Required Report - public distribution

**Date:** 8/27/2008

**GAIN Report Number:** E48082

E48082

**EU-27**

**Biotechnology**

**Annual**

**2008**

**Approved by:**

Elizabeth B. Berry/Bobby Richey Jr.

U.S. Embassy, Paris

**Prepared by:**

Marie-Cecile Henard, Dietmar Achilles, Barrie Williams and the group of
FAS biotech specialists in the EU

**Report Highlights:**

There are seven Member States (MS) commercially producing
genetically-engineered (GE) crops, with Spain being, by far, the largest
producer. Under the EU policy framework for agricultural biotechnology,
MS policy varies greatly. Coexistence frameworks have been set up in
most MS or are currently being prepared, and 5 MS continue to maintain
national bans. However, the EU is a major consumer of biotech products,
mainly soybean meal imported to feed livestock and poultry, with at
least 80 percent of EU soy crush estimated to be genetically modified.
Finally, agricultural biotechnology research in Europe is declining,
mainly due to political pressure.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Paris \[FR1\]

\[E4\]

Table of Contents

[Executive Summary 3](#__RefHeading___Toc211742358)

[Biotechnology Research, Trade and Production
4](#biotechnology-research-trade-and-production)

[EU BIOTECH AREA GRADUALLY EXPANDING
4](#eu-biotech-area-gradually-expanding)

[DESPITE POLITICS, EU IS A MAJOR BIOTECH CONSUMER
4](#despite-politics-eu-is-a-major-biotech-consumer)

[EU RESEARCHERS SEEK MORE SUPPORTIVE ENVIRONMENTS:
5](#eu-researchers-seek-more-supportive-environments)

[Biotech Regulatory System in the EU-27
5](#biotech-regulatory-system-in-the-eu-27)

[EU-27 Framework for Environmental Release
5](#eu-27-framework-for-environmental-release)

[Labeling of Food and Feed and Traceability of Biotech Products
6](#labeling-of-food-and-feed-and-traceability-of-biotech-products)

[International Trade Issues Continue
7](#international-trade-issues-continue)

[Member States Policy VarIES Greatly
7](#member-states-policy-varies-greatly)

[New Technologies 8](#new-technologies)

[Food Products from Cloned Animals
8](#food-products-from-cloned-animals)

[Nanotechnology 8](#nanotechnology)

[Annexes 10](#annexes)

[Annex I: Member States Individual Situations
10](#annex-i-member-states-individual-situations)

[Annex II: Community Register of Authorized Genetically Modified Food
and Feed
19](#annex-ii-community-register-of-authorized-genetically-modified-food-and-feed)

[Annex III: Genetically modified food and feed pending authorization
27](#annex-iii-genetically-modified-food-and-feed-pending-authorization)

[Annex IV: Regulation (EC) No 258/97, Genetically Modified Food
Authorized (until January 17, 2006)
31](#annex-iv-regulation-ec-no-25897-genetically-modified-food-authorized-until-january-17-2006)

[Annex V: Genetically Modified Feed Authorized Under Directive
2001/18/EC
33](#annex-v-genetically-modified-feed-authorized-under-directive-200118ec)

[Annex VI: Pending Authorizations Under Directive 2001/18
35](#annex-vi-pending-authorizations-under-directive-200118)

[Annex VII: Member States Policies
36](#annex-vii-member-states-policies)

[Annex VIII: EU -27 Production of GE Crops by Region
43](#annex-viii-eu--27-production-of-ge-crops-by-region)

[Annex IX -- Field Register Status by EU Member State
44](#annex-ix-field-register-status-by-eu-member-state)

[Annex X - Extent of Field Releases of GE Crops
46](#annex-x---extent-of-field-releases-of-ge-crops)

The report represents a group effort of the following FAS analysts:

Dietmar Achilles FAS/Berlin covering Germany

Mila Boshnakova FAS/Sofia covering Bulgaria

Monica Dobrescu FAS/Bucharest covering Romania

Bob Flach FAS/The Hague covering the Benelux Countries

Mike Hanley FAS/Dublin covering Ireland

Marie-Cecile Henard FAS/Paris covering France

Roswitha Krautgartner FAS/Vienna covering Austria

Hasse Kristensen FAS/Copenhagen covering Denmark

Jolanta Figurska FAS/Warsaw covering Poland, Latvia, Lithuania & Estonia

Asa Lexmon FAS/Stockholm covering Sweden and Finland

Arantxa Medina FAS/Madrid covering Spain and Portugal

Jana Mikulasova FAS/Prague covering the Czech Republic and Slovakia

Andreja Misir FAS/Zagreb covering Slovenia

Ferenc Nemes FAS/Budapest covering Hungary

Sandro Perini FAS/Rome covering Italy

Stamatis Sekliziotis FAS/Athens covering Greece

Barrie Williams FAS/USEU/Brussels

Jennifer Wilson FAS/London covering the U.K.

# 

# 

# 

Executive Summary

This report consolidates and updates the annual biotechnology reports
prepared in 2006 in individual EU Member States (MS).

In the past several years, yield benefits and cost savings of
genetically engineered (GE) crops have made them attractive to EU
farmers, and the production of biotechnology crops (currently only one
corn event) continues to expand in certain Member States. Despite
regulatory restrictions and political threat, the area devoted to
biotech corn is expected to increase to approximately 110,000 ha in 2009
(mainly located in Spain, the Czech Republic, Portugal, Slovakia and
Germany).

Under the EU policy framework for agricultural biotechnology, MS policy
varies greatly. Virtually all MS have transcribed EU Directive 2001/18
and implement EU regulations on traceability and labeling. Most MS have
set up national coexistence frameworks for biotech and non-biotech crops
(Belgium, Czech Republic, Germany, Hungary, Portugal, Romania, Slovakia)
or are currently preparing coexistence rules (France, Spain, the United
Kingdom). Some MS continue to maintain national bans on
genetically-engineered crops (Austria, France, Greece, Hungary and
Italy).

The main biotech products used are in animal feed, human food, planting
seeds, and the textile industry. They consist of soybeans and products,
corn and its derivatives, and cotton. The largest categories of GE
products consumed primarily consist of soybean meal, where GE products
are estimated to represent 80 to 95 percent, and of corn and corn
products (mainly corn gluten feed), in which GE products are estimated
to account for 10-25 percent only.

While research in agricultural biotechnology is a stated priority of the
European Commission and many MS, in reality, many research scientists
have either been forced to drop activities due to political pressure or
have moved to institutions (particularly in the United States) where
support for such research is undeterred. This reduction in research
activities has also translated into a reduction in field trials, which
have also suffered from actions of intimidation by activist groups.

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# Biotechnology Research, Trade and Production 

## EU BIOTECH AREA GRADUALLY EXPANDING 

Since the approval of the first biotech corn event for planting in the
EU, Spain has been the country that has most rapidly adopted its use.
Prior to its accession to the EU, Romania was a major producer of
biotech soybeans. However, since biotech soybeans are not approved for
planting in the EU, this ended in 2007 with its accession to the EU.
Interest across farming groups in the EU in the use of agricultural
biotechnology continues to expand, particularly as the cost of inputs is
increasing. This has made the yield benefits and cost saving especially
attractive. As a result, the area devoted to biotech crops (currently
only one corn event) continues to expand gradually. However, many
growers are constrained by restrictions placed in land rental contracts,
threats by neighbors, and intimidation by NGO's. See Annex VIII for
biotech crop production in EU member states in 2007 and 2008. In several
EU member states (Austria, the Czech Republic, France, Germany, Greece
and Romania), farmers producing biotech corn must register their fields
with government bodies. The specificity of these registration
requirements varies greatly from country to country. See Annex IX for a
summary of field registry requirements.

![](media/image2.wmf){width="5.414583333333334in"
height="4.417361111111111in"}

## DESPITE POLITICS, EU IS A MAJOR BIOTECH CONSUMER 

The main biotech products used in each Member State are in animal feed,
human food, planting seeds, and the textile industry. They consist of
soybeans and products, corn and its derivatives, and cotton.

The largest category of GE products consumed by Member States consists
of soybean meal, which is used in animal feed. The EU-27 roughly
consumes 33 million MT of soybean meal annually in animal feed (see
EU-27 report E48062 dated 05/30/2008). The bulk of the soybean meal
consumed in the EU is imported or produced from imported soybeans,
mainly coming from North and South America. GE products are estimated to
represent 80 to 95 percent of the total soybean meal used by Member
States, i.e., 26 to 31 million MT. Similarly, the EU-27 crushes
approximately 14 million MT of soybeans annually, and at least 80
percent is estimated to be GE products, i.e., 11 million MT.

However, there is a niche market for non-GE soybeans and soybean meal
used in animal feed, mainly for the poultry sector and other animal
production undertaken under the Identity Preservation program or
geographical indications, or for human consumption for soybeans (such as
in baby food).

Corn and corn products (mainly corn gluten feed) represent the second
largest category of GE products used in animal feed. However, the share
of GE products out of total corn consumption is generally estimated to
be significantly lower (10-25 percent) than for soybean products. This
is mainly due to the fact that the EU-27 does not rely as much on
imports of corn and corn-derived products as for soybean products.

## EU RESEARCHERS SEEK MORE SUPPORTIVE ENVIRONMENTS: 

Research into agricultural biotechnology is a stated priority of the
European Commission and many of the Member States. However in reality,
many research scientists have either been forced to drop activities due
to political pressure or have moved to institutions (particularly in the
United States) where support for such research is undeterred. This
reduction in research activities has also translated into a reduction in
the operation of field trials. For several years, researchers and
universities were able to implement field trial activities successfully.
However, beginning in 2007, activist groups succeeded in intimidating
many research stations and universities into dropping field trial work.
As a result, the requests for permits to conduct field trials fell
dramatically in 2008. In addition, field trial destructions have
continued with little or no response from police and judicial
authorities in many areas. See Annex X for a summary of field trials in
the EU-27.

The situation and policy issues across EU member states vary greatly.
Please see Annex I for an overview of the most important issues
currently facing agricultural biotechnology in each member state.

# Biotech Regulatory System in the EU-27

## EU-27 Framework for Environmental Release 

## 

Europe's regulatory framework for biotechnology was established with the
adoption of [Council Directive
90/220/EEC](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0220:19940512:EN:PDF)
"on the deliberate release into the environment of genetically
engineered organisms" and [Council Directive
90/219./EEC](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0219:20050305:EN:PDF)
"on the contained use of genetically modified micro-organisms."

The framework was significantly revised by [Council Directive
2001/18/EC](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0018:20080321:EN:PDF)
to strengthen existing rules on the deliberate release of genetically
engineered products into the environment. Directive 2001/18/EC is
implemented in each EU Member State through national legislation. It
sets out procedural guidelines for experimental field trials (Part B
Authorization) and commercial introduction into the market (Part C
Authorization). Specific measures include:

-   environmental risk assessment,

-   mandatory post-market (environmental) monitoring,

-   mandatory supply of information to the public,

-   mandatory labeling and traceability at all stages of placing on the
    market,

-   and the establishment of a molecular register.

Authorizations, which can be renewed, are granted for a maximum period
of ten years starting from the date when the authorization is first
issued. If a GE product reaches the EU market, the applicant is obliged
to ensure that post-market monitoring and reporting is carried out
according to the conditions specified in the authorization.

[Council Directive
98/81/EC](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0081:19981205:EN:PDF),
amending Directive 90/219/EEC, regulates research and industrial work
involving the contained use of genetically engineered micro-organisms.

In addition to these Directives, there is a series of EU Regulations
which govern the approval and use of genetically engineered products
(Note: Unlike EU Directives, EU Regulations do not need to be transposed
into national legislation, and therefore are immediately and
simultaneously enforceable as law in all EU Member States).

Applications are first submitted to the competent authority in a Member
State where the product is to be marketed. The application must clearly
define the scope (i.e. for cultivation, for import, etc...), and must
also include a monitoring plan, a labeling proposal, and a detection
method for the GE product. The national authority informs the European
Food Safety Agency (EFSA), and acknowledges receipt of the application
within 14 days. After a "completeness check" to ensure all required
documentation has been properly submitted, EFSA endeavors to deliver an
Opinion within six months. In practice, the "6 month EFSA clock" can
stop at any point to request supplemental information from the
applicant. During this time, EU Member States can also comment on the
pending application. Once EFSA has completed an Opinion, the Commission
has three months to draft a proposal for granting or denying
authorization. The Commission's proposal can be approved by a qualified
majority vote of the Member States in the Standing Committee on the Food
Chain and Animal Health. If the Committee is unable to agree on the
Commission's proposal, it is then subject to a qualified majority vote
by the [Council of
Ministers](http://www.consilium.europa.eu/cms3_fo/showPage.asp?lang=EN).
If the Council does not act within 3 months, the Commission adopts the
Decision. For more information on EFSA and the EU regulatory process:

<http://www.efsa.europa.eu/EFSA/Non_Scientific_Document/gmo_factsheet2,0.pdf>.

## Labeling of Food and Feed and Traceability of Biotech Products 

Labeling requirements for GE food were first adopted in the Novel Foods
[Regulation (EC) No
258/97](http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997R0258&model=guichett).
Specific requirements for GE corn and soybean lines were outlined in
[Council Regulation (EC) No
1139/98](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:159:0004:0007:EN:PDF),
and were later amended in [Commission Regulation (EC) No
49/2000](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:006:0013:0014:EN:PDF).
While maintaining the idea that a GE food or ingredient could not be
considered equivalent to its non-GE counterpart (as long as the genetic
engineering was detectable), the latter regulation attempted to address
the problem of unintended presence of GM by introducing the concept of a
threshold. As long as the GM-derived food ingredient material was below
1 percent of individual ingredients, food stuffs would not be subject to
specific labeling requirements. Food additives and flavorings are
regulated under [Commission Regulation (EC) No
50/2000](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:006:0015:0017:EN:PDF).

With the introduction of [Regulation (EC) No
1829/2003](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003R1829:20080410:EN:PDF)
on '*genetically modified food and feed*', and [Regulation (EC) No
1830/2003](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:268:0024:0028:EN:PDF)
on '*the traceability and labeling of genetically modified organisms*',
the EU sought to create greater coherence in the regulatory framework
for authorization, labeling and traceability. Regulation (EC) No
1829/2003 establishes a "one door, one key" principle, enabling a single
application for authorization of release into the environment (according
to the criteria set in Directive 2001/18/EC), and the authorization for
use as food or feed. The authorization depends on a positive risk
assessment by the [European Food Safety Authority
(EFSA)](http://www.efsa.europa.eu/EFSA/KeyTopics/efsa_locale-1178620753812_GMO.htm)
and a risk management process involving the European Commission and EU
Member States through a [regulatory committee
procedure](http://ec.europa.eu/food/committees/regulatory/index_en.htm).

Note: See Annex II for a list of all genetically engineered food and
feed events approved in the EU, including those events whose
authorizations have expired. Annex III contains products whose
applications are pending. Annex IV lists those genetically engineered
foods authorized under Regulation (EC) no 258/97. Annex V contains those
genetically engineered feeds authorized under Directive 2001/18/EC.Aneex
VI contains Applications pending under Directive 2001/18.

## International Trade Issues Continue 

The EU regulatory approach to biotechnology has had a significant impact
on international trade. In 2006, the [WTO Dispute Settlement
Body](http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm)
found that the EU had breached [Article
8](http://www.wto.org/English/tratop_e/sps_e/spsagr_e.htm) of the SPS
Agreement by instituting a *de facto* moratorium on the approval of
biotech products. The European Commission and the United States have a
continuing dialogue on how to normalize trade in products of modern
agricultural biotechnology. This dialogue is an effort to address and
correct the WTO inconsistent parts of the EU's process. Aside from the
WTO case, the EU is facing great challenges in the asynchronous approval
of products already legally available in other countries. Trade has been
periodically disrupted by products that have been approved for
cultivation in other countries, but remain illegal in the EU. For
example, U.S. market access for corn gluten feed and distillers dried
grains has been effectively lost due to this problem. Such disruptions
tend to affect availability and prices. EU labeling regulations provide
for a 0.9 percent threshold for the \"adventitious\", that is,
accidental and technically unavoidable, presence of authorized biotech
event in a non-biotech food or feed. Amounts above 0.9 percent must be
labeled. The EU also temporarily authorized a 0.5 percent threshold for
genetically engineered material not yet authorized by the EU, but that
had already received a favorable EU scientific assessment. Although the
0.5 percent threshold provision expired in April 2007, discussions are
currently under way to re-evaluate the technical definition of "zero
tolerance."

The EU is a party to the Cartagena Protocol on Biosafety, and regulates
the transboundary movement of genetically modified organisms through
[Regulation (EC) No
1946/2003](http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:287:0001:0010:EN:PDF).

## Member States Policy VarIES Greatly 

## 

Virtually all Member States have transcribed EU Directive 2001/18 and
implement regulations on traceability and labeling. Most Member States
have set up national coexistence frameworks for organic, biotech, and
conventional crops (Belgium, Czech Republic, Germany, Hungary, Portugal,
Romania, Slovakia) or are currently preparing coexistence rules (France,
Spain, the United Kingdom). Some Member States continue to maintain
national bans on genetically-engineered crops (Austria, France, Greece,
Hungary, Italy, and Poland). See Annex VII for detailed information on
detailed Member States policies.

