Required Report - Public distribution

**Date:** 7/13/2007

**GAIN Report Number:** EZ7005

EZ7005

**Czech Republic**

**Biotechnology**

**Annual Report**

**2007**

**Approved by:**

![](media/image1.wmf)Quintin Gray

FAS Prague

**Prepared by:**

Petra Hrdlickova

**Report Highlights:**

The Czech Republic, as a member of the EU, follows the EU's legislative
framework for biotechnology. Act 78/2004, amended by 346/05, replaced
the first Act on GMO 153/2000. The Ministry of Environment is the
competent authority for handling biotech product notifications, and the
Ministry of Agriculture is responsible for notifications of biotech food
and feed. The Czech Republic ratified the Cartagena Protocol on
Biosafety in October 2001. This year between 5,000 and 6,000 hectares of
Bt corn (MON 810) is being grown in the Czech Republic, a four-fold
increase since last year. The Czech Republic's coexistence rules require
isolation distances and notifications to the Ministry of Agriculture and
the Ministry of Environment. When voting on biotech approvals at various
levels in the EU, the Czech Republic takes a case-by-case approach and
bases its decision on scientific evidence.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Prague \[EZ1\]

\[EZ\]

# SECTION I. EXECUTIVE SUMMARY

The U.S. exports soybean meal and soybean oil to the Czech Republic. It
is difficult to estimate the exact amount, since most soybean meal is
transshipped through Germany where U.S., Brazilian, and other suppliers'
soybean meal is mixed. In 2005, the Czech Republic imported over 650,000
MT of soybean meal, which was more than double the amount in 2001. The
higher demand for soybean meal is the result of Europe's BSE outbreak in
2001, when meat-bone-meal was replaced by soybean meal in feed mixtures.

Round-up Ready (RR) soybeans were one of the first biotech varieties
approved by the Ministry of Environment, when the first Act 153/2001 on
Genetically Modified Organisms (GMO) came into effect. Biotech
regulations have not impacted U.S. exports of soybean meal or soybean
oils significantly, but they have impacted the export of some food
products (e.g. corn chips or products containing soybeans) as retailers
requested certification products do not contain biotech ingredients. An
importer of U.S. products has to assess which products may contain
biotech products and have those products tested in the Czech Republic,
which is very costly. If the test result is less than 0.9% for biotech
content, the importer receives a certificate that states that the
product does not contain "GMOs". If biotech content is higher than 0.9%,
the importer will most probably not import this product, since retailers
refuse to carry products containing biotech ingredients. However, there
are exceptions for products with labels stating "contains GMO" (e.g.
soybean oil) and consumers buy these products. These consumers either do
not read the label or do not think biotech products (or GMOs) are
dangerous. On the other hand, there are products (especially organic),
which carry a voluntary 'negative' label "does not contain GMO" as a
marketing tool.

### Czech biotechnology regulatory system -- recent developments

The Czech Republic, as a member of EU, follows the EU's legislative
framework for biotechnology. Even before EU accession on May 1, 2004 and
during the 'legislation harmonization process, Act 153/2000 on the use
of genetically modified organisms and genetic products was in effect
since January 1, 2001. According to this Act, the Ministry of
Environment evaluates applications and registers biotech products for
laboratory use, release into the environment, and on the market. The
Ministry keeps a list of all approved biotech products and a list of
users.

Act 153/2000 was replaced by Act 78/2004, which came into effect on
February 25, 2004 and was later amended by Act 346/2005. The competent
authority handling notifications and regulating the use of biotech
products in the Czech Republic is the Ministry of Environment (according
to EU Directive 2001/18/EC). It cooperates with the Ministry of Health
in respect to human health risks and with the Ministry of Agriculture in
respect to agricultural risks including crops, feeds, and animal health.
The Czech Commission for the Use of GMOs and Genetic Products
("Commission"), the expert advisory body to the Ministry of Environment,
has 14 members and consists of administrative authorities, scientists,
and researchers. The main task of the Commission is to assess the
environmental risk of the notified GMOs. The Czech Republic ratified the
Cartagena Protocol on Biosafety in October 2001.

