2003/653/EC: Commission Decision of 2 September 2003 relating to national provisions on banning the use of genetically modified organisms in the region of Upper Austria notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty (Text with EEA relevance) (notified under document number C(2003) 3117)
Date: 2003-09-02
Institutions: European Commission
Subjects: Upper Austria, derogation from EU law, genetically modified organism, national law

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 2 September 2003

relating to national provisions on banning the use of genetically modified organisms in the region
of Upper Austria notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty

(notified under document number C(2003) 3117)

(Only the German text is authentic)

(Text with EEA relevance)

(2003/653/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 95(5) and (6) thereof,

Whereas:

I. FACTS

(1)

In a letter dated 13 March 2003, the Austrian Permanent
Representation to the European Union notified the
Commission, in accordance with Article 95(5) of the EC
Treaty of a draft Upper Austrian Act on the prohibition
of genetic engineering 2002 banning the use of geneti-
cally modified organisms in the region of Upper Austria
the
(hereinafter national provisions)
provisions of Directive 2001/18/EC of
the European
Parliament and of the Council (1).

in derogation of

1. Article 95(5) and (6) of the EC Treaty

The Commission shall, within six months of the
6.
notification as referred to in paragraphs (…) 5, approve
or reject the national provisions involved after having
verified whether or not they are a means of arbitrary
discrimination or a disguised restriction to trade between
Member States and whether or not they shall constitute
an obstacle to the functioning of the internal market.

In the absence of a decision by the Commission within
this period the national provisions referred to in para-
graphs (…) 5 shall be deemed to have been approved.

When justified by the complexity of the matter and in
the absence of danger for human health, the Commis-
sion may notify the Member State concerned that the
period referred to in this paragraph may be extended for
a further period of up to six months.’

2. Relevant Community legislation

(2)

Article 95(5) and (6) of the Treaty provides:

2.1. Directive 2001/18/EC on the deliberate release into the

environment of genetically modified organisms

(…) If, after the adoption by the Council or by the
‘5.
Commission of a harmonisation measure, a Member
State deems it necessary to introduce national provisions
based on new scientific evidence relating to the protec-
tion of the environment or the working environment on
grounds of a problem specific to that Member State
arising after the adoption of the harmonisation measure,
it shall notify the Commission of the envisaged provi-
sions as well as the grounds for introducing them.

(1) OJ L 106, 17.4.2001, p. 1.

(3)

The deliberate release of genetically modified organisms
(GMOs) into the environment is governed by Directive
2001/18/EC as of 17 October 2002, on which date
Member States are required to have implemented the
relevant national measures. This Directive is based on
Article 95 of
the Treaty establishing the European
Community and aims at approximating legislation and
procedures in Member States for the authorisation of
GMOs intended for deliberate release into the environ-
ment.

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in place a step-by-step
Directive 2001/18/EC puts
approval process on a case-by-case assessment of the
risks to human health and the environment before any
GMO or product consisting of or containing GMOs or
genetically modified micro-organisms (GMMs) can be
released into the environment or placed on the market.

The Directive provides for two different procedures, for
experimental releases (referred to as part B releases) and
for placing on the market releases (referred to as part C
releases). Part B releases require an authorisation at
national level, whereas part C releases are subject to a
Community procedure, with an eventual decision being
valid throughout the European Union.

At the current time, authorisation for placing on the
market of genetically modified seeds for the purpose of
cultivation is exclusively provided for by Directive 2001/
18/EC. To date, no genetically modified seeds have been
authorised under this Directive although 22 applications
are pending authorisation some of which include uses
that include cultivation.

18 authorisations for the placing on the market of
GMOs were granted under the previous Council Direc-
tive 90/220/EEC (1), which was repealed by Directive
2001/18/EC on 17 October 2002. Of these products,
seeds from three genetically modified maize varieties,
three genetically modified oilseed rape varieties and a
chicory variety have been authorised for the placing on
the market to include cultivation as a use. In addition,
approval has also been granted for cultivation of two
genetically modified carnation varieties.

risk, Member States may

tive constitutes a risk to human health or the environ-
ment, that Member State may provisionally restrict or
prohibit the use and/or sale of that GMO as or in a
product on its territory’. Furthermore, in the event of a
severe
emergency
measures, such as the suspension or termination of the
placing on the market of a GMO and must inform the
Commission of the decision taken on the basis of Article
23, as well as the reasons for having made such a deci-
sion. On this basis, a decision shall be taken at Commu-
nity level on the invoked safeguard clause, in accordance
with the comitology procedure foreseen under Article
30(2) of Directive 2001/18/EC.

take

(10) Directive 2001/18/EC has not yet been transposed into
the Austrian legal order, in contradiction with the provi-
sions of its Article 34, which requires Member States to
bring into force the laws, regulations and administrative
provisions necessary to comply with this Directive by 17
October 2002.

2.2. Council Directive 90/219/EEC (as amended by Directive

98/81/EC)

(11) Directive 90/219/EEC (2), as amended by Directive 98/
81/EC (3), governs the contained use of genetically modi-
fied micro-organisms (GMMs). Austria, as well as 11
other Member States, has transposed this Directive in
order to also cover other GMOs,
including transgenic
animals and fish, and not just GMM. This is admissible
under the contained use Directive. Progeny have already
been bred from transgenic animals and fish in certain
Member States under the contained use conditions of
Directive 90/219/EC as transposed into their national
law. However, consents for such activities are issued on
a national basis, under the provisions of the Directive,
with no associated Community procedure.

