Tools for risk assessment

European Food Safety Autority (EFSA) guidelines:

ICGEB Risk Assessment Searching Mechanism (RASM)

The Risk Assessment Searching Mechanism is an on line tool for the exchange of information on risk assessment on the deliberate release of LMOs into the environment for commercial purpose, in accordance with Article 10 of the Cartagena Protocol. It is operative since March 2002 and has been developed by ICGEB with the financial support of the Ministry for the Environment, Land and Sea Protection,
The RASM collects official documents, related to the official government decisions concerning the commercial release of GMOs worldwide, irrespective of the individual CBD signatory status.
From the appropriate drop-down menus it is possible to select the following research criteria about a LMO: taxonomical classification, OECD identifier or Company identifier, trait; gene; year (assessment date); country and type of authorised use.
RASM is associated to a mailing list which receives the notice of the insertion of new documents by providing shortcuts to facilitate research and consultation.

OECD Biosafety Bio-Track

The Biosafety Bio-Track is an online database developed by  the Organization for Economic Cooperation and Development (OECD) that provides information on products derived from the use of modern biotechnology, as well as some products with novel traits acquired by the use of conventional breeding or mutagenesis, that have been approved for commercial application in terms of food, feed or environmental safety in the OECD member countries.

Bibliosafety

Bibliosafety is a database developed by ICGEB with the financial support of the Ministry for the Environment, Land and Sea Protection. It shows almost all of abstracts and bibliographic references to the scientific referenced literature published since 1990 in the field of LMOs risk assessment. The articles received monthly by CABI International (Centre for Agricultural Bioscience International, link to http://www.cabi.org), are screened, classified and made available to the public in the Bibliosafety database. The database is also interoperable with the central portal of the Biosafety Clearing-House, hosted by the Convention on Biological Diversity.

Legislation

Union legislation

The European Union has adopted a regulatory framework on GMOs to ensure the necessary levels of safety for the environment and human health as provided by the Cartagena Protocol. In the European Union, GMOs are authorised for deliberate release into the environment for experimental and commercial purposes only after passing a rigorous risk assessment procedure according to the principles and methodology set out in directive 2001/18/EC, to avoid any possible negative effect, unintentional or undesirable, direct or indirect, on the environment and on human health. To know more

The Italian competent authority responsible for complying with requirements of directive 2001/18/EC is the Ministry for Environment and Land and Sea Protection.
  

Italian legislation

Legislative Decree 8 July 2003 n. 224, implementing directive 2001/18/EC, shall, in accordance with the precautionary principle, establish appropriate measures to protect human and animal health and the environment in case of:

  • deliberate release of GMOs for purposes other than placing on the market;
  • placing on the market of GMOs as such or in products. To know more

The Italian competent authority responsable for complying with requirements of legislative decree 8 July 2003, n. 224 is the Ministry for Environment and Land and Sea Protection.

Legislative decree 14 November 2016, no. 227 implementating directive (EU) 2015/412, amending directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) on their territory, amended legislative decree 8 July 2003, n. 224, introducing a mechanism that makes it possible to restrict or prohibit the cultivation of GMOs on Italian territory. To know more.

Pursuant to article 32 of legislative decree 8 July 2003, n. 224, decree of 8 November 2018 was issued adopting "The general plan for the surveillance of the deliberate release into the environment of GMOs".

For the sake of completeness of information it is usefull to mention the legislaton on the contained use of Genetically Modified Microorganisms (GMMO).
Legislative decree 12 April 2001, n. 206 establishes measures for the contained use of GMMOs to protect human health and the environment. The national competent authority is the Ministry of Health.

European Union legislation

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.

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.

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.