2006/47/EC: Commission Decision of  16 January 2006  concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product ( Zea mays  L., hybrid MON 863 × MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize  (notified under document number C(2005) 5980)
Date: 2006-01-16
Institutions: European Commission
Subjects: cereal product, food safety, genetically modified organism, labelling, maize, market approval, marketing standard, plant health control, plant health legislation

31.1.2006

EN

Official Journal of the European Union

L 26/17

COMMISSION DECISION

of 16 January 2006

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of a maize product (Zea mays L., hybrid MON 863 × MON 810)
genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize

(notified under document number C(2005) 5980)

(Only the German text is authentic)

(2006/47/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

the development and assignment of unique identifiers for
genetically modified organisms (3).

(3)

(4)

(5)

(6)

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/18/EC of
the Council of 12 March 2001 on the
Parliament and of
deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC (1), and
in particular the first subparagraph of Article 18(1) thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)

(2)

Pursuant to Directive 2001/18/EC, the placing on the
market of a product containing or consisting of a
genetically modified organism or a combination of
genetically modified organisms
to written
consent being granted by the competent authority of a
Member State,
in accordance with the procedure laid
down in that Directive.

subject

is

A notification concerning the placing on the market of
two genetically modified maize products (Zea mays L.,
line MON 863 and hybrid MON 863 × MON 810) was
submitted by Monsanto Europe S.A. to the competent
authority of Germany (Reference C/DE/02/9). A unique
identifier
(MON-ØØ863-5×MON-ØØ81Ø-6) has been
assigned to the MON 863 × MON 810 maize for the
purposes of Regulation (EC) No 1830/2003 of
the
the Council of 22
and of
European Parliament
September 2003 concerning
and
traceability
the
labelling of genetically modified organisms and the trace-
ability of
food and feed products produced from
genetically modified organisms and amending Directive
2001/18/EC (2) and Commission Regulation (EC) No
65/2004 of 14 January 2004 establishing a system for

The notification originally covered importation and use
as for any other maize grains including feed, with the
exception of food use and cultivation in the Community
of varieties derived from the MON 863 transformation
event and of the MON 863 × MON 810 hybrid.

forwarded

In accordance with the procedure provided for in Article
14 of Directive 2001/18/EC, the competent authority of
Germany prepared an assessment
report, which was
forwarded in April 2003 to the Commission. The
Commission
and
the
assessment report to the other Member States in May
2003. That
that no
reasons have emerged on the basis of which consent
for the placing on the market of MON 863 as well as
MON 863 × MON 810 should be withheld,
if specific
conditions are fulfilled.

notification

assessment

concludes

report

full

The competent authorities of other Member States raised
objections to the placing on the market of MON 863 as
well as MON 863 × MON 810.

line MON 810), pursuant

The placing on the market of MON 810 maize is
authorised in accordance with Commission Decision
98/294/EC of 22 April 1998 concerning the placing
on the market of genetically modified maize (Zea mays
L.
to Council Directive
90/220/EEC (4). The placing on the market of MON
863 is authorised in accordance with Commission
Decision 2005/608/EC of 8 August 2005 concerning
the placing on the market, in accordance with Directive
the
2001/18/EC of
Council, of a maize product (Zea mays L.,
line MON
to corn
resistance
863)
rootworm (5).

the European Parliament and of

genetically modified

for

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

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

(3) OJ L 10, 16.1.2004, p. 5.
(4) OJ L 131, 5.5.1998, p. 32.
(5) OJ L 207, 10.8.2005, p. 17.

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Official Journal of the European Union

31.1.2006

On 2 April 2004, the European Food Safety Authority
considered that it is scientifically valid to use the data
from the single lines MON 863 and MON 810 to
support
the safety assessment of MON 863 × MON
810, but decided, with regard to the need for confirm-
atory data for the safety assessment of the hybrid itself,
to request a 90-day sub-chronic rat study with the maize
hybrid in order to complete its safety assessment.

(14)

(7)

(8)

(9)

The opinion adopted on 8 June 2005 by the European
Food Safety Authority, concluded,
from all evidence
provided,
that MON 863 × MON 810 is unlikely to
have an adverse effect on human and animal health or
the environment in the context of its proposed use. The
European Food Safety Authority also deemed that the
scope of the monitoring plan provided by the applicant
was in line with the intended uses of MON 863 × MON
810.

On 8 July 2005, Monsanto Europe S.A. agreed to limit
the present Decision to import and
the scope of
processing. An application for
the placing on the
market of food and feed containing, consisting of, or
produced from MON 863 × MON 810 has been made
by Monsanto Europe S.A. under Regulation (EC) No
1829/2003 of
the
Council of 22 September 2003 on genetically modified
food and feed (1).

the European Parliament and of

the information submitted in the
(10) An examination of
notification,
the objections maintained by Member
States in the framework of Directive 2001/18/EC, and
the European Food Safety Authority,
the opinion of
discloses no reason to believe that the placing on the
market of Zea mays L. hybrid MON 863 × MON 810
will adversely affect human or animal health or the envi-
ronment.