Directive 2001/18/EC provides for the placing on the
market and experimental release into the environment of
transgenic animals on the basis that they are classified as
GMOs. Whilst no transgenic animals or fish have as yet
been approved for these purposes, or applications for
such submitted for approval, the Directive does provide
for this possibility.

(12)

2.3. Seeds legislation

The seeds legislation comprises Council Directives 66/
401/EEC (4), 66/402/EEC (5), 2002/54/EC (6), 2002/55/
EC (7), 2002/56/EC (8)
last
amended by Directive 2003/61/EC (10). These Directives
foresee that a seed variety can circulate freely within the
Community provided that:

and 2002/57/EC (9),

as

(4)

(5)

(6)

(7)

(8)

(9)

In addition to the above provisions regarding the author-
isation procedures, Article 23 of Directive 2001/18/EC
this
contains a ‘safeguard clause’. The provisions of
Article mainly foresee that, ‘where a Member State, as a
result of new or additional information made available
since the date of the consent and affecting the environ-
mental risk assessment or reassessment of existing infor-
mation on the basis of new or additional scientific
knowledge, has detailed grounds for considering that a
GMO as or in a product which has been properly noti-
fied and has received written consent under this Direc-

(1) OJ L 117, 8.5.1990, p. 15.

— the variety has passed with success tests proving that
is distinct, stable and sufficiently homogenous.
it must have a satisfactory use and

it
Furthermore,
cultivation value,

(2) OJ L 117, 8.5.1990, p. 1.
(3) OJ L 330, 5.12.1998, p. 13.
(4) OJ 125, 11.7.1966, p. 2298/66.
(5) OJ 125, 11.7.1966, p. 2309/66.
(6) OJ L 193, 20.7.2002, p. 12.
(7) OJ L 193, 20.7.2002, p. 33.
(8) OJ L 193, 20.7.2002, p. 60.
(9) OJ L 193, 20.7.2002, p. 74.
(10) OJ L 165, 3.7.2003, p. 23.

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— if the seeds of this variety have been, at a later stage,
officially examined with regard to their qualities and
certified as basic seeds or certified seeds or, for some
species, officially examined and admitted as commer-
cial seeds.

for such products, an environmental risk assessment
must always be undertaken to ensure environmental
safety. The Regulation therefore imposes a specific envir-
onmental risk assessment similar to that laid down in
Directive 2001/18/EC, but must also include the assess-
ment of the suitability of the product to be used as a
food or food ingredient.

(13)

These directives have therefore an agronomic and bota-
nical objective, and only aim at GMO as seeds, which
have to fulfil the same criteria as conventional seeds
under the same Directives.

(14)

To be placed on the market and allowed to move freely
throughout the Community, a genetically modified seed
has to pass successively two separate stages:

— its genetic modification has to receive prior authori-
sation according to part C of Directive 2001/18/EC,

— its characteristic as a variety has to have been subject
to tests foreseen by Community legislation on seeds.

(15)

If results are positive, Member States register this variety
in the corresponding national catalogue of seeds, which
allows the seeds of this variety to circulate freely on the
Member State territory and be admitted for commercial
cultivation (once officially examined and certified). It is
only once it has been registered in the Community cata-
this variety can
logue of varieties that
benefit
the
throughout
Community territory (also only once officially examined
and certified).

the seeds of
from freedom of movement

(16)

Therefore, there is not only one Directive regulating in a
specific and global manner the issue of transgenic seeds,
but two Directives (Directive 2001/18/EC and the rele-
vant seeds Directive applying to the GMO at stake)
which apply jointly and regulate two separate aspects of
the genetically modified variety.

2.4. Regulation (EC) No 258/97 of the European Parliament

and of the Council on novel foods

(17)

Regulation (EC) No 258/97 (1) sets out rules for authori-
sation and labelling of novel
foods including food
products containing, consisting of or produced from
GMOs. This Regulation notably foresees that risks to the
foods or
environment may be associated with novel
novel
food ingredients, which contain or consist of
genetically modified organisms. Therefore, it establishes
a link with Directive 2001/18/EC, which stipulates that,

(1) OJ L 43, 14.2.1997, p. 1.

3. National provisions notified

3.1. Scope of the national provisions notified

(18)

(19)

The draft Act (2) is primarily concerned with the protec-
tion of GMO-free (organic) production systems in the
province of Upper Austria. Protection of nature and the
environment as well as natural biodiversity are also cited
as objectives.

In its first page,
the Committee on
the Report of
National Economic Affairs (3), hereinafter ‘the Committee
Report’ gives a summary of the grounds for and content
of the draft Act:

‘The use of genetically modified organisms (GMOs) in
agriculture and forestry, and in crop farming in parti-
cular, is not, according to current scientific knowledge,
free from risk with respect to either the maintenance of
GMO-free agricultural production (coexistence) or the
conservation of the natural environment (biodiversity).

