PART A GENERAL PROVISIONS

(1)

‘organism’means any biological entity capable of replication or of transferring genetic material;

(2)

‘genetically modified organism (GMO)’

means an organism, with the exception of human beings, 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:

(3)

‘deliberate release’means any intentional introduction into the environment of a GMO or a combination of GMOs for which no 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;

(4)

‘placing on the market’

means making available to third parties, whether in return for payment or free of charge;

The following operations shall not be regarded as placing on the market:

(5)

‘notification’means the submission of the information required under this Directive to the competent authority of a Member State;

(6)

‘notifier’means the person submitting the notification;

(7)

‘product’means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market;

(8)

‘environmental risk assessment’means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II.