EUROPA - Food Safety - Biotechnology - Rules on GMOs in the EU

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:

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.
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.
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. link to the overal opinion related to refined oil produced from Gt73 oilseed rape for food uses	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. link to the overal opinion related to foods and food ingredients produced from MON810 maize link to the overal opinion on food additives and feed produced from MON810	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.