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Overview of EU biotech food legislation

(Wednesday, July 2, 2003 -- CropChoice news) -- The following is an overview of the new European Union rules on genetically modified food and feed.

The new rules include a whole range of improvements compared to the current legal situation.

1. Authorisation instead of notification for GM food / feed All food and feed products which contain, consist of or have been produced from GMOs will in the future have to undergo a uniform and consistent authorisation procedure. GM food/ feed must not have adverse effects on human health, animal health or the environment. But also "other legitimate factors" will be taken into account by decision-makers. There will be a ten-year limitation on product approvals.

Product approval: for the first time feed produced from GMOs will require a pre-marketing authorisation.

The simplified fast-track notification procedure foreseen in the Novel-Food-Regulation for allegedly "substantially equivalent" GM food products, has been abandoned.

2. Dual-use authorisation requirement
Before products which are likely to be used as both food and feed may be placed on the market, a marketing authorisation covering both uses is required.

3. Exception from authorisation requirement: 0.5% for 3 years
While the Commission had suggested a tolerance level of 1% for the "adventitious or technically unavoidable" presence of traces of "not yet authorised GMOs", Council and Parliament agreed to halve this threshold; the threshold will also automatically expire after three years. Upon the expiry of these three years, zero-tolerance for unauthorised GMOs and GM materials will apply, as originally demanded by Parliament.

4. Monitoring
In the case of all food and feed products that contain or consist of live GMOs, post-marketing monitoring of environmental effects will be mandatory. The Community may require monitoring of (long-term) effects on human health in the case of all genetically modified food and feed products.

5. Mandatory labelling for all genetically modified food and feed
The current labelling rules (under which only GM products that contain DNA or protein resulting from a GMO have to be labelled) will be extended to include all genetically modified food and feed of GMO origin, irrespective of the detectability of DNA or protein. Thus products, such as highly refined GM soy oil and GM sugar, will have to be labelled under the new Regulation.

Mandatory labelling: for all GM food / feed products, including GM food/feed not containing any protein or DNA resulting from a GMO ( e.g sweeteners, oils). And: feed produced from GMOs. The meat production sector will finally get the possibility to avoid GM feed.

6. Exception from mandatory labelling
While the Commission had proposed to set a threshold for the labelling of products which contain "adventitious or technically unavoidable" traces of authorised GMOs in comitology, Parliament and Council have agreed on a ceiling of 0.9%. This labelling threshold may be reduced to take into account advances in science and technology. This new labelling threshold is a clear improvement compared to the current legal situation. The current deliberate release Directive (2001/18/EC) does not foresee any maximum labelling threshold but leaves this decision to the comitology procedure.

Member States may also take co-existence measures in order to avoid as far as possible any contamination (see below 9).

7. Mandatory labelling: ethical or religious concerns
Under the new Regulation the GM label will also indicate if a GM food or feed product may give rise to ethical or religious concerns.

8. Traceability
In the future GMOs as well as GM food and feed shall be traceable from cradle to grave. And as in the case of the new labelling scheme, GM products shall be traceable irrespective of whether the genetic modification is analytically detectable in the final product or not.

Traceability shall facilitate the monitoring and, where necessary, the withdrawal of GM products as well as the control of compliance with the labelling requirements.

9. Genetic contamination - Co-existence
At the core of the compromise are the new rules concerning genetic contamination. According to most lawyers, the current deliberate release Directive does not allow Member States to require producers or users of GMOs already authorised for marketing by the EU, to take measures which aim to prevent the genetic contamination of conventional or organic products. Under current law, not only the farmers concerned but also Member States seemed to have no other option than to let genetic contamination of conventional and organic products happen and to accept the economic damage caused by such GMO pollution.

The new co-existence rule, which will become part of the deliberate release directive, will explicitly allow Member States to take appropriate measures to avoid the unintended presence of GMOs in other products. The Commission will publish guidelines regarding "co-existence" and shall bring forward necessary proposals, including legislative proposals if there is a need.