid down in
Article 36 (2).

The Authority shall publish detailed guidance concerning

6.
the preparation and the presentation of the application.

S e c t i o n 2

Labelling

Article 13

Scope

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

(cid:151) contain or consist of genetically modified organisms, or

(cid:151) are produced from or contain ingredients produced from

genetically modified organisms.

This Section shall not apply to foods containing material
2.
which contains, consists of or is produced from genetically
modified organisms
than the
thresholds established in accordance with the procedure laid
down in Article 36 (2), provided that
this presence is
adventitious or technically unavoidable.

in a proportion no higher

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the presence of

is
In order to establish that
adventitious or technically unavoidable, operators must be in
a position to supply evidence to satisfy the competent auth-
orities that they have taken appropriate steps to avoid the
presence of the genetically modified organisms (or produce
thereof).

this material

Article 14

Requirements

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

requirements

other

In addition to the labelling requirements laid down in
3.
the
paragraph 1 and as
labelling of
this Section
foods falling within the scope of
which do not have a conventional counterpart shall contain
the nature and the charac-
appropriate information about
teristics of the foods concerned.

specified in the authorisation,

Article 15

Implementing measures

Detailed rules for implementing this Section may be adopted in
accordance with the procedure laid down in Article 36 (2).

(a) Where the food consists of more than one ingredient, the
words (cid:145)genetically modified(cid:146) or (cid:145)produced from genetically
modified [name of organism] but not
containing a
genetically modified organism(cid:146) shall appear in the list of
in Article 6 of Directive
ingredients provided for
2000/13/EC in parentheses
immediately following the
these words may
ingredient
appear in a footnote to the list of ingredients. It shall be
printed in a font of at least the same size as the list of
ingredients.

concerned. Alternatively,

(b) Where the ingredient
the words

is designated by the name of a
category,
ingredient]
[name of
(cid:145)contains
produced from genetically modified [name of organism]
but not containing a genetically modified organism(cid:146) shall
appear in the list of ingredients.

(c) Where there is no list of ingredients, the words (cid:145)genetically
modified(cid:146) or (cid:145)produced from genetically modified [name of
containing a genetically modified
organism] but not
organism(cid:146) shall appear clearly on the labelling.

CHAPTER III

GENETICALLY MODIFIED FEED

S e c t i o n 1

Authorisation and Monitoring

Article 16

Scope

1.

This Section shall apply to:

(a) genetically modified organisms for feed use;

(b) feed containing or consisting of genetically modified

organisms;

(c)

feed produced from genetically modified organisms.

(d) Where the food is offered for sale to the ultimate consumer
or to mass caterers without pre-packaging, the information
required under this paragraph must be displayed on or in
connection with the display of the food.

2. Where necessary,
it may be determined in accordance
with the procedure laid down in Article 36 (2) whether a
type of feed falls within the scope of this Section.

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

(a) Where a food is not equivalent

to its conventional

counterpart as regards:

(cid:151) composition,

Article 17

Requirements

1.

Feed referred to in Article 16 (1) must not:

(a) present a risk for animal health, human health or the

environment;

(cid:151) nutritional value or nutritional effects,

(b) mislead the user;

(cid:151) intended use of the food,

(c) harm the consumer by impairing the distinctive features of

the animal products;

(cid:151) implications for the health of certain sections of the

population.

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

(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.

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No person shall place on the market, use or process a
2.
product referred to in Article 16 (1) for feed use or feed falling
within the scope of this Section unless it is covered by an
authorisation granted in accordance with this Section and the
relevant conditions of the authorisation are adhered to.

3.
No product referred to in Article 16 (1) for feed use or
feed falling within the scope of this Section shall be authorised
unless the applicant for such authorisation has adequately and
sufficiently demonstrated that it satisfies the requirements of
paragraph 1.

4.

The authorisation referred to in paragraph 2 may cover:

(cid:151) a genetically modified organism and feed containing or
consisting of that genetically modified organism as well
as feed produced from that genetically modified organism,
or

they have taken appropriate steps to avoid the presence of
the genetically modified organisms (or produce thereof).

