GMO COMPASS - Information on genetically modified organisms
  Jul 20, 2008 | 1:59 am
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EU-Law Overview

The Two Laws Governing Genetically Modified Plants

There are two different set of rules governing the authorisation of genetically modified products in the EU: one is for the use of GM plants, while the other is for food and feed made from them.

 
EU-Regulation Directive on the Deliberate Release into the Environment of Genetically Modified Organisms (2001/18) Regulation on Genetically Modified Food and Feed (1829/2003)
Scope of application Commercial use of a GM plant (that is able to reproduce); release into the environment involved with growing the plant or importing plant material Food and feed that was made from or contains GM plants
In effect since 17 April 2001 19 April 2004

Adoption by federal governements

 Deadline expired on 17 October 2002 not needed; regulations directly apply to all Member States
Former regulations Release Directive (90/220) Regulation on novel foods (258/97)
Safety requirements No harmful effects on humans or environment (environmental impact assessment) No harmful effects on human or animal health or on the environment

not mislead the consumer
Requirements for authorisation Scientific safety assessment

Standardised method for detecting the GMO

Monitoring

 Scientific safety assessment: just as safe as a comparable conventional product

Labelling

Detection Method

Post-market monitoring (not mandatory)
Proceedings* Submit application to federal authorities

Initial assessment (scientific opinion) by national agencies

Documents forwarded to the national authorities of the Member States and to the European Commission

In the case of objections and open questions:Safety assessments at the EU level (EFSA)

 Application submitted to the European Food Safety Authority (EFSA)

scientific evaluation from expert committee

recommendation made by EFSA
Decision for authorisation Draft for decision from the European Commission

Vote in the "Standing Committee for the Food Chain and Food Safety" (Member States): The European Commission's draft may be accepted or rejected with a qualified majority.

If no qualified majority can be reached, the European Commission submits its draft to the Council of Ministers.

Vote in the Council of Ministers: Approval or rejection by qualified majority - without qualified majority the Commission's draft takes effect.

Authorisation expires after: 10 Years 10 Years
Existing authorisations granted based on old regulations Existing authorisations remain in effect. Processes pending that were begun when old regulations (90/220) were still in effect will be completed according to the new regulations. Applications must be supplemented with additional information. Authorised products of GMOs can be considered "existing products" after providing some additional information. The authorisation must be renewed within nine years from the original date of authorisation.

 

Comments:

* Applications seeking authorisation according to the directive on the deliberate release into the environment of genetically modified organisms (2001/18) may select one of two options: Along with the possibility outlined above (submitting application to federal authorties), applicants may submit an application directly to EFSA. The proceedings would then continue according to regulation 1829/2003.

See also on GMO Compass:

 
February 15, 2006 [nach oben springen]

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