2007/305/EC: Commission Decision of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products (notified under document number C(2007) 1805)
Date: 2007-04-25
Institutions: European Commission
Subjects: genetically modified organism, oil seed rape, seed, withdrawal from the market

5.5.2007

EN

Official Journal of the European Union

L 117/17

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed
rape and its derived products

(notified under document number C(2007) 1805)

(Only the German text is authentic)

(2007/305/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

The consents were based on the information contained in
the dossiers submitted under Directive 90/220/EEC and
all the information submitted by the Member States.

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1829/2003 of
the
European Parliament and the Council of 22 September 2003
on genetically modified food and feed (1), and in particular
Article 8(6) and 20(6) thereof,

Whereas:

(4)

(5)

(1)

(2)

organisms (2)

Seeds of hybrid oilseed rape Ms1xRf1 (ACS-BNØØ4-
7xACS-BNØØ1-4) have been granted consent pursuant
to Council Directive 90/220/EEC of 23 April 1990 on
the deliberate release into the environment of genetically
modified
Commission Decision
by
96/158/EC of 6 February 1996 concerning the placing
on the market of a product consisting of a genetically
modified organism, hybrid herbicide-tolerant swede-rape
seeds (Brassica napus L. oleifera Metzq. MS1Bn x RF1Bn) (3)
for the use of growing for obtaining seed but not for the
use
feed. Directive
90/220/EEC has been recast and repealed by Directive
2001/18/EC.

for human food or

animal

Seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-
to
BNØØ1-4 have been granted consent pursuant
Council Directive 90/220/EEC by Commission Decision
97/392/EC of 6 June 1997 concerning the placing on
the market of genetically modified swede-rape (Brassica
napus L. oleifera Metzg. MS1, RF1) pursuant to Council
Directive 90/220/EEC (4) for the intended use of growing
and handling in the environment before and during
processing to non-viable fractions.

(1) 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).
(2) OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive
(OJ

the European Parliament and the Council

2001/18/EC of
L 106, 17.4.2001, p. 1).
(3) OJ L 37, 15.2.1996, p. 30.
(4) OJ L 164, 21.6.1997, p. 38.

Processed oil from ACS-BNØØ4-7, ACS-BNØØ1-4 and
the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4
oilseed rape was 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 (5).

foods and novel

ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combi-
nation ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape and
their derived products have subsequently been notified by
Bayer CropScience AG (hereafter the notifier) as existing
products under Article 8(1)(a) and Article 20(1) of Regu-
lation (EC) No 1829/2003 (hereafter the Regulation) and
entered in the Community Register of genetically
modified food and feed. The scope of the notification
covered food (processed oil) produced from the male
sterile MS1Bn (B91-4) oilseed rape line and all conven-
tional crosses,
the fertility restorer RF1Bn (B93-101)
oilseed rape line and all conventional crosses and the
hybrid combination MS1xRF1 (ACS-BNØØ4-7xACS-
BNØØ1-4) as well as feed containing or consisting of
oilseed swede-rape derived from the male sterile MS1
(B91-4), cultivar Drakkar, oilseed rape line (Brassica
napus L. oleifera Metzg.), the fertility restorer RF1 (B93-
101), cultivar Drakkar, oilseed rape line (Brassica napus L.
oleifera Metzg.) and the hybrid combination MS1xRF1
(ACS-BNØØ4-7xACS-BNØØ1-4)
L.
oleifera Metzg. MS1Bn x RF1Bn) for the intended uses
of growing and handling in the environment before
and during processing to non-viable fractions.

(Brassica

napus

(6)

The notifier of hybrid oilseed rape ACS-BNØØ4-7xACS-
BNØØ1-4,
in a letter to the Commission dated 15
November 2005, indicated that varieties containing this
event were no longer offered for sale on a global basis
and that all inventory seed were recalled and destroyed
after the 2003 sales season.

(5) 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).

