list of implemented legal acts - GMO.sk

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Dec 1, 2012 (4 years and 4 months ago)

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1

Only the Slovak text is authentic


Act No. 151/2002
Coll.
as amended
by the acts

No. 587/2004

Coll., No. 77/2005 Coll.,

No. 100/2008 Coll.
,


No. 515/2008 Coll.

and Act No. 117/2010 Coll.



P A R T O N E

G E N E R A L P R O V I S I O N S



Art. 1

Th
e scope of the act


(1) This act regulates rights and duties of users when using genetic technologies and
genetically modified organisms, as well as responsibilities of the State administration
authorities.



(2) Rights and duties of users in relation

to transboundary movements of genetically
modified organisms are regulated in the separate regulation
1)

.



Art. 2

Genetic technologies


(1) Any genetic engineering activities as well as modern biotechnology by means of
which living genetically modified
organisms are created and used including microorganisms
are genetic technologies.


(2) Use of genetic technologies

a) must not restrain biological diversity of wild species, nor affect the balance of the
biological chain of organisms in the nature,



b) must not introduce genes into organisms to be released into the environment that confer
resistance of humans and animals to antibiotics, that are used as human pharmaceuticals or
veterinary medicines.


(3) Application of genetic method and genetic tech
nique to a genome of a living organism
forms the contents of the genetic technology.



Art. 3

Genetic methods and genetic techniques



(1) Particular targeted methods and techniques using a vector to insert genetic material
from one organism ("donor" her
einafter) to genetic material of another organism ("recipient"
hereinafter), or using a vector to delete or to modify part of original genetic material of an



1)

Regulation of the European Parliament and the Council (ES) No. 1946/2003 of

15 July 2003 on the Cross
-
border Movement

of Genetically Modified Organisms (O.J. ES L 287, 5.11.2003 )


2

organism, the result of which is genetically modified organism are genetic methods and
genetic tec
hniques.



(2) Pursuant to the par. 1, genetic techniques are:

a) recombinant nucleic acid techniques involving the formation of new combinations of
genetic material by the insertion of nucleic acid molecules produced by whatever means
outside an organism,

into any virus, bacterial plasmid or other vector system and their
incorporation into a host organism in which they do not naturally occur but in which they
are capable of continued propagation;

b) techniques involving the direct introduction into an orga
nism of heritable material prepared
outside the organism including micro
-
injection, macro
-
injection and micro
-
encapsulation;

c)
cell fusions including fusion of protoplasts and hybridisation techniques where living cells
with new combinations of heritable
genetic material are formed through the fusion of two
or more cells originating from taxonomically different families and that do not occur
naturally.


(3) For the purposes of this Act, the following methods and techniques are not considered
genetic method
s and techniques that cause genetic change

a) without use of recombinant nucleic acid molecules,

b) by naturally occurring way, especially in vitro fertilisation, conjugation, transduction,
transformation, polyploidy induction, mutagenesis and plant cell

fusion by traditional
cultivation methods, or

c) by use of organisms genetically modified by means of:

1. by cell fusion of prokaryotic microorganism species that exchange genetic material by
known physiological processes including fusion of protoplasts,

2. by cell fusion of eukaryotic microorganism species including
fusion of protoplasts,
hybridomas

production and plant cell fusion, or

3. by s
elf
-
cloning consisting in the removal of nucleic acid sequences from a cell of an
organism which may or may not b
e followed by reinsertion of all or part of that
nucleic acid (or a synthetic equivalent) with or without prior enzymatic or mechanical
steps, into cells of phylogenetically closely related species, or without these steps if
microorganisms can exchange gen
etic material by natural physiological processes
where the resulting micro
-
organism is unlikely to cause disease to humans, animals or
plants.




(4) Self
-
cloning shall be a genetic technique where both, donor and recipient belong to the
same biologic
al species. Pursuant to the par. 3 letter c), item 3 the self
-
cloning may include
also application of recombinant vectors with long history of safe use of microorganisms.


(5) Application of genetic techniques according to par. 2 is prohibited

a)

on in vivo

human germ cells or cells that can generate germ cells,

b)

for modification of human germ cells and their use in assisted human reproduction,

c)

for use also on human somatic cells for other than diagnostic, therapeutic or research
purposes.







3



Art. 4

Ge
netically modified organism



(1) Genetically modified organism shall mean an organism with genetic material that was
modified by way not naturally occurring during mating or natural recombination.


(2)

Genetically modified microorganism shall mean an org
anism with genetic material
that was modified by way not naturally occurring during mating or natural recombination.



(3) Organism shall mean a biological entity capable to reproduce or to transfer genetic
material by another way. Human organism is not co
nsidered (as an) organism for the purposes
of this Act.


(4) Microorganism shall mean a cellular entity or non
-
cellular entity capable to reproduce
and to transfer genetic material, including viruses, viroids, animal cells and cells of plant
cultures.


(5)

Genetic material shall mean deoxyribonucleic acid and ribonucleic acid.



Art. 5

Environmental risk assessment


(1) Environmental risk assessment

(hereinafter referred to as „risk“) shall mean an
evaluation of potential harmful effects of genetically modi
fied organisms on humans and the
environment.
19
)



(2) According to the principle of prevention and preliminary caution, the risk assessment
must take into account any scientifically verified knowledge, available experience and works
performed in relation t
o the use of genetic technologies and genetically modified organisms
on international level.


(3) Risk assessment is performed for each application of genetic technologies and for each
usage of genetically modified organisms.


(4) Written report resulting

from risk assessment forms a part of user
'
s documentation
(Art. 11 point 4).



Art. 6

Emergency plan





19
)

Art. 2 and

9 of
the Act No. 17/1992 Coll. on the Environment as amended by the Slovak Parliament
Act No. 287/1994 Coll.


4

(1) For the purposes of this Act, emergency plan shall mean a written document
containing measures to be taken in case of accident and with the aim to re
move the
consequences on humans and environment of such accident.


(2) For the purposes of this Act, accident shall mean any case of uncontrolled release of
genetically modified organisms in the course of the use thereof which might pose a risk to
humans

or environment.



Art. 7

Application methods of genetic technologies and genetically modified organisms


(1) Genetic technologies and genetically modified organisms may be used

a) in hermetically closed facilities and upon application of protective me
asures (hereinafter
referred to as “contained use”),

b) by deliberate release without application of protective measures (hereinafter referred to as
„deliberate release").


(2) Physical
barriers

occasionally combined with biological and chemical barriers,
as well
as specific control and safety measures aimed to avoid contact of genetically modified
organisms with human population and the environment are protective measures.



P A R T T W O

CONTAINED USE


Art. 8

Contained use




(1) Contained use shall m
ean any activity by means of which organisms are genetically
changed or when genetically modified organism are grown, kept, replaced, disposed of,
destroyed or used in another manner and upon application of protective measures.


(2) Laboratories, greenhou
ses, growing premises and other closed facilities equipped with
safety appliance preventing release of genetically modified organisms in research,
development or production facilities of the user are considered containment (hereinafter
referred to as "GMO
facilities").



(3) Provisions of this Act on contained use do not apply to genetically modified organisms
that meet safety criteria as stipulated in relevant executive regulation (Art. 39) after decision
of the competent EU Authorities on the basis o
f proposals by competent bodies of the
Member States. Exclusion of genetically modified organisms from the application of
provisions on contained use does not apply to their deliberate release and it will apply only in
case of use of genetically modified o
rganisms pursuant to the par. 1.




Art. 9

Obligations of the user


5



(1) User shall mean legal entity or natural person that uses genetic technologies and
genetically modified organisms; it shall not mean the end consumer of products introduced
into t
he market.


(2) The user is obliged

a) to create a Safe Use Committee for contained use (hereinafter referred to as „Safety
Committee"),

b) to designate a person responsible for safe contained use of genetic technologies and
genetically modified organi
sms (hereinafter referred to as „head of project"),

c) to ensure that by its construction and technical layout, indoor localisation, operation pattern
and material and technical equipment (hereinafter referred to as "requirements for GMO
facilities") the G
MO facilities shall comply with the principles set out in the

par. 8, and
shall meet the requirements of the special regulations for waste handling
3)

and for
industrial waste waters
4)
.


