Required Report - Public distribution

**Date:** 6/5/2007

**GAIN Report Number:** E47044

E40000

**EU-27**

**Biotechnology**

**Annual Agricultural Biotechnology Report**

**2007**

**Approved by:**

![](media/image1.wmf)Debra Henke

U.S. Mission to the European Union

**Prepared by:**

Stan Cohen

**Report Highlights:**

Since 1998, the EU has approved nine biotech events in the face of
considerable Member State (MS) resistance. Over 35 events are in the
pipeline still waiting approval. The pace of approvals has slowed over
the last year. The debate on biotechnology in the EU is highly
politicized. Few of the contentious issues now confronting the EU are
related to human health and environmental safety. Over the last 8 years
the EU has implemented a comprehensive regulatory system to guarantee
that biotech products are fully evaluated to ensure their safety. In
September 2006, the WTO upheld the central claims of the United States,
Argentina and Canada that the EU had imposed a de facto moratorium on
the approval of biotech products that is inconsistent with WTO rules.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Brussels USEU \[BE2\]

\[E4\]

**Table of Contents**

Trade and Production 2

Policy 5

Regulatory Framework 5

Commission Reform of EFSA's Risk Assessment Procedures 6

Political Factors 6

Product Authorizations 7

Marketing Bans 8

Coexistence 9

Labeling 10

An Example of How to Label 11

Labeling of GMMs and Processing Aides 11

Seed Labeling Legislation 12

Traceability 12

Cartagena Biosafety Protocol 13

Trade Barriers 13

Marketing Issues 14

Bt10 Corn 14

LL601 Long Grain Rice 15

# Biotechnology Trade and Production

Status of Product Approvals

Syngenta's Bt11 sweet corn for human consumption was authorized for
marketing in May 2004. This was the first new biotech product approved
since the EU imposed an unofficial moratorium in 1998. Over the last 3
years, the EU has approved an additional 8 events (see table below).
These are the only new biotech products that the EU has authorized for
marketing since 1998. ("Authorized for marketing" means that the product
is reviewed and approved for sale for a specific use or uses. Possible
uses include for import, cultivation, processing, food, feed and
industrial.)

  ----------------------- ----------------------- -----------------------
  Event                   Company                 Use

  Insect Tolerant Corn    Syngenta                Food [1/]{.underline}
  Bt11                                            

  Herbicide Tolerant Corn Monsanto                Import, Processing,
  NK603                                           Food [2]{.underline}/

  Herbicide Tolerant      Monsanto                Import, Processing
  Rapeseed Gt73                                   [3]{.underline}/

  Insect Resistant Corn   Monsanto                Import, Processing,
  MON863                                          Food [4]{.underline}/

  Herbicide Tolerant Corn Monsanto                Food [5]{.underline}/
  GA21                                            

  Insect Tolerant Corn    Monsanto                Import, Processing
  MON863 X MON810                                 [6/]{.underline}

  Herbicide and Insect    Pioneer/Mycogen         Import, Processing,
  Tolerant Corn 1507                              Food, Feed

  Herbicide Tolerant      Bayer Crop Science      Import, Processing,
  Hybrid Rapeseed                                 Food, Feed
  (Ms8Rf3)                                        

  Modified Color          Florigene               Import for cut flowers
  Carnation Moonlite                              
  123.2.38                                        
  ----------------------- ----------------------- -----------------------

[1]{.underline}/ Approved for import and feed uses prior to 1998.

[2]{.underline}/ Authorized for use as feed materials, feed additives
and food additives in April 2005 under the "existing products"
provisions. See section on Product Authorizations below.

[3]{.underline}/ Authorized for use as feed materials, feed additives
and food additives in April 2005 under the "existing products"
provisions.

[4]{.underline}/ Authorized for use as feed materials, feed additives
and food additives in April 2005 under the "existing products"
provisions. (Food approval pending.)

[5]{.underline}/ Authorized for use as feed materials, feed additives
and food additives in April 2005 under the "existing products"
provisions.

[6/ A]{.underline}uthorized for use as feed materials in April 2005
under the "existing products" provisions.

Since 1998 no EU regulatory committee made up of the Member States has
voted in favor of authorizing the marketing of a product despite
consistently positive risk assessments from EFSA.

For all 9 events approved since May 2004, the Commission recommended
that the Member States authorize the marketing of these products based
on the positive risk assessments issued. Despite this the Member States
failed to reach a qualified majority for or against approval and the
Commission then asked the Council of Ministers to come to a decision.
After three months, the Council also deferred and sent the matter back
to the Commission. The Commission then authorized the marketing of the
biotech events. Anti-biotech Member States and other groups have accused
the Commission of thus "rubber-stamping" the approvals.

The Council of Minister's involvement in the approval process for
biotech events is a dramatic departure from normal legislative
procedures. Agriculture Ministers meet to approve major CAP reforms or
EU trade policy positions in the WTO Doha round. Typically, working
level officials drawn from the Member States meet in a regulatory
committee to review technical issues and would make decisions on biotech
events.

Currently, there are more than 35 biotech events in the pipeline for
approval. Those furthest along in the process are presented in the
following table. An increasing number of the applications are for
cultivation. Since the cultivation of biotech crops is now the most
politically-charged aspect of the biotech debate in Europe, the approval
process will likely continue at the current leisurely pace.

