2009/184/EC: Commission Decision of 10 March 2009 authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2009) 1541) (Text with EEA relevance)
Date: 2009-03-10
Institutions: European Commission
Subjects: animal nutrition, consumer information, genetically modified organism, health policy, market approval, oil seed rape

L 68/28

EN

Official Journal of the European Union

13.3.2009

COMMISSION DECISION

of 10 March 2009

authorising the placing on the market of products containing or produced from genetically modified
oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third
countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of
the Council

(notified under document number C(2009) 1541)

(Only the German text is authentic)

(Text with EEA relevance)

(2009/184/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1829/2003 of
the Council of 22 September
European Parliament and of
2003 on genetically modified food and feed (1), and in
particular Articles 7(3) and 19(3) thereof,

Whereas:

(1)

(2)

On 28 October 2005, Bayer CropScience AG submitted
to the competent authority of the United Kingdom an
in accordance with Articles 5 and 17 of
application,
Regulation (EC) No 1829/2003, for the placing on the
market of foods, food ingredients, and feed containing or
produced from T45 oilseed rape.

The application also covers the placing on the market of
other products containing T45 oilseed rape for the same
uses as any other oilseed rape with the exception of
in accordance with Articles 5(5)
cultivation. Therefore,
and 17(5) of Regulation (EC) No 1829/2003,
it
includes the data and information required by Annexes
the European
III and IV 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 (2) and information and conclusions about
the risk assessment carried out in accordance with the
principles set out in Annex II to Directive 2001/18/EC.

(4)

(5)

(6)

(7)

On 17 April 2007, Bayer CropScience AG submitted to
the Commission an application,
in accordance with
Articles 8(4)
and 20(4) of Regulation (EC) No
1829/2003, for the authorisation of existing products
produced from T45 oilseed rape (food additives and
feed materials produced from T45 oilseed rape).

The applicant
indicated in its applications and in
communications to the Commission that the commercia­
lisation of T45 oilseed rape seeds was stopped after the
2005 planting season.

Therefore, the only purpose of these applications is to
cover the presence of T45 oilseed rape resulting from its
past cultivation in third countries.

is unlikely that

the placing on the market of

On 5 March 2008, the European Food Safety Authority
(‘EFSA’) gave a single comprehensive favourable opinion
for both applications in accordance with Articles 6 and
18 of Regulation (EC) No 1829/2003 and concluded that
it
the
products containing or produced from T45 oilseed rape
as described in the applications (‘the products’) will have
any adverse effects on human or animal health or the
environment in the context of their intended uses (3). In
its opinion, EFSA considered all the specific questions
and concerns
in the
context of the consultation of the national competent
authorities as provided for by Articles 6(4) and 18(4)
of that Regulation.

raised by the Member States

compositional

In particular, EFSA concluded that as no indication of
biologically relevant
and agronomical
changes was identified for seeds from T45 oilseed rape
the PAT protein, no further
except
animal safety studies with the whole food/feed (e.g. a
90-day toxicity study in rats) are needed.

the presence of

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 106, 17.4.2001, p. 1.

(3) http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?

question = EFSA-Q-2005-278

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L 68/29

(8)

characteristics of oilseed rape

In its opinion, EFSA also concluded that the environmen­
tal monitoring plan, consisting of a general surveillance
plan, submitted by the applicant
is in line with the
the products. However, due to the
intended use of
and
physical
methods of
transportation, EFSA recommended that
appropriate management systems should be in place to
minimise accidental loss and spillage of transgenic oilseed
rape
and
processing. The monitoring plan submitted by the
applicant has been modified to take into account this
EFSA recommendation.

storage, handling

transportation,

during

seeds

protection of particular ecosystems/environment and/or
geographical areas, as provided for
(e) of
Articles 6(5)
and 18(5) of Regulation (EC) No
1829/2003.

in point

(14) All relevant

information on the authorisation of

the
products should be entered in the Community register
of genetically modified food and feed, as provided for in
Regulation (EC) No 1829/2003.

(9)

In order to monitor the phasing out of T45 oilseed rape,
its presence in imported products should be regularly
reported.

(10)

Taking into account those considerations,
it is appro­
priate to grant an authorisation to cover the presence
in products of T45 oilseed rape resulting from the
commercialisation of T45 oilseed rape seeds in third
countries until 2005.

(11) A unique identifier should be assigned to each GMO as
provided for
in Commission Regulation (EC) No
65/2004 of 14 January 2004 establishing a system for
the development and assignment of unique identifiers for
genetically modified organisms (1).

(12) On the basis of the EFSA opinion, no specific labelling
requirements other than those provided for in Articles
13(1) and 25(2) of Regulation (EC) No 1829/2003,
appear to be necessary for foods, food ingredients and
feed containing, or produced from T45 oilseed rape.
However,
in order to ensure the use of the products
within the limits of the authorisation provided for by
this Decision, the labelling of feed containing the GMO
and other products than food and feed containing the
GMO for which authorisation is requested should be
complemented by a clear indication that the products
in question must not be used for cultivation.

of

Parliament

(15) Article 4(6) of Regulation (EC) No 1830/2003 of the
of
and
European
22 September 2003 concerning the traceability and
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),
lays down labelling requirements for
products consisting or containing GMOs.

Council

the

(16)

This Decision is to be notified through the Biosafety
Clearing-House to the Parties to the Cartagena Protocol
on Biosafety to the Convention on Biological Diversity
pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC)
No 1946/2003 of the European Parliament and of the
Council of 15 July 2003 on transboundary movements
of genetically modified organisms (3).

