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6-Regulation: Croatian draft law prohibits GMO import and use



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TITLE:  Draft Law Bans Biotech Products
SOURCE: US Department of Agriculture, Foreign Agricultural Service
        GAIN Report #HR1009
        http://www.fas.usda.gov/gainfiles/200111/135682680.pdf
DATE:   November 13, 2001

------------------ archive: http://www.gene.ch/genet.html ------------------


GAIN Report
Global Agriculture Information Network
Voluntary Report - public distribution
Date: 11/13/2001
GAIN Report #HR1009

Croatia

Biotechnology

Draft Law Bans Biotech Products

2001

Approved by: Robert Curtis U.S. Embassy Vienna
Prepared by: Ryan Scott

Report Highlights: This draft law shows that Croatia is heading toward a 
ban on the importation, marketing, use, and production of the products of 
agricultural biotechnology. The ban would be in place until biotechnology 
is regulated by other, more specific legislation. The draft is dated 
September/October 2001. The draft law is just one aspect of the Croatian 
government’s an anti-GMO policy. The government also conducted an anti-GMO 
ad campaign this summer promoting Croatia as a GMO-free tourist destination 
(see HR 1008).

Includes PSD changes: No Includes
Trade Matrix: No
Unscheduled Report Vienna [AU1], HR

Begin Unofficial Translation of Draft Croatian Biotechnology Law

I. CONSTITUTIONAL BASIS FOR ENACTMENT OF THIS BILL

The constitutional basis for this Bill is provided in Article 2, Section 4, 
Subsection 1, and Article 50, Section 2 of the Constitution of the Republic 
of Croatia.

II. POSITION STATEMENT AND KEY ISSUES THAT THIS BILL PROPOSES TO REGULATE, 
AND EXPECTED IMPACTS OF THE BILL

1. Position Statement

The Republic of Croatia has yet to regulate, either by law or by other 
regulation, the issues related to the import, placing on the market, use 
and production of genetically modified organisms and products. Under the 
Convention on Biological Diversity, ratified by the Republic of Croatia in 
1996, the Protocol on Biological Safety provides the obligation of all 
parties to the Convention to enact the legislation with which they shall 
regulate the above-referred to issues with respect to genetically modified 
organisms and products.

The Croatian National Parliament, recognizing the possible impacts of the 
use of genetically modified organisms and products, on 27 November 1998 
passed a Resolution instructing the Government of the Republic of Croatia 
to appoint a Bioethics Committee and propose the legal framework with 
respect to this issue. In April 1999, the Government of the Republic of 
Croatia set up as its advisory body the Bioethics Committee for the 
monitoring of genetically modified organisms, within the Ministry of 
Agriculture and Forestry. Furthermore, in April 2001, the Government of the 
Republic of Croatia appointed a separate National Bioethics Committee for 
medical issues, under the authority of the Ministry of Health.

The Strategy and the Action Plan for the Protection of Biological and 
Countryside Diversity of the Republic of Croatia, adopted by the Croatian 
National Parliament in 1999 (Official Gazette No. 81/99), provided the 
obligation to enact Genetically Modified Organisms Act. Under Resolution of 
the Government of the Republic of Croatia of December 2000, the Ministry of 
Agriculture and Forestry was given mandate to draft a Bill on genetically 
modified organisms, and to that purpose, a Working Group was appointed 
which commenced the work on the draft. At the same time, the Ministry of 
Environmental Protection and Spatial Planning began drafting a Bill on 
environmental protection and, in accordance with its authority, built into 
the said Draft Bill the provisions of the Protocol on Biological Safety 
related to the release of genetically modified living organisms into the 
environment and their placing on the market, with the aim of protecting the 
biological diversity.

However, the Draft Bill on environmental protection does not apply to the 
issues related to the import, use, labeling, handling and transport of 
genetically modified organisms and products, particularly those that are 
intended for use as human food. These issues shall be regulated by a 
separate piece of legislation on foods and food ingredients, the drafting 
of which is also under way. The Draft Bill on foods is sponsored by the 
Ministry of Agriculture and Forestry and the Ministry of Health.