The aim of this Act is to safeguard organic farming as
well as traditional agricultural crop and animal products
from GMO contamination (hybridisation). In addition,
natural biodiversity, particularly in sensitive ecological
areas, as well as genetic resources in nature, including
those of hunting and fishing, are to be protected from
GMO contamination.’

(20) On this basis, the draft Act primarily seeks to ban the
use of genetically modified seeds (including those with
Community authorisation)
in the province of Upper
Austria as a means to (i) safeguard organic and tradi-
tional
farming (coexistence) and (ii) protect natural
biodiversity, particularly in sensitive ecological areas, as
well as genetic resources from ‘contamination’ of GMOs.
It does, however, accept adventitious traces of genetically
modified seeds in conventional stocks to a level of 0,1 %
(apparently both authorised and non-authorised geneti-
cally modified seed).

(2) Provincial Act, prohibiting the cultivation of genetically modified
seed and planting material and the use of transgenic animals for
breeding purposes as well as the release of transgenic animals espe-
cially for the purposes of hunting and fishing (Upper Austrian Act
prohibiting genetic engineering 2002).

(3) Report of the Committee on National Economic Affairs concerning
the Provincial Act prohibiting the cultivation of genetically modified
seed and planting material and the use of transgenic animals for
breeding purposes as well as the release of transgenic animals espe-
cially for the purposes of hunting and fishing (Upper Austrian Act
prohibiting genetic engineering 2002).

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(21)

(22)

It also seeks to ban the use of transgenic animals for
breeding and in particular their release for hunting and
fishing.

It requires that Upper Austria will provide compensation
to persons for monetary losses due to the presence of
GMOs in conventional products.

(23)

The Act is a temporary measure, applicable for three
years after its adoption.

3.2. Impact on Community legislation of the national provi-

sions notified

(24)

The scope of the draft Upper Austrian Act implies that it
will primarily impact on:

— experimental releases of GMOs in accordance with
the provisions of part B of Directive 2001/18/EC,

— the cultivation of genetically modified seed varieties
authorised under the provisions of part C of Direc-
tive 2001/18/EC,

— the cultivation of genetically modified seed varieties
already approved under the provisions of Directive
90/220/EEC as now governed by Directive 2001/18/
EC. The consents for these products will have to be
renewed under Directive 2001/18/EC but not until
the year 2006,

— contained use activities involving the breeding of
transgenic animals and fish. However, this would not
be in contradiction of the Directive per se, given that
the provisions of Directive 90/219/EEC as amended
by Directive 98/81/EC (as opposed to those of
laws) do not explicitly extend to such
national
GMOs,

— placing on the market and experimental release into
the environment of transgenic animals on the basis
that they are classified as GMOs, if such approvals
were to be granted (which is not the case for the
time being) in accordance with Directive 2001/18/
EC.

(25)

In this context it
is also important to mention that
during second reading of the Commission Proposal for a
Regulation on genetically modified food and feed, the
European Parliament adopted an amendment aiming to
introduce a new Article 26a in Directive 2001/18/EC.
Following agreement from the Council on 22 July 2003,
this Article will be inserted into the Directive on the
the new Regulation. The Article
entry into force of
reads:

‘Member States may take appropriate measures to avoid
the unintended presence of GMOs in other products.

The Commission shall gather and coordinate informa-
tion based on studies at Community and national level,
observe the developments regarding coexistence in the
Member States and, based on the information and obser-
vations, develop guidelines on the coexistence of geneti-
cally modified, conventional and organic crops.’

(26) On the other hand, the draft Act is unlikely to impact
on the novel food Regulation. This Regulation addresses
food or food ingredients containing or consisting of a
GMO, which are not to be used as seed or planting
material. Therefore, the novel food Regulation shall be
considered as out of the scope of the draft Act.

(27)

issue of coexistence,

Regarding the horizontal
the
Commission adopted, on 23 July 2003, a Recommenda-
tion with guidelines for the development of national
strategies and best practices to ensure the coexistence of
genetically modified crops with conventional
and
organic farming (1). The Recommendation states that:

‘It is important to make a clear distinction between the
economic aspects of coexistence and the environmental
and health aspects dealt with under Directive 2001/18/
EC on the deliberate release of GMOs into the environ-
ment.

According to the procedure laid down in Directive
2001/18/EC, the authorisation to release GMOs into the
environment is subject to a comprehensive health and
environmental risk assessment. The outcome of the risk
assessment can be one of the following:

— a risk of an adverse effect to the environment or
health that cannot be managed is identified, in which
case authorisation is refused,

— no risk of adverse effects on the environment or
health is identified,
in which case authorisation is
granted without requiring any additional manage-
ment measures
specifically
prescribed in the legislation,

those

other

than

— risks are identified, but they can be managed with
appropriate measures (e.g. physical separation and/or
monitoring); in this case the authorisation will carry
risk
the obligation to implement environmental
management measures.

If a risk to the environment or health is identified after
the authorisation has been granted, a procedure for the
withdrawal of the authorisation or for modifying the
conditions of consent can be initiated under the safe-
guard clause set out in Article 23 of the Directive.

(1) OJ L 189, 29.7.2003, p. 36.