# New Technologies

As reporting and knowledge about the development of new technologies in
agriculture and food production has expanded, many of the same public
perception issues have arisen in the EU that have faced agricultural
biotechnology over the past 10 years. These include traceability and
labeling, advantages for consumers, and regulatory regimes. At the
present, there do not appear to be any emerging advocates for these new
technologies in the EU. However, it is clear the same EU groups that
have actively opposed the timely regulation and adoption of agricultural
biotechnology are ready to activate negative campaigns and burdensome
regulatory requirements regarding new agricultural or food technologies.
For example, the European Commission recently proposed a new novel foods
regulation which includes coverage of food products from cloning and
nanotechnology. In its current form, many key components of this
proposal are ill-defined. In addition, it envisions an onerous
pre-market approval process. It could also require products approved
under the regulation to carry mandatory labels and to be subject to
significant post-market monitoring, even if determined to be
substantially equivalent to conventional counterparts.

## Food Products from Cloned Animals 

Currently, the EU claims that there are no food products in the EU
market derived from cloned animals or their progeny.

In December 2007, the European Food Safety Agency (EFSA) provided a
draft scientific opinion on food safety and welfare and environmental
impact of animals derived from cloning by somatic cell nucleus transfer
and their offspring and products obtained from these animals. A report
was issued on July 24, 2008. In the draft report EFSA stated that
researchers found no difference exceeding the normal variability in the
composition and nutritional value of meat from swine and cattle and cow
milk between healthy clones or the progeny of clones and their
conventional counterparts. The currently available data indicate that
food products from cloned cattle and pigs and their progeny are as safe
as food products of livestock derived by conventional breeding.

EFSA stated that based on current knowledge there is no expectation that
clones or their progeny would pose any new or additional environmental
risk compared with conventionally bred animals. The entire report can be
accessed at the following address:
<http://www.efsa.europa.eu/EFSA/DocumentSet/sc_opinion_clon_public_consultation.pdf>
.

In January 2008, the European Group of Ethics (EGE) published their
opinion on ethical aspects of animal cloning for food supply. The EGE
has doubts as to whether cloning animals for food supply is ethically
justified. Whether this applies also to progeny is open to further
scientific research. The entire report can be accessed at the following
address:
<http://ec.europa.eu/european_group_ethics/activities/docs/press_release_opinion23_en.pdf>.

## Nanotechnology 

Nanotechnology is a broad field in which the manipulation of matter at
the molecular or atomic level occurs. Rapid advances are being made in
industrial manufacturing and chemicals (such as food additives and
supplements) in Europe. The news media and NGOs have in recent years
exaggerated claims about hazards and potential use for this technology.
Consumer groups have begun to ask questions about risks of
nanoparticle-containing products and processes. They are demanding
definitions and nano-specific legislation and post market regulation.
Products such as sun creams, cosmetics and textiles containing
nanoparticles have raised concerns as these are already available on the
market.

The United States and the EU have established a working group focusing
on food and agricultural applications of nanotechnology. This
research-oriented group continues to discuss advances made in
nano-biotechnology, with applications that could directly benefit
consumers through better food packaging, spoilage detection and nutrient
absorption.

# Annexes

## Annex I: Member States Individual Situations

**Austria:** Austria remains one of the leading forces within the EU
Europe against agricultural biotechnology. Zones restricting the use of
biotechnology exist in all nine provinces, and all Austrian provinces
are members of the "European Network of GMO-free Regions". National
ordinances still effectively prevent the planting of EU approved biotech
crops. Responding to consumers' and politicians' anti-biotech attitudes,
and NGOs' anti-biotech lobbying, the Austrian retail sector has agreed
to refrain from stocking or selling biotech foods. Presently, only
biotech feed (soybean meal) can be found in the Austrian market.

Since their inception, the Austrian Government successfully defended
national bans on EU approved biotech crops because the European
Commission proposals to require their removal were blocked by the EU
Council. However, since there was no Council agreement, the European
Commission, in May 2008, adopted a decision ordering Austria to lift the
safeguard clause on the import and processing ban of MON 810 and T 25
corn events. This decision did not affect Austria's safeguard action on
cultivation. While Austria lifted the import and processing bans on MON
810 and T25, it proposed new import bans on MON 863 corn and three
oilseed rape lines, Ms8, Rf3 and Ms8xRf3. These new Austrian bans could
be implemented by mid July, 2008.

In March 2008, Greenpeace Austria staged a demonstration near the U.S.
Embassy in Vienna against potential U.S. retaliatory actions against
Austria in response to the WTO Case. In May 2008, FAS Vienna and an
American Soybean Producers' (ASA) delegation organized a roundtable
discussion to discuss biotech crops with Austrian stakeholders in the
food, feed and crop industries. The Austrians were very receptive to the
ASA message.

  ------------------ ------------------------------------- ---------------
  Previous Austria                                         
  GAIN Reports                                             

  AU7007             Austria fails to win EU support for   12/18/2007
                     biotech corn ban                      
  ------------------ ------------------------------------- ---------------

**The Benelux:** In 2007, the Benelux region imported approximately US\$
2.4 billion of agricultural and food products from the U.S. A large
share of this trade was feed products, which required labeling for
biotech content under the European Union's traceability and labeling
legislation. The slow approval process of new GM events by the European
Union has significantly affected U.S. exports to the Benelux region in
particular corn gluten feed (CGF) and Distillers Dried Grains (DDGs).
Also exports of U.S. food products such as rice and processed products
have declined. Slow EU approval of the new Roundup soybean variety could
also limit U.S. soybean exports to the region if placed into commercial
market channels before authorization is obtained in the EU.

The Netherlands and the Belgian regions, Flanders and Wallonia, just
recently implemented coexistence regulations. Sector sources believe
that the combination of restrictions will practically ban the
cultivation of biotech events, particularly in the Walloon Region. The
Dutch Farmers Organization (LTO) and Belgian Farmers Organization
(Boerenbond) are both pragmatic and in favor of using biotech crops. But
both organizations point to the resistance of retailers and consumers
towards food products containing biotech components, in particular in
export markets.

Field trials of biotech crops are almost impossible in the Benelux. In
the Netherlands, crop trials are effectively prevented by cumbersome
regulations imposed by the government and by the threat of protests from
environmental groups. While the Dutch Government issued over thirty
licenses for field trials of biotech crops, only seven were used in
2007. In Belgium and Luxembourg, there have been no licenses issued for
field trials since 2004.

**Bulgaria:** In 2004, Bulgaria passed a major biotech law which de
facto prohibited cultivation of biotech events. The law is not fully
harmonized with EU regulations. As a result, no research or commercial
plots exist in the country. Research conducted prior to 2004 has been
terminated.

In April, the law was amended to make some changes to allow research
field trials for cotton only.  A proposal for such trials was submitted
to the Biosafety Commission but there has been no final decision because
the dossier was deemed incomplete. Another amendment to allow research
trials was proposed in June.  The discussions and the vote are scheduled
for July. If successful, then some corn field trails could be carried
out in 2009.

**Czech Republic:** The Czech Republic is a pro-biotech country with a
pragmatic approach. Czech farmers have grown Bt corn since 2005. From
270 hectares in 2005, the acreage has expanded to almost 10,000 hectares
in 2008.

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'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. The coexistence rules 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).

In terms of food use, some dairy processors refuse to buy milk from
farmers who feed their cattle with biotech soybeans or corn. Even though
retail chains generally avoid biotech food products, many supermarkets
(including Tesco) in the Czech Republic carry items containing biotech
components, such as cooking oils, and these products are labeled.

  ------------------ ------------------------------------- ---------------
  Previous Czech                                           
  Republic GAIN                                            
  Reports                                                  

  EZ7008             Biotech Conference in Prague          12/10/2007

                                                           
  ------------------ ------------------------------------- ---------------

**Finland:** In Finland, there is no commercial production of biotech
crops. Several seed companies have, however, developed their own GE
varieties, including herbicide tolerant rapeseed, herbicide tolerant
sugar beet and starch potatoes. In August 2007, the Finnish meat
industry publicly abandoned its voluntary ban on biotech animal feed due
to rising feed costs. The announcement was met with unexpectedly strong
media reaction. As a result, the Finnish Minister of Agriculture,
Sirkka-Liisa Anttila, called for voluntary labeling of meat from animals
not fed with biotech feed.

**France:** Prior to 2008, France was the second largest producer of
biotech corn in the EU. There was a fourfold increase between 2006 and
2007 to 22,000 ha, due to the favorable results of the 2006 crop. In
addition, the implementation of new a EU regulation on mycotoxin levels
for grains spurred French farmer interest.

However, this dramatically changed in 2008 when the current French
government, under the lead of the Ministry of Environment, implemented a
number of policy initiatives threatening the future of agricultural
biotechnology in France. First, France banned MON810 production in
January 2008 (pending its no-year reevaluation by EU authorities).
Second, the GOF passed a new biotech bill in May 2008 mandating public
disclosure of commercial biotech fields at the plot level. The law also
reorganized the national authority evaluating genetically-engineered
products, to include not only scientists but also a socio-economic
committee.

France is actively trying to move its socio-economic evaluation of
agricultural biotechnology to the European level through initiatives
during its Presidency of the European Union in the second half of 2008.

In France, lack of consumer acceptance of agricultural biotechnology
continues, particularly for food products. Food products labeled as
containing or derived from biotech are generally not available on the
French market. Anti-biotech activists are well organized and work
consistently to discourage biotech acceptance. During the summer of 2006
and 2007, activists destroyed two thirds of the open-field test plots.
Less visible to the public, but still very effective, is the pressure
imposed by these groups on the food and feed industry and retailers. For
example, the Greenpeace website has a "blacklist" identifying biotech
food products marketed in France. The negative publicity generated by
selling a biotech product in a French supermarket has been so
detrimental that they are no longer available, and processors have
tended to reformulate to avoid labeling.

  ------------------ ------------------------------------- ---------------
  Previous French                                          
  GAIN Reports                                             

  FR8008             GOF Action on Biotech -- One Year     06/06/2008
                     Overview                              
  ------------------ ------------------------------------- ---------------

**Germany:** In the past two years, Germany has become one of the most
vocal opponents of biotechnology in the EU. In 2007, the current German
grand coalition government amended the national genetech law,
complicating the cultivation of biotech plants. It increased distance
requirements between biotech corn and conventional or organic corn to
150 and 300 meters respectively. As part of the public field registry,
farmers must report the exact location of their biotech crop fields. The
new law also redefined the term "genetech free" and provided a basis to
label livestock products as such if the animals are not fed biotech feed
during a certain period prior to slaughter or milking. It is unclear how
extensive this labeling option will be used, given the rapidly
increasing price non-biotech animal feed.

Despite a high level of public and media opposition against biotech
crops, German farmers increased the area planted to Bt corn to 3371
hectares in 2008, up almost 700 hectares from 2007. An additional 36
hectares have been planted as test fields mainly for variety testing of
corn. The second most important crop for researchers and breeders is
potatoes, which are planted on about ten hectares of test fields. Tests
with rapeseed have been discontinued in Germany because of the risk of
out-crossing. In the summer of 2007, the western corn root worm
diabrotica virgifera was detected for the first time in several
locations in Southern Germany. German authorities try to eradicate the
pest through conventional methods such as chemical seed treatment and
cultivation bans but were unsuccessful.

The German Minister of Agriculture's position on biotech is that
cultivation of biotech crops is not needed since current traits provide
no benefits to the consumer. The German livestock feed industry and
swine producers' organizations are currently calling loudly for an
acceleration of the EU biotech approval process. The industries fear
that the importation of soybeans and soybean meal will become more
difficult and more expensive when farmers in the U.S. begin to cultivate
second generation biotech soybeans.

Outreach activities continue to focus on providing farmers, processors
and press contacts information about the practical experiences of U.S.
farmers using agricultural biotechnology. These activities have been
primarily funded through U.S. Department of State.

  ------------------ ------------------------------------- ---------------
  Previous German                                          
  GAIN Reports                                             

  GM7042             Biotech Traces in German Rapeseed     09/07/2007
                     Seeds                                 

  GM7052             Biotech Outreach Programs to Germany  11/05/2007

  GM8003             Without Biotech Food Label Standard   01/22/2008

  GM8006             German Bundestag Passed Amendment of  01/31/2008
                     Biotech Law                           

  GM8014             German Genetech Law Finalized         03/05/2008

  GM8022             German Argumentation paper            05/07/2008
  ------------------ ------------------------------------- ---------------

**Hungary:** Hungary has a mixed record with regard to agricultural
biotechnology. The GOH introduced the first Act on Biotechnology in
1998. Since then the Act has been amended several times. In November
2006, the last time it was amended, the GOH approved a "Coexistence
Regulation" (Act CVII. of 2006). The coexistence regulation is so
stringent that it virtually prohibits biotech cultivation because of
isolation distances, neighbor liability contracts, etc. The GOH is
preparing another amendment to the Act under pressure from opponents of
biotechnology in the Parliament. The amendment is to be filed for EU
notification later this year. It is unclear what changes will be made.

Hungary's biotechnology legislation reflects the general thinking that
the country's current "GM-free" status is a marketing boon. The country
is a major seed and feed corn producer in Europe. The general public is
rather pragmatic about biotechnology and scientists have a good
reputation in Hungary. The country's life science institutes are active
participants in international biotechnology research. For example in
2006, pro-biotech institutions and scientists from neighboring countries
(with similar ecological conditions) established the "Pannonian" Plant
Biotechnology Association to coordinate their activities. Environmental
groups and the Ministry of Environment are trying to block the use of
the new technology.

Since 2005, Hungary has maintained a moratorium on the planting of the
biotech corn variety MON 810. The moratorium is not only inconsistent
with EU regulations but is also controversial within the GOH. The
Council of Environmental Ministers has voted down the proposal of the
European Commission to lift the ban two times, last on February 20,
2007. EFSA evaluated Hungary's studies in support of its safeguard
clause and issued an opinion in July 2008, finding "no new scientific
evidence" that would invalidate the previous (EFSA) risk assessments
(see at The EFSA Journal (2008) 756, 1-18). It is unclear if the
Commission will place a new vote to the agenda and if so, when. It is
possible that the 10-year re-evaluation for MON 810 within the EU
regulatory regime will affect the Hungarian moratorium.

**Ireland:** While the Irish government has a policy of science-led
decision making on the issue of agricultural biotechnology, a change of
government in 2007 resulted in these decisions being changed at the
political level. At that time, the Green Party entered the ruling
coalition. As part of its Program for Government, the Green Party
aspired for a "GM-free" island of Ireland. This aspiration is undergoing
refinement as the difficulties of the implementation of such a policy
are now being slowly realized.

Irish farmers rely on imported feedstuffs to supplement the diets of the
mainly grass-fed animals. Primary components of these diets are maize
by-products such as corn gluten meal and distillers dried grains.
However, most if not all of these products now contain genetically
engineer derived crops and the implementation of a 'ban' on imports
would cause untold economic hardship on Irish farming. With the arrival
of new varieties of soybeans, Irish hog and poultry producers could face
feed supply difficulties in 2009 and 2010 without EU approval of these
new events.

There is no doubt that the cultivation and field trials of biotechnology
crops under the present government will not be allowed. Recently,
opposition to biotechnology has waned from a media-driven frenzy in the
late 1990's to general commentary editorials as the current food and
fuel debate rages worldwide.

**Italy:** Since 2007, there have been no significant developments
regarding biotechnology in Italy. However, there are signs that the new
Berlusconi Government approach may differ from that of its predecessor.

After the Constitutional Court's decision of 2006, the responsibility
for delineating *coexistence* regulations was mandated to the regions.
In 2007 a special body (State-Regions Conference) established the
guidelines, although not mandatory, that the regions would have to
follow when establishing their own coexistence regulations. To date, no
Italian region has taken such action. Until these guidelines are
established, there will remain a de facto moratorium on planting biotech
crops in Italy. Field trails are also blocked due to opposition from the
Ministry of the Environment. The approval for field trials must come
from a committee of ten (two from the Ministry of Agriculture, two from
the Ministry of Environment, and six from the regions). With regard to
seeds for planting*,* Italy applies a "zero tolerance" for adventitious
GM presence. The main authority is the Ministry of Agriculture, which
also controls registration of seed varieties with the National Register.

Italy has, except for limited cases last year, continued to vote no on
the approval of biotech events with in the EU regulatory process.
However, there are growing expectations of a possible change in this
based upon statements recently made by the new government.

**Poland:** Since 2006, Poland has maintained an official anti-biotech
position and consistently opposes EU approval of new biotech products,
and has announced that Poland should be a "GM-free" country. The
government banned the sale and registration of biotech seeds in mid-2006
and, passed legislation that was to prohibit import, production and use
of animal feed derived from biotech crops by August 12, 2008. 
Cultivation is still possible, but not the sale of seeds. FAS Warsaw
estimates there are about 300 hectares of biotech corn in Poland. EU
officials have determined these bans are inconsistent with EU
regulations. A new cultivation law is under preparation, but barriers
may be set at 1 kilometer with neighbors approving planting. Corn
producers lose an estimated \$300 million in crop value each year due to
losses caused by the European corn borer, which could be prevented by Bt
corn. Organic farmers and environmental groups are lobbying hard against
relaxing restrictions.