(11) Adventitious or

organisms

technically

unavoidable
in

of
genetically modified
are
exempted from labelling and traceability requirements
under
in
Directive
(EC)
No 1829/2003.

established
Regulation

accordance with

2001/18/EC

thresholds

products

traces

and

(12)

it

In the light of the opinion of the European Food Safety
Authority,
is not necessary to establish specific
conditions for the intended uses with regard to the
handling or packaging of the product and the protection
of particular ecosystems, environments or geographical
areas.

(13)

Prior to the placing on the market of the product, the
necessary measures to ensure its labelling and traceability

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

at all stages of its placing on the market, including veri-
fication by appropriate validated detection methodology,
should be applicable.

The measures provided for in this Decision are not in
accordance with the opinion of
the Committee esta-
blished under Article 30 of Directive 2001/18/EC and
the Commission therefore submitted to the Council a
relating to these measures. Since on the
proposal
expiry of
the period laid down in Article 30(2) of
Directive 2001/18/EC, the Council had neither adopted
the proposed measures nor indicated its opposition to
in accordance with Article 5(6) of Council
them,
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (2), the measures should be
adopted by the Commission,

HAS ADOPTED THIS DECISION:

Article 1

Consent

Without prejudice to other Community legislation, in particular
Regulation (EC) No 258/97 of the European Parliament and of
the Council (3) and Regulation (EC) No 1829/2003, written
shall be granted by the competent authority of
consent
Germany to the placing on the market,
in accordance with
identified in Article 2, as
this Decision, of
notified by Monsanto Europe S.A. (Reference C/DE/02/9).

the product

The consent shall, in accordance with Article 19(3) of Directive
2001/18/EC, explicitly specify the conditions to which the
consent is subject, which are set out in Articles 3 and 4.

Article 2

Product

The genetically modified organisms to be placed on the market
as or in products, hereinafter ‘the product’, are grains of maize
(Zea mays L. MON 863 × MON 810), obtained by conventional
breeding of MON 863 and MON 810. Descriptions of the MON
810 and MON 863 maizes are provided for in Decisions
98/294/EC and 2005/608/EC respectively.

Article 3

Conditions for placing on the market

The product may be put to the same uses as any other maize,
with the exception of cultivation and uses as or in food and
feed, and may be placed on the market subject to the following
conditions:

(2) OJ L 184, 17.7.1999, p. 23.
(3) OJ L 43, 14.2.1997, p. 1. Regulation as amended by Regulation (EC)

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

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Official Journal of the European Union

L 26/19

(a)

the period of validity of the consent shall be 10 years
starting from the date on which the consent is issued;

(b) the unique identifier of the product shall be MON-ØØ863-

5×MON-ØØ81Ø-6;

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the consent holder shall, whenever requested to do so,
the
make positive
product, or
reference materials
available
to the competent authorities and inspection
services of Member States as well as to the Community
control laboratories;

its genetic material, or

and negative

samples of

control

(d) without prejudice to specific labelling requirements provided
by Regulation (EC) No 1829/2003 the words ‘This product
contains genetically modified maize’ or
‘This product
contains genetically modified MON 863 × MON 810’ shall
appear either on a label or in a document accompanying
the product, except where other Community legislation sets
a threshold below which such information is not required;

(e) as long as the product has not been authorised for the
placing on the market for the purpose of cultivation, the
words ‘not for cultivation’ shall appear either on a label or
in a document accompanying the product.

Article 4

Monitoring

ensure

the period of validity of
shall

the
the consent,
1.
Throughout
consent holder
the monitoring plan,
contained in the notification and consisting of a general
surveillance plan, the objective of which is to check for any
adverse effects on human and animal health or the environment
arising from handling or use of the product, is put in place and
implemented.

that

The consent holder shall directly inform the operators and
2.
users concerning the safety and general characteristics of the
product and of the conditions as to monitoring, including the
appropriate management measures to be taken in case of acci-
dental grain spillage.

The consent holder shall submit to the Commission and
the Member States annual

3.
to the competent authorities of
reports on the results of the monitoring activities.

to the

agreement of

4. Without prejudice to Article 20 of Directive 2001/18/EC
the monitoring plan as notified shall, where appropriate and
subject
the Commission and the
competent authority of the Member State which received the
original notification, be revised by the consent holder and/or by
the competent authority of the Member State which received
the original notification, in the light of the results of the moni-
toring activities. Proposals for a revised monitoring plan shall be
submitted to the competent authorities of the Member States.

5.
The consent holder shall be in the position to give
evidence to the Commission and the competent authorities of
the Member States:

(a)

that the monitoring networks as specified in the monitoring
plan contained in the notification collect the information
relevant for the monitoring of the product, and

(b) that the members of these networks have agreed to make
available that information to the consent holder before the
date of the submission of the monitoring reports to the
the Member
Commission and competent authorities of
States in accordance with paragraph 3.

Article 5

Applicability

This Decision shall apply from the date on which a Community
Decision authorising the placing on the market of the product
referred to in Article 1 for uses as or in food and feed within
the meaning of Regulation (EC) No 178/2002 of the European
the Council (1) and including a method,
Parliament and of
validated
for
detection of the product is applicable.

the Community

laboratory,

reference

by

Article 6

Addressee

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 16 January 2006.

For the Commission

Stavros DIMAS
Member of the Commission

(1) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).