Difference between revisions of "Team:Aix-Marseille/Legislation"
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[[File:T--Aix-Marseille--Jury.png|500px|right|thumb|Regulatory framework for KILL XYL release in the market.]] | [[File:T--Aix-Marseille--Jury.png|500px|right|thumb|Regulatory framework for KILL XYL release in the market.]] | ||
| − | One of the main substance of our product, the phage-like particle, is a GMO in accordance with the EC Directive of 12 March 2001 and with the article 48 of the EC Regulation of 21 October 2009. This qualification of | + | One of the main substance of our product, the phage-like particle, is a GMO in accordance with the EC Directive of 12 March 2001 and with the article 48 of the EC Regulation of 21 October 2009. This qualification of GMO has many consequences on the potential market release of our product. |
In addition to the assessment provided for by the EC Regulation of 21 October 2009, a plant protection product containing an GMO should be examined concerning the amendment accordance with that directive. | In addition to the assessment provided for by the EC Regulation of 21 October 2009, a plant protection product containing an GMO should be examined concerning the amendment accordance with that directive. | ||
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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). | 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 article 13 of Directive 2001/18/EC, the notification must contain a great deal of information. Subsequently, EFSA draws up an evaluation report which indicates whether or not the GMOs can be placed on the market and under which conditions. | + | According to article 13 of Directive 2001/18/EC, the notification must contain a great deal of information. Subsequently, the 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" ([https://www.anses.fr/en ANSES]) concerning the active substance of his plant protection product. | 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" ([https://www.anses.fr/en ANSES]) concerning the active substance of his plant protection product. | ||
Revision as of 13:44, 29 September 2017
Legislation
Research and legislation
Research ensures innovation, access to new markets and a competitive edge 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.
Release on the market
One of the main substance of our product, the phage-like particle, is a GMO in accordance with the EC Directive of 12 March 2001 and with the article 48 of the EC Regulation of 21 October 2009. This qualification of GMO has many consequences on the potential market release of our product.
In addition to the assessment provided for by the EC Regulation of 21 October 2009, a plant protection product containing an GMO should be examined concerning the amendment accordance with that directive.
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 "Autorité Européenne de Sécurité Alimentaire" ([http://www.efsa.europa.eu/fr/ EFSA]) website.
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 article 13 of Directive 2001/18/EC, the notification must contain a great deal of information. Subsequently, the 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 his plant protection product.
