More recent developments
EFSA opinions on applications under the Regulation on GM food and feed
GA21 maize
This opinion is related to an application for cultivation of genetically modified GA21.
EFSA opinion
MON 1445 maize - renewal of the authorisation
This opinion is related to the renewal of an authorization for placing on the market food and feed produced from MON 531 cotton.
MON89034x1507xMON88017x59122 maize
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MON89034x1507xMON88017x59122 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
MON89034x1507xNK603 maize
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MON89034x1507xNK603 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
MON88017 maize
This opinion is related to an application for cultivation of genetically modified MON 88017.
Cotton MON 531 – Renewal of the authorisation
This opinion is related to an application for the renewal of the authorisation of food and feed produced from genetically modified MON 531 cotton (e.g. additives, cottonseed oil and meal)
356043 Soybean
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified 356043 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).
MON 87701 Soybean
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MON 87701 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).
A5547-127 Soybean
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified A5547-127 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).
Soybean 40-3-2 – renewal of the authorisation
Two overall opinions are related to two applications for renewal of the authorisation of genetically modified soybean 40-3-2 . These overall opinions are related to two applications for the placing on the market of food, feed and other products containing or consisting of genetically modified 40-3-2 soybean and food and feed produced from this soybean (meal, cake, oil). One single scientific opinion was adopted by EFSA covering the entire scope.
- link to the overall opinion as regards the second application
MON89034x1507xMON88017x59122 maize
This opinion is related to an application for the placing on the market of insect-protected and herbicide tolerant genetically modified maize MON89034x1507xMON88017x59122 maize for food and feed uses under Regulation (EC) No 1829/2003 from the Company Dow Agro Sciences & Monsanto
MON89034x1507xNK603 maize
This opinion is related to an application for the placing on the market of insect-protected and herbicide-tolerant genetically modified maize MON89034x1507xNK603 maize for food and feed uses under Regulation (EC) No 1829/2003 from the Company Dow Agro Sciences & Monsanto
281-24-236/3006-210-23 cotton
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified 281-24-236/3006-210-23 cotton or food (oil) and feed produced from this cotton (e.g. meal, oil).
Bt11 x MIR604 x GA21 maize
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified Bt11 x MIR604 x GA21 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
MIR604 x GA21 maize
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MIR604 x GA21 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
Bt11 x MIR604 maize
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified Bt11 x MIR604 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
MON 89034 x MON 88017
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MON 89034 x MON 88017 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
Maize MON 863 – Renewal of the authorisation
This opinion is related to an application for the renewal for the authorisation of food and feed produced from genetically modified MON 863 (e.g. additives).
Oilseed rape GT73 – renewal of the authorisation
Two overall opinions are related to an application for renewal of the authorisation of genetically modified oilseed rape GT73 for some food and feed uses. One single scientific opinion was adopted by EFSA covering the entire scope.
Maize MON89034xNK603
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified MON89034xNK603 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
Maize Bt11xGA21
This opinion is related to an application for the placing on the market of food, feed and other products containing or consisting of genetically modified Bt11xGA21 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
Evaluation of the EU legislation on GMOs
Hearing on "Socio-economic dimensions of GMO cultivation" - 18 October 2011
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The Commission held a conference in Brussels on "socio-economic dimensions of GMO cultivation" on 18 October 2011, under the chairmanship of Commissioner John Dalli.
Members of the European Parliament, EU countries' competent authorities, non-EU countries, industry, NGOs and the scientific community were invited to express their views.
The debate was web streamed and might be viewed at: http://scic.ec.europa.eu/str/index.php?sessionno=d37124c4c79f357cb02c655671a432fa
Agenda of this event, including the presentations 
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2010 Monitoring report of MON 810 Maize cultivation
Monsanto has submitted to the Commission its 2010 monitoring report on MON810 maize cultivation. This report has been transmitted to EFSA requesting an analysis of the results.
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Spanish Refuge Implementation Communication Materials
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GAP Leaflet
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IRM advertisement
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ANOVE Farmer letter
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Train the trainers presentation
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IRM poster
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IRM sticker
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2010 Farmer questionnaire survey
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MON810 literature review - June 2010
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Food and Feed - July 2011
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Environment - July 2011
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User guide farmer questionnaire
Annexes:
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Harmonisation of controls for non-authorised GMOs in feed material
On 24 June 2011 the Commission adopted Regulation EC 619/2011 harmonising implementation of the zero-tolerance policy on non-authorised genetically modified (GM) material in feed to enter into force on 15 July 2011. It addresses EU businesses' uncertainty when marketing feed imported from non-EU countries.
