Law on genetically modified organisms. Country/Territory Croatia Document type Legislation Date 2019 Source FAO, FAOLEX Subject Agricultural & rural development, Livestock, Environment gen., Food & nutrition, Cultivated plants, Waste & hazardous substances Keyword Genetically modified organism (GMO) Biodiversity Biosafety Biosecurity Offences/penalties Food quality control/food safety Inspection Standards Procedural matters Processing/handling Animal feed/feedstuffs Biotechnology Hazardous substances Hazardous waste Waste management Geographical area Europe, Europe and Central Asia, European Union Countries, Mediterranean, Southern Europe Entry into force notes This text entered into force eight days after its publication in the Official Gazette (published on 24 December 2019). Abstract This Law regulates and determines basic rules and principles aimed for the treatment of genetically modified organisms and products consisting of or containing a genetically modified organism (GMO) or a combination of GMOs, restricted use of GMOs, approval of the use of drugs (medical products) consisting of or contain GMOs or a combination of GMOs, the deliberate release into the environment of a GMO for a purpose other than the placing on the market, restriction or prohibition of the cultivation of GMOs, the placing on the market of GMOs and products consisting of or containing GMOs or a combination of GMOs - handling, transport and packaging of GMOs, management of waste generated by the use of GMOs, liability for damage caused by unauthorized use of GMOs. This text further sets the competent authorities and the tasks of such competent authorities for the implementation of rules here stipulated, related standards, including official controls and administrative measures and misdemeanor or penalty provisions. This Law also transposes and implements several European Union legislative documents as listed in article 2 (paragraphs 1 and 2). The use of GMOs shall be carried out in a way that prevents or minimizes the danger to biodiversity, taking into account the dangers to human, animal and environmental health. In order to prevent a negative impact on the conservation and sustainable use of biodiversity, taking into account the dangers to human, animal and environmental health, appropriate protection measures are ensured and implemented for the safe use of GMOs. These rules are related to animals, plants, food, environment, and human health. Full text Croatian Website www.nn.hr References - Legislation Implements Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Legislation | European Union | 2001 (2018) Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Access-to-information, Precautionary principle, Biotechnology Source: FAO, FAOLEX Directive 2009/41/EC of the European Parliament and of the Council on the contained use of genetically modified micro-organisms. Legislation | European Union | 2009 Keyword: Biosafety, Biotechnology, Genetically modified organism (GMO), Authorization/permit, Public health, Basic legislation Source: FAO, FAOLEX Repeals Law on Genetically Modified Organisms. Legislation | Croatia | 2005 Keyword: Genetically modified organism (GMO), Biosecurity, Consumer protection, Processing/handling, Packaging/labelling, Transport/storage, Waste management Source: FAO, FAOLEX Implemented by Regulation on the content of the notification and technical documentation for the placing on the market of GMOs or products consisting of or containing GMOs or a combination of GMOs. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Data collection/reporting, Registration, Legal proceedings/administrative proceedings, Internal trade, International trade, Packaging/labelling, Biotechnology Source: FAO, FAOLEX Regulation on the content and scope of risk assessment for placing on the market of genetically modified organisms or products consisting of or containing GMOs or a combination of GMOs, the methodology for making the assessment and the conditions that must be met by a legal entity for making a risk assessment. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), PIC-prior informed consent, Risk assessment/management Source: FAO, FAOLEX Regulation on risk assessment for intentional introduction of genetically modified organisms into the environment. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), Risk assessment/management Source: FAO, FAOLEX Regulation on contents and manner of submitting the application for deliberate introduction of genetically modified organisms into the environment. Legislation | Croatia | 2020 Keyword: Biosafety, Biosecurity, Genetically modified organism (GMO), Data collection/reporting, Authorization/permit, Biotechnology Source: FAO, FAOLEX Regulation on the conditions to be met by official and national reference laboratories for genetically modified organisms. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), Data collection/reporting, Inspection, Research, Food quality control/food safety, Biotechnology Source: FAO, FAOLEX Regulation on conditions for monitoring, labelling and packaging of genetically modified organisms and products consisting of or containing genetically modified organisms or a combination of genetically modified organisms. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), Food quality control/food safety, Monitoring, Packaging/labelling, Risk assessment/management Source: FAO, FAOLEX Regulation on scopes and content of the report on the assessment of suitability for placing on the market of genetically modified organisms and products consisting of or containing a genetically modified organism or a combination of genetically modified organisms. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), Data collection/reporting, Inspection, Internal trade, International trade, Risk assessment/management Source: FAO, FAOLEX Regulation on the form and manner for keeping the single register of genetically modified organisms and on the manner for determining costs. Legislation | Croatia | 2020 Keyword: Genetically modified organism (GMO), Registration, Biosafety, Legal proceedings/administrative proceedings, Access-to-information, Data collection/reporting Source: FAO, FAOLEX Decision on the establishment of the Council for genetically modified organisms. Legislation | Croatia | 2021 Keyword: Genetically modified organism (GMO), Institution, Protection of environment, Risk assessment/management Source: FAO, FAOLEX