Serbia. Agricultural Biotechnology Annual. July 2015 July 20, 2015
Serbia has not yet adopted the changes to the current Law on Genetically Modified Organisms ("GMOs") that would make it World Trade Organization (WTO) compliant, despite strong engagement by the European Union (EU), the United States, and other WTO members. The current "Law on GMOs" strictly prohibits the importation, production, or commercial growing of genetically engineered crops. When adopted, the new "Law on GMOs" will represent the general framework for biotechnology in Serbia and would also create a mechanism for genetically engineered (GE) crops and products to be reviewed by the government for consideration to import and cultivation. The restrictive Law continues to be one of the main obstacles to Serbia's accession to the WTO. The European Commission's Progress Report for 2014, specifically noted that Serbia needs to align its agricultural biotechnology legislation with the EU's legislation to enable WTO accession.
Under the Law on Genetically Modifies Organisms ("GMOs") adopted in 2009, Serbia strictly prohibits all imports, production, and commercial growing of genetically engineered (GE) crops or products containing GE traits. This law does not provide a mechanism to review applications to cultivate or sell GE products and represents one of the main obstacles to Serbia's World Trade Organization (WTO) accession process.
Since the adoption of the restrictive law, Serbia has been considering potential amendments to make the law WTO compliant. Namely, it would create a mechanism that would allow for a scientific risk assessment of applications to import or grow GE crops and products. The current proposal being considered would establish a general framework for regulating biotechnology and adopt several by-laws to cover the use of GE products in closed systems, the placing of GE products on the market, labeling and traceability, authorized laboratories, packaging, transportation, and other related issues. There also would be some changes in terminology to the four existing by-laws.
As a result of repeated interventions from the European Union (EU), the United States , and other WTO members during the last several years, Serbian trade and agriculture officials recognize the international trade issues caused by the restrictive 2009 agricultural biotechnology Law, but have yet to change the problematic provisions. It is expected that, when adopted, the new amended "Law on GMOs" and other by-laws will be fully harmonized with the EU Directive 2001/18/EC on Biotechnology and the Amendments to Directive 412/2015 adopted in March 11, 2015. The amended "Law on GMOs" is expected to allow the import and cultivation of GE crops and products, but only under very strict control of the State. It will be a general framework law on biotechnology in Serbia and all the specifics will be provided in additional by-laws that will be adopted immediately after passing the amended "Law on GMOs". The additional by-laws will cover such topics as the use of GE products in closed systems, the placing of products derived from agricultural biotechnology on the market, labeling and traceability, and authorized laboratories. In addition to those new by-laws, there will be some changes in terminology in the already existing four by-laws.
There has been strong political resistance to make any changes to the current "Law on GMOs".
According to the Serbian Organic Association, over 100 Serbian cities and municipalities have signed the so called "Declaration on GMOs" calling for a ban on GE products in their municipalities. In January 2013, Serbia signed the "Danube Soya Association" promoting non-GE soy cultivation and processing in the Danube region of Europe. "Danube Soya Association" is an international non-profit association based in Vienna, Austria which was founded in 2012, whose main members are farmers, agricultural traders, feed companies, major retailers, and green organizations. Association's intention is to promote sustained GE-free soya bean cultivation in Europe. Also during the last few years, a number of new civil society groups have appeared sponsoring anti-GE crop campaigns. The number of public events and the level of media coverage on the agricultural biotechnology issue have increased over the last 3-4 years. However, agricultural biotechnology remains extremely unpopular in Serbia – and it is this angle that is typically covered by the press. Several political organizations on the extremes of the political spectrum have also taken up the issue of genetic engineering, hoping to use it to fuel anti-EU and U.S. sentiments. Both the Green Party and right-wing groups are vocal opponents of lifting the current ban on GE products and crops.
According to the European Commission's Progress Report for 2014, there has been limited progress in the area of Chapter 12 (food safety, veterinary and phytosanitary policy). The European Commission especially emphasized the Serbian need to align its GE legislation with the EU's legislation to enable WTO accession.