Commission Decisions on GMOs authorisation
17 June 2011, Decision 2011/365/EU on Renewal of 1507 Maize
17 June 2011, Decision 2011/366/EU on MON89034 x MON88017 Maize
17 June 2011, Decision 2011/354/EU on GHB614 Cotton
28 July 2010, Decision 2010/432/EU on 1507x59122 Maize
28 July 2010, Decision 2010/428/EU on 59122x1507xNK603 Maize
28 July 2010, Decision 2010/429/EU on MON88017xMON810 Maize
28 July 2010, Decision 2010/426/EU on Bt11xGA21 Maize
28 July 2010, Decision 2010/419/EU on Renewal of Bt11 Maize
28 July 2010, Decision 2010/420/EU on MON89034xNK603 Maize
2 March 2010, Decision 2010/135/EU on Starch Potato EH92-527-1 for cultivation
2 March 2010, Decision 2010/136/EU on Starch Potato EH92-527-1 for food and feed uses
2 March 2010, Decision 2010/139/EU on MON863xMON810xNK603
2 March 2010, Decision 2010/140/EU on MON863xMON810
2 March 2010, Decision 2010/141/EU on MON863xNK603
30 November 2009, Decision 2009/866 on MIR604
30 October 2009, Decision 2009/813 on MON89034
30 October 2009, Decision 2009/814 on MON88017
30 October 2009, Decision 2009/815 on 59122xNK603
10th March 2009, Decision 2009/184 on Oilseed rape T45
4th December 2008, Decision 2008/933 on MON89788 Soybean
29th October 2008, Decision 2008/837 on LLCotton25
8th September 2008, Decision 2008/730 on A2704-12 Soybean
28th March 2008 Decision 2008/280 on Maize GA 21
2010 Monitoring report of Amflora potato cultivation
Post-market Monitoring Report Annex 1 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 Annex 7 Annex 8 Annex 9 Annex 10 Annex 11 Annex 12 Annex 13 Annex 14Commission Report on socio-economic implications of GMO cultivation in the EU - 15/04/2011
Press release
More about the report
Debate on GMO risk assessment and management - 17/03/2011
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Commissioner Dalli chaired a public debate on "GMO risk assessment and management" on 17 March 2011 in Brussels. Members of the European Parliament, EU countries' competent authorities, non-EU countries, industry, NGOs and the scientific community were invited to express their views. The debate was web streamed and might be viewed at
http://scic.ec.europa.eu/str/index.php?sessionno=4cb811134b9d39fc3104bd06ce75abad. Agenda of this event including the presentations
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Evaluation of the EU legislation Framework in the Field of Cultivation
In December 2008, the Commission launched a technical evaluation of the regulatory framework of the cultivation of GMOs under Directive 2001/18/EC on the deliberate release into the environment of GMOs and Regulation (EC) No 1829/2003 on GM food and feed and the marketing of their other uses under the Directive.
The aim of the evaluation is to assess to what extent the legislative framework on the cultivation and marketing of GMOs and its up to date implementation have achieved its objective of protecting human and animal health, the environment and consumers' interest, while ensuring the effective and efficient functioning of the internal market.
The evaluation will cover topics such as risk assessment, management and communication, authorisation procedures, national safeguard measures, inspections and controls and confidentiality rules.
The contractor of this exercise is GHK, member of the EPEC consortium. Within the framework of their task, they will analyse the GMO legislation and a series of available documents, reports and studies related to its implementation. Moreover they will consult a wide range of stakeholders, including the Member States' Competent Authorities under the GMO legislation, professional associations, biotech industry and civil society organisations involved in biotechnology issues.
The results of this work are expected for the first quarter of 2011.
Working Group on New Techniques
The Commission set up a specialised Working Group in December 2008 to consider new biotechnological techniques being applied in plant breeding and/or the modification of other organisms. Member States have each appointed scientific experts to participate in the work of the Group, which is examining a range of new techniques to assess whether they should be considered to lead to GMOs or GMMs as defined under Directive 2001/18/EC or Directive 90/219/EEC, respectively.
