Required Report - public distribution

**Date:** 7/6/2005

**GAIN Report Number:** HU5008

HU5008

**Hungary**

**Biotechnology**

**Annual Report**

**2005**

**Approved by:**

![](media/image1.wmf)Sarah Hanson

U.S. Embassy

**Prepared by:**

Dr. Ferenc Nemes

**Report Highlights:**

Hungary's biotechnology policy for feed corn production, corn seed
production, and soybean product (soybean meal) imports negatively
impacts U.S. exports to Hungary. Field corn and seed corn production
(about one fifth of the EU's corn crop) is dominated by American
varieties. Four corn varieties passed the evaluation process and are
waiting approval, two others are still under field trials. In January
2005, the GOH imposed a moratorium on the varieties of the MON 810 corn
event. Legal and technical debates about the moratorium and coexistence
regulation (in preparation) may hamper the commercialization of
biotechnology crop varieties in Hungary over the next few years.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[HU\]

# Executive Summary

Hungary's biotechnology policy for feed corn production, corn seed
production, and soybean product (soybean meal) imports negatively
impacts U.S. exports to Hungary. Field corn and seed corn production
(about one fifth of the EU's corn crop) is dominated by American
varieties. Four corn varieties passed the evaluation process and are
waiting approval, two others are still under field trials. In January
2005, the GOH imposed a moratorium on the varieties of the MON 810 corn
event. Legal and technical debates about the moratorium and coexistence
regulation (in preparation) may hamper the commercialization of
biotechnology crop varieties in Hungary over the next few years.

# Biotechnology Trade and Production\--Status of Product Approvals

No biotechnology crop varieties are produced in Hungary. Three varieties
have gone through field trials and are waiting registration, including:

Field trials finished in 2003:

MEB 470 BT (DK 440 BTY) MON 810 code number corn borer resistant
(MONSANTO)

NX 3035 (Alpha BT) Bt11 code number corn borer resistant (Syngenta)

X 0987ZT MON 810 code number corn borer resistant (Pioneer Hi-Bred Rt.)

The Ministry of Agriculture and Rural Development (MARD) refused to
approve the registration of the above varieties because coexistence
regulation is not yet in place.

Additional corn varieties subject to field trials include:

MEB 471 RR (DK 440 RR) NK603 code number Roundup Ready tolerant
(MONSANTO)

MEB 391 RR (DK 391 RR) NK603 code number Roundup Ready tolerant
(MONSANTO)

X1019VT BT code number corn borer resistant (PIONEER Hi-Bred Rt.)

On January 20, 2005, the Government of Hungary (GOH) imposed a
moratorium on corn varieties containing the MON 810 event. The
moratorium went into effect by a Minister's Decree, and the legal
paperwork for the moratorium is now in Brussels for official review.

The four main reasons for the moratorium were the following:

1). The negative results of an environment effect study. The research
carried out in Hungary under the direction of the Plant Protection
Institute of the Hungarian Academy of Sciences focused on genetically
modified maize DK 440 BTY containing the genetic construction
YieldGardTM MON 810. Laboratory and small-scale parcel field experiments
showed that the long-term presence of the plant might have adverse
effects on the ecosystem. (*Darvas et al. (2003)* [EFFECT OF POLLEN OF
DK-440-BTY (YIELDGARD) BT MAIZE ON THE LARVAE OF *INACHIS IO* L.
(NYMPHALIDAE)]{.underline} Hungarian Academy of Sciences, Plant
Protection Institute, Ecotoxicology Department, Budapest)

2). The need to repeat the late 1990s EU trials using contemporary
methodology for this event.

3). The specific ecological conditions of the " Pannonian biogeographic
region" (a region containing parts of Hungary, Austria, and Slovenia)
questions the validity of risk assessment based on the ecosystems of the
older Member States, owing to its different environmental features.

4). Hungary has no coexistence regulation yet.

Hungary is an active participant in the development of biotechnology
crops at the basic science level, as well as in the research of the
environmental, feeding, etc. effects of these crops in cooperation with
other countries.

Hungary does not import biotechnology crops, but imports soybean meal,
peanut butter, sauces and other products containing biotech raw
materials.

