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GM Regulation

European GMO deliberate release legislation: Consents and pending applications, including UK assessment reports and opinions

Information on this page:

1. Overview
2. UK Assessment reports
3. UK opinions
4. EU Decisions on Part C Marketing Applications
5. Final outcome of part C marketing applications

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1. Overview

This document (PDF) (60 KB) - last updated 31 May 2008 - contains tables that give an overview of the current state of play of authorisations granted, and applications pending, for placing genetically modified products on the EU single market under GM deliberate release legislation.

• Table 1 shows applications for Part C consents under the new GMO deliberate release Directive 2001/18, since it entered fully into force on 17 October 2002. Further information and details of how to make comments on these applications can be found on the European Commission's website at http://gmoinfo.jrc.it.
• Table 2 shows GM products that already have Part C consents under European GMO deliberate release legislation.

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2. UK Assessment reports

Assessment reports of the UK competent authority in accordance with Directive 2001/18/EC have been published as follows:

• Notification C/GB/02/M3/3 from Monsanto Europe S.A. for consent to market hybrid maize (NK603 X MON810) (5 March 2004) (PDF) (120 KB).
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (70 KB)
• Notification C/GB/03/M5/3 from Bayer Cropscience Ltd for consent to market LLRICE62 (7 January 2004) (PDF) (130 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (65 KB)
• GM Herbicide Tolerant T25 Maize
  This paper explains the safety assessments that have been conducted on T25 maize as part of its regulatory approval in Europe for cultivation, feed and food uses.

Assessment Reports published before Directive 2001/18 came into force:

• Environmental Risks of Herbicide-Tolerant Oilseed Rape: a Review of the PGS Hybrid Oilseed Rape

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3. UK opinions

The procedures under Directive 2001/18 allow all Member States the opportunity to comment upon applications following a positive assessment by the lead Member State. The UK has so far commented as follows (listed in order of publication):

• Further UK opinion on notification C/NL/06/01 from Florigene Ltd for consent to market a GM carnation modified for flower colour (Sept 2007) (PDF) (15 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (60 KB).
• UK opinion on notification C/NL/06/01 from Florigene Ltd for consent to market a GM carnation modified for flower colour (June 2007) (PDF) (15 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (60 KB).
• Further UK opinion on application C/NL/04/02 from Florigene Ltd for consent to market carnation modified for colour (18 August 2006) (PDF) (15 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (60 KB).
• Further UK Opinion on application C/SE/96/3501: BASF Plant Science - Potato clone EH92-527-1 Modified for enhanced content of the amylopectin component of starch (4 December 2006) (PDF) (20 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (50 KB).
• Further UK Opinion on application C/BE/96/01. Bayer CropScience - GM oilseed rape (events Ms8, Rf3 & Ms8xRf3) (2 December 2005) (PDF) (20 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (100 KB).
• Further UK opinion on application C/DE/02/09: Monsanto - maize genetically modified for insect resistance, lines MON 863 and MON 863 x MON 810 (7 September 2005) (PDF) (20 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (190 KB).
• Further UK opinion on application C/SE/96/3501: BASF Plant Science - potato clone EH92 527 1 modified for enhanced content of the amylopectin component of starch (27 January 2005) (PDF) (20 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (70 KB).
• UK opinion on application C/NL/04/02 from Florigene Ltd for consent to market carnation modified for colour (4 May 2005) (PDF) (100 KB). See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (110 KB) .
• Further UK Opinion on application C/NL/04/01: Agrigenetics Inc. d/b/a Mycogen Seeds c/o Dow AgroSciences LLC - A GM cotton line that contains two transformation events that have been combined through conventional breeding. Insect resistant and herbicide tolerant cottonseed (7 April 2005) (PDF) (10 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (70 KB)
• Further UK Opinion on application C/BE/96/01: Bayer CropScience - Oilseed rape genetically modified to introduce a pollination control hybrid system and tolerance to glufosinate ammonium, lines Ms8, Rf3 and Ms8xRf3 (9 December 2004). (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (85 KB)
• UK Opinion on application NL/04/01: Agrigenetics Inc. d/b/a Mycogen Seeds c/o DowAgroSciences LLC - A GM cotton line that contains two transformation events that have been combined through conventional breeding. Insect resistant and herbicide tolerant cottonseed (30 November 2004). (PDF) (10 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (65 KB)
• UK Opinion on application SE/96/3501: BASF Plant Science - potato clone EH92-527-1 modified for enhanced content of the amylopectin component of starch (1 July 2004). (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (65 KB)
• Text of letter sent to the European Commission on 14 June 2004 regarding genetically modified herbicide-tolerant maize, consents C/F/95/12-07 and C/F/94/11-03: proposals for amendment to consents pursuant to Article 20 of Directive 2001/18/EC (PDF) (10 KB); following the response of the French Competent Authority (in French (PDF) (10 KB)) and (Defra English translation (PDF) (10 KB))
• Further UK Opinion on application ES/01/01: Pioneer Hi-Bred International Inc. and Mycogen Seeds - Maize geneticaly modified for insect resistance and herbicide tolerance (1507) (4 May 2004) (PDF) (30 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (80 KB)
• UK Opinion on application BE/96/01: Bayer CropScience - GM Oilseed rape (Events Ms8, Rf3 & MsxRf3) (28 April 2004) (PDF) (40 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (70 KB)
• Text of letter sent to French Competent Authority under Directive 2001/18 on 9 March 2004. Genetically modified herbicide-tolerant maize, consents C/F/95/12-07 and C/F/94/11-03 Proposals for amendment to consents (22 March 2004) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (120 KB)
• Further UK Opinion on application F/96/05/10: Syngenta seeds SAS - insect resistant and herbicide tolerant GM Maize (Bt11) (21 February 2004) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (85 KB)
• Further UK Opinion on application NL/00/10: Pioneer Hi-Bred International Inc. and Mycogen Seeds - Maize geneticaly modified for insect resistance and herbicide tolerance (1507) (4 February 2004) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (65 KB)
• UK Opinion on application DE/02/09: Monsanto Europe S.A. - Insect resistant maize (MON 863 and MON 863 x MON 810) (6 November 2003) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (85 KB)
• UK Opinion on application NL/00/10: Pioneer Hi-Bred International Inc. and Mycogen Seeds - Maize geneticaly modified for insect resistance and herbicide tolerance (1507) (16 October 2003) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (60 KB)
• Further UK Opinion on application ES/01/01: Pioneer Hi-Bred International Inc. and Mycogen Seeds - Maize geneticaly modified for insect resistance and herbicide tolerance (1507) (16 October 2003) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (80 KB)
• Further UK Opinion on application NL/98/11: Monsanto - glyphosate tolerant oilseed rape (Event GT73). For import only, not for cultivation in EU (1 October 2003) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (80 KB)
• UK Opinion on application C/F/96/05/10: Syngenta seeds SAS - Insect resistant and herbicide tolerant maize (Bt11) (25 September 2003) (PDF) (25 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (75 KB)
• Further UK Opinion on application ES/00/01: Monsanto - glyphosate tolerant maize (Event NK603). For import only, not for cultivation in EU (27 August 2003) (PDF) (20 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (80 KB)
• UK Opinion on notification C/DE/02/09: Monsanto Europe S.A - Insect resistant maize (MON 863 and MON 863 x MON 810) (1 July 2003) (PDF) (25 KB)
  See also the relevant advice from ACRE (Advisory Committee on Releases to the Environment) (PDF) (80 KB)
• UK Opinion on application NL/98/11: Monsanto - glyphosate tolerant oilseed rape (Event GT73). For import only, not for cultivation in EU (25 March 2003) (PDF) (15 KB)
• UK Opinion on application ES/00/01: Monsanto - glyphosate tolerant maize (Event NK603). For import only, not for cultivation in EU (25 March 2003) (PDF) (45 KB)

