Laws and Regulations

All functions pursuant to the Cartagena Protocol on Biosafety

2002/811/EC: Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII 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 repealing Council Directive 90/220/EEC

All functions pursuant to the Cartagena Protocol on Biosafety

2002/812/EC: Council Decision of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products

All functions pursuant to the Cartagena Protocol on Biosafety

2002/813/EC: Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market

All functions pursuant to the Cartagena Protocol on Biosafety

Biosafety Co-ordinating Committee Regulations, 2002 (L.N. 290 of 2002 )

LMOs for direct use as food, Intentional introduction into the environment (AIA), LMOs for direct use as feed, LMOs for processing

Commission Decision 2009/770/EC establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms

Public awareness and participation, Competent National Authorities and National Focal Points, Information Sharing, Intentional introduction into the environment (AIA), Confidential Information

Commission Decision of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council

Human and/or Animal Health, Competent National Authorities and National Focal Points, Intentional introduction into the environment (AIA), Risk assessment and management, Handling, transport, packaging and identification

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

Public awareness and participation, Competent National Authorities and National Focal Points, LMOs for direct use as food, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, LMOs for direct use as feed, LMOs for processing

Commission Implementing Regulation (EU) No 120/2014 of 7 February 2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the Community reference laboratory for genetically modified organisms

Transboundary movement (import/export), Public awareness and participation, Human and/or Animal Health, Competent National Authorities and National Focal Points, LMOs for direct use as food, Unintentional transboundary movements and emergency measures, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, Illegal transboundary movements, LMOs for direct use as feed, LMOs for processing

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

Transboundary movement (import/export), Risk assessment and management, Handling, transport, packaging and identification

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

Competent National Authorities and National Focal Points, LMOs for direct use as feed, LMOs for processing

Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed

Public awareness and participation, Competent National Authorities and National Focal Points, LMOs for direct use as food, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, LMOs for direct use as feed, LMOs for processing

Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms

Public awareness and participation, Competent National Authorities and National Focal Points, LMOs for direct use as food, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, LMOs for direct use as feed, LMOs for processing

Commission Regulation (EC) No 641/2004 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

Information Sharing, Handling, transport, packaging and identification

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

Transboundary movement (import/export), Handling, transport, packaging and identification, LMOs for direct use as feed

Commission Regulation (EU) No 619/2011 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

Contained use, Transit

Contained Use of Genetically Modified Micro-Organisms Regulations, 2008 (L.N. 127 of 2008 as amended by L.N. 265 of 2010 and repealing L.N. 169 of 2002))

All functions pursuant to the Cartagena Protocol on Biosafety

Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety

LMOs for direct use as food, Handling, transport, packaging and identification, LMOs for direct use as feed, LMOs for processing

Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products

Contained use, Risk assessment and management

Decree of the Ministry of Social Affairs and Health on principles of risk assessment of the contained use of genetically modified micro-organisms, on classification of the contained use, and on containment and other protective measures (1053/2005)

Intentional introduction into the environment (AIA), Risk assessment and management, LMOs for processing

Decree of the Ministry of Social Affairs and Health on the deliberate release of genetically modified organisms ( 110/2005)

Simplified Procedure, Intentional introduction into the environment (AIA), field trials

Decree of the Ministry of Social Affairs and Health on the differentiated procedure relating to the deliberate release of genetically modified organisms (90/2005)

Transboundary movement (import/export), Public awareness and participation, Intentional introduction into the environment (AIA), Pharmaceuticals, Risk assessment and management, Handling, transport, packaging and identification

Deliberate Release into the Environment of Genetically Modified Organisms Regulations, 2010 (L.N. 485 of 2010 repealing L.N. 170 of 2002)

Public awareness and participation, Human and/or Animal Health, Competent National Authorities and National Focal Points, Intentional introduction into the environment (AIA), Transit, Unintentional transboundary movements and emergency measures, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, Illegal transboundary movements

Directive (EU) 2015/412 of the European Parliament and of the Council 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

Public awareness and participation, Human and/or Animal Health, Competent National Authorities and National Focal Points, Intentional introduction into the environment (AIA), Transit, Unintentional transboundary movements and emergency measures, Confidential Information, Risk assessment and management, Handling, transport, packaging and identification, Illegal transboundary movements

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

Competent National Authorities and National Focal Points, Pharmaceuticals, Risk assessment and management

Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use