Serbia's agriculture experts believe that the country's competitive advantage will be realized by seeking a premium for high quality "natural" or "organic" products rather than competing on volume. Thus, there is a concern about the potential market consequences of adopting pro-GE policies as well as a strong bias against GE products as somehow being "unnatural." Additionally, Serbian politicians and the general public remain misinformed about GE products and view them as potentially dangerous.
Marketing or promotion of GE food does not exist in Serbia. There is a strong, negative public attitude towards the acceptance of GE crops and products derived from GE crops. Consumer awareness of genetic engineering is very low and public discussions of biotechnology related issues are very limited. Currently there is no foreign company in Serbia engaged in GE experimental research.
The U.S. Department of Agriculture (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/Foreign Agricultural Service (FAS) has trained Serbian participants to critically examine the technical and economic aspects of biotechnology policies and pursue strategies to optimize their implementation. Activities on agricultural biotechnology included also the assistance to Serbian scientists in designing and conducting field trials of genetically modified crops. Since mid-2009 until the end of 2010, USDA technical assistance targeted assisting Serbian agricultural biotechnology experts in preparing amendments to the "Law on GMOs". During 2012 and 2013, FAS Belgrade organized two visits of biotechnology speakers to Serbia, as a part of the State Department's Program "Biotech Outreach Strategy," in order to improve the understanding of agricultural biotechnology issues among Serbian policy makers and the public.
Plant and Animal Biotechnology
CHAPTER 1: PLANT BIOTECHNOLOGY
Part A: Production and Trade
a) PRODUCT DEVELOPMENT: In Serbia, there are no GE crops under development.
b) COMMERCIAL PRODUCTION: Serbia does not commercially cultivate any GE crops.
c) EXPORTS: Serbia does not export GE crops.
d) IMPORTS: Imports of GE crops are not allowed. While there is no mechanism to approve GE crops, there is a framework for doing research work, which is governed by a strict application and monitoring process. Currently there are no GE field trials being conducted. However, in theory, permits for research work and contained use of GE materials can be obtained from the Serbian Ministry of Agriculture and Environmental Protection after the State's regulatory requirements have been met. Prior to the adoption of the current "Law on GMOs" in 2009, Serbia imported soybean meal which contained approved Roundup Ready™ soybeans. Imported quantities reached 70,000-100,000 metric tons annually, valued at $40-60 million.
e) FOOD AID RECIPIENT COUNTRIES: Serbia is not a food aid recipient country.
Part B: Policy
a) REGULATORY FRAMEWORK: The Serbian Parliament adopted the current "Law on GMOs" in May 2009. This Law, which was published in Official Gazette No.41/2009, went into effect on June 12, 2009 and it completely bans the trade and commercial cultivation of GE products. The law does not provide any mechanism to conduct a transparent science based risk assessment process. Reportedly the Ministry of Agriculture and Environmental Protection has drafted a revision to the "Law on GMOs" that incorporates the suggestions from the United States and the EU to make it more WTO compliant. Namely, it would create a mechanism for a risk assessment of applications to import or grow GE crops and products. The new Law will establish the general framework for regulating biotechnology in Serbia and then there will be specific by-laws to cover the use of GE products in closed systems, the placing of GE products on the market, labeling and traceability, trans-border movement, sampling, authorized laboratories, packaging, transportation and other related issues. In addition to these new by-laws, there will be some changes in terminology to the four existing by-laws. The four by-laws (Rulebooks) that were adopted in 2002 are still in effect, although some of the provisions are not in use under the 2009 law, but will become active again once the law is amended.
The following are the Rulebooks that are still valid:
- Rulebook on "Contained use of genetically modified organisms", No.1244/1 issued November 13, 2002;
- Rulebook on "Regulation on the content and data of products derived from GMOs", No. 1669/1 issued December 15, 2002 (will be amended with new terminology after adoption of the new "GMO" Law);
- Rulebook on "Commercial release of 'GMOs' or products derived from same", No.1245/1 issued November 13, 2002 (not used due to the current "Law on GMOs");
- 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 new "Law on GMOs").