Article 19

Application for authorisation

To obtain the authorisation referred to in Article 17 (2),

1.
an application shall be submitted to the Authority.

shall

The Authority

2.
the
application, in writing, to the applicant within 15 days of its
receipt. The acknowledgement shall state the date of receipt of
the application.

acknowledge

receipt

of

3.

The application shall be accompanied by the following:

(a)

the name and the address of the applicant;

(cid:151) a feed produced from a genetically modified organism as

well as feed produced from or containing that feed.

(b) the designation of the feed referred to in Article 16 (1), and
its specification, including the transformation event(s) used;

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

(c) where appropriate,

the information for the purpose of
complying with Annex II of the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity;

The applicant

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

(d) where appropriate, a detailed description of the method of
production, manufacturing and intended uses of the feed
referred to in Article 16 (1);

Authorisation under this Regulation is without prejudice

7.
to Directive 70/457/EEC and Directive 70/458/EEC.

Article 18

Adventitious or

technically unavoidable presence of

genetically modified material

The presence in feed of material which contains, consists of or
is produced from genetically modified organisms
in a
proportion no higher than 1 % or lower thresholds established
in accordance with the procedure laid down in Article 36 (2),
shall not be considered to be in breach of Article 17 (2),
provided that
technically
unavoidable and that
the genetically modified material has
to a scientific risk assessment made by the
been subject
the European Food
relevant
this material does not
Authority, which concludes
present a risk for human health, animal health or
the
environment.

this presence is adventitious or

Scientific Committee(s) or

that

(e) a copy of the studies which have been carried out and any
other material which is available to demonstrate that the
feed referred to in Article 16 (1) complies with the criteria
laid down in Article 17 (1), and in particular for feed falling
within the scope of Directive 82/471/EEC, the information
required under Directive 83/228/EEC on the fixing of
guidelines for the assessment of certain products used in
animal nutrition;

(f) either an analysis, supported by appropriate information
the feed referred to in
and data, demonstrating that
feed,
to a conventional
is not different
Article 16 (1)
having regard to the criteria specified in Article 27 (3) (c),
or a proposal for labelling the feed referred to in Article
16 (1) in accordance with Article 27 (3) (c) and (4);

(g) either a reasoned statement that the feed referred to in
Article 16 (1) does not give rise to ethical or religious
concerns, or a proposal
in accordance
with Article 27 (3) (d);

for labelling it

In order to establish that
is
adventitious or technically unavoidable, operators must be in
a position to demonstrate to the competent authorities that

the presence of

this material

(h) where appropriate,

referred to in Article 16 (1) on the market,
specific conditions for use and handling;

the conditions for placing the feed
including

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(i) a method for detection,

including sampling and identifi-
cation of the transformation event and, where applicable,
for the detection and identification of the transformation
event in the feed referred to in Article 16 (1);

(j)

samples of the feed referred to in Article 16 (1) and their
control samples;

(k) where appropriate, a proposal for post-market monitoring
for the use of the feed referred to in Article 16 (1) for
animal consumption;

(l) a summary of the dossier.

In the case of an application relating to a GMO for feed
4.
use, references to (cid:145)feed(cid:146) 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.

Article 20

Opinion of the Authority

1.
Save in exceptionally complex cases, the Authority shall
give an opinion within 6 months of the receipt of a valid
application.

request

to supplement

The Authority may, where appropriate,

the
2.
applicant
the particulars accompanying the
application within a specific time limit. Where the Authority
requests supplementary information, the time limit laid down
in paragraph 1 shall be suspended until such time that this
information has been provided. Likewise, this time limit shall
be suspended for the time allowed to the applicant to prepare
oral or written explanations.

3.