On July 11, 2008, the Senate (upper house of the Polish Parliament)
voted to delay introduction of a ban on biotech feed, which had been
scheduled to enter into effect August 12, 2008, until December 31,
2012.  The proposal was then signed by the Polish President and entered
into force. The feed ban would have jeopardized roughly \$6.4 billion in
pork and poultry production, plus additional losses for feed
compounders. Poland has some of the highest feed prices in Europe and
this is one significant reason why Polish pork, beef, and poultry
imports are growing due to increasing competition from Western European
countries. Many industry associations, scientists, producers, and
regional political leaders are calling for changes to biotechnology
policy in Poland; and played a key role in delaying the introduction of
the proposed feed ban until January 2013.

  ------------------ ------------------------------------- ---------------
  Previous Poland                                          
  GAIN Reports                                             

  PL8020             Biotechnology Feed Ban Consequences   06/19/2008
                     for Pork and Poultry                  

  PL8003             EU Overturns Polish anti-GM laws      02/15/2008
  ------------------ ------------------------------------- ---------------

**Portugal:** Total acreage for biotech corn in Portugal for 2008 is
expected to reach about 4,700 hectares. This would represent a
significant increase over 2007.

Portugal was one of the first EU Member States to implement a
coexistence regulation, to evaluate its effects, and to establish rules
for declaring biotechnology-free zones. A first-year coexistence
compliance monitoring report indicated that currently required buffer
zones kept the adventitious presence in surrounding corn crops well
below the 0.9 percent threshold required to claim biotechnology-free
status. While rootworm-resistant corn is the only agriculture
biotechnology crop currently grown in Portugal, many Portuguese farmers
are interested in additional biotech crops as potential solutions to
other problems.

While root-worm resistant biotechnology corn production is making its
mark, the Portuguese Farmers Association has indicated that corn farmers
would be even more interested in herbicide resistant corn, as it could
be grown on a wider range of Portugal's tillable acreage. Farmers are
also looking at ethanol production from biotechnology corn, and other
crops in response to Portugal's new biofuels initiative (PO7001).

  ------------------ ------------------------------------- ---------------
  Previous Portugal                                        
  GAIN Reports                                             

  PO7011             Biotech Update                        12/18/2007

  PO7007             Biotech Update                        09/13/2007
  ------------------ ------------------------------------- ---------------

**Romania:** Romania continues to be part of the EU group using the
opportunity of planting biotech seeds for commercial use. Prior to EU
accession, Romania was the only country in Eastern Europe to plant
biotech soybeans. The acreage grew 8 fold from 2001 through 2006,
reaching 137,000 hectares. This was discontinued in 2007, when Romania
acceded to the EU. In 2008, Romanian farmers planted biotech corn for
commercial purposes on 7,500 hectares, up from 331 hectares in 2007.

Inspired by the movements of the EU countries opposing biotechnology,
the Environment Minister announced in April 2008 that steps towards
imposing a moratorium on biotech crops will be taken. In this regard, a
new Biosafety Commission was established, with its first task being
re-assessment MON 810. The Environment Minister hoped to influence the
members of the Biosafety Commission and receive an immediate unfavorable
risk-assessment which might have blocked 2008 planting. Nevertheless,
the Biosafety Commission proved to be an independent body with rules and
organizational principles that led to a proper framework for conducting
risk-assessments and taking decisions on biotech events. At the present,
it is hard to predict when the Biosafety Commission will complete the
risk-assessment (basically a review of the available scientific papers)
and when a decision will be taken.

The Environment Minister's initiative to restrict access to biotech
crops angered many farmers, who view this as a violation of their right
to use any approved technology on their farms. Unlike the Environment
Ministry, the Agricultural Ministry has been very supportive of farmers'
complaints, claiming that farmers should have access to all three types
of agriculture: conventional, organic, biotech.

Green organizations continued to be very active, trying to slow or
reverse biotech crop expansion and in misleading consumer groups
regarding biotech derived food-products. Their public campaigns have not
only targeted crops, but also food, such as soy-based products.

In June 2008, FAS/Bucharest organized a series of events promoting
agricultural biotechnology. These were attended mainly by Government
officials, members of Parliament, scientists, and media, creating an
atmosphere for lively discussions about the current state and future
perspectives of agricultural biotechnology in Romania. In the
countryside, farmers were the main target and their number and active
participation exceeded expectations.

  ------------------ ------------------------------------- ---------------
  Previous Romania                                         
  GAIN Reports                                             

  RO8011             Romanian Parliament declines the      07/14/2008
                     initiative on biotech labeling        

  RO8002             Initiative on biotech labeling        03/10/2008
                     rejected by Senate                    
  ------------------ ------------------------------------- ---------------

**Slovakia :** Slovak farmers started growing Bt corn in 2006 on 30
hectares. The acreage has been gradually growing, exceeding 1,500
hectares in 2008. Slovakia has fully implemented all EU regulations on
biotechnology. The decree administering coexistence came into force in
February 2007.

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

-   issue consents for the contained use of genetic technologies and GE
    products; the introduction of GE products 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
    GE products; the introduction of GE products into the environment;
    and the placing of the product on the market

-   keep a record of used genetic techniques

-   keep a register of the facilities including the records of users of
    biotechnologies or GE products, safety committees and heads of the
    projects

For matters regarding genetic technologies and modern biotechnology, the
MoE is the national point of notification to the bodies of the European
Union and the national centre for the safety of genetic engineering and
modern biotechnology.

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).

**Slovenia:** In Slovenia, agricultural biotechnology is confined to
laboratories and to production facilities. So far, there have not been
biotech field trials in Slovenia and there is no commercial production.
This might change after the adoption of the Act on Co-existence of
Genetically Modified Plants with Other Agricultural Plants in the near
future.

In general, Slovenians have a negative opinion of biotech products and,
if possible, they would avoid consuming them.

The legislative and administrative framework of biosafety in Slovenia is
established in accordance with the legal order of the EU and the
international Cartagena Protocol on Biosafety. Special regulations,
within the competency of the [Ministry of
Health](http://www.biotechnology-gmo.gov.si/eng/ministrstva/ministry_of_health/index.html)
and the [Ministry of Agriculture, Forestry and
Food](http://www.biotechnology-gmo.gov.si/eng/ministrstva/ministry_of_agriculture_forestry_and_food/index.html)
regulate following issues: [medicinal
products](http://www.biotechnology-gmo.gov.si/eng/slovenija/zakonodaja/po_podrocju/zdravila/index.html)
for the use in human and veterinary medicine, which contain biotech
products or are composed of biotech products or their combinations;
biotech products used for food, which contains or are composed of
biotech products; food made from GE products or containing ingredients
made from GE products; GE products used for feed which contains or is
composed of GE products, and fodder made from GE products.

**Spain:** Spain has been and remains the biotechnology "powerhouse" of
Europe. In Spain, biotech maize has been commercially grown since 1998,
giving it the longest practical experience in cultivating biotech events
in the EU. Spanish corn farmers increased biotechnology corn plantings
during marketing year 2007 at a near record-setting pace, while total
corn planted increased (first time in recent history) only slightly. In
2008, due to excessive rain, farmers experienced some difficulties in
corn planting. Initial estimates expect reduction in total acreage,
however Bt corn area is expect to remain stable.

Spanish farmers in regions with known corn borer infestations
increasingly planted biotechnology corn, while corn farmers in regions
where infestations are more inconsistent (weather dependent) are also
turning to MON 810 varieties as a means of minimizing risk, increasing
productivity and quality, reducing their environmental footprint, and
maximizing profit. The biotechnology corn planted and harvested in Spain
is used exclusively in the production of domestic compound feeds where
it is labeled as containing "genetically modified organisms."

The debate continues on a GOS coexistence decree, the first draft of
which was made public in 2004. Spanish corn farmers continue growing
biotechnology corn without environmental incident and without a Decree
to "protect" organic farmers as demanded by the anti-biotechnology
lobby. With each successive successful year the "case" for a
Government-imposed national decree becomes increasingly more difficult.
However over the years, the terms and conditions of potential
co-existence regulations, particularly regarding buffer zones and
isolation distances have become more imposing. While nothing has been
finalized, it is widely understood that the Environment Ministry is
holding out for even more severe conditions that would likely eliminate
the possibility of agriculture biotechnology production in Spain.

  ------------------ ------------------------------------- ---------------
  Previous Spain                                           
  GAIN Reports                                             

  SP7030             Biotech Update                        12/18/2007
  ------------------ ------------------------------------- ---------------

**Sweden:** There is no commercial production of biotech crops in
Sweden. Several seed companies have, however, developed their own GE
varieties, including herbicide tolerant rapeseed, herbicide tolerant
sugar beet and starch potatoes. According to the Swedish Institute for
Food and Agricultural Economics (SLI), growing biotech crops in Sweden
would be economically beneficial for Swedish farmers. SLI has concluded
that growing biotech crops instead of conventional crops would result in
a 4-12% profitability increase. The largest potential benefit is noted
for potatoes. Possible costs for co-existence measures such as safety
distances between biotech and conventional fields are not considered in
the analyses.

Prior to 2006, Sweden did not import biotech products or crops. However
since January 2006, when the meat industry lifted its ban on biotech
feed, small quantities of biotech soy products have been imported into
Sweden. While demand for this product has been limited, there has
reportedly been no negative reaction from the Swedish trade. The food
processing and retail sectors remain concerned about the possibility of
negative consumer reaction and anti-biotech demonstrations.

**United Kingdom:** The UK government is one of the strongest advocates
of agricultural biotechnology in the European Union. Indeed, in June
2008 the UK Environment Minister re-ignited the agriculture biotech
debate by suggesting that biotech crops could play a positive role in
alleviating global food price rises. In addition, the British Prime
Minister is reported to have urged fellow EU leaders to look again at
biotech as a way of reducing the cost of food for the world's poorest
countries. This action is likely triggered by the current world
attention on finding solutions to the global food price issue, sustained
pressure from industry for the government to take action over animal
feed prices and the recent publication of UK research findings showing
positive socio-economic and environmental impacts of GE crops over the
last ten years ([PG
Economics](http://www.pgeconomics.co.uk/gm_crop_economic_environmental_impact.htm)).

The Agricultural Biotechnology Council (ABC which comprised of UK
representatives from the major technology providers) provides supporting
evidence to the UK government. ABC is calling for an end to the
requirement to make biotech crop trials public, a faster regulatory
framework and a de-politicization of the genetically engineer crop
approval process.

Non-governmental organizations (NGOs) such as Friends of the Earth and
Greenpeace are opposed to any such changes, touting their efforts
through "GM Freeze". NGOs question the argument for biotechnology as
part of the solution to the food price crisis, drawing on the negative
findings in the recently published report from the International
Assessment of Agricultural Knowledge, Science & Technology for
Development (ISAASTD).

In 2004, the UK government declared that there was no scientific case
for a blanket ban on the cultivation of biotech crops in the UK, but
that proposed uses needed to be assessed for safety on a case-by-case
basis. There is still no commercial production of biotech crops in the
UK as varieties that are currently approved within the EU are not suited
to the growing conditions in the UK. A consultation exercise opened in
July 2006 by the Department for Environment, Food and Rural Affairs
(Defra) looked at options for managing the coexistence of biotech,
conventional and organic crops. The results of the exercise reflected
the polarization of the debate with anti-biotech against coexistence in
any form, while advocates were largely supportive of the measures
proposed.

In response to consumers' lack of enthusiasm for the technology and to
avoid EU labeling rules, UK supermarkets and big brand food
manufacturers have reformulated their food products to remove biotech
ingredients. The number of products that are labeled is very limited.
The effective de facto ban on biotech food in the UK, and consequent
lack of consumer choice, will remain until supermarkets start to stock
more products with a biotech content.

  ------------------ ------------------------------------- ---------------
  Previous UK GAIN                                         
  Reports                                                  

  UK8011             UK minister re-opens biotech debate   06/25/2008
  ------------------ ------------------------------------- ---------------

##  Annex II: Community Register of Authorized Genetically Modified Food and Feed

Updated versions of this table are available at the following site:
<http://ec.europa.eu/food/dyna/gm_register/index_en.cfm>.

  ---------------------------------------- -------------------------- ------------------------------------------------------------------------------------------------- ----------------- -----------------------------------------------------
  **Genetically modified cotton**                                                                                                                                                         

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Cotton (MON1445)\                      Genetically modified       Food produced from MON1445 cotton (cottonseed oil)                                                18/12/2011        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        cotton that contains:\                                                                                                                         
  [MON-Ø1445-2]{.underline}\               \                                                                                                                                              
  \                                        **cp4 epsps** gene                                                                                                                             
  Monsanto**                               inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Food additives produced from MON1445 cotton                                                       Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed produced from MON1445 cotton (feed materials and feed additives)                             Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Cotton (MON15985)\                     Genetically modified       Food additives produced from MON-15985-7 cotton                                                   Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        cotton that contains:\                                                                                                       authorization     
  [MON-15985-7]{.underline}\               \                                                                                                                            ongoing           
  \                                        **cry1Ac** and **cry2Ab2**                                                                                                                     
  Monsanto**                               genes inserted to confer                                                                                                                       
                                           insect-resistance highly                                                                                                                       
                                           selective in controlling                                                                                                                       
                                           Lepidopteran insects                                                                                                                           

                                                                      Feed produced from MON 15985 cotton (feed materials and feed additives)                           Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Cotton (MON15985 x MON1445)\           Genetically modified       Food additives produced from MON15985 x MON1445 cotton                                            Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        cotton that contains:\                                                                                                       authorization     
  [MON-15985-7 x MON-Ø1445-2]{.underline}\ \                                                                                                                            ongoing           
  \                                        **cry1Ac** and **cry2Ab2**                                                                                                                     
  Monsanto**                               genes inserted to confer                                                                                                                       
                                           insect-resistance highly                                                                                                                       
                                           selective in controlling                                                                                                                       
                                           Lepidopteran insects\                                                                                                                          
                                           \                                                                                                                                              
                                           **cp4 epsps** gene                                                                                                                             
                                           inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Feed produced from MON15985 x MON1445 cotton (feed materials and feed additives)                  Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Cotton (MON531)\                       Genetically modified       Food produced from MON 531 cotton (cottonseed oil)                                                18/12/2011        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        cotton that contains:\                                                                                                                         
  [MON-ØØ531-6]{.underline}\               \                                                                                                                                              
  \                                        **cry1A(c)** gene inserted                                                                                                                     
  Monsanto**                               to confer                                                                                                                                      
                                           insect-resistance                                                                                                                              

                                                                      Food produced from MON 531 cotton (food additives)                                                Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed produced from MON 531 cotton (feed materials and feed additives)                             Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Cotton (MON531 x MON1445 )\            Genetically modified       Food additives produced from MON531 x MON1445 cotton                                              Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        cotton that contains:\                                                                                                       authorization     
  [MON-ØØ531-6 x MON-Ø1445-2]{.underline}\ \                                                                                                                            ongoing           
  \                                        **cry1A(c)** gene inserted                                                                                                                     
  Monsanto**                               to confer                                                                                                                                      
                                           insect-resistance\                                                                                                                             
                                           \                                                                                                                                              
                                           **cp4 epsps** gene                                                                                                                             
                                           inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Feed produced from MON 531 x MON 1445 cotton (feed materials and feed additives)                  Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Genetically modified maize**                                                                                                                                                          

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Maize (Bt11)\                          Genetically modified maize Foods and food ingredients containing, consisting of or produced from Bt11 maize                  18/05/2014\       ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                              Renewal ongoing   
  [SYN-BT Ø11-1]{.underline}\              \                                                                                                                                              
  \                                        **cryIA (b)** gene                                                                                                                             
  Syngenta**                               inserted to confer                                                                                                                             
                                           insect-resistance\                                                                                                                             
                                           \                                                                                                                                              
                                           **pat gene** inserted to                                                                                                                       
                                           confer tolerance to the                                                                                                                        
                                           herbicide                                                                                                                                      
                                           glufosinate-ammonium                                                                                                                           

                                                                      Food additives produced from Bt11 maize                                                           Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed containing, consisting of or produced from Bt11 maize (feed materials and feed additives)    Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of Bt11 maize with the exception of cultivation           Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Maize (DAS1507)\                       Genetically modified maize Foods and food ingredients containing, consisting or produced from DAS1507 maize (including food  02/03/2016        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\            additives)                                                                                                          
  [DAS-Ø15Ø7-1]{.underline}\               \                                                                                                                                              
  \                                        **cry1F** gene inserted to                                                                                                                     
  Pioneer and Dow AgroSciences**           confer resistance to the                                                                                                                       
                                           European corn borer and                                                                                                                        
                                           certain other lepidopteran                                                                                                                     
                                           pests\                                                                                                                                         
                                           \                                                                                                                                              
                                           **pat** gene inserted to                                                                                                                       
                                           confer tolerance to the                                                                                                                        
                                           herbicide                                                                                                                                      
                                           glufosinate-ammonium                                                                                                                           

                                                                      Feed containing or consisting of DAS1507 maize                                                    15/03/2016        

                                                                      Feed produced from DAS1507 maize (feed materials and feed additives)                              Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of DAS1507 with the exception of cultivation              15/03/2016        