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Since only authorised GMOs can be cultivated in the
European Union, and the environmental and health
aspects are already covered by Directive 2001/18/EC,
the pending issues still to be addressed in the context of
coexistence concern the economic aspects associated
with the admixture of genetically modified and non-
genetically modified crops.’

(32)

The basis for the Act, as detailed in the report, is that
the use of GMOs is not free from risk with respect to
either the maintenance of genetically modified-free agri-
cultural production (coexistence) or the conservation of
the natural environment (biodiversity). The Müller study
produces a broad compilation of generic information on
GM crops and coexistence, together with scientific data
on causes and contexts of GMOs contamination.

(28)

Concerning territorial measures,
states:

the Recommendation

‘While considering all
the options available, priority
should be given to farm-specific management measures
and to measures aimed at coordination between neigh-
bouring farms.

Measures of a regional dimension could be considered.
Such measures should apply only to specific crops
whose cultivation would be incompatible with ensuring
coexistence, and their geographical scale should be as
limited as possible. Region-wide measures should only
be considered if sufficient levels of purity cannot be
achieved by other means. They will need to be justified
for each crop and product type (e.g. seed versus crop
production) separately.’

(29)

From the above considerations,
it clearly appears that
the main Community legislation potentially affected by
the Austrian notification is Directive 2001/18/EC.
In
fact, this horizontal piece of legislation can be seen as
the cornerstone of any deliberate release of GMOs in the
European Union, notably since authorisations under
seeds and novel foods legislation are carried out in line
with its governing principle. This
interpretation is
accepted in the assessment carried out by the Austrian
authorities in their Committee Report that states:

legislator's

‘The national
room to manoeuvre with
regards to authorised GMOs is therefore determined in
accordance with the specific primary law stipulations
relating to the “Release Directive” (1) or in accordance
with the safeguard clause of the same Directive.’

(30)

For these reasons, the legal assessment contained in this
Decision will focus on Directive 2001/18/EC and will
legislation covering
not
biotechnology, since their importance is minor in the
present context.

touch upon other pieces of

(33)

The Müller study purportedly confirms long-term nega-
tive effects on genetically modified-free agricultural
production and naturally occurring crop formations
cannot be ruled out.

(34)

The study suggests that it is practically impossible for
organic and conventional production to coexist along-
side a large GMO cultivation, with a feared long-term
damage to the environment. The above justification, in
terms of biodiversity and coexistence, is applied to trans-
genic animals in a similar manner as to genetically modi-
fied seeds. Along this line, the Müller study considers
that:

‘The danger as far as the (Upper) Austrian environment
is concerned lies in the fact that recombinated genes
may harm conventional genetically modified-free and
organic agricultural crop production. If genetically modi-
fied varieties of seed or planting material are cultivated
extensively, genetically modified-free agricultural crop
production would no longer be possible in future. Since
the danger facing this type of production appears to
relate to all products that are permitted as seed and
planting material, all these products are covered by the
cultivation ban contained in the draft. The same applies
to transgenic animals used for breeding purposes and, to
the release of
the
purposes of hunting and fishing. In the long run, these
the
animals reproduce and threaten the existence of
naturally occurring animal.’

transgenic animals especially for

4. Justifications put forward by Austria

(35) On this basis, the Müller study concludes that:

(31)

the draft Act

Justification for
is provided by the
Committee report and a recent study on coexistence
commissioned by the province of Upper Austria and the
Federal Ministry of Social Security and Generations,
hereinafter ‘the Müller Study’ (2).

(1) The “Release Directive” being defined prior in the Committee Report

as Directive 2001/18/EC.

(2) ‘Genetically modified-free areas of farming: conception and analysis
of scenarios and steps for realisation’, Werner Müller, 28 April
2002 (carried out on behalf of the department for environment of
the region of Upper Austria and of the Federal Ministry for social
security and generations).

‘Genetically modified-free areas represented the only
approach, which could ensure long-term security in rela-
tion to the problems of coexistence within the small-
structured Austrian agricultural sector. Given that the
proportion of organic farmers is particularly high in
Upper Austria (around 7 %), hardly any areas would be
available for a GMO cultivation if the intention was to
safeguard
agricultural
products by establishing protection zones with a 4 km
radius from sources of foreign contamination.’

production of

organic

the

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(36)

The specificity to the province of Upper Austria is
founded on the fact that production in this region is
based on a small-structured farming system and that
management measures to control the presence of GMOs
in organic/conventional production systems
is not
possible. The Committee Report therefore concludes:

‘(…)
it must be emphasised in Austria's case that in
accordance with the study mentioned, “genetically modi-
fied-free areas” represent the only approach which can
ensure the long-term security of coexistence within
Austria's “small-structured agricultural sector”. In relation
to the province of Upper Austria,
it arises from this
study that hardly any areas would be available for a
GMO cultivation if the intention is to safeguard the
organic production of agricultural products by estab-
lishing protection zones with a 4 km radius from the
foreign contamination source. In this regard, particular
reference is made to the high proportion of organic
farmers (in the case of Upper Austria) who are distrib-
uted over the province as a whole and whose existence
would be threatened.’