In order to prepare its opinion, the Authority:

5.
For genetically modified organisms and feed referred to
respectively in Article 16 (1) (a) and (b), the application shall
also be accompanied by:

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 19, and
examine whether the feed referred to in Article 16 (1)
complies with the criteria laid down in Article 17 (1);

(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 genetically modified organisms has
been authorised under Part C of Directive 2001/18/EC, a
copy of the authorisation decision;

(b) a monitoring plan for environmental effects according to
Annex VII to Directive 2001/18/EC, including a proposal
for the time-period of
this time-
period may be different from the proposed period for the
consent.

the monitoring plan;

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
subject under other
placing on the market of which is
provisions of Community law to its inclusion on a list of
substances 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,
may establish, in accordance with the procedure laid down in
Article 36 (2), implementing rules for the application of this
Article.

The Authority shall publish detailed guidance concerning

8.
the preparation and the presentation of the application.

(b) shall make

supplementary
information supplied by the applicant available to the
Member States and to the Commission;

application and any

the

(c) shall make the summary of

the dossier mentioned in

Article 19 (3) (l) available to the public;

(d) may ask the appropriate feed assessment body of a Member
State to carry out a safety assessment of the feed referred to
in Article 16 (1);

(e) may ask a competent authority designated in accordance
with Article 4 of Directive 2001/18/EC to carry out an
environmental risk assessment;

(f)

shall
forward to the Community reference laboratory
referred to in Article 33 the particulars referred to in
Article 19 (3)
to test and
the method of detection and identification
validate
proposed by the applicant;

(i) and (j) and shall ask it

(g) shall,

(c),
in verifying the application of Article 27 (3)
examine the information and data submitted by the
applicant
the feed
referred to in Article 16 (1) are not different in comparison
with the conventional counterpart, having regard to the
accepted limits of natural variations for such characteristics.

the characteristics of

showing that

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(a) and (b),

In the case of genetically modified organisms and feed
4.
referred to respectively in Article 16 (1)
the
evaluation shall respect the environmental safety requirements
laid down in Directive 2001/18/EC to ensure that all appro-
priate measures are taken to prevent the adverse effects on
human and animal health and the environment which might
arise from the deliberate release of genetically modified
organisms. During evaluation of requests for the placing on
the market of products containing or consisting of genetically
modified organisms, the necessary consultations shall be held
by the Authority with the bodies set up by the Community
and/or
in accordance with Directive
2001/18/EC.

the Member States

5.
In the event of an opinion in favour of authorising the
feed referred to in Article 16 (1), the opinion shall also include
the following particulars:

(a) the name and address of the applicant;

(b) the designation of the feed referred to in Article 16 (1), and

its specification;

(c) where appropriate, the information required under Annex
II of the Cartagena Protocol on Biosafety to the Convention
on Biological Diversity;

(d) the proposal for the labelling of the feed referred to in

Article 16 (1);

(e) where appropriate, any conditions or restrictions which
should be imposed on the placing on the market,
including specific conditions or restrictions for use and
including post-market monitoring requirements
handling,
based on the outcome of the risk assessment;

(f) a method for detection,

including sampling and identifi-
cation of the transformation event and, where applicable,
for the detection and identification of the transformation
event in the feed referred to in Article 16 (1);

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

Article 19 (5) (b).

shall

The Authority

its opinion to the
6.
Commission, the Member States and the applicant, including
a report describing its assessment of the feed referred to in
Article 16 (1) and stating the reasons for its opinion.

forward

Article 21

Authorisation by the Community

1.
Save in exceptionally complex cases, within three months
of receipt of the opinion of the Authority, the Commission
shall prepare a draft of the decision to be taken in respect of
the application, taking into account Community law and other
legitimate factors relevant to the matter under consideration.
Where the draft decision is not in accordance with the opinion
of the Authority, the Commission shall provide an explanation
of the reasons for the differences.

In the event of a draft decision which envisages the
2.
granting of authorisation, the draft decision shall include the
particulars mentioned in Article 20 (5), the name of the auth-
orisation-holder, and, where appropriate,
the unique code
attributed to the genetically modified organism as referred to
in the Regulation (EC) No . . ./. . . of the European Parliament
the Council concerning traceability and labelling of
and of
genetically modified organisms and traceability of
food and
feed products produced from genetically modified organisms.

