(acts Whose Publication Is Obligatory) Regulation (ec) No 1829 ...
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Official Journal of the European Union
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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
(4)
Differences between national laws, regulations and
EUROPEAN UNION,
administrative provisions concerning the assessment and
authorisation of genetically modified food and feed may
hinder their free movement, creating conditions of
Having regard to the Treaty establishing the European Com-
unequal and unfair competition.
munity, and in particular Articles 37, 95 and Article 152(4)(b)
thereof,
(5)
An authorisation procedure involving Member States
Having regard to the proposal from the Commission (1),
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
Having regard to the opinion of the European Economic and
1997 concerning novel foods and novel food ingredi-
Social Committee (2),
ents (5). This procedure should be streamlined and made
more transparent.
Having regard to the opinion of the Committee of the
Regions (3),
(6)
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-
Acting in accordance with the procedure referred to in Article
lence is a key step in the procedure for assessment of
251 of the Treaty (4),
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
Whereas:
genetically modified food, this notification procedure
should be abandoned in respect of genetically modified
foods.
(1)
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
(7)
Feed consisting of or containing genetically modified
citizens, and to their social and economic interests.
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
(2)
A high level of protection of human life and health
2001/18/EC of the European Parliament and of the
should be ensured in the pursuit of Community policies.
Council of 12 March 2001 on the deliberate release into
the environment of genetically modified organisms (7);
no authorisation procedure exists for feed produced
(3)
In order to protect human and animal health, food and
from GMOs; a single, efficient and transparent Commu-
feed consisting of, containing or produced from geneti-
nity authorisation procedure for feed consisting of,
cally modified organisms (hereinafter referred to as
containing or produced from GMOs should be estab-
genetically modified food and feed) should undergo a
lished.
safety assessment through a Community procedure
before being placed on the market within the Commu-
nity.
(8)
The provisions of this Regulation should also apply to
feed intended for animals which are not destined for
(1) OJ C 304 E, 30.10.2001, p. 221.
food production.
(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
(5) OJ L 43, 14.2.1997, p. 1.
published in the Official Journal), Council Common Position of 17
(6) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/
March 2003 (OJ C 113 E, 13.5.2003, p. 31), Decision of the
18/EC.
European Parliament of 2 July 2003 (not yet published in the Offi-
(7) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council
cial Journal) and Council Decision of 22 July 2003.
Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).
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(9)
The new authorisation procedures for genetically modi-
to
this
authorisation
procedure,
food
additives
fied food and feed should include the new principles
containing, consisting of or produced from GMOs
introduced in Directive 2001/18/EC. They should also
should fall also within the scope of this Regulation for
make use of the new framework for risk assessment in
the safety assessment of the genetic modification, while
matters of food safety set up by Regulation (EC) No
the final authorisation should be granted under the
178/2002 of the European Parliament and of the
procedure referred to in Directive 89/107/EEC.
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-
dures in matters of food safety (1). Thus, genetically
modified food and feed should only be authorised for
placing on the Community market after a scientific
evaluation of the highest possible standard, to be under-
(13)
Flavourings falling within the scope of Council Directive
taken under the responsibility of the European Food
88/388/EEC of 22 June 1988 on the approximation of
Safety Authority (Authority), of any risks which they
the laws of the Member States relating to flavourings for
present for human and animal health and, as the case
use in foodstuffs and to source materials for their
may be, for the environment. This scientific evaluation
production (3) which contain, consist of or are produced
should be followed by a risk management decision by
from GMOs should also fall within the scope of this
the Community, under a regulatory procedure ensuring
Regulation for the safety assessment of the genetic modi-
close cooperation between the Commission and the
fication.
Member States.
(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
(14)
Council Directive 82/471/EEC of 30 June 1982
products should only be authorised when fulfilling
concerning certain products used in animal nutrition (4)
authorisation criteria for both food and feed.
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.
(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
(15)
Council Directive 70/524/EEC of 23 November 1970
that GMO will not need an authorisation under this
concerning additives in feedingstuffs (5), provides for an
Regulation, but will be subject to the requirements
authorisation procedure for placing on the market addi-
referred to in the authorisation granted in respect of the
tives used in feedingstuffs. In addition to this authorisa-
GMO. Furthermore, foods covered by an authorisation
tion procedure, feed additives containing, consisting of
granted under this Regulation will be exempted from the
or produced from GMOs should also fall within the
requirements of Regulation (EC) No 258/97 concerning
scope of this Regulation.
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.
(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
(12)
Council Directive 89/107/EEC of 21 December 1988 on
in the food or in the feed. Processing aids which are only
the approximation of laws of the Member States
used during the food or feed production process are not
concerning food additives authorised for use in food-
covered by the definition of food or feed and, therefore,
stuffs intended for human consumption (2) provides for
authorisation of additives used in foodstuffs. In addition
(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).
(1) OJ L 31, 1.2.2002, p. 1.
(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive
(2) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/
1999/20/EC (OJ L 80, 25.3.1999, p. 20).
34/EC of the European Parliament and of the Council (OJ L 237,
(5) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regula-
10.9.1994, p. 1).
tion (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).
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are not included in the scope of this Regulation. Nor are
(22)
In addition, the labelling should give information about
food and feed which are manufactured with the help of
any characteristic or property which renders a food or
a genetically modified processing aid included in the
feed different from its conventional counterpart with
scope of this Regulation. Thus, products obtained from
respect to composition, nutritional value or nutritional
animals fed with genetically modified feed or treated
effects, intended use of the food or feed and health
with genetically modified medicinal products will be
implications for certain sections of the population, as
subject neither to the authorisation requirements nor to
well as any characteristic or property which gives rise to
the labelling requirements referred to in this Regulation.
ethical or religious concerns.
(17)
In accordance with Article 153 of the Treaty, the
Community is to contribute to promoting the right of
consumers to information. In addition to other types of
(23)
Regulation (EC) No 1830/2003 of the European Parlia-
information to the public provided for in this Regula-
ment and of the Council of 22 September 2003
tion, the labelling of products enables the consumer to
concerning the traceability and labelling of genetically
make an informed choice and facilitates fairness of trans-
modified organisms and traceability of food and feed
actions between seller and purchaser.
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
(18)
Article 2 of Directive 2000/13/EC of the European
GMOs and food and feed produced therefrom and
Parliament and of the Council of 20 March 2000 on the
should thereby facilitate accurate labelling.
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
(24)
Despite the fact that some operators avoid using geneti-
manufacturing.
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,
(19)
Additional requirements for the labelling of genetically
transport or processing. In such cases, this food or feed
modified foods are laid down in Regulation (EC) No
should not be subject to the labelling requirements of
258/97, in Council Regulation (EC) No 1139/98 of 26
this Regulation. In order to achieve this objective, a
May 1998 concerning the compulsory indication, on the
threshold should be established for the adventitious or
labelling of certain foodstuffs produced from genetically
technically unavoidable presence of genetically modified
modified organisms, of particulars other than those
material in foods or feed, both when the marketing of
provided for in Directive 79/112/EEC (2) and in Commis-
such material is authorised in the Community and when
sion Regulation (EC) No 50/2000 of 10 January 2000
this presence is tolerated by virtue of this Regulation.
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).
(25)
It is appropriate to provide that, when the combined
level of adventitious or technically unavoidable presence
(20)
Harmonised labelling requirements should be laid down
of genetically modified materials in a food or feed or in
for genetically modified feed to provide final users, in
one of its components is higher than the set threshold,
particular livestock farmers, with accurate information
such presence should be indicated in accordance with
on the composition and properties of feed, thereby
this Regulation and that detailed provisions should be
enabling the user to make an informed choice.
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
(21)
The labelling should include objective information to the
into account advances in science and technology, should
effect that a food or feed consists of, contains or is
be provided for.
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
(26)
It is indispensable that operators strive to avoid any acci-
precludes potential misleading of consumers as regards
dental presence of genetically modified material not
methods of manufacture or production.
authorised under Community legislation in food or feed.
However, in order to ensure the practicability and feasi-
(1) OJ L 109, 6.5.2000, p. 29. Directive as amended by Commission
bility of this Regulation, a specific threshold, with the
Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).
possibility of establishing lower levels in particular for
(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.
