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):

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 Labeling Law (Regulation 1830/2003):

These are the EU's most recent laws on GMO authorizations and came into full effect across the bloc on April 18, 2004.

They set down criteria and standardized procedures for evaluating potential risks, as well as rules on Labeling feed that consists of GMOs, contains GMOs or is produced from GMOs.

All GM feed and foods produced from GMOs -- including those that do not contain GM material in the final product -- must be labeled.

This applies, for example, to biscuits made from GM maize, refined soyoil made from GM soybeans, and corn gluten feed made from GM maize. The threshold for Labeling products where there is presence of an EU-authorized GMO product is 0.9 percent.

If there is presence of GMOs that have not yet been EU-approved but do have a positive EFSA safety assessment, then the threshold is 0.5 percent. Above that level, the product may not be put on the market.

However, there is no requirement to label products such as meat, milk or eggs that are obtained from animals fed with modified feed or treated with modified medicinal products.

SEEDS (Directive 98/95)

EU rules on biotech seeds date from December 1998 and are long overdue for an update. However, EU states disagree over the Commission's proposed thresholds for GMO presence in organic and conventional seeds -- and the thresholds are being redrafted.

Currently, they are a 0.3 percent GMO limit for organic and conventional rapeseed, 0.5 percent for maize and 0.7 percent for soybeans. Conventional seeds that contain genetically modified seeds below these thresholds would not have to be labeled.

Two separate committees have been discussing the thresholds: the EU's environment committee under the Deliberate Release law, and the seeds committee under separate seeds legislation. But there has been little progress for several years.

At present, national authorities that have agreed to the use of a seed on their territory must notify the Commission, which examines the information supplied.

If the Commission approves, it includes the variety in the "Common Catalogue of varieties of Agricultural Plant Species" which means the seed can be marketed throughout the EU.

However, the seeds law also requires that biotech seeds must also be authorized under the Deliberate Release law before they are included in the Catalogue and marketed in the EU.

COEXISTENCE: THE LAST PIECE OF THE JIGSAW

In July 2003, the Commission issued guidelines on how farmers should separate organic, conventional and biotech crops, to ensure that these crop types can be safely grown alongside each other with a minimal risk of cross-pollination.

But rather than pushing for EU-wide legislation, demanded by some countries, it wants EU states to use national laws. As of early 2008, 15 countries had notified coexistence laws, and these must be endorsed by the Commission before they can proceed further. Of these, seven states have adopted actual legislation.

The Commission guidelines refer, for example, to isolation distances between crops, buffer zones and pollen barriers such as hedgerows. They also advise on cooperation between farmers on sowing plans and crop varieties with different flowering times.

The issue is highly controversial as the main problem for countries will be how to determine economic liability. When does a farmer growing GM crops have to pay if a neighbor complains of organic crops being contaminated?