2005/465/EC: Commission Decision of 22 June 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate (notified under document number C(2005) 1838) Text with EEA relevance
Date: 2005-06-22
Institutions: European Commission
Subjects: market approval, oil seed rape, transgenic plant

24.6.2005

EN

Official Journal of the European Union

L 164/57

COMMISSION DECISION

of 22 June 2005

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically
modified for tolerance to the herbicide glyphosate

(notified under document number C(2005) 1838)

(Only the Dutch text is authentic)

(Text with EEA relevance)

(2005/465/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/18/EC of
Parliament and of
the Council of 12 March 2001 on the
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)

(3)

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
to written
genetically modified organisms
consent being granted by the competent authority
concerned, in accordance with the procedure laid down
in that Directive.

subject

is

A notification concerning the placing on the market of a
genetically modified oilseed rape product (Brassica napus
L., GT73 line) was submitted by Monsanto SA to the
competent authority of the Netherlands.

The notification covers the same uses as for any other
oilseed rape, with the exception of the uses as or in food
and the cultivation in the Community of varieties derived
from the genetically modified product (GT73 transfor-
mation event). The notification covers the importation
and storage of the GT73 oilseed rape, and its use as
feed as well as in the processing for
feed, and its
industrial uses as or in products.

In accordance with the procedure provided for in Article
14 of Directive 2001/18/EC, the competent authority of
the Netherlands prepared an assessment report, which is
submitted to the Commission and the competent autho-
rities of 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
GT73 oilseed rape should be withheld.

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

The opinion adopted on 11 February 2004 by the
European Food Safety Authority, as established by Regu-
lation (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, estab-
lishing the European Food Safety Authority and laying
down procedures in matters of food safety (2), concluded,
line
from all evidence provided, that Brassica napus L.
safe as conventional oilseed rape for
GT73 is as
humans
the
proposed uses,
the environment. The European
Food Safety Authority also found that the monitoring
plan provided by the consent holder was appropriate
for the intended uses of the GT73 oilseed rape.

and animals,

and in the

context of

for

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 Brassica napus L. line GT73 will
adversely affect human or animal health or the envir-
onment.

Refined oil from GT73 oilseed rape has been commer-
cially released for food purposes in the Community in
accordance with the procedure referred to in Article 5 of
Regulation (EC) No 258/97 of the European Parliament
and of the Council of 27 January 1997 concerning novel
foods and novel food ingredients (3).

(5)

(6)

(7)

(8)

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

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

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

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

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

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

L 164/58

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Official Journal of the European Union

24.6.2005

(9)

the European Parliament and of

A unique identifier should be assigned to the GT73
oilseed rape for the purposes of Regulation (EC) No
1830/2003 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 and Commission Regu-
lation (EC) No 65/2004 of 14 January 2004 establishing
a system for the development and assignment of unique
identifiers for genetically modified organisms (1).

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 (2).

the European Parliament and of

2001/18/EC

established

Regulation

thresholds

products

and

HAS ADOPTED THIS DECISION:

Article 1

Consent

Without prejudice to other Community legislation, in particular
Regulation (EC) No 258/97 and Regulation (EC) No
the
1829/2003, written consent
competent authority of the Netherlands 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/NL/98/11).

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

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.

1.
The genetically modified organisms to be placed on the
market as or in products (hereinafter ‘the product’), are grains of
oilseed rape (Brassica napus L.), with tolerance to the herbicide
glyphosate, derived from the oilseed rape GT73 line, which has
been transformed with Agrobacterium tumefaciens, using the
vector PV-BNGT04. The product contains the following DNA
in two cassettes:

In the light of the opinion of the European Food Safety
Authority, an appropriate management system should be
in place to prevent grains of GT73 oilseed rape entering
cultivation.

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
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
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 (3) the measures should be
adopted by the Commission,

(1) OJ L 10, 16.1.2004, p. 5.
(2) OJ L 268, 18.10.2003, p. 1.
(3) OJ L 184, 17.7.1999, p. 23.

(a) Cassette 1

A 5-enolpyruvylshikimate-3-phospate synthase (epsps) gene
derived from Agrobacterium sp. strain CP4 (CP4 EPSPS),
which confers glyphosate tolerance, under the regulation
of the modified figwort mosaic virus promoter (P-CMoVb),
terminator sequences from the pea rbcS E9 gene encoding
the small subunit of ribulose bisphosphate carboxylase/ox-
ygenase and the N-terminal chloroplast transit peptide CTP2
sequence from the epsps gene of Arabidopsis thaliana.