(4) See page 24 of this Official Journal.
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GMOs sold directly to the final consumer, should be
(32)
It is recognised that, in some cases, scientific risk assess-
established as a transitional measure for minute traces in
ment alone cannot provide all the information on which
food or feed of this genetically modified material, where
a risk management decision should be based, and that
the presence of such material is adventitious or techni-
other legitimate factors relevant to the matter under
cally unavoidable and provided that all specific condi-
consideration may be taken into account.
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.
(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
(27)
In order to establish that the presence of this material is
authorisation, or of applying for the environmental risk
adventitious or technically unavoidable, operators must
assessment to be carried out at the same time as the
be in a position to demonstrate to the competent autho-
safety assessment under this Regulation. In the latter
rities that they have taken appropriate steps to avoid the
case, it is necessary for the evaluation of the environ-
presence of the genetically modified food or feed.
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-
(28)
Operators should avoid the unintended presence of
dance with Article 12(4) of Directive 2001/18/EC, for
GMOs in other products. The Commission should gather
the national competent authorities designated under the
information and develop on this basis guidelines on the
said Directive in all cases concerning GMOs and food
coexistence of genetically modified, conventional and
and/or feed containing or consisting of a GMO to be
organic crops. Moreover, the Commission is invited to
consulted by the Authority before it finalises the envir-
bring forward, as soon as possible, any further necessary
onmental risk assessment.
proposal.
(34)
In the case of GMOs to be used as seeds or other plant-
propagating materials falling within the scope of this
(29)
The traceability and labelling of GMOs at all stages of
Regulation, the Authority should be under an obligation
placing on the market, including the possibility of estab-
to delegate the environmental risk assessment to a
lishing thresholds, is ensured by Directive 2001/18/EC
national competent authority. Nonetheless, authorisa-
and Regulation (EC) No 1830/2003.
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/
(30)
It is necessary to establish harmonised procedures for
193/EEC, 92/33/EEC (6), 92/34/EEC (7), 2002/54/EC (8),
risk assessment and authorisation that are efficient, time-
2002/55/EC, 2002/56/EC (9) or 2002/57/EC (10) which
limited and transparent, and criteria for evaluation of the
regulate in particular the certification and the marketing
potential risks arising from genetically modified foods
of seeds and other plant-propagating materials.
and feed.
(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-
(31)
In order to ensure a harmonised scientific assessment of
tive 2001/64/EC.
(6) OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation
genetically modified foods and feed, such assessments
(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
should be carried out by the Authority. However, as
(7) OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regula-
specific acts or omissions on the part of the Authority
tion (EC) No 806/2003.
under this Regulation could produce direct legal effects
(8) OJ L 193, 20.7.2002, p. 12.
on applicants, it is appropriate to provide for the possi-
(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).
bility of an administrative review of such acts or omis-
(10) OJ L 193, 20.7.2002, p. 74. Directive amended by Commission
sions.
Directive 2003/45/EC (OJ L 138, 5.6.2003, p. 40).
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(35)
It is necessary to introduce, where appropriate and on
(42)
Provision should be made for consultation of the
the basis of the conclusions of the risk assessment, post-
European Group on Ethics in Science and New Technol-
market monitoring requirements for the use of geneti-
ogies established by Commission Decision of 16
cally modified foods for human consumption and for
December 1997, or any other appropriate body estab-
the use of genetically modified feed for animal consump-
lished by the Commission, with a view to obtaining
tion. In the case of GMOs, a monitoring plan concerning
advice on ethical issues regarding the placing on the
environmental effects is compulsory under Directive
market of genetically modified food or feed. Such
2001/18/EC.
consultations should be without prejudice to the compe-
tence of Member States as regards ethical issues.
(36)
To facilitate controls on genetically modified food and
(43)
In order to provide a high level of protection of human
feed, applicants for authorisation should propose appro-
life and health, animal health and welfare, environment
priate methods for sampling, identification and detec-
and consumer interests in relation to genetically modi-
tion, and deposit samples of the genetically modified
fied food and feed, requirements arising from this Regu-
food and feed with the Authority; methods of sampling
lation should apply in a non-discriminatory manner to
and detection should be validated, where appropriate, by
products originating in the Community and imported
the Community reference laboratory.
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 trade commitments of the European
(37)
Technological progress and scientific developments
Communities and of the requirements of the Cartagena
should be taken into account when implementing this
Protocol on Biosafety to the Convention on Biological
Regulation.
Diversity as regards importer obligations and notifica-
tion.
(38)
Food and feed falling within the scope of this Regulation
(44)
Certain instruments of Community law should be
which have been lawfully placed on the Community
repealed and others amended as a result of this Regula-
market before the date of application of this Regulation
tion.
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
(45)
The implementation of this Regulation should be
sampling, identification and detection as appropriate,
reviewed in the light of experience gained in the short
including the transmission of samples of the food and
term, and the impact of the application of this Regula-
feed and their control samples within six months after
tion on human and animal health, consumer protection,
the date of application of this Regulation.
consumer information and the functioning of the
internal market should be monitored by the Commis-
sion,
(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
HAVE ADOPTED THIS REGULATION:
studies, and to methods for sampling, identification and
detection. Non-confidential data should be made avail-
able to the public.
CHAPTER I
(40)
In order to stimulate research and development into
OBJECTIVE AND DEFINITIONS
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
Article 1
be limited in time in order to avoid the unnecessary
repetition of studies and trials which would be against
the public interest.
Objective
The objective of this Regulation, in accordance with the general
(41)
The measures necessary for the implementation of this
principles laid down in Regulation (EC) No 178/2002, is to:
Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
(a) provide the basis for ensuring a high level of protection of
down the procedures for the exercise of implementing
human life and health, animal health and welfare, environ-
powers conferred on the Commission (1).
ment and consumer interests in relation to genetically
modified food and feed, whilst ensuring the effective func-
(1) OJ L 184, 17.7.1999, p. 23.
tioning of the internal market;
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(b) lay down Community procedures for the authorisation and
11. ‘control sample’ means the GMO or its genetic material
supervision of genetically modified food and feed;
(positive sample) and the parental organism or its genetic
material that has been used for the purpose of the genetic
modification (negative sample);
(c) lay down provisions for the labelling of genetically modi-
fied food and feed.
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;
Article 2
14. ‘placing on the market’ means the holding of food or feed
for the purpose of sale, including offering for sale, or any
Definitions
other form of transfer, whether free of charge or not, and
the sale, distribution and other forms of transfer them-
selves.
For the purposes of this Regulation:
15. ‘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
1. the definitions of ‘food’, ‘feed’, ‘final consumer’, ‘food busi-
packaging encloses the food completely or only partially,
ness’ and ‘feed business’ given in Regulation (EC) No 178/
provided that the contents cannot be altered without
2002 shall apply;
opening or changing the packaging.
2. the definition of ‘traceability’, laid down in Regulation (EC)
16. ‘mass caterer’ means ‘mass caterer’ as referred to in Article
No 1830/2003;
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
CHAPTER II
control;
GENETICALLY MODIFIED FOOD
4. the definitions of ‘organism’, ‘deliberate release’ and ‘envir-
onmental risk assessment’ referred to in Directive 2001/
18/EC shall apply;
Se c ti on 1
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
A ut h ori sation an d supervi sion
the techniques of genetic modification listed in Annex I B
to Directive 2001/18/EC;
6. ‘genetically
modified
food’ means food containing,
Article 3
consisting of or produced from GMOs;
Scope
7. ‘genetically
modified
feed’
means
feed
containing,
consisting of or produced from GMOs;
1.
This Section shall apply to:
8. ‘genetically modified organism for food use’ means a GMO
(a) GMOs for food use;
that may be used as food or as a source material for the
production of food;
(b) food containing or consisting of GMOs;
9. ‘genetically modified organism for feed use’ means a GMO
(c) food produced from or containing ingredients produced
that may be used as feed or as a source material for the
from GMOs.
production of feed;
2.
