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A Pleysier


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NK603 Regulatory Status

NK603 Regulatory Status

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  • 1. NK603 Regulatory Status Annick Pleysier 23 March 2010 Monsanto Company 1
  • 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? 2
  • 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 3
  • 4. When can we reasonably expect to have NK603 authorised for cultivation in the EU? Jun ’09 EFSA opinion “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 4
  • 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 : 5
  • 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 6
  • 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 7
  • 8. Thank you! 8