Serbia | BCH-NR3-RS-115183 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)
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BCH-NR3-RS-115183-1   |   PDF   |   Print   |  
last updated: 27 Sep 2019
General Information


- Ministry of Agriculture, Forestry and Water Management: Plant Protection Directorate, Veterinary Directorate<br />- Ministry of Health<br />- Customs Administration<br />- Expert Council for Biosafety
EN

01 Jan 2013
01 Jan 2018
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is partially in place
EN
2001 or earlier
EN
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
Yes, to some extent
EN
The budget for the operation of the national biosafety framework is part of the overall budget allocated to the Ministry of Agriculture, Forestry and Water Management, which is the national competent authority responsible for GMO issues. The budget for the work of the competent authority is established each year by the Law on the Budget of the Republic of Serbia for the current year
EN
Yes
EN
One
EN
No
EN
Regulations governing the use of GMOs exist since 2001, when the first Law on GMOs was adopted and in accordance with it the bylaws. These regulations were adopted at the federal level by the parliament of the Federal Republic of Yugoslavia, which consisted of the Republic of Serbia and the Republic of Montenegro, and applied in the period from 2001 to 2009. This Law on GMO, together with the accompanying regulations, enabled the issuing permit of all types of GMO use (contained use of GMOs, cultivation of GMOs and placing on the market of GMOs or GMO products), but following a rigorous procedure involving adequate risk analysis. After the redefinition of political relations between Serbia and Montenegro, the State Union of Serbia and Montenegro was created, and the Federal Republic of Yugoslavia ceased to exist. In 2006, Serbia and Montenegro became members of the Cartagena Protocol. In 2009, the Government of the Republic of Serbia adopted the following laws which has been regulates the field of GMOs: Law on Genetically Modified Organisms ("Official Gazette of RS", No. 41/09), Law on Food Safety ("Official Gazette of the Republic of Serbia", No. 41/09). Law on Genetically Modified Organisms (Official Gazette of RS, No. 41/09) regulates the procedure for issuing approvals for use in closed systems, for deliberate release into the environment of GMO for the purpose of carrying out experiments, demonstration experiments and development of new varieties, conditions for use in closed systems and for deliberate release into the environment GMO, handling, packaging and transport of GMOs and products containing GMO, as well as other issues of importance for GMO and products containing GMO. This law regulates only experimental work with GMOs. Also, this law prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia, which is not in compliance with Kartagena Protocol on Biosafety. However, the Food Safety Law ("Official Gazette of the Republic of Serbia", No. 41/09) prescribes procedures for the first placing on the market of GM food and GM feed in the territory of the Republic of Serbia, for labelling and traceability of GM food and feed, as well as for record keeping of approved of GM food and feed. Given that the Law on GMO&nbsp; and the Food Safety Law are in opposition to one another in the field of regulating GM food and feed, the Law on GMO&nbsp; as the law that specifically regulates GMOs is considered to be a Lex specialis, because of that the ban on the placing on the market of GMOs and GMO products in the Republic of Serbia, as defined by the Law on GMOs, is in force.
EN
Article 5 - Pharmaceuticals
Yes, to some extent
EN
The Law on GMO ("Official Gazette of the Republic of Serbia", No. 41/09)&nbsp; is not responsible for the regulation of GMOs (LMOs) used as pharmaceuticals.<br />This area is partially regulated by the Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia", No. 30/2010; 107/2012).
EN
No
EN
Competencies over the implementation of the Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia", No. 30/2010; 107/2012) is under the authority of the Ministry of Health, so the Ministry of Agriculture, Forestry and Water Management has no accurate information on this issue.
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
No
EN
As candidate country for EU membership, Serbia has been start with harmonisation of legislation with EU legislation in this area. Regulation (EC) No 1946/2003 on transboundary movement of GMOs, as well as the Directive 2009/41/EC on the contained use of genetically modified micro-organisms have been transposed into the Law on GMO. As we said, in Serbia, commercial cultivation of GMOs, as well as the placing on the market of GMOs and GMO products, were denied. We did not have&nbsp; any a notification of the transit of GMOs (LMOs). Also, we did not have applications for contained use of GMOs (LMOs). Also the transit is regulated by the Customs Law ("Official Gazette of the Republic of Serbia", No.18/2010-3, 111/2012-3, 29/2015-6, 108/2016-16, 113/2017-192 (other law)) for which the Customs Administration is competent authority .