  **Maize (DAS59122)\                      Genetically modified maize Foods and food ingredients containing, consisting of, or produced from DAS-59122-7 maize          23/10/2017        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that expresses:\           (including food additives)                                                                                          
  [DAS-59122-7]{.underline}\               \                                                                                                                                              
  \                                        the Cry34Ab1 and Cry35Ab1                                                                                                                      
  Pioneer and Dow AgroSciences**           proteins which confer                                                                                                                          
                                           protection against certain                                                                                                                     
                                           coleopteran pests such as                                                                                                                      
                                           corn rootworm larvae                                                                                                                           
                                           (Diabrotica spp.)\                                                                                                                             
                                           \                                                                                                                                              
                                           the PAT protein which                                                                                                                          
                                           confers tolerance to the                                                                                                                       
                                           glufosinate-ammonium                                                                                                                           
                                           herbicide                                                                                                                                      

                                                                      Feed containing, consisting of, or produced from DAS-59122-7 maize (feed materials and feed                         
                                                                      additives)                                                                                                          

                                                                      Products other than food and feed containing or consisting of DAS-59122-7 maize for the same uses                   
                                                                      as any other maize with the exception of cultivation                                                                

  **Maize (DAS1507xMON603)\                Genetically modified maize Foods and food ingredients containing, consisting of, or produced from DAS-Ø15Ø7-1xMON-ØØ6Ø3-6    23/10/2017        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that expresses:\           maize (including food additives)                                                                                    
  [DAS-Ø15Ø7-1xMON-ØØ6Ø3-6]{.underline}\   \                                                                                                                                              
  \                                        the Cry1F protein which                                                                                                                        
  Pioneer and Dow AgroSciences**           confers protection against                                                                                                                     
                                           certain lepidopteran pests                                                                                                                     
                                           such as the European corn                                                                                                                      
                                           borer (Ostrinia nubilalis)                                                                                                                     
                                           and species belonging to                                                                                                                       
                                           the genus Sesamia,\                                                                                                                            
                                           \                                                                                                                                              
                                           the PAT protein which                                                                                                                          
                                           confers tolerance to the                                                                                                                       
                                           glufosinate-ammonium                                                                                                                           
                                           herbicide\                                                                                                                                     
                                           \                                                                                                                                              
                                           the CP4 EPSPS protein                                                                                                                          
                                           which confers tolerance to                                                                                                                     
                                           the glyphosate herbicide                                                                                                                       

                                                                      Feed containing, consisting of, or produced from DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize (feed materials                      
                                                                      and feed additives)                                                                                                 

                                                                      Products, other than food and feed, containing or consisting of DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize for                   
                                                                      the same uses as any other maize with the exception of cultivation                                                  

  **Maize (GA21)\                          Genetically modified maize Foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize          27/3/2018         ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that expresses:\           (including food additives)                                                                                          
  [MON-ØØØ21-9]{.underline}\               \                                                                                                                                              
  \                                        mEPSPS protein which                                                                                                                           
  Syngenta**                               confers tolerance to                                                                                                                           
                                           herbicide glyphosate                                                                                                                           

                                                                      Feed containing, consisting of, or produced from MON-ØØØ21-9 maize (feed materials and feed                         
                                                                      additives)                                                                                                          

                                                                      Products other than food and feed containing or consisting of MON-ØØØ21-9 maize for the same uses                   
                                                                      as any other maize with the exception of cultivation                                                                

  **Maize (MON810)\                        Genetically modified maize Foods and food ingredients produced from MON810 (including food additives)                        Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                              authorization     
  [MON-ØØ81Ø-6]{.underline}\               \                                                                                                                            ongoing           
  \                                        **cryIA (b)** gene                                                                                                                             
  Monsanto**                               inserted to confer                                                                                                                             
                                           resistance to lepidopteran                                                                                                                     
                                           pests                                                                                                                                          

                                                                      Feed containing or consisting of MON810 maize                                                     Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed produced from MON810 maize (feed materials feed additives)                                   Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      [Seeds for                                                                                        Renewal of        
                                                                      cultivation](http://ec.europa.eu/food/plant/propagation/catalogues/comcat_agricultural/80.html)   authorization     
                                                                                                                                                                        ongoing           

  **Maize (MON863)\                        Genetically modified maize Food containing, consisting of, or produced from MON 863 maize                                    12/01/2016        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                                                
  [MON-ØØ863-5]{.underline}\               \                                                                                                                                              
  \                                        a trait gene **cry3Bb1**                                                                                                                       
  Monsanto**                               inserted to confer insect-                                                                                                                     
                                           resistance\                                                                                                                                    
                                           \                                                                                                                                              
                                           **nptII** gene inserted as                                                                                                                     
                                           a selection marker                                                                                                                             

                                                                      Food additives produced from MON 863 maize                                                        Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed containing or consisting of MON 863 maize                                                    12/02/2016        

                                                                      Feed produced from MON 863 maize (feed materials and feed additives)                              Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of MON863 with the exception of cultivation               12/02/2016        

  **Maize (MON863 x NK603)\                Genetically modified maize Food additives produced from MON863 x NK603 maize                                                 Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                              authorization     
  [MON-ØØ863-5 x MON-ØØ6Ø3-6]{.underline}\ \                                                                                                                            ongoing           
  \                                        **nptII** gene inserted as                                                                                                                     
  Monsanto**                               a selection marker\                                                                                                                            
                                           \                                                                                                                                              
                                           a trait gene **cry3Bb1**                                                                                                                       
                                           inserted to confer insect-                                                                                                                     
                                           resistance\                                                                                                                                    
                                           \                                                                                                                                              
                                           **cp4 epsps** gene                                                                                                                             
                                           inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Feed produced from MON863 x NK603 maize (feed materials and feed additives)                       Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Maize (MON863 x MON810 )\              Genetically modified maize Feed materials produced from MON863 x MON810 maize                                                Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                              authorization     
  [MON-ØØ863-5 x MON-ØØ81Ø-6]{.underline}\ \                                                                                                                            ongoing           
  \                                        **cryIA (b)** gene                                                                                                                             
  Monsanto**                               inserted to confer                                                                                                                             
                                           resistance to lepidopteran                                                                                                                     
                                           pests\                                                                                                                                         
                                           \                                                                                                                                              
                                           **cry3Bb1** gene inserted                                                                                                                      
                                           to confer resistance to                                                                                                                        
                                           certain coleopteran pests,                                                                                                                     
                                           principally corn rootworm\                                                                                                                     
                                           \                                                                                                                                              
                                           **nptII** gene inserted as                                                                                                                     
                                           a selection marker                                                                                                                             

  **Maize (NK603)\                         Genetically modified maize Food containing, consisting of, or produced from NK603 maize                                      02/03/2015        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                                                
  [MON-ØØ6Ø3-6]{.underline}\               \                                                                                                                                              
  \                                        **cp4 epsps** gene                                                                                                                             
  Monsanto**                               inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Food additives produced from NK603 maize                                                          Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed containing or consisting of NK603 maize                                                      17/10/2014        

                                                                      Feed produced from NK603 maize (feed materials and feed additives)                                Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of NK603 with the exception of cultivation                17/10/2014        

  **Maize (NK603 x MON810)\                Genetically modified maize Foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6    23/10/2017        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that expresses:\           maize (including food additives)                                                                                    
  [MON-ØØ6Ø3-6 x MON-ØØ81Ø-6]{.underline}\ \                                                                                                                                              
  \                                        the **CP4 EPSPS** protein                                                                                                                      
  Monsanto**                               which confers tolerance to                                                                                                                     
                                           glyphosate herbicides and\                                                                                                                     
                                           \                                                                                                                                              
                                           the **Cry1Ab** protein                                                                                                                         
                                           which confers protection                                                                                                                       
                                           against certain                                                                                                                                
                                           lepidopteran insect pests                                                                                                                      
                                           (Ostrinia nubilalis,                                                                                                                           
                                           Sesamia spp.)                                                                                                                                  

                                                                      Feed containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize (feed materials                      
                                                                      and feed additives)                                                                                                 

                                                                      Products other than food and feed containing or consisting of MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize for                     
                                                                      the same uses as any other maize with the exception of cultivation                                                  

  **Maize (T25)\                           Genetically modified maize Food and food ingredients produced from T25 maize                                                 Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        that contains:\                                                                                                              authorization     
  [ACS-ZMØØ3-2]{.underline}\               \                                                                                                                            ongoing           
  \                                        **pat** gene inserted to                                                                                                                       
  Bayer**                                  confer tolerance to the                                                                                                                        
                                           herbicide                                                                                                                                      
                                           glufosinate-ammonium                                                                                                                           

                                                                      Feed containing, consisting of, or produced from T25 maize (feed materials and feed additives)    Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Seeds for cultivation                                                                             Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Genetically modified microorganisms**                                                                                                                                                 

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Bacterial biomass\                     Bacterial protein,         Feed produced from GMO bacteria: \" bacterial biomass\"                                           Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        by-product from the                                                                                                          authorization     
  [(pCABL- Bacterial biomass               production by fermentation                                                                                                   ongoing           
  )]{.underline}\                          of L-Lysine HCl obtained                                                                                                                       
  \                                        from (Brevibacterium                                                                                                                           
  Ajinomoto Eurolysine SAS**               lactofermentum) the                                                                                                                            
                                           recovered killed                                                                                                                               
                                           microorganisms. The source                                                                                                                     
                                           is the Brevibacterium                                                                                                                          
                                           lactofermentum strain                                                                                                                          
                                           SO317/pCABL                                                                                                                                    

  **Yeast biomass\                         NOVO Yeast Cream is a      Feed materials produced from GMO yeast: \"yeast biomass\"                                         Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        product produced from                                                                                                        authorization     
  [(pMT742 or pAK729-Yeast biomass         genetically modified yeast                                                                                                   ongoing           
  )]{.underline}\                          strains (Saccharomyces                                                                                                                         
  \                                        cerevisiae) cultivated on                                                                                                                      
  NOVO Nordisk A/S**                       substrates of vegetable                                                                                                                        
                                           origin. The source is the                                                                                                                      
                                           Saccharomyces cerevisiae                                                                                                                       
                                           strain MT663/pMT742 or                                                                                                                         
                                           pAK729                                                                                                                                         

  **Genetically modified oilseed rape**                                                                                                                                                   

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Oilseed rape (GT73)\                   Genetically modified       Food produced from GT73 oilseed rape (refined oil and food additives)                             Renewal of        ![](media/image3.png){width="0.25in" height="0.25in"}
  \                                        oilseed rape that                                                                                                            authorization     
  [MON-ØØØ73-7]{.underline}\               contains:\                                                                                                                   ongoing           
  \                                        \                                                                                                                                              
  Monsanto**                                **cp4 epsps** and                                                                                                                             
                                           **goxv247** genes inserted                                                                                                                     
                                           to confer tolerance to the                                                                                                                     
                                           herbicide glyphosate                                                                                                                           

                                                                      Feed containing and consisting of GT73 oilseed rape                                               20/02/2017        

                                                                      Feed produced from GT73 oilseed rape (feed materials and feed additives)                          Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of GT73 with the exception of cultivation                 20/02/2017        

  **Swede-rape (MS8, RF3, MS8xRF3)\        Genetically modified       Food produced from MS8, RF3, MS8 x RF3 swede-rape (processed oil)                                 Renewal of        ![](media/image3.png){width="0.24861111111111112in"
  \                                        oilseed rape that                                                                                                            authorization     height="0.24861111111111112in"}
  [ACS-BNØØ5-8ACS-BNØØ3-6ACS-BNØØ5-8 x     contains:\                                                                                                                   ongoing           
  ACS-BN003-6]{.underline}\                \                                                                                                                                              
  \                                        a **bar (pat)** gene                                                                                                                           
  Bayer**                                  inserted to confer                                                                                                                             
                                           tolerance to herbicides                                                                                                                        
                                           based on glufosinate                                                                                                                           
                                           ammonium\                                                                                                                                      
                                           \                                                                                                                                              
                                           **barnase** gene inserted                                                                                                                      
                                           to lead to lack of viable                                                                                                                      
                                           pollen and male sterility\                                                                                                                     
                                           \                                                                                                                                              
                                           **barstar** gene inserted                                                                                                                      
                                           to lead to lack of viable                                                                                                                      
                                           pollen and male sterility                                                                                                                      

                                                                      Feed containing or consisting of MS8, RF3, MS8 x RF3 swede-rape                                   24/05/2017        

                                                                      Feed produced from MS8, RF3, MS8 x RF3 swede-rape                                                 Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of MS8, RF3, MS8 x RF3 swede-rape with the exception of   24/05/2017        
                                                                      cultivation                                                                                                         

  **Oilseed rape (T45)\                    Genetically modified       Food additives produced from T45 oilseed rape                                                     Renewal of        ![](media/image3.png){width="0.24861111111111112in"
  \                                        oilseed rape that                                                                                                            authorization     height="0.24861111111111112in"}
  [ACS-BNØØ8-2]{.underline}\               contains:\                                                                                                                   ongoing           
  \                                        \                                                                                                                                              
  Bayer**                                  **pat** gene inserted to                                                                                                                       
                                           confer tolerance to the                                                                                                                        
                                           herbicide                                                                                                                                      
                                           glufosinate-ammonium                                                                                                                           

                                                                      Feed materials produced from T45 oilseed rape                                                     Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Genetically modified soya**                                                                                                                                                           

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Soya (MON40-3-2)\                      Genetically modified soya  Food containing, consisting of, or produced from MON 40-3-2 soybean (including food additives)    Renewal of        ![](media/image3.png){width="0.24861111111111112in"
  \                                        that contains:\                                                                                                              authorization     height="0.24861111111111112in"}
  [MON-Ø4Ø32-6]{.underline}\               \                                                                                                                            ongoing           
  \                                        **cp4 epsps** gene                                                                                                                             
  Monsanto**                               inserted to confer                                                                                                                             
                                           tolerance to the herbicide                                                                                                                     
                                           glyphosate                                                                                                                                     

                                                                      Feed containing or consisting of MON 40-3-2 soybean                                               Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Feed produced from MON 40-3-2 soybean (feed materials and feed additives)                         Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

                                                                      Other products containing or consisting of MON 40-3-2 soybean with the exception of cultivation   Renewal of        
                                                                                                                                                                        authorization     
                                                                                                                                                                        ongoing           

  **Genetically modified sugar beet**                                                                                                                                                     

  **Transformation event/\                 **Genes Introduced /       **Authorized use**                                                                                **Authorization   **Details**
  [Unique ID]{.underline}/\                Characteristics**                                                                                                            Expiration Date** 
  Company**                                                                                                                                                                               

  **Sugar beet (H7-1)\                     Genetically modified       Foods and food ingredients produced from KM-ØØØH71-4 sugar beet                                   23/10/2017        ![](media/image3.png){width="0.24861111111111112in"
  \                                        sugarbeet that expresses:\                                                                                                                     height="0.24861111111111112in"}
  [KM-ØØØ71-4]{.underline}\                \                                                                                                                                              
  \                                        a CP4 EPSPS protein                                                                                                                            
  KWS SAAT and Monsanto**                  confers tolerance to                                                                                                                           
                                           glyphosate containing                                                                                                                          
                                           herbicides                                                                                                                                     

                                                                      Feed produced from KM-ØØØH71-4 sugar beet                                                                           
  ---------------------------------------- -------------------------- ------------------------------------------------------------------------------------------------- ----------------- -----------------------------------------------------