II. PROCEDURE

(37)

(38)

(39)

In a letter dated 13 March 2003, the Austrian Permanent
Representation to the European Union notified the
Commission, in accordance with Article 95(5) of the EC
Treaty, of a draft Upper Austrian Act on the prohibition
of genetic engineering 2002 banning the use of geneti-
cally modified organisms in the region of Upper Austria
in derogation of the provisions of Directive 2001/18/EC.

By a letter dated 25 March 2003,
the Commission
informed the Austrian authorities that it had received
the notification under Article 95(5) of the EC Treaty and
that the six-month period for its examination pursuant
to Article 95(6) had begun on 14 March 2003, the day
after the notification was received.

By a letter dated 6 May 2003, the Commission informed
the other Member States of the request received from
the Austrian Republic. The Commission also published a
notice regarding the request in the Official Journal of the
European Union (1) to inform the other parties concerned
of the draft national measures that Austria intended to
adopt (2).

III. LEGAL ASSESSMENT

1. Consideration of admissibility

(40) Article 95(5) of the Treaty reads as follows: ‘If, after the
adoption by the Council or by the Commission of a
harmonisation measure, a Member State deems it neces-
sary to introduce national provisions based on new
scientific evidence relating to the protection of the envir-
onment or the working environment on grounds of a

(1) OJ C 126, 28.5.2003, p. 4.
(2) Comments were received from Italy, the Netherlands and Euro-

pabio.

problem specific to that Member State arising after the
adoption of the harmonisation measure, it shall notify
the Commission of the envisaged provisions as well as
the grounds for introducing them.’

(41)

The notification submitted by the Austrian authorities
on 14 March 2003 is intended to obtain approval for
the introduction of new national provisions which are
deemed to be incompatible with Directive 2001/18/EC,
a Community measure concerning the approximation of
the laws, regulations and administrative provisions of
the Member States, aiming at
the establishment and
operation of the Internal Market.

(42) Directive 2001/18/EC harmonises at Community level
the rules with regards to deliberate release of GMOs, for
experimental release or for placing on the market. This
horizontal piece of legislation can be seen as the corner-
stone of any deliberate release of GMOs in the European
Union, notably since authorisations under seeds and
novel foods legislation are carried out in line with its
the reasons
governing principle. Therefore, and for
developed in detail under point III.2, the legal assessment
contained in this Decision will focus on Directive 2001/
18/EC and will not touch upon other pieces of legisla-
tion covering biotechnology, which importance is minor
in the present context.

(43) As required by Article 95(5) of the EC Treaty, Austria
notified the Commission of the exact wording of the
draft provisions, which are incompatible with those set
out namely in Directive 2001/18/EC, as well as of an
explanation of the reasons which, in its opinion, justifies
the introduction of those provisions.

(44) When comparing the provisions of Directive 2001/18/
EC and the national measures notified, it emerges that
the latter are more restrictive than those contained in
the Directive, notably in the following aspects:

— the governing principle of Directive 2001/18/EC is a
case-by-case risk analysis, whereas the Austrian Act
foresees a ‘blanket’ ban,

— Directive 2001/18/EC, in combination with the seeds
Directives, enable free circulation of genetically
modified seeds
approved at Community level,
whereas the Austrian Act foresees prohibition of all
genetically modified seeds,
irrelevant whether they
have been approved or not.

(45)

The justifications put
that:

forward by Austria are mainly

— the Müller study commissioned by the Region of
Upper Austria has brought to light new scientific
evidence showing a danger for the (Upper) Austrian
environment,

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— the same study has also demonstrated that the Upper
Austrian agricultural structure was specific (notably
since based on small-scale farms, with a substantial
proportion of organic farming),

— the Müller study was published after the adoption of
Directive 2001/18/EC and according to Austria, the
issue of coexistence, which is not tackled by this
Directive, is still considered as unsolved.

(46)

In the light of the foregoing, the Commission considers
that the notification submitted by Austria in order to
obtain approval for the introduction of national provi-
sions derogating from the provisions of Directive 2001/
18/EC is therefore to be considered admissible under
Article 95(5) of the EC Treaty.

2. Assessment of merits

(47)

In accordance with Article 95(6) of
the
Commission must ensure that all the conditions enabling
a Member State to avail itself of the possibilities of dero-
gation provided for in this Article are fulfilled:

the Treaty,

‘6.
The Commission shall, within six months of the
notification as referred to in paragraphs (…) 5, approve
or reject the national provisions involved after having
verified whether or not they are a means of arbitrary
discrimination or a disguised restriction to trade between
Member States and whether or not they shall constitute
an obstacle to the functioning of the internal market.

In the absence of a Decision by the Commission within
this period the national provisions referred to in para-
graphs (…) 5 shall be deemed to have been approved.

When justified by the complexity of the matter and in
the absence of danger for human health, the Commis-
sion may notify the Member State concerned that the
period referred to in this paragraph may be extended for
a further period of up to six months.’

(48)

therefore assess whether

The Commission must
the
conditions provided for by Article 95(5) of the Treaty
are met. This Article requires that when a Member State
deems it necessary to introduce national provisions dero-
gating from a harmonisation measure,
that Member
State should base the introduction on:

— new scientific evidence relating to the protection of

the environment or the working environment,

— grounds of a problem specific to that Member State
the harmonisation

the adoption of

arising after
measure.

