Hungarian legislation on genetically modified organisms (GMOs) has been in place since 1998. Hungary acceded the European Union in 2004, its legislation is in harmonization with current EC legislation. The main legal measures which are in harmonization with the EU legal framework are provided at <a href="http://biodiv.kvvm.hu/cooperation/research/fol935505">http://biodiv.kvvm.hu/cooperation/research/fol935505</a> include:<br />Hungarian Act on gene technological activities (Act No. XXVII of 1998)<br /> Decree 82/2003. (VII. 16.) of the Ministry of Agriculture and Rural Development on the order of the registering and supplying data as well as on the documentation which shall be enclosed in the notification regarding the gene technological activity.<br /> Parliamentary Resolution 94/2003 (IX. 23.) on the Ratification of the Cartagena Protocol on Biosafety.<br /> Joint Decree 111/2003 (XI. 5.) of the Ministry of Agriculture and Rural Development, the Ministry of Economy and Transport, the Ministry of Health, Social and Family Matters and the Ministry of Environment and Water on activities which shall be considered and not considered as gene technological activity as well as on authorities which are entitled to supervise the gene technological activity.<br /> Decree 128/2003. (XII. 19.) of the Ministry of Agriculture and Rural Development on the organization and the activity of the Gene Technological Advisory Committee<br /> Government Decree 148/2003. (IX. 22.) on the imposing gene technological penalties<br /> Act on the publication of the Cartagena Protocol on Biosafety signed in 24 May 2000 in Nairobi (Act No. CIX of 2004)<br /> Government Decree Nr. 132/2004. (IV. 29.) on the authorization procedure of the gene technological activity as well as on the liaison with the European Commission<br /> Decree 138/2004. (IX. 23.) of the Ministry of Agriculture and Rural Development on the authorization fees for the authorization of the gene technological activity<br /> Decree 142/2004. (IX. 30.) of the Ministry of Agriculture and Rural Development and the Ministry of Economy and Transport on certain rules of the gene technological activity in the field of agriculture and industry.<br />Decree 31/2006. (IV. 29.) of the Ministry of Agriculture and Rural Development and the Ministry of Economy and Transport and the Ministry of Finance on the import and market of genetically modified feeds<br />Decree 86/2006. (XII. 23.) of the Ministry of Agriculture and Rural Development on coexistence measures on the cultivation of genetically modified, conventional and organic plants<br />Decree 14/2008. (IV. 17.) of the Ministry of Health on the designation of the competent authority dealing with the gentechnological activites related to human-health, production of human medicines, and chemicals in contact with the human body; and designation of the special authority contributing to the authorization procedures relating to agricultural, food production and other industrial uses of gene technology.<br />

For more details see the EU implementation report.

For more details see the EU implementation report.<br /><br />transit: Decree 31/2006. (IV. 29.) of the Ministry of Agriculture and Rural Development and the Ministry of Economy and Transport and the Ministry of Finance on the import and market of genetically modified feeds.<br /><br />contained use: see also the Hungarian Act on gene technological activities (Act No. XXVII of 1998)<br />

For more details see the EU implementation report.<br />Hungary has prohibited cultivation through safeguard measures on individual authorized GMOs, such as MON810 and&nbsp; genetically modified Amflora potato.<br />

The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU. <br />With regard to the decisions taken for placing on the market of LMOs-FFP, it has to be noted that those decisions are taken for the whole European territory and not by the MS individually. <br />

Hungary has not made use of the simplified procedure for imports of LMOs as specified in Article 13.

Hungary has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1).