(3) The Safety Committee shall control the contained use of genetic te
chnologies and
genetically modified organisms, mainly it shall check the correctness of the risk assessment
and categorisation into risk class, evaluate fulfilment of protective measures corresponding
with the risk class as well as the protection efficienc
y, re
-
evaluate the emergency plan,
cooperate with the project head and issue proposals to the management of the user how to
perform necessary measures in order to correct the shortages found. The Safety Committee
shall consist of the minimum number of fiv
e members; majority of them shall not be the
user´s employees.


(4) Head of project shall ensure working safety and health protection for his employees,
and control of Good Microbiological Practice during application of genetic technologies and
geneticall
y modified organisms, as well as coordination with the Safety Committee.


(5) The user shall designate

a) only a natural person who has not been finally convicted of intentional criminal act, with
respective graduation and three years of expertise in appl
ication of genetic technologies and
genetically modified organisms as a member of the Safety Committee,

b) only a person who has not been finally convicted of intentional criminal act, and who has
sufficient expertise as a head of project.


(6) For the p
urposes of this Act, any person who has not been finally convicted of
intentional criminal act or of a criminal act by which a

life of people or the environment was
endangered is considered person without criminal record unless the court decided to
conditi
onally suspend the execution of a

sentence of deprivation of liberty; the
aforementioned facts shall be proved by means of the extract from Criminal Conviction
Records not older than three months.





3)

Act No. 223/2001 Coll. on Waste and on amendment of several acts, as amended later.

4)

Art. 2 letter i) of the Act No. 364/2004 Coll. on Waters and
on change of Slovak Parliament Act No.
372/1990 Coll. on Offences as amended later (Water Act).

5)

For example Art. 161, 284,

285, 300 and 309 of the Criminal Act



6

(7) Sufficient expertise means university degree in corres
ponding field, minimum three
years of experience in genetic engineering and
new

biotechnologies and regular participation
in training.


(8) The user is obliged to ensure application of the following principles of working safety
and health protection, as
well as Good Microbiological Practice in contained use:

a) the level of exposure to the effects of genetically modified organisms of the GMO
facilities shall be maintained on the minimum possible level,

b) the hazard resource shall be object of the prote
ctive measures taken, and when necessary,
with respect to the protection level corresponding to the categorisation into risk class, the
employees must be provided individual protective means and device,

c) equipment of the GMO facilities should be maintai
ned on the level corresponding with the
protection level according to the risk class categorisation,

d) in case of suspicion of failure of protective measures, presence of used viable
microorganisms outside of the primary physical control must be investig
ated,

e) disinfection and decontamination procedures should be elaborated for the case of a release
of genetically modified organisms from the GMO facilities,

f) effective disinfection substances, sanitary and decontamination devices and mechanisms
shoul
d be available,

g) local safety principles should be developed and applied in practice by employees of the
user,

h) warning signs on biohazard should be installed in the GMO facilities and its vicinity, if the
activities belonging to class 2 to 4 are perf
ormed,

i) the employees should have access to necessary training,

j) detailed documentation should be kept on activities performed in the GMO facilities,

k) smoking, drinking, eating, using of cosmetic products and storage of food should be
prohibited
in the GMO facilities,

l) mouth pipetting should be prohibited,

m) written standard procedures should be available if it is necessary for the safety reasons,

n) safe storage of contaminated laboratory equipment and materials should be ensured.


(9) Docume
ntation pursuant to par. 8 j) should keep data on any important circumstances
on the contained use.



Art. 10


(1) Prior to new contained use, the user is obliged to

a) take measures in order to prevent possible harmful effects to humans and the environm
ent
that might result from it,

b) assess the risks resulting from the planned contained use, especially to identify potential
harmful effects to humans and the environment,

c) classify the prepared used of genetic technology into a risk class on the bas
is of risk
assessment results (par. 3),

d) ensure protection level corresponding to the risk class, as well as requirements for the
GMO facilities and the consequent individual protective measures,

e) elaborate emergency plan (Art. 6) for activities belon
ging to risk classes 2 to 4, and to
publish the listed measures for human and environmental protection by Internet, or by
additional appropriate means,


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f) to make available substantial information on the emergency plan content to the bodies that
could be
impacted by the accident, and when the activities are classified as class 3 or 4
also to the local authority and municipality,

g
)
to announce (Art. 12) or to apply for permit for contained use, unless it is not stated
otherwise below (Art. 13).



(2) Th
e user shall classify the planned contained use into one of the following risk classes:

a) risk class 1


activities of no or only negligible risk, where protection level 1 is suitable,

b) risk class 2


activities of low risk, where protection level 2
is suitable,

c) risk class 3


activities of moderate limited risk, where protection level 3 is suitable,

d) risk class 4


activities of high risk, where protection level 4 is suitable.


(3) When there is a doubt as to the classification, the planned us
e will be classified into
the higher class until there are grounds justifying classification in a lower risk class.


(4) Protection level comprises a set of protection measures (Art. 7 point 2) as well as the
work procedures in the facility that correspon
d to the particular risk class according to the par.
3.


(5) Emergency plan contents should be regularly updated by the user when changing
contained use, when emergency plan change and when changed permit for contained use is
issued. Information provided t
o bodies that could be affected by the accident are delivered
also to the Ministry of Environment of the Slovak Republic (hereinafter referred to as
"Ministry") as national notification body [Art. 24 par. 2 a), first point], as well as to the
national cent
re for transboundary movements and for biological safety [Art. 24 par. 2 letter
b)], and also to the local authority and the municipality when activities in question are
classified into class 3 to 4.



(6) Classification into risk class is not needed for t
ransit and for inland road, railway,
water and air transportation of genetically modified organisms. When the genetically
modified organisms transit is performed according to international treaties on transport of
dangerous goods
5a

, a permit pursuant to
this Act is not needed (Art. 13, 17 and 21).




Art. 11

Classification re
-
assessment


(1) The user is obliged during the period of contained use to re
-
assess regularly the risk
classification. He is obliged to do so whenever he finds out that

a) the used p
rotective measures ceased to be sufficient for the requested level of protection of
users employees,

b) classification to the risk class ceased to correspond with the protection level or it does not
correspond with the result of risk assessment any more,




5a


Regulation on the

International Railway Transport
of Dangerous Goods
(
RID
)
, as amended
(Notification No. 40/2007 Coll.)
.

European Agreement
on
the
International Road Transport of
Dangerous Goods (ADR)
, as amended (Notification No. 60/2007 Coll.)
.





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c) there is a reason to suppose that the performed risk assessment does not correspond with
the new scientific knowledge and achieved level of genetic methods and genetic
techniques.


(2) Classification re
-
assessment should take into consideration

a) was
te and waste water disposal level,

b) genes contained in genetically modified organisms that cause resistance to antibiotics used
as human pharmaceuticals or veterinary medicines.


(3) Whenever activities classified into a higher risk class as before the
re
-
assessment are
performed after the reassessment of the contained use, the user shall take necessary safety
measures for protection of humans and the environment.


(4) The user is obliged to keep the risk assessment reports (Art. 5 par. 4) as well as re
-
assessment records during ten year period since the classification into a risk class or since the
re
-
evaluation of this classification.

Art. 12

Notification


(1) The notifier is a person who is obliged to notify pursuant to this Act, par. 2.


(2) The not
ifier is obliged to notify to the Ministry

a) data on the project head and on the Safety Committee members, as well as changes of
these data,

b) start of the contained use activities when it comprise activities classified as risk class 1,

c) start of c
ontained use activities classified as risk class 2 when all preconditions set out in
the permit issued according to the Art. 13 par. 1 letter a) were met,

d) ascertaining of new information on activities that could have severe impact to the risk,

e) chan
ges in requirements for contained use [Art. 9 par. 2 letter c)] if they have influence to
the application of principles according to the Art. 9 par. 8, or to requirements in special
regulations on waste handling
3)

or on industrial waste water handling
4)
.


(3) After the first notification pursuant to the par. 2 letter c), it is not necessary to notify
any further
contained use

activities classified as risk class 1.