Where necessary, it may be determined in accordance
10. ‘produced from GMOs’ means derived, in whole or in part,
with the procedure referred to in Article 35(2) whether a type
from GMOs, but not containing or consisting of GMOs;
of food falls within the scope of this Section.
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Article 4
2.
The application shall be sent to the national competent
authority of a Member State.
Requirements
(a) The national competent authority:
1.
Food referred to in Article 3(1) must not:
(i) shall acknowledge receipt of the application in writing
to the applicant within 14 days of its receipt. The
(a) have adverse effects on human health, animal health or the
acknowledgement shall state the date of receipt of the
environment;
application;
(ii) shall inform without delay the European Food Safety
(b) mislead the consumer;
Authority (hereinafter referred to as the Authority);
and
(c) differ from the food which it is intended to replace to such
an extent that its normal consumption would be nutrition-
(iii) shall make the application and any supplementary
ally disadvantageous for the consumer.
information supplied by the applicant available to the
Authority.
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
(b) The Authority
authorisation granted in accordance with this Section and the
(i) shall inform without delay the other Member States and
relevant conditions of the authorisation are satisfied.
the Commission of the application and shall make the
application
and
any
supplementary
information
3.
No GMO for food use or food referred to in Article 3(1)
supplied by the applicant available to them;
shall be authorised unless the applicant for such authorisation
(ii) shall make the summary of the dossier referred to in
has adequately and sufficiently demonstrated that it satisfies the
paragraph 3(1) available to the public.
requirements of paragraph 1 of this Article.
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
(a) the name and the address of the applicant;
well as foods produced from or containing ingredients
produced from that GMO; or
(b) the designation of the food, and its specification, including
the transformation event(s) used;
(b) food produced from a GMO as well as foods produced
from or containing that food;
(c) where applicable, the information to be provided for the
(c) an ingredient produced from a GMO as well as food
purpose of complying with Annex II to the Cartagena
containing that ingredient.
Protocol on Biosafety to the Convention on Biological
Diversity (hereinafter referred to as the Cartagena Protocol);
5.
An authorisation as referred to in paragraph 2 shall not
(d) where applicable, a detailed description of the method of
be granted, refused, renewed, modified, suspended or revoked
production and manufacturing;
except on the grounds and under the procedures set out in this
Regulation.
(e) a copy of the studies, including, where available, indepen-
dent, peer-reviewed studies, which have been carried out
6.
The applicant for an authorisation as referred to in para-
and any other material which is available to demonstrate
graph 2 and, after the authorisation is granted, the authorisa-
that the food complies with the criteria referred to in
tion-holder or his representative, shall be established in the
Article 4(1);
Community.
(f) either an analysis, supported by appropriate information
7.
Authorisation under this Regulation shall be without
and data, showing that the characteristics of the food are
prejudice to Directive 2002/53/EC, Directive 2002/55/EC and
not different from those of its conventional counterpart,
Directive 68/193/EEC.
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);
Article 5
(g) either a reasoned statement that the food does not give rise
to ethical or religious concerns, or a proposal for labelling
Application for authorisation
it in accordance with Article 13(2)(b);
1.
To obtain the authorisation referred to in Article 4(2), an
(h) where appropriate, the conditions for placing on the
application shall be submitted in accordance with the following
market the food or foods produced from it, including
provisions.
specific conditions for use and handling;
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(i) methods for detection, sampling (including references to
Article 6
existing official or standardised sampling methods) and
identification of the transformation event and, where
applicable, for the detection and identification of the trans-
Opinion of the Authority
formation event in the food and/or in foods produced from
it;
1.
In giving its opinion, the Authority shall endeavour to
(j) samples of the food and their control samples, and infor-
respect a time limit of six months as from the receipt of a valid
mation as to the place where the reference material can be
application. Such time limit shall be extended whenever the
accessed;
Authority seeks supplementary information from the applicant
as provided for in paragraph 2.
(k) where appropriate, a proposal for post-market monitoring
regarding use of the food for human consumption;
2.
The Authority or a national competent authority through
the Authority may, where appropriate, request the applicant to
(l) a summary of the dossier in a standardised form.
supplement the particulars accompanying the application
within a specific time limit.
4.
In the case of an application relating to a GMO for food
3.
In order to prepare its opinion the Authority:
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.
(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 5 and
examine whether the food complies with the criteria
5.
In the case of GMOs or food containing or consisting of
referred to in Article 4(1);
GMOs, the application shall also be accompanied by:
(b) may ask the appropriate food assessment body of a
Member State to carry out a safety assessment of the food
(a) the complete technical dossier supplying the information
in accordance with Article 36 of Regulation (EC) No 178/
required by Annexes III and IV to Directive 2001/18/EC
2002;
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
(c) may ask a competent authority designated in accordance
the market of the GMO has been authorised under part C
with Article 4 of Directive 2001/18/EC to carry out an
of Directive 2001/18/EC, a copy of the authorisation
environmental risk assessment; however, if the application
decision;
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-
(b) a monitoring plan for environmental effects conforming
ment;
with Annex VII to Directive 2001/18/EC, including a
proposal for the duration of the monitoring plan; this dura-
tion may be different from the proposed period for the
(d) shall forward to the Community reference laboratory
consent.
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;
In such case, Articles 13 to 24 of Directive 2001/18/EC shall
not apply.
(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
6.
Where the application concerns a substance, the use and
different from those of its conventional counterpart, having
placing on the market of which is subject, under other provi-
regard to the accepted limits of natural variations for such
sions of Community law, to its inclusion on a list of substances
characteristics.
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.
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
7.
The Commission, having first consulted the Authority,
that all appropriate measures are taken to prevent the adverse
shall establish, in accordance with the procedure referred to in
effects on human and animal health and the environment
Article 35(2), implementing rules for the application of this
which might arise from the deliberate release of GMOs. During
Article, including rules concerning the preparation and the
evaluation of requests for the placing on the market of
presentation of the application.
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
8.
Before the date of application of this Regulation, the
consulted by the Authority. The competent authorities shall
Authority shall publish detailed guidance to assist the applicant
have three months after the date of receiving the request within
in the preparation and the presentation of the application.
which to make their opinion known.
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5.
In the event of an opinion in favour of authorising the
3.
A final decision on the application shall be adopted in
food, the opinion shall also include the following particulars:
accordance with the procedure referred to in Article 35(2).
(a) the name and address of the applicant;
4.
The Commission shall without delay inform the applicant
(b) the designation of the food, and its specification;
of the decision taken and publish details of the decision in the
Official Journal of the European Union.
(c) where applicable, the information required under Annex II
to the Cartagena Protocol;
5.
The authorisation granted in accordance with the proce-
(d) the proposal for the labelling of the food and/or foods
dure referred to in this Regulation shall be valid throughout the
produced from it;
Community for 10 years and shall be renewable in accordance
with Article 11. The authorised food shall be entered in the
(e) where applicable, any conditions or restrictions which
Register referred to in Article 28. Each entry in the Register
should be imposed on the placing on the market and/or
shall mention the date of authorisation and shall include the
specific conditions or restrictions for use and handling,
particulars referred to in paragraph 2.
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-
6.
The authorisation under this Section shall be without
tions for the protection of particular ecosystems/environ-
prejudice to other provisions of Community law governing the
ment and/or geographical areas;
use and placing on the market of substances which may only
be used if they are included in a list of substances registered or
(f) the method, validated by the Community reference labora-
authorised to the exclusion of others.
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
7.
The granting of authorisation shall not lessen the general
food and/or in foods produced from it; an indication of
civil and criminal liability of any food operator in respect of
where appropriate reference material can be accessed;
the food concerned.
(g) where appropriate, the monitoring plan referred to in
Article 5(5)(b).
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
6.
The Authority shall forward its opinion to the Commis-
Regulation.
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, including the opinions of the competent authorities
when consulted in accordance with paragraph 4.
Article 8
7.
The Authority, in conformity with Article 38(1) of Regu-
lation (EC) No 178/2002, shall make its opinion public, after
Status of existing products
deletion of any information identified as confidential in accor-
dance with Article 30 of this Regulation. The public may make
1.
