Required Report - public distribution

**Date:** 7/14/2005

**GAIN Report Number:** LO5006

LO5006

**Slovakia**

**Biotechnology**

**Annual Report**

**2005**

**Approved by:**

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

U.S. Embassy

**Prepared by:**

Jana Mikulasova

**Report Highlights:**

As an EU member, Slovakia has fully implemented EU regulations on
biotechnology, and the growing of biotech crops is not prohibited.
However, Slovakia still does not have coexistence regulations in place,
and no biotech crops are grown or tested in the country. There is a
growing lack of consumer acceptance for biotechnology due to intense
anti-biotech campaigns led by NGOs and the influence of neighboring
countries. However, Slovak consumers have not been strongly averse to
buying biotech products in the past, and several retail chains offer
cooking oils made from biotech soybeans.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Vienna \[AU1\]

\[LO\]

**TABLE OF CONTENTS**

[SUMMARY 3](#summary-1)

[BIOTECHNOLOGY TRADE AND PRODUCTION
3](#biotechnology-trade-and-production)

[Biotechnology Crops in Slovakia 3](#biotechnology-crops-in-slovakia)

[Trade/Import of Biotech Crops 3](#tradeimport-of-biotech-crops)

[Food Aid 3](#food-aid)

[BIOTECHNOLOGY POLICY 3](#biotechnology-policy)

[Regulatory Framework 4](#regulatory-framework)

[Responsible Government Ministries
4](#responsible-government-ministries)

[Biosafety Committee 5](#biosafety-committee)

[Political Factors That May Influence Regulatory Decisions
5](#political-factors-that-may-influence-regulatory-decisions)

[Approved Biotechnology Crops 6](#approved-biotechnology-crops)

[Field Testing 6](#field-testing)

[Coexistence 6](#coexistence)

[Labeling 6](#labeling)

[Biosafety Protocol 8](#biosafety-protocol)

[Trade Barriers 8](#trade-barriers)

[MARKETING ISSUES 8](#marketing-issues)

[Market Acceptance 8](#market-acceptance)

[Country Specific Studies 8](#country-specific-studies)

[CAPACITY BUILDING AND OUTREACH 8](#capacity-building-and-outreach)

[Country Specific Needs or Strategies
8](#country-specific-needs-or-strategies)

[ADDITIONAL INFORMATION 8](#additional-information)

#   {#section .unnumbered}

# SUMMARY {#summary-1}

Slovakia still does not have coexistence regulations in place, and no
biotech crops are grown or tested in the country. However, the growing
of biotech crops is not prohibited. However, there is a growing lack of
acceptance of biotechnology in Slovakia because of an intense
anti-biotech campaign led by Greenpeace and the strong negative
influence of neighboring countries.

At the same time, Slovak consumers do not have major objections to
buying products containing biotech content, and several retail chains
offer cooking oils made from biotech soybeans.

Slovakia has already implemented all the necessary acts and established
responsible authorities for implementing all EU regulations on
biotechnology. The main responsible authority for biotech issues is the
Ministry of Environment.

U.S. seed companies interested in the Slovak market will probably not be
able to introduce their biotech seeds into the Slovak market before
2006/7.

# BIOTECHNOLOGY TRADE AND PRODUCTION

## Biotechnology Crops in Slovakia

Currently there are no biotechnology crops produced in Slovakia. The
main reason is politically motivated and due to the complicated Slovak
legislation that is stricter than the EU legislation.

For the average farmer it would be very difficult to provide all the
documents required by the Slovak Act on GMOs. Therefore, the growing of
biotechnology crops in Slovakia is essentially precluded at the moment.
This is also the main reason why U.S. biotechnology companies decided
not to place their seeds on the Slovak market this year.

Currently, Slovakia can be considered a "GMO-free" country. There are no
biotechnology crops under development and no field trials. Because the
biotechnology companies decided not to place their seeds on the Slovak
market this year, there are no seeds being planted either.

## Trade/Import of Biotech Crops

Slovakia imports soybean meal and oils that are produced from biotech
soybeans. Most of these biotech products are imported to Slovakia from
EU countries with a large percentage of the imports coming from the
Czech Republic and the Netherlands. However, the origin of most of these
transshipped products is U.S. or Brazilian.

Imports of soybean meal and oil to Slovakia have stagnated in recent
years. According to the Global Trade Atlas, Slovakia imports less than
200 thousand metric tons of soybean meal (HTS code 2304) and about 6
thousand MT of soybean oil (HTS code 1507) annually.

## Food Aid

Slovakia is not a food aid recipient. In fact, the country has been
facing agricultural overproduction. As a member of the EU, Slovakia is
not expected to need food aid in the future.

