As a member state of the European Union, Bulgaria applies the relevant EU legislation. EU legal acts concerning genetically modified organisms (GMO)/ living modified organisms (LMO) include: - Directive 2009/41/EC on the contained use of genetically modified micro-organisms; - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms; - Directive 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms in their territory; - Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage; - Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms; - Regulation (EC) No 1829/2003 on genetically modified food and feed; - Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms; - Commission Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation; - Commission Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms; - Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired; - Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006; - Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms; - Commission Decision 2000/608/EC concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms; - Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC; - Council Decision 2002/812/EC establishing pursuant to Directive 2001/18/EC the summary information format relating to the placing on the market of genetically modified organisms as or in products; - Council Decision 2002/813/EC establishing, pursuant to Directive 2001/18/EC, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market; - Commission Decision 2003/701/EC establishing pursuant to Directive 2001/18/EC a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market; - Commission Decision 2004/204/EC laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC; - Commission Decision 2009/770/EC establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC. The European Regulations and Decisions are directly applicable at the national level. Directives 2001/18/EC and 2009/41/EC are transposed into national legislation by the Bulgarian Genetically Modified Organisms Act, Ordinance on the contained use of GMOs and the Ordinance on the deliberate release and placing of GMOs on the market. Control activities carried out by the Bulgarian Ministry of Environment and Water are in accordance with the Instruction on the organization and procedure for control by the structures of the Ministry of Environment and Water on the contained use of GMOs and their release into the environment. LMOs intended for direct use as food or for processing are regulated by the Bulgarian Foodstuffs Act and those for feed by the Bulgarian Act on Fodders. Control of the placing on the market and trade of food and feed consisting or containing GMOs is carried out by the Ministry of Agriculture and Food and its agencies.

As a member state of European Union, Bulgaria applies the relevant EU legislation. EU legal acts concerning medicinal products that consist of or contain Genetically Modified Organisms (GMO)/ Living Modified Organisms (LMO) include: - Directive 2001/83/EC on the Community code relating to medicinal products for human use; - Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; - Regulation (EC) No 1394/2007 on advanced therapy medicinal products. The medical products for human use, which consist of or contain GMO or are produced from GMOs, are regulated by the Bulgarian Medicinal Products in Human Medicine Act. The control of the placing on the market of GMOs as veterinary medicinal products consisting of or containing GMOs or a combination of GMOs is regulated by the Bulgarian Veterinary Practice Act, which enforcement is in the remit of the Ministry of Agriculture and Food and the Bulgarian Food Safety Agency.

Contained use: Directive 2009/41/EC on the contained use of genetically modified micro-organisms is implemented in the Genetically Modified Organisms Act and the Ordinance on the contained use of GMOs. The Act also contains provisions for the import of GMOs for contained use. On Question 18: Bulgarian Ministry of Environment and Water registers facilities for contained use of GMOs. The registration also contains permission to import GMOs that will be used in those facilities. Transit: Regulation (EC) 1946/2003 addresses transboundary movement of GMO and in particular the requirements for exports of GMOs to third countries as well as for unintentional transboundary movements. According to Article 13 of the Regulation 1946/2003, the exporter shall ensure notification of the transit of GMOs through their territory and BCH has to be informed. Procedures for the transit of GMOs are stipulated in Bulgarian national legislation. Under the provisions of Article 99 of the Genetically Modified Organisms Act, the operator which intends to transit GMOs through the territory of Bulgaria is required to submit written notification to the Ministry of Environment and Water, containing mandatory information. The Minister of Environment and Water issues a written certificate to the notifier at the latest three days before the transit. In addition, the Ministry of Environment and Water notifies the Customs Agency and the Ministry of Agriculture and Food for each issued certificate for transit of GMO.

Export of GMOs is regulated under the provisions of Chapter II of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms which is directly applicable in Bulgaria. During the reporting period no Bulgarian operators have exported GMO. Bulgaria as part of the EU Single Market can be considered a Party of import during the reporting period, because the decisions for placing GMOs on the market are taken at EU level. Bulgaria has been participating since 1st January 2007 (the date of full membership in the EU), in the authorisation procedure. The procedure requires evaluation of the risks for human health and environment. Those risk assessments are prepared by the notifiers and reviewed by all member states. An operator who wishes to introduce GMOs into the environment for purposes other than placing on the market must first obtain written authorisation from the Bulgarian Ministry of Environment and Water. The authorisation is given on the basis of a risk assessment of that GMO for the environment and human health. According to Bulgarian Genetically Modified Organisms Act risk assessments should be carried out in scientifically sound and transparent manner, based on the available scientific and technical data. Required information may vary depending on the type of GMO concerned, intended use and potential receiving environment, taking into account, inter alia, GMOs already released into the environment.

