EU legislation has been transposed into the national law: The Genetically modified organisms Law (https://e-tar.lt/portal/lt/legalAct/TAR.10BD9188E48C/asr), the secondary national acts (https://gmo.biip.lt/teises-aktai/)

A Framework Law on Genetically Modified Organisms has been adopted on 12 June 2001 and has entered into force on 31 December 2002 . The Law on Genetically Modified Organisms regulates the state management of GMOs in a broad sense while other domestic orders fully implement the EU-Directives. The EU-Regulations are directly applicable in Lithuanian legislation. The list of legal measures pertaining to GMOs has been submitted to the Biosafety Clearing-House. An overview on the Lithuanian legal framework is provided at national GMO Database: http://gmo.am.lt. Further information is provided in the EU 5th Nationl Report.

EU pharmaceutical legislation provides that a medicinal product may only be placed on the market in the EU if it has received a marketing authorisation, granted either by the European Commission or by a Member State. As regards medicinal products containing or consisting of GMOs, the assessment in the context of the procedure for the granting of a marketing authorisation as medicinal product must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC. As regards exports of pharmaceuticals, Regulation 1946/2003 on transboundary movements of GMOs provides that pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from its scope, thereby mirroring the provisions of the Cartagena Protocol.

Regulation (EC) No 1946/2003 addresses transboundary movement of GMOs with the aim to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol. According to Article 13 of Regulation (EC) No 1946/2003, the exporter from the EU shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision. Transit procedures through the EU are regulated by transport legislation and the Union Customs Code (Regulation (EU) No 952/2013 laying down the Union Customs Code). Notably, the transport of dangerous goods in the EU is subject to specific legislation, such as Directive 2008/68/EC on the inland transport of dangerous goods, covering transport by road, rail and inland waterways; or Regulation (EU) 2018/1139 on common rules in the field of civil aviation, which includes the safe handling of dangerous goods. Imports of GMOs to the EU for contained use must comply with the rules for contained use of GMOs. The contained use of genetically modified micro-organisms is governed by Directive 2009/41/EC, as transposed into Member States’ national law. Contained use of other genetically modified organisms is governed by national legislation in some Member States.

The EU applies its legislative framework instead of the Protocol's advanced informed agreement procedure. This framework is in line with the provisions of the Protocol. The EU legislative framework is built on a range of legislative measures described above in reply to Question 13. An operator intending to market a GMO in the EU for intentional introduction into the environment (referred to as “deliberate release into the environment” in the EU regulatory framework for GMOs) must first obtain an authorisation to this end. The authorisation for placing the GMO on the market involves all Member States, as authorised products are granted free movement throughout the territory of the EU. The so-called "notification" or "application" submitted by the interested operator must include an evaluation of potential risks to human and animal health and to the environment. It is only after a decision for authorisation is adopted based on a prior risk assessment that the operator can proceed with the release or placing on the market of the GMO in the EU. An operator who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the competent national authority of the Member State within whose territory the experimental release is to take place. The authorisation is given based on an assessment of the risks presented by the GMO for the environment and human and animal health.

The EU has developed a comprehensive legal framework on GMOs, which also applies to the import of GMOs intended for direct use as food or feed, or for processing. The main piece of legislation in this area, governing the placing on the market of GMOs for food or feed use and of GM food and feed, is Regulation 1829/2003 on genetically modified food and feed. 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. The EU has also declared that it applies the EU GMO framework to imports of GMOs into the EU instead of the procedures of the Cartagena Protocol, in accordance with Article 14(4) of the Cartagena Protocol. With regard to the decisions taken for placing on the market of LMOs intended for direct use as food or feed or for processing, those decisions are taken at EU level for the whole European territory and not by the Member States individually.

The relevant provisions are set in Art 20 Directive 2001/18/EC and Art 21 and 22 of Regulation (EC)1829/2003.

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

The EU has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1). The EU has determined as per Article 14(4) and 9(2)(c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing-House.