+-------------------+---------+--------------------------+-----------+
| Event             | Company | Use                      | EFSA Risk |
|                   |         |                          | A         |
|                   |         |                          | ssessment |
+-------------------+---------+--------------------------+-----------+
| Insect Tolerant   | S       | Cultivation              | Positive  |
| Corn Bt11         | yngenta |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | P       | Cultivation              | Positive  |
| Herbicide         | ioneer/ |                          |           |
| Tolerant Corn     | Mycogen |                          |           |
| 1507              |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Potato, Altered   | BASF    | Cultivation and          | Positive  |
| Starch,           | Plant   | production of starch,    |           |
| EH92-527-1        | Science | food/feed uses           |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | M       | Import, Processing,      | Positive  |
| Herbicide         | onsanto | food/feed                |           |
| Tolerant Corn     |         |                          |           |
| MON863 X NK603    |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | M       | Import, Processing,      | Positive  |
| Herbicide         | onsanto | food/feed                |           |
| Tolerant Corn     |         |                          |           |
| NK603 X MON810    |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | M       | Import, Processing,      | Positive  |
| Herbicide         | onsanto | feed/ food               |           |
| Tolerant Corn     |         |                          |           |
| MON863 X MON810 X |         |                          |           |
| NK603             |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | P       | Import, Food/Feed        | Positive  |
| Herbicide         | ioneer/ |                          |           |
| Tolerant Corn     | Mycogen |                          |           |
| 1507 X NK603      |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | Bayer   | Import, Processing,      | Positive  |
| Tolerant LL       | Crop    | Food/ Feed               |           |
| Cotton 25         | Science |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | M       | Import, Processing,      | Positive  |
| Tolerant Sugar    | onsanto | Food/ Feed               |           |
| Beet H7-1         |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | P       | Import, Processing,      | Positive  |
| Herbicide         | ioneer/ | Food/feed                |           |
| Tolerant Corn     | Mycogen |                          |           |
| 59122             |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | P       | Cultivation              | Opinion   |
| Herbicide         | ioneer/ |                          | Pending   |
| Tolerant Corn     | Mycogen |                          |           |
| 59122             |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | Bayer   | Import, Processing       | Opinion   |
| Tolerant Rapeseed | Crop    |                          | Pending   |
| (T45)             | Science |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | Bayer   | Import, Processing,      | Opinion   |
| Tolerant Rice     | Crop    | Food/ Feed               |           |
| Liberty Link 62   | Science |                          | Pending   |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | Bayer   | Import, Processing,      | Opinion   |
| Tolerant Soybean  | Crop    | Food/ Feed               |           |
| A27014-12         | Science |                          | Pending   |
+-------------------+---------+--------------------------+-----------+
| Insect Tolerant   | S       | Import, Processing,      | Opinion   |
| Corn MIR604       | yngenta | Food/Feed                |           |
|                   |         |                          | Pending   |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | M       | Cultivation              | Opinion   |
| Tolerant Corn     | onsanto |                          | Pending   |
| NK603             |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | M       | Cultivation              | Opinion   |
| Herbicide         | onsanto |                          | Pending   |
| Tolerant Corn     |         |                          |           |
| NK603 X MON810    |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | S       | Import, Processing,      | Opinion   |
| Tolerant Corn     | yngenta | Food/feed                | Pending   |
| GA21              |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Corn, Altered     | S       | Import, Processing,      | Opinion   |
| Composition       | yngenta | Food/feed                | Pending   |
| (ethanol) 3272    |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | P       | Cultivation              | Opinion   |
| Herbicide         | ioneer/ |                          | Pending   |
| Tolerant Corn     | Mycogen |                          |           |
| 1507 X NK603      |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Insect and        | Pioneer | Cultivation, Import,     | Opinion   |
| Herbicide         |         | Food/feed                | Pending   |
| Tolerant Corn     |         |                          |           |
| 59122 X 1507 X    |         |                          |           |
| NK603             |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | M       | Cultivation              | Opinion   |
| Tolerant          | onsanto |                          | Pending   |
|                   |         |                          |           |
| Soybean 40-3-2    |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| Herbicide         | Bayer   | Import, Processing,      | Opinion   |
| Tolerant          | Crop    | Food/ Feed               | Pending   |
|                   | Science |                          |           |
| Soybean A2704-12  |         |                          |           |
+-------------------+---------+--------------------------+-----------+
| High Lysine       | R       | Import, Processing,      | Opinion   |
|                   | enessen | Food/ Feed               | Pending   |
| Corn LY038        | LLC     |                          |           |
+-------------------+---------+--------------------------+-----------+

# 

# Biotechnology Policy

Regulatory Framework

Technology providers can file an application for the authorization of
agricultural biotech products under two EU regulations. Under
[Regulation (EC) No
1829/2003](http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf),
a company can file a single application for the biotech event and all
its uses (known as the "one door, one key "principle). The company
submits the application to the competent authorities of the Member State
where the product will first be marketed. Within 14 days, the Member
State must forward the application to the European Food Safety Authority
(EFSA) for review. The review conducted applies to all EU Member States.

EFSA conducts a single risk assessment and a single authorization can be
granted for an event and all its uses (cultivation, importation,
processing into food, feed or industrial products). While EFSA attempts
to issue an opinion within 6 months, they may request additional
information from the applicant thus lengthening the time frame. If EFSA
issues a positive risk assessment, the application is forwarded to the
European Commission, who has responsibility for risk management.

