Authorization of the GMO in the European Union

The European Union authorizes the marketing of a Organisme genetically modified according to the défines criteria by the Community directing 2001/18/CE, relating to the voluntary dissemination of genetically modified organizations in the Environnement.

General information

As of the beginning of the year 1990, the European Union installed a regulation framework for the GMO, which is always in the course of evolution. The objective of this Community legislation is to make compatible the creation of a single European market of the Biotechnologies with the protection of the public health and the respect of the environment.

The scopes of application of this regulation are the following:

the confined use of micro-organisms genetically modified in research and industry. This east field governs by the directive 90/219/CE, modified by the directive 98/81/CE of the Council.

disseminations on an experimental basis and marketings of GMO. The directive 90/220/CEE was into force until October 17th, 2002 in this field. It was repealed on this date to be replaced by the Directive 2001/18/CE relating to the voluntary dissemination of genetically modified organizations. At the beginning of 2004, this new directive was not transcribed yet in the French right.

the traceability of the genetically modified organizations and their food derivatives for the intended products with human or animal consumption. The Règlement 1830/2003/CE concerning this traceability of the GMO is applicable since April 18th, 2004. It sets up the obligation of traceability of the food GMO and their derivatives throughout the dies, except the cases of fortuitous presence.

the labelling of the foodstuffs and feedingstuffs containing of the organizations genetically modified or produced starting from such organizations. The Payment 1829/2003/CE of the European Parliament and the Council of September 22nd, 2004 concerning the foodstuffs and feedingstuffs genetically modified, applicable since April 18th, 2004, envisages new rules of labelling for the food die (see paragraph hereafter). It fixes in particular a threshold of fortuitous presence of 0,9% below which labelling is not obligatory. Previously, the presence of derivative products of the GMO in food was framed by the payment n° 258/97/CE of January 27th, 1997 relating to new food and the new food ingredients. It related to for example the concentrate or the Ketchup obtained starting from genetically modified Tomate S.

the authorization of the drugs intended for the man and the animals is governed by the payment n° 2309/93, which also covers the derivative products of the GMO. This text establishes the Community procedures for the authorization and the monitoring of these drugs.

the protection of workers against the risks is governed by the directive 90/679/CE. This one relates to the protection of workers against the risks related to the exposure to biological agents to work, and it regulates the GMO as well as other biological agents.

Community legislation of the marketing of the GMO

The procedure of voluntary authorization of dissemination and marketing of the genetically modified organizations is fixed by the Directive 2001/18/CE of March 12th, 2001, to replace the directive 90/220/CE. This new regulation:

introduces more rigorous principles into the evaluation of the risks for the environment,
clarifies and extends the criteria of evaluation of the risks,
limit the duration of the renewable authorization at 10 years,
introduces a posterior obligatory monitoring with the marketing authorization,
improves the transparency by an obligation to consult the public,
obliges the European commission to publish every three years a report on the experiment relating to the marketings.

Associations estimate however that the procedures envisaged by the Directive 2001/18/CE are still insufficient to evaluate and limit the risks related to the marketing of the GMO.

In France, the transposition in the national right of the Directive 2001/18/CE was not made yet, which raises problems compared to the development of the commercial cultures of GMO.

Authorized genetically modified plants

Decisions of marketing authorization

The European commission authorized the marketing of Maïs, of Colza, Soja, eyelet S, of Chicorée and Tabac Transgénique S. These authorizations relate more precisely to events of transformation, and they allow putting into circulation of corresponding harvests of plants genetically modified in the food circuts.

On the whole, between October 1991 and January 2004, the European Union granted 18 marketing authorizations of GMO, including 16 concerning GMO intended to be used in the food products. No authorization was delivered since October 1998, whereas 13 requests were under examination during abrogation of the directive 90/220/CEE and its replacement by the Directive 2001/18/CE, governing these marketings.

In January 2004, the European commission received 22 notifications relative to requests for marketings of GMO, pursuant to the Directive 2001/18/CE.

