Required Report - public distribution

**Date:** 4/7/2004

**GAIN Report Number:** EZ4011

EZ4011

**Czech Republic**

**Biotechnology**

**New GMO Law**

**2004**

**Approved by:**

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

U.S. Embassy

**Prepared by:**

Petra Choteborska

**Report Highlights:**

In February 2004, the Czech Republic passed law 78/2004 on genetically
modified organisms (GMO) replacing law 153/2000. The law officially came
into force on February 25, 2004, and major changes include an easier
approval process for contained use GMOs, as well as changes for the
participation of civic associations in the approval process. In January
2004, the Ministry of Environment approved Monsanto's YieldGuard corn
(MON810) for release on the market.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[EZ\]

######### New GMO Law 

######### 

######### Law 78/2004 on the handling of genetically modified organisms and genetic products ('GMO law') came into force on February 25, 2004 and replaced Law 153/2000 on GMOs. Law 74/2004 reflects the new EU Directive 2001/18/EC (GMO -- release into environment and on the market) and removes flaws from the first law on GMO and prepares the Czech Republic for EU membership (it establishes relations for the European Commission, which is common in the current EU countries). 

Major changes in the new law 74/2004 include:

-   Easier approval process for contained use (law 53/2000 was more
    strict than the EU directives, now it's in line with EU directives)

-   Approvals for release on the market - at the EU level

-   Approval processes are described in more detail

-   Information sharing with the public is different -- in law 53/2000
    civic associations (e.g. Greenpeace) could participate in the
    approval process; according to law 74/2004 the Ministry of
    Environment informs the public (on Ministry webpage:
    [www.env.cz](http://www.env.cz/) and in a Ministry bulletin) about
    the most important part of the application and the Ministry's
    decision -- within 30 days; anybody may appeal; if comments concern
    risks, the Ministry must set up a public hearing, and the Ministry
    must take the public hearing's vote into account when making a
    decision

-   Exchange of information with the EU

Law 74/2004 concerns only living organisms and products containing
living organisms (according to Cartagena Protocol). It does not concern
drugs, feeds, foodstuffs, herbicides containing GMO, and contained use
of safe genetically modified microorganisms (GMM).

Like 53/2000 law 74/2004 regulates GMO for:

-   Contained use -- laboratories, greenhouses (approval is issued to
    users; easier procedure now: 1^st^ and 2^nd^ risk category -- only
    announcement, 3^rd^ and 4^th^ risk category -- request for approval)

-   Release into environment -- field trials, growing on small areas
    (approval is issued to users)

-   Release on the market -- import, processing, sale, growing including
    variety testing (approval is issued for GMO, anyone can use it if
    approved); after accession European Commission will be part of
    approval process; member states voting; complicated procedure

> Requirements on GMO approval for release on the market:

-   Labeling

-   Growers of GM crops must inform Ministry of Environment about place
    of the growing

-   Co-existence rules (Ministry of Agriculture is working on the
    decree)

-   Monitoring and sending samples to the Ministry of Environment

> (according to regulation ES 1830/2003 on labeling and monitoring)

When a GMO is approved for release on the market, it is automatically
approved for the whole EU. However, plant varieties containing a GMO
registered on the national registers are not automatically registered at
the EU level.

So far the Ministry of Environment approved the following biotech
products:

-   In the environment: Bt corn, RR corn, potatoes, flax, rapeseed

-   On the market: Bt corn, RR soya (only for import, not for growing)

After EU accession on May 1, 2004, the following regulations will apply
for the Czech Republic directly (sanctions will be applied according to
national regulations) in regards to GMOs:

-   Regulation 1829/2003 on genetically modified foodstuffs and feeds

-   Regulation 1830/2003 on labeling and monitoring of GMO, foodstuffs
    and feeds

-   Regulation 1946/2003 on border-crossing of GMO (Cartagena Protocol
    -- regulates export; 74/2004 will regulate import)

###### Results of test on GMO in food products

######### Last year the State Agricultural and Food Inspection (SAIF) tested over 192 products and detected 24 containing GMOs. All contained soybeans or products made of soybeans. GMO content was 0.9 %, and therefore products did not require labeling (they have to labeled if GMO content is over 1 %). 

**Monsanto's YieldGard corn (MON810) approved**

In January 2004, the Ministry of Environment finally approved Monsanto's
YieldGuard corn (MON810) for commercial planting (in compliance with the
seed legislation) and import (approval for release on the market). For
more background information on problems with this approval -- please see
report GAIN Report EZ3018 at
[www.fas.usda.gov](http://www.fas.usda.gov/).

[Related Reports:]{.underline}

EZ4010 National Biosafety Framework

EZ4001 Status of Biotech Regulations -- Central Europe

EZ3020 Consumer Perceptions of Biotechnology

EZ3015 Biotechnology from a Czech Perspective