The Commission will then present a proposal to the Member States
recommending that they authorize marketing of the product. The
Commission may impose certain conditions (e.g., harvesting, transport,
and monitoring) concerning the product. The Commission has 3 months to
draft the proposal. The Member States then review and vote on the
proposal in a regulatory committee. A qualified majority (QM) is
required to approve or defeat the proposal. If the proposal fails to
obtain a QM, the proposal then goes to the Council of Ministers for
review. The Council has three months to make a decision. If the Council
fails to reach a decision, the Commission may then authorize the
marketing of the product. (See also the report AGR E47043 on the [FAS
Website](http://www.fas.usda.gov/scriptsw/attacherep/default.asp) for
additional information on the decision-making procedure.)

Alternatively, a company can file an application under [Directive
2001/18/EC](http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=32001L0018&model=guichett)
for the purpose of marketing a biotech event for cultivation,
importation and processing into different products. While the procedure
under this directive resembles that of Regulation (EC) No 1829/2003,
there are some differences. When the application is submitted in the
Member State, that country's competent authorities perform an
assessment. Should they issue a negative assessment, the applicant's
only option is to submit the file in another Member State. However, if
the Member State does issue a favorable assessment, then the results are
shared with the Commission and all other Member States who may approve
the event for marketing within the EU or raise objections. Should
objections be raised, then the Commission will ask EFSA to conduct a
study. From this point on, the approval procedure resembles that of
Regulation (EC) No 1829/2003.

The Commission's Directorate General for Health and Consumer
Protection\--known by the French acronym SANCO\--handles applications
that are submitted under Regulation (EC) No 1829/2003. Typically, the
Agriculture Council of Ministers reviews Commission proposals under this
legislative authority when the Member States are deadlocked. The
Directorate General for the Environment handles applications submitted
under Directive 2001/18/EC with the Environment Council of Ministers
reviewing Commission proposals when the Member States fail to reach a
QM.

Commission Reform of EFSA's Risk Assessment Procedures

Spearheaded by Austria, a number of Member States have complained that
the Commission has been obliged to approve all 9 events since May 2004.
In all cases, the Member States failed to muster a qualified majority in
favor or against approval as required under community law. (Qualified
majority gives more votes to the most populous Member States.) Most
Member States have preferred to abstain rather than risk alienating key
political constituencies.

In response to criticisms of EFSA, the Commission announced a number of
changes to EFSA's procedures in mid-2006. Key changes included:

\--EFSA will work more closely with national scientific bodies, with a
view to resolving possible diverging scientific opinions with Member
States.

\--EFSA will provide more detailed justification, in its opinions on
individual applications, for not accepting scientific objections raised
by the national competent authorities.

\--EFSA will clarify the specific protocols that should be used by
applicants to carry out scientific studies (for example regarding
toxicology) demonstrating safety.

\--Applicants and EFSA will also be asked to address more explicitly
potential long-term effects and bio-diversity issues in their risk
assessments for the placing on the market of GMOs.

\--If after EFSA has issued a positive opinion and the Commission or a
Member State raises important new scientific questions not properly or
completely addressed by the EFSA opinion, the Commission may suspend the
procedure and refer back the question for further consideration.

Environment and Sanco Commissioners Dimas and Kyprianou contended that
these changes will make the approval process more transparent, allay
Member States' concerns, and thus compel them to vote for or against
approval instead of abstaining.

Other Commissioners reportedly are less sanguine, commenting that these
new requirements could result in undue delays in the authorization
procedure. To date, the latter concerns appear justified. Over the last
year, the number of new product approvals has dropped dramatically and
the backlog of applications at EFSA has increased.

Political Factors

The debate concerning biotechnology in the EU is highly politicized. Few
of the contentious biotech issues now confronting the EU are related to
human health and environmental safety. Over the last 8 years the EU has
implemented a comprehensive regulatory system to ensure that biotech
products are fully evaluated to ensure their safety. The European Food
Safety Authority (EFSA) and the Member State competent authorities have
the final scientific say before a product is authorized for release on
the market.

Now the EU and the Member States are deadlocked over a number of issues
that are based on economic considerations, and not safety: 1) the
on-going search for seed labeling legislation for biotech events
approved by EFSA and 2) the development of coexistence measures for
biotech, conventional and organic agriculture that equally protect the
interests of all farmers. Similarly, the EU Commission has stated that
Member State marketing bans have not been based on legitimate safety
concerns.

Product Authorizations

Please refer to the link below for a list of biotech food products that
were approved under the Novel Food Regulation (EC) No 258/97:

<http://europa.eu.int/comm/food/food/biotechnology/authorisation/258-97-ec_authorised_en.pdf>

The Novel Food Regulation (EC) No 258/97 has since been superseded by
Regulation (EC) 1829/2003.

Please refer to the link below for a list of biotech feed products that
were approved under the Directive No 2001/18/EC:

<http://europa.eu.int/comm/food/food/biotechnology/authorisation/2001-18-ec_authorised_en.pdf>

On April 18 2005, the Commission published a list of 26 biotech products
that have been legally on the EU market since before the new legislative
framework was introduced in April 2004 for authorizing biotech food and
feed had entered into effect. These so-called "existing products" were
either approved under former EU legislation, or did not require approval
at the time that they were put on the market. They have been added to a
specific section of the Community register of biotech food and feed in
order to clarify exactly which products can be sold in the EU.