+-----------------------------------------------------------------------+
| **Products subject to Commission Decisions on withdrawal from the     |
| market**                                                              |
|                                                                       |
|   ------                                                              |
| --------------------------------- ----------------------------------- |
| --------------- ----------------------------------------------------- |
|   **Transformation event/\                                            |
|        **Withdrawal**                                     **Details** |
|   [Unique ID]{.underline                                              |
| }/\                                                                   |
|   Company**                                                           |
|                                                                       |
|                                                                       |
|   **Ma                                                                |
| ize (Bt176)\                        The period of authorization for t |
| he cultivation    ![](media/image3.png){width="0.24861111111111112in" |
|   \                                       and the placi               |
| ng on the market of SYN-EV176-9 maize height="0.24861111111111112in"} |
|   [SYN-EV176-9]{.underli                                              |
| ne}\              and its derived products in the Community ended on  |
|   \                                                                   |
|                   18/04/2007. A decision (2007/304/EC) was adopted    |
|   Syngenta**                                                          |
|                   on 25 April 2007. In order to ensure effective      |
|                                                                       |
|                   withdrawal from the market of seeds from inbred     |
|                                                                       |
|                   lines and hybrids derived from SYN-EV176-9 maize    |
|                                                                       |
|                   for the purpose of cultivation the notifier shall   |
|                                                                       |
|                   comply with the measures set out in the Decision    |
|                                                                       |
|                   Annex.\                                             |
|                                                                       |
|                   The presence of material which contains, consists   |
|                                                                       |
|                   of or is produced from SYN-EV176-9 maize in food    |
|                                                                       |
|                   or feed products notified under Article 8(1) and    |
|                                                                       |
|                   Article 20(1) of the Regulation shall be tolerated  |
|                                                                       |
|                   until 5 years after the date of notification of     |
|                                                                       |
|                   this Decision:\                                     |
|                                                                       |
|                   (a) provided that this presence is adventitious or  |
|                                                                       |
|                   technically unavoidable; and\                       |
|                                                                       |
|                   (b) in a proportion no higher than 0,9pct.          |
|                                                                       |
|   **Ma                                                                |
| ize (GA21 x MON810)\                The period of authorization for t |
| he cultivation    ![](media/image3.png){width="0.24861111111111112in" |
|   \                                       and the placi               |
| ng on the market of                   height="0.24861111111111112in"} |
|   [MON-ØØØ21-9 x                                                      |
|                   MON-ØØØ21-9xMON-ØØ81Ø-6 maize and its derived       |
|   MON-ØØ81Ø-6]{.underlin                                              |
| e}\               products in the Community ended on 18/04/2007. A    |
|   \                                                                   |
|                   decision (2007/308/EC) was adopted on 25 April      |
|   Monsanto**                                                          |
|                   2007.\                                              |
|                                                                       |
|                   The presence of material produced from              |
|                                                                       |
|                   MON-ØØØ21-9xMON-ØØ81Ø-6 maize in food or feed       |
|                                                                       |
|                   products notified under Article 8(1)(b) and         |
|                                                                       |
|                   Article 20(1)(b) of the Regulation shall be         |
|                                                                       |
|                   tolerated until five years after the date of        |
|                                                                       |
|                   notification of this Decision:\                     |
|                                                                       |
|                   (a) provided that this presence is adventitious or  |
|                                                                       |
|                   technically unavoidable; and\                       |
|                                                                       |
|                   (b) in a proportion no higher than 0,9 %.           |
|                                                                       |
|   **Sw                                                                |
| ede-rape (MS1, RF1, MS1xRF1)\       The period of authorization for t |
| he cultivation    ![](media/image3.png){width="0.24861111111111112in" |
|   \                                       and the placi               |
| ng on the market of                   height="0.24861111111111112in"} |
|   [ACS-BNØØ4-7\                                                       |
|                   ACS-BNØØ4-7xACS-BNØØ1-4 hybrid oilseed rape and     |
|   ACS-BNØØ1-4\                                                        |
|                   its derived products in the Community ended on      |
|   ACS-BNØØ4-7xACS-BNØØ1-                                              |
| 4]{.underline}\   18/04/2007. A decision (2007/305/EC) was adopted    |
|   \                                                                   |
|                   on 25 April 2007. In order to ensure effective      |
|   Bayer**                                                             |
|                   withdrawal from the market of seeds of hybrid       |
|                                                                       |
|                   oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 for the        |
|                                                                       |
|                   purpose of cultivation the notifier shall comply    |
|                                                                       |
|                   with the measures set out in the Decision Annex.\   |
|                                                                       |
|                   The presence of material which contains, consists   |
|                                                                       |
|                   of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4     |
|                                                                       |
|                   and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4  |
|                                                                       |
|                   oilseed rape in food or feed products notified      |
|                                                                       |
|                   under Article 8(1)(a) and Article 20(1) of the      |
|                                                                       |
|                   Regulation shall be tolerated until five years      |
|                                                                       |
|                   after the date of notification of this Decision:\   |
|                                                                       |
|                   (a) provided that this presence is adventitious or  |
|                                                                       |
|                   technically unavoidable; and\                       |
|                                                                       |
|                   (b) in a proportion no higher than 0,9 %.           |
|                                                                       |
|   **Sw                                                                |
| ede-rape (MS1, RF2, MS1xRF2)\       The period of authorization for t |
| he cultivation    ![](media/image3.png){width="0.24861111111111112in" |
|   \                                       and the placi               |
| ng on the market of                   height="0.24861111111111112in"} |
|   [ACS-BNØØ4-7\                                                       |
|                   ACS-BNØØ4-7xACS-BNØØ2-5 hybrid oilseed rape and     |
|   ACS-BNØØ2-5\                                                        |
|                   its derived products in the Community ended on      |
|   ACS-BNØØ4-7xACS-BNØØ2-                                              |
| 5]{.underline}\   18/04/2007. A decision (2007/306/EC) was adopted    |
|   \                                                                   |
|                   on 25 April 2007. In order to ensure effective      |
|   Bayer**                                                             |
|                   withdrawal from the market of seeds of hybrid       |
|                                                                       |
|                   oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5 for the        |
|                                                                       |
|                   purpose of cultivation the notifier shall comply    |
|                                                                       |
|                   with the measures set out in the Decision Annex.\   |
|                                                                       |
|                   The presence of material which contains, consists   |
|                                                                       |
|                   of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5     |
|                                                                       |
|                   and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5  |
|                                                                       |
|                   oilseed rape in food or feed products notified      |
|                                                                       |
|                   under Article 8(1)(a) and Article 20(1) of the      |
|                                                                       |
|                   Regulation shall be tolerated until five years      |
|                                                                       |
|                   after the date of notification of this Decision:\   |
|                                                                       |
|                   (a) provided that this presence is adventitious or  |
|                                                                       |
|                   technically unavoidable; and\                       |
|                                                                       |
|                   (b) in a proportion no higher than 0,9 %.           |
|                                                                       |
|   **Sw                                                                |
| ede rape (TOPAS19/2)\               The period of authorization for t |
| he cultivation    ![](media/image3.png){width="0.24861111111111112in" |
|   \                                       and the placi               |
| ng on the market of ACS-BNØØ7-1       height="0.24861111111111112in"} |
|   [ACS-BNØØ7-1]{.underli                                              |
| ne}\              oilseed rape and its derived products in the        |
|   \                                                                   |
|                   Community ended on 18/04/2007. A decision           |
|   Bayer**                                                             |
|                   (2007/307/EC) was adopted on 25 April 2007.\        |
|                                                                       |
|                   The presence of material which contains, consists   |
|                                                                       |
|                   of or is produced from ACS-BNØØ7-1 oilseed rape in  |
|                                                                       |
|                   food or feed products notified under Article        |
|                                                                       |
|                   8(1)(a) and Article 20(1) of the Regulation shall   |
|                                                                       |
|                   be tolerated until five years after the date of     |
|                                                                       |
|                   notification of this Decision:\                     |
|                                                                       |
|                   (a) provided that this presence is adventitious or  |
|                                                                       |
|                   technically unavoidable; and\                       |
|                                                                       |
|                   (b) in a proportion no higher than 0,9 %.           |
|   ------                                                              |
| --------------------------------- ----------------------------------- |
| --------------- ----------------------------------------------------- |
|                                                                       |
| Last update: 6-11-2007                                                |
+-----------------------------------------------------------------------+

## Annex III: Genetically modified food and feed pending authorization

Updated versions of this table are available at the following address:
<http://www.efsa.europa.eu/EFSA/ScientificPanels/GMO/efsa_locale-1178620753812_GMOApplications.htm>.

***A yellow background color means that this application was updated.***

GMO Applications

  ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**   **Application Scope**     **Status**        **Document Link**
  ----------------- ------------------- ------------------------- ----------------- ------------------------------------------------------------------------------------------------
  FR-2008-59        *PT73 Escherichia   Feed                      Under             [[More
                    coli* (TM) dried                              completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178717517295.htm)
                    killed bacterial                              check             
                    biomass                                                         

  UK-2008-58        MON15985 x MON1445  Food, feed import and     Under             [[More
                    Cotton              processing                completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178713189861.htm)
                                                                  check             

  UK-2008-57        MON15985 Cotton     Food, feed import and     Under             [[More
                                        processing                completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178713189489.htm)
                                                                  check             

  UK-2008-56        Bt11 x MIR604 x     Food, feed import and     Under             [[More
                    GA21 Maize          processing                completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178712755940.htm)
                                                                  check\*\*         

  DK-2008-55        B12 with            Food produced from GM     Under             [[More
                    recombinant human   plants or containing      completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178712755706.htm)
                    intrinsic factor    ingredients produced from check             
                                        GM plants (Arabidopsis                      
                                        thaliana)                                   

  CZ-2008-54        MON88017 Maize      CULTIVATION               Under             [[More
                                                                  completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178706493564.htm)
                                                                  check             

  UK-2008-53        98140 Maize         Food, feed import and     Under             [[More
                                        processing                completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178704672756.htm)
                                                                  check\*\*         

  NL-2008-52        A5547-127 Soybean   Food, feed import and     Under             [[More
                                        processing                completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178700247771.htm)
                                                                  check             

  NL-2008-51        GHB614 Cotton       Food, feed import and     Valid application [[More
                                        processing                                  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178682960942.htm)

  UK-2007-50        Bt11 x MIR604 Maize Food, feed import and     Valid             [[More
                                        processing                application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178665943048.htm)
  ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GMO Applications

  --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**       **Application       **Status**        **Document Link**
                                            Scope**                               
  ----------------- ----------------------- ------------------- ----------------- ------------------------------------------------------------------------------------------------
  UK-2007-49        Bt11 x GA21 Maize       Food, feed import   Valid             [[More
                                            and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178665942974.htm)

  UK-2007-48        MIR604 x GA21 Maize     Food, feed import   Valid             [[More
                                            and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178665942931.htm)

  NL-2007-47        305423 x 40-3-2 Soybean Food, feed import   Valid application [[More
                                            and processing                        info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178647174542.htm)

  NL-2007-46        T25 Maize               Food, Feed import   Valid application [[More
                                            and processing                        info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178625648249.htm)
                                            CULTIVATION                           

  NL-2007-45        305423 Soybean          Food, feed, import  Valid             [[More
                                            and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621168376.htm)

  FR-2007-44        PT73 Escherichia coli   Feed                Valid             [[More
                    (THR) dried killed                          application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620788439.htm)
                    bacterial biomass                                             

  UK-2007-43        356043 Soybean          Food, feed import   Valid             [[More
                                            and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620788422.htm)

  UK-2007-42        MON88913 x MON15985     Food, feed import   Valid             [[More
                    Cotton                  and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620788404.htm)

  UK-2007-41        MON88913 Cotton         Food, feed import   Valid             [[More
                                            and processing      application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620788387.htm)

  FR-2007-40        PL73 Escherichia coli   Feed                Valid             [[More
                    (LYS) dried killed                          application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787622.htm)
                    bacterial biomass                                             
  --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GMO Applications

  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**   **Application Scope**  **Status**        **Document Link**
  ----------------- ------------------- ---------------------- ----------------- ------------------------------------------------------------------------------------------------
  NL-2007-39        MON 89034 x MON     Food, feed import and  Valid             [[More
                    88017 Maize         processing             application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787604.htm)

  NL-2007-38        MON 89034 x NK 603  Food, feed import and  Valid application [[More
                    Maize               processing                               info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787528.htm)

  NL-2007-37        MON 89034 Maize     Food, feed import and  Valid             [[More
                                        processing             application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787403.htm)

  NL-2006-36        MON 89788 Soybean   Food, feed import and  Valid Application [[More
                                        processing                               info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787358.htm)

  NL-2006-35        LLCotton25 x MON    Food, feed produced    Under             [[More
                    15985 Cotton        from GM plants         completeness      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787248.htm)
                                        (derived products)     check\*\*         

  UK-2006-34        Event 3272 Maize    Food, feed import and  Valid             [[More
                                        processing             application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620787231.htm)

  CZ-2006-33        MON 88017 x MON 810 Food and feed import   Valid             [[More
                    Maize               and processing         application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786922.htm)

  NL-2006-32        LY038 x MON810      Food and feed Import   Valid             [[More
                    Maize               and processing         application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786705.htm)

  NL-2006-31        LY038 Maize         Food and feed import   Valid             [[More
                                        and processing         application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786616.htm)

  UK-2006-30        59122 x 1507 x      Food, feed import and  Valid             [[More
                    NK603 Maize         processing CULTIVATION application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786527.htm)
  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GMO Applications

  --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**   **Application     **Status**              **Document Link**
                                        Scope**                                   
  ----------------- ------------------- ----------------- ----------------------- ------------------------------------------------------------------------------------------------
  UK-2006-29        59122 x NK603 Maize Food, feed import WITHDRAWAL OF THE       [[More
                                        and processing    APPLICATION BY THE      info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178625240870.htm)
                                        CULTIVATION       APPLICANT ON 3 January  
                                                          2007                    

  NL-2005-28        1507 x 59122 Maize  Food, feed import Valid application\*\*   [[More
                                        and processing                            info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786466.htm)
                                        CULTIVATION                               

  CZ-2005-27        MON 88017 Maize     Food, feed import Valid Application\*\*   [[More
                                        and processing                            info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786384.htm)

  NL-2005-26        NK603 x MON810      CULTIVATION       Valid Application\*\*   [[More
                    Maize                                                         info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786292.htm)

  UK-2005-25        T45 Oilseed rape    Food, feed import EFSA overall opinion    [[More
                                        and processing    published               info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786239.htm)

  NL-2005-24        40-3-2 Soybean      CULTIVATION       Valid application\*\*   [[More
                                                                                  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786168.htm)

  NL-2005-23        59122 Maize         Food, feed import Valid application\*\*   [[More
                                        and processing                            info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620786039.htm)
                                        CULTIVATION                               

  NL-2005-22        NK603 Maize         Food, feed import Valid application\*\*\  [[More
                                        and processing    Validation method       info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785999.htm)
                                        CULTIVATION       reports published       

  UK-2005-21        59122 x 1507 x      Food, feed import Valid application\*\*   [[More
                    NK603 Maize         and processing                            info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785990.htm)

  UK-2005-20        59122 x NK603 Maize Food, feed import Valid application\*\*   [[More
                                        and processing                            info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785973.htm)
  --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GMO Applications

  ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**   **Application        **Status**         **Document Link**
                                        Scope**                                 
  ----------------- ------------------- -------------------- ------------------ ------------------------------------------------------------------------------------------------
  UK-2005-19        GA21 Maize          Food, feed import    EFSA Overall       [[More
                                        and processing       opinion published  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785956.htm)

  NL-2005-18        A2704-12 Soybean    Food, feed, import   EFSA overall       [[More
                                        and processing       opinion published  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785771.htm)

  UK-2005-17        1507 x NK603 Maize  Food and feed,       Valid              [[More
                                        import and           application\*\*    info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785723.htm)
                                        processing,                             
                                        CULTIVATION                             

  NL-2005-16        281-24-236 x        Food, feed           Valid              [[More
                    3006-210-23 Cotton                       application\*\*\   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785660.htm)
                                                             Validation method  
                                                             reports published  

  NL-2005-15        1507 x 59122 Maize  Food, feed import    Valid              [[More
                                        and processing       application\*\*\   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785602.htm)
                                                             Validation method  
                                                             reports published  

  UK-2005-14        Amylopectin Potato  Food, feed           EFSA overall       [[More
                    event EH92-527-1                         opinion published  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785504.htm)

  NL-2005-13        LLCotton25          Food, feed import    EFSA overall       [[More
                                        and processing       opinion published  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785856.htm)

  NL-2005-12        59122 Maize         Food, feed import    EFSA overall       [[More
                                        and processing       opinion published  info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785273.htm)

  UK-2005-11        MIR604 Maize        Food, feed import    Valid              [[More
                                        and processing       application\*\*    info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785196.htm)

  UK-2005-10        MON 15985 and MON   Food, feed produced  Valid              [[More
                    15985 x MON 1445    from GM plants       application\*\*    info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785169.htm)
                    Cotton              (derived products)                      
  ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

**GMO [Applications]{.underline}**

  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **EFSA-GMO-No**   **Event/Species**   **Application Scope**  **Status**        **Document Link**
  ----------------- ------------------- ---------------------- ----------------- ------------------------------------------------------------------------------------------------
  UK-2005-09        MON 531 x MON 1445  Food, feed produced    Valid             [[More
                    Cotton              from GM plants         application\*\*   info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785114.htm)
                                        (derived products)                       

  UK-2004-08        H7-1 Sugar Beet     Food, feed produced    EFSA overall      [[More
                                        from GM plants         opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620785055.htm)
                                        (derived products)                       

  BE-2004-07        MON863 x MON810 x   Food, feed import and  EFSA overall      [[More
                    NK603 Maize         processing             opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784943.htm)

  UK-2004-06        MON863 x NK603      Food, feed import and  EFSA overall      [[More
                    Maize               processing             opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784791.htm)

  UK-2004-05        1507 x NK603 Maize  Food, feed import and  EFSA overall      [[More
                                        processing             opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784648.htm)

  UK-2004-04        LLRICE62 Rice       Food, feed import and  EFSA overall      [[More
                                        processing             opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784584.htm)

  DE-2004-03        MON863 x MON810     Food, feed             EFSA overall      [[More
                    Maize                                      opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784282.htm)

  NL-2004-02        1507 Maize          Food                   EFSA overall      [[More
                                                               opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784553.htm)

  UK-2004-01        NK603 x MON810      Food, feed             EFSA overall      [[More
                    Maize                                      opinion published info]{.underline}](http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620784153.htm)
  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

## Annex IV: Regulation (EC) No 258/97, Genetically Modified Food Authorized (until January 17, 2006)

This table is available at the following address:
<http://ec.europa.eu/food/food/biotechnology/authorisation/258-97-ec_authorised_en.pdf>

![](media/image4.wmf){width="5.995833333333334in"
height="7.947916666666667in"}

![](media/image5.wmf){width="5.995138888888889in"
height="7.1194444444444445in"}

## Annex V: Genetically Modified Feed Authorized Under Directive 2001/18/EC

Updated versions of this table are available at the following address:
<http://ec.europa.eu/food/food/biotechnology/authorisation/2001-18-ec_authorised_en.pdf>.