The Serbian Ministry of Agriculture and Environmental Protection needs to prepare a final up-dated version of the new "Law on GMOs" for review and approval by Serbia's 18-member National Biosafety Council. After the Council Review, the final version of the law must be approved by the Serbian Minister of Agriculture and Environmental Protection and adopted by the Serbian Parliament. Once adopted, the Ministry of Agriculture and Environmental Protection would implement the following by-laws:
- Regulation on the use of "GMOs" in closed systems;
- Regulation on deliberate release of "GMOs" into the environment;
- Regulation on the placing on the market of "GMOs" and products of "GMOs";
- Regulation on labeling and traceability of "GMOs" and products of "GMOs";
- Regulation on the content and data of the Register of "GMOs" and products of "GMOs";
- Regulation on authorized laboratories;
- Regulation on the handling, packaging and transport of "GMOs" and "GMO" products;
- Regulation on trans-border movement of "GMOs" and products of "GMOs";
- Regulation on sampling of "GMOs" and products of "GMOs";
The Ministry for Agriculture and Environmental Protection is the competent authority responsible for all agricultural biotechnology issues in Serbia. The Ministry deals with all contained use of GE plants and is the focal point for the Cartagena Protocol, Biosafety Clearing House, plant varieties registration and protection, genetic resources, and accreditation of laboratories. The Agricultural Ministry and Environmental Protection is also responsible for appointing members to the Biosafety Expert Council.
The Ministry of Agriculture and Environmental Protection supervises the application of the "Law on GMOs" and its subsequent regulations through a national inspectorate. It manages all phytosanitary inspectorates and quality control of food and feed production. It also is responsible for financing research projects in the fields of agriculture and the protection of plant genetic resources.
b) APPROVALS: The current law regulates only conditions for the contained use, research activities, and field trials of GE products under the strict control of the state. There is a strict and detailed application process for obtaining a permit for research using genetic engineering. The application must provide all the necessary data on the particular GE event or GE crop and stipulate parameters for safety procedures and measures. All applications must be submitted to the Serbian Ministry of Agriculture and Environmental Protection for review and approval. Risk assessments are evaluated by the Biosafety Expert Council, which is composed of representatives from the scientific research institutions in the fields of agriculture, ecological, and biological science. The applicant must submit to the Ministry of Agriculture and Environmental Protection any renewal requests six months prior to the expiry of the original approval.
c) FIELD TESTING: The application for field-testing must be submitted to the Serbian Ministry of Agriculture and Environmental Protection for review and approval. Risk assessments are evaluated by the Biosafety Expert Council. The application must provide all the necessary data on the particular GE event or GE crop and stipulate the safety procedure parameters and measures.
d) STACKED EVENT APPROVALS: No stacked event approvals have been issued by the Serbian Ministry of Agriculture and Environmental Protection. Furthermore, it is expected that even with amendments to the current "Law on GMOs," each GE event would have to be approved individually.
e) ADDITIONAL REQUIREMENTS: N/A
f) COEXISTANCE: Serbia does not have a coexistence policy; it has a strict ban on planting GE crops. However, a coexistence policy is planned to be incorporated into the new changed Law on GMOs."
g) LABELING AND TRACEABILITY: Under the current "Law on GMOs," labeling and traceability are not defined. Once the "Law on GMOs" is changed, the Ministry of Agriculture and Environmental Protection plans to adopt a separate Regulation on the labeling and traceability of GE crops and products of agricultural biotechnology, per EU Regulation 1830/2003 and Regulation 65/2004.
h) TRADE BARRIERS: The current "Law on GMOs" adopted in 2009 is a major trade barrier as it strictly prohibits all imports, production, and commercial growing of GE crops or products containing GE traits. The ban does not provide any mechanism for future products to be reviewed as there is no transparent science based risk assessment/approval process.
i) INTELLECTUAL PROPERTY RIGHTS (IPR): Although Serbia is not yet a WTO member, the legal regime for Intellectual Property Rights (IPR) protection has improved substantially in recent years as Serbia has revised laws to meet the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) standards. The TRIPS Agreement is a multilateral WTO Agreement and, as such, applicable to all 147 members of the WTO. It is also binding for every country that accedes to the WTO. The Agreement's general obligations require countries to apply the principles of national treatment (same treatment of foreign title holders and domestic title holders) and most favored nation treatment (same treatment of foreign title holders regardless of their country of origin). TRIPS sets minimum standards of protection with respect to all forms of intellectual property: copyright, trademarks and service marks, geographical indications, industrial designs, patents, layout designs of integrated circuits, and trade secrets. Intellectual property rights (IPR) in Serbia are treated in a series of laws, as follows: The Law on Copyright and Related Rights (2009), The Law on Patents (2004), The Law on Trademarks (2009) and the Law on Geographical Indications (2010).
