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Croatian legislation

In 2003, two key pieces of legislation were enacted regulating this area during a longstanding legal vacuum in the GMO area, a de facto moratorium was applied in the absence of any legal grounds. They are the Nature Protection Act (Official Gazette No. 162/2003) and the Food Act (Official Gazette No. 117/2003).

Mentioned here, are other Acts that regulate various areas from waist, transport, and agricultural production to science. Some of them clearly state their connection with the GMO issue but in others it is not so. Also not clearly stated, is the relation to these Acts neither in the "Umbrella law" as it is the Nature Protection Act or the new proposed GMO Act. At base level, this has created confusion with regulators on the subject of ‘the holding of ultimate responsibility’ for regulating in various different fields ( Annex 1.). For the purpose of stressing the fact that there is a need for clarification of inter-relations, listed here are all these Acts, although some of them are connected to GMOs but only indirectly.
Because there are numerous Acts which are directly or indirectly covering biotechnology and biosafety we have listed them here in their chronological appearance, but we have placed the by-laws under the ‘Act’ they belong to.

The Water Management Act (Official Gazette No. 107/1995)

This Act regulates the legal status of water and water estate, the methods and conditions of water management (water use, water protection, regulation of watercourses and other water bodies, and protection from adverse effects of water), the method of organizing and performing water management tasks and functions, basic conditions for carrying out of water management activities; powers and duties of Government administration and other Government bodies, local authorities and other legal subjects, and other issues of importance to water management.

The Act also establishes "Croatian Waters" - the legal entity in charge of water management tasks. Under the conditions of this Act, water permits can be or are issued. Water permits are issued under certain conditions for some of the dangerous substances in water. These substances are defined under the Regulation on Dangerous Substances in Water (Official Gazette No. 78/1998). Sometimes different biological agents, which can consist of or are GMOs, are used in the water treatment facilities. The following Articles: 70, 72, 76 and 128-134 refer to these subjects. The Department of water management (MAFWM) is responsible for implementation of this Act.

The_Water_Management_Act.pdf 261.71 kB

The Regulation on Dangerous Substances in Water (Official Gazette No. 78/1998)

This Regulation on Dangerous Substances in water defines substances and their quantities in accordance with Article 70 of The Water Management Act that are considered dangerous substances in a water environment.

The Ecological Production of Agricultural and Food Products Act (Official Gazette No. 12/2001)

The Ecological Production of Agricultural and Food Products Act came into force on 22 February 2001. This Act governs ecological production of agricultural and food products, processing in ecological production, trade in ecological products, unprocessed vegetable and animal products, products fully or partly consisting of such products, marking in ecological production, performance of expert and inspection control and other issues relevant for the implementation of a unique system of ecological production. In article 15 of this Act, it is specifically stated that the use of GMOs and all products that consist of or are produced from GMOs are "banned" in ecological production. It is also prohibited to use GMOs as reproduction material, secondary raw material, additives and secondary substances or as packaging. The MAFWM is responsible of implementation of this Act.

The Minor Offences Act (Official Gazette No. 88/2002)

The Minor Offences Act came into force on 1 October 2002. Article 30, directly specifies which type of fine will be issued for offences committed, during import, transit, contained use, placing on the market and release into environment of GMOs. The Ministry of Justice is responsible for implementation of this Act.

Consumer protection act (Official Gazette No. 96/2003)

The Consumer Protection Act came into force on 18 June 2003. This Act covers general law on consumer protection. In Article 17, product content declarations are described. Amongst other label declarations, a statement by the manufacturer on the existence of any modified features of products including organisms, ingredients, parts & additives should be included, plus the type of modification, if any, should be in line with special regulations. It also states that other by-laws will define specific declaration for specific products. The Ministry of Economy, Labour and Entrepreneurship is in charge of implementation of this Act.