# BIOTECHNOLOGY POLICY

## Regulatory Framework

Slovakia is in the process of completing its legislative and
administrative framework for biosafety. The basic infrastructure is
already in place. Slovakia has participated since January 2003 in
UNEP/GEF (United Nations Environmental Program / Global Environmental
Fund) to implement the Cartagena Protocol provisions.

Act no. 151/2002 On the Use of Genetic Technologies and Genetically
Modified Organisms (Act on GMOs) is the main legislative act that
outlines the rules for use of genetically modified organisms. This act
came into force on April 1, 2002 and was recently amended by the Act on
GMOs no. 77/2005, which went into force on February 3, 2005.

The amendment lays out provisions for implementing the Cartagena
Protocol on preventing biotechnological risks, as well as implementing
regulation (EC) No.
[1946/2003](http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=en&type_doc=Regulation&an_doc=2003&nu_doc=1946)
of the European Parliament and of the Council on Transboundary Movement
of Genetically Modified Organisms. The Amendment designates one focal
point and competent authority in Slovakia. A single entity -- the
Ministry of Environment -- will fulfill the function of both the focal
point and the competent authority.

As of June 1, 2002, the regulation administering the Act on GMOs is
Decree no. 252/2002. The Ministry of Environment has been currently
working on an amendment to this decree. The decree outlines details
regarding:

a)  the content of an emergency response plan,

b)  requirements for the containment facility of a user, in which
    genetic technologies shall be used,

c)  the professional qualifications and training for the heads of
    projects related to contained uses of genetic technologies,

d)  the environmental risk assessment of using genetic technologies and
    on the procedures and criteria for assignment of genetic
    technologies to risk classes and on the content of containment
    levels,

e)  the procedures for evaluating the direct and indirect, immediate and
    delayed effects of introducing genetically modified organisms into
    the environment and the performance of analysis of cumulative
    long-term effects of genetically modified organisms on humans and
    the environment,

f)  the content of a dossier on the usage of genetic technologies and
    genetically modified organisms and on the manner for keeping its
    record,

g)  the content of a report on introducing genetically modified
    organisms into the environment,

h)  the content and keeping of registers for used genetic methods and
    genetic techniques and used modified genes,

i)  proprieties of particular notifications and evaluations of their
    content,

j)  other properties for applications on registering facilities and
    issuing consents

k)  the content of an evaluation report.

The amendment is supposed to simplify the forms used for the
above-mentioned procedures (i.e. registrations, notifications).

## Responsible Government Ministries

The competent authority under Directive 2001/18/EC is the Ministry of
Environment (MoE). The competencies of the MoE are mainly to:

-   issue consents for the contained use of genetic technologies and
    genetically modified organisms; the introduction of genetically
    modified organisms into the environment; and the placing of the
    product on the market

-   receive and assess notifications

-   receive notices on accidents and on detected changes on deliberate
    releases

-   receive applications for contained uses of genetic technologies and
    genetically modified organisms; the introduction of genetically
    modified organisms into the environment; and the placing of the
    product on the market

-   keeping a record of used genetic techniques

-   keeping a register of the facilities including the records of users
    of biotechnologies or GMOs, safety committees and heads of the
    projects

A listing of the registered users of genetic technologies and GMOs is
available on the MoE web site at
[www.enviro.gov.sk](http://www.enviro.gov.sk/). Currently there are 22
registered users of genetic technologies and GMOs for contained use that
are mainly Slovak research institutes and universities.

For matters regarding genetic technologies and modern biotechnology, the
MoE is the national notifier to the bodies of the European Communities
and the national centre for the safety of genetic engineering and modern
biotechnology. The Slovak Ministry of Environment participates in OECD
and EFSA (European Food Safety Authority).

Other competencies are covered by the Ministry of Agriculture (food,
feed, seed) and the Ministry of Health (community feeding).

Inspection and control authorities include the State Veterinary and Food
Administration (food control and inspection) and Central Institute for
Supervising and Testing in Agriculture (seeds, coexistence).

## Biosafety Committee

On September 27, 2004, the Minister of Environment appointed a Biosafety
Committee by Decision no. 46/2004. The Biosafety committee plays the
role as the advisory body to the Ministry of Environment and makes
recommendations.

Biosafety Committee members are specialists in biosafety. The chairman
of the Committee is Mr. Igor Ferencik, Director of Biosafety Dept. of
the Ministry of Environment (see more details in section CONTACTS).
Other Committee members are from ministries, institutes, associations
and university.