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes, to some extent
EN
In accordance with the Law on GMOs (Official Gazette of RS, No. 41/09), mechanisms for decision making for the first intentional transboundary movements of LMOs for intentional introduction into the environment have been established, but only for the contained release of a GMOs for the purpose of carrying out experiments, demonstration experiments and development of new varieties.<br />This law prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia. The existent national law and by-laws are not in line with Carthagena Protocol on Biosafety.
EN
Yes
EN
No
EN
No
EN
Yes
EN
Yes
EN
Less than 5
EN
None
EN
None
EN
None
EN
Since 2009, when the current Law on GMO&nbsp; was adopted, we did not have any application for the deliberate introduction of GMOs into the environment. Consequently, we have not made any decision regarding the transboundary movement of GMOs for the purpose of introduction into the environment.<br />In the period from 2001 to 2009 (when the Law on GMO&nbsp; ("Official Gazette of FRY", No. 21/2001 was in force)), permits for field trials were issued (GM corn (NK603) resistant to Roundup Ready herbicide, as well as GM Arabidopsis and GM tobacco for the purpose of detecting mines in the ground). Each of these permits was accompanied by precisely defined obligations for adequate risk management. Also, was issued the permit for the placing on the market of GM soybean meal (processed) as feed (in a form that is not live modified organism and does not pose a threat to the environment).
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
No
EN
No
EN
No
EN
No
EN
No
EN
Yes
EN
Less than 5
EN
None
EN
None
EN
In accordance with the Law on GMO we have general ban on commercial growing of GMOs, as well as on placing on the market of GMOs and products of GMOs in Republic of Serbia
EN
Article 12 – Review of decision
No
EN
No
EN
No
EN
None
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
Yes
EN
None
EN
No
EN
Free trade agreements between Serbia and the EFTA countries, then the CEFTA countries, the Russian Federation, etc. None of these agreements is LMO-related.<br />Stabilization and Association Agreement between the EU and Serbia (signed 2013)
EN
As a candidate country for EU accession, Serbia has to harmonize domestic legislation with EU legislation. The draft of the new GMO law is under preparation and will be harmonized with the relevant EU legislation.
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes, to some extent
EN
Yes but to some extent. The Law on GMO imply the risk assessment as the obligatory procedure that has to be a component part of decision making process. The submitted application dossier to the Competent Authority has to contain the document - assessment of the risks to human health and to the environment. Submitted application are re-evaluated by the Expert Council for Biosafety to undertake a risk assessment. The Expert Council for Biosafety is an scientific consultative advisory body that is in charge with risk assessment and scientific review of applications. The Expert Council shall operate under the “case by case” procedure, and in its activities it shall be guided by data based on scientific knowledge and observe the precautionary principle.<br />However, there are not sufficient experience in evaluation of risk assessment for LMOs, lack of a domestic guidelines for Risk assessment in line with the Annex III of the Protocol.There is critical needs for capacity building for training of risk evaluators and expertise for LMOs.&nbsp;
EN
Yes
EN
One or more
EN
One or more
EN
One or more
EN
No
EN
No
EN
No
EN
No
EN
Yes
EN
Yes
EN
No
EN
No
EN
Yes
EN
Yes
EN
No
EN
No
EN
No
EN
Yes
EN
  • Field trial
  • LMOs for Contained use
No
EN
In some cases only
EN
None
EN
No
EN
Yes
EN
Yes
EN
Testing of GMOs and GMO products for the purpose of detection, identification and quantification of genetic modification is carried out by laboratory designated by the Ministry of Agriculture, Forestry and Water Management. At this point, the four laboratories are designated to carry out detection, identification and quantification of genetic modifications in GMOs and products of GMO, for the needs of the Ministry of Agriculture. Members of the Expert Council for Biosafety have some experience in conducting risk assessments of LMOs, intended for contained use, as well as for field trials, but not for cultivation for commercial purposes or direct use as food, feed, or for processing. Although some of our experts have been invited to the workshops organized at the EU level to update their knowledge, additional training and hands-on experience would be welcomed particularly for regulators and administrators in the country as well as for other experts, particularly for inspections service who&nbsp; supervise&nbsp; the implementation of the Law on GMOs.
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes, to some extent
EN
Seed and mercantile crops (maize, soybeans, swede-rape, oilseed repe, sugar beet) are compulsorily sampled at the border by the Border Phytosanitary Inspection and samples are sent to authorized laboratories for testing for the presence of GMOs.<br />Phytosanitary Inspection conduct monitoring of crop varieties and agricultural/food products in the local market and in the field.