(4) The notifier is obliged to notify

a) immediately after the notification reason appeared
, and


b) within seven days before the start of the activity, if notification according to the par. 2
letter c) and

d) is concerned.


§ 12a

Applicant for approval


Applicant for approval is a person under this law
, who is obliged

to apply for approval f
or

contained use according to Art. 13, for approval f
or

introduction into the environment
according to Art.

17
or
for approval
for placing a product on the market according to Art. 21.




Art. 13


9

Approval of contained use


(1) Approval by the Ministry is nec
essary for contained use [Art. 24 par. 1 letter b) point
one], if the following issues are subject of it:

a) first contained use,

b) activities classified into risk class 2 when all preconditions of the issued permit were not
fulfilled,

c) activities cl
assified as risk classes 3 and

4,

d) change of classification of the risk classes 2 to 4 and their classification into lower risk
level,

e) continuation of activities suspended during inspection.


(2) When the GMO facilities were used for activities cl
assified into risk classes 2 to 4
according to the permit pursuant to par. 1 letter b) or

c), and when all conditions for approval
were met, new usage classified into the risk class 2 needs only an announcement (Art. 12).



(3) When the approval accor
ding to par. 1 letter e) was not issued within 45 days since the
application, activities that were suspended can continue only in case of classification into risk
class 2.


(4) Activities pursuant to par. 1 letter c) a

d) can be performed only on the basis

of
approval of contained use.


Art. 14

Procedure in case of accident


(1) When an accident occurs (Art. 6 par. 2) in use of risk classes 2, 3 or 4, the user is
obliged to immediately

a) announce the accident to the Ministry,

b) inform directly threatened

persons in a vicinity of the contained use, and when the accident
has transboundary impacts, also the bodies of the threatened states,

c) take safety measures according to the emergency plan,

d) publish data on accident and applied measures to the public

by appropriate form,

e) inform regional coordination centre of the Integrated Rescue System
5b

, when the accident
relates to activities classified into risk classes 3 or 4.


(2) Announcement pursuant to par. 1 letter a) and information pursuant to par. 1

letter b)
and

e) contain

a) description of the accident circumstances,

b) identification and amount of genetically modified organisms that were spread out of
control,

c) information necessary for evaluation of accident impacts for human health and t
he
environment,

d) information on measures taken.





5b


Art. 5 of the Act No. 129/2002 Coll. on Integrated Rescue System as amended by Act No. 57
9/2004
Coll.




10

(3) Whenever also transboundary impacts are possible, the user shall provide information
according to the par. 2 also to the Ministry as well as to the national centre for transboundary
movements and for b
iological safety [Art. 24 par. 2 letter b)].


(4) The user is obliged to collect all available data on the accident, to analyse the reasons
of the accident, to investigate its consequences, to elaborate proposal for prevention of similar
accidents in the f
uture and for reduction of their consequences, and to provide these data to
the Ministry.


P A R T T H R E E

DELIBERATE RELEASE


Art. 15

Introductory provisions


(1) Intentional introduction of genetically modified organism or a combination of
genetical
ly modified organisms into the environment is a deliberate release („release into the
environment“ hereinafter), or their placement onto the market where no protective measures
were applied for limitation of their contact with humans and with the environme
nt in order to
ensure high safety level.


(2) Use of genetically modified organisms in the environment for experimental purposes,
especially seeding, planting, production breeding, release to the nature pursuant to par. 1 is
introduction into the environ
ment.


(3) Each introduction of products, whether in return for payment or free of charge, to the
third parties on the market pursuant to par. 4 is placing on the market for the purposes of this
Act, except introduction of genetically modified organisms i
ncluding sets of cultures for their
contained use or for introduction to the environment.


(4) Product shall mean a preparation composed of genetically modified organism, its part,
or preparation containing genetically modified organism or combination the
reof that is placed
on the market.


(5) Transit as well as national transport of genetically modified organisms by road,
railway, water, air transportation is not a deliberate release.


(6) Provisions on the deliberate release form a prerequisite for ap
plication of special
regulations on

a) permissions of testing and control of drugs made of genetically modified organisms in
human medicine and veterinary medicine
6)
,

b) cultivation of genetically modified plants in agricultural production
7)
,

c) production

and placing on the market of genetically modified food and feed
8)
,

d) variety testing and variety registration of the cultivated genetically modified plants and
placing on the market of
reproductive

material of those plants
9)


11

e) evaluation of proposals fo
r placing on the market of foods for special nutrition purposes
as well as new foods.
10)



Art. 16


General obligations of the user


(1) Prior to any start of deliberate release, the user has the obligation

a) to take measures for prevention of possible h
armful effects to human health and to the
environment that could result from the deliberate release,

b) to assess the risk caused by planned deliberate release, especially to identify and to
evaluate direct and indirect, immediate and delayed impacts of ge
netically modified
organisms to human beings and to the environment,

c) to perform analysis of cumulative long
-
term effects of genetically modified organisms to
human beings and to the environment,

d)

to decide on the need and on the method of risk manage
ment (par. 3), and on application of
best available genetic method,

e) to elaborate emergency plan (Art. 6) and to publish the included measures

for human
beings and environmental protection on Internet, or by another appropriate manner,

f) to submit the

substantial information on the emergency plan content to persons possibly
affected in the case of accident,

g) to assess each case of possible adverse effects resulting from direct or indirect gene transfer
from genetically modified organisms to other or
ganisms,

h) to apply for approval (Art. 17 and 21), and to meet the conditions set out in this approval.


(2) In the framework of analysis of cumulative long
-
term effects according to [par. 1
letter c)], the user is obliged to investigate the effects of
genetically modified organisms to
human health, animals and plants, soil fertility, food chain, ecosystems, biological diversity of
plants and animals and to resistance to antibiotics used as human pharmaceuticals and
veterinary pharmaceuticals.





6)

Art. 14 par. 6 and Art. 15 par. 6 letter a) of the Act No. 140/1998 Coll. on Drugs and Health Care
Appliances, on amendment of the Act No. 455/1991 Coll. on in Trade (Trade Act) as amended, and on
amendment and supplement of the Slovak Pa
rliament Act No. 220/1996 Coll. on Advertisement, as
amended.

7)
Art. 2 letter a) of the Act No. 184/2006 Coll. on Cultivation of Genetically Modified Plants in
Agricultural Production.

8)
Directive of the European Parliament and the Council (ES) No. 1829
/2003 of

22 September 2003 on
Genetically Modified Food and Feed (O.J. EU L 268, 18.10.2003).

Art. 6 par. 2 and Art. 9 par. 6 of the Slovak Parliament Act No. 152/1995 Coll. on Food as amended by
Act No. 546/2005 Coll.

Art. 2 par. 6 of the Act no. 271/2005

Coll. on Production, Placing on the Market and Use of Feed (Feed
Act).

9)
Art. 4 letter a) and

c) of the Act No. 597/2006 Coll. on Responsibilities of the State Administration
Authorities in the Field of Registration of varieties of Cultivated Plants and
Placing on the Market of
reproductive material of the Cultivated Plants.

10)

Art. 13 par. 4 letter g) of the Slovak Parliament Act No. 355/2007 Coll. on Protection, Support and
Development of Public Health.






12

(3) Risk
management [par. 1 letter d)] means observation of imported or newly developed
living genetically modified organism with application of protective measures prior to its
introduction into the environment, for a minimum period of one life cycle of the organi
sm, or
one generation, in order to evaluate the performed risk assessment (Art. 5).


(4) Information on emergency plan content [par. 1 letter f)] shall be regularly updated
after emergency plan change and after change of the issued approval (Art. 17 and

21
).
Substantial information that is submitted to persons who could be impacted by the accident
are delivered also to Ministry as a national notifier [Art. 24 par. 2 letter a) point one], and also
to the national centre for transboundary movements and for bi
ological safety [Art. 24 par. 2
letter b)], as well as to the local authority and municipality.

I n t r o d u c t i o n i n t o t h e e n v i r o n m e n t


Art. 17

Approval of the introduction into the environment


(1) Approval issued by the Ministr
y of the Environment for introduction into the
environment is required for

a) the first and any subsequent introduction of genetically modified organism or combination
of genetically modified organisms into the environment,

b) change of introduction of
genetically modified organism, multiple genetically modified
organisms and combination of genetically modified organisms that could have serious
effects to human beings or to the environment, or that could bring new knowledge of such
effects,

c) import of

genetically modified organisms intended for introduction into the environment.