j) CARTAGENA PROTOCOL RATIFICATION: Serbia is a party to the Convention on Biological Diversity, ratified in 2002, and ratified the Cartagena Protocol on Biosafety in 2006. According to Serbia's obligations under the protocol, it must create a Biosafety Clearing House (BCH) consisting of a national database keeping record of all GE trials, production, and trade activities in the country.
k) INTERNATIONAL TREATIES/FORA: Serbia is currently a member of Codex Alimentarius, the European Plant Protection Organization (EPPO), the Convention on 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 (IPPC).
l) RELATED ISSUES: N/A
m) MONITORING AND TESTING: In Serbia, the responsibility for monitoring and testing of GE food, feed, and seeds falls under the Ministry of Agriculture and Environmental Protection, as defined by the "Law on GMOs" and the Food Safety Law. Serbia's phytosanitary inspectors are instructed to carry out surveillance of possible unauthorized imports of GE crops or products at the border and the internal inspectors from the Ministry of Agriculture and Environmental Protection control what is planted in the fields. The phytosanitary inspectors use "Reveal for CP4" test strips to test for Roundup Ready™ soybeans and apply herbicides to small test areas in soybean fields to determine if any illegal GE soybeans have been planted.
During 2014, the Serbian Phytosanitary Inspectorate of the Ministry of Agriculture and Environmental Protection inspected approximately 1,600 plots or approximately 50 Ha of land with soybeans. Inspectorate detected 45 soybean samples that were GE out of a total of 49 samples taken from 1,600 plots. The largest number of GE soybean plots was located in parts of Mačva, South Bačka and Srem (Vojvodina). The GE soybeans were destroyed or removed from the field and the farmers were fined according to the current "Law on GMOs" (30,000-50,000 dinars or USD$ 273-455) for the deliberate release into the environment without obtaining an approval.
n) LOW LEVEL PRESENCE POLICY: According to the current "Law on GMOs", agricultural products of non-animal origin are considered "genetically modified organisms" when they exceed a 0.9% threshold for genetically "modified" (engineered) content. For seeds and reproductive material, the threshold is 0.1%.
PART C: Marketing
a) MARKET ACCEPTANCE: Serbian agricultural experts believe that Serbia's competitive advantage depends on seeking a premium for high quality "natural" or "organic" products rather than competing on volume. Thus, there is a concern about the potential market consequences of adopting pro-agricultural biotechnology policies as well as a strong bias against genetically engineered products as somehow being "unnatural". Over the past several years, the profile of the issue has been raised and it is now a topic for debate amongst politicians, scientists, farmers, and industry representatives as well as the media. Generally, there appears to be a negative attitude towards the acceptance of GE crops in most of the social media outlets, although consumer awareness of GE products and public discussion of biotechnology related issues is fairly limited. The Ministry of Agriculture and Environmental Protection is keen to promote Serbia's non-GE and organic production and has done little to dispel any misinformation about agricultural biotechnology and EU approved GE events. Several Serbian crushing facilities have long-term contracts with EU buyers to export non-GE soybeans and products.
In 2015, the Ministry of Agriculture and Environmental Protection will continue to offer a 12,000 dinars/hectare (Ha) (USD 110/Ha) subsidy, of which 6,000 dinars/Ha (USD 54/Ha) is for fuel, certified planting seeds, and fertilizers, while the remaining 6,000 dinars/Ha (USD 54/Ha) is for direct payments. The Ministry of Agriculture and Environmental Protection has limited the payments to smaller agricultural concerns by reducing the maximum eligible farm size from 100 Ha to only 20 Ha. Also, farmers that lease State owned agricultural land are not entitled to State subsidies.
