EuropaBio Background Briefing
1507 maize
4 March 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).

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." 

1507 maize dossiers awaiting EU approval:

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_opinions/663_en.html

Following a positive safety opinion from the GMO Panel of the European Food Safety Authority on 24 September 2004, the European Commission issued its Decision, recommending the approval of 1507 maize for import and processing, including animal feed use. The EU Regulatory Committee established under Art. 30 of Directive 2001/18 is scheduled to vote on this Decision on March 7.

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_opinions/827_en.html

The Commission will now draft a Decision, which will be presented to the Regulatory Committee  for an opinion.  The Regulatory Committee is composed of representatives of Member States.  If the Regulatory Committee votes to accept the decision by a qualified majority, then the European Commission would allow the product to be placed on the market.

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_opinions/826_en.html

The Commission will now draft a Decision, which will be presented to the Regulatory Committee  for an opinion.  The Regulatory Committee is composed of representatives of Member States.  If the Regulatory Committee votes to accept the decision by a qualified majority, then the European Commission would allow the product to be placed on the market.

Worldwide approvals of 1507 maize: (as of March 2005)

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EuropaBio, the European Association for Bioindustries, has 50 direct members operating worldwide and 25 national biotechnology associations representing some 1500 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products.