Croatia
Country introduction:
The Republic of Croatia is a Member State of the European Union and the EU Regulations of GM foods takes place at the EU level. The Republic of Croatia is a party to the Convention on Biological Diversity and the Cartagena Protocol on Biosafety. National legislation complies with the provisions of the Cartagena Protocol on Biosafety and the provisions of European Union legislation in the field of genetically modified organisms. The European Union has established a legal framework to ensure that the development and use of recombinant DNA organisms in industry, agriculture and the environment, and in particular GMOs, takes place in safe conditions with the aim of protecting human and animal health and the environment, applying a safety assessment based on the highest possible standards at EU level before the introduction into the environment or the placing on the market of any GMOs. The procedure for authorisation of GMOs in the European Union is centralised and implemented in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003 and Directive (EU) 2015/412. Only approved genetically modified organisms can be placed on the market of the European Union and thus on the market of the Republic of Croatia, which must be entered in the EU Register https://ec.europa.eu/food/food-feed-portal/screen/gmo/search
At EU level, the European Food Safety Authority (EFSA) is the body responsible for carrying out the risk assessment of GMOs with regard to human and animal health and environmental effects. The role of EFSA in carrying out the scientific risk assessment for GMOs is governed by the provisions of Directive (EU) 2018/350, Implementing Regulation (EU) 503/2013 and Regulation (EU) 2017/625. At EU level, Regulation (EU) 1830/2003 established a system of traceability and labelling of genetically modified organisms and traceability of food and feed produced from genetically modified organisms in order to protect human health as well as the transparency and sustainability of the EU risk assessment in the food chain in accordance with the provisions of Regulation (EU) 2019/1381.
The EU legislation in the field of GMOs has been fully transposed into Croatian legislation by the Act on Genetically Modified Organisms (OG 126/2019), Act on the Implementation of European Union Regulations on Traceability and Labeling of Genetically Modified Food and Animal Feed (Official Gazette, No. 18/13, 47/14, 114/18, 83/22) and Act of the Transboundary movement Genetically Modified organisms (OG 81/13) and a number of implementing regulations and directly applicable Commission Regulations and Implementing Decisions.
The notification procedures of deliberate release into environment and placing on the market of GMOs and contained use of genetically modified microorganisms (GMMs), requirements for analysing the notifications and requests for authorization, procedures for issuing permits, scientific and advisory committees as well as procedure for public information are established. Information related to GMOs is gathered, managed and published through the Register of GMOs taking into account the provisions of intellectual property rights and confidentiality interests in applications of GMOs and next website of the Ministry of Health https://zdravlje.gov.hr/o-ministarstvu/djelokrug-1297/javnozdravstvena-zastita/1347.
The Act on Genetically Modified Organisms (OG 126/19) regulates the handling of GMOs, products consisting of or containing GMOs and a combination of GMOs, the contained use of GMOs indoors, the deliberate release of GMOs into the environment, the cultivation of GMOs, the placing on the market of GMOs consisting of or containing GMOs or a combination of GMOs, the handling of GMOs, the transport and packaging of GMOs, the management of waste generated by the use of GMOs, the liability for damage, the authorities responsible for components and official controls. Several central state administration bodies are responsible for the implementation of legislation in the field of GMOs, including the Ministry of Health, the central and coordinating body for the performance of professional activities related to GMOs, which is also the competent authority for the placing on the market of GMOs, the Ministry of Agriculture, Forestry and Fisheries, the competent authority for the cultivation of GMOs and the placing on the market of seed and reproductive matter, the Ministry of Science, Education and Youth, the competent authority for closed systems and limited use of GMOs, the Ministry of Environmental Protection and Green Transition for the deliberate release of GMOs or a combination of GMOs into the environment for purposes other than placing on the market, and the State Inspectorate of the Republic of Croatia, the competent authority for the performance of official controls/ inspections on the implementation of legislation in the field of GMOs.
At EU level, the European Food Safety Authority (EFSA) is the body responsible for carrying out the risk assessment of GMOs with regard to human and animal health and environmental effects. The role of EFSA in carrying out the scientific risk assessment for GMOs is governed by the provisions of Directive (EU) 2018/350, Implementing Regulation (EU) 503/2013 and Regulation (EU) 2017/625. At EU level, Regulation (EU) 1830/2003 established a system of traceability and labelling of genetically modified organisms and traceability of food and feed produced from genetically modified organisms in order to protect human health as well as the transparency and sustainability of the EU risk assessment in the food chain in accordance with the provisions of Regulation (EU) 2019/1381.
