2004/657/EC: Commission Decision of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1865)
Date: 2004-05-19
Institutions: European Commission
Subjects: foodstuffs legislation, maize, market approval, transgenic plant

L 300/48

EN

Official Journal of the European Union

25.9.2004

COMMISSION

COMMISSION DECISION

of 19 May 2004

authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a
novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament
and of the Council

(notified under document number C(2004) 1865)

(only the Dutch text is authentic)

(2004/657/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients (1), (hereinafter referred
to as the Regulation), and in particular Article 7 thereof,

Whereas:

(1)

(2)

(3)

Consent has been granted on 22 April 1998 for the
placing on the market of grains of genetically modified
maize line Bt11 to be used for feed, processing and
importing (2),
in accordance with Council Directive
90/220/EEC of 23 April 1990 on the deliberate release
into
genetically modified
organisms (3).

environment

the

of

Food and food ingredients derived from the original
transformant Bt11 and any inbred and hybrid lines
derived from it and containing the introduced genes
may be placed on the market
in the Community
following a notification (4) pursuant to Article 5 of Regu-
lation (EC) No 258/97.

On 11 February 1999, Novartis
(in the meantime:
Syngenta), submitted a request to the competent autho-
rities of the Netherlands for placing sweet maize from
genetically modified maize line Bt11 on the market as a
novel food or as a novel food ingredient.

(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(2) Commission Decision 98/292/EC (OJ L 131, 5.5.1998, p. 28).
(3) OJ L 117, 8.5.1990, p. 15. Directive amended by Commission

Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

(4) OJ C 181, 26.6.1999, p. 22.

(4)

(5)

(6)

(7)

In their initial assessment report of 12 May 2000, the
Netherlands’ competent food assessment body came to
the conclusion that Bt11 sweet maize is as safe as
conventional sweet maize.

The Commission forwarded the initial assessment report
to all Member States on 15 June 2000. Within the 60
days period laid down in Article 6(4) of the Regulation,
reasoned objections to the marketing of the product were
raised in accordance with that provision.

On 13 December 2000, the Commission requested an
in
opinion from the Scientific Committee on Food,
accordance with Article 11 of the Regulation. On 17
April 2002, the Scientific Committee on Food delivered
its opinion that Bt11 sweet maize is as safe for human
food use as its conventional counterparts. This opinion
focused, as requested by the Commission, on the issues
raised in the comments made by Member States’ autho-
including molecular characterisation and toxicity
rities,
studies. The concerns
the
‘Agence française de sécurité sanitaire des aliments’
(AFSSA) of 26 November 2003 do not bring any new
scientific elements in addition to the initial assessment of
sweet maize Bt11.

raised in the opinion of

The data provided by the applicant and the safety
assessment of
followed the
the product carried out
criteria and requirements laid down in the Commission
Recommendation 618/97/EC (5) concerning the scientific
aspects and the presentation of applications under the
Novel Food Regulation. The methodology used for the
safety assessment of Bt11 was also in line with the recent
guidelines prepared by the Scientific Steering Committee
concerning the assessment of GMOs, GM food and GM
feed and with the Codex Principles and Guidelines on
Foods Derived from Biotechnology.

(5) OJ L 253, 16.9.1997, p. 1.

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L 300/49

(8)

(9)

Article 46(1) of Regulation (EC) No 1829/2003 of the
European Parliament and of the Council of 22 September
2003 on genetically modified food and feed (1) provides
that requests submitted under Article 4 of Regulation
(EC) No 258/97 before the date of application of this
Regulation shall be processed under the provisions of
Regulation (EC) No 258/97, notwithstanding Article 38
of Regulation (EC) No 1829/2003,
in cases where the
additional assessment report required in accordance with
Article 6(3) of Regulation (EC) No 258/97 has been
transmitted to the Commission before the date of appli-
cation of Regulation (EC) No 1829/2003.

(JRC) of

Joint Research Centre

in collaboration with the

the European
The
Commission,
European
Network of GMO Laboratories (ENGL), has carried out
a full validation study (ring-trial) following internationally
accepted guidelines to test the performance of a quanti-
tative event-specific method to detect and quantify the
Bt11 transformation event in sweet maize. The method
validated had been developed by the National Veterinary
Institute of Norway and INRA, France. The materials
needed in the study (GM and non-GM DNA as well as
the method-specific reagents) had been provided by
the method
Syngenta. The JRC has considered that
performance was appropriate for
its aimed purpose,
the performance criteria proposed
taken into account
regulatory
by the ENGL for methods submitted for
compliance as well as the current scientific understanding
about satisfactory method performance. Both the method
and the results of the validation have been made publicly
available.