(2) Only one permit for introduction into the environment may be issued in case of
introduction of identical genetically modified organism or identical combination of
genetica
lly modified organisms into the same site, or into different sites but at the same
purpose and at the same time.


Art. 18

Principles for introduction into the environment


(1) Stepwise introduction into the environment is carried out. First, test trial is

performed
with significant limitation of reproduction and spreading of genetically modified organisms,
later on, after thoroughful evaluation of test trial, in compliance with modern state of science
and technology when no adverse effects to human beings
and to the environment are foreseen
according to evaluation of risk level, the introduction can be performed in full scale, under
controlled reproduction and spreading of genetically modified organisms in the environment.


(2) When the adverse effects to
human beings and to the environment are nor foreseen
prior to commencement of introduction into the environment, in accordance with science and
technology status during the risk assessment, introduction of genetically modified organisms
into the environmen
t can be performed on the basis of issued permit for introduction into the
environment in full scale, without the test trial.


Art. 19

User’s obligations in relation to the introduction into environment



13

(1) The user is obliged

a) to immediately announce
the Ministry any change found out in the course of the
introduction into the environment or deviation from the expected course that could
have adverse effects to human beings or to the environment, and if necessary, to apply
for update of the issued approv
al or to request for a new approval,

b) during the introduction into the environment to check acceptability and completeness of
safety measures according to the emergency plan (Art. 6), and if necessary, to update the
emergency plan immediately,

c) to ke
ep detailed documentation concerning the introduction into the environment,

d) to submit a report on the results of the introduction into the environment (Art. 20) to the
Ministry.

(2) If any changes are found out during the introduction into the enviro
nment that could
cause adverse effects to human beings or to the environment, the user shall immediately
introduce safety measures according to the emergency plan that are necessary for human
being and environmental protection, and to revise the protective

measures, as well as to
announce the Ministry on such changes.


(3) Announcement referred to in par. 2 contains

a) description of changes identified during the introduction into the environment,

b) identification and amount of genetically modified org
anisms concerned by the identified
change,

c) knowledge, data and information needed for evaluation of the change impacts from the risk
assessment point of view (Art. 5),

d) measures taken including the content of performed revision of protective measures

(Art. 7
par. 2).


(4) The user is obliged to record data on circumstances of the introduction into the
environment according to par. 1 letter c) in his documentation, especially implementation plan
containing phases of stepwise introduction and its course
, description of site of introduction as
well as evaluation of life cycle of introduced genetically modified organisms; details on
documentation content will be set out in the executive regulation (Art. 39).




Art. 20

Report on the results of the int
roduction into the environment


(1) After the introduction into the environment, as well as after each finalised trial or other
phase of stepwise introduction set out in the approval of the introduction into the
environment, the user is obliged to elaborat
e a report on results of the introduction (results)
focused onto identification of risks for health of human beings, animals and plants, and to
deliver this report to the Ministry. The report shall contain knowledge, data and information
gained from resear
ch and development activities performed during the introduction into the
environment, as well as from the risk assessment (Art. 5).


(2) If preparation of a product supposed to be placed on the market is the final objective of the
introduction into the env
ironment, the report shall contain also the possible risks resulting
from the future usage of that product, as well as proposed conditions of product usage and its
handling, as a basis for decision making of the authorities regarding the handling of food a
nd
feed and their placing on the market.



14


P l a c i n g o n t h e m a r k e t


Art. 21

Approval of placing of product on the market


(1) The Ministry’s approval is required for placing a product on the market in the
following cases:

a) the first pl
acing on the market of the new product,

b) repeated placing on the market of the same product when it is intended for different
purpose,

c) substantial change of the product already placed on the market,

d) import of the product to be placed on the market

for the first time.

(2) The obligation set out in par. 1 applies to product when it contains genetically
modified organism or part of it that is able to transfer genetic information and when it is
dedicated for processing.


(3) Approval according to par.
1 is not required for placing on the market

a) of a product composed exclusively from raw materials and semi
-
products that do not
require such approval or that already received it,

b) of imported product that was permitted by the Commission or that was
permitted by the
competent foreign authority when it is stipulated by an International Treaty.


(
4
) Approval pursuant to par. 1 can be issued for limited period only, maximum for 10
years since the validity date of the decision on approval according to pa
r. 1. In the case for
placing on the market of the seed of genetically modified organism or its offspring, the first
permit may be issued for the maximum period of 10 years.



(
5
) A State Supervision Authority may decide that genetically modified org
anisms
introduced into the environment without a approval, the products that were imported without
a permit, or the products placed on the market without a permit will be destroyed on the user
's
own costs
; the appeal against such decision shall not have su
spensive effect.



Art. 21a

Safety measures


(1) When it can be supposed after issuing of the approval according to art. 21 par. 1 or

par.
3 b), as a result of new or additional information availability that influence risk assessment, or
after re
-
evaluat
ion of existing information on the basis of additional scientific information that
the product represents a risk for human health or for the environment, Ministry can
temporarily limit or prohibit the use of such product in the territory of the Slovak Repu
blic.

(2) If it is established on the basis of the information included in the par. 1 that serious risk
threatens human health or the environment, the Ministry shall decide to interrupt or terminate
the placement on the market of this product and it will
inform immediately the public.

(3) Appeal against the decisions pursuant to the par. 1 and 2 does not have suspensive
effects.



15

Art. 22

Obligations of the user after placement on the market


(1) The user is obliged to ensure that

a) the products introduce
d on the market will be packed in compliance with the requirements
for safe transport and storage, in compliance with the intended use as well as the
conditions mentioned in the issued approval for product placement on the market,

b) the text "This produc
t contains genetically modified organisms" will be shown on the
product or its package and in the accompanying documents,

c) label of the product as well as the accompanying documentation will contain

1. description of recommended use or instructions for

use when the usage of product is
not apparent from its construction or function or when it is not known in general,

2. data on unacceptable usage of the product together with instructions for protection of
human beings and the environment in case of unac
ceptable usage,

3. data on recommended storage of the product and on handling and disposal of unused
residues or packaging,

4. data on producer and also on importer if any imported product is concerned,

5. expiration period,

6. other data according to s
pecial regulations.


(2) The user is obliged

a) to make available to the State supervision authorities control samples of the products
placed on the market according to art. 25 and to allow them to take samples,

b) to develop monitoring plan, to monitor

the product on the market according to this plan
and to evaluate the monitoring results,

c) to organise training of the vendor
's

employees when the usage of the product requires
knowledge or skills that are not obvious from the product function or from u
sers manual,

d) to elaborate a report on monitoring results and to submit it to the authority issuing the
approval for placement on the market,

e) to publish on the Internet and possibly by any other appropriate means the results of
monitoring of the prod
uct placed on the market in order to inform the public.




P A R T F O U R

STATE ADMINISTRATION


Art. 23

State administration authorities


Pursuant to this Act, the following bodies are the state administration authorities:

a) the Ministry,

b) Slovak En
vironmental Inspection („Inspection“ hereinafter).




Art. 24

Ministry


(1) The Ministry


16

a) is a central state administration body which deals with the matters concerning the usage of
genetic technologies and genetically modified organisms

b) is an ad
ministrative body competent to:

1. issue approvals pursuant to the art. 13, 17 and

21,

2. receive notifications and evaluate their content (art. 12 and 32),

3. receive accident notifications (art. 14 par. 2) and notifications of identified changes in
th
e deliberate release (art. 19 par. 3) and on safety measures


(art. 21a),

4. receive applications pursuant to art. 33, 34 and

35,

c) keeps the registers of genetically modified organisms and records of introduction into the
environment according to art.

17 par. 1 a),

d) keeps the records of users, Safety Committees and project heads,

e) provides users information, methodological instructions and expert guidance and organises
training of project heads (art. 9 par. 7).


