2008/470/EC: Commission Decision of 7 May 2008 concerning the provisional prohibition of the use and sale in Austria of genetically modified maize ( Zea mays L. line T25) pursuant to Directive 2001/18/EC of the European Parliament and of the Council (notified under document number C(2008) 1715) (Text with EEA relevance)
Date: 2008-05-07
Institutions: European Commission
Subjects: Austria, food safety, genetically modified organism, maize, market approval

21.6.2008

EN

Official Journal of the European Union

L 162/31

COMMISSION

COMMISSION DECISION

of 7 May 2008

concerning the provisional prohibition of the use and sale in Austria of genetically modified maize
(Zea mays L. line T25) pursuant to Directive 2001/18/EC of the European Parliament and of the
Council

(notified under document number C(2008) 1715)

(Only the German text is authentic)

(Text with EEA relevance)

(2008/470/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)

By Commission Decision 98/293/EC of 22 April 1998
concerning the placing on the market of genetically
modified maize (Zea mays L.
to
Council Directive 90/220/EEC (2)
it was decided that
consent was to be given for the placing on the market
of that product.

line T25), pursuant

On 3 August 1998 the French authorities granted such
consent. The consent covers all uses of
the product,
namely import, processing into food and feed products
and cultivation.

Pursuant to Article 35(1) of Directive 2001/18/EC which
replaced Council Directive 90/220/EEC (3), procedures in
respect of notifications concerning the placing on the

market of genetically modified organisms which have not
been completed by 17 October 2002 are subject
to
Directive 2001/18/EC.

On 8 May 2000 Austria informed the Commission of its
decision to prohibit provisionally the use and sale of Zea
mays L. line T25 for all uses and gave reasons for that
decision in accordance with Article 16(1) of Directive
90/220/EEC.

Products derived from Zea mays L. line T25 (starch and
all its derivatives, crude and refined oil, all heat-processed
or fermented products obtained from Zea mays L.
line
T25, as well as feed produced from Zea mays L. line T25)
are authorised under Regulation (EC) No 258/97 of the
European Parliament and of the Council (4) and Regu-
lation (EC) No 1829/2003 of the European Parliament
and of the Council (5). These uses are not subject to the
safeguard clause notified by Austria.

The Scientific Committee on Plants concluded on 20 July
2001 that the information submitted by Austria did not
constitute new relevant scientific evidence which had not
been taken into account during the original evaluation of
the dossier and which would occasion a review of that
Committee’s original opinion on this product.

On 9 January 2004, as well as on 9 and 17 February
2004, Austria submitted to the Commission additional
information in support of
its national measures
concerning maize line T25.

(4)

(5)

(6)

(7)

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Directive

2008/27/EC (OJ L 81, 20.3.2008, p. 45).

(2) OJ L 131, 5.5.1998, p. 30.
(3) OJ L 117, 8.5.1990, p. 15. Directive as

last amended by

(5) OJ L 268, 18.10.2003, p. 1. Regulation as last amended by Regu-

(4) 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).

Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

lation (EC) No 298/2008 (OJ L 97, 9.4.2008, p. 64).

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Official Journal of the European Union

21.6.2008

(8)

(9)

(10)

28(1)

accordance with Article

of Directive
In
2001/18/EC,
the Commission consulted the European
Food Safety Authority (EFSA), as established by Regu-
lation (EC) No 178/2002 of the European Parliament
and of the Council (1), under which it has replaced the
relevant scientific committees.

The EFSA concluded on 8 July 2004 (2) that the infor-
mation submitted by Austria did not constitute new
scientific evidence sufficient to invalidate the environ-
mental risk assessment of maize line T25,
justifying a
prohibition of the use and sale of that product in Austria.

Since, under the circumstances, there was no reason to
consider that the product constituted a risk to human
health or the environment, the Commission submitted
on 29 November 2004 a draft Decision, requesting
Austria to repeal
its provisional safeguard measure, for
established under
the Committee
consideration by
Article 30 of Directive 2001/18/EC, in accordance with
the procedure laid down in Article 30(2) of
that
Directive.

(11) However, that Committee did not deliver an opinion and,
in accordance with Article 5(4) of Council Decision
1999/468/EC of 28 June 1999 laying down the
implementing powers
procedures for
conferred on the Commission (3),
the Commission
submitted to the Council a proposal relating to the
measures to be taken.

the exercise of

(12) On 24 June 2005,

in accordance with Article 5(6) of
Decision 1999/468/EC, the Council, acting by qualified
majority, rejected this proposal.

