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Voluntary Report - public distribution

**Date:** 10/24/2003

**GAIN Report Number:** EZ3012

EZ3012

**Czech Republic**

**Biotechnology**

**Status of Biotech Regulations**

**2003**

**Approved by:**

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

#### U.S. Embassy

**Prepared by:**

Petra Choteborska

**Report Highlights:**

The Czech Republic is harmonizing its biotech legislation to that of the
European Union (EU) in anticipation of EU accession May 1, 2004. Act
153/2000 is the current law regulating registration and use of biotech
products in the Czech Republic. The law came into force in January 2001
and is based on EU rules on biotechnology. Currently, there is a new law
in the Parliament that should replace 153/2000. U.S. biotechnology
companies operating in the Czech Republic are working to achieve public
acceptance of biotech products. They are explaining biotechnology to
regulators, so that new member states will be able to stand together and
defend scientific views and oppose political arguments of current EU
members.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[EZ\]

**Relevant Laws And Regulations**

Act 153/2000 is the current law regulating registration and use of
biotech products in the Czech Republic. The law came into force in
January 2001 and is based on EU rules on biotechnology. It only
regulates living organisms and products containing living organisms
(e.g. tomatoes), not foods made from these products (e.g. ketchup), and
not feed. Foods and feeds have additional regulations.

The responsible government authority for controlling biotech product use
and biosafety is the Ministry of Environment (Environmental Risks
Department). It cooperates with the Ministry of Health and the Ministry
of Agriculture. The law establishes a Commission for the Use of
Genetically Modified Organisms (GMOs), which acts as an advisory body to
the Ministry of Environment. The Commission is made up government
officials, scientists, and representatives from non-government
organizations (NGOs). The Commission assesses applications for biotech
product releases or uses and provides its recommendation to Ministry.

Act 153/2000 defines several lists:

List of users -- companies and organizations using and working with
biotech products (e.g. Monsanto, universities, research institutions)

List for contained use (List A) -- for microorganisms; used more for
medical and pharmaceutical purposes ('red biotechnology')

List for introduction into the environment (List B) -- field trials of
biotech crops

List of placement on the market (List C) -- for import and growing
biotech crops

If biotech products are to be used in foods, they must be registered
according to Act 153/2000 and then according to Food Act 306/2002. The
State Health Institute tests the products and sends its comments to the
Ministry of Health, which is the responsible authority for approving
biotech products in foodstuffs.

If a biotech product is to be used in feed, it first has to be
registered according to Act 153/2000, and then Feed Act 91/1996 is
applied. Feed companies have to notify the Central Control and Testing
Institute in Agriculture (CCTIA, in Czech UKZUZ). Currently, there is a
draft of the amendment to Act 91/1996 in the Parliament in which feed
companies would not need to notify CCTIA. In addition, feeds would come
under the EU's Food and Feed Regulation as of May 2004.

If a biotech product is to be used as seed, it has to be registered
according to Act 153/2000, and then the Plant Varieties Act 219/2003 is
applied.

Pesticides for use on biotech crops (e.g. Round-up Ready herbicide) are
regulated by Phytosanitary Act 147/1996. If the herbicide itself
contains some biotech product, it first has to be registered according
to Act 153/2000, and then 147/1996 is applied.

Before a variety is approved for commercial growing, it has to be field
tested for three years and approved according to Act 153/2000 for
placement on the market.

The New Act on GMOs, which should replace Act 153/2000 and which
implements EU Directive 18/2001, is now in the Parliament. Major
(expected) changes include:

Market release is approved by competent authority of the EU member state

Establishes links to the EU approval process (Czechs will also have some
say in the approval process in the EU and varieties approved in the EU
will be automatically approved in the Czech Republic)

Tracebility -- public registration (farmers); however, information about
their location will not be available on the Internet

NGOs are removed from direct participation in the approval process

There is more information on monitoring

If approved by Parliament, it should become effective in the last
quarter of 2003.

Feed Act 91/1996 has now been amended in the Parliament, and the
conditions for labeling and registration for biotech feeds has been
withdrawn. In May 2004, the EU's new Food and Feed Regulation will be
applied.

**Biotech Crops Registered in the Czech Republic**

[Approved:]{.underline}

RR Soya -- registered in List C for placement on the market (January
2001) with approval granted for 10 years. The Czech Republic does not
have the climatic conditions to grow soya. Therefore, it is only
approved for import. It is also approved for use in food according to
Act 306/2002 and for use in feeds according to Act 91/1996.

YieldGard corn (Bt corn) -- registered in List B for field trials
(January 2002) with approval granted for 3 years. For field trials only,
registration according to Act 153/2000 is necessary.

YieldGard corn (Bt corn) -- applied (October 2002) for placement on the
market (List D, for import, processing, and growing). Still in
registration process. If approved, biotech product can be grown
commercially after three years of variety registration trials (according
to Plant Varieties Act 219/2003).

RR corn -- registered in List B for field trials (February 2002) with
approval granted for 3 years. Again, only registration according to Act
153/2000 is necessary.

[Not approved:]{.underline}

RR wheat -- applied for registration in List B for field trials (June
2001). The Ministry of Environment returned the application for
incomplete documentation. After many discussions the applicant (a
biotechnology company) decided not to provide the requested confidential
information.

#### Regulatory Process

The approval process for registration of biotech products contains the
following steps:

Interested party fills out the application (on and sends four copies to
the Department of Environmental Risks at the Ministry of Environment
(MoE).

GMOs section of MoE sends copies to the Ministry of Agriculture (MoA),
the Ministry of Health (MoH), the Chairman of the Czech Commission for
GMOs Approval at MoE, and maintains one copy for its own reference and
use.

