Voluntary Report - public distribution

**Date:** 3/3/2005

**GAIN Report Number:** E35044

E35044

**EU-25**

**Biotechnology**

**Recent Biotech Developments in the EU**

**2005**

**Approved by:**

![](media/image1.wmf)Norval Francis

U.S. Mission to the EU

**Prepared by:**

Stan Cohen

**Report Highlights:**

The new EU Commission has decided to engage in a policy debate on
biotech sometime during the next 2 months. Faced with a number of
challenges to its regulatory approach to biotech, the Commission\'s
decision to undertake the debate has likely been prompted by a number of
contentious and unresolved issues:

\--the inability to get member states to approve biotech events and to
overturn marketing bans dating back to 1997;

\--the emergence of trade-restricting member state proposals for
national coexistence laws;

\--Hungary\'s recent banning of the planting of MON810;

\--the absence of seed labeling legislation for the presence of biotech
seed;

\--and finally, about 30 biotech events in the pipeline awaiting
approval.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU \[BE2\]

\[E3\]

**Biotech Regulatory Process**

Many of the contentious biotech issues now confronting the EU are not
related to human health and environmental safety. Over the last 6 years
the EU has implemented a comprehensive regulatory system to ensure that
biotech products are fully evaluated to ensure their safety. The EU
Commission, the European Food Safety Authority (EFSA) and the member
state competent authorities have the final 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 more on economic considerations, and not safety: 1) the
on-going search for seed labeling legislation for biotech seed
commingled with conventional seed 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 the marketing bans in 6 member states are not based on
legitimate safety concerns.

# Status of Biotech Approvals

Syngenta's Bt11 sweet corn for human consumption was authorized for
marketing in May 2004. Monsanto's NK603 herbicide tolerant corn was
authorized in November 2004 for import for both food and feed uses.
These are the only biotech products that the EU has authorized for
marketing since 1998.

Currently, there are about 30 biotech events in the pipeline for
approval. Those furthest along in the process are presented in the
following table.