A final decision on the application shall be adopted in

3.
accordance with the procedure laid down in Article 36 (2).

4.
The Commission shall without delay inform the applicant
of the decision taken. The decision shall be published in the
Official Journal of the European Communities.

authorisation granted in accordance with the
5.
The
laid down in this Regulation shall be valid
procedure
throughout
ten years and shall be
the Community for
renewable in accordance with Article 25. The authorised feed
shall be entered in the Register referred to in Article 30. Each
entry in the Register shall mention the date of authorisation
include the particulars referred to in paragraph 2.
and shall

6.
The authorisation under this Section shall be without
prejudice to other provisions of Community law governing
the use and placing on the market of substances which may
only be used subject to their inclusion in a list of substances
authorised to the exclusion of others.

The granting of authorisation shall not diminish the
liability of any feed operator in

7.
general civil and criminal
respect of the feed concerned.

The Authority shall make its opinion public, after deletion
7.
of any information identified as confidential,
in accordance
with Article 31. The public may make comments to the
Commission within 30 days from this publication.

8.
Before the entry into application of this Regulation, the
Commission shall publish a recommendation on the nature of
the risk assessment to be undertaken by the Authority for the
purpose of preparing its opinion.

Article 22

Status of existing products

1.
By derogation to Article 17 (2), products as referred to in
Article 16 (1) which have been authorised before the date of
application of this Regulation

(cid:151) under Directives 90/220/EEC or 2001/18/EC, including use

as feed,

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(cid:151) under Directive 82/471/EEC, which are produced from

GMOs, or

Detailed rules for implementing this Article shall be
6.
adopted in accordance with the procedure laid down in
Article 36 (2).

(cid:151) under Directive 70/524/EEC which contain, consist of or

are produced from GMOs,

may continue to be placed on the market, used and processed
provided that the following conditions are met:

(a) within six months of the entry into force of this Regu-
lation, the person responsible for placing on the market
the concerned products shall notify the Authority of the
date at which they were first placed on the market in the
Community. This notification shall be accompanied by the
particulars mentioned in Article 19 (3) and (5), as appro-
priate, which the Authority
to the
Commission and the Member States. The Authority shall
forward to the Community reference laboratory referred to
in Article 33 the particulars referred to in Article 19 (3) (i)
and (j) and shall ask it to test and validate the method of
detection and identification proposed by the applicant;

forward

shall

Article 23

Supervision

After an authorisation has been issued in accordance with
1.
this Regulation, the authorisation-holder shall comply with any
conditions or restrictions which have been imposed in the
authorisation. Where post-market monitoring as referred to
in Article 19 (3) (k) and Article 19 (5) (b) has been imposed
on the authorisation-holder, he shall ensure that it is carried
out and shall submit reports to the Authority in accordance
with the authorisation.

2.
If the authorisation-holder proposes to modify the terms
of the authorisation, he shall submit an application to the
Authority.

shall,

verification that

(b) within one year of the entry into force of this Regulation,
the Authority
the
after
information required has been submitted, notify the
Commission that it has received the information required
under this Article. The products concerned shall be entered
in the Register. Each entry in the Register shall mention the
date at which the concerned products were first placed on
the market and shall include the particulars referred to in
Article 21 (2) as appropriate.

all

forthwith inform the
3.
shall
The authorisation-holder
Authority of any new scientific or
information
technical
which might influence the evaluation of the safety in use of
the feed referred to in Article 16 (1). In particular, the author-
forthwith inform the Authority of any
isation-holder shall
prohibition
competent
by
authority of any third country in which the feed referred to
in Article 16 (1) is placed on the market.

restriction

imposed

the

or

2. Within nine years from the date at which the concerned
the person
products were
responsible for placing them on the market shall submit an
application in accordance with Article 25, which shall apply in
a like manner.

first placed on the market,

3.
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 23, 24 and 35, which
shall apply in a like manner.

