Required Report - public distribution

**Date:** 7/12/2006

**GAIN Report Number:** SR6007

SR6007

**Serbia**

**Biotechnology**

**Agriculture Biotechnology Report Annual**

**2006**

**Approved by:**

![](media/image1.wmf)Hassan F. Ahmed

U.S. Embassy

**Prepared by:**

Tatjana Buric-Maslac

**Report Highlights:**

A new Serbian law on GMO is currently in the drafting and adoption
process. The new law would expand the areas and issues covered under the
existing law and simplify import procedures of approved biotech
products. Monsanto has obtained the Serbian governmental approval to
resume its field trials of RR corn for an additional four years. USDA
continues its technical assistance program in biotechnology to Serbia,
with a workshop on Bio-safety Enforcement and Compliance that is
scheduled in July 2006.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Belgrade \[YU1\]

\[SR\]

# 

#  Table of Contents

[EXECUTIVE SUMMARY 3](#executive-summary)

[BIOTECHNOLOGY POLICY 3](#biotechnology-policy)

[Laws and Regulations 3](#laws-and-regulations)

[Monitoring and Enforcement Authorities
4](#monitoring-and-enforcement-authorities)

[BIOTECHNOLOGY PRODUCTION AND TRADE
4](#biotechnology-production-and-trade)

[MARKETING 5](#marketing)

[CAPACITY BUILDING AND OUTREACH 6](#capacity-building-and-outreach)

[USDA/ICD activities in Serbia 6](#usdaicd-activities-in-serbia)

[Activities in 2006 6](#activities-in-2006)

[REFERENCE MATERIAL 7](#reference-material)

# 

# 

# EXECUTIVE SUMMARY 

Serbia is in the process of adopting a new law on GMO that will expand
the areas and issues covered under the current law. Under the proposed
new GMO law, the process of importing RR soybean meal for commercial
feed manufacturing in Serbia will be simplified. A permit for joint
scientific research activities conducted by Monsanto with local seed
institutes on transgenic corn has been renewed in May 2006 by the
Serbian Ministry of Agriculture following last year's interruption of
activities. USDA trade capacity building activities in the biotechnology
area under ICD technical assistance programs in Serbia continue with a
Bio-safety Enforcement and Compliance workshop scheduled to take place
in July 2006.

# BIOTECHNOLOGY POLICY

## Laws and Regulations

The current Serbia law that governs Genetically Modified Organisms (GMO)
was adopted in 2001 and followed by implementing regulations in five
Rule Books issued in 2002 and 2003. The implementation of the law has
been designed to follow the GMO regulations in the European Union (EU)
in accordance with EU directives 90/220 and 90/219. These five rulebooks
are:

-   Rulebook on "Commercial release of 'GMOs' or products derived from
    same", No.1245/1 issued November 13, 2002

-   Rulebook on "Contained use of genetically modified organisms",
    No.1244/1 issued November 13, 2002

-   Rulebook on "Deliberate release of biotech products into the
    environment", No.1246/1 issued November 13, 2002

-   Rulebook on "Regulation on the content and data of products derived
    from GMOs", No. 1669/1 issued December 15, 2002

-   Rulebook on "Labeling of genetically modified products", No.16/18
    issued February 27, 2003

The current Serbian law on GMO allows research activities and use of
biotech products under the strict control of the state. There is a
strict and detailed application process for obtaining GMO event or
research permit. 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 conducted by the National Biosafety Committee, which is
composed of representatives of scientific research institutions in the
fields of agriculture, ecological and biological science. Following the
risk assessment and the scientific recommendation of the Biosafety
Committee, the Ministry of Agriculture, as the administrative authority
in charge, must issue a decree on the specific biotech event. Every
application is evaluated on a case-by-case basis.

Recently, a committee of Serbian biotech experts has completed its work
on a draft of a new GMO law. The legal department of the Agricultural
Ministry is currently reviewing the draft of the new law. Following the
approval by its legal department, the draft law will be submitted for a
30 day period of public comments, after which the Ministry will send the
draft law to the parliament for approval procedures that are expected to
take place in the fall of 2006. The new law on GMO will be expanded in
its regulations and will cover more issues than the existing law. There
will also be a large number of rule books (about 15 being drafted) to
explain the regulations of the new law. The new rulebooks will be
written in accordance with EU Regulations EC 2001/18, 1829/2003,
1830/2003, 1946/2003.

