2008/62/EC: Commission Decision of 12 October 2007 relating to Articles 111 and 172 of the Polish Draft Act on Genetically Modified Organisms, notified by the Republic of Poland pursuant to Article 95(5) of the EC Treaty as derogations from the provisions of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms (notified under document number C(2007) 4697) (Text with EEA relevance)
Date: 2007-10-12
Institutions: European Commission
Subjects: Poland, approximation of laws, derogation from EU law, environmental protection, evaluation method, genetically modified organism, health policy

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 12 October 2007

relating to Articles 111 and 172 of the Polish Draft Act on Genetically Modified Organisms, notified
by the Republic of Poland pursuant to Article 95(5) of the EC Treaty as derogations from the
provisions of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate
release into the environment of genetically modified organisms

(notified under document number C(2007) 4697)

(Only the Polish text is authentic)

(Text with EEA relevance)

(2008/62/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

shall constitute an obstacle to the functioning of the
internal market.’

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

establishing the European

(2)

Whereas:

1. PROCEDURE

(1)

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

‘5.
(…) If, after the adoption by the Council or by the
Commission of a harmonisation measure, a Member
State deems it necessary to introduce national provisions
relating to the
based on new scientific
protection of
the environment or the working envi-
ronment on grounds of a problem specific to that
Member State arising after the adoption of the harmoni-
sation measure,
it shall notify the Commission of the
envisaged provisions as well as the grounds for intro-
ducing them.

evidence

(3)

(4)

In a letter dated 13 April 2007, the Polish Permanent
Representation to the European Union notified the
Commission,
in accordance with Article 95(5) of the
EC Treaty, of Articles 111 and 172 of a draft Act on
Genetically Modified Organisms,
the
the European
provisions of Directive 2001/18/EC of
Parliament and the Council (1) on the deliberate release
into the environment of genetically modified organisms
(hereinafter: Directive 2001/18/EC).

in derogation of

By a letter of 9 July 2007, the Commission informed the
Polish 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 following this notification.

The Commission published a notice regarding the request
in the Official Journal of the European Union (2) to inform
the other parties
the draft national
concerned of
measures that Poland intended to adopt (3).

as

referred to in paragraphs

The Commission shall, within six months of the
6.
(…) 5,
notifications
approve or reject the national provisions involved after
having verified whether or not
they are a means of
arbitrary discrimination or a disguised restriction on
trade between Member States and whether or not they

(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 C 173, 26.7.2007, p. 8.
(3) The observations were issued from Lithuania, EuropaBio,

the
European Seed Association and Greenpeace. Observations were
also made by individuals, professional associations and Polish insti-
tutions.

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2. RELEVANT COMMUNITY LEGISLATION

2.2. Regulation (EC) No 1829/2003 on genetically

2.1. Directive 2001/18/EC on the deliberate release
into the environment of genetically modified
organisms

(7)

It

at

aims

approximating

Directive 2001/18/EC is based on Article 95 of the EC
Treaty.
legislation and
procedures in Member States for the authorisation of
GMOs intended for deliberate release into the envir-
In accordance with its Article 34, Member
onment.
States were required to transpose it into national
law
by 17 October 2002.

modified food and feed

(b)

the basis

(a) providing

to its Article 1, Regulation (EC) No
According
1829/2003 of
the
the European Parliament and of
Council of 22 September 2003 on genetically modified
food and feed (1)
(hereinafter Regulation (EC) No
1829/2003)
for
at
aims
ensuring a high level of protection of human life and
health, animal health and welfare, environment and
consumer interests in relation to genetically food and
feed, whilst ensuring the effecting functioning of
the
in laying down Community
internal market;
the authorisation and supervision of
procedures
in laying
genetically modified food and feed and (c)
genetically
down
for
modified food and feed. Taken into account
these
different objectives, this Regulation is based on Article
37, 95 and 152(4)(b), of the EC Treaty. This Regulation
applies to GMOs for food and feed use, food or feed
containing or consisting of GMOs and food or feed
produced from or
containing ingredients produced
from GMOs. As recalled in recital 11 of the Regulation,
authorisation may also be granted to a GMO to be used
as a source material for production of food and feed.

