2005/772/EC: Commission Decision of 3 November 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium (notified under document number C(2005) 4192)
Date: 2005-11-03
Institutions: European Commission
Subjects: EU control, genetically modified organism, labelling, maize, market approval, marketing, marketing standard, plant health treatment

L 291/42

EN

Official Journal of the European Union

5.11.2005

COMMISSION DECISION

of 3 November 2005

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for
resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium

(notified under document number C(2005) 4192)

(Only the Dutch text is authentic)

(2005/772/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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)

(2)

(3)

(4)

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
to written
genetically modified organisms
consent being granted by the competent authority of a
Member State,
in accordance with the procedure laid
down in that Directive.

subject

is

A notification concerning the placing on the market of a
genetically modified maize product
line
1507) was submitted by Pioneer Hi-Bred International,
INC and Mycogen Seeds to the competent authority of
the Netherlands (ref C/NL/00/10).

(Zea mays L.,

The notification covers importation and use as for any
other maize grains including feed, with the exception of
cultivation and uses as or in food, in the Community, of
varieties derived from the 1507 transformation event.

In accordance with the procedure provided for in Article
14 of Directive 2001/18/EC, the competent authority of
the Netherlands prepared an assessment report, which
was submitted to the Commission and the competent
the other Member States; whereby the
authorities of
concluded that no reasons have
assessment

report

(5)

(6)

(7)

(8)

(9)

emerged on the basis of which consent for the placing
on the market of Zea mays L.
line 1507 should be
withheld, provided that specific conditions are fulfilled.

The competent authorities of other Member States raised
objections to the placing on the market of the product.

The opinion adopted on 24 September 2004 by the
European Food Safety Authority, concluded that Zea
mays L. line 1507 is unlikely to have an adverse effect
on human and animal health or the environment in the
context of its proposed use. The European Food Safety
Authority also deemed that the monitoring plan provided
by the applicant was in line with the intended uses of
1507 maize.

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 Zea mays L.
line 1507 will
adversely affect human or animal health or the envir-
onment.

A unique identifier should be assigned to the 1507 maize
for the purposes of Regulation (EC) No 1830/2003 of
the Council of 22
the European Parliament and of
September 2003 concerning
and
labelling of genetically modified organisms and the trace-
food and feed products produced from
ability of
genetically modified organisms and amending Directive
2001/18/EC (2) and Commission Regulation (EC) No
65/2004 of 14 January 2004 establishing a system for
the development and assignment of unique identifiers for
genetically modified organisms (3).

traceability

the

organisms

technically

accordance with

unavoidable
in

traces of
Adventitious or
are
genetically modified
exempted from labelling and traceability requirements
under
in
(EC) No
Directive
1829/2003 of
the
Council of 22 September 2003 on genetically modified
food and feed (4).

the European Parliament and of

2001/18/EC

established

Regulation

thresholds

products

and

(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).

(2) OJ L 268, 18.10.2003, p. 24.
(3) OJ L 10, 16.1.2004, p. 5.
(4) OJ L 268, 18.10.2003, p. 1.

(10)

(11)

(12)

5.11.2005

EN

Official Journal of the European Union

L 291/43

it

In view 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 product and the protection
of particular ecosystems, environments or geographical
areas.

(Ostrinia nubilalis) and certain other lepidopteran pests and with
tolerance to the herbicide glufosinate-ammonium, derived from
Zea mays line 1507, which has been transformed using particle
acceleration technology with the
linear DNA fragment
PHI8999A containing the following DNA in two cassettes:

(a) cassette 1:

Prior to the placing on the market of the product, 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
expiry of
the period laid down in Article 30(2) 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 (1) the measures should be
adopted by the Commission;

HAS ADOPTED THIS DECISION:

Article 1

Consent

a synthetic version of the truncated cry1F gene derived from
Bacillus thuringiensis subsp. aizawai, which confers resistance
to the European corn borer (Ostrinia nubilalis) and certain
other lepidopteran pests such as the pink borer (Sesamia
spp.), fall armyworm (Spodoptera frugiperda), black cutworm
(Diatraea
ipsilon) and southwestern corn borer
(Agrotis
grandiosella),
ubiquitin
the
promoter ubiZM1(2) derived from Zea mays and the
ORF25PolyA terminator
from Agrobacterium tumefaciens
pTi15955;

regulation

under

the

of

(b) cassette 2:

a synthetic version of the pat gene derived from Streptomyces
viridochromogenes strain Tü494, which confers tolerance to
the herbicide glufosinate-ammonium, under the regulation
of the 35S Cauliflower Mosaic Virus promoter and terminator
sequences.

2.
The consent shall cover grains from progeny derived from
crosses of maize line 1507 with any traditionally bred maize as
or in products.

Without prejudice to other Community legislation, in particular
Regulation (EC) No 258/97 of the European Parliament and of
the Council (2) and Regulation (EC) No 1829/2003, written
consent shall be granted by the competent authority of the
Netherlands to the placing on the market, in accordance with
this Decision, of the product identified in Article 2, as notified
by Pioneer Hi-Bred International,
Inc. and Mycogen Seeds
(Reference C/NL/00/10).

Article 3

Conditions for placing on the market

The product may be put to the same uses as any other maize,
with the exception of cultivation and uses as or in food, and
to the following
may be placed on the market
conditions:

subject

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.

(a)

the period of validity of
starting from the date on which the consent is issued;

the consent shall be 10 years

(b) the unique identifier of the product shall be DAS-Ø15Ø7-1;

Article 2

Product

The genetically modified organisms to be placed on the
1.
market as or in products, hereinafter ‘the product’, are grains of
maize (Zea mays L.), with resistance to the European corn borer

(1) OJ L 184, 17.7.1999, p. 23.
(2) OJ L 43, 14.2.1997, p. 1.

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the consent holder shall, whenever requested to do so,
make positive
the
product, or
reference materials
available
to the competent authorities and inspection
services of Member States as well as to the Community
control laboratories;

its genetic material, or

and negative

samples of

control

L 291/44

EN

Official Journal of the European Union

5.11.2005

(d) without prejudice to specific labelling requirements provided
by Regulation (EC) No 1829/2003 the words ‘This product
contains genetically modified organisms’ or ‘This product
contains genetically modified 1507 maize’ 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;

(e) as long as the product has 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 product.

Article 4

Monitoring

the period of validity of
shall

1.
Throughout
the
the consent,
the monitoring plan
consent holder
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 product, is put in place and implemented.

ensure

that

2.
The consent holder shall directly inform the operators,
users, national agencies for animal nutrition and feed research
as well as veterinary services of the introduction of 1507 maize
into the Community as well as on the safety and general char-
acteristics of the product and of the conditions as to moni-
toring.

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.

to the

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
the competent authority of the Member State which received
the original notification, in the light of the results of the moni-

agreement of

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 monitoring networks as specified in the monitoring
plan contained in the notification collect the information
relevant for the monitoring of the product and

(b) that the members of these networks have agreed to make
available that information to the consent holder before the
date of the 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 a Community
Decision authorising the placing on the market of the product
referred to in Article 1 for uses as or in food within the
meaning of Regulation (EC) No 178/2002 of the European
the Council (1) and including a method,
Parliament and of
for
validated
detection of the product is applicable.

the Community

laboratory,

reference

by

Article 6

Addressee

This Decision is addressed to the Kingdom of the Netherlands.

Done at Brussels, 3 November 2005.

For the Commission

Stavros DIMAS
Member of the Commission

(1) OJ L 31, 1.2.2002, p. 1.