After almost two years activities supported by the U.S. and EU, in December 2010 Serbia finalized amendments to the very restrictive Law on GMO that was adopted in May 2009.
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
Required Report - public distribution
GAIN Report Number: RB1113
Agricultural Biotechnology Annual
Biotechnology Annual Report
After almost two years activities supported by the U.S. and EU, in December 2010 Serbia finalized
amendments to the very restrictive Law on GMO that was adopted in May 2009. Amended law on
GMO will represent general framework on biotechnology that will be fully harmonized with EU
regulations. It will allow importing and growing GMO crops and products but under strict control of the
state. All specifics will be further regulated by already existing four by-laws and additional eight by-
laws that Serbia is planning to adopt after accepting amendments to the current law. Restrictive GMO
Law is one of the obstacles left for Serbia in the process of accession to WTO.
Section I. Executive Summary:
As a result of the Law on GMO, adopted in May 2009, Serbia strictly prohibits all imports, production
and commercial growing of GMO crops or products containing GMO. This law was adopted without
any scientific basis and represents one of the main obstacles for Serbia?s WTO accession process.
Beside a ban on trade and commercial cultivation of GMO products, law is extremely problematic in the
compliance with WTO rules.
After encountering strong reaction from the U.S., the EU and other WTO members, problems with the
2009 GMO law were recognized by the Serbian trade and agriculture officials but no changes were done
so far. It is expected that when adopted, the new amended GMO Law and other by-laws will be fully in
accordance with EU Directives on biotechnology 2001/18/EC; No.1829/2003; No.1830/2003;
No.65/2004 and No.641/2004. The proposed amendments will allow to import and to grow GMO crops
and products but only under very strict control of the state. Amended Law on GMO will represent the
general framework on biotechnology in Serbia, while all specifics will be regulated by additional eight
by-laws that are planned to be adopted immediately after passing a new amended GMO Law and will
cover the use of GMO in closed systems, placing GMO on the market, labeling and traceability,
authorized laboratories and others. In addition to those new by-laws, there will be some changes in
terminology in already existing four by-laws.
Since 2001, Monsanto Europe S.A. started field trials on RR corn with local research institutes in
Serbia. In July 2009, the Ministry of Agriculture issued to Monsanto last approval for field trails valid
for a year. Since the approval was issued too late in the year, there was not enough time for RR corn
field trails to take place in 2009. In 2010 and 2011, Monsanto did not require new approvals for RR
corn field trials since it decided to put RR corn field trails in Serbia on hold for the time being.
Therefore, currently there is no foreign company in Serbia engaged in biotech experimental research.
Marketing or promotion of GMO food does not exist in Serbia. There is a strong, negative public
attitude towards the acceptance of biotech crops and products derived from GMO crops. Consumer
awareness of GMO is very low and public discussions of biotechnology related issues are very limited.
USDA has been assisting in developing Serbia?s capacities in the research and regulations of
agricultural biotechnology since 2001. Through numerous seminars, workshops and field visits (both in
Serbia and in the United States) USDA/OCBD has been training Serbian participants to critically
examine the technical and economic aspects of biotechnology policies and pursue strategies to optimize
their implementation. USDA technical assistance activities on biotech were also assisting Serbian
scientists to design and conduct field trials of genetically modified crops. Since mid-2009 until the end
of 2010, USDA technical assistance was targeted at assisting Serbian biotech experts in preparing
amendments to GMO Law. In May 2010, FAS/Belgrade organized visit of Professor Martina
McGloughlin from University of California Davis to Serbia, as a part of the State Department?s
Program ?Biotech Outreach Strategy?.