(50)

(51)

(52)

(53)

the basis of the protection of the environment or the
working environment, on grounds of a problem specific
to that Member State arising after the adoption of the
harmonisation measure, and which are justified by new
scientific evidence.

Furthermore, under Article 95(6) of the EC Treaty, the
Commission is either to approve or reject
the draft
national provisions in question after verifying whether
or not they are a means of arbitrary discrimination or a
disguised restriction on trade between Member States,
and whether or not they shall constitute an obstacle to
the functioning of the internal market.

Therefore,
the national provisions notified and the
reasons given by the Member State are examined in light
of the Community harmonisation measure from which
they derogate, in this case, the provisions of Directive
2001/18/EC on the deliberate release into the environ-
ment of GMOs. Again,
for the reasons developed in
detail under point I.3.2, the legal assessment contained
in this Decision will focus on Directive 2001/18/EC and
will not touch upon other pieces of legislation covering
biotechnology, which are of minor importance in the
present context.

This specific Directive is affected, in so far as the draft
act bans the use of all GMOs in the region of Upper
Austria, whereas the Directive foresees a case-by-case
risk analysis prior to the authorisation of a GMO.

The proposed ban on the cultivation of genetically modi-
fied seeds in the province of Upper Austria also creates
an obstacle to the placing on the market of genetically
modified seeds that would have been authorised for this
purpose under Directive 2001/18/EC. The draft Act
would, therefore, have implications for genetically modi-
fied seeds already approved for the placing on the
market under existing Community legislation as well as
future approvals.

are

regulated

(54) Whilst the Act does not seek to ban genetically modified
this is only on the
seeds for experimental releases,
proviso that
these activities are effected in closed
systems. Experimental releases of genetically modified
under Directive 2001/18/EC
seeds
although at a national rather than Community level.
National authorities have the jurisdiction to include
‘containment type measures’, such as isolation distances
and barriers, in consents issued for experimental releases
on the basis of potential risk to human health or the
environment (1). However,
to put
in place national
such releases have to be
measures
requiring that
conducted under ‘closed systems’,
irrespective of any
potential risk, has to be considered in contradiction with
the Directive.

(49) Article 95(5) of the EC Treaty applies to new national
measures, which introduce incompatible requirements
with those of a Community harmonisation measure on

(1) In this context it is also important to mention that the seeds Direc-
tives stipulate the adoption of such measures to ensure a high level
of purity for basic and certified seeds. However, no distinction is
made regarding admixture between conventional and genetically
modified varieties.

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(55)

(56)

In addition to this, Directive 2001/18/EC does not
contain any (de minimis) thresholds for the adventitious
or technically unavoidable presence of non-authorised
GMOs in seeds. Consequently, Member States do not
have discretion in judging which quantities of GMOs are
dangerous, and subsequently introduce such thresholds.

Finally, in accordance with Article 23 of Directive 2001/
18/EC, if on the basis of new information, made avail-
able since the date of consent, a Member State has
detailed grounds for considering that a GMO as or in a
product which has been properly notified and has
received written consent under Directive 2001/18/EC
constitutes a risk to human health or the environment,
that Member State may provisionally restrict or prohibit
the use and/or sale of that GMO as or in a product on
its territory. The Committee Report shows that Austria
is fully aware of this possibility, but considers it inap-
propriate to meet its objective, which is a total ban of
GMOs in the province of Upper Austria:

‘The Upper Austrian Act prohibiting genetic engineering
2002 is not only to apply to individual GMOs (that have
already been authorised) but also makes provision for a
general ban on all GMOs as or in a product that are
already presently approved and those
to be
approved in future.

still

(…)

It does appear somewhat impractical, however, to carry
out a procedure in accordance with Article 23 of the
“Release Directive” following every approval procedure
conducted in relation to a GMO.’

(57)

In accordance with the Court's case law, any exception
to the principle of the uniform application of Commu-
nity law and of the unity of the internal market must be
strictly interpreted. Article 95(5) of
the EC Treaty
provides an exception to the principles of uniform appli-
cation of Community law and the unity of the market.
Therefore, it must be interpreted in such a way that its
scope is not extended beyond the cases for which it
formally provides.

(58)

In the light of the time-frame established by Article
95(6) of the EC Treaty, the Commission, when exam-
ining whether the draft national measures notified under
Article 95(5) are justified, has to take as a basis ‘the
grounds’ put forward by the Member State. This means
that, under the Treaty, the responsibility of proving that
these measures are justified lies with the Member State

(59)

(60)

(61)

(62)

(63)

framework
making the request. Given the procedural
established by Article 95 of the EC Treaty, including in
particular a strict deadline for a Decision to be adopted,
the Commission normally has to restrict itself to exam-
ining the relevance of the elements which are submitted
by the requesting Member State, without having to seek
possible justifications itself.

The introduction of national measures which are incom-
patible with a Community harmonisation measure needs
to be justified by new scientific evidence concerning the
protection of the environment or the working environ-
ment. Of course, whether the scientific evidence is new
must be judged in light of developments in scientific
knowledge.

is therefore up to the Member State, which has
to
the

It
requested that
provide new scientific evidence,
measures notified.

there is a need for a derogation,

in support of

The Austrian authorities argue that ‘the extensive use of
genetically modified seed and planting material in crop
production would at first interfere with and then, in the
long-term, displace organic and conventional genetically
modified-free production, resulting in an expansion of
the GMO cultivation’.

