EU regulatory framework on biosafety: Decisions for the placing on the market of GMOs in accordance with Directives 2001/18/EC and 90/220/EEC

Since the entry into force of Regulation (EC) No. 1829/2003 on genetically modified food and feed, only a few dossiers relating to GMOs not intended for use as food and/or feed have been processed under Directive 2001/18/EC (for example, cut flowers, or a transgenic potato variety developed for the industrial production of amylopectin-enriched starch). Almost all the applications for marketing authorisation of transgenic plants are now submitted under Regulation (EC) No. 1829/2003, despite the fact that the legislation gives notifiers the possibility of splitting applications between the Regulation (for food/feed aspects) and the Directive (for cultivation aspects). Clearly, therefore, the notifiers prefer the single authorisation procedure ("one door – one key"), making it possible to submit a single application for authorisation for food and feed use, cultivation or deliberate release into the environment.

Graph: Evolution of the number of dossiers submitted under Directive 2001/18/EC (Directive 90/220/EEC before 2001). Source: SBB book.

The list of GMO approved for commercialisation in accordance with Directive 2001/18/EC or the previous Directive 90/220/EEC is provided below (all the links refer to Eur-lex, the electronic Official Journal of the EU - © European Union, 1998-2016).
Two GMOs only have been authorised for cultivation in the EU: Maize MON810 (1998) and Potato EH92-527-1 (2010). GM carnations are authorised for ornamental use only and cultivation is not allowed. The other GMOs in the list below are authorised for food and/or feed use and not for cultivation.

Placing on the market of GMOs under Directive 2001/18/EC

COMMISSION IMPLEMENTING DECISION (EU) 2015/694 of 24 April 2015 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 26407) genetically modified for flower colour (notified under document C(2015) 2768) (OJ L 112, 30.4.2015, p.52)
COMMISSION IMPLEMENTING DECISION (EU) 2015/692 of 24 April 2015 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 25958) genetically modified for flower colour (notified under document C(2015) 2765) (OJ L 112, 30.4.2015, p.44)
COMMISSION DECISION 2010/135/EU of 2 March 2010 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch (notified under document C(2010) 1193) (OJ L 53, 4.3.2010, p.11)
COMMISSION DECISION 2009/244/EC of 16 March 2009 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 123.8.12) genetically modified for flower colour (notified under document number C(2009) 1673) (OJ L 72, 18.3.2009, p.18)
COMMISSION DECISION 2007/364/EC of 23 May 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 123.2.38) genetically modified for flower colour (notified under document number C(2007) 2120) (OJ L 138, 30.5.2007, p.50)
COMMISSION DECISION 2007/232/EC of 26 March 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium (notified under document number C(2007) 1234) (OJ L 100, 17.4.2007, p.20)
COMMISSION DECISION 2006/47/EC of 16 January 2006 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., hybrid MON 863x MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize (notified under document number C(2005) 5980) (OJ L 26, 31.1.2006, p.17)
COMMISSION DECISION 2005/772/EC of 3 November 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium (notified under document number C(2005) 4192) (OJ L 291, 5.11.2005, p.42)
COMMISSION DECISION 2005/635/EC of 31 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate (notified under document number C(2005) 3110) (OJ L 228, 3.9.2005, p.11)
COMMISSION DECISION 2005/608/EC of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm (notified under document number C(2005) 2950) (OJ L 207, 10.8.2005, p.17)
COMMISSION DECISION 2004/643/EC of 19 July 2004 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance (notified under document number C(2004) 2761) (OJ L 295, 18.9.2004, p.35)