4. Where the notification and accompanying particulars
referred to in paragraph 1 (a) are not supplied within the
period specified or are found to be incorrect, or where an
application is not submitted as required by paragraph 2
within the period specified,
the Commission, acting in
accordance with the procedure laid down in Article 36 (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.

Article 24

Modification, suspension and revocation of authorisations

1. Where, on its own initiative or following a request from a
Member State or from the Commission, the Authority is of the
opinion that an authorisation granted in accordance with this
Regulation should be modified, suspended or revoked, it shall
forthwith transmit this opinion to the Commission.

The Commission shall examine the opinion of
2.
Authority as soon as possible and prepare a draft of
decision to be taken.

the
the

In the event of a draft decision which envisages the modi-
3.
fication of the authorisation, the draft decision shall
include
any amendment needed to the particulars mentioned in Ar-
ticle 21 (2).

A final decision on the modification, the suspension or
the authorisation shall be adopted in

4.
the revocation of
accordance with Article 36 (2).

In case of authorisations not issued to a specific holder,
5.
the person who imports, produces or manufactures
the
products referred to in this Article shall submit the information
or the application to the Authority.

The Commission shall without delay inform the author-
the decision taken. The decision shall be
the European Communities.

5.
isation-holder of
published in the Official Journal of
The Register shall be amended as appropriate.

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Article 25

Renewal of authorisations

1. Without prejudice to the right of a third party to submit
an application for authorisation for a feed essentially similar to
a feed for which an authorisation has already been granted,
authorisations under this Regulation shall be renewable for
ten-years periods, on application to the Authority by the auth-
orisation-holder at the latest one year before the expiry date of
the authorisation.

The Authority shall acknowledge receipt of the application, in
writing,
its
receipt. The acknowledgement shall state the date of receipt
of the application.

to the authorisation-holder within 15 days of

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
environment;

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

than the thresholds established in
proportion no higher
accordance with the procedure laid down in Article 36 (2),
provided that
technically
unavoidable.

this presence is adventitious or

the presence of

to establish that

In order
feed is
adventitious or technically unavoidable, operators must be in
a position to supply evidence to satisfy the competent auth-
orities that they have taken appropriate steps to avoid the
presence of the genetically modified organisms (or produce
thereof).

this

Article 27

Requirements

1. Without prejudice
to the
Community law concerning the
referred to in Article 16 (1) shall be subject
specific labelling requirements laid down in this Article.

other
labelling of

of
feed
to additional

requirements

feed,

By way of derogation from the previous paragraph the
2.
exemptions for labelling requirements provided for in Article 6
(3)
to Directive 96/25/EC shall not be applicable for feed
referred to in Article 16 (1).

No person shall place a feed referred to in Article 16 (1)
3.
on the market unless he ensures that the particulars specified
below are shown,
legible and indelible
in a clearly visible,
manner, on an accompanying document or, where appropriate,
on the packaging, on the container or on a label attached
thereto:

3.

Article 20 and Article 21 shall apply in a like manner.

(a) the name of the feed:

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

extended until

shall

5.
The implementing rules for the application of this Article
shall be established by the Commission after consulting the
in accordance with the procedure laid down in
Authority,
Article 36 (2).

The Authority shall publish detailed guidance concerning

6.
the preparation and the presentation of the application.

S e c t i o n 2

Labelling

Article 26

Scope

(cid:151) for genetically modified feed the name shall be:

(cid:145)genetically modified [name of the feed](cid:146);

(cid:151) for feed produced from genetically modified organisms:
(cid:145)produced from genetically modified [name of the feed
from which the feed is produced] but not containing a
genetically modified organism(cid:146);

(b) for feed referred to in Article 16 (1) (b) the name of the
feed shall be accompanied by the relevant unique code as
established in Regulation (EC)
the European
Parliament and of the Council concerning traceability and
labelling of genetically modified organisms and traceability
food and feed products produced from genetically
of
modified organisms;

. . ./. . . of

(c) as specified in the authorisation, any characteristic of the
feed referred to in Article 16 (1) such as those indicated
hereunder, which is not equivalent
to its conventional
counterpart:

1.
This
Article 16 (1).

Section shall

apply

to feed referred to in

(cid:151) composition,

(cid:151) nutritional properties,

2.
This Section shall not apply to feed containing, consisting
of or produced from genetically modified organisms in a

(cid:151) intended use,

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(cid:151) implications

for

the health of certain species or

categories of animals;

competitive position. Verifiable justification must be given in
such cases.