The EU legislation in the field of GMOs has been fully transposed into Croatian legislation by the Act on Genetically Modified Organisms (OG 126/2019), Act on the Implementation of European Union Regulations on Traceability and Labeling of Genetically Modified Food and Animal Feed (Official Gazette, No. 18/13, 47/14, 114/18, 83/22) and Act of the Transboundary movement Genetically Modified organisms (OG 81/13) and a number of implementing regulations and directly applicable Commission Regulations and Implementing Decisions.
The notification procedures of deliberate release into environment and placing on the market of GMOs and contained use of genetically modified microorganisms (GMMs), requirements for analysing the notifications and requests for authorization, procedures for issuing permits, scientific and advisory committees as well as procedure for public information are established. Information related to GMOs is gathered, managed and published through the Register of GMOs taking into account the provisions of intellectual property rights and confidentiality interests in applications of GMOs and next website of the Ministry of Health https://zdravlje.gov.hr/o-ministarstvu/djelokrug-1297/javnozdravstvena-zastita/1347.
The Act on Genetically Modified Organisms (OG 126/19) regulates the handling of GMOs, products consisting of or containing GMOs and a combination of GMOs, the contained use of GMOs indoors, the deliberate release of GMOs into the environment, the cultivation of GMOs, the placing on the market of GMOs consisting of or containing GMOs or a combination of GMOs, the handling of GMOs, the transport and packaging of GMOs, the management of waste generated by the use of GMOs, the liability for damage, the authorities responsible for components and official controls. Several central state administration bodies are responsible for the implementation of legislation in the field of GMOs, including the Ministry of Health, the central and coordinating body for the performance of professional activities related to GMOs, which is also the competent authority for the placing on the market of GMOs, the Ministry of Agriculture, Forestry and Fisheries, the competent authority for the cultivation of GMOs and the placing on the market of seed and reproductive matter, the Ministry of Science, Education and Youth, the competent authority for closed systems and limited use of GMOs, the Ministry of Environmental Protection and Green Transition for the deliberate release of GMOs or a combination of GMOs into the environment for purposes other than placing on the market, and the State Inspectorate of the Republic of Croatia, the competent authority for the performance of official controls/ inspections on the implementation of legislation in the field of GMOs.
Regulatory framework:
My country has a regulatory framework that requires the competent authority to conduct safety assessment of GM food.
Structure for GM food safety assessment:
My country has competent authority, agency, organization, ministry, department, committee, commission or a system/mechanism that is tasked to conduct or review GM food safety assessment.
Supplemental information (regulatory framework):
With regard to safety considerations/risk assessment due to the application of recombinant DNA techniques, recombinant DNA organisms and their performance in industry, agriculture and the environment, from a precautionary point of view, the Republic of Croatia, as an EU Member State, applies common EU risk assessment policies in the field of GMOs and in the field of food and feed, ensuring clear labelling of GMOs placed on the market and ensuring traceability of GMOs placed on the market. Representatives of the Republic of Croatia participate in the work of EFSA committees that assess the risks of GMOs on the basis of analyses of the characteristics of the GMO and its deliberate introduction into the environment in which the GMO would be introduced and the biodiversity that could be exposed to the risks of either placing on the market of GMOs or for use in limited use of GMOs on a case by case basis depending on the type of use. If the application covers both cultivation, EFSA prepares an environmental risk assessment of the EU Member State and submits the environmental risk assessment report to everyone for reconsideration together with the requests for exemption of the territory of the Member States on cultivation of the GMO concerned. In order to monitor the situation and developments in the field of GMO handling and to provide expert assistance to competent authorities in the implementation of GMO legislation and management, the National Scientific Expert Bodies of the GMO Council of GMOs, and Committees (the Committee on contained use of GMOs and the Committee for the evaluation of the effects of the release of GMOs into the environment) have a major role to play in providing their opinions regarding the scientific, technological, social and other conditions of use of GMOs in order to identify and assess on a case-by-case basis the possible adverse effects of GMOs on the environment, agriculture and human health in accordance with the main principles, methods and procedures for impact assessment set out in the regulations on risk assessments on human health and the environment.
Relevant contact details:
The Ministry of Health is central and coordinative body for all scientific and administrative issues in the fields of GMOs in the Republic of Croatia.
