The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996

Exemptions from requirement to carry out risk assessments

3.—(1) A person who imports or acquires genetically modified organisms shall be exempt from the requirements of section 108(1)(a) of the Act in so far as they relate to the protection of human health.

(2) A person who imports or acquires genetically modified organisms shall be exempt from the requirements of section 108(1)(a) of the Act where the organisms to be imported or acquired—

(a) are, within the meaning of regulation 2(1) of the Contained Use Regulations, genetically modified micro-organisms;

(b) are organisms, within the meaning of regulation 2(1) of the Contained Use Regulations, other than micro-organisms within the meaning of regulation 2(1) as aforesaid, which are modified by means of—

(i) the application of the techniques which, by virtue of Part II of Schedule 1 to the Contained Use Regulations, are not considered to result in genetic modification for the purposes of the definition of that expression in regulation 2(1) of those Regulations; or

(ii) the application of the techniques to which, by virtue of regulation 3(3) of and Part III of Schedule 1 to the Contained Use Regulations, those Regulations do not apply;

(c) are or are contained in a medicinal product for human or veterinary use which is the subject of a market authorisation under Council Regulation (EEC) No. 2309/93(1);

(d) consist of, or are included in, an approved product as defined in the Genetically Modified Organisms (Deliberate Release) Regulations 1992(2) which is imported or acquired in accordance with the conditions and limitations to which the use of the product is subject.

(1)

OJ No. L214 24.8.93, p. 1.

(2)

S.I. 1992/3280 as amended by S.I. 1993/152 and S.I. 1995/304.