Non-government organizations (NGOs) are informed about the request and,
if they are interested, become part of the administrative process and
send their comments to MoE.

If the MoE approves a biotech product that NGOs advised not to approve,
NGOs may appeal to the Analytical Commission of MoE, whose lawyers and
experts will solve the dispute.

MoA and MoH have 45 days to send their comments to MoE.

The Department of Hygiene, Epidemiology, and Microbiology at MoH sends
the request to the State Health Institute (SHI) in Brno. The Institute
has a Working Group of five people for studying the request and
preparing comments for the Ministry of Health. If necessary the working
group asks various external specialists for their views. The comment
from the working group is sent to MoH, where the Chief Hygienist signs
and sends the comment to the MoE. MoA's Commission of Agricultural
Production Department assesses the biotech product from an agricultural
standpoint. The six member committee includes: the director of the
department as chairman, two department officials, two officials from the
Control and Testing Institute in Agriculture, and one official from the
State Agricultural and Food Inspection.

When MoE receives comments from both MoA and MoH, the GMOs section of
MoE assesses the comments and decides whether to approve and register
the biotech product.

If the request cannot be approved it is returned to the applicant, who
can add missing information and resubmit the request. According to Act
153/2000, MoE has to reply to the applicant within 90 days of receiving
the request for a biotech product approval.

If MoE approves an application and a civic organization such as
Greenpeace becomes part of the administrative procedure and does not
agree with the decision, the civic organization may appeal the decision
to the Analytical Commission of the Ministry of Environment within 15
days.

Once MoE approves a biotech crop for growing, it has to be registered
according to Plant Variety Act 219/2003 in the Control and Testing
Institute for Agriculture (3 years of variety registration trials).

#### 

#### Documentation

A complete packet of information required for consideration of approval
of biotech crop is in supplements of Decree 374/2000 and is available on
Ministry of Environment webpage (see end of report). It contains the
following requirements:

Detailed information about the user (person or a company)

Information on a scientific advisor

Purpose and time period of use for biotech product

Detailed risk assessment

Detailed information on GMO, method of its insert into the crop, its
detection, if it was approved in some country, amount of biotech product
to be used, etc.

Detailed information about biotech product, use, method of biotech
detection, packaging, labeling

Handling biotech products. In case of import, country of origin,
importer, transportation, etc.

Supplementary information including evidence of biotech products,
storage, communication with the Ministry, etc.

#### Penalties

The State Agricultural and Food Inspection Service tests agricultural
products for biotech content on a random basis. If a product with
containing over 1 percent of biotech product is not labeled, the
Ministry of Environment may issue a fine from 100,000 CZK to up to 3
million CZK. Soybeans are tested quite often, while corn is seldom
tested.

#### Labeling and Tracebility

There is no tracebility system being implemented yet. The Czech Republic
is waiting until EU accession and then will apply the EU\'s Tracebility
and Labeling Regulation. Registered products (e.g. RR soya) have to be
labeled as biotech products.

One percent is the threshold requirement for labeling. There is no
documentation needed for agricultural products containing over 1 percent
of biotech product. However, they must be labeled.

Information on the label must say, "contains genetically modified
organism". Terms like "biotech-free", "non-biotech", "GMO-free", or "may
contain" do not appear in the Czech legislation. Some companies put "non
GMO" or "GMO-free" on their products (e.g. on oils) as part of it's
marketing strategy to attract customers. All products that have
ingredients containing over 1 percent of biotech product must be labeled
(including consumer ready products).

Feeds containing RR soya will not have to be labeled until May 2004
according to the amended Feed Act 91/1996.

#### Government and Other Contacts

Organization: Ministry of Environment

Contact: Dr. Karel Blaha

Title: Head of Environmental Risks Department

Address: Vrsovicka 65, 100 10 Praha 10, Czech Republic

Tel: +420-267-122-532

Fax: +420-267-310-013

E-mail: blaha \@env.cz

URL: www.env.cz

Organization: Ministry of Agriculture

Contact: Dr. Ivan Branzovsky

Title: Deputy Director of Agricultural Production Department

Address: Tesnov 17, 117 05 Praha 1, Czech Republic

Tel: +420-221-812-693

Fax: +420-221-812-705

E-mail: branzovsky@mze.cz

URL: www.mze.cz

Organization: Ministry of Health

Contact: Dr. Karla Rihova

Title: Director of Hygiene and Epidemiology

Address: Palackeho nam. 4, 128 01 Praha 1, Czech Republic

Tel: +420-224-972-434

Fax: +420-224-916-007

E-mail: karla.rihova@mzcr.cz

URL: www.mzcr.cz

Organization: State Health Institute

Contact: Dr. Jiri Ruprich

Title: Chief Hygienist, Food Chain Hygiene Center

Address: Palackeho 1-3, 612 42 Brno, Czech Republic

Tel: +420-549-250-251

Fax: +420-541-211-764

E-mail: jruprich@chpr.szu.cz

URL: www.szu.cz

Organization: State Agricultural and Food Inspection

Contact: Dr. Jana Palackova

Title: Deputy Director

Address: Kvetna 15, 603 00 Brno, Czech Republic

Tel: +420-543-540-203

Fax: +420-543-540-210

E-mail: jana.palackova@szpi.gov.cz

URL: www.szpi.cz

Organization: Biotrin, Civic Accosition

Contact: Prof. Jaroslav Drobnik

Title: Chairman

Address: Vinicna 5, 128 44 Praha 2, Czech Republic

Tel: +420-221-953-405

Fax: +420-224-918-862

E-mail: j.drobnik@atlas.cz

URL: www.biotrin.cz

(Exchange rate: October 2003: 1\$ = 28 CZK)