The planted area to non-GE soybeans in marketing year (MY) 2014/15 was 180,000 Ha. With an average yield of 2.4 metric tons (MT)/Ha, total production of soybeans in MY 2014/15 was approximately 430,000 MT. During 2014, Serbia's soybean exports totaled 17,100 MT, while imports reached approximately 32,000 MT. Serbia mostly exports to neighboring and EU countries such as Bosnia (4,630 MT), Hungary (3,827 MT), Belgium (3,569 MT), Italy (2,561), Macedonia (866 MT), Romania (541 MT), etc. For the last three years, Serbian soybean exporters have been able to secure official certificates from the Serbian Ministry of Agriculture and Environmental Protection that the "Law on GMOs" banning all commercial growing, trade and transit of GE varieties in Serbia has been implemented. With this official confirmation, Serbian exporters have been able to secure a premium for their non-GE crops and be more competitive internationally.
b) PUBLIC/PRIVATE OPINIONS: Serbian politicians and the general public remain misinformed about GE products and view them as potentially dangerous. Public opinion is generally negative towards biotechnology as there have not been any systematic attempts by the government to educate consumers. The media consistently chooses to reinforce negative perceptions rather than report on technological advances. The issue has proven to be too politically charged, so that even politicians in favor of innovation do not take a public stance. Grain farmer and trader organizations are not united on the issue, as there is both an import and export interest involved. Serbian researchers are well educated and are not anti-agricultural bioechnology, but are not active in passing these messages to the general public. Serbian livestock and poultry farmers are aware of the fact that with the adoption of 2009 "Law on GMOs," Serbia blocked all GE soybean meal imports for cattle feed resulting in a significant increase in feed prices. Livestock farmers and cattle feed producers are eager to buy EU approved GE soybean meal from Argentina, Brazil or the United States to reduce input costs. However, Serbian consumers continue to reject biotechnology publicly in the erroneous belief that domestic production is effectively "organic."
Several mayors have adopted a "Declaration on 'GMOs'" and designated their territories as GE-free. Also during the last few years, a number of new civil society groups have appeared sponsoring anti-GE crop campaigns. The number of public events and the level of media coverage on the agricultural biotechnology issue have increased over the last 3-4 years. However, GE products remain extremely unpopular in Serbia – and it is this angle that is typically covered by the press. Several political organizations on the extremes of the political spectrum have also taken up the GE issue, hoping to use it to fuel anti-EU and anti-United States sentiments. Both the Green Party and right-wing groups are vocal opponents of lifting the current ban on products from agricultural biotechnology.
In 2013, Serbia officially supported the "Danube Soya Association". "Danube Soya Association" is an international non-profit association based in Vienna, Austria which was founded in 2012, whose main members are farmers, agricultural traders, feed companies, major retailers, and green organizations. Association's intention is to promote sustained non-GE soybean cultivation in Europe. "Danube Soya Association" opened representational office in Serbia and is active in organizing different events in promoting production of non-GE soybeans and products. The most recent event in Serbia was organized together with the domestic company, owner of the major soybean crushing facility in Serbia and with different seed companies present in the Serbian market. The purpose of the event was to promote non-GE varieties of soybeans to the Serbian Farmers Associations and to encourage production in accordance with the "GMO Free" standards.
c) MARKET STUDIES: There are several reports published by international organizations that include Serbia in their analysis, such as the West Balkan Research Center and the International Service for the Acquisition of Agri-biotech Applications.
PART D: Capacity Building and Outreach
a) ACTIVITIES: The U.S. Department of Agriculture has provided extensive technical assistance in the area of agricultural production and some of this has included developing Serbia's research capabilities and regulatory oversight. The Office of Capacity Building and Development (OCBD), a part of USDA/FAS, has trained Serbian participants to critically examine the technical and economic aspects of crop production and how to optimize the various tools available to increase yields, including integrated pest management, good agricultural practices and biotechnology.
In May 2013, the North American Export Grain Association (NAEGA) hosted a speaker at two feed events in Serbia. The topics were best practices in grain production, biotechnology legislation in the United States and the EU, and how to manage mycotoxins. The expert explained the importance of adopting internationally recognized science-based standards that foster innovation and trade.