Section II. Plant Biotechnology Trade and Production:
As a result of the Biotech Law adopted in June 2009, Serbia does not produce any genetically modified
organism (GMO) crops and no biotechnology varieties are permitted for imports to Serbia. According to
this law, biotechnology crops are only allowed for laboratory work, research and field tests. Imports of
biotech crops and products including soybean meal that was allowed for import before this law,
soybeans and corn are prohibited. All shipments of soybeans, corn, potato and rapeseed and their
products entering Serbia must be tested for GMO content, and are allowed to be imported only if they
Imports of RR soybeans for crushing or other commercial purpose are not allowed in Serbia. The
current law does not prohibit the research work with genetically modified organisms but puts them
under the strict supervision of the state. Permits for research work and contained use of biotech
materials can be obtained from the Serbian Ministry of Agriculture after meeting the state?s regulatory
According to the 2009 GMO Law, Serbia is no longer able to import soybean meal from Round-Up
Ready soybeans or feed stuffs that contain GMO soybean meal. Thus, for the past year local cattle feed
producers were left to buy only locally produced soybean meal, very often almost $80/MT higher than
in other EU countries allowing imports of RR soybean meal. The leading producer of soybean meal in
Serbia is the largest soybean crushing facilities in this part of Europe called ?Sojaprotein? from Becej in
Vojvodina. ?Sojaprotein? is owned by the local company ?Victoria Group?, one of the leading company
in agriculture production and processing in Serbia. Prior to adopting the 2009 GMO Law, only GMO
products that were allowed for import to Serbia was GMO soybean meal. However, every shipment was
required to obtain approval from the Ministry of Agriculture through very complicated procedure.
Only non-GMO soybeans are allowed to be grown in Serbia. Area planted to non-GMO soybeans has
been growing steadily from 2001 to 2011, mainly as a result of the increased demand for soybean meal
for animal feed. Since 2005, Serbian phytosanitary inspection services started to inspect and to restrict
illegal planting of GMO soybeans. The amount of illegally planted GMO soybeans that was confiscated
in the past was crushed under state control and allowed to be used for animal feed or for export.
Area planted to non-GMO soybeans in MY10/11 was 170,000 HA and with average yield of 3 MT/HA,
total production of soybeans in MY10/11 was on the record level of 510,000 MT. For MY11/12
soybeans were planted this spring on 166,000 HA, or about 2.3 percent less than the previous year. It is
estimated that soybean production in MY11/12 can reach 490,000 MT. It is estimated that in MY10/11
Serbia produced 300,000 MT of non-GMO soybean meal. Due to a ban on imports of RR soybean meal,
in MY10/11 Serbia imported only 30,000 MT of non-GMO soybean meal. In the previous years Serbia
was importing about 92 percent of GMO soybean meal from Brazil (71 percent) and Argentina (21
percent) and the remaining quantity (8 percent) from neighboring countries.
Consumption of soybean meal in Serbia is estimated at around 400,000-420,000 MT, with possible
deficit of around 100,000-120,000 MT that can be covered only by imports.
Current market price of soybean meal at Novi Sad Commodity Exchange is 33-34 din/kg (471-486
USD/MT) , which is about 70-80 USD/MT higher comparing to price of soybean meal from Argentina
(44/45%) on parity FOB Hamburg Germany (390-400 USD/MT). Even with adding transportation costs
and customs taxes price Serbian soybean meal remains one of the highest in Europe. This is the result of
the monopoly on soybean meal supply by only one local company at the Serbian market and official ban
on imports of soybean meal from abroad. Monopoly of soybean meal supply puts Serbian farmers and
cattle producers in very bad situation. Because of the high price of inputs for cattle feed, Serbian cattle
production is reducing for the last couple of years. Price of meat cannot follow price of inputs, due to
the limited incomes of the local population causing meat demand to be very low.
For every shipment of soybeans and soybean meal at the border phytosanitary inspectors at border are
instructed to carry our surveillance of possible unauthorized imports of biotech crops or products, while
the internal inspectors from the Ministry of Agriculture control what is planted on the field in Serbia.
The phytosanitary inspectors use test strips ?Reveal for CP4? on testing for RR soybeans presence or
apply herbicides on small areas of the soya fields to identify illegal GMO soybean planting. When
border or field tests are positive samples are sent to an accredited laboratory by the Ministry of
Agriculture for further testing. There are three accredited laboratories that the Ministry of Agriculture is
using for GMO testing:
1. SP Laboratory (member of ?Victoria Group?),
Address: Industrijska Zona bb, Becej
Phone: +381 21 453 191
2. Laboratory for Seed Tasting (part of Institute for Crops and Vegetables Novi Sad),
Address: 30 Maksima Gorkog, Novi Sad
Phone: +381 21 421 248
Web page: http://www.nsseme.com/en/contact/?opt=lis&cat=contact
3. A Bio Tech Lab,
Address: Vojvode Putnika bb, Sremska Kamenica
Phone: + 381 21 489 3661
Web page: http://www.abiotechlab.com/
All three laboratories have accreditation for work from the National Accreditation Board of Serbia and
they are following the International Seed Testing Association (ISTA) proficiency testing on GMO.
