“View of Asynchronous Approvals from the EU”

111

Rosario, 17 September 2012Beat Späth, Public Affairs Manager,

Green Biotechnology, EuropaBio

Contents

I. Four global trends

II. The EU’s import dependence

III.The EU approvals backlog

2

I. Four global trends

Trend 1:

More GM cultivation in more countries

3

I. Four global trends

Trend 2:

More crops, more traits

4Current numbers and estimations of future numbers of GM crops worldwide Source: Nature Biotechnology (2010) 28, 23-25 International trade and the global pipeline of new GM crops

I. Four global trends

Trend 3:

More global commodity trade

Millions of tonnes of grain traded globally

5

I. Four global trends

Trend 4:

Widening transatlantic gap on GM approval timelines

6

Country Approval timeline (2011)

Ambition for next years

Comments

Argentina 18 months Cut timeline by 50% Timeline concerns single events, stacks somewhat longer

US 25 months Aims for 18 months

Brazil 27 months

Canada 30 months

EU 45 months No stated ambition to speed up. Upcoming new requirements may slow down

Timeline concerns import approvals Approach to stacks = problematic

II. The EU’s dependence on imports

EU Commission – Mapping Agri-Trade Policy (May 2012)

7

_____________________________________________________________________________________________

8Source: USDA, ACTI

II. The EU’s dependence on imports

• Only 2% of soybean consumption in the EU is produced from soybeans grown in the EU.

• Soy imports and domestic = 35mlnt/year (about 60kg per EU citizen)

• 90% of imported soy is from biotech crops.

• Non-GM soy difficult & costly to source.

Imported soybean meal 23 mil tons

32%Produced from imported soybeans 11mil ton

66%

Produced from EU soybeans 0.8 mil tons

2%

II. The EU’s dependence on imports

99

Study on the Implications of Asynchronous GMO Approvals for EU Imports, on behalf of the EU Commission Directorate-General for Agriculture (December 2010)

•“In the long run, the full segregation of commodities in exporting countries is almost impossible” (EU authorized from EU unauthorized GMOs)

•“…The demand for maize and soybean, and their derived products, is growing rapidly … the relative importance of the EU market… inevitably diminishes. This will discourage efforts by producers and traders in exporting countries to invest in segregating EU approved from non-approved GM material and to continue trading with the EU.”

10

III. The EU approvals backlog

10

State of Play EU Approvals - 3 Sept 2012: •47 GM crop products are authorised in total•75 GM crop products in the authorisation system•twice as many products enter the system than exit it (average ’04 -’12)

_____________________________________________________________________________________________

“Approvals of GMOs in the European Union”. Report available from EuropaBio.

11

III. The EU approvals backlog

_____________________________________________________________________________________________

11

Undue delays at political stage:11 months on average between EFSA opinion and first vote. The law prescribes 3 months. Accumulated undue delay: 37 years

Average duration of GM imports authorisation. 45 months

_____________________________________________________________________________________________

“Approvals of GMOs in the European Union”. Report available from EuropaBio.

12

III. The EU approvals backlog

• EU Authorisation system is not working as it should– Some EU governments vote against EFSA scientific advice for political reasons– For cultivation, the agreed process has never been correctly implemented

• Significant backlog continues to grow

• EU process takes substantially longer than comparable systems

• Slow process cannot be explained by safety concerns alone– Commission routinely delays political votes (11 months on average instead of

legally prescribed 3 months) – New assessment requirements lacking scientific basis are introduced– New requirements are applied retroactively

• Efficiency gains possible on risk assessment for stacked products

Crisis management rather than forward looking policies

____________________________________________________________________________________________“

Thank you for your attention! Questions?

131313

Beat Späth, Public Affairs Manager, Green Biotechnology, EuropaBiob.spaeth@europabio.org