Introduction

A Genetically Modified Organism (GMO) is an organism whose genetic material has been altered either by adding or deleting certain traits. 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
• Regulation EC 65/2004 on establishing a system for development & assignment of unique identifiers for GMOs
• 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.

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.

The Food Safety Authority of Ireland (FSAI) is the competent authority for the implementation of legislation governing genetically modified (GM) food. It ensures that only EU-authorised genetically modified foods are allowed on the market and that they are labelled appropriately.

The Department of Environment, Climate and Communications and the Environmental Protection Agency (EPA) are responsible for the environmental aspects of GM technology, including contained use, crop trials and the placing on the market of GM crops for general cultivation purposes.

The seed certification division of the Department of Agriculture, Food and the Marine (DAFM) works with the EPA in respect of GM seed regulation, while the animal feed section of DAFM regulates the importation and use of GM feed.

The use of GMOs in medicines and pharmaceuticals is the responsibility of the Health Products Regulatory Authority (HPRA).

The European Commission website provides information on all aspects of GMOs, their use and regulation in food and in feed.