S.L. 549.60 Art. 2Interpretation.

In these regulations, unless the context otherwise requires:

"the Commission" means the European Commission;

"the competent authority" means the Environment and Resources Authority as prescribed by the Nomination of the Competent

Authority Order, and such other body or person as the Minister responsible for the environment may by order in the Gazette prescribe and different bodies or persons may be designated as the competent authority for different provisions and different purposes of these regulations: Provided that the competent authorities for issues relating to genetically modified organisms for food and feed and their placing on the market shall be the same as the entities responsible for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed in Malta, as provided in the Enforcement of Various European Union Regulations on Food Safety Regulations. "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; "the Directive" means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC; "environment 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 Schedule II; "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 or natural recombination, and within the terms of this definition:

(a) genetic modification occurs at least through the use of the techniques listed in Schedule I A, part 1;

(b) the techniques listed in Schedule I A, part 2, are not considered to result in genetic modification; "Member State" means Member State of the European Community; "notification" means the submission, in writing and digital format, of the information required under these regulations to the competent authority; "notifier" means any legal or physical person submitting a notification or, where the context so requires, any legal or physical person responsible for a deliberate release or for a placing on the market, or for meeting any other requirement of these regulations in relation to a deliberate release or a placing on the market; "organism" means any biological entity capable of replication or of transferring genetic material; "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:

(a) making available genetically modified micro-organisms for activities regulated under the Contained

Use of Genetically Modified Micro-organisms Regulations, including culture collections;

(b) making available GMOs other than micro-organisms referred to in paragraph (a), to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with, and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in the Contained Use of Genetically Modified Micro-organisms Regulations;

(c) making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in Part B of these regulations; "product" means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market.