The GM authorisation story so far...

In 1998, a number of EU Member States expressed concern at the inadequancy of the appraisal procedures for GM products. They requested the EU Commission to develop a risk evalaution procedure to determine the safety of each GM product (e.g. food, animal feed of crop) prior to it being sold within the EU.

Pending the completion of such a procedure, a 'de facto' moratorium was placed on the authorisation of new GM products across the EU and as a consequence no new GM food, feed or crop variety was approved until the risk evaluation procedure was fully operational.

The EU Commission reponded to these concerns by introducinng a series of legislative measures in the period 1998 to 2003. These measures formed the framework for the present day GMO evalation process which is designed to address all food safety and/or environmental concerns through a precautionary, science based, case-by-case approach to regulatory approval process for all GMOs across Europe.

The strenghtened regulatory process has now been adopted by all EU Member States including Ireland. The main aspects of this legislation are outlined as follows:

Directive 2001/18/EC - deliberate release of GMOs into the environment

This Directive applies to two types of activities:

1. The experimental release of GMOs into the environment for experimental purposes (e.g. in connection with field tests)
2. The placing on the market of GMOs (products containing or consisting of GMOs) for cultivation, import or processing into industrial products

Directive 2001/18 puts in place a step-by-step approval process, baced on a case-by-case assessment for the risks to human health and the environment before any GMO or product consisting of, or containing a GMO, can be relaesed into the environment or placed on the market.

European Commission Recommendation 2003/556/EC - coexistence

Recommendation 2003/556 lays down guidelines for the development of national strategies and best practices to ensure the effective coexistence (or segregation) of GM, conventional and organic crop systems.

EU Regulation 1829/2003 - food and feed

1829/2003 sets down the authorisation procedure and labelling and traceability requirements for GM food and feed. In addition, it updates the provisions of EU Regulation 258/97 concerning novel foods and novel food ingredients.

EU Regulation 1830/2003 - traceability and labelling

1830/2003 sets down the requirements for the traceability and labelling of GM products, including food and feed products derived from GM crops.

EU Regulation 1946/2003

1946/2003 relates to the trans-border movement of GM crops and sets down procedures on prior informed consent in relation to the exportation of GM products as provided for in the Cartagena Prrotocol.

Directive 98/95/EC

This directive amends the various seeds marketing directives, sets down certain conditions for the marketing of seed of GM varieties, in particular that the GM event must have received authorisation under the appropriate procedures above and that packages of the seed must be clearly labelled as being GM.

All the above legislation lays down the conditions which, for example, a company or university research department must satisfy before being allowed to develop, use or market a GMO or a food product derived from GMOs (see the illustration below or view the Authorisation Process in Motion)

It is important to note that in addition to the above legislation, a GM crop/product may also have to satisfy other non-GM regulatory procedures. For example any new GM crop variety (like a new conventional variety) must undergo variety testing and receive a positive VCU (Value for Cultivation and Use) approval before being submitted into the Irish National Catalogue of Agricultural Plant Varieties and/or the EU Common Catalogues

For full details concerning the above Directive and Regulations visit the website of the European Commission

Acknowledgement:

• 'Authorisation Process in Motion' animation was generously supplied by GMO Compass.