Concerning the Corn Transgénique, the authorizations delivered by the European commission are the following ones:

Decision 97/98/CE of the 1/23/1997 : event of transformation LT 176 conferring resistance to the European corn borer.

In France, the decree of the 2/5/1998 registered with the official catalog three varieties of Maïs Transgénique: César Cb, Furio Cb, Occitan Cb of the company Novartis Seeds. The Council of State suspended then restored the validity of this decree.
the decree of the 8/3/1998 registered 6 additional varieties in France: Benji (late grain ½), Garonna (early ensilage), Navarès (very early ensilage), Pactol Cb (early grain ½), Seven (late grain), Odyssey (late grain ½) of the company Novartis Seeds.

Decision 98/294/CE of the 4/22/1998 : event of transformation MY 810 conferring resistance to the European corn borer. In France, the decree of the 8/3/1998 registered with the official catalog six varieties of Maïs Transgénique:

Obtenteur Pioneer Hi-Bred : Bolsa (grain 400), Elgina (grain 580), Lévina (grain 560), Olimpica (grain 520).
Obtenteur Co-operative of Pau and Pau seeds: Novelis (grain and early ensilage ½).
Obtenteur Dekalb : DK 513 (late grain).

Decision 98/293/CE of the 22/25/1998 : event of transformation T 25 conferring the tolerance on a Weedkiller, the Glufosinate ammonium. There is no variety corresponding registered to the official catalog in France. The sale of the seeds is thus not authorized in France.

Decision 98/292/CE of the 4/22/1998 : event of transformation LT 11 conferring resistance to the European corn borer, and the tolerance with a Weedkiller, the Glufosinate ammonium.

the authorization of the European commission relates only to the importation of harvests, the transformation and the animal feeds.
It thus does not have there variety corresponding registered to the official catalog in France, and the sale of the seeds is not authorized in France.

Decision 2004/657/CE of the 5/19/2004 : event of transformation LT 11 for soft Corn as a new food or new food ingredient.

This soft corn GMO, as well as food containing this soft corn, is labelled in accordance with the Règlement 1829/2003/CE with the mention “ soft corn genetically modified ”, and they must respect the requirements of traceability envisaged by the Règlement 1830/2003/CE.
This marketing authorization involved the end of the moratorium in fact which prevented the new authorizations of GMO in the European Union.
It does not have there variety corresponding registered to the official catalog in France, and the sale of the seeds is thus not authorized in France.

Decision 2004/643/CE of the 7/19/2004 : event of transformation NK 603 conferring the tolerance on a Weedkiller, the Glyphosate.

the authorization of the European commission stipulates under the conditions of marketing, that this product can be used for the same uses as any other Maïs, except for the culture and of the human consumption.
the mention “ This product contains genetically modified organizations ” or “ This product contains corn genetically modified ” appears on the label of the product.
As long as the product did not receive a marketing authorization at ends of culture, the mention “ not intended for the culture ” appears on the label of the product.
the product is thus authorized only with the importation in the European Union, and only for animal feeds.
Consequently, it does not have there variety corresponding registered to the official catalog in France, and the sale of the seeds is thus not authorized in France.

Decision 2005/608/CE of the 8/8/2005 : event of transformation MY 863 conferring resistance to the Chrysomèle of the corn.

the authorization of the European commission stipulates under the conditions of marketing, that this product can be used for the same uses as any other Maïs, except for the culture and of the human consumption.
the mention “ This product contains genetically modified organizations ” or “ This product contains corn genetically modified MY 863 ” appears on the label of the product.
As long as the product did not receive a marketing authorization at ends of culture, the mention “ not intended for the culture ” appears on the label of the product.
the product is thus authorized only with the importation in the European Union, and only for animal feeds.
Consequently, it does not have there variety corresponding registered to the official catalog in France, and the sale of the seeds is thus not authorized in France.
It MY 863 was the subject of a polemic because of an internal study of MONSANTO showing a significant growth of the number of white globules, and changes of structure of the kidneys and liver of the rats nourished with MY 863. The presence of a gene marker of Antibiotic resistance to the S.A. also raised of the objections. The competent authority of Germany concluded with the absence from scientific elements attesting a risk for the human health or the environment. The Commission consulted the European Autorité of safety of the food (AESA), which concluded that the corn MY 863 is as sure as the traditional varieties and than it is not likely to involve undesirable effects.
Several favorable opinions with the transgenic importation of corn MY 863, were given in 2004:

by the Commission of the biomolecular genius (CGB) in France,
by the French Agency of public health of food (AFSSA),
by the European Agency for the safety of food (EFSA),

on November 30th, 2004, the 25 Member States could not agree on the request for importation of corn GMO MY 863 formulated by Monsanto. Twelve States refused this request and eights voted for, five abstained from.

Corn transgenic authorized in culture or with the importation in the European Union

Currently, in short, the European Union authorizes following corn transgenic only with the importation, for introduction into the food dies for the animals or the men:

LT 11, imported for the
LT 11, imported in soft corn,
NK 603, imported for the animal feed,
MY 863, imported for the animal feed.

On the other hand, the following corn are also authorized in culture, or more precisely, the marketing of the seeds of the corresponding varieties is authorized:

LT 176,
MY 810,
T 25 (the sale of the seeds is not authorized in France, fault of varieties corresponding registered to the official Catalog of the seeds and varieties).

End of moratorium GMO in the European Union

There was not of new marketing authorization delivered by the European commission between October 1998 and May 2004. This moratorium was a moratory in fact and not a lawful decision. Contrary to what is sometimes written in the press, it is not a question of a prohibition of cultures GMO (the authorizations delivered into 1998 are always valid), but of a stop of the issue of new permits.

It was applied in the European Union, because of the position of several countries (Denmark, France, Greece, Italy, Luxembourg), which estimated that the procedures of evaluation, follow-up and Traçabilité of the GMO were to be reinforced before carrying out the issue of new permits of setting in culture and marketing.

The new European regulation, adopted in June 2003 and imposing of the standards of traceability and labelling for the products containing more than 0,9% of GMO, involved the end of this moratorium in May 2004, with the marketing authorization of soft corn LT 11 (see previously).

However, the authorizations of new corn GMO delivered into 2004 relate to marketings for the food dies, but not for seeds intended for the setting in culture.

Process of authorization

When a firm holder of a GMO, having finished its studies in confined surroundings, wishes to obtain an authorization of marketing in the European Union, it must pass by:

Procedure of voluntary authorization of dissemination

To make experiments in the open air:

deposit of a request for voluntary authorization of Dissemination of GMO,
evaluation of the risks by the competent authority of the Member State. In France, it is about the Commission of the biomolecular genius (CGB), whose opinion is examined by the ministries in charge with agriculture and the environment.
delivery of the voluntary authorization of Dissémination of GMO (in France, by the minister in charge for agriculture, which in fact of the " tests with the champs" legal.

Procedure of marketing authorization

Deposit of a request for authorization of marketing, with presentation of the studies led in confined surroundings and at the time of the voluntary disseminations of GMO.
Evaluation of the risks by the competent authorities of the Member State. In France, it is about the Commission of the biomolecular genius (C.G.B.), of the French of public health and food Agence (A.F.S.S.A.), and of the Commission of study of the toxicity of the plant health products (case of the plants Transgénique S tolerating with a Herbicide).
Sending of the evaluation dossier to the European commission (EFSA), which diffuses it with the other Member States.
If one or more Member States present objections, the opinion of the scientific committees of the European Union is required. The Council of Ministers then returns a decision of marketing authorization de or refusal.
If there is no objection, the marketing authorization is granted.

Community legislation of the marketing

The procedure of voluntary authorization of dissemination and marketing of the genetically modified organizations is fixed by the Directive 2001/18/CE, is published on October 17th, 2002, to replace the directive 90/220/CE. This new regulation:

introduces more rigorous principles into the evaluation of the risks for the environment,
clarifies and extends the criteria of evaluation of the risks,
limit the duration of the renewable authorization at 10 years,
introduces a posterior obligatory monitoring with the marketing authorization,
improves the transparency by an obligation to consult the public,
obliges the European commission to publish every three years a report on the experiment relating to the marketings.