It is at the same time a competent authority for all administrative issues for placing on the market GMO and products containing of or consisting of GMOs or combinations of GMO s as GM food, GM feed, technical material and for deliberate release as medicines (medicine products) consisting of GMOs or containing GMOs or a combination of GMOs and for conducting official control in closed system on contained used of GMM that are used as medicine in the advanced therapy pursuant to the articles 4 and 5 of the Act of genetically modified organisms (Official Gazette, 126/19).In accordance to the article 4 of the Act of genetically modified organisms (Official Gazette, 126/19) the Ministry of Agriculture is responsible for administrative issues for cultivation GMO plants and for placing on the market seeds and reproductive agriculture plant, forestry seeds and reproductive forestry plants and veterinary products which containing of or consisting of GMOs or combinations of GMOs. The Ministry of Agriculture – according to articles 15., 21. 35. and 45. of the Act of seeds, planting material and recognition of agricultural plant varieties (Official Gazette, 110,21) has prescribed production and denotation of seeds and reproductive agriculture plants that are produced for the purpose of placing on the market. The State Inspectorate of the Republic of Croatia carries out official controls and monitoring of genetically modified organisms (GMOs) in accordance with the annual official control plans. For the purposes of official testing, control, and monitoring of GMOs and GMO products placed on the market of the Republic of Croatia, the State Inspectorate uses an authorized Official GMO Laboratory or National Reference Laboratories for GMOs. National Reference laboratories are members of the European Network of GMO Laboratories (ENGL), in accordance with the provisions of Commission Regulation (EC) No 1981/2006, as last amended by Commission Regulation (EU) No 120/2014.
It is at the same time a competent authority for all administrative issues for placing on the market GMO and products containing of or consisting of GMOs or combinations of GMO s as GM food, GM feed, technical material and for deliberate release as medicines (medicine products) consisting of GMOs or containing GMOs or a combination of GMOs and for conducting official control in closed system on contained used of GMM that are used as medicine in the advanced therapy pursuant to the articles 4 and 5 of the Act of genetically modified organisms (Official Gazette, 126/19).In accordance to the article 4 of the Act of genetically modified organisms (Official Gazette, 126/19) the Ministry of Agriculture is responsible for administrative issues for cultivation GMO plants and for placing on the market seeds and reproductive agriculture plant, forestry seeds and reproductive forestry plants and veterinary products which containing of or consisting of GMOs or combinations of GMOs. The Ministry of Agriculture – according to articles 15., 21. 35. and 45. of the Act of seeds, planting material and recognition of agricultural plant varieties (Official Gazette, 110,21) has prescribed production and denotation of seeds and reproductive agriculture plants that are produced for the purpose of placing on the market. The State Inspectorate of the Republic of Croatia carries out official controls and monitoring of genetically modified organisms (GMOs) in accordance with the annual official control plans. For the purposes of official testing, control, and monitoring of GMOs and GMO products placed on the market of the Republic of Croatia, the State Inspectorate uses an authorized Official GMO Laboratory or National Reference Laboratories for GMOs. National Reference laboratories are members of the European Network of GMO Laboratories (ENGL), in accordance with the provisions of Commission Regulation (EC) No 1981/2006, as last amended by Commission Regulation (EU) No 120/2014.
GM food safety assessment guidelines:
My country follows the relevant Codex Guidelines or national/regional guidelines that are in line with the Codex Guidelines in conducting safety assessment of GM food.
Conduct of GM food safety assessment:
My country regularly conducts food safety assessment of GM food.
Supplemental information (assessment):
Regulation stacked events:
Stacked events require full assessment as a new GM event.
Supplemental information (stacked events):
GM food/feed production:
My country produces GM food or feed for commercial and research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information (production and trade):
LLP/AP incidents:
My country has not faced any LLP/AP situations in the last 10 years.
Supplemental information (LLP/AP incidents):
Labelling requirement:
My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).
Supplemental information (labelling requirement):
The EU legislation in the field of GMOs has been fully transposed into Croatian legislation by the Act on Genetically Modified Organisms (OG 126/2019), the Act on the Implementation of European Union Regulations on Traceability and Labeling of Genetically Modified Food and Animal Feed (Official Gazette, No. 18/13, 47/14, 114/18, 83/22) and a number of Commission implementing Decisions authorising the placing on the market of products containing, consisting of or produced from genetically modified food and feed.
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