Besides the three areas of work covered by the existing GMO law (work
under contained use, deliberate use of biotech crops and marketing of
biotech events) the proposal of the new law will regulate trade on GMO
materials. It will stipulate procedures for internal and international
trade of biotech events, handling, transportation, packaging, transit,
traceability, labeling and processing of GMO materials. It will set up
conditions and measures for removal of potential risks from GMO,
supervision of the application under the existing law and its
regulations through the system of inspection service, definition of
responsibilities and fees for illegal use of GMO crops. The new law will
also regulate the work of the National Biosafety Committee and work of
the National Laboratories responsible for analysis of biotech events.

Serbia ratified the Cartagena Protocol on Biosafety in February 2006.
According to its obligations under the protocol it will create a
Biosafety Clearing House in Serbia consisting of a national database
that will keep record of all biotech trials, production and trade
activities in the country. The main objective of this Biosafety Clearing
House is to implement a traceability system for all biotech products
from production to consumption.

## Monitoring and Enforcement Authorities

The Serbian Ministry of Agriculture is the main administrative authority
in charge of monitoring biotechnology in Serbia. The contact information
at the Ministry of Agriculture is:

***Mrs. Vanja Kojic***,

Address: Omladinskih brigada 1/1^st^ floor/office #75,

11070 New Belgrade

Serbia

Phone: ++ 381 11 2604 457

Fax: ++ 381 11 3131 971

E-mail: <vanja.kojic@minpolj.sr.gov.yu>

The Serbian Ministry of Agriculture is authorized to supervise the
application of the GMO law and its subsequent regulations through a
system of Republic inspectors. These field inspectors control and take
samples at the border and inland for materials suspected to be of
biotech origin.

# BIOTECHNOLOGY PRODUCTION AND TRADE 

The law on GMO approved in 2001 is still applied in Serbia and currently
allows only for research and field tests of biotechnology crops. It does
not allow the commercial use of biotech crops. Permits for research
work, contained use and marketing of biotech materials can be obtained
by meeting the state's regulatory requirements.

At the present time, the only application approved in Serbia is for
commercial import of soybean meal from Roundup Ready (RR) soybeans. RR
soybeans for crushing or other commercial purpose are not allowed for
import. Due to high demand, Serbia continues to increase area planted
with non-GMO soybeans. In spring 2006, soybeans were planted on a record
high area of 166,605 HA, or 26,605 HA more than in the previous year.
With an expected average yield of 2 MT/HA Serbia could produce about
330,000 MT of soybeans. Despite the significant increase in soybeans
production in Serbia in the last few years, it has a constant deficit of
soybean meal and needs to import up to 120,000 MT annually, mostly
coming from Argentina and Brazil due to their price competitiveness over
U.S. soybean meal.

According to the existing law for import of GMO soybean meal into
Serbia, the importer must request an approval from the Ministry of
Agriculture. Under the new law, however, this import procedure will be
simplified and importers will no longer need to request an import permit
but will only be obliged to notify the Ministry of Agriculture when the
soybean meal shipment is imported into the country. In addition to
simplifying the import procedures, importers will no longer be charged
import administrative taxes. The Ministry of Agriculture will continue
to be the agency to be notified by the importers.

Apart from the RR soybean meal, there are no other biotechnology crops
or products that are permitted for import into Serbia. The government
inspectors at border posts are instructed to carry out surveillance of
possible unauthorized imports or introductions of biotech crops or
products, while internal phytosanitary inspectors control what is
planted on local fields. In 2005, the Ministry of Agriculture discovered
about 2,000 HA (7,800 MT) of GMO soybeans planted to individual plots
with soybean planting seeds that were illegally imported and sowed in
farms in the Macva region (Eastern Serbia near the Bosnian-Serbian
border). Under the current GMO law, these illegally planted areas of
soybeans must be destroyed. However, following a number of strong
protests by the farmers who planted the GMO soybeans, the Serbian
Ministry of Agriculture made an exception to the regulations. Farmers
were allowed to harvest and crush the transgenic crop with the
conditions that the products were only used for cattle feed under strict
supervision from the Ministry's inspection service.

Following last year's publicized GMO soybeans planting incident, the
Serbian Government announced that it will not allow this to happen again
and will not tolerate any violation of the law on GMO. The government
has reiterated that it will use the inspection service to identify and
destroy all fields planted with GMO crops. Actions taken by the
government against illegal growing of GMO soybeans during December 2005
to March 2006 included the confiscation of about 8,400 kg of GMO soybean
seeds by the plant inspection service in the Macva and Srem region. The
confiscated GMO soybean seeds were destroyed with highly publicized
media coverage event in April 2006. The soybean farmers in the Macva
area, who realized how profitable the GMO crop over growing non-GMO
conventional seeds, have asked the government to allow them to grow GMO
soybeans and formed an Association for GMO soybean producers in Bogatic,
Macva to defend their interest. The main goal of the Association is to
lobby for changing the Serbian legislations to allow for the production
and trade of biotech crops in Serbia.

