THE CROATIAN PARLIAMENT
3318
Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the
DECISION
PROMULGATING THE ACT ON AMENDMENTS TO THE ACT ON
GENETICALLY MODIFIED ORGANISMS
I hereby promulgate the Act on Amendments to the Act on Genetically Modified Organisms,
passed by the Croatian Parliament at its session on 30 October 2009.
Class: 011-01/09-01/194
Reg. No: 71-05-03/1-09-2
Zagreb, 6 November 2009
The President
of the Republic of Croatia
Stjepan Mesić, m.p.
ACT
ON AMENDMENTS TO THE ACT ON GENETICALLY MODIFIED
ORGANISMS
Article 1
In the Act on Genetically Modified Organisms (Official Gazette 70/05), Article 2 is amended
to read:
“The terms used in this Act have the following meaning:
– biological diversity means the entirety of all living organisms that are constituent parts of
ecosystems and includes the diversity within species, between species, living communities
and diversity of ecosystems,
– genetic material means a part of a plant, animal, fungus, microorganism or virus, which
contains hereditary information,
– genetic modification means the intentional change in the hereditary genetic material of an
organism in a manner that cannot be achieved by a natural recombination and induction of
mutations, or introduction of foreign hereditary genetic material into the hereditary genetic
material of an organism, or removal of a part of the hereditary genetic material of an
organism; genetic modification occurs through application of the following methods:
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 organism of heritable material prepared
outside the organism including micro-injection, macro-injection and micro-encapsulation,
c) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with
new combinations of heritable genetic material are formed through the fusion of two or more
cells by means of methods that do not occur naturally, while for in vitro fertilisation, natural
processes such as conjugation, transduction, transformation, polyploidy induction it is
believed they do not lead to genetic modification, on the condition that they do not involve the
use of recombinant nucleic acids molecules or genetically modified organisms other than
those produced by techniques/methods that this Act is not applicable to,
– genetic diversity means the entirety of genes of all living organisms and their diversity
among specimens, populations, species and higher taxonomic categories,
– genetically modified organism (GMO) means an organism, with the exception of human
beings, in which the genetic material has been altered in a way that does not occur naturally
by mating and/or natural recombination,
– user means any legal or natural person who, in conformity with the provisions of this Act,
performs contained use of GMOs, deliberate release of GMOs into the environment, produces
and/or places GMOs or products containing GMOs on the market or uses GMOs,
– living modified organism means any GMO capable of replication or of transferring genetic
material, including sterile organisms capable for growth,
– competent authority means the state administration body determined pursuant to the
provisions of this Act,
– deliberate release of GMOs into the environment means any intentional introduction into the
environment of a GMO or a combination of GMOs for which no specific containment
measures are used to limit their contact with and to provide a high level of safety for the
general population and the environment, for the purpose of for example scientific research,
field trials and other non-commercial purposes,
– unintended release of GMOs into the environment means accidental release of living
modified organisms into the environment due to unforeseen events, accidents, inappropriate
handling or storing of living modified organisms and other activities,
– contained use of GMOs means any use in the course of which GMOs are cultured,
reproduced, stored, transported, destroyed, disposed of, or in any other way used in a closed
system, or in space for which physical barriers, or a combination of physical barriers together
with chemical and/or biological barriers are used to limit their contact with the environment
or their impact on it,
– notifier who submits the notification for use, introduction and placement of GMOs on the
market means any natural or legal person who intends to, or performs, contained use of
GMOs, intends to, or deliberately releases GMOs into the environment, or intends to, or
places, these products on the market,
– monitoring means planned and systematic monitoring and supervision of GMOs and the
receiving environment, contained use of GMOs, procedures for deliberate release of GMOs
into the environment, and placing on the market GMOs and products containing and/or
consisting of, or originating from GMOs, and possible adverse effects, pursuant to
regulations,
– transboundary movement of GMOs means:
a) deliberate transboundary movement of GMOs or products containing and/or consisting of,
or originating from GMOs (import, export and transit) or
b) unintended transboundary movement of GMOs via a carrier (such as man, animal, wind,
water etc.),
– notification means an application that contains the prescribed information, that the notifier
submits to the competent authority in order to obtain an approval or certificate,
– environmental risk assessment means determining and evaluating hazards to biological
diversity, or to human health that may occur due to contained use of GMOs, deliberate release
into the environment or placement on the market, for each specific case,
– GMO product means a preparation consisting of and/or containing one or more GMOs,
regardless of the degree to which it was treated, which is intended for placement on the
market,
– transit of living modified organisms means any transport of GMOs intended for a user in
another country, which passes across the territory of the Republic of Croatia,
– placement of GMOs and products on the market means to make GMOs and products
available to third parties, whether in return for payment or free of charge, with the exception
of making GMOs or GMO products available to authorised persons exclusively for the
purpose of contained use or deliberate release into the environment,
– closed system means a laboratory or a production department, or other space isolated from
the environment in which GMOs are handled,
– Biosafety Clearing-House – BCH means the mechanism set-up for the purpose of exchange
of information on biosafety, established under Article 20 of the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity. The Cartagena Protocol on Biosafety has
been ratified by virtue of the Act on Ratification of the Cartagena Protocol on Biosafety to the
Convention on Biological Diversity (Official Gazette – International Agreements, 7/02) –
hereinafter: the Protocol,
– micro-organism means any microbiological entity, cellular or non-cellular, capable of
replication or of transferring genetic material, including viruses, viroids, animal and plant
cells in culture,
– coexistence of genetically modified crops with conventional and organic agriculture means
coexistence in crop production in a specific area, under the conditions and in a manner which
enables a choice to be made between conventional, organic and GM-crop production,
– genetically modified micro-organism (GMM) means a micro-organism in which the genetic
material has been altered in a way that does not occur naturally by mating and/or natural
recombination.”