The following techniques were identified as the starting point for the consideration for the "new techniques working group", by the Competent Authorities:
- Zinc Finger Nuclease Technology (ZFN) (comprising ZFN-1, ZFN-2 and ZFN-3 as defined in this report)
- Oligonucleotide Directed Mutagenesis (ODGM)
- Cisgenesis (comprising Cisgenesis and Intragenesis)
- RNA-dependent DNA methylation via RNAi/siRNA
- Grafting
- Reverse Breeding
- Agro-infiltration
- Synthetic Biology
In parallel a study is being carried out by two institutes of DG Joint Research Centre of the European Commission: Institute for Prospective Technological Studies (IPTS) and Institute for Health and Consumer Protection (IHCP) investigate the current dimension of the research and commercial activities in these technologies, prospects of commercial use of the application and potential impacts of this commercialisation, including detection and monitoring aspects presented by these new techniques.
The European Commission will view the results of the Working Group and the analysis of the Competent Authorities in parallel with the JRC studies on: (i) adoption and economic impacts and (ii) monitoring and detection challenges of these techniques as well as the outcome of the evaluation exercise of the GMO legislation (which covers food/feed and cultivation aspects). The findings of the Working Group may be also referred to EFSA for their opinion.
The next meeting of the Working Group is planned for 26 and 27 January 2011 in Brussels.
2009 monitoring report of MON 810 maize cultivation
Monsanto has submitted to the Commission its 2009 monitoring report on MON810 maize cultivation. This report has been transmitted to EFSA requesting an analysis of the results.
Annual monitoring report on the cultivation of MON 810 in 2009
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GAP Leaflet
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IRM advertisement
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ANOVE Farmer letter
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Train the trainers presentation
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IRM poster
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IRM sticker
ECB Baseline susceptibility 2009
Insect resistance monitoring 2009
2009 Farmer questionnaire survey
MON810 literature review - June 2009
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Food and Feed - June 2010
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Environment - June 2010
Environmental Risk Assessment guidance
According to the Directive 2001/18/EC, which regulates the deliberate release into the environment of genetically modified organisms (GMO) in Europe, the potential adverse effects on human health and the environment are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with the principles of the Directive 2001/18/EC and the supplementary guidelines.
Following a specific mandate of the Commission to EFSA in March 2008, supported in the Council conclusions of December 2008, an updated version of the current environmental risk assessment (ERA) guidance has been published by EFSA on the 12th of November 2010. In parallel the EFSA GMO panel has delivered an opinion to address the evaluation of potential impact of GM plants on non-target organisms (NTOs).
The Commission will continue the discussion on ERA guidance with Member States to clarify all the specific aspects of this guidance before being transformed into a legal text. This guidance will be the basis for applicants when submitting applications for GM authorization and for Member States and EFSA when assessing the environmental risk of GM plants.
EU's new approach on GMO cultivation
On July 13 2010, the Commission adopted a comprehensive proposal that provides this freedom to the Member States. The EU's existing science-based authorisation system remains unaffected. The proposal also provides for non-binding guidelines that better reflect the possibilities already available to the Member States to adopt measures in order to avoid the unintended presence of GMOs in conventional and organic crops. In a nutshell, the comprehensive proposal represent the Commission's new flexible approach on GMO cultivation, which takes into consideration Member States desires, but also retains the basis of solid science for any GMO authorisation.
The package includes:
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A Communication from the Commission, explaining the new approach on the freedom for Member States to decide on the cultivation of genetically modified crops.
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A new Commission Recommendation on co-existence of GM crops with conventional and/or organic crops.
It better reflects the possibility under the existing legislation for Member States to handle the co-existence of GM and other types of crops. This new Recommendation gives more flexibility for Member States to define such co-existence measures. It allows them, for example, to aim at levels of unintended GMO presence that are lower than the 0.9% labelling threshold of the EU legislation.
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A proposal to be adopted by the European Parliament and the Council for revising the GMO legislation (Directive 2001/18/EC) as regards the possibility for Member States to restrict or prohibit the cultivation of GMOs in their territory.
For more information see:
- Press Release - GMOs: Member States to be given full responsibility on cultivation in their territories
- Questions and Answers on the EU's new approach to the cultivation of GMOs
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GMO cultivation citizen's summary
Standing Committees for Food Chain and Animal Health
19 April 2010 - Agenda
09 March 2010 - Agenda
9-10 February 2010 - Agenda and Minutes
14 December 2009 - Agenda
16 November 2009 - Agenda and Minutes
19 October 2009 - Agenda and Minutes
22 July 2009 - Agenda and Minutes
29-30 June 2009 - Agenda
and Minutes
Parliamentary questions
Soon available
