1) NK603 is currently in the EU approval process, having received a positive opinion from EFSA. It is expected to complete the comitology process by the end of 2010, allowing for its authorization. 2) Monsanto is preparing for post-market environmental monitoring of NK603 by collaborating with EuropaBio and member states on farmer surveys and monitoring networks. They are also monitoring scientific literature and reporting potential adverse effects. 3) If NK603 receives EU authorization by the end of 2010 and individual member states complete variety registration and herbicide approvals, NK603 could potentially be launched in some markets in 2011.

1. NK603 Regulatory
Status
Annick Pleysier
23 March 2010
Monsanto Company
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2. Outline
• Where is NK603 in the overall approval process?
• When can we reasonably expect to have NK603 authorised for
cultivation in the EU?
• How is Monsanto preparing for the Post Market Environmental
Monitoring of NK603?
• When can we reasonably expect to have NK603 on the market?
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3. Where is NK603 in the overall approval
process? EFSA Completeness check √
Member State
EFSA review √ Consultation √
CRL method validation √
Public
NK603 – food, feed, import, cultivation Consultation √
NK603 – Art 8(1)(b), 20(1)(b) renewal Commission Proposal
SCFCAH Vote (Q/M)
NK603 already authorised
<255
• for import and processing under Dir.
2001/18/EC acc. to Commission Decision Council Decision (Q/M)
2004/643/EC
• for use as foods and food ingredients <255
under Reg. (EC) No. 258/97 acc. to
Commission Decision 2005/448/EC Commission decision
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4. When can we reasonably expect to have
NK603 authorised for cultivation in the EU?
Jun ’09 EFSA opinion
http://www.efsa.europa.eu/en/scdocs/scdoc/1137.htm
“Within 3 months”, Commission shall submit a Public
draft of the Decision to the SCFCAH Consultation √
(Art 7(1) & 19(1) of Reg. (EC) No. 1829/2003)
Time limit determined by SCFCAH chairman
Apr ’10 ? Commission Proposal
“according to the urgency of the matter”
(Art 5(2) of Council Decision 1999/468/EC)
If no Q/M in SCFCAH, Commission forwards
Jun ’10 ? SCFCAH Vote (Q/M)
proposal to the Council of Ministers “without
delay” (Art 5(4) of Council Decision 1999/468/EC) <255
and the Council of Ministers may act “within 3
months” (Art 35(2) of Reg. (EC) No. 1829/2003) Oct ’10 ? Council Decision (Q/M)
If no Q/M in Council of Ministers, Commission <255
adopts the decision (no legal time limit)
Nov ’10 ? Commission decision
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5. How is Monsanto preparing for the PMEM of
NK603?
The EFSA opinion concluded that Case-Specific Monitoring was not required for NK603,
so only General Surveillance (GS) needs to be implemented.
GS will include:
• Activities in cooperation with other companies under EuropaBio Monitoring WG
umbrella and in collaboration with EU and MS
– Harmonisation of farmer questionnaire
– Identification, selection of appropriate existing networks and reporting process
• Monsanto’s stewardship activities
– Monitoring of peer-reviewed scientific literature
• Since first placing on the market (2001 in US) until Nov 2009: 44 publications on NK603
(via ISI WOK), overall confirming the conclusions of the original risk assessment
– Monsanto’s adverse effects reporting system
– Monsanto’s issue alerts system
• e.g. Austrian mouse study on NK603 x MON 810 and de Vendomois/Seralini et al.
paper on NK603, (MON 863 and MON 810)
• Monsanto response on Monsanto website - For the record :
http://www.monsanto.com/products/techandsafety/fortherecord_science/default.asp
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6. When can we reasonably expect to have
NK603 on the market?
… 2011 …
Launch
NK603 registration
EU
Variety registration
Member States and EU catalogue
Roundup formulation registration
Member States
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7. Conclusion
• NK603 has an EFSA opinion and entered the comitology process
• If timelines laid out in EU legislation are respected, it is reasonable
to expect NK603 authorisation at the end of 2010
• Monsanto is preparing for General Surveillance of NK603 in
cooperation with EuropaBio, in collaboration with EU and MS and
internally, as part of its stewardship activities
• If the EU NK603 event authorisation is in place and a MS has a
Roundup formulation for the appropriate use and the appropriate
NK603 variety registered by end 2010/beginning 2011, then NK603
may be launched next year in that MS
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8. Thank you!
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