Commission Notice (2021/C 80/01) on the submission of notifications under Articles 13 and 17 of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC and under the relevant provisions of Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381.

Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC.

Directive 2001/18/EC (consolidate text 2021 of 27 March 2021) of the European Parliament and the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.

Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19).

Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC.

Regulation (EU) 2019/1243 of the european Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union.

Commission implementing Regulation (EU) 2019/723 of 2 May 2019 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States.

Commission Implementing Decision (EU) 2018/1790 of 16 November 2018 repealing decision 2002/623/EC establishing guidance notes on the environmental risk assessment of genetically modified organisms.

Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms.

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/ EC and Council Decision 92/438/EEC (Official Controls Regulation).

Directive (EU) 2015/412 of the European Parliament and of the Council of the European Union, of 11 March 2015 amending directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory.

Regulation (EC) No 503/2013, of 3 April 2013, on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006.

Regulation (EU) No 619/2011 of the Commission of 24 July 2011, laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.

Recommendation 2010/C/200/01 of the Commission of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops.

Decision 2009/770/EC of the Commission of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council.

Directive 2008/27/EC of the European Parliament and the Council of the European Union, of 11 March 2001, amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission.

Decision 2005/463/EC of the Commission of 21 June 2005 establishing a network group for the exchange and coordination of information concerning coexistence of genetically modified, conventional and organic crops.

Recommendation 2004/787/ECof the Commission of 4 October 2004 on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as such or contained in products in the context of Regulation (EC) No. 1830/2003.

Regulation (EC) n. 2004/882 of the European Parliament and the Council of April 29, 2004, on official controls performed to ensure the compliance with feed and food law, animal health and animal welfare.

Regulation (EC) n. 641/2004 of Commission of 6 April 2004, on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.

Decision 2004/204/EC of the Commission of 23 February 2004 laying down detailed arrangements for the functionality of the registers mode for recording information on genetic modifications in GMOs under Directive 2001/18/EC of the European Parliament and the Council.

Regulation (EC) no. 65/2004of the Commission of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.

Decision 2003/701/EC of the Commission of 29 September 2003, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, laying down the format for presenting the results of the deliberate release of genetically modified higher plants for other purposes than marketing.

Regulation (EC) n. 1946/2003 of the European Parliament and the Council of 15 July 2003 on transboundary movements of genetically modified organisms.

Regulation (EC) n. 1830/2003 of the European Parliament and the Council of 22 September 2003 on the traceability and labeling of genetically modified organisms, as well as amending Directive 2001/18/EC.

Regulation (EC) n. 1829/2003of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed.

Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC.

Decision 2002/813/EC of the Council of 3 October 2002, pursuant to Directive 2001/18/EC of the European Parliament and of the Council laying down the template for the synthesis of the notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than marketing.

Decision 2002/812/EC of the Council of 3 October 2002, pursuant to Directive 2001/18/EC of the European Parliament and of the Council lays down, the template for the synthesis of the placing on the market of genetically modified organisms as such or in products.

Decision 2002/811/ECof the Council of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms and repeals Directive 90/220 / EEC Council.

Decision 2002/623/EC of the Commission of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repeals Council Directive 90/220/EEC Council.

Regulation (EC) no 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

Directive 2001/18/EC of the European Parliament and the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.