Agricultural Biotechnology Annual

An Expert's View about Crops and Support Services in Croatia

Posted on: 30 Jul 2012

Croatia is a net food importer and government policy is geared towards raising agricultural productivity and, to a lesser extent, limiting imports.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 6/15/2012 GAIN Report Number: HR1207 Croatia Agricultural Biotechnology Annual Update Approved By: James Dever Prepared By: Andreja Misir Report Highlights: Croatia is a net food importer and government policy is geared towards raising agricultural productivity and, to a lesser extent, limiting imports. EU membership is a priority for the Croatian government, and new laws and agricultural policies mirror those of the EU. The Croatian public remains very skeptical about agricultural biotechnology. There has also been a general demonization of U.S. food products as "Frankenstein Foods." In Croatia, several pieces of legislation have been introduced to regulate the importation and cultivation of biotech crops and foods. Section I. Executive Summary: Croatia is a net food importer. The primary goal of agricultural policy is to increase productivity, and to a lesser extent, limiting imports. EU membership is a priority for the Croatian government, and new laws and agricultural policies mirror those of the EU. The Croatian public remains very skeptical about agricultural biotechnology and consumers often consider U.S. food products to be “Frankenstein Foods.” In 2004, the government randomly tested samples of foodstuffs and seed taken from the market for biotech traces, which resulted in the withdrawal of some products due to improperly labeling of products containing biotech. The Croatian Government then penalized the importers. Several pieces of legislation regulate the importation and cultivation of biotech crops and foods. The laws regulating biotechnology include the Food Act and the Law on Genetically Modified Organisms. Additional important legal documents on biotechnology include Government Ordinances on GMO Levels in Products Under Which Products Placed on the Market Do Not Have to be Labeled as Products Containing GMO (Governmental Gazette 92/2008, Governmental Gazette 36/2009, Governmental Gazette 33/2010, Governmental Gazette 88/2011, and Governmental Gazette 39/2012). These ordinances list the biotech events that can be contained in a product in trace amounts. Section II. Plant Biotechnology Trade and Production: a. Croatia does not commercially produce biotech crops or seeds. b. Croatia is not developing any biotech crops. c. In Croatia there are no approved biotech crops for food or feed, but there is a 0.9% threshold level for biotech events in food and feed that are on the official list (Section III) of permitted GMO events (the list is created from the list of biotech events previously tested and licensed in the EU and was published in Croatia as Ordinance in 2008 with amendments in 2009, 2010, 2011 and 2012). If the biotech event is on the list and is present in the product up to 0.9%, it does not need to be labeled for sale on the Croatian market. However, if the biotech content is above 0.9%, the product must be labeled as GM. The biotech threshold level drops to 0.0% for biotech products that are not on the list of permitted events. The same applies to feed. Officially Croatia does not import biotech crops/products because GM labeling is mandatory and currently there are no GM labeled products on the market. d. Croatia is not a food aid recipient. e. Croatia does not produce any biotech crops developed outside of the United States or any biotech crops in general. Section III. Plant Biotechnology Policy: a. Agricultural biotechnology regulatory framework: The Food Act governs the possible importation, licensing, and labeling of any foods/feed containing biotech ingredients. Parliament approved the latest Food Act on April 25, 2007 and published in Government Gazette number 46 on May 7, 2007. This law outlines many regulations that would enable biotech products to enter the market and be labeled. Publication of many of those regulations was on hold until the approach of Croatian EU accession when many regulations had to be published. The four government ordinances regulate the labeling threshold for biotech content (“GMO Levels in Products Under Which Products Placed on the Market Do Not Have to be Labeled as Products Containing GMO”) passed on July 31, 2008, (Governmental Gazette 92/2008); March 18, 2009 (Governmental Gazette 36/2009); March 11, 2010 (Governmental Gazette 33/2010); April 2, 2011 (Governmental Gazette 88/2011); and March 2012 (Governmental Gazette 39/2012) (see section IIIbi for additional details). Penalties for companies violating the "novel food" provisions of the Food Law concerning placing novel foods on the market and/or labeling them range from HRK 100,000 to HRK 500,000($ 17,034 – $ 85,169), with responsible individuals fined from HRK 5,000 to HRK 10,000 ($ 852 – $ 1,703). The Law on Genetically Modified Organisms (Law on GMOs) is an overarching law for biotechnology. The Law on Genetically Modified Organisms (Governmental Gazette 70/2005, 137/2009) together with the Food Act and subsequent regulations regulate the importation, transshipment, production, usage, and sale of products of agricultural biotechnology (all food, feed, and seed). This Law established a testing and licensing regime that is very restrictive. The highest penalties for breaching the provisions of this Law range from HRK 500,000 to HRK 1,000,000 ($ 85,169 – $ 170,338) for the responsible company and from HRK 20,000 to HRK 70,000 ($ 3,407 - $ 11,924) for the responsible employee in the company. i. Responsible Ministries and Their Roles: Ministry of Science (MOS), Education and Sport: According to the Law on GMOs, the MOS is responsible for the limited and contained use of GMOs. Ministry of Health (MOH): According to the Food Act, the MOH is responsible for all the issues regarding food, foodstuff, and feed containing biotechnology content and inspections. Additionally, the Law on GMOs proscribes that MOH is responsible for the usage and inspection of the GMO products in cosmetics, pharmaceutical products, and products for human health protection. According to the Law on GMOs, the MOH is the umbrella ministry and coordinating body for all biotechnology issues. Service for Biodiversity in the Ministry of Environment and Nature Protection (MENP) that in 2012 replaced Environment Protection Directorate in the Ministry of Culture (MOC): According to the Law on GMOs the MOC is responsible for the intentional introduction of GMOs into the environment. Ministry of Agriculture(MOA): According to the Food Act, the Ministry of Agriculture is the central body of the Government responsible for food/feed safety, quality, and hygiene. This Ministry is also a contact point for the EU for related issues. The Ministry of Agriculture and the Ministry of Health have joint responsibility concerning all issues regarding food, foodstuff, and feed containing plant or animal biotechnology content and their inspections. According to the Law on GMOs, the MOA has responsibility for inspections of biotech feed; biotech reproduction material in agriculture and veterinary medicine; and drugs in veterinary medicine and pesticides. Furthermore, the MOA is responsible for giving its consent for the intentional release of biotech products into the environment. State Inspectorate: According to the Law on GMOs, the State Inspectorate has responsibility for inspecting GMO labeling. ii. Role and Membership of Biosafety Committee (if any): The Law on GMOs required the establishment of a Council for GMOs with the specific task of assisting governmental bodies to apply the Law. The Council has 17 members appointed by the Government of Croatia based on nominations from the pertinent Ministries. Council membership lasts for four years. The Council’s work is independent and public. According to the Law, the Council’s tasks include: tracking gene technology development and usage, tracking scientific breakthroughs and giving opinion and incentives for usage of gene technology and GMOs, giving opinions on social, ethical, technical, scientific, and other conditions of GMO use, advising responsible institutions on GMO and gene technology issues, informing the public on GMO and gene technology development, and presenting viewpoints and opinions. The Law on GMOs also calls for establishing a Board for Limited Usage of GMOs with 11 members composed of scientists from the fields of microbiology, genetics, medicine, biochemistry, molecular biology, pharmacy, biotechnology, agriculture, forestry, veterinary medicine, nature and environmental protection, and occupational protection. In addition, the Law on GMOs requires the establishment of a board for the introduction of biotech products into the environment that consists of nine scientists from the fields of: genetics, ecology, nature protection, environmental protection, agriculture, forestry, veterinary medicine, biochemistry, molecular biology, microbiology, and medicine. The tasks of these boards include: giving opinions on biotech usage in terms of legal procedures as outlined by the Law on GMOs; giving opinions