![](media/image6.wmf){width="5.872222222222222in"
height="8.131944444444445in"}

![](media/image7.wmf){width="5.992361111111111in"
height="8.38263888888889in"}

## Annex VI: Pending Authorizations Under Directive 2001/18

Updated versions of this table are available at the following address:
<http://ec.europa.eu/food/food/biotechnology/authorisation/2001-18-ec_pending_en.pdf>.

![](media/image8.wmf){width="6.241666666666666in"
height="4.6090277777777775in"}

## Annex VII: Member States Policies

+---------+-----------------+------------+---------------------------+
| *       | **National      | **Impl     | **National Coexistence    |
| *Member | Competent/**    | ementation | rules**                   |
| State** |                 | of EU      |                           |
|         | **Relevant**    | policy**   |                           |
|         | **Authorities** |            |                           |
+---------+-----------------+------------+---------------------------+
| Austria | Federal         | Austria    | The EU Commission adopted |
|         | Ministry of     | has fully  | a decision ordering       |
|         | Health, Family  | i          | Austria to lift the       |
|         | and Youth       | mplemented | safeguard clause in place |
|         |                 | EU         | on the import and         |
|         |                 | r          | processing of the two     |
|         |                 | egulations | biotech corn lines MON    |
|         |                 | on         | 810 and T 25.             |
|         |                 | bio        |                           |
|         |                 | technology |                           |
|         |                 |            |                           |
|         |                 | Biotech    |                           |
|         |                 | food and   |                           |
|         |                 | feed       |                           |
+---------+-----------------+------------+---------------------------+
|         | Federal         | Planting   | National ordinances still |
|         | Ministry of     | of biotech | effectively prevent the   |
|         | Agriculture,    | crops      | planting of EU approved   |
|         | Forestry,       |            | biotech crops.            |
|         | Environment and |            |                           |
|         | Water           |            |                           |
|         | Management      |            |                           |
+---------+-----------------+------------+---------------------------+
|         | Provincial      | Pre        | GMO restricting zones     |
|         | Governments     | cautionary | have been established in  |
|         |                 | Bills      | all of the nine provinces |
|         |                 |            | of Austria and all        |
|         |                 |            | Austrian provinces are    |
|         |                 |            | members of the "European  |
|         |                 |            | Network of GMO-free       |
|         |                 |            | Regions."                 |
+---------+-----------------+------------+---------------------------+
| Belgium | Federal         | -2001/18   | -The two Belgian Regions, |
|         | Government      | i          | Flanders and Wallonia,    |
|         | Department for  | mplemented | are responsible for       |
|         | Health, Food    | in 2005    | formulating and           |
|         | Chain Safety    |            | implementing a            |
|         | and Environment | -1829/2003 | coexistence policy.       |
|         |                 | and        |                           |
|         |                 | 1830/2003  | -In March 2007, the       |
|         |                 | are by EC  | Flemish Government        |
|         |                 | law        | decided upon a framework  |
|         |                 | directly   | for the coexistence       |
|         |                 | enforced   | regulations for Flanders. |
|         |                 | in entire  |                           |
|         |                 | EU         | -The regulations          |
|         |                 |            | reportedly guarantee free |
|         |                 |            | choice for the farmer to  |
|         |                 |            | plant GMOs, and include a |
|         |                 |            | liability fund. The       |
|         |                 |            | conditions for            |
|         |                 |            | compensation are not yet  |
|         |                 |            | agreed upon. For border   |
|         |                 |            | zones see table below.    |
|         |                 |            |                           |
|         |                 |            | -In February 2006, the    |
|         |                 |            | Walloon Government        |
|         |                 |            | approved coexistence      |
|         |                 |            | regulations.              |
|         |                 |            |                           |
|         |                 |            | -According to the Walloon |
|         |                 |            | Government, the           |
|         |                 |            | regulations on            |
|         |                 |            | cultivating GMOs are as   |
|         |                 |            | restrictive as possible   |
|         |                 |            | within the scope of the   |
|         |                 |            | harmonized EU             |
|         |                 |            | regulations. The          |
|         |                 |            | regulations contain       |
|         |                 |            | possibilities to impose   |
|         |                 |            | GMO free zones, and a     |
|         |                 |            | liability fund paid by    |
|         |                 |            | the farmer planting GMO   |
|         |                 |            | crops. For border zones   |
|         |                 |            | see table below.          |
|         |                 |            |                           |
|         |                 |            | -Sector sources believe   |
|         |                 |            | that the combination of   |
|         |                 |            | restrictions will         |
|         |                 |            | practically ban the       |
|         |                 |            | cultivation of GMOs.      |
+---------+-----------------+------------+---------------------------+
| Czech   | Ministry of     | Tra        | Distance requirements:    |
| R       | Agriculture     | nsposition | The isolation distances   |
| epublic |                 | of the     | were decreased in 2006    |
|         | (Act 441/2005   | 2001/18 in | from 100 meters for       |
|         | amending the    | 2004 in    | conventional agriculture  |
|         | Act on          | Act no.    | to 70 meters (or 35 rows  |
|         | Agriculture     | 78/2004    | of non-GM crops as a      |
|         |                 |            | barrier or a combination  |
|         | and             |            | of a distance and a       |
|         |                 |            | buffer zone, in which     |
|         | Decree 89/2006  |            | case 1 row equals 2       |
|         | on more         |            | meters) and for organic   |
|         | detailed        |            | agriculture from 600      |
|         | requirements    |            | meters to 200 meters (or  |
|         | for cultivation |            | 100 m and 50 rows of non  |
|         | of genetically  |            | GM crop as a buffer       |
|         | modified        |            | zone).                    |
|         | variety)        |            |                           |
|         |                 |            | No genetic-free zones     |
|         |                 |            | managed by the decree.    |
|         |                 |            |                           |
|         |                 |            | No constraint for biotech |
|         |                 |            | crops with regard to      |
|         |                 |            | nature conservation       |
|         |                 |            | districts.                |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | \- Act     | \- Act 78/2004 on         |
|         | Environment     | 78/2004 on | genetically modified      |
|         |                 | g          | organisms and genetic     |
|         |                 | enetically | products                  |
|         |                 | modified   |                           |
|         |                 | organisms  | \- Decree 209/2004 on     |
|         |                 | and        | detailed conditions for   |
|         |                 | genetic    | the use of genetically    |
|         |                 | products   | modified organisms and    |
|         |                 |            | genetic products          |
|         |                 | \- Decree  |                           |
|         |                 | 209/2004   |                           |
|         |                 | on         |                           |
|         |                 | detailed   |                           |
|         |                 | conditions |                           |
|         |                 | for the    |                           |
|         |                 | use of     |                           |
|         |                 | g          |                           |
|         |                 | enetically |                           |
|         |                 | modified   |                           |
|         |                 | organisms  |                           |
|         |                 | and        |                           |
|         |                 | genetic    |                           |
|         |                 | products   |                           |
+---------+-----------------+------------+---------------------------+
| France  | French          | France     | \- The GOF initiated a    |
|         | Ministries of   | transposed | safeguard clause freezing |
|         | Environment and | EU         | cultivation of MON810 in  |
|         | Agriculture     | Directive  | January, 2008.            |
|         |                 | 2001/18 in |                           |
|         |                 | the        | -The 2008 biotech bill    |
|         |                 | biotech    | creates a new biotech     |
|         |                 | bill       | authority, establishes    |
|         |                 | adopted in | technical conditions for  |
|         |                 | spring     | producing biotech crops   |
|         |                 | 2008       | through a new coexistence |
|         |                 |            | framework, and sets       |
|         |                 |            | harsher penalties for     |
|         |                 |            | biotech crop destruction. |
|         |                 |            | The decrees implementing  |
|         |                 |            | the bill will have to be  |
|         |                 |            | prepared and published in |
|         |                 |            | the French Official       |
|         |                 |            | Journal. Of high interest |
|         |                 |            | will be the decrees       |
|         |                 |            | detailing biotech and     |
|         |                 |            | non-biotech crop          |
|         |                 |            | coexistence measures.     |
+---------+-----------------+------------+---------------------------+
|         | Fraud Control   | Biotech    |                           |
|         | Office, French  | tr         |                           |
|         | Ministry of     | aceability |                           |
|         | Economy         | and        |                           |
|         | (DGCCRF)        | labeling   |                           |
|         |                 | is under   |                           |
|         |                 | the        |                           |
|         |                 | resp       |                           |
|         |                 | onsibility |                           |
|         |                 | of DGCCRF, |                           |
|         |                 | and EU     |                           |
|         |                 | r          |                           |
|         |                 | egulations |                           |
|         |                 | on NF/NF   |                           |
|         |                 | and T&L    |                           |
|         |                 | have been  |                           |
|         |                 | i          |                           |
|         |                 | mplemented |                           |
|         |                 | since      |                           |
|         |                 | April 2004 |                           |
+---------+-----------------+------------+---------------------------+
| Germany | Bundesamt f.    | Germany    | To date, Germany has only |
|         | Ve              | has fully  | established distance      |
|         | rbraucherschutz | i          | requirements for corn     |
|         | und             | mplemented | production.               |
|         | Lebensm         | EU         |                           |
|         | ittelsicherheit | r          | 150 meters to             |
|         |                 | egulations | conventional corn fields, |
|         |                 | on         |                           |
|         |                 | biot       | 300 meters to organic     |
|         |                 | echnology: | corn fields               |
|         |                 |            |                           |
|         |                 | German     |                           |
|         |                 | Genetech   |                           |
|         |                 | Law, last  |                           |
|         |                 | amended in |                           |
|         |                 | February   |                           |
|         |                 | 2008       |                           |
+---------+-----------------+------------+---------------------------+
|         | On the          | German     | Farmers must report their |
|         | regulatory side | Gen        | intention to cultivate    |
|         | the German      | etech-Free | biotech seeds three       |
|         | Federal         | Labeling   | months before planting to |
|         | Ministry of     | Law, last  | a national register. This |
|         | Food,           | amended    | field register is         |
|         | Agriculture and | 2008       | publicly accessible on    |
|         | Consumer        |            | the internet.             |
|         | Protection has  |            |                           |
|         | prime           |            | <http://194.95.22         |
|         | responsibility  |            | 6.237/stareg_web/bundesla |
|         | for             |            | ndStatistic.do?year=2008> |
|         | biotechnology.  |            |                           |
+---------+-----------------+------------+---------------------------+
|         |                 |            | Liability: Biotech        |
|         |                 |            | farmers remain liable to  |
|         |                 |            | their conventional or     |
|         |                 |            | organic farming neighbors |
|         |                 |            | even if they adhered to   |
|         |                 |            | all good management       |
|         |                 |            | rules. Farmers have to    |
|         |                 |            | prevent any level of      |
|         |                 |            | out-crossing.             |
+---------+-----------------+------------+---------------------------+
|         |                 |            | Effective July 2008, the  |
|         |                 |            | German food processing    |
|         |                 |            | industry has the option   |
|         |                 |            | of labeling livestock     |
|         |                 |            | products genetech-free if |
|         |                 |            | the animals have not been |
|         |                 |            | fed biotech feeds for a   |
|         |                 |            | certain period prior to   |
|         |                 |            | slaughter and milking.    |
+---------+-----------------+------------+---------------------------+
|         |                 |            | GMO restrictive zones     |
|         |                 |            | have been established in  |
|         |                 |            | many German regions.      |
|         |                 |            | Their number is growing.  |
+---------+-----------------+------------+---------------------------+
| Greece  | Ministry of     | Greece has | The EU Commission adopted |
|         | Environment for | fully      | a decision ordering       |
|         | new crop        | i          | Greece to lift the        |
|         | approvals and   | mplemented | safeguard clause it had   |
|         | Ministry of     | EU         | in place on the import    |
|         | Agriculture     | r          | and processing of the two |
|         | with EFET       | egulations | biotech corns, MON 810    |
|         | (Hellenic       | on         | and T 25. GOG does not    |
|         | Agency for Food | bio        | comply with EU decisions  |
|         | Control) on     | technology | in adopting a coexistence |
|         | food ingredient |            | system in a certain       |
|         | and food item   | Biotech    | period of time using      |
|         | approvals.      | food and   | numerous ways to justify  |
|         |                 | feed but   | the delay. The            |
|         |                 | serious    | constraints are           |
|         |                 | problems   | political.                |
|         |                 | are        |                           |
|         |                 | reported   |                           |
|         |                 | in         |                           |
|         |                 | enforcing  |                           |
|         |                 | the        |                           |
|         |                 | re         |                           |
|         |                 | gulations. |                           |
|         |                 | EFET is in |                           |
|         |                 | charge of  |                           |
|         |                 | e          |                           |
|         |                 | nforcement |                           |
|         |                 | in         |                           |
|         |                 | c          |                           |
|         |                 | ooperation |                           |
|         |                 | with GOG   |                           |
|         |                 | Ministry   |                           |
|         |                 | of         |                           |
|         |                 | A          |                           |
|         |                 | griculture |                           |
|         |                 | but there  |                           |
|         |                 | is lack of |                           |
|         |                 | funds and  |                           |
|         |                 | personnel. |                           |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | Planting   | To date, they prevent the |
|         | Agriculture,    | of biotech | planting of EU approved   |
|         | And Local       | crops      | biotech crops. The whole  |
|         | Authorities at  |            | country is a GMO          |
|         | Prefecture and  |            | restricted zone (see also |
|         | Municipality    |            | 2007 map of such regions: |
|         | Levels          |            | <                         |
|         |                 |            | http://genet.iskra.net/>) |
+---------+-----------------+------------+---------------------------+
| Hungary | Hungarian       | Act. No.   |                           |
|         | Parliament      | XXVII. Of  |                           |
|         |                 | 1998 On    |                           |
|         |                 | Bio        |                           |
|         |                 | technology |                           |
|         |                 | Activities |                           |
+---------+-----------------+------------+---------------------------+
|         |                 | Act. No.   |                           |
|         |                 | LXVII. Of  |                           |
|         |                 | 2002 On    |                           |
|         |                 | the        |                           |
|         |                 | Amendment  |                           |
|         |                 | of the Act |                           |
|         |                 | No. XXVII. |                           |
|         |                 | Of 1998    |                           |
+---------+-----------------+------------+---------------------------+
|         |                 | Act. No.   | This Act (amendment)      |
|         |                 | CVIII. Of  | contains the so called    |
|         |                 | 2006 On    | "Coexistence Regulation." |
|         |                 | the        |                           |
|         |                 | Amendment  | The most debated          |
|         |                 | of the Act | provisions are the prior  |
|         |                 | No. XXVII. | written consent           |
|         |                 | Of 1998    | requirements of all       |
|         |                 |            | landowners and land users |
|         |                 |            | of the neighboring        |
|         |                 |            | parcels, and the big      |
|         |                 |            | isolation distances       |
|         |                 |            | required between biotech  |
|         |                 |            | and conventional or       |
|         |                 |            | organic crop fields. The  |
|         |                 |            | latter is 400 meters for  |
|         |                 |            | corn, more than double    |
|         |                 |            | that of the distance used |
|         |                 |            | in hybrid seed            |
|         |                 |            | propagation worldwide and |
|         |                 |            | much larger than the      |
|         |                 |            | required isolation in     |
|         |                 |            | Member States already     |
|         |                 |            | producing biotech crops.  |
+---------+-----------------+------------+---------------------------+
|         | The Government  | I          |                           |
|         | of Hungary      | mplemented |                           |
|         |                 | moratorium |                           |
|         |                 | on         |                           |
|         |                 | production |                           |
|         |                 | of         |                           |
|         |                 | g          |                           |
|         |                 | enetically |                           |
|         |                 | modified   |                           |
|         |                 | (GM),      |                           |
|         |                 | insect     |                           |
|         |                 | resistant  |                           |
|         |                 | corn (MON  |                           |
|         |                 | 810) by    |                           |
|         |                 | invocation |                           |
|         |                 | of         |                           |
|         |                 | safeguard  |                           |
|         |                 | clause, on |                           |
|         |                 | January 18 |                           |
|         |                 | 2005.      |                           |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | Several    |                           |
|         | Agriculture     | Orders     |                           |
|         | (together with  | (a         |                           |
|         | other           | pplication |                           |
|         | Ministries such | rules)     |                           |
|         | as M. of        | setting    |                           |
|         | Environment,    | the role   |                           |
|         | Economy,        | of lower   |                           |
|         | Health)         | level      |                           |
|         |                 | ins        |                           |
|         |                 | titutions, |                           |
|         |                 | fees and   |                           |
|         |                 | fines etc. |                           |
|         |                 | concerning |                           |
|         |                 | the        |                           |
|         |                 | e          |                           |
|         |                 | nforcement |                           |
|         |                 | of above   |                           |
|         |                 | Acts       |                           |
+---------+-----------------+------------+---------------------------+
| Ireland | Department of   | SI 424     |                           |
|         | Agriculture,    | (2004):    |                           |
|         | Fisheries and   | transposes |                           |
|         | Food            | the        |                           |
|         |                 | Feedstuffs |                           |
|         |                 | elements   |                           |
|         |                 | of the EU  |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
+---------+-----------------+------------+---------------------------+
|         | Department of   | In         | Has not yet transposed    |
|         | Health          | relation   | the elements of EU        |
|         |                 | to the     | legislation in relation   |
|         |                 | food       | to food                   |
|         |                 | elements   |                           |
|         |                 | of the     |                           |
|         |                 | r          |                           |
|         |                 | egulations |                           |
+---------+-----------------+------------+---------------------------+
|         | Department of   | Directive  |                           |
|         | the Environment | 2001/18    |                           |
|         | and Local       | transposed |                           |
|         | Government      | in         |                           |
|         |                 | SI500/2003 |                           |
|         |                 | on the     |                           |
|         |                 | deliberate |                           |
|         |                 | release.   |                           |
|         |                 |            |                           |
|         |                 | Directive  |                           |
|         |                 | 90/219     |                           |
|         |                 | transposed |                           |
|         |                 | in SI73    |                           |
|         |                 | (2001) on  |                           |
|         |                 | c          |                           |
|         |                 | ontainment |                           |
+---------+-----------------+------------+---------------------------+
| Italy   | Regions for     |            | Coexistence regulations   |
|         | coexistence     |            | have not yet been issued  |
|         |                 |            | by any of the 20 Italian  |
|         |                 |            | regions. As a result, a   |
|         |                 |            | de facto moratorium on GM |
|         |                 |            | crop planting continues   |
|         |                 |            | to exist.                 |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | 2001/18    |                           |
|         | Environment.    | was        |                           |
|         | For the         | i          |                           |
|         | approval of new | mplemented |                           |
|         | events,         | in 2003    |                           |
|         | however, other  |            |                           |
|         | Ministries are  |            |                           |
|         | responsible:    |            |                           |
|         | Health,         |            |                           |
|         | Welfare,        |            |                           |