Recognizing the possible negative impacts of the import, placing on the 
market, production and use of genetically modified organisms and products, 
the Ministry of Health, Ministry of Agriculture and Forestry, Ministry of 
Environmental Protection and Spatial Planning and the Ministry of Science 
and Technology propose as an interim solution, until the enactment of a 
separate piece of legislation that shall regulate the issues related to 
genetically modified organisms, to impose a ban or restriction on the 
import, placing on the market, use and production of genetically modified 
organisms and products.

The area of genetically modified organisms and products is regulated in the 
European Union by the following legislation:

- Directive 90/219/EEC on the contained use of genetically modified micro-
  organisms, as amended by Directive 98/81/EEC and Council Directive 2001/
  204/EC;
- Directive 90/220/EEC on the approval of the deliberate release of 
  genetically modified organisms into the environment, as modified by the 
  following amendments:
  - European Council Directive 94/211/EC;
  - European Commission Directive 92/146/EEC;
  - European Commission Directive 94/15/EC;
  - European Parliament Directive and Council Directive 2001/18/EC which 
    replaced Directive 90/220/EEC;
- EC Regulation No. 258/97 on novel foods and food ingredients;
- EC Regulation 1139/98 on the additional specific details on the labels of 
  foods and food ingredients derived from genetically modified soya and 
  maize;
- EC Regulation No. 49/2000 replacing EC Regulation No. 1139/98;
- EC Regulation No. 50/2000 on the additional requirements for labeling of 
  foods and food ingredients intended for final consumers and mass 
  catering, which contain additives and/or spices that are genetically
  modified or derived from genetically modified organisms.

All developed European countries have already in place a legal framework 
for the above referred to issues related to the import, placing on the 
market or production of genetically modified organisms and products.

Therefore, and recognizing particularly the obligation to preserve and 
protect the nature and environment, as well as human health. It is 
essential that the Republic of Croatia regulate this issue by imposing a 
ban on the import, placing on the market, use or production of genetically 
modified organisms and products, until such time as the issue may be 
regulated by appropriate legislation compliant with the international 
conventions and the European practice.

2. Scope of the Bill This Bill regulates the following key issues:
 1. to impose a ban or restriction on the import, placing on the market, 
    use and production of genetically modified organisms and products;
 2. to regulate the issues related to the administrative control and 
    inspection;
 3. to designate the legal person responsible for the expert work 
    (laboratory work) related to the tracing of genetically modified
    organisms;
 4. to determine the procedure for disposal of genetically modified 
    organisms and products.

III. ASSESSMENT AND SOURCES OF FUNDS REQUIRED FOR ENFORCEMENT OF THE BILL

The funds required for the enforcement of this Bill amount to HRK 
1.600.000,00, specifically for the costs of fitting and equipping the 
laboratories. The funds in question have already been appropriated from the 
State Budget for the year 2001, within the appropriate items of the 
Ministry of Health (HRK 500.000,00), Ministry of Environmental Protection 
and Spatial Planning (HRK 300.000,00), Ministry of Agriculture and Forestry 
(HRK 300.00,00) and the Croatian Public Health Institute (HRK 500.000,00). 
The inspection services competent for the law enforcement shall carry out 
inspection controls within their scope of authority so that there is no 
need for additional employment in the government agencies with respect to 
the activities related to the administrative control and inspection.

In accordance with the above, the enforcement of this Bill does not require 
any additional appropriations from the State Budget.

IV. LANGUAGE OF THE BILL WITH THE EXPLANATORY MEMORANDUM

The language of this Bill for an Act to ban the import, placing on the 
market, use and production of genetically modified organisms and products 
represents the final text of the Bill with the explanatory memorandum.

V. JUSTIFICATION OF THE EMERGENCY PROCEDURE

Under Article 165 of the Rules of Procedure of the House of Representatives 
of the Croatian National Parliament (Official Gazette No. 9/01), emergency 
bills may be introduced when such emergency procedure is justified by, 
among other reasons, particularly important interests of the State.

Recognizing the justifiable concern of the Government with prevention and 
removal of possible negative impacts on the environment and human health by 
imposing a ban on the import, placing on the market, use and production of 
genetically modified organisms and products, the sponsor hereby proposes 
that this Bill be enacted in an emergency procedure.