Article 2
Article 3 is amended to read:
“For performing expert and administrative activities, in case of GMO and/or products
containing and/or consisting of, or originating from GMOs:
– contained use in closed system: the competent authority is the central state administration
body responsible for science,
– deliberate release into the environment: the competent authority is the central state
administration body responsible for nature protection,
– placing on the market:
a) as food and feed: the competent authority is the central state administration body competent
for health issues;
b) as reproductive material in agriculture and veterinary medicine: the competent authority is
the central state administration body competent for agriculture and veterinary medicine,
c) as seed, plant parts and plant propagating material for forest taxa and hybrids used in
forestry, the competent authority is the central state administration body competent for
forestry,
d) as medicinal products in veterinary medicine and plant protection products: the competent
authority is the central state administration body competent for agriculture and veterinary
medicine.
For using GMOs and/or products containing and/or consisting of, or originating from GMOs
in cosmetics, pharmacy and health services for people: the competent authority is the central
state administration body competent for health issues.
On the administrative procedures carried out within their scope of work, the bodies referred to
in paragraph 1 subparagraphs 1, 2 and 3 items b), c), d) of this Article shall, by 31 March at
the latest, submit for the preceding year an annual report to the central state administration
body competent for health issues.
Approval for placement of GM food or GM feed on the market shall be issued by the minister
competent for health issues, with the approval of the minister competent for agriculture and
veterinary medicine.”
Article 3
Article 5 is amended to read:
“The provisions of this Act do not apply to the use of genetically modified microorganisms in
a closed system when the genetic modification is achieved through application of the
following techniques/methods:
1) mutagenesis,
2) cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic
material through known physiological processes,
3) cell fusion (including protoplast fusion) of eukaryotic species,
including hybridoma production and plant cell fusion,
4) self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism
which may or may not be followed by reinsertion of all or part of that nucleic acid (or a
synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same
species or into cells of phylogenetically closely related species which can exchange genetic
material by natural physiological processes where the resulting micro-organism is unlikely to
cause disease to humans, animals or plants. Self-cloning may include the use of recombinant
vectors with an extended history of safe use in the particular micro-organisms.
The provisions of this Act do not apply to deliberate release of GMOs into the environment
and placement of GMOs on the market when the genetic modification is achieved through
application of the following techniques/methods:
1. mutagenesis,
2. cell fusion (including protoplast fusion) of the plant cells of organisms that can exchange
genetic material through traditional breeding methods, under the condition that these
techniques/methods of genetic modification do not include the use of recombinant nucleic
acid molecules or genetically modified organisms different from those produced with one or
more techniques/methods.
The provisions of this Act do not apply to the transport of GMOs by rail, road, inland
waterways, sea or air, apart from the provisions of this Act which relate to risk assessments
and to proposing measures and undertaking measures in the event of an accident during use of
GMOs in a closed system.
The provisions of the Food Act and of special regulations apply to import, transit, placing on
the market, use and production of food and feed containing and/or consisting of and/or
originating from GMOs.
The provisions of this Act apply to import, transit, placing on the market, use and production
of medicinal products containing and/or consisting of, or originating from GMOs, only when
it is explicitly prescribed.”