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

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

after

to

In

the

addition

requirements

4.
in
paragraph 3 (a) and (b) and as specified in the authorisation,
the labelling or accompanying documents of feed 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 feed concerned.

down

laid

Information relating to the following shall not be

3.
considered confidential:

(a) name

and composition of

genetically modified
organism, food or feed referred to in Articles 3 (1) and
16 (1) and, where appropriate, indication of the substrate
and the micro-organism;

the

Article 28

Implementing measures

(b) general description of the genetically modified organism
and the name and address of the authorisation-holder;

Detailed rules for implementing this Section may be adopted in
accordance with the procedure laid down in Article 36 (2).

CHAPTER IV

COMMON PROVISIONS

Article 29

Products likely to be used as food and feed

1. Where a product is likely to be used both as food and
feed, a single application under Articles 6 and 19 shall be
submitted and shall give rise to a single opinion from the
Authority and a single Community decision.

The Authority may consider whether the application for

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

Article 30

Community Register

The Commission

1.
establish and maintain a
Community Register of Genetically Modified Food and Feed,
referred to in this Regulation as (cid:145)the Register(cid:146).

shall

2.

The Register shall be made available to the public.

Article 31

Confidentiality

1.
The applicant may indicate which information submitted
under the present Regulation he wishes to be treated as confi-
dential because its disclosure may significantly harm its

(c) physico-chemical and biological

the
genetically modified organism, food or feed referred to in
Articles 3 (1) and 16 (1);

characteristics of

(d) effects of the genetically modified organism, food or feed
referred to in Articles 3 (1) and 16 (1) on human and
animal health and on the environment;

(e) effects of the genetically modified organism, food or feed
referred to in Articles 3 (1) and 16 (1) on the characteristics
of animal products and its nutritional properties;

(f) methods for detection,

including sampling and identifi-
cation 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
16 (1) and, where applicable, monitoring requirements and
a summary of the results of the monitoring;

(g)

information on waste treatment and emergency response.

Notwithstanding paragraph 2,

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

5.
The Commission, the Authority and the Member States
shall keep confidential all the information identified as confi-
dential under paragraph 2 except for information which must
be made public if circumstances so require, in order to protect
human health, animal health or the environment.

If

an applicant withdraws or has withdrawn an
6.
application, the Authority, the Commission and the Member
the confidentiality of commercial and
States shall
industrial
including research and development
information as well as information on which the Authority
and the applicant disagree as to its confidentiality.

respect
information,

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Article 32

Data protection

The scientific data and other information in the application
dossier required under Article 6 (3) and (5) and Article 19
(3) and (5) may not be used for the benefit of another
applicant for a period of ten years from the date of author-
isation, unless the other applicant has agreed with the author-
isation-holder that such data and information may be used. On
expiry of this ten-years 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 he can
demonstrate that the food or feed for which he is seeking
authorisation is essentially similar to a food or feed already
authorised under this Regulation.

Article 33

Community reference laboratory

The Community reference laboratory and its duties and tasks
shall be those laid down in the Annex.

National
laboratories may
accordance with the procedure laid down in Article 36 (2).

established

reference

be

in

Detailed rules for implementing this Annex and any changes to
it may be adopted in accordance with the procedure laid down
in Article 36 (2).

Article 34

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 established by Commission
Decision of 16 December 1997, with a view to obtaining its
opinion on ethical issues.

2.
The Commission shall make available to the public the
opinions of the European Group on Ethics in Science and New
Technologies.