Consumer_Protection_Act.pdf 222.04 kB

The Food Act (Official Gazette No.117/2003)

The Food Act regulates the problem areas of health safety and food safety surveillance. In compliance with European practice, a new category of foods, namely ‘Novel foods’, has been introduced into the Act for the first time. The term ‘Novel food’ relates to either a food manufactured by using new technologies, or one that was not until now extensively used for nutrition in Croatia.

Therefore, Novel food could have a potential hazardous effect, which must not be overlooked or completely excluded. Consequently, Novel foods come under special procedures for food risk assessment and for authorization of their placement on the market. Belonging to this category are GMO foods or GMO containing foods that have been manufactured from a GMO whatever the degree of processing involved.

In addition to the fulfilment of health safety requirements and of special marketing requirements, the law requires that a special authorization by the MHSW be issued for such food products before their first appearance on the market. The MAFWM is competent to issue authorization for such feeds.

The_Food_Act.pdf 618.00 kB

The Medicinal Products and Medical Devices Act (Official Gazette No.121/2003)

The Medicinal Products and Medical Devices Act came into force on 6 August 2003. This Act defines testing within marketing procedures, production, marking, classification, trade, monitoring of side effects, advertising & information, control over medicines and medical products, also with quality checks for medicines and assessment of conformity for medical products, requirements and type of marketing & control of homeopathic products. The Act also defines the term "substance", which, inter alia, can also be GMOs. Prior consent from the MHSW is required, inter alia, for clinical research of a ready medicine intended for gene therapy, treatment with somatic cells, including xenogenetic cells, and treatment with medicines containing GMOs. The Articles that refer to this issue are: 2, 7,121-138. The MHSW has established the "Agency for Medicinal Products and Medical Devices", which is responsible of implementation of this Act in October 2003. The MHSW is monitoring the legal activities of the Agency. The Agency controls production & issuing permits for placing on the market of medicinal products and homeopathic products, permits for research, etc. Under this Act the National Medical Bioethical Committee has to be established. This Committee is advising the Government on ethical and law issues regarding development and implementation of biomedical research on humans, and is giving recommendations to Government to change existing or to adopt new legislation in this field.

Act_on_Medicinal_Products_and_Medical_Devices.pdf 218.89 kB

The Decision Promulgating the Science and Higher Education Act (Official Gazette No. 123/03)

The Scientific Activity and University Education Act (Official Gazette No. 123/03), which came into force on 16th August 2003, also regulates the system of scientific activities (scientific and development research). Croatian Parliament, upon proposals by the Government, will appoint the "Committee for Ethics in Science and Higher Education". The task of the Committee is promotion of ethical principles and values in science and higher education, in business relations and in relations to the public, also, application of current technologies as well as in the protection of the environment. The Committee shall adopt the "Code of Ethics". More details about this Committee can be found in Article 112. The Ministry of Science, Education & Sports is responsible of implementation of this Act.

Decision_Promulgating_the_Science_and_Higher_Education_Act.pdf 424.00 kB

Amendments on Decision Promulgating the Science and Higher Education Act (Official Gazette No. 105/2004)

It defines more specific fields of this Act without any specific references to research or the Ethics Committee.

The Amendments Act to the Transport of Dangerous Substances Act (Official Gazette No. 151/2003)

This Act came into force on 2 October 2003 and regulates transport of dangerous substances- type of transport & cargo, the duties of personnel involved in the transportation, conditions for packaging & for transportation and governmental bodies responsibilities for inspections in transport.

Regulations on the transportation of dangerous substances:

The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) applies to roads,
The Ordinance on International Carriage of Dangerous Goods by Railway (RID) applies to railways,
The European Agreement concerning the International Carriage of Dangerous Goods by Inland,
Waterways (ADN) apply to rivers & lakes within the country,
The International codex of dangerous cargo (IMDG Code) applies to sea transport,
The Convention on International civil air transport, Annex 18, applies to air transportation.

The packaging of the products that contain or are made from GMOs is prepared in accordance with this Act. The MSTTD is responsible for its implementation.

The Waste Act (Official Gazette No. 151/2003)

The Waste Act came into force on 1 January 2004. This Act regulates rights, obligations and responsibilities of institutions and persons dealing with waste and wastage. The MEPPPC is responsible for implementation of this Act.

