GENET archive


6-Regulation: Court rules on member state rights over GMO approvals

----------------------------- GENET-news -----------------------------

TITLE:  Court rules on member state rights over GMO approvals
SOURCE: Reuters
DATE:   March 22, 2000

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Court rules on member state rights over GMO approvals

LUXEMBOURG - The European Court of Justice ruled yesterday that 
France had no right to block the sale of three genetically modified 
(GM) crop strains after they had been approved at European Union 
level. The case dates back to 1998, when the French government - 
faced with mounting public opposition to new GM crop varieties - 
declined to ratify an EU decision clearing new types of maize 
developed by Swiss life sciences group Novartis.

The court said GMOs approved by European Union countries and the 
European Commission may be withheld from the market if new 
information calls into question the safety of such foods. "New 
information indicating that a GMO constitutes a risk for human health 
and the environment allows the procedure for placing a GMO on the 
market to be stopped pending a fresh Commission decision," the court 

The court told France it could not unilaterally withdraw approval for 
a Novartis maize developed to resist corn borers (ZEA mays L) 
approved by France in 1998, but said it could ask the Commission to 
re-take its decision based on new information. The court's decision 
confirms that once a member state has approved a GMO, it is the EU 
institutions and not that member state which has the authority to 
decide whether that GMO will be approved for sale.

"A member state which has forwarded an application with a favourable 
opinion must authorise the GMO to be placed on the market after the 
Commission has adopted a favourable decision. ... Nevertheless...the 
member state may not give its consent to the placing of a product on 
the market if new information reveals a risk after the Commission has 
adopted its decision," the court said in a statement. "In that case, 
it must inform the Commission which must then adopt a fresh decision 
in the light of that new information."

In fact the court said any member state which has justifiable reasons 
to consider that a GMO constitutes a risk may restrict or prohibit 
use of the product on its territory but then must inform the 
Commission it has taken this step. The court reminded GMO producers 
that they too have the responsibility to "immediately inform the 
competent national authority of any new information enabling a better 
assessment to be made of the product's risk to human health and the 
environment." The court's decision makes the point that it is the 
responsibility of the member state which submits a favourable opinion 
in the first place to assess the risks of a GMO.

An application to approve the controversial transgenic maize which 
carries an ampicillin resistant tracer gene was first submitted by 
France with a favourable opinion and other member states had the 
opportunity to submit objections at that time. According to the 
court, this procedure provides sufficient precaution as any 
objections can and will be vetted by expert EU scientific committees 
as well as other competent national authorities.

After the French government gave the Swiss group Novartis approval to 
sell its genetically modified maize in 1998, Greenpeace challenged 
that decision before the French court as procedurally flawed and 
submitted new evidence to support a claim that the maize posed real 
health risks.

Greenpeace argued France had ignored the "precautionary principle"-a 
measure championed by France that allows authorities to restrict 
products without scientific certainty of harm. The French court found 
Greenpeace's supporting information compelling enough to suspend 
France's approval of the maize and asked the Euro court to rule on 
the margin of discretion left to France to restrict a GMO approved 
under European legislation.

Additionally, the Euro court said that if a French court finds that 
the original favourable opinion submitted by France to the European 
Commission was reached by a flawed examination of the GMO, that 
national court must refer the matter to the European Court of 
Justice. "The Court of Justice alone has competence to rule on the 
legality of a Community act. If there proves to have been an 
irregularity in the procedure at national level, the court could 
annul the Community decision which led to national consent being 
given," the court said in a statement. This case will now go back to 
the French court, the Conseil d'Etat, for a ruling in the case 
between Greenpeace and French Ministry of Agriculture.


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