Under EC Regulation 1829/2003 on Genetically Modified Food and Feed, the
competent authority for handling notifications and approvals of biotech
food and feed is the Ministry of Agriculture, Food Safety and Technology
of the Living Environment Department.

The Ministry of Agriculture prepared rules for coexistence of biotech
crops with conventional and organic farming in preparation for planting
Bt corn in the spring of 2005*.* The rules in 2005, were part of the
Government Regulation on Conditions for Providing Top-up Payments to
Direct Payment for 2005. As of this year conditions for GM crop growing
are set by the amendment 441/2005 of the Act on Agriculture 252/1997 and
by Decree 89/2006. Together they set out the following requirements:

a)  information -- a farmer must inform his neighbors and the Ministry
    of Agriculture that he plans to plant a GM crop (currently Bt corn
    is approved and grown) by March 1, then within 15 days after
    planting he must inform his neighbors again, within 30 days the
    Ministry of Agriculture and within 60 days the Ministry of
    Environment

b)  isolation distances -- for GM corn and conventional corn the
    distances are 70 m or 35 rows of non GM crop as a barrier or a
    combination of a distance and a buffer zone, in which case 1 row
    equals 2 meters. For Bt corn and organic corn it is 200 m or 100 m
    and 50 rows of non GM crop as a buffer zone; for potatoes (not grown
    yet) the distances are between 3-20 m

c)  keeping records -- a farmer must keep all records on purchase,
    storage, planting and sale of all GM seed or crop for 5 years

d)  control and evidence -- a farmer, for his evidence and the purpose
    of control, must know where exactly his GM fields start and end.

# SECTION II. BIOTECHNOLOGY TRADE AND PRODUCTION

### Production of biotech crops

In 2005, Czech farmers were allowed for the first time to plant Bt corn
(MON 810), which is marketed under the name YieldGard Cornborer and
distributed by Pioneer. As a result, over 60 farmers planted Bt MON810
corn on a total area of about 300 ha. In 2006, farmers grew Bt corn on
1,290 hectares and this year the Ministry of Agriculture estimates Bt
corn planting on 5,000 to 6,000 hectares (total corn area in the Czech
Republic is 275,500 hectares).

Last fall the Ministry of Agriculture conducted another survey among
farmers that grew Bt corn last year in order to find out first results.
According to this survey, farmers that grew Bt corn reported a 5 to 20%
increase in yield; lower occurrence of corn borer; and lower myco-toxin
levels. However, the farmers complained about complicated government
requirements and higher seed prices.

Czech farmers see new opportunities for GM crops use, not only for food
and feed, but also for fast growing bioethanol production. In terms of
food use, some dairy plants refuse to buy milk from farmers who feed
their cattle with GM crops (soybeans, corn) although there is no
legislative requirement and meat and milk of animals with fed with
biotech crops have been proved safe. Products containing GMO are
available in Czech supermarkets, e.g. vegetable oils (and they are
labeled).

### Import of biotech crops

The Czech Republic imports soybean meal and soybean oil from RR
soybeans. Even though statistics show most imports originate from
Germany, the soybean meal comes from other countries (mostly from the
U.S. or Brazil depending on the season). Soybeans are mixed in Germany
and sold by quality type\--not country of origin, so it's hard to know
exactly how much product is exported to the Czech Republic from the U.S.
In 2005, the Czech Republic imported over 650,000 MT, which was over a
100% increase since 2001.

A small quantity of corn is also imported from the U.S. (in 2004 about
500 MT). The Czech Republic is increasing its growing area of corn,
which reduces the need for corn imports. In 1999, the Czech Republic
imported 76,000 MT of corn, last year it was only 10,000 MT. Over 90% of
total imported corn comes from Slovakia.

For U.S. exporters there is an opportunity to export soybean meal,
soybean oil, and corn seeds.

The Czech Republic is not a food aid recipient, and as a member of the
EU it is not likely to be a food aid recipient in the near future.

No biotech crops developed outside of the US are produced in the Czech
Republic.