(2) In the matters of genetic tech
nologies and modern biotechnology, the Ministry has the
position of

a) national notification body to the Commission and especially, it is competent

1. to perform notification when the contained use or deliberate release has a
transboundary consequences

or when an accident has or could have a transboundary
consequences;

2. to consult the content and implementation of the emergency plans as well as knowledge
gained from the analysis of accident reasons and consequences;

3. to submit annual summary report
on issued approvals for contained use classified into
risk classes 3 and

4, comprising description, purpose and risks, as well as reporting in
form of summary announcement information format,

4. to elaborate evaluation report when products are placed on t
he market,

5. each third year, to submit the report about the implementation of this Act,

6. to report the monitoring of product on the market pursuant to art. 22 par. 2 d) and also
to report each third year on the experience with placing of the product o
n the market,

7. to immediately inform about detected unauthorized introduction into the environment
or placement on the market and on adopted safety measures pursuant to art. 21a,

8. to inform within 30 days on each application for approval to introduce t
o the
environment (art. 34) and on each issued permit according to art. 35 to 37,

9. to report the results of introduction into the environment (art. 20),

b) national centre for genetic engineering and modern technologies safety and for
transboundary
10
c)

as well as for biological safety,
10d)

that especially:

1. fulfils the role of national contact point for the clearing centre of biological safety and
the main contact point for the European Community, that also submits to them
necessary data and inform
ation on transboundary movements,


2.

implement preventive measures and sanctions in order to prevent illegal transboundary
movements, and also announce their appearance to the clearing centre of biological
safety.




(3) On the Internet as well as by any

other appropriate means, the Ministry is obliged to
inform the public




10c)

Par. 15 and

19 of the Directive of the
European Parliament and the Council (ES) No. 1946/2003 in
force.

10d)


Par. 19 of the Cartagena Protocol on Biological Safety to the Biodiversity Convention

(Announcement No. 82/2004 Coll.)



17


a) on the substantial part of content of the applications for approval pursuant to art. 33, 34
and

35, as well as on issued permits,


b) summary report according to par. 2
a), item three,


c) evaluation reports according to par. 2 a) item four,


d) reports on monitoring results of products on the market according to par. 22 art. 2 d),


e) information according to art. 2 a) item seven,


f) decisions on

adopted safety measures according to par. 21a.


(4) Ministry is obliged to inform immediately the Member States about any detected
unauthorized introduction into the environment or placement of a product on the market and
on adopted safety measures accor
ding to art. 21a, together with a justification, with re
-
evaluation of the original risk assessment and with statement whether and by which means the
approval conditions should be changed, or whether the approval should be redrawn, and to
submit actual inf
ormation that serve as a basis for adoption of safety measures.



Art. 25

Inspection


(1) The Inspection is the state authority for the supervision over the usage of the genetic
technologies and genetically modified organisms (hereinafter referred to as “s
tate
surveillance”) and it shall

a) perform the state surveillance and

b) impose fines for administrative infractions (art. 28 and 29) and deal with delicts (art. 30).


(2) Inspection does not perform

a) supervision over human health protection and human

health risk assessment that are
performed by the public health authorities according to the separate regulations,
11)

b) veterinary controls, veterinary inspections and veterinary supervision that are performed
by the state administration bodies in veteri
nary field according to the separate
regulations,
12)

c) supervision over the sector of plants, seeds and plantations as well as plant protection that
are performed by the state administration bodies according to the separate regulations,
13)




11)

Art. 54 of the Act of the Slovak Parliament No. 355/2007 C
oll. on the Protection, Support and
Development of the Public Health and on amendment of certain Acts.

12)

Art. 4 par. 3 of the Act No. 39/2007 Coll. on Veterinary Care. Art. 40 par. 4 of the Act No. 182/2005
Coll. on Wine Production and Viticulture.

13)

A
rt. 4 of the Act No. 193/2005 Coll. on Plant Protection as amended, Art. 9 of the Act No. 271/2005
Coll. o. Production, Placing on the Market and Use of Feed (Feed Act), Art. 6 to 8 of the Act No.
184/2006 Coll. on Cultivation of Genetically Modified Plan
ts in Agricultural Production, Art. 4 of the
Act No. 597/2006 Coll. on Responsibilities of State Administration Authorities in the Field of
Registration of Varieties and on Placing on the Market of reproductive material of cultivated plants,

14)

Art. 3 o
f the Act No. 128/2002 Coll. on State Control of the Internal Market and Protection of
Consumer and on amendment of certain acts, and

the Act of Slovak Parliament No. 152/1995 Coll. .as
amended.

15)

Art. 2 of the Act No. 125/2006 Coll. o. Labour Inspection

and on amendment of the Act No. 82/2005
Coll. on Illegal Labour and Illegal Employment

and on amendment of certain acts as amended by the
Act No. 309/2007 Coll.


16)

Art. 8 to 16 of the Slovak Parliament Act No. 10/1996 Coll. on Control Procedures in t
he State
Administration as amended by the Act No. 502/2001 Coll.



18

d) state cont
rol of product sale in the internal market that is performed by internal market
control bodies according to the separate regulations
14)

e) supervision over the working safety and health protection that is performed by the bodies
of work inspection accord
ing to the separate regulations.
15)


(3) State supervision shall mean control over the observance of this Act, generally binding
legal regulations for the execution thereof as well as over meeting their obligations resulting
from decisions rendered pursuan
t to this Act by the users.


(4) When the inspection will detect any breach of duties or other shortages in the activities
of the user, it shall address a warning to him and, the user shall be imposed the obligation to
remove the shortage in the appropriat
e period of time. When the activities of the user means a
direct threat of an accident, (Art. 6 par. 2) including threat to human health outside of the
contained use, inspection will prohibit further usage of genetic technologies or genetically
modified or
ganisms.


(5) For the purposes of this Act, the state supervision is performed according to the basic
principles of control procedures.
16)


Art. 26

Duty not to disclose


(1) The following persons are obliged to maintain confidentiality on the facts, data a
nd
information that are subject of intellectual property rights or trade secret of the notifier

a) inspectors (Art. 25), if they learned them during the state supervision,

b) employees of the Ministry and inspection, if they learned them from the annou
ncement or
information or during the procedures pursuant to this Act,

c) members of the committee and expert panel pursuant to Art. 27, if they learned them under
activities pursuant to Art. 27.


(2) They may be released from the duty not to disclose by t
he notifier or applicant for the
approval, or the Minister of Environment of the Slovak Republic in the case of information
that is necessary for clarification and investigation of a criminal act.


(3) The notifier or the applicant for the permit can mark
the data and information
available during the state supervision or involved in the permit or the application for permit as
a subject of intellectual property rights, or as a subject of trade secret and he can ask to keep
them unpublished, and he is obliged

to justify his request. The content of the proposal will be
judged by the Ministry that will inform him on the outputs.


(4) Data and information that the Ministry considered a subject of intellectual property
rights or a subject of trade secret will not

be published neither divulged to other parties and
organs of foreign states, even in the case that the notifier withdrawn the notification or the
applicant withdrawn the application for approval.


(5) The following data and information may not be subject

of intellectual property right
nor trade secret:







19

a) general characteristics (description) of the genetically modified organism,

b) trade name and address of the notifier or applicant for approval,

c) trade name of the user, and trade name of the foreign p
roducer and the importer in the case
of import,

d) classification of the contained use to the risk class and related level of protection,

e) results of risk assessment and its re
-
evaluation,

f) evaluation of the predictable effects, especially adverse effe
cts to human beings and the
environment.

g) purpose and site of
the use
, and expected exploitation of the genetically modified organism,

h) monitoring methods, monitoring plans and accidental response.


Art. 27

Committee for Biological Safety and its Expe
rt Panel



(1) Ministry establishes a Committee for Biological Safety ("Committee" hereinafter)
as its advisory body, and also Expert Panel.



(2) Statute and Rule of Procedure of the Committee, setting out details on the positions
and activities of the C
ommittee and its Expert Panel will be issued by the Minister of
Environment of the Slovak Republic. Development of expert opinions for the Ministry
pursuant to this Act is the main objective of the Committee.