+---------------+--------+-----------------------+---------+----------+
| Event         | C      | Use                   | Risk    | Status   |
|               | ompany |                       | Ass     |          |
|               |        |                       | essment |          |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Mo     | I                     | P       | At       |
| Tolerant      | nsanto | mport/Processing/Feed | ositive | Co       |
| Rapeseed,     |        |                       |         | mmission |
| GT73          |        |                       |         | for      |
|               |        |                       |         | Final    |
|               |        |                       |         | Consent  |
+---------------+--------+-----------------------+---------+----------+
| MON863 Corn,  | Mo     | Import                | P       | Co       |
| Insect        | nsanto | /Processing/Feed/Food | ositive | mmission |
| Resistance    |        |                       |         | to Refer |
|               |        |                       |         | to       |
|               |        |                       |         | Council  |
|               |        |                       |         | &        |
|               |        |                       |         | Re       |
|               |        |                       |         | gulatory |
|               |        |                       |         | Cmt.     |
|               |        |                       |         | Decision |
|               |        |                       |         | (food)   |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Mo     | Food                  | P       | Re       |
| Tolerant      | nsanto |                       | ositive | gulatory |
| Corn, GA21    |        |                       |         | Cmt.     |
|               |        |                       |         | D        |
|               |        |                       |         | ecision, |
|               |        |                       |         | March    |
+---------------+--------+-----------------------+---------+----------+
| MON863XMON810 | Mo     | Import                | Pending | EFSA     |
| Corn, Insect  | nsanto | /Processing/Feed/Food |         | opinions |
| Resistance    |        |                       |         | pending  |
+---------------+--------+-----------------------+---------+----------+
| Yiel          | Mo     | Import                | Pending | Ra       |
| dGard/Roundup | nsanto | /Processing/Feed/Food |         | pporteur |
| Ready Corn,   |        |                       |         | Review   |
| Insect        |        |                       |         | (Spain)  |
| Resistance    |        |                       |         | and EFSA |
| and Herbicide |        |                       |         | opinion  |
| Tolerance     |        |                       |         | pending  |
+---------------+--------+-----------------------+---------+----------+
| 1507 Corn,    | Pi     | I                     | P       | Re       |
| Insect        | oneer/ | mport/Processing/Feed | ositive | gulatory |
| Resistance    | M      |                       |         |          |
|               | ycogen |                       |         | Cmt.     |
|               |        |                       |         | D        |
|               |        |                       |         | ecision, |
|               |        |                       |         | March    |
+---------------+--------+-----------------------+---------+----------+
| Bt11 Corn,    | Sy     | Cultivation           | EFSA    | N/A      |
| Insect        | ngenta |                       | Opinion |          |
| Resistance    |        |                       | Pending |          |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Bayer  | I                     | SCP     | EFSA     |
| Tolerant      | Crop   | mport/Processing/Feed | 1998    | opinion  |
| Hybrid        | S      |                       | p       | pending  |
| Rapeseed      | cience |                       | ositive |          |
| (Ms8Rf3)      |        |                       | [1      |          |
|               |        |                       | ]{.unde |          |
|               |        |                       | rline}/ |          |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Bayer  | Import/Processing     | To be   | App      |
| Tolerant      | Crop   |                       | sent to | lication |
| Rapeseed      | S      |                       | EFSA    | in UK    |
| (T45)         | cience |                       |         | since    |
|               |        |                       |         | March    |
|               |        |                       |         | 2004     |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Bayer  | Import                | EFSA    | N/A      |
| Tolerant Rice | Crop   | /Processing/Food/Feed | o       |          |
| Liberty Link  | S      |                       | pinions |          |
| 62            | cience |                       |         |          |
|               |        |                       | pending |          |
+---------------+--------+-----------------------+---------+----------+
| Herbicide     | Bayer  | Import                | To be   | Appl     |
| Tolerant      | Crop   | /Processing/Feed/Food | sent to | ications |
| Cotton        | S      |                       | EFSA    | in       |
| Liberty Link  | cience |                       |         | Spain,   |
| 25            |        |                       |         | 3/2004   |
|               |        |                       |         | and NL,  |
|               |        |                       |         | 3/2005   |
+---------------+--------+-----------------------+---------+----------+

[1]{.underline}/ Positive risk assessments issued under the old
Scientific Committee on Plants (SCP) under Directive 90/220.

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 both BT 11 and NK 603, 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 3 months,
the Council also deferred and sent the matter back to the Commission.
The Commission then authorized the marketing of the two biotech events.

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 consulting in a regulatory
committee would make decisions on biotech events.

Reportedly, Health and Consumer Protection Commissioner Markos Kyprianou
has expressed frustration with the inability of the member states to
reach agreements on biotech approvals despite comprehensive
traceablility and labeling regulations and positive risk assessments.

# Member State Marketing Bans

Marketing bans for a number of events remain in effect in effect in
Austria, Denmark, France, Luxembourg, Germany, and Greece. 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
has referred the matter to the Council who has three months to make a
decision. (It is expected that the March 10 Environment Council will
consider the proposal.) Since it is likely the Council will fail to
reach a decision, the Commission will then be able to lift the bans.

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

# MON810 and the EU Seeds Labeling Proposal

# 

In September 2004, the EU Commission approved the inscription of 17
varieties of Monsanto's biotech corn (MON810) into the EU common
catalogue for seeds. Seed of varieties in the common catalogue can be
marketed in the entire EU, whereas those in the national catalogues can
only be marketed in the country concerned. The inscription of the MON810
varieties is the first time biotech varieties have been inscribed in the
common catalogue.

MON810 corn has been approved in the EU since 1998. 17 varieties of corn
derived from MON810 are inscribed in national catalogues: 6 in France
and 11 in Spain. Typically, seeds entering the national catalogue are
immediately entered into the EU common catalogue. However, a number of
member states attempted to block this procedure, insisting that the
Commission first develop labeling legislation for biotech seeds
establishing maximum thresholds for the adventitious presence (AP) of
biotech seed commingled with conventional and organic seed.