|         | Agriculture,    |            |                           |
|         | Economic        |            |                           |
|         | Development,    |            |                           |
|         | Education. (see |            |                           |
|         | our IT7016)     |            |                           |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | Food &     |                           |
|         | Health          | Feed,      |                           |
|         |                 | Labeling   |                           |
|         |                 | and        |                           |
|         |                 | Tr         |                           |
|         |                 | aceability |                           |
+---------+-----------------+------------+---------------------------+
| Neth    | -Ministry of    | -2001/18   | -On November 2, 2004, the |
| erlands | Public Health,  | i          | Dutch agricultural sector |
|         | Welfare and     | mplemented | and NGOs jointly          |
|         | Sport           | in 2003    | presented their           |
|         |                 |            | coexistence agreement to  |
|         | -Ministry of    | -1829/2003 | the Dutch Ministry of     |
|         | Housing,        | and        | Agriculture, Nature and   |
|         | Regional        | 1830/2003  | Food Quality.             |
|         | Planning and    | are by EC  |                           |
|         | Environment     | law        | \- The Dutch sector still |
|         |                 | directly   | needs to reach agreement  |
|         | -Ministry of    | enforced   | on the scope of a         |
|         | Agriculture,    | in entire  | compensation fund for     |
|         | Nature and Food | EU         | possible damage to        |
|         | Quality         |            | conventional and organic  |
|         |                 |            | crops, and a monitoring   |
|         |                 |            | system in the field. For  |
|         |                 |            | border zones see table    |
|         |                 |            | below: proposed border    |
|         |                 |            | zones in the Benelux      |
|         |                 |            | (meters):                 |
|         |                 |            |                           |
|         |                 |            |   ------------ -----      |
|         |                 |            | ---------- --------- ---- |
|         |                 |            | ---------- -------------- |
|         |                 |            |                **T        |
|         |                 |            | he                     ** |
|         |                 |            | Flanders**   **Wallonia** |
|         |                 |            |                           |
|         |                 |            |          Netherlands**    |
|         |                 |            |                           |
|         |                 |            |                           |
|         |                 |            |                           |
|         |                 |            |          **C**            |
|         |                 |            | **O**                     |
|         |                 |            |                           |
|         |                 |            |   **Potato*               |
|         |                 |            | *   **3**           **10* |
|         |                 |            | *    **-**          **-** |
|         |                 |            |                           |
|         |                 |            |   **Sugar                 |
|         |                 |            |     **1.5**         **3** |
|         |                 |            |      **-**          **-** |
|         |                 |            |   beet                    |
|         |                 |            | **                        |
|         |                 |            |                           |
|         |                 |            |                           |
|         |                 |            |   **Maize**               |
|         |                 |            |    **25**          **250* |
|         |                 |            | *   **200**        **50** |
|         |                 |            |   ------------ -----      |
|         |                 |            | ---------- --------- ---- |
|         |                 |            | ---------- -------------- |
|         |                 |            |                           |
|         |                 |            | C = distance from         |
|         |                 |            | conventional production   |
|         |                 |            |                           |
|         |                 |            | O = distance from organic |
|         |                 |            | production                |
|         |                 |            |                           |
|         |                 |            | Summaries of the MS       |
|         |                 |            | coexistence regulations   |
|         |                 |            | can be found on:          |
|         |                 |            | <http                     |
|         |                 |            | ://www.gmo-safety.eu/en/c |
|         |                 |            | oexistence/513.docu.html> |
+---------+-----------------+------------+---------------------------+
| Poland  | Food products:  | 2001/18 -- | Work on new regulations   |
|         |                 | i          | for Genetically Modified  |
|         | approval -Chief | mplemented | Organisms, including the  |
|         | Sanitary        | in May     | coexistence rules is      |
|         | Inspectorate,   | 2003.      | currently in progress     |
|         | lab testing     |            | within the Ministry of    |
|         | -National       | -impl      | Environment.  It is       |
|         | Sanitary        | ementation | expected to be completed  |
|         | Inspectorate    | of         | by the end of 2008 (this  |
|         | working under   | 1829/2003  | date was officially       |
|         | the Ministry of | -- April   | presented to EC by        |
|         | Health          | 18, 2004   | Poland's GOV).            |
|         |                 |            |                           |
|         | Feeds: Ministry | and        | On July 11, 2008, the     |
|         | of Agriculture  | 1830/2003  | Senate (upper house of    |
|         | and Rural       | -- April   | the Polish Parliament)    |
|         | Development,    | 25, 2004.  | voted to delay            |
|         |                 |            | introduction of a ban on  |
|         | Veterinary      | []{.mark}  | biotech feed, which was   |
|         | Inspection      |            | scheduled to enter into   |
|         | (testing,       |            | effect August 12, 2008,   |
|         | labeling        |            | until December 31, 2012;  |
|         | issues)         |            | the proposal was then     |
|         |                 |            | signed by the Polish      |
|         | Legal           |            | President and entered     |
|         | regulations on  |            | into force.               |
|         | Planting/       |            |                           |
|         |                 |            | []{.mark}                 |
|         | Coexistence:    |            |                           |
|         | Ministry of     |            | New regulations on        |
|         | Environment     |            | Genetically Modified      |
|         |                 |            | Organisms, including the  |
|         |                 |            | coexistence rules is      |
|         |                 |            | currently in progress     |
|         | []{.mark}       |            | within the Ministry of    |
|         |                 |            | Environment.  It is       |
|         |                 |            | expected to be completed  |
|         |                 |            | by end of 2008. []{.mark} |
|         |                 |            |                           |
|         |                 |            | []{.mark}                 |
+---------+-----------------+------------+---------------------------+
| P       | Environment     | Tra        | The GOP published a       |
| ortugal | Ministry/       | nsposition | coexistence decree in     |
|         |                 | of the     | September 2005. Farmers   |
|         | Ministry of     | 2001/18 in | are required to implement |
|         | Agriculture     | 2003 by    | 200-meter isolation zones |
|         |                 | law        | between biotechnology and |
|         |                 | 9/2003.    | traditional corn crops,   |
|         |                 |            | and 300-meter zones       |
|         |                 |            | between biotechnology and |
|         |                 |            | organic corn production.  |
|         |                 |            | This distance may be      |
|         |                 |            | replaced by a 24-row      |
|         |                 |            | conventional-seed buffer  |
|         |                 |            | zone, or by combining a   |
|         |                 |            | 50-meter isolation zone   |
|         |                 |            | with a 28-row             |
|         |                 |            | conventional-seed buffer  |
|         |                 |            | zone. In the case of      |
|         |                 |            | insect resistant          |
|         |                 |            | varieties, producers need |
|         |                 |            | to create "refuge" zones  |
|         |                 |            | equal to 20 percent of    |
|         |                 |            | field area, which must be |
|         |                 |            | populated with            |
|         |                 |            | conventional corn         |
|         |                 |            | varieties. The current    |
|         |                 |            | coexistence decree        |
|         |                 |            | effectively restricts     |
|         |                 |            | biotechnology-seed use in |
|         |                 |            | most corn growing         |
|         |                 |            | districts, because of the |
|         |                 |            | prevalence of small       |
|         |                 |            | properties making it      |
|         |                 |            | difficult, if not         |
|         |                 |            | impossible, to meet the   |
|         |                 |            | isolation zone            |
|         |                 |            | requirements.             |
+---------+-----------------+------------+---------------------------+
| Romania | Ministry of     | \-         | According to national     |
|         | Environment     | [Directive | regulations issued by the |
|         |                 | 2001/      | Min. of Agriculture,      |
|         | Ministry of     | 18](http:/ | biotech farmers have to   |
|         | Agriculture and | /eur-lex.e | avoid cross-contamination |
|         | Rural           | uropa.eu/L | by setting a minimum      |
|         | Development;    | exUriServ/ | isolation distance        |
|         |                 | site/en/oj | between the biotech and   |
|         | Veterinary and  | /2001/l_10 | conventional fields,      |
|         | for Food Safety | 6/l_106200 | according to the general  |
|         | National        | 10417en000 | regulations on seeds      |
|         | Authority;      | 10038.pdf) | certification. The        |
|         | Ministry of     | transposed | farmers should also       |
|         | Public Health;  | through    | establish a "buffer zone" |
|         |                 | Emergency  | and carefully plan the    |
|         | National Guard  | Ordinance  | sowing season. In case of |
|         | for             | 43/2007    | biotech corn, the minimum |
|         | Environment.    |            | isolation distance is 200 |
|         |                 | (June      | meters.                   |
|         |                 | 2007)      |                           |
|         |                 |            | During the harvesting,    |
|         |                 | \-         | transportation and        |
|         |                 | [Directive | storage process, farmers  |
|         |                 | 90/219]    | have to avoid commingling |
|         |                 | (http://eu | GM seed with organic or   |
|         |                 | r-lex.euro | conventional seeds        |
|         |                 | pa.eu/LexU | through separate storage, |
|         |                 | riServ/Lex | through cleaning of       |
|         |                 | UriServ.do | machinery for sowing and  |
|         |                 | ?uri=CELEX | conditioning, cleaning    |
|         |                 | :31990L021 | transportation means,     |
|         |                 | 9:EN:HTML) | according to specific     |
|         |                 | transposed | legislation on certified  |
|         |                 | through    | seeds.                    |
|         |                 | Emergency  |                           |
|         |                 | Ordinance  | It is mandatory that      |
|         |                 | 44/2007    | biotech farmers notify in |
|         |                 |            | writing both land owners  |
|         |                 | (June      | and land users with plots |
|         |                 | 2007)      | nearby about their        |
|         |                 |            | intention to cultivate    |
|         |                 | \-         | biotech plants.           |
|         |                 | Regulation |                           |
|         |                 | 1829/2003  | Planting biotech crops    |
|         |                 | transposed | inside the natural        |
|         |                 | through    | protected areas is        |
|         |                 | Government | forbidden, but there are  |
|         |                 | Decision   | no limits set for the     |
|         |                 | 256/2006   | area around these         |
|         |                 | (Feb 2006) | protected areas.          |
|         |                 |            |                           |
|         |                 | \-         | []{.mark}                 |
|         |                 | Regulation |                           |
|         |                 | 1830/2003  |                           |
|         |                 | transposed |                           |
|         |                 | through    |                           |
|         |                 | Government |                           |
|         |                 | Decision   |                           |
|         |                 | 173/2006   |                           |
|         |                 | (Feb 2006) |                           |
|         |                 |            |                           |
|         |                 | **-**      |                           |
|         |                 | Biosafety  |                           |
|         |                 | Commission |                           |
|         |                 | (Since     |                           |
|         |                 | April      |                           |
|         |                 | 2008)      |                           |
+---------+-----------------+------------+---------------------------+
| S       | Ministry of     | -Act on    | Ministry of Environment   |
| lovakia | Environment     | the Use of | is about to prepare a new |
|         |                 | Genetic    | National Biosafety        |
|         |                 | Techniques | strategy by the end of    |
|         |                 | and        | this year.                |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Organisms  |                           |
|         |                 |            |                           |
|         |                 | no.        |                           |
|         |                 | 151/2002   |                           |
|         |                 | from April |                           |
|         |                 | 1, 2002,   |                           |
|         |                 | amended by |                           |
|         |                 | the Act    |                           |
|         |                 | no.        |                           |
|         |                 | 77/2005    |                           |
|         |                 | that came  |                           |
|         |                 | into force |                           |
|         |                 | on         |                           |
|         |                 | February   |                           |
|         |                 | 3, 2005    |                           |
|         |                 |            |                           |
|         |                 | Decree no. |                           |
|         |                 | 399/2005   |                           |
|         |                 | a          |                           |
|         |                 | dministers |                           |
|         |                 | the Act on |                           |
|         |                 | GMOs       |                           |
|         |                 | 77/2005    |                           |
|         |                 | (contained |                           |
|         |                 | use etc.)  |                           |
+---------+-----------------+------------+---------------------------+
|         | Ministry of     | Act        | The minimum isolation     |
|         | Agriculture     | n          | distances for             |
|         |                 | o.184/2006 | conventional crops is 200 |
|         |                 | on Growing | meters for corn, 400      |
|         |                 | of GM      | meters for rapeseed, 50   |
|         |                 | Crops in   | meters for sugar beets,   |
|         |                 | A          | 20 meters for potatoes.   |
|         |                 | griculture | For organic production    |
|         |                 |            | the isolation distances   |
|         |                 | Decree     | are 300, 600, 50, and 20  |
|         |                 | 69/2007    | meters respectively.      |
|         |                 | im         |                           |
|         |                 | plementing |                           |
|         |                 | the Act    |                           |
|         |                 | no.        |                           |
|         |                 | n          |                           |
|         |                 | o.184/2006 |                           |
|         |                 | and        |                           |
|         |                 | providing  |                           |
|         |                 | details on |                           |
|         |                 | technical  |                           |
|         |                 | measures,  |                           |
|         |                 | isolation  |                           |
|         |                 | distances  |                           |
|         |                 | and        |                           |
|         |                 | handling   |                           |
|         |                 | GM crops   |                           |
+---------+-----------------+------------+---------------------------+
| S       | Ministry of     | -          | Act on Co-existence of    |
| lovenia | Environment and | Management | Genetically Modified      |
|         | Spatial         | of         | Plants and Other          |
|         | Planning        | G          | Agricultural Plants       |
|         |                 | enetically | currently under           |
|         |                 | Modified   | discussion.               |
|         |                 | Organisms  |                           |
|         |                 | Act        |                           |
|         |                 | (Official  |                           |
|         |                 | Gazette of |                           |
|         |                 | the RS     |                           |
|         |                 | 67/02)     |                           |
|         |                 | (reflects  |                           |
|         |                 | Directives |                           |
|         |                 | 90/219,    |                           |
|         |                 | 98/81,     |                           |
|         |                 | 2002/18    |                           |
|         |                 | and some   |                           |
|         |                 | provisions |                           |
|         |                 | of the     |                           |
|         |                 | CPB)       |                           |
|         |                 |            |                           |
|         |                 | -          |                           |
|         |                 | Management |                           |
|         |                 | of         |                           |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Organisms  |                           |
|         |                 | Act        |                           |
|         |                 | (Official  |                           |
|         |                 | Gazette of |                           |
|         |                 | the RS     |                           |
|         |                 | 23/2005)   |                           |
+---------+-----------------+------------+---------------------------+
| Spain   | Ministry of     | Tra        | The debate continues on a |
|         | Environment&    | nsposition | GOS coexistence decree,   |
|         | Agricul         | of 2001/18 | the first draft of which  |
|         | ture/Autonomous | (by        | was made public in 2004.  |
|         | Regions         | National   |                           |
|         | Authorities     | Law 9/2003 | Coexistence liability     |
|         |                 | -- 25,     | could be managed from the |
|         |                 | April      | new Environmental         |
|         |                 | 2003)      | Responsibility Law (rules |
|         |                 |            | currently under           |
|         |                 |            | development) without the  |
|         |                 |            | need of a specific        |
|         |                 |            | regulation for            |
|         |                 |            | coexistence.              |
+---------+-----------------+------------+---------------------------+
|         | Health and      | Monitors   |                           |
|         | Consumer        | and        |                           |
|         | Affairs         | enforces   |                           |
|         | Ministry        | labeling   |                           |
|         |                 | r          |                           |
|         |                 | equirement |                           |
|         |                 | compliance |                           |
+---------+-----------------+------------+---------------------------+
| United  | Department for  | Directive  | No coexistence measures   |
| Kingdom | Environment,    | 2001/18 is | finalized. Public comment |
|         | Food & Rural    | i          | period in 2006 generated  |
|         | Affairs (Defra) | mplemented | very polarized feedback   |
|         |                 | by the     | between pro- and          |
|         |                 | Env        | anti-biotech supporters.  |
|         |                 | ironmental | Since no commercial       |
|         |                 | Protection | production is expected in |
|         |                 | Act and    | the UK in the short term, |
|         |                 | (in        | Defra is not moving       |
|         |                 | England)   | forward on this issue at  |
|         |                 | the        | present.                  |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Organisms  |                           |
|         |                 | (          |                           |
|         |                 | Deliberate |                           |
|         |                 | Release)   |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | 2002       |                           |
|         |                 | (similar   |                           |
|         |                 | r          |                           |
|         |                 | egulations |                           |
|         |                 | have been  |                           |
|         |                 | i          |                           |
|         |                 | mplemented |                           |
|         |                 | in         |                           |
|         |                 | Northern   |                           |
|         |                 | Ireland,   |                           |
|         |                 | Scotland   |                           |
|         |                 | and        |                           |
|         |                 | Wales).    |                           |
+---------+-----------------+------------+---------------------------+
|         | Department for  | Regulation |                           |
|         | Environment,    | 1829/2003  |                           |
|         | Food & Rural    | is         |                           |
|         | Affairs (Defra) | i          |                           |
|         |                 | mplemented |                           |
|         |                 | in England |                           |
|         |                 | through    |                           |
|         |                 | the        |                           |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Food       |                           |
|         |                 | (England)  |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | 2004 and   |                           |
|         |                 | the        |                           |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Animal     |                           |
|         |                 | Feed       |                           |
|         |                 | (England)  |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | 2004       |                           |
|         |                 | (similar   |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | have been  |                           |
|         |                 | i          |                           |
|         |                 | mplemented |                           |
|         |                 | in         |                           |
|         |                 | Northern   |                           |
|         |                 | Ireland,   |                           |
|         |                 | Scotland   |                           |
|         |                 | and        |                           |
|         |                 | Wales).    |                           |
+---------+-----------------+------------+---------------------------+
|         | Department for  | Regulation |                           |
|         | Environment,    | 1830/2003  |                           |
|         | Food & Rural    | has been   |                           |
|         | Affairs (Defra  | i          |                           |
|         |                 | mplemented |                           |
|         |                 | in England |                           |
|         |                 | by way of  |                           |
|         |                 | the        |                           |
|         |                 | G          |                           |
|         |                 | enetically |                           |
|         |                 | Modified   |                           |
|         |                 | Organisms  |                           |
|         |                 | (Tr        |                           |
|         |                 | aceability |                           |
|         |                 | and        |                           |
|         |                 | Labeling)  |                           |
|         |                 | (England)  |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | 2004       |                           |
|         |                 | (similar   |                           |
|         |                 | R          |                           |
|         |                 | egulations |                           |
|         |                 | have been  |                           |
|         |                 | i          |                           |
|         |                 | mplemented |                           |
|         |                 | in         |                           |
|         |                 | Scotland,  |                           |
|         |                 | Northern   |                           |
|         |                 | Ireland    |                           |
|         |                 | and        |                           |
|         |                 | Wales).    |                           |
+---------+-----------------+------------+---------------------------+

