EuropaBio Background Briefing on 1507 maize

December 20, 2005

Brussels, 19 Dec 2005

Biotech maize 1507 is genetically modified with the Bt trait to make it resistant to certain insect pests (in Europe these typically include Ostrinia nubilalis, commonly known as the European corn borer and Sesamia calamistis, known as the pink stalk borer) and meets all the latest EU regulatory requirements. Biotech maize 1507 was jointly developed by Pioneer Hi-Bred International, Inc. (a DuPont subsidiary) and by Mycogen Seeds, (a Dow AgroSciences subsidiary).

1. 1507 maize has been assessed as safe:

1507 maize meets all the latest EU regulatory requirements, part of which was the condition for the termination of the EU moratorium on new GMO approvals, and has been judged by the European Food Safety Authority to be as safe as conventional maize.

  • The Cry1F protein provides the maize plant with built-in resistance to protect the plant from target insect pests and reduces the need for spraying

  • The Cry1F and PAT proteins expressed in 1507 maize are not toxic or allergenic to humans and animals

  • The PAT protein conferring tolerance to glufosinate-ammonium herbicide was used as the selectable genetic marker

  • 1507 maize poses no concerns with hybridisation with wild populations in the EU

  • 1507 maize is substantially and nutritionally equivalent to, and at least as safe as conventional maize

  • There is no adverse environmental impact of 1507 maize compared to conventional maize

  • Bt sprays have a long history of safe use, including use by organic growers for more than 40 years

Positive Opinion - GMO Scientific Panel - EFSA

The European Food Safety Authority (EFSA) in reviewing the 1507 maize 'import and processing' dossier (Ref: C/NL/00/10 expressed the opinion that 1507 maize is as safe for human and animal health and for the environment as conventional maize:

"In conclusion, the Panel considers that the information available for 1507 maize addresses the outstanding questions raised by Member States and considers that 1507 maize will not have an adverse effect on human and animal health or the environment in the context of its proposed use."

"No data has emerged to indicate that maize line 1507 is any less safe than its non-GM comparators."

"Analysis of kernel chemical composition from field trials in South America and Europe showed that 1507 was substantially equivalent to its non-GM comparator. Furthermore, appropriate animal feeding trials indicated that 1507 is nutritionally equivalent to its non-GM comparator."

2. 1507 maize dossiers awaiting EU approval have Positive Safety Assessments from EFSA:

There are currently three different applications for 1507 maize in the EU approval process:

1. Import and processing, including animal feed use (Ref: C/NL/00/10) · Dossier submitted under Directive 90/220/EEC to the Dutch Competent Authority in November 2000

  • Dossier updated under Directive 2001/18/EC in November 2002

  • Dutch Competent Authority issued a positive safety assessment report in September 2003: http:///gmoinfo.jrc.it/csnifs/C-NL-00-10_ AssessmentReport.pdf

  • EFSA adopted a positive safety opinion on the dossier on 24 September 2004: http:///www.efsa.eu.int/science/gmo/gmo_o pinions/663_en.html

  • Following a positive safety opinion from the GMO Panel of the European Food Safety Authority, the European Commission issued its Decision, recommending the approval of 1507 maize for import and processing, including animal feed use.

  • Vote at EU Agriculture and Fisheries Council of 20 September 2005 - no decision. Decision passed back to Commission.

  • Commission adopted Decision 2005/772/EC to approve the import and processing including animal feed use of 1507 maize on 3 November 2005 with publication of the decision in the EU Official Journal on 5 November 2005.

  • Awaiting consent by the Dutch Competent Authority giving the official approval.

2. Cultivation (Ref: C/ES/01/01)

  • Dossier submitted under Directive 90/220/EEC to the Spanish Competent Authority in July 2001

  • Dossier updated under Dir 2001/18/EC in December 2002

  • Spanish Competent Authority issued a positive safety assessment in August 2003: http:///gmoinfo.jrc.it/csnifs/C-ES-01-01_ AssessmentReport.pdf

  • EFSA adopted a positive safety opinion on the dossier on 19 January 2005: http:///www.efsa.eu.int/science/gmo/gmo_o pinions/8_en.html

  • Awaiting decision by EU Commission and then to be forwarded to Regulatory Committee - date of meeting not yet specified.

3. Human food use (Ref: EFSA/GMO/NL/2004/02)

  • Dossier submitted under Regulation (EC) 258/97 to the Dutch Competent Authority in February 2001

  • Dutch Competent Authority issued a positive safety assessment in November 2003

  • Dossier updated under Regulation (EC) 1829/2003

  • Dutch Competent Authority accepted updated dossier and forwarded to EFSA: http:///www.efsa.eu.int/science/gmo/gm_ff _applications/more_info/503/efsa_gmo_nl_ 2004_02_update1.pdf

  • EFSA adopted a positive safety opinion on the dossier on 19 January 2005: http:///www.efsa.eu.int/science/gmo/gmo_o pinions/826_en.html

  • Following a positive safety opinion from the GMO Panel of the European Food Safety Authority, the European Commission issued its Decision, recommending the approval of 1507 maize for human food use.

  • Vote at Regulatory Committee meeting on 3 June 2005 - no decision. Decision forwarded to Council on 5 October 2005.

  • Vote at EU Agriculture and Fisheries Council of 20 December 2005 - if no decision. Decision will be passed back to Commission for adoption.

1507 maize detection method validated

In accordance with Regulation (EC) 1829/03 and in line with the above applications for approval of 1507 maize, Pioneer and Dow AgroSciences provided the Community Reference Laboratory (CRL) with an event-specific quantitive PCR detection method for 1507 maize for validation. The detection method was validated on 15 February 2005 and the validated method is publicly available from the JRC-CRL website: http:///gmo-crl.jrc.it/summaries/TC1507-r eport_mm.pdf

3. Worldwide approvals of 1507 maize: (as of December 2005) Country Food approval (year) Feed approval (year) Cultivation approval (year) Argentina 2005 2005 2005 Australia & New Zealand 2003 2003   Canada 2002 2002 2002 China 2004 2004   Japan 2002 2002 2002 Mexico 2003     Philippines 2003 2003   South Africa 2002 2002   South Korea 2002     Taiwan 2003 2003   United States 2001 2001 2001

For more information, contact

Adeline Farrelly Tel: +32 2 735 0313 Direct: +32 2 739 1174 Mobile: +32 475 93 17 24
Email: a.farrelly@europabio.org

Simon Barber, Tel: +32 2 735 0313 Direct: +739 1172 Mobile: +32 476 44 24 20
Email: s.barber@europabio.org

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