2008/495/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 MON810) pursuant to Directive 2001/18/EC of the European Parliament and of the Council (notified under document number C(2008) 1718) (Text with EEA relevance)
Date: 2008-05-07
Institutions: European Commission
Subjects: Austria, food safety, genetically modified organism, maize, market approval

2.7.2008

EN

Official Journal of the European Union

L 172/25

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

II

DECISIONS

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 MON810) pursuant to Directive 2001/18/EC of the European Parliament and of
the Council

(notified under document number C(2008) 1718)

(Only the German text is authentic)

(Text with EEA relevance)

(2008/495/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

namely import, processing into food and feed products
and cultivation.

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)

By Commission Decision 98/294/EC of 22 April 1998
concerning the placing on the market of genetically
modified maize (Zea mays L.
line MON810), pursuant
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.

(2)

On 3 August 1998 the French authorities granted such
the product,
consent. The consent covers all uses of

(3)

(4)

(5)

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 2 June 1999 Austria informed the Commission of its
decision to prohibit provisionally the use and sale of Zea
mays L. line MON810 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 MON810 (food
and food ingredients produced from maize flour, maize
gluten, maize semolina, maize starch, maize glucose and
maize oil produced from Zea mays L. line MON810) are
authorised under Regulations (EC) No 258/97 (4) and
(EC) No 1829/2003 of the European Parliament and of
the Council (5). These uses are not
to the
safeguard clause notified by Austria.

subject

(3) OJ L 117, 8.5.1990, p. 15.
(4) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

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

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

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

(2) OJ L 131, 5.5.1998, p. 32.

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

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

L 172/26

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Official Journal of the European Union

2.7.2008

(6)

(7)

(8)

(9)

concluded on
The Scientific Committee on Plants
24 September 1999 that the information submitted by
Austria did not constitute new relevant scientific evidence
which had not been taken into account during the
the dossier and which would
original evaluation of
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 MON810.

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 MON810, justifying
a prohibition of the use and sale of that product in
Austria.

(10)

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
its provisional safeguard measure, for
Austria to repeal
consideration by
established under
the Committee
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.

(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).

(13)

(14)

(15)

(16)

(17)

(18)

[…] MON810’

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]
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 pre-
cautionary measure [its] placing on the market
[is]
justified and, whether the authorisation of such [an]
of
the
organism still meets
Directive 2001/18/EC’.

requirements

safety

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 MON810 maize was likely to cause any
adverse effects to human health or the environment
under
the
EFSA was requested to take account of any further
scientific information that had arisen subsequent to the
previous scientific opinion concerning the safety of this
GMO.

the conditions of consent.

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 MON810 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

In
of Decision
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
on
Environment
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’.

(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, 1-15.

subject

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Official Journal of the European Union

L 172/27

(19)

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

(25)

(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 abovemen-
tioned Council decision. In accordance with Article 23 of
Directive 2001/18/EC, Austria is invited to provide the
Commission with all the scientific evidence that it has
collected as well as any new risk assessment as soon as it
is completed and inform all Member States thereof.

(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

line
The food and feed safety aspects of Zea mays L.
MON810 covered by
granted under
the
Directive 90/220/EEC (including import and processing)
are identical throughout Europe and have been assessed
by the EFSA, which concluded that
is
unlikely to cause any adverse effects for human and
animal health.

this product

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
MON810.

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 Decision
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
MON810, authorised for placing on the market by Decision
98/294/EC are not
justified under Article 23 of Directive
2001/18/EC.

Article 2

Austria shall take the necessary steps to terminate the prohib-
ition of import and processing into food and feed products of
Zea mays L. line MON810 at the latest 20 days after its noti-
fication.

This Decision is addressed to the Republic of Austria.

Article 3

Done at Brussels, 7 May 2008.

For the Commission

Stavros DIMAS
Member of the Commission