Since the entry into force of Regulation 1829/2003 on biotech food and
feed in April 2004, all biotech products seeking to enter the EU market
as food or feed have to undergo a thorough authorization procedure,
including a scientific safety assessment by EFSA. However, there are
certain biotech food and feed products that can be legally sold in the
EU according to the rules in place before Regulation 1829/2003.

In order to cover these GM products, Regulation 1829/2003 stipulated
that operators who wished to continue marketing an "existing product"
had to notify the Commission and submit detailed information on the
biotech event before October 18, 2004. Non-notified products will no
longer be allowed on the EU market. The Commission and its research
agency the Joint Research Center, examined the validity of the
notifications it received and agreed to enter 26 biotech products into a
specifically created section of the Community register of genetically
modified food and feed. Once one of these "existing products" is on this
register, it can legally be sold in the EU for a set period of between
3-9 years, after which it has to resubmit an application for the renewal
of the authorization. For the register of biotech "existing products",
see:

[EUROPA - Food Safety - Biotechnology - Authorisation - Community
Register of GM Food and
Feed](http://europa.eu.int/comm/food/dyna/gm_register/index_en.cfm)

Specific legislation governing these products can be found at the
following link:

[http://europa.eu.int/comm/food/food/biotechnology/gmfood/~reg641~\_2004_en.pdf](http://europa.eu.int/comm/food/food/biotechnology/gmfood/reg641_2004_en.pdf)

Member State Marketing Bans of Biotech Products

Starting in 1997, Austria, Denmark, France, Luxembourg, Germany, and
Greece invoked national safeguard measures (Directive 2001/18/EC,
Article 23) in order to ban the marketing of a number of biotech
products. In November 2004, EU Member States met in a regulatory
committee to review the Commission's proposal recommending the lifting
of the bans. The Commission based its recommendation on EFSA opinions
asserting that there was no scientific basis for the Member State bans.
Nevertheless, the regulatory committee failed to reach a decision and
the Commission referred the matter to the Council.

On June 24, 2005 the Environment Council, consisting of the Environment
Ministers of the Member States in the European Union, voted against the
Commission proposal to lift the bans or restrictions imposed on biotech
products. The Council voted against all eight Commission proposals. A
number of these eight safeguard clauses include bans or restrictions on
cultivation, while others include bans on imports and use in food and
feed. This was the first time that the Council reached a qualified
majority against a Commission proposal on biotech since 1998.

The events banned are presented in the following table. The Commission
had approved these products for marketing based on positive risk
assessments issued by EU scientific committees.

  ----------------------- ----------------------- -----------------------
  Country                 Event Banned            Date of Ban

  Austria                 Syngenta Bt176 Corn,    1997, 2000, 1999
                          Bayer T25 Corn,         
                          Monsanto MON810 corn    

  France                  Bayer Rapeseeds Topas   1998 for both
                          19/2 and MS1XRf1        

  Germany                 Syngenta Bt176 corn     2000

  Greece                  Bayer Rapeseed Topas    1998
                          19/2                    

  Luxembourg              Syngenta Bt176          1997

  Hungary                 MON810 corn             2005
  ----------------------- ----------------------- -----------------------

On April 12, 2006, EFSA once again reaffirmed the safety of the banned
biotech products, stating that "there is no reason to believe that the
continued placing on the market of the 5 products is likely to cause any
adverse effects for human and animal health or the environment." In the
light of the EFSA opinion, the Commission proposed two draft Council
decisions requesting Austria to repeal its measures concerning MON810
and T25 maize. In December 2006, the Council rejected the proposals of
the Commission to lift the national marketing bans. The Commission has
now three options according to EU comitology rules: to submit amended
proposals to the Council; re-submit the same proposals or present
legislative proposals through co-decision procedure.

In 2007, the companies that developed three of the banned products
(Bt176, Ms1Rf1 and Topas 19/2) notified the Commission that they no
longer wished to market these products. The companies didn\'t plan to
file applications to renew EU licenses for these three products (plus
two others) before the products\' authorization expired on April 18. The
Commission stated that \"if the companies responsible for these GMOs
wanted to continue marketing them in the EU after that date, they had to
submit an application to the Commission. For the 5 GMOs affected \... no
applications for renewal are expected. This is due to the fact that they
are no longer being used and the companies no longer have any commercial
interest in them.\"

In March 2007, the Commission and Member States voted to withdraw
approval for five biotech products no longer in commercial use. Three of
the products withdrawn were cited in the WTO case brought by the United
States, Argentina and Canada against the EU: Bt-176 (Syngenta corn); and
2 Bayer rapeseed events (Topas 19/2 and Ms1Rf1). The other products
withdrawn were Monsanto's MON810 X GA21 corn and Bayer's Ms1Rf2
rapeseed. The Commission's decisions concerning these products can be
viewed at the following sites:

[http://eur-~lex~.europa.eu/LexUriServ/site/en/oj/2007/l_117/l\_~11720070505en00140016~.pdf](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_117/l_11720070505en00140016.pdf)

[http://eur-~lex~.europa.eu/~LexUriServ~/site/en/oj/2007/l\_~117~/l_11720070505en00170019.pdf](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_117/l_11720070505en00170019.pdf)

[http://eur-lex.europa.eu/~LexUriServ~/site/en/oj/2007/l_117/l\_~11720070505en00200022~.pdf](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_117/l_11720070505en00200022.pdf)

<http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_117/l_11720070505en00230024.pdf>