provisions

labeling

the

for

of

(5)

(6)

the

release

into the

regarding

throughout

Directive 2001/18/EC puts
in place a step-by-step
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
European Union. Directive
2001/18/EC provides for the placing on the market
and experimental
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, the Directive does
In addition to the above
provide for this possibility.
procedures,
provisions
authorisation
the
Article 23 of Directive 2001/18/EC contains
a
‘safeguard clause’. The provisions of this Article mainly
foresee that, ‘where a Member State, as a result of new or
additional information made available since the date of
the
risk
assessment or reassessment of existing information 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 notified and has
received written consent under this Directive 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’.
Furthermore, in the event of a severe risk, Member States
may take 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 decision. On this basis, a decision shall be
taken at Community level on the invoked safeguard
clause,
foreseen
in accordance with the procedure
under Article 30(2) of Directive 2001/18/EC.

and affecting the

environmental

consent

(8)

and

by Annexes

Regulation (EC) No 1829/2003 establishes a centralised
system for the authorisation of GMOs (Articles 3 to 7 for
genetically modified food and Article 15 to 19 for
genetically modified feed). Every application shall be
accompanied by a dossier supplying the information
required
IV to Directive
III
2001/18/EC and information and conclusions about
the risk assessment carried out in accordance with the
principles set out in Annex II to Directive 2001/18/EC
(Articles 5(5)(a) and 17(5)(a)). The European Food Safety
Authority (EFSA) prepares an opinion on each authori-
sation (Articles 6 and 18). In case of GMOs to be used as
seeds or other plant-propagating materials falling within
the scope of the Regulation, Articles 6(3)(c) and 18(3)(c)
requires EFSA to delegate
risk
assessment to a national competent authority. Article 8
of the Regulation lays down rules applicable to ‘existing
products’ defined as food products placed on the market

environmental

the

(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).

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the products were placed on the market

under Council Directive 90/220/EEC (1) before the entry
into force of Regulation (EC) No 258/97 of the European
Parliament and of the Council (2) or in accordance with
the provisions referred to in Regulation (EC) No 258/97
or other products which have been lawfully placed on
the market before the date of application of this Regu-
lation, and for which operators responsible of the placing
on the market have notified to the Commission within
six months of the date of application of this Regulation
in the
that
Community before the date of the application of this
Regulation. According to the same Article 8,
these
products may continue to be placed on the market,
used and processed under certain conditions. Article 20
of the Regulation sets out the same procedure for feed
products which have been authorised under Directives
90/220/EEC or 2001/18/EC,
feed,
under Directive 82/471/EEC (3), which are produced
from GMO, or under Council Directive 70/524/EEC (4),
which contain, consist or are produced from GMOs.
Within one year from the date of application of the
Regulation, and after verification that all the information
required has been submitted and examined, the products
concerned entered the Community Register of genetically
modified food and feed (The Register).

including use as

(9)

3. NATIONAL PROVISIONS NOTIFIED

3.1. Scope of the national provisions notified.

Poland has attached to its notification all the provisions
of the draft Act. Nevertheless, according to the expla-
natory note submitted by Poland,
the derogation to
Directive 2001/18/EC would concern only points 5
and 6 of Article 111(2) of Part IV of the draft Act,
which concerns
for
experimental purposes, and its Article 172. Accordingly,
the assessment in the present decision will be limited to
those provisions, without prejudice to other official
procedures which will eventually assess the conformity
of the rest of the Act — including the other provisions
of Article 111 — with Community legislation.

the deliberate release of GMOs

3.1.1. Article 111 (deliberate

releases

for

experimental

purposes)

(10) Article 111 lays down the content of an application for
the issuing of a decision for the deliberate release of a
GMO.

(1) OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive

2001/18/EC.

(2) 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).

(3) OJ L 213, 21.7.1982, p. 8. Directive as

last amended by
Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).
last amended by
L 317,

(4) OJ L 270, 14.12.1970, p. 1. Directive as

(EC) No 1800/2004 (OJ

Commission Regulation
16.10.2004, p. 37).