Article 4
In Article 12, new paragraphs 1 and 2 are added and read:
“Transboundary movement of GMOs shall be performed in accordance with the provisions of
international agreements the Republic of Croatia is a party to, the provisions of this Act and
subordinate regulations adopted on the basis thereof.
Handling GMOs during transboundary movement of GMOs shall be prescribed by the
Government of the Republic of Croatia by virtue of a regulation, at the proposal of the head of
the central state administration body competent for nature protection and with the approval of
the heads of the central state administration bodies competent for health issues, environmental
protection, agriculture, forestry and science.”
The former paragraphs 1 and 2 become paragraphs 3 and 4.
Article 5
In Article 19, paragraph 3 is amended to read:
“The period during which the competent authority shall make the official acts referred in
paragraph 1 of this Article available for inspection and for expression of opinions and remarks
may not be shorter than fifteen days or longer than thirty days from the day of publication of
the acts concerned. This period shall not be included into the period for issuing the approval
pursuant to Article 22 of this Act.”
Article 6
In Article 35, paragraph 3 is amended to read:
“The period during which the competent authority will allow inspection and expression of
opinions and remarks may not be shorter than fifteen days or longer than thirty days from the
day of publication of the acts concerned, and will not be included into the period for issuing
the approval.”
Article 7
In Article 38 paragraph 1, after the words: “and inform the competent authority” the words
“competent for nature protection” are added and the words “and State Institute for Nature
Protection” are deleted.
Article 8
In Article 46 paragraph 2 is amended to read:
“Approval for placing on the market shall be issued for a ten-year period, with the possibility
of extension pursuant to the provisions of this Act and special regulations.”
Article 9
In Article 49 paragraph 3 is amended to read:
“Validity of the approval may be extended for a maximum of ten years.”
Article 10
In Article 51 paragraph 2 is amended to read:
“The label must clearly state „genetically modified organism” or have a sentence „this
product contains genetically modified organisms” or „this product originates from genetically
modified organisms” in accordance with the provisions of special regulations on labelling
GMOs.”
After paragraph 4, paragraph 5 is added and reads:
“A GMO being placed on the market or deliberately released into the environment must not
contain genes exhibiting resistance to antibiotics used in medicine and veterinary medicine.”
Article 11
After Article 52, Articles 52.a and 52.b are added and read:
“Article 52.a
Release into the environment of genetically modified plants and animals for which approval
for placement on the market for the purpose of breeding has been issued shall not be
permitted in protected areas and in areas of the ecological network, in accordance with special
regulations governing nature protection, areas intended for ecological production of
agricultural products and ecological forms of tourism, and areas representing protected zones
of impact as well as in areas which have, by a decision of the competent body of the local or
regional self-government unit, been proclaimed as GMO-free areas.
The Regulation of the Government of the Republic of Croatia referred to in Article 27
paragraph 1 of this Act prohibits the release of genetically modified reproductive plant
material into the environment in the areas referred to in paragraph 1 of this Article.
Article 52.b
The final user of the GMO whose placement on the market for breeding purposes has been
approved must obtain the approval of the central state administration body in charge of nature
protection referred to in Article 3 of this Act, competent for deliberate release of GMOs into
the environment.
For the purpose of obtaining the approval referred to in paragraph 1 of this Article, the final
user shall submit an application containing the following data:
– name, surname and seat of the final user in the Republic of Croatia,
– common and commercial name of the GMO they intend to breed and the planned purpose,
– exact breeding location (number of cadastral plot) accompanied by an excerpt from the
cadastral plan,
– planned beginning date and method of cultivation,
– written consent from the owners of the land plots bordering the plot(s) where the GMO will
be released and the owners of the plots located in the protected zone of impact which prevents
the spreading of GMOs to surrounding areas.
The competent body shall issue the breeding approval if all the prescribed requirements have
been met, subject to prior approval from the central state administration bodies competent for
health issues, agriculture, fisheries and rural development and forestry. The approval shall
define the requirements under which breeding may be carried out and the protected zone of
impact which prevents the spreading of GMOs to surrounding areas, especially if they include
areas in which deliberate release of GMOs is prohibited.”
Article 12
After Title III LIABILITY FOR DAMAGES CAUSED BY THE USE OF GMOs and Article
55, Title III.a and Article 55.a are added and read:
“Title III.a COEXISTENCE OF GENETICALLY MODIFIED CROPS WITH
CONVENTIONAL AND ORGANIC AGRICULTURE
Article 55.a
The issue of coexistence of genetically modified crops with conventional and organic
agriculture in the Republic of Croatia shall be regulated in accordance with the National
Strategy for coexistence of genetically modified crops with conventional and organic
agriculture.”
