2007/232/EC: Commission Decision of 26 March 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of oilseed rape products ( Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium (notified under document number C(2007) 1234)
Date: 2007-03-26
Institutions: European Commission
Subjects: marketing standard, oil seed rape, plant health legislation, transgenic plant

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Official Journal of the European Union

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(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 26 March 2007

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and
Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium

(notified under document number C(2007) 1234)

(Only the Dutch and French texts are authentic)

(2007/232/EC)

THE COMMISSION OF THE EUROPEAN UNION,

L., lines Ms8, Rf3 and Ms8xRf3) was submitted by Bayer
BioScience nv to the competent authority of Belgium.

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)

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
concerned, in accordance with the procedure laid down
in that Directive.

subject

is

(2)

A notification concerning the placing on the market of
genetically modified oilseed rape products (Brassica napus

(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).

(3)

(4)

(5)

(6)

The notification covered cultivation and import of the
genetically modified oilseed rape products
(Brassica
napus L.,
lines Ms8, Rf3 and Ms8xRf3) for all uses as
for any other oilseed rape including use as or in feed,
but with the exception of uses as or in food,
in the
Community.

In accordance with the procedure provided for in Article
14 of Directive 2001/18/EC, the competent authority of
Belgium prepared an assessment
report, which was
submitted to the Commission and the competent autho-
rities of other Member States; whereby the assessment
report concluded that the genetically modified oilseed
rape products (Brassica napus L.,
lines Ms8, Rf3 and
Ms8xRf3) should be placed on the market for import
and processing and for use as any other oilseed rape
but not for the requested use of cultivation.

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

In view of
of Belgium and
authority
concerning
cultivation of
oilseed rape products (Brassica napus L.,
and Ms8xRf3),
import and processing, including use in feed.

the objections raised by the competent
States
genetically modified
lines Ms8, Rf3
the opinion of EFSA is restricted to

other Member

the

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L 100/21

(7)

(8)

(9)

The opinion adopted in September 2005 by the
the
European Food Safety Authority, concluded that
genetically modified oilseed rape products
(Brassica
napus L.,
lines Ms8, Rf3 and Ms8xRf3) are as safe as
conventional oilseed rape for humans and animals, and
in the context of the intended uses, for the environment.
The European Food Safety Authority also concluded that
the monitoring plan provided in the notification was
acceptable in view of the intended uses.

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 the genetically modified oilseed
rape products (Brassica napus L.,
lines Ms8, Rf3 and
Ms8xRf3) will adversely affect human or animal health
or the environment.

from genetically modified oilseed rape
Processed oil
derived from (a)
the Ms8 oilseed rape line and all
conventional crosses, (b) the Rf3 oilseed rape line and
all conventional crosses and (c) the hybrid combination
Ms8xRf3 has been placed on the market in accordance
with Article 5 of Regulation (EC) No 258/97 of the
European Parliament and of the Council of 27 January
food ingre-
1997 concerning novel
dients (1). As
to the
requirements provided for in Article 8 of Regulation
(EC) No 1829/2003 of the European Parliament and of
the Council of 22 September 2003 on genetically
modified food and feed (2) and may be placed on the
market and used in accordance with the conditions
mentioned in the Community register of genetically
modified food and feed.

foods and novel
it

consequence,

subject

is

a

(10) Unique identifiers should be assigned to the genetically
modified oilseed rape products (Brassica napus L.,
lines
Ms8, Rf3 and Ms8xRf3) for the purposes of Regulation
(EC) No 1830/2003 of the European Parliament and 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 (3) 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 (4).

traceability of

food

(11) Adventitious or

technically

genetically modified

organisms

unavoidable
in

products

traces

of
are

(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) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission
Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

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

(12)

(13)

(14)

(15)

exempted from labelling and traceability requirements in
accordance with thresholds established under Directive
2001/18/EC and Regulation (EC) No 1829/2003.

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 products and the protection
of particular ecosystems, environments or geographical
areas.

In the light of the opinion of the European Food Safety
Authority, an appropriate management system should be
in place to prevent grains of the genetically modified
lines Ms8, Rf3
oilseed rape products (Brassica napus L.,
and Ms8xRf3) entering cultivation.

Prior to the placing on the market of the products, 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
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 (5) 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 Belgium to the placing on the market,
in accordance with this Decision, of the products identified in
Article 2, as notified by Bayer BioScience nv (Reference
C/BE/96/01).

granted

shall

by

be

(5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

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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.

— part of the 3’ non-coding region (3’ nos) of the nopaline

synthase gene of Agrobacterium tumefaciens;

Article 2

Products

4. PssuAra-bar-3’g7:

The genetically modified organisms to be placed on the
1.
market as or in products, hereinafter ‘the products’, are grains of
oilseed rape (Brassica napus L.) from the individual female and
male lines containing events Ms8 and Rf3 respectively as well
grains obtained from traditional crossings (Ms8xRf3 hybrid)
lines, which contain
between these female and male parental
the following inserted DNA:

F e m a l e l i n e ( M s 8 )

1. PTA29-barnase-3’nos:

— the tapetum cell-specific promoter PTA29 from Nicotiana

tabacum,

— the PssuAra promoter from Arabidopsis thaliana,

— the bar gene isolated from Streptomyces hygroscopicus
glufosinate-

to the herbicide

tolerance

conferring
ammonium,

— the 3’ untranslated sequence of the TL-DNA gene 7 of

Agrobacterium tumefaciens.