# SECTION III. BIOTECHNOLOGY POLICY

### Responsible government Ministries and their role

Under Directive 2001/18 EC and Act 78/2004 amended by Act 346/2005, the
competent authority responsible for handling notifications and
regulating the use of biotech products in the Czech Republic is the
Ministry of Environment. It cooperates with the Ministry of Health in
respect to human health risks and with the Ministry of Agriculture in
respect to agricultural risks including crops, feeds, and animal health.
After receiving comments from these cooperating Ministries, and an
expert assessment from the Czech Committee on GMOs (see below) the
Ministry of Environment issues an authorization for field trials or
contained use of biotech products. In the case of notifications for
placing biotech products on the market in the EU, the Ministry of
Environment sends comments or assessment reports to the European
Commission and formulates all final positions of the Czech Republic for
a vote in the regulatory committee under Directive 2001/18/EC or the
Environmental Council. If the regulatory committee's decision is
negative, additional voting is carried out by the Council of Ministers.
If positive, it may be released on the market, if negative the
Commission may then authorize release on the market.

A slightly different situation applies to biotech products for food and
feed. Under Regulation 1829/2003 EC on Food and Feed, a company can
apply for biotech product approvals at the Ministry of Agriculture, Food
Safety and Technology of the Living Environment Department, which has to
forward the application to the European Food Safety Authority (EFSA)
within 14 days for review. EFSA will conduct a risk assessment and if it
issues a positive recommendation, the application is forwarded to the
European Commission, which sends it to member states for assessment.
Member states then vote on the proposal in a Regulatory Committee and if
a qualified majority votes "yes", the biotech event concerned may be
released on the market. If the Regulatory Committee's decision is
negative, a second voting is carried out by the Council of Ministers. If
positive, it may be released on the market, if negative the Commission
may then authorize release on the market.

In summary, the approval of biotech products for import, cultivation and
processing falls under Directive 18/2001, transferred to national acts
(in the Czech Republic Act 78/2004 amended by Act 346/2005) and the
competent authority is the Ministry of Environment, which has to
generate an expert assessment and then forward it to the European
Commission and other member states for voting. In the case of biotech
products for food and feed, Regulation 1829/2003 applies and the
competent authority is the Ministry of Agriculture, which only collects
applications, which it forwards to EFSA for an expert

assessment (it's a more cautious approach since it directly concerns
food). EFSA sends the assessment to the European Commission and other
member states for voting.

### Role and membership of Biosafety Committee

An expert advisory body to the Ministry of Environment is the Czech
Commission for the Use of GMOs and Genetic Products. The Commission has
14 members and consists of representatives of administrative
authorities, scientists, and researchers. The main task of the
Commission is the environmental risk assessment of the notified biotech
products. A list of members is on Ministry of Environment's webpage:

<http://www.env.cz/AIS/web-pub.nsf/$pid/MZPMVF8OSAI0>

### Political factors

Non-government-organizations (NGOs), among which the strongest one in
the Czech Republic is Greenpeace, have a strong influence on the
Ministry of Environment and the public. According to the first Act on
GMOs No. 153/2000, NGOs were part of the regulatory process, which made
GMO approvals much more complicated. For example, when the Czech GMO
Commission made a positive recommendation and the Ministry of
Environment had approved a biotech product but the NGO's recommendation
was negative, the NGO, as a member of the administrative process, could
appeal the decision to the Analytical Commission of the Ministry of
Environment. This delayed the approval of biotech products by months
(e.g. in the case of Bt corn MON 810).

Act 78/2004, which replaced Act 153/2000, and was later amended by Act
346/2005 does not include NGOs in the regulatory process. Under this
Act, NGOs may send comments to the Ministry of Environment during the
registration process, but once the decision is made, the decision cannot
be delayed by any NGO appeals. However, according to Act on Providing
Information on the Environment 123/1998, the Ministry of Environment
must give information about Bt corn growers to anybody who asks for it.
In July 2006, the Ministry of Environment gave a list of Bt corn growers
to Greenpeace, so at present farmers worry about vandalism and/or
intentional damaging of their crops.

Organic farmers with fears of biotech are also being heard. According to
EU Regulations 2092/1991 and 1804/1994, the use of biotech products in
organic production is prohibited. Even though Czech farmers grow organic
corn on a very small area (around 1,000 hectares), they fear
contamination of their fields by biotech varieties. The rules of
coexistence only list sanctions for farmers not meeting the requirements
set in these rules. However, the rules do not discuss cases when a
farmer meets all the requirements but his neighbor's field is
'contaminated' with biotech products, which is very unlikely since a 200
meter separation has proved a very safe distance.