L 117/18

EN

Official Journal of the European Union

5.5.2007

(7)

(8)

(9)

(10)

(11)

(12)

The notifier has further indicated to the Commission that
it has no intention to submit an application for renewal
of the authorisation of ACS-BNØØ4-7, ACS-BNØØ1-4
combination ACS-BNØØ4-7xACS-
and
the hybrid
the Regulation in
rape under
BNØØ1-4 oilseed
accordance with the first sub-paragraph of Article 8(4),
Article 11, Article 20(4) and Article 23 respectively.
Therefore neither the cultivation nor the placing on the
market of ACS-BNØØ4-7xACS-BNØØ1-4 hybrid oilseed
rape and its derived products will be authorised in the
Community after 18 April 2007.

Measures should therefore be adopted in order to ensure
effective withdrawal from the market of seeds of hybrid
oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4. As a conse-
quence of
the non-availability of seeds, any products
derived from ACS-BNØØ4-7, ACS-BNØØ1-4 and the
hybrid
ACS-BNØØ4-7xACS-BNØØ1-4
oilseed rape can be expected to disappear from the
food and feed chain in a reasonable period of time.

combination

Since the notifier has stopped selling seeds of hybrid
oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 after
the
2003 planting season, stocks of products derived from
ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combi-
nation ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape have
been used up and are not expected to be present on the
market after 18 April 2007. However, minute traces of
genetically modified material from ACS-BNØØ4-7, ACS-
BNØØ1-4 and the hybrid combination ACS-BNØØ4-
7xACS-BNØØ1-4 oilseed rape might remain present in
food or feed products for a certain period of time.

For reasons of legal certainty, it is therefore necessary to
provide for a transitional period of time within which
food and feed products may contain such material
without being considered to be in breach of Article
4(2) or Article 16(2) of
the Regulation where this
presence is adventitious or technically unavoidable.

The tolerated level and the period of time should be set
taking into account the time needed until the effective
withdrawal from the market of the seeds produces its
effects throughout the food and feed chain. In all cases,
the tolerated level shall remain below the labelling and
traceability threshold of no higher than 0,9 % provided
for by the Regulation for the adventitious or technically
unavoidable presence of GM material in food and feed.

the Regulation,

The entries in the Community Register of genetically
modified food and feed, as provided for in Article 28
of
regarding ACS-BNØØ4-7, ACS-
BNØØ1-4 and the hybrid combination ACS-BNØØ4-
7xACS-BNØØ1-4 oilseed rape should be modified in
order to take account of this Decision.

(13)

(14)

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

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

In order to ensure effective withdrawal from the market of seeds
of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 for the
purpose of cultivation the notifier
shall comply with the
measures set out in the Annex.

from the date of notification of

this
Within six months
Decision,
to the Commission a
report on the implementation of the measures set out in the
Annex.

the notifier

submit

shall

Article 2

The presence of material which contains, consists of or is
produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and the
hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed
rape in food or feed products notified under Article 8(1)(a)
and Article 20(1) of the Regulation shall be tolerated until
five years after the date of notification of this Decision:

(a) provided that this presence is adventitious or technically

unavoidable; and

(b) in a proportion no higher than 0,9 %.

Article 3

The entries in the Community Register of genetically modified
food and feed, as provided for in Article 28 of the Regulation,
regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid
combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape shall
be modified in order to take account of this Decision.

Article 4

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

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

5.5.2007

EN

Official Journal of the European Union

L 117/19

ANNEX

Measures to be complied with by the notifier in order to ensure effective withdrawal from the market of seeds
of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 for the purpose of cultivation

(a) Inform commercial operators in the Community of the commercial and legal status of the seed.

(b) Recall remaining commercial seed stock held by operators.

(c) Destroy remaining commercial seed stock.

(d) Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify

and attest that the seed has been destroyed.

(e) Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed cata-

logues.

(f)

Implement an in-house program to avoid presence of the event in breeding and seed production.