Team:Aix-Marseille/Legislation

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Legislation

Research and legislation

Research ensures innovation, access to new markets and competitivity in the global marketplace for countries like France. To enable scientists to carry out their research without too many constraints, the French legislator has established very few barriers. Research on genetically modified organisms (GMOs) is promoted by the L241-1 to L241-3 articles of the Research Code. Thus, all experimentation conducted during wet lab session was authorized.

Marketing authorization

Regulatory framework for KILL XYL release in the market (Diagram from EFSA).

One of our product substance, the phage-like particle, is a GMO in accordance with the EC Directive of 12 March 2001. This qualification of GMO has many consequences on the potential market release of KILL XYL.

A plant protection product containing a GMO should be examined concerning the amendment in accordance with the EC Regulation of 21 October 2009. An authorization under this regulation might be granted only if the authorization referred to Article 19 of Directive 2001/18/EC. The authorization procedure for a GMO can be found on the European Food Safety Authority website ([http://www.efsa.europa.eu/fr/ EFSA]).

Before the placing on the market and the authorization procedure for a plant protection product, a notification must be sent to the competent authority of a Member State (for France: the Minister of Research).

According to the article 13 of Directive 2001/18/EC, the notification must contain a great deal of information, like:

• the phenotypic and genetic characteristics of the GMO.
• the verification of the genetic stability of the GMO and factors affecting this stability.
• organisms with which genetic transfer is known to occur naturally.

Some of these questions have been answered with our environmental test.

Subsequently, the ([http://www.efsa.europa.eu/fr/ EFSA]) draws up an evaluation report which indicates whether or not the GMOs can be placed on the market and under which conditions. Once the authorization has been obtained, the applicant can then submit his application for authorization to the "Agence Nationale de SÉcurité Sanitaire de l’alimentation, de l’environnement et du travail" (ANSES) concerning the active substance of the plant protection product.

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