Article 2
For the purposes of this Directive the following definitions shall apply:
- (a)
‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture;
- (b)
‘genetically modified micro-organism’ (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition:
- (i)
genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
- (ii)
the techniques listed in Annex I, Part B, are not considered to result in genetic modification;
- (i)
- (c)
‘contained use’ means any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment;
- (d)
‘accident’ means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
- (e)
‘user’ means any natural or legal person responsible for the contained use of GMMs;
- (f)
‘notification’ means the presentation of the requisite information to the competent authorities of a Member State.