Laboratory accreditation insures that the laboratory follows seed testing according to the requirements
of the ISTA regulations.
In 2001, Monsanto first obtained approval for contained use for Roundup Ready herbicide corn
(NK603) from the Ministry of Agriculture for a period of four years. Field trials of the RR corn took
place in two research institutes, the Maize Institute Zemun Polje, near Belgrade and the Institute for
Vegetables and Crops in Novi Sad. Field trials were conducted in accordance with Serbia?s
requirements for biotech contained use of GMO materials, i.e. confinement measures that included 200
meters isolation distance, four border rows and 14 days of temporal isolation. In May 2006, the Ministry
of Agriculture granted Monsanto an approval to continue its RR corn field trials for another year. In
2007, the National Biosafety Committee and the Ministry of Agriculture did not grant Monsanto a
renewal to resume their RR corn field trials due to uncompleted application submitted by Monsanto. In
July 2009, Ministry of Agriculture issued to Monsanto a new approval for one year, but since the
approval was issued too late in the year, no RR corn field trails took place that year. In 2010 and 2011,
Monsanto did not require new approvals for RR corn field trials since it decided to put RR corn field
trails in Serbia on hold for the time being. Therefore, currently there is no foreign company in Serbia
engaged in biotech experimental research.
Section III. Plant Biotechnology Policy:
Law on Genetically Modified Organisms (GMO) was adopted by the Serbian Parliament in May 2009.
Law was published on 06/02/09 in the Official Gazette No.41/2009 and became effective from June 12,
2009. This law completely banned all trade and commercial cultivation of biotech products, or trade
with biotech products and products delivered from biotechnology and regulates basic conditions for the
use GMO in closed systems and deliberate release into the environment.
The current law regulates only conditions for the contained use, research activities and field trials of
biotech products under the strict control of the state. There is a strict and detailed application process for
obtaining a permit for GMO research. The application must provide all the necessary data on the
particular biotech event or biotech crop and stipulate parameters for safety procedures and measures. All
applications must be submitted to the Serbian Ministry of Agriculture for review and approval. Risk
assessments are evaluated by the Biosafety Expert Council, which is composed of representatives of
scientific research institutions in the fields of agriculture, ecological and biological science.
Since June 2009, Serbia was following the EU?s lead in most of the biotech issues. The Serbian
Government received negative comments on the new law from the European Union, since the law is not
in accordance with EU Directives and it does not include any regulations concerning trade, transport,
marketing, packaging, traceability and labeling of GMO products. When adopted, the new amended
GMO Law and other by-laws will be fully in accordance with EU Directives on biotechnology
2001/18/EC; No.1829/2003; No.1830/2003; No.65/2004 and No.641/2004.
Four by-laws (Rulebooks) that were adopted in 2002 are still in effect (of which number 3. and 4. are
not in use with the current law, but will be once the law gets amended).
Rulebooks that are still valid are:
1. Rulebook on ?Contained use of genetically modified organisms?, No.1244/1 issued November
2. Rulebook on ?Regulation on the content and data of products derived from GMOs?, No. 1669/1
issued December 15, 2002 (will be amended with new terminology after adoption of the
amendments to the current GMO Law)
3. Rulebook on ?Commercial release of ?GMOs? or products derived from same?, No.1245/1
issued November 13, 2002 (not used due to the new Law on GMO)
4. Rulebook on ?Deliberate release of biotech products into the environment?,
No.1246/1 issued November 13, 2002 (will be amended with the new terminology after
adoption of the amendments to the current GMO Law)
Following the adoption of the current Serbian GMO law, Ministry of Agriculture is planning to
implement regulations in the new rulebooks. After almost two years long pressure from representatives
of different countries, in December 2010 Serbia currently completed the work on preparing amendments
to the current very restrictive Law on GMO adopted in 2009. Serbian Government is not able to say
when the new amended GMO Law will be adopted by the Parliament. The amendments will allow to
import and to grow GMO crops and products but only under very strict control of the state. Amended
Law on GMO will represent general framework on biotechnology that will be fully harmonized with EU
regulations on biotechnology, while all specifics will be regulated by additional eight by-laws that
Serbia is planning to adopt in addition to already existing four by-laws.