The EU has put in place a comprehensive system of risk assessment and risk management of releases into the environment and placing on the market of GMOs, whether imported into or developed within the EU. The EU legal framework on GMOs is based on a prior risk assessment before authorisation can be given. Any person submitting an application/notification under the authorisation procedures for GMO releases into the environment or placing on the market of GMOs needs to carry out an environmental risk assessment (Article 4 Directive 2001/18/EC). Applications for GM food and feed also require a human and animal health safety assessment (Articles 5 and 17 Regulation 1829/2003). For applications/notifications for the placing on the market, the risk assessment 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 initial 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. Risk assessment: In accordance with the precautionary principle, environmental risk assessment must be based on the following principles: - 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; - Risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data; - Risk assessment should be carried out on a case by case basis; - New information on the GMO and its effects may need to be assessed in order to determine whether the risk has changed and whether there is a need for amending the risk management accordingly. Annex III of Directive 2001/18/EC specifies the information that may be necessary to carry out the risk assessment. The environmental risk assessment is conducted for each relevant area of risk and comprises six steps: 1. Problem formulation including hazard identification, aimed at identifying: (i) changes in the characteristics of the organism, linked to the genetic modification, (ii) potential adverse effects on human health or the environment which are linked to these changes, (iii) relevant assessment endpoints, (iv) exposure pathways or other mechanisms through which adverse effects may occur, either directly or indirectly, (v) testable hypotheses, and relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s), (vi) possible uncertainties, including knowledge gaps and methodological limitations. 2. Hazard characterisation aimed at evaluating the magnitude of each potential adverse effect, taking into account the receiving environment(s) into which the GMO is intended to be released and the scale and conditions of the release. 3. Exposure characterisation aimed at evaluating the likelihood or probability of each identified potential adverse effect. 4. Risk characterisation, by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect. Where relevant, the uncertainty for each identified risk shall be described. 5. Risk management strategies, to be proposed where risks are identified that require, on the basis of their characterisation, measures to manage them. The risk management strategies shall be described in terms of reducing the hazard or the exposure, or both, and shall be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the environmental risk assessment. 6. Overall risk evaluation and conclusions, providing a qualitative and, where possible, quantitative evaluation of the overall risk of the GMO taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty. The overall risk evaluation and conclusions shall also propose specific requirements for the monitoring plan of the GMO and, where appropriate, the monitoring of the efficacy of the proposed risk management measures. Risk management: Annex VII of Directive 2001/18/EC provides guidance on the monitoring plan as part of the risk management strategy. 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. The design of the monitoring plan should, among others: - Be detailed on a case by case basis; - Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions; - Incorporate general surveillance for unanticipated adverse effects; - 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.; - Provide for the use of already established routine surveillance practices where appropriate. More information is available at http://www.efsa.europa.eu/en/topics/topic/gmo. As regards GM food and feed, authorisations for the placing on the market in the EU are granted subject to a single risk management process involving the Commission and the Member States through the regulatory committee procedure, taking into account the results of the risk assessment by EFSA. Regulation 1829/2003 also specifies that other legitimate factors relevant to the matter under consideration are considered on a case-by-case basis.

Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.

The EU legal framework addresses the requirements for handling, transport, packaging and identification of living modified organisms (Art. 18 of Cartagena Protocol) in the following acts: As regards Article 18(1) of Cartagena Protocol: - Directive 2008/68/EC on the inland transport of dangerous goods contains rules on the safe transport, handling and packaging. As regards Article 18(2)(a) of Cartagena Protocol: - Regulation (EC) No 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed has to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable. - Regulation (EC) No 1830/2003 provides that business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. In particular, the Regulation requires that: -- Operators are to have systems and standardized procedures in place to identify to whom and from whom products are made available; -- At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product: (a) that it contains or consists of GMOs; (b) the unique identifier(s) assigned to those GMOs; and -- in the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, written information on the unique identifier(s) assigned to the GMOs of which the product consists or which are contained in it, may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture. - Regulation (EC) No 65/2004 established a system for the development and assignment of unique identifiers for genetically modified organisms. - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist. Article 12 further stipulates that for GMOs intended for direct use as food or feed, or for processing, the above information must be supplemented by a declaration by the exporter: -- stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and -- giving details of the contact point for further information. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing, the above identification requirements may be replaced by a list of unique identifiers used to constitute the mixture. In relation to Article 18(2)(b) of Cartagena Protocol, the EU legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol: - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist. Article 12 further stipulates that for GMOs intended for contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify: -- any requirements for the safe handling, storage, transport and use of these GMOs; -- the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned. Finally, as regards Article 18(2)(c) of Cartagena Protocol, Regulation No (EC) 1946/2003 requires exporters of GMOs destined for deliberate release into the environment to ensure that documentation accompanying the GMO states: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist; In addition, this information shall be supplemented by a declaration by the exporter which shall specify: -- the identity and relevant traits and characteristics of the GMOs; -- any requirements for the safe handling, storage, transport and use of these GMOs; -- the contact points for further information and, as appropriate, the name and address of the importer and exporter; and -- a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter. The above requirements regarding identification and documentation of GMOs are in line with Article 18 of the Protocol and without prejudice to further specific requirements imposed by EU legislation.