Article 35

Emergency measures

1. Where a Member State, as a result of new information or
a reassessment of existing information, has detailed grounds for
considering that
the use of a food or feed authorised in
accordance with this Regulation endangers human health,
immediately
it
animal health or
inform the Authority and the Commission.

the environment,

shall

considers that emergency measures are necessary, it may adopt
them in accordance with Article 36 (3). These emergency
measures may remain in place until a final decision is taken
in accordance with Article 11 or Article 24, as appropriate.

Article 36

Implementing powers of the Commission

1.
The Commission shall be assisted by the Committee
referred to in Article 57 (1) of Regulation (EC) No . . ./2001
laying down the general principles and requirements of food
law, establishing the European Food Authority, and laying
down procedures in matters of food safety.

2. When reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
in compliance with Article 7 and Article 8
shall apply,
thereof. The period provided for in Article 5 (6) of Decision
1999/468/EC shall be three months.

3. When reference is made to this paragraph, the safeguard
procedure laid down in Article 6 of Decision 1999/468/EC
in compliance with Article 7 and Article 8
shall apply,
thereof. Any Member State may refer
the Commission’s
decision to the Council within 15 days from the receipt of
in which case the Council,
the notification of this decision,
acting by a qualified majority, may take a different decision
within one month from the date of referral to the Council.

Article 37

Repeals

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

(cid:151) Regulation (EC) No 1139/98;

(cid:151) Regulation (EC) No 49/2000;

(cid:151) Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

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

1. The following provisions are deleted:

(cid:151) Article 1 (2) (a) and (b),

(cid:151) Article 3 (2) second paragraph and (3),

(cid:151) Article 8 (1) (d),

2.
If the Commission, following information received from a
Member State pursuant to paragraph 1 or on its own initiative,

(cid:151) Article 9,

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2. In Article 3, the first sentence of paragraph 4 is replaced by

the following:

feed or Regulation . . ./. . ./EC on genetically modified food
and feed.(cid:146)

(cid:145)By way of derogation from paragraph 2, the procedure laid
down 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
the
on the basis of an opinion delivered by one of
are
referred to in Article 4 (3),
competent bodies
substantially equivalent to existing foods or food ingredients
as regards their composition, nutritional value, metabolism,
intended use and the level of undesirable substances
contained therein.(cid:146)

3. In Article 12 (1), the words (cid:145)or the environment(cid:146) are deleted.

Article 39

Amendments to Directive 82/471/EEC

Article 41

Amendments to Directive 70/458/EEC

Directive 70/458/EEC is amended with effect from the date of
application of this Regulation as follows:

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

(cid:145)3.
Further, when material derived from a plant variety is
intended to be used in food falling within the scope of
Article 3, or feed falling within the scope of Article 16 of
Regulation . . ./. . ./EC on genetically modified food and feed,
the variety shall only be accepted if it has been approved in
accordance with that Regulation.(cid:146)

Directive 82/471/EEC is amended with effect from the date of
application of this Regulation as follows:

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

The following paragraph is added to Article 1:

(cid:145)3.
This Directive does not apply to products which act
as direct or indirect protein sources that fall within the
scope of Regulation . . ./. . ./EC on genetically modified
food and feed(cid:146).

Article 40

Amendments to Directive 70/457/EEC

Directive 70/457/EEC is amended with effect from the date of
application of this Regulation as follows:

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

(cid:145)5.
Further, when material derived from a plant variety is
intended to be used in food falling within the scope of
Article 3, or feed falling within the scope of Article 16 of
Regulation . . ./. . ./EC on genetically modified food and feed,
the variety shall only be accepted if it has been approved in
accordance with that Regulation.(cid:146)

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

(cid:145)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 . . ./2001 laying down the general prin-
ciples and requirements of
food law, establishing the
European Food Authority, and laying down procedures in
matters of food safety, is accepted only if it has been auth-
orised pursuant to Regulation (EC) No 258/97 for food or
under Directive 90/220/EEC or Directive 2001/18/EC for

(cid:145)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 . . ./2001 laying down the general prin-
ciples and requirements of
food law, establishing the
European Food Authority, and laying down procedures in
matters of food safety, is accepted only if it has been auth-
orised pursuant to Regulation (EC) No 258/97 for food or
Directive 90/220/EEC or Directive 2001/18/EC for feed or
Regulation . . ./. . ./EC on genetically modified food and
feed.(cid:146)

