MEXICAN REGULATION LAWS
In our country; Mexico, the Biosecurity Law for Genetically Modified Organisms (GMO) is in charge of the regulation of the activities related with the use, commerce and research of the GMO.
According to this law, our product is catalogued as a derived from a GMO; any product in which production process was involved a GMO input or extract but the final product; which will be commercialized, does not contain it.
Since the process is made by a GMO, it is necessary to make a risk evaluation and to analyze the alternative options that could be performed in order to avoid the use of GMO. The enterprise must consider having the capacity and the regulations to avoid the accidental liberation to the environment of the GMO from the remains of any process in which it had been involved. There are not special requirements since we are not commercializing a GMO.
The GMO use; during the process, it is just for contained use; activities that involved the modification of genetic material and the use of physical, biological or both barriers in order to avoid the contact between the environment and the population. Nevertheless, the following control activities must be done:
- To register the activities in which the OGMs will be involve during the process.
- To implement activities for risk management, final disposure and removal of OGM remains
- To stablish an action plan in case of the accidental liberation of GMO to environment.
The “Ley General de Salud” is involved in the sanitary control of the product and the process also; according to this law, since our product will be developed for pharmaceutical use it is considered to be an input for health.
The “Reglamento para insumos de la salud” regulates the activities, sanitary control, services and establishments related with the inputs for health.
The FDA stablishes that shrimp-derived chitosan is Generally Recognized as Safe (GRAS) which means that the chitosan does not make reactions on the human body.
Biophrame is looking for the international delivery of chitosan. The Cartagena Protocol stablishes the main aspects for the transportation of GMO’s and it does not apply to products derived from genetically modified organisms.
“Ley de Bioseguridad de organismos genéticamente modificados” Cámara de Diputados del H. Congreso de la Unión. 2005.
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