2.
The consent shall cover grains from progeny derived from
crosses of oilseed rape line Ms8, Rf3 and Ms8xRf3 with any
traditionally bred oilseed rape as or in products.

— the barnase gene from Bacillus amyloliquefaciens to engineer

male sterility,

Article 3

Conditions for placing on the market

— part of the 3’ non-coding region (3’ nos) of the nopaline

synthase gene of Agrobacterium tumefaciens;

The products 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:

2. PssuAra-bar-3’g7:

— the PssuAra promoter from Arabidopsis thaliana,

(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;

— the bar gene isolated from Streptomyces hygroscopicus
glufosinate-

to the herbicide

tolerance

conferring
ammonium,

— the 3’ untranslated sequence of the TL-DNA gene 7 of

Agrobacterium tumefaciens;

M a l e l i n e ( R f 3 )

3. PTA29-barstar-3’nos:

— the tapetum cell-specific promoter PTA29 from Nicotiana

tabacum,

— the barstar gene from Bacillus amyloliquefaciens to engineer

fertility restoration,

(b) the unique identifiers of the products shall be:

— ACS-BNØØ5-8 for

lines containing the Ms8 event

alone;

— ACS-BNØØ3-6 for lines containing the Rf3 event alone,

and;

— ACS-BNØØ5-8 x ACS-BNØØ3-6 for hybrid lines

containing both the Ms8 and Rf3 events;

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

and negative

samples of

control

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(d) without prejudice to specific labelling requirements provided
by Regulation (EC) No 1829/2003, the words ‘This product
contains genetically modified oilseed rape’ or ‘This product
contains genetically modified Ms8 oilseed rape’ or ‘This
product contains genetically modified Rf3 oilseed rape’ or
‘This product contains genetically modified Ms8xRf3 oilseed
rape’, as appropriate, 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 products have 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 products.

Article 4

Monitoring

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, to check for any adverse effects on human
and animal health or the environment arising from handling or
use of the products, is put in place and implemented.

ensure

that

2.
The consent holder shall directly inform the operators and
users concerning the safety and general characteristics of the
products and of the conditions as to monitoring,
including
the appropriate management measures to be taken in case of
accidental 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
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

agreement of

to the

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 existing monitoring networks, as specified in the
monitoring plan contained in the notification, gathers the
information relevant for the monitoring of the products;
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 detection
methods specific to the Ms8 and Rf3 events and the Ms8xRf3
hybrid oilseed rape are validated by the Community Reference
Laboratory as referred to in the Annex of 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.

This Decision is addressed to the Kingdom of Belgium.

Done at Brussels, 26 March 2007.

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 should inform operators in the Community who handle and process bulk mixtures of imported

oilseed rape grains which may contain Ms8, Rf3 and Ms8xRf3 oilseed rape that:

(a) Ms8, Rf3 and Ms8xRf3 oilseed rape has received consent for import and use, in accordance with the definition

given in Article 3 of the Decision, in the Community;

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

the market of Ms8, Rf3 and Ms8xRf3 oilseed rape for the above uses is a condition of consent.

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

adverse effects.

3. The consent holder should inform operators that the possibility of and consequences arising from accidental spillage of
Ms8, Rf3 and Ms8xRf3 oilseed rape have been evaluated by the European Food Safety Authority (EFSA) in the context
of its intended uses. The consent holder should 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 should ensure that operators are alert to the possibility that accidental spillage of imported oilseed
rape grains in ports and crushing facilities may result in the germination and establishment of volunteer plants,
including Ms8, Rf3 and Ms8xRf3 oilseed rape.

5. In the event that volunteer oilseed rape plants include Ms8, Rf3 and Ms8xRf3 oilseed rape, the consent holder should:

(a)

inform operators that these plants should be eradicated to minimise the potential for unanticipated adverse effects
arising from the Ms8, Rf3 and Ms8xRf3 oilseed rape;

(b) provide operators with appropriate plans for eradicating volunteer oilseed rape plants that include Ms8, Rf3 and

Ms8xRf3 oilseed rape.

6. Under Article 4(5) of Directive 2001/18/EC and section C.1.6 of the Annex to Council Decision 2002/811/EC (1)
establishing guidance notes supplementing Annex VII to Directive 2001/18/EC, Member States may carry out checks
and/or additional monitoring with respect to accidental spillage of Ms8, Rf3 and Ms8xRf3 oilseed rape grains and
identification of potential unanticipated adverse effects arising from such spillage.

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