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4. EU Decisions on Part C Marketing Applications

This section contains summaries of the draft Commission decisions that are to be considered by member states at the 2001/18 regulatory committee.

• EU Vote on application C/SE/96/3501: BASF Plant Sciences GM Potato (EH92-527-1) modified to enhance the starch content for import and use as any other potato grown for starch extraction with the exception of use as food and feed (PDF) (20 KB) (04 December 2006)
• EU vote on application C/NL/04/02: Florigene's GM carnation line 123.2.38 modified for petal colour and herbicide tolerance for import, distribution and retailing of cut flowers (PDF) (20 KB)(18 September 2006)
• EU Vote on application C/BE/96/01: Bayer Cropscience's glufosinate ammonium resistant oilseed rape (Ms8, Rf3 and Ms8xRf3) for import only, not for cultivation in the EU (5 December 2005) (PDF) (10 KB) (02 December 2005)
• EU Vote on application C/DE/02/09: Monsanto's corn rootworm resistant Maize (MON863 x MON810) for import only, not for cultivation in the EU (PDF) (10 KB) (19 September 2005)
• EU Vote on application NL/00/10: Pioneer & Mycogen Glufosinate and insect resistant Maize (1507) for import only, not for cultivation in the EU (PDF) (10 KB) (7 March 2005)
• EU vote on application C/DE/02/9: Monsanto insect resistant maize (MON863). For import only, not for cultivation or use as food in the EU (PDF) (10 KB)
• EU vote on application C/NL/98/11: Monsanto - glyphosate tolerant oilseed rape (GT73). For import only, not for cultivation in EU (PDF) (15 KB)
• EU vote on application ES/00/01: Monsanto - glyphosate tolerant maize (Event NK603). For import only, not for cultivation in EU (PDF) (15 KB)

5. Final outcome of part C marketing applications

This section provides a summary of final decisions on part C dossiers that have been considered under the 2001/18 regulatory process.

• Monsanto GM Maize Line MON 863 x MON 810 (PDF) (20 KB) (February 2006)
• Pioneer and Mycogen GM Maize Line 1507 (PDF) (20 KB) (January 2006)
• Monsanto GM Maize Line NK603 (PDF) (20 KB) (January 2006)
• Monsanto GM Oilseed Rape Line GT73 (PDF) (20 KB) (January 2006)
• Monsanto GM Maize Line MON 863 (PDF) (20 KB) (16 updated 31 August 2005)

Page last modified 20 November 2007
Page published 18 February 2003

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