Several different procedures apply for authorising a biotech product, depending on the uses that the manufacturer specifies in its request for EU approval. The most common requests are for cultivation, use in food that is destined for human consumption, use as an ingredient in food following industrial processing, and in animal feed.
Some of the most important laws on authorisation have been updated and replaced since the bloc started its effective moratorium on authorising new gene crops and products in 1998.
There are other laws for instance covering contained use (such as in research laboratories) and transboundary movement; and to assign unique identifiers to GMO products.
Here is a simplified guide to the GMO legislation and authorisation process:
APPLICATION PROCEDURE
A company that intends to market a GMO must:
1. apply to the competent national authority of the EU member state where the product will first be placed on the market, and include a full risk assessment.
2. if the authority gives a favourable opinion, the member state informs other member states via the European Commission.
3. if there are no objections by other member states, the notifying state or its national food safety authority may authorise the product for marketing throughout the EU.
4. if there are objections which are sustained, a decision is needed at EU level and the following procedure is initiated:
- depending on the law used, the Commission asks a committee of member state scientists or the independent European Food Safety Authority for an opinion.
- if the opinion is favourable, the Commission submits a draft decision to a regulatory committee of either food safety or environment experts from the member states. If they agree, the Commission adopts the decision, and authorises the new GMO.
- if the committee does not agree, the Commission sends its draft approval to the Council of Ministers, likely to be either agriculture or environment ministers, who have three months to reject or adopt it. If they do not act within this time, the Commission may adopt its own decision and authorise the new GMO.
EUROPE'S GMO LAWS
1. Deliberate Release Law (Directive 2001/18):
This is the EU's main GMO law, dating from October 2002. First approvals under this law are limited to 10 years maximum.
The law covers any environmental release of products that contain or consist of GMOs. This includes GMO products for planting, as well as those for use in feed and processing.
The law also has a "safeguard clause" whereby a member state may provisionally restrict or prohibit the use of a GMO on its territory if it has cause to consider that an approved GMO product poses a risk to human health or the environment.
This clause has been invoked at least 10 times; usually, the Commission rules that the restrictions must be withdrawn.
2. Novel Foods Law (Regulation 258/97):
This law dates from January 1997 and covers food products and food ingredients derived from GMOs -- such as flour, starch or oil from a GM maize, paste or ketchup from a GM tomato. Only products deemed safe for human consumption may be marketed.
The law has a special procedure for foods derived from GMOs but no longer containing them. If a food is "substantially equivalent" to existing foods or ingredients, the company may notify the Commission itself (with a scientific justification).
This law has now been replaced by the GM Food and Feed Regulation. Only those products with a risk assessment issued before the new regulation came into force in 2004 -- currently four -- may still be processed under the Novel Foods law.
3. GM Food and Feed Law (Regulation 1829/2003) and GMO Traceability and Labelling Law (Regulation 1830/2003):
These are the EU's most recent laws on GMO authorisations and came into full effect across the bloc on April 18, 2004.
They set down criteria