(17)

The applicant has been consulted on the measures
provided for in this Decision.

(18)

The Standing Committee on the Food Chain and Animal
Health has not delivered an opinion within the time limit
the Commission has
laid down by its Chairman;
to the Council on
therefore submitted a proposal
30 October 2008 in accordance with Article 5 of the
Council Decision 1999/468/EC (4),
the Council being
required to act within three months.

(13)

Similarly, the EFSA opinion does not justify the impo­
sition of specific conditions or restrictions for the placing
on the market and/or specific conditions or restrictions
for the use and handling,
including post-market moni­
toring requirements, or of specific conditions for the

(1) OJ L 10, 16.1.2004, p. 5.

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

(2) OJ L 268, 18.10.2003, p. 24.
(3) OJ L 287, 5.11.2003, p. 1.
(4) OJ L 184, 17.7.1999, p. 23.

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Official Journal of the European Union

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HAS ADOPTED THIS DECISION:

Article 4

Article 1

Monitoring for environmental effects

1.
The authorisation holder shall ensure that the monitoring
plan for environmental effects, as set out in point (h) of the
Annex, is put in place and implemented.

Genetically modified organism and unique identifier
Genetically modified oilseed rape (Brassica napus L.) T45, as
is
specified in point
assigned the unique identifier ACS-BNØØ8-2, as provided for
in Regulation (EC) No 65/2004.

the Annex to this Decision,

(b) of

2.
The authorisation holder shall submit to the Commission
annual reports on the implementation and the results of the
activities set out in the monitoring activities.

Article 2

Authorisation

Article 5

Monitoring of the phasing out

The purpose of this Decision is to grant an authorisation
1.
covering,
the
for the products referred to in paragraph 2,
presence of ACS-BNØØ8-2 oilseed rape resulting directly or
indirectly from the commercialisation, until 2005, of ACS-
BNØØ8-2 oilseed rape seeds in third countries.

1.
The authorisation holder shall ensure that shipments of
oilseed rape imported in the European Union from a third
country in which ACS-BNØØ8-2 oilseed rape seeds were
commercialised until 2005 are sampled and tested for the
presence of ACS-BNØØ8-2 oilseed rape.

The following products are authorised for the purposes of
2.
Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in
accordance with the conditions set out in this Decision:

The method used for the sampling of oilseed rape shall be
2.
internationally recognised. The testing shall be made in a duly
accredited laboratory and in accordance with the validated
method of detection as set out in the Annex to this Decision.

(a)

foods and food ingredients containing or produced from
ACS-BNØØ8-2 oilseed rape;

(b) feed containing or produced from ACS-BNØØ8-2 oilseed

rape;

3.
The authorisation holder shall submit to the Commission,
together with the reports referred to in Article 4(2), annual
reports on the monitoring activities for the presence of ACS-
BNØØ8-2 oilseed rape.

Article 6

Community register

(c) products other than food and feed containing ACS-BNØØ8-
2 oilseed rape for the same uses as any other oilseed rape
with the exception of cultivation.

The information set out in the Annex to this Decision shall be
entered in the Community register of genetically modified food
and feed, as provided for in Article 28 of Regulation (EC) No
1829/2003.

Article 3

Labelling

For the purposes of the labelling requirements laid down
1.
in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003
and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name
of the organism’ shall be ‘oilseed rape’.

Article 7

Authorisation holder

The authorisation holder shall be Bayer CropScience AG.

The words ‘not for cultivation’ shall appear on the label of
2.
and in documents accompanying products containing ACS-
BNØØ8-2 oilseed rape referred to in Article 2(2)(b) and (c).

Article 8

Validity

This Decision shall apply for a period of 10 years from the date
of its notification.

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Article 9

Addressee

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Straße 50, 40789 Monheim am Rhein,
Germany.

Done at Brussels, 10 March 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

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Official Journal of the European Union

13.3.2009

ANNEX

(a) Applicant and Authorisation holder:

Name:

Bayer CropScience AG

Address:

Alfred-Nobel-Straße 50, 40789 Monheim am Rhein, Germany.

(b) Designation and specification of the products:

1. Foods and food ingredients containing or produced from ACS-BNØØ8-2 oilseed rape.

2. Feed containing or produced from ACS-BNØØ8-2 oilseed rape.

3. Products other than food and feed containing ACS-BNØØ8-2 oilseed rape for the same uses as any other oilseed

rape with the exception of cultivation.

The genetically modified ACS-BNØØ8-2 oilseed rape, as described in the application, expresses the PAT protein which
confers tolerance to the glufosinate-ammonium herbicide.

(c) Labelling:

1. For the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No
1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘oilseed
rape’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing

ACS-BNØØ8-2 oilseed rape referred to in Article 2(2)(b) and (c) of this Decision.

(d) Method for detection:

— Event specific real-time PCR-based method for the quantification of ACS-BNØØ8-2 oilseed rape.
— Validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003,

published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

— Reference Material: AOCS 0208-A accessible via the American Oil Chemists Society at http://www.aocs.org/

tech/crm/bayer_canola.cfm

(e) Unique identifier:

ACS-BNØØ8-2

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological

Diversity:
Biosafety Clearing-House, Record ID: see (to be completed when notified)

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
(Link: plan published on the Internet)

(i) Post-market monitoring requirements for the use of the food for human consumption:

Not required.

Note: links to relevant documents may need to be modified over time. Those modifications will be made available to the
public via the updating of the Community register of genetically modified food and feed.