(13)

The Council, in its declaration, stated that ‘there is still a
degree of uncertainty in relation to the national safeguard
measures on the market of [the] genetically modified
maize variet[y] […] T25’ and called on the Commission
‘to gather further evidence on the GMO in question and
further assess, whether the measure taken by [Austria]
aimed at
suspending as a temporary precautionary
measure [its] placing on the market [is] justified and,
whether the authorisation of such [an] organism still
meets the safety requirements of Directive 2001/18/EC’.

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).

(2) Opinion of the Scientific Panel on Genetically Modified Organisms
on a request from the Commission related to the Austrian invoke of
Article 23 of Directive 2001/18/EC, The EFSA Journal (2004) 78,
1-13.

(3) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(14)

(15)

(16)

(17)

(18)

(19)

In November 2005, the EFSA was consulted again by the
Commission as to whether
there was any scientific
reason to believe that
the continued placing on the
market of T25 maize was likely to cause any adverse
effects to human health or the environment under the
conditions of consent.
the EFSA was
requested to take account of any further scientific infor-
mation that had arisen subsequent
to the previous
scientific opinion concerning the safety of this GMO.

In particular,

In its opinion of 29 March 2006 (4), EFSA concluded
that there is no reason to believe that the continued
placing on the market of T25 maize is likely to cause
any adverse effects for human and animal health or the
environment under the conditions of its consent.

accordance with Article

of Decision
In
1999/468/EC, the Commission submitted a proposal to
the Council requesting Austria to repeal
its safeguard
measure.

5(6)

accordance with Article
the

In
1999/468/EC,
18 December 2006,
qualified majority, to the proposal.

of Decision
Environment
on
Council,
indicated its opposition by

5(6)

In its Decision, the Council referred to the environmental
risk assessment as provided in the Directive 2001/18/EC
and indicated that ‘the different agricultural structures
and regional ecological characteristics in the European
Union need to be taken into account
in a more
systematic manner in the environmental risk assessment’.

In accordance with Article 5(6) of Decision 1999/468/EC
the Commission submitted an amended proposal
in
the Council Decision of
order to take into account
18 December 2006 which refers only to the environ-
mental aspects of the Austrian safeguard clause, namely
cultivation aspects.

(20) Austria has

in particular

initiated work to collect any relevant
scientific evidence on these aspects, which in the view
of Austria justifies provisionally the maintenance of the
in reference to ‘the
safeguard clause,
different agricultural structures and regional ecological
characteristics’ as indicated in recital 3 of
the above
mentioned Council
accordance with
decision.
Article 23 of Directive 2001/18/EC, Austria is invited
the scientific
to provide the Commission with all
evidence that it has collected as well as any new risk
assessment as soon as it is completed and inform all
Member States thereof.

In

(4) Opinion of the Scientific Panel on Genetically Modified Organisms
on a request from the Commission related to genetically modified
crops (Bt176 maize, MON810 maize, T25 maize, Topas 19/2
oilseed rape and Ms1xRf1 oilseed rape)
to safeguard
clauses invoked according to Article 16 of Directive 90/220/EEC,
The EFSA Journal (2006) 338, pp. 1-15.

subject

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L 162/33

(21) On the basis of Austria’s submission and its scientific
assessment,
in accordance
with Article 23 of Directive 2001/18/EC on these
aspects of the Austrian measure.

the Commission will act

(22)

(23)

consent

The food and feed safety aspects of Zea mays L. line T25
granted under Directive
covered by
the
90/220/EEC (including import
are
and processing)
identical throughout Europe and have been assessed by
the EFSA, which concluded that this product is unlikely
to cause any adverse effects for human and animal
health.

The Commission proposal takes into account only food
and feed aspects of the Austrian prohibition namely the
prohibition on import and processing of unprocessed
kernels as source materials for further processing or for
direct food or feed use.

(24) Under

these circumstances Austria should repeal

its
safeguard measures at least with regard to import and
processing into food and feed of Zea mays L. line T25.

(25)

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
in accordance with Article 5(6) of Decision
them,

1999/468/EC, the measures should be adopted by the
Commission,

HAS ADOPTED THIS DECISION:

Article 1

The measures taken by Austria to prohibit the import and the
processing into food and feed products of the Zea mays L. line
T25, authorised for placing on the market by Decision
98/293/EC are not
justified under Article 23 of Directive
2001/18/EC.

Article 2

Austria shall take the necessary steps to terminate the pro-
and processing into food and feed
hibition of
products of Zea mays L.
line T25 at the latest 20 days after
its notification.

import

Article 3

This Decision is addressed to the Republic of Austria.

Done at Brussels, 7 May 2008.

For the Commission

Stavros DIMAS
Member of the Commission