16. 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;
(b)genetically modified micro-organisms are made available for activities regulated under the Contained Use Directive;
(c)genetically modified organisms other than micro-organisms falling within 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 Council Regulation (EEC) No. 2309/93(1), as amended by Commission Regulation EC No. 649/98(2), is marketed; or
(f)a novel food or novel food ingredient within the scope of Regulation EC No. 258/97 of the European Parliament and of the Council(3) is marketed in accordance with that Regulation.
OJ No. L214, 24.8.1993, p.1.
OJ No. L88, 24.3.1998, p.7.
OJ No. L43, 14.2.1997, p.1.