(12)

Information on the identification of sweet maize from
genetically modified maize line Bt11,
including the
validated detection method and the reference material,
contained in the annex, shall be retrievable from the
established by the Commission in
Register
accordance with Article 28 of Regulation (EC) No
1829/2003.

to be

(13) Genetically modified maize Bt11 has been notified to the
Biosafety Clearing-House, pursuant to Articles 11(1) and
20(3)(c) of the Cartagena Protocol on Biosafety to the
Convention on Biological Diversity.

(14)

The Standing Committee on the Food Chain and Animal
Health has not given an opinion; the Commission has
to the Council on 4
therefore submitted a proposal
February 2004 pursuant to Article 13(4)(b) of Regulation
(EC) No 258/97 and in accordance with Article 5,
paragraph 4 of the Council Decision 1999/468/EC (3),
the Council being required to act within three months.

(15) However, the Council has not acted within the required
time limit; a Decision should now be adopted by the
Commission,

(10)

Reference material
for sweet maize from genetically
modified maize line Bt11 has been produced by the
Joint Research Centre (JRC) of the European Commission.

HAS ADOPTED THIS DECISION:

(11)

Sweet maize from genetically modified maize line Bt11
and food containing sweet maize
from genetically
modified maize line Bt11 as ingredient shall be labelled
in accordance with the provisions of Regulation (EC)
No 1829/2003 and shall be subject to the traceability
requirements
(EC)
No 1830/2003 concerning the traceability and labelling
of genetically modified organisms and the traceability of
food and feed products produced from genetically
modified
Directive
and
2001/18/EC (2).

Regulation

organisms

amending

down

laid

in

Article 1

Sweet maize from genetically modified maize line Bt11 (here-
inafter referred to as the product), as designated and specified in
the Annex, may be placed on the Community market as a novel
food or novel food ingredient.

Article 2

The product shall be labelled as ‘genetically modified sweet
maize’,
laid
down in Article 13 of Regulation (EC) No 1829/2003.

in accordance with the labelling requirements

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 268, 18.10.2003, p. 24.

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

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Article 3

The product and the information included in the Annex shall be
entered in the Community register of genetically modified food
and feed.

Article 4

This Decision is addressed to Syngenta Seeds BV, Westeinde 62,
1600 AA Enkhuizen, The Netherlands, representing Syngenta

Seeds AG, Switzerland.
10 years.

It

shall be valid for a period of

Done at Brussels, 19 May 2004.

For the Commission

David BYRNE
Member of the Commission

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L 300/51

Information to be entered in the Community Register of Genetically Modified Food and Feed

ANNEX

(a) Authorisation holder:

Name:

Syngenta Seeds BV

Address:

Westeinde 62, 1600 AA Enkhuizen, The Netherlands

On behalf of: Syngenta Seeds AG, Schwarzwaldallee 215, CH-4058 Basel, Switzerland

(b) Designation and specification of the product:

Sweet maize, fresh or canned, that is progeny from traditionally crosses of traditionally bred maize with genetically
modified maize line Bt11 that contains:
— a synthetic version of the cryIA (b) gene derived from Bacillus thuringiensis kurstaki strain HD1 under the control of a
35S promoter from Cauliflower Mosaic Virus, and IVS 6 intron from the maize alcohol dehydrogenase gene and
the nopaline synthase terminator sequence of Agrobacterium tumefaciens, and

— a synthetic version of the pat gene derived from Streptomyces viridochromogenes under the control of a 35S promoter
from Cauliflower Mosaic Virus, an IVS intron from the maize alcholdehydrogenase gene and the nopaline synthase
terminator sequence of Agrobacterium tumefaciens.
‘Genetically modified sweet maize’

(c) Labellin:

(d) Method for detection:

— Event specific real-time quantitative PCR based method for genetically modifiedBt11 sweet maize, published in

European Food Research and Technology, Vol. 216/2003, pages 347-354.

— Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European

Network of GMO Laboratories (ENGL), published at http://engl.jrc.it/crl/oj/bt11sm.pdf.

— Reference Material: IRMM-412R, produced by the Joint Research Centre (JRC) of the European Commission.

(e) Unique identifier: SYN-BT Ø11-1

(f) Information required under Annex II to the Cartagena Protocol:

Biosafety Clearing House, Record ID 1240
(see: http://bch.biodiv.org/Pilot/Record.aspx?RecordID=1240)

(g) Conditions or restrictions on the placing on the market of the product: Not applicable

(h) Post-market monitoring requirements: Not appropriate