2007/307/EC: Commission Decision of 25 April 2007 on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products (notified under document number C(2007) 1809)
Date: 2007-04-25
Institutions: European Commission
Subjects: genetically modified organism, oil seed rape, withdrawal from the market

5.5.2007

EN

Official Journal of the European Union

L 117/23

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived
products

(notified under document number C(2007) 1809)

(Only the German text is authentic)

(2007/307/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
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,

(4)

Whereas:

(1)

the

environment

Seeds of oilseed rape (Brassica napus L. spp. oleifera)
derived from traditional breeding crosses between non-
genetically modified oilseed rape and a line resulting
from transformation event Topas 19/2 (ACS-BNØØ7-1)
have been granted consent pursuant to Council Directive
90/220/EEC of 23 April 1990 on the deliberate release
into
genetically modified
organisms (2) by Commission Decision 98/291/EC of
22 April 1998 concerning the placing on the market
of genetically modified spring swede rape (Brassica
napus L.
to Council Directive
90/220/EEC (3) for handling in the environment during
import and before and during storage and processing.
Directive 90/220/EEC has been recast and repealed by
Directive 2001/18/EC.

ssp oleifera) pursuant

of

(2)

The consent was based on the opinion of 10 February
1998 of the Scientific Committee on Plants established
by Commission Decision 97/579/EC (4).

(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 Directive as repealed by Directive
the Council

the European Parliament and of

2001/18/EC of
(OJ L 106, 17.4.2001, p. 1).

(5)

(6)

Processed oil from seeds of oilseed rape ACS-BNØØ7-1
and all conventional crosses 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 1997 concerning novel foods and novel food
ingredients (5).

ACS-BNØØ7-1 oilseed rape and its 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 Regulation (EC) No
1829/2003 (hereafter the Regulation) and entered in the
Community Register of genetically modified food and
feed. The
the notification covered food
(processed oil) produced from seeds of oilseed rape
ACS-BNØØ7-1 and all conventional crosses as well as
feed containing or consisting of or produced from ACS-
BNØØ7-1 oilseed rape for the placing on the market of
the product or handling in the environment during
import and before and during storage and processing.

scope of

The notifier of oilseed rape ACS-BNØØ7-1, 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.

The notifier has further indicated to the Commission that
it has no intention to submit an application for renewal
of the authorisation of ACS-BNØØ7-1 oilseed rape under
the Regulation in accordance with the first subparagraph
of Article 8(4), Article 11, Article 20(4) and Article 23
respectively. Therefore ACS-BNØØ7-1 oilseed rape and
its derived products cannot be placed on the market in
the Community after 18 April 2007.

(3) OJ L 131, 5.5.1998, p. 26.
(4) OJ L 237, 28.8.1997, p. 18.

(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 117/24

EN

Official Journal of the European Union

5.5.2007

(7)

(8)

(9)

Measures to ensure effective withdrawal from the market
of seeds of oilseed rape ACS-BNØØ7-1 for the purpose
of cultivation are not necessary since these seeds could
never be legally placed on the market in the Community.
Since the notifier has stopped selling seeds of oilseed
rape ACS-BNØØ7-1 after the 2003 planting season,
stocks of products derived from ACS-BNØØ7-1 oilseed
rape have been used up and are not expected to be
present on the market after 18 April 2007. However,
minute traces of ACS-BNØØ7-1 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.

(10)

The entries in the Community Register of genetically
modified food and feed, as provided for in Article 28
of the Regulation, regarding ACS-BNØØ7-1 oilseed rape
should be modified in order to take account of this
Decision.

(11)

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

(12)

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

The presence of material which contains, consists of or is
produced from ACS-BNØØ7-1 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 2

The entries in the Community Register of genetically modified
food and feed, as provided for in Article 28 of the Regulation,
regarding ACS-BNØØ7-1 oilseed rape shall be modified in
order to take account of this Decision.

Article 3

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