A BILL FOR AN ACT TO BAN THE IMPORT, PLACING ON THE MARKET, USE AND 
PRODUCTION OF GENETICALLY MODIFIED ORGANISMS AND PRODUCTS - FINAL TEXT

Article 1.
(1) The purpose of this Act is to ban the import, placing on the market, 
use and production of genetically modified organisms and products in the 
territory of the Republic of Croatia, with the aim of protecting human 
health, as well as the nature and environment.
(2) The provisions of this Act do not apply to the import, placing on the 
market, use and production of medicinal drugs, which are regulated by a 
separate piece of legislation.

Article 2. For the purpose of this Act, the following legal definitions 
shall apply:
1. "Organism” is any biological entity, cellular or non-cellular, capable 
of replication or transferring genetic material, including viruses, viroids 
and the animal or plant cells in crops;
2. "Genetic modification” means a deliberate alteration of the genetic 
material of an organism in a way that does not occur by natural 
recombination, i.e. introduction of a foreign genetic material in the 
genetic material of an organism or removal of a part of the genetic 
material of an organism;
3. "Genetically modified organism” means an organism, excepting human 
beings, whose genetic material has been modified by genetic manipulation;
4. "Product” means a preparation consisting of, and/or containing, one or 
more genetically modified organisms, regardless of the degree of its 
processing, intended to be placed on the market.
5. "Contained use” means any use of genetically modified organisms for 
scientific and/or research purposes, in an area contained by physical 
barriers or a combination of physical and chemical or biological barriers, 
used to prevent the contact between genetically modified organisms and the 
general population and environment.
6. "User” means any legal or natural person, who imports, places on the 
market, uses or produces genetically modified organisms and products.

Article 3.
(1) A ban is hereby imposed on the import, placing on the market, use and 
production of genetically modified organisms.
(2) Notwithstanding the provision from Paragraph 1 above, the import, use 
and/or production of genetically modified organisms may be approved for the 
purpose of conducting scientific research, provided that the user warrants 
and ensures a contained use of such organisms.

Article 4.
(1) An approval of the import, use and/or production in accordance with 
Article 3, Paragraph 2 above, following the application submitted by a 
legal person, may be issued by the minister of science and technology, 
based on a prior consent issued by the minister of health, minister of 
environmental protection and spatial planning and the minister of 
agriculture and forestry.
(2) The approval procedure from Paragraph 1 above shall be defined by the 
law enforcement regulation issued by the minister of science and technology.

Article 5.
(1) Administrative control with respect to the enforcement of this Act 
shall be conducted by the Ministry of Health, Ministry of Environmental 
Protection and Spatial Planning, Ministry of Agriculture and Forestry and 
the Ministry of Science and Technology, each within its scope of authority.
(2) The inspection control over the enforcement of this Act shall be 
carried out by official inspection services for food safety, animal health 
and plant cultivation, border inspection services for plant health, 
environmental inspection services, as well as by the economic inspection 
offices of the State Inspectorate, each within its own scope of authority, 
in compliance with separate regulations.

Article 6.
(1) If the competent inspection authority has grounds to believe that a 
genetically modified organism or product is being imported, placed on the 
market, used or produced, the said inspection authority shall demand the 
user to present valid documentation verifying that the organism or product 
in question has not been genetically modified.
(2) If the user fails to present valid documentation within the prescribed 
period of time, the competent inspector shall temporarily prohibit the 
import, use and/or production, and sample the organism or product in 
question for analysis in a designated laboratory.
(3) The competent laboratories from Paragraph 2 above, shall be designated 
by the minister of health.
(4) The competent laboratories from Paragraph 2 above shall meet the 
criteria stipulated by the law enforcement regulation issued by the 
minister of health, based on the consent issued by the minister of 
environmental protection and spatial planning, minister of agriculture and 
forestry and the minister of science and technology.
(5) If the analysis confirms that the organism and/or product in question 
has been genetically modified, the inspector shall permanently prohibit the 
import, placing on the market, use or production of such organism and/or 
product, and the samples, or the confiscated genetically modified organisms 
and products, shall be safely disposed of.
(6) If the analysis confirms that the organism and/or product in question 
is a genetically modified organism and/or product, the costs of analysis 
and safe disposal, as well as the costs of the interim safekeeping and 
custody, shall be borne by the user.