[http://eur-lex.europa.eu/LexUriServ/site/en/oj/~2007~/l_117/l\_~11720070505en00250026~.pdf](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_117/l_11720070505en00250026.pdf)

In January 2005, Hungary invoked the safeguard clause in order to
prohibit the cultivation of MON 810 corn. The Commission submitted the
information provided by Hungary to EFSA for its evaluation. In June
2005, EFSA concluded that this information did not invalidate the
initial risk assessment of MON 810. On September 18, 2006, a Sanco
regulatory committee made of Member State officials failed to reach a
qualified majority either in favor or against any of these proposals.
Under these circumstances, and in accordance with EU comitology
procedures, the proposals were transmitted to the Council. On February
20, 2007, the Council rejected the proposal of the Commission to lift
the national safeguard clauses. The Commission now has three options
according to EU comitology rules: to submit amended proposals to the
Council; re-submit the same proposals or present legislative proposals
through co-decision procedure.

Coexistence

Commission officials have stated on numerous occasions that coexistence
is an economic and marketing issue, and not a safety issue. Coexistence
rules and practices apply only to biotech events that have been
authorized for marketing by the Commission and have received a positive
risk assessment from EFSA.

In March 2006, the Commission released a report reviewing the
experiences of the 25 Member States in the implementation of coexistence
measures for organic, conventional and biotech crops. The Commission
concluded that harmonized, EU-wide rules on coexistence are not
justified at the moment because of a lack of experience in implementing
national measures.

Agriculture Commissioner Fischer-Boel stated that, \"growing conditions
are very varied from country to country and experience with GM crops is
still limited in Europe. It therefore does not seem appropriate to
propose unified EU rules at this time.\" Fifteen countries have notified
the Commission of their draft national rules so far. A complete summary
of the proposed rules of the Member States can be viewed at the
[Commission
website](http://europa.eu.int/comm/agriculture/coexistence/index_en.htm).

Initiated by Austria, the Commission organized a conference on
coexistence in Vienna in April 2006. EU Agriculture Commissioner Fischer
Boel again reiterated that EU-wide rules on coexistence are not
justified at present in view of the limited experience with the
cultivation of biotech crops and the fact that the process of
introducing national coexistence measures has not yet been completed.
\"Whatever our personal views may be, the use of GM technology is
spreading, as is the use of GM crops,\" she said. \"It is already
completely legal to grow certain GM crops within the European Union and
the list of permitted crops will almost certainly become longer if we
look years ahead. GM farming has arrived,\" she told the conference.

At the conference, EU Environment Commissioner Dimas again expressed his
misgivings on a number of aspects of biotech. According to him, there is
still no satisfactory scientific assessment of the long-term impact of
biotech crops. He also stated that biotech products used for cultivation
presented a \"whole series of possible risks to the environment, notably
potential longer-term effects that could impact on biodiversity."
Currently, 8 GM products for cultivation are wending their way through
EU\'s regulatory process (of which 3 have already gotten positive risk
assessments). Dimas encouraged continued research to improve
conventional varieties. \"We must, therefore, persist in looking at the
means to continually improve these varieties. We should not ignore the
use of upgraded conventional varieties as an alternative to GM crops,
particularly where similar characteristics can be introduced without
genetic modification,\" he said.

Austria, Denmark, and Italy have taken the lead in pressing the
Commission to adopt an EU-wide regulation for the coexistence of biotech
crops and conventional and organic agriculture. Along with Germany, each
of these countries has drafted coexistence laws that are extremely
restrictive in terms of what farmers of biotech crops are required to
do. Faced with such challenges, farmers will likely not run the risk of
planting biotech crops. Moreover, certain aspects of these laws would
appear to violate the internal market rules of the EU which guarantees
"free circulation", and is reiterated in Article 22 of Directive
2001/18/EC which regulates the deliberate release into the environment
of genetically modified organisms.

Labeling

The EU's labeling requirements are intended to address consumer
concerns, and are not related to safety. Before a product can be labeled
as biotech, the Commission must review its safety and authorize the
marketing of it. Similarly, the EFSA must issue a positive risk
assessment.

Labeling regulations for products containing or consisting of GMOs are
presented in [Regulation (EC) No
1830/2003](http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf),
article 4B. In general, these labeling regulations apply to bulk
agricultural commodities such as whole grains and oilseeds. The scope of
GMO products covered is defined in Directive 2001/18.

Labeling regulations for food and feed products that are produced from
GMOs are presented in [Regulation (EC) No
1829/2003](http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf),
articles 12-13 for food and articles 24-25 for feed. These products have
undergone varying degrees of processing.

In general, all food and feed products containing/consisting of GMOs
and/or produced from GMOs, including products that no longer contain
detectable traces of GMOs, must be labeled.  The allowable adventitious
presence level for EU-approved varieties of GMOs for use in food and
feed is set at 0.9 percent.  Above this level, all products must be
labeled.  For [GM varieties, which are not yet formally approved but
which have received a positive EU risk
assessment](http://europa.eu.int/comm/food/food/biotechnology/gmfood/events_en.pdf),
the adventitious presence level is set 0.5 percent.  This provision will
expire after 3 years. Above this threshold, the product is not allowed
on the EU market.  Operators must demonstrate that the presence of GM
material was adventitious or technically unavoidable.

The regulation does not require labeling of products that are not food
ingredients, such as processing aids.  Meat, milk or eggs obtained from
animals fed with GM feed or treated with GM medicinal products do not
require GM labeling.