In April 2013, five Serbian experts participated in an "Open World" program on genetic engineering research and legislation. "Open World" programs provide an opportunity for countries to exchange views on a particular theme. The team visited Washington D.C. and Tulsa, OK.
In September 2012, the US Embassy sponsored two speakers - Dr. Ralph Scorza, USDA/Agriculture Research Service (ARS) plant breeding scientist and Victor Felix Nicolescu, member of Romania's National Sanitary, Veterinary and Food Safety Authority to discuss United States and and EU biotechnology regulatory frameworks. Dr Scorza also described his research on a GE plum resistant to the Sharka (plum pox).
b) STRATEGIES AND NEEDS: The lack of awareness concerning agricultural biotechnology and its potential is significant. Activities should encourage a scientific discussion of the technology in an environment that would generate media coverage. Not only do key decision makers and the public need to be better informed, but an opportunity needs to be created for Serbian scientists to take a public stance and help deliver the message that biotechnology is an important tool for innovation. Journalists also need to have access to reliable scientific information and the opportunity to learn more about the issue, in order not to contribute to the misinformation being circulated by some of the social media outlets.
CHAPTER 2: ANIMAL BIOTECHNOLOGY
Cloning is an animal biotechnology that developers frequently utilize in conjunction with other animal biotechnologies such as genetic engineering and therefore included in this report. Animal genetic engineering results in the modification of an animal's deoxyribonucleic acid (DNA) to introduce new traits and change one or more characteristics of the animal. Animal cloning is an assisted reproductive technology and does not modify the animal's DNA. Cloning is therefore different from the genetic engineering of animals (both in the science and often in the regulation of the technology and/or products derived from it).
PART E: Production and Trade
a) BIOTECHNOLOGY PRODUCT DEVELOPMENT: According to the Serbian Ministry of
Agriculture and Environmental Protection, no applications have been submitted to conduct research in this area.
b) COMMERCIAL PRODUCTION: There are no livestock clones or other GE animals (including fish, birds, insects, mammals) or GE genetics being used in commercial production in Serbia.
c) BIOTECHNOLOGY EXPORTS: N/A
d) BIOTECHNOLOGY IMPORTS: Imports of GE animals are not allowed. There is no mechanism to approve GE animals even for doing research work in Serbia. Permits for research work and/or for the commercial use of GE animals cannot be obtain, as there is no legal framework regulating these animals or genetic materials. It is not known what genetic materials have been imported.
PART F: Policy
a) REGULATION: The institutions listed under Plant Biotechnology have the same responsibilities relating to Animal Biotechnology.
b) LABELING AND TRACEABILITY: There are no laws or regulations covering animal biotechnology nor do they appear to be envisioned in the amendments to the "GMO" law currently being considered.
c) TRADE BARRIERS: No country-specific legislation.
d) INTELLECTUAL PROPETRY RIGHTS (IPR): Please see Plant Biotechnology Chapter.
e) INTERNATIONAL TREATIES/FORA: Serbia is a member of Codex Alimentarius (Codex) and the World Organization for Animal Health (OIE).
PART G: Marketing
a) MARKET ACCEPTANCE: Currently no GE imports are permitted and no applications have been made to do research. However, with current public perceptions about biotechnology, it is likely that animal biotechnology would have a difficult time with market acceptance.
b) PUBLIC/PRIVATE OPINIONS: Generally unfavorable
c) MARKETING STUDIES: N/A
PART H: Capacity Building and Outreach
a) ACTIVITIES: The focus has been on encouraging Serbia to work with WTO recognized standard setting bodies, like the OIE and Codex, to adopt transparent norms that facilitate trade and are consistent with a science-based system for assessing risk/approving new technologies.
b) STRATEGIES AND NEEDS: The United States will continue to focus on working with Serbia to adopt internationally recognized transparent standards that facilitate trade and are WTO compliant and consistent with a science-based system for assessing risk/approving new technologies. Serbia's scientific community needs to have access to peer reviewed recognized scientific information and Serbia's media needs to be better informed and base its reporting on credible information obtained from reliable sources.