Table 1.
Existing guidelines and regulatory framework for MC, FF and ERA
| References | Title |
|---|---|
| Directive 2001/18/EC | Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (a) |
| Regulation No. 1829/2003 | Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (b) |
| EFSA GMO Panel (2010) | Guidance on the environmental risk assessment of genetically modified plants |
| EFSA GMO Panel (2011a) | Guidance for risk assessment of food and feed from genetically modified plants |
| EFSA GMO Panel (2011b) | Guidance on the Post‐Market Environmental Monitoring (PMEM) of genetically modified plants |
| EC Regulation No. 503/2013 | Commission Implementing Regulation (EU) 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 (c) |
| EFSA GMO Panel (2015) | Guidance on the agronomic and phenotypic characterisation of genetically modified plants (ERA) |
| Guidance on Uncertainty Analysis in Scientific Assessments | |
| EFSA GMO Panel (2017) | Guidance on allergenicity assessment of genetically modified plants |
| Commission Directive 2018/350 | 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 (d) |
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ‐ Commission Declaration. OJ L 106, 17.4.2001, p. 1–39.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
Commission Implementing Regulation (EU) 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. OJ L 157, 8.6.2013, pp. 1–48.
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.