Associations estimate however that the procedures envisaged by the Directive 2001/18/CE are still insufficient to evaluate and limit the risks related to the marketing of the GMO.

In France, the transposition in the national right of the Directive 2001/18/CE was not made yet, which raises problems compared to the development of the commercial cultures of GMO.

Labelling

Pursuant to the right of the consumers to information, the European Union made compulsory since 1997, labelling indicating the presence of GMO.

Measurements relating to labelling are the following ones:

Obligation for the Member States to take all the necessary measures to guarantee labelling, at all the stages of the marketing, the GMO marketed as products or elements of products, required by the Directive 2001/18/CE since October 17th, 2002, modified by the Payment 1829/2003/CE.

Obligation of labelling of the seeds of genetically modified varieties, fixed by the directive 98/95/CE and the Payment 1829/2003/CE.

Obligation of labelling of food and the food ingredients containing of the GMO or which made up, are required by it by the payment on the new food n° 258/97/CE of January 27th, 1997, modified by the Règlement 1829/2003/CE.

Obligation of labelling of the additives and the flavors when DNA or proteins resulting from a genetic modification present in the finished product, is fixed by the Règlement 1829/2003/CE, which repeals the payment n° 50/2000/CE.

Obligation of labelling of food genetically modified for the animals, installation with the Payment 1830/2003/CE come into effect on April 18th, 2004.

minimum Threshold of 0,9% of accidental presence of DNA or proteins resulting from a genetic modification, in lower part of which labelling is not necessary, fixed by the Règlement 1830/2003/CE. Preceding Community legislation established this threshold with 1%, by the payment n° 49/2000/CE.

Use of the concept of equivalence for the labelling of the food produced starting from GMO, but which does not contain any more, fixed by the payment on new food. The principle of equivalence means that if characteristic or property (composition, food value or nutritional effects, projected use) made that a food or a food ingredient is not equivalent any more to an existing counterpart, labelling must announce the genetic modification at the origin of this characteristic.

Measurements relating to the labelling of food and the food ingredients derived from a varity of Corn Transgénique and from a variety of Soya Transgénique, authorized pursuant to the directive 90/220/CEE but before the coming into effect of the payment on the new food . These measurements were fixed by the payment n° 1139/98/CE, repealed by the Règlement 1829/2003/CE, according to the presence of DNA or proteins resulting from the genetic modification. This criterion is used as model with the rules applicable to the labelling of all other food and food ingredients.

Tolerance levels

The European commission prepares a draft Directive fixing the tolerance levels of “fortuitous presence” (accidental or technically inevitable) of GMO in the conventional seed S, beyond whose these seeds would be regarded as GMO and are labelled like such.

The tolerance levels suggested at the end of December 2003 by the European commission, on the basis of opinion of the European Scientific committee of the plants, are the following:

0,3% for the seeds of Colza.
0,5% for the seeds of Corn, the Cotton, the Beet, the Potato, the Chicorey, and the Tomato.
0,7% for the seeds of Soya.

The Police chief European of the environment wishes that these tolerance levels of fortuitous presence of GMO be as low as possible. Various organizations opposed to the GMO also ask for a fall of these thresholds, and the Peasant confederation estimates that a threshold of 0% is the only acceptable one. On the other hand, the professionals of the seeds estimate that a reduction of these thresholds would undermine the economic viability of the coexistence between dies GMO and not-GMO.

As example of the legal consequences of the level of the tolerance levels GMO in the conventional seeds, of the persons in charge of a subsidiary company of Monsanto were continued for “marketing without authorization of GMO”, because of detection by the Fraud Squads of less than 0,2% of GMO in seeds of Soja imported in France.

Authorized genetically modified animals

August 1st

Authorized genetically modified micro-organisms

August 1st

See too

Regulation of the GMO

Environment

Crop protection