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REGULATION & RISK ASSESSMENT: EU court clarifies conditions for emergency measures for GMO ban under market approval regulation



                                  PART 1


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TITLE:   COURT CLARIFIES CONDITIONS FOR EMERGENCY MEASURES

SOURCE:  Europolitics, Belgium

AUTHOR:  Anne Fekete

URL:     http://www.europolitics.info/sectorial-policies/court-clarifies-conditions-for-emergency-measures-art312388-11.html

DATE:    08.09.2011

SUMMARY: "A member state that wishes to adopt emergency measures that suspend and then temporarily ban the use or placing on the market of a GMO notified as an ?existing product? in keeping with Regulation 1829/2003 on genetically modified food and feed may only do so under the conditions established by this regulation [...] In such a case, the member state must officially inform the European Commission of the need to take emergency measures. [...] The state must also establish, in addition to the urgency, the existence of a situation that is likely to constitute a clear and serious risk to human health, animal health or the environment."

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COURT CLARIFIES CONDITIONS FOR EMERGENCY MEASURES

A member state that wishes to adopt emergency measures that suspend and then temporarily ban the use or placing on the market of a GMO (authorised by the EU) notified as an ?existing product? in keeping with Regulation 1829/2003 on genetically modified food and feed may only do so under the conditions established by this regulation, ruled the EU Court of Justice, on 8 September (1).

In such a case, the member state must officially inform the European Commission of the need to take emergency measures. If the Commission fails to act, the member state must inform it and the other member states immediately of the content of the interim measures adopted. The state must also establish, in addition to the urgency, the existence of a situation that is likely to constitute a clear and serious risk to human health, animal health or the environment. These measures may be adopted only if they are based on a risk assessment which is as complete as possible in view of the particular circumstances of the individual case, which indicate that measures are necessary.

The case concerns MON 810 maize, authorised by a Commission decision in April 1998 upon application by Monsanto Europe. This go-ahead was granted on the basis of Directive 90/220/EEC on the deliberate release into the environment of GMOs (repealed by Directive 2001/18/EC). In application of this decision, France gave its written consent to the placing on the market of this variety.

In July 2004, Monsanto notified MON 810 maize to the Commission as an ?existing product? under Regulation 1829/2003 and then applied for renewal of its authorisation on the basis of the same regulation. In 2007, France adopted an order suspending on its national territory the transfer and use of MON 810 seed, and in 2008, two orders prohibiting the cultivation of MON 810 seed.

Monsanto and other seed producers initiated actions for annulment of those measures before the French Council of State. In the course of those actions, the question arose of whether France could adopt emergency measures on the basis of Directive 2001/18/EC, which allows for the adoption of such measures by a member state directly and on its own initiative, or whether they should have been adopted on the basis of Regulations 1829/2003 and 178/2002, which allow a state to adopt emergency measures only once it has informed the Commission officially of the need to take such measures and the Commission has failed to act.

The ECJ ruled that, in such circumstances, a member state may not invoke the safeguard clause contained in Directive 2001/18/EC to adopt emergency measures.

Greenpeace EU policy adviser Stefanie Hundsdorfer said: ?Monsanto based this case on a technicality, which doesn?t change the fact that France and the six other countries banning MON 810 have the legal right to do so, given the scientific concerns about the crop?s safety. We urge France to improve the legal details of its ban as soon as possible?. n

(1) Joined Cases C-58/10 to C-68/10



                                  PART 2

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TITLE:   FRANCE INTENDS TO MAINTAIN MON810 BAN AFTER EU COURT RULING

SOURCE:  NASDAQ, USA

AUTHOR:  Dow Jones Newswires, USA, by James Fidler

URL:     http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201109081221dowjonesdjonline000573&title=france-intends-to-maintain-mon810-ban-after-eu-court-ruling

DATE:    08.09.2011

SUMMARY: "France intends to maintain its ban on the domestic cultivation of genetically-modified corn MON810 and will re-submit its application to prohibit the seed stock, French Ecology Minister Nathalie Kosciusko-Morizet said Thursday. [...] Kosciusko-Morizet said the decision to ban the crop ?remains valid at this stage and the prohibition of cultivation of varieties of GM maize MON810 continues on French territory.? She didn?t say when France would re-submit the decision to ban the crop."

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FRANCE INTENDS TO MAINTAIN MON810 BAN AFTER EU COURT RULING

BRUSSELS -(Dow Jones)- France intends to maintain its ban on the domestic cultivation of genetically-modified corn MON810 and will re-submit its application to prohibit the seed stock, French Ecology Minister Nathalie Kosciusko-Morizet said Thursday.

The European Court of Justice, Europe?s highest court, ruled earlier Thursday that the French government hadn?t followed the correct procedure in applying a ban. A European Commission spokesman later said France could re-submit the application using different regulations.

Kosciusko-Morizet said the decision to ban the crop ?remains valid at this stage and the prohibition of cultivation of varieties of GM maize MON810 continues on French territory.?

She didn?t say when France would re-submit the decision to ban the crop.

The seed patent for corn MON810 is owned by U.S.-based agro-biotech firm Monsanto Co..