Bulgaria has not taken any decisions during the reporting period. As member state of the EU, Bulgaria participates in the decision making process for placing on the EU market of LMOs for direct use as food or feed, or for processing. See also the reply to this question in the Report of the European Union.

Bulgaria has not taken any decisions during the reporting period. As member state of the EU, Bulgaria participates in the decision making process for placing of LMOs on the EU market.

Bulgaria has made no use of the simplified procedure for import of LMOs as specified in Article 13.

Bulgaria is member state of European Union. Bulgarian public bodies, analytical laboratories and academic institutions participate in the activities related to LMO at EU level, for example EFSA, EU Committees and Working Parties, European Network of GMO laboratories (ENGL), etc. Bulgaria has been Party to the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (Aarhus Convention) since 2003. Bulgaria has also ratified the amendment to the Convention on GMO (Almaty Amendment). Bulgaria is also member of FAO GM Foods Platform.

Two risk assessments related to intentional introduction of LMOs into the environment were for clinical trials of medicinal products for human use. As a member state of the European Union, Bulgaria applies the EU legislative framework related to Risk Assessment and Risk Management of LMOs, including the relevant guidance documents. Three risk assessments related to intentional introduction of LMOs into the environment were for clinical trials of medicinal products for human use. Twenty-three risk assessments were related to contained use of LMOs including for registration of laboratory facilities, production facilities and premises for clinical trials of medicinal products for human use. As member state of the EU, Bulgaria participates in the risk assessment activities carried out at EU level.

Article 14 of Regulation (EC) 1946/2003 stipulates the measures to be taken in cases of release under Bulgarian jurisdiction that lead, or may lead, to an unintentional transboundary movement. This article also requires that appropriate measures be taken to prevent unintentional transboundary movements of GMOs.

Bulgaria applies the comprehensive EU legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification requirements covered by Article 18. On Question 82: The traceability and labelling requirements are stipulated in Articles 4 and 5 of Regulation (EC) No 1830/2003. The Regulation does not specify explicitly the form of the document. On Question 84: The traceability and labelling requirements are stipulated in Article 26 and Annex IV of Directive 2001/18/EC in the case GMOs to be used exclusively for contained use activities. The Directive does not specify the form of the document, but usually the relevant information is provided as part of existing types of documentation. On Question 86: The traceability and labelling requirements are stipulated in Article 4 of Regulation (EC) No 1830/2003, Articles 21 and 26 and Annex IV of Directive 2001/18/EC in the case GMOs intended for intentional introduction into the environment, including those to be used exclusively for deliberate releases complying under part B of Directive 2001/18/EC. The Regulation and Directive do not specify explicitly the form of the document. On Question 95: Some of those laboratories may be no longer active.

Bulgaria has designated competent authorities and national focal points for the Cartagena Protocol and Biosafety Clearing-House. The information is available through BCH. On Question 100: No specific initiative has been undertaken, but adequate mechanisms for information exchange and cooperation are established between national focal points, competent national authorities and other institutions on biosafety-related matters. The Bulgarian competent national authorities also collaborate and share information with the competent authorities of EU and the other EU member states.

On Question 112 c), e), g), h), i), k), l), m), n), o), p) and q): There is no information which is required to be published in the BCH.

On Question 105: Information from BCH is used in all relevant cases of decision making.

Part Six of Bulgarian Genetically Modified Organisms Act stipulates that applicants may indicate which information submitted should be treated as confidential. Under Article 105 the following information is always made available to the public: general description of the GMO, the name and address of the authorisation holders, the risk assessment information, plans for emergency responses, etc.

Bulgaria has not participated in any GEF funded project related to LMOs during the current reporting period.

