FACTBOX: EU's legal labyrinth of GMO legislation

(Reuters) - European Union rules on genetically modified organisms (GMOs) are a legal labyrinth.

Several different procedures apply for authorizing 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 authorization have been updated and replaced since the bloc started its effective moratorium on authorizing 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 authorization 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 favorable 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 authorize 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 favorable, 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 authorizes 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 authorize the new GMO.

EUROPE'S GMO LAWS 1. Deliberate Release Law (Directive 2001/18):