## An Example of to How to Label for Food Produced from GMOs

Article 13 of Regulation 1829/2003 specifies the wording to be used on
the label as follows:

\(a\) Where the food consists of more than one ingredient, the following
wording must follow immediately after the ingredient concerned, in
brackets: \"genetically modified\" or \"produced from genetically
modified \[name of ingredient\].  A compound ingredient with a
constituent X which is produced from a GMO Y must be labeled \"contains
X produced from genetically modified Y.

Example:  a biscuit containing soy flour derived from GM-soy must be
labeled \"contains soy flour from genetically modified soy\".

\(b\) Where the ingredient is designated by the name of a category, the
following wording must be used in the list of ingredients: \"contains
genetically modified \[name of organism\]\" or \"contains \[name of
ingredient\] produced from genetically modified \[name of organism\]\".

Example:  for vegetable oils containing rape oil produced from
genetically modified rape, the reference \"contains rape oil from
genetically modified rape\" must appear in the list of ingredients.

\(c\) Where there is no list of ingredients, the words \"genetically
modified\" or \"produced from genetically modified \[name of
organism\]\" must appear clearly in the labeling.

Example 1:  \"a spirit containing caramel produced from genetically
modified corn\".\
Example 2:  \"genetically modified sweet corn\"

\(d\) If the product consists of or contains a GMO e.g. sweet corn in a
Mexican salad, the label must state \"genetically modified sweet corn\"

The designations in (a) and (b) may appear in a footnote to the
ingredients list, provided they are printed in a font at least the same
size as that of the list of ingredients or, where there is no list of
ingredients, clearly on the labeling.

Labeling for Genetically Modified Microorganisms (GMMs) and "Processing
Aides"

[The Commission stated on September 24,
2004](http://europa.eu.int/comm/food/committees/regulatory/scfcah/modif_genet/summary03_en.pdf)
that "food and feed (including food and feed ingredients such as
additives, flavorings and vitamins) produced by fermentation using a GMM
which is kept under contained conditions and is not present in the final
product are not included in the scope of Regulation (EC) No. 1829/2003.
These food and feed products have to be considered as having been
produced with the GMM, rather than from the GMM."

Therefore, these products don't have to be labeled like products
produced from agricultural biotechnology. This was contrary to the
original position taken by the Commission in [April 2004 when the
Commission had proposed that these products be labeled (see point 2D,
Fermentation
Products).](http://europa.eu.int/comm/food/committees/regulatory/scfcah/general_food/summary10_en.pdf)

Likewise in the case of GMMs such as yeast used in alcoholic beverages,
the Commission doesn't require labeling if the GMM is not present in the
final food. Like vitamins, the EU justifies its stance on the basis that
the "...resulting food is considered to have been produced with a GMM,
but not from a GMM". This is also true of cheese that has been produced
"with" the use of chymosin, an enzyme that is genetically modified. Such
processing aides don't fall within the scope of the labeling
regulations.

Status of Seed Labeling Legislation

While the former Prodi College of Commissioners had intended in
September 2004 to propose a seed labeling amendment for the presence of
GM seeds commingled with conventional seed, the different directorate
generals (DG) couldn't reach agreement. Reportedly, DG Environment and
DG Agriculture pressed for a maximum AP of 0.3 percent for corn whereas
DG Health and Consumer Protection favored 0.5 percent. There was
agreement of 0.3 percent for rapeseed. Faced with this impasse, the
Prodi Commission called for additional research to determine the
economic impact of different thresholds on farmers and seed producers
before taking any further action. The Commission has been trying to
develop a policy on seed labeling since 2001 when the Scientific
Committee on Plants presented recommendations on AP levels for a number
of biotech seeds (corn---0.5 percent; soybeans---0.7 per cent; and
rapeseed -- 0.3 percent).

In the absence of a EU seed labeling regulation for the presence of
biotech seed, the Commission has stated that since no thresholds for the
AP of GMOs in conventional seed lots have been established, any seed lot
containing GM seed authorized for the cultivation has to be labeled as
containing GMOs. Seed lots containing GM seeds that are not authorized
for cultivation can not be marketed in the EU.

Some members of the new Barroso Commission appear to favor setting AP
thresholds at the level of detection\--0.1 percent. Environment
Commissioner Stavros Dimas has voiced support for 0.1. Likewise,
Agriculture Commissioner Mariann Fischer-Boel, one of the architects of
Denmark's tough coexistence law and a strong proponent of organic
agriculture, also reportedly favors very low thresholds.

In February 2006, the Joint Research Center, released a
[report](http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/230&format=HTML&aged=0&language=EN&guiLanguage=en)
demonstrating how farmers can reduce the adventitious presence of
biotech material in non-biotech crops, and in general supported higher
thresholds than reportedly proposed by the Directorate Generals of
Environment and Agriculture. "The report concludes that conventional
(non-GM) seed production in Europe with adventitious GM presence not
exceeding 0.5% is feasible with few (maize) or no changes (sugar-beet
and cotton) of current seed production practices. For maize seed
production, such changes would build on existing practices (namely the
implementation of larger isolation distances than those currently used
to separate maize seed and maize crop production fields). In addition,
lowering the seed threshold to 0.3 % would require additional measures
(for example arranging GM and non-GM seed plots in the farm in a way
that takes into account dominant winds). Finally, guaranteeing that
maize seeds will contain no more than 0.1 % adventitious GM presence is
not possible if co-existence measures are limited to action on
individual farms or coordination between neighboring farms."