Art. 28

Administrative offences



(1)
The Inspection will impose a fine up to
33

193,91 EUR


a) to the notifier who failed to notify pursuant to Art. 12,


b) to the applicant failed to apply for approval pursuant to the Art. 13, 17 or 21,


c) in the framework of transboundary

movements pursuant to the separate
regulation
17)
, to any person who failed to


1. notify the third state,


2. keep documentation on transboundary movements for required period, or who


3. submit to the third state co
rresponding documentation, or who submit it


incomplete or containing false data, or


d) to any person who did not submit to the Ministry report or any other document
pursuant to this Act.


(2) The Inspection will impose a fine from
1

659,69 EUR

up to
165

969,59 EUR
to the
user (Art. 9 par. 1) , who

a) applied contained use that does not comply with requirements for contained use or
requirements for waste handling or with industrial waste waters (Art. 9 par. 2),

b) applied contained u
se without establishing the Safety Committee or without nomination of
project head (Art. 9 par. 2),

c) failed to ensure appropriate protection level of the contained use that corresponds to the
classification into risk class (Art. 9 par. 8),

d) has not k
ept the required documentation or who has not recorded substantial circumstances,
or who has not kept his documentation for requested period (Art. 5 par. 4, Art. 9 par. 9,
Art. 11 par. 4 , Art. 19 par. 4 and Art. 20),


20

e) did not implement measures for prev
ention of possible adverse effects to human beings end
the environment, or protective measures resulting from the protection level corresponding
to the risk class, even if any accident did not happen (Art. 10 par. 1 and Art. 16 par. 1),

f) did not assess r
isks or did not assess it by the required method, and who did not classify the
planned use or transboundary movements into a risk class (Art. 10 par. 1 to 3 and Art. 16
par. 1 to 3),

g) failed to elaborate emergency plan, did not submit substantial infor
mation from it or did
not publish them by requested method (Art. 10 par. 1 and

5 and Art. 16 par. 1 and 4),

h) failed to re
-
evaluate classification into risk class (Art. 11),

i) failed to fulfil his obligations during the accident (Art. 14),

j) used genet
ic technologies or genetically modified organisms, or moved them across borders
without permit or without notification (Art. 12, 13, 17 and 21),

k) placed on the market a product without permit, or did not fulfilled the obligation after
placement to the ma
rket (Art. 21 and 22),

l) did not allow participation of project head in the training organised by the Ministry [Art. 9
par. 8 letter i)].


(3) The Inspection will impose a fine to the user or notifier from
33

193,91 EUR

to
331

939,18 EUR
, when an accident

happened due to administrative infraction pursuant to par.
1 or par. 2 (Art. 6 par. 2) and that accident has brought consequences on human life or health
or serious consequences to the environment.



Art. 29

Imposing of fines


(1) The proceedings to impos
e a fine pursuant to Art. 28 may commence within one year
since the day when the inspection learned about the breach of obligations, however, not later
than three years since the day when the breach of obligation happened.



(2) Seriousness and duration o
f illegal act are considered while imposing a fine, as well
as the degree of impact to the human population and to the environment.


(3) Inspection may also impose, in its decision on fine, the obligation to implement
measures to remove or mitigate/reduce

in determined period of time the consequences of the
administrative infraction for which the fine had been imposed. When the obliged body fails to
take such measures within determined period of time, the inspection has right to impose an
additional fine i
n the amount of double maximum fine pursuant to the Art. 28.


(4) When a person who was punished by a fine will breach again the same duties within
one year since the decision on fine will enter into force, the inspection will impose a fine up
to double am
ount of the maximum fine.


(5) The benefit from the fines makes an income to the Environmental Fund.


(6) The imposed fine is payable within 30 days since the decision on the fine comes into
force, unless there is other time period stated in that decision
.



Art. 30


21

Delicts


(1) Any one shall commit a delict who


a) used genetic technologies pursuant to this Act, or genetically modified organisms in
contained use without notification according to the Art. 12 or without the approval according
to the

Art. 13,


b) has released genetically modified organisms according to the Art. 17 or 21.


(2) A fine amounting up to
1

659,69 EUR

may be imposed for the offence according to
the par. 1 and prohibition to undertake professional activities for the ter
m up to two years.


(3) General legal regulations on offences apply to the delicts and to proceedings
thereon.
18)


P A

R T

F I V E

PROCEEDINGS



Art. 31

Introductory provisions


(1) Proceedings pursuant to this Act are regulated by general regulation o
n administrative
proceedings,
19)

unless provided otherwise in this Act.



(2) General regulation on administrative proceedings shall not apply to

a) notification and evaluation of notifications (Art. 12 and 32),

b) announcement of the accident (Art. 14

par. 2) and of detected changes in the deliberate
release (Art. 19 par. 2).

c) evaluation of a proposal to classify a genetically modified organisms into the list pursuant
to the Art. 8, par. 3 (Art. 31a).


(3) The Ministry may request for the officia
lly authenticated translation of annexes and
supporting documents attached to the application (Art. 34 a

35).



Art. 31a

Evaluation of the proposal for incorporation to the list


(1) A proposal for incorporation of genetically modified microorganism to t
he list of
genetically modified microorganisms that are not subjected to the provisions of this Act
regarding their contained use, contains in addition to the general requirements also
documentation that comprises detailed and justified evidence enabling t
o assess whether the
statements on safety of genetically modified organism are legitimate from the defined criteria
point of view. The documentation may comprise also results of earlier tests, literature
references or records confirming safety of the micro
organism.




18)

Act of the Slovak Parliament No. 372/1990 Coll. as amended

19)

Act No
. 71/1967 Coll. on Administrative Procedures (Rules of Administrative Procedures).



22

(2) The Ministry, during evaluation of the proposal for incorporation of the genetically
modified organism to the list, will

a) examine the completeness of the documentation,

b) call the user for completion of the documentation in a due time whe
n it is incomplete.


(3) When a positive result of the evaluation is reached, the Ministry will submit the
proposal to the corresponding organs of the European Union. The user will be provided
written information about the results.



Art. 32

Evaluation of

notifications


(1) In the course of evaluation, the Ministry (Art. 12)

a) shall examine/check the completeness
of the notification according to the type and purpose
thereof
,

b) shall address a

request for completion in due time to the notifier in case o
f any
incompleteness of the notification,

c) may request the notifier for submission of more detailed data or for completion of the
application by additional documents if it is necessary for the evaluation of the notification,

d) may impose on the inspect
ion the task to perform state supervision over a

notifier for
certain period of time and in certain extent.



(2) In the case of notification as referred to in the Art. 12, par. 2 b) or c), the Ministry
shall furthermore

a) evaluate/assess the notification

contents by means of the comparison of it with the
requirements for contained use pursuant to this Act, as well as in accordance with
corresponding Executive Regulation, especially the Ministry shall examine and evaluate

1. completeness and accuracy of da
ta and information in the notification of prepared start
of operation or transboundary movements,

2. correctness of risk assessment and classification into risk category,

3. appropriateness and correctness of proposed protective measures that shall corre
spond
with the required level of protection,

4. contents of the emergency plan and appropriateness of proposed safety measures,

5. proposed waste and waste water handling,

6. technical, organisational and personal conditions for the notified operations,

b)

compare data and information with available scientific knowledge and technical
specifications,

c) before starting the notified operation classified into the risk class 2, the Ministry may call
the notifier to carry out the following steps in determined pe
riod of time:

1.

to perform additional tests, measurements or other forms of examination in order to
verify the data and information reported in the notification,

2.

to implement additional measures in order to remove the shortages of the prepared
contained use

recognised by the state supervision,

3.

to elaborate simplified notification with the view of its publication in order to inform the
public about the prepared contained use.


(3) In order to carry out the evaluation according to the para
graph
s 1 and 2, the
Ministry
may request the notifier for
postponement

of the start of the contained use or for interruption

23

of the started operation; such interruption shall last until the time required for the evaluation
of the notification.


(4) Based on the evaluation o
f the notification, the Ministry shall inform the notifier that

a) either there are no objections against the notified operation, either there are additional
recommendations, or

b) the notified operation may start only upon approval (Art. 13) and furtherm
ore, the Ministry
shall request the user to submit the application for the commencement of proceedings on
issuing such approval (Art. 33).