Mark Buckingham, Europe public affairs spokesman for Monsanto, said the company was ?pleased that the arguments raised by French farmers and seed companies have been accepted by the court.?

In a February 2008 decision, France said MON810 maize was ?a serious risk to the environment.?

EU rules require that member states show a health risk or environmental threat to take emergency measures banning GMOs, which must be supported by the European Food Safety Authority.



                                  PART 3

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TITLE:   EU COURT SAYS FRENCH GM MAIZE BAN WAS ILLEGAL

SOURCE:  Thomson Reuters, USA

AUTHOR:  Charlie Dunmore & Julien Toyer

URL:     http://www.trust.org/alertnet/news/eu-court-says-french-gm-maize-ban-was-illegal

DATE:    08.09.2011

SUMMARY: "France acted illegally when it imposed a ban on the cultivation of a genetically modified (GM) maize variety developed by U.S. biotech giant Monsanto in 2008, Europe?s highest court ruled on Thursday. The French authorities did have the right to impose a moratorium on the growing of Monsanto?s insect-resistant MON810 maize, but based its decision on the wrong EU legislation, the Luxembourg-based European Court of Justice said."

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EU COURT SAYS FRENCH GM MAIZE BAN WAS ILLEGAL

- Says France based its decision on wrong EU legislation

- France says GMO maize ban still in place despite ruling

- Monsanto says allow French farmers choice to use the maize

LUXEMBOURG, Sept 8 (Reuters) - France acted illegally when it imposed a ban on the cultivation of a genetically modified (GM) maize variety developed by U.S. biotech giant Monsanto in 2008, Europe?s highest court ruled on Thursday.

The French authorities did have the right to impose a moratorium on the growing of Monsanto?s insect-resistant MON810 maize, but based its decision on the wrong EU legislation, the Luxembourg-based European Court of Justice said.

In reaction to the ruling, France said its embargo on MON810 maize was still valid and that it would restart a procedure if needed.

To impose such a ban, member states must demonstrate a potentially serious risk to human or animal health or the environment, and notify EU authorities of the need to take emergency measures, the court said.

Emergency measures must be based on science and backed by an assessment from the European Food Safety Authority (EFSA), according to the European Commission.

France imposed its safeguard clause against MON810 maize in February 2008, citing a ?serious risk to the environment.?

Six other EU countries -- Germany, Austria, Bulgaria, Greece, Hungary and Luxembourg -- have similar safeguard clauses in place.

Having tried and failed to force several EU countries to lift their cultivation bans, last year the Commission proposed letting member states decide themselves whether to grow or ban GM crop cultivation.

A spokesman for EU health and consumer commissioner John Dalli said talks on the proposal would continue, but France would have to abide by the court?s ruling.

?It?s now up to the French administrative court to decide whether to table a new safeguard clause,? the spokesman said.

French Environment Minister Nathalie Kosciusko-Morizet said the EU decision did not mean the end of France?s ban on the MON810 maize.

?If the French clause was annuled for procedure reasons, we would take a new safeguard clause under a procedure considered adequate by the European Court of Justice, because environmental questions remain unanswered,? she said in a statement.

A spokesman for Monsanto said the ruling confirmed its argument that the French authorities failed to follow the correct procedures when imposing the ban.

?Over the last 15 years, MON810 has proven agronomic, economic and environmental benefits and its safety has been confirmed consistently. French farmers should no longer be denied the choice to use it,? he said. (Reporting by Charlie Dunmore and Julien Toyer, additional reporting by Sybille de La Hamaide, editing by Rex Merrifield)



                                  PART 4

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TITLE:   EUROPE?S ANTI-GM NATIONS WARNED AGAINST UNILATERAL ACTION

SOURCE:  Expatica, France

AUTHOR:  Agence France Press, France

URL:     http://www.expatica.com/fr/news/french-news/europe-s-anti-gm-nations-warned-against-unilateral-action_174184.html

DATE:    08.09.2011

SUMMARY: "US biotech giant Monsanto scored points Thursday in a battle with GM sceptics in the EU, when Europe?s highest court warned against fresh unilateral action against genetically-modified crops. In a ruling targeting France in particular, the European Court of Justice said EU states in the future must notify the European Commission before banning GM crops. They must moreover provide evidence ?of a situation which is likely to constitute a clear and serious risk to human health, animal health or the environment?, the court added."

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EUROPE?S ANTI-GM NATIONS WARNED AGAINST UNILATERAL ACTION

US biotech giant Monsanto scored points Thursday in a battle with GM sceptics in the EU, when Europe?s highest court warned against fresh unilateral action against genetically-modified crops.

In a ruling targeting France in particular, the European Court of Justice said EU states in the future must notify the European Commission before banning GM crops.

They must moreover provide evidence ?of a situation which is likely to constitute a clear and serious risk to human health, animal health or the environment?, the court added.

The decision stems from a long-running bid by Monsanto to overturn a 2008 ban by France on genetically-modified MON 810 maize. But six other nations too have banned Monsanto maize -- Austria, Bulgaria, Germany, Greece, Hungary and Luxembourg.

