Difference between revisions of "Team:Aix-Marseille/Legislation"
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==Research and legislation== | ==Research and legislation== | ||
| − | Research ensures innovation, access to new markets and competitivity in the global marketplace | + | Research ensures innovation, access to new markets and competitivity in the global marketplace. |
| + | To enable scientists to carry out their work with minimal constraints, the French legislation establishes very few barriers. | ||
| + | Research on genetically modified organisms (GMOs) is regulated by articles L241-1 to L241-3 of the Research Code. | ||
| + | All the experimentation conducted during our wet lab was authorized under this legislation. | ||
==Marketing authorization== | ==Marketing authorization== | ||
| − | [[File:T--Aix-Marseille--Jury.png|500px|right|thumb|Regulatory framework for '''KILL XYL''' | + | [[File:T--Aix-Marseille--Jury.png|500px|right|thumb|Regulatory framework for the release of '''KILL XYL''' into the market (Diagram from EFSA).]] |
| − | One of our product | + | One of the components of our product, the phage-like particle, is a GMO according to the EC Directive of 12 March 2001. |
| + | This qualification as a GMO has many consequences for the market release of '''KILL XYL'''. | ||
| − | A plant protection product | + | A plant protection product needs to be authorised in accordance with the EC rule of 21 October 2009. |
| + | For products containing a GMO, an authorization under this rule can only be granted if the GMO is authorize under Article 19 of Directive 2001/18/EC. | ||
| + | The authorization procedure for the GMO can be found on the European Food Safety Authority website ([http://www.efsa.europa.eu/fr/ EFSA]). | ||
| − | + | The first step in obtaining authorization is to send a notification to the competent national authority (for France: the Minister of Research). | |
| − | According to the | + | According to the Directive 2001/18/EC, the notification must contain a great deal of information, including: |
* the phenotypic and genetic characteristics of the GMO. | * the phenotypic and genetic characteristics of the GMO. | ||
* the verification of the genetic stability of the GMO and factors affecting this stability. | * the verification of the genetic stability of the GMO and factors affecting this stability. | ||
* organisms with which genetic transfer is known to occur naturally. | * organisms with which genetic transfer is known to occur naturally. | ||
| + | * an environmental impact study. | ||
Some of these questions have been answered with our [[Team:Aix-Marseille/M13_test|environmental test]]. | Some of these questions have been answered with our [[Team:Aix-Marseille/M13_test|environmental test]]. | ||
| − | + | The ([http://www.efsa.europa.eu/fr/ EFSA]) then draws up an evaluation report which indicates whether or not the GMOs can be placed on the market and under which conditions. | |
| + | Once the GMO authorization has been obtained, the applicant can then submit his application for authorization of the plant protection product to the "Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail" ([https://www.anses.fr/en ANSES]) containing information on all the components of the product. | ||
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Revision as of 09:00, 1 November 2017
Legislation
Research and legislation
Research ensures innovation, access to new markets and competitivity in the global marketplace. To enable scientists to carry out their work with minimal constraints, the French legislation establishes very few barriers. Research on genetically modified organisms (GMOs) is regulated by articles L241-1 to L241-3 of the Research Code. All the experimentation conducted during our wet lab was authorized under this legislation.
Marketing authorization
One of the components of our product, the phage-like particle, is a GMO according to the EC Directive of 12 March 2001. This qualification as a GMO has many consequences for the market release of KILL XYL.
A plant protection product needs to be authorised in accordance with the EC rule of 21 October 2009. For products containing a GMO, an authorization under this rule can only be granted if the GMO is authorize under Article 19 of Directive 2001/18/EC. The authorization procedure for the GMO can be found on the European Food Safety Authority website ([http://www.efsa.europa.eu/fr/ EFSA]).
The first step in obtaining authorization is to send a notification to the competent national authority (for France: the Minister of Research).
According to the Directive 2001/18/EC, the notification must contain a great deal of information, including:
- 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.
- an environmental impact study.
Some of these questions have been answered with our environmental test.
The ([http://www.efsa.europa.eu/fr/ EFSA]) then draws up an evaluation report which indicates whether or not the GMOs can be placed on the market and under which conditions. Once the GMO authorization has been obtained, the applicant can then submit his application for authorization of the plant protection product to the "Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail" (ANSES) containing information on all the components of the product.
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