By way of derogation from Article 4(2), products falling
comments to the Commission within 30 days from such
within the scope of this Section which have been lawfully
publication.
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
Article 7
conditions are met:
Authorisation
(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
1.
Within three months after receiving the opinion of the
referred to in Regulation (EC) No 258/97, operators
Authority, the Commission shall submit to the Committee
responsible for placing on the market the products
referred in Article 35 a draft of the decision to be taken in
concerned shall, within six months after the date of applica-
respect of the application, taking into account the opinion of
tion of this Regulation, notify the Commission of the date
the Authority, any relevant provisions of Community law and
on which they were first placed on the market in the
other legitimate factors relevant to the matter under considera-
Community;
tion. Where the draft decision is not in accordance with the
opinion of the Authority, the Commission shall provide an
(b) in the case of products which have been lawfully placed on
explanation for the differences.
the market in the Community but are not covered by point
(a), operators responsible for placing on the market the
2.
Any draft decision which envisages the granting of
products concerned shall, within six months after the date
authorisation shall include the particulars referred to in Article
of application of this Regulation, notify the Commission
6(5), the name of the authorisation-holder and, where appro-
that the products were placed on the market in the
priate, the unique identifier attributed to the GMO as referred
Community before the date of application of this Regula-
to in the Regulation (EC) No 1830/2003.
tion.
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2.
The notification referred to in paragraph 1 shall be
been imposed in the authorisation and shall in particular make
accompanied by the particulars mentioned in Article 5(3) and
sure that products not covered by the authorisation are not
(5), as appropriate, which the Commission shall forward to the
placed on the market as food or feed. Where post-market
Authority and the Member States. The Authority shall forward
monitoring as referred to in Article 5(3)(k) and/or monitoring
to the Community reference laboratory the particulars referred
as referred to in Article 5(5)(b) has been imposed on the
to in Article 5(3)(i) and (j). The Community reference labora-
authorisation-holder, the authorisation-holder shall ensure that
tory shall test and validate the method of detection and identifi-
it is carried out and shall submit reports to the Commission in
cation proposed by the applicant.
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-
3.
Within one year from the date of application of this
dance with Article 30.
Regulation and after verification that all the information
required has been submitted and examined, the products
concerned shall be entered in the Register. Each entry in the
2.
If the authorisation-holder proposes to modify the terms
Register shall include the particulars referred to in Article 7(2)
of the authorisation, the authorisation-holder shall submit an
as appropriate and, in the case of the products referred to in
application in accordance with Article 5(2). Articles 5, 6 and 7
paragraph 1(a), shall mention the date on which the products
shall apply mutatis mutandis.
concerned were first placed on the market.
3.
The authorisation-holder shall forthwith inform the
4.
Within nine years from the date on which the products
Commission of any new scientific or technical information
referred to in paragraph 1(a) were first placed on the market,
which might influence the evaluation of the safety in use of the
but in no case earlier than three years after the date of applica-
food. In particular, the authorisation-holder shall forthwith
tion of this Regulation, operators responsible for placing them
inform the Commission of any prohibition or restriction
on the market shall submit an application in accordance with
imposed by the competent authority of any third country in
Article 11, which shall apply mutatis mutandis.
which the food is placed on the market.
Within three years from the date of application of this Regula-
4.
The Commission shall make the information supplied by
tion, operators responsible for placing on the market products
the applicant available to the Authority and the Member States
referred to in paragraph 1(b) shall submit an application in
without delay.
accordance with Article 11, which shall apply mutatis mutandis.
5.
Products referred to in paragraph 1 and food containing
Article 10
them or produced from them shall be subject to the provisions
of this Regulation, in particular Articles 9, 10 and 34, which
Modification, suspension and revocation of authorisations
shall apply mutatis mutandis.
1.
On its own initiative or following a request from a
6.
Where the notification and accompanying particulars
Member State or from the Commission, the Authority shall
referred to in paragraphs 1 and 2 are not supplied within the
issue an opinion on whether an authorisation for a product
period specified or are found to be incorrect, or where an
referred to in Article 3(1) still meets the conditions set by this
application is not submitted as required by paragraph 4 within
Regulation. It shall forthwith transmit this opinion to the
the period specified, the Commission, acting in accordance
Commission, the authorisation-holder and the Member States.
with the procedure referred to in Article 35(2), shall adopt a
The Authority, in conformity with Article 38(1) of Regulation
measure requiring the product concerned and any products
(EC) No 178/2002, shall make its opinion public, after deletion
derived from it to be withdrawn from the market. Such a
of any information identified as confidential in accordance with
measure may provide for a limited period of time within which
Article 30 of this Regulation. The public may make comments
existing stocks of the product may be used up.
to the Commission within 30 days from such publication.
7.
In the case of authorisations not issued to a specific
2.
The Commission shall examine the opinion of the
holder, the operator who imports, produces or manufactures
Authority as soon as possible. Any appropriate measures shall
the products referred to in this Article shall submit the infor-
be taken in accordance with Article 34. If appropriate, the
mation or the application to Commission.
authorisation shall be modified, suspended or revoked in accor-
dance with the procedure referred to in Article 7.
8.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure referred to in Article
3.
Articles 5(2), 6 and 7 shall apply mutatis mutandis.
35(2).
Article 11
Article 9
Renewal of authorisations
Supervision
1.
Authorisations under this Regulation shall be renewable
1.
After an authorisation has been issued in accordance with
for 10-year periods, on application to the Commission by the
this Regulation, the authorisation-holder and parties concerned
authorisation-holder at the latest one year before the expiry
shall comply with any conditions or restrictions which have
date of the authorisation.
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2.
The application shall be accompanied by the following:
4.
Appropriate lower thresholds may be established in
accordance with the procedure referred to in Article 35(2) in
(a) a copy of the authorisation for placing the food on the
particular in respect of foods containing or consisting of GMOs
market;
or in order to take into account advances in science and tech-
nology.
(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
Article 13
environment;
(d) where appropriate, a proposal for amending or comple-
menting the conditions of the original authorisation, inter
Requirements
alia the conditions concerning future monitoring.
3.
Articles 5(2), 6 and 7 shall apply mutatis mutandis.
1.
Without prejudice to the other requirements of Commu-
nity law concerning the labelling of foodstuffs, foods falling
within the scope of this Section shall be subject to the
4.
Where, for reasons beyond the control of the authorisa-
following specific labelling requirements:
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
(a) where the food consists of more than one ingredient, the
taken.
words ‘genetically modified’ or ‘produced from genetically
modified (name of the ingredient)’ shall appear in the list of
5.
The Commission, having first consulted the Authority,
ingredients provided for in Article 6 of Directive 2000/13/
may establish, in accordance with the procedure referred to in
EC in parentheses immediately following the ingredient
Article 35(2), implementing rules for the application of this
concerned;
Article, including rules concerning the preparation and the
presentation of the application.
(b) where the ingredient is designated by the name of a cate-
gory, the words ‘contains genetically modified (name of
6.
The Authority shall publish detailed guidance to assist the
organism)’ or ‘contains (name of ingredient) produced from
applicant in the preparation and the presentation of its applica-
genetically modified (name of organism)’ shall appear in the
tion.
list of ingredients;
(c) where there is no list of ingredients, the words ‘genetically
S e c ti on 2
modified’ or ‘produced from genetically modified (name of
organism)’ shall appear clearly on the labelling;
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
Article 12
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;
Scope
1.
This Section shall apply to foods which are to be deliv-
(e) where the food is offered for sale to the final consumer as
ered as such to the final consumer or mass caterers in the
non-pre-packaged food, or as pre-packaged food in small
Community and which:
containers of which the largest surface has an area of less
than 10 cm2, the information required under this para-
(a) contain or consist of GMOs; or
graph must be permanently and visibly displayed either on
the food display or immediately next to it, or on the packa-
(b) are produced from or contain ingredients produced from
ging material, in a font sufficiently large for it to be easily
GMOs.
identified and read.
2.
This Section shall not apply to foods containing material
which contains, consists of or is produced from GMOs in a
2.