Article 13
In Article 62 paragraph 5 is amended to read:
“Anyone shall have the right to access the information from the GMO register, except for the
data marked as confidential. Information marked as confidential or information protected
pursuant to a special regulation must also be entered into the GMO register.”
Article 14
Article 64 is amended to read:
“For the performance of inspectional activities over GMOs and/or products containing and/or
consisting of and/or originating from GMOs:
– in contained use, deliberate transboundary movement, placed on the market as GM food in
accordance with special regulations, cosmetics and medicinal products; the competent
authority is the central state administration body competent for health issues,
– placed on the market as food, at the production and processing level, as GM food of animal
origin, GM food containing ingredients of animal origin, GM feed regardless of origin; the
competent authority is the central state administration body competent for veterinary medicine
in accordance with special regulations;
– placed on the market as food, at the retail sale level, GM feed regardless of origin; the
competent authority is the central state administration body competent for veterinary medicine
in accordance with special regulations;
– placed on the market as food, at import, GM feed regardless of origin, GM food of animal
origin; the competent authority is the central state administration body competent for
veterinary medicine in accordance with special regulations, while for GM food which
contains ingredients of animal and non-animal origin, the competent authority is the central
state administration body competent for veterinary medicine and the central state
administration body competent for health issues in accordance with special regulations,
– placed on the market as reproductive seed and plant material in agriculture, as reproductive
material in veterinary medicine, and as medicinal products in veterinary medicine and as plant
protection products; the competent authority is the central state administration body
competent for veterinary medicine and the central state administration body competent for
agriculture and veterinary medicine in accordance with special regulations,
– placed on the market as seed material, plant parts and plant propagating material for forest
taxa and hybrids used in forestry, the competent authority is the central state administration
body competent for forestry,
– for the labelling of GMOs the competent authority is the State Inspectorate,
– for cases of deliberate/unintended release of GMOs into the environment, the competent
authority is the central state administration body competent for nature protection.
On the inspectional supervisions under their scope of competence, the bodies referred to in
paragraph 1 of this Article shall annually submit, by 31 March at the latest for the previous
year, a report to the central state administration body competent for health issues.
In the event of immediate danger to human health and with the aim of protecting the
environment against the effects of GMOs, the head of the central state administration body
competent for health issues shall coordinate the inspectional supervision activities performed
by the bodies referred to in paragraph 1 of this Article.”
Article 15
After Article 64, Article 64.a is added and reads:
“Article 64.a
In performing official control of the presence of GMOs, the competent inspectional
authorities referred to in Article 64 of this Act shall use the following control methods and
techniques:
1. collection of samples of raw materials, half-products and finished products,
2. analysis and testing of collected samples in accordance with special analytical tests and
methods,
3. inspection of documentation and other records which might be relevant in assessing
conformity with this Act and special regulations,
4. control of monitoring plans of GMO users and notifiers,
5. publication of analysis results.
Inspectional supervision in the implementation of the official control referred to in paragraph
1 of this Article shall include:
– supervision of facilities for contained use,
– supervision of producers of primary products and business entities involved in operating
with GM food and feed, including the area surrounding their business facilities, the facilities,
equipment, plant and machinery, vehicles and the food and feed themselves,
– inspection of labelling, presentation and advertisement of GMOs,
– assessment of good production practices, good agricultural practices, in accordance with
special regulations,
– interviews with business entities involved in operating with GMOs.”
Article 16
Article 65 is amended to read:
“In the implementation of inspectional supervision, the competent inspector shall have the
right and obligation to issue a decision prohibiting persons under supervision who do not have
the approval of the competent authority and other certificates, from carrying out
transboundary movement, transit, contained use, deliberate release into the environment, and
placing on the market of GMOs and products containing and/or consisting of, or originating
from GMOs.
The inspector may order emergency measures to protect the lives of animals and human
beings and to reduce damages resulting from the performance of unauthorised activities,
actions, or operations.
In implementing inspectional supervision the inspector shall be authorised to collect samples
of products containing and/or consisting of, or originating from GMOs.
Samples of products referred to in paragraph 3 of this Article must be handled carefully and
labelled in the prescribed manner, thus ensuring their integrity and suitability for the planned
analyses.
When collecting samples referred to in paragraph 3 of this Article, relevant European Union
recommendations must be taken into account.