‘An application for the
According to Article 111(1):
issuing of a decision in the matter of deliberate release
should contain’:

According to Article 111(2):
following shall
accompany an application for the issuing of a decision
in the matter of a deliberate release’:

‘The

1. a

risk assessment prepared for
the
modified organisms being released (…);

genetically

2. documentation relating to the preparation of the risk

assessment (…);

3. technical documentation of the deliberate release;

4. a programme of action in the case of a risk to the
health of persons or animals or the safety of the
environment associated with the deliberate release;

5. certification from the mayor of the municipality, town
or city that in the local spatial development plan, with
local environment,
regard to the need to protect
in
nature
question, provision is made for the possibility of
deliberate release;

landscape of

and cultural

area

the

6. written declarations from the holders of farms neigh-
boring the location of the deliberate release that they
do not object to the release;

7. notarised copy of the contract for the conduct of the

deliberate release (…);

8. summary of the application.

3.1.2. Article 172 (establishment of special zones for

the

cultivation of GMOs)

(11) Article 172 stipulates:

It

‘1.
shall be prohibited to cultivate genetically
modified plants, subject to the provisions of paragraph 2.

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the municipality (gmina)

The Minister with responsibility for agriculture, in
2.
consultation with the Minister with responsibility for the
environment and after seeking the opinion of the council
in which the genetically
of
issue a
modified plants are to be cultivated,
decision concerning the creation of a zone designated
for the cultivation of genetically modified plants in a
specified area situated within the territory of the munici-
pality (zone designated for the cultivation of genetically
submission by the
modified plants),
applicant mentioned in Article 4(21)(f) of an application
for the issue of a decision concerning a zone designated
for the cultivation of genetically modified plants.

following the

shall

An application for

3.
a decision
concerning the creation of a zone designated for the
cultivation of genetically modified plants should contain:

issue of

the

2. the council of

the municipality within which the

genetically modified plants are to be cultivated;

and these, within 45 days following the date of delivery
to them of a copy of
the application mentioned in
paragraph 3, shall convey their position in the matter,
indicating the reasons therefore,
to the Minister with
responsibility for agriculture.

The Minister with responsibility for

7.
the envi-
ronment shall convey to the Minister with responsibility
for agriculture the position mentioned in paragraph 6(1)
the Team mentioned in
after seeking the opinion of
Article 26(4)
the Committee
mentioned in Article 25.

and the opinion of

1. the forename and surname or name and registered
office and the address of the applicant mentioned in
Article 4(21)(f);

2. the species and variety of genetically modified plant,
the genetic

the properties obtained as a result of
modification and the unique identifier;

3. the number of

the cadastral parcel containing the
agricultural parcel within the meaning of the regu-
lations on the national system for keeping records
of producers, records of farms and records of appli-
cations for the award of payments, the area of the
the
agricultural parcel
the location of
in hectares,
the
agricultural parcel within the cadastral parcel,
sheet number of the cadastral map for that cadastral
parcel, the name of the cadastral region and the name
of the municipality and voivodship.

The application shall be submitted in writing and in

4.
electronic form.

5.
The application mentioned in paragraph 3 shall be
accompanied by written declarations from the holders of
land within the area of spatial isolation from the land on
is planned to cultivate genetically modified
which it
plants that
to the intention to
create a zone designated for the cultivation of genetically
modified plants.

they do not object

A copy of the application for the issue of a decision
6.
concerning a zone designated for
the cultivation of
genetically modified plants shall be sent, in writing and
in electronic form, within five days following the date on
which the application is submitted, by the Minister with
responsibility for agriculture to:

1. the Minister with responsibility for the environment;

the municipality mentioned in
8.
The council of
paragraph 6(2) shall,
receiving the
immediately after
application, make the information contained therein
publicly known in the town or village in which the
zone is
in the manner customarily
to be created,
adopted in the area in question.’

(12)

Poland has notified to the Commission all provisions of
Article 172. Without prejudice
to other official
procedures which will assess the conformity of the rest
of the Act with Community legislation, the Commission
considers that all provisions of Article 172 derogate from
Directive 2001/18/EC.

3.2. Impact on Community legislation of

the

national provisions notified

3.2.1. Impact of points 5 and 6 of Article 111(2)

(13)

The scope of the latter provisions, in conjunction with
the explanation of the explanatory note, implies that it
will primarily impact on the release of GMOs for any
other purpose than for placing on the market (primarily
for field trials) under Part B (Articles 5 to 11) of Directive
2001/18/EC.