In addition to the labelling requirements referred to in
proportion no higher than 0,9 per cent of the food ingredients
paragraph 1, the labelling shall also mention any characteristic
considered individually or food consisting of a single ingre-
or property, as specified in the authorisation, in the following
dient, provided that this presence is adventitious or technically
cases:
unavoidable.
(a) where a food is different from its conventional counterpart
3.
In order to establish that the presence of this material is
as regards the following characteristics or properties:
adventitious or technically unavoidable, operators must be in a
position to supply evidence to satisfy the competent authorities
(i) composition;
that they have taken appropriate steps to avoid the presence of
such material.
(ii) nutritional value or nutritional effects;
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(iii) intended use of the food;
Article 16
(iv) implications for the health of certain sections of the
population;
Requirements
(b) where a food may give rise to ethical or religious concerns.
1.
Feed referred to in Article 15(1) must not:
3.
In addition to the labelling requirements referred to in
paragraph 1 and as specified in the authorisation, the labelling
(a) have adverse effects on human health, animal health or the
of foods falling within the scope of this Section which do not
environment;
have a conventional counterpart shall contain appropriate
information about the nature and the characteristics of the
(b) mislead the user;
foods concerned.
(c) harm or mislead the consumer by impairing the distinctive
features of the animal products;
Article 14
(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.
Implementing measures
1.
Detailed rules for implementing this Section, amongst
2.
No person shall place on the market, use or process a
other things regarding the measures necessary for operators to
product referred to in Article 15(1) unless it is covered by an
comply with the labelling requirements, may be adopted in
authorisation granted in accordance with this Section and the
accordance with the procedure referred to in Article 35(2).
relevant conditions of the authorisation are satisfied.
2.
Specific rules concerning the information to be given by
3.
No product referred to in Article 15(1) shall be authorised
mass caterers providing food to the final consumer may be
unless the applicant for such authorisation has adequately and
adopted in accordance with the procedure referred to in Article
sufficiently demonstrated that it satisfies the requirements of
35(2).
paragraph 1 of this Article.
In order to take into account the specific situation of mass
4.
The authorisation referred to in paragraph 2 may cover:
caterers, such rules may provide for adaptation of the require-
ments of Article 13(1)(e).
(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
CHAPTER III
or containing that feed.
GENETICALLY MODIFIED 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
S e c ti on 1
Regulation.
A uthori sat ion an d sup ervisi on
6.
The applicant for an authorisation as referred to in para-
graph 2 and, after the authorisation is granted, the authorisa-
tion-holder or his representative, shall be established in the
Community.
Article 15
7.
Authorisation under this Regulation shall be without
Scope
prejudice to Directive 2002/53/EC, Directive 2002/55/EC and
Directive 68/193/EEC.
1.
This Section shall apply to:
(a) GMOs for feed use;
Article 17
(b) feed containing or consisting of GMOs;
(c) feed produced from GMOs.
Application for authorisation
2.
Where necessary, it may be determined in accordance
1.
To obtain the authorisation referred to in Article 16(2),
with the procedure referred to in Article 35(2) whether a type
an application shall be submitted in accordance with the
of feed falls within the scope of this Section.
following provisions.
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2.
The application shall be sent to the national competent
(i) methods for detection, sampling (including references to
authority of a Member State.
existing official or standardised sampling methods) and
identification of the transformation event and, where
(a) The national competent authority:
applicable, for the detection and identification of the trans-
formation event in the feed and/or in the feed produced
(i) shall acknowledge receipt of the application in writing
from it;
to the applicant within 14 days of its receipt. The
acknowledgement shall state the date of receipt of the
application;
(j) samples of the feed and their control samples and informa-
tion as to the place where the reference material can be
(ii) shall inform the Authority without delay; and
accessed;
(iii) shall make the application and any supplementary
information supplied by the applicant available to the
(k) where appropriate, a proposal for post-market monitoring
Authority.
for the use of the feed for animal consumption;
(b) The Authority:
(l) a summary of the dossier in a standardised form.
(i) shall inform without delay the other Member States and
the Commission of the application and shall make the
application
and
any
supplementary
information
4.
In the case of an application relating to a GMO for feed
supplied by the applicant available to them;
use, references to ‘feed’ in paragraph 3 shall be interpreted as
(ii) shall make the summary of the dossier referred to in
referring to feed containing, consisting of or produced from the
paragraph 3(1) available to the public.
GMO in respect of which an application is made.
3.
The application shall be accompanied by the following:
5.
In the case of GMOs or feed containing or consisting of
GMOs, the application shall also be accompanied by:
(a) the name and the address of the applicant;
(b) the designation of the feed and its specification, including
(a) the complete technical dossier supplying the information
the transformation event(s) used;
required by Annexes III and IV to Directive 2001/18/EC
and information and conclusions about the risk assessment
(c) where applicable, the information to be provided for the
carried out in accordance with the principles set out in
purpose of complying with Annex II to the Cartagena
Annex II to Directive 2001/18/EC or, where the placing on
Protocol;
the market of the GMOs has been authorised under part C
of Directive 2001/18/EC, a copy of the authorisation
decision;
(d) where applicable, a detailed description of the method of
production and manufacturing and intended uses of the
feed;
(b) a monitoring plan for environmental effects conforming
with Annex VII to Directive 2001/18/EC, including a
(e) a copy of the studies including, where available, indepen-
proposal for the duration of the monitoring plan; this dura-
dent, peer-reviewed studies, which have been carried out
tion may be different from the proposed period for the
and any other material which is available to demonstrate
consent.
that the feed complies with the criteria referred to in Article
16(1), and, in particular for feed falling within the scope of
In such case, Articles 13 to 24 of Directive 2001/18/EC
Directive 82/471/EEC, the information required under
shall not apply.
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);
6.
Where the application concerns a substance, the use and
(f) either an analysis, supported by appropriate information
placing on the market of which is subject under other provi-
and data, showing that the characteristics of the feed are
sions of Community law to its inclusion on a list of substances
not different from those of its conventional counterpart,
registered or authorised to the exclusion of others, this must be
having regard to the accepted limits of natural variations
stated in the application and the status of the substance under
for such characteristics and to the criteria specified in
the relevant legislation must be indicated.
Article 25(2)(c), or a proposal for labelling the feed in
accordance with Article 25(2)(c) and (3);
7.
The Commission, having first consulted the Authority,
(g) either a reasoned statement that the feed does not give rise
shall establish, in accordance with the procedure referred to in
to ethical or religious concerns, or a proposal for labelling
Article 35(2), implementing rules for the application of this
it in accordance with Article 25(2)(d);
Article, including rules concerning the preparation and the
presentation of the application.
(h) where appropriate, the conditions for placing the feed on
the market, including specific conditions for use and hand-
ling;
8.
Before the date of application of this Regulation, the
Authority shall publish detailed guidance to assist the applicant
(1) OJ L 126, 13.5.1983, p. 23.
in the preparation and the presentation of the application.
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Article 18
5.
In the event of an opinion in favour of authorising the
feed, the opinion shall also include the following particulars:
Opinion of the Authority
(a) the name and address of the applicant;
(b) the designation of the feed, and its specification;
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
(c) where applicable, the information required under Annex II
the Authority seeks supplementary information from the appli-
to the Cartagena Protocol;
cant as provided in paragraph 2.
(d) the proposal for the labelling of the feed;
2.
The Authority or a national competent authority through
(e) where applicable, any conditions or restrictions which
the Authority may, where appropriate, request the applicant to
should be imposed on the placing on the market and/or
supplement the particulars accompanying the application
specific conditions or restrictions for use and handling,
within a specific time limit.
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-
3.
In order to prepare its opinion, the Authority:
tions for the protection of particular ecosystems/environ-
ment and/or geographical areas;
(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 17, and
(f) the method, validated by the Community reference labora-
examine whether the feed complies with the criteria laid
tory, for detection, including sampling, identification of the
down in Article 16(1);
transformation event and, where applicable, for the detec-
tion and identification of the transformation event in the
(b) may ask the appropriate feed assessment body of a Member
feed and/or in feed produced from it; an indication of
State to carry out a safety assessment of the feed in accor-
where appropriate reference material can be accessed;
dance with Article 36 of Regulation (EC) No 178/2002;
(g) where appropriate, the monitoring plan as referred to in
(c) may ask a competent authority designated in accordance
Article 17(5)(b).