and proposals for preparing other legislation on GMO usage; and giving opinions and proposals to responsible ministries on biotech usage issues and other expert work as outlined by the GMO Law and related regulations. According to the law, these two boards should report to the GMO Council once a year. The old and new Food Act/s called for the establishment of the Croatian Food Agency, which began its work in 2004. The Agency’s work consists of providing scientific and technical support to legislators as well as providing scientific advice in all areas that have direct and indirect influence on food and feed safety. Additionally, the Food Agency is required to work on many other issues concerned with feed, food, and nutrition and provides scientific opinions to the Ministry of Health and the Ministry of Agriculture regarding the placement of GMO food and/or feed on the market. iii. Assessment of political factors that may influence regulatory decisions related to agricultural biotechnology: Although EU membership is a priority for the Croatian government and the country’s new laws and agricultural policies mirror those of the EU, biotech opponents in Croatia have been emboldened by the perceived success of Austria and Slovenia in standing up to the European Commission on biotech approvals. Thus, complying with EU regulations has little meaning as long as Croatia positions itself within a regional group of “healthy,” GMO-free countries. Currently, Croatia clearly sees its future as a “niche market for healthy food” (NOTE: In Croatia, the word “healthy” encompasses everything from conventional and organic to non-biotech products), and biotech seed imports are not necessary for Croatia given a lack of agricultural demand for biotech products to combat drought, pests, or soil problems. Government officials acknowledge the legal obligation to open their agricultural market to foreign imports and openly acknowledge that Croatia is positioning itself as a GMO-free, “healthy” tourist destination. The Croatian public is generally very opposed to biotech products. iv. Distinctions between the regulatory treatment of approval for food, feed, processing, and environmental release are the following: There are similar long and complicated procedures to approve food and feed products, but the approval process for environmental release is different. At the end of the regulatory procedure for food and feed, biotech products must gain special permission to market the product. Some agricultural seed varieties (biotech and conventional); however, must first go through a variety registration process. After the Croatian Seed and Seedlings Institute registers the variety, it is placed on the list of seed varieties that can be marketed in Croatia. Biotech seeds, in additional to variety registration, require special permission to be placed on the market, including permission for the intentional environmental release of GMOs. b. Biotechnology crops approved for: i. Food, processing and feed: Croatia has not approved any biotech crops for food or feed use in Croatia, but there is a 0.9% threshold level for some biotech events in food and feed. Under a special ordinance from 2008 and its amendments from 2009, 2010, 2011 and 2012 the threshold for biotech content in food depends upon whether or not the biotech event is on the Ordinance’s list of permitted GMO events (the list is created from the list of biotech events previously tested and licensed in the EU). If the biotech event is on the Ordinance’s list, it does not need to be labeled for sale on the Croatian market--provided separate tests within Croatia confirm that the product contains up to 0.9% biotech content (for products that consist of more than one ingredient, the 0.9% threshold is permitted per product’s ingredient). However, if the biotech content is above 0.9%, the product must be labeled. The biotech threshold level drops to 0.0% for biotech products that are not on the Ordinance’s list. The same applies to feed. List of GMOs allowed up to the 0.9% threshold level: Num C Possible ode Plant Producer Modification . Usage 1. Carnation Moonlite carnation Florigene Ltd flower color import (Dianthus and caryophyllus L. processin line 123.2.38) g 2. Carnation carnation Florigene Ltd flower color cultivatin Mooshadow 1 g 3. Carnation carnation Florigene Ltd long life Moonshadow 2 4. Carnation carnation Florigene Ltd flower color import Moondust and processin g 5. 1507 corn Pioneer/Dow insect resistance AgroScience Lepidoptera food and (Ostrinia nubilalis) feed and herbicide tolerance 6. 