### Biotechnology Policy\--Regulatory Framework

In the case of green (agricultural) biotechnology, the MARD takes the
lead concerning the cultivation, importation, and processing into
food/feed. The Hungarian Food Safety Authority (HFSA) under the Ministry
of Health (MH) is the top umbrella organization, but most of the
administrative responsibilities and the institutional background belong
to the MARD. The Ministry of Environment and Water Management (MEW)
handles certain biotechnology regulation portfolios and also
participates in the work of the Biotechnology Committee (BC). MH is
responsible for the red biotechnology (medicinal use), and the Ministry
of Economy and Transport (MET) handles foreign trade and strategic
investment affairs. Both the MH and the MET are advocates of
biotechnology as the key to further economic development but firmly
differentiate between red (thought of positively) and green (thought
questionably) biotechnology.

The Biotechnology Committee (BC) has a key role in evaluating the
applications (new varieties, genes, etc.) although the approval is
formally made by the MARD. The Hungarian Academy of Science (MTA) may
delegate five members, the relevant Ministries (MARD, MET, MH, MEW) and
the Ministry of Education delegate one each, and NGOs may nominate seven
delegates (including one by the pro-biotech Zoltan Barabas Biotechnology
Association) to the 17 member BC. Civil Servants (government employees)
are not members of the BC. Ministries nominate scientists or experts
from 'think tanks' belonging to their Department. The "independent" BC
sets its own rules, supposing that the question is not regulated in the
Act No. XXVII. of 1998 On Biotechnology or elsewhere (e.g. 111/2003.
(XI.5.) Order of Ministers of MARD, MET, MH, and MEW on Genetic
Modification and Like Processes, and their Inspection Authorities).

### 

### Administrative and service charges of the Committee and other authorities inspecting biotechnology experiments are set in the 138/2004. (IX.23) [Order of the Minister of MARD]{.underline} o[n the administrative and Service Fees for the Approval of Gene-technology Activities.]{.underline}

Regulatory decisions may be influenced by different political factors,
including:

\- EU market orientation of Hungary's corn and corn seed production.
Traditionally strong cooperation with Austria and Germany, main
opponents of GMOs.

\- The Hungarian consumer is pragmatic, but domestic and international
green organizations are increasingly active in Hungary.

\- Politicians, government officers, journalists and sometimes
scientists are shy to express their opinions about biotechnology or even
participate in topical seminars.

# Biotechnology Research

Besides testing biotechnology crop varieties, Hungarian biotechnology
laboratories are dealing with the analysis of different GMO materials.
Use of these biotechnology materials (for variety field test or any
other feeding, environmental effect, etc. trials) must also be approved
by the BC. Lists of biotechnology materials and programs are available
at the website of the Godollo Agricultural Biotechnology Center
([www.abc.hu](http://www.abc.hu/)) and the website of the EU Commission,
Directorate General, Joint Research Centre (http://biotech.jrc.it)
quoted in ANNEX I.

According to a Biotech Committee Decision, stacked events are taken for
new events, considering possible cross effects.

# Coexistence Regulation

The MARD finished the drafting and first panel discussions of the
Hungarian coexistence regulation in June 2005. The new piece of
legislation will be a chapter of the amendment to the Act on
Biotechnology. The draft coexistence regulation has been sent for
Commission approval. The drafting period (first half of 2005) included
vivid discussions at different government and NGO forums.
Representatives of the biotechnology industry and the Biotechnology
Association participated in the work of the Coexistence Working
Committee. The responsible Ministries are also drafting the application
orders of the coexistence regulation.

# Labeling rules

Act No LXXXII of 2003 on Food (AF) is a general, "umbrella" piece of
legislation. The Act does not contain the domestic versions of EU
(European Council or Commission) directives, so it does not need to be
revised whenever any EU directive is changed. The domestic directives
are contained in the **Hungarian Food Codex (HFC)** or other separate
legal rules (such as legislation for Wine, for Mineral Water, and for
Meat and Meat Products). General prescriptions of the Act must be
applied together with HFC directives and other corresponding
regulations.