The debate about biotechnology in the Czech Republic is, like in the EU,
highly politicized and opponents of biotechnology admit that they are
concerned not only about food safety or the impacts of biotech products
on the environment but also about economic factors. Opponents also argue
that 'if consumers want "GMO-free" products, we have to deliver them'.
As of January 2007, the Czech Republic has a new Minister of
Environment, Martin Bursik, who is also a Chairman of the Green Party,
which has an impact on some positions the Czech Republic takes on GMO in
the EU, e.g. in February 2007 the Czech Republic supported Hungary's ban
on GM crop against the EU Commission's attempt to force Hungary to
remove the ban.

Recent media news on GMO have been rather negative, e.g. on main TV news
demonstrating Greenpeace members in trial field for corn NK603 talking
about danger of this crop etc. It was immediately refuted on local TV by
the U.S. company that was testing this new variety.

### Approved biotech crops

Since the EU accession on May 1, 2004, biotech food and feed products
approved by the EU are valid in the Czech Republic.

For the register of existing biotech products, see:

<http://europa.eu.int/comm/food/dyna/gm_register/index_en.cfm>

Specific legislation governing these products can be found at:

<http://europa.eu.int/comm/food/food/biotechnology/gmfood/legisl_en.htm>

The Ministry of Environment handles notifications and approvals for
contained use, field trials and cultivation. The Ministry of the
Environment has so far received about 100 notifications for biotech
products for use, mostly for contained use. All contained uses involve
class 1 and 2, there are no cases of class 3 nor 4 contained use in the
Czech Republic.

The Czech Ministry of Environment issued approvals for small-scale field
testing of oilseed rape, potato, flax and virus-resistant plum trees for
scientific and breeding purposes before EU accession. Field trials with
Monsanto Bt maize MON 810 were approved in 2002. Following approval for
placing the maize MON 810 on the market, more testing of this crop,
including variety registration trials took place in 2004. Field trials
with Monsanto Roundup Ready maize NK 603 have been approved for the
period 2002 - 2004. The field trials with
GM-herbicide-tolerant-rapeseed, notified by Aventis, were terminated in
2002 by the company. Presently, the Ministry of Environment has issued
an approval for field trials of genetically modified potatoes with
altered starch content notified by BASF (notification under part B of
the Directive 2001/18/EC, the same GM potatoes are being tested also in
other EU member countries, similar notification submitted in Sweden in
2003 for placing on the market -- part C of the Directive and is pending
in the EU approval process).

A list of authorized users and a list of approved biotech products,
together with the relevant legislation and other information, is
available to the public and updated on the website of the Czech Ministry
of the Environment at the address: [www.env.cz](http://www.env.cz/).

### Field tests

The Czech Republic allows field tests of biotech crops. Currently there
are several research projects including biotech potatoes (BASF),
herbicide tolerant corn GA21 (Syngenta), Roundup Ready corn NK603
(Monsanto), flax (Agritec) and other varieties. Research of some of
these varieties is also carried out by Czech research institutes and
universities.

### Coexistence rules

In 2005, Bt corn was grown for the first time in the Czech Republic, and
the rules for coexistence had to be prepared very quickly. Normally
there is a three-year period for variety tests after a biotech product
is approved. Bt corn MON810 was approved by the Ministry of Environment
in February 2004, and in September 2004 the EU registered 17 varieties
with MON810, which means that Czech farmers could plant Bt corn for this
first time in spring 2005. The Ministry of Agriculture prepared
provisional rules, which were included in the Government Regulation on
Conditions of Receiving Additional Payments to Direct Payments
("top-ups") for 2005. As of this year, conditions for GM crop growing
are set by the amendment 441/2005 of the Act on Agriculture 252/1997 and
by Decree 89/2006.