The Ordinance on Classification of Waste (Official Gazette No. 27/1996)

This Ordinance is to define the different types of waste; how they should be managed; which type of documentation is needed; methods of testing the physical and chemical attributes of hazardous waste; sampling of waste and charges implemented for non appliance with this Ordinance. Under this Ordinance, the characteristics of hazardous waste are specified. If the waste that consists of GMOs has the characteristics of hazardous waste under this Ordinance, it has to be managed by The Regulation on conditions on the handling of hazardous waste (Official Gazette No. 32/1998). This Regulation regulates the safety & technological conditions for area; buildings or equipment used for storage, processing or the depositing of hazardous waste and qualifications needed for personnel handling hazardous waste.

The Seeds, Plant Material and Registration of Varieties of Agricultural Plants Act (Consolidated text, Official Gazette No. 137/2004)

The Government of the Republic of Croatia at its session held on 21 September 2004 passed the ‘Consolidated’ text of this Act. It regulates production and trade of agricultural seeds, seedlings, mycelium of edible and medicinal fungi, agricultural seed material, recognition of varieties of agricultural plants and other topics, which are important for establishing a unique system for agricultural seeds and seedlings. Production and trade of genetically modified agricultural seeds, seedlings, mycelium of edible and medicinal fungi, agricultural seed material, and registration of varieties of genetically modified plants, are also governed by provisions of a special law. The MAFWM is responsible for implementation of this Act.

The_Law_on_the_Seed_and_Plant_Material.pdf 281.64 kB

The Nature Protection Act (Official Gazette No. 70/2005)

The Nature Protection Act came into force on 16 June 2005.

Systems (which were done for the purpose of making the Draft of the national biosafety framework for Croatia in April 2005) under the Nature protection act are in Annex 3., and systems under the proposed GMO Act are in Annex 4..

The Regulation on the minimum threshold for GMO’s in products below which the products placed on the market shall not have to be labelled as products containing GMO's (Official Gazette No. 34/2004)

Pursuant to Article 133, paragraph 3 of the Nature Protection Act, the Government of the Republic of Croatia at its session held on 12 March 2003 passed this regulation. This Regulation lays down the minimum threshold for genetically modified organisms in products below which the products placed on the market shall not have to be labelled as products containing GMOs. It has imposed a limit of 0.9% per individual ingredient of a product as the level of random or technologically unavoidable contamination for the 15 types of GMO allowed in the EU. In addition, plant reproductive material containing GMOs in any amount must be labelled in accordance with a special regulation.
In spring 2004 the GMO laboratory had detected 0.5-0.7% of GM seeds amongst a sample of conventional corn seed. Under this Regulation the MAFWM decided to plug down all the corn plants, which were owned by farmers and agriculture companies. There was no authorization of GMO, risk analysis had not been done and it was concluded that danger of GMO genes spreading to conventional corn, due to no existing barriers between them, could have been realised. The farmers were paid cca. 1.000 Euro per hectare, while the Government had officially accused the company that had imported the seed without authorization.

Regulation_on_the_minimum_threshold_for_GMOs_in_products.pdf 36.21 kB

The Ordinance on the conditions to be fulfilled by a laboratory for testing, control and monitoring of GMOs and products containing GMOs (Official Gazette No. 98/2004)

Pursuant to Article 138, paragraph 4 of the Nature Protection Act this Ordinance has been passed. This Ordinance establishes the conditions related to the premises, equipment and employees qualifications, to be fulfilled by laboratories for testing, control and monitoring of GMOs and products containing GMOs. In August 2004, the Minister for Health & Social Welfare (MHSW) had granted authorization for testing, control and monitoring of GMOs and products containing GMOs to the laboratory, which was set up in the Croatian National Institute for Public Health (CNIPH), Zagreb, in September 2003.

The_Ordinance-laboratories_for_testing_of_GMOs.pdf 34.78 kB

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