Article 7.
(1) Any legal or natural person found importing, placing on the market, 
using and/or producing genetically modified organisms and products contrary 
to the provisions of this Act, shall pay a fine in the amount of HRK 
100.000,00 to HRK 500.000,00.
(2) The responsible natural person within the legal person from Paragraph 1 
above, shall pay a fine in the amount of HRK 20.000,00 to HRK 60.000,00.
(3) Genetically modified organisms and products that are the subject of the 
violation from Paragraph 1 above, shall be confiscated.

Article 8.
(1) Any legal person who has commenced scientific research in the area of 
genetic modification prior to the commencement of this Act, shall notify 
the Ministry of Science and Technology of such research within a period of 
forty-five days after the commencement of this Act.
(2) The Ministry of Science and Technology shall inform the Ministry of 
Health, Ministry of Environmental Protection and Spatial Planning and the 
Ministry of Agriculture and Forestry of such research projects in the area 
of genetic modification, within a period of fifteen days after the 
expiration of the deadline from Paragraph 1 above.
(3) The decision on the approval or termination of the scientific research 
from Paragraph 1 above, shall be made by the Ministry of Science and 
Technology, with the consent of the Ministry of Health, Ministry of 
Environmental Protection and Spatial Planning and the Ministry of 
Agriculture and Forestry, within a period of sixty days after the receipt 
of the notification from Paragraph 1 above.
(4) If the decision on the approval or termination is not made within the 
deadline stipulated by Paragraph 3 above, the approval shall be deemed 
given.

Article 9.
In the event that this Act grants the authority to the competent minister 
to approve the regulation for the enforcement of this Act, the competent 
minister in question shall approve the said regulation within a period of 
three months after the commencement of this Act.

Article 10.
This Act shall take effect on the date of its publication in the Official 
Gazette.

EXPLANATORY NOTES TO CERTAIN PROVISIONS OF THIS ACT

Note to Article 1.
The provisions of Article 1 define the scope of this Act, specifically the 
ban on the import, placing on the market, use and/or production of 
genetically modified organisms and products in the territory of the 
Republic of Croatia, aimed at protection of human health, the nature and 
environment. This Article expressly exempts medicinal drugs from the scope 
of this Act, as the products in question are regulated by a separate piece 
of legislation.

Note to Article 2.
Article 2 provides the legal definitions of the terms used in this Act.

Note to Article 3.
Article 3 stipulates the ban on the import, placing on the market, use and 
production of genetically modified organisms and products, and exempts from 
the ban the import, use and production of the genetically modified 
organisms and products intended for scientific research. This Article also 
provides the criteria for the approval of the import or use of the 
genetically modified organisms intended for scientific research.

Note to Article 4.
The provisions of this Article provide the authority for the approval of 
the import, use and/or production of the genetically modified organisms 
intended for scientific and research purposes.

Note to Article 5.
This Article stipulates the administrative control and inspection 
authorities with respect to the enforcement of this Act.

Note to Article 6.
The provisions of this Article stipulate the procedure and the authority of 
the competent inspector if there is sufficient grounds to believe that a 
genetically modified organism or product is being imported, placed on the 
market, used and/or produced; stipulate the method of determining the 
competent legal person to conduct the analysis of the same; and grant the 
authority to the competent inspector to undertake measures if the analysis 
confirms that a genetically modified organism or product is being imported, 
placed on the market, used and/or produced. If analysis confirms that 
genetically modified organisms or products are being imported, placed on 
the market, used and/or produced, the provisions of this Article stipulate 
that the costs of analysis and safe disposal, and in certain cases the 
costs of safekeeping and custody, of the organisms or products in question 
shall be borne by the user.

Note to Article 7.
This Article stipulates the acts in violation of the provisions of this Act 
and provides the fine for those found in violation, and stipulates the 
confiscation of the organism or product that is the subject of the 
violation.

Note to Article 8.
This Article stipulates that any legal person who has commenced scientific 
research prior to the commencement of this Act, must notify the Ministry of 
Science and Technology; stipulates deadlines for procedures, as well as the 
procedure for the approval or termination of the research, and the 
authority of the state administration bodies with respect to the approval 
procedure.

Note to Article 9.
This Article provides the authority to adopt law enforcement regulations 
and stipulates the deadline for their adoption.

Note to Article 10.
This Article stipulates when this Act shall commence.



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|                   GENET                     |
| European NGO Network on Genetic Engineering |
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