The rules of coexistence set requirements on information, isolation
distances, record keeping and control. The isolation distances were
decreased in 2006 from 100 meters for conventional agriculture to 70
meters (or 35 rows of non GM crop as a barrier or a combination of a
distance and a buffer zone, in which case 1 row equals 2 meters) and for
organic agriculture from 600 meters to 200 meters (or 100 m and 50 rows
of non GM crop as a buffer zone). Farmers also have to notify his
neighbors and the Ministry of Agriculture (before and after sowing) and
the Ministry of Environment (after sowing).

### 

### Labeling

Czech act 78/2004 and decree 209/2004 on handling GMOs sets the
conditions for contained use, field tests, placing on the market, and
requirements for applications for registration, risk assessment,
labeling requirements, and a plan for handling accidents. The Act
78/2004 implements Directive
[2001/18/EC](http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=en&type_doc=Directive&an_doc=2001&nu_doc=18)
of the European Parliament and of the Council of 12 March 2001 on the
deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC. Amendment of the
above mentioned Act is valid since 2005 -- the Act 346/2005.

EU regulation No 1829/2003 of the European Parliament and of the Council
on genetically modified food and feed lay down Community procedures for
the authorization and supervision of genetically modified (GM) food and
feed and also lay down provisions for the labeling of GM food and feed.

EU regulation No 1830/2003 of the European Parliament and of the Council
concerning the traceability and labeling of genetically modified
organisms and traceability of food and feed products produced from GMOs
and amending Directive 2001/18/EC. This Regulation provides a framework
for the traceability of products consisting of or containing GMOs, and
food and feed produced from GMOs, with the objectives of facilitating
accurate labeling monitoring the effects on the environment and, where
appropriate, on health, and the implementation of the appropriate risk
management measures including, if necessary, withdrawal of products.

Even products with no detectable protein (e.g. oil) must be labeled if
they are produced from GMOs. The threshold for labeling is \> 0.9% of
particular GMO. Labeling must contain words "genetically modified" or
"produced from genetically modified soy/corn etc." as part of the
ingredient list concerned with label/tag. Also unique identifiers of
particular GMOs should be included on the label/tag.

Products are labeled for consumer's right to know, not for health/safety
reasons.

Below is an example of labeling on feed mixture containing biotech
product:

![](media/image2.jpeg){width="5.990277777777778in"
height="7.675694444444445in"}

The Czech Republic ratified the Cartagena Protocol on Biosafety in
October 2001 and has a Biosafety Clearing House in place (see
[www.biosafety.cz](http://www.biosafety.cz/)).

### Czech's position on biotech products in the EU

The Czech Republic takes a 'case-by-case' approach in terms of voting on
biotech

products in the Regulatory Committee or the Ministers' Council. In
February 2007, the Ministry of Environment supported Hungary's ban on GM
corn growing (MON810) against the EU Commission (political decision),
while only two months earlier the Czechs supported the EU Commission
against Austria on the same issue -- ban on GM corn growing.

The Ministry of Agriculture has a more pragmatic approach and in the
spring EU Standing Committee vote supported all three stacked biotech
corn varieties (NK603xMON810, 1507xNK603, Herculex Root Worm
DAS59122-7).

In summary, the Czech Republic is among the more pragmatic countries in
the EU in biotechnology and takes a science-based approach, however,
some decisions may be politically motivated.

# SECTION IV. MARKETING ISSUES

### Market acceptance by producers, importers, and retailers

Many Czech importers and producers of food products have in their
'mission statement' that they do not use biotech products in their
products. Since they want to sell products on the whole EU market, they
are afraid that negative attitudes of European consumers (at least this
is what they read in various articles in Czech newspapers and magazines)
would damage their sales.

All Czech retail chains (Makro, Ahold, Tesco, Carrefour etc.) are owned
by strong European companies and follow their European headquarters in
their policy on biotech products. E.g. UK Tesco says: "Our customers
continue to tell us that they are not yet convinced of the benefits of
GM. We do not therefore have any own-brand GM foods on our shelves."

(<http://www.tescocorporate.com/page.aspx?pointerid=6A750D771BFE4E98A3F0741AA32E5489>)

Even though policy of retail chains in general is not in favor of GM
products, many supermarkets (including Tesco) carry items containing
GMO, such as cooking oils and these products are labeled (even under
Tesco private label).