Placing on the market of GMOs under Directive 90/220/EEC

Carnation lines genetically modified for flower color have been approved for placing on the market on 20 October 1998 (consent issued by the Dutch competent authority in the absence of objections of other Member States authorities)
Carnation lines genetically modified for improved vase life have been approved for placing on the market on 20 October 1998 (consent issued by the Dutch competent authority in the absence of objections of other Member States authorities)
COMMISSION DECISION 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (OJ L 131, 5.5.1998, p.33)
COMMISSION DECISION 98/293/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC (OJ L 131, 5.5.1998, p.30)
COMMISSION DECISION 98/292/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line Bt-11), pursuant to Council Directive 90/220/EEC (OJ L 131, 5.5.1998, p.28)
COMMISSION DECISION 98/291/EC of 22 April 1998 concerning the placing on the market of genetically modified spring swede rape (Brassica napus L. ssp. oleifera), pursuant to Council Directive 90/220/EEC (OJ L 131, 5.5.1998, p.26)
NOTE: This GMO has been withdrawn from the market on 25 April 2007. see COMMISSION DECISION 2007/307/EC of 25 April 2007 on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products (OJ L 117, 5.5.2007, p.23)
Carnation lines genetically modified for flower color have been approved for placing on the market on 1st December 1997 (consent issued by the Dutch competent authority in the absence of objections of other Member States authorities)
COMMISSION DECISION 97/549/EC of 14 July 1997 concerning the placing on the market of T102-test (Streptococcus thermophilus T102), pursuant to Council Directive 90/220/EEC (OJ L 225, 15.8.1997, p.34)
COMMISSION DECISION 97/393/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF2), pursuant to Council Directive 90/220/EEC (OJ L 164, 21.6.1997, p.40)
NOTE: This GMO has been withdrawn from the market on 25 April 2007. See COMMISSION DECISION 2007/306/EC of 25 April 2007 on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products (OJ L 117, 5.5.2007, p.20)
COMMISSION DECISION 97/392/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF1), pursuant to Council Directive 90/220/EEC (OJ L 164, 21.6.1997, p.38)
NOTE: This GMO has been withdrawn from the market on 25 April 2007. See COMMISSION DECISION 2007/305/EC of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products (OJ L 117, 5.5.2007, p.17)
COMMISSION DECISION 97/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium, pursuant to Council Directive 90/220/EEC (OJ L 31, 1.2.1997, p.69)
NOTE: This GMO has been withdrawn from the market on 25 April 2007. See COMMISSION DECISION 2007/304/EC of 25 April 2007 on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products (OJ L 117, 5.5.2007, p.14)
COMMISSION DECISION 96/424/EC of 20 May 1996 concerning the placing on the market of genetically modified male sterile chicory (Cichorium intybus L.) with partial tolerance to the herbicide glufosinate ammonium, persuant to Council Directive 90/220/EEC (OJ L 175, 13.7.1996, p.25)
COMMISSION DECISION 96/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L.) with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 90/220/EEC (OJ L 107, 30.4.1996, p.10)
COMMISSION DECISION 96/158/EC of 6 February 1996 concerning the placing on the market of a product consisting of a genetically modified organism, hybrid herbicide-tolerant swede-rape seeds (Brassica napus L. oleifera Metzg. MS1Bn x RF1Bn), pursuant to Council Directive 90/220/EEC (OJ L 37, 15.2.1996, p.30)
NOTE: This GMO has been withdrawn from the market on 25 April 2007. see COMMISSION DECISION 2007/305/EC of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products (OJ L 117, 5.5.2007, p.17)
COMMISSION DECISION 94/385/EC of 8 June 1994 concerning the placing on the market of a product consisting of a genetically modified organism, seeds of herbicide-resistant tobacco variety ITB 1000 OX, pursuant to Article 13 of Council Directive 90/220/EEC (OJ L 176, 9.7.1994, p.23)
COMMISSION DECISION 93/572/EEC of 19 October 1993 concerning the placing on the market of a product containing genetically modified organisms pursuant to Article 13 of Council Directive 90/220/EEC (RABORAL vaccine) (OJ L 276, 9.11.1993, p.16)
COMMISSION DECISION of 18 December 1992 concerning the placing on the market of a GMO containing product, the vaccine Nobi-Porvac Aujeszky live (gI, tk), pursuant to Article 13 of Council Directive 90/220/EEC.
NOTE: This decision has been amended by the COMMISSION DECISION 94/505/EC of 18 July 1994. (OJ L 203, 6.8.1994, p.23)