Biosafety

Biosafety means all measures, policies and procedures necessary to minimize the potential risks to the environment and to human health resulting from modern biotechnology

The Convention on Biological Diversity (CBD) recognizes that modern biotechnology is a relevant tool, also for the conservation and sustainable use of biological diversity (Article 16.1 and Article 19.1-2); on the other hand, the CBD seeks to ensure the development of appropriate procedures to improve its safety in order to reduce all potential threats to biological diversity, also taking into account risks to human health.

The international principles on biosafety are deal with in the Cartagena Protocol, one of the CBD protocols, which, referring to the precautionary principle, has the objective to protect the environment and human health from potential risks arising from transfer, manipulation and use of Living Modified Organisms obtained from modern biotechnologies.

The European Union (EU) and its Member States have adopted regulatory instruments to ensure the required levels of safety for the environment and human health as provided for in the Protocol.

In the EU Genetically Modified Organisms (GMOs) may only be authorized for the deliberate release into the environment for experimental purposes and for marketing after a rigorous risk assessment procedure to avoid any possible negative effects on the environment and human health. The principles and the methodology for risk assessment are dealt with by directive 2001/18/EC on the deliberate release into the environment of GMOs.

Based on the results of the risk assessment appropriate risk management measures are taken in each phase of manipulation and use of the GMOs, and post-marketing monitoring activities are carried out to observe the occurrence of any unexpected effects.