2006/69/EC: Commission Decision of  13 January 2006  authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 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) 5940)
Date: 2006-01-13
Institutions: European Commission
Subjects: Netherlands, food safety, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, market approval

7.2.2006

EN

Official Journal of the European Union

L 34/29

COMMISSION DECISION

of 13 January 2006

authorising the placing on the market of foods and food ingredients produced from genetically
modified Roundup Ready maize line GA21 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) 5940)

(Only the French and Dutch texts are authentic)

(2006/69/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), and in particular
Article 7 thereof,

Whereas:

(6) With respect

under

to the use of

the product as or

in
feed, Monsanto submitted, on 12 December 1997, a
notification
Part C of Council Directive
90/220/EEC (3). The opinion adopted on 22 September
2000 by the Scientific Committee on Plants concluded
that there is no evidence to indicate that the placing on
the market of GA21 maize for this use is likely to cause
any adverse effects on human health and the envir-
onment. However,
the application was withdrawn for
commercial reasons.

(1)

(2)

(3)

(4)

On 24 July 1998, Monsanto submitted to the competent
in accordance
authorities of the Netherlands a request,
with Article 4 of Regulation (EC) No 258/97, for placing
on the market foods and food ingredients derived from
genetically modified maize line GA21 as novel foods or
novel food ingredients.

In its initial assessment report of 21 December 1999, the
Netherlands’ competent food assessment body came to
the conclusion that GA21 maize and foodstuffs and food
ingredients made from it are as safe to eat as maize and
maize products that have not been genetically modified.

The Commission forwarded the initial assessment report
to all Member States on 18 February 2000. Within the
60-day period laid down in Article 6(4) of Regulation
(EC) No 258/97, reasoned objections to the marketing of
the product were
raised in accordance with that
provision.

(7)

(8)

11

(SCF)

of Regulation

On 18 May 2000, the Commission requested an opinion
in
from the Scientific Committee on Foods
accordance with Article
(EC)
No 258/97. On 27 February 2002 the SCF delivered
its opinion that from the point of view of consumer
health, GA21 maize and derived products are as safe as
grain and derived products from conventional maize
lines (2). In delivering its opinion the SCF considered 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 (4) 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
in cases where the
of Regulation (EC) No 1829/2003,
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.

The Joint Research Centre of the European Commission
in collaboration with the European Network of
(JRC)
GMO Laboratories (ENGL), has validated a method for
detection of GA21 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
GA21 transformation event
in maize. The materials
needed in the study had been provided by Monsanto.
The JRC has considered that the method performance
was appropriate for
taken into
criteria proposed by the
account
ENGL for methods submitted for regulatory compliance
as well as the current scientific understanding about satis-
factory method performance. Both the method and the
results of the validation have been published by the JRC.

its aimed purpose,

the performance

(5)

On 24 April 2002, Monsanto asked to limit the request
to food and food ingredients produced from genetically
modified maize line GA21.

(9)

Reference material for GA21 maize has been produced
by the JRC.

(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) http://europa.eu.int/comm/food/fs/sc/scf/index_en.html

(3) OJ L 117, 8.5.1990 p. 15. Directive repealed by Directive
2001/18/EC of the European Parliament and of the Council
(OJ
L 106, 17.4.2001, p. 1).
(4) OJ L 268, 18.10.2003, p. 1.

L 34/30

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Official Journal of the European Union

7.2.2006

(10)

(11)

(12)

(13)

Food and food ingredients from GA21 maize should be
labelled in accordance with the provisions of Regulation
(EC) No 1829/2003 and should be subject to the trace-
ability requirements laid down in Regulation (EC) No
and the
1830/2003 of
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).

the European Parliament

traceability of

food

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

Information, contained in the Annex, on the identifi-
foods and food ingredients produced from
cation of
GA21 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.

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 29 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.

HAS ADOPTED THIS DECISION:

Article 1

Foods and food ingredients produced from genetically modified
maize line GA21 (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.

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

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

L 34/31

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 produced from genetically modified maize (Zea mays L.)
line GA21 with increased
tolerance to the herbicide glyphosate and from all
its crosses with traditionally bred maize lines. GA21 maize
contains the modified 5-enolpyruvylshikimate-3-phosphate synthase (mEPSPS) coding sequence under the regulation
of the rice actin 1 promoter (r-act) and an optimised transit peptide (OPT) sequence based on chloroplast transit
peptide sequences from Helianthus annuus and the RuBisCo gene from Zea mays L.

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 GA21,

— 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-414 produced by the Joint Research Centre (JRC) of the European Commission.

5. Unique identifier:

MON-ØØØ21-9.

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.