The body of experts consists of specialists from the following fields:

-   GMOs and food produced from GMOs

-   genetically modified plants and food produced from genetically
    modified material

-   genetically modified animals and feed and food produced from
    genetically modified material

-   GMOs and their impact on ecosystems

-   GMOs and their impact on human health

## Political Factors That May Influence Regulatory Decisions

The Slovak Ministry of Environment has quite a close relationship with
the Hungarian Ministry of environment and maintains contact with the
Austrian Ministry of Environment as well. The Slovak Ministers of
Environment and Agriculture are members of the Hungarian Coalition
party, which may influence them to follow Hungarian policy.

The neighboring countries of Slovakia (Austria, Hungary, Poland) belong
to a so-called "GMO free zone" in Europe, and in this regard there is a
slight political pressure on Slovakia to remain "GMO-free" as well.

According to sources, the Slovak decision-making process regarding
biotech policy is influenced more by politics/political issues than by
science-based facts.

Another factor that has a strong influence on regulatory decisions is
the pressure from NGOs, especially Greenpeace. Greenpeace Slovakia has
led an intense campaign against genetic engineering. As part of the
campaign, they issued a publication in color called "Consumers Guide,
How to Shop without GMOs". Based on such actions several Slovak retail
chains were forced to stop selling products containing GMOs in order to
avoid public criticism by Greenpeace and potential loss of their
customers.

Unfortunately, the Slovak mass media pays more attention to the
provocative actions of NGOs rather than the serious factual information
provided by scientists or private companies.

## Approved Biotechnology Crops

In Slovakia there are the same biotechnology crops approved for food,
processing, and feed as in the EU. So far there have been no approvals
for releasing biotechnology crops into the environment or for
field-testing.

On June 2, 2003, the Slovak Ministry of Environment issued an approval
(valid for 5 years) for importing and placing MON 810 YieldGard® on the
market for feed, food and technical purposes. However, because Slovak's
complicated regulatory system practically precludes the growing of
biotech crops, no commercial planting of biotech crops takes place in
Slovakia at present.

## Field Testing

The Slovak legislation allows field-testing. However, there are no field
trials taking place yet. The Research Institute of Plant Production and
some private companies will probably apply for the approval for field
tests next year.

## Coexistence

The Act on Coexistence is in preparation, but no rules on coexistence
are in place yet. The Central Institute for Supervising and Testing in
Agriculture, which is directed by the Ministry of Agriculture, is in
charge of preparing the act. However, the act will probably not come
into force before the summer of 2006.

This may have a negative impact on U.S. exports of biotech seeds and
seedlings to Slovakia. Nevertheless, U.S. biotechnology companies are
interested in the Slovak market and keep making efforts to change the
situation and enter the Slovak market in the near future.

## Labeling

In the European Union, the main legislation outlining the rules for
labeling packaged foods and products is Directive 2000/13/EC. As of
April 28, 2004, the labeling requirements in Slovakia are outlined in
the Food Codex by the Ministry of Agriculture and the Ministry of Health
under the second chapter, decree no. 1187/2004-100. The purpose of
labeling is mainly consumer's right to know.

General Requirements on labeling:

-   A food product must be labeled in a way that is not misleading for
    consumers, especially in relation to the characteristics, nature,
    place of origin, content, quantity, shelf-life, and way of
    processing. Graphical representation on the label must not be in
    contradiction to the structure of the food product. The label can
    contain other written, graphical or pictured information if those
    are not in contradiction to obligatory labeling and do not mislead
    consumers. Additional information must not decrease the legibility
    of the text.

-   Labeling by sellers is obligatory for wrapped and unwrapped food
    products.

-   Any false identification in labeling, cleaning, overwriting, or the
    removal of information is qualified as "falsification" of the food
    product.

-   According to the Food Codex, the text on labels (of distributed food
    products) must be in the Slovak language. Other language text is not
    forbidden, however it must not be an obstacle of legibility for the
    Slovak language.

-   Food products can enter the country with standard U.S. labels or
    unlabeled. However, products must be labeled according to the Food
    Codex chapter on labeling before placement on the market.

-   Stick on-labels meeting the local requirements are permitted. Food
    products introduced into circulation must be labeled on packages for
    final consumers, on external packages, or on its integral parts.