Monsanto is the only foreign company involved in biotech experimental
research work in Serbia. Last year, Monsanto's biotech research permit
for joint field trials on Roundup Ready corn (NK603) with two local seed
institutes in Novi Sad and Zemun Polje was suspended by the National
Biosafety Committee. In May 2006, the Ministry of Agriculture granted
Monsanto the approval to resume its RR corn field trials for another
four years.

# MARKETING

A negative public attitude towards acceptance of biotech crops or
marketing of products derived from GMOs is strongly present in Serbia.
When the Ministry of Agriculture in 2005 discovered about 2,000 HA
planted with GMO soybeans, a large number of negative articles against
biotech crops were published in the Serbian press. Several soybean
crushing plants in Serbia have long-term contracts with EU buyers to
export non-GMO soybean meal and products. The Serbian Ministry of
Agriculture is supporting local crushing plants to promote Serbia as
non-biotech crop producers and support the notion that Serbian producers
can achieve higher profits through marketing non-biotech crops. The
Serbian government generally follows EU's lead in most of the biotech
issues, thus any future market for biotech events will depend, to large
extent, on EU decisions on growing and trading of transgenic crops.

# CAPACITY BUILDING AND OUTREACH

## USDA/ICD activities in Serbia

USDA has been assisting Serbia to develop its capacities in the research
and regulations of agricultural biotechnology. Through numerous
seminars, workshops and field visits, USDA/ICD has been training
participants in Serbia to critically examine technical and economic
aspects of biotechnology policies and pursue strategies to optimize
their implementation. In addition, ICD biotech activities are assisting
the 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 assessments.

With increased interest from major research institutions to establish
internal biosafety bodies that would provide guidance to their biotech
activities, USDA is providing further technical assistance in
establishing biosafety councils at key agricultural research
institutions in Serbia. This initiative to establish a biosafety council
resulted from cooperative work between U.S. experts and the Serbian
National Biosafety Council.

During 2005, FAS/ICD biotech activities in Serbia included two major
workshops with participation of government officials working on
biotechnology and the members of the National Biosafety Committee. In
February 2005, a workshop on management and safety procedures for
experimental work with genetically engineered crops was organized in
Banja Vrujici, Serbia. The workshop included a one-day seminar on
management of GMO field trials, application procedures for managing gene
flow, Confinement Analysis of Critical Control Points and application of
research safety guidelines. In May 2005, FAS/ICD conducted a workshop on
systematic approaches to biosafety testing, risk assessment and
monitoring that took place in Palic, Serbia. The workshop included
training to evaluate risk assessment data through a mock risk assessment
exercise, planning of subsequent monitoring, managing of confidential
business information and other measures to avoid conflict-of-interest in
the assessment process.

## Activities in 2006

In June 2006, a group of phytosanitary inspectors and Government
officials from Serbia visited the U.S. and attended training in lab,
greenhouse and field inspections. The training focused on compliance and
enforcement of biosafety regulations and guidelines for field-testing of
transgenic crops. In July 2006, USDA will organize a Workshop on
Biosafety Enforcement and Compliance in Novi Sad, Serbia, where local
scientists and field inspectors will participate in training exercises
on mock plots.

These USDA capacity building activities in the area of biotechnology
have been instrumental in promoting biotech cooperation between the U.S.
and Serbia and helped improve the understanding of the potential role of
biotech in increasing productivity and growth of Serbia's agriculture
sector.

# 

# 

# REFERENCE MATERIAL 

Relevant information can be found at the following web pages:

[www.minpolj.sr.gov.yu](http://www.minpolj.sr.gov.yu/) (Ministry of
Agriculture, Forestry and Water Management)

[www.zelenamreza.org.yu](http://www.zelenamreza.org.yu/) ("Green Network
of Vojvodina")

<http://www.unep.ch/biosafety/partcountries/YUcountrypage.htm> (UN
Environment Program - GEF/Biosafety Projects)

The full texts of Law on GMO and relevant Rulebooks in English are
available at the FAS Office Belgrade, Serbia: Phone: ++ 381 11 306 4802;
Fax: ++ 381 11 3064922;

E-mail: <tatjana.buric@usda.gov>