The Austrian authorities have commissioned the ‘Müller
study’, on which the Committee Report is based, and
‘new
which demonstrates, according to Austria,
scientific evidence has now come to light which justifies
an Upper Austrian Act prohibiting genetic engineering
2002 in the form proposed’. Furthermore, this study is
also supposed to demonstrate that ‘genetically modified-
free areas’ represent the only approach which can ensure
the long-term security of coexistence within Austria's
‘small-structured agricultural sector’.

that

the full Austrian notifica-
The Commission has sent
tion (1) to the European Food Safety Authority (herein-
after the EFSA) and requested it in a mandate (2), under
Article 29(1) and in accordance with Article 22(5)(c) of
Regulation (EC) No 178/2002 of the European Parlia-
ment and of
to provide a scientific
opinion as to whether:

the Council (3),

‘— the information provided by Austria in the Report
entitled GMO-free agricultural areas — Design and
analysis of scenarios and implementational measures
provides any new scientific evidence, in terms of risk

(1) These documents are: Letter dated 13 February 2003 Ref: Verf-5-
1300000/37-GM;
‘Notification to the Commission concerning the
introduction of a national provision (draft Committee Report) prohi-
biting the cultivation of genetically modified seeds and propagating
material, the use of transgenic animals for breeding purposes and
the release of transgenic animals,
in particular for hunting and
fishing purposes (Upper Austria Genetic Engineering Prohibition
Act 2002. (Oö: GTVG 2002)), in accordance with Article 95(5) of
‘Report of the Committee on National Economic
the EC Treaty’;
Affairs concerning the Provincial Act prohibiting the cultivation of
genetically modified seed and planting material and the use of trans-
genic animals for breeding purposes as well as the release of trans-
genic animals especially for the purpose of hunting and fishing
(Upper Austrian Act prohibiting genetic engineering 2002)’; ‘GMO-
free agricultural areas: Design and analysis of scenarios and imple-
mentation measures’, study by Engineer Werner Müller;
‘Green
Report 2001, Report on the economic and social situation of Upper
Austrian agriculture and forestry in 2001’; and ‘Report on the
Implementation of NATURA 2000 in Upper Austria over the next
five years’.

(2) Question No EFSA-Q-2003-001.
(3) OJ L 31, 1.2.2002, p. 1.

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to human health and the environment, that would
justify the banning of cultivation of genetically modi-
fied seeds and propagating material, the use of trans-
genic animals for breeding purposes and the release
of transgenic animals, authorised for these purposes
under Directive 90/220/EEC or Directive 2001/18/
EC,

— in particular, EFSA is requested to comment as to
whether the scientific information presented in the
report provides new data that would invalidate the
provisions for the environmental risk assessment
under the above legislation.’

(67)

It therefore appears that Austrian concerns about coexis-
tence relate more to a socio-economic problem than to
the protection of the environment or the working envir-
onment. Again,
is confirmed by the
EFSA, which opinion states:

this assessment

‘No evidence was presented in the report to show that
coexistence is an environmental or human health risk
issue. EFSA was not asked by the Commission to
comment on the management of coexistence of geneti-
cally modified and non-genetically modified crops, but
the Panel recognised that it is an important agricultural
issue.’

(64)

The EFSA concluded, on 4 July (1), that: The Scientific
the
Panel on Genetically Modified Organisms is of
opinion that

‘— the scientific information presented in the report
provided no new data that would invalidate the
provisions for the environmental risk assessment
established under Directive 90/220/EEC or Directive
2001/18/EC,

— the scientific information presented in the report
provided no new scientific evidence, in terms of risk
to human health and the environment, that would
justify a general prohibition of cultivation of geneti-
cally modified seeds and propagating material, the
use of transgenic animals for breeding purposes and
the release of
transgenic animals, authorised for
these purposes under Directive 90/220/EEC or
Directive 2001/18/EC in this region of Austria.’

(65) With regard to the ‘new’ scientific information,

the
Commission considers that the Müller Report contains
data, which were for a large part available prior to the
adoption of Directive 2001/18/EC on 12 March 2001.
This assessment is confirmed by the EFSA. In addition to
this, Austria relies on the fact that the Müller Study was
released on 28 April 2002, about a year after the date of
adoption of Directive 2001/18/EC (12 March 2001).
However, the vast majority of the sources referred to in
the bibliography were published prior to the adoption of
Directive 2001/18/EC. Therefore, the core of the study
appears more as a validation of previous works than like
new material identifying specific problems arising after
the adoption of Directive 2001/18/EC.

(66) Moreover, the Austrian authorities have not provided
any new scientific evidence, which specifically concerns
the protection of the environment or the working envir-
onment.

(1) Opinion of the Scientific Panel on Genetically Modified Organisms
on a question from the Commission related to the Austrian notifica-
tion of national legislation governing GMOs under Article 95(5) of
the Treaty, The EFSA Journal (2003) 1, 1-5.