If food products require special conditions for handling, or if consumer
must be informed about food product properties, the label has to
indicate this information. Such cases include:

-   food products for special nutritional purpose, or special use

-   the presence of GMOs, their parts, derivatives and metabolites or
    their products

-   treatment of food products or their components by ionizing radiation

-   actual nutritional value of food product, package of which contains
    the nutritional claims

-   possible unfavorable influence on human health

In the case of new food products (including GMO), the following must be
stated:

-   content, nutritional value or nutritional influences if the food
    product contains new characteristics different from the common food
    product with the same name

-   presence of matter, which the common food product does not contain
    and which may have an influence on the health of certain groups of
    consumers

-   information, that the food product contains GMOs, their parts,
    derivatives and metabolites or their products, if this is stated by
    Food Codex

-   presence of the new matter, which is not present in common food
    products

Act on Feeds no. 184/1993 as amended by Act no. 472/2003 was recently
replaced with a new Act on Feeds no. 271/2005, which came into force on
July 1, 2005 and is harmonized with EU legislation. The act lays down
rules for:

-   registration of feed producers

-   requirements for introducing feed on the market

-   control of feeds

-   responsible government institutions

-   penalties for infringement of the Feed Act and of valid EU
    regulations.

Feed labeling has to be in accordance with Regulation (EC) No. 1830/2003
of the European Parliament and of the Council of September 22, 2003
Concerning The Traceability And Labeling Of Genetically Modified
Organisms And The Traceability Of Food And Feed Products Produced From
Genetically Modified Organisms And Amending Directive 2001/18/EC.

The rules for labeling are enforced by the State Veterinary and Food
Inspection authorities, and by the Ministry of Agriculture and by the
Central Institute for Control and Testing in Agriculture.

The inspection and control authority for food labeling is the State
Veterinary and Food Administration. The inspection and control authority
for feed labeling is the Central Institute for Supervising and Testing
in Agriculture and also the State Veterinary and Food Administration
(feeds for direct feeding at farms, feeds with animal origin). These
authorities take samples of products and impose fines for infringements
of the rules.

## Biosafety Protocol

Slovakia ratified the Cartagena Protocol on Biosafety on November 20,
2003, and it came into force on February 22, 2004. It was implemented in
the Act on GMOs No. 77/2005. The Act on GMOs No. 77/2005 implements the
precautionary principle for the safe transfer, handling and use of
living modified organisms resulting from modern biotechnology that may
have adverse effects on the conservation and sustainable use of
biological diversity and takes into account the risks to human health
and includes rules on transboundary movements.

## Trade Barriers

The Act on Coexistence is still being prepared and will probably take
another year to finish. Before the act comes into force, we cannot
expect U.S. biotech companies to introduce their biotech seeds to the
Slovak market.

Another trade barrier has been created by NGOs (Greenpeace) that have
led a strong campaign against genetic engineering and GMOs. Because of
Greenpeace several retail chains stopped selling products containing
biotech products. However, there are retail chains that are not afraid
to sell products containing GMOs (for example cooking oils).

The pressure on retailers has a negative impact on suppliers and
producers. Some retailers require a statement by the producers that
their products do not come from animals that were fed with GM feed. This
is a reason why U.S. soybean meal exports to Slovakia have stagnated
over recent years.

# MARKETING ISSUES

## Market Acceptance

The typical Slovak consumer is still quite price sensitive and biotech
content in a food product would not be a major factor in the buyer's
decision making process. This might change in the near future due to
threatening and sometimes misleading information about "GMOs" that is
systematically presented to the public by Greenpeace.

## Country Specific Studies 

In 2003, the Biosafety Department of the Ministry of Environment
organized a detailed opinion poll on the acceptance of GMOs by Slovak
citizens. The results can be downloaded from
[www.gmo.sk](http://www.gmo.sk/), and information about the poll can
also be found GAIN report LO4002.

# 

# CAPACITY BUILDING AND OUTREACH

Slovak officials have participated in agricultural biotechnology
programs under the Cochran Fellowship Program organized and sponsored by
USDA.

## Country Specific Needs or Strategies

According to the Ministry of Environment, Slovakia needs an institution
that could provide the MoE with support in research and monitoring
biotech crops and related tasks.

In regards to biotech policy, Slovakia's neighboring countries
significantly influence it. If the neighboring countries (mainly
Hungary) became less negative towards biotechnology, changes could be
expected in Slovakia as well.

# 

# ADDITIONAL INFORMATION

For more information, related contacts, and emerging issues regarding
biotechnologies in Slovakia see the following attaché reports. The
reports are available on-line at
<http://www.fas.usda.gov/scriptsw/AttacheRep/default.asp>.

LO5003 U.S. Seed Companies Agree Not to Plant Biotech Varieties this
Year (FAS internal use only)

LO5002 Amendment to GMO Act No. 151/2002

LO5001 NGOs Urge Slovak Ministry of Environment to Ban MON 810 (FAS
internal use only)

LO4011 Slovakia's Biosafety Framework

LO4002 Consumer Perception of Biotech

LO3005 Status of Biotech Regulations