59122 corn Pioneer Hi- insect resistance and Bred/Mycoge herbicide tolerance n seeds food, food ingredient 7. 1507 X NK603 corn Pioneer Hi- insect resistance and and feed Bred/Mycoge herbicide tolerance n seeds 8. MON863 corn Monsanto insect resistance food, feed and 9. GA21 corn Syngenta herbicide tolerance processin g 10. MON863X corn Monsanto insect resistance food, feed MON810 and cultivatin g 11. NK603 corn Monsanto herbicide tolerance 12. Bt11 corn Syngenta insect resistance and herbicide tolerance * food, 13. MON810 corn Monsanto herbic food ide tolerance ingredient 14. T25 s and feed corn Monsanto herbicide tolerance * products different 15. MON863 X corn Monsanto insect resistance and than food NK603 herbicide tolerance and feed with 16. NK603 X corn Monsanto insect resistance and exception MON810 herbicide tolerance of cultivatio 17. MON1445 cotton Monsanto herbicide tolerance n 18. MON531 cotton Monsanto insect resistance 19. MON15985 cotton Monsanto herbicide tolerance 20. MON15985 X cotton Monsanto insect resistance and MON1445 herbicide tolerance 21. MON531 X cotton Monsanto insect resistance and MON1445 herbicide tolerance 22. MON40-3-2 soybean Monsanto herbicide tolerance * food, feed and food and feed ingredient s * products different than food and feed with exception of cultivatio n 23. MS8 X RF3 canola Bayer sterility, herbicide food, CropScience resistance feed, import and processin g 24. GT73 canola Monsanto herbicide resistance 25. T45 canola Bayer herbicide resistance food and CropScience feed 26. H7-1 sugar beet KWS Saat herbicide resistance food, food AG/Monsant ingredient o s and feed Bayer 27. A2704-12 soybean C he od, rbicide resistanc * foe ropScience food ingredient 28. LL Bayer Cotton 25 cotton C herbicide resistance ropScience s and feed * products 29. MON Monsanto -89788-1 soybean Eur erbicide resistance ope S.A h different 30. T45 canola Bayer herbicide tolerance than food CropScience and feed Monsanto insect resistance and with 31. MON 88017 corn Europe SA herbicide tolerance exception Pioneer of insect resistance and 32. 59122xNK603 corn Overseas cultivatio C herbicide tolerance orporation n Monsanto 33. MON 89034 corn Eur resistance ope SA insect 34. MIR Syngenta insect resistance 604 corn Seeds S.A.S. (Diabrotica spp.) C * food, hanged starch type feed and (higher content of food and starch amylopectin when feed compared with 35. EH92 potato(Solanu-527-1 m tube BASF ingredientrosum amylosee) s L.) * for nptII gen used as cultivatio selection marker n * food, feed and food insect resistance Cole ingredientoptera s (Diabrotica spp.), MON * products Lepidoptera(Ostrin different 36. 863xMON810x corn Monsanto ia nubilalis, NK than food 603 Sesammia spp.) and and feed herbicide tolerance with nptII gen used as exception selection marker of cultivatio n * food, feed and food insect resistance Cole ingredientoptera s (Diabrotica spp.), MON * products 863xMON81 Lepidoptera(Ostrin 37 corn Monsanto different 0 ia nubilalis, than food Sesammia spp.) and feed nptII gen used as with selection marker exception of cultivatio n * food, feed and food ingredient insect resistance Cole s optera * products (Diabrotica spp.), different 38. MON863xNK603 corn Monsanto and herbicide than food tolerance and feed nptII gen used as with selection marker exception of cultivatio n * food, feed and food ingredient s * products MON insect resistance 89034xNK60 different 39. corn Monsanto Lepidoptera, and 3 than food herbicide tolerance and feed with exception of cultivatio n * food, feed and food ingredient s * products insect resistance different 40. Bt11xGA21 corn Syngenta Lepidoptera, and than food herbicide tolerance and feed with exception of cultivatio n insect resistance * food, 59122x1507xNK60 41. corn Pioneer Lepidoptera, feed and 3 Coleoptera, and food herbicide tolerance ingredient s * products different than food and feed with exception of cultivatio n * food, feed and food ingredient s insect resistance * products MON88017xMON different 42. corn Monsanto Lepidoptera, 810 Coleoptera, and than food herbicide tolerance and feed with exception of cultivatio n * food, feed and food ingredient Dow s Agr insect resistance * products oSciences Lepidoptera, different 43. 