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  Rules on GMOs in the EU - Authorisationslide
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The Regulation on genetically modified food and feed introduces a centralised procedure of authorisation by the European Commission based on an independent risk assessment carried out by the European Food Safety Authority (EFSA). It also introduces rules for the labelling of GM food and feed and a threshold for the presence of GM material that is adventitious or technically unavoidable.

The authorisation procedure is as follows:

  1. The submission of an application for an authorisation for the placing on the market of a GM food or feed.
    The application has to be sent to the competent authority at national level which has to acknowledge the receipt of the application and inform EFSA without delay.

  2. The preparation and the delivery of an opinion by EFSA.
    EFSA publishes summaries of the applications on the EFSA website. Applications are sent to the European Commission and to the Member States, who are consulted on the application over a 3 month period. If a GMO is to be used as seeds EFSA has to ask the appropriate authority at national level to carry out the appropriate environmental risk assessment (Art. 6 and 18 of Reg. (EC) 1829/2003).

    EFSA must give its opinion within 6 months of receiving the application. However, if additional data is requested during the scientific assessment the time limit is extended.

    An overview of the applications received by EFSA can be found on the following website:
    http://www.efsa.europa.eu/en/gmo/gmoapplications.htm

    The scientific opinions adopted by the GMO Panel of EFSA can be found here.

    A favourable opinion by EFSA, is issued with supplementary information from its GMO Panel such as a proposal for labelling, appropriate conditions or restrictions for the placing on the market of the GM product. This supplementary information contributes to the overall EFSA opinion. It is therefore important to make a clear distinction between the scientific opinions of the GMO Panel and the overall EFSA opinions that are required by the Regulation.

    The verification of the detection method of GM food and feed is part of the centralised authorisation procedure which is conducted by the European Commission’s Joint Research Centre (JRC) in its capacity of Community Reference Laboratory for GM Food and Feed, and assisted by the European Network of GMO Laboratories (ENGL). These verifications are published on the JRC website.

  3. The preparation and adoption of a Decision.
    The European Commission submits a draft Decision to the Standing Committee of Food Chain and Animal Health (SCoFCAH) within 3 months of receiving the overall EFSA opinion. The rules for the adoption of a Decision can be found on the following website:
    http://ec.europa.eu/transparency/regcomitology/faq_en.htm.

Comments from the public

The general public may make comments on the overall EFSA opinion within 30 days of its publication. Comments should be addressed to the European Commission. Once an EFSA opinion is available, the European Commission opens a consultation on this website. After 30 days of publication of the opinion, the European Commission analyses all the comments received and consults EFSA to determine whether they have an impact on its opinion.


Open consultations

Event EFSA opinion Form to make comments1

Opinions for which the deadline for comments has expired1

Event EFSA opinion Comments received1
Cotton MON 531 x MON 1445 – authorisation and renewal of the authorisation

Two overall opinions on application for authorisation of food and feed produced from GM cotton MON 531 x MON 1445 (cottonseed oil) and on application for renewal of authorisation for continued marketing of food additives, feed materials and feed additives produced from cotton MON 531 x MON 1445, both submitted under Regulation (EC) No. 1829/2003 by Monsanto. One single scientific opinion was adopted by EFSA covering both applications.
28 March 2012
28 March 2012
28 April 2012
MON87701xMON89788 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 x MON 89788 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).
15 February 2012 16 March 2012
GA21 maize

This opinion is related to an application for cultivation of genetically modified GA21.
16 December 2011 2 February 2012
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.
16 December 2011 No comments submitted
MON88017 maize

This opinion is related to an application for cultivation of genetically modified MON 88017.
10 November 2011 10 December 2011
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).
10 November 2011 10 December 2011
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).
10 November 2011 10 December 2011
MON 531 Cotton

opinion of the Scientific Panel on Genetically Modified Organisms to renew an application for authorization on placing on the market of food and feed produced from genetically modified MON 531 cotton, under Regulation (EC) No 1829/2003 from the Company Monsanto Europe S.A.
16 September 2011 21 October 2011
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).
26 July 2011 27 August 2011
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).
26 July 2011 27 August 2011
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).
10 May 2011 10 June 2011
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
1 December 2010 13 January 2011
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
27 September 2010 27 October 2010
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
27 September 2010 27 October 2010
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).
15 June 2010 20 July 2010
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 maize (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
15 June 2010 no comments submitted
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).
18 May 2010 19 June 2010
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).
18 May 2010 19 June 2010
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).
30 March 2010 no comments submitted
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).
30 March 2010 1 May 2010
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.

15 December 2009 30 January 2010
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).
29 September 2009 no comments submitted
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).
22 September 2009 no comments submitted
Oilseed rape Ms8, Rf3, Ms8xRf3 - renewal of the authorisation

This opinion is related to an application for renewal of the authorisation for the placing on the market of food and feed produced from this oilseed rape (e.g. oil).
22 September 2009 no comments submitted
Maize MIR 604

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 MIR 604 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
21 July 2009 no comments submitted
Maize MON 88017xMON 810

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 88017xMON 810 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
21 July 2009 No non-confidential comment submitted
Maize 1507x59122

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 1507x59122 maize (e.g. maize grains or food and feed produced from this maize (e.g. flour, oil).

