2006/68/EC: Commission Decision of  13 January 2006  authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council  (notified under document number C(2005) 5939)
Date: 2006-01-13
Institutions: European Commission
Subjects: Germany, food safety, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, market approval

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Official Journal of the European Union

7.2.2006

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 13 January 2006

authorising the placing on the market of foods and food ingredients derived from genetically
modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC)
No 258/97 of the European Parliament and of the Council

(notified under document number C(2005) 5939)

(Only the French and Dutch texts are authentic)

(2006/68/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

The Commission forwarded the initial assessment report
to all Member States on 3 June 2003 with additional
comments raised by the Member States.

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), and in particular
Article 7 thereof,

Whereas:

(1)

(2)

On 15 July 2002, Monsanto submitted to the competent
authorities of Germany a request,
in accordance with
Article 4 of the Regulation, for placing on the market
foods and food ingredients derived from genetically
modified maize line MON 863 (hereinafter referred to
as MON 863 maize) as novel foods or novel food ingre-
dients, in accordance with Regulation (EC) No 258/97.

initial assessment

report of 8 April 2003,
In its
Germany’s competent
food assessment body came to
an additional
assessment was
the
conclusion that
the presence of an antibiotic
required because of
resistance marker gene (nptII) used in the product
concerned.

(4)

(5)

On 9 December 2003 the Commission requested a
scientific opinion from the European Food Safety
Authority (EFSA) in accordance with Article 11 of the
Regulation. On 2 April 2004 the EFSA delivered its
opinion that
from the point of view of consumer
health, MON 863 maize and derived products are as
safe as grain and derived products from conventional
maize lines (2).
In delivering its opinion the EFSA
addressed all specific questions and concerns raised by
the Member States.

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 (3) 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) or 6(4) of Regulation (EC) No 258/97 has
been transmitted to the Commission before the date of
application of Regulation (EC) No 1829/2003.

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

gmo_opinions/383/opinion_gmo_07_en1.pdf

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

(3) OJ L 268, 18.10.2003, p. 1.

(2) EFSA Journal (2004) 50, 1-25; http://www.efsa.eu.int/science/gmo/

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Official Journal of the European Union

L 34/27

(6)

(7)

(8)

(9)

(10)

The Joint Research Centre of the European Commission
(JRC),
in collaboration with the European Network of
GMO Laboratories (ENGL), has validated a method for
detection of MON 863 maize. The JRC 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
MON 863 transformation event in maize. The materials
needed in the study had been provided by Monsanto. The
JRC has considered that the method performance was
the
appropriate for
performance
for
methods submitted for regulatory 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.

taken into account
ENGL
the

criteria proposed by

its purpose,

Reference material
produced by the JRC.

for MON 863 maize has been

Food and food ingredients from MON 863 maize should
be labelled in accordance with the provisions of Regu-
lation (EC) No 1829/2003 and should be subject to the
traceability requirements laid down in Regulation (EC)
No 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the trace-
ability and labelling of genetically modified organisms
and feed products
and the
produced from genetically modified organisms
and
amending Directive 2001/18/EC (1).

traceability of

food

In accordance with Commission Regulation (EC) No
65/2004 (2), a unique identifier has been assigned to
the product
for the purposes of Regulation (EC) No
1830/2003.

Information, contained in the Annex, on the identifi-
foods and food ingredients derived from
cation of
MON 863 maize,
including the validated detection
method and the reference material, should be retrievable
from the Register referred to in Article 28 of Regulation
(EC) No 1829/2003.

(12)

The Standing Committee on the Food Chain and Animal
Health has not given an opinion; the Commission has
therefore submitted a proposal to the Council on 26 July
2005 in accordance with Article 5(4) of the Council
Decision 1999/468/EC (3),
the Council being required
to act within three months.

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

HAS ADOPTED THIS DECISION:

Article 1

Foods and food ingredients derived from genetically modified
maize line MON 863 (hereinafter referred to as the products), as
designated and specified in the Annex, may be placed on the
Community market as novel foods or novel food ingredients.

Article 2

The products shall be labelled as ‘genetically modified maize’ or
‘produced from genetically modified maize’ in accordance with
the labelling requirements laid down in Article 13 of Regulation
(EC) No 1829/2003.

Article 3

The products 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 Monsanto Europe SA, Belgium,
representing Monsanto Company, USA. It shall be valid for a
period of 10 years.

Done at Brussels, 13 January 2006.

(11) On the basis of the information available, it is established
that MON 863 maize complies with criteria laid down in
Regulation (EC) No 258/97.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 24.
(2) OJ L 10, 16.1.2004, p. 5.

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

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Official Journal of the European Union

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ANNEX

INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF GENETICALLY MODIFIED FOOD
AND FEED

1. Applicant and authorisation holder:

Name: Monsanto Europe SA

Address: Avenue de Tervuren 270-272, B-1150 Brussels, Belgium

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, USA.

2. Designation and specification of the products:

Foods and food ingredients derived from genetically modified maize (Zea maize L.) line MON 863 with increased
protection to insects and from all
its crosses with traditionally bred maize lines. MON 863 maize contains two
cassettes:

(a) cassette 1:

A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, which confers resistance to the
corn rootworm Diabrotica spp., under the regulation of the 4AS1 promoter derived from Cauliflower Mosaic Virus,
the wtCAB translation enhancer from wheat (Triticum aestivum), the transcription enhancer ract1 intron from the
actin 1 gene of rice (Oryza sativa) and terminator sequences tahsp 17 3’ from wheat;

(b) cassette 2:

The nptII gene from E. coli, which confers resistance to aminoglycosides comprising kanamycin and neomycin,
under the regulation of the 35S Cauliflower Mosaic Virus promoter, and the NOS 3’ terminator sequences from
Agrobacterium tumefaciens as well as the non-functional, truncated ble gene from E. coli.

3. Labelling:

‘Genetically modified maize’ or ‘produced from genetically modified maize’.

4. Method for detection:

— Event-specific real-time quantitative PCR based method for genetically modified maize line MON 863.

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

Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm

— Reference material: IRMM-416 produced by the Joint Research Centre (JRC) of the European Commission.

5. Unique identifier:

MON-ØØ863-5

6. Information required under Annex II to the Cartagena Protocol:

Not applicable.

7. Conditions or restrictions for the placing on the market of the product:

Not applicable.

8. Post market monitoring requirements:

Not applicable.