3.2.2. Impact of Article 172

(14)

The scope of Article 172(1) of the draft Act implies that
it will primarily impact on:

— the cultivation of genetically modified seed varieties
authorised under the provisions of part C (Articles 12
to 24) of Directive 2001/18/EC,

— the cultivation of genetically modified seed varieties
already approved under the provisions of Directive
90/220/EEC and now notified as existing products
under Articles 8 and 20 of Regulation (EC) No
1829/2003,

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— the cultivation of genetically modified seed varieties
authorised under the provisions of Regulation (EC)
No 1829/2003.

(20)

These proposals (namely, to condition the release to the
consent of the neighbouring owners of farm parcels and
the provisions of
local spatial plans) place additional
obligations on applicants, but they do not exclude the
carrying out of work involving the deliberate release of
GMOs into the environment. The restrictive approach to
the question of release is also linked to the structure of
Polish agriculture, which is among the most fragmented
in the Community. This poses a serious problem not
only for commercial growing of GM plants, but also
for the safe location of field experiments.

(21)

The Polish authorities make no reference to any new
scientific evidence since
the Directive has been adopted
relating to the protection of the environment.

4.2. Justifications put forward for Article 172

(22) According to the Polish notification (pages 4 and 5) and
explanatory note (16 and 17), the rules on commercial
cultivation in the national provisions are based to a large
extent on Commission Recommendation 2003/556/EC
of 23 July 2003 on guidelines for the development of
national strategies and best practices to ensure the co-
existence of genetically modified crops with conventional
and organic farming (1).

(23)

The idea of creating zones designated for the cultivation
is a development of
of genetically modified plants
paragraph 3.3 of the aforementioned Recommendation,
which concerns
cooperation between neighbouring
farms. Account was also taken of paragraph 2 and
paragraph 3.3.2 (coordinated management measures),
the voluntary clustering of
fields of
which speaks of
different
similar crop
the cultivation of
for
varieties (GM, conventional or organic)
in a particular
area,
subparagraph 3.3.3 concerning
as
voluntary agreements among farmers on zones of a
single production type.

as well

farms

4. JUSTIFICATION PUT FORWARD BY POLAND

(15)

Information for the draft Act, offering interpretation
the Act’s
impact on and conformity with
about
Community legislation,
is provided in the submitted
explanatory note on the draft Act (pages 12 and 16
and 17) and the text of the notification (pages 3 to 5).

4.1. Justifications put forward for points 5 and 6 of

Article 111(2)

(16) According to the Polish notification (pages 3 and 4) and
explanatory note (page 12), following arguments support
the existence of ‘elements related to specific conditions’
in the sense of Article 95(5) EC Treaty.

for

In the drafting of
the rules governing the deliberate
release of genetically modified organisms into the envi-
ronment
the principle
experimental purposes,
adopted was that a set of arrangements as strict as
possible should be created for assessing the safety of a
given field experiment in the context of its safety for the
environment. This is especially important because release
is the first stage of research where the new genetically
modified organism comes into contact with the envi-
ronment and the experiment is conducted without such
effective protective measures as are applied in closed
systems.

The effect of such an organism on the environment is
unknown and may be potentially harmful (this applies
particularly to organisms other than genetically modified
higher plants). Such action therefore requires special
conditions of safety to be maintained, which is in
accordance with the precautionary principle that applies
in EU Member States. In view of the richness of biodi-
versity in Poland, the introduction of genetically modified
organisms
into the environment may cause serious
disturbances to its functioning.

(17)

(18)

(19)

The overriding principle was therefore adopted that there
should be as strict as possible an assessment of all
component
a given field experiment.
Particular emphasis was placed on the environmental
conditions (soil composition,
flora, presence of
protected species, climatic conditions, etc.).

elements of

fauna,

(24) According to the draft act, cultivation of genetically
modified plants should be limited to areas which do
not contain elements of value from a nature conservation
standpoint and whose agrarian structure enables safe
cultivation of transgenic plants, without damaging the
operations of other farmers.