List of additional by-laws that Serbia will need to adopt after changing current GMO Law in order to
harmonize its legislation on biotechnology with EU Directives:
? Regulation on the use of GMOs in closed systems (Directive 2009/41/EC);
? Regulation on deliberate release of GMOs into the environment (Directive 2001/18);
? Regulation on the placing on the market of GMOs and products of GMOs (Directive 2001/18,
Regulation 1829/2003, Regulation 1830/2003, Regulation 641/2004, Regulation 1946/2003);
? Regulation on labeling and traceability of GMOs and products of GMOs (Regulation 1830/2003,
? Regulation on the content and data of the Register of GMOs and products of GMOs;
? Regulation of the authorized laboratories (Commission Recommendation 2004/787/EC),
? Regulation of confidential information;
? Regulations for the handling, packaging and transport of GMOs and GMO products.
Current GMO Law regulates the work of the Biosafety Expert Council (before known as National
Biosafety Committee), the network of National Laboratories responsible for analysis of biotech events,
and defines the role of the Institutional Biosafety Committee (IBC). Serbia is a party to the Convention
on Biological Diversity, ratified in 2002 and the Cartagena Protocol on Biosafety has been accepted by
Serbia since May 2006. According to Serbia?s obligations under the protocol, it must create a Biosafety
Clearing House (BCH) consisting of a national database to keep record of all biotech trials, production
and trade activities of GMO in the country.
Serbia is currently a member of the CODEX Alimentarius; the European Plant Protection Organization
(EPPO), the Convention of Biodiversity (CBD); the International Union for the Protection of the new
Varieties of Plants (UPOV); the World Intellectual Property Organization (WIPO); the European
Cooperative Program for Crop Genetic Resources Networks (ECP/GR); and is a signatory of the Aarhus
Convention and the International Plant Protection Convention.
The Ministry for Agriculture, Forestry and Water Management is the competent authority responsible
for all GMO issues in Serbia. The Ministry deals with all contained use of GMOs and is the focal point
for Cartagena Protocol; Biosafety Clearing House; plant varieties registration and protection; genetic
resources and accreditation of laboratories. The Agricultural Ministry is also responsible for appointing
members of the Biosafety Expert Council.
Contact information for GMO issues at the Ministry of Agriculture is:
Mrs. Vanja Kojic
Address: 1, Omladinskih brigade street
Phone: + 381 11 311 75 91
Fax: + 381 11 311 70 94
The Ministry of Agriculture supervises the application of the GMO law and its subsequent regulations
through a system of Republic Inspectors. It manages all phytosanitary inspectorates and quality control
of food and feed production. It is also responsible for financing research projects in the fields of
agriculture and protection of genetic resources.
Section IV. Plant Biotechnology Marketing Issues:
Marketing or promoting GMO food does not exist in Serbia. There is a strong negative public attitude
towards the acceptance of biotech crops or products derived from GMOs. With the adoption of GMO
Law in 2009, the Ministry of Agriculture in Serbia openly expressed their attitude against GMOs.
Consumer awareness of GMO and public discussions of biotechnology related issues are very limited.
During 2009 and 2010, Serbian officials continued to strongly promote a campaign in the Serbian
Province of Vojvodina, for creation of this region known as the Serbian ?bread-basket? as a GMO-free
region. The government is also encouraging a GMO-free Serbian agriculture and in favor of a strict
control over GMO production, reaching some of the potential EU markets for non-GMO and organic
products. As a result of this campaign and strong support to domestic soybean crushing capacities
dealing only with non-GMO soybeans, the Ministry of Agriculture decided to adopt the 2009 GMO
Law completely bans any growing or trading of GMOs.
The last media anti-GMO campaign in Serbia started in the beginning of January 2011. Anti-GMO
campaign was present on almost daily bases in the most popular daily newspapers and shows on
national TV stations in Serbia. Campaign included different agriculture experts, journalists, professors
and government officials presenting modern biotechnology in a very negative way. Also, U.S. company
?Monsanto? was very often accused through media in the past for illegal introduction of GMO soybeans
and corn seeds to the Serbian farmers.
Concerning marketing of non-GMO, the Ministry of Agriculture is supporting local soybean producers
and soybean crushing plants to promote Serbia as a non-biotech soybean producer and support the
notion that Serbian producers can realize higher profits through marketing non-biotech crops. Several
Serbian crushing plants have long-term contracts with EU buyers to export non-GMO soybean meal and
products. Serbian soybean producers are receiving production subsidies of 14,000 dinars/HA (200
USD/Ha) as a state assistance for purchasing seeds, fertilizers and diesel.
