2005/608/EC: Commission Decision of 8 August 2005 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., line MON 863) genetically modified for resistance to corn rootworm (notified under document number C(2005) 2950)   (Text with EEA relevance)
Date: 2005-08-08
Institutions: European Commission
Subjects: Germany, cereal product, food safety, genetically modified organism, labelling, maize, market approval

10.8.2005

EN

Official Journal of the European Union

L 207/17

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 8 August 2005

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., line MON 863) genetically modified
for resistance to corn rootworm

(notified under document number C(2005) 2950)

(Only the German text is authentic)

(Text with EEA relevance)

(2005/608/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 SA to the competent authority
of Germany.

(3)

The notification covers importation and use as for any
other maize grains including feed but not food use, with

(4)

(5)

(6)

the exception of the cultivation in the Community of
varieties derived from the MON 863 transformation
event as well as with the exception of the cultivation
in the Community of MON 863 × MON 810 hybrids.

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
submitted to the Commission and the competent autho-
rities of the other Member States. That assessment report
concludes that no reasons have emerged on the basis of
which consent for the placing on the market of MON
863 maize as well as MON 863 × MON 810 maize
should be withheld, if specific conditions are fulfilled.

The competent authorities of other Member States raised
objections to the placing on the market of the product.

The opinion adopted on 2 April 2004 by the European
Food Safety Authority,
in accordance with Regulation
(EC) No 178/2002 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
food safety (2), concluded,
procedures
from all evidence provided, that Zea mays L. line MON
863 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
found that the scope of the monitoring plan provided by
the consent holder is in line with the intended uses of
MON 863.

in matters of

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

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

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

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

L 207/18

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Official Journal of the European Union

10.8.2005

(7)

(8)

(9)

it

the
Concerning the hybrid MON 863 × MON 810,
European Food Safety Authority considered that
is
scientifically valid to use the data from the single lines
MON 863 and MON 810 to support
safety
assessment of the hybrid MON 863 × MON 810, but
decided regarding the need for confirmatory 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. Thus, only the
safety assessment of the maize line MON 863 has been
finalised.

the

An examination of each of the objections in the light of
Directive 2001/18/EC, of the information submitted in
the notification and of the opinion of the European Food
Safety Authority, discloses no reason to believe that the
placing on the market of Zea mays L. line MON 863 will
adversely affect human or animal health or the envir-
onment.

for

A unique identifier should be assigned to the MON 863
the purposes of Regulation (EC) No
maize
the
the European Parliament and of
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) and Commission
Regulation (EC) No 65/2004 of 14 January 2004 estab-
lishing a system for the development and assignment of
unique identifiers for genetically modified organisms (2).

traceability of

food

(10) Adventitious or

traces

organisms

technically

accordance with

unavoidable
in

of
genetically modified
are
exempted from labelling and traceability requirements
under
in
(EC) No
Directive
1829/2003 of
the
Council of 22 September 2003 on genetically modified
food and feed (3).

the European Parliament and of

2001/18/EC

established

Regulation

thresholds

products

and

(11)

(12)

(13)

it

In 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.

Prior to the placing on the market of the product, the
necessary measures to ensure its labelling and traceability
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 estab-
lished 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
the period laid down in Article 30(2) of
expiry of

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

Directive 2001/18/EC the Council had neither adopted
the proposed measures nor indicated its opposition to
them in accordance with Article 5(6) of Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (4) 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 and Regulation (EC) No
1829/2003, written consent
the
competent authority of Germany to the placing on the
market, in accordance with this Decision, of the product iden-
tified in Article 2, as notified by Monsanto Europe SA
(Reference C/DE/02/9).

granted

shall

by

be

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

1.
The genetically modified organisms to be placed on the
market as or in products, hereinafter ‘the product’, are grains of
maize (Zea mays L.), with resistance to the corn rootworm
(Diabrotica spp.), derived from the Zea mays cell culture line
AT824 (initiated from immature embryos of an inbred maize
line AT), which has been transformed using particle acceleration
technology with a MluI DNA restriction fragment isolated from
plasmid PV-ZMIR13.

The product contains the following DNA in 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
the
transcription enhancer ract1 intron from the actin 1 gene
of rice (Oryza sativa) and terminator sequences tahsp 17 3’
from wheat.

(Triticum aestivum),

(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 Agro-
bacterium tumefaciens as well as the non-functional, truncated
ble gene from E. coli.

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

10.8.2005

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Official Journal of the European Union

L 207/19

The consent shall cover grains from progeny derived from
2.
crosses of maize line MON 863 with any traditionally bred
maize as or in products.

appropriate management measures to be taken in case of acci-
dental grain spillage.

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
may be placed on the market
to the following
conditions:

subject

(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;

(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 organisms’ or ‘This product
contains genetically modified MON 863 maize’
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

the period of validity of
shall

the
the consent,
1.
Throughout
consent holder
the monitoring plan,
contained in the notification, to check for any adverse effects
on human and animal health or the environment arising from
is put in place and imple-
handling or use of the product,
mented.

ensure

that

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.

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
Commission and competent authorities of
the Member
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 within the
meaning of Regulation (EC) No 178/2002 and including a
method, validated by the Community reference laboratory, for
detection of the product is applicable.

Article 6

Addressee

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 8 August 2005.

2.
The consent holder shall directly inform the operators and
users concerning the safety and general characteristics of the
product and of the conditions as to monitoring, including the

For the Commission

Stavros DIMAS
Member of the Commission