The EU domestic legal framework, based on a prior risk assessment before authorisation is given, is applicable. The EU has put in place a comprehensive system of risk assessment and risk management dealing with releases into the environment or placing on the market of GMOs, whether imported into or developed within the EC. The notification provided by the company indending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is assessed by the European Food Safety Authority (EFSA), with an active involvement of Member States, notably as regards the authorisation of GMOs for cultivation, where they carry out the intial risk assessment. The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment. <br />See <a href="http://www.efsa.europa.eu/en/science/gmo/gmo_guidance.html">http://www.efsa.europa.eu/en/science/gmo/gmo_guidance.html</a><br />In accordance with the precautionary principle, environmental risk assessments must be based on the following principles:<br /> GMO characteristics and GMO use that have the potential to cause adverse effects are to be compared to characteristics and use of the non-modified organism from which the GMO is derived;<br /> Risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;<br /> Risk assessment should be carried out on a case by case basis;<br /> New information on the GMO and its effects may need to be readdressed in order to determine whether the risk has changed and whether there is a need for amending the risk management accordingly.<br />Article 4 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms demands that any person submitting a notification under the authorisation procedures for GMO releases into the environment or placing on the market of GMOs as or in products needs to carry out an environmental risk assessment. Annex III of the Directive specifies the information that may be necessary to carry out the risk assessment. The environmental risk assessment comprises several steps that need to be addressed:<br /> Identification of characteristics which may cause adverse effects. These characteristics will vary from case to case and may include direct effects on human health or the environment as well as indirect effects occurring through a causal chain of events, through interactions with other organisms, transfer of genetic material or changes in use or management. As observations of indirect effects are likely to be delayed, immediate effects during the period of the release of the GMO as well as delayed effects that become apparent at a later stage or after termination of the release need to be considered.<br /> Evaluation of the potential consequences of each adverse effect, if it occurs.<br /> Evaluation of the likelihood of the occurrence of each identified potential adverse effect. <br /> Estimation of the risk posed by each identified characteristic of the GMO.<br /> Application of management strategies for risks from the deliberate release or marketing of GMOs.<br /> Determination of the overall risk of the GMO.Annex VII of the Directive provides guidance on the monitoring plan as part of the risk management strategy. More specific guidance notes are provided in Council Decision 2002/811/EC of 3 October 2002. The objective of the monitoring plan is to confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the risk assessment are correct, and to identify the occurrence of adverse effects of the GMO or its use which were not identified in the risk assessment.<br /><br />The design of the monitoring plan should, among others:<br /> Be detailed on a case by case basis;<br /> Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions;<br /> Incorporate general surveillance for unanticipated adverse effects;<br /> Provide for case-specific monitoring for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed and indirect effects which have been identified in risk assessment.;<br /> Provide for the use of already established routine surveillance practices where appropriate<br />The EC has cooperated with members of the European Economic Area (Norway, Iceland and Liechtenstein) on the issue of antibiotic resistance markers in risk assessment.<br />

The competent Hungarian authorities carry out risk assessments on the basis of the relevant EC legislation. For an overview of the EU procedure for risk assessment and risk management please see the EU’s implementing report.

For more details see the EU's implementing report.

Hungary is a Member State of the European Union, its legislation is in line with the legal framework of the EU. For more details please see the EU's implementation report.

In Hungary, the Ministry of Rural Development has been designated as focal point for the Biosafety Clearing-House (BCH) (Contact: Ms Rita Andorkó, Ministry of Rural Development, Biodiversity and Gene Conservation Unit, Strategy Department. Address: H-1055 Budapest, Kossuth tér. 5., Hungary.). For more details see the EU's implementation report.

For more details see the EU's implementation report.

Public awareness and participation is an integral part of the regulatory framework on GMOs of the EC and Hungary. For more details see the EC implementation report.<br />Public information on activities regarding genetically modified organisms (including information on all intentional releases of GMOs into the environment) on the Hungarian Biosafety Websites (see question 1 above). Drafts and final authorization decisions are published in the Official Journal as well as on the website of the Ministry of Agriculture and Rural Development.<br />Hungary is also Party to the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters signed on 3rd July 2001 and published on 4th December 2001.<br />For more details see the EU's implementing report.<br />

For more details see the EU's implementing report.

For more details see the EU's implementing report.<br />Hungary also contributed to the EU's report on the socio-economic implications of GMO cultivation. Since there has not been any GMO cultivation in Hungary for the time being, the coutry has no practical experience regarding this issue. Therefore, in case of Hungary, social and economical implications of the cultivation of GM crops can only be estimated, for example with ex ante analysis.<br />

For more details see the EU's implementing report.

For more details see the EU's implementing report.

See Question 15.

The Ministry of Rural Development is responsible for public awareness programmes. The above mentioned Roadshow was organised at local level, in different countries of Hungary. The Ministry of Rural Development organised the largest and most visited agricultural and food exhibition in Hungary (the 76th National Agriculture and Food Exhibition). Besides, civil organisations are also active in this field.