The procedures for public participation regarding the release of GMOs into the environment and regarding placing of GMOs on the market are similar. In the former case the Ministry of Environment and Water (MOEW) is the competent authority and in the latter - the Ministry of Agriculture and Food. The public hearing procedure is in brief as follows: Within 45 days after the Advisory Committee on GMOs delivers an opinion on an application for release of a GMO into the environment, MOEW organizes a public consultation/hearing. During the public hearing, a summary of the application dossier and the risk assessment and along with the Committee's opinion are presented. No later than 30 days prior to the hearing, the subject, date and venue of the public consultation as well as the place where the necessary information is available to stakeholders should be announced on the web site of the Ministry, in one national daily newspaper, through the local media and by posting notices in the mayoralties in the area where the release is to take place. When considering placing of GMOs on the market, MAFF makes a summary of application dossier and the risk assessment report available to the public. The hearing is held within 30 days. MAFF summarizes the remarks and comments made during the consultation and sends them to the European Commission. That procedure is carried out only when the Committee advises that the GMO may be placed on the market. The Ministry of Environment and Water organises public hearings when application is received for contained uses with genetically modified microorganisms (GMM) classes 3 (moderate risk activities) and 4 (high risk activities) and with GMOs other than GMMs class B (high risk activities). Within 30/45 days (depending on the specific activities planned) after the Advisory Committee on GMOs delivers an opinion on an application for contained use of a GMO, MOEW organizes a public consultation/hearing. During the public hearing, a summary of the application dossier and the risk assessment as well as the Committee's opinion are presented. No later than 30 days prior to the hearing, the subject, date and venue of public consultation as well as the place where the necessary information is available to stakeholders are announced on the web site of the Ministry, in one national daily newspaper, through the local media and by posting notices in the mayoralties in the area where the contained use activities are to take place. In the current reporting period, no applications have been made for release of GMOs into the environment, placing of GMOs on the market or for contained use at relevant safety classes and volumes, which require national consultation and participation activities. On Question 128: The website of the Ministry of Environment Water maintains public registers of: issued permits for release of GMOs into the environment; location and size of the areas authorized for the release of GMOs; facilities registered for contained use of GMOs; and issued permits for contained use activities with GMOs. The website of the Ministry of Agriculture and Food maintains public register of the areas planted with genetically modified plants authorised for placing on the market of the European Union. In addition to those websites, the public can ask and get access to information held by Bulgarian administration, incl. information related to the decision-making on GMOs. No access is granted in the legislatively provided cases when the information is confidential, trade secret or personal. In addition, Bulgaria has been Party to the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (Aarhus Convention) since 2003. Bulgaria has also ratified the amendment to the Convention on GMO (Almaty Amendment). The implementation of the Convention at the EU level is done through Regulation (EC) No 1367/2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies and Commission Decision 2008/50/EC laying down detailed rules for the application of Regulation (EC) No 1367/2006 on the Aarhus Convention as regards requests for the internal review of administrative acts. At national level access to public information on environment, incl. on GMOs/LMOs is regulated through the Access to Public Information Act and Chapter II of Environmental Protection Act.

The imports of LMOs to the EU Common market take place under the provisions of Regulation (EC) 1946/2003.

Penalties for infringement of Directive 2001/18/EC and Regulation (EC) 1946/2003 are stipulated in the Bulgarian Genetically Modified Organisms Act.

Discussions related to socio-economic considerations are ongoing at the national and EU level including information exchange with European Commission and other EU member states. On Question 151: socio-economic considerations arising from the impact of LMOs have been taken into account when formulating the Bulgarian positions on allowing import of GMOs to the European Union Common Market.

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One or more national laws: Liability for Preventing and Remedying Ecological Damages Act (LPREDA); Genetically Modified Organisms Act.; One or more national regulations: Ordinance on the type of preventive and remedial measures in the cases envisioned by ALPRED and on the minimum costs for their implementation; Ordinance on the public register of operators carrying out the activities under Annex No 1 of LPREDА.; One or more sets of guidelines: Methodology for classification of cases under LPREDА and determination/valuation of preventive/remedial measures in accordance with the act and its subordinate legislation.

As a member state of European Union, Bulgaria applies the relevant EU legislation. The EU legal instrument is Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage (known as Environmental Liability Directive – ELD). It addresses the liability for the prevention and remedying of environmental damage caused by various activities, incl. the use of GMOs. The same approach is used in the Bulgarian legislation. Directives 2004/35/EC is transposed in national legislation by Bulgarian Liability for Preventing and Remedying Ecological Damages Act (LPREDA). On Question 161: One or more national laws, regulations and sets of guidelines are in place. That could not be marked in the electronic form, as only one choice was possible to that question. On Question 166: The definition of “operator” under LPREDA is broad (but identical with Annex III of ELD) and covers all natural or legal persons that perform activities with GMOs as specified in the Genetically Modified Organisms Act or other relevant legislation. On Question 168: State authorities carry out all relevant activities when the responsible operator is unknown or for some reason cannot fulfil its obligations under LPREDA. On Questions 169 and 170: Financial security shall be provided by the operator for the implementation of the preventive and remedial measures and those can be chosen among the four possible ways insurance, bank guaranty, mortgage/property rights over real estate and/or rights over claims, movable items or securities. The State authority executes/covers the expenses for necessary preventive/remedial measures when the responsible operator is unknown or cannot cover them on time. The State authority has the right to recover costs and expenses of the evaluation of damage and the implementation of prescribed by the competent authority response measures on behalf the operator, incl. through the use of Courts. On Question 171: The civil liability procedures as stipulated in the Bulgarian legislation are applicable in respect of damages caused by GMOs/LMOs.