1507x59122 corn and Pioneer Ove Coleoptera, and than food rseas C herbicide tolerance and feed orporation with exception of cultivatio n * food, feed and Insect resistance, food 44. GHB Bayer Crop 614 cotton and herbicide ingredient Science tolerance s * products different than food and feed with exception of cultivatio n * food, feed and food ingredient s insect resistance * products MON 89034 x different 45. MON corn Monsanto Lepidoptera, 88017 Coleoptera, and than food herbicide tolerance and feed with exception of cultivatio n * food, feed and food ingredient s insect resistance * products Bt11x MIR 604 Syngenta Lepidoptera, different 46. corn xGA21 Seeds Coleoptera, and than food herbicide tolerance and feed with exception of cultivatio n * food, feed and food ingredient insect resistance s enta Lepidoptera, 47. B Syngt11xMIR 604 corn * products Seeds Coleoptera, and different herbicide tolerance than food and feed with exception of cultivatio n * food, feed and food ingredient s insect resistance * products 281-24-236x3006- Syngenta Lepidoptera, different 48. corn 210-23 Seeds Coleoptera, and than food herbicide tolerance and feed with exception of cultivatio n * food, feed and food ingredient s Dow insect resistance * products Lepidoptera, different 49. cotton AgroSciences Eur Coleoptera, and than food opa herbicide tolerance and feed with exception of cultivatio n ii. Environment: Croatia has not approved any biotech seed variety for planting. In addition, there are no seed varieties in the process of approval. Thus, currently, there is a de facto ban on biotech seed plantings in Croatia with a biotech seed threshold level in regular varieties of 0.0%. c. Situation for within-country biotech crop field-tests: According to the Law on GMOs and consequent Regulations, field tests of biotech crops are allowed after all the conditions prescribed by the Law and Regulations are satisfied. However, such tests are not conducted in Croatia. d. Treatment of stacked events: To date, Croatian legislation does not specifically deal with or specifically outline the treatment of stacked events. Future regulations may address this issue. e. Additional product registration required, above and beyond approval, prior to use: Biotech food and feed products require special permission as GMO products to be placed on the market and permission as GMO food and/or feed products to be placed on the market. Additionally, some agricultural seed varieties (regular and biotech) must go through a variety registration process before they are placed on the list of seeds that can be marketed in Croatia. Biotech seeds, in addition to variety registration, require special permission to be placed on the market, including permission for the intentional environmental release of GMOs. f. Legal framework for coexistence between biotech and non-biotech crops: The Law on GMOs forbids planting of registered biotech crops in nature-protected areas, ecological areas, areas for organic agricultural production or eco-tourism, in protected areas (i.e. as defined as protection impact zones with previously enlisted zones), and in areas that were defined by local government as GMO-free zones. In addition, biotech crop plantings for reproduction are allowed only in the areas that are designated by the Ministry of Agriculture and the Ministry of Environment and Nature Protection and approved by the Croatian Government in a special ordinance. g. Labeling of packaged foods or feeds: According to the Food Act, food and feed containing agricultural biotechnology ingredients must have special, additional information on the label that informs consumers of all of its characteristics. h. Biosafety Protocol: Croatia signed and ratified the Cartagena Biosafety Protocol. Officially, there is no trade in biotech products, especially not in seeds. However, it is currently difficult to tell whether the Biosafety Protocol is being applied and working in practice. i. Croatia is a member of the International Plant Protection Convention (IPPC), Codex Alimentarius (Codex), and the World Organization for Animal Health (OIE), but Croatia does not appear to take an active position regarding plant biotechnology in these organizations. j. The Croatian legislative framework for biotechnology is very strict and Croatian consumers are very negative towards modern, biotech foods. k. Beyond current legislation, there is no additional pending, plant-biotechnology legislation with potential to affect U.S. exports. A potential future exception could be legislation regarding bioengineered animals. l. Biotech crops are not planted commercially in Croatia. Croatia has intellectual property rights legislation in place and is a member of The International Union for the Protection of New Varieties of Plants (UPOV). Section IV. Plant Biotechnology Marketing Issues: a. Market acceptance issues: The average Croatian consumer views food derived from biotech crops negatively. Farmers are afraid to grow biotech crops. There is a feeling that biotechnology is something unnatural and that food should be