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-
6.
The Authority shall forward its opinion to the Commis-
gating material, the Authority shall ask a national compe-
sion, the Member States and the applicant, including a report
tent authority to carry out the environmental risk assess-
describing its assessment of the feed and stating the reasons for
ment;
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.
(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
7.
The Authority, in conformity with Article 38(1) of Regu-
method of detection and identification proposed by the
lation (EC) No 178/2002, shall make its opinion public, after
applicant;
deletion of any information identified as confidential in accor-
dance with Article 30 of this Regulation. The public may make
(e) shall, in verifying the application of Article 25(2)(c),
comments to the Commission within 30 days from such
examine the information and data submitted by the appli-
publication.
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.
Article 19
4.
In the case of GMOs or feed containing or consisting of
GMOs, the environmental safety requirements referred to in
Authorisation
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
1.
Within three months after receiving the opinion of the
which might arise from the deliberate release of GMOs. During
Authority, the Commission shall submit to the Committee
evaluation of requests for the placing on the market of
referred in Article 35 a draft of the decision to be taken in
products consisting of or containing GMOs, the national
respect of the application, taking into account the opinion of
competent authority within the meaning of Directive 2001/18/
the Authority, any relevant provisions of Community law and
EC, designated by each Member State for this purpose shall be
other legitimate factors relevant to the matter under considera-
consulted by the Authority. The competent authorities shall
tion. Where the draft decision is not in accordance with the
have three months after the date of receiving the request within
opinion of the Authority, the Commission shall provide an
which to make their opinion known.
explanation for the differences.
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2.
Any draft decision which envisages the granting of
in the Community the products concerned shall, within six
authorisation shall include the particulars referred to in Article
months after the date of application of this Regulation,
18(5), the name of the authorisation-holder and, where appro-
notify the Commission that the products were placed on
priate, the unique identifier attributed to the GMO as referred
the market in the Community before the date of application
to in Regulation (EC) No 1830/2003.
of this Regulation.
3.
A final decision on the application shall be adopted in
2.
The notification referred to in paragraph 1 shall be
accordance with the procedure referred to in Article 35(2).
accompanied by the particulars mentioned in Article 17(3) and
(5), as appropriate, which the Commission shall forward to the
4.
The Commission shall without delay inform the applicant
Authority and the Member States. The Authority shall forward
of the decision taken and publish details of the decision in the
to the Community reference laboratory the particulars referred
Official Journal of the European Union.
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.
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
3.
Within one year from the date of application of this
with Article 23. The authorised feed shall be entered in the
Regulation and after verification that all the information
Register referred to in Article 28. Each entry in the Register
required has been submitted and examined, the products
shall mention the date of authorisation and shall include the
concerned shall be entered in the Register. Each entry in the
particulars referred to in paragraph 2.
Register shall include the particulars referred to in Article 19(2)
as appropriate and, in the case of the products referred to in
6.
The authorisation under this Section shall be without
paragraph 1(a), shall mention the date on which the products
prejudice to other provisions of Community law governing the
concerned were first placed on the market.
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.
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-
7.
The granting of authorisation shall not lessen the general
tion of this Regulation, operators responsible for placing them
civil and criminal liability of any feed operator in respect of the
on the market shall submit an application in accordance with
feed concerned.
Article 23, which shall apply mutatis mutandis.
8.
References made in parts A and D of Directive 2001/18/
Within three years from the date of application of this Regula-
EC to GMOs authorised under part C of that Directive shall be
tion, operators responsible for placing on the market products
considered as applying equally to GMOs authorised under this
referred to in paragraph 1(b) shall submit an application in
Regulation.
accordance with Article 23, which shall apply mutatis mutandis.
5.
Products referred to in paragraph 1 and feed containing
Article 20
them or produced from them shall be subject to the provisions
of this Regulation, in particular Articles 21, 22 and 34, which
Status of existing products
shall apply mutatis mutandis.
1.
By way of derogation from Article 16(2), products falling
6.
Where the notification and accompanying particulars
within the scope of this Section which have been lawfully
referred to in paragraphs 1 and 2 are not supplied within the
placed on the market in the Community before the date of
period specified or are found to be incorrect, or where an
application of this Regulation may continue to be placed on
application is not submitted as required by paragraph 4 within
the market, used and processed provided that the following
the period specified, the Commission, acting in accordance
conditions are met:
with the procedure laid down in Article 35(2), shall adopt a
measure requiring the product concerned and any products
(a) in the case of products which have been authorised under
derived from it to be withdrawn from the market. Such a
Directives 90/220/EEC or 2001/18/EC, including use as
measure may provide for a limited period of time within which
feed, under Directive 82/471/EEC, which are produced
existing stocks of the product may be used up.
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
7.
In the case of authorisations not issued to a specific
concerned shall, within six months after the date of applica-
holder, the operator who imports, produces or manufactures
tion of this Regulation, notify the Commission of the date
the products referred to in this Article shall submit the infor-
on which they were first placed on the market in the
mation or the application to the Commission.
Community;
(b) in the case of products which have been lawfully placed on
8.
Detailed rules for implementing this Article shall be
the market in the Community but which are not referred to
adopted in accordance with the procedure referred to in Article
in point (a), operators responsible for placing on the market
35(2).
L 268/16
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18.10.2003
Article 21
Article 23
Supervision
Renewal of authorisations
1.
Authorisations under this Regulation shall be renewable
1.
After an authorisation has been issued in accordance with
for 10-year periods, on application to the Commission by the
this Regulation, the authorisation-holder and the parties
authorisation-holder at the latest one year before the expiry
concerned shall comply with any conditions or restrictions
date of the authorisation.
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
2.
The application shall be accompanied by the following
post-market monitoring as referred to in Article 17(3)(k) and/or
particulars and documents:
monitoring as referred to in Article 17(5)(b) has been imposed
(a) a copy of the authorisation for placing the feed on the
on the authorisation-holder, the authorisation-holder shall
market;
ensure that it is carried out and shall submit reports to the
Commission in accordance with the terms of the authorisation.
(b) a report on the results of the monitoring, if so specified in
The monitoring reports referred to shall be made accessible to
the authorisation;
the public after deletion of any information identified as confi-
dential in accordance with Article 30.
(c) any other new information which has become available
with regard to the evaluation of the safety in use of the feed
2.
If the authorisation-holder proposes to modify the terms
and the risks of the feed to animals, humans or the envir-
of the authorisation, the authorisation-holder shall submit an
onment;
application in accordance with Article 17(2). Articles 17, 18
(d) where appropriate, a proposal for amending or comple-
and 19 shall apply mutatis mutandis.
menting the conditions of the original authorisation, inter
alia the conditions concerning future monitoring.
3.
The authorisation-holder shall forthwith inform the
Commission of any new scientific or technical information
3.
Articles 17(2), 18 and 19 shall apply mutatis mutandis.
which might influence the evaluation of the safety in use of the
feed. In particular, the authorisation-holder shall forthwith
4.
Where, for reasons beyond the control of the authorisa-
inform the Commission of any prohibition or restriction
tion-holder, no decision is taken on the renewal of an authori-
imposed by the competent Authority of any third country in
sation before its expiry date, the period of authorisation of the
which the feed is placed on the market.
product shall automatically be extended until a decision is
taken.
4.
The Commission shall make the information supplied by
the applicant available to the Authority and the Member States
5.
The Commission, having first consulted the Authority,
without delay.
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.
Article 22
6.
The Authority shall publish detailed guidance to assist the
applicant in the preparation and the presentation of its
Modification, suspension and revocation of authorisations
application.
1.
On its own initiative or following a request from a
Member State or from the Commission, the Authority shall
Se c ti on 2
issue an opinion on whether an authorisation for a product
referred to in Article 15(1) still meets the conditions set by this
Regulation. It shall forthwith transmit this opinion to the
Labelling
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
Article 24
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.
Scope
1.
