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The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

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15.  The cases and circumstances prescribed for the purposes of sections 108(7) and 111(7) of the Act in which persons are exempt from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent), respectively, insofar as they relate to marketing genetically modified organisms, are all cases and circumstances in which–

(a)an approved product is marketed for a use for which it has approval [F1and in accordance with the limitations and conditions to which the use of that product is subject];

(b)genetically modified micro-organisms are made available for activities regulated under the Contained Use Directive (including culture collections);

(c)genetically modified organisms other than micro-organisms referred to in paragraph (b) are made available to be used exclusively for activities where appropriate stringent containment measures based on the same principles of containment as laid down in the Contained Use Directive are used to limit their contact with and to provide a high level of safety for the general population and the environment;

(d)genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II;

(e)a genetically modified organism authorised under Regulation 2309/93 [F2or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency] is marketed;

[F3(f)a novel food or novel food ingredient within the meaning of Council Regulation (EC) No. 258/97, as amended by the Food and Feed Regulation and Council Regulation 1882/2003, is marketed; and]

[F4(g)genetically modified food or feed authorised under the Food and Feed Regulation is marketed.]

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