The European Union has designated its own competent authority and focal point, while EU Member States have also designated their own national focal points and competent authorities. According to the Law on Genetically Modified Organisms, the Ministry of Environment is a competent national authority responsible for the implementation of the Cartagena Protocol on Biosafety together with the Interest Institutions: The Ministry of Agriculture, The Ministry of Health and State Food and Veterinary Service. There is close collaboration and information sharing between EU and national administrations.

National Focal point is designated by the Ministry of the Environment, who regularly updates information on the BCH.

The EU applies its domestic legislative framework, which is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign developers of GMOs. All scientific data and information supporting requests for authorizations of GMOs is made publicly available in a proactive manner and easily accessible as early as possible in the risk assessment process. Directive 2001/18/EC on the deliberate release into the environment of GMOs, Regulation (EC) No 1829/2003 on genetically modified food and feed and Regulation (EC) No 1946/2003 on transboundary movements of GMOs allow notifiers, applicants and exporters, respectively, to indicate which information submitted by them should be treated as confidential, based on verifiable justification. Decisions regarding those confidentiality claims are adopted by EFSA or the Member States. The European Commission, EFSA and the Member States take the necessary measures to ensure that confidential information notified or exchanged under the Directive or the Regulations is not made public. In Lithuania, the information provided by the notifier may be considered confidential in accordance with the GMO Law and subordinate legislation, which complies with EU GMO legislation.

Please refer to the EC report for further details.

EU legislation on GMOs promotes public awareness and participation as an integral part of its regulatory framework. Moreover, the EU is Party to the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters. An amendment to the Aarhus Convention was adopted in May 2005 and entered into force in April 2025. This amendment makes more specific the obligations placed on Parties with regard to public participation in genetically modified organism (GMO) decision-making processes. Relevant EU law governing GMOs, and in particular Directive 2001/18/EC and Regulation (EC) No 1829/2003, incorporates provisions for public participation in decision-making on GMOs, consistent with the amendment to the Aarhus Convention. The European Union ratified this amendment on 1 February 2008. Article 9 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms stipulates that Member States shall consult the public and, where appropriate, groups on the proposed deliberate release of GMOs into the environment for any other purpose than for placing on the market. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion. Member States are to make available to the public information on all intentional releases of GMOs into the environment in their territory, and the Commission shall make available to the public the information contained in the system of exchange of information established within the EU. In cases of GMO notifications for placing on the market of GMOs as or in products, Article 24 of Directive 2001/18/EC stipulates that the Commission shall make available to the public the summary dossier that is to accompany notifications for placing on the market of GMOs or a combination of GMOs as or in products. It also provides for the Commission to make available the assessment report issued by the national authority of the Member State which received the notification. The public can make comments to the Commission. EFSA also makes its scientific opinion public. The Directive provides for a public register recording information on GMOs authorised under that Directive. Regulation (EC) No 1829/2003 on genetically modified food and feed establishes a register of genetically modified food and feed authorised under that Regulation, including product specific information. Article 29 of the Regulation stipulates that EFSA shall make public the application for authorization for placing on the market of GM food and feed and its scientific opinion on the application. The public can make comments to the Commission on EFSA’s opinion. Monitoring reports are also made available to the public after deletion of confidential information. Directive 2009/41/EC on the contained use of GM micro-organisms states that EU Member States may provide, where appropriate, that the public shall be consulted on any aspect of the proposed contained use. It includes a requirement that information on emergency plans and safety measures to be taken in the event of an accident is made publicly available. With regard to transboundary movements of GMOs, Article 6 of Regulation (EC) No 1946/2003 requires the Commission to make available to the public all non-confidential documents related to notifications of exports of GMOs to third countries in accordance with the EU rules on access to environmental information. In cases of unintentional transboundary movements of GMOs that are likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, Article 14 requires Member States to take the appropriate measures to inform, among others, the public about the movement. The main legal instrument to align EU Member States legislation with the provisions of the Aarhus Convention on access to information is Directive 2003/4/EC of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC. To further support citizens’ rights of access to information and public participation, the EU has also adopted Directive 2003/35/EC on public participation, Regulation 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents and Regulation 1642/2003 of 22 July 2003, amending Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. The EU General Food Law (GFL, Regulation (EC) No 178/2002) defines risk communication as an essential part of the risk analysis process. A Regulation on the transparency and sustainability of the EU risk assessment in the food chain (Regulation (EU) 2019/1381), amending the GFL, entered into force in 2019 and became applicable in 2021. The Regulation was introduced with the aim of increasing the transparency of risk assessment in the food chain, strengthening the reliability, objectivity and independence of the studies submitted to EFSA, and reinforcing the governance of EFSA in order to ensure its long-term sustainability. In particular, it stipulates that: • Citizens have access to studies and information submitted by industry in the risk assessment process. Stakeholders and the general public are also consulted on submitted studies. • EFSA is made aware of all commissioned studies to guarantee that companies applying for authorisations submit all relevant information. EFSA will also offer advice to applicants prior to the submission of dossiers. • The European Commission may ask EFSA to commission additional studies and may carry out fact-finding missions to verify that laboratories/studies comply with quality standards. In line with transparency requirements, EFSA has developed Open EFSA (https://open.efsa.europa.eu/), a dedicated portal that provides comprehensive information on its risk assessment process. The EU maintains online information systems that provide the public with up-to-date information on the legislative framework for GMOs, applications for GMO authorisations and imports, decisions taken by relevant authorities, the results of environmental risk assessment and measures provided as part of risk management. The EU's main information portals for these purposes are: https://food.ec.europa.eu/plants/genetically-modified-organisms_en and https://food.ec.europa.eu/plants/genetically-modified-organisms/gmo-register_en Further information sites include: - European Union Reference Laboratory for GM Food and Feed: http://gmo-crl.jrc.ec.europa.eu/ - European Food Safety Authority: https://www.efsa.europa.eu/