The ruling, which is not legally binding, is to go before France?s highest administrative court for consideration.

But should the court, the Council of State, ratify the Luxembourg-based court?s decision, the government will have to scrap its so-called ?safeguard clause? against GM crops.

Environmental campaigners responded angrily to the move and French Environment Minister Nathalie Kosciusko-Morizet wasted no time in warning that should the ban be overturned by the court, ?we will introduce a new safeguard clause?.

?The European Court of Justice at no time raised the environmental and health risks posed by GMs. It simply raised concerns over procedure,? said Greens? European parliamentarian Jose Bove.

?We risk seeing GMs back in our fields from next spring,? said Greenpeace France director Sylvain Tardy.

GM lobby EuropaBio predictably welcomed the ruling ?as a step towards choice in Europe.?

?French farmers should no longer be denied the choice to use this GM maize,? it said in a statement.

The European Court of Justice?s opinion follows a series of battles between European Union nations with a distaste for GM crops and the biotech industry, and comes two days after a key ruling on honey containing traces of GM pollen.

The European Commission has been willing to let individual EU states ban GM crops, on certain grounds designed to get round World Trade Organization rules, but only if Brussels is notified first.

MON 810, which is used for animal feed and is resistant to certain parasites, is one of only two GM crops to have been authorised in the 27-nation European Union. The other is German group BASF?s Amflora potatoes, used to make paper.

The EU top court said that while France could adopt emergency measures, it should have applied a different set of EU rules.

?The member state must therefore inform the commission ?officially? of the need to take emergency measures,? the court said.

?If the commission fails to act, the member state must inform it and the other member states ?immediately? of the content of the interim measures which it has adopted,? it said.

In a separate ruling Tuesday, the court said that honey containing even tiny traces of pollen from GM maize could not be sold in the EU without prior authorisation.



                                  PART 5

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TITLE:   MIXED RESPONSE TO ECJ RULING ON GM CROPS

SOURCE:  The Parliament, Belgium

AUTHOR:  Martin Banks

URL:     http://www.theparliament.com/latest-news/article/newsarticle/mixed-response-to-ecj-ruling-on-gm-crops/

DATE:    08.09.2011

SUMMARY: "The European Court of Justice has ruled that a French ban on the cultivation of genetically modified crops is procedurally incorrect. The case concerned a French national ban on the cultivation of Monsanto?s genetically modified maize Mon810. In a key ruling on Thursday, the Court of Justice argued that France had based its ban on the ?wrong legislation?."

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MIXED RESPONSE TO ECJ RULING ON GM CROPS

The European Court of Justice has ruled that a French ban on the cultivation of genetically modified crops (GM) is procedurally incorrect.

The case concerned a French national ban on the cultivation of Monsanto?s genetically modified (GM) maize Mon810.

In a key ruling on Thursday, the Court of Justice argued that France had based its ban on the ?wrong legislation?.

In February 2008, the French government banned the cultivation of Mon810.

Days later, Monsanto, Pioneer, the French association of maize producers and seed producers started legal proceedings against the measure before the Conseil d?Etat, the highest French administrative court.

The Conseil d?Etat referred the case to the EU court.

On Thursday, the top legal advisor to the ECJ, advocate general Paolo Mengozzi, said that only the EU itself could institute such bans and that the French government did not have the authority to adopt the ban.

Mengozzi also said that risks involved ?cannot be considered as hypothetical?.

Other European countries with a ban on the cultivation of Mon810 are Germany, Austria, Hungary, Greece, Luxembourg and Bulgaria.

The court decision was met with a mixed response.

Greenpeace EU policy adviser Stefanie Hundsdorfer said, ?Monsanto based this case on a technicality, which doesn?t change the fact that France and the six other countries banning Mon810 have the legal right to do so, given the scientific concerns about the crop?s safety.

?We urge France to improve the legal details of its ban as soon as possible.?

But the organisation EuropaBio, the European association for bioindustries, welcomed the ruling as a ?step towards choice in Europe?.

Carel du Marchie Sarvaas, EuropaBio?s director of green biotechnology Europe, said, ?French farmers should no longer be denied the choice to use this GM maize.

?The ECJ ruling has confirmed the arguments raised by the French farmers and seed companies that the 2008 French government order suspending Mon810 use by French farmers did not follow applicable procedural regulations.

?In addition, the ECJ indicated that any measures can be invoked only in case of the existence of the situation which is likely to constitute a clear and serious risk to human health, animal health or environment.

?Over the last 15 years, this GM maize has been cultivated worldwide and has proven agronomic, economic and environmental benefits. Its safety has been consistently confirmed.?

She added, ?The ECJ has given a clear verdict today: EU member states cannot ban GM based on myths and hearsay.

?In fact, French farmers had three years of experience planting GM crops prior to this ban.

?European scientists have shown again and again that GM crops pose no risk to health or the environment and, in fact, have health, socio-economic and environmental benefits.

?After all, they are grown on nearly 150 million hectares worldwide by over 15 million farmers, 90 per cent of whom are resource-poor farmers working in developing countries.?