Article 42

Amendments to Directive 2001/18/EC

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

The following Article 12a is inserted:

(cid:145)Article 12a

Adventitious presence of GMOs in products

Articles 13 to 21 shall not apply to the placing on the
market of traces of a GMO or combination of GMOs in
products intended for direct use as food or feed, or for
processing, in a proportion no higher than 1 % or lower
thresholds established in accordance with the procedure
laid down in Article 30 (2), provided that these traces of
GMOs are adventitious or technically unavoidable and that
the GMOs have been subject to a scientific risk assessment
the
made by the relevant Scientific Committee(s) or
European Food Authority, which concludes
the
that
GMOs do not present a risk for human health or the
environment.

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In order to establish that traces of GMOs are adventitious
or technically unavoidable, operators must be in a position
to demonstrate to the competent authorities that they have
taken appropriate steps to avoid them(cid:146).

The labelling requirements laid down in this Regulation
2.
shall not apply to products which have been lawfully manu-
factured and labelled in the Community, or which have been
lawfully imported into the Community and put into circulation,
before the date of application of this Regulation.

Article 43

Information to be provided in accordance with the
Cartagena Protocol on Biosafety

1.
Any authorisation, renewal, modification, suspension or
revocation of authorisation of a genetically modified organism,
food or feed referred to in Articles 3 (1) (b) and 16 (1) (b) shall
be notified by the Commission to the Parties to the Cartagena
Protocol on Biosafety through the Biosafety Clearing-House in
accordance with Article 11 (1) or Article 12 (1) of
the
Cartagena Protocol on Biosafety, 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.

The Commission shall also process requests for additional
2.
information made by any Party in accordance with Article 11
(3) and will provide copies of
regulations and
guidelines in accordance with Article 11 (5) of the Cartagena
Protocol on Biosafety.

the laws,

Article 44

Penalties

The Member States shall
lay down the rules on penalties
applicable to infringements of the provisions of this Regulation
and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective,
proportionate and dissuasive. The Member States shall notify
those provisions to the Commission by [six months after the
date of publication of this Regulation] at the latest and shall
notify it without delay of any subsequent amendment affecting
them.

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

Requests submitted for products referred to in Article 16
4.
(1) (c) under Article 7 of Directive 82/471/EEC before the entry
into force 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 16
(1) under Article 4 of Directive 70/524/EEC before the entry
into force of
this Regulation shall be complemented by
applications under Chapter III, Section 1 of this Regulation.

Article 46

Review

1.
No later than two years from the date of entry into force
of this Regulation and in the light of experience gained, the
Commission shall forward to the European Parliament and to
the Council a report on the implementation of this Regulation
accompanied, where appropriate, by any suitable proposal.

2.
Notwithstanding the review provided for in paragraph 1,
the Commission shall monitor the application of this Regu-
lation and its impact on human and animal health, consumer
protection, consumer information and the functioning of the
internal market and, if necessary, will bring forward proposals
at the earliest possible date.

Article 45

Transitional measures

Article 47

Entry into force

Requests submitted under Article 4 of Regulation (EC)
1.
this Regulation
No 258/97 before the entry into force of
II,
shall be transformed into applications under Chapter
this Regulation where the initial assessment
Section 1 of
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.

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

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.

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ANNEX

Duties and Tasks of the Community reference laboratory

1. The Community reference laboratory referred to in Article 33 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 (cid:145)European Network of GMO laboratories(cid:146).

3. The Community reference laboratory shall be notably responsible for:

(cid:151) reception, preparation, storage and maintenance of the appropriate positive and negative control samples;

(cid:151) testing and validation of the method for detection, including sampling and identification of the transformation
event and, where applicable, the detection and identification of the transformation event in the food or feed;

(cid:151) 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;

(cid:151) submitting full evaluation reports to the Authority.

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

results of the tasks outlined in this Annex.