All kinds of food, including food imported for commercial sale, fall
under the ruling of the Act. (Products from other EU member countries
are considered as domestic products (§7. (2)) See the AF in English at
<http://www.fvm.hu/files/elelmiszeripar/elszi_5_en.pdf>

Other corresponding regulations include:

**19/2004. (Feb 26.) Order of the Min of Agr-Min of Health-Min of
Economy [On labeling of Foodstuffs]{.underline}**

**138/2004 (Sep 23.) Order of the Min of Agriculture** **[On the
administrative and Service Fees for the Approval of Gene-technology
Activities]{.underline}**

e.g. -Fees for the approval of commercial sales of GMOs and products
thereof

-Fees for the approval of the export-import trade of above products

**142/2004. (Sep 30.) Order of Min of Agr-Min of Economy** **[On Some
Rules of Gene-technology Activities in Agriculture and
Industry]{.underline}**

e.g. Labeling of products containing GMOs (above the threshold level).

Hungary is not an importer of biotech products, excluding animal feed.
Plant propagation materials (seeds) go through systematic sampling and
laboratory analyses. However, for feed and food, where the exporter must
declare the quality of the product, only random sampling takes place.
The breakdown of samples analyzed in the official biotech testing
laboratory of the Agricultural Biotechnology Center at Godollo in 2004
included the following:

62% Corn

10% Soybean

10% Feed

9% Processed soya

7% Processed corn

2% Other products

Source: [www.abc.hu/](http://www.abc.hu/) under Services, than State
laboratory for GMO testing.

# Cartagena Biosafety Framework

Hungary has ratified the Biosafety Protocol. The legislation is the
CIX./2004. Act on the Promulgation of the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity. The implementation
rules of the Act have not yet been prepared.

**Capacity Building and Outreach**

Post has sponsored government officers, scientists and journalists on
agricultural biotechnology programs in the US through the Cochran
Fellowship Program over the past few years.

The International Visitor Program of State Department has also been used
for sending a Hungarian government official to the United States as part
of an outreach activity.

In 2005, the USDA/FAS Biotechnology unit co-sponsored the travel of a
Hungarian journalist to participate at the congress of the International
Service for the Acquisition of Agri-biotech Applications (ISAAA) in
Singapore, March 18-24, 2005. The goal of the Hungarian participation
was to facilitate the establishment of a Hungarian 'node', a national
knowledge center, of the ISAAA.

ANNEX

I. Deliberate releases, Plants -- Hungary, 2005

  --------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------- --------- ------------- ------------- ------------ --------- ------------- ---------------------- ---------------------- --
  Notification Number                                                                                                                                                                                   State         Publication                          Name of       Project title                                 
                                                                                                                                                                                                                                                           Institution                                                 
                                                                                                                                                                                                                                                           or Company                                                  

  **[B/HU/05/01/4](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/4' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trial program of                        
                                                                                                                                                                                                                                                           Hi-Bred       genetically modified                          
                                                                                                                                                                                                                                                           Hungary Ltd.  maize resistant to                            
                                                                                                                                                                                                                                                                         certain Lepidopteran                          
                                                                                                                                                                                                                                                                         and Coleopteran                               
                                                                                                                                                                                                                                                                         insects and tolerant                          
                                                                                                                                                                                                                                                                         to two herbicides                             
                                                                                                                                                                                                                                                                         (59122x1507xNK603                             
                                                                                                                                                                                                                                                                         maize)                                        

  **[B/HU/05/01/5](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/5' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trials program                          
                                                                                                                                                                                                                                                           Hi-Bred       of genetically                                
                                                                                                                                                                                                                                                           Hungary Ltd.  modified maize                                
                                                                                                                                                                                                                                                                         resistant to certain                          
                                                                                                                                                                                                                                                                         Coleopteran insects                           
                                                                                                                                                                                                                                                                         and tolerant to two                           
                                                                                                                                                                                                                                                                         herbicides                                    
                                                                                                                                                                                                                                                                         (59122xNK603 maize)                           

  **[B/HU/05/01/6](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/6' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trials program                          
                                                                                                                                                                                                                                                           Hi-Bred       of genetically                                
                                                                                                                                                                                                                                                           Hungary Ltd.  modified maize                                
                                                                                                                                                                                                                                                                         varieties resistant to                        
                                                                                                                                                                                                                                                                         certain Lepidopteran                          
                                                                                                                                                                                                                                                                         and Coleopteran                               
                                                                                                                                                                                                                                                                         insects and tolerant                          
                                                                                                                                                                                                                                                                         to                                            
                                                                                                                                                                                                                                                                         glufosinate-ammonium                          
                                                                                                                                                                                                                                                                         herbicide (1507x59122                         
                                                                                                                                                                                                                                                                         maize)                                        