Citing the absence of a law for coexistence as the ostensible reason,
the Hungarian government recently banned the planting of MON810. Like
its neighbor, Slovakia is now also reportedly under pressure from
various groups to ban MON810.

While the former Prodi College of Commissioners had also 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 0.03 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\--5 percent; soybeans\--7 per cent; and rapeseed
\-- 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 in the EU 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. In his parliamentary
hearings in September, Environment Commissioner Stavros Dimas 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.

#  

# Coexistence

Agriculture Commissioner Fischer-Boel has indicated that she is giving
consideration to modifying the current Commission policy that encourages
countries to develop their own guidelines for the coexistence of biotech
and conventional agriculture. She has recently suggested the possibility
of developing a EU "framework legislation" that would presumably impose
tighter controls on farmers, and yet still allow some flexibility to
account for differences among countries. This would mark a departure
from the non-binding guidelines
(<http://europa.eu.int/comm/agriculture/res/index_en.htm> ) published by
the Commission in July 2003. However before proposing any changes,
Commissioner Fischer-Boel will await the results of a EU review of the
experiences of the member states in developing coexistence laws due out
in late 2005.

Austria, Denmark, and Italy have taken the lead in pressing the
Commission to adopt a 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. In the past, the Prodi Commission has
been critical of Germany's proposed coexistence law.

# The New Commission's Policy on Biotech

The new Commission has decided to engage in a policy debate on biotech
sometime during the next 2 months. The Commissioners (Agriculture,
Environment, Health and Consumer Protection, Research, and Trade)
responsible for biotech will reportedly hold an initial discussion on
the subject, and then share its conclusions with the College of
Commissioners.

Faced with a number of challenges to its regulatory approach to biotech,
the Commission\'s decision to undertake the debate has likely been
prompted by a number of contentious and unresolved issues:

\--the inability to get the member states to approve biotech events and
to overturn marketing bans dating back to 1997;

\--the emergence of trade-restricting member state proposals for
national coexistence laws;

\--Hungary's banning of the planting of MON810;

\--the absence of seed labeling legislation for the presence of biotech
seed;

\--and finally, 30 biotech events in the pipeline awaiting approval.

**Visit our website:** our website
**[www.useu.be/agri/usda.html]{.underline}** provides a broad range of
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access to USEU reports, trade information and other practical
information. E-mail: AgUSEUBrussels@usda.gov

**Related reports from USEU Brussels:**

+--------------+------------------------------------+-----------------+
| **Report     | **Title**                          | **Date          |
| Number**     |                                    | Released**      |
+--------------+------------------------------------+-----------------+
| E35026       | 20 EU Regions Defend Right to Ban  | 2/10/05         |
|              | Biotech Production                 |                 |
+--------------+------------------------------------+-----------------+
| E35008       | The EU's Biotech Regulatory        | 1/13/05         |
|              | Process: Who's Being Protected     |                 |
+--------------+------------------------------------+-----------------+
| E34096       | The EU's Biotech Regulatory        | 12/3/04         |
|              | Process---                         |                 |
|              |                                    |                 |
|              | A New Tower of Babel               |                 |
+--------------+------------------------------------+-----------------+
| E34078       | EU Commission Approves Monsanto's  | 11/1/04         |
|              | Biotech Corn, NK603                |                 |
+--------------+------------------------------------+-----------------+
| E34057       | MON810 Biotech Corn Enters EU      | 9/9/04          |
|              | Common Catalogue                   |                 |
+--------------+------------------------------------+-----------------+
| E34009       | Update on the EU's Biotech         | 5/6/04          |
|              | Approval Process                   |                 |
+--------------+------------------------------------+-----------------+
| E24069       | Antibiotic Resistance Marker Genes | 4/21/04         |
+--------------+------------------------------------+-----------------+
| E24045       | Safe as Conventional Rapeseed      | 4/4/04          |
+--------------+------------------------------------+-----------------+
| E23234       | Bt11 Sweet Corn                    | 12/9/03         |
+--------------+------------------------------------+-----------------+
| E23233       | Safe as Conventional Corn          | 12/8/03         |
+--------------+------------------------------------+-----------------+