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Genetically modified organisms (GMOs) are organisms, such as plants and animals, whose genetic characteristics are being modified artificially in order to give them a new property. Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called genetically modified (GM) food or feed.



In order to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in complete safety, the European Union has established a legal framework regulating genetically modified (GM) food and feed in the EU. This framework pursues the global objective of ensuring a high level of protection of human life and health and welfare, environment and consumer interests, whilst ensuring that the internal market works effectively.







More recent developments

2011 Monitoring report of Amflora potato cultivation

BASF has submitted to the Commission its 2011 monitoring report on Amflora potato cultivation. This report has been sent to EFSA for an analysis of the results.

Post-market Monitoring Reportpdf
Annex 1pdf
Annex 2pdf
Annex 3pdf
Annex 4pdf
Annex 5pdf
Annex 6pdf
Annex 7pdf
Annex 8pdf
Annex 9pdf
Annex 10pdf
Annex 11pdf
Annex 12pdf
Annex 13pdf
Annex 14pdf
Annex 15pdf


Public hearing on “Environmental monitoring of GM crops”

On 29 March 2012 , the Commission organised a hearing on "Environmental monitoring of GM crops" in Brussels, the third of a series after the two on "GMO risk assessment and management" (March 2011) and "Socio-economic dimensions of GMO cultivation" (October 2011).

The aim was to exchange views on GM crops monitoring in the EU and how to strengthen it through the existing environmental monitoring programs.

Participants included European Parliament members, non-EU and EU national authorities, private sector stakeholders, NGOs, the scientific community and the press. The hearing was webstreamed and might be viewed at http://scic.ec.europa.eu/str/index.php?sessionno=2bd235c31c97855b7ef2dc8b414779af.

EFSA opinions on applications under the Regulation on GM food and feed

Please click here

Evaluation of the EU legislation on GMOs

As part of the continuous process of reviewing the existing legislation and the improvement of its implementation, the Commission carried out an evaluation of the GMO legislation between 2009 and early 2011. Two different consultancies addressed GMO cultivation and GM food and feed aspects. The main goal of the exercise was to collect facts and opinions, particularly from stakeholders and competent authorities. The evaluations assessed the effectiveness and efficiency of adjustment of the system.

Hearing on "Socio-economic dimensions of GMO cultivation" - 18 October 2011

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 pdf

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.

Report pdf

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IRM planpdf

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TUG examplespdf

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Spanish Refuge Implementation Communication Materialspdf

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2010 Farmer questionnairepdf

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2010 Farmer questionnaire surveypdf

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MON810 literature reviewpdf - June 2010

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User guide farmer questionnairepdf

Annexes:

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Interview pdf

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.

Read more


Commission Decisions on GMOs authorisation

25 June 2013, Decision 2013/327/EU on oilseed rape Ms8, Rf3 and Ms8 × Rf3pdf

10 February 2012, Decision 2012/84/EU on 356043 Soybeanpdf

10 February 2012, Decision 2012/81/EU on A5547-127 Soybeanpdf

10 February 2012, Decision 2012/83/EU on MON 87701Soybeanpdf

10 February 2012, Decision 2012/82/EU on Renewal of MON 40-3-2 Soybeanpdf

22 December 2011, Decision 2011/894/EU on maize Bt11xMIR604xGA21

22 December 2011, Decision 2011/893/EU on maize Bt11xMIR604

22 December 2011, Decision 2011/892/EU on maize MIR604xGA21

22 December 2011, Decision 2011/891/EU on cotton 281-24-236x3006-210-23

17 June 2011, Decision 2011/365/EU on Renewal of 1507 Maizepdf

17 June 2011, Decision 2011/366/EU on MON89034 x MON88017 Maizepdf

17 June 2011, Decision 2011/354/EU on GHB614 Cottonpdf

28 July 2010, Decision 2010/432/EU on 1507x59122 Maizepdf

28 July 2010, Decision 2010/428/EU on 59122x1507xNK603 Maizepdf

28 July 2010, Decision 2010/429/EU on MON88017xMON810 Maizepdf

28 July 2010, Decision 2010/426/EU on Bt11xGA21 Maizepdf

28 July 2010, Decision 2010/419/EU on Renewal of Bt11 Maizepdf

28 July 2010, Decision 2010/420/EU on MON89034xNK603 Maizepdf

2 March 2010, Decision 2010/135/EU on Starch Potato EH92-527-1 for cultivationpdf

2 March 2010, Decision 2010/136/EU on Starch Potato EH92-527-1 for food and feed usespdf

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

BASF has submitted to the Commission its 2010 monitoring report on Amflora potato cultivation. This report has been transmitted to EFSA for an analysis of the results.

Post-market Monitoring Reportpdf
Annex 1pdf
Annex 2pdf
Annex 3pdf
Annex 4pdf
Annex 5pdf
Annex 6pdf
Annex 7pdf
Annex 8pdf
Annex 9pdf
Annex 10pdf
Annex 11pdf
Annex 12pdf
Annex 13pdf
Annex 14pdf


Commission Report on socio-economic implications of GMO cultivation in the EU - 15/04/2011

On 15 April 2011, the Commission published a report on the socio-economic implications of GMO cultivation in the European Union.

Press release
More about the report

Debate on GMO risk assessment and management - 17/03/2011

Debate on GMO risk assessment and management - 17 March 2011
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 pdf


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:

  1. Zinc Finger Nuclease Technology (ZFN) (comprising ZFN-1, ZFN-2 and ZFN-3 as defined in this report)
  2. Oligonucleotide Directed Mutagenesis (ODGM)
  3. Cisgenesis (comprising Cisgenesis and Intragenesis)
  4. RNA-dependent DNA methylation via RNAi/siRNA
  5. Grafting
  6. Reverse Breeding
  7. Agro-infiltration
  8. 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.

Terms of Referencepdf

2009 monitoring report of MON 810 maize cultivation

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:

  • A Communication from the Commissionpdf, explaining the new approach on the freedom for Member States to decide on the cultivation of genetically modified crops.
  • A new Commission Recommendationpdf 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.
  • A proposalpdf 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:

Standing Committees for Food Chain and Animal Health

19 April 2010 - Agenda pdf

09 March 2010 - Agenda pdf

9-10 February 2010 - Agenda pdf and Minutespdf

14 December 2009 - Agendapdf

16 November 2009 - Agendapdf and Minutes pdf

19 October 2009 - Agendapdf and Minutes pdf

22 July 2009 - Agendapdf and Minutes pdf

29-30 June 2009 - Agenda pdf and Minutes pdf

20 April 2009 - Agenda pdf and Minutes pdf

16 February 2009 - Agenda pdf and Minutes pdf

Parliamentary questions

Soon available


 
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