The new opportunity for biotech producers is in bioethanol production.
There are several bioethanol plants in the Czech Republic and a few more
are being built. The plants use grain, including GM corn, as feedstock
and bioethanol producers already declared that they would buy GM corn
for ethanol production.

Importers of commodities for feed, e.g. soybeans import biotech crops
and label them.

### Study on public opinions

The State Health Institute, Center for the Hygiene of Food Chains,
conducted three studies of public acceptance of biotech products, in
2003, 2004 and 2005. The graph from the State Health Institute shows
that negative attitude towards GMO has increased and that a fairly high
percentage (one third of people) say they do not have enough information
on the subject.

![](media/image3.wmf){width="5.9944444444444445in"
height="4.454861111111111in"}

# SECTION V. CAPACITY BUILDING AND OUTREACH

### USDA and State Department's programs

During the past six or seven years Czech scientists, researchers,
regulators, and journalists visited the US under the Cochran Fellowship
Program. A few people also participated in the State Department's VolVis
(Voluntary Visitors) and IVP (International Visitor Program) programs on
biotechnology.

### 

In 1999, a Czech scientist and promoter of biotechnology Prof. Drobnik
of the civic association Biotrin visited the United States under the
Cochran Fellowship Program, and he with a small two-person TV crew made
a documentary film called "Genes of Controversy", which was dubbed into
several languages and broadcasted in several central European countries.
The film can be found at [www.biotrin.cz](http://www.biotrin.cz/)

### Suggestions for increasing science-based regulations

All of these programs (CFP, IVP, VolVis) have been extremely useful for
Czech participants and participants a lot of information on
biotechnology. Continuing these programs would be beneficial.

Seminars with good U.S. biotech speakers on U.S. regulatory system and
experience from other European countries for Czech regulators,
journalists, and food producers would help increase consumer awareness
(articles in papers and magazines) and would stir up a debate among food
producers and regulators about use of biotech products in foods.

# In September 2007, USDA and the State Department will organize a regional conference on biotechnology with emphasis on growing and use of biotech products in new areas, such as biofuels.

# 

# SECTION VI. REFERENCE MATERIAL

### Important webpage links

European Union:

<http://europa.eu.int/comm/food/food/biotechnology/index_en.htm>

European Food Safety Authority (EFSA):

<http://efsa.eu.int/>

Czech Ministry of Environment (in Czech):

<http://www.env.cz/AIS/web.nsf/pages/gmo>

Biosafety Clearing House -- Czech Republic (in English):

<http://www.biosafety.cz/>

Czech Ministry of Agriculture (in Czech):

<http://www.mze.cz/default.asp?ids=2292&ch=73&typ=2&val=2292>

Text of the Strategy for Food Safety (document prepared by the Ministry
of Agriculture, Food Safety and Technology of the Living Environment
Dept.) (in English):

<http://www.mze.cz/attachments/Food_Safety_Strategy_compl..doc>

NGO (for biotech) Biotrin (in English):

<http://www.biotrin.cz/>

NGO (against biotech) Greenpeace (in Czech):

<http://www.greenpeace.cz/gmo/>

### Related reports

Previous reports on biotechnology regarding the Czech Republic may be
found on FAS homepage
<http://www.fas.usda.gov/scriptsw/AttacheRep/default.asp> under the
following numbers:

EZ6009 Biotech Annual

EZ6005 Biotech Update

EZ5003 Biotechnology - Consumer Perceptions

EZ4011 New GMO Law

EZ4010 National Biosafety Framework

EZ4001 Status of Biotech Regulations -- Central Europe

EZ3020 Consumer Perceptions of Biotechnology

EZ3018 Status of Bt Corn Registration in Czech Republic

EZ3015 Biotechnology from a Czech Perspective

EZ3012 Status of Biotech Regulations

EZ3003 Biotechnology - Status of GM Approvals

EZ1016 Implementation of GM Labling Law - Consumer Products

EZ1011 GMO Approval Process

EZ0020 New Law Comes Into Force January 1, 2001

EZ0015 Biotechnogy -- GMO Survey and Press Roundup

EZ0003 Update on Biotechnology Legislation