Samples referred to in paragraph 3 of this Article shall be delivered to official laboratories for
analysis of collected samples, which must be accredited in accordance with relevant
standards.”
Article 17
In Article 67, after paragraph 2, paragraphs 3, 4, 5 and 6 are added and read:
“The perpetrator shall be punished for attempting to commit the misdemeanour referred to in
paragraphs 1 and 2 of this Article.
The responsible person in the legal person or the natural person performing a GMO-related
activity shall be fined by the inspector on the spot, at the site where the misdemeanour has
been committed, in the amount of HRK 1,000.00, if they fail to comply with the provisions of
this Act and subordinate regulations adopted on the basis thereof.
If the person punished for a misdemeanour offence referred to in paragraph 4 of this Article,
commits the same offence a second time, they shall be fined on the spot at the site where the
misdemeanour has been committed, in the amount of HRK 3,000.00.
In addition to the monetary fine referred to in paragraphs 1 and 2 of this Article, a protective
measure prohibiting the performance of activities for three months to one year may also be
pronounced against the legal or natural person.”
Article 18
In Article 68 paragraph 1, subparagraph 2 is amended to read:
“– performs transboundary movement of GMOs contrary to the provisions of this Act,”
Subparagraph 20 is amended to read:
“– places on the market a GMO product without the necessary documentation, or which has
not been labelled in the prescribed manner (Articles 51 and 52), that is, acts contrary to the
provisions of Article 52.a and 52.b of this Act,”
After paragraph 2, paragraphs 3, 4, 5 and 6 are added and read:
“The perpetrator shall be punished for attempting to commit the misdemeanour referred to in
paragraphs 1 and 2 of this Article.
The responsible person in the legal person or the natural person performing a GMO-related
activity shall be fined by the inspector on the spot, at the site where the misdemeanour has
been committed, in the amount of HRK 1,000.00, if they fail to comply with the provisions of
this Act and subordinate regulations adopted on the basis thereof.
If the person punished for a misdemeanour offence referred to in paragraph 4 of this Article,
commits the same offence a second time, they shall be fined on the spot, at the site where the
misdemeanour has been committed, in the amount of HRK 3,000.00.
In addition to the monetary fine referred to in paragraphs 1 and 2 of this Article, a protective
measure prohibiting the performance of activities for three months to one year may also be
pronounced against the legal or natural person.”
Article 19
After Article 68, Articles 68.a and 68.b are added and read:
“Article 68.a
A member of the Council or of the Committee or an associate that is involved in the work of
the Council or of the Committee or in the issuance of approvals pursuant to this Act shall be
fined for misdemeanour in the amount ranging from HRK 15,000.00 to 50,000.00 if during
their mandate and following the termination of their mandate they do not keep information
labelled as confidential in accordance with the provisions of this Act (Article 6 paragraphs 1
and 2).
Article 68.b
A legal person shall be fined for misdemeanour in the amount ranging from HRK 350,000.00
to 1,000,000.00 if they act contrary to the provisions of Article 55.a of this Act.
The responsible person in the legal person shall also be fined in the amount ranging from
HRK 10,000.00 to 15,000.00 for the misdemeanour referred to in paragraph 1 of this Article.
For the misdemeanour referred to in paragraph 1 of this Article a natural person shall be fined
in the amount ranging from HRK 10,000.00 to 15,000.00.
The perpetrator shall be punished for attempting to commit the misdemeanour referred to in
paragraph 1 of this Article.
In addition to the monetary fine referred to in paragraphs 1 and 2 of this Article, a protective
measure prohibiting the performance of activities for three months to one year may also be
pronounced against the legal or natural person.”
Article 20
The general and special requirements for the coexistence of genetically modified crops with
conventional and organic agriculture shall be established by the National Strategy for
coexistence of genetically modified crops with conventional and organic agriculture which
shall, on the basis of the expert opinion of the Committee for Release of GMOs into the
Environment and after a public debate organised in accordance with special regulations
governing provision of information and participation of the public concerned in
environmental protection issues, be adopted by the Croatian Parliament, at the proposal of the
Government of the Republic of Croatia.
Article 21
Within six months from the date of entry into force of this Act, the Government of the
Republic of Croatia shall adopt the regulations for which it is authorised under this Act.
Article 22
This Act shall enter into force on the eighth day after the day of its publication in the Official
Gazette.
Class: 310-26/09-01/02
Zagreb, 30 October 2009
THE CROATIAN PARLIAMENT
The President of the
Croatian Parliament
Luka Bebić, m.p.