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Law, Regulation or Guideline
Record information and status
Record ID
7214
Status
Published
Date of creation
2004-12-21 05:04 UTC (mariakara@moew.government.bg)
Date of last update
2019-08-02 11:41 UTC (ntsvetkov@moew.government.bg)
Date of publication
2019-08-02 11:41 UTC (ntsvetkov@moew.government.bg)

General Information
Country
  • Bulgaria
Jurisdiction
  • Bulgaria
Title of document
Summary of regulatory system
Legislative details
Type of document
  • Regulatory summary / national biosafety framework
Subject areas
  • All functions pursuant to the Cartagena Protocol on Biosafety
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
Bulgaria is member state of European Union and applies the relevant EU legislation. The main European legal acts relevant to the application of the Cartagena Protocol on Biosafety are 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; 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 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; and Commission regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms. The Regulations above are directly applicable in Bulgaria.

Directives 2001/18/EC and 2009/41/EC are transposed in national legislation by the Bulgarian Genetically Modified Organisms Act, the main national legal instrument in the field of GMO/LMO. The Act aims to protect human health and the environment and regulates:
1. the contained use of GMOs;
2. the release of the GMOs in the environment;
3. the placing on the market of GMOs or combination of them as products or ingredient of
products;
4. the transfer of GMOs;
5. the import, export and transit of GMOs;
6. the control over the activities under items 1-5.

The Genetically Modified Organisms Act does not apply to:
1. placing on the market, import, export and transit of:
(a) GMOs for use in / or as food, genetically modified foods, foods containing ingredients produced from GMOs, which are regulated by the Foodstuffs Act;
(b) GMOs for use in / or as feed, genetically modified feed, feed containing ingredients produced from GMOs, which are regulated by the Act on Fodders and the Veterinary Practices Act;
(c) veterinary medicinal products consisting of or containing GMOs or a combination of GMOs or produced from GMOs, which are regulated by the Veterinary Practices Act;
2. contained use, release into the environment, placing on the market, import, export and transit of medicinal products for human use, consisting of or containing GMOs or a combination of GMOs or produced by GMOs, which are regulated by the Medicinal Products in Human Medicine Act.

The Genetically Modified Organisms Act also assigns the competent national authorities in the field of GMO:
I. The Minister of Environment and Water:
1. Grants, modifies and withdraws authorizations for:
(a) contained use of GMOs;
(b) deliberate release of GMOs into the environment;
2. Registers premises for contained use of GMOs;
3. Organizes public consultation on deliberate release of GMOs into the environment;
4. Coordinates control function of the other governmental authorities with respect of GMOs;
5. Establishes and maintains a Biosafety Clearing-House information system for implementation of obligations under the Cartagena Protocol on Biosafety to the Convention on Biological Diversity and for exchange of scientific, technical, environmental and legal information about GMOs.

II. The Minister of Agriculture, Food and Forests:
1. Grants, modifies and withdraws authorizations for placing on the market of GMO or combination of GMOs as products or ingredient of products;
2. Organizes public consultation on the release of GMOS on the market.

The Ministers in the exercise of their powers receive scientific and technical advice from the Consultative Commission on GMOs that consists of fifteen scientists with relevant expertise in the field of modern biology.

The provisions of the GMO Act are further elaborated in the Ordinance on the contained use of GMOs and the Ordinance on the deliberate release and placing of GMOs on the market.

The provisions of the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress have been implemented with Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage. Directive 2004/35/EC is transposed with the Act on Liability for Preventing and Remedying Ecological Damages. It regulates the liability for prevention and remedying of ecological damages while observing "the polluter pays" principle and the principle of sustainable development and applies in the cases of caused ecological damages or imminent threat for appearing of ecological damages, caused by action or inaction. The Act covers damages that are or can be caused by the use of GMOs.
The Act defines:
1. the ecological damages and the imminent threat for appearing of such damages;
2. the authorities of the executive bodies and the rights and obligations of the operators;
3. the procedures for choice and realizing preventive and remedial measures, including consultations with the public;
4. property liability of the operators and the financial-economical organization for providing the activities for prevention and remedying of ecological damages;
5. the requirements for cooperation and exchange of information in relation to ecological damages with other states and with the European Commission.
Regulatory contact information
Contact person
Ministry of Environment and Water
22 Maria Louisa Blvd
Sofia
Bulgaria, 1000
Phone:+3592 940 6123
Fax:+3592 940 6127
Email:ntsvetkov@moew.government.bg
Url:Bulgarian Biodiversity Portal,Ministry of Environment and Water
Ministry of Agriculture, Food and Forests
55 Hristo Botev Blvd
Sofia
Bulgaria, 1040
Phone:+359 2 985 11 306
Fax:+359 2 980 18 62
Email:ipetkova@mzp.government.bg
Url:Ministry of Agriculture, Food and Forests
Ministry of Health
5 Sveta Nedelia Sq
Sofia
Bulgaria, 1000
Phone:+359 2 93 01 271
Fax:+359 2 988 34 13
Email:stcherkezova@mh.government.bg
Url:Ministry of Health