natural. These negative opinions are based largely on emotions. b. Country-Specific Studies on Acceptance of Biotechnology: A Croatian market research agency carried out a study in 2009 on “consumers’ recognition of healthy food” that among other things researched the opinions and knowledge of Croatian consumers on GMOs. In this study, 51% of respondents said that they would not eat GMO food products under any circumstances and 29% of respondents thought that they did not know enough about GM foodstuffs. The study showed that 90% of respondents thought that GM foodstuffs should be clearly labeled on the store shelves. The same agency did a study in 2005and 2008 on public opinion on GMOs. In this study, 67% (2005) and 58% (2008) of respondents said that they would not eat GM food products under any circumstances and only 16% (2005) and 26% (2008) of respondents thought that they didn’t know enough about GM foodstuffs. Section V. Plant Biotechnology Capacity Building and Outreach: a. List of the U.S. Government / USDA funded capacity-building / outreach activities that have been carried out in Croatia over the past two years: 2012: Sponsorship of a speaker for a feed conference (KRMIVA): The topic of the conferences was Animal Feed, and FAS Zagreb provided a speaker on the following topic - “Bt Corn in Italy: a missed opportunity for farmers and feeders”. 2011: Sponsorship of a speaker for a feed conference (KRMIVA): The topic of the conferences was Animal Feed, and FAS Zagreb provided a speaker on the following topic - “Asynchronous Authorization and the Low-level Presence of Unauthorized GMOs and GM-derived Materials in Imports of Feed Commodity Crops from outside the European Union”. 2009: Sponsorship for of a speaker for a feed conference (KRMIVA): The topic of the conference was Biotechnology in Feed for which U.S. Grains Council (funding) and USDA (logistics) sponsored a speaker. Section VI. Animal Biotechnology: I. Development and Use: a. Genetic engineering and cloning are not practiced in Croatia for the development of agricultural animals. b. There are no genetically engineered animals or products derived from the animals intended for or currently in commercial production in Croatia. II. Regulation: a. Croatia does not have in place any legislation specifically related to the development, commercial use and/or import of these animals or products. However, last amendment to the Law on GMOs (Governmental Gazette 137/2009) mentions briefly that it is forbidden to plant registered biotech crops or breed registered biotech animals in nature-protected areas, ecological areas, areas for organic agricultural production or eco-tourism, in protected areas (i.e. as defined as protection impact zones with previously enlisted zones) and in areas that were by local government defined as GMO-free zones. Additionally the Law on GMOs mentions that The Ministry of Agriculture and the Ministry of Health have joint responsibility concerning all issues regarding food, foodstuff, and feed containing plant or animal biotechnology content and their inspections. b. Currently, the FAS office in Croatia is not aware of any discussions of related regulatory or research policies on these technologies. c. Government entities that would likely regulate these technologies, regarding both food and environmental safety issues related to research on or commercial use of these animals, include: Ministry of Agriculture; Ministry of Health; Ministry of Environment and Nature Protection; Ministry of Science, Education and Sport; Croatian Food Agency, and Council for GMOs. d. Labeling and/or traceability of these animals or products is expected to be an issue in Croatia. There are indications that the Croatian Government might require mandatory labeling of products derived from GE or cloned animals. III. Stakeholder/Public Opinions: a. There are active organizations that lobby against the genetic engineering or cloning of agricultural animals. In addition, the Croatian press is expected to actively oppose this technology. b. In Croatia, it can be expected that the market would reject these products. IV. International Organizations: a. We are not aware that Croatia actively participates in discussions in international organizations related to the genetic engineering of agricultural animals. V. Outreach, Needs, and Strategies: a. Croatia is strongly opposed to bioengineering in plants and efforts to promote animal biotechnology are unlikely to succeed. Section VII. Author Defined: Average exchange rate for May 2012 $1:Kn 5,870676
Posted: 30 July 2012

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