(68) On this basis, and in line with the definition of coexis-
tence contained in its Recommendation on the issue (2),
the Commission therefore considers that the concerns
relating to coexistence raised by Austria cannot be speci-
fically regarded as protection of the environment or the
working environment within the meaning of Article
95(5) of the EC Treaty.

(69)

(70)

The Commission also considers that any measure for
coexistence, to be introduced on a regional basis, in the
context of economic risk should be proportionate. In
accordance with the new Article 26(a) of Directive
2001/18/EC and the Commission Recommendation of
coexistence, such measures would have to take account
of (i) specific crop-type, (ii) specific crop use and (iii) if
sufficient levels of purity cannot be achieved by other
means.

Furthermore, in light of the documentation provided by
Austria, particularly the excerpts from the Müller study
included with the notification, it is clear that small-struc-
tured farming systems are certainly not specific to this
region and exist in all Member States. The acceptance of
the Act with regard to Article 95(5) of
the Treaty
cannot, therefore, be founded on such justification.

(71)

There again, the EFSA opinion does not corroborate the
Austrian justification:

‘The scientific evidence presented contained no new or
uniquely local scientific information on the environ-
mental or human health impacts of existing or future
GM crops or animals. No scientific evidence was
presented which showed that this area of Austria had
unusual or unique ecosystems that required separate risk
assessments from those conducted for Austria as a whole
or for other similar areas of Europe. No specific cases
were presented of
impacts of GMOs on biodiversity,
either directly or through changes in agricultural prac-
tices.’

(2) See recital 27.

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(77) Under Article 95(6) of the EC Treaty, the Commission is
either to approve or reject the draft national provisions
in question after verifying whether or not they are a
means of arbitrary discrimination or a disguised restric-
tion on trade between Member States, and whether or
not they shall constitute an obstacle to the functioning
of the internal market.

(78)

(79)

Since the request made by Austria does not fulfil the
basic conditions set out in Article 95(5), there is no need
for the Commission to verify whether or not the notified
national provisions are a means of arbitrary discrimina-
tion or disguised restriction on trade between Member
States, and whether or not they constitute an obstacle to
the functioning of the internal market.

In light of the elements which it had available to assess
the merits of
forward for the
the justifications put
national measures notified, and in light of the considera-
tions set out above,
the Commission considers that
introducing national provisions
for
Austria's request
derogating from Directive 2001/18/EC, submitted on 13
March 2003:

— is admissible,

— does not fulfil the conditions set out in Article 95(5)
of the EC Treaty, as Austria did not provide new
scientific evidence relating to the protection of the
environment or
environment on
the working
grounds of a problem specific to Upper Austria.

(80)

The Commission therefore has grounds to consider that
the national provisions notified cannot be approved in
accordance with Article 95(6) of the Treaty,

HAS ADOPTED THIS DECISION:

Article 1

The national provisions on banning the use of GMOs in Upper
Austria notified by Austria pursuant to Article 95(5) of the EC
Treaty are rejected.

This Decision is addressed to the Republic of Austria.

Article 2

Done at Brussels, 2 September 2003.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(72) As for the arguments, which, in the view of the Austrian
authorities,
justify recourse to the precautionary prin-
ciple, the Commission must point out that ‘recourse to
the precautionary principle presupposes that potentially
dangerous effects deriving from a phenomenon, product
or process have been identified, and that scientific
evaluation does not allow the risk to be determined with
sufficient certainty’ (1).
from the
Indeed,
Community courts'
interpretation of the precautionary
principle (2) that a preventive measure may be taken only
if the risk, although the reality and extent thereof have
not been ‘fully’ demonstrated by conclusive scientific
evidence, appears nevertheless to be adequately backed
up by the scientific data available at the time when the
measure was taken. A preventive measure cannot prop-
erly be based on a purely hypothetical approach to the
risk, founded on mere conjecture, which has not yet
been scientifically verified.

follows

it

(73)

the allegations being
The Commission considers that
made for recourse to the precautionary principle are too
general and lack substance. Furthermore, the EFSA has
not identified a risk that would justify taking action on
the basis of the precautionary principle at Community
or national level. As a result, in this case, there is no
justification for applying the precautionary principle.

IV. CONCLUSION

(74) Article 95(5) of the EC Treaty requires that, if a Member
States deems it necessary to introduce national provi-
sions in derogation from Community harmonisation
measures, the national provisions must be justified by
new scientific evidence relating to the protection of the
environment or the working environment, there must be
a problem specific to the State making the request, and
the problem must have arisen after the adoption of the
harmonisation measure.

(75)

In this case, after having examined the Austrian request,
the Commission considers that Austria has not provided
new scientific evidence relating to the protection of the
environment or the working environment, and has not
demonstrated that there is a specific problem within the
territory of Upper Austria, which arose following the
adoption of Directive 2001/18/EC on the deliberate
release into the environment of GMOs, and which makes
it necessary to introduce the notified national measures.

(76)

Consequently, the request from Austria for introducing
national measures aimed at prohibiting the use of GMOs
in Upper Austria does not fulfil the conditions set out in
Article 95(5).

(1) See the Commission Communication on recourse to the precau-

tionary principle (COM(2000)1 final, 2.2.2000).

(2) See in particular judgments in cases T-13/99 and T-70/99 of the

Court of First Instance, (2002) ECR-II, p. 3305.