(5) The Ministry shall evaluate the received notification within

a) 90 days in the case referred to in the Art.
12 par. 2 c),

b) 45 days in other cases.


(6) The periods as referred to in the par. 5 shall not start running

a) since the day of announcement of the call to the notifier pursuant to par. 1 b) and

c) and
par. 2 c) until the day of fulfilling the requir
ement,

b) in the course of inspection in the site of the notifier.


(7) It is presumed that the Ministry has no objections against the notified action unless it
fails to act pursuant to the par. 5 nor it informs the notifier that the application is needed
.


(8) If the notifier fails to meet the requirements by the Ministry pursuant to the par. 2 or 3,
the Ministry may issue its decision to prohibit the notified action or to impose a

fine in the
amount up to
331,93 EUR

to the notifier.



P r o c e e d i n
g s o n a p p r o v a l


Art. 33

Proceedings on approval of the contained use


(1) Written application is considered motion to commence proceedings. In addition to
general elements of a

submission
20)
, the application shall include further elements
as shall be
provided for in the executive regulation (Art. 39).


(2) Applicant for approval (Art. 13, par. 1) is party to the proceedings
21)
. Association of
citizens may be party to the proceedings as well which has the objective to protect the
environmen
t or consumers pursuant to its Charter, provided that

a) on the date of submission
20

of its application pursuant to the subpar. b), it was registered as
association of citizens
22)

with the above mentioned objectives at least for one year,

b) within 10 da
ys since the publication of the request for approval, it submits written
application with the Ministry pursuant to this Act and




20) Article 19, par. 1 of the A
ct No. 71/1967, Coll.

21) Article 14 of Act No. 71/1967, Coll.

22) Act No. 83/1990 Coll. on Associations of Citizens.

23) Act No. 85/1990 Coll. on Right to Petition.



24

c) the petition
23)

is included in the application pursuant to the subpar. b) which has to be
signed by at least 100 natural pers
ons supporting this application.


(3) The Ministry shall request for completion of the application by any data in relation to
the performed tests, measurements or any other tests.


(4) The Ministry shall

a) provide the
applicant for approval

its written c
onfirmation of the submission of the
application

b) immediately publish on the Internet the data on the submitted application and, if
appropriate, in newspapers as well together with the call for submission of objections and
with the time period thereof.


(5) The decision on granting the approval shall be issued within following periods of time:

a) 45 days provided that approval of new contained use classified as risk class 3 and 4 is
subject of it and provided that all conditions were met for the previous
approval that had
been issued as for contained use in the same or higher risk level,

b) 90 days if the approval for any other case is subject of it.




(6) The Ministry may join the proceedings on approval of first contained use (Art. 13, par. 1
a)) with
the evaluation of the notification pursuant to the Art. 12, par. 2 b) provided that the
following conditions are met: :

a) upon request by the notifier,

b) actions assigned the risk class 1 are subject of it,

c) the application has the elements of the moti
on to commence proceedings pursuant to the
par. 1 as well as the elements of the notification and

d) the notifier shall start operation/action within 60 days since the date on which the decision
by the Ministry comes into force.


(7) The notifier has the
obligation to submit notification pursuant to the Art. 12, par. 2 b)
unless he starts contained use in the period of time as provided for in the par. 6 b).


(8) The Ministry shall dismiss the application for approval if

a) the applicant is not the owner ne
ither tenant/hirer of the facilities to be used for the
contained use,

b) facilities designed for contained use do not meet the requirements pursuant to the Article 9,
par. 2 c) or the application of the principles according to the Art. 9, par. 8 is imposs
ible to
be ensured inside of such premises,

c) user is subject to declaration of bankruptcy.




Art. 34


Proceedings on approval of introduction into the environment


(1) Written application is considered motion to commence proceedings. In addition to
ge
neral elements of a

submission, it shall include

a) technical dossier necessary for evaluation of risk assessment


25

b)

report from risk assessment performed by the user, together with references to the scientific
literature and to used gene methods and gene
techniques, as well as knowledge, data and
results of the introduction by the different notifiers,

c) further elements as will be provided for in the generally binding legal regulation (Art. 39).


(2) Applicant for approval
21)

is party to the proceedings
(Art. 17, par. 1). Association of
citizens may be party to the proceedings as well which has the objective to protect the
environment or consumers pursuant to its Charter provided that

a) on the date of submission of its application pursuant to the subpar
. b), it was registered as
association of citizens
22)

with the above mentioned objectives at least for one year,

b) within 10 days since the publication of the request for approval, it submits written
application with the Ministry pursuant to this Act an
d

c) the petition
23)

is included in the application pursuant to the subpar. b), which has to be
signed by at least 100 natural persons supporting this application.


(3) The Ministry may decide to grant status of participant to the proceedings
23a
) to the
association of citizens pursuant to the par. 2 provided that granting of approval of introduction
of such genetically modified organisms in the environment with comparable biological and
geological conditions in relation to which approval had been granted
before is subject of
proceedings and provided that there is enough experience with introduction in comparable
ecosystems.



(4) The Ministry shall confirm to the applicant the submission of the application and it
shall immediately publish the data about s
ubmitted application in the Internet and, if
purposeful, also in other appropriate manner together with public call for submission of
objections within the 30 days time period since the date of publication.


(5) The time limit is 90 days for making decisi
on on approval. This time period shall not
run since the date of publication on the Internet until the elapse of time limit pursuant to the
par. 4
, but it may not exceed 120 days.



(6) Decision on importing genetically modified organisms designed to

be introduced into
environment is part of the decision on approval of introduction into environment.



Art. 35

Proceedings on approval to place a

product on the market


(1) Written application is considered motion to commence proceedings. In addition to

general elements
20)

of a

submission, the application shall include further elements as shall be
provided for in the statutory instrument/executive regulation (Art. 39).


(2) Applicant for approval (Art. 21, par. 1) is party to the proceedings
21)
. Associ
ation of
citizens may be party to the proceedings as well which has the objective to protect the
environment or consumers pursuant to its Charter provided that

a) on the date of submission of its application pursuant to the subpar. b), it was registered a
s
association of citizens
22)

with the above mentioned objectives at least for one year,

b) within 10 days since the publication of the request for approval, it submits written
application with the Ministry pursuant to this Act and


26

c) the petition
23)

is i
ncluded in the application pursuant to the subpar. b), which has to be
signed by at least 100 natural persons supporting this application.


(3) If granting of approval to place on the market of a

product that was subject to prior
approval or that is design
ed for research or for collection of cultures is subject of proceedings,
the Ministry may decide that the association of citizens pursuant to the par. 2 has status of
participant in the proceedings
23a)
.


4) The Ministry

a) shall issue written confirmatio
n of the submission of the application to the applicant for
approval and it shall refer to the Member States‘ Authorities as well as to the Comm
ission
the set of documentation

b)


immediately publish on the Internet the data on submitted application and, i
f appropriate,
it also shall publish it in other adequate manner together with public call for submission of
objections and with indication on time limit for such submissions; the Ministry shall
suspend the proceedings for maximum period of 60 days in the
course of the time period
indicated for submission of comments of for public debates,

c) within 90 days since the date on which the application is considered complete, the
Ministry shall elaborate evaluation report and it serves it to the applicant for co
nsent; in
the evaluation report, there is always a

conclusion in relation to whether or not the product
is supposed to be placed on market,

d) shall publish on the Internet its evaluation report and, if appropriate, it shall publish it in
another adequate
manner together with the call for submission of objections within 30
days deadline,

e) to the applicant for approval, it shall serve the copy of the application, evaluation report
possibly completed with new data or standpoint of the applicant for approval

or remarks
from the public; these documents shall be served to the applicant within minimum time
period of 15 days since the delivery thereof but the maximum period is 105 days since
submission of application; the same documents shall be referred to the E
uropean
Communities‘ Authorities unless the applicant withdrawn his application within that
period of time,

f) shall decide to grant the approval to place a

product on market upon prior service of the
standpoint by the European Communities‘ Authorities con
cerning the evaluation report.