## 

## Traceability

The EU's traceability requirements are intended to address consumer
concerns, and are not related to safety. Before a product can be sold in
the EU, the Commission must review its safety and authorize the
marketing of it. Similarly, the EFSA must also issue a positive risk
assessment.

Under the rules for traceability in [Regulation (EC) No
1830/2003](http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf),
business operators must transmit and retain information about products
that contain or are produced from GMOs at each stage of the placing on
the market.  Information concerning the presence of GMOs must be
transmitted throughout the commercial chain and must be retained for
five years.  The regulation covers all products, including food and
feed, containing or derived from GMOs that received an EU authorization,
e.g. GM seeds, GM grain, tomato paste and ketchup derived from a GM
tomato or starch, oil or flour produced from a GM maize.

\--for GMOs intended for deliberate release into the environment: 
operators must transmit specified information on the identity of the
individual GMO(s) a product contains;

\--for GMOs intended for food, feed or for processing:  business
operators may either transmit the specified information or transmit a
declaration that the product shall only be used as food or feed or for
processing together with the identity of the GMO(s) from which the
product was derived;

\--for food and feed produced from GMOs:  operators must inform the next
operator in the chain that the product is produced from GMO(s).

On January 14, 2004, the European Commission published [Commission
Regulation
65/2004](http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_010/l_01020040116en00050010.pdf)
establishing a system for the development and assignment of unique
identifiers for GMOs.  A unique identifier is assigned to each GMO as a
means of tracking its presence and reflecting the specific
transformation event covered by the consent or authorization for placing
that GMO on the market.

Cartagena Biosafety Protocol

The EU is a signatory to the biosafety protocol. To align its regulatory
framework with the provisions of the Protocol, the EU has implemented a
[Regulation on transboundary movements of
GMOs](http://europa.eu.int/comm/environment/biotechnology/pdf/regu1946_2003.pdf)
that addresses in particular exports of living modified organisms. The
regulation was approved by the Council of Ministers on 13 June and
entered into force in September 2003.

Trade Barriers

The current EU regulatory system and approval process for biotech
products is a barrier to trade. Since 1998, the EU has approved only 9
biotech events. Currently, the EU has a backlog of about 35 products
that are awaiting approval. In view of the unwieldy and less than
transparent process for application and approval, it is unlikely that
this backlog will be reduced significantly in the short term.

In May 2003, the United States announced that it would initiate a WTO
dispute settlement process focused on the EU\'s de facto moratorium on
approvals of biotechnology products, and on the existence of individual
Member State marketing prohibitions on previously approved biotechnology
products. In March 2004, the WTO formed a panel to consider the
challenge of the United States, Argentina and Canada to the EU's
moratorium on the approval of new agricultural biotech products. The
panel hearing the dispute delivered its interim report in February 2006
and published the final report on September 29, 2006.

[The panel upheld the central claims of the United
State](http://www.ustr.gov/assets/Trade_Sectors/Agriculture/Biotechnology/asset_upload_file690_8901.pdf)s
and the other complainants that the EU had imposed a de facto moratorium
on agricultural biotechnology products that is inconsistent with WTO
rules. The European Commission has not yet indicated how it plans to
implement the panel's decision.

On April 18, 2004, the EU\'s newest regulations (EC No 1829/2003 and EC
No 1830/2003) concerning the labeling and traceability of biotech food
and feed products went into effect. These new regulations were intended
to address the Member States\' concerns about protecting consumer and
environmental interests. Despite the passage of these regulations, the
Member States continue to thwart the approval of new biotech products
that have received favorable risk assessments from the European Food
Safety Authority and the support of the EU Commission. In addition,
Austria and Hungary continue to maintain illegal marketing bans on
approved biotech events.

Regulations 1829/2003 and 1830/2003 are frequently difficult to
understand and comply with and have had an adverse impact on trade. The
Commission has been slow to provide guidance documents to help exporters
interpret these new regulations. In particular, exporters have had
difficulty determining if their product (s) are subject to the new
labeling requirements. Finally, Sanco and the Member States decided that
products (such as beer, wine and cheese) that are produced with
genetically modified \"processing aids\" are not subject to these
regulations. This is inconsistent with the intent of the new
regulations.

In accordance with DG Agriculture\'s guidance document on the
coexistence of biotech and conventional crops, which recommended a
regional approach to coexistence issues, a number of Member States,
including Denmark, Germany, and three regions in Austria, have drafted
new coexistence laws. These laws have taken a maximalist approach,
requiring extensive liability systems be put in place and mandating
extremely low thresholds for adventitious presence. Once enacted, the
European Commission may initiate infringement proceedings against a
Member States\' coexistence law if it is judged to be incompatible with
EU law. However, there is no time limit on how quickly the Commission
must act.

# Marketing Issues

The breakdown in the EU\'s approval process for products made from
biotechnology has blocked most U.S. exports of corn and hinders trade in
other products.  Many food processors and exporters have either
reformulated or sought out non-biotech sources in response to the
implementation of mandatory traceability and labeling requirements in
April 2004. Consumer-ready products have been particularly hard hit.
Most European retailers' own-store brands are non-GM, while they may
consider carrying private supplier brands containing biotech
ingredients. Since labeling hasn't been required for animal products
such as meat and dairy, biotech feed ingredients have generally fared
better. Reportedly, about 2/3 of the animal feed consumed in the EU is
currently labeled as genetically modified. However, some consumer groups
are pressuring retailers to carry meat and dairy products produced from
non-biotech feed ingredients. Agricultural biotechnology continues to be
more of a political than a scientific issue in Europe and the prospects
for improvement remain dim.