(b) Cassette 2

The variant 247 of the original glyphosate oxidoreductase
gene (goxv247) derived from Ochrobactrum anthropi strain
LBAA, which confers glyphosate tolerance, under the regu-
lation of
the modified figwort mosaic virus promoter
(P-CMoVb), terminator sequences from Agrobacterium tume-
transit peptide
faciens
sequence CTP1 from the ribulose bisphosphate carboxyla-
se/oxygenase (Arab-ssu1a) gene of Arabidopsis thaliana.

and the N-terminal

chloroplast

The product does not contain the adenyltransferase gene (aad)
encoding resistance to streptomycin and spectinomycin, as
present in the transformation vector used.

2.

The unique identifier of the product is MON-00073-7.

(11)

(12)

(13)

(14)

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L 164/59

The consent shall cover grains from progeny derived from
3.
crosses of oilseed rape line GT73 with any traditionally bred
oilseed rape as or in products.

Article 3

Conditions for placing on the market

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

(a)

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

(b) the unique identifier of the product shall be MON-00073-7;

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the consent holder shall, whenever requested to do so,
make positive
the
product, or
reference materials
its genetic material, or
available to the competent authorities;

and negative

samples of

control

(d) the words

‘This product contains genetically modified
organisms’ or ‘This product contains genetically modified
GT73 oilseed rape’ 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; and

(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,
Throughout
1.
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
handling or use of the product,
is put in place and imple-
mented.

ensure

that

dental grain spillage. Technical guidelines for the implemen-
tation of this Article are provided in the Annex to this Decision.

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.

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

agreement of

to the

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 existing monitoring networks, as specified in the
monitoring plan contained in the notification, gathers the
information relevant for the monitoring of the product; and

(b) that

these existing monitoring networks have agreed to
make available that
information to the consent holder
before the date of 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 detection
method specific to the GT73 oilseed rape is validated by the
Community reference laboratory as referred to in the Annex to
Regulation (EC) No 1829/2003, and as specified in Commission
Regulation (EC) No 641/2004 (1) on detailed rules for the
implementation of Regulation (EC) No 1829/2003.

Article 6

Addressee

This Decision is addressed to the Kingdom of the Netherlands.

Done at Brussels, 22 June 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
appropriate management measures to be taken in case of acci-

For the Commission

Stavros DIMAS
Member of the Commission

(1) OJ L 102, 7.4.2004, p. 14.

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ANNEX

Technical guidelines for the implementation of Article 4(2)

1. The consent holder shall inform operators in the Community, namely traders and processors of bulk mixtures of

imported oilseed rape grains, which may contain GT73 oilseed rape, that:

(a) GT73 oilseed rape has received consent for import and use in the Community, and

(b) establishment of a general surveillance plan for any unanticipated adverse effects arising from the placing on the

market of GT73 oilseed rape for the above uses is a condition of consent.

2. The consent holder will provide operators with a national contact person for the reporting of any unanticipated

adverse effects.

3. The consent holder shall inform operators that the possibility of and consequences arising from accidental spillage of
GT73 oilseed rape have been evaluated by the European Food Safety Authority (EFSA) in the context of its intended
uses. The consent holder will maintain regular contact with operators to ensure that they are informed of any changes
to current practice which may change the conclusions of the environmental risk assessment.

4. The consent holder shall ensure that operators are alert to the possibility that accidental spillage of imported oilseed
rape grain in ports and crushing facilities may result in the germination and establishment of volunteer plants, which
could include GT73 oilseed rape.

5. In the event that volunteer oilseed rape plants could include GT73 oilseed rape, the consent holder shall:

(a)

inform operators that these plants should be eradicated to minimise the potential for unanticipated adverse effects
arising from the GT73 oilseed rape, and

(b) provide operators with appropriate plans for eradicating volunteer oilseed rape plants that could include GT73

oilseed rape.

6. Member States may, taking account of Article 4(5) of Directive 2001/18/EC and section C.1.6 of Council Decision
2002/811/EC (1), carry out checks and/or additional monitoring with respect to accidental spillage of GT73 oilseed
rape grains and identification of potential unanticipated adverse effects arising from such spillage.

(1) OJ L 280, 18.10.2002, p. 27.