(5) The time limit for decision on approval is 120 days; this time limit shall not run

a) since the date of notification to the
applicant for approval

of call for completion of the
application or for removal of shortages unt
il the date of fulfilling that requirement,

b) in the course of elaboration of the evaluation report, 90 days maximum,

c) since the date of service to the
applicant for approval

of the evaluation report until the date
of service of
applicant’s

opinion, 3
0 days maximum,

d) in the course of debating the evaluation report pursuant to the par. 4 e).


(6) In addition to the general elements of the decision
24)
, the decision shall include

a) definition of the scope of the decision including the identity of th
e genetically modified
organism in the product as well as its unambiguous identificator,

b) time limit for the validity of the approval,


27

c) conditions for introduction on market of the product including conditions for use,
manipulation and packaging as we
ll a
21
s conditions for protection of ecosystems and
geographical areas,

d) requirements for labelling of the product,

e) requirements for monitoring of the product on market including time schedule of
monitoring as well as obligations of the vendors.


(7)
The decision shall be published on the Internet, in the Official Journal of the Ministry
of Environment of the Slovak Republic and by other appropriate means.



Art. 36

Modification or cancellation of the decision on approval



(1) Proceedings on modificat
ion or cancellation of the decision on approval shall commence
upon user’s application or upon the motion by the Ministry itself. If it is commenced on the
basis of the application by the notifier, the Art. 33, 34 or the Art. 35 shall apply depending on
th
e contents of the application. .


(2) The Ministry shall commence proceedings upon its own motion provided that

a) the user fails to observe his obligations pursuant to this Act or requirements contained in
the decision on approval despite notice and fine

imposed,

b) it is necessary in order to fulfil an international obligation of the Slovak Republic including
negotiations on objections by the European Communities‘ Authorities in relation to the
evaluation report,

c) unintentional modification of delibera
te release occurred and that modification might have
harmful influences on humans and environment,

d) there is a

need to modify the monitoring plan on the basis of objections by a

Member State
or the Commission which result from the negotiations in relatio
n to the report about
monitoring results.



Art. 37

Extension of the validity of the decision to approve the placing on market



(1) The application for extension of the validity of the decision to approve placing on
market issued within proceedings purs
uant to the Articles 33 to 35 may be submitted 9
months at the latest before the expiration of the validity of the approval issued.


(2) Written application is considered motion to commence proceedings. In addition to
general elements of a

submission, it

shall include the copy of the rendered decision to
approve, possibly proposals to modify the contents of the approval issued and, if
a

modification is concerned of the decision to approve placing product on market, it shall also
include the report about r
esults of monitoring of the product on market.





23a) Art. 15a of the Act No. 71/1967 Coll. as amended by the Act No. 527/2003 Coll.

24) A
rt. 47 of the Act No. 71/1967 Coll.



28

(3) The Ministry shall issue written confirmation of the submission of the application and
if the application is complete, it shall refer one copy of it together with the evaluation report
to the European Co
mmunities‘ Authorities. It shall send to the applicant one copy of the
evaluation report as well.


(4) The decision is based on the evaluation report by the European Communities‘
Authorities.


(5) The time limit for making decision is 30 days since deliv
ery of the evaluation report
pursuant to the par. 4. If there is a

need to negotiate problems found on the basis of the
objections included in the evaluation report, the time limit for taking decision is 30 days since
the date of termination of negotiation
s.


(6) Decision pursuant to the par. 1 may be issued only on the basis of implementation of
the requirements resulting from evaluation report pursuant to the par. 4. The article 21, par.
4
applies to the contents of the decision. The Art. 21, par.
4

appl
ies to the time period of the
extension; however, according to the result of evaluation of the product on market, this time
period may be extended or reduced as appropriate.


PART SIX

COMMON, TRANSITIONAL AND FINAL PROVISIONS


Art. 38

Common provisions



(
1) General regulations on food
(8)

shall apply to the labelling of food placed on the
market.


(1)

For the purposes of liability for damage, contained use as well as deliberate release are
considered operating activities pursuant to a

separate regulation
25)
.



Art. 39

Authorizing provision


The Ministry shall issue generally binding legal regulations that will set out details on


a) content of the emergency plan (Art. 6),

b) requirements for the contained use (Art. 8),

c) professional qualification of the p
roject heads an on their professional training (Art. 9),

d) risk assessment (Art. 5) and on procedure and criteria for classification into risk classes, as
well as on the content of protection levels (Art. 10),

e) procedure for evaluation of direct and ind
irect, immediate and delayed effects and for
performance of analysis of cumulative long term effects (Art. 16),

f) content of documentation and on procedure for its keeping and maintenance (Art. 5, 9 and
19),




25) Art. 420a, Civil Code.



29

g) content of the report on the results of in
troduction into the environment (Art. 20),

h) properties of the individual notifications and on evaluation of their content (Art. 32)

i) other properties of the applications for issuing of the permit (Art. 33 to

37),

j) content of the evaluation report (A
rt. 35),

k)
safety
criteria
of genetically modified microorganisms that will not be regulated by the
provisions of this Act on contained use, and will elaborate a list of such genetically modified
microorganisms (Art. 8).


Art. 40

Transitional provisions


(1) Any entrepreneur and other legal entities that performed their activities using genetic
technologies or genetically modified organisms to the date of 1st April, 2002, may continue
their operation only provided that they meet the following requirements
until the 31 March,
2003 :

a) adjust their position according to requirements for the user,

b) adjust facilities in accordance with the technical and organisational requirements for the
facility pursuant to this Act and the legally binding regulation (
Art. 39),

c) establish Safety Committee and nominate project head for each facility and for each use of
genetic technologies and genetically modified organisms,

d) assess the risk,

e) elaborate emergency plan, and

f) submit an application for issu
ing the permit.


(2) Any entrepreneur and legal entity is obliged to terminate their operation until the 31
March, 2003 if they fail to meet the requirements pursuant to the par. 1.


(3) Until 30 June, 2002 at the latest, entrepreneurs and legal entities a
re obliged to notify the
Ministry any data necessary for keeping register of equipments, used genetic methods, genetic
techniques and used modified genes.


(4) The Ministry has right to impose fine in the maximum amount of 50.000 Sk to any
entrepreneur or

other legal entity pursuant to the par. 1 which

a) fails to meet the requirements pursuant to the par. 1 or fails to terminate its operation within
the time limit as provided for in the par. 2,

b) fails to notify the data within the time limit determine
d in the par. 3.



(5) Genetically modified organisms containing genes for resistance to antibiotics applied as
human pharmaceuticals or veterinary pharmaceuticals must be

a) withdrawn from the market till December 31, 2004

b) refused from the introduction

to the environment till December 31, 2008


by the users.




Art. 40a

Final provision



The enclosed legal acts of the European Communities and European Union are
transposed by this Act.


30




Art. 41

Effectiveness


This Act shall become effective the 1st A
pril, 2002 with the exception made of the
art.35, par. 4 and the Art. 37, par. 4 that shall become effective on the day of the accession to
the European Union of the Slovak Republic.











The Act is supplemented by the Appendix which reads:


„Appendi
x to the Act N
o. 151/2002 Collection of Laws




LIST OF
IMPLEMENTED LEGAL AC
TS

OF THE EUROPEAN COMM
UNITIES AND EUROPEAN

UNION



1. Council Directive No. 90/219/EHS of April 23, 1990 on Contained Use of Genetically
Modified Organisms (special edition of the

O.J. EU 15/1), as amended.


2. Directive 2009/41/EC of the European Parliament and the Council of 6

May 2009 on
the contained use of genetically modified micro
-
organisms (Recast) (
O.J.EU L 125,
21 May
2009)
.


3
. Directive 2001/18/ES of the European Parlia
ment and the Council of March 12, 2001
on Deliberate Release of Genetically Modified Organisms into the Environment, and on
repealing of the Council Directive 90/220/EHS (special edition of the O.J. EU 15/6) as
amended.







Effectiveness:

-

A
ct No. 587/200
4 Coll. became effective on the 1
st

January 2005,

-

Act No. 77/2005 Coll. became effective on the 1
st

April 2005,

-

Act No. 100/2008 Coll. became effective on the 1
st

July 2008
,


31

-

Act No. 515/2008 Coll.
b
ecame effective on the 1
st

January 2009.

-

Act No. 117/2010
Coll. became effective on the 1
st

May 2010.