This Section shall apply to feed referred to in Article
2.
The Commission shall examine the opinion of the
15(1).
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-
2.
This Section shall not apply to feed containing material
dance with the procedure referred to in Article 19.
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
3.
Articles 17(2), 18 and 19 shall apply mutatis mutandis.
adventitious or technically unavoidable.
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3.
In order to establish that the presence of this material is
(d) as specified in the authorisation, any characteristic or prop-
adventitious or technically unavoidable, operators must be in a
erty where a feed may give rise to ethical or religious
position to supply evidence to satisfy the competent authorities
concerns.
that they have taken appropriate steps to avoid the presence of
such materials.
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
4.
Appropriate lower thresholds may be established in
this Section which does not have a conventional counterpart
accordance with the procedure referred to in Article 35(2), in
shall contain appropriate information about the nature and the
particular in respect of feed containing or consisting of GMOs,
characteristics of the feed concerned.
or in order to take into account advances in science and tech-
nology.
Article 26
Article 25
Implementing measures
Detailed rules for implementing this Section, amongst other
Requirements
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).
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.
CHAPTER IV
COMMON PROVISIONS
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
Article 27
the container or on a label attached thereto.
Products likely to be used as both food and feed
Each feed of which a particular feed is composed shall be
1.
Where a product is likely to be used as both food and
subject to the following rules:
feed, a single application under Articles 5 and 17 shall be
submitted and shall give rise to a single opinion from the
(a) for the feeds referred to in Article 15(1) (a) and (b), the
Authority and a single Community decision.
words ‘genetically modified (name of the organism)’ shall
appear in parentheses immediately following the specific
name of the feed.
2.
The Authority shall consider whether the application for
authorisation should be submitted both as food and 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;
Article 28
(b) for the feed referred to in Article 15(1)(c), the words
Community register
‘produced from genetically modified (name of the
organism)’
shall appear
in
parentheses
immediately
1.
The Commission shall establish and maintain a Commu-
following the specific name of the feed.
nity register of genetically modified food and feed, hereinafter
referred to as ‘the Register’.
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
2.
The Register shall be made available to the public.
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
Article 29
hereunder, which is different from its conventional counter-
part:
Public access
(i) composition;
1.
The application for authorisation, supplementary infor-
(ii) nutritional properties;
mation from the applicant, opinions from the competent
(iii) intended use;
authorities designated in accordance with Article 4 of Directive
2001/18/EC, monitoring reports and information from the
(iv) implications for the health of certain species or cate-
authorisation holder, excluding confidential information, shall
gories of animals;
be made accessible to the public.
L 268/18
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Official Journal of the European Union
18.10.2003
2.
The Authority shall apply the principles of Regulation
5.
The use of the detection methods and the reproduction of
(EC) No 1049/2001 of the European Parliament and of the
the reference materials, provided under Article 5(3) and 17(3)
Council of 30 May 2001 regarding public access to European
for the purpose of applying this Regulation to the GMOs, food
Parliament, Council and Commission documents (1) when hand-
or feed to which an application refers, shall not be restricted by
ling applications for access to documents held by the
the exercise of intellectual property rights or otherwise.
Authority.
6.
The Commission, the Authority and the Member States
3.
Member States shall handle applications for access to
shall take the necessary measures to ensure appropriate confi-
documents received under this regulation in accordance with
dentiality of the information received by them under this Regu-
Article 5 of Regulation (EC) No 1049/2001.
lation except for information which must be made public if
circumstances so require in order to protect human health,
animal health or the environment.
Article 30
7.
If an applicant withdraws or has withdrawn an applica-
tion, the Authority, the Commission and the Member States
Confidentiality
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
1.
The applicant may indicate which information submitted
Commission and the applicant disagree.
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.
Article 31
2.
Without prejudice to paragraph 3, the Commission shall
determine, after consultation with the applicant, which infor-
Data protection
mation should be kept confidential and shall inform the appli-
cant of its decision.
The scientific data and other information in the application
dossier required under Article 5(3) and (5) and Article 17(3)
3.
Information relating to the following shall not be
and (5) may not be used for the benefit of another applicant
considered confidential:
for a period of 10 years from the date of authorisation, unless
the other applicant has agreed with the authorisation-holder
(a) name and composition of the GMO, food or feed referred
that such data and information may be used.
to in Articles 3(1) and 15(1) and, where appropriate, indi-
cation of the substrate and the micro-organism;
On the expiry of this 10-year period, the findings of all or part
(b) general description of the GMO and the name and address
of the evaluation conducted on the basis of the scientific data
of the authorisation-holder;
and information contained in the application dossier may be
used by the Authority for the benefit of another applicant if
(c) physico-chemical and biological characteristics of the
the applicant can demonstrate that the food or feed for which
GMO, food or feed referred to in Articles 3(1) and 15(1);
it is seeking authorisation is essentially similar to a food or feed
already authorised under this Regulation.
(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;
Article 32
(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;
Community reference laboratory
(f) methods for detection, including sampling and identifica-
tion of the transformation event and, where applicable, for
The Community reference laboratory and its duties and tasks
the detection and identification of the transformation event
shall be those referred to in the Annex.
in the food or feed referred to in Articles 3(1) and 15(1);
(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).
4.
Notwithstanding paragraph 2, the Authority shall on
request supply the Commission and Member States with all
Applicants for authorisation of genetically modified food and
information in its possession.
feed shall contribute to supporting the costs of the tasks of the
Community reference laboratory and the European Network of
(1) OJ L 145, 31.5.2001, p. 43.
GMO laboratories mentioned in the Annex.
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Official Journal of the European Union
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The contributions from applicants shall not exceed the costs
To this effect a request shall be submitted to the Commission
incurred in carrying out the validation of detection methods.
within two months from the day on which the party concerned
became aware of the act or omission in question.
Detailed rules for implementing this Article, the Annex and any
changes to it may be adopted in accordance with the procedure
The Commission shall take a decision within two months
referred to in Article 35(2).
requiring, if appropriate, the Authority to withdraw its decision
or to remedy its failure to act.
Article 33
Article 37
Consultation with the European Group on Ethics in
Science and New Technologies
Repeals
1.
The Commission, on its own initiative or at the request
The following Regulations shall be repealed with effect from
of a Member State, may consult the European Group on Ethics
the date of application of this Regulation:
in Science and New Technologies or any other appropriate
body it might establish, with a view to obtaining its opinion on
— Regulation (EC) No 1139/98,
ethical issues.
— Regulation (EC) No 49/2000,
2.
The Commission shall make these opinions available to
— Regulation (EC) No 50/2000.
the public.
Article 38
Article 34
Emergency measures
Amendments to Regulation (EC) No 258/97
Where it is evident that products authorised by or in accor-
Regulation (EC) No 258/97 is hereby amended with effect from
dance with this Regulation are likely to constitute a serious risk
the date of application of this Regulation as follows:
to human health, animal health or the environment, or where,
1. The following provisions shall be deleted:
in the light of an opinion of the Authority issued under Article
10 or Article 22, the need to suspend or modify urgently an
— Article 1(2)(a) and (b),
authorisation arises, measures shall be taken under the proce-
— Article 3(2), second subparagraph, and (3),
dures provided for in Articles 53 and 54 of Regulation (EC) No
178/2002.
— Article 8(1)(d),
— Article 9.
2. In Article 3, the first sentence of paragraph 4 shall be
Article 35
replaced by the following:
Committee procedure
‘4.
By way of derogation from paragraph 2, the proce-
dure referred to in Article 5 shall apply to foods or food
1.
The Commission shall be assisted by the Standing
ingredients referred to in Article 1(2)(d) and (e) which, on
Committee on the Food Chain and Animal Health, set up by
the basis of the scientific evidence available and generally
Article 58 of Regulation (EC) No 178/2002, hereinafter referred
recognised or on the basis of an opinion delivered by one of
to as the ‘Committee’.
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,
2.
Where reference is made to this paragraph, Articles 5 and
intended use and the level of undesirable substances
7 of Decision 1999/468/EC shall apply having regard to the
contained therein.’
provisions of Article 8 thereof.