EN
No
EN
No
EN
Never
EN
Article 18 – Handling, transport, packaging and identification
Yes, to some extent
EN
In accordance with the Law on GMO ("Official Gazette of Republic of Serbia", No. 41/2009) during handling, packaging and transport, including transit over the whole territory of the Republic of Serbia, the GMOs and GMO products shall be accompanied by the documentation which must contain the data clearly indicating that they are GMOs and GMO products. For use GMO in closed systems, the documentation must contain the conditions and requirements for safe handling, transport and use, the place for obtaining information, including the name and address of the person or institution that has been consigned the GMO. For deliberate release into the environment of GMO intended for field trials, the documentation must include identity and the appropriate characteristics of the GMOs and GMO products, conditions for safe handling, storage, transport and use, as well as the place for obtaining information. However, in accordance with this law, commercial&nbsp; growing of GMO , as well as the placing on the market of GMOs and GMO products is prohibited in Serbia.
EN
No
EN
No
EN
Yes
EN
Existing types of documentation
EN
Yes
EN
Existing types of documentation
EN
No
EN
Yes, to some extent
EN
None
EN
Yes, to some extent
EN
One or more
EN
Yes
EN
One or more
EN
One or more
EN
The Ministry of Agriculture, Forestry and Water Management, as the competent authority for GMO issues, authorized 4 laboratories for the detection, identification and quantification of genetic modification in the tested material. However, we still do not have a nominated reference laboratory to be able to ensure validation of methods for detection, identification and quantification of GMOs .
EN
Article 19 – Competent National Authorities and National Focal Points
No
EN
Yes, to some extent
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information available but only partially available in the BCH
EN
Information available but only partially available in the BCH
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Yes, to some extent
EN
In cooperation with the TAIEX (Technical Assistance and Information Exchange Instrument of the European Commission) a series of training workshops relevant to this field were held
EN
Yes, to some extent
EN
Yes, in some cases
EN
No
EN
No
EN
5 or more
EN
One or more
EN
  • National Libraries
Article 21 – Confidential information
Yes
EN
Yes, always
EN
Article 22 – Capacity-building
No
EN
Yes
EN
Regional channels
EN
No
EN
Yes
EN
Average
EN
  • Development of national biosafety frameworks
Yes
EN
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
No
EN
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Socio-economic considerations
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
No
EN
No
EN
Less than 1 per year
EN
No
EN
Serbia still needs financial and technical assistance from the parties of the Cartagena Protocol and other international institutions in biosafety capacity building&nbsp;&nbsp; as well as implementing of the Cartagena Protocol.
EN
Article 23 – Public awareness and participation
Yes, to some extent
EN
Procedure for public participation at the decision making process prescribed by the national legislation.
EN
No
EN
No
EN
No
EN
None
EN
No
EN
Yes
EN
Yes
EN
Yes, to some extent
EN
It is possible to find this information on the national website
EN
  • National website
National website
EN
No
EN
One or more
EN
One or more
EN
Yes
EN
Yes
EN
Never
EN
A number of meetings and workshops organized for stakeholders and decision makers: GMO inspection - Enforcement of GMO legislation, Workshop on GMOs Food and Feed, meetings at the Serbian Academy of Sciences and Arts on biosafety<br />Participation in training courses in the organization of TAIEX, BTSF
EN
Article 24 – Non-Parties
No
EN
No
EN
No
EN
-
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Never
EN
In accordance with current Law on GMO, no genetically modified organisms or product containing genetically modified organisms can be traded or grown for commercial use at the territory of the Republic of Serbia
EN
Article 26 – Socio-economic considerations
No
EN
Not applicable
EN
One or more
EN
-
EN
No
EN
-
EN
Article 27 – Liability and Redress
No
EN
No
EN
No
EN
Yes
EN
Q 199: Steps have been taken to initiate the procedure of ratification of the Supplementary Protocol under the Cartagena Protocol on Biosafety<br />Q 200: There are penal provisions in national legislation if the use of GMOs and GMO products&nbsp; causes harmful consequences for human health and the environment
EN
Article 28 – Financial Mechanism and Resources
n/a
EN
Article 33 – Monitoring and reporting
Yes
EN
Yes
EN
No
EN
  • Lack of financial resources to gather the necessary information
  • Lack of relevant information at the national level
  • Difficulty in compiling the information from various sectors
Other information
The current Law on GMO ("Official Gazette of the Republic of Serbia", No. 41/09), which was adopted in 2009, regulates only experimental work with GMOs and prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia. This was reffered in 2nd National Report. <br />This Law is still in the force
EN
Comments on reporting format
Due to lack of financial and human resources Serbia has difficulties with gathering necessary information for submission of the Cartagena Protocol National Reports.<br />
EN