Section V. Plant Biotechnology Capacity Building and Outreach:
In the past there were several technical assistance and capacity building activities provided in the areas
of biotechnology and biosafety areas by various international donors in Serbia. These included
OCBD/USDA, the United Nations Environment Program (UNEP) and the EU (The Netherlands). The
UNEP technical assistance activities focused mostly on providing support in the areas of risk
assessment, risk management and establishing a Biosafety Clearing House. The Netherlands? activities
were mainly focused on conducting workshops and training in the area of biosafety.
USDA has been assisting Serbia to develop its capacities in the research and regulations of agricultural
biotechnology since 2001. Through numerous seminars, workshops, and field visits (in the U.S. and
Serbia) OCBD experts have been training participants to critically examine technical and economic
aspects of biotechnology policies and pursue strategies to optimize their implementation. USDA biotech
activities were also assisting Serbian scientists to design and conduct field trials of genetically modified
crops (e.g., insect resistant maize, disease resistant plum) and utilize molecular genetics for food safety
In addition, USDA has been providing technical assistance in establishing biosafety councils at key
agricultural research institutions in Serbia in response to increased interest in establishing internal
bodies to provide guidance on carrying out biotech activities. The initiative to establish a biosafety
council was a result of cooperative efforts between USDA experts and the Serbian National Biosafety
Council (NBC). The following is a summary of USDA/OCBD recent activities in Serbia.
Previous USDA activities in supporting Biotechnology in Serbia:
As part of OCBD activities, USDA consultant visited Belgrade two times in FY2010 in order to
continue to work with Serbian officials on amending current GMO Law. Serbian side expressed their
strong interest to communicate with the U.S. experts regarding finalizing amendments to the current
GMO law. With assistance to USDA consultant Serbian biotech experts in Working Group drafted new
proposed amendments on current GMO Law in December 2010.
Public Diplomacy Program ?Biotech Outreach Strategy?
Through State Department ?Biotech Outreach Strategy? program in 2010 FAS Office organized a visit
to Serbia for biotech speaker Professor Martina McGloughlin from University of California Davis.
Though this program Professor McGloughlin gave presentations on topics ?Modern Trends in
Biotechnology? and ?Environmental Impacts of Biotechnology? at Agriculture Faculties in Zemun and
Novi Sad. Three Biotech Roundtables were organized at the Institute for Biological Research, Institute
for Crops and Vegetables and Expert Biosafety Council of Serbia and number of meetings were held
with Serbian Government officials responsible for biotechnology legislation. In addition to these events
Professor McGloughlin gave interviews to two national TV stations and daily newspapers that brought
up significant interest of the scientific community in Serbia. The purpose of this program was to initiate
discussion about agriculture biotechnology trends and to reach media, government officials, food
industry, agriculture faculties and scientists in order to create more favorable environment for pro-
Possible future activities:
After changing a Law on GMO, Serbia will need significant expertise in various fields relevant to
biosafety. More emphasis will be needed on training in risk assessment for commercial approval of
transgenic plants; on collaborative efforts of education and training activities that link biosafety to
biodiversity; environmental and health issues, e.g. biological, social, legal, and medical aspects. These
programs should be tailored to specific needs, particularly in the area of risk assessment and public
participation in biotech issues in Serbia.
Section VI. Animal Biotechnology:
Genetic engineering and/or cloning are not used in Serbia for the development of agriculturally-relevant
animals. Serbia does not have in place any legislation related to the development, commercial use
and/or import of these animals or products.
Section VII. Author Defined:
REFERENCES AND RELATED NATIONAL WEB LINKS
The full text of the current Serbian Law on GMO is attached. The full text of four existing by-laws is
also available at the FAS Office Belgrade, Serbia: Phone: + 381 11 306 4802; Fax: + 381 11 306 4922,
Ministry for Agriculture, Trade, Forestry and Water Management
Ministry for Science and Technological Development
Ministry of Environment and Spatial Planning
Serbian Environmental Protection Agency
Ministry for Health
Institute for Field and Vegetable Crops, Novi Sad
Maize Research Institute, Zemun Polje
Institute for Molecular Genetics and Genetic Engineering
Institute for Biological Research?Sini?a Stankovi??
Faculty of Agriculture, University of Novi Sad
Faculty of Biology, Belgrade University
Faculty of Agriculture, Belgrade University
Fruit Research Institute ?a?ak