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
The following paragraph shall be added to Article 1 of Direc-
Article 36
tive 82/471/EEC with effect from the date of application of this
Regulation:
Administrative review
‘3.
This Directive does not apply to products which act
as direct or indirect protein sources that fall within the
Any decision taken under, or failure to exercise, the powers
scope of Regulation (EC) No 1829/2003 of the European
vested in the Authority by this Regulation may be reviewed by
Parliament and of the Council of 22 September 2003 on
the Commission on its own initiative or in response to a
genetically modified food and feed (*).
request from a Member State or from any person directly and
individually concerned.
(*) OJ L 268, 18.10.2003, p. 1.’
L 268/20
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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:
Article 42
1. Article 4(5) shall be replaced by the following:
‘5.
Further, when material derived from a plant variety is
Amendment to Directive 68/193/EEC
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
Article 5ba(3) of Directive 68/193/EEC shall be replaced by the
and of the Council of 22 September 2003 on genetically
following wording with effect from the date of application of
modified food and feed (*), the variety shall be accepted only
this Regulation:
if it has been approved in accordance with that Regulation.
‘3. (a) Where products derived from vine-propagating
(*) OJ L 268, 18.10.2003, p. 1.’
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-
2. Article 7(5) shall be replaced by the following:
lation (EC) No 1829/2003 of the European Parlia-
‘5.
Member States shall ensure that a variety intended to
ment and of the Council of 22 September 2003 on
be used in food or feed as defined in Articles 2 and 3 of
genetically modified food and feed (*), the vine
Regulation (EC) No 178/2002 of the European Parliament
variety concerned shall be accepted only if it has
and of the Council of 28 January 2002 laying down the
been authorised pursuant to the said Regulation.
general principles and requirements of food law, establishing
the European Food Safety Authority, and laying down
(b) Member States shall ensure that a vine variety, from
procedures in matters of food safety (*) is accepted only if it
the propagating material of which products were
has been authorised under the relevant legislation.
derived intended for use in food and feed pursuant
to Articles 2 and 3 of Regulation (EC) No 178/
(*) OJ L 31, 1.2.2002, p. 1.’
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 (**) shall be accepted only if it has been
Article 41
authorised pursuant to the relevant legislation.
(*) OJ L 268, 18.10.2003, p. 1.
Amendments to Directive 2002/55/EC
(**) 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:
Article 43
1. Article 4(3) shall be replaced by the following:
Amendments to Directive 2001/18/EC
‘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
Directive 2001/18/EC is hereby amended with effect from the
Regulation (EC) No 1829/2003 of the European Parliament
date of entry into force of this Regulation, as follows:
and of the Council of 22 September 2003 on genetically
modified food and feed (*), the variety shall be accepted only
1. The following Article shall be inserted:
if it has been approved in accordance with that Regulation.
(*) OJ L 268, 18.10.2003, p. 1.’
‘Article 12a
Transitional measures for adventitious or technically
2. Article 7(5) shall be replaced by the following:
unavoidable presence of genetically modified organisms
‘5.
Member States shall ensure that a variety intended to
having benefited from a favourable risk evaluation
be used in food or feed as defined in Articles 2 and 3 of
Regulation (EC) No 178/2002 of the European Parliament
1.
Placing on the market of traces of a GMO or combina-
and of the Council of 28 January 2002 laying down the
tion of GMOs in products intended for direct use as food or
general principles and requirements of food law, establishing
feed or for processing shall be exempted from Articles 13 to
18.10.2003
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Official Journal of the European Union
L 268/21
21 provided that they meet the conditions referred to in
mented. The penalties provided for must be effective, propor-
Article 47 of Regulation (EC) No 1829/2003 of the
tionate and dissuasive. The Member States shall notify those
European Parliament and of the Council of 22 September
provisions to the Commission six months after the date of
2003 on genetically modified food and feed (*).
entry into force of this Regulation at the latest and shall notify
it without delay of any subsequent amendment affecting them.
2.
This Article shall be applicable for a period of three
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 46
‘Article 26a
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.
2.
The Commission shall gather and coordinate informa-
1.
Requests submitted under Article 4 of Regulation (EC) No
tion based on studies at Community and national level,
258/97 before the date of application of this Regulation shall
observe the developments regarding coexistence in the
be transformed into applications under Chapter II, Section 1 of
Member States and, on the basis of the information and
this Regulation where the initial assessment report provided for
observations, develop guidelines on the coexistence of
under Article 6(3) of Regulation (EC) No 258/97 has not yet
genetically modified, conventional and organic crops.’
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
Article 44
processed under the provisions of Regulation (EC) No 258/97,
notwithstanding Article 38 of this Regulation.
Information to be provided in accordance with the
Cartagena Protocol
2.
The labelling requirements referred to in this Regulation
1.
Any authorisation, renewal, modification, suspension or
shall not apply to products, the manufacturing process of
revocation of authorisation of a GMO, food or feed referred to
which has commenced before the date of application of this
in Articles 3(1)(a) or (b) or 15(1)(a) or (b) shall be notified by
Regulation, provided that these products are labelled in accor-
the Commission to the Parties to the Cartagena Protocol
dance with the legislation applicable to them before the date of
through the biosafety clearing house in accordance with Article
application of this Regulation.
11(1) or Article 12(1) of the Cartagena Protocol, as the case
may be.
3.
Notifications concerning products including their use as
The Commission shall provide a copy of the information, in
feed submitted under Article 13 of Directive 2001/18/EC
writing, to the national focal point of each Party that informs
before the date of application of this Regulation shall be trans-
the Secretariat in advance that it does not have access to the
formed into applications under Chapter III, Section 1 of this
biosafety clearing house.
Regulation where the assessment report provided for in Article
14 of Directive 2001/18/EC has not yet been sent to the
2.
The Commission shall also process requests for additional
Commission.
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.
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.
Article 45
Penalties
5.
Requests submitted for products referred to in Article
15(1) of this Regulation under Article 4 of Directive 70/524/
The Member States shall lay down the rules on penalties applic-
EEC before the date of application of this Regulation shall be
able to infringements of the provisions of this Regulation and
supplemented by applications under Chapter III, Section 1 of
shall take all measures necessary to ensure that they are imple-
this Regulation.
L 268/22
EN
Official Journal of the European Union
18.10.2003
Article 47
5.
This Article shall remain applicable for a period of three
years after the date of application of this Regulation.
Transitional measures for adventitious or technically
unavoidable presence of genetically modified material
which has benefited from a favourable risk evaluation
Article 48
1.
The presence in food or feed of material which contains,
Review
consists of or is produced from GMOs in a proportion no
higher than 0,5 % shall not be considered to be in breach of
1.
No later than 7 November 2005 and in the light of
Article 4(2) or Article 16(2), provided that:
experience gained, the Commission shall forward to the
(a) this presence is adventitious or technically unavoidable;
European Parliament and to the Council a report on the imple-
mentation of this Regulation and in particular of Article 47,
(b) the genetically modified material has benefited from a
accompanied, where appropriate, by any suitable proposal. The
favourable
opinion
from
the
Community
Scientific
report and any proposal shall be made accessible to the public.
Committee(s) or the Authority before the date of applica-
tion of this Regulation;
2.
Without prejudice to the powers of national authorities,
(c) the application for its authorisation has not been rejected
the Commission shall monitor the application of this Regula-
in accordance with the relevant Community legislation; and
tion and its impact on human and animal health, consumer
protection, consumer information and the functioning of the
(d) detection methods are publicly available.
internal market and, if necessary, will bring forward proposals
2.
In order to establish that the presence of this material is
at the earliest possible date.
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
Article 49
materials.
Entry into force
3.
The thresholds referred to in paragraph 1 may be lowered
in accordance with the procedure referred to in Article 35(2),
This Regulation shall enter into force on the 20th day
in particular for GMOs sold directly to the final consumer.
following that of its publication in the Official Journal of the
European Union.
4.
Detailed rules for implementing this Article shall be
adopted in accordance with the procedure referred to in Article
It shall apply from six months after the date of publication of
35(2).
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
For the Council
The President
The President
P. COX
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.