  **[B/HU/05/02/1](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/02/1' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trial program of                        
                                                                                                                                                                                                                                                           Hi-Bred       genetically modified                          
                                                                                                                                                                                                                                                           Hungary Ltd.  maize varieties                               
                                                                                                                                                                                                                                                                         resistant to certain                          
                                                                                                                                                                                                                                                                         Lepidopteran insects                          
                                                                                                                                                                                                                                                                         and tolerant to two                           
                                                                                                                                                                                                                                                                         herbicides (1507xNK603                        
                                                                                                                                                                                                                                                                         maize)                                        

  **[B/HU/05/02/2](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/02/2' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trials program                          
                                                                                                                                                                                                                                                           Hi-Bred       of maize varieties                            
                                                                                                                                                                                                                                                           Hungary Ltd.  resistant to certain                          
                                                                                                                                                                                                                                                                         Coleopteran insects                           
                                                                                                                                                                                                                                                                         and tolerant to a                             
                                                                                                                                                                                                                                                                         herbicide (59122                              
                                                                                                                                                                                                                                                                         maize)                                        

  **[B/HU/05/02/4](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/02/4' , '_blank'))**                                                                                                           Hungary       24/05/2005                           Pioneer       Field trial program                           
                                                                                                                                                                                                                                                           Hi-Bred       for the testing of                            
                                                                                                                                                                                                                                                           Hungary Ltd.  biotech maize tolerant                        
                                                                                                                                                                                                                                                                         to glyphosate                                 
                                                                                                                                                                                                                                                                         herbicide                                     
                                                                                                                                                                                                                                                                         (E5846.49.7.12 and                            
                                                                                                                                                                                                                                                                         E5846.53.9.4)                                 

                                                                                                **[B/HU/05/01/1](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/1' , '_blank'))**   Hungary                               16/02/2005   Pioneer                                        Trial program for the  
                                                                                                                                                                                                                                                 Hi-Bred                                        testing of 1507        
                                                                                                                                                                                                                                                 Hungary                                        biotech maize          
                                                                                                                                                                                                                                                 Ltd.                                           varieties resistant to 
                                                                                                                                                                                                                                                                                                certain Lepidopteran   
                                                                                                                                                                                                                                                                                                insects and tolerant   
                                                                                                                                                                                                                                                                                                to                     
                                                                                                                                                                                                                                                                                                glufosinate-ammonium   
                                                                                                                                                                                                                                                                                                herbicide              

                                                                                                **[B/HU/05/01/2](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/2' , '_blank'))**   Hungary                               16/02/2005   Pioneer                                        Program of field       
                                                                                                                                                                                                                                                 Hi-Bred                                        agronomic trials and   
                                                                                                                                                                                                                                                 Hungary                                        registration trials    
                                                                                                                                                                                                                                                 Ltd.                                           with NK603 maize       
                                                                                                                                                                                                                                                                                                varieties tolerant to  
                                                                                                                                                                                                                                                                                                glyphosate herbicide   

                                                                                                **[B/HU/05/01/3](javascript:PostForm('gmp_report_onepag.asp', 'B/HU/05/01/3' , '_blank'))**   Hungary                               16/02/2005   Pioneer                                        Program of field       
                                                                                                                                                                                                                                                 Hi-Bred                                        agronomic trials and   
                                                                                                                                                                                                                                                 Hungary                                        registration trials    
                                                                                                                                                                                                                                                 Ltd.                                           with NK603xMON810      
                                                                                                                                                                                                                                                                                                maize varieties        
                                                                                                                                                                                                                                                                                                tolerant to glyphosate 
                                                                                                                                                                                                                                                                                                herbicide and          
                                                                                                                                                                                                                                                                                                resistant to certain   
                                                                                                                                                                                                                                                                                                lepidopteran insects   
  --------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------- --------- ------------- ------------- ------------ --------- ------------- ---------------------- ---------------------- --