## Annex VIII: EU -27 Production of GE Crops by Region

+-------------+--------------+-----------------+-----------+----------+
| **Member    | **Producing  | **2006**        | **2007**  | **2008** |
| State**     | Region**     |                 |           |          |
|             |              | **(Hectares)**  | **(He     | **(Hec   |
|             |              |                 | ctares)** | tares)** |
+-------------+--------------+-----------------+-----------+----------+
| **Czech     | **Total**    | **1,290**       | **5,000** | *        |
| Republic**  |              |                 |           | *9,000** |
+-------------+--------------+-----------------+-----------+----------+
| **France**  | M            |                 | 16,117    | 0        |
|             | idi-Pyrenees |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Aquitaine    |                 | 5,061     | 0        |
+-------------+--------------+-----------------+-----------+----------+
|             | Poit         |                 | 516       | 0        |
|             | ou-Charentes |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Rhones-Alpes |                 | 271       | 0        |
+-------------+--------------+-----------------+-----------+----------+
|             | Other        |                 | 170       | 0        |
+-------------+--------------+-----------------+-----------+----------+
|             | **Total**    | **5,200**       | *         | **0**    |
|             |              |                 | *22,135** |          |
+-------------+--------------+-----------------+-----------+----------+
| **Germany** | Eastern      |                 | 2,654     | 3,340    |
|             | Germany      |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Southern     |                 | 14        | 17       |
|             | Germany      |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Northern     |                 | 17        | 14       |
|             | Germany      |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Western      |                 | 0         | 0        |
|             | Germany      |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | **Total**    | **947**         | **2,685** | *        |
|             |              |                 |           | *3,371** |
+-------------+--------------+-----------------+-----------+----------+
| *           | Alentejo     |                 | 2,306     | 2,069    |
| *Portugal** |              |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Lisboa/Vale  |                 | 1,291     | 1,154    |
|             | do Tejo      |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Norte        |                 | 62        | 146      |
+-------------+--------------+-----------------+-----------+----------+
|             | Centro       |                 | 490       | 1,292    |
+-------------+--------------+-----------------+-----------+----------+
|             | Algarve      |                 | 51        | 51       |
+-------------+--------------+-----------------+-----------+----------+
|             | **Total**    | **1,254**       | **4,199** | *        |
|             |              |                 |           | *4,711** |
+-------------+--------------+-----------------+-----------+----------+
| **Romania** | North-east   |                 | 65        | n/a      |
|             | and          |                 |           |          |
|             | south-east   |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | South        |                 | 226       | n/a      |
+-------------+--------------+-----------------+-----------+----------+
|             | Southwest    |                 | 40        | n/a      |
|             | and west     |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | **Total**    | **137,300**     | **331**   | *        |
|             |              |                 |           | *7,500** |
+-------------+--------------+-----------------+-----------+----------+
| *           | **Total**    |                 | **930**   | *        |
| *Slovakia** |              |                 |           | *1,930** |
+-------------+--------------+-----------------+-----------+----------+
| **Spain**   | Aragon       |                 | 35,860    | 33,000   |
+-------------+--------------+-----------------+-----------+----------+
|             | Catalonia    |                 | 23,013    | 21,000   |
+-------------+--------------+-----------------+-----------+----------+
|             | Extremadura  |                 | 6,460     | 6,000    |
+-------------+--------------+-----------------+-----------+----------+
|             | Navarra      |                 | 5,327     | 5,300    |
+-------------+--------------+-----------------+-----------+----------+
|             | Castilla-La  |                 | 3,659     | 3,700    |
|             | Mancha       |                 |           |          |
+-------------+--------------+-----------------+-----------+----------+
|             | Others       |                 | 829       | 1,000    |
+-------------+--------------+-----------------+-----------+----------+
|             | **Total**    | **53,667**      | *         | **       |
|             |              |                 | *75,148** | 70,000** |
+-------------+--------------+-----------------+-----------+----------+
| **Grand     |              | **199,658**     | **        | **       |
| Total**     |              |                 | 109,498** | 94,582** |
|             |              | (with Romania)  |           |          |
|             |              |                 |           |          |
|             |              | **62,358**      |           |          |
|             |              |                 |           |          |
|             |              | (without        |           |          |
|             |              | Romania)        |           |          |
+-------------+--------------+-----------------+-----------+----------+

## Annex IX -- Field Register Status by EU Member State

+-----------+----------------------------------------------------------+
| **Member  | **Field Registry**                                       |
| States**  |                                                          |
+-----------+----------------------------------------------------------+
| Austria   | An Austrian field register table theoretically exists.   |
|           | The Gene Technology Act 1994 (latest amendments in 2005) |
|           | earmarks a gene technology register. Part III of the     |
|           | register includes approved field releases, whereas Part  |
|           | IV deals with the planting of approved biotech crops. To |
|           | date, there have been no approved field releases or      |
|           | plantings of biotech crops. According to the law the     |
|           | register is public.                                      |
+-----------+----------------------------------------------------------+
| Benelux   | n/a                                                      |
+-----------+----------------------------------------------------------+
| Czech     | A national field register exists but it is not directly  |
| Republic  | accessible to the public. The information about          |
|           | locations of GM crops can be obtained by a special       |
|           | official written request to the Ministry of Environment. |
+-----------+----------------------------------------------------------+
| France    | A national register exists and each commercially-grown   |
|           | biotech plot must be listed. Made compulsory in spring   |
|           | 2008.                                                    |
+-----------+----------------------------------------------------------+
| Germany   | Farmers have to report the exact location and size of    |
|           | their biotech plantings to a national field register,    |
|           | which is accessible to the general public.               |
+-----------+----------------------------------------------------------+
| Greece    | Field register tables exist at prefecture level which is |
|           | supposed to be developed and revised annually, and is    |
|           | only for conventional crops. The Greek Ministry of       |
|           | Agriculture's decentralized stations at the prefecture   |
|           | level (named KEPYELs) receive farmer's declarations      |
|           | annually per crop, variety and acreage on what they      |
|           | intend to cultivate, per category. EU approved biotech   |
|           | crops are not grown in Greece based on numerous          |
|           | Ministerial Decisions. Coexistence system applications   |
|           | have never progressed in Greece. The GOG finds multiple  |
|           | ways to postpone implementation of coexistence           |
|           | practices.                                               |
+-----------+----------------------------------------------------------+
| Hungary   | n/a                                                      |
+-----------+----------------------------------------------------------+
| Ireland   | n/a                                                      |
+-----------+----------------------------------------------------------+
| Italy     | n/a                                                      |
+-----------+----------------------------------------------------------+
| Poland    | n/a                                                      |
+-----------+----------------------------------------------------------+
| Romania   | Data on farmers authorized to plant biotech crops for    |
|           | commercial use is recorded in the National Registry of   |
|           | Biotech Farmers. The county office of the Ministry of    |
|           | Agriculture keeps and updates the County Register with   |
|           | full information about farmers: acreages planted with    |
|           | biotech crops, seeds source, the varieties sown,         |
|           | harvested production and its purpose of use.             |
|           | Subsequently, this information is inserted in the        |
|           | National Registry of Biotech Growers.                    |
|           |                                                          |
|           | The legislation is not clear to what level the content   |
|           | of the registry may become public information. So far,   |
|           | the Ministry of Agriculture has published information on |
|           | total area planted with biotech crops at the level of    |
|           | each county, without publishing the location of the      |
|           | biotech fields.                                          |
|           |                                                          |
|           | According to the national regulations, it is mandatory   |
|           | for biotech farmers to inform, in writing, all the legal |
|           | owners of the neighboring plots within the limit set for |
|           | co-existence (200 m for corn) as well as the             |
|           | city/community hall about their intention to plant       |
|           | biotech crops. Further, the legislation states that when |
|           | farmers prove to have a legitimate interest in           |
|           | preventing potential cross-contamination with organic or |
|           | conventional plots, the local agricultural offices will  |
|           | make available information about the type of agriculture |
|           | practiced by the neighbors of those farmers.             |
+-----------+----------------------------------------------------------+
| Slovakia  | A national field register exists but it is not directly  |
|           | accessible to the public. The information about          |
|           | locations with GM crops is kept by the Central           |
|           | Controlling and Testing Institute in Agriculture         |
|           | (UKSUP).                                                 |
+-----------+----------------------------------------------------------+
| Spain     | Information on area by region is publicly available at   |
|           | the Ministry of Agriculture web page. No farmer register |
|           | is published.                                            |
+-----------+----------------------------------------------------------+
| Portugal  |                                                          |
+-----------+----------------------------------------------------------+
| UK        | n/a                                                      |
+-----------+----------------------------------------------------------+

## Annex X - Extent of Field Releases of GE Crops

+-------------+-------+--------+------+-------+----------+----------+
|             | 2003  | 2004   | 2005 | 2006  | 2007     | 2008     |
+-------------+-------+--------+------+-------+----------+----------+
| Austria     | 0     | 0      | 0    | 0     | 0        | 0        |
+-------------+-------+--------+------+-------+----------+----------+
| Benelux     |       |        |      |       | 14 ha    | 24 ha    |
| (N          |       |        |      |       | (apples, | (apples, |
| etherlands) |       |        |      |       | p        | p        |
|             |       |        |      |       | otatoes) | otatoes, |
|             |       |        |      |       |          | corn)    |
+-------------+-------+--------+------+-------+----------+----------+
| Czech       | 0     | 0      | 1    | 5     | 17 plots | 8 plots  |
| Republic    |       |        | p    | plots |          |          |
|             |       |        | lot, | 9,500 | 92,200   | 13,500   |
|             |       |        | 624  | m2    | m2       | m2       |
|             |       |        | m2   |       |          |          |
|             |       |        | (p   | (pota | (p       | (p       |
|             |       |        | otat | toes, | otatoes, | otatoes, |
|             |       |        | oes) | corn) | corn,    | corn,    |
|             |       |        |      |       | flax,    | flax)    |
|             |       |        |      |       | prunus)  |          |
+-------------+-------+--------+------+-------+----------+----------+
| France      | 17 ha | 7 ha   | 23   | 3 ha  | 4 ha     | Corn,    |
|             |       |        | ha   |       |          | poplar,  |
|             | 56    | 48     | 80   | 30    | 28 plots | vine     |
|             | plots | plots  | p    | plots | (Poplar, |          |
|             | (Co   | (C     | lots | (G    | corn,    |          |
|             | ffee, | offee, | (Gr  | rass, | tobacco, |          |
|             | rape  | rap    | ass, | corn, | vine.)   |          |
|             | seed, | eseed, | pop  | po    |          |          |
|             | g     | grass, | lar, | plar, |          |          |
|             | rass, | corn,  | c    | tob   |          |          |
|             | corn, | p      | orn, | acco, |          |          |
|             | po    | oplar) | v    | vine) |          |          |
|             | plar, |        | ine) |       |          |          |
|             | tob   |        |      |       |          |          |
|             | acco) |        |      |       |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Germany     | 0     | 0      | 19   | 81 ha | 47 ha    | 25 ha    |
|             |       |        | ha   | (     | (corn)   | (corn)   |
|             |       |        | (c   | corn) |          |          |
|             |       |        | orn) |       | 21 ha    | 11 ha    |
|             |       |        |      |       | (su      | (su      |
|             |       |        |      |       | garbeet, | garbeet, |
|             |       |        |      |       | p        | p        |
|             |       |        |      |       | otatoes, | otatoes, |
|             |       |        |      |       | winter   | winter   |
|             |       |        |      |       | wheat)   | wheat)   |
+-------------+-------+--------+------+-------+----------+----------+
| Greece      | 0     | 0      | 0    | 0     | 0        | 0        |
+-------------+-------+--------+------+-------+----------+----------+
| Hungary     | Corn, | Corn,  | Wh   | Corn, | Corn,    | n/a      |
|             | w     | wheat, | eat, | w     | wheat,   |          |
|             | heat, | p      | corn | heat, | potato,  |          |
|             | po    | otato, |      | po    | barley   |          |
|             | tato, | t      |      | tato, |          |          |
|             | to    | obacco |      | to    |          |          |
|             | bacco |        |      | bacco |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Ireland     | n/a   |        |      |       |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Italy       | n/a   |        |      |       |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Poland      | 0     | 0      | 0    | 100   | 100 ha   | 300 ha   |
|             |       |        |      | ha    |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Romania     | Po    | Corn   | Corn | Corn  | Corn,    | 435 Kg   |
|             | tato, |        |      |       | Soybean, | seeds    |
|             | sugar |        |      |       | Plum     |          |
|             | beet, |        |      |       | tree     | (corn)   |
|             | corn, |        |      |       |          |          |
+-------------+-------+--------+------+-------+----------+----------+
| Slovakia    | 0     | 0      | 0    | 0     | 4 plots  | 23 plots |
|             |       |        |      |       |          |          |
|             |       |        |      |       | 0.64 ha  | 65 ha    |
|             |       |        |      |       |          |          |
|             |       |        |      |       | (corn)   | (corn)   |
+-------------+-------+--------+------+-------+----------+----------+
| Spain       | n/a   | n/a    | n/a  | n/a   | P        | Cotton,  |
|             |       |        |      |       | otatoes, | corn,    |
|             |       |        |      |       | cotton,  | sugar    |
|             |       |        |      |       | orange.  | beet,    |
|             |       |        |      |       | Various  | and      |
|             |       |        |      |       | plots    | oranges  |
+-------------+-------+--------+------+-------+----------+----------+
| Portugal    | n/a   | n/a    | n/a  | n/a   | n/a      | corn     |
+-------------+-------+--------+------+-------+----------+----------+
| United      | n/a   | n/a    | n/a  | n/a   | 0.1 ha,  | 2 ha, 1  |
| Kingdom     |       |        |      |       | 1 plot   | plot     |
|             |       |        |      |       |          | (p       |
|             |       |        |      |       | (p       | otatoes) |
|             |       |        |      |       | otatoes) |          |
+-------------+-------+--------+------+-------+----------+----------+

##