As regards imports of GMOs, the EU applies its legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol. As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation (EC) No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol. Copies of the respective documents are sent to the competent authority of the EU Member State from which the GMO is exported and to the European Commission (Article 6). EU exports of LMOs to third countries will be reported in the national reports of individual Member States from which they are exported.

According to Directive 2001/18/EC, the Member States are obliged to take domestic measures to prevent and penalise illegal transboundary movements of GMOs. EU legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of EU legislation. These penalties shall be effective, proportionate and dissuasive. Specific requirements on Member States to determine penalties applicable to breaches of European and national GMO rules can be found in: - Article 33 of the Directive 2001/18/EC on the deliberate release into the environment of GMOs; - Article 18 of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms; and - Article 45 of Regulation (EC) No 1829/2003 on genetically modified food and feed. Article 53 of Regulation (EC) No 178/2002 (GFL) provides for the obligation to adopt appropriate EU emergency measures for food and feed imported from a third country in order to protect human health, animal health and the environment, when there is a serious risk to human or animal health or to the environment and when this risk cannot be contained satisfactorily by means of measures taken by the Member States concerned. On this basis the Commission adopted in 2008 emergency measures regarding the unauthorised genetically modified rice Bt 63 in products originating in or consigned from China (Commission Decision 2008/289/EC). The Commission adopted stricter requirements with a new Decision on emergency measures in 2011 (Commission Decision 2011/884/EU) with further amendments introduced in 2013 (Commission Decision 2013/287/EU). The Decision is still in force.

Cultivation is an issue with strong national, regional and local dimensions, given its link to land use, to local agricultural structures and to the protection or maintenance of local habitats, ecosystems and landscapes. In this respect, as set out in Directive 2001/18/EC (following its amendment in 2015), an EU Member State may decide to restrict the cultivation of an authorized GMO, based on grounds related to environmental or agricultural policy objectives, or other compelling grounds including socioeconomic impacts, which might arise from the cultivation of the GMO on the territory of the Member State concerned. Currently, commercial GMO cultivation is not carried out in Lithuania. Under EU Directive 2015/412, which has been transposed into Lithuanian law, it is possible to refuse to grow GMOs on the basis of a much broader range of policy considerations than before, including agricultural policy objectives and social and economic impacts, and this has been done by this legislation: https://www.e-tar.lt/portal/lt/legalAct/be9a751062be11e589fccd6fa118e11c

Lithuania participates in EU scientific forums (The European Food Safety Authority and etc.).

Lithuania has fully transposed into national Law the Directive 2004/35/EC on environmental liability with regard to prevention and remedying of environmental damage

Lithuania ratified the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress on 12 of September 2012 and the protocol came into effect on 05 March 2018. The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage, the Environmental Liability Directive (ELD), which establishes a framework based on the "polluter pays" principle, according to which the polluter pays and repairs when environmental damage occurs. this directive has been transposed into Lithuanian national law.