Exports of Bt10 Corn

On March 22, 2004 Commission officials were advised that the company
Syngenta had inadvertently marketed the biotech corn Bt10 in the United
States from 2001-2004. Since Bt10 had not been authorized for marketing
in the EU, the Commission introduced [emergency inspection
measures](http://www.agriculture.gov.ie/feedingstuffs/leg2/Genetically_Modified_Feed/EU_Legislation/Cion Decision 317 of 2005 Concerning Bt10 .pdf)
to identify the presence of Bt10 in exports of corn gluten feed and
distiller's dried grain to the EU. The inspection system went into
effect on April 18, 2005, and was to remain in place for 6 months at
which time a review would be conducted to determine whether it was still
necessary. In October 2005, Member States voted to extend the measures.
In 2003/04, the United States shipped about 3.4 million tons of corn
gluten feed, a pelletized feed ingredient valued at about \$340 million,
to the European Union as a feed ingredient used in compound animal feed.

On January 16, 2007, the Commission and Member States voted in favor of
lifting the emergency inspection measures for corn gluten feed and
distiller's dried grain. [The Commission
decision](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_068/l_06820070308en00080009.pdf)
repealing the measures went into effect on March 7, 2007.

Exports of U.S. Long Grain Rice

On August 18, 2006, U.S. Secretary of Agriculture, Mike Johanns
announced that the U.S. Department of Agriculture (USDA) and U.S. Food
and Drug Administration had been notified by Bayer Crop Science that the
company had detected trace amounts of a biotech rice known as Liberty
Link 601 in samples taken from commercial long grain rice. At the time
of the announcement, LL601 was not approved for marketing in the United
States nor the EU. The EU is a major export destination for U.S. long
grain rice. In CY2005, U.S. exports of rice to the EU-25 equaled \$86.5
million, the bulk of which was long grain.

Since LL601 had not been authorized for marketing in the EU, the
Commission introduced [emergency
measures](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_230/l_23020060824en00080010.pdf)
on August 23 to identify the presence of LL601 in exports of U.S. long
grain rice. The measures required that all exports of long grain rice be
accompanied with an analytical report stating that the product doesn't
contain LL601. The USDA and Bayer Crop Science developed and validated a
methodology to test for the presence of LL601 in U.S. long grain rice
exported to the EU. Upon receipt of reference material from Bayer Crop
Science, the Joint Research Center of the Commission validated this
detection method. Under the emergency measures, the Commission
instructed Member States to use this detection method to carry out
random sampling and analysis.

The Commission reported on September 11 that Dutch authorities detained
a 20,000 ton shipment consisting of 23 barges of rice. Three barges
tested positive for LL601 while 20 barges tested negative. Dutch and
Commission authorities ordered the rice to be returned to the United
States or destroyed. Over the following weeks, other Member States
detected traces of LL601 in bulk shipments and processed products
resulting in numerous cases of product rejections and returned
shipments. Because of the heightened financial risks of product
rejection, U.S. exports of rice all but stopped.

While all U.S. rice shipments were required to be accompanied by an
analytical reports attesting to the absence of LL601, the testing
protocols employed in the United States at origin and in the EU at
destination yielded divergent results. (Testing at destination was at
this point at the discretion of Member State authorities, and not
mandatory.) In response, the U.S. government began intensive talks with
Commission officials to establish a common protocol for the sampling and
analysis of rice shipments in an effort to avoid mandatory testing at
destination. These talks failed to produce an agreement and the
Commission with Member State support introduced [mandatory testing at
destination on October
23](http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_306/l_30620061107en00170020.pdf),
2006. This had the effect of continuing the effective embargo on trade
in long grain rice from the United States.

Coincident with the U.S. government's notification to the EU of the
presence of LL601 in long grain rice, [Greenpeace and the Friends of the
Earth reported the week of September 4, 2006 that they had found
evidence of a biotech rice in products imported from
China.](http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/1175)
Since that time, Member States have notified the Commission on 12
separate occasions concerning the positive detection of unauthorized GM
rice and processed rice products from China. The [most recent
notification](http://ec.europa.eu/food/food/rapidalert/reports/week19-2007_en.pdf)
occurred on May 10, 2007.

To date, the Commission has not imposed emergency measures mandating the
inspection of Chinese rice products at origin in China nor at
destination in the EU. All sampling and analysis that has been conducted
by Member State authorities has been at their discretion. Moreover,
Commission officials are still working\-\--nearly 9 months later\--to
validate with Chinese officials a method for the detection of
unauthorized Chinese biotech rice exports. U.S. officials presented to
their EU counterparts a validated methodology on August 23, 2008, 4 days
after they notified the EU of the detection of LL601.

To review the Commission and MS deliberations concerning unauthorized
Chinese biotech rice, please click on the following links:

[March 2, 2007 Sanco Standing Committee
Report](http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/summary02032007_en.pdf)

[January 16, 2007 Sanco Standing Committee
Report](http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/summary12_en.pdf)

[October 23, 2006 Sanco Standing Committee
Report](http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/summary11_en.pdf)

[September 11, 2006 Sanco Standing Committee
Report](http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/summary10_en.pdf)

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