6 May 2009 6-6-2009
Maize MON 810 – renewal of the authorisation

Three overall opinions are related to an application for renewal of the authorisation of genetically modified MON 810 for cultivation and food and feed. One single scientific opinion was adopted by EFSA covering the entire scope.

30 June 2009 15-8-2009
Maize NK603

This opinion is related to an application for the authorisation of genetically modified NK603 for cultivation and food and feed.

11 June 2009 15-7-2009
Maize 1507 – renewal of the authorisation

This opinion is related to an application for renewal of the authorisation for the placing on the market of feed produced from maize 1507 (e.g. feed additives).

11 June 2009 no comments submitted
Maize 1507x59122

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 1507x59122 maize (e.g. maize grains or food and feed produced from this maize (e.g. flour, oil).

6 May 2009 6-6-2009
Maize MON88017

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 MON88017 maize (e.g. maize grains or food and feed produced from this maize (e.g. flour, oil).

6 May 2009 6-6-2009
Maize 59122x1507xNK603

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 59122x1507xNK603 maize (e.g. maize grains or food and feed produced from this maize (e.g. flour, oil).

8 April 2009 8-5-2009
Cotton GHB614

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 GHB614 or food (e.g. oil) and feed produced from this cotton (e.g. meal, oil).

10 March 2009 10 April 2009
Maize Bt11 – renewal of the authorisation

This opinion is related to an application for renewal of the authorisation for the placing on the market of food, feed and other products containing or consisting of genetically modified Bt11 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).

17 February 2009 17 March 2009 - No comments submitted
Maize MON89034

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 MON89034 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).

18 December 2008 18 January 2009
Maize 59122xNK603

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 59122xNK603 maize (e.g. maize grains or food and feed produced from this maize (e.g. flour, oil).

25 November 2008 25 December 2008
MON89788 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 MON89788 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).

11 July 2008 11 August 2008
Oilseed rape T45

This opinion is related to an application for the placing on the market of food, feed and other products containing, consisting of or produced from genetically modified oilseed rape T45 (e.g. meal, oil).

5 March 2008 5 April 2008
Rice LLRICE62

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 rice LLRICE62 (e.g. rice grains) or food and feed produced from this rice (e.g. flour, starch).

30 November 2007 30 December 2007
Maize GA 21

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 maize GA 21 (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).

02 October 2007 02 November 2007
A2704-12 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 A2704-12 Soybean or food and feed produced from this soybean (e.g. meal, cake and oil).

10 August 2007 10 September 2007
LLCotton25

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 LLCotton25 or food (e.g. oil) and feed produced from this cotton (e.g. meal, oil).

16 April 2007 16 May 2007
Maize 59122

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 maize "59122" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).

02 April 2007 02 May 2007
Sugar beet H7-1

An opinion of EFSA has been published on the 20 December 2006. This opinion is related to an application for the placing on the market of products produced from glyphosate-tolerant genetically modified sugar beet "H7-1" for food and feed uses. The scope of this application is for food produced from or containing ingredients produced from genetically modified sugar beet H7-1 (e.g. sugar) and feed (e.g. pulp) produced from genetically modified sugar beet H7-1. The GM sugar beet H7-1 has been developed to be tolerant to glyphosate containing herbicides. Comments on the EFSA opinion may be provided until the 20th of January by filling the provided form.

20 December 2006 20 January 2007
Starch potato EH92-527-1

This opinion is related to an application for the placing on the market of food and feed containing,consisting or produced from the geneticallly modified starch potato "EH92-527-1".
10 November 2006 10 December 2006
Maize 1507xNK603

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 maize "1507xNK603" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
12 May 2006 12 June 2006
Maize NK603xMON810

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 maize "NK603xMON810" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
03 Apr 2006 03 May 2006
MON863xMON810

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 maize "MON863xMON810" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
03 Apr 2006 03 May 2006
MON863xNK603

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 maize "MON863xNK603" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
03 Apr 2006 03 May 2006
Maize MON863xMON810xNK603

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 maize "MON863xMON810xNK603" (e.g. maize grains) or food and feed produced from this maize (e.g. flour, oil).
03 Apr 2006 03 May 2006
Maize 1507

This opinion is related to an application for the placing of the market of foods consisting or containing the genetically modified maize "1507" (e.g. fresh or canned sweet maize) or food produced from this maize (e.g. flour, oil).
04 Mar 2005 04 Apr 2005


1 When comments are CLOSED (deadline for comments expired), the closure date is indicated and linked to the received comments. When comments are still allowed, they are indicated as OPEN CONSULTATION and linked to the form for comment submission.


 
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