2007/304/EC: Commission Decision of 25 April 2007 on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products (notified under document number C(2007) 1804)
Date: 2007-04-25
Institutions: European Commission
Subjects: genetically modified organism, maize, seed, withdrawal from the market

L 117/14

EN

Official Journal of the European Union

5.5.2007

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products

(notified under document number C(2007) 1804)

(Only the English text is authentic)

(2007/304/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

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,

(3)

Whereas:

(1)

organisms (2)

Bt176 (SYN-EV176-9) maize has been granted consent
pursuant to Council Directive 90/220/EEC of 23 April
1990 on the deliberate release into the environment of
by Commission
genetically modified
Decision 97/98/EC of 23 January 1997 concerning the
placing on the market of genetically modified maize (Zea
mays L.) with the combined modification for insecticidal
properties conferred by the Bt-endotoxin gene and
glufosinate
herbicide
increased
ammonium,
of Council Directive
90/220/EEC (3). Directive 90/220/EEC has been recast
and repealed by Directive 2001/18/EC.

the
to
application

tolerance
on

(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 Directive as repealed by Directive
2001/18/EC of the European Parliament and of the Council
(OJ
L 106, 17.4.2001, p. 1).
(3) OJ L 31, 1.2.1997, p. 69.

The consent was based on the respective opinions of the
Scientific Committee for Animal Nutrition established by
Commission Decision 76/791/EEC (4), of the Scientific
Committee
by Commission
Decision 95/273/EC (5) and of the Scientific Committee
established by Commission Decision
for Pesticides
78/436/EEC (6).

established

Food

for

SYN-EV176-9 maize and its derived products have subse-
quently been notified by Syngenta Crop Protection AG
(hereafter ‘the notifier’) as existing products under Article
8(1) 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 scope
of
the notification covered food consisting of and/or
containing or produced from SYN-EV176-9 maize,
food additives produced from SYN-EV176-9 maize,
feed consisting of
containing SYN-EV176-9
maize,
feed materials produced from SYN-EV176-9
maize and feed additives produced from SYN-EV176-9
maize.

and/or

(4)

The notifier of SYN-EV176-9 maize,
in a letter to the
Commission dated 19 September 2005, indicated that it
has stopped selling seeds of SYN-EV176-9 maize in the
Community after the 2005 planting season.

(4) OJ L 279, 9.10.1976, p. 35.
(5) OJ L 167, 18.7.1995, p. 22.
(6) OJ L 124, 12.5.1978, p. 16.

5.5.2007

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Official Journal of the European Union

L 117/15

(5)

(6)

(7)

(8)

(9)

The notifier has further indicated to the Commission that
it has no intention to submit an application for renewal
of the authorisation of SYN-EV176-9 maize under the
Regulation in accordance with Article 8(4), Article 11,
Article 20(4) and Article 23 respectively. Therefore
neither the cultivation nor the placing on the market
of SYN-EV176-9 maize 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 from
inbred lines and hybrids derived from SYN-EV176-9
the non-availability of
maize. As a consequence of
seeds, any products derived from SYN-ENV176-9 maize
can be expected to disappear from the food and feed
chain in a reasonable period of time.

Since the notifier has stopped selling seeds of SYN-
EV176-9 maize in the Community after
the 2005
planting season, stocks of products derived from SYN-
EV176-9 maize 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 SYN-EV176-9 maize 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.

(11)

(12)

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
from inbred lines and hybrids derived from SYN-EV176-9
maize for the purpose of cultivation the notifier shall comply
with the measures set out in the Annex.

Within 6 months from the date of notification of this Decision,
the notifier shall submit to the Commission a report on the
implementation of the measures set out in the Annex.

Article 2

The presence of material which contains, consists of or is
produced from SYN-EV176-9 maize in food or feed products
notified under Article 8(1) and Article 20(1) of the Regulation
shall be tolerated until 5 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 SYN-EV176-9 maize shall be modified in order to
take account of this Decision.

Article 4

This Decision is addressed to Syngenta Crop Protection AG,
P.O. Box, CH-4002 Basel, Switzerland.

Done at Brussels, 25 April 2007.

(10)

The entries in the Community Register of genetically
modified food and feed, as provided for in Article 28
of the Regulation, regarding SYN-EV176-9 maize should
be modified in order to take account of this Decision.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 117/16

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Official Journal of the European Union

5.5.2007

ANNEX

Measures to be complied with by the notifier in order to ensure effective withdrawal from the market of seeds
from inbred lines and hybrids derived from SYN-EV176-9 maize 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.