Genetically modified organisms

Information

A Genetically Modified Organism is an organism whose genetic material has been altered. It usually involves adding genetic material into an organism’s genome to generate new traits. (A geonome is the complete genetic material of a living organism). The European Commission has developed a broad legislative framework to ensure that GMOs and GMO-derived products that are grown, marketed and imported to the EU meet certain safety standards.

The main legislation now in place is as follows:

• Directive 2001/18/EC on the deliberate release into the environment of GMOs: this applies to the experimental release of GMOs into the environment and the placing on the market of GMOs
• The placing on the market of GMO food and feed or food and feed products containing or consisting of GMOs is regulated by Regulation (EC) No 1829/2003 on genetically modified food and feed
• Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms governs unintentional transboundary movements of GMOs as well as exports of GMOs to third countries
• Directive 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified microorganisms (GMMs). This Directive regulates research and industrial work activities involving GMMs
• Labelling and traceability requirements are laid down in Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003
• There is also a range of legislation which provides for the implementation of these rules.

The GMO legislation provides that there must be an assessment of the risks to human health and the environment before any GMO or product consisting of, or containing GMOs can be released into the environment or placed on the market.

The other main features of the regulation of GMOs are:

• There is a system of monitoring of GMOs after they have been put on the market
• Public information must be provided
• Member states must ensure labelling and traceability at all stages of the placing on the market.

If a company wants to market GMOs, it must apply to the national authority in the first member state where the product is to be marketed. (In Ireland, this is the Food Safety Authority of Ireland). The compoany must include an environmental risk assessment with the application. If the national authority favours the application, it must tell the European Commission which then informs all the other member states. If there are no objections, the national authority gives consent and the product can be marketed in all the member states. If there are objections, the Scientific Committees are asked for their opinions. If these are favourable, the Commission proposes a Decision to the Regulatory Committee which is composed of representatives of the member states for opinion. If the Regulatory Committee gives a favourable opinion, the Commission adopts the Decision.

If not, the draft Decision is submitted to the Council of Ministers for adoption by qualified majority or rejection. If the Council does not act within 3 months, the Commission can adopt the decision.

EU provides public information about the process in each case.