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

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(25)

The regulations proposed in the draft act permit mini-
misation of the risk associated with the mixing of repro-
ductive material or crossing of genetically modified
plants with unmodified plants, and make it possible to
inspect genetically modified crops.

specific to that Member State arising after the adoption
of the harmonisation measure, and which are justified by
new scientific evidence.

(26) A ground for the introduction of derogations in the
national provisions as regards the restriction of the culti-
vation of transgenic plants, is the need to fulfil the expec-
tations of Polish society. Provisions restricting the culti-
vation of GM plants have the purpose of preventing the
possible damage which may result should transgenes
cross over into conventional crops. Concerns relating
to the cultivation of GM plants are associated mainly
with the impossibility of eliminating the risk of conta-
mination of crops due to possible crossing. This results
from the fact that Polish agriculture is fragmented to a
very high degree. Poland has almost two million farms,
and the average area of a farm is less than 8 ha. Polish
agriculture is characterised by a conventional production
system, and there is also increasing interest in organic
production. Given this high level of fragmentation, it is
not possible to isolate GM crops from conventional and
organic crops, and this may also pose a serious threat to
Poland’s developing organic farming. In this situation, the
uncontrolled introduction of transgenic plants into culti-
vation may inflict losses on farmers.

(30)

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.

(31)

The notification submitted by the Polish authorities on
13 April 2007 is intended to obtain approval for the
introduction of the new Article 111(2) points 5 and 6
and Article 172 of the Act which Poland considers to be
a derogation to Directive 2001/18/EC.

(32)

Poland submitted this notification as derogation to
the
Directive
legal
Therefore,
2001/18/EC only.
assessment contained in this Decision will
focus only
on Directive 2001/18/EC.

(27)

The reluctance of Polish farmers is also increased by the
absence of provisions on compensation for agricultural
losses
resulting from the uncontrolled crossing of
varieties. At present, there are no national provisions
relating to the coexistence of the three forms of agri-
culture — conventional, organic and using transgenic
plants — the draft provisions are the first attempt to
regulate this matter.

(33) Directive 2001/18/EC harmonises at Community level
to the deliberate release of
the rules with regards
GMOs, for experimental release or for placing on the
market. This horizontal piece of legislation can be seen
as the cornerstone of any deliberate release into the
environment of GMOs in the European Union, notably
since authorisations in accordance with the legislation for
genetically modified food and feed (Regulation (EC) No
1829/2003) are
carried out also in line with its
governing principles.

(28)

The Polish authorities make no reference to any new
scientific evidence since the Directive has been adopted
relating to the protection of the environment.

(34) 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:

5. LEGAL ASSESSMENT

(29) Article 95(5) of the EC Treaty applies to new national
measures, which introduce incompatible requirements
with those of a Community harmonisation measure on
the basis of the protection of the environment or the
a problem
working

environment, on grounds of

— in accordance with the provisions of Part B of the
Directive 2001/18/EC, experimental releases of GMOs
are not subject to the consent of any third parties
(such as neighbouring farmers, as stipulated by the
Polish draft Act) and any authorities other than the
Competent Authorities designated under Article 4(4)
of
the Directive (such as local municipalities, as
stipulated by the Polish draft Act),

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— Directive 2001/18/EC, enables

5

7

of

and

Council

free circulation of
genetically modified seeds approved at Community.
Articles 13-18 of the Directive establish an authori-
sation procedure which includes the assessment of
each individual notification for GMO(s) by the
competent authorities and, under circumstances, the
authorisation through the Committee procedure of
Articles
Decision
1999/468/EC (1).
In accordance with Article 19 of
‘(…) only if a written
the Directive (‘Consent’),
consent has been given for
the placing on the
market of a GMO as or in a product may that
product
notification
throughout the Community in so far as the specific
conditions of use and the environments and/or
geographical areas stipulated in these conditions are
strictly adhered to.’ Moreover, Article 22 of
the
‘without
Directive (Free circulation) stipulates that
prejudice to Article 23, Member States may not
prohibit,
impede the placing on the
market of GMOs, as or in products, which comply
with the requirements of this Directive’.

used without

restrict or

further

be

(35)

In view of the above, if a GMO receives a consent for
cultivation in the EU under the procedure provided for
by Directive 2001/18/EC, Member
cannot
introduce any additional restrictions to its cultivation.
cultivation
However
unless designated in specific zones, even if no such
restriction is established by the written consent given
under the Directive.

the Polish Act prohibits

States

their

(36) Directive 2001/18/EC is affected, in so far as the draft act
restricts the cultivation of all GMOs in Poland, whereas
the Directive (Articles 13-18)
foresees a procedure
providing at a EC level a case-by-case risk analysis
prior to the authorisation of the placing on the market
of a GMO.

(38) Article 111(2)(5, 6) of

the draft Polish Act seeks to
restrict the cultivation of genetically modified seeds for
experimental releases. Experimental releases of genetically
modified seeds are regulated under Directive 2001/18/EC
although at a national rather than Community level. In
accordance with Article 6(1) of the Directive (Standard
authorisation procedure), the notification for each experi-
mental release of GMOs is submitted to the Competent
Authority of the Member State within whose territory the
release is to take place. In accordance with Article 6(8),
the notifier may proceed with the release only when he
has
the competent
and in conformity with any conditions
authority,
required in the consent. Therefore,
the provisions of
the notified draft Act which establish additional admi-
nistrative requirements for
the authorisation of such
such as mayors’ certifications and written
releases,
declarations for the neighboring farmers that they do
irrespective of any potential
not object to the releases,
risk, have to be considered in contradiction with the
Directive.

received the written consent of

(39) Article 172(1) prohibits the cultivation of genetically
modified plants, subject to the provisions of paragraph
2, namely the designation of specific zones by the
Ministry of Agriculture. This general ban is in breach
of Article 19 of Directive 2001/18/EC, which stipulates
that if a written consent has been given for the placing
on the market of a GMO as or in a product, that product
may be used without further notification throughout the
Community in so far as the specific conditions of use
areas
and
stipulated in these conditions are strictly adhered to.
Furthermore, the general ban of the draft Polish Act is
in breach of Article 22 of the Directive, which stipulates
that Member States may not prohibit, restrict or impede
the placing on the market of GMOs, as or in products,
which comply with the requirements of this Directive.

environments

geographical

and/or

the

(37)

The proposed restrictions of the cultivation of genetically
modified seeds in Poland also create 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 modified seeds already
approved for the placing on the market under existing
Community legislation as well as future approvals.

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

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

(40)

in accordance with Article 23 of Directive
Finally,
2001/18/EC, if on the basis of new information, made
available 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. This provision indicates that the cultivation of a
GMO can be prohibited only on a case-by-case basis and
upon particular
(new information made
available since the date of consent), without providing
the basis to any Member State to adopt a general ban
of the cultivation or any other use of GMOs.

conditions

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Official Journal of the European Union

19.1.2008

(41)

It results from the above that, as the Polish authorities
explained in their notification, point 5 and 6 of Article
111(2) and Article 172 are not compatible with Directive
2001/18/EC. Under these circumstances, there is no need
to further examine them under other Community legis-
lation and in particular under Regulation 1829/2003/EC
the
this Decision. Nevertheless,
in the
not
assessment
under Directive 2001/18/EC will
prejudice the assessment on the compliance of
the
notified draft Act with other parts of Community law,
and especially Regulation (EC) No 1829/2003 in the
context of other EC procedures.

context of

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

(43)

the EC Treaty,

In the light of the time-frame established by Article 95(6)
of
the Commission, when examining
the draft national measures notified under
whether
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
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
the elements which are
examining the relevance of
submitted by the requesting Member State, without
having to seek possible justifications itself.

to restrict

itself

— new scientific evidence,

— relating to the protection of the environment or the

working environment,

— grounds of a problem specific to that Member State,

— arising after
measure.

the adoption of

the harmonisation

(46)

Therefore, under the abovementioned Article, the intro-
duction of national measures which are incompatible
with a Community harmonisation measure first of all
needs
evidence
concerning the protection of the environment or the
working environment.

justified by new scientific

to be

(47) As it results from paragraph 45 of this Decision, it is up
to the Member State, which has requested that there is a
need for a derogation, to provide new scientific evidence,
in support of the measures notified.

(48)

The justifications put forward by Poland (text of notifi-
cation, pages 3-5) are that:

— the uncertainty surrounding the first stage of research
where the new genetically modified organism comes
into contact with the environment, where the effect
of such a genetically modified organism on the envi-
ronment is unknown and potentially harmful,

(44) Moreover, and given the exceptional character of
the burden of proof

the
for
national measure concerned,
the
the
adoption of such a measure in accordance with Article
95(5) of the EC Treaty, lies with the Member State which
notifies the measure.

requirements

justifying

existence

the

of

— the need to limit
the cultivation of genetically
modified plants
to areas which do not contain
conservation
elements of value
standpoint and whose agrarian structure enables
safe
plants, without
of
damaging the operations of other farmers,

from a nature

cultivation

transgenic

concerns

— the need to fulfil the expectations of Polish society,
while
cultivation of
genetically modified plants are associated mainly
with the impossibility of eliminating the risk of
contamination of crops due to possible crossing,

to the

relating

(45) Article 95(5) of the Treaty requires that when a Member
State deems it necessary to introduce national provisions
derogating
those
provisions shall be justified on the following cumulative
conditions (1):

from a harmonisation measure,

(1) ECR, C-439/05 P and C-454/05 P, points 56-58.

— a high level of fragmentation of Polish agriculture,
where it is not possible to isolate GM crops from
conventional and organic crops,
thus posing the
uncontrolled introduction of transgenic plants into
cultivation may inflict losses on farmers,

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Official Journal of the European Union

L 16/25

(49)

— the reluctance of Polish farmers towards the culti-
vation of GMOs which is increased by the absence
of provisions on compensation for agricultural losses
resulting from the uncontrolled crossing of varieties,
there are no national provisions
while at present
relating to the coexistence of the three forms of agri-
culture (conventional, organic and transgenic plants).

It results from the justifications put forward by Poland
that Polish authorities make no reference to any new
information related to the protection of the environment
in their notification or in the accompanying explanatory
note. Their justifications concern broader issues such as
the uncertainty surrounding the first stage of research,
the conservation of nature and the matter of liability.
There is no reference to any new scientific studies,
researches,
literature or any other possible findings
emerged after the adoption of Directive 2001/18/EC
and indicating new evidence concerning the protection
of the environment or working environment.

(50) Under

those circumstances,

in the absence of new
the Commission did not have any
scientific element
the notification to the European
reason to submit,
Food Safety Authority EFSA and ask its opinion,
in
accordance with Article 28(2) of Directive 2001/18/EC.

(51) Given the fact

that

the submission of new scientific
the
evidence constitutes a cumulative condition for
fulfillment of
the requirements of Article 95(5) EC
Treaty, their absence has as consequence the rejection
of the notification without the need to further examine
the fulfillment of other conditions.

6. CONCLUSION

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

(53)

The Polish notification does not provide any new
scientific evidence relating to the protection of the envi-
ronment or the working environment, which could arose

(54)

(55)

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.

Consequently, the request from Poland for introducing
Articles 111(2)(5, 6) and 172 aimed at derogating
from the provisions of Directive 2001/18/EC concerning
the experimental release and cultivation of GMOs in
Poland does not fulfill the conditions set out in Article
95(5).

forward for

In light of the elements which it had available to assess
the
the justifications put
the merits of
national measures notified, and in light of the consi-
derations set our above, the Commission considers that
Poland’s request for introducing national provisions dero-
gating from Directive 2001/18/EC, submitted on 13
April 2007, does not fulfill the conditions set out in
Article 95(5) of
the EC Treaty, as Poland did not
provide new scientific evidence relating to the protection
of
the environment or the working environment on
grounds of a problem specific to Poland.

(56)

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

HAS ADOPTED THIS DECISION:

Article 1

Points 5 and 6 of Article 111(2) and Article 172 of the draft
Law on Genetically Modified Organisms notified by Poland
pursuant to Article 95(5) of the EC Treaty, are rejected.

Article 2

This Decision is addressed to the Republic of Poland.

Done at Brussels, 12 October 2007.

For the Commission

Stavros DIMAS
Member of the Commission