HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 34/12
EN
Official Journal of the European Union
7.2.2012
COMMISSION IMPLEMENTING DECISION
of 3 February 2012
amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period
for traces of Ms1xRf1 (ACS-BN4-7xACS-BN1-4) hybrid oilseed rape, Ms1xRf2 (ACS-
BN4-7xACS-BN2-5) hybrid oilseed rape and Topas 19/2 (ACS-BN7-1) oilseed rape, as
well as of their derived products
(notified under document C(2012) 518)
(Only the German text is authentic)
(2012/69/EU)
THE EUROPEAN COMMISSION,
(3)
Decisions 2007/305/EC and 2007/306/EC also set out a
series of measures that the notifier has to take to ensure
the effective withdrawal from the market of Ms1xRf1
Having regard to the Treaty on the Functioning of the European
(ACS-BN4-7xACS-BN1-4) hybrid oilseed rape,
Union,
Ms1xRf2 (ACS-BN4-7xACS-BN2-5) hybrid
oilseed rape and their derived products. Similar
measures were not considered necessary in Decision
Having regard to Regulation (EC) No 1829/2003 of the
2007/307/EC since the notifier had stopped selling
European Parliament and of the Council of 22 September
seeds of oilseed rape ACS-BN7-1 after the 2003
2003 on genetically modified food and feed (
planting season and in light of the fact that stocks of

1 ), and in
particular Articles 8(6) and 20(6) thereof,
products derived from ACS-BN7-1 oilseed rape had
been used up before 18 April 2007. However, given that
minute traces of ACS-BN7-1 oilseed rape might
remain present in food or feed products for a certain
Whereas:
period of time it was necessary to adopt Decision
2007/307/EC.
(1) Commission
Decisions
2007/305/EC
( 2 ), 2007/306/EC ( 3 )
and 2007/307/EC ( 4 ) set out the rules for the withdrawal
from the market of the following genetically modified
(4) In
the
absence
of
experience
or
concrete
data
on
the
time
material (‘the GM material’): Ms1xRf1 (ACS-BN4-
needed to ensure a complete withdrawal from the market
7xACS-BN1-4) hybrid oilseed rape, Ms1xRf2 (ACS-
of the GM material, the tolerated level of presence of that
BN4-7xACS-BN2-5) hybrid oilseed rape and
material and the time needed to ensure total withdrawal
Topas 19/2 (ACS-BN7-1) oilseed rape, as well as
from the food and feed chains provided for in Decisions
their derived products. Those Decisions have been
2007/305/EC, 2007/306/EC and 2007/307/EC were set
adopted after the notifier of the GM material had
on the basis of data available at this time and results of
indicated to the Commission that it had no intention
testing by stakeholders.
to submit an application for renewal of the authorisation
of that material in accordance with the first subparagraph
of Article 8(4), Article 11, Article 20(4) and Article 23 of
(5) In
accordance
with
the
requirements
of
Decisions
Regulation (EC) No 1829/2003.
2007/305/EC and 2007/306/EC, the authorisation
holder submitted detailed reports in October 2007 and
November 2011 on the implementation of discon
(2) All
three
Decisions
provide
for
a
transitional
period
of
tinuation measures for the above GM oilseed rape
time of 5 years, during which food and feed containing
events. These reports outline past and current measures
the GM material are allowed to be placed on the market,
which have been implemented by the authorisation
in accordance with Article 4(2) or Article 16(2) of the
holder in accordance with the abovementioned
Regulation, subject to a number of conditions. The
decisions to ensure the removal of this GM material
Decisions require in particular that the presence of the
from the market. These include, among others, steps
GM material in food and feed does not exceed a
taken to inform commercial operators in the EU of the
threshold of 0,9 % and that the presence of this GM
discontinued status of this GM material, the implemen
material be adventitious or technically unavoidable. The
tation of a series of measures to ensure the recall and
purpose of the transitional period is to take into
destruction of remaining commercial seed stock, the
consideration the fact that minute traces of the GM
conclusion of agreements with all third parties involved
material can be present in the food and feed chain
in the commercialisation of this GM material to ensure
some time after the notifier has decided to stop selling
that the seed from this GM material is either sent back to
seeds derived from the GMO, even if the notifier has
the authorisation holder or is effectively destroyed, the
taken all measures to avoid that presence.
actions undertaken to ensure the deregistration of
registered varieties of the event concerned from the
national seed catalogue and the implementation of an
( 1 ) OJ L 268, 18.10.2003, p. 1.
in-house program based on a quality assurance process
( 2 ) OJ L 117, 5.5.2007, p. 17.
( 3 ) OJ L 117, 5.5.2007, p. 20.
to avoid the presence of these GM events in breeding and
( 4 ) OJ L 117, 5.5.2007, p. 23.
seed production.

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EN
7.2.2012 Official
Journal
of
the
European
Union L
34/13
(6) Recent
test
results
notified
by
stakeholders
to
the
‘By 1 January 2014, the notifier shall submit to the
Commission show that the measures undertaken by the
Commission a report on the implementation of the
authorisation holder have allowed the removal of nearly
measures set out in the Annex.’;
all the GM material from the market. However, these
results also show that minute traces (< 0,1 %) of the
(b) Article 2 shall be replaced by the following:
GM material may still be present in the food or feed
chain at the end of the transitional period set
‘Article 2
out in Decisions 2007/305/EC, 2007/306/EC and
2007/307/EC. The presence of remaining traces after
The presence of material which contains, consists of or is
the expiry date set out in these decisions, despite the
produced from ACS-BN4-7, ACS-BN1-4 and
measures undertaken by the notifier, can be explained
the hybrid combination ACS-BN4-7xACS-BN1-4
by the biology of oilseed rape which can remain
oilseed rape in food or feed products notified under
dormant for long periods as well as by the farm
Article 8(1)(a) and Article 20(1) of Regulation (EC) No
practices which have been employed to harvest the
1829/2003 shall be tolerated until 31 December 2016:
seed and resulting accidental spillage, the level of which
was difficult to estimate at the date of adoption of the
(a) provided that this presence is adventitious or technically
three abovementioned Decisions.
unavoidable; and
(7) Against
this
background
it
is
necessary
to
extend
the
(b) in a proportion no higher than 0,1 %.’;
current transitional period of time for another 5 years,
that is until 31 December 2016. This supplementary
2. Decision
2007/306/EC
is
amended
as
follows:
transitional period should provide sufficient time to
allow the total removal of the GM material from the
(a) the second paragraph of Article 1 shall be replaced by the
food and feed chain, taking into account the abovemen
following:
tioned parameters linked to the biology of oilseed rape
and the past farming practices used to harvest the crops.
‘By 1 January 2014, the notifier shall submit to the
Commission a report on the implementation of the
measures set out in the Annex.’;
(8) In
order
to
further
contribute
to
the
removal
of
oilseed
rape ACS-BN7-1 from the food and feed chains, it is
also appropriate to provide in Decision 2007/307/EC
(b) Article 2 is replaced by the following:
that the notifier implements an in-house program to
avoid the presence of this event in the breeding and
‘Article 2
seed production process.
The presence of material which contains, consists of or is
produced from ACS-BN4-7, ACS-BN2-5 and
(9) By
1
January
2014,
the
notifier
should
submit
a
report
to
the hybrid combination ACS-BN4-7xACS-BN2-5
the Commission providing information on the imple
oilseed rape in food or feed products notified under
mentation during the additional period of time granted
Article 8(1)(a) and Article 20(1) of the Regulation (EC) No
by this decision of the measures set out in the Annex to
1829/2003 shall be tolerated until 31 December 2016:
Decisions 2007/305/EC and 2007/306/EC, as well as in
Article 1(1) of Decision 2007/307/EC.
(a) provided that this presence is adventitious or technically
unavoidable; and
(10) In
view
of
the
very
low
trace
levels
which
have
been
(b) in a proportion no higher than 0,1 %.’;
reported, it is appropriate to reduce to 0,1 % the level
of presence of the GM material that is tolerated in food
and feed.
3. Article
1
of
Decision
2007/307/EC
is
replaced
by
the

following:
(11) Decisions
2007/305/EC,
2007/306/EC
and
2007/307/EC
‘Article 1
should therefore be amended accordingly.
1. The
notifier
shall
implement
an
in-house
program
to
avoid the presence of ACS-BN7-1 oilseed rape in breeding
(12) The
measures provided for in this Decision are in
and seed production and shall report to the Commission on
accordance with the opinion of the Standing
the implementation of this measure by 1 January 2014.
Committee on the Food Chain and Animal Health,
2. The presence of material which contains, consists of or
HAS ADOPTED THIS DECISION:
is produced from ACS-BN7-1 oilseed rape in food or feed
products notified under Article 8(1)(a) and Article 20(1) of
the Regulation (EC) No 1829/2003 shall be tolerated until
Article 1
31 December 2016:
1. Decision
2007/305/EC
is
amended
as
follows:
(a) provided that this presence is adventitious or technically
unavoidable; and
(a) the second paragraph of Article 1 shall be replaced by the
following:
(b) in a proportion no higher than 0,1 %.’

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L 34/14
EN
Official Journal of the European Union
7.2.2012
Article 2
The entries in the Community Register of genetically modified food and feed, as provided for in Article 28
of Regulation (EC) No 1829/2003, regarding ACS-BN4-7, ACS-BN1-4 and the hybrid combination
ACS-BN4-7xACS-BN1-4 oilseed rape, ACS-BN4-7, ACS-BN2-5 and the hybrid combination
ACS-BN4-7xACS-BN2-5 oilseed rape, and ACS-BN7-1 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, 40789 Monheim am Rhein,
Germany